Operator Manual IGS 620 630

InnovaTM IGS 620,
InnovaTM IGS 630

Operator Manual
WARNING: BEFORE USING THIS SYSTEM

THIS SYSTEM SHOULD BE USED ONLY BY EMPLOYEES ADEQUATELY TRAINED IN THE USE OF THIS EQUIPMENT. BEFORE USING
THIS SYSTEM, THE OPERATOR SHOULD BE THOROUGHLY ACQUAINTED WITH THE INSTRUCTIONS FOR USE AND SAFETY
RECOMMENDATIONS PROVIDED IN THIS MANUAL.
FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE AND SAFETY RECOMMENDATIONS PROVIDED IN THIS MANUAL CAN CAUSE
SERIOUS INJURY TO THE PATIENT, TO THE OPERATOR OR TO OTHER PERSONS.
5719150-1-1EN
Revision 2
InnovaTM IGS 620,
InnovaTM IGS 630
Direction 5719150-1-1EN , Revision 2

!

2
InnovaTM IGS 620,
InnovaTM IGS 630
Table of contents
Chapter 1 - Foreword 27
1 Using This Module 27

2 Printing this Module 27
3 Electronic Operator Manual 28
4 Quebec 29
Chapter 2 - Introduction 30
Chapter 3 - Safety and Regulatory 31
1 Regulatory Requirements 31
1-1 Electromagnetic Compatibility (EMC) 31
1-1-1 Electromagnetic Compatibility of the vascular system 31
1-1-2 Detailed Electromagnetic Compatibility of the vascular system 31
1-1-3 Electromagnetic Compatibility of the vascular system with Fluoro UPS (Innova option) 32
1-1-4 Detailed Electromagnetic Standard Compliance conditions 32
1-1-4-1 Essential performance list 32
1-1-4-2 Electromagnetic Emission 33
1-1-4-3 Electromagnetic Immunity 33
1-1-4-4 Recommended Separation Distances for Portable and Mobile RF Communications 36
Equipment
1-1-4-5 Limitations Management 36
1-1-4-6 Use Limitation 37
1-1-4-7 Installations Requirements and Environment Control 37
1-2 Additional Regulatory Requirements 38
1-3 Product Storage and Handling limits 40
1-4 Specific Requirements for product with a third party monitor suspension 41
1-5 Recycling 42
1-6 Control of Pollution caused by Electrical and Electronic Product (EEPs) 42
1-6-1 Explanation of Pollution Control Label 43
1-6-2 Name and Concentration of Hazardous Substances 43
1-7 Vermont labeling regulations (US) on Mercury 44
1-8 Canada labeling regulations on Mercury 44
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1-9 Patient Confidentiality 44

2 General Safety 45
2-1 Equipment Application Specification 45
2-1-1 Patient Population 45
2-1-2 Intended Operator 45
2-1-3 Application 47
2-2 Be Sure the Equipment is Functioning Before each Use 47
2-3 Always Be Alert to Patient Safety Concerns 49
2-4 Operator Position 49
2-5 Radiation Safety 49
2-6 Establish Emergency Procedures 49
2-7 Equipment Installed in Patient Vicinity 49
2-8 Accessories 50
2-9 Periodic maintenance and inspection 51
2-10 Storage media 52
2-11 Extra Iodine Injection 52
2-12 Image Presentation 52
3 Protection against radiation 52
3-1 Biological Deterministic Effects of Dose 52
3-2 Dose Monitoring 53
3-3 Concept of Interventional Reference Point (Patient Entrance Reference Point) 53
3-4 Significant Zone of Occupancy 54
3-5 Skin Spacer Use 54
3-6 How to Reduce Radiation Exposure Dose 54
3-6-1 Radiation Time 54
3-6-2 Protection 55
3-6-3 Other Methods to decrease Exposure Dose 55
3-7 Avoid Unnecessary Exposure to Radiation 56
3-8 Protective devices and Accessories 56
3-9 Retake - Improper Use 56
3-10 Dose and Dose Rate Measuring Procedure 56
3-10-1 Test Equipment 56
3-10-1-1 Phantom 56
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3-10-1-2 Dosimeter 56
3-10-2 Measurement Procedure 56
3-10-2-1 Relevant parameters 56
3-10-2-2 Positioning of phantom and measuring chamber 57
3-10-2-3 Checking the test conditions 57
3-10-2-4 Basic measurements 57
3-10-2-5 Operator selectable parameters 57
3-10-3 Compliance Criteria 57
4 Protection against electrical hazards 58
4-1 Covers 58
4-2 Cabinet Air Flow 58
4-3 Uninterruptible Power Supply UPS 58
4-4 Laser 58
5 Protection against mechanical hazards 58
5-1 Patient Positioning on Tabletop 59
5-2 Use Extreme Care when Positioning the Equipment 59
5-3 Movement of Patient on the Table 60
5-4 Tableside Cart (Option) 60
5-5 System Collision 61
5-6 Split or Punctured Table 61
5-7 Driving the Table 61
5-8 Cardiac Pulmonary Resuscitation (CPR) 61
5-8-1 CPR with Omega Table 62
5-9 Patient Loading/Unloading 62
5-9-1 Biplane System User Interface 63
5-10 Clearance of the Patient in case of Emergency (Power Loss, Equipment Failures) 63
5-11 Check Equipment after collision 63
5-12 Table Brakes failure 63
5-13 3rd Party Imaging/Data Medical Device 63
6 Protection against contamination / infection / allergy / toxicity hazards / 63
biological hazards
6-1 General Information 64
6-2 Equipment Cleaning Instructions 64
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6-3 Suspensions Cleaning 65

6-4 Disinfection 65
6-5 High Level Disinfection 65
6-6 Recommended Cleaning Agents 65
6-7 Recommended Disinfecting Agents 65
6-8 Guidance for the Use of the Cleaning and Disinfecting Agents Listed 66
6-9 Flammable Gasses 66
6-10 Latex 66
7 Protection against effect of incorrect output data sent to network (Dicom) 66
7-1 Stenosis Analysis on networked devices 66
Chapter 4 - Safety and Regulatory Instructions for Use 67
1 Indications for Use 67

2 Contraindications 67
3 Safety 67
3-1 Environmental Conditions 67
3-2 Equipment Classifications 67
4 Electrical Hazards 69
4-1 Power-off the System 69
4-2 Emergency STOP Procedure 70
4-3 Emergency STOP Recovery 70
5 Protection regarding Ionizing Radiations Hazards for Innova IGS 620 71
5-1 Mode of Operation 71
5-1-1 Innova Digital 72
5-1-2 Reference Image Monitor 72
5-1-3 Live Image Monitor 73
5-1-4 Table Side Status Control (TSSC) 75
5-1-5 Innova Central touch screen 76
5-2 Dose to Patient for Single Plane 77
5-2-1 Skin Dose Levels 78
5-2-2 Available Settings 78
5-2-3 Radiation Data 79
5-2-4 IQ Standard 79
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5-2-5 Receptor Dose Limited Standard 85

5-2-6 IQ Plus 90
5-2-7 Receptor Dose Limited Plus 95
5-3 Dose to Patient for Biplane 99
5-3-6 IQ Plus 111
5-4 Dose to Patient in Japan 119
5-4-1 Fluoroscopy/Roadmap/Subtracted Fluoroscopy Skin Dose Levels 119
5-5 Dose to Patient in Australia/WA and Australia/ACT 119
5-6 Dose to Patient in Canada/Ontario 119
5-7 Dose to Operator (Isodoses) 120
5-7-1 Frontal Gantry in Vertical position - Dose at 1 meter from ground 120
5-7-2 Frontal Gantry in Vertical position - Dose at 1.5 meter from ground 120
5-7-3 Frontal Gantry in Lateral position - Dose at 1 meter from ground 121
5-7-4 Frontal Gantry in Lateral position - Dose at 1.5 meter from ground 122
5-7-5 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1 meter from ground 123
5-7-6 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1.5 meter from ground 124
5-8 Technical Factors Range 125
5-9 Contribution of Filtration with 21 cm Detector 125
5-9-1 Contribution of Filtration along the Beam 125
5-9-2 Total filtration 126
5-10 Disable X-ray whenever X-ray are not necessary 126
5-11 Dosimetric Calibration 126
5-12 Application Mode and Service Mode are not exclusive 126
5-13 Leakage Radiation 127
5-14 Spectral Filtration 127
6 Protection regarding Ionizing Radiations Hazards for Innova IGS 630 127
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6-1 Mode of Operation 128

6-1-1 Innova Digital 128
6-1-2 Reference Image Monitor 129
6-1-3 Live Image Monitor 130
6-1-4 Table Side Status Control (TSSC) 131
6-1-5 Innova Central touch screen 132
6-2 Dose to Patient for Single Plane 133
6-2-6 IQ Plus 148
6-3 Dose to Patient for Biplane 157
6-3-6 IQ Plus 169
6-4 Dose to Patient in Japan 178
6-5 Dose to Patient in Australia/WA and Australia/ACT 178
6-6 Dose to Patient in Canada/Ontario 179
6-7 Dose to Operator (Isodoses) 179
6-7-1 Frontal Gantry in Vertical position - Dose at 1 meter from ground 179
6-7-2 Frontal Gantry in Vertical position - Dose at 1.5 meter from ground 179
6-7-3 Frontal Gantry in Lateral position - Dose at 1 meter from ground 180
6-7-4 Frontal Gantry in Lateral position - Dose at 1.5 meter from ground 181
6-7-5 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1 meter from ground 182
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6-7-6 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1.5 meter from ground 183
6-8 Technical Factors Range 184
6-9 Contribution of Filtration with 31 cm Detector 184
6-9-1 Contribution of Filtration along the Beam 184
6-9-2 Total filtration 185
6-10 Disable X-ray whenever X-ray are not necessary 185
6-11 Dosimetric Calibration 185
6-12 Application Mode and Service Mode are not exclusive 185
6-13 Leakage Radiation 186
7 Protection regarding Functional Hazards 186
7-1 3rd Party Software 186
7-2 Loss of Imaging 186
7-3 Loss of Power 186
7-4 System Recovery after a power Cut 187
7-5 Emergency Procedure for Image Recovery or System Lock Up with 19" monitors 187
7-6 Emergency Procedure for Image Recovery or System Lock Up with Large Display 188
Option
7-7 Latency and Polymerization Time 190
7-8 Control of transfer of data to an archiving system 191
7-9 SID Failure - Degraded mode 191
7-10 Prevent Unnecessary Interruption of a Procedure Arising from a Collision 192
7-11 Automatic Exposure Control 192
7-12 Lead Shield Positioning 192
7-13 Degraded Mode 192
7-14 Risk of confusion between live Fluoro images and automatic replay of stored Fluoro 194
images
7-15 Monitor Suspension Positioning 195
8 Protection regarding Mechanical Hazards 195
8-1 Table Motion User Interfaces 195
8-2 Precaution regarding Detector Anti-Collision Device 197
9 Protection against Contamination / Infection Hazards / Biological Hazards 197
9-1 Attachment of Protective (Sterile) Drapes 197
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9-1-1 Equipment (image receptor, X-ray tube-collimator assembly, Smart Handle, Smart Box, 197
Table Side Status Control, Innova Central touch screen)
9-1-2 Accessories 199
10 Symbols 200
10-1 Audio/Visual Indications 201
10-2 Special Notices 203
10-3 X-ray Tube 204
10-4 Power ON and OFF 205
10-5 Type B applied part 206
10-6 Electrical Class 206
10-7 Electrical Current 206
10-8 Ground 206
10-9 Collimator 207
10-10 Cardiac Pulmonary Resuscitation (CPR) 207
10-11 Maximum Patient Weight 208
10-12 Table Head Extender 208
10-13 Table end rail maximum load 209
10-14 Footswitch 209
10-15 Smart Handle/Smart Box/Table Side Status Control 209
10-16 Innova Console 209
10-17 Application 210
10-18 Grid Out 211
10-19 Acquisition 212
10-20 Status Icons 212
10-21 Remote Stand (Option) 213
10-23 Patient Browser Network Status Icons 214
10-24 Electronic Operator Manual 215
10-25 X-ray LED 215
10-26 Filtration 216
10-27 Bolus Handle 216
10-28 Product identification 216
10-29 Emergency Back-Out 216
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Chapter 5 - Radiation Safety 218
1 How X-ray Radiation is created and the "Dose" concept 218

2 Doses parameters 218
2-1 Incident dose 218
2-2 Surface dose 219
2-3 Exit dose 219
2-4 Image receptor dose 220
2-5 Dose rate at image receptor 220
2-6 Dose-area product 220
2-7 Body dose and effective dose 221
2-8 Maximum Symmetrical Radiation Field 222
3 Effect of Ionizing Radiation on Humans 222
3-1 Concept of Intervention Reference Point 222
4 General Dose Reduction Measures for The Patient 223
4-1 Distance between the X-ray tube and the patient 223
4-1-1 Inverse square law 223
4-2 Distance between the patient and the detector 223
4-3 Collimation 223
4-4 Compression 224
4-5 Anti scatter grid 224
4-6 Record and Fluoro mode selections 225
4-7 Frame rates 225
4-8 Field of View 225
4-9 Radiation filtration / hardening 225
5 General Dose Reduction Measures for the Staff 225
5-1 Protection from X-ray Radiation 225
5-1-1 Distance 225
5-1-2 Shielding 226
5-2 General Precautions 226
6 Dose Reduction Measures on the Innova System 227
7 Smart Fluoro 227
7-1 Benefits of LIH 227
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7-3 Tabletop 227
8 Special Case 227
8-1 Pediatrics 228
9 Legal Provisions 228
10 Dose Reduction: 7 easy steps to remember 228
Chapter 6 - Revolution Digital Detector 230
1 Imaging Chain 230

2 Digital Image Quality 231
3 Detective Quantum Efficiency 232
4 The Impact of Noise 232
5 The Role of Contrast 232
6 The Role of Spatial Resolution 233
6-1 Definition and settings 233
6-2 Detector spatial resolution vs. Modulation Transfer Function (MTF) 233
6-3 Detector spatial resolution performances 234
6-4 System spatial resolution performances 234
7 Radiation Dose 235
Chapter 7 - Innova System 236
1 General Description 236

2 System Components 236
2-1 Basic Components 236
2-2 Option 237
2-3 Option Connection 238
3 Innova Console 239
4 General Specifications 240
4-1 Generator 240
4-2 Gantry 240
4-2-1 LC Positioner (Frontal) 241
4-2-2 LP Positioner (Lateral) 241
4-3 Omega Table 242
4-4 Innova Digital 242
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4-5 Innova Imaging 242

4-5-1 Innova IGS 620 242
4-5-2 Innova IGS 630 243
5 How to Perform System Power-Up 243
6 How to Perform System Power-Down 247
7 Vascular Control Interface Module 247
Chapter 8 - Innova Digital 249
1 Guidelines for the best usage of the system 249

2 Innova Digital Screen 249
2-1 Monitoring Bar 250
2-1-1 ECG Status 250
2-1-2 Disk Space Status 250
2-1-3 Heat Units Status 251
2-1-4 X-ray Timer 252
2-1-5 Fluoro / Record Ready 253
2-1-6 X-ray Disable Button 253
2-2 Utilities Key 254
2-3 Exam / Utilities Charring 254
3 How to prepare for a New Patient Acquisition 255
4 How to modify Patient Information 258
5 How to select an Acquisition Protocol 259
5-1 List of Categories 260
5-2 List of Protocols 261
6 Fluoroscopy and Acquisition 263
6-1 Fluoro UPS (Option) 264
7 No Sub Fluoroscopy Acquisition 266
7-1 Field of View (FOV) 267
7-2 Fluoro Detail 268
7-3 Fluoro Frame Rate 270
7-4 Fluorostore 272
7-5 X-ray Timer 273
7-6 Cumulated Time 274
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7-7 Image Rotation 275

7-8 Patient Orientation 276
7-9 Image Flip 285
8 How to perform a Blended Roadmap Fluoroscopy Acquisition (Option) 287
8-1 How to configure blended roadmap on one plane 287
8-1-1 How to create the Vessel Image 288
8-1-2 How to enter / exit Blended Roadmap 288
8-1-3 How to reposition the Gantry/Table 290
8-1-4 How to acquire the mask and finetune the Registration 291
8-1-5 Blended Roadmap Acquisition 292
8-1-6 Landscape and Vessels Adjustment 293
8-1-7 FOV Management in Blended Roadmap 293
8-2 How to use Blended Roadmap in biplane mode 294
9 How to perform a Roadmap Fluoroscopy Acquisition 297
10 How to perform a Subtracted Fluoroscopy Acquisition 300
11 Simultaneous Fluoro Sub / NoSub Display (Option) 303
12 How to perform a Record Acquisition 305
12-1 DSA Mode 305
12-2 Dynamic Mode 311
TM
12-3 InnovaChase Mode (Available on Frontal plane only) 312
12-4 InnovaBreezeTM Mode (Option available on Innova IGS 630 Frontal plane only) 313
12-4-1 Before You Start 313
12-4-1-1 On the Positioner 313
12-4-1-2 Patient Positioning 314
12-4-1-3 Anticollision Precaution 314
12-4-1-4 On the Innova Console 315
12-4-1-5 On the Control Panel 315
12-4-2 Making an Acquisition in Bolus Mode 316
12-4-2-1 On the Innova Console 316
12-4-2-2 In the Examination Room 316
12-4-2-3 At the Console 316
12-5 Innova 3D / Innova CT Modes (Options available on Frontal plane only) 318
12-5-1 Application Description 318
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12-5-2 3D Spin Acquisition 319

12-5-2-1 3D Spin Images Acquisition 319
12-5-2-2 Patient Positioning 319
12-5-2-3 Scatter Management 320
12-5-2-4 On the Innova Digital Screen 320
12-5-2-5 Making an acquisition in 3D Spin 321
12-5-3 Image Network 322
12-5-4 3D Image Reconstruction 322
12-5-5 3D Model Display 322
12-5-6 3D Image Archiving 323
12-5-7 3D Quick Guide 323
12-5-7-1 3D Acquisition 323
12-5-7-2 3D reconstruction 324
12-5-7-3 3D display 325
13 How to select an Acquisition Mode 328
14 How to review a Sequence/Photo 328
14-1 Sequence/Photo Viewer 328
15 How to End an Exam 332
16 How to Abort an Exam 332
17 Stenosis Analysis (Option) 332
17-1 Analysis Limitations 333
17-2 Stenosis Analysis at a Glance 333
17-3 Performing Stenosis Analysis 334
17-4 Reference Description for Stenosis Analysis Toolbar 335
17-5 Calibrating on a Catheter Diameter 336
17-6 How to achieve an accurate catheter calibration 337
17-7 Stenosis Quantification (available for Dynamic, subtracted DSA, Bolus and 339
subtracted 3D Modes only)
17-7-1 In case of Auto-calibration 340
17-7-2 In case of Catheter Calibration 341
17-8 Stenosis Quantification Results (available for Dynamic, subtracted DSA, Bolus and 341
17-9 Measure Distance 343
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17-10 Multi Segments 344

17-11 Innova OneTouchQA (option available on the optional Innova Central touch screen) 344
18 Ventricular Analysis (Option) 353
18-1 Ventricular Analysis at a glance 354
18-2 Performing Ventricular Analysis 354
18-3 Reference description for Ventricular Analysis Tool Menu 355
18-4 Draw Diastolic Contour 356
18-5 Draw Systolic Contour 357
18-6 Global Ejection Fraction Analysis 358
18-7 Wall Motion Analysis 363
18-8 Multi Segments 367
19 StentViz (Option) 368
19-1 Automatic StentViz Workflow 369
19-2 Manual StentViz Workflow 372
19-3 StentViz Best Practice 374
19-4 StentViz User Messages 374
20 Remote Control 375
20-1 Collage / In-Room Browser 376
20-2 Send Angle 379
21 DL Keypad 379
21-1 Edge Enhancement Filter Selection 380
22 Dose Information Record 381
23 How to Check or Reset the ECG signal (Option) 381
23-1 ECG icon indication on the DL by color and on the live display 382
23-2 ECG icon indication on the live display 384
23-2-1 Status "Online" 384
23-2-2 Status "Stabilizing" 385
23-2-3 Status "No Trigger" 385
23-2-4 Status "Offline" 386
24 How to Check the Disk Space 387
25 How to Check the Heat Unit Informations 388
26 How to Delete 389
26-1 How to delete a Patient 389
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26-2 How to delete an Exam 391

26-3 How to delete a Sequence 391
26-4 How to delete a Photo 392
27 How to Network Images to a Workstation, Archive Stations 392
27-1 Auto Archive 392
27-2 How to configure and select a Host 393
27-3 How to Network Patient 397
27-4 How to Network Exam 398
27-5 How to Network Sequence / Photos 398
27-6 How to check the status of Network Image operations 399
27-7 Network Queue Management 401
27-7-1 SENDING/ARCHIVING Queues 402
27-7-2 SENDING/ARCHIVING Queues Functions 403
28 How to use Worklist 403
28-1 How to configure and select a Worklist host 404
28-2 Retrieving the worklist 406
28-3 Worklist settings configuration 407
28-4 Creating Innova patients from worklist 408
29 Modality Performed Procedure Step (MPPS) 411
29-1 How to configure and select a MPPS host 411
29-2 How to send MPPS 413
29-3 How to check status of MPPS transfers 413
29-4 How to integrate MPPS with Mac-Lab/CardioLab and Carddas system 414
29-4-1 Known limitations with Mac-Lab/CardioLab system 415
30 How to Network Dicom Structured Dose Report (Dose SR) to Dose SR 415
Receiving stations
30-1 How to configure and select a Dose SR host 415
30-2 How to Network Dicom Structured Dose Reports 417
30-3 How to check the status of Dose SR transfers 418
30-4 How to integrate Dose SR with AW system 419
30-4-1 Known limitations with AW Reporting Tool display 419
31 Innova Screens Image Display 420
31-1 Technique factors display accuracy 424
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31-2 Dose Estimation 424

31-3 Monitor Pattern 426
31-3-1 Monitor Contrast Adjustment Check 426
31-4 Stopwatch 427
31-5 Electronic Shutter 428
Chapter 9 - InnovaSpinTM (Option available on Frontal plane only) 431
1 Safety Recommendations 431

2 Acquisition Procedure and Timing 431
3 Trajectories Settings 432
4 User Messages 432
Chapter 10 - Innova Positioner 434
1 How to move the Table/Gantry 434

1-1 Omega Smart Box 434
1-2 Smart Handle 435
1-3 Manual L-Arm Positioning 437
1-4 Additional Table Panning Handle 437
1-5 Table Side Status Control (TSSC) 438
1-6-1 General description 440
1-6-2 Environmental working conditions 441
1-6-3 How to move the Tableside Cart 441
1-6-4 Table Side User Interfaces on the Tableside Cart 442
1-6-5 Cable Routing 442
1-6-6 Safety mechanism 443
1-7 Error Management 444
1-8 Remote Stand (Option) 444
1-9 Omega Cable Holder 445
1-9-1 How to swap TSUIs 446
1-9-2 How to Rotate the Table beyond 90 deg. when Cable Holder is in use 447
1-9-3 How to Use with Remote Stand 448
1-9-4 How to Remove and Install the Sheath 448
1-9-4-1 Detaching the Sheath 448
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1-9-4-2 Attaching the Sheath 449

1-9-5 How to Loop the Extra Cable Length 449
2 Collimator Control 450
2-1 Contour Filter Control 451
3 Auto Positioning 452
3-1 Auto Positioning Control 452
3-2 Auto Position Selector 452
3-3 Park/Iso Function 453
4 Lateral Carriage Positioning 454
5 Lateral Plane Off Iso 455
6 Digital Detector Housing Controls 455
6-1 Up/Down Control 455
6-2 Emergency Back-Out 456
6-3 InnovaSense patient contouring (Option available on Frontal plane only) 456
7 Collision Sensors 457
7-1 Level 1 458
7-2 Level 2 (Digital Detector only) 459
8 Skin Spacer 459
9 Innova Central touch screen 460
9-1 Innova Central touch screen Installation 460
9-2 Innova Central touch screen Menus 460
9-2-1 X-Ray tab 461
9-2-1-1 Record tab 461
9-2-1-2 Fluoro tab 462
9-2-1-3 Review tab 463
9-2-2 AW tab 464
9-2-3 MLab tab 464
9-2-3-1 Mac-Lab tab 464
9-2-3-2 CardioLab tab 466
9-3 Innova Central touch screen customization 468
9-3-1 Location of the customized pages (Favorites tab) 469
9-3-2 Creation and renaming of Favorites sub-tabs 469
9-3-3 How to populate Favorite sub-tabs 470
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9-3-4 Button arrangement on a favorite sub-tab or between tabs 472

9-3-4-1 Move a button inside the current tab 473
9-3-4-2 Arrange buttons between tabs 474
9-3-4-3 Delete a button from the current tab 475
9-3-5 Advanced features to manage Favorites sub-tabs 476
9-3-5-1 How to change the tab order 477
9-3-5-2 How to delete the content of a favorite sub-tab 478
9-3-5-3 How to delete a Favorites sub-tab 479
9-4 Smart Nav 479
9-4-1 Navigation and function selection through the Menu 480
9-4-2 Functions descriptions 480
Chapter 11 - Alarm Systems 482
1 Alarm management 482

2 Alarm Message Format 482
3 Alarm System Performances 482
4 Degraded Mode of the Alarm Management 483
5 List of Alarm Messages 483
Chapter 12 - Large Display Monitor Option 487
1 General Description 487

2 System Components 487
2-1 Basic Components 487
2-2 Option 487
3 Safety recommendations 487
4 Connection of external devices 487
5 How to control the Large Display Monitor 488
5-1 How to Manage Groups 488
5-1-1 How to Create a New Group 489
5-1-1-1 Group naming 489
5-1-1-2 Selecting a starter group 490
5-1-1-3 Composing a group 490
5-1-1-4 Advanced Filtering 492
5-1-2 How to Modify a selected Group 494
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5-1-3 How to Modify the name of the selected layout 495

5-1-4 How to Delete a selected Group 496
5-2 How to change the Large Display Monitor layout 497
5-3 How to Identify Innova monitors 497
5-4 How to Identify the presence/absence of signal 498
5-5 How to recognize availability of the Large Display Monitor 498
6 Second Large Display Monitor (Replica) (Option) 499
Chapter 13 - Monitor Suspension 500
1 LCD Monitor Suspensions 500

1-1 6 or 8 LCD Monitors Suspension 500
1-2 Large Display Monitor Suspension 500
1-2-1 Standard use 500
1-2-2 Degraded Mode 502
1-3 Third party Monitor Suspension 503
1-4 Precautions 503
1-5 Operation 504
1-6 Cleaning 504
1-7 Periodic Maintenance 504
2 In-Room AW LCD Monitor (Option) 504
2-1 LCD Holder General Description 504
2-2 LCD Holder 504
2-3 Suggested LCD Monitor Models 505
2-4 Operating Instructions 505
2-5 Periodic Maintenance 506
2-6 Qualified Service 506
2-7 User Service and Maintenance 506
2-8 PMS Data Record Attachment for LCD Holder 507
2-9 Functional Check of LCD Holder 507
Chapter 14 - Cathlab Frontiers Solutions (Option) 509
1 General Application Description 509

2 Integrated Vivid E9 solution (Option) 509
2-1 System Setup 510
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2-2 Safety recommendations 510

2-3 Procedure specific layouts 511
Chapter 15 - Quality Assurance Program (QAP) 512
1 Introduction 512
1-1 What is QAP? 512
1-2 How to launch QAP? 512
1-3 Web Pages 512
1-4 Status 513
1-4-1 Other System Measurements 513
1-4-2 Recommendation #1 513
1-4-3 Recommendation #2 513
1-4-4 Use of metallic phantoms 513
1-5 Display of the IEC pattern 514
2 Parameter monitoring 515
2-1 The parameters that are monitored are 515
2-2 Frequency 515
3 Quality criteria 515
4 Material 515
Chapter 16 - User Quality Control (QC) Mode 517
1 How to launch QC Mode (not intended for clinical use) 517

2 X-Ray Control Parts Test 518
2-1 Detector Lead Blocker 519
2-2 X-Ray Tube Heat Units Available 520
3 "For Processing" Images 520
4 "For Presentation" Images 521
5 Calibration inputs for fields in the DICOM Dose SR: Update Calibration 522
Factor
6 Protocol Export 522
6-1 Electronic documentation available 522
6-2 SFTP mechanism 523
6-2-1 Pre-requisite for the remote device and the user's firewall 523
6-2-2 To connect to the SFTP server and transfer the file(s) 523
22
InnovaTM IGS 620,
InnovaTM IGS 630
7 Protocol Comparison 524

8 Access to DICOM Dose SR 524
9 How to exit QC Mode? 525
Chapter 17 - ILinq User Guide 527
1 Introduction 527
2 Starting ILinq 527
3 Features 528
3-1 Applications Self Help 528
3-2 Contact GE 528
3-3 Community 529
3-4 Messages 529
3-5 Virtual Assist 529
3-6 Online Tutorial 531
3-7 Help 531
3-8 Close 531
Chapter 18 - Advantage Workstation (AW) Configuration (Option) 532
1 Introduction 532
2 Helpful Information 532
3 In-Room Monitor Display 532
Chapter 19 - Diamentor M4 KDK (Option) 533
1 Introduction 533
1-1 General description of the Diamentor M4 KDK 533
1-2 Dose Measurement at Interventional Reference Point 534
2 Operating Controls and Indicators 534
2-1 Diamentor M4 KDK, front view 534
2-2 Diamentor M4 KDK, top view 535
3 Performing a Measurement 536
3-1 Constancy Check 536
3-2 Measurement 537
3-2-1 Note on warm-up time 537
3-2-2 Chamber-Patient Distance 538
23
InnovaTM IGS 620,
InnovaTM IGS 630
4 System Configuration (Setup Menu) 539

4-1 Some Basic Facts 539
4-2 Factory Settings 540
4-3 Displaying the Setup Menu 541
4-4 Selecting the Language 541
4-5 Selecting the Display Format (Display Submenu) 541
4-6 Bar Graph Limits (Display Submenu) 543
4-7 Filter Depth (Display Submenu) 543
4-8 Time (Option) 544
4-9 Sensitivity (Display Submenu) 544
4-10 Display Test (Display Submenu) 544
4-11 Date & Time (Date & Time Menu) 544
4-12 Zero Adjustment (Corrections Menu) 545
4-13 Chamber Temperature, Air Pressure and Correction Factors (Corrections Menu) 545
4-14 Source-Chamber Distance 546
4-15 Printer Control (Printer Menu) 546
4-16 Entering the Label Headline 547
4-17 Dose Area Product Unit 547
4-18 RS232 Interface (SERIAL port 9) 547
4-19 Print Mode 547
5 Maintenance 548
6 Restrictions 548
Chapter 20 - Maintenance Schedule 549
Chapter 21 - Appendix - Technical Publications 557
1 System Line Voltage 557

2 System Line Voltage - Options 557
3 System Line Current Specifications 557
4 Generator Rating and Duty Cycle 557
4-1 High Voltage Generator Classification for Japan 557
4-2 Generator rating in primary contacted mode 557
4-3 Generator rating in gridded mode 558
4-4 Generator duty-cycle 558
24
InnovaTM IGS 620,
InnovaTM IGS 630
4-5 Minimum mAs 558

5 System: Maximum deviation of kVp and mA actual parameters from the 558
displayed parameters (during exposure)
6 System: Nominal Tube Current at Maximum kVp 558
7 System: Nominal Tube Voltage Range when mA is Maximum 558
8 System: Maximum Power 559
9 System: Maximum mA at nominal tube voltage 559
Chapter 22 - Appendix - Radiation Safety Tutorial 560
1 Warning 560
2 Learning objective 560
3 Teaching points 560
4 Radiation dose is a natural consequence of x-ray imaging 560
5 Displayed Dose Parameters 560
5-1 Cumulated Air Kerma 561
5-2 Cumulated Dose Area Product (DAP) 561
6 Effects of ionizing radiation on humans 562
6-1 Deterministic effects 562
6-2 Stochastic effects 563
7 Dose reduction measures for the patient 563
7-1 List 563
7-2 Appropriate protocols 563
7-3 Equipment distances and angulations 564
7-4 Sequence duration, Last Image Hold 564
7-5 Virtual collimation 565
7-6 FOV selection 565
7-7 AutoExposure preferences, Normal/Low setting 566
7-8 Frame Rate 567
7-9 Fluoro limit 567
7-10 Threshold 568
8 Dose reduction measures for the staff 568
9 Pediatrics Case 569
9-1 Dose-related parameters default values 569
25
InnovaTM IGS 620,
InnovaTM IGS 630
9-2 List of pediatric protocols 570

9-3 Dose settings for pediatrics in Innova IGS systems 570
10 Electrophysiology (EP) Exam Case 571
11 Legal Provisions 572
Chapter 23 - Glossary 573
1 Acronyms in use 573

Chapter 24 - Importer Offices of GE Healthcare 579
Chapter 25 - Revision History 580
26
InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 1 - Foreword
1 Using This Module
Throughout the text in this manual, certain type styles and symbols differentiate between one tool or graphic and
another. The conventions are as follows:
• Menu titles and window names appear in boldface: Application menu.
• Menu options appear in boldface: Done.
• Graphical mouse-selected or key-selected buttons (on-screen "soft keys") or field names (filled in by the user)
appear in boldface, within brackets: [View].
• Graphical touchkey buttons (Innova console on-screen buttons) appear in boldface, within braces: {TUBE
WARMUP}.
• On-screen prompts and messages appear in boldface typewriter font: Login:.
• User typed-in responses appear in regular typewriter font: root.
• Keyboard hardkeys, mouse buttons and Table Side User Interfaces (TSUI) hardkeys/buttons with text inside,
are within <> : <Enter>, <left>, <M>, <Fr>, <Low>, <Med>, <High>, <Pref>, <STOP>, <+>, <->.
• Icon with drawing/symbol inside (on-screen "soft keys") or TSUI buttons with drawing/symbol inside : the symbol
of the button appears in the text. Symbol examples: Stopwatch, Room Light, Rotation Brakes, Lat/Long Brakes.
Symbols may also be represented as the name of the symbol in boldface white on a gray background:
Stopwatch
• Functions for the TSUI joystick and panning handle are in boldface: Table Panning handle, Collimator joystick.
To continue this module, select item from menu list in panel on the left.
2 Printing this Module

Note: The print feature is not available from the DL. To print, you must first load the OM DVD on an external
PC and then print using the Acrobat Reader software.
Acrobat Reader software installation:
If Acrobat Reader software is not already installed on your PC, follow the steps described further to install it:
• Open Windows Explorer
• Click on the DVD drive
• Click on Acrobat
• Click on Acroread5
• Double click on rp500enu.exe to launch the installation.
How to print
Clicking on the PRINT button hereafter will launch Acrobat Reader and display this OM in PDF file format in the
current language.
Use the standard Acrobat Reader Print icon and define your print range "All", "Current page", "Page from ... to ..."
After print the completion, close Acrobat Reader.
You are now back to the Online Operator Manual.
Note: If you need to print in another language, you must return to the Title Page and select the language before
clicking on the PRINT button.
Printing
Foreword 27
InnovaTM IGS 620,
InnovaTM IGS 630
Click on the PRINT button:
3 Electronic Operator Manual

This device is delivered with an electronic Operator Manual.
This section explains how to access the electronic Operator Manual that contains the instructions necessary to use
the system.
Note: Some operator manual addendums are delivered in paper only. Some options or accessories are delivered
with a paper operator manual.
Symbol indicating that the Instruction For Use (Operator

Manual) is supplied in electronic format.
The operator manual is available on the system itself (see section Utilities Key)
The Operator Manual is also available on the Internet at:
http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library
• On the home page enter the part number of the Operator Manual in the search window and click on [Search] to
launch the search.
The part number is indicated in the table below. Choose the one matching your language.
OM part-no Language
5719150-1-1CS Czech
5719150-1-1DE German
5719150-1-1EN English
5719150-1-1ES Spanish
5719150-1-1FR French
5719150-1-1ID Indonesian
5719150-1-1IT Italian
5719150-1-1JA Japanese
5719150-1-1KO Korean
5719150-1-1NL Dutch
5719150-1-1PL Polish
5719150-1-1PT-BR Portuguese (Brazil)
5719150-1-1PT-PT Portuguese (Portugal)
5719150-1-1RU Russian
5719150-1-1TR Turkish
5719150-1-1ZH-CN Simplified Chinese
28 Foreword
InnovaTM IGS 620,
InnovaTM IGS 630
1 - Search window
This screen capture is given as an example and is not legally binding.
The result of the search will be the Operator Manual in pdf format in one language.
• Click on the underlined Filename.
• In the next window, click on [ACCEPT] to download the file.
A paper copy of Operator Manual can be ordered at no additional cost. Please, send a request to your Sales or
Service representative. They will transfer your request to CEMEURDIST@med.ge.com. In application of the EU
Commission Regulation on electronic instructions for use of medical devices, in European Union, your request
should be treated within 7 days.
4 Quebec
GE Healthcare=”GE Santé” in Province of Quebec - Canada.
Foreword 29
InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 2 - Introduction
Product Name: Medical X-ray angiography equipment.
The Innova IGS 620, Innova IGS 630 is a biplane angiographic x-ray system consisting of a floor mounted
three-axis C-arm and a ceiling suspended C-arm.
Product Software Version: IGS6_2.0
30 Introduction
InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 3 - Safety and Regulatory

US federal law restricts this device to sale by or on the order of a physician.
This symbol stands for the prescription legend statement "Caution: US federal law restricts this
device to sale by or on the order of a physician."
1 Regulatory Requirements
The Innova IGS 620 and Innova IGS 630 need special precautions regarding EMC. The Innova IGS 620 and
Innova IGS 630 have to be installed and put into service according to the EMC requirements joined in the
accompanying document OM and PIM Chapter Safety and Regulatory.
1-1 Electromagnetic Compatibility (EMC)
1-1-1 Electromagnetic Compatibility of the vascular system
This equipment complies with IEC60601-1-2 Edition 2.1 (YY0505-2012) and Edition 3 EMC standard for medical
devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio
frequency interference to other medical and non-medical devices and radio communications nearby.
In order to provide a reasonable interference protection against radio communication services, this product
complies with the IEC60601-1-2 Edition 2.1 (YY0505-2012) and Edition 3 standard requirements at the premises of
a typical user, and the CISPR11 (GB 4824) standard emission limits (CISPR11 (GB 4824) Group1 Class A).
In order to provide reasonable interference protection against other medical and non-medical devices, this product
complies with the IEC60601-1-2 Edition 2.1 (YY0505-2012) and Edition 3 standard requirements at the premises of
a typical user, and the emission amplitude is controlled in the Innova vicinity, in the CISPR11 (GB 4824) standard
Group1 bandwidth (150 KHz - 1 GHz).
The Innova system has no significant intentional radio emitter, which radiates electromagnetic energy and
electromagnetic fields (EMF) susceptible to induce known adverse health effects.
The Innova system complies with the 2004/40/EEC EMF directive for workers, and the 1999/518/EC
recommendation for the general public.
The level of these non-ionizing radiation was assessed under the required and recommended limits, addressing the
workers and general public located nearby the Innova system.
Compliance with these limits will ensure that workers and the general public exposed to the electromagnetic fields
are protected against all known adverse health effects in the 0 Hz to 300 GHz bandwidth.
1-1-2 Detailed Electromagnetic Compatibility of the vascular system
Detailed requirements and recommendations about the power supply distribution and installation are listed in the
next paragraph called "Detailed Electromagnetic Standard Compliance conditions", and in the PIM document
(Pre-Installation Manual).
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment on and off),
the user (or qualified service personnel) should attempt to correct the problem by one or more of the following
measure(s):
• Reorient or relocate the affected device(s),
• Increase the separation between the equipment and the affected device,
• Power the equipment from a source different from that of the affected device,
• Consult the point of purchase or service representative for further suggestions.
Safety and Regulatory 31

InnovaTM IGS 620,
InnovaTM IGS 630
The manufacturer is not responsible for any interference caused by using other than recommended interconnect
cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications
could void the users' authority to operate the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded, except when technologically
prohibited. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency
interference.
Do not use devices, which intentionally transmit RF signals (cellular phones, transceivers, or radio-controlled
products) in the vicinity of this equipment, as it may cause performance outside the published specifications.
Recommended separation distances are detailed in the next paragraph called "Detailed Electromagnetic Standard
Compliance conditions", and in the PIM document (Pre-Installation Manual).
Keep the power to these type devices turned off when near this equipment.
The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who
may be around this equipment to fully comply with the above requirement.
In order to achieve the Electromagnetic Compatibility for a typical installation, and this medical system, further
detailed data & requirements are described in the next paragraph called "Detailed Electromagnetic Standard
Compliance conditions", and in the PIM document (Pre-Installation Manual).
The magnetic field environment from an MRI device located nearby is a risk of interference. The recommended
maximum magnetic field amplitude is specified in the next paragraph called "Detailed Electromagnetic Standard
Compliance conditions", and in the PIM document.
1-1-3 Electromagnetic Compatibility of the vascular system with Fluoro UPS (Innova option)
In addition, in case of using the Fluoro UPS option (Uninterruptible Power Supply), the installation requirements
shall be applied for the Electromagnetic Compatibility of the full vascular system with the Fluoro UPS option.
The PDB (Power Distribution Panel) associated with the Fluoro UPS option, requires the correct cable sizing and
routing, and component installation, as per defined in the next paragraph called "Detailed Electromagnetic
Standard Compliance conditions", and in the associated PIM document (Pre-Installation Manual).
1-1-4 Detailed Electromagnetic Standard Compliance conditions
This equipment complies with IEC60601-1-2 Edition 2.1 (YY0505-2012) and Edition 3 EMC standard for medical
devices.
The Innova system is suitable to be used in the electromagnetic environment, as per the limits & recommendations
described in the tables here after:
• Emission Compliance level & limits (see Table 1).
• Immunity Compliance level & recommendations to maintain equipment clinical utility (see Table 2, Table 3 and
Table 4).
Note: This system complies with above–mentioned EMC standard when used with supplied cables up to maximum
lengths referenced in the MIS MAPS or system cables interconnect diagrams.
1-1-4-1 Essential performance list
Essential Performance IEC standard reference Comments

Access to CPR position in less IEC 60601-1 Clause 4.3 - From Risk CPR position is defined as:
than 15 s (+1 s in tilted conditions) Management tilt angle =0° and table top fully moved to-
wards feet along the longitudinal axis.
Ability to position patient support IEC 60601-1 Clause 4.3 - From Risk
for imaging the zone of interest Management
Ability to position and orient the X- IEC 60601-1 Clause 4.3 - From Risk Also includes the ability to position gantry
ray beam vs. patient Management isocenter vs. patient for Discovery IGS 7x0.
32 Safety and Regulatory

InnovaTM IGS 620,
InnovaTM IGS 630
Ability to distinguish anatomic IEC 60601-2-54: Imaging perfor- Ability to distinguish images noise or arti-
structures and interventional de- mances facts from anatomic structures and inter-
vices in images IEC 60601-2-54: Automatic Control ventional devices.
System The automatic control system regulates the
acquisition parameters to make visible
anatomic structures of interest and inter-
ventional devices.
Ability to guide interventional ges- IEC 60601-2-54: Imaging perfor-
ture with X-Ray imaging mances
Ability to export DICOM Radiation IEC60601-2-43: Radiation dose doc- Capability to export DICOM Radiation Dose
Dose Structured Report umentation Structured Report through the network.
System reset in less than 3 IEC60601-2-43: Recovery manage-
minutes. ment
1-1-4-2 Electromagnetic Emission

Table 1
The Innova system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Innova system should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment
Radio–Frequency Group1 The Innova system uses Radio Fre-
quency energy only for its internal
Emissions Class A
function. Therefore, its Radio Fre-
CISPR11 (GB 4824) limits quency emissions are very low and
are not likely to cause any interfer-
ence in nearby electronic equipment.
The Innova system is suitable for use
in all establishments other than do-
mestic and those directly connected
to the public low-voltage power supply
network that supplies buildings used
for domestic purposes.
Harmonic emissions IEC 61000-3-2 Not Applicable The Innova system is suitable for use
(GB 17625.1) in all establishments other than do-
Voltage fluctuations / flicker emissions Not Applicable The Innova system is suitable for use
IEC 61000-3-3 (GB 17625.2) in all establishments other than do-
1-1-4-3 Electromagnetic Immunity

Table 2

InnovaTM IGS 620,
InnovaTM IGS 630
IMMUNITY Test IEC 60601-1-2 Compliance Level Electromagnetic Environment
Edition 2.1
(YY0505-2012)
and Edition 3 Test
Level
Electrostatic discharge +/- 6 kV contact +/- 6 kV contact Floors are wood, concrete or ceramic tile or
(ESD) +/- 8 kV air +/- 8 kV air floors are covered with synthetic material and
IEC 61000-4-2 (GB/T the relative humidity is at least 30 %.
17626.2)
Electrical fast transient/ +/- 2 kV for power +/- 2 kV for power Mains power quality is that of a typical commer-
burst supply lines supply lines cial or hospital environment.
IEC 61000-4-4 (GB/T +/- 1 kV for input/ +/- 1 kV for input/
17626.4) output output
lines lines
Surge +/- 1 kV line(s) to +/- 1 kV line(s) to Mains power quality is that of a typical commer-
IEC 61000-4-5 (GB/T line(s) line(s) cial or hospital environment.
17626.5) +/- 2 kV line(s) to +/- 2 kV line(s) to
earth earth
Voltage dips, short <5% UT (>95% dip <5% UT (>95% dip Mains power quality is that of a typical commer-
interruptions and in UT) for 5 s in UT) for 5 s cial or hospital environment. If the user of the
voltage variations Innova system requires continued operation
on power supply during power mains interruptions, it is recom-
input lines mended that the Innova system be powered
IEC 61000-4-11 (GB/T from an uninterruptible power supply.
17626.11)
Power frequency 3 A/m 3 A/m Power frequency magnetic fields is at levels
(50/60 Hz) characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
IEC 61000-4-8 (GB/T
17626.8)
Note: UT is the a.c. mains voltage prior to application of the test level.
Table 3
IMMUNITY Test IEC 60601-1-2 Edi- Compliance Level Electromagnetic Environment
tion 2.1
(YY0505-2012) and
Edition 3
Test Level

InnovaTM IGS 620,
InnovaTM IGS 630
Portable and mobile RF communications equip-

Conducted Radio Fre- 3 Vrms V1 = 3 V
ment is used no closer to any part of the Innova
quency 150 kHz to 80 MHz
system, including cables, than
IEC 61000-4-6 (GB/T
the recommended separation distance calculated
17626.6)
from the equation applicable to the frequency of
the transmitter.
Radiated Radio Fre- 3 V/m E1 = 3 V/m Recommended separation distance
quency 80 MHz to 2.5 GHz
See statement be-
IEC 61000-4-3 (GB/T
See statement below low for Large Per-
17626.3)
for Large Permanently manently Installed
Installed Medical Medical Equipment
Equipment
where P is the maximum output power rating of

the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in meters (m).
Field strengths from fixed RF transmitters, as de-
termined by an electromagnetic site survey*, are
less than the compliance level in each frequency
range **.
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
Note: * Field strengths from fixed transmitters, such as base stations for cellular telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be performed. If the measured field strength exceeds the RF compliance level above, observe the Innova
system to verify normal operation in each use location. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Innova system.
** Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.
THE INNOVA IGS SYSTEM IS A LARGE, PERMANENTLY-INSTALLED MEDICAL EQUIPMENT

FOR WHICH THE SIMULATED OPERATION IN AN ANECHOIC CHAMBER IS NOT FEASIBLE
AND CONSEQUENTLY IS EXEMPT FROM THE TESTING REQUIREMENT SPECIFIED BY IEC
61000-4-3 (GB/T 17626.3). THE INNOVA IGS SYSTEM HAS NOT BEEN TESTED FOR
RADIATED RF IMMUNITY OVER THE ENTIRE FREQUENCY RANGE 80 MHz TO 2.5 GHz. THE
INNOVA IGS SYSTEM HAS BEEN TESTED IN SITU FOR RADIATED RF IMMUNITY ONLY AT
SELECTED FREQUENCIES IN THE RANGE 80 MHz TO 2.5 GHz.
ISM Frequencies (MHz) Field level Modulation

InnovaTM IGS 620,
InnovaTM IGS 630
433.920 (ISM)* 3 V/m 80% AM at 1 kHz rate

915 (ISM)*
1440
1750
1920
2450 (ISM)*
Note: *Industrial, Scientific and Medical (ISM) radio bands.

Equipment used for tests:
• RF signal generator
• RF power amplifier
• Transmitting antenna
• Field sensor
• Field meter
The Recommended Separation Distances are listed in section "Recommended Separation Distances for Portable
and Mobile RF Communications Equipment" Table 4.
These are guidelines. Actual conditions may vary.
1-1-4-4 Recommended Separation Distances for Portable and Mobile RF Communications Equipment
Table 4
Frequency of Transmit- 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
ter
Equation
Rated Power of Trans- Distance (meters) Distance (meters) Distance (meters)

mitter (watts)
10 mW 0.11 0.11 0.22
100 mW 0.37 0.37 0.74
1 1.1 1.1 2.3(*)
10 3.7 3.7 7.4
100 12 12 23
For transmitters rated at a power not listed above, the DISTANCE can be estimated using the equation in the
corresponding column, where P is the power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note: These are guidelines. Actual conditions may vary.
1-1-4-5 Limitations Management
Adhering to the distance separation recommended in section "Recommended Separation Distances for Portable
and Mobile RF Communications Equipment" Table 4, between 150 KHz & 2.5 GHz, will reduce disturbances
recorded at the image level, but may not eliminate all disturbances. However, when installed and operated as
specified herein, the system will maintain its essential performance by continuing to acquire, display, and store
diagnostic quality images safely.
For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put 2.3 meters (see (*) in section

InnovaTM IGS 620,
InnovaTM IGS 630
"Recommended Separation Distances for Portable and Mobile RF Communications Equipment" Table 4) apart
from the Innova system (in order to avoid images interferences risks).
1-1-4-6 Use Limitation
THE USE OF ACCESSORIES, TRANSDUCERS, AND CABLES OTHER THAN THOSE

SPECIFIED MAY RESULT IN DEGRADED ELECTROMAGNETIC COMPATIBILITY OF THE
INNOVA SYSTEM.
1-1-4-7 Installations Requirements and Environment Control
In order to minimize interference risks, the following requirements shall apply:
• Cables shielding & grounding:

All interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not
properly shielded and grounded may result in the equipment causing radio frequency interference.
• Separated Power supply distribution panel & separated power line:
– This product complies with the radiated emission limits as per the CISPR11 (GB 4824) Group1 ClassA
standard.
– The Innova system is predominantly intended for use (e.g. in hospitals) with a dedicated supply system, and
with an X–ray shielded room.
– In case of using in a domestic environment (e.g. doctors’ offices), in order to avoid interferences, it is
recommended to use a separated AC power distribution panel & separated power line, and an X–ray
shielded room.
• Subsystem & accessories Power supply distribution:
All components, accessories subsystems, systems which are electrically connected to the Innova system, have
to be all AC power supplied by the same power distribution panel & line.
Note: In order to avoid interferences, the same AC power distribution panel should supply all components,
accessories, the Innova system (& subsystems as the Advantage Workstation). The separated AC power line
should supply the whole AC power distribution panel sockets.
• Stacked components & equipment:
The Innova system should not be used adjacent to or stacked with other equipment; if adjacent or stacked use
is necessary, the Innova system should be observed to verify normal operation in the configuration in which it
will be used.
• Low frequency magnetic field:
– In case of an Innova system, the Gantry (digital detector) shall be apart 1 meter from the X-Ray generator
cabinet, 1 meter from the PDB cabinet, 1 meter from the UPS cabinet, and 1 meter apart from monitors.
These distances specifications shall minimize the low frequency magnetic field interference risk.
– Other electrical equipment may disturb and interfere with these Innova components. The control of the
clearing distances from the noise sources is recommended from the HF electrosurgery generator, power
supplies converters from nearby monitors or from other close electrical equipment). Refer to respective
device manufacturers instructions & recommendations in such cases.
• Static magnetic field limits:
– In order to avoid interference on the Innova system, static field limits from the surrounding environment are
specified.
– Static field is specified less than <1 Gauss in Examination room, and in the Control Area.
– Static field is specified less than <3 Gauss in the Technical Room.
• Electrostatic discharges environment & recommendations:
– In order to reduce electrostatic discharge interference, install a charge dissipative floor material to avoid
electrostatic charge buildup.

InnovaTM IGS 620,
InnovaTM IGS 630
– The relative humidity shall be at least 30 percent.

– The dissipative material shall be connected to the system ground reference, if applicable.
1-2 Additional Regulatory Requirements
This product complies with the regulatory requirements of the following:
• Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:
For a system, the location of the CE marking label is described in the system manual.
Manufacturer's name and address, address of the manufacturing site and European registered
place of business (the two addresses correspond to the same entity):
GE MEDICAL SYSTEMS SCS GE Medical Systems SCS

283 RUE DE LA MINIERE 283 rue de la Minière
78530 BUC - FRANCE BP 34 78533 Buc Cedex
Tel: +33 1 30 70 40 40 France
Tel: +33 1 30 70 40 40
FOR CONTINUOUS COMPLIANCE WITH THE MEDICAL DEVICE DIRECTIVE 93/42/CEE (CE
MARKING), CONSULT YOUR GE REPRESENTATIVE BEFORE ADDING OPTIONS OR
ACCESSORIES OTHER THAN THOSE INDICATED IN THIS MANUAL. THE CE LABEL FOR
THE SYSTEM IS LOCATED ON THE C-ARC OF THE GANTRY.
• Every system has a unique marking for identification (which includes the Product Model identifier). The Unique
Device Identification (UDI) marking is located on the C-arc of the frontal gantry.
Scan or enter the information from the label into the patient health record as required by the governing laws.
System Product Model Identifier

Innova IGS 620 Innova IGS 620 002
Innova IGS 630 Innova IGS 630 002
• Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration,
Department of Health, USA).
• Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
Note: Power Distribution Box (PDB) for country other than North America are not compliant to this standard.
• Canadian Standards Association (CSA).
Note: Power Distribution Box (PDB) for country other than North America are not compliant to this standard.
• International Electro technical Commission, international standards organization, when applicable.
• EMC IEC 60601-1-2: Edition 2.1 (2004) (YY0505-2012) and Edition 3 (2007).
• Innova IGS system has been designed, manufactured and tested to meet the applicable requirements of 21
CFR 1020.30, 1020.32. When the Innova IGS system is installed and tested according to the manufacturer
instructions, the system meets the applicable requirements. Each components falling under the performances
regulated in 21 CFR 1020.30 bears a certification label mentioning the following text:
"COMPLIES WITH DHHS RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J".
• CDRH certification label of the C1 cabinet, C2 cabinet can be found on the door of the cabinet.
• CDRH certification label of the Jedi generator can be found on the door of the C1 Cabinet.
• CDRH certification label on the Collimator, Tube and Detector of frontal are located on the L-arm.

InnovaTM IGS 620,
InnovaTM IGS 630
• CDRH certification label on the Collimator, Tube and Detector of lateral are located on the C-arm.
• CDRH certification label of VCIM (Vascular Control Interface Module) and TSSC (Table Side Status Control) are
located on the parts.
• CDRH certification label of Tabletop can be found on the backside of the tabletop.
• Chinese registration information:
– Registration applicant name, address, and contact:
Name: GE MEDICAL SYSTEMS SCS
Address: 283 RUE DE LA MINIERE, 78530 BUC FRANCE
Contact: 283 RUE DE LA MINIERE, 78530 BUC FRANCE
– Manufacturer‘s name, address and contact, address of the manufacturing site:
Name: GE MEDICAL SYSTEMS SCS
Address of manufacturer and manufacturing site: 283 RUE DE LA MINIERE, 78530 BUC FRANCE
Contact: 283 RUE DE LA MINIERE, 78530 BUC FRANCE
– Agent name, address, and contact / After-sale service name, address, and contact:
Name: GE Medical Systems Trade & Development (Shanghai) Co., Ltd
Address: Building 1, 96 Yiwei Road, Pilot Free Trade Zone, Shanghai, China
Contact: Building 1, 96 Yiwei Road, Pilot Free Trade Zone, Shanghai, China
– China References Numbers:
Model Name Medical device Registra- Product Technical Re- Release

tion Certificate Number quirements Number software
Version
Innova IGS 630 20173306458 20173306458 IGS6_2
– Manufacture date: refer to System rating plate. This rating plate (label) is located on the C-arm.
– Regarding the "useful life: see operator manual" mentioned on the Chinese label, the detailed information is
given as below.
"The Expected Service Life, as defined by IEC 60601-1: 2005, for GE medical X-ray angiography equipment
is 10 years from the date of first use of the equipment. GE medical X-ray angiography equipment has the
ability to operate for this period of time provided that the equipment is properly used, maintained and stored
as per the accompanying product documentation.”
The reliability of the X-ray tube assembly depends on the customer usage and can be intrinsically expressed
in terms of energy consumption. Thus, the CFDA Expected Service Life of the X-ray tube assembly is 1864
kWh. Expected Service Life is not equivalent to warranty life, nor does it correlate with warranty life.
The CFDA Expected Service Life of the detector is 10 years. Expected Service Life is not equivalent to
warranty life, nor does it correlate with warranty life.
• Eurasian Conformity (EAC)
This product passed all conformity assessment (approval) procedures that correspond to the requirements of
applicable technical regulations of the Customs Union.
This product complies with the regulatory requirements set in the regulation CU TR 020 / 2011 ‘electromagnetic
compatibility of technical products'.
• Authorized Representative in Ukraine
LLC "GE Ukraine"

InnovaTM IGS 620,
InnovaTM IGS 630
st. Shovkovychna 42-44, m. Kyiv, 01004, Ukraine

This product complies with the Technical Regulation on Medical Devices #753 when it bears the following
Ukrainian mark of conformity:
• Argentina information
Note: With Innova IGS 620 and IGS 630 systems, biplane fluoro performed at 25 fps on the 12 cm Field of View is
not compliant with the French Quality Control protocol of November 2006 and shall not be used.
1-3 Product Storage and Handling limits
Note: Avoid extremes in temperatures.
Storage and transport - Relative Humidity and Temperature
Component RELATIVE HUMIDITY (NON- TEMPERATURE ATMOSPHERIC PRESSURE

CONDENSING) (see Note (2)) (hPa)
MIN MAX MIN MAX MIN MAX
Frontal Posi- 5% 95% -40°C -40°F +70°C +158°F 525 1013
tioner
Lateral Position- 5% 95% -40°C -40°F +70°C +158°F 525 1013
er
Table Omega 5% 95% -40°C -40°F +70°C +158°F 48 1220
IV, Omega V
TSUI (TSSC, 5% 95% -40°C -40°F +70°C +158°F 500 1010
Smart box,
Smart handle,
TPD)
Footswitch 10% 100% -20°C -4°F +60°C +140°F 500 1060
Monitor LCD 5% 95% -20°C -4°F +60°C +140°F 540 1053
Eizo
Monitor LDM 10% 90% -20°C -4°F +55°C +131°F 200 1050
Cabinets C1 10% 100% -40°C -40°F +70°C +158°F 500 1060
Frt, C1 Lat, C2
UPS 3KVA 5% 90% -20°C -4°F +40°C +104°F 697 1130

InnovaTM IGS 620,
InnovaTM IGS 630
Power Distribu- 5% 95% -30°C -22°F +70°C +158°F 500 1060

tion Box (PDB)
CE
Power Distribu- 10% 95% -30°C -22°F +70°C +158°F 500 1060
tion Box (PDB)
UL
UL Fluoro UPS 0% 95% -20°C -4°F +50°C +122°F 500 1013
cabinet (*)
CE Fluoro UPS 0% 95% -20°C -4°F +50°C +122°F 500 1013
cabinet (*)
LDM cabinet LD 5% 95% -40°C -40°F +70°C +158°F 700 1060
core
Detector condi- 5% 95% -40°C -40°F +70°C +158°F 120 1060
tioner
Tube chiller 10% 100% -40°C -40°F +70°C +158°F 500 1060
Coolix 4100
VCIM 5% 95% -40°C -40°F +70°C +158°F 525 1013
Digital detector Refer to Note (1) below - -
Large Display 10% 100% -40°C -40°F +70°C +158°F 500 1060
Option Interface
Box
Note: (1) The detector should be stored at 10 to 40 °C (50 to 104 °F) and less than or equal to 90% RH in the
plastic wrapped shipping box. (This should include two bags of desiccant as well). The lowest temperature (e.g. 10
ºC (50 °F)) and humidity is preferable. If they are to be stored outside of their shipping box or in the inner shipping
box without plastic wrapping they should be stored at 20 °C (68 °F) or less and 30% RH or less. In terms of
transportation, do not expose to temperatures below -20 ºC (-4 °F) in its shipping box for more than 15 hours. The
detector will reach the ambient temperature after 20 to 25 hours. The detector should not be allowed to reach
temperatures less than -10 ºC (14 °F) or irreparable damage to the detectors scintillator will occur. Care must be
taken when removing a detector from a shipping box. If the detector has been subject to cold temperatures for an
extended period the detector in the box should be allowed to sit in the plastic wrapped box to reach room
temperature. This will prevent condensation from occurring. Condensation on the detector can cause irreparable
damage to the electronics. Storage 10 to 40 ºC (50 to 104 °F); 10 to 90 % RH, 250 day storage transportation -20
to +60 ºC (-4 to 140 °F) and 10 to 80% RH. The Detector chiller is shipped within GE Healthcare packaging.
Note: (2) Special Humidity Instructions: The following parts can be can be shipped in standard shipment conditions
with the requirement that on arrival to installation site, and before supplying power to these parts, they shall be kept
in an environmental relative humidity equal or lower than their specified capability, and that’s for a minimum of 48
hours.
• 3kVA UPS 110 V & 220 V (Maximum specified relative humidity capability = 90%)
• LDM Monitor (Maximum specified relative humidity capability = 90%)
• Diamentor (Maximum specified relative humidity capability = 80%)
• 1MP MX191 LCD Monitor (Maximum specified relative humidity capability = 80%)
1-4 Specific Requirements for product with a third party monitor suspension
If the customer does not order any of the suspension model proposed in the catalog with the IGS system, then
GEMS provides a kit to interface the system with a third party monitor suspension which will have to comply with
GEMS specifications and be installed in accordance with GE instructions.
For Innova IGS Systems with a third party monitor suspension, the overhead monitor suspension shall be installed

InnovaTM IGS 620,
InnovaTM IGS 630
by strictly following the GEMS installation instructions. The manufacturer specifically disclaims any and all liability
arising out of or relating to the use or performance of the monitor suspension (including cables), including, without
limitation, any liability or claims relating to patient injury, death, or the reliability of such monitors suspension(s).
In this case, the Innova IGS System is delivered without the standard fully integrated Mavig overhead suspension,
its associated suspension rails and cables, to allow the customer (purchaser) to choose his (their) own monitors
suspension(s). Only GE monitors are permitted as primary image display.
The Innova IGS system is delivered with up to 10 exam-room 19" monitors; the display features are then the same
than with a Innova IGS System delivered with a standard Mavig monitors suspension.
Note: It does not modify the Control room monitor configuration delivered with the Innova IGS system.
Where an overhead monitor suspension(s) is supplied by the Purchaser of the Innova IGS System, the overhead
monitors suspension(s) shall comply with the applicable Regulation enforced in the country (e.g., when installed in
an European Community country, the associated monitors suspension(s) shall be CE marked under Directive
93/42/EEC).
The association of Innova IGS system and the third party monitor suspension is not covered by Innova IGS product
certification.
1-5 Recycling
• Instruments or accessories at end of life span:
Disposal of equipment and accessories must meet the applicable national regulations for waste treatment.
Equipment and accessories at the end of their life span must have all materials or components removed that
can be hazardous to the environment (such as accumulators, batteries, transformer oil, etc). Please consult
your local GEHC contact before disposing of these products.
• Packaging:
The materials used for our equipment packaging are recyclable. These materials must be collected and
processed according to the regulations applicable in the countries in which equipment or accessories are
unpacked.
• Waste Electric, Electronic Equipment (WEEE - 2002/96/EC):
This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted
municipal waste and must be collected separately. Please contact an authorized representative of the
manufacturer for information concerning the decommissioning of your equipment.
• Battery recycling (Battery 2006/66/EC):
The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be
recycled or disposed of in accordance with local or country laws. The letters below the separate collection
symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery.
To minimize potential effects on the environment and human health, it is important that all marked batteries that
you remove from the product are properly recycled or disposed.
For information on how the battery may be safely removed from the device, please consult the service manual
or equipment instructions. Information on the potential effects on the environment and human health of the
substances used in batteries is available at this url:
http://www.gehealthcare.com/euen/weee-recycling/index.html.
1-6 Control of Pollution caused by Electrical and Electronic Product (EEPs)

InnovaTM IGS 620,
InnovaTM IGS 630
The following product pollution control information is provided according to SJ/T11364-2014 Marking for Restriction
of Hazardous Substances caused by electrical and electronic products.
1-6-1 Explanation of Pollution Control Label
This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese
standard GB/T 26572 Requirements of concentration limits for certain restricted substances in electrical and
electronic products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the
period during which the hazardous substances contained in electrical and electronic products will not leak or
mutate under normal operating conditions so that the use of such electrical and electronic products will not result in
any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is "Year".
In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and
environmental conditions as defined in the product manual.
Consumables or certain parts may have their own label with an EFUP value less than the product.
This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled
properly after decommissioning.
1-6-2 Name and Concentration of Hazardous Substances
Hazardous substances' name and concentration
Component Hazardous substances' name

Name
Pb Hg Cd Cr (VI) PBB PBDE
C1 Frontal Cab- O O O O O O
inet
C1 Lateral Cab- O O O O O O
inet
C2 Cabinet X O O O O O
PDB O O O O O O
Large Display O O O O O O
Cabinet
UPS X O O O O O
Tube Chiller O O O O O O
and autotrans-
former
Detector Chiller O O O O O O
X-ray Tube Col- X O O O O O
limator
LC Gantry X O X O O O
LP Gantry X O X O O O
X-ray Tube As- X O O O O O
sembly
Patient Table O O O O O O

InnovaTM IGS 620,
InnovaTM IGS 630
User Interfaces O O O O O O
(TSUI, key-
board mouse,
Innova Central
touch screen,
DL keypad)
DL console O X O O O O
19" Monitors O O O O O O
Large Display O O O O O O
Monitor
AW Monitor X X O O O O
This table is prepared according to SJ/T 11364.
O: Indicates that this hazardous substance contained in all of the homogeneous materials for this part is below the
limit requirement in GB/T 26572.
X: Indicates that this hazardous substance contained in at least one of the homogeneous materials used for this
part is above the limit requirement in GB/T 26572.
• Data listed in the table represents best information available at the time of publication.
• Applications of hazardous substances in this medical device are required to achieve its intended clinical uses,
and/or to provide better protection to human beings and/or to environment, due to lack of reasonably
(economically or technically) available substitutes.
1-7 Vermont labeling regulations (US) on Mercury

This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance
with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury,
except 19" High Bright monitor.)
Devices containing Mercury bear the following label:
Lamp contains mercury, dispose according to state/local law.
1-8 Canada labeling regulations on Mercury

This notice is provided in accordance with the Products Containing Mercury Regulation SOR/2014-254 November
7, 2014 as annexed in the Canadian Environmental Protection Act, 1999.
Notification about this product:
• Contains mercury.
• For safe handling procedures and the measures to be taken in case of accidental breakage, and for options
available for disposal and recycling, please refer to
https://www.ec.gc.ca/mercure-mercury/Default.asp?lang=En&n=DB6D2996-1. If additional support is needed,
please contact your GE representative.
• This product should be disposed of or recycled in accordance with the applicable laws.

InnovaTM IGS 620,
InnovaTM IGS 630
1-9 Patient Confidentiality

For some maintenance operations related to image quality, it may be necessary for the Service organization to
send some images back to the manufacturer for analysis. The images may be sent through CDs or via Insite
connection. The images may contain personally identifiable information (for example, a patient’s name or Social
Security number) in the Patient Identification field. Some countries have laws related to the confidentiality of
personally identifiable information.
To comply with these laws, the customer shall send anonymized data to GE. The customer shall follow its internal
anonymization procedures or the following procedure to suppress the Patient Identification field before archiving
the images for non-medical purposes (such as image quality investigation):
1. If the images are still on hard disk, suppress the patient identification as follows:
a. Enter the patient information screen,
b. Click on the Patient Identification field,
c. Suppress manually the Patient Identification,
d. Click on [Apply] to confirm. Then, archive this exam.
2. If the images were already networked, first restore the images on the AW or CA1000 workstation, and then use
the [Anonymous Maker] to remove the Patient Identification field prior to burning images on CD/DVD.
2 General Safety
In case of a discrepancy between a generic and a specific instruction for use, the specific instruction will always
prevail.
This system contains operating safeguards to provide maximum safety. Before calling for service, be certain proper
operating procedures are being used.
Satisfactory equipment performance requires the use of service personnel specially trained on X-ray apparatus. GE
Healthcare is responsible for the effects on safety, reliability and performance only if the following conditions are
met:
• The electrical wiring of the relevant rooms complies with all national and local codes as well as the Regulations
for the electrical equipment of buildings published by the Institution of Electrical Engineers.
• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by GE Healthcare's
authorized service representatives.
• The equipment is used in accordance with the instructions for use.
ALWAYS BE ALERT TO SAFETY WHEN YOU OPERATE THIS EQUIPMENT. YOU MUST BE
FAMILIAR ENOUGH WITH THE EQUIPMENT TO RECOGNIZE ANY MALFUNCTIONS THAT
CAN BE A HAZARD. IF A MALFUNCTION OCCURS OR A SAFETY PROBLEM IS KNOWN TO
EXIST, DO NOT USE THIS EQUIPMENT UNTIL QUALIFIED PERSONNEL CORRECT THE
PROBLEM.
NO EQUIPMENT SHALL BE CONNECTED TO THE POWER STRIP OF THE CONTROL ROOM

EXCEPT THOSE EXPLICITLY SPECIFIED IN THE SERVICE MANUAL. ANY SUCH
MODIFICATION OR ADDITION LEADS TO A MODIFIED MEDICAL SYSTEM THAT IS NOT
COVERED BY MEDICAL STANDARD IEC 60601-1 AND CAN RESULT IN A REDUCED LEVEL
OF SAFETY.
2-1 Equipment Application Specification
2-1-1 Patient Population
• Age: newborn to geriatric.
• Weight: 204 kg maximum.
2-1-2 Intended Operator
• Knowledge: The usage of the system described in this Operator Manual requires specific technical and medical

InnovaTM IGS 620,
InnovaTM IGS 630
knowledge and skills regarding, at a minimum, radiation protection, safety procedures and patient safety.
People using, moving, working with the system must have acquired such knowledge and skills during their
education curriculum.
• Language Understanding:
Operator Manual and System Screens are translated* in the following languages. Users must understand one of
these languages before using the system.
Code Operator Manual System Screens (GUI)

PT-BR Brazilian Portuguese English
CS Czech English
NL Dutch Dutch
EN English English
FR French French
DE German German
ID Indonesian English
IT Italian Italian
JA Japanese English
KO Korean English
PL Polish English
PT-PT Portuguese Portuguese
RU Russian English
ES Spanish Spanish
TR Turkish English
ZH-CN Simplified Chinese English
Note: * Depending on the region of sale, some translations may not be available.
• Equipment Training: Training is available from GE Healthcare. Some country regulations require that equipment
training be followed before any use of the system. The facility’s management should assess the initial and
continuous training needs of qualified users, radiologists or other physicians responsible for the interpretation
and / or acquisition parameters. The facility should identify the individuals that should take part in the training
relative to dose-reduction features, and dose related acquisition parameters.
Contact GE Healthcare representative for training options.
• Training Options: From in person application training to self-training with the Online Operator Manual delivered
with the Innova IGS System and the safety instructions of the paper booklet, Operator Manual DVD. The
Operator Manual DVD shall be placed in a location easily accessible to the operator in case of emergency.
• Training Frequency Recommendation: The facility’s management should assess the initial and continuous
training needs of qualified users, radiologists or other physicians responsible for the interpretation and / or
acquisition parameters. The facility should identify the individuals that should take part in the training relative to
dose-reduction features, and dose related acquisition parameters.
For safe and effective use of the system, GE Healthcare recommends that each user of the equipment reviews
the procedures and safety precautions at least on annual basis and specially for dose management, GE
Healthcare recommends a semestrial training.
Contact GE Healthcare representative for refresher training options as part of the Radiological Technologists
continued education requirements for a licensure maintenance.
It is highly recommend that physicians be provided adequate time to participate in training and image quality
feedback.

InnovaTM IGS 620,
InnovaTM IGS 630
2-1-3 Application
Environment:
• General
– Indoor use only.
– The Innova is suitable for Interventional X-ray procedures (angiograms, device placement, non vascular or
minimally invasive surgery) and can be used:
• either in an Interventional Room.
• or in a dedicated lab within an Operating Room Environment which is outside a location designated for
marked "AP" or "APG" Equipment. Category AP Equipment is an Equipment or Equipment part complying
with specified IEC60601-1 requirements on construction, marking and documentation in order to avoid
sources of ignition in a flammable anaesthetic mixture with Air. Category APG Equipment is an
Equipment or Equipment part complying with specified IEC60601-1 requirements on construction,
marking and documentation in order to avoid sources of ignition in a flammable anaesthetic mixture with
Oxygen or Nitrous Oxide.
– The device is not to be used to do open surgical procedures.
– The Operating Room Environment is an environment which has environmental characteristics equivalent to
an Operating Room for infection control. Special attention is required to clean suspended equipment as per
device recommendation and Preventive Maintenance.
• Conditions of Visibility
– Ambiant luminance: 150 lux maximum.
• Environmental Room Condition
Exam Room Control Room

Temperature 15°C to 32°C 15°C to 35°C
range
Relative humidity 30% to 70%, non condensing 30% to 75%, non condensing
range
Altitude range Sea level to 2000 m (15-32°C). Sea level to 2000 m (15-32°C).
Note: The chiller is able to dissipate maximum
continuously power at 3000 meters in an ambient
temperature up to 20°C, for this altitude the tech-
nical room temperature shall not exceed 20°C.
Atmospheric 794 hPa to 1060 hPa 794 hPa to 1060 hPa
pressure range
Read and understand all the instructions in the Operator Manual before attempting to use the system and request
additional training from GE Healthcare if needed.
Periodically open the Operator Manual to review the procedures and safety precautions.
FAILURE TO FOLLOW THE OPERATING INSTRUCTIONS AND SAFETY PRECAUTIONS

COULD RESULT IN SERIOUS INJURY TO THE PATIENT, OTHERS OR YOURSELF.
FAILURE TO FOLLOW THE OPERATING INSTRUCTIONS AND SAFETY PRECAUTIONS

PROVIDED IN MANUFACTURER’S INSTRUCTIONS OF HIGH FREQUENCY SURGICAL TOOL,
CARDIAC DEFIBRILLATORS AND CARDIAC DEFIBRILLATOR-MONITOR COULD RESULT IN
SERIOUS INJURY TO THE PATIENT, OTHERS OR YOURSELF. ATTENTION IS DRAWN TO
THE FACT THAT THE INNOVA IGS SYSTEM IS NOT PROTECTED AGAINST
DEFIBRILLATION SHOCKS.

InnovaTM IGS 620,
InnovaTM IGS 630
2-2 Be Sure the Equipment is Functioning Before each Use

Visually inspect the equipment for damage and missing parts. Do not turn on electrical power if any of the cover
panels are not in place or broken; hazardous electrical or mechanical parts could be exposed. Damaged parts may
lose their degree of protection against harmful ingress of liquids or may fall. Replace the damaged or missing parts.
Verify that the following controls are operating correctly:
• Motion Controls, Motion Enables, and Table Top Brakes.
– Perform a daily check of the gantry pivot axis (RAO/LAO rotation) position by moving it to PA position by
using the Auto Positioner command.
Check that the gantry C arm is in vertical position and that "RAO/LAO 0 deg" +/- 1 deg is displayed on the
Geometry area, left on the live display.
Move the gantry pivot axis and check that the displayed angle is updated.
In case of mismatch detected, call your local Service Representative.
– For system using an Omega IV or Omega V Table, perform a daily check of the table Up/Down axis by
moving the table to its lowest position.
Check that " " is displayed on the Geometry area, left on the live display.
Move the table Up and check that the displayed value is updated.
In case of mismatch detected, call your local Service Representative.
• Emergency Stops.
ACTIVATE THE WALL AND CONTROL PANEL EMERGENCY STOPS MONTHLY.
• Collision Sensors and the routine for clearing collisions.
CHECK THE COLLISION SENSORS DAILY BY DEPRESSING ANY SENSOR.
• Large Display Monitor suspension.
CHECK DAILY THE PRESENCE OF THE LIVE IMAGE AND THE REFERENCE DISPLAY ON
THE 2 BACKUP MONITORS THAT ARE LOCATED EITHER AT THE BACK OF THE
SUSPENSION OR ON AN ADDITIONAL SUSPENSION.
• Innova Central touch screen.
– Check functionally the Innova Central touch screen mechanical fixing on the rail.
– Inspect visually the Innova Central touch screen housing and cable integrity.
– Inspect visually the Innova Central touch screen for chemical residuals or blinded spots.
– Check the operation of the touch-button selection, the joystick motion and pushbutton functions.
ASK FOR EXCHANGE IF ANY OF THE ABOVE FUNCTIONS SHOW DETERIORATION.
• Audible signal and error messages display.

• Verify no alarm message is displayed on the console or on the monitor (refer to Alarm Systems / List of Alarm
Messages).
Damaged controls could result in unintended motion. Do not operate the equipment if the controls are not operating
properly.

InnovaTM IGS 620,
InnovaTM IGS 630
When covering the equipment with sterile drapes or other protective covering, be sure the covering does not
interfere with the Motion Controls or Motion Enables.
Note: As per local regulations, record of these functional checks have to be kept with the equipment.
2-3 Always Be Alert to Patient Safety Concerns
Provide assistance for getting the patient on and off the table. Be sure all patient health lines (IV, oxygen, etc.) are
positioned so they will not be caught when moving the equipment. Never leave the patient unattended while in the
system room. An unattended patient could fall from the table, activate a motion control, or encounter other
problems which could be hazardous.
2-4 Operator Position
Operator should position around the table in area 1 or behind console in area 2.
The size of area 1 depends on usage of the cart option.
2-5 Radiation Safety

Always use proper Technique factors for each procedure to minimize X-ray exposure and to produce the best
diagnostic results. In particular, you must be thoroughly familiar with safety precautions before operating this
System.
2-6 Establish Emergency Procedures
It is not always possible to determine when some components, such as X-ray tubes, are nearing the end of their
operating lives. These components could stop operating during a patient examination.
ESTABLISH PROCEDURES FOR HANDLING THE PATIENT IN CASE OF THE LOSS OF

FLUOROSCOPIC IMAGING OR OTHER SYSTEM FUNCTIONS DURING AN EXAM. FAILURE
OF FLUOROSCOPIC IMAGING MAY HOWEVER BE RECOVERED BY FOLLOWING THE
PROCEDURE SPECIFIC FOR EACH VASCULAR SYSTEM.
2-7 Equipment Installed in Patient Vicinity
Note: Patient vicinity is defined as a space within the room 1.83 m beyond the perimeter of the examination table
and extending vertically 2.29 m above the floor.
The components that may be installed within patient vicinity are:

InnovaTM IGS 620,
InnovaTM IGS 630
• Omega Table: mattress and mattress slicker

• Innova LC Positioner and Lateral Positioner
• Monitors
– Monitors installed in the patient vicinity may not be medical equipment (i.e.: compliant with medical
equipment standard - IEC 60601-1). If this is the case, an additional ground protection wire is connected to
the monitor to meet medical system safety requirement.
• Injector
• Rad-shield
• Table Side User Interfaces (TSUI)
– Smart Box
– Smart Handle
– Table Side Status Control
– Table Panning Handle
• Innova Central touch screen
– Cable which connects the Innova Central touch screen to the Innova system through a dedicated connector
on the Patient table.
• In-room 3D Mouse
• Accessories:
– Table Head Extender
THE TABLE HEAD EXTENDER SHALL NOT BE USED WHILE THE TABLE IS TILTED.
FAILURE TO DO SO MAY RESULT IN SEVERE PATIENT INJURY.
X-ray exposure must not be performed with the X-ray tube above the table with the table extender between
the patient and the image receptor.
– Mattress and mattress slicker
All these components are medical components.
2-8 Accessories
All accessories are removable.
To avoid improper operation of accessories, always verify proper connection by checking

the label above the connector when attaching an accessory to the table.
Attach only GE approved accessories to the table. Be sure to connect each accessory to the
proper connector, as labeled on the table. In particular, be sure to connect the grounding
cables.
Table accessory rail load consideration:
1 - On the table accessory rails:

The maximum load a table-side accessory rail can handle is 40 kg.
In case of heavy injector (i.e. MEDRAD Avanta - 33.5 kg - ...) installed on the table accessory rail, only light
extra load not exceeding 5 kg at 100 mm from the rail (i.e.: IV pole with its accessories: saline bag, etc. Use
IV Pole to hang only IV Fluids. The max load on the IV pole shall be 1 kg max per hook.) is allowed to be
installed on the same rail as the injector.
Typical installation on the front table accessory rail is Smart Handle or Smart Box, Table Side Status
Control (TSSC), Innova Central touch screen, Table panning device and cables support.
Here are some GEHC accessories and their weight:

InnovaTM IGS 620,
InnovaTM IGS 630
Devices on table rails Weight (kg)

Smart Box with cables 5.8
Smart Handle with cables 4.3
TSSC with cables 5.7
Innova Central touch screen 4.1
In-room 3D Mouse 2.9
Cable support 0.5
Table Panning Device (TPD) 1.0
Rad-shield 13.6
On each screw of the table accessory rail, the maximum allowed torque is 64 N.m. All GEHC accessories
listed above are compliant with this specification. In case of non-GEHC accessory installation on the table
accessory rail, make sure the torque remains below 64 N.m.
2 - If needed, an optional rail can be installed at table foot end of the Omega V table for other accessories
installation. The total weight of all devices installed on this rail shall remain below 20 kg.
In any case, always make sure the weight of devices on the table side-rail remains below 40 kg, and below
20 kg on the optional table foot end rail. Also, make sure the torque on each screw is below 64 N.m,
according to the following formula:
Torque = 10 x weight (kg) x distance to the rail (m).
For example, a 5 kg load, located 10 cm away from the rail, has a torque of : 10 x 5 (kg) x 0.1 (m) = 5 N.m.
To avoid damage to an accessory or the table covers, no accessory, should be placed too
low or in the vicinity to come into contact with the table covers during vertical or tilt
motions.
Check that each accessory is properly mounted and clamped if provided with clamps before
any use.
2-9 Periodic maintenance and inspection
Periodic maintenance is required for continued SAFE operation. Qualified personnel should
perform periodic maintenance as specified in the maintenance schedule of the Service
Manual and Operator Manual.
• Descriptions and scheduled frequency of the required periodic maintenance are provided in the Service
documentation supplied with the equipment. It is the owner's responsibility to supply or arrange for this service.
Refer to Periodic Maintenance Program Chapter for the list of the periodic maintenance requirements.
• Inspection intervals are based on average daily use of one eight-hour shift. More frequent inspection is
appropriate where equipment use is above average. Refer to Section Safety and Regulatory / General Safety /
Be Sure the Equipment is Functioning Before each Use in this chapter or refer to the table below for details.
Daily Checks
Actions Refer to
-
Shutdown at least once per day
Gantry pivot axis check Safety and Regulatory / General Safety / Be Sure the Equipment is
Functioning Before each Use
Table up/down check Safety and Regulatory / General Safety / Be Sure the Equipment is

InnovaTM IGS 620,
InnovaTM IGS 630
Collision sensors check Safety and Regulatory / General Safety / Be Sure the Equipment is
Diamentor constancy check Diamentor M4 KDK (Option) / Performing a Measurement / Constan-
cy Check
Innova Central touch screen Safety and Regulatory / General Safety / Be Sure the Equipment is
Monthly checks
Actions Refer to
Wall and control panel emergency stop Safety and Regulatory / General Safety / Be Sure the Equipment is
Suspensions cleaning Safety and Regulatory / Protection against contamination / infection /
allergy / toxicity hazards / biological hazards / Suspensions Cleaning
QAP check Quality Assurance Program (QAP) / Parameter monitoring / Fre-
quency
Check Once every 3 months

Action Refer to
UPS battery recharge if not used Innova Digital / Fluoroscopy and Acquisition / Fluoro UPS (Option)
FAILURE TO PERFORM THE PERIODIC INSPECTION AND MAINTENANCE COULD ALLOW

DETERIORATING CONDITIONS TO DEVELOP WITHOUT BEING DETECTED. THIS
DETERIORATION COULD RESULT IN EQUIPMENT FAILURES WHICH COULD CAUSE
SERIOUS INJURY OR EQUIPMENT DAMAGE.
2-10 Storage media
Put storage media (tapes, CDs) in safe conditions: temperature (see the instructions on CD
packages).
2-11 Extra Iodine Injection
When used in automatic mode, the injector can be triggered by the system before or after X-ray (X-ray delay or
Inject delay).
When the injector is fired before X-ray, there is always an unpredictable residual risk that X-ray will not start, so, the
injection could be lost (our internal data give a very low occurance rate).
Always use the X-ray delay mode (injection first then X-ray) only when clinically appropriate.
2-12 Image Presentation
The image presentation does not automatically follow the patient position over the table top
(Prone, Supine, Head to Toes reversed…). It is under the responsibility of the operator to
select the patient position according to his/her actual position on the table in order to get
proper image orientation.
3 Protection against radiation

3-1 Biological Deterministic Effects of Dose

InnovaTM IGS 620,
InnovaTM IGS 630
Biological effects of any dose should be divided into low and high levels. During most procedures, the effects of
patient irradiation are low. Cardiac or neurology procedures could give the patient high doses of radiation, and this
can be the cause of injuries to the patient (e.g.: skin injuries, alopecias). In order to minimize this risk without
adversely affecting the clinical objectives of the procedure, it is currently admitted that precautions should be taken
when skin dose in a single location can exceed 1 Gy.
Due to the duration of total fluoroscopic time and the number of acquisition sequences in a single location, the risk
is particularly important in cardiac and neurology procedures.
GE Healthcare equipment includes dose limitations mechanisms; in particular, the conventional entrance skin Air
Kerma rate is maintained below 87 mGy/min (10 R/min), or at a lower level depending of local regulation, in a plane
representative of patient skin dose, and positioned 30 cm from the entrance of the Image Receptor. Therefore, in
this plane, the value of 1 Gy may be reached in 10 to 12 minutes of fluoroscopy for thick body parts, or for body
parts of average patients viewed with a large angulation, or for obese patients; usual levels of fluoroscopy of the
head or for average patients without large angulation are 2 to 5 times lower.
In particular configurations required for an examination, patient skin could be significantly closer to the X-ray
source, with dose rate increased as the inverse square of the distance.
In case of long procedures and/or when X-ray is focused on a single location. Use low
fluoro and record detail in order to reduce risk of patient injury due to ionizing radiation and
other recommendation listed in Safety and Regulatory / Protection against radiation / How
to Reduce Radiation Exposure Dose.
3-2 Dose Monitoring
• "Dose monitoring" is a feature of the Innova system, displaying air kerma rate, cumulated air kerma and DAP.
• Output parameters are displayed in the DL console and on the live & reference displays.
• The dose levels are determined with a measurement method based on the measured Generator X-ray
Technique parameters (kVp, mAs), on the Spectral Filtration position reported by the collimator, on measured
mR/mAs calibration values obtained with a radiation dosemeter, and on a transfer function (computation).
• The air kerma (referred as "Exposure Dose" / "Rate") and exam dose (referred as "Exposure Dose" /
"Cumulated") parameters are computed for the Interventional Reference Point.
• The DAP (Dose Area Product) is computed based on collimator opening (FOV and collimation).
• The accuracy of the displayed dose rate and cumulated dose is ±35% down to 100 mGy for dose and 6
mGy/min for dose rate. The accuracy of the DAP is ±30% down to 2.5 Gy.cm2 for DAP.
3-3 Concept of Interventional Reference Point (Patient Entrance Reference Point)
The PATIENT ENTRANCE REFERENCE POINT is called the Interventional Reference Point (IRP) in this
document.
The INTERVENTIONAL REFERENCE POINT, is intended to be representative of the point of intersection of the
X-ray beam axis with the patient. For the GE Healthcare systems including an isocenter, the INTERVENTIONAL
REFERENCE POINT is the point on the reference axis 15 cm from the isocenter towards the focal spot.
This distance is assumed to represent a good approximation of the value of the actual focal spot to skin distance
during interventional procedures. If one considers currently available methods to estimate absorbed doses to
selected tissues for radioscopic and cine-angiographic examinations of the coronary arteries of adults, these
methods rely on the use of distinct operating conditions commonly used in radiological examinations of the heart.
These operating conditions are associated with a view, an arterial projection, and technique factors on the X-ray
equipment such as the X-ray tube voltage (kV), the half value layer (HVL), and the focal spot to skin distance, the
focal spot to image receptor distance and the entrance field size.
A review of the operating conditions derived from analyses of practice indicates that the defined interventional
reference point is, in fact, a fair approximation of the focal spot to skin distance for each field. Unfortunately, similar
data are not available for non-cardiac diagnostic and interventional procedures.
The error in estimating the total absorbed dose to the skin introduced from the defined interventional reference
point should average out as long as the interventional procedure is composed of multiple views. When the

InnovaTM IGS 620,
InnovaTM IGS 630
interventional procedure is limited to one or a few views, the possibility of error in estimating the absorbed dose to
the skin may be higher. However, even under worst-case conditions, errors should be less than a factor of two.
Of course, assessing the position of the patient and calculating the appropriate correction factor can eliminate most
of this error.
Isocenter
Isocenter is the point at which the rotational axes of the L-Arm and the rotational axis of the C-Arm intersect.
Focal Spot to Interventional Reference Point Distance
For Frontal plane X-ray Tube: 57 cm (22.4").
For Lateral plane X-ray Tube (biplane system only): 56 cm to 73 cm (22" to 28.7").
3-4 Significant Zone of Occupancy
There is a significant zone surrounding the table that identifies proximity to the radiation source. Included in the
significant area is the table side area where the Physician stands to perform the procedure.
3-5 Skin Spacer Use
EXPOSURE RATE IS APPROXIMATELY 1.5 TIMES GREATER AT 305 mm FROM THE FOCAL
SPOT THAN AT 380 mm. USE THE SKIN SPACER TO ENSURE A MINIMUM DISTANCE OF
380 mm.
3-6 How to Reduce Radiation Exposure Dose
3-6-1 Radiation Time
In Fluoro: check and control the elapsed fluoroscopy time. When possible change the entry point of the beam in
order to reduce local dose.
In Record: try to keep the frame rate at the lowest value compatible with medical requirements; minimize the total

InnovaTM IGS 620,
InnovaTM IGS 630
sequence.
3-6-2 Protection
When the tube is positioned under the table the patient helps protect the staff.
Additional lead aprons and protective devices such as lead gloves, glasses and thyroid shields are also effective in
limiting occupational exposure dose.
IN ORDER TO REDUCE RISKS ASSOCIATED WITH IONIZING RADIATION AND FACILITATE

COMPLIANCE WITH LOCAL REGULATION CONCERNING RADIATION PROTECTION,
ALWAYS USE RADIATION SHIELDING DEVICES (CEILING MOUNTED AND TABLE-SIDE
RAD-SHIELDS). THEY WILL PROTECT THE OPERATOR AGAINST STRAY RADIATION
(RADIATION LEAKAGE PLUS RADIATION SCATTERED BY THE PATIENT); THIS
PROTECTION SHOULD BE CONSIDERED AS PARTICULARLY CRITICAL WHEN
PERFORMING INTERVENTIONAL OR LONG PROCEDURES.
3-6-3 Other Methods to decrease Exposure Dose
• Select a protocol with RDL auto exposure preference whenever possible.
• Select a protocol with "Max Dose Reduction" setting instead of "Balanced IQ/Dose" setting for Fluoro 15 fps, 7.5
fps and 3.75 fps (only for no sub fluoroscopy).
• Use Low fluoro detail whenever possible.
• Use lowest fluoro available frame rate whenever possible.
• Maximize the distance between the patient and the X-ray tube.
• Minimize the distance between the patient and the Image Receptor.
• Collimate.
• Remove grid only for infants up to 1 year old at Field of View smaller than 20 cm.
Note: It is recommended that anti-scatter grids be used with minimal air gap in both planes for all biplane imaging

InnovaTM IGS 620,
InnovaTM IGS 630
applications except for infants. Overall imaging efficiency, in terms of image quality achieved for a given Air Kerma,
is equal or better using grid and minimal air gap compared to no grid with air gap except for the smallest patient
anatomies (e.g.: infants) at Field of View smaller than 20 cm.
For all anatomies, except for infants (patients up to 1 year old) at Field of View smaller than 20 cm, it is preferable
to use the grid with minimum air gap.
3-7 Avoid Unnecessary Exposure to Radiation
When possible stay behind the lead glass radiation shield or lead screen.
When in unshielded areas wear protective apparel such as goggles, lead aprons, and gloves.
3-8 Protective devices and Accessories
Refer to the accessories catalog for a complete list of available radio-protection devices. (Rad shield, gloves,
apron, glasses, etc.)
3-9 Retake - Improper Use
Improper use of the Digital equipment could lead to retakes of diagnostic images, thus
requiring additional patient and operator exposure to radiation. Therefore, observe
operating instructions.
3-10 Dose and Dose Rate Measuring Procedure
This procedure is intended to provide the details to be able to conduct measurement of radiation data consistently
with radiation data documented in the user instructions specific to each vascular system.
3-10-1 Test Equipment
3-10-1-1 Phantom
Material - Polymethyl-methacrylate (PMMA)
Rectangular blocks with sides equal to or exceeding 25 cm.
Nominal thickness: 20 cm. (the phantom may be fabricated from layers of material) area density of the nominal 20
cm.
Phantom: 23.5 gcm-2 +/- 5 %.
3-10-1-2 Dosimeter
The measuring probe must be small enough to cover not more than 80 % of the area of the X-ray beam in the
plane of measurement and the area of its surface perpendicular to the source-detector axis must not exceed 30
cm².
3-10-2 Measurement Procedure
3-10-2-1 Relevant parameters
The following are the factors that need to be referenced, when relevant to the equipment settings concerned:
• Equipment configuration:
1. Orientation of the X-ray BEAM (vertical unless otherwise specified);
2. PATIENT SUPPORT in or out;
3. ANTI-SCATTER GRID in or out;
4. Appropriate ENTRANCE FIELD SIZE selected (FOV).
• Operating settings (representative of normal use):
1. Technical details of parameters included in each mode of operation;
2. Frame rate;
3. Selectable added filters automatically applied;

InnovaTM IGS 620,
InnovaTM IGS 630
4. Selectable added filters manually applied.

• Test geometry:
1. Focal spot to image receptor distance (SID);
2. Focal spot to detector distance;
3. X-ray field size at the measuring detector;
4. Positioning of phantom;
5. Positioning of measuring detector.
For each of these factors, a value is assigned and is indicated prior the radiation data stated (see hereafter in the
user instructions specific to each vascular system) they must absolutely be used in case of measurement of
radiation data.
3-10-2-2 Positioning of phantom and measuring chamber
The phantom is placed near the image receptor, leaving as much of the available distance as possible between the
X-ray tube assembly and the entrance surface of the phantom. (This is to minimize the effect of scattered radiation
on the measurements). Refer to radiation data in the user instructions specific to each vascular system.
Recommendation:
Position the measuring detector at a point that is either at the interventional reference point (see Safety and
Regulatory / Protection against radiation / Concept of Interventional Reference Point (Patient Entrance Reference
Point") (only if there is at least 20 cm distance between the measuring detector and the phantom) or half-way
between the focal spot and the entrance surface of the phantom. In that case, the readings are to be corrected to
the appropriate distance. Any other position that would minimize stray radiation may be used.
The surface of the phantom must be aligned perpendicular to the X-ray beam axis within ±2 degrees in all
directions.
3-10-2-3 Checking the test conditions
Before any dosimetric measurements are done, verify that the equipment settings under test and the associated
measuring arrangements are in compliance with Configurations of the equipment and test geometries defined
in radiation data in the user instructions specific to each vascular system.
Dosimetry is not to proceed, and therefore compliance with dosimetric statements cannot be determined, unless
the associated information is in itself compliant.
3-10-2-4 Basic measurements
Measure the dose rate (air kerma rate) for each of the radioscopic settings.
Measure the air kerma per image for each radiographic settings.
Measurements are made using the 20 cm phantom.
3-10-2-5 Operator selectable parameters
For settings in normal mode measured in previous paragraph "Basic measurements", measure the dose rate (air
kerma rate) using the nominal 20 cm PMMA phantom:
• for each operator selectable entrance field size (FOV); (as defined in radiation data).
• for each operator selectable added filter; (if applicable as defined in radiation data).
• for each operator selectable pulse repetition frequency; (if applicable).
3-10-3 Compliance Criteria
From the measured values obtained in the tests, calculate the corresponding values of reference air kerma (rate) at
Interventional Reference Point by using the inverse square law if necessary.
Compliance is verified if:

InnovaTM IGS 620,
InnovaTM IGS 630
• no value stated in the instructions for use (hereafter in paragraph "radiation data") differs from the
corresponding calculated value by more than 50 % of the stated value;
• in respect with the two radioscopic modes of operation, the ratio of the "normal" value to the "low" value is not
less than 2*.
The values are only valid for the factory settings. When settings are changed they may deviate.
* In some isolated specific cases, a normal to low ratio down to 1.8 could be seen. Compliance is maintained since
these are isolated cases, with a ratio difference comparable to the typical measurement gage and since other
means are available to the operator to reduce the reference air kerma rate (FOV change, fps change, Autoexp
selection change), and therefore an equivalent safety can be maintained.
4 Protection against electrical hazards

4-1 Covers
DO NOT REMOVE COVERS OR PANELS. OPERATOR CONSOLE AND CABINETS CONTAIN

HIGH VOLTAGE CIRCUITS FOR GENERATING AND CONTROLLING X-RAYS. PREVENT
POSSIBLE ELECTRIC SHOCK BY LEAVING COVERS OR PANELS ON THE EQUIPMENT.
THERE ARE NO OPERATOR SERVICEABLE PARTS OR ADJUSTMENTS INSIDE THE
CABINETS. ONLY TRAINED AND QUALIFIED PERSONNEL SHOULD BE PERMITTED
ACCESS TO THE INTERNAL PARTS OF THIS EQUIPMENT.
4-2 Cabinet Air Flow
Do not lay any object on the cabinets that would restrict airflow from the top of the cabinet.
4-3 Uninterruptible Power Supply UPS
AFTER POWERING OFF THE SYSTEM BY THE GENERAL BREAKER OR THE CONSOLE
ON/OFF, SOME PARTS CONTINUE TO BE ENERGIZED THROUGH A BATTERY FOR A
COUPLE OF MINUTES IN ORDER TO PROPERLY SHUTDOWN THE COMPUTERIZED
COMPONENTS. BEFORE INSPECTING OR SERVICING THE SYSTEM, ENSURE THAT ALL
PARTS ARE CORRECTLY DE-ENERGIZED. (REFER TO THE SAFETY PROCEDURE DEFINED
IN THE SERVICE MANUAL).
4-4 Laser
A laser product is used to connect external modalities to the Large Display Monitor.
This product implements an optical module used for data transmission, manufactured by OPTICIS CO., LTD., and
classified as laser Class 1.
Center wavelength minimum = 1300 nm and maximum = 1550 nm.
Invisible LED radiation not in excess of class 1 safety limits (CDRH and EN 60825).
If applicable:
Switch off the laser product before moving optical fibers.
Do not put your eye in front of the laser diode aperture.
Class 1 Laser Product
5 Protection against mechanical hazards

InnovaTM IGS 620,
InnovaTM IGS 630
5-1 Patient Positioning on Tabletop

The system anti collision device is based on a virtual volume representing the patient loaded on the tabletop in
"standard position".
This "standard position" is defined as head of the patient located at head end (gantry side) of the tabletop.
1 Patient Head
For any other position of the patient over the table top (use of table head extender, patient positioned lower on the
table top, patient head to toes reversed...), a special attention is required from users to watch any gantry motion
when approaching the patient, the virtual patient volume being in this case not in the same location than the patient
on the table top.
5-2 Use Extreme Care when Positioning the Equipment
The safety of everyone near the moving equipment depends on the operator at the controls. Although collision
sensors are provided on the image receptor and collimator, they are not intended to be a substitute for careful
operation. Be sure the equipment path is clear before starting a motion. When positioning the equipment, carefully
observe the moving parts, and stop the motion before making contact. The sensors are provided for added
protection in case of inadvertent contact, and are not to be relied on as a normal means for stopping the motion.
Improper equipment positioning could result in serious injury or equipment damage.
THE OPERATOR'S ATTENTION IS DRAWN TO THE PRESSURE THAT MAY BE APPLIED ON

THE PATIENT BODY IN CASE OF ACTIVATION OF SYSTEM ANTI-COLLISION DEVICES
(BUMPERS, SWITCH PLATE). EVEN IF THE PRESSURE APPLIED IS FAR FROM 200 N (20
kg) WHICH IS THE MAXIMUM PRESSURE RECOMMENDED BY SAFETY STANDARD FOR
INTENTIONAL APPLICATION OF AN ACCESSORY ON THE PATIENT BODY FOR CLINICAL
PURPOSE, THE PRESSURE MAY SOMETIMES BE IMPORTANT FOR PATIENTS HAVING
UNDERGONE RECENT SURGERY (ON THE THORAX/ABDOMEN FOR INSTANCE).
SPECIAL ATTENTION MUST BE TAKEN REGARDING THE POSITIONING OF THE IN-ROOM

MONITOR SUSPENSION. BEFORE RAISING OR TILTING (IF APPLICABLE) THE TABLE,
ALWAYS POSITION THE MONITOR SUSPENSION TO AVOID COLISION WITH THE PATIENT
AND THE EQUIPMENT. FAILURE TO THIS RECOMMENDATION MAY CREATE PATIENT
INJURY AND/OR EQUIPMENT DAMAGE.
IN THE "FOLLOW THE GANTRY" MODE, USER’S ATTENTION IS MORE FOCUSED ON THE
AW IN-ROOM MONITOR THAN ON THE MOVING GANTRY. DURING SUCH OPERATION,
ALSO KEEP CONSTANT ATTENTION TO THE GANTRY TO AVOID COLLISION WITH THE
PATIENT AND PEOPLE WORKING CLOSE TO THE GANTRY. FAILURE TO FOLLOW THIS
RECOMMENDATION COULD RESULT IN SEVERE INJURIES TO THE PATIENT OR STAFF
WORKING IN THE ROOM.
SPECIAL ATTENTION MUST BE TAKEN WHEN MOVING THE SUSPENSION OR IF THE

GANTRY PUSHES THE SUSPENSION IN ORDER TO AVOID COLLISIONS WITH THE
PATIENT OR THE USERS.

InnovaTM IGS 620,
InnovaTM IGS 630
Always use proper accessories to hold the patient and prevent risk of injury during the
motion of the equipment.
5-3 Movement of Patient on the Table
Never leave the patient unattended. An unattended patient could fall from the table, activate
a motion control, or encounter other problem, which could be hazardous. In addition, it is
recommended to use restraints, such as Velcro straps. The restraints limit, but do not
eliminate the risk for the Patient to fall; in no way they can be used to support the Patient
weight.
The Omega tabletop mattress is provided with three Velcro strips on each side. While loading or unloading
the patient, it is recommended to grip the Velcro strips to avoid the mattress shifting.
Ensure the Velcro strips are well stuck on the tabletop prior to loading or unloading the patient.
5-4 Tableside Cart (Option)

The Tableside Cart is provided to the customer fully installed and ready to use.
Any mechanical configuration modification must be performed by qualified and trained engineers only.
This product must be serviced with Manufacturer approved original replacement parts only. Failure to follow this
recommendation will void the Manufacturer’s warranty and will release the Manufacturer from liability and warranty
claims.
The Manufacturer cannot be held liable for unauthorized modifications made to the system or use of the system for
unintended purposes. Since improper modifications may impair proper operation, safety, or reliability of the system,
all modifications need to be authorized by the Manufacturer.
NEVER POSITION THE TABLESIDE CART IN A LOCATION WHERE IT COULD ENTER IN

COLLISION WHILE THE TABLE IS TILTED OR MOVED UP OR DOWN.
When positioning or moving the Tableside Cart, avoid collision with other equipment.
Failure to do so may lead to severe damage on both the Tableside Cart and other
equipment. In case of severe collision or equipment damage, immediately stop operation of
the system. Keep the area around the Tableside Cart clear of any equipment.
The Tableside Cart is not designed to hold other accessories than those installed at tableside of GE angiographic
X-ray system.
Compatible Table Side User Interface (TSUI) allowed to be installed on the Tableside Cart:
• Smart Box/Smart Handle,
• Table Side Status Control (TSSC),
• Innova Central touch screen,

InnovaTM IGS 620,
InnovaTM IGS 630
• In-room 3D Mouse.
The Tableside Cart is not designed to hold the injector head or injector control panel.
The maximum weight a rail can hold is limited to 13 kg, which is always more than any combination of 2 of the
above TSUI.
The maximum weight the Tableside Cart can hold is limited to 50 kg. Do not stand on wheels or Tableside Cart
base.
To prevent the Tableside Cart from falling over, never move or use it on a slope greater than
10°.
Do not open covers.
5-5 System Collision
Anti-collision software and sensors are provided for patient safety. The sensor pads, which surround the X-ray tube
and the Image Receptor, contain pressure sensitive collision sensors. There is one level of collision sensing for
X-ray tube sensor and there are two levels for Image Receptor sensor.
DEPENDING ON SYSTEM CONFIGURATION: THE REAR OF THE IMAGE RECEPTOR LIFT IS

NOT PROTECTED BY COLLISION SENSOR. WHEN THE GANTRY L-ARM IS ROTATED BY
AT LEAST +45°, A COLLISION BETWEEN THE REAR OF THE IMAGE RECEPTOR LIFT AND
THE PATIENT COULD OCCUR DURING A GANTRY MOTION. SPECIAL ATTENTION TO THE
PATIENT IS REQUIRED WHEN WORKING WITH THE GANTRY L-ARM ROTATED BY AT
LEAST +45°.
5-6 Split or Punctured Table
A SPLIT OR PUNCTURED TABLETOP MAY INJURE PATIENT AND OPERATOR HAND.

REPLACE TABLETOP IMMEDIATELY.
SIGNIFICANT TABLETOP DAMAGE WILL REDUCE STRUCTURAL INTEGRITY AND REQUIRE IMMEDIATE
REPLACEMENT OF TABLETOP. MINOR DAMAGE, SPLINTERS, AND CHIPS, WILL NOT REDUCE
INTEGRITY BUT REQUIRE CARE IN USE AND PATIENT POSITIONING TO AVOID INJURY.
5-7 Driving the Table
DRIVING THE TABLE TOP INTO FIXED OBJECTS MAY SEVERELY INJURE PATIENT. BE
SURE TO CHECK FOR OBSTRUCTIONS ABOVE AND BELOW THE TABLE BEFORE
RAISING OR LOWERING THE TABLE TOP.
5-8 Cardiac Pulmonary Resuscitation (CPR)
IF CARDIAC PULMONARY RESUSCITATION (CPR) IS REQUIRED WHILE THE PATIENT IS

ON THE TABLE, IT IS MANDATORY TO MOVE THE TABLE TOP TOWARD THE FOOT END,
POSITIONING IT OVER THE BASE OF THE TABLE AS DEMONSTRATED BY THE TWO
LABELS LOCATED ON THE SIDE OF THE TABLE BASE. CPR CAN THEN BE PERFORMED.
AT NO TIME SHOULD AN ADDITIONAL PERSON OR HEAVY EQUIPMENT BE PLACED ON
THE TABLE TOP WHILE PERFORMING CPR. ALWAYS MAINTAIN SUFFICIENT CLEARANCE
AROUND THE PATIENT SO AS TO BE ABLE TO CONDUCT CPR. WITH BIPLANE SYSTEM, IF
THE LATERAL PLANE IS IN THE "OFF ISO RANGE", THE LATERAL GANTRY MAY HAVE TO
BE MOVED TOWARD THE PARKING POSITION UNTIL THE TABLE TOP CAN BE ROTATED.
LATERAL CARRIAGE AND LATERAL PIVOT CAN ALWAYS BE MOVED MANUALLY (2
PERSONS MAY BE REQUIRED TO MOVE THE LATERAL GANTRY).

InnovaTM IGS 620,
InnovaTM IGS 630
THE GANTRY AND TABLE MOTIONS MAY BE SLOWED DOWN BECAUSE OF A NEAR
COLLISION RISK. IN THIS CASE, IT MAY BE FASTER TO USE MANUAL COMMANDS TO
MOVE THE PATIENT TO A CPR POSITION.
5-8-1 CPR with Omega Table
CPR position can be reached by manually moving all needed axes.
To reach CPR position, move the table top toward the foot end. CPR can be performed when the system is in this
position.
In addition to reaching the CPR position as described above, the table height may be lowered and Detector may be
moved to its highest position.
In the event of power loss the table may be manually pushed longitudinally to the foot end
and rotated. This operation may require more than one person.
5-9 Patient Loading/Unloading
BEFORE LOADING OR UNLOADING THE PATIENT ONTO OR OFF THE TABLE:
1 - ADJUST THE TABLE HEIGHT AND MOVE THE TABLE TOP TOWARD THE FOOT END FOR THE BEST
PATIENT ACCESS.
2 - ACTIVATE THE POSITIONER DISABLE BUTTON TO ENSURE THAT NONE OF THE TABLE AND GANTRY
WILL MOVE.
3 - DISABLE X-RAY.
4 - REMOVE ALL ACCESSORIES AND CONTROLS.
5 - HOLD THE TABLETOP.
Involuntary mechanical shocks on the Smart Box joysticks may produce unwanted
positioner motion and cause injuries. In case the Smart Box needs to be removed from the
table, always leave it in an area where its joysticks are protected from shocks.
With the Omega table, the Positioner Enable/Disable button only enables/disables
commands from the Smart Box/Handle and Table Side Status Control. It does not
enable/disable table top brakes command from the Fluoro/Record footswitch or the Table
Panning handle.
ALSO, THE PATIENT SHOULD BE SECURELY SUPPORTED BY HOSPITAL STAFF AS THE TRANSFER IS

InnovaTM IGS 620,
InnovaTM IGS 630
MADE FROM BED/GURNEY TO TABLE AND VICE VERSA.

It is mandatory to comply with these instructions in order to minimize the risk of patient falling from table
during loading or unloading process.
Hold the tabletop and securely support the patient as the transfer is made from table to
bed/gurney. It is mandatory to comply with these instructions in order to minimize the risk
of patient falling from table during unloading process.
5-9-1 Biplane System User Interface
Omega Table Side Status Control (TSSC)
12 Positioner Enable/Disable: activate this button to disable all table/gantry axis commands (button light ON).
Press again on this button to reactivate all table/gantry axis commands (button light OFF)
5-10 Clearance of the Patient in case of Emergency (Power Loss, Equipment Failures)
In the event of power loss with the patient positioned between the image receptor and table,
the patient may be released by manually moving the table longitudinally to the foot end and
then rotating it. This operation may require more than one person.
If the lateral plane is in the "Off ISO Range", the lateral gantry may have to be moved toward
the parking position until the table top can be rotated. Lateral carriage and lateral pivot can
always be moved manually (2 persons may be required to move the lateral gantry).
5-11 Check Equipment after collision
In case of collision between two parts of the system (e.g. gantry against a monitor) have the parts carefully
inspected before resuming the procedure.
5-12 Table Brakes failure
IN CASE OF FAILURE OF THE TABLE BRAKES, IT IS STILL POSSIBLE TO OVERCOME THE

TABLE BRAKES LOCK BY PUSHING MANUALLY ON THE TABLE TOP WITH SUFFICIENT
STRENGTH SO AS TO CLEAR THE PATIENT AS NEEDED IN CASE OF EMERGENCY
SITUATION.
5-13 3rd Party Imaging/Data Medical Device
For 3rd party imaging/data medical devices, refer to the safety recommendations in section Cathlab Frontiers
Solutions (Option).
6 Protection against contamination / infection / allergy / toxicity hazards /

InnovaTM IGS 620,
InnovaTM IGS 630
biological hazards
THE MATTRESS DELIVERED WITH THE OMEGA TABLE IS NOT FULLY WATERPROOF. TO
AVOID MATTRESS CONTAMINATION DUE TO FLUID ABSORPTION AND BIOLOGICAL
HAZARDS, ALWAYS USE A SLICKER (COVER THE MATTRESS WITH A FULLY
WATERPROOF SHEET OR COVER) BEFORE INSTALLING THE PATIENT ON THE
MATTRESS.
ALWAYS COVER THE TABLE TOP AND OTHER ACCESSORIES DIRECTLY IN CONTACT
WITH THE PATIENT WITH A SHEET OR A MATTRESS BEFORE INSTALLING THE PATIENT
ON THE TABLE TO PREVENT THE DIRECT CONTACT OF THE PATIENT WITH THE TABLE
TOP AND OTHER ACCESSORIES.
In order to prevent any patient contamination and according to the local regulation, after
each procedure, always clean and disinfect parts of the equipment which were in patient
vicinity (table top, mattress and/or mattress cover, shoulder rest, image receptor, monitors,
any parts that could be contaminated by operators...) with a bactericidal, germicidal and
antiviral solution. Check the solution used is also active against HIV and hepatitis B virus.
Mattress should be used with Omega tables. Mattress, slickers or sheets in direct contact with the patient must be
ISO 10993 certified.
6-1 General Information
Adequate cleaning and disinfection is necessary to prevent disease transmission. Be sure

to thoroughly clean and disinfect equipment surfaces that contact the patient and all
equipment surfaces likely to become soiled during use, in particular the waterproof
mattress.
Improper cleaning methods or the use of certain cleaning and disinfecting agents can
damage the equipment, cause poor imaging performance or increase the risk of electric
shock.
To avoid possible injury or equipment damage:
• Do not use harsh detergents, abrasive cleaners, high alcohol concentration or Methanol at any concentration.
• Do not expose equipment parts to steam or high temperature sterilization.
• Never allow liquids to enter the internal parts of the equipment. Do not apply cleaning sprays or liquids directly
to the equipment; always use a clean cloth dampened with the spray or liquid. If you become aware of liquid
entry, disconnect the electrical supply and have the equipment checked by qualified service personnel before
returning it to use.
6-2 Equipment Cleaning Instructions
The entire system surfaces should be scrubbed as needed using a soft, damp gauze or cloth to remove all visible
residue. Scrubbing with a soft bristle brush (such as a toothbrush) may be necessary to reach corners or to remove
material that has dried onto the surface.
Subsequent disinfection may not be effective if the surfaces are not thoroughly clean.
Rinse all surfaces with clean water to remove visible soap residue, taking care to avoid liquid entry to internal
equipment parts. Dry surfaces with a soft cloth to remove any visible residue.
Due to the relationship between length and multiple widths of the mattress, it is absolutely recommended not to
remove the cover from the mattress for laundry. Otherwise, it would then be extremely difficult to reposition the
mattress in its cover.
Although the footswitches are compliant with the applicable standards, it is recommended
to avoid liquid (bodily fluids, contrast agents, cleaning agents...) ingress into the footswitch.
In case of liquid ingress, ensure the footswitch is thoroughly rinsed and dried.

InnovaTM IGS 620,
InnovaTM IGS 630
In addition we recommend to put a drape over the footswitch to avoid any bodily fluids, contrast agents,
cleaning agents ingress.
6-3 Suspensions Cleaning

At least once a month, external metallic surfaces and exposed tracks, should be wiped to remove any foreign
material that may have accumulated.
If the tracks are wiped with a cloth slightly moistened with oil, sufficient lubrication will be provided to insure smooth
operations and to protect again rust. Enameled surfaces should be cleaned using a clean cloth moistened slightly
with a good mild cleaner and polish acceptable for such use.
6-4 Disinfection
Exam room equipment including system, monitors, suspensions and accessories, can be disinfected with suitable
liquid chemical germicide, bactericide and antiviral. Surfaces must first be cleaned of all visible contamination (see
above). The disinfecting liquid must have a minimum contact time with the surface to be effective. Equipment parts
should be wiped with a wet cloth as directed by the instructions for use provided with the disinfecting liquid. Further
rinsing or wiping with clear water and drying with a soft cloth should be done to remove any disinfecting liquid
residue that may remain. Take care to avoid liquid entry to internal equipment parts.
Note: Only handles from the Large Display Monitor suspension can be disinfected.
For non GE equipment refer to respective device manufacturers instructions and

recommendations for cleaning and disinfection.
6-5 High Level Disinfection

In the event that you feel a high level disinfection is necessary due to equipment contact with broken skin, or being
used with infected or immune compromised patients, the same patient contact surfaces may be high level
disinfected with a liquid chemical germicide rated for high-level disinfections. The same process used as that for
intermediate level disinfections is generally followed; however, the time of contact is usually much longer for
high-level disinfections.
6-6 Recommended Cleaning Agents
• Soap with lukewarm water.
6-7 Recommended Disinfecting Agents
The following legally marked products have been used on GE equipment without causing equipment damage.
• SURFANIOS (Supplier: ANIOS)
• CLEANSINALD (Supplier: TASKI) replacing the TASKI DS 5001 no more available

InnovaTM IGS 620,
InnovaTM IGS 630
• MORNING MIST (Supplier: BUTCHERS)

6-8 Guidance for the Use of the Cleaning and Disinfecting Agents Listed
Note: For the Large Display Monitor, only Surfanios, Cleansinald and Morning Mist products have been tested.
Always follow the cleaning and disinfecting agents manufacturer's instructions and
precautions for mixing, storage, method of application, contact time, rinsing requirements,
protective clothing, shelf life and disposal to help assure effective and safe use of the
product.
6-9 Flammable Gasses
Do not use equipment in the presence of flammable gasses.
6-10 Latex
There is no presence of latex in the system and no part in contact with the patient contains latex.
7 Protection against effect of incorrect output data sent to network (Dicom)

Attention of users is drawn on the fact that data sent through Dicom network are not fail-safe.
FOR EVERY EQUIPMENT CONNECTED ON THE NETWORK AND USING DICOM, USERS
MUST VERIFY THE COMPATIBILITY THROUGH DICOM CONFORMANCE STATEMENT.
7-1 Stenosis Analysis on networked devices
Stenosis Analysis used on networked devices and using data acquired on the angiography equipment must be
used with the equivalent precautions as those described for the equipment (See the specific Stenosis Analysis
chapter of this manual).

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 4 - Safety and Regulatory Instructions for Use

X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR. UNLESS
MEASURES OF PROTECTION ARE STRICTLY OBSERVED. THOUGH THIS EQUIPMENT IS

BUILT TO THE HIGHEST STANDARDS OF ELECTRICAL AND MECHANICAL SAFETY, THE
USEFUL X-RAY BEAM BECOMES A SOURCE OF DANGER IN THE HANDS OF THE
UNAUTHORIZED OR UNQUALIFIED OPERATOR. EXCESSIVE EXPOSURE TO X-RADIATION
CAUSES DAMAGE TO HUMAN TISSUE. THEREFORE, ADEQUATE PRECAUTIONS MUST BE
TAKEN TO PREVENT UNAUTHORIZED OR UNQUALIFIED PERSONS FROM OPERATING
THIS EQUIPMENT OR EXPOSING THEMSELVES OR OTHERS TO ITS RADIATION. BEFORE
OPERATION, PERSONS QUALIFIED AND AUTHORIZED TO OPERATE THIS EQUIPMENT
SHOULD BE FAMILIAR WITH THE RECOMMENDATIONS OF THE INTERNATIONAL
COMMISSION ON RADIOLOGICAL PROTECTION, CONTAINED IN ANNALS NUMBER 26 OF
THE ICRP, AND WITH APPLICABLE NATIONAL STANDARDS.
1 Indications for Use

The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating
fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic
and interventional procedures.
2 Contraindications
None.
3 Safety
3-1 Environmental Conditions
The conformity with the standard IEC 601-1 series has been established for an ambient temperature up to 32°
Celsius.
3-2 Equipment Classifications
The following equipment classifications are applicable to the product:
Classification category Equipment classification

Protection against electric shock Class I*.
TO AVOID THE RISK OF ELECTRIC
SHOCK, THIS EQUIPMENT MUST ONLY BE CON-

NECTED TO A SUPPLY MAINS WITH PROTECTIVE
EARTH.
Degree of protection against electric shock Type B applied parts
Applied parts complying with the specified requirements

of the IEC 60601-1 standard to provide protection against
electric shock, particularly regarding allowable patient
leakage current and patient auxiliary current include Mat-
tress.
Safety and Regulatory Instructions for Use 67

InnovaTM IGS 620,
InnovaTM IGS 630
Degree of protection against harmful ingress of water Ordinary equipment (enclosed equipment without protec-
tion against ingress of water); except footswitch which is
a watertight device (protected against the effects of sub-
mersion, IPX8).
Method(s) of sterilization or disinfection recommendedby Sterilization: not applicable.
the manufacturer Disinfection: refer to operator manual (Chapter Safety
and Regulatory section Disinfection), recommended dis-
infecting agents.
Degree of safety of application in the presence of a flam- Equipment not suitable for use in the presence of a flam-
mable anesthetic mixture with air or with oxygen or ni- mable anesthetic mixture with air or with oxygen or ni-
trous oxide trous oxide.
Mode of operation Continuous operation with intermittent loading.
* Classification Exemption:
The following accessible conductible parts are not grounded but are designed in double insulation as per IEC/EN
60601-1.
Omega Smart Box: Items 1, 2, 3 and 4
Omega Smart Handle: Items 1 and 2
68 Safety and Regulatory Instructions for Use

InnovaTM IGS 620,
InnovaTM IGS 630
Omega Table Side Status Control (TSSC): Items 1, 2 and 3
The Innova systems are compliant to electromagnetic compatibility IEC 60601-1-2 Edition 2.1 (2004)
(YY0505-2012) and Edition 3 (2007) standards for medical devices.
For further information, see the pre-installation manual.
4 Electrical Hazards
4-1 Power-off the System
WHEN THE SYSTEM IS POWERED OFF AT INNOVA CONSOLE OR AT THE PDB (POWER
DISTRIBUTION BOX), THE FOLLOWING PARTS IN THE SYSTEM - BACKED UP THROUGH
AN IN INTERRUPTIBLE SUPPLY (UPS) - ARE STILL LIVE DURING A PERIOD (AROUND 5
MINUTES) TO PROPERLY SHUTDOWN THE COMPUTERIZED PARTS OF THE SYSTEM.
• C1 FRONTAL AND LATERAL CABINET
• INNOVA DIGITAL SCREEN AND REMOTE KVM POWER SUPPLY (MOUSE AND KEYBOARD POWER
SUPPLY BOX)
• THE LARGE DISPLAY CABINET IN THE TECHNICAL ROOM AND THE LARGE DISPLAY MONITOR IN
THE EXAM ROOM
IN CASE OF UNSAFE SITUATION, REACT ON THE GENERAL EMERGENCY BUTTON

LOCATED 1.5 METERS ABOVE THE FLOOR NEAR THE ACCESS DOOR. THIS BUTTON

InnovaTM IGS 620,
InnovaTM IGS 630
WILL REMOVE ALL POWER FROM THE SYSTEM (EXCEPT THE INPUT CABLE OF THE 3
kVA UPS FOR CE CONFIGURATION WITHOUT FLUORO UPS), INCLUDING UPS AND
FLUORO UPS OUTPUTS.
4-2 Emergency STOP Procedure
Your system has a large Emergency STOP Button installed at an accessible location.
Emergency Stop button
PRESS THE EMERGENCY STOP BUTTON ANYTIME THERE IS AN EMERGENCY

CONDITION. THIS WILL REMOVE ALL POWER FROM THE SYSTEM (EXCEPT THE INPUT
CABLE OF THE 3 kVA UPS FOR CE CONFIGURATION WITHOUT FLUORO UPS), INCLUDING
UPS AND FLUORO UPS OUTPUTS.
• The emergency button should be used for emergencies only.
4-3 Emergency STOP Recovery
After an emergency, if you have used the Emergency STOP button, the system can be returned to normal
operation following few simple steps:
1. Go to the technical room where the Power Distribution Box (PDB) and the UPS stand.
2. Wait for at least 50 s after the Emergency STOP push button has been released.
3. Push the PDB ON push button (green button on the PDB front panel).
PDB CE PDB UL
4. Push the UPS ON push button during 3 s (Item 1).

5. Wait for 30 s that the UPS 3KVA "STATUS LED" stays ON (no more blinking) (Item 2).

InnovaTM IGS 620,
InnovaTM IGS 630
6. If the Large Display Monitor option is installed:

– Push the Large Display Cabinet UPS ON push button during 3 s (Item 1).
– Wait for 30 s that the UPS "Power On Indicator" stays ON (no more blinking) (Item 2).
7. Go back to the control room and push the ON/OFF button on the Innova Console (see Innova System / How to
Perform System Power-Up).
8. When ON/OFF button is pushed, gantry and table motions are available in less than 1 minute and new exam
creation is available in less than 4 min 10 sec.
5 Protection regarding Ionizing Radiations Hazards for Innova IGS 620

Innova IGS 620 is provided with a choice of 4 AutoExposure Preferences: "IQ Plus", "IQ Standard", "RDL Plus
(Receptor Dose Limited Plus)" and "RDL Standard (Receptor Dose Limited Standard)". Dose ratios mentioned
below are air kerma rate ratios measured according to IEC 60601-2-43 conditions.
• IQ Plus – High Contrast, 100% Dose lQ Plus produces images of arteries and guidewires optimized for high
object contrast at a nominal dose of 100%.
• IQ Standard – Low Noise, 70% Dose Using approximately 70% of the dose of IQ Plus, lQ Standard is
optimized to produce images with low fluoroscopic scintillation noise.
• Receptor Dose Limited Plus – High Contrast, 50% Dose Using approximately 50% of the dose of IQ Plus,
Receptor Dose Limited Plus (RDL Plus) is optimized to produce images with high contrast.
• Receptor Dose Limited Standard – Low Noise, 35% Dose Working with a low dose -approximately 35% of
that of IQ Plus -Receptor Dose Limited Standard (RDLS) is optimized to produce images with low fluoroscopic
scintillation noise and recommended for long time procedures.
Dose Reduction Strategy allows two modes selection for the Fluoro Low Frame Rates, 15 fps and 7.5 fps: either
the "Balanced IQ/Dose" mode allowing up to 25% (with fluoro 15 fps) and up to 44% (with fluoro 7.5 fps) dose
reduction versus fluoro 30 fps or the "Max Dose Reduction" mode allowing up to 50% (with fluoro 15 fps) and up to
75% (with fluoro 7.5 fps) dose reduction versus fluoro 30 fps.
In both strategies 3.75 fps offers 50% dose reduction compared to 7.5 fps.
Dose for Low Detail mode is about 50% of Normal Detail mode for Fluoroscopy, Cardiac Record and
InnovaChaseTM (except for fluoroscopy around high reference dose (87 mGy, 43 mGy, 21 mGy)), Low Detail mode
in DSA and 3DCT offers a smaller, but still significant dose reduction, see detailed data below.
Auto exposure preferences and fluoro low frame rates dose reduction strategy can be set independently in each
acquisition protocol at system installation.
Depending on system configuration and available options, several acquisition modes can be available.
• DSA mode: primary use for general angiography procedures.
• Cardiac mode: primary use for general cardiac procedures.
• InnovaChaseTM (Chase) mode: primary use for non subtracted Dynamic acquisition over any region of interest
(available on Frontal plane only).
• Innova 3D (3D) mode / Innova CT (3DCT) mode: primary use for 3D reconstruction and display of any region of
interest (available on Frontal plane only).

InnovaTM IGS 620,
InnovaTM IGS 630
5-1 Mode of Operation

5-1-1 Innova Digital
1 Record Auto-exposure: IQ Standard, IQ+, RDL Standard and RDL+

Fluoro Auto-exposure: IQ Standard, IQ+, RDL Standard and RDL+
Fluoro Dose Reduction Strategy: Balanced IQ, Max Dose Reduction
2 Frontal plane FOV selection: 20 cm, 17 cm, 15 cm, 12 cm
Lateral plane FOV selection: 20 cm, 17 cm, 15 cm, 12 cm
3 Record mode selection: Dynamic, DSA, Chase, 3D, 3D CT
4 Record parameters selection: frame rate, detail level, duration, Plane selection, Subtraction on/off, auto inject
on/off, injection delay value, X-ray delay value
Frontal plane record technique parameters display: Spectral Filter, kV, mA, ms
Lateral plane record technique parameters display: Spectral Filter, kV, mA, ms
5 Fluoro mode selection: No Sub, Subtracted Fluoro, Roadmap, Blended Roadmap on Frontal Plane and
Blended Roadmap on Lateral Plane
6 Fluoro parameters selection: frame rate, detail level
Frontal plane fluoro technique parameters display: Spectral Filter, kV, mA
Lateral plane fluoro technique parameters display: Spectral Filter, kV, mA, Landscape value, Enable Simulta-
neous display, Vessel value
5-1-2 Reference Image Monitor

InnovaTM IGS 620,
InnovaTM IGS 630
1 Record parameters display: record mode, detail level, frame rate, acquisition duration and X-ray/inject delay
Frontal plane record technique parameters display: kV, mA (peak for DSA and Chase, otherwise: average),
ms
Lateral plane record technique parameters display: kV, mA (peak for DSA, otherwise: average), ms
2 Fluoro parameters display: fluoro mode, detail level and frame rate
Frontal plane fluoro technique parameters display: kV, mA
Lateral plane fluoro technique parameters display: kV, mA
5-1-3 Live Image Monitor

InnovaTM IGS 620,
InnovaTM IGS 630
Frontal Live Image Monitor
Lateral Live Image Monitor

InnovaTM IGS 620,
InnovaTM IGS 630
1 Frontal plane selected FOV display

2 Frontal plane Source to Image Distance (SID)
3 Table Height displays the distance it is above or below isocenter of the system
4 Lateral plane selected FOV display
5 Lateral plane Source to Image Distance (SID)
6 Lateral plane Source to Object Distance (SOD)
5-1-4 Table Side Status Control (TSSC)

InnovaTM IGS 620,
InnovaTM IGS 630
4 Frontal FOV/2 switches + 1 digital display

5 Lateral FOV/2 switches + 1 digital display
13 Fluoro NoSub/Sub, NoSub/Roadmap, NoSub/Blended Rdmp Frt or NoSub/Blended Rdmp Lat.
5-1-5 Innova Central touch screen
Innova Central Touch screen Record tab
1 Record mode selection: Dynamic, DSA, Chase, Bolus, 3D, 3D CT

2 Record parameters selection: frame rate
3 Record parameters selection: detail level

InnovaTM IGS 620,
InnovaTM IGS 630
Innova Central Touch screen Fluoro tab
1 Fluoro mode selection: No Sub, Subtracted Fluoro,

Roadmap, Blended Roadmap on Frontal plane and
Blended Roadmap on Lateral plane
2 Fluoro parameters selection: frame rate
3 Fluoro parameters selection: detail level
5-2 Dose to Patient for Single Plane

Note 1: Fluoroscopy, Subtracted Fluoroscopy, Roadmap and Blended Roadmap acquisition modes belong to the
Radioscopy category, while all the other modes belong to Radiography.
Note 2: Roadmap, Blended Roadmap and Subtracted Fluoroscopy specific settings are the same, thus tables are
only provided for Roadmap, the Roadmap radiation data are directly applicable for Blended Roadmap and
Subtracted Fluoroscopy as well.
Note 3: Single plane and biplane Roadmap/Blended Roadmap/Subtracted Fluoroscopy specific settings differ only
for the highest frame rates (30 fps vs. 25 fps respectively), thus detailed Roadmap/Blended Roadmap/Subtracted
Fluoroscopy tables are provided only in Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 620 / Dose to Patient for Biplane / Available Settings. The 30 fps single plane
Roadmap/Blended Roadmap/Subtracted Fluoroscopy dose-rates can be calculated from the 25 fps biplane
Roadmap/Blended Roadmap/Subtracted Fluoroscopy dose rates by multiplication with a factor of 1.2. For smaller
frame rates (15 fps and 7.5 fps) the biplane Roadmap/Blended Roadmap/Subtracted Fluoroscopy radiation data
are directly applicable for single plane Roadmap/Blended Roadmap/Subtracted Fluoroscopy as well.
Note 4: All the following information is given for the Frontal and Lateral plane except InnovaChaseTM, and Innova

InnovaTM IGS 620,
InnovaTM IGS 630
3D/3DCT which are only Frontal.

Note 5: InnovaSpinTM has the same available settings as InnovaChaseTM, but those applications are only available
on frontal plane.
Note 6: 3D and 3DCT acquisition can be used in unsubtracted and subtracted modes. In these cases the same
loading factors are used, that results in identical dose/ frame values. For this reason detailed data are provided
only for unsubtracted 3D modes. Since subtracted 3D and 3DCT requires 2 consecutive spins, thus the integrated
dose in subtracted 3D modes is the double of the unsubtracted acquisition.
Note 7: Unsubtracted fluoroscopy in 3.75 fps uses the same settings per frame as in 7.5 fps. This results in
identical kVp, pulse width, and spectral filters, while the time averaged mA and dose rate in 3.75 fps fluoroscopy
are half of the corresponding 7.5 fps values. Because of this direct relationship separate tables for 3.75 fps are not
provided.
5-2-1 Skin Dose Levels
The skin dose levels in normal use may be high enough to cause deterministic effects. The availability of the
different settings (table below) has a considerable effect on the radiation quality, the delivered dose rate and the
image quality.
5-2-2 Available Settings
Available set- Fluoroscopy/ DSA Dynamic InnovaChase 3D 3DCT

tings Subtracted Record
Fluoroscopy/
Roadmap/
Blended
Roadmap
Available configurations
Orientation of 0 deg. (vertical) to horizontal (- 117 / + 105 degrees)
the X-ray beam
Patient support In
Anti-scatter In or Out
grid
Field of View 20 cm (nominal), 17 cm, 15 cm, 12 cm
Operating settings
Technical de- Selected kV: Selected kV: Selected kV: Selected kV: Selected kV: Selected kV:
tails of parame- 60-120 kV 50-125 kV 60-120 kV 60-120 kV 60-120 kV 60-120 kV
ters included in
mA: 31.2 mA mA: 41.7 - mA: 1 - 866 mA: 100 - 866 mA: 1 - 866 mA: 100 - 866
each mode of
Average @ 30 1000
operation
fps, 10 ms pw
Focal spot: 0.6 Focal spot: Focal spot: Focal spot: 1.0 Focal spot: 0.6 Focal spot: 0.6
0.3, 0.6 or 1.0 0.6 or 1.0 or 1.0 or 1.0
Frame rate 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 fps 5 fps 30 fps 50 fps
7.5 fps, 3.75 fps, 1.875 fps,
fps (only for no 1.0 fps, 0.5 fps
sub fluoro)

InnovaTM IGS 620,
InnovaTM IGS 630
Selectable Without or with Without or with Without or with Without or with Without or with Without or with
added filters one of the be- one of the be- one of the be- one of the below one of the below one of the below
automatically low Cu thick- low Cu thick- low Cu thick- Cu thicknesses: Cu thicknesses: Cu thicknesses:
applied nesses: nesses: nesses: 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu,
0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu,
0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, 0.3 mm Cu 0.3 mm Cu, 0.3 mm Cu
0.3 mm Cu, 0.3 mm Cu, 0.3 mm Cu, 0.6 mm Cu,
0.6 mm Cu, 0.6 mm Cu 0.6 mm Cu, 0.9 mm Cu
0.9 mm Cu 0.9 mm Cu
Geometry
Source to im- Frontal Plane: 85 to 119 cm +/- 1 cm
age distance Lateral Plane: 83.7 to 137.5 cm +/- 1 cm except in PA (88 to 118 cm)
(SID)
Modes of oper- Low, Normal Low, Normal Low, Normal Low, Normal Low, Normal Low, Normal
ation
Default detail Normal/Low Normal/Low Normal/Low Normal/Low Normal/Low Normal/Low
in Adult/Pe-
diatric mode
Loading factors Low or Normal: Low or Normal: Low or Normal: Low or Normal: Low or Normal: Low or Normal:
range after se- 60 - 120 kV 50 - 125 kV 60 - 120 kV 60 - 120 kV 60 - 120 kV 60 - 120 kV
lection of the
mA: Min: Normal mA: Normal mA: 1 - mA: 100 - 866 Normal mA: Normal mA:
mode
0.0075 mA Av- 41.7 - 1000 866 1 - 866 100 - 866
erage @ 3.75
Low mA: Low mA: Low mA: Low mA:
fps, 2 ms pw
41.7 - 500 1 - 681 1 - 786 100 - 786
Max: 31.2 mA
Average @ 30
fps, 10 ms pw
Highest refer- See tables at No dose limits No dose limits No dose limits No dose limits No dose limits
ence dose (IRP each Auto Ex- applied: applied: applied: applied: applied:
= Interventional posure Prefer-
Normal setting Normal setting Normal setting Normal setting Normal setting
Reference ence
gives approx. 2 gives approx. 2 gives approx. 2 gives approx. 2 gives approx. 2
Point)
times more times more times more dose times more dose times more dose
dose than Low dose than Low than Low setting than Low setting than Low setting
setting setting
Typical set of values in cardiac procedures
Diagnostic Normal Normal Normal Normal Normal Normal
Interventional Normal Normal Normal Normal Normal Normal
Note: For 5 R receptor dose limited countries, refer to Safety and Regulatory Instructions for Use / Protection
regarding Ionizing Radiations Hazards for Innova IGS 620 / Dose to Patient for Single Plane / Receptor Dose
Limited Standard.
5-2-3 Radiation Data
Procedure for measuring dose rate.
Refer to the section: Generic Safety and Regulatory instructions for use for vascular systems.
WHEN MEASURING DOSE, ALWAYS DO A FLUORO RUN PRIOR TO THE RUN IN STEP1
(ACQUIRING TECHNIQUE FACTORS), OTHERWISE SPECTRAL FILTER SELECTION, AND
THUS THE MEASURED DOSE MAY NOT BE REPRODUCIBLE.

InnovaTM IGS 620,
InnovaTM IGS 630
5-2-4 IQ Standard
Dose rate with 20 cm PMMA Configuration and Operating Settings
Available con- Fluoroscopy DSA Dynamic InnovaChase 3D 3DCT

figurations Record
Orientation of Vertical Spin
the X-ray beam
Patient support In (Out for dosemeter measurement)
Anti-scatter grid In
Field of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 fps 5 fps 30 fps 50 fps
7.5 fps, 3.75 fps, 1.875 fps,
fps (only for no 1.0 fps, 0.5 fps
sub fluoro)
Selectable In Low 30 fps: In Low: 0.1 In Low: 0.3 mm In Low: 0.2 mm In Low: 0 mm In Low: 0.3 mm
added filters 0.9 mm Cu mm Cu Cu Cu Cu Cu
automatically In Normal 30
In Normal: 0.1 In Normal: 0.2 In Normal: 0.1 In Normal: 0 mm In Normal: 0.3
applied fps:
mm Cu mm Cu mm Cu Cu mm Cu
0.6 mm Cu
In Low 15 fps:
0.9 mm Cu
In Normal 15
fps:
0.6 mm Cu
In Low 7.5 fps:
0.9 mm Cu
In Normal 7.5
fps:
0.9 mm Cu
Geometry
Source to im- 102.5 cm Max SID
age distance
(SID)
Distance of fo- 67.5 cm 72 cm
cal spot to
measuring de-
tector
X-ray field size Square of: 174 cm² Square of: 198 cm²
at the measur-
ing detector
Positioning of Distance between top of phantom and anticollision plate (airgap): Phantom centered in isocenter
phantom 17 cm
Note 1: For all data in this section, measurements are done in 2-steps: 1st step (technique factors acquisition) in
automatic mode with PMMA and table in; 2nd step - Dose measurement in manual mode, repeating the technique
factors for Frontal (or Lateral) plane only (single plane acquisition) without PMMA and table.
Note 2: In 3D/3DCT the 2nd step of the measurement method is different form other (2D) modes. The 1st step

InnovaTM IGS 620,
InnovaTM IGS 630
(technique factors acquisition) is done at maximum SID during a 3D/3DCT spin, when the gantry is in PA position.
2nd step (dose measurement) is done with the dosemeter probe in isocenter on the table.
Note 3: IEC 601 conditions for all dose rate data are derived by applying a geometrical correction factor using the
inverse square law. For all acquisition modes except 3D/3DCT, the dose values without the correction factor of 1.4
correspond to the dose rates at US regulation conditions (21 Code Of Federal Regulation).
Dose rate in fluoroscopy (radioscopy) with 20 cm PMMA
For "Dose to Patient" and "Variation of factors" data with country settings Austria, Denmark, Germany,
Switzerland, Luxembourg and New Zealand, please refer to the corresponding data in Safety and Regulatory
Instructions for Use / Protection regarding Ionizing Radiations Hazards for Innova IGS 620 / Dose to Patient for
Single Plane / Receptor Dose Limited Standard.
Dose rate in fluoroscopy (radioscopy) at 30 fps with 20 cm PMMA
Mode of Operation Low Normal
Loading factors automatically selected 73.1 kVp, 24.4 mA avg 78.5 kVp, 25 mA avg
Dose rate at International Standardization 6.7 x 1.4 mGy/min 17.5 x 1.4 mGy/min
conditions (IEC 601)
Loading factors automatically selected 74.8 kVp, 15.6 mA avg 76.8 kVp, 18.6 mA avg
Note: The dose data above correspond to the default Fluoro Low Frame-Rate Dose Reduction Strategy selection
(Balanced IQ/Dose). If Max Dose Reduction is used, the dose rates in 15 fps are the 50% of the 30 fps measured
values.
Dose rate in fluoroscopy (radioscopy) at 7.5 fps with 20 cm PMMA
(Balanced IQ/Dose). If Max Dose Reduction is used, the dose rates in 7.5 fps are the 25% of the 30 fps measured
values.
Note: The dose rates at 3.75 fps in no sub fluoroscopy are the 50% of the dose rates of the 7.5 fps measured
values.
Highest reference doses in fluoroscopy (radioscopy)
Innova Biplane system is a dual C-Arm type of Fluoroscope (21 CFR 10.20.30 (3) (b)).

InnovaTM IGS 620,
InnovaTM IGS 630
Highest reference dose Low Frame-rate Dose Reduction Strategy

(IRP = Interventional Reference
Balanced IQ/Dose Max Dose Reduction
Point)
at 30 cm from im- at IRP and maxi- at 30 cm from im- at IRP and maxi-
age receptor mum SID age receptor mum SID
Frame- 30 fps Normal < 87.6 mGy/min < 194.7 mGy/min < 87.6 mGy/min < 194.7 mGy/min
Rate (10 R/min) (10 R/min)
Low < 43.8 mGy/min < 97.4 mGy/min < 43.8 mGy/min < 97.4 mGy/min
(5 R/min) (5 R/min)
15 fps Normal < 87.6 mGy/min < 194.7 mGy/min < 43.8 mGy/min < 97.4 mGy/min
(10 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
7.5 fps Normal < 43.8 mGy/min < 97.4 mGy/min < 21.9 mGy/min < 48.7 mGy/min
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Dose in Dynamic Record (radiography) with 20 cm PMMA

For "Dose to Patient" and "Variation of factors" data with country settings Austria, Germany, New Zealand,
Switzerland, please refer to the corresponding data in Safety and Regulatory Instructions for Use / Protection
Limited Standard.
Loading factors automatically select- 71.2 kVp, 73.7 mA avg (30 fps), 69.5 kVp, 137.6 mA avg (30 fps), 7
ed 5.0 ms ms
Dose rate at International Standard- 45.3 x 1.4 µGy/frame 112.2 x 1.4 µGy/frame
ization conditions (IEC 601)
Note: Data applicable to all frame rates.

Dose in DSA (radiography) with 20 cm PMMA
Limited Standard.
Dose in DSA <7.5 fps (radiography) with 20 cm PMMA
Loading factors automatically selected 84.5 kVp, 311.9 mA peak, 46.7 92.1 kVp, 353.2 mA peak, 58.2 ms
ms PW PW

InnovaTM IGS 620,
InnovaTM IGS 630
Dose rate at International Standardiza- 0.95 x 1.4 mGy/frame 1.66 x 1.4 mGy/frame
tion conditions (IEC 601)
Note: Data applicable to all frame rates lower than 7.5 fps.
Dose in DSA 7.5 fps (radiography) with 20 cm PMMA
ms PW PW
Dose in InnovaChase (radiography) with 20 cm PMMA
Loading factors automatically selected 73.6 kVp, 26.1 mA avg, 7 ms PW 78.3 kVp, 29.1 mA avg, 7 ms
PW
Dose rate at International Standardization 162 x 1.4 µGy/frame 328 x 1.4 µGy/frame
Dose in 3D (radiography) with 20 cm PMMA (Max SID)
Loading factors automatically 74.0 kVp, 50.1 mA avg, 3.5 ms PW 73.0 kVp, 98.7 mA avg, 7 ms PW
selected
Dose rate at actual 3D mea- 112 µGy/frame 234 µGy/frame

surement conditions
Dose rate at US regulation con- 112 x 0.73 µGy/frame 234 x 0.73 µGy/frame
ditions (21 Code Of Federal
Regulation)
Dose rate at International Stan- 112 x 1.6 µGy/frame 234 x 1.6 µGy/frame
dardization conditions (IEC
601)
Dose in 3DCT (radiography) with 20 cm PMMA (Max SID)
Loading factors automatically 86.4 kVp, 88.0 mA avg, 4.7 ms PW 83.2 kVp, 195.9 mA avg, 7 ms PW
selected
Dose rate at actual 3DCT mea- 57.1 µGy/frame 112.7 µGy/frame

surement conditions

InnovaTM IGS 620,
InnovaTM IGS 630
Dose rate at US regulation con- 57.1 x 0.73 µGy/frame 112.7 x 0.73 µGy/frame
Regulation)
Dose rate at International Stan- 57.1 x 1.6 µGy/frame 112.7 x 1.6 µGy/frame
601)
Field of View dependence of Dose rate in fluoroscopy and dose in Dynamic

Record/DSA/InnovaChase/3D/3DCT with 20 cm PMMA
Field of View 20 cm 17 cm 15 cm 12 cm
(nominal)
Mode of operation Fluoroscopy (Radioscopy) @ 30 fps (mGy/min)
Low 6.7 mGy/min 7.8 mGy/min 8.6 mGy/min 11.0 mGy/min
Normal 17.4 mGy/min 20.1 mGy/min 22.7 mGy/min 29.0 mGy/min
Mode of operation Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)
Mode of operation Dynamic Record (Radiography) (µGy/frame)
Low 45.3 µGy/frame 67.3 µGy/frame 100 µGy/frame 123 µGy/frame
Normal 112 µGy/frame 154 µGy/frame 186 µGy/frame 225 µGy/frame
Mode of operation DSA 7.5 fps (Radiography) (mGy/frame)
Low 0.97 mGy/frame 0.99 mGy/frame 0.98 mGy/frame 0.92 mGy/frame
Normal 1.54 mGy/frame 1.56 mGy/frame 1.57 mGy/frame 1.48 mGy/frame
Mode of operation DSA <7.5 fps (Radiography) (mGy/frame)
Mode of operation InnovaChase (Radiography) @ 5 fps (µGy/frame)
Low 162 µGy/frame 193 µGy/frame 243 µGy/frame 331 µGy/frame

InnovaTM IGS 620,
InnovaTM IGS 630
Mode of operation 3D (Radiography) @ 30 fps (µGy/frame) (Max SID)
Mode of operation 3DCT (Radiography) @ 50 fps (µGy/frame) (Max SID)
Low 57.1 µGy/frame 60.2 µGy/frame 60.1 µGy/frame 65.4 µGy/frame
5-2-5 Receptor Dose Limited Standard

For InnovaChase Normal/Low, 5 fps, please refer to measurements in Dose to Patient for IQ Standard.
Available config- Fluoroscopy DSA Dynamic Record 3D 3DCT

urations
Orientation of the Vertical
X-ray beam
Field of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 7.5 fps, 3.75 fps, 30 fps, 15 fps 30 fps 50 fps
fps, 1.875 fps, 1.0 fps,
3.75 fps (only for 0.5 fps
no sub fluoro)
Selectable added In Low 30 fps: In Low: 0.1 mm In Low: 0.3 mm Cu In Low: 0 mm Cu In Low: 0.3 mm Cu
filters automatical- 0.9 mm Cu Cu
In Normal: 0.3 mm In Normal: 0 mm In Normal: 0.3 mm
ly applied In Normal 30 fps:
In Normal: 0.1 Cu Cu Cu
0.6 mm Cu
mm Cu
In Low 15 fps:
0.9 mm Cu
In Normal 15 fps:
0.6 mm Cu
In Low 7.5 fps:
0.9 mm Cu
In Normal 7.5 fps:
0.6 mm Cu
Geometry
Source to image 102.5 cm Max SID
distance (SID)

InnovaTM IGS 620,
InnovaTM IGS 630
Distance of focal 67.5 cm 72 cm

spot to measuring
detector
X-ray field size at Square of: 174 cm² Square of: 198 cm²
the measuring de-
tector
Positioning of Distance between top of phantom and anticollision plate Phantom centered in isocenter
phantom (airgap): 17 cm
The "Dose to Patient" and "Variation of factors" data below also apply to countries limited to 5 R/min in Fluoroscopy
(Luxembourg, New Zealand). These countries differ from other receptor dose limited countries only in the highest
reference doses. See Safety and Regulatory Instructions for Use / Protection regarding Ionizing Radiations
Hazards for Innova IGS 620 / Dose to Patient for Single Plane / Receptor Dose Limited Standard / Highest
reference doses in fluoroscopy (radioscopy) for Luxembourg and New Zealand, limited to 5 R/min.
Loading factors automatically selected 73 kVp, 11.7 mA avg 71.1 kVp, 18.7 mA avg
values.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
values.
Highest reference doses in fluoroscopy (radioscopy) for all countries except Luxembourg and New
Zealand

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Highest reference doses in fluoroscopy (radioscopy) for Luxembourg and New Zealand, limited to 5
R/min

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Loading factors automatically selected 67 kVp, 57.1 mA avg (30 fps), 5.0 67 kVp, 117.0 mA avg (30 fps), 7
ms PW ms PW
Dose rate at International Standardization 28.4 x 1.4 µGy/frame 58.4 x 1.4 µGy/frame

ms PW PW
ms PW PW

InnovaTM IGS 620,
InnovaTM IGS 630
Loading factors automatically 75.0 kVp, 28.2 mA avg, 3.3 ms PW 76.0 kVp, 49.7 mA avg, 4.7 ms PW
selected
Dose rate at actual 3D mea- 73.1 µGy/frame 133 µGy/frame

surement conditions
Dose rate at US regulation con- 73.1 x 0.73 µGy/frame 133 x 0.73 µGy/frame
Regulation)
Dose rate at International Stan- 73.1 x 1.6 µGy/frame 133 x 1.6 µGy/frame
601)
selected

surement conditions
Regulation)
601)
Field of View dependence of Dose rate in fluoroscopy and dose in Dynamic Record/DSA/3D/3DCT
with 20 cm PMMA
(nominal)
Mode of opera- Fluoroscopy (Radioscopy) @ 30 fps (mGy/min)

tion

InnovaTM IGS 620,
InnovaTM IGS 630

tion
Mode of opera- Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)

tion
Mode of opera- Dynamic Record (Radiography) (µGy/frame)

tion
Normal 58.5 µGy/frame 66.1 µGy/frame 84.3 µGy/frame 109 µGy/frame
Mode of opera- DSA 7.5 fps (Radiography) (mGy/frame)

tion
Mode of opera- DSA <7.5 fps (Radiography) (mGy/frame)

tion
Mode of opera- 3D (Radiography) @ 30 fps (µGy/frame) (Max SID)

tion
Mode of opera- 3DCT (Radiography) @ 50 fps (µGy/frame) (Max SID)

tion
Normal 34.7 µGy/frame 36.7 µGy/frame 36.6 µGy/frame 40.0 µGy/frame
5-2-6 IQ Plus
For DSA and InnovaChase, all frame rates, please refer to measurements in Dose to Patient for IQ Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
Available Fluoroscopy Dynamic Record 3D 3DCT

configurations
Orientation of the Vertical Spin
X-ray beam
Field of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 30 fps, 15 fps 30 fps 50 fps
3.75 fps (only for no
sub fluoro)
Selectable added Low 30 fps: 0.6 mm Cu In Low: 0.1 mm Cu In Low: 0 mm Cu In Low: 0.3 mm Cu
filters automati- Normal 30 fps: 0.3 mm In Normal: 0.1 mm Cu In Normal: 0 mm Cu In Normal: 0.3 mm Cu
cally applied Cu
Low 15 fps: 0.6 mm Cu
Normal 15 fps: 0.3 mm
Cu
Low 7.5 fps: 0.3 mm
Cu
Normal 7.5 fps: 0.3 mm
Cu
Geometry
Source to image 102.5 cm Max SID
distance (SID)
spot to measur-
ing detector
the measuring
detector
Positioning of Distance between top of phantom and anticolli- Phantom centered in isocenter
phantom sion plate (airgap): 17 cm
inverse square law. The values without the correction factor of 1.4 correspond to the dose rates at US regulation
conditions (21 Code Of Federal Regulation).

InnovaTM IGS 620,
InnovaTM IGS 630
For "Dose to Patient" and "Variation of factors" data with country settings Japan, for the Low Dose preference,
please refer to the corresponding data in Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 620 / Dose to Patient for Single Plane / IQ Standard. The only exception is Max
Dose Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when using "IQ Plus".
For "Dose to Patient" and "Variation of factors" data with country settings Australia/WA, Australia/ACT,
Australia/QLD, Australia/VIC, please refer to the corresponding data in Safety and Regulatory Instructions for Use
/ Protection regarding Ionizing Radiations Hazards for Innova IGS 620 / Dose to Patient for Single Plane / IQ
Standard.
Dose rate at International Standardiza- 8.7 x 1.4 mGy/min 21.3 x 1.4 mGy/min
values.
values.
values.

InnovaTM IGS 620,
InnovaTM IGS 630

Point)
at 30 cm from im- at IRP and maxi- at 30 cm from im- at IRP and maximum
age receptor mum SID age receptor SID
Low < 87.6 mGy/min < 194.7 mGy/min < 87.6mGy/min < 194.7 mGy/min
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Limited Standard.
For "Dose to Patient" and "Variation of factors" data with country settings Italy, Spain, Portugal and Belgium,
Radiations Hazards for Innova IGS 620 / Dose to Patient for Single Plane / IQ Standard.
Loading factors automatically selected 68.4 kVp, 62.9 mA avg (30 fps), 67.2 kVp, 128.9 mA avg (30 fps),
5.0 ms PW 7.0 ms PW
Dose rate at International Standardization 78.1 x 1.4 µGy/frame 153 x 1.4 µGy/frame

selected

InnovaTM IGS 620,
InnovaTM IGS 630

surement conditions
Regulation)
601)
selected

surement conditions
Regulation)
601)
Field of View dependence of Dose rate in fluoroscopy and dose in Dynamic Record/3D/3DCT with
20 cm PMMA
(nominal)

tion

tion

tion

InnovaTM IGS 620,
InnovaTM IGS 630

tion

tion

tion
5-2-7 Receptor Dose Limited Plus

For DSA, 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor Dose
Limited Standard.
Available Fluoroscopy Dynamic Record 3D

configurations
Orientation of the X- Vertical Spin
ray beam
Field of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 30 fps, 15 fps 30 fps
3.75 fps (only for no sub fluo-
ro)
Selectable added fil- Low 30 fps: 0.6 mm Cu In Low: 0.2 mm Cu In Low: 0 mm Cu
ters automatically ap- Normal 30 fps: 0.6 mm Cu In Normal: 0.2 mm Cu In Normal: 0 mm Cu
plied Low 15 fps: 0.9 mm Cu
Normal 15 fps: 0.6 mm Cu
Low 7.5 fps: 0.9 mm Cu
Normal 7.5 fps: 0.6 mm Cu
Geometry

InnovaTM IGS 620,
InnovaTM IGS 630
Source to image dis- 102.5 cm Max SID

tance (SID)
Distance of focal spot 67.5 cm 72 cm
to measuring detector
X-ray field size at the Square of: 174 cm² Square of: 198 cm²
measuring detector
Positioning of phan- Distance between top of phantom and anticollision plate Phantom centered in isocenter
tom (airgap): 17 cm
For "Dose to Patient" and "Variation of factors" data with country settings Luxembourg, New Zealand, please refer
to the corresponding data in Safety and Regulatory Instructions for Use / Protection regarding Ionizing Radiations
Hazards for Innova IGS 620 / Dose to Patient for Single Plane / Receptor Dose Limited Standard.
Radiations Hazards for Innova IGS 620 / Dose to Patient for Single Plane / Receptor Dose Limited Standard. The
only exception is Max Dose Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when
using "Receptor Dose Limited Plus".
values.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
values.

Point)
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
5.0 ms PW 7.0 ms PW

InnovaTM IGS 620,
InnovaTM IGS 630
selected
Dose rate at actual 3D mea- 57.3 µGy/frame 105.8 µGy/frame

surement conditions
Regulation)
601)
Field of View dependence of Dose rate in fluoroscopy and dose in Dynamic Record/3D with 20 cm
PMMA
(nominal)

tion

tion

tion

tion
Normal 74.9 µGy/frame 92.9 µGy/frame 119 µGy/frame 161 µGy/frame

tion

InnovaTM IGS 620,
InnovaTM IGS 630
5-3 Dose to Patient for Biplane

provided.
image quality.
Available settings Fluoroscopy Roadmap / Subtract- DSA Dynamic Record

ed Fluoroscopy
Orientation of the 0 deg. (vertical) to horizontal (- 117 / + 105 degrees)
Frontal X-ray beam
Orientation of the Lat- 0 deg. (vertical) to horizontal (- 117 / + 105 degrees)
eral X-ray beam
Patient support In
Anti-scatter grid In or Out
Operating settings
Technical details of Selected kV: Selected kV: Selected kV: Selected kV:
parameters included in 60-120 kV 60-120 kV 50-125 kV 60-120 kV
each mode of opera-
mA: 31.5 mA Average mA: 26.0 mA Average mA: 41.7 - 1000 mA: 1 - 866
tion
@ 25 fps, 9.7 ms pw Max @ 25 fps – 8 ms
pw
Focal spot: 0.6 Focal spot: 0.6 Focal spot: Focal spot:
0.3, 0.6 or 1.0 0.6 or 1.0
Frame rate 25 fps, 15 fps, 7.5 fps, 25 fps, 15 fps, 7.5 fps 3.75 fps, 1.875 fps, 25 fps, 15 fps
3.75 fps (only for no 1.0 fps, 0.5 fps
sub fluoro)

InnovaTM IGS 620,
InnovaTM IGS 630
Selectable added fil- Without or with one of Without or with one of Without or with one of Without or with one of
ters automatically ap- the below Cu thick- the below Cu thick- the below Cu thick- the below Cu thick-
plied nesses: nesses: nesses: nesses:
0.6 mm Cu, 0.6 mm Cu, 0.6 mm Cu 0.6 mm Cu,
0.9 mm Cu 0.9 mm Cu 0.9 mm Cu
Geometry
Source to image dis- Frontal Plane: 85 to 119 cm +/- 1 cm
tance (SID) Lateral Plane: 83.7 to 137.5 cm +/- 1 cm
Modes of operation Low, Normal Low, Normal Low, Normal Low, Normal
Default mode Normal Normal Normal Normal
Loading factors range Low or Normal: Low or Normal: Low or Normal: Low or Normal:
after selection of the 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV
mode
mA: Min: 0.0075 mA mA: Min: 0.015 mA Normal mA: Normal mA:
Average @ 3.75 fps, 2 Average @ 7.5 fps, 2 41.7 - 1000 1 - 866
ms pw ms pw
Low mA: Low mA:
Max: 31.5 mA Aver- Max: 26.0 mA Aver-
41.7 - 500 1 - 681
age @ 25 fps, 9.7 ms age @ 25 fps, 8 ms
pw pw
Highest reference See tables at each Au- See tables at each Au- No dose limits applied: No dose limits applied:
dose (IRP = Interven- to Exposure Prefer- to Exposure Prefer-
Normal setting gives Normal setting gives
tional Reference ence ence
approx. 2 times more approx. 2 times more
Point)
dose than Low setting dose than Low setting
Diagnostic Normal Normal Normal Normal
Interventional Normal Normal Normal Normal
regarding Ionizing Radiations Hazards for Innova IGS 620 / Dose to Patient for Biplane / Receptor Dose Limited
Standard.
5-3-4 IQ Standard
Available configura- Fluoroscopy Roadmap / Subtract- DSA Dynamic Record

tions ed Fluoroscopy
Orientation of the X- Vertical
ray beam

InnovaTM IGS 620,
InnovaTM IGS 630

Field of View 20 cm
Operating settings
sub fluoro)
Selectable added fil- In Low 25 fps: In Low 25 fps: In Low: 0.1 mm Cu In Low: 0.3 mm Cu
ters automatically ap- 0.9 mm Cu 0.9 mm Cu
In Normal: 0.1 mm Cu In Normal: 0.2 mm Cu
plied In Normal 25 fps: In Normal 25 fps:
0.6 mm Cu 0.6 mm Cu
In Low 15 fps: In Low 15 fps:
0.9 mm Cu 0.6 mm Cu
In Normal 15 fps: In Normal 15 fps:
0.6 mm Cu 0.3 mm Cu
In Low 7.5 fps: In Low 7.5 fps:
0.9 mm Cu 0.6 mm Cu
In Normal 7.5 fps: In Normal 7.5 fps:
0.6 mm Cu 0.3 mm Cu
Geometry
Source to image dis- 102.5 cm
tance (SID)
Distance of focal spot 67.5 cm
X-ray field size at the Square of: 174 cm²
measuring detector
Positioning of phantom Distance between top of phantom and anticollision plate (airgap): 17 cm
Note 1: For all data in this section, measurements are done in 2-steps.
1st step - Recording of technique factors for the Frontal (or Lateral) plane during the biplane acquisition, with
PMMA and table in the beam and full collimation at the smallest FOV on the Lateral (or Frontal) plane.
2nd step - Dose measurement in manual mode, repeating the technique factors for Frontal (or Lateral) plane only
(single plane acquisition) without PMMA and table.
Dose rate in fluoroscopy (radioscopy) and roadmap/subtracted fluoroscopy (radioscopy) with 20 cm
PMMA
Biplane / Receptor Dose Limited Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
Dose rate in roadmap/subtracted fluoroscopy (radioscopy) at 25 fps with 20 cm PMMA
Note: The dose data above correspond to the default Fluoro/Roadmap/Subtracted Fluoroscopy Low Frame-Rate
Dose Reduction Strategy selection (Balanced IQ/Dose). If Max Dose Reduction is used, the dose rates in 15 fps
are the 60% of the 25 fps measured values.
values
Dose rate in roadmap/subtracted fluoroscopy (radioscopy) at 7.5 fps with 20 cm PMMA

InnovaTM IGS 620,
InnovaTM IGS 630
Dose Reduction Strategy selection (Balanced IQ/Dose). If Max Dose Reduction is used, the dose rates in 7.5 fps
Highest reference doses in fluoroscopy (radioscopy) and roadmap/subtracted fluoroscopy
(radioscopy)

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Standard.
Loading factors automatically select- 71.6 kVp, 59.5 mA avg (25 fps), 69.3 kVp, 111.6 mA avg (25 fps), 7
ed 5.0 ms ms
Dose rate at International Standard- 44.5 x 1.4 µGy/frame 110 x 1.4 µGy/frame

InnovaTM IGS 620,
InnovaTM IGS 630

Standard.
ms PW PW
ms PW PW
Field of View dependence of Dose rate in fluoroscopy/roadmap/subtracted fluoroscopy and dose in
Dynamic Record/DSA with 20 cm PMMA
(nominal)
Mode of operation Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 25 fps (mGy/min)

InnovaTM IGS 620,
InnovaTM IGS 630
Mode of operation Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)


ray beam
Field of View 20 cm
Operating settings
3.75 fps (only for no 1.875 fps, 1.0 fps, 0.5
sub fluoro) fps

InnovaTM IGS 620,
InnovaTM IGS 630
Selectable added fil- In Low 25 fps: In Low 25 fps: In Low: 0.1 mm Cu In Low: 0.3 mm Cu
ters automatically ap- 0.9 mm Cu 0.9 mm Cu
In Normal: 0.1 mm Cu In Normal: 0.3 mm Cu
plied In Normal 25 fps: In Normal 25 fps:
0.6 mm Cu 0.6 mm Cu
In Low 15 fps: In Low 15 fps:
0.9 mm Cu 0.6 mm Cu
In Normal 15 fps: In Normal 15 fps:
0.6 mm Cu 0.3 mm Cu
In Low 7.5 fps: In Low 7.5 fps:
0.9 mm Cu 0.6 mm Cu
In Normal 7.5 fps: In Normal 7.5 fps:
0.6 mm Cu 0.3 mm Cu
Geometry
tance (SID)
measuring detector
PMMA
Hazards for Innova IGS 620 / Dose to Patient for Biplane / Receptor Dose Limited Standard / Highest reference
doses in fluoroscopy (radioscopy) for Luxembourg and New Zealand, limited to 5 R/min.

InnovaTM IGS 620,
InnovaTM IGS 630
values.

InnovaTM IGS 620,
InnovaTM IGS 630
Zealand

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
R/min

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Loading factors automatically selected 67 kVp, 45.8 mA avg (25 fps), 5.0 67 kVp, 93.9 mA avg (25 fps), 7.0
ms PW ms PW

ms PW PW
Dose rate at International Standardization 0.46 x 1.4 mGy/frame 0.85 x 1.4 mGy/frame
ms PW PW
Dose rate at International Standardization 0.46 x 1.4 mGy/frame 0.85 x 1.4 mGy/frame

InnovaTM IGS 620,
InnovaTM IGS 630
(nominal)

InnovaTM IGS 620,
InnovaTM IGS 630
5-3-6 IQ Plus
For DSA Normal/Low, all frame rates, please refer to measurements in Dose to Patient for IQ Standard.
Available Fluoroscopy Roadmap / Subtracted Dynamic Record

configurations Fluoroscopy
ray beam
Field of View 20 cm
Operating settings
Frame rate 25 fps, 15 fps, 7.5 fps, 3.75 fps (only for no sub fluoro) 25 fps, 15 fps
Selectable added fil- Low 25 fps: 0.6 mm Cu Low 25 fps: 0.6 mm Cu In Low: 0.1 mm Cu
ters automatically ap- Normal 25 fps: 0.3 mm Cu Normal 25 fps: 0.6 mm Cu In Normal: 0.1 mm Cu
plied Low 15 fps: 0.6 mm Cu Low 15 fps: 0.6 mm Cu
Normal 15 fps: 0.3 mm Cu Normal 15 fps: 0.3 mm Cu
Low 7.5 fps: 0.3 mm Cu Low 7.5 fps: 0.6 mm Cu
Normal 7.5 fps: 0.3 mm Cu Normal 7.5 fps: 0.3 mm Cu
Geometry
tance (SID)
to measuring detec-
tor
measuring detector
Positioning of phan- Distance between top of phantom and anticollision plate (airgap): 17 cm
tom
PMMA

InnovaTM IGS 620,
InnovaTM IGS 630
Radiations Hazards for Innova IGS 620 / Dose to Patient for Biplane / IQ Standard. The only exception is Max
/ Protection regarding Ionizing Radiations Hazards for Innova IGS 620 / Dose to Patient for Biplane / IQ Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
(radioscopy)

Point)
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

InnovaTM IGS 620,
InnovaTM IGS 630

Standard.
Radiations Hazards for Innova IGS 620 / Dose to Patient for Biplane / IQ Standard.
5.0 ms PW 7.0 ms PW
Dose rate at International Standardization 76.2 x 1.4 µGy/frame 152 x 1.4 µGy/frame

Dynamic Record with 20 cm PMMA
(nominal)

InnovaTM IGS 620,
InnovaTM IGS 630

For DSA Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor Dose Limited
Standard.
Available Fluoroscopy Roadmap / Subtracted Fluo- Dynamic Record

configurations roscopy
ray beam
Field of View 20 cm
Operating settings
Frame rate 25 fps, 15 fps, 7.5 fps, 3.75 fps (only for no sub fluoro) 25 fps, 15 fps
Selectable added fil- Low 25 fps: 0.6 mm Cu Low 25 fps: 0.6 mm Cu In Low: 0.2 mm Cu
ters automatically ap- Normal 25 fps: 0.3 mm Cu Normal 25 fps: 0.6 mm Cu In Normal: 0.2 mm Cu
plied Low 15 fps: 0.9 mm Cu Low 15 fps: 0.6 mm Cu
Normal 15 fps: 0.6 mm Cu Normal 15 fps: 0.3 mm Cu
Low 7.5 fps: 0.9 mm Cu Low 7.5 fps: 0.6 mm Cu
Normal 7.5 fps: 0.6 mm Cu Normal 7.5 fps: 0.3 mm Cu
Geometry
tance (SID)
measuring detector
tom

InnovaTM IGS 620,
InnovaTM IGS 630
PMMA
Radiations Hazards for Innova IGS 620 / Dose to Patient for Biplane / Receptor Dose Limited Standard. The only
exception is Max Dose Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when

InnovaTM IGS 620,
InnovaTM IGS 630
values.
(radioscopy)

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
5.0 ms PW 7.0 ms PW

(nominal)

InnovaTM IGS 620,
InnovaTM IGS 630
Normal 73.3 µGy/frame 91.4 µGy/frame 118 µGy/frame 159 µGy/frame
5-4 Dose to Patient in Japan

5-4-1 Fluoroscopy/Roadmap/Subtracted Fluoroscopy Skin Dose Levels
Japan dose regulation enforced April 1st, 2001 requires that standard exams be carried out at a patient
fluoroscopic dose not exceeding 50 mGy/min and permits for exams requiring high level of fluoroscopic dose that
the dose exceeds this value without exceeding however 125 mGy/min.
On Innova IGS 620, standard exams will have to be performed using the Fluoroscopy/Roadmap/Subtracted
Fluoroscopy "Low" detail button located on the Innova Digital screen or on the Innova Central touch screen.
Exams requiring high level of fluoroscopy dose shall be performed using the fluoroscopy "Normal" detail button
located on the Innova Digital screen or on the Innova Central touch screen. The usage of this special mode, in the
case the patient dose is not limited at 50 mGy/min, will be indicated permanently on the Reference in-room monitor
by the annotation "Normal" and by a permanent audible signal.
5-5 Dose to Patient in Australia/WA and Australia/ACT
In Australia/WA and Australia/ACT the highest reference dose rates in fluoroscopy (radioscopy) at 30 cm from
image receptor are limited to 43.8 mGy/min. (43.8 x 1.4 mGy/min at IEC 601 International Standardization
conditions).
The data given in the OM tables are directly applicable to Australia/WA and Australia/ACT, whenever the provided
dose rate is lower than the limit of 43.8 x 1.4 mGy/min (IEC 601 conditions), while in other cases the dose rate is
reduced by the system to this limiting level (in Fluoro, Roadmap, and Subtracted Fluoroscopy modes only.)
5-6 Dose to Patient in Canada/Ontario
TO ENSURE LOCAL REGULATORY COMPLIANCE FOR CANADA/ONTARIO IN TERM OF

PATIENT DOSE, IT IS RECOMMENDED TO SET AUTO EXPOSURE PREFERENCE IQstd,

InnovaTM IGS 620,
InnovaTM IGS 630
RDLplus, OR RDLstd.
5-7 Dose to Operator (Isodoses)
You will find hereafter the Isokerma Maps representing the dose values in the vicinity of the equipment.
The measurements have been conducted on a biplane system in accordance with the protocol given in annex FF
of the IEC 601-2-43.
5-7-1 Frontal Gantry in Vertical position - Dose at 1 meter from ground
Note: Lateral Gantry in Vertical position has a similar map.
Units: Relative Air Kerma: µGy/Gy.cm2
Note:
1 µGy/Gy.cm2 = 0.01 µGy/µGy.m2
1 µGy/µGy.m2 = 100 µGy/Gy.cm2
Distances: Radius at 1, 2 and 3 meter
Vertical 1 meter
5-7-2 Frontal Gantry in Vertical position - Dose at 1.5 meter from ground
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Vertical 1.5 meter
5-7-3 Frontal Gantry in Lateral position - Dose at 1 meter from ground

Note: Lateral Gantry in Lateral position has a similar map.
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Lateral 1 meter
5-7-4 Frontal Gantry in Lateral position - Dose at 1.5 meter from ground
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Lateral 1.5 meter
5-7-5 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1 meter from ground
Note:
50% radiation emitted on each plane, frontal & lateral

InnovaTM IGS 620,
InnovaTM IGS 630
Biplane 1 meter
5-7-6 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1.5 meter from ground
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Biplane 1.5 meter
5-8 Technical Factors Range

• kVp range: 40-125 kVp +/- 10%;
• mA range: 1 - 1000 mA peak +/- 20% +/- 1 mA.
5-9 Contribution of Filtration with 21 cm Detector
5-9-1 Contribution of Filtration along the Beam

InnovaTM IGS 620,
InnovaTM IGS 630
5-9-2 Total filtration

IPEM publication(*) with the minimum Half Value Layers (HVL) specifications has been used to determine the total
filtration.
At the X-ray tube voltage of 70 kV minimum total equivalent filtration of : 3.5 mm Al equivalent.
Tube Head Filter of 3.3 mm AL equivalent at 70 kV.
Luxembourg only: range of total filtration: 2.5 mm to 3.5 mm Al equivalent at 70 kV.
(*) IPEM: Institute of Physics and Engineering in Medicine, Fairmount House, 230 Tadcaster Road, York, Y024
1ES, UK. Report 78 Catalog of Diagnostic X-Ray Spectra and Other Data K Cranley, B.J. Gilmore, G.W.A Fogarty
and L. Desponds (Electronic Version prepared by D. Sutton)
http://www.ipem.org.uk/new/publications/pubs-list%201.htm
5-10 Disable X-ray whenever X-ray are not necessary
X-ray should be disabled whenever they are not necessary to prevent the possibility of
irradiation being emitted through the inadvertent actuation of an irradiation switch.
Press on the X-ray disable button on the touchscreen or the digital screen (monitoring bar) to disable/re-enable
X-ray.
The button is lit when X-ray are disabled (refer to Innova Digital / Innova Digital Screen / Monitoring Bar / X-ray
Disable Button).
In case of obvious X-ray emission (audible signal and/or red light signal on) without image on the live display, the
user shall perform the following actions:
• First, to release the footswitch.
• Second, if X-ray are still emitted, to depress the "RESET" button on the Innova console until the system resets.
• Third, if X-ray are still emitted, to switch off the Power Distribution Box (PDB) by turning to OFF the RED PDB
switcher on the system cabinet, in the technical area.
5-11 Dosimetric Calibration
To maintain the calibrations of all dosimetric indications, the "mR/mAs" calibration procedure shall be strictly made
following the Periodic Maintenance (PM) interval for that calibration (6 months). (Refer to the Logbook).
5-12 Application Mode and Service Mode are not exclusive

InnovaTM IGS 620,
InnovaTM IGS 630
NEVER MAKE X-RAY WITH A PATIENT ON THE TABLE, IF THE REFERENCE DISPLAY
LISTS THE FOLLOWING:
"CALIBRATION" IN PLACE OF "PROTOCOL NAME"
"SERVICE" IN PLACE OF "EXAM TYPE"
THAT MEANS THAT THE SYSTEM IS NOT PROPERLY SET FOR APPLICATION AND THOSE ACQUISITION
PARAMETERS MIGHT BE INADEQUATE.
5-13 Leakage Radiation
The maximum operating factors (leakage technique factors) of the Innova IGS 620 are: Fluoro, 120 kV, 16 mA, SID
max.
In these conditions, the leakage radiation of the radiation source assembly measured is: 0.45 mGy (52
milliroentgens) in 1 hour (worst case 0.65 mGy (75 milliroentgens)) at one meter in any direction from the
diagnostic source assembly composed of:
• X-ray Tube Performix 160A.
• Beam Limiting Device (Card Collimator AMP).
5-14 Spectral Filtration
Spectral filtration is added filtration that is inserted between the X-ray tube source and the patient in order to
harden the beam and reduce the soft radiation. The harder the beam, the better the penetration of the anatomy
allowing the X-ray photons to exit the patient and reach the digital detector. The spectral filters also absorb the
softer radiation so that it never reaches the patient and keeps the skin dose radiation and absorbed dose to a
minimum.
In addition, the beam limiting device features additional filters of: 0.1, 0.2, 0.3, 0.6 and 0.9 mm Cu which
corresponds to 6.5, 9.6, 12.6, 22 and 30 mm Al equivalent at 70 kV. One of these copper filters is automatically
selected by the system for each acquisition to optimize patient dose and image quality.
The value of the additional spectral filtration is permanently displayed in the Fluoro and Record window located at
the bottom of the Innova Digital screen.
The additional spectral filtration value is part of the Fluoro or Record techniques.
FOR PEDIATRIC PROCEDURE, AND IF DEMANDED BY LOCAL REGULATION, THE

PRESENCE OF THE MINIMUM REQUESTED ADDITIONAL SPECTRAL FILTRATION MUST BE
CHECKED BEFORE PERFORMING ANY RECORD OR FLUORO ACQUISITION. IF THE
MINIMUM REQUESTED ADDITIONAL SPECTRAL FILTRATION IS NOT IN PLACE, SELECT
THE APPROPRIATE PEDIATRIC PROTOCOL.
6 Protection regarding Ionizing Radiations Hazards for Innova IGS 630

Innova IGS 630 is provided with a choice of 4 AutoExposure Preferences: "IQ Plus", "IQ Standard", "RDL Plus
(Receptor Dose Limited Plus)" and "RDL Standard (Receptor Dose Limited Standard)". Dose ratios mentioned
below are air kerma rate ratios measured according to IEC 60601-2-43 conditions.
• IQ Plus – High Contrast, 100% Dose lQ Plus produces images of arteries and guidewires optimized for high
object contrast at a nominal dose of 100%.
• IQ Standard – Low Noise, 95% Dose Using approximately 90% of the dose of IQ Plus, lQ Standard is
optimized to produce images with low fluoroscopic scintillation noise.
• Receptor Dose Limited Plus – High Contrast, 75% Dose Using approximately 65% of the dose of IQ Plus,
Receptor Dose Limited Plus (RDL Plus) is optimized to produce images with high contrast.
• Receptor Dose Limited Standard – Low Noise, 45% Dose Working with a low dose -approximately 45% of
that of IQ Plus -Receptor Dose Limited Standard (RDLS) is optimized to produce images with low fluoroscopic
scintillation noise and recommended for long time procedures.

InnovaTM IGS 620,
InnovaTM IGS 630
Dose Reduction Strategy allows two modes selection for the Fluoro Low Frame Rates, 15 fps and 7.5 fps: either
the "Balanced IQ/Dose" mode allowing up to 25% (with fluoro 15 fps) and up to 44% (with fluoro 7.5 fps) dose
reduction versus fluoro 30 fps or the "Max Dose Reduction" mode allowing up to 50% (with fluoro 15 fps) and up to
75% (with fluoro 7.5 fps) dose reduction versus fluoro 30 fps.
In both strategies 3.75 fps offers 50% dose reduction compared to 7.5 fps.
Dose for Low Detail mode is about 50% of Normal Detail mode for Fluoroscopy, Cardiac Record and
InnovaChaseTM (except for fluoroscopy around high reference dose (87 mGy/min, 43 mGy/min, 21 mGy/min)). Low
Detail mode in DSA, Bolus and 3DCT offers a smaller, but still significant dose reduction, see detailed data below.
Auto exposure preferences and fluoro low frame rates dose reduction strategy can be set independently in each
acquisition protocol at system installation.
• Cardiac mode: primary use for general cardiac procedures.
• InnovaBreezeTM (Bolus) mode: primary use for subtracted lower limbs arteriogram (available on Frontal plane
only).
6-1 Mode of Operation
6-1-1 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
1 Record Auto-exposure: IQ Standard, IQ+, RDL Standard and RDL+

Fluoro Auto-exposure: IQ Standard, IQ+, RDL Standard and RDL+
Fluoro Dose Reduction Strategy: Balanced IQ, Max Dose Reduction
2 Frontal plane FOV selection: 30 cm, 20 cm, 16 cm, 12 cm
Lateral plane FOV selection: 30 cm, 20 cm, 16 cm, 12 cm
4 Record parameters selection: frame rate, detail level, duration, Plane selection, Subtraction on/off, auto inject
on/off, injection delay value, X-ray delay value,
Frontal plane record technique parameters display: Spectral Filter, kV, mA, ms
Lateral plane record technique parameters display: Spectral Filter, kV, mA, ms
5 Fluoro mode selection: No Sub, Subtracted Fluoro, Roadmap, Blended Roadmap on Frontal Plane and
Blended Roadmap on Lateral Plane
6 Fluoro parameters selection: frame rate, detail level
Frontal plane fluoro technique parameters display: Spectral Filter, kV, mA
Lateral plane fluoro technique parameters display: Spectral Filter, kV, mA, Landscape value, Enable Simulta-
neous display, Vessel value
6-1-2 Reference Image Monitor
1 Record parameters display: record mode, detail level, frame rate, acquisition duration and X-ray/inject delay
Frontal plane record technique parameters display: kV, mA (peak for DSA and Bolus, otherwise: average),
ms
Lateral plane record technique parameters display: kV, mA (peak for DSA, otherwise: average), ms

InnovaTM IGS 620,
InnovaTM IGS 630
2 Fluoro parameters display: fluoro mode, detail level and frame rate
Frontal plane fluoro technique parameters display: kV, mA
Lateral plane fluoro technique parameters display: kV, mA
6-1-3 Live Image Monitor
Frontal Live Image Monitor
Lateral Live Image Monitor

InnovaTM IGS 620,
InnovaTM IGS 630
1 Frontal plane selected FOV display

2 Frontal plane Source to Image Distance (SID)
3 Table Height displays the distance it is above or below isocenter of the system
4 Lateral plane selected FOV display
5 Lateral plane Source to Image Distance (SID)
6 Lateral plane Source to Object Distance (SOD)
6-1-4 Table Side Status Control (TSSC)

InnovaTM IGS 620,
InnovaTM IGS 630
4 Frontal FOV/2 switches + 1 digital display

5 Lateral FOV/2 switches + 1 digital display
13 Fluoro NoSub/Sub, NoSub/Roadmap, NoSub/Blended Rdmp Frt or NoSub/Blended Rdmp Lat.
6-1-5 Innova Central touch screen
Innova Central Touch screen Record tab

2 Record parameters selection: frame rate
3 Record parameters selection: detail level

InnovaTM IGS 620,
InnovaTM IGS 630
Innova Central Touch screen Fluoro tab
1 Fluoro mode selection: No Sub, Subtracted Fluoro,

Roadmap, Blended Roadmap on Frontal plane and
Blended Roadmap on Lateral plane
2 Fluoro parameters selection: frame rate
3 Fluoro parameters selection: detail level
6-2 Dose to Patient for Single Plane

Note 3: Single plane and biplane Roadmap/Blended Roadmap/Subtracted Fluoroscopy specific settings differ only
for the highest frame rates (30 fps vs. 25 fps respectively), thus detailed Roadmap/Blended Roadmap/Subtracted
Fluoroscopy tables are provided only in Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 630 / Dose to Patient for Biplane / Available Settings. The 30 fps single plane
Roadmap/Blended Roadmap/Subtracted Fluoroscopy dose-rates can be calculated from the 25 fps biplane
Roadmap/Blended Roadmap/Subtracted Fluoroscopy dose rates by multiplication with a factor of 1.2. For smaller
frame rates (15 fps and 7.5 fps) the biplane Roadmap/Blended Roadmap/Subtracted Fluoroscopy radiation data
are directly applicable for single plane Roadmap/Blended Roadmap/Subtracted Fluoroscopy as well.
Note 4: All the following information is given for the Frontal and Lateral plane except Bolus, InnovaChaseTM and

InnovaTM IGS 620,
InnovaTM IGS 630
Innova 3D/3DCT which are only Frontal.

Note 5: InnovaSpinTM has the same available settings as InnovaChaseTM, but those applications are only available
on frontal plane.
Note 6: 3D and 3DCT acquisition can be used in unsubtracted and subtracted modes. In these cases the same
loading factors are used, that results in identical dose/ frame values. For this reason detailed data are provided
only for unsubtracted 3D modes. Since subtracted 3D and 3DCT requires 2 consecutive spins, thus the integrated
dose in subtracted 3D modes is the double of the unsubtracted acquisition.
provided.
image quality.
Available Fluoroscopy/ DSA Dynamic Inno- Bolus 3D 3DCT

settings Subtracted Flu- Record vaChase
oroscopy/
Roadmap/
Blemded
Roadmap
Orienta- 0 deg. (vertical) to horizontal (-117 / + 105 degrees)
tion of the
X-ray
beam
Patient In
support
Anti- In or Out
scatter
grid
Field of 30 cm (nominal), 20 cm, 16 cm, 12 cm 30 cm (nominal) 30 cm (nominal), 20 cm, 16
View cm, 12 cm
Operating settings
Technical Selected kV: Selected kV: Selected Selected kV: Selected kV: Selected kV: Selected kV:
details of 60-120 kV 50-125 kV kV: 60-120 kV 50-125 kV 60-120 kV 60-120 kV
parame- 60-120 kV
ters in-
mA: 31.2 mA Av- mA: 41.7 - mA: 1 - 866 mA: 100 - mA : 41.7- 866 mA: 1 - 866 mA: 100 - 866
cluded in
erage @ 30 fps, 1000 866
each
10 ms pw
mode of
operation Focal spot: 0.6 Focal spot: Focal spot: Focal spot: Focal spot: Focal spot: Focal spot:
0.3, 0.6 or 0.6 or 1.0 1.0 0.6 or 1.0 0.6 or 1.0 0.6 or 1.0
1.0

InnovaTM IGS 620,
InnovaTM IGS 630
Frame 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 5 fps 1 fps, 2 fps 30 fps 50 fps
rate 7.5 fps, 3.75 fps fps, 1.875 fps
(only for no sub fps, 1.0 fps,
fluoro) 0.5 fps
Selectable Without or 0.1 Without or Without or Without or 0.1 mm Cu Without or 0.1 0.3 mm Cu
added fil- mm Cu, 0.2 mm 0.1 mm Cu, 0.1 mm Cu, 0.1 mm Cu, mm Cu, 0.2 mm
ters auto- Cu, or 0.3 mm 0.2 mm Cu, 0.2 mm Cu, 0.2 mm Cu, Cu, or 0.3 mm
matically Cu or 0.3 mm or 0.3 mm or 0.3 mm Cu
applied Cu Cu Cu
Geometry
Source to Frontal Plane: 89 to 119 cm +/- 1 cm
image dis- Lateral Plane: 83.7 to 137.5 cm +/- 1 cm except in PA (88 to 118 cm)
tance
(SID)
Modes of Low, Normal Low, Normal Low, Nor- Low, Normal Low, Normal Low, Normal Low, Normal
operation mal
Default Normal/Low Normal/Low Normal/ Normal/Low Normal/Low Normal/Low Normal/Low
detail Low
in Adult/
Pediatric
mode
Loading Low or Normal: Low or Nor- Low or Low or Nor- Low or Normal: Low or Normal: Low or Nor-
factors 60 - 120 kV mal: Normal: mal: 50 - 125 kV 60 - 120 kV mal:
range af- 50 - 125 kV 60 - 120 kV 60 - 120 kV 60 - 120 kV
ter selec-
mA: Min: 0.0075 Normal mA: Normal mA: 100 - Normal mA: Normal mA: 1 - Normal mA:
tion of the
mA Average @ 41.7 - 1000 mA: 1 - 866 866 41.7 - 866 866 100 - 866
mode
3.75 fps, 2 ms
Low mA: Low mA: 1 Low mA: 41.7 - Low mA: 1 - 786 Low mA: 100 -
pw
41.7 - 500 - 681 500 786
Max: 31.2 mA
Average @ 30
fps, 10 ms pw
Highest See tables at No dose limits applied:
reference each Auto Expo-
Normal setting gives approx. 2 times dose than Low setting
dose (IRP sure Preference
= Inter-
ventional
Reference
Point)
Diagnostic Normal Normal Normal Normal Normal Normal Normal
Interven- Normal Normal Normal Normal Normal Normal Normal
tional
Limited Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
6-2-4 IQ Standard
Available Fluoroscopy DSA Dynamic InnovaChase Bolus 3D 3DCT

configura- Record
tions
Orientation of Vertical Spin
the X-ray
beam
Patient sup- In (Out for dosemeter measurement)
port
Anti-scatter In
grid
Field of View 20 cm 30 cm 20 cm
Operating settings
Frame rate 30 fps, 15 7.5 fps, 3.75 30 fps, 15 fps 5 fps 1 fps, 2 fps 30 fps 50 fps
fps, 7.5 fps, fps, 1.875
3.75 fps (only fps, 1.0 fps,
for no sub flu- 0.5 fps
oro)
Selectable In Low: In Low: 0.1 In Low: 0.2 In Low: 0.1 In Low: 0.1 In Low: 0 mm In Low: 0.3
added filters 0.3 mm Cu @ mm Cu mm Cu mm Cu mm Cu Cu mm Cu
automatically 30 fps
In Normal: In Normal: 0.2 In Normal: 0.1 In Normal: 0.1 In Normal: 0 In Normal: 0.3
applied 0.3 mm Cu @
0.1 mm Cu mm Cu mm Cu mm Cu mm Cu mm Cu
15 fps
0.3 mm Cu @
7.5 fps
In Normal:
0.3 mm Cu @
30 fps
0.3 mm Cu @
15 fps
0.3 mm Cu @
7.5 fps
Geometry
Source to im- 102.5 cm Max SID Max SID, 108
age distance cm
(SID)
Distance of 67.5 cm 72 cm
focal spot to
measuring
detector

InnovaTM IGS 620,
InnovaTM IGS 630
X-ray field Square of: 174 cm² Square of: Square of: 198 cm²
size at the 390 cm²
measuring
detector
Positioning of Distance between top of phantom and anticollision plate (airgap): 17 Phantom centered in isocen-
phantom cm ter
(technique factors acquisition) is done at maximum SID (or at 108 cm SID), during a 3D/3DCT spin, when the
gantry is in PA position. 2nd step (dose measurement) is done with the dosemeter probe in isocenter on the table.
values.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
values.

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Limited Standard.
5.0 ms 7.0 ms
Dose rate at International Standardiza- 53.9 x 1.4 µGy/frame 102.8 x 1.4 µGy/frame

InnovaTM IGS 620,
InnovaTM IGS 630

Limited Standard.
ms PW PW
ms PW PW
Dose in InnovaChase (radiography) with 20 cm PMMA
Loading factors automatically selected 78.3 kVp, 14.5 mA avg, 7 ms 78.3 kVp, 28.8 mA avg, 7 ms PW
PW
Dose in Bolus (radiography) with 20 cm PMMA
Focal Spot FS 0.6 FS 1.0
Mode of Operation Low Normal Low Normal
Loading factors auto- 108.7 kVp, 188.1 mA 111.4 kVp, 280.0 mA 90.8 kVp, 500 mA 92.8 kVp, 700.9 mA
matically selected peak, 15.8 ms PW peak, 19.4 ms PW peak, 10.0 ms PW peak, 13.7 ms PW
Dose rate at Interna- 0.362 x 1.4 mGy/ 0.708 x 1.4 mGy/ 0.390 x 1.4 mGy/ 0.803 x 1.4 mGy/
tional Standardiza- frame frame frame frame
tion conditions (IEC
601)

InnovaTM IGS 620,
InnovaTM IGS 630
selected

surement conditions
Regulation)
601)
Loading factors automatically 91 kVp, 67.4 mA avg, 7.0 ms PW 89.2 kVp, 154.8 mA avg, 7.0 ms PW
selected
Dose rate at actual 3DCT mea- 48.4 µGy/frame 104 µGy/frame

surement conditions
Regulation)
601)
Dose in high resolution 3DCT (radiography) with 20 cm PMMA (108 cm SID)
Loading factors automatically 90.3 kVp, 52.6 mA avg, 7 ms PW 88.0 kVp, 123.7 mA avg, 7.0 ms PW
selected

surement conditions
Regulation)
601)

Record/DSA/InnovaChase/Bolus/3D/3DCT with 20 cm PMMA

InnovaTM IGS 620,
InnovaTM IGS 630
(nominal)
Low 25.3 µGy/frame 53.9 µGy/frame 72.9 µGy/frame 104 µGy/frame
Mode of operation InnovaChase (Radiography) @ 5 fps (µGy/frame)
Mode of operation Bolus FS 0.6 (Radiography) (mGy/frame)
Low 0.362 mGy/frame N/A N/A N/A
Normal 0.708 mGy/frame N/A N/A N/A

InnovaTM IGS 620,
InnovaTM IGS 630
Mode of operation High Resolution 3DCT (Radiography) @ 50 fps (µGy/frame) (108 cm SID)

Available configu- Fluoroscopy DSA Dynamic Bolus 3D 3DCT

rations Record
ray beam
Field of View 20 cm 30 cm 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 7.5 fps, 3.75 30 fps, 15 1 fps, 2 fps 30 fps 50 fps
fps, 3.75 fps (only fps, 1.875 fps
for no sub fluoro) fps, 1.0 fps,
0.5 fps
Selectable added fil- In Low 30 fps: In Low: 0.1 In Low: 0.3 In Low: 0.1 mm In Low: 0.3 mm In Low: 0.3
ters automatically 0.3 mm Cu mm Cu mm Cu Cu Cu mm Cu
applied In Normal 30 fps:
In Normal: In Normal: In Normal: 0.1 In Normal: 0.2 In Normal: 0.3
0.3 mm Cu
0.1 mm Cu 0.3 mm Cu mm Cu mm Cu mm Cu
In Low 15 fps:
0.3 mm Cu
In Normal 15 fps:
0.3 mm Cu
In Low 7.5 fps:
0.3 mm Cu
In Normal 7.5 fps:
0.3 mm Cu

InnovaTM IGS 620,
InnovaTM IGS 630
Geometry
Source to image dis- 102.5 cm Max SID Max SID, 108
tance (SID) cm
spot to measuring
detector
X-ray field size at the Square of: 174 cm² Square of: 390 Square of: 198 cm²
measuring detector cm²
Positioning of phan- Distance between top of phantom and anticollision plate Phantom centered in isocenter
tom (airgap): 17 cm
(technique factors acquisition) is done at maximum SID (or 108 cm SID), during a 3D/3DCT spin, when the gantry
is in PA position. 2nd step (dose measurement) is done with the dosemeter probe in isocenter on the table.
Hazards for Innova IGS 630 / Dose to Patient for Single Plane / Receptor Dose Limited Standard / Highest
reference doses in fluoroscopy (radioscopy) for Luxembourg and New Zealand, limited to 5 R/min.
values.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
values.
Zealand

Point)
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
R/min

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Loading factors automatically select- 71.0 kVp, 43.7 mA avg (30 fps), 5 68.0 kVp, 116.3 mA avg (30 fps), 7 ms
ed ms PW PW

ms PW PW
ms PW PW

InnovaTM IGS 620,
InnovaTM IGS 630
Dose in Bolus (radiography) with 20 cm PMMA
Focal Spot FS 0.6 FS 1.0
Mode of Operation Low Normal Low Normal
Loading factors auto- 99.2 kVp, 226.4 mA 103.1 kVp, 280 mA 88.1 kVp, 500 mA 88.6 kVp, 734.1 mA
matically selected peak, 12.3 ms PW peak, 17.5 ms PW peak, 9.5 ms PW peak, 12.4 ms PW
Dose rate at Interna- 0.277 x 1.4 mGy/ 0.535 x 1.4 mGy/ 0.350 x 1.4 mGy/ 0.672 x 1.4 mGy/
tional Standardiza- frame frame frame frame
tion conditions (IEC
601)
selected

surement conditions
Regulation)
601)
selected

surement conditions
Regulation)
601)

InnovaTM IGS 620,
InnovaTM IGS 630
selected

surement conditions
Regulation)
601)

Record/DSA/Bolus/3D/3DCT with 20 cm PMMA
(nominal)

InnovaTM IGS 620,
InnovaTM IGS 630
Mode of operation High Resolution 3DCT (Radiography) @ 50 fps (µGy/frame) (108 cm SID)
6-2-6 IQ Plus
For DSA, Bolus, and InnovaChase, all frame rates, please refer to measurements in Dose to Patient for IQ
Standard.
Available Fluoroscopy Dynamic Record 3D 3DCT

configurations
Orientation of the Vertical Spin
X-ray beam
Field of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 30 fps, 15 fps 30 fps 50 fps
fps, 3.75 fps (only for
no sub fluoro)

InnovaTM IGS 620,
InnovaTM IGS 630
Selectable Low 30 fps: 0.3 mm Low: 0.2 mm Cu Low: 0.2 mm Cu Low: 0.3 mm Cu
added filters au- Cu Normal: 0.2 mm Cu Normal: 0 mm Cu Normal: 0.3 mm Cu
tomatically ap- Normal 30 fps: 0.3
plied mm Cu
Low 15 fps: 0.3 mm
Cu
Normal 15 fps: 0.3
mm Cu
Low 7.5 fps: 0.3 mm
Cu
Normal 7.5 fps: 0.2
mm Cu
Geometry
Source to image 102.5 cm Max SID Max SID, 108 cm
distance (SID)
spot to measur-
ing detector
the measuring
detector
Positioning of Distance between top of phantom and anticolli- Phantom centered in isocenter
phantom sion plate (airgap): 17 cm
Radiations Hazards for Innova IGS 630 / Dose to Patient for Single Plane / IQ Standard. The only exception is Max
/ Protection regarding Ionizing Radiations Hazards for Innova IGS 630 / Dose to Patient for Single Plane / IQ
Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
values.
values.

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Limited Standard.
Radiations Hazards for Innova IGS 630 / Dose to Patient for Single Plane / IQ Standard.
Loading factors automatically se- 74.3 kVp, 78.2 mA avg (30 fps), 5.0 73.3 kVp, 148.9 mA avg (30 fps), 7.0
lected ms ms
dardization conditions (IEC 601)

Loading factors automatically 81.0 kVp, 40.4 mA avg, 7 ms PW 74.0 kVp, 84.8 mA avg, 7.0 ms PW
selected

surement conditions
Regulation)

InnovaTM IGS 620,
InnovaTM IGS 630
601)
selected

surement conditions
Regulation)
601)
selected

surement conditions
Regulation)
601)
Field of View dependence of Dose rate in fluoroscopy and dose in Dynamic Record/3D/3DCT with
20 cm PMMA
(nominal)

tion

InnovaTM IGS 620,
InnovaTM IGS 630

tion

tion

tion

tion
Normal 261 µGy/frame 228.3 µGy/frame 389.3 µGy/frame 458 µGy/frame

tion
Mode of opera- High Resolution 3DCT (Radiography) @ 50 fps (µGy/frame) (108 cm SID)
tion

For DSA, Bolus, and 3DCT Normal/Low, all frame rates, please refer to measurements in Dose to Patient for
Receptor Dose Limited Standard.
Available Fluoroscopy Dynamic Record 3D

configurations
ray beam

InnovaTM IGS 620,
InnovaTM IGS 630

Field of View 20 cm
Operating settings
Frame rate 30 fps, 15 fps, 7.5 fps, 3.75 30 fps, 15 fps 30 fps
fps (only for no sub fluoro)
Selectable added fil- Low 30 fps: 0.3 mm Cu Low: 0.3 mm Cu Low: 0.3 mm Cu
ters automatically ap- Normal 30 fps: 0.3 mm Cu Normal: 0.3 mm Cu Normal: 0.2 mm Cu
plied Low 15 fps: 0.3 mm Cu
Normal 15 fps: 0.3 mm Cu
Low 7.5 fps: 0.3 mm Cu
Normal 7.5 fps: 0.3 mm Cu
Geometry
Source to image dis- 102.5 cm Max SID
tance (SID)
Distance of focal spot 67.5 cm 72 cm
X-ray field size at the Square of: 174 cm² Square of: 198 cm²
measuring detector
Positioning of phantom Distance between top of phantom and anticollision plate Phantom centered in isocen-
(airgap): 17 cm ter
Radiations Hazards for Innova IGS 630 / Dose to Patient for Single Plane / Receptor Dose Limited Standard. The
only exception is Max Dose Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when

InnovaTM IGS 620,
InnovaTM IGS 630
values.
values.
values.

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Loading factors automatically se- 69.1 kVp, 69.1 mA avg (30 fps), 5.0 69.1 kVp, 134.2 mA avg (30 fps), 7.0
lected ms ms
dardization conditions (IEC 601)

selected

surement conditions
Regulation)
601)
Field of View dependence of Dose rate in fluoroscopy and dose in Dynamic Record/3D with 20 cm
PMMA

InnovaTM IGS 620,
InnovaTM IGS 630
(nominal)

tion

tion

tion

tion

tion
6-3 Dose to Patient for Biplane

provided.

InnovaTM IGS 620,
InnovaTM IGS 630
image quality.
Available settings Fluoroscopy Roadmap / Subtract- DSA Dynamic Record

ed Fluoroscopy
Orientation of the 0 deg. (vertical) to horizontal (-117 / + 105 degrees)
Frontal X-ray beam
Orientation of the Lat- 0 deg. (vertical) to horizontal (-117 / + 105 degrees)
eral X-ray beam
Patient support In
Anti-scatter grids In or Out
Operating settings
Technical details of Selected kV: Selected kV: 60-120 Selected kV: Selected kV:
parameters included in 60-120 kV kV 50-125 kV 60-120 kV
each mode of opera-
mA: 26.0 mA Average mA: 20.8 mA Average mA: 41.7 - 1000 mA: 1 - 866
tion
@ 25 fps, 8 ms pw Max @ 25 fps – 8 ms
pw
Focal spot: 0.6 Focal spot: 0.6 Focal spot: Focal spot:
0.3, 0.6 or 1.0 0.6 or 1.0
sub fluoro)
Selectable added fil- Without or with one of Without or with one of Without or with one of Without or with one of
ters automatically ap- the below Cu thick- the below Cu thick- the below Cu thick- the below Cu thick-
plied nesses: 0.1 mm Cu, nesses: 0.1 mm Cu, nesses: 0.1 mm Cu, nesses: 0.1 mm Cu,
0.2 mm Cu, 0.3 mm 0.2 mm Cu, 0.3 mm 0.2 mm Cu, 0.3 mm 0.2 mm Cu, 0.3 mm
Cu, 0.6 mm Cu, 0.9 Cu, 0.6 mm Cu, 0.9 Cu, 0.6 mm Cu Cu, 0.6 mm Cu, 0.9
mm Cu mm Cu mm Cu
Geometry
Source to image dis- Frontal Plane: 89 to 119 cm +/- 1 cm
tance (SID) Lateral Plane: 83.7 to 137.5 cm +/- 1 cm
Modes of operation Low, Normal Low, Normal Low, Normal Low, Normal
Default mode Normal Normal Normal Normal
Loading factors range Low or Normal: Low or Normal: Low or Normal: Low or Normal:
after selection of the 60 - 120 kV 60 - 120 kV 50 - 125 kV 60 - 120 kV
mode
mA: Min: 0.0075 mA mA: Min: 0.015 mA Normal mA: 41.7 - Normal mA: 1 - 866
Average @ 3.75 fps, 2 Average @ 7.5 fps, 2 1000
Low mA:
ms pw ms pw
Low mA: 1 - 681
Max: 26.0 mA Aver- Max: 20.8 mA Aver-
41.7 - 500
age @ 25 fps, 8 ms age @ 25 fps, 8 ms
pw pw

InnovaTM IGS 620,
InnovaTM IGS 630
Highest reference See tables at each Au- See tables at each Au- No dose limits applied: No dose limits applied:
dose (IRP = Interven- to Exposure Prefer- to Exposure Prefer-
Normal setting gives Normal setting gives
tional Reference ence ence
approx. 2 times dose approx. 2 times dose
Point)
than Low setting than Low setting
Diagnostic Normal Normal Normal Normal
Interventional Normal Normal Normal Normal
Standard.
6-3-4 IQ Standard

ray beam
Field of View 20 cm
Operating settings
sub fluoro)
Selectable added fil- In Low: In Low: In Low: 0.1 mm Cu In Low: 0.2 mm Cu
ters automatically ap- 0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps
In Normal: 0.1 mm In Normal: 0.2 mm Cu
plied 0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
Cu
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
In Normal: In Normal:
0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps
0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
Geometry
Source to image dis- Frontal: 102.5 cm
tance (SID) Lateral: 102.5 cm

InnovaTM IGS 620,
InnovaTM IGS 630

measuring detector
tom
PMMA
Loading factors automatically selected 87 kVp, 3.2 mA avg 80 kVp, 10.9 mA avg

InnovaTM IGS 620,
InnovaTM IGS 630
values.
(radioscopy)

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Standard.
Loading factors automatically select- 69.5 kVp, 53.7 mA avg (25 fps), 5 69.0 kVp, 107.4 mA avg (25 fps), 7
ed ms ms

Standard.
ms PW PW

InnovaTM IGS 620,
InnovaTM IGS 630
ms PW PW
(nominal)
Mode of op- Fluoroscopy (Radioscopy) @ 25 fps (mGy/min)

eration
Mode of op- Fluoroscopy (Radioscopy) @ 15 fps (mGy/min)

eration
Mode of op- Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)

eration
Mode of op- Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 25 fps (mGy/min)

eration
Mode of op- Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 15 fps (mGy/min)

eration
Mode of op- Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)

eration

InnovaTM IGS 620,
InnovaTM IGS 630
Mode of op- Dynamic Record (Radiography) (µGy/frame)

eration
Mode of op- DSA 3.75 fps (Radiography) (mGy/frame)

eration
Mode of op- DSA <3.75 fps (Radiography) (mGy/frame)

eration


ray beam
Field of View 20 cm
Operating settings
sub fluoro)
Selectable added fil- In Low: In Low: In Low: 0.1 mm Cu In Low: 0.3 mm Cu
ters automatically ap- 0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps
In Normal: 0.1 mm In Normal: 0.3 mm Cu
plied 0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
Cu
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps
0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
Geometry

InnovaTM IGS 620,
InnovaTM IGS 630
Source to image dis- Frontal: 102.5 cm

tance (SID) Lateral 102.5 cm
measuring detector
tom
(single plane acquisition) without
without PMMA and table.
PMMA
Hazards for Innova IGS 630 / Dose to Patient for Biplane / Receptor Dose Limited Standard / Highest reference
doses in fluoroscopy (radioscopy) for Luxembourg and New Zealand, limited to 5 R/min.

InnovaTM IGS 620,
InnovaTM IGS 630
values.
Zealand

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(5 R/min) (5 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
R/min

Point)
(2.5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

InnovaTM IGS 620,
InnovaTM IGS 630
Loading factors automatically select- 71 kVp, 35.1 mA avg (25 fps), 5 ms 68.0 kVp, 96.1 mA avg (25 fps) 7 ms
ed

ms PW PW
ms PW PW
(nominal)

tion

tion

tion

InnovaTM IGS 620,
InnovaTM IGS 630
Mode of opera- Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 25 fps (mGy/min)

tion

tion
Mode of opera- Roadmap/Subtracted Fluoroscopy (Radioscopy) @ 7.5 fps (mGy/min)

tion

tion
Mode of opera- DSA 3.75 fps (Radiography) (mGy/frame)

tion
Mode of opera- DSA <3.75 fps (Radiography) (mGy/frame)

tion
6-3-6 IQ Plus
For DSA Normal/Low, all frame rates, please refer to measurements in Dose to Patient for IQ Standard.


InnovaTM IGS 620,
InnovaTM IGS 630
Orientation of the X-ray Vertical

beam
Field of View 20 cm
Operating settings
Frame rate 25 fps, 15 fps, 7.5 fps, 3.75 fps (only for no sub 25 fps, 15 fps
fluoro)
Selectable added filters au- In Low: In Low: Low: 0.2 mm Cu
tomatically applied 0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps Normal: 0.2 mm Cu
0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps
0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
0.2 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
Geometry
Source to image distance Frontal: 102.5 cm
(SID) Lateral: 102.5 cm
Distance of focal spot to 67.5 cm
measuring detector
X-ray field size at the mea- Square of: 174 cm²
suring detector
PMMA
Radiations Hazards for Innova IGS 630 / Dose to Patient for Biplane / IQ Standard. The only exception is Max
/ Protection regarding Ionizing Radiations Hazards for Innova IGS 630 / Dose to Patient for Biplane / IQ Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
values.

InnovaTM IGS 620,
InnovaTM IGS 630
(radioscopy)

Point)
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)

Standard".
Radiations Hazards for Innova IGS 630 / Dose to Patient for Biplane / IQ Standard.

InnovaTM IGS 620,
InnovaTM IGS 630
Loading factors automatically select- 74.6 kVp, 61.3 mA avg (25 fps) 5 73.2 kVp, 122.5 mA avg (25 fps) 7
ed ms ms

(nominal)

tion

tion

tion

tion

tion

tion

InnovaTM IGS 620,
InnovaTM IGS 630

tion

For DSA Normal/Low, all frame rates, please refer to measurements in Dose to Patient for Receptor Dose Limited
Standard.

Orientation of the X-ray Vertical
beam
Field of View 20 cm
Operating settings
Frame rate 25 fps, 15 fps, 7.5 fps, 3.75 fps (only for no sub 25 fps, 15 fps
fluoro)
Selectable added filters au- In Low: In Low: In Low: 0.3 mm Cu
tomatically applied 0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps In Normal: 0.3 mm Cu
0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
0.3 mm Cu @ 25 fps 0.3 mm Cu @ 25 fps
0.3 mm Cu @ 15 fps 0.3 mm Cu @ 15 fps
0.3 mm Cu @ 7.5 fps 0.3 mm Cu @ 7.5 fps
Geometry
Source to image distance Frontal: 102.5 cm
(SID) Lateral: 102.5 cm
Distance of focal spot to 67.5 cm
measuring detector
X-ray field size at the mea- Square of: 174 cm²
suring detector

InnovaTM IGS 620,
InnovaTM IGS 630

PMMA
Radiations Hazards for Innova IGS 630 / Dose to Patient for Biplane / Receptor Dose Limited Standard. The only
exception is Max Dose Reduction 7.5 fps Low Dose preference which is already limited to 21.9 mGy/min when

InnovaTM IGS 620,
InnovaTM IGS 630

values.
(radioscopy)

Point)

InnovaTM IGS 620,
InnovaTM IGS 630
(10 R/min) (10 R/min)
(5 R/min) (2.5 R/min)
(5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
(2.5 R/min) (2.5 R/min)
Loading factors automatically select- 69.2 kVp, 55.2 mA avg (25 fps) 5 69.2 kVp, 108.9 mA avg (25 fps), 7
ed ms ms

(nominal)

tion

tion

tion

InnovaTM IGS 620,
InnovaTM IGS 630

tion

tion

tion

tion
6-4 Dose to Patient in Japan

Japan dose regulation enforced April 1st, 2001 requires that standard exams be carried out at a patient
fluoroscopic dose not exceeding 50 mGy/min and permits for exams requiring high level of fluoroscopic dose that
the dose exceeds this value without exceeding however 125 mGy/min.
On Innova IGS 630, standard exams will have to be performed using the Fluoroscopy/Roadmap/Subtracted
Fluoroscopy "Low" detail button located on the Innova Digital screen or on the Innova Central touch screen.
Exams requiring high level of fluoroscopy dose shall be performed using the fluoroscopy "Normal" detail button
located on the Innova Digital screen or on the Innova Central touch screen. The usage of this special mode, in the
case the patient dose is not limited at 50 mGy/min, will be indicated permanently on the Reference in-room monitor
by the annotation "Normal" and by a permanent audible signal.
6-5 Dose to Patient in Australia/WA and Australia/ACT
In Australia/WA and Australia/ACT the highest reference dose rates in fluoroscopy (radioscopy) at 30 cm from
image receptor are limited to 43.8 mGy/min. (43.8 x 1.4 mGy/min at IEC 601 International Standardization
conditions).
The data given in the OM tables are directly applicable to Australia/WA and Australia/ACT, whenever the provided
dose rate is lower than the limit of 43.8 x 1.4 mGy/min (IEC 601 conditions), while in other cases the dose rate is

InnovaTM IGS 620,
InnovaTM IGS 630
reduced by the system to this limiting level (in Fluoro, Roadmap, and Subtracted Fluoroscopy modes only.)
6-6 Dose to Patient in Canada/Ontario
TO ENSURE LOCAL REGULATORY COMPLIANCE FOR CANADA/ONTARIO IN TERM OF

PATIENT DOSE, IT IS RECOMMENDED TO SET AUTO EXPOSURE PREFERENCE IQstd,
RDLplus, OR RDLstd.
6-7 Dose to Operator (Isodoses)
You will find hereafter the Isokerma Maps representing the dose values in the vicinity of the equipment.
The measurements have been conducted on a biplane system in accordance with the protocol given in annex FF
of the IEC 601-2-43.
6-7-1 Frontal Gantry in Vertical position - Dose at 1 meter from ground
Note:
Vertical 1 meter
6-7-2 Frontal Gantry in Vertical position - Dose at 1.5 meter from ground

InnovaTM IGS 620,
InnovaTM IGS 630

Note:
Vertical 1.5 meter
6-7-3 Frontal Gantry in Lateral position - Dose at 1 meter from ground

Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Lateral 1 meter
6-7-4 Frontal Gantry in Lateral position - Dose at 1.5 meter from ground
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Lateral 1.5 meter
6-7-5 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1 meter from ground
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Biplane 1 meter
6-7-6 Biplane Frontal and Lateral Gantry at isocenter - Dose at 1.5 meter from ground
Note:

InnovaTM IGS 620,
InnovaTM IGS 630
Biplane 1.5 meter
6-8 Technical Factors Range

• kVp range: 40-125 kVp +/- 10%;
• mA range: 1 - 1000 mA peak +/- 20% +/- 1 mA.
6-9 Contribution of Filtration with 31 cm Detector
6-9-1 Contribution of Filtration along the Beam

InnovaTM IGS 620,
InnovaTM IGS 630
6-9-2 Total filtration

IPEM publication(*) with the minimum Half Value Layers (HVL) specifications has been used to determine the total
filtration.
At the X-ray tube voltage of 70 kV minimum total equivalent filtration of : 3.5 mm Al equivalent.
Tube Head Filter of 3.3 mm AL equivalent at 70 kV.
Luxembourg only: range of total filtration: 2.5 mm to 3.5 mm Al equivalent at 70 kV.
(*) IPEM: Institute of Physics and Engineering in Medicine, Fairmount House, 230 Tadcaster Road, York, Y024
1ES, UK. Report 78 Catalog of Diagnostic X-Ray Spectra and Other Data K Cranley, B.J. Gilmore, G.W.A Fogarty
and L. Desponds (Electronic Version prepared by D. Sutton)
http://www.ipem.org.uk/new/publications/pubs-list%201.htm
6-10 Disable X-ray whenever X-ray are not necessary
X-ray should be disabled whenever they are not necessary to prevent the possibility of
irradiation being emitted through the inadvertent actuation of an irradiation switch.
Press on the X-ray disable button on the touchscreen or the digital screen (monitoring bar) to disable/re-enable
X-ray.
The button is lit when X-ray are disabled (refer to Innova Digital / Innova Digital Screen / Monitoring Bar / X-ray
Disable Button).
In case of obvious X-ray emission (audible signal and/or red light signal on) without image on the live display, the
user shall perform the following actions:
• First, to release the footswitch.
• Second, if X-ray are still emitted, to depress the "RESET" button on the Innova console until the system resets.
• Third, if X-ray are still emitted, to switch off the Power Distribution Box (PDB) by turning to OFF the RED PDB
switcher on the system cabinet, in the technical area.
6-11 Dosimetric Calibration
To maintain the calibrations of all dosimetric indications, the "mR/mAs" calibration procedure shall be strictly made
following the Periodic Maintenance (PM) interval for that calibration (6 months). (Refer to the Logbook).
6-12 Application Mode and Service Mode are not exclusive

InnovaTM IGS 620,
InnovaTM IGS 630
NEVER MAKE X-RAY WITH A PATIENT ON THE TABLE, IF THE REFERENCE DISPLAY
LISTS THE FOLLOWING:
"CALIBRATION" IN PLACE OF "PROTOCOL NAME"
"SERVICE" IN PLACE OF "EXAM TYPE"
THAT MEANS THAT THE SYSTEM IS NOT PROPERLY SET FOR APPLICATION AND THOSE ACQUISITION
PARAMETERS MIGHT BE INADEQUATE.
6-13 Leakage Radiation
The maximum operating factors (leakage technique factors) of the Innova IGS 630 are: Fluoro, SID max, 120 kV,
mA current corresponding to 10 R (87.6 mGy) (typically 16 to 18 mA for a new Tube).
In these conditions, the typical leakage radiation of the radiation source assembly measured is: 0.45 mGy (52
milliroentgens) in 1 hour at one meter in any direction from the diagnostic source assembly composed of:
• X-ray Tube Performix 160A.
• Beam Limiting Device (Collimator) AF DSA 01.
minimum.
In addition, the beam limiting device features three additional filters of: 0.1, 0.2 and 0.3 mm Cu which corresponds
to 6.5, 9.6, 12.6 mm Al equivalent at 70 kV. One of these copper filters is automatically selected by the system for
each acquisition to optimize patient dose and image quality.
The value of the additional spectral filtration is permanently displayed in the Fluoro and Record window located at
the bottom of the Innova Digital screen.
The additional spectral filtration value is part of the Fluoro or Record techniques.
FOR PEDIATRIC PROCEDURE, AND IF DEMANDED BY LOCAL REGULATION, THE

PRESENCE OF THE MINIMUM REQUESTED ADDITIONAL SPECTRAL FILTRATION MUST BE
CHECKED BEFORE PERFORMING ANY RECORD OR FLUORO ACQUISITION. IF THE
MINIMUM REQUESTED ADDITIONAL SPECTRAL FILTRATION IS NOT IN PLACE, SELECT
THE APPROPRIATE PEDIATRIC PROTOCOL.
7 Protection regarding Functional Hazards

7-1 3rd Party Software
INSTALLING AND USING UNVALIDATED SOFTWARE MAY CAUSE SYSTEM TO FAIL OR

NOT WORK AS INTENDED. SOFTWARE INSTALLATION TO BE DONE ONLY BY QUALIFIED
GE PERSONNEL.
7-2 Loss of Imaging
ESTABLISH PROCEDURES FOR HANDLING THE PATIENT IN CASE OF THE LOSS OF

FLUOROSCOPIC IMAGING OR OTHER SYSTEM FUNCTIONS DURING AN EXAM. FAILURE
OF IMAGING MAY HOWEVER BE RECOVERED IN FOLLOWING PROCEDURE SET BELOW.
7-3 Loss of Power

InnovaTM IGS 620,
InnovaTM IGS 630
THE INTERRUPTION OF THE MAIN POWER SUPPLY TO THE EQUIPMENT DURING ITS USE
COULD LEAD TO A HAZARDOUS SITUATION. THE EQUIPMENT MAIN POWER SUPPLY
MUST BE PROVIDED THROUGH AN UNINTERRUPTIBLE POWER SUPPLY (UPS) AT
FACILITY LEVEL OR USING THE FLUORO UPS OPTION, OR THROUGH A STAND-BY
GENERATOR. REFER TO SECTION APPENDIX - TECHNICAL PUBLICATIONS / SYSTEM
LINE VOLTAGE WITHOUT FLUORO UPS FOR THE CHARACTERISTICS OF THE INPUT LINE.
Functions maintained in Equip- Equipment with Fluo- Equipment with institu- Equipment with institu-
case of power supply ment ro UPS option tional stand-by genera- tional uninterruptible
main failure tor3 power supply3
Preservation of stored im- Yes Yes Yes Yes
ages
Availability of fluoroscopy No Yes1* After boot2 Yes
2
Availability of record No No After boot Yes
1 2
Availability of equipment No Yes After boot Yes
motion
1
: Functions remain available until batteries are unloaded. At least 5 minutes of fluoroscopy are available if the
batteries are fully loaded.
2
: When the power supply is restored by the generator, the system needs to be powered-on following the procedure
available in the instruction for use.
3
: Refer to section Appendix - Technical Publications / System Line Voltage without Fluoro UPS for the
characteristics of the input line.
*
: On configurations with Large Display Monitor Option, the images display is guaranteed on the backup monitors
only.
7-4 System Recovery after a power Cut
• Overview
The Innova System provides an automatic shutdown for the power cut of more than 500 ms. An UPS
(Un-interruptible Power Supply) delivers power to the DL and the RTAC to make this shutdown clean.
• System restart
After the power down, the Innova System will restart after the user or the electrician rearms the main circuit and
the ON button depressed on the Innova Console.
• Power cut during X-ray
If the power cut occurs during X-ray, sometimes the access to the last exam is prohibited (error message:
"Database inconsistency"), then to recover the full system functionality you need to push and save all the
accessible exams and perform a disk cleanup (logged as DL Service Program/tool/DLTool/patientcleanup).
DISK CLEANUP ERASES ALL THE EXAMS. BE SURE YOU HAVE PUSHED THEM ALL.
7-5 Emergency Procedure for Image Recovery or System Lock Up with 19" monitors
There may still be a residual risk of:
• One system lock up every 1 000 patients.
• One X-ray exposure sequence interrupted every 10 000 records.
Handle Emergency or at risk procedures with precaution.

InnovaTM IGS 620,
InnovaTM IGS 630

InnovaTM IGS 620,
InnovaTM IGS 630
7-6 Emergency Procedure for Image Recovery or System Lock Up with Large Display
Option
There may still be a residual risk of:
• One system lock up every 1 000 patients.
• One X-ray exposure sequence interrupted every 10 000 records.
• The Large Display option may experience power cut separately to the Innova system.
Handle Emergency or at risk procedures with precaution.
THE LARGE DISPLAY MONITOR IS POWERED SEPARATELY TO THE INNOVA SYSTEM

AND DOES NOT INCLUDE A UPS (UN-INTERRUPTIBLE POWER SUPPLY). DEPENDING ON
THE CONNECTION TO THE POWER SUPPLY NETWORK OF THE HOSPITAL AND THE
PRESENCE OF A UPS FOR THE INNOVA SYSTEM, IT MAY EXPERIENCE A POWER CUT
WHILE THE INNOVA SYSTEM IS STILL OPERATIONAL. THE OPTION INCLUDES 2 INNOVA
BACKUP MONITORS BEHIND THE SUSPENSION THAT ARE POWERED BY THE INNOVA
SYSTEM TO PROVIDE THE FRONTAL LIVE IMAGE AND FRONTAL REFERENCE IMAGE TO
OPERATE THE INNOVA SYSTEM. ROTATE YOUR SUSPENSION TO ACCESS THE BACKUP
FRONTAL MONITORS FIXED ON THE BACK. THEN MOVE THE LATERAL CARRIAGE
TOWARD THE PARKING POSITION IN ORDER TO DISABLE X-RAY ON THE LATERAL
PLANE. CHECK DAILY THAT THE BACKUP MONITORS ARE WORKING PROPERLY AND
DISPLAYING IMAGES.

InnovaTM IGS 620,
InnovaTM IGS 630

InnovaTM IGS 620,
InnovaTM IGS 630
7-7 Latency and Polymerization Time
LATENCY IS DEFINED AS THE TIME LAG BETWEEN THE OPERATOR ACTION AND THE
DISPLAY OF THAT ACTION ON THE MONITOR. THIS LAG VARIES DEPENDING ON THE
ACQUISITION FRAME RATE.
• ABOUT 200 MS FOR FRAME RATES OVER 15 FPS.
• ABOUT 850 MS FOR FRAME RATE OF 1.9 FPS.
THE OPERATOR SHOULD BE AWARE OF THESE LATENCY DATA IN THE JUDICIOUS CHOICE OF
EMBOLIC AGENTS USED DURING INTERVENTIONS (I.E., POLYMERIZATION TIME).
There is a residual risk of a frozen Image being displayed on the live display if a failure occurs, this has never been
observed though . If X-ray has been interrupted during Fluoro or Record, a Frozen image may remain displayed on
the live display. The X-ray on indicator is active, "X-ray acquisition in progress message" is displayed, and the
X-ray on light remains on. Special precautions should then be taken for all interventional procedures and
manipulation.
7-8 Control of transfer of data to an archiving system
Innova System does not feature archiving but provides capability to connect an archiving system. So, not being an
archiving system, Innova ensures the control of transfer of the data to the archiving system.
The control of transfer is ensured by:
• the double confirmation before deletion of an item if this one is not successfully transferred,
• the network queue.
In the network queue items selected for archive are flagged using the following statuses:
• ACTIVE: The data transfer is in progress; only one item is flagged as "ACTIVE" in the queue.
• PENDING: The data transfer is waiting to be performed; multiple items can be flagged as "PENDING".
• FAILED: The data transfer was not completed due to an error ("FAILED"). The user shall re-transfer the item.
An item may be a patient, an exam, a sequence or a photo.
If the data was successfully transferred, the item is removed from the network queue. An empty queue means that
all items were successfully transferred.
In case of successful transfer, the DL guarantees that the transfer occurred with no data loss, but the DL does not
give any guarantee that the data has been successfully archived on the receiving system, it is recommended that
the user checks that the data is correct on the receiving system before deleting it from DL.
7-9 SID Failure - Degraded mode
In case of SID failure, the following message is displayed on the in-room monitor:
SID failure, Collimation activated. To raise detector, use pink button
If this message appears on the in-room monitor, user has to move the detector towards its highest position in using
the emergency back-out button (1) placed on the detector as shown above. X-rays are available even if the error

InnovaTM IGS 620,
InnovaTM IGS 630
message is shown, applied x-ray parameters ensures minimal dose to the user and the patient.
7-10 Prevent Unnecessary Interruption of a Procedure Arising from a Collision
Note: Different measures have been implemented to prevent unnecessary interruption of a procedure arising from
a collision. At obstacle approach:
• The gantry slows down (half speed).
• Warning icons are displayed on live display.
• An optional audible signal warns the operator of an imminent close collision.
7-11 Automatic Exposure Control
The procedure to verify the Automatic Exposure Control is available in the DVD SM "Innova 2121-IQ, 3131-IQ
Biplane Cardiovascular Imaging System, Innova IGS 620, Innova IGS 630" (Functional Checks Tabs/CHK0063 -
ABC Stabilization Point Checks). Apply this Job Card.
7-12 Lead Shield Positioning
SPECIAL ATTENTION MUST BE TAKEN WHEN MOVING THE LEAD SHIELD CLOSE TO THE
PATIENT DURING A PROCEDURE. ALWAYS VERIFY FIRST THAT THE CATHETER CANNOT
BE ACCIDENTALY WITHDRAWN FROM THE PATIENT BEFORE MOVING THE LEAD SHIELD.
7-13 Degraded Mode
The management of error messages is designed such way than:
• In case of problem related to the Frontal plane only, the error message is displayed on the Frontal live display.
• In case of problem related to the Lateral plane only, the error message is displayed on the Lateral live display.
• In case of problem related to both planes, the message is displayed on both Frontal and Lateral live displays.
All error messages are also always displayed at the bottom of the control room digital screen.

InnovaTM IGS 620,
InnovaTM IGS 630
Innova Digital Screen
1 Frontal plane error messages

2 Lateral plane error messages

InnovaTM IGS 620,
InnovaTM IGS 630
Frontal or Lateral Live Display
1 Error message on the exam room monitor
When the frontal or the lateral plane is indicated as not available, always select the opposite plane. The system
should operate in degraded mode on the available plane.
7-14 Risk of confusion between live Fluoro images and automatic replay of stored
Fluoro images
ATTENTION TO OPERATORS IS DRAWN REGARDING A POTENTIAL MISINTERPRETATION

BETWEEN LIVE FLUORO IMAGES AND REPLAY OF FLUOROSTORE IMAGES. WHEN THE
OPERATOR WHO DEPRESSES THE FLUORO PEDAL (EXPOSURE) IS DIFFERENT FROM
THE OPERATOR PERFORMING THE INTERVENTION, THERE IS A RISK THIS OPERATOR
UNDERTAKES AN INTERVENTIONAL GESTURE ON THE MISTAKEN ASSUMPTION THAT A
CURRENTLY DISPLAYED IMAGE IS LIVE WHILE IT IS A FLUORO REVIEW IMAGE. ALWAYS
ENSURE THE REVIEW PICTOGRAMS (as shown with arrows on illustration below) ARE NOT
DISPLAYED, PRIOR TO UNDERTAKE INTERVENTIONAL GESTURE.

InnovaTM IGS 620,
InnovaTM IGS 630
7-15 Monitor Suspension Positioning
SPECIAL ATTENTION MUST BE GIVEN WHEN MOVING THE MONITOR SUSPENSION

CLOSE TO THE PATIENT DURING A PROCEDURE. BEFORE MOVING IT ALWAYS VERIFY
THAT THE CATHETER CANNOT BE ACCIDENTALY WITHDRAWN FROM THE PATIENT.
8 Protection regarding Mechanical Hazards

8-1 Table Motion User Interfaces
Table Side Status Control (TSSC)
WHEN LOADING OR UNLOADING THE PATIENT ONTO OR OFF THE TABLE:

InnovaTM IGS 620,
InnovaTM IGS 630
1 - ADJUST THE TABLE HEIGHT AND MOVE THE TABLE TOP TOWARD FOOT END SIDE FOR BEST
PATIENT ACCESS.
2 - ACTIVATE THE POSITIONER DISABLE BUTTON TO ENSURE THAT NONE OF THE TABLE AND GANTRY
AXIS WILL MOVE.
Omega Smart Box
Involuntary mechanical shocks on the Smart Box joysticks may produce unwanted
positioner motion and cause injuries. In case the Smart Box needs to be removed from the
table, always leave it in an area where its joysticks are protected from shocks.
WHILE CLAMPING TSUI ON RAIL (ON THE TABLE SIDE, ON THE CART OR ON THE
REMOTE STAND), IT IS IMPORTANT TO DOUBLE CHECK THAT TSUI IS CORRECTLY
CLAMPED ON BOTH ITS LATERAL SIDES. THERE IS A RISK OF TSUI FALL, UNWANTED
TABLE AND GANTRY MOTION AND INJURY WHEN THE TSUI IS NOT CORRECTLY
CLAMPED.
Upper side

InnovaTM IGS 620,
InnovaTM IGS 630
Lower side
TSUI is correctly clamped TSUI is not correctly clamped
8-2 Precaution regarding Detector Anti-Collision Device
ATTENTION OF OPERATORS IS DRAWN REGARDING THE PRESSURE THAT MAY BE

APPLIED ON THE PATIENT BODY IN CASE OF ACTIVATION OF DETECTOR
ANTI-COLLISION DEVICES (BUMPERS, SWITCH PLATE). YOUNG PATIENT (i.e. BABIES),
NARROW AND SMALL HUMAN OBJECTS (i.e. NOSE), SENSITIVE AREAS (i.e. AFTER
SURGERY) ARE MORE SENSITIVE TO PRESSURE. THEREFORE ATTENTION OF
OPERATOR IS DRAWN TO AVOID ANY POTENTIAL COLLISION. IN ADDITION, IT IS
RECOMMENDED TO TURN PATIENT'S HEAD TO THE RIGHT/LEFT AND TO REDUCE
GANTRY SPEED WHEN IN THE VICINITY OF THE PATIENT'S HEAD.
9 Protection against Contamination / Infection Hazards / Biological Hazards

9-1 Attachment of Protective (Sterile) Drapes
TO PROTECT AGAINST POSSIBLE BIOLOGICAL HAZARDS, ISO 10993 CERTIFIED DRAPES

SHALL BE USED ON THE DETECTOR, IN DIAGNOSTIC AND INTERVENTIONAL CONTEXTS.
Bodily fluids may damage internal components if they are allowed inside the equipment.
Use drapes, if necessary, to protect equipment when performing procedures.
If you are performing a procedure where draping is necessary, you can choose among the following solutions. You
can contact your local GE representative for more information on how to order these solutions.
ALL THE DRAPES USED ON ACCESSORIES, ON MATTRESS AND ON DETECTOR SHALL

BE ISO 10993 CERTIFIED.
9-1-1 Equipment (image receptor, X-ray tube-collimator assembly, Smart Handle, Smart Box, Table Side Status
Control, Innova Central touch screen)

InnovaTM IGS 620,
InnovaTM IGS 630
Image Receptor
X-ray tube - Collimator assembly
Smart Handle

InnovaTM IGS 620,
InnovaTM IGS 630
Smart Box
Table Side Status Control (TSSC)
Innova Central touch screen
9-1-2 Accessories

InnovaTM IGS 620,
InnovaTM IGS 630
Injector Control Console
3D Mouse Box
10 Symbols
Symbols used on the vascular systems and in its accompanying documents are shown and explained in this
section.
• Audio/Visual Indications
• Special Notices
• X-ray Tube
• Power ON and OFF
• Type B applied part
• Electrical Class
• Electrical Current
• Ground
• Collimator
• Cardiac Pulmonary Resuscitation (CPR)
• Maximum Patient Weight
• Table Head Extender
• Table end rail maximum load

InnovaTM IGS 620,
InnovaTM IGS 630
• Footswitch
• Smart Handle/Smart Box/Table Side Status Control
• Innova Console
• Application
• Grid Out
• Acquisition
• Status Icons
• Remote Stand (Option)
• Tableside Cart (Option)
• Patient Browser Network Status Icons
• Electronic Operator Manual
• X-ray LED
• Filtration
• Bolus Handle
• Product identification
• Emergency Back-Out
10-1 Audio/Visual Indications
This table provides a summary of the major audio/visual indications provided by the console.
INDICATIONS CAUSE COMMENT

VISUAL AUDIO * OTHER
None. Normal procedure dur- Normal radioscopy oper-
ing radioscopy X-ray ation.
exposure (Record)
Medium, low-pitched, con-
tinuous tone.
Brief flash on VCIM Normal procedure dur- Normal fluoroscopy op-
at the initiation of ing fluoroscopy X-ray eration.
fluoro. exposure (Fluoro):
Brief tone. brief audible signal at
the initiation of irradia-
tion.
None. X-ray Timer reaches Press the X-ray Timer
5.0 minutes. Reset button to silence
the audible signal and
FLASHING Pulsed tone. reset timer to 0 minute.
In Italy, X-rays are dis-
abled after 10 minutes
without reset.
None. HUA (Heat Unit Avail- Wait for X-ray tube to
able) value is below or cool (HUA greater than
equal to 20%. 20%).
High, continuous tone.

InnovaTM IGS 620,
InnovaTM IGS 630
None. None. Shows status of ECG Green means signal is

signal. detected and online, yel-
low means system is sta-
bilizing, orange may
need reset and white
means system is offline.
Note: * The behavior may change depending on country selection. Refer to Safety and Regulatory Instructions for
Use / Protection regarding Ionizing Radiations Hazards for Innova IGS 620 / Dose to Patient in Japan or Safety and
Regulatory Instructions for Use / Protection regarding Ionizing Radiations Hazards for Innova IGS 630 / Dose to
Patient in Japan for more detail.
Buzzer Kit: Allows transmission of all audio indications in the exam room.
• The loudness of the loudspeaker was adjusted at installation. Contact your GE Service Representative for any
further modification.
• For cleaning, unplug the power source before cleaning. Do not use liquid cleaners or aerosol cleaners. Use a
damp cloth for cleaning.
• Do not attempt to open covers or to service any part of the speaker yourself.
Fluoroscopy and Radioscopy audible signals may be configured. Push Fluoro icon or Record icon in monitoring bar
to open the sound configuration window:
The following settings are available for Fluoroscopy and Radioscopy. By default at installation, the system is
configured with a short beep for Fluoroscopy and a continuous tone for Radioscopy.
NONE BEEP CONTINUOUS

FLUOROSCOPY No audible signal Short tone at the initiation of -
irradiation
RADIOSCOPY Continuous tone during irra-
diation
Note for Japan: As described in Safety and Regulatory Instructions for Use / Protection regarding Ionizing
Radiations Hazards for Innova IGS 620 / Dose to Patient in Japan or Safety and Regulatory Instructions for Use /
Protection regarding Ionizing Radiations Hazards for Innova IGS 630 / Dose to Patient in Japan, the usage of
special high level Fluoroscopy mode is indicated permanently on the Reference in room monitor by the annotation
"Normal" and by a permanent audible signal. Therefore, Fluoro and Record beep settings do not apply in this
special mode.
Note: With the continuous tone setting, slower frame rates will sound like a beep signal.
Fluoroscopy and Radioscopy sound can be selected from the respective drop-down menu:

InnovaTM IGS 620,
InnovaTM IGS 630
Extra caution should be taken if the Fluoro or Record sound is set to "None". Inadvertent
x-ray activation and unknowingly activating the footswitch will not be detectable by an
audible signal because the sound will be deactivated.
10-2 Special Notices
Caution advises of an avoidable condition that

could cause minor physical injury, or damage to
equipment or data.
WARNING ADVISES OF AN AVOIDABLE CONDI-

TION THAT MAY ALLOW OR CAUSE A PERSONAL
INJURY OR THE CATASTROPHIC DESTRUCTION
OF EQUIPMENT OR DATA.
DANGER ADVISES OF AN AVOIDABLE CONDI-

TION THAT WILL CAUSE SERIOUS OR FATAL IN-
JURY.
Dangerous voltage. Indicates an avoidable dangerous

high voltage hazard.
Warning: dangerous voltage.
This symbol on the equipment means that the operat-

ing instructions should be consulted to assure safe op-
eration.
This symbol on the equipment means that the operat-

ing instructions should be consulted to assure safe op-
eration.

InnovaTM IGS 620,
InnovaTM IGS 630
Identifies an emergency stop control device.
Identifies an emergency stop control device. Located

on Power Distribution Box (PDB).
General warning sign.
General mandatory action sign.
General prohibition sign.
Follow Operating Instructions.
Follow instructions for use.
10-3 X-ray Tube

InnovaTM IGS 620,
InnovaTM IGS 630
X-ray emission. X-ray tube head is emitting X-rays.

Take adequate precautions to prevent the possibility of
any persons carelessly, unwisely, or unknowingly ex-
posing themselves or others to radiation.
X-ray source assembly. Indicated a reference to an X-

ray source assembly.
X-ray tube. Indicates a reference to the X-ray tube, i.e.

to mark the surface of a grid that is to be oriented to-
wards the X-ray tube.
Identifies controls or indicators associated with normal

rotational speed of the X-ray anode.
Identifies the plane where is located the X-ray tube fo-

cal spot into the system.
10-4 Power ON and OFF
Switch or switch position that applies and removes

power to part of the equipment. This does not apply
main voltage.
A white <SYSTEM RESET> button. Use this button to

reset the Innova System.

InnovaTM IGS 620,
InnovaTM IGS 630
Switch or switch position that applies mains voltage.

Indicated connection to the main voltage for all main
switches or their positions. This symbol is used in all
cases where safety is involved.
Switch or switch position that removes the main volt-

age. Indicated disconnection from the mains for all
main switches or their positions. This symbol is used in
all cases where safety is involved.
10-5 Type B applied part
Applied part complying with the specified requirements

of the IEC 60601-1 standard to provide protection
against electric shock, particularly regarding allowable
patient leakage current and patient auxiliary current.
10-6 Electrical Class
Class II Equipment. Protection against electrical shock does not rely on basic insulation
only, but in which additional safety precautions such as double or reinforced insulation
are provided. There is no provision for protective earthing or reliance upon insulation
conditions.
10-7 Electrical Current
Alternating Current. Indicates equipment that is suit-

able for alternating current only.
Direct Current. Indicates equipment that is suitable for

direct current only.
Both direct and alternating current. Indicates equip-

ment that is suitable for both direct and alternating cur-
rent.
10-8 Ground
Functional Earth (ground) Terminal. Terminal directly

connected to a point of a measuring supply or control
circuit or to a screening part which is intended to be
earthed for functional purposes.

InnovaTM IGS 620,
InnovaTM IGS 630
Noiseless (clean) earth (ground). Identifies any termi-

nal of a specially designed earthing system where
noise from earth of leads will not cause a malfunction
of the equipment.
Protective earth (ground). Identifies any terminal which

is intended for connection of an external protective
conductor to protect against electrical shock in case of
a fault.
Frame or chassis. Identifies the frame or chassis termi-

nal.
Equipotentiality. Identifies terminals that bring the vari-

ous parts of equipment or systems to the same poten-
tial when connected together. These terminals are not
necessarily at earth (ground) potential. The value of
the potential may be indicated next to the symbol.
10-9 Collimator
Identifies controls for opening the collimator blades, or

indicates partially or fully open state.
Identifies controls for closing the collimator blades, or

indicates closed state.
Collimator blades closed. The controlled blades are

shown in thicker lines.
Collimator Blades open. The controlled blades are

shown in thicker lines.

InnovaTM IGS 620,
InnovaTM IGS 630
10-10 Cardiac Pulmonary Resuscitation (CPR)
Move the table top toward the foot end and center it
laterally over the table base before performing a CPR
procedure
10-11 Maximum Patient Weight
The maximum patient weight the Omega table can ac-

cept is 204 kg
The maximum patient weight the table can accept is

204 Kg.
The maximum permissible load including accessories

the Omega Table can accept is 304 kg.
The maximum permissible load including accessories

the Omega Table can accept is 304 kg.

InnovaTM IGS 620,
InnovaTM IGS 630
10-12 Table Head Extender
Label for maximum patient weight on head extender.
10-13 Table end rail maximum load
20 kg maximum load allowed
10-14 Footswitch
Do not use the footswitch cover as a footrest or stand on it
Brake release
10-15 Smart Handle/Smart Box/Table Side Status Control
This sticker is located on the back side of each Table Side User Interface
(TSUI). Do not place TSUI on the floor. Unwanted table or gantry motion
could be activated.

InnovaTM IGS 620,
InnovaTM IGS 630
10-16 Innova Console
Radiation Hazard Symbol.

This sticker is located on VCIM. Caution X-rays.
10-17 Application
Displayed on left side of the live display to show that the displayed image is a
live fluoroscopic image.
Displayed on left side of the live display during a fluoro performed in Auto Fluo-
rostore mode.
Displayed on left side of the live display to show that the displayed image is a
recorded image.
Displayed on live display to show that the displayed image is the frozen last flu-
oroscopic image.
Displayed on live display to show that the displayed image, previously record-
ed, is reviewed.
Displayed on left side of the live display to show that a mask is available for the
Roadmap fluoro.
Displayed on the left side of the live display to show the system is in Blended
Roadmap and the selected percentage of vessel visibility
30% Displayed on left side of the live display to show the selected level of landscape
for Subtracted or Roadmap fluoro.
Displayed at the bottom right of the live display to show that the displayed im-
age is a previously recorded image reviewed in Play mode Forward nominal
speed (review in loop)
age is a previously recorded image reviewed in Play mode Forward half speed
(review in loop)
age is a previously recorded image reviewed in Play mode Forward high speed
(review in loop)
age is a previously recorded image reviewed in Play mode Backward nominal

InnovaTM IGS 620,
InnovaTM IGS 630
age is a previously recorded image reviewed in Play mode Backward half
age is a previously recorded image reviewed in Play mode Backward high
age is a previously recorded image reviewed in Pause mode (frozen image)
age is a previously stored fluoroscopic image reviewed in Play mode Forward
nominal speed (review in loop)
half speed (review in loop)
high speed (review in loop)
age is a previously stored fluoroscopic image reviewed in Play mode Backward
age is a previously stored fluoroscopic image reviewed in Pause mode (frozen
image)
Displayed on left side of the live display to show that an ECG signal is being
detected
Source to Image Distance (SID)
Source to Object Distance (SOD)
Table Height displays the distance it is above or below isocenter of the system
Used to indicate the Frontal plane.
Used to indicate the Lateral plane.
10-18 Grid Out

InnovaTM IGS 620,
InnovaTM IGS 630
Displayed on left side on the live display, in the Geometry area, to show that
the anti-scatter grid has been removed and is not in the X-ray beam.
10-19 Acquisition
Displayed at the bottom of the control room console to show that a fluoroscopic
or record acquisition is in progress
10-20 Status Icons
Displayed on the right side of the right side of the reference display to show
that disk space is still available.
Displayed on the right side of the right side of the reference display to show
that disk starts to be full.
Blinking icon displayed on the right side of the reference display to show that
disk is near to be full.
Displayed on the right side of the reference display to show that disk is full.
Displayed on the right side of the reference display to show that at least 50% of
heat units are still available in the X-ray tube.
Displayed on the right side of the reference display to show that available heat
units in the X-ray tube are between 30% and 50%.
Blinking icon displayed on the right side of the reference display to show that
available heat units in the X-ray tube are below 30%.
Displayed on the right side of the reference display to show that the maximum
heat units are reached in the X-ray tube.
Displayed on the right side of the reference display to show that the Fluoro is
ready (enabled).
Displayed on the right side of the reference display to show that the Fluoro is
not available (disabled).
Displayed on the right side of the reference display to show that the Record is
ready (enabled).

InnovaTM IGS 620,
InnovaTM IGS 630
Displayed on the right side of the reference display to show that the Record is
not available (disabled).
10-21 Remote Stand (Option)
Label for Locking Direction Note:

The direction label also posted on the backside to take care of both RH and LH
Installations.
Label for Maximum Load Warning Note:

The warning labels are also posted on the bottom side of the arms to reference
both the right handed or left handed installations.

InnovaTM IGS 620,
InnovaTM IGS 630
This sticker is located close to the middle of each rail. No more than 13 kg on
each rail.
This sticker is located at the base of the Tableside Cart. No more than 50 kg for
overall weight on the base of the Tableside Cart.
This sticker is located on each front wheel.

Do not stand on the Tableside Cart base or wheels.
10-23 Patient Browser Network Status Icons

InnovaTM IGS 620,
InnovaTM IGS 630
The below icons appear in the Network Status column of the Patient, Exam, Sequence and Photo Browser.
Network Status refers to the consolidated transfer status of all the network activities in the DICOM network.
Network activity in Innova includes:
(a) DICOM Worklist
(b) DICOM MPPS
(c) DICOM Image Push
(d) DICOM Image Storage commitment
(e) DICOM Dose Structured Report Push
(f) DICOM Dose Structured Report Storage commitment
Indications Cause Comment

Empty No network activity available Can either be deleted (if not used) or perform some ac-
tions.
Sending Some network activity is in-progress Recommended not to perform a delete operation.
If deletion is still required, the system will provide warn-
ings and perform the deletion operation after user’s con-
firmation.
Archiving Archival is in-progress (Image or Dose This activity can take some time. Depends on the
Structured Report) Archiving station setup.
Recommended not to perform a delete operation.
If deletion is still required, the system will provide warn-
ings and perform the deletion operation after user’s con-
firmation.
Information Some network activity did not take Recommended to place the mouse over the icon to read
place (or) all the network activities and perform the action required.
completed but the patient exam is still
Recommended not to perform a delete operation.
active.
Completed All network activities completed. Can be safely deleted.
Failed Some network activity failed. Recommended to place the mouse over the icon to read
and perform the action required.
Recommended not to perform delete operation.
10-24 Electronic Operator Manual
Symbol indicating that the Instruction For Use (Operator Manual) is sup-
plied in electronic format. It is located on the L-arm.
10-25 X-ray LED

InnovaTM IGS 620,
InnovaTM IGS 630
X-ray ready
10-26 Filtration
To indicate a reference to a radiation filter or a value of filtration.
10-27 Bolus Handle
Bolus button
Table Speed
10-28 Product identification
Indicates the medical device manufacturer.
Indicates the date when the medical device was manufactured.
Indicates the manufacturer's catalogue number so that the medical device can be
identified.
Indicates the manufacturer's serial number so that a specific medical device can be
identified.

InnovaTM IGS 620,
InnovaTM IGS 630
10-29 Emergency Back-Out
Frontal Positioner This symbol indicates that emergency back out button should be pressed in
order to move detector to its highest position; the detector lift speed is faster
than normal, in the indicated direction.
Lateral Positioner

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 5 - Radiation Safety

Radiation safety and the amount of dose the patient and staff receive during a procedure is a growing concern
today. This section is to increase your knowledge and to help you develop safe work habits. It will give you a quick
overview of the topic of X-ray radiation and dose through a simple explanation of the equipment, technology and to
discuss the different techniques available to reduce dose.
• How X-ray radiation is created and the "Dose" Concept
• Dose Parameters
• Effects of ionizing radiation on humans
• General Dose reduction measures for the patient
• General Dose reduction measures for the staff
• Special Dose reduction measures
• Dose reduction measures on the Innova System
• Special Case
• Legal Provisions
• Dose Reduction: 7 easy steps to remember
1 How X-ray Radiation is created and the "Dose" concept

X-ray radiation is produced by an X-ray tube that directs a beam of energetic high speed electrons at a target. The
force with which the electrons strike the target depends upon the accelerating voltage measured in kilovolt peak
(kVp). Higher voltage produces greater force and increases the quality (energy) of the X-rays by increasing their
penetrating power. Increasing the electron current measured in milliamperes (mA) without changing the kVp will
increase the quantity of radiation without improving the quality.
As the X-ray beam leaves the tube, lower energy X-rays what have little diagnostic value due to their poor
penetrating power, are filtered out by the tube wall and the exit portal. Filtration of the primary beam can be
increased by adding aluminum or other filtering material to the exit portal of the tube. This is referred to as the
inherent filtration. The lower energy X-rays that are filtered out are less penetrating and therefore, do not supply
any diagnostic value as the more penetrating higher energy X-rays do. As radiation penetrates objects and human
bodies, it passes through them and is weakened in the process. This weakening is equivalent to a reduction in the
number of individual radioactive particles. The measurement of the amount of radiation is what we call "dose". It
could be dose to the patient or dose to the detector.
In a fluoroscopic and a radiographic exposure, it is advised to use the highest kVp possible that will produce good
diagnostic image quality while penetrating the patient and at the same time using the greatest filtration to minimize
the patient's exposure. In other words, not all the radiation particles generated during an X-ray are used to produce
the resulting images, and because radiation can cause damage to the human body, we try to achieve the greatest
possible effect; the best image with the smallest amount of radiation dose.
2 Doses parameters
There are different types of dose depending on where and how the measurement is taken and if the measurement
is for the patient or the detector dose.
2-1 Incident dose
The incident dose is the dose measured in the middle of a radiation field on the surface of a body or a phantom.
However, it is only measured at this point if there is no body in the path of the X-ray beam. Thus, there is no scatter
radiation from the body during this measurement. When radiation strikes a substance, there is always a certain
scattering of radioactive particles. This is comparable to light striking a glass surface; a certain portion of the light is
always reflected.
The unit used to measure the incident dose is joules per kilogram, and is known as "Gray" where 1 Gray (Gy) = 1
218 Radiation Safety

InnovaTM IGS 620,
InnovaTM IGS 630
J/kg. The former unit used to measure the incident dose was the "Rad", and using this unit, 1 Rad (rd) = 0.01 Gy,
or 1 Gy = 100 rd. But because today's doses are generally very small, they are usually described using the unit
"mGy", that is, 0.001 Gy.
Incident dose = the dose measured on the intended surface of the patient, but without the presence of the
patient
The System International unit (SI unit) used to measure the incident dose is the Gray, where 1 Gy = 1 J/kg
2-2 Surface dose

The surface dose is measured with the body in the path of the beam. Because of the scattered radiation that
results on the surface and in the depths of the body, the surface dose differs from the incident dose by including
the amount of scattered radiation.
Thus we can say:
Surface dose = incident dose + scattered radiation from the body
The SI unit used to measure the surface dose is the Gray (Gy)
2-3 Exit dose

The exit dose serves in the evaluation of the X-ray image. It is measured in the radiation field in immediate
proximity to the surface of the body where the beams exit from the body. On the basis of the exit dose and the
surface dose, we can calculate how much radiation must have remained in the patient's body.
Radiation in the body = surface dose - exit dose
The SI unit used to measure the exit dose is the Gray (Gy)
Radiation Safety 219

InnovaTM IGS 620,
InnovaTM IGS 630
2-4 Image receptor dose

The image Receptor dose is measured at Revolution Digital Detector. The image receptor dose is generally smaller
than the exit dose, because the radiation weakens before it reaches the image receptor, for example by
encountering objects after the patient's body such as the anti-scatter grid.
Image receptor dose <= exit dose
The SI unit used to measure the image receptor dose is the Gray (Gy)
2-5 Dose rate at image receptor

In order to measure a dose, the beam must operate for a certain period of time. The dose rate therefore represents
the measured dose for the amount of time required to complete the dose measurement. If the image receptor dose
is measured in the process, then the dose rate is the image receptor dose rate. If the dose is measured at a
different site, then the dose rate is determined using one of the previously mentioned dose parameters.
measured dose
Dose rate = ----------------------
required time
The SI unit used to measure the dose rate is Gray per second: (Gy/s) or in usual unit (mGy/min).
2-6 Dose-area product
The dose-area product is a measurement of the amount of radiation that the patient absorbs. It is usually measured
behind the multi-leaf collimator, that is, on the side of the patient where the radiation enters the body, by attaching
a measuring device in front of the X-ray tube and passing a beam through it. The dose-area product is independent
of the distance between the X-ray tube and the measuring device because the further away from the X-ray tube
this measurement is taken, the more the size of the device increases, and the dose itself decreases (see diagram).
The dose to the patient can be calculated from the dose-area product, the size of the measuring device, and the

InnovaTM IGS 620,
InnovaTM IGS 630
distance to the X-ray tube and the patient.

Dose-area product = dose * surface area of the measuring device
The SI unit used to measure the dose-area product is the Gray * meter² (Gy*m²) or in usual unit cGy*cm² or
Gy*cm².
Dose-area product
The dose-area product at 50 cm from X-ray tube is just as great as dose-area for 100 cm or 200 cm, because the
size of the measuring device increases with greater distance to the X-ray tube. But the dose itself decreases with
greater distance to the tube. Thus the dose-area product is the same at each position if the size of the measuring
device enables it to detect all of the radiation.
2-7 Body dose and effective dose
The body dose is the comprehensive concept for the organ or partial-body dose equivalent and the effective dose.
In the practical application of radiation protection, however, local and individual doses are monitored, because body
doses cannot be measured directly. The Radiation Protection Regulations therefore use the concept of effective
dose, in which all the individual doses to the irradiated organs or parts of the body are multiplied by a factor and
then added together. The resulting value may not exceed the dose limit for the effective dose that a patient is
allowed to receive.
Body dose = sum of all organ or partial-body doses
Effective dose <= patient dose limit
The SI unit used to measure the body dose and the effective dose is the sievert, where 1 sievert = 1 Sv = 1
Joule/kilogram = 1 Gray

InnovaTM IGS 620,
InnovaTM IGS 630
2-8 Maximum Symmetrical Radiation Field

Maximum Symmetrical radiation: 370 mm x 400 mm at 1 m according to IEC 60806.
3 Effect of Ionizing Radiation on Humans

Biological effects of any dose should be divided into low and high levels. During most procedures, the effects of
patient irradiation are low. Cardiac procedures could give the patient high doses of radiation, and this can be the
cause of injuries to the patient (e.g.: skin injuries or hair loss). In order to minimize this risk without adversely
affecting the clinical objectives of the procedure, it is currently admitted that precautions should be taken when skin
dose in a single location can exceed 1 Gy.
The danger of radiation exposure is increased as the area of the body that receives the exposure is increased.
Certain tissues such as bone marrow are more sensitive to radiation than others. Genetic effects of radiation are
considered as a special hazard when the gonads are exposed to radiation. Lens of the Eyes, the Thyroid, blood
forming organs or a developing embryo is the most radiation sensitive.
Radiation damage to the body is generally greater when the dose is given in a one shot exposure than if the dose
is spread over a greater period of time. The effects of large doses or radiation usually show up in a short period of
time. However, delayed effects of radiation may show up after many years in a form such as cancer or leukemia.
Due to the duration of total fluoroscopic time and the number of acquisition sequences in a single location, the risk
is particularly important in cardiac procedures. GEHC equipment includes dose limitations mechanisms; in
particular, the conventional entrance skin dose rate is maintained below 87 mGy/min (10 R/min), in a plane
representative of patient skin dose, and positioned 30 cm from the entrance of the Revolution Digital Detector.
Therefore, in this plane, the value of 1 Gy may be reached in 10 to 12 minutes of fluoroscopy.
In particular configurations required for an examination, patient skin could be significantly closer to the X-ray
source, with dose rate increased as the inverse square of the distance.
3-1 Concept of Intervention Reference Point
The Interventional Reference Point, recently introduced in the X-ray standardization, is intended to be
representative of the point of intersection of the X-ray beam axis with the patient. For the Innova systems including
an isocenter, the Interventional Reference Point is the point on the reference axis 15 cm from the isocenter towards
the focal spot.
This distance is assumed to represent a good approximation of the value of the actual focal spot to skin distance
during interventional procedures. If one considers currently available methods to estimate absorbed doses to
selected tissues for radioscopic and cine-angiographic examinations of the coronary arteries of adults, these
methods rely on the use of distinct operating conditions commonly used in radiological examinations of the heart.
These operation conditions are associated with a view, an arterial projection, and technique factors on the X-ray
equipment such as the X-ray tube voltage (kV), the half value layer (HVL), the focal spot to skin distance, the focal
spot to image receptor distance and the entrance field size.
A review of the operating conditions derived from analyses of practice indicates that the defined interventional
reference point is, in fact, a fair approximation of the focal spot to skin distance for each field.
The error in estimating the total absorbed dose to the skin introduced from the defined Interventional Reference

InnovaTM IGS 620,
InnovaTM IGS 630
Point should average out as long as the interventional procedure is composed of multiple views. When the
interventional procedure is limited to one or a few views, the possibility of error in estimating the absorbed dose to
the skin may be higher. However, even under worse case conditions, errors should be less than a factor of two.
Of course, most of this error can be eliminated by assessing the position of the patient and calculating the
appropriate correction factor.
4 General Dose Reduction Measures for The Patient

4-1 Distance between the X-ray tube and the patient
4-1-1 Inverse square law
A bundle of X-rays corresponds to the shape of a cone, with the tube at its tip. The intensity or dose of the radiation
emitted from the source of the X-ray beam diminishes with the square of its distance from the source. If you double
the distance x, the dose changes by a factor of 1/(2²), and if you triple it, the dose changes by a factor of 1/(3²).
Inverse square law
In general, the dose amounts to 1/x². Therefore, if you double the detector-to-target distance, you will need four
times as much radiation to achieve the same image blackening.
A Skin Spacer may be used to assure a minimum distance of 380 mm to the patient's skin. If you positioned the
patient too close, this would lead to excessive skin dose radiation to the patient; thus, increasing the distance
between the X-ray tube and patient helps to reduce the amount of skin dose radiation to the patient. For example,
the exposure rate is approximately 1.5 times greater at 305 mm from the focal spot to the patient than 380 mm.
4-2 Distance between the patient and the detector
The detector should be kept as close to the patient as possible for all exposures. This helps the Innova system to
select the lowest optimal technique factors to visualize the anatomy properly. When the distance between the
patient and the detector is excessive, not only is the magnification increased but so are the technique parameters
which could lead to a poor image that is too gray and flat losing small vessel detail.
4-3 Collimation
Collimation brings about a genuine dose reduction and also produces better image quality. Collimation is performed
using collimators (multi-leaf collimators or iris diaphragms) that are attached directly in front of the X-ray tube.
Collimation at the target is the most effective radiation protection for the patient and personnel, because it narrows

InnovaTM IGS 620,
InnovaTM IGS 630
the area that the radiation can strike.

4-4 Compression
Because radiation scatters in a body exposed to X-rays, compression of the body is another way to reduce the
radiation dose. Scattered radiation also produces an undesirable reduction in contrast in the X-ray image. With
compression, the thickness of the body is reduced, and so a lower dose is absorbed by the body. Additionally,
compression ensures that less scattered radiation occurs.
4-5 Anti scatter grid
Before mounting, check if the reference is the same on the anti-scatter grid and the following illustration:
Anti scatter grid 21 cm Anti scatter grid 31 cm
Supplier Reference: Supplier Reference:

Anti scatter grid 21 cm lateral: 9896 010 61691 Anti scatter grid 31 cm lateral: 9896 010 61681
Anti scatter grid 21 cm frontal: 9896 010 60571 Anti scatter grid 31 cm frontal: 9896 010 29681
Cross section of an anti scatter grid
The anti-scatter grid is located between the patient and the Revolution Digital Detector. It is the most effective
method of reducing scattered radiation. The grid absorbs a portion of the scattered radiation in its lead plates.
This absorbed dose therefore does not reach the Revolution Digital Detector, even though it has already passed
through the patient. Thus, the use of an anti-scatter grid leads to an increase in the dose, because the amount of
radiation that reaches the Revolution Digital Detector, is not reduced until it has passed through the patient: if the

InnovaTM IGS 620,
InnovaTM IGS 630
anti-scatter grid is used, the patient must be exposed to a higher dose of radiation in order for the minimum dose to
reach the Revolution Digital Detector. But, we are not talking about excessive amounts of increased dose and one
needs to understand the benefits as well as the trade offs of using a grid. In cardiac procedures, the chest area of
the patient , where the X-ray beam has to penetrate, is the largest portion of the patient as well as some patients
are over weight and present a challenge to imaging to begin with. Then add steep angles for the views of the heart,
and you have fairly high techniques as compared with the rest of the body. If there was no grid used, all the
secondary scatter exiting the patient would reach the detector as well as the primary beam. The scatter has no
usefulness for creating a good image so the grid helps to eliminate it before it can affect the overall image quality.
We can differentiate between individual anti-scatter grids using their grid ratios. This is the relationship between the
height of the plates to the distance from each other.
The greater the grid ratio, the greater the grid's effect. Thus, the required dose increases with the grid ratio. The
typical grid ratio is 14:1 for the Innova Systems.
4-6 Record and Fluoro mode selections
The Innova System provides the user with two Record modes and two Fluoroscopy modes. The Low selection for
each will use lower dose to the receptor while providing lower patient skin dose. The image quality of the Low mode
may be compromised because of the patient's size or the steepness of the angle. In that case, the Normal mode
should be used. Neither mode will increase the skin dose to the patient beyond the allowed limit of the country.
When possible, change the entry point of the beam in order to reduce the local dose to the patient. For long
interventional procedures, this will help to reduce any potential of skin burns to the patient.
4-7 Frame rates
In Record mode, try to keep the frame rate at the lowest value compatible with the medical requirement. Frame
rates are set depending on the blood flow of the vessel and or the movement of the anatomy. In addition, the
shorter the length of the sequence and the fewer sequences acquired will help to reduce the total exam dose to the
patient.
4-8 Field of View
There are four Field of Views available on the Innova Systems. Even though the detector doesn't need additional
dose to create an optimal image, there is a slight increase of dose to the receptor to minimize the noise seen in the
image. Even though this dose increase is minimal, using the largest Field of View with the least amount of
magnification will assure the least amount of dose used.
4-9 Radiation filtration / hardening
The quality of the X-ray also plays a great role in the size of the administered dose. X-ray radiation normally has
so-called "hard" and "soft" particles, that is, particles with a lot of energy and particles with little energy. Hard
particles are better for the patient, because they pass through the body. Soft particles, by contrast, get caught
inside the body because they are too weak to pass through and out of it. Therefore, it is primarily soft radiation that
creates unnecessary exposure to the patient. For this reason, copper and aluminum are used as filters in front of
the X-ray tube. The soft radiation is caught in the filter plates, and the remaining radiation emerging from the filter is
"harder". This additional filtration can also reduce the dose to the patient without diminishing image quality,
because in any case only the "hard" rays reach the Revolution Digital Detector.
5 General Dose Reduction Measures for the Staff

Following the dose reduction measures for the patient will indirectly effect the dose to the staff. Personnel in the
Cardiac Cath lab are exposed to X-ray radiation at all times and need to follow additional recommendations to
reduce the amount of radiation they receive in the work place.
5-1 Protection from X-ray Radiation
5-1-1 Distance
Distance is a very effective, and in many cases, is the most easily applied method of radiation protection.
The inverse square law applies to most sources of X-ray. Each time you double your distance from the source of

InnovaTM IGS 620,
InnovaTM IGS 630
radiation, the intensity of the radiation per unit mass is reduced by a factor of four.
For the greatest safety, stay as far from the source of radiation as possible. When the tube is positioned under the
table the patient helps to protect the staff. Radiation travels in a straight line. Don't stand where the tube is pointing
towards you, but behind the X-ray tube if possible. Also, any distance six feet (1.83 m) or more away from the X-ray
source and patient is considered safe.
Significant Zone of Occupancy
There is a significant zone surrounding the table that identifies proximity to the radiation source. Included in the
significant area is the tableside area where the Physician stands to perform the procedure. All equipment within this
zone 1.5 m around the patient are medical components (table, positioner, monitors, injector, radiation protection
shield, etc.) that must be in compliance with medical device regulation.
5-1-2 Shielding
Any material placed between you and the source of X-ray radiation will absorb some of the radiation, thus reducing
its intensity. The more material with the greatest density will absorb more radiation. High atomic number materials
such as lead, are the most useful for absorbing X-rays. Depending on the energy of the X-rays, only 1 or 2 mm of
lead will reduce the radiation dose by a factor of more than 100.
Shielding can come in many forms. Lead aprons and protective devices such as lead gloves, glasses, thyroid
shields are also effective in limiting occupational exposure dose. When working near the X-ray equipment other
objects can be placed in between you and the radiation. An eye and thyroid lead window shield, a lead radiation
shield mounted on the table or equipment, or a mobile stand shield. Of course, the best shielding is standing
behind lead window panels and lead walls outside the angiographic room.
Proper shielding cannot eliminate X-ray, but it can reduce the quantity to an acceptable level.
5-2 General Precautions
1. Stay as far away as possible from the source of radiation. Know the path of the primary beam and work as far
from it as possible.

InnovaTM IGS 620,
InnovaTM IGS 630
2. Minimize your time near radiation sources.

3. Always wear your dosimeter and be aware of all radiation levels in your environment.
4. Employ appropriate thickness and quantities of shielding. Use all available protective barriers like lead aprons,
thyroid shields, lead glasses, lead drapes, and lead screens.
5. Use lead masks, collimators and other devices to limit the primary beam to the minimum opening consistent
with the information needed.
6 Dose Reduction Measures on the Innova System

With the development of the all digital Innova system and the Revolution Digital Detector, one of the main
objectives was to provide superior image quality with the least amount of dose. To accomplish this, several features
are used in conjunction with each other. More information about the system as a whole is found in the Instructions
for Use section.
7 Smart Fluoro
Fluoroscopy is performed at low dose compared to record and inherently shows more noise. Quantum noise is a
direct function of the quantity of X-rays. At a given level of clinically acceptable noise, dose reduction can be
achieved either by at least two methods: Slowing the pulsing rate or advanced digital processing of successive
frames acquired with low dose pulsed fluoroscopy.
Fast (30 fps) pulsed fluoroscopy uses short, high intensity pulses to better freeze motion in the image. It is also
possible to skip pulses, filling the "gap" with previous image. This reduces the quantity of X-rays used and results in
less dose per image. When you reduce the pulse rate, the inherent temporal averaging performed by the human
visual system is less effective and images may look a bit noisier at lower frame rate. This can be compensated by
increasing dose per frame appropriately, yet achieving dose saving in reduced frame rate mode to the extent
possible. The images may appear slightly jerky at lower frame rates. Innova systems offer reduced pulse rate
option during fluoroscopy.
An alternative method of lowering dose is to digitally process images, by averaging several successive images into
one. This allows the use of the same X-rays more than once. This is equivalent to more photons to the image, for
the same patient dose. Using image processing, the temporal averaging effect of the eye is thus further enhanced.
During digital processing, moving objects have to be treated differently to avoid blurring. GE has a unique and
patented technique called Smart Fluoro for effective temporal averaging of frames. The algorithm effectively
discriminates moving object edges from the background and reduces noise and improving image quality.
7-1 Benefits of LIH
Last Image Hold (LIH) provides an image in between the live fluoro images to use as a reference image and
eliminates the need for extended fluoro exposures
minimum. The Innova Systems have automatic spectral filtration that appropriately inserts either 0.1 mm, 0.2 mm,
0.3 mm, 0.6 mm or 0.9 mm of copper (depending on system) into the fluoroscopy or record exposure if needed.
7-3 Tabletop
The material from which the tabletop is constructed is also significant for the required dose, because the tabletop is
penetrated by the radiation and weakens it before it reaches the image intensifier. Therefore, if at all possible the
tabletop should not contain any material that strongly weakens the radiation or absorbs it well, such as lead or
metals in general. Carbon fiber has proven to be the best material for X-ray system tabletops because its radiation
absorption is minimal and the tabletop can take a great amount of stress; today a tabletop is expected to be able to
support a patient weighing up to 204 kg or 450 pounds.
8 Special Case

InnovaTM IGS 620,
InnovaTM IGS 630
8-1 Pediatrics
Because children have a greater sensitivity to radiation than adults, special conditions apply to pediatric radiology.
When possible, an attempt should be made to avoid X-ray examinations altogether and to use alternative
procedures. But when X-rays can not be avoided, there are a few basic practices that can be used to minimize the
dose to a child.
For infants up to 1 year old anti-scatter grid can be removed for acquisitions performed at Field of View smaller
than 20 cm.
Collimation to the specific area of interest is still the first choice of reducing dose to a child.
And when possible, it is especially important to use a gonad shield.
For access to specific dose settings for pediatrics in Innova Systems, select a protocol on the DL console where
the name contains ‘peds’ or ‘pediatrics’ (see Innova Digital / How to select an Acquisition Protocol).
For details about how the system optimizes the exposure techniques and how it complies with regulation about
dose settings for pediatrics, (SV-Richtlinie, point about Tabelle I 1, Kinder KB25 < 0.2 µGy/s and the alternative
application note E21), please refer to Appendix “Dose settings for pediatrics in Innova systems” or the following
article:
Barry Belanger, John Boudry: Management of pediatric radiation dose using GE fluoroscopic equipment. Pediatr
Radiol (2006) 36 (Suppl 2): 204–211.
9 Legal Provisions
In many countries or states, by means of rules, guidelines or regulations, lawmakers have contributed to improving
radiation protection for patients and medical personnel; after all, medical exposure to radiation is the single largest
source of radiation exposure among the general population. On an international level, guidelines are laid down by
the International Commission on Radiological Protection (ICRP). Many of the rules, guidelines or regulations are
governed by the ALARA concept (As Low As Reasonably Achievable), meaning the production of a diagnostically
relevant image at minimum possible dose.
10 Dose Reduction: 7 easy steps to remember

1 Use LOW vs. NORMAL Details • Will reduce the dose by around 50%.
• Use LOW vs. NORMAL Details only if Image Quality is adequate.
• LOW can be set up by default in Protocols (ask Applications Spe-
cialist).
2 Use the lowest acceptable frame rates • Lower frame rate can further reduce the dose by around 50%.
(example 15 fps vs. 30 fps)
• Different default fps between Record and Fluoro can be stored in
protocols.
3 Minimize duration of X-ray • Don’t image longer than necessary in fluoro and record.
• Avoid using one anatomical view for long periods of time/many
runs.
• Consider using InnovaSpin in lieu of prolonged imaging in one in-
cidence.
4 Detector close to patient • Bring the Detector as close as possible to the patient.
• Can further reduce the dose by around 15%.
• Use Innova Sense if available.
5 Highest table working height • Use the highest table working height acceptable.
• Maximize X-ray tube to patient distance.

InnovaTM IGS 620,
InnovaTM IGS 630
6 Collimate • Always collimate to the anatomical area of interest.

• Use the largest acceptable image detector Field of View, with col-
limation, in lieu of image magnification.
• If image magnification is required, use the lowest acceptable
dose rate.
7 Monitor cumulative patient dose • Set thresholds of cumulative patient dose (Yellow/Orange/Red
levels).
• Keep track of cumulative dose display on monitor relative to these
thresholds during the case.
Image Quality Trajectories • Options are available to reduce dose up to 75%.
• Review with GEHC Applications or Service the available IQ Tra-
jectories.
• Ask them to customize the IQ protocols (IQ+, IQ Standard, RDL+,
RDL).
• Dose strategy need to be adjusted according to system intended
use.
As Low As Reasonably Achievable.

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 6 - Revolution Digital Detector

Cardiovascular Angiography has been using the Image Intensifier (II) and the associated imaging chain since
the1950's. The II technology has been developed and improved for many years but is now at the end of it's life.
There are few if any improvements that haven't been tried and tested to increase the image quality for the type of
diagnostic and interventional procedures that are now being performed in the Cath lab. Businesses had to look at
today's technology and see what was being developed that could eventually be applied to the medical industry's
needs. Computers and digital technology were developing together and made a perfect fit.
GE Healthcare (GEHC) started their development of the digital flat panel in the early 1980's. In 2000, GEHC
introduced the first Revolution Digital Flat-Panel detector (DFP) the Innova 2000.
The DFP replaces the analog image intensifier (II), camera optics, pickup tube or CCD camera, and analog to
digital converters. It therefore provides the first full digital imaging chain. Because it replaces the components that
degrade image quality with a DFP detector, it can capture information with minimal loss. The result is improved
image quality.
The Innova IGS 620, Innova IGS 630 is using the same Digital Flat-Panel detector (DFP) of 21 cm or 31 cm on the
Frontal and on the Lateral plane validated in the 2100-IQ/3100-IQ product.
1 Imaging Chain
Conventional Cardiac Imaging Chain with Image Intensifier
The components of the image intensifier:

• The image intensifier receives X-rays transmitted through the patient
• The Image Intensifier transforms X-ray into light.
• An aperture located between the output phosphor and video camera controls the amount of light delivered to the
camera.
• The video camera converts the light into an analog electronic signal.
• The analog signal is routed through the analog to digital converter.
• The digital signal is displayed as a binary set of numbers and displayed on an image monitor
Now consider what happens when we add a digital detector to the equation.
Digital Cardiac Imaging Chain with Flat-panel Detector
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• The digital detector receives the X-rays transmitted through the patient
The Revolutionary Digital Detector replaces everything but the X-ray tube and patient.
As you can see, there is a reduction of the total number of parts that make up the digital versus the analog imaging
chain. Image quality can be affected by each component in the chain. Not only are there fewer parts that can fail,
but fewer to optimize. An image chain is only as good as it's weakest link. Note that at each stage in this process,
the X-ray signal is degraded to some extent, even if the individual components are optimized for the application. As
a result, typically less than 40% of the original image information is available for use in image production.
Because of its high Detective Quantum Efficiency (DQE), it has the potential to capture over 80% of the original
image information. And it equips the user with a wide range of post-processing tools to further improve that signal -
including many that can be applied automatically.
2 Digital Image Quality

Let's look at what makes up the digital flat-panel and other factors that contribute to the improved image quality.
The flat-panel detector consists of a two dimensional array of amorphous silicon thin-film transistors (TFTs) and
photodiodes, with cesium iodide scintillator, all deposited on a single substrate. Using technology similar to that
used in the fabrication of integrated circuits, layers of amorphous silicon and various metals and insulators are
deposited on glass substrate to form TFTs, diodes, interconnects, and contacts. The scintillator, which converts
X-rays to light, is evaporated on top of these materials. Electronics for scanning out the detector and for sensing
and digitizing the signals are attached to the contact fingers at the sides of the detector. The TFT switches are
activated by scan electronics connected to one edge (or two opposite edges) of the detector to read out the stored
charge. Data collection electronics connected to the other two edges of the detector convert the charge to digital
values.
The operation:
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• A cesium iodide scintillator absorbs X-ray photons, converting them to light

• Light is converted into an electronic charge by an array of low noise photodiodes, each representing a pixel or
picture element.
• The electronic charge at each pixel is read out by low noise electronics and turned into digital data sent to an
image processor.
New Standard for Digital Imaging Quality

Earlier we mentioned the image quality improvement as a result of Detective Quantum Efficiency (DQE). But what
is DQE and why is it so important with this new technology?
3 Detective Quantum Efficiency

DQE is the measurement of the combined effect of detector noise and contrast performance. DQE is widely
recognized in the scientific imaging community as the most accurate gauge of image quality - a gauge that
incorporates most traditional image-quality measurements, including signal-to-noise ratios and spatial frequency.
Digital systems that focus on DQE, rather than limiting spatial resolution, provide benefits in object detectability.
Higher DQE, especially at the low-to-mid spatial frequencies where most clinically relevant information is found,
means detectability even for low contrast objects.
4 The Impact of Noise

Quantum and electronic noise are unavoidable in a digital imaging chain. The effect, often expressed as
signal-to-noise ratio (SNR), can vary widely from system to system.
High SNR, or low system noise, is key to capturing the greatest proportion of useful image information in a digital
image. Often the only way to compensate for poor SNR is to increase radiation dose, which is often an
unacceptable trade-off.
5 The Role of Contrast

Contrast performance describes a system's ability to capture and display an object's actual contrast - especially
critical when imaging such inherently low-contrast objects as balloons and stents under fluoroscopy that has a
limited amount of X-ray dose that can be used.
Most digital X-ray detectors have a wide dynamic range to permit capture of a wide range of low-to-high signal

InnovaTM IGS 620,
InnovaTM IGS 630
intensities, as well as very high contrast resolution to permit the display of thousands of shades of gray. In fact,
that's one of the digital X-ray's great advantages over conventional imaging systems. Digital X-ray detectors can
successfully image areas that might be under or over exposed.
6 The Role of Spatial Resolution

6-1 Definition and settings
Spatial resolution is the ability to visualize individual spatial or 2D frequencies on an image. It is generally assessed
using targets made of high image contrast line pairs at known frequencies in line pair per millimeter (lp/mm). Spatial
resolution, measured in the plane of the detector, is bound by pixel pitch on digital images.
The Innova IGS 630 system has a detector size of 31 cm x 31 cm comprising a 1536 x 1536 array of imaging
elements or pixels on a 200 micron pitch.
The Innova IGS 620 system has a detector size of 21 cm x 21 cm comprising a 1024 x 1024 array of imaging
elements or pixels on a 200 micron pitch.
The detector spatial resolution, as defined in IEC 61223-3-1 1999, is the highest spatial frequency of the specified
line pair target that can be resolved on a digital image, measured with the line-pair tool as close as possible to the
detector entry, collimated to the edge of the phantom, no attenuating layer, anti-scatter grid in, at maximum SID,
Line-pair tool oriented at 45°. The lines of a group shall be detectable over the major part of the total length
meaning that more than half of the length of the line pair group should be visible in order for the group to be
resolved.
The detector spatial resolution defined in the French standard uses the same setup as the IEC 61223-3-1 1999, but
resolution is assessed differently. The detector spatial resolution is, starting from the lowest frequencies, the
frequency just before the first spatial frequency of the specified line-pair target that cannot be resolved on a digital
image.
The system spatial resolution is a measure of the system capability to resolve small objects in the plane of the
patient through the thickness of the patient body modelled by 20cm of PMMA or water equivalent.
The resolution test phantoms used for detector and system resolution measurements in IEC 61223-3-1 1999 is:
phantom 07-535 CN 15400 of thickness 0.05 mm Pb, and groups 0.6 to 5.0 lp/mm.
When testing very low dose acquisition modes, it is recommended to use 0.1mm Pb thick phantoms such as:
phantom 07-541 (typ 41) of thickness 0.1 mm Pb, and groups 0.6 to 3.4 lp/mm.
6-2 Detector spatial resolution vs. Modulation Transfer Function (MTF)
An imaging system's ability to render the contrast of an object as a function of object detail is traditionally
expressed as its Modulation Transfer Function (MTF).
But MTF is normally measured under ideal laboratory conditions, using high contrast objects and high dose while
minimizing scatter radiation and noise. Therefore, it is not a reliable indicator of performance in real clinical
situations. MTF can be useful for film-based systems that have no post processing, but doesn't apply with digital
systems that can achieve any desired MTF through the use of post processing features.
On the other hand, spatial resolution can be tested in clinical conditions using a representative level of dose, of
patient absorption and level of noise on the image.
Spatial resolution is the preferred way to measure how well individual objects can be rendered by an imaging

InnovaTM IGS 620,
InnovaTM IGS 630
system.
6-3 Detector spatial resolution performances
All measurements are done without PMMA.
Acceptance criteria in DSA mode (IQ Standard)
FOV (cm) < 20 > 20

Detector spatial resolution (lp/mm) 2.00 1.00
The detector spatial resolution performances of the Innova IGS Systems also answer to country regulations.
Detector spatial resolution acceptance criteria per modes for Germany
Acquisition type Fluoro No Sub DSA Dynamic Record InnovaChaseTM

Detector spatial reso- 1.0 1.2 1.0 1.2
lution (lp/mm) in max
FOV
Detector spatial resolution acceptance criteria in fluoroscopy for France
FOV range (cm) 11 to 13 15 to 18 20 to 25 28 to 33 35 to 42

Detector spatial 2.00 1.80 1.40 1.25 0.90
resolution (lp/mm)
Note: With Innova IGS 620 and 630 systems, biplane fluoro performed at 25 fps on the 12 cm Field of View is not
compliant with the French Quality Control protocol of November 2006 and shall not be used.
Detector spatial resolution acceptance criteria in fluoroscopy for Italy and Spain
FOV range (cm) 15 to 18 23 to 25 30 to 35

Detector spatial resolution 1.4 1.0 0.8
(lp/mm)
Detector spatial resolution acceptance criteria for Australia VIC and QLD
FOV range(cm) <14 14 to < 23 >23

Detector spatial resolution 1.6 1.2 0.8
(lp/mm)
6-4 System spatial resolution performances

All measurements are done with 20 cm PMMA.
System spatial resolution acceptance criteria in fluoroscopy for Australia NSW
FOV range (cm) 11 to <18 18 to <26 26 to <30 30 to 36 >36

System spatial 1.8 1.6 1.4 1.2 1.0
resolution (lp/mm)

InnovaTM IGS 620,
InnovaTM IGS 630
System spatial resolution acceptance criteria for France
Acquisition type Dynamic Record DSA InnovaChaseTM

FOV (cm) Closest to 20 Closest to 20 Closest to 20
System spatial resolution (lp/mm) 1.6 1.6 1.6
7 Radiation Dose
Reducing radiation dose is another potential advantage of digital detectors. A detector with high DQE has the
potential to deliver significant object detectability improvement at the equivalent dose, or to permit object
detectability comparable to film's at a reduced dose. Or to say it another way, high DQE allows acquisition of the
same image quality at a lower dose, or better image quality at the same dose. Now the cardiologist can choose
between superior image quality or dose savings to the patient or staff. For example, the doctor may not need the
same image quality for a diagnostic study and can choose a setting that will allow for lower dose. But if the
procedure develops into an interventional procedure, the doctor can then select a different setting allowing for
superior image quality for placing the balloon or stent.
In addition, with the development of AutoEx, allows for the selection of the optimal exposure technique for the
patient size and the level of contrast and sharpness desired. This allows for the entire procedure to be viewed with
the same image quality throughout no matter what angle or Field of View (magnification). In addition during
fluoroscopy, GEHC uses a dynamic fluoro noise reduction (FNR) algorithm that adjusts depending on the size of
the patient and the level of noise seen in the image. On small to average size patients, the system is rarely pushed
to the maximum technique or dose limit. But for large patients and steep angles, that is a different story. In the US,
the skin dose radiation that the patient can receive during fluoroscopy is 10R/min. But many countries are reducing
that limit to 5R/min. As we have already discussed, the less Signal (dose) you have the more noise in the image
you have. To counteract that, the dynamic FNR will adjust to provide for a smoother more contrasty fluoroscopy
image when the dose is limited or at the maximum amount allowed.

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 7 - Innova System

1 General Description
The Innova Cardiovascular Imaging System incorporates GE's exclusive Revolution Solid-state Digital Detector to
reliably provide consistently high imaging performance through the full range of angiography procedures. The
Innova is a fully integrated imaging system that meets all clinical needs for interventional and diagnostic
angiography procedures with advanced image quality, innovative dose management and ease of positioning.
1 Gantry 7 Smart Handle

2 Table 8 X-ray Tube
3 Smart Box 9 Digital Detector
4 Table Side Status Control (TSSC) 10 Dual Footswitch
5 Innova Central touch screen 11 LCD Monitors Suspension
6 In-Room 3D
2 System Components
Availability of configurations may vary according to the country regulatory registration.
2-1 Basic Components
• Innova LC Positioner and Lateral Positioner (including Gantries, control cabinets)
• Innova IGS 620: Angio Table Omega V or Cardiac Table Omega IV (all with mattress included)
• Innova IGS 630: Angio Table Omega V (with mattress included)
• Table Side Controls: Smart Box or Smart Handle, Table Side Status Control (TSSC)
• Dual footswitch with table unlock
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• X-ray high-frequency and high-voltage generators: JEDI 100 kW
• X-ray tubes: Performix 160A
• Collimators
• Chillers
• Digital Flat Panel Detectors
• Image Display: In-room and control monitors
• Accessories (table panning device, IV pole & Mount...)
• Power Distribution Box
• UPS
• VCIM
• DL Keypad
• IR transmitter and receiver
• Buzzer kit
• Arm support
• Velcro quick strap
2-2 Option
THE USE OF THE ACCESSORY, TRANSDUCER OR CABLE WITH INNOVA IGS 620 OR
INNOVA IGS 630 OTHER THAN THOSE SPECIFIED MAY RESULT IN INCREASED
EMISSIONS OR DECREASED IMMUNITY OF THE INNOVA IGS SYSTEM.
Availability of options may vary according to configuration and to the country regulatory registration.
• Monitor suspension
• Wall-mount suspension
• Diamentor (This option is not available for China)
• Table head extender
• Table foot extender
• Patient Head Holder
• IV pole and mount
• Arm board with pad
• Fluoro UPS
• Innova In-room 3D Mouse
• Large Display Monitor, Cabinet and UPS
• Image Monitors
• TSUI options: Smart Handle, Smart Box, second Smart Box, second Smart Handle, second TSSC, Remote
TSSC
• Omega Table Foot end rail
• Second Footswitch with cover
• Remote Stand
• Tableside Cart
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• Software:
– InnovaBreezeTM
– InnovaSpinTM
– Innova 3D
– Innova Subtracted 3D
– Innova CT HD
– Stentviz
– InnovaSense patient contouring
– Innova OneTouchQA
– Stenosis Analysis Application
– Ventricular Analysis Application
– Fluoro Sub/NoSub simultaneous display
– Blended Roadmap
– ECG Acquisition Package
(*) These options are delivered with their own instructions for use. Refer to them before any use.
Note: Refer to Innova IGS 620, Innova IGS 630 Operator Manual (This manual) for the information related to the
use of the Tableside Cart on how to configure the Table Side User Interfaces (TSUIs) when using the Tableside
Cart.
2-3 Option Connection
Some options need to connect a ground cable for equalizing potential on Omega table (Injectors...), refer to item 1.
Omega table provides a specific connector to synchronize injectors, refer to item 2.
Peripheral Device connections for Omega Table
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1 - Equalization socket connector

2 - Injector connector
Reference of injector validated with Innova Systems:

• MEDRAD Mark 7 Arterion Injector (*)
• MEDRAD Avanta (*)
• ACIST CVI (*)
(*) These options are delivered with their own instructions for use. Refer to them before any use.
More information can be found in the service manual provided with the system.
When the cover is opened, do not touch the accessible contacts of connectors and the patient simultaneously.
3 Innova Console
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InnovaTM IGS 620,
InnovaTM IGS 630
1 Innova Digital Color LCD Monitor

2 Exposure Hand Switch
3 Innova Console
4 Console Keyboard and Mouse
4 General Specifications
Specifications may be subject to change without modification in the behavior of the system.
4-1 Generator
Specifications apply to generator independently from tube association and system applications.
• Peak power
Maximum peak power: 100 kW (may be limited, depending on the mode or application)
• Average power
Average power is intended to be the average power computed in a wide time frame, greater than one hour.
Maximum average power: 3.2 kW (may be limited, depending on the mode or application)
• Range of high frequency used by the high-voltage generator: 20 kHz - 60 kHz
• kV-mA range
kV from 40 kV to 125 kV
Maximum mA: 1000 mA
• Large focus
Maximum mA: 1000 mA
Maximum power: 100 kW
• Small focus
Maximum mA: 400 mA
• Compressed focus
Maximum mA: 200 mA
4-2 Gantry
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4-2-1 LC Positioner (Frontal)

• L-arm rotates on its vertical axis +/- 100° (+/- 95° motorized limit set).
• Offset C-arm (Pivot) permits -117°/+105° RAO/LAO rotation.
• The C-arm permits 50° cranial and 45° caudal angulation of the imaging system.
• The combination of movements of the C-arm and L-arm permits +/- 55° cranial and caudal angulations.
• The offset arm throat depth of 107 cm (42") with L-arm at 0° provides femoral coverage on most patients.
• Rotation speed of Offset-C-arm (Pivot) and C-arm; 0° - 15° per second when Lateral plane is parked (0°-20° per
second with InnovaSense option); 0° - 10° per second when Lateral plane in ISO range.
• Rotation speed of L-arm: 10° per second.
• SID fully motorized (8.9 cm/s - 3.5 in/s).
• SID range of 85 cm to 119 cm (33.5" to 46.8") for Innova IGS 620. Travel distance of 34 cm (13.4").
• SID range of 89 cm to 119 cm (35" to 46.8") for Innova IGS 630. Travel distance of 30 cm (11.8").
• X-ray Tube Focal Spot to isocenter 72 cm (28.3").
• Isocenter to the floor of 107 cm (42").
• X-ray tube reference axis is tilted by 3° versus the X-ray beam axis in the anode direction on the Innova IGS
620.
• A green LED is located on Pivot inner cover (Item 1) to indicate the X-ray status. This LED is on when the
frontal plane is ready to perform X-rays, otherwise the LED is off.
4-2-2 LP Positioner (Lateral)

• The C-arm permits angulations from 2° LAO to 115° LAO.
• The C-arm Pivot permits from 45° cranial to 90° caudal angulations of the imaging system.
• Rotation speed of C-arm and C-arm pivot: 0° - 10° per second.
• X-ray tube Focal Spot to Isocenter range of 71 cm to 88 cm ( 27.9" to 34.6").
• Detector entrance to Isocenter range of 13 cm to 49 cm (5.1" to 19.3").
• SID range of 84 cm to 137 cm (33.1" to 54").
• Isocenter to the floor of 107 cm (42").
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• Detector and tube lift speed is 89 mm/s.

• Lateral carriage 25 mm/s at ISO and 200 mm/s at parking/homing.
• X-ray tube reference axis is tilted by 3° versus the X-ray beam axis in the anode direction on the Innova IGS
620.
• A green LED is located on the Carriage fix cover (Item 2) to indicate the X-ray status. This LED is on when the
lateral plane is ready to perform X-rays, otherwise the LED is off.
4-3 Omega Table
The Omega table can operate while engaging the motor drive, table height up and down while fully extended,
supporting a maximum table weight of 304 kg: maximum of 204 kg for patient weight, maximum weight of 40 kg of
accessories can be installed on each table accessory rail and maximum of 20 kg on the table end rail.
Omega IV (with Innova IGS 620 only) Omega V

Table Top filtration Less than 0.85 mm aluminium equivalent
Mattress 2.5 cm (1") Mattress + Slicker: less than 0.70 mm aluminium equivalent
Maximum Patient Weigth 204 kg (450 lb)
Maximum Table Load 304 kg (670 lb)
Tabletop Length 300 cm (118") 333 cm (131")
Tabletop Width 46 cm (18") in Patient Trunk Area - 67 cm (26.4") max
Horizontal Float Movement 8-way
Horizontal Motorized Movement NA 2-way
Longitudinal Speed NA 0 to 15 cm/s
Longitudinal Travel 110 cm (43.3") 170 cm (67")
Equivalent Fluoroscopic Coverage 126 cm (49.6") 186 cm (73")
Transverse Travel Manual +/-14 cm (+/-5.5")
Vertical Travel 30 cm (12")
Vertical Travel above Floor From 78 cm (30.7") to 108 cm (42.5")
Vertical Speed 2 cm/s (0.8"/s) at 50 Hz
2.5 cm/s (1"/s) at 60 Hz
Table Base 61 cm x 52 cm (24" by 20.5")
Table Rotation +/- 180°
4-4 Innova Digital

DICOM V3.0 implementation in the Innova Digital is described in its Conformance Statement. It can be used to
verify compatibility with other DICOM devices.
On the DL image disk, it is possible to store up to 4000 sequences and photos altogether per plane as long as disk
space is still available.
4-5 Innova Imaging
4-5-1 Innova IGS 620
All modes except 25 fps Biplane modes:
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0 Mag 1 Mag 2 Mag 3 Mag
Available input screen size of detector (cm) 20 17 15 12
Horizontal center resolution (not less than); (lp/mm) 2.5 2.5 2.5 2.5
For 25 fps Biplane modes:
Vertical center resolution (not less than); (lp/mm) 1.25 1.25 1.25 1.25
4-5-2 Innova IGS 630

All modes except 25 fps Biplane modes:
For 25 fps Biplane modes:
Vertical center resolution (not less than); (lp/mm) 0.83 1.25 1.25 1.25
• Hi-resolution 1249 line analog video output.

• Hi-resolution 1249 line monitor, 50 Hz.
5 How to Perform System Power-Up

To turn on power to the Innova system:
• Press the [On/Off] button on the Innova Console for 0.5 seconds.
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InnovaTM IGS 620,
InnovaTM IGS 630
1 X-ray Indicator
2 Audible Signals
3 System Reset
4 ON/OFF
5 X-ray Timer Reset
6 Auto inject ON/OFF
Whenever the Innova System Main power has been removed with the wall main circuit breaker, turning ON the
Innova will require additional steps.
• Verify the wall emergency button is unlocked.
• Switch ON the wall main circuit breaker, if needed.
• Go to the technical room where the Power Distribution Box (PDB) and the UPS stand.
• Verify the PDB emergency button is unlocked.
• Verify the Power failure test button is on "normal" position.
• For PDB (CE):
– Close the disconnecting switch S5 (Item 3), then the breaker DM6 (Item 2), then DM1 (handles in the vertical
position) (Item 1), if needed.
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1 DM1
2 DM6
3 S5
4 Emergency Power Off Button (EPO)
5 Power failure test button
6 Pilot lamp H1
7 Pilot lamp H2
8 Pilot lamp H3
– Ensure the Pilot lamp H1 (Item 6) is lit on.

– Wait for 20 seconds then ensure the Pilot lamps H2 (Item 7) and H3 (Item 8) are lit on.
– Wait for 30 seconds that the PDB provides power to the UPS cabinet.
– Push the PDB START push button (S2 - green button on the PDB front panel).
• For PDB(UL):
– Close the breaker CB3 (Item 1) then CB6 (Item 2), then CB1 (Item 3), if needed.
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InnovaTM IGS 620,
InnovaTM IGS 630
– Ensure the pilot lamp PL4 is lit on.
1 PL1
2 PL2
3 PL3
4 PL5
5 PDB OFF
6 Emergency Power Off Button (EPO)
7 PDB start button
8 Power failure test button
9 PL4
– Wait for 20 seconds then ensure that the pilots lamps PL1 (Item 1), PL2 (Item 2) and PL3 (Item 3) are lit on.
– Wait for 30 seconds that the PDB provides power to the UPS cabinet.
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– Push the PDB start button (Item 7), then ensure that the pilots lamps PL5 (Item 4) is lit on.
• Ensure that UPS Cabinet front panel (Item 1) is activated.
• Wait for 15 seconds and push the UPS ON button (Item 2). Hold it on for 5 seconds.
• A message "UPS is starting..." is displaying on UPS front panel. Then ensure that UPS power on indicator (Item
3) is lit on.
• If the Large Display Monitor option is installed:

– Ensure that UPS front panel (Item 1) is activated.
– Push the Large Display Cabinet UPS ON button (Item 2). Hold it on for 5 seconds.
– A message "UPS is starting..." is displaying on UPS front panel. Then ensure that UPS power on indicator
(Item 3) is lit on.
• Now the system is ready to start. Go back to the control room and push the ON/OFF button on the Innova
Console (see Innova System / How to Perform System Power-Up).
The system will be ready in approximately 5 minutes.
6 How to Perform System Power-Down

• Select [End Exam] on the Digital console.
• Press the [On/Off] button on the Innova console for 2 seconds.
7 Vascular Control Interface Module
Innova System 247

InnovaTM IGS 620,
InnovaTM IGS 630
1 X-ray ON Indicator
2 Audible Signals
- X-ray timer
- X-ray on
3 System RESET
4 System ON-OFF
5 X-ray Timer Reset
6 Auto Inject ON/OFF
The Innova Console controls are:

• ON/OFF Turn system power off and on.
To switch ON press for at least 0.5 s.
To switch OFF press for at least 2 s.
When the operator uses the on/off button of the Innova console, by default the system starts with the patient
management screen when boot is complete.
• SYSTEM RESET Press the Reset button for 2 s to reset the system.
Note: The reset button is inhibited for 60 s after a system boot is started.
• INDICATOR LAMP for X-ray (Fluoroscopy and Record).
• X-RAY ON appears in the right side of the console, and the console beeps when X-rays are being produced.
X-rays are produced when the X-ray prep/exposure switch on the hand control or footswitch is pressed.
• Auto Inject ON/OFF
Press on the button (button lit) to synchronize the injection with the acquisition.
• X-ray Timer Reset

Depending on local regulation, press the button to reset the X-ray timer after the elapsed duration.
248 Innova System

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 8 - Innova Digital

1 Guidelines for the best usage of the system
• Boot the system one hour before the first acquisition (Fluoro or Record) to work at stable temperature and so
get the best image quality.
• To avoid saturation in the image, always collimate and use appropriate contour filters.
• While performing Fluoro, do not close collimator blades more than 50 % of the FOV size.
• Always perform a Fluoro between two Record acquisitions.
• Always check the number of available exposures before starting a Record acquisition.
• For optimal performance, shutdown the system once daily.
2 Innova Digital Screen
1 Exam Management Screen

2 Utilities Menu
3 X-Ray Timer and Dose Information Window
4 Acquisition Protocol Window
5 Application Selection Window
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6 Record Information Window

7 Monitoring Bar
8 Patient Browser
9 Worklist Browser
10 Fluoroscopy Information Window
No selection is allowed during Record or Fluoro acquisition. Only Monitoring Bar can be opened by clicking on one
of the monitoring icon.
2-1 Monitoring Bar
The monitoring bar consists of the seven icons, which provide information about the state and availability of the
following functions: ECG Signal, Disk Space, Heat Units, X-ray Timer, Fluoro, Record, X-ray disable button.
ECG Status Disk Space Sta- Heat Units Sta- X-Ray Timer Fluoro Ready Record Ready X-ray Disable
Button tus Button tus Button Status Button Icons Icons Button
A color code with five levels is used:

• (0) White: function is disabled.
• (1) Green: function is OK / Ready or ECG is Online.
• (2) Yellow: function is above a first threshold. ECG is Stabilizing the signal.
• (3) Yellow flashing: function is above a second threshold.
• (4) Orange: function is not available. User action may be needed (reset X-ray timer, free disk space, reset
R-peak detection, etc). ECG is not detecting a trigger.
Clicking on one of the first four icons will open a pop up window containing more detailed info.
The X-ray disable button does not obey to this color code (refer to Innova Digital / Innova Digital Screen /
Monitoring Bar / X-ray Disable Button).
2-1-1 ECG Status
Click on the ECG button to display:
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InnovaTM IGS 620,
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2-1-2 Disk Space Status
Click on the Disk Space button to display:

• The estimated exposures available.
• The run time available.
• The Disk Space allocated.
• The different thresholds for each warning level shall be as defined:
– Strictly below 1 sequence, Warning level is ORANGE. X-rays are not allowed anymore.
– Between 1 and 3 sequences, Warning level is blinking YELLOW.
– Between 3 and 10 sequences, Warning level is YELLOW.
– Higher than 10 sequences is GREEN.
Disk space informations refer to each plane separately and show the remaining disk space per plane.
When it is not possible anymore to acquire images on one plane, the corresponding Record Ready icon switches to
orange color.
In case of biplane acquisition, it could happen that only the frontal Record Ready icon switches to orange color. A
fast way to continue the procedure could be to select Lateral plane only, for which some remaining disk space is
still available.
Note: Always check that enough disk space is available on both plane before starting a procedure.
2-1-3 Heat Units Status
Click on the Heat Units Status button to display Heat Units Information.
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The value indicates the current system availability per plane.

There are 3 thresholds defining 4 states:
• Equal 0%, Warning level is ORANGE. X-rays are not allowed anymore.
• Between [0, 30]% , Warning level is blinking YELLOW.
• Between [30, 50]%, Warning level is YELLOW.
• Higher or equal to 50% Warning level is GREEN.
In addition to the different colors of the Heat Units Status button, the message "Heat Unit Remaining is equal or
under 20%" is displayed at the bottom of the live display when the remaining heat units reaches 20%.
A continuous audible signal is also activated as long as the remaining heat units are lower than 20%.
If X-rays are ON when the 20% threshold is reached, the audible signal is activated only after the X-ray switch is
released.
2-1-4 X-ray Timer
Click on the X-ray Timer Status button to display the elapsed X-ray time.
There are 2 thresholds defining 3 states (depending on country local regulation):

• From 0 to 5 minutes, Warning level is GREEN.
• After 5 minutes, Warning level is blinking YELLOW.
• After 10 minutes of cumulated X-rays, warning level is ORANGE and X-rays are disabled until the X-ray timer is
reset. This threshold is enabled only in Italy.
Maximum continuous acquisition: if a fluoro acquisition is maintained continuously without interruption, it will be
terminated automatically after 10 min.
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Note: The icon is still yellow after the 10 min continuous X-rays in all countries but Italy.
This timer counts the cumulated time while the fluoro footswitch is depressed.
Note: For US only (Compliance to 21 CFR 10.20.32), this timer counts the total cumulated time while the Fluoro or
Record foot/hand switch is depressed.
2-1-5 Fluoro / Record Ready
Click on the Fluoro Ready Icons to display: Click on the Record Ready Icons to display:
Each function shall have 3 states: plane not selected, enable and disable. The color shall use yellow, green and
orange.
• Yellow Color means related plane is not selected.
• Green Color means related plane is READY (enable) for X-ray - Fluoro and / or Record.
• Orange Color means X-ray (disable) not available on related plane (End Exam, disk full, Over limit Heat
Units...).
2-1-6 X-ray Disable Button
The X-ray button allows disabling or enabling X-rays, outside an acquisition, by pressing the button.
The X-ray button has three states:
• INACTIVE state: during an acquisition, the button is inactive:
• DISABLED state: outside an acquisition, when X-rays are disabled:
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InnovaTM IGS 630
• ENABLED state: outside an acquisition, when X-rays are enabled:
2-2 Utilities Key
iLinq: Access to direct interactive communication with GEHC via In Site Connection.
Service: Access to a panel of menus such as Quality Assurance Program (QAP), InnovaSpin Parameters,
configuration and Service...
When selecting Service, a pop up window opens:
Click OK after the Warning was read and understood

Help: Access to the Operator Manual.
Alarm messages: Access to the list of translated Alarm messages.
Snapshots: Allows to capture all screens including images (image must be paused first) and the last Error Log.
Product Software Version: Access to the Software Version information of the product.
2-3 Exam / Utilities Charring
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3 How to prepare for a New Patient Acquisition

Note: Always check the disk space available before to perform a new Patient acquisition.
Note: Before patient creation, we recommend to delete patients whose data has been pushed/archived.
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To enter information for a new patient:

• Click on the "PATIENT" tab at the upper left of DL Screen.
• Select from the PATIENT BROWSER. The Patient and Exam Info window appears:
• Click on the "Other Exam Info" tab:
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Fill in the patient information. Patient Name and Identification are required fields. If they are left blank, an error
message appears.
• Last -First Names.
• Identification number.
• Date of birth.
• Sex.
• Height/weight.
• Other Patient ID
• Physician Name (this is a list box).
• Select the Exam Type (this is a list box).
• Select [Apply] to create patient and return to Patient Browser.
• Select [Cancel] to cancel patient entry.
• Select [Start Exam] to begin a procedure.
Note: If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting system, the Start Exam
information is also sent to that system using the DICOM "MPPS in progress" message.
In case of test acquisitions needed, select the "Test Patient" on top right of the menu. Patient Last Name and
Patient Identification fields will be automatically filled with "Test GE" information.
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4 How to modify Patient Information

The button allows the user to review the patient’s name and identification as well as the exam
information that has been entered for a procedure. Also, it allows the modification of this information.
To modify the information for an existing patient:

• Click on the “PATIENT” tab at the upper left of the DL screen.
• Select from the PATIENT BROWSER. The Patient/Exam Info window appears:
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• Click on the lock icon to modify patient information.
• New and editable fields will appear and can be modified while the original patient information is still shown on
the left side.
Note: If the patient information was retrieved from a worklist, it cannot be modified and the patient and identification
fields will remain grayed out. Only information manually typed in can be modified.
• Click on [Apply] to accept the changes.
• Click on [Cancel] to exit with no changes.
• Click on [Start Exam] to begin the procedure.
5 How to select an Acquisition Protocol

Acquisition protocols can be selected either from the Innova Digital screen or from the Innova Central touch screen
located at table side.
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Innova Digital Screen
The protocols are classified inside categories. The list of protocols is organized in a 2 levels hierarchy.
A folder list displays and selects protocols.
5-1 List of Categories
Find below the list of categories available:
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Abdomen
Cardiac & Combo
Chest
EP DoseSense
Head
Lower Limbs
Pediatrics
Upper Limbs
Vascular
X-Ray Quality Test
5-2 List of Protocols

Find below the list of default protocols available:
Category Protocol Name

Abdomen 1 Abdomen dose limited
Aorta
Needle Placement
Pelvis
Record Dose Limited Needle
Single Shot
Cardiac & Combo 1 Cardiac dose limited
Cardiac 1
Cardiac 2
Combo 1
Combo 2
Coronaries
Needle Placement
Ventriculogram
Chest 1 Chest dose limited
Aorta Arch
Pulmonary
EP DoseSense DoseSense EXTRA LOW
DoseSense LOW
DoseSense MEDIUM
DoseSense NORMAL
DoseSense MAPPING
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Head 1 Head dose limited

Carotids
Cerebral
Cerebral Sharp
CT High Resolution
Single Shot
Soft Tissues
Lower Limbs 1 Lower Limbs dose limited
Femoral
Foot
Lower Leg
Pelvis
Popliteal
Pediatrics Pedia Abdomen
Pedia Cardiac
Pedia Cardiac Neonate
Pedia Cerebral
Pedia Chest
Pedia Lower Limbs
Pedia Upper Limbs
Upper Limbs 1 Upper Limbs dose limited
Elbow-Forearm
Hand
Shoulder-Humerus
Vascular DSA 0.3 Focal Spot
REC 0.6 Focal Spot
REC 1.0 Focal Spot
REC 2 fps-20 s, Fl 15 fps
X-Ray Quality Test Quality Assessment Cardiac
Quality Assessment DSA
USE THE "NEEDLE PLACEMENT" PROTOCOL LOCATED EITHER IN THE ABDOMEN OR

CARDIAC ANATOMY WHICH AUTOMATICALLY DISABLES THE INNOVASENSE PATIENT
CONTOURING FUNCTION IN CASE OF PROCEDURE THAT INVOLVES THE USE OF SMALL
INVASIVE OBJECTS/DEVICES (I.E. BIOPSY OR OTHER NEEDLES) OR OBJECTS MADE OF
NON-CONDUCTIVE MATERIALS (PLASTIC... I.E. OXYGEN MASK) WHICH PROJECT OUT
FROM THE PATIENT SKIN SURFACE, THESE OBJECTS/DEVICES BEING TOO SMALL
AND/OR NOT DETECTED BY THE CAPACITIVE SENSORS. FAILURE TO THIS MAY CAUSE
SEVERE PATIENT INJURY IN CASE THE DETECTOR HITS THE INVASIVE OBJECT/DEVICE.
From the Protocols:
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• Using the mouse, select a protocol by clicking on the protocol name.

From the Innova Central touch screen:
• Press the Protocols button on the Fluoro or Record sub-tab of Innova tab.
• Select the Category.
• Select the protocol; the pull down list automatically closes.
The selected protocol is then displayed in reverse video.
Note:
• The "X-Ray Quality Test" anatomy is for Service usage only. It is recommended not to select the "Quality
Assessment Cardiac" or "Quality Assessment DSA" protocol.
• In case a navigation system using electromagnetic waves is required during a cardiac procedure, it is
recommended to select/use the "DoseSense MAPPING" protocol which is set to reduce/optimize the image
artefacts created by the navigation system.
• On the Innova IGS 630, to optimize the visibility of soft tissues in the brain during intra cranial procedures, it is
recommended to select/use the "Soft Tissues" protocol located in the "Head" category when a 3DCT acquisition
at 16 or 28°/s is required using the 30 cm Field of View. Best visibility will be obtained with gantry rotation speed
set at 16°/s. The SID being reduced for such 3DCT acquisition, particular attention must be brought to well
center the patient's head in lateral to avoid risk of collision between gantry and table top.
• To optimize the visibility of small and contrasted objects in the brain such as intracranial stents, it is
recommended to select the "Innova CT High Resolution" protocol located in the "Head" category when a 3DCT
acquisition is required. Best resolution will be obtained with a small FOV centered on the object of interest and
the gantry rotation speed set at 16°/s. This protocol uses a 108 cm SID and if the patient and table position is
off-centered too much, may cause the test spin to collide with the table and fail. If the desired positioning is to be
off-centered, then choose another protocol or have a GE representative modify this protocol to use the larger
SID of 119 cm.
• To adjust the edge enhancement filter level used by default in a protocol, refer to section Innova Digital / DL
Keypad / Edge Enhancement Filter Selection.
All acquisition protocols are preloaded with parameters to deliver a standard image quality. It is always possible to
modify the preloaded protocol parameters in order to customize/optimize the Record, Fluoro NoSub, Fluoro Sub
and Fluoro Roadmap image quality.
It is also possible to customize the protocol to support up to 900 frame limit for fluorostore.
If needed, contact your GE Healthcare Representative for any acquisition protocol modification/optimization.
Any parameters, protocols and/or application changes to GEHC Equipment shall be Customer's sole responsibility
as well as any decision having regard to such clinical responsibilities and duty of care owed to patients.
Accordingly, the Customer will be solely liable for the decision to modify the protocol and the consequences
thereof. GEHC shall in no event be held liable for any damages resulting directly or indirectly from such
modification by the Customer of the protocol, as such modification will be made on Customer's instructions only.
6 Fluoroscopy and Acquisition

Fluoroscopy and Acquisition Footswitch
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Depending on local regulation, the large footswitch cover may be mandatory. In option, a second footswitch can be
installed in control room. In this case, it is recommended to install the large cover on the footswitch located in
remote position.
The second footswitch that can be installed in control room is different from the primary footswitch installed in exam
room. They shall not be inverted.
Footswitch includes user activation of:
1 Biplane Fluoro
2 Lateral Fluoro
3 Frontal Fluoro
4 Record
5 Table Top Longitudinal and Lateral Brakes Release
Depending on system configuration, the biplane fluoro pedal can be located at right or left side of the lateral fluoro
pedal.
Frontal, Lateral and Biplane record activation is done through the same pedal. Frontal/Lateral/Biplane selection is
made at touchscreen or console.
Do not use the footswitch cover as a foot rest or stand on it. The cover may brake and lead
to uncontrolled X-ray.
Footswitch for exam room and footswitch for control room are different. Do not invert.
6-1 Fluoro UPS (Option)
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Note: Fluoro UPS usage requires the system to be powered-on: Fluoro UPS is not available for system boot.
In case of main power failure, the Innova system is suddently unavailable.
With the use of the Fluoro UPS, all functionalities of the Innova system, except Record acquisition, are still
available and secured for 5 minutes.
Note: Biplane Fluoro is not available while the Innova system is running under Fluoro UPS.
THE AUTONOMY TIME IS GUARANTEED IF BOTH:
- THE BATTERY IS FULLY CHARGED. THE BATTERY CHARGE DURATION TIME IS ABOUT 8 HOURS.
- A REGULAR MAINTENANCE CHECK IS ENSURED BY PERIODIC PREVENTIVE MAINTENANCE (REFER
TO YOUR SERVICE CONTRACT)
In case of main power failure, the Innova system will automatically switch to UPS mode within 2 s maximum.
The message "Powered with UPS" displayed at bottom of the live display will inform users that the Innova system
is working under UPS.
Note: In case of main power failure during a Record acquisition, the acquisition will be aborted but already acquired
images will be saved on the image disk.
While Innova system is running under UPS mode:
• When less than 3 minutes of UPS power are available, the message "!!! 3 min before X-ray inhibit. UPS low.
Secure patient (1.9)" is displayed on the live display for 1 min.
• When less than 2 minutes of UPS power are available, the message "!!! 2 min before X-ray inhibit. UPS low.
Secure patient (1.9)" is displayed on the live display for 1 min.
• When less than 1 minute of UPS power are available, the new message "!!! 1 min before X-ray inhibit. UPS low.
Secure patient (1.9)" is displayed on the live display for 40 s.
PATIENT MUST BE SECURED IMMEDIATELY. INNOVA SYSTEM IS GOING TO SHUTDOWN

VERY SOON.
• When less than 20 seconds of UPS power are available, the permanent message "System near to be shutdown.
Exit exam" is displayed on the live display.
INNOVA SYSTEM IS READY TO SHUTDOWN.
If the main power is back before the UPS battery is discharged, the Innova system automatically switches off from
UPS mode within 2 s maximum.
In case of main power recovery during a fluoro acquisition, the message "Power restored. Release fluoro for full
functionality" is displayed. The Innova system will switch off from UPS mode only after the end of the fluoro in
progress.
Notes:
Regular Preventive maintenances are required to ensure the availability of the fluoro UPS option. In addition, the
UPS device has the ability to detect cases of undercharged batteries and some failure conditions of the UPS.In
both cases, the message "!! Exam interruption risk if power is lost. UPS failure. Call Service (2.15)" will be
displayed.
This message will be cleared if the batteries are recharged, or if the UPS failure condition disappears. Note that if
the operator presses the Mute button on the UPS, this message will also disappear while the error condition
remains and will remain unnoticed until the next UPS automatic test. It is therefore important to contact GE service
when pressing the Mute button on the fluoro UPS.
• If the Innova system does not recover full acquisition functionality after the main power is restored, reselect the
protocol in use and resume.
• All Maintenance and Service of the UPS must be performed by qualified personnel only.
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• In case of UPS storage for more than 3 months, recharge UPS battery every 3 months to prevent any battery
damage.
7 No Sub Fluoroscopy Acquisition
No Sub - Innova Digital Screen
No Sub - Innova Central touch screen
No Sub Fluoro can be activated from:
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• The Innova Digital screen by selecting the No Sub tab in the Fluoro window.
• The Innova Central touch screen by pressing the No Sub button on the Fluoro tab.
• The Table Side Status Control (TSSC).
The fluoro icon is displayed on the left side of the live display during fluoro to show that the displayed
image is a live fluoroscopic image.

After each fluoro exposure, a Last Image Hold (LIH) is displayed on the live display.
The Biplane Technics button allows to visualize the predicted biplane technics which will be used for the next
biplane fluoro.
7-1 Field of View (FOV)
There are four FOV available to the operator:
• 20 cm, 17 cm, 15 cm and 12 cm for Innova IGS 620.
• 30 cm, 20 cm, 16 cm and 12 cm for Innova IGS 630.
For each plane, the FOV can be changed on the Innova Digital screen (see Illustration FOV - Innova Digital
Screen) or on the Table Side Status Control (TSSC).
For Innova IGS 620: 20 cm = 0 Mag, 17 cm = 1 Mag, 15 cm = 2 Mag and 12 cm = 3 Mag.
For Innova IGS 630: 30 cm = 0 Mag, 20 cm = 1 Mag, 16 cm = 2 Mag and 12 cm = 3 Mag.
There are two directional arrows to allow for ease of up/down selection on the tableside control (see Illustration
FOV - TSSC, Item 4 (Frontal Detector Field of View Selection) and 5 (Lateral Detector Field of View Selection)).
FOV - Innova Digital screen
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1 Frontal plane FOV drop down list

2 Lateral plane FOV drop down list
FOV - TSSC
The FOV can be changed when the system is in idle, or dynamically during fluoroscopy without releasing the pedal.
This provides the clinician improved flexibility and workflow on the Innova IGS 620 and Innova IGS 630. The
default FOV is 20 cm for Innova IGS 620 and 30 cm for Innova IGS 630.
Note: For Innova IGS 620 and IGS 630 systems used in France, larger FOV than 12 cm must be selected when
performing 25 fps biplane fluoro to be compliant with the French Quality Control protocol of November 2006.
7-2 Fluoro Detail
There are two settings Low and Normal that can be selected on the Innova Digital screen (see Illustration Fluoro
Detail - Innova Digital Screen) and on the Innova Central touch screen (see Illustration Fluoro Detail - Innova
Central touch screen).
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Fluoro Detail - Innova Central touch screen
Note: The level of fluoro detail selected is always displayed with the fluoro parameters on the reference display
while under Ready for Exam.
Note: The level of fluoro detail selected is common for both Frontal or Lateral plane.
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InnovaTM IGS 620,
InnovaTM IGS 630
Fluoro Detail - Innova Digital Screen
7-3 Fluoro Frame Rate

Frame rate can be selected either from the Innova Digital screen or from the Innova Central touch screen.
Fluoro can be performed at different frame rates:
• 30 fps, 15 fps or 7.5 fps or 3.75 fps when only one plane, Frontal or Lateral, is selected.
• 25 fps, 15 fps or 7.5 fps or 3.75 fps when biplane mode is selected.
Note: 30/25 fps or 30/15 fps displayed in the Fluoro Frame rate field means that Biplane Fluoro is performed at 25
fps or 15 fps and Single Plane Fluoro is performed at 30 fps.
Note: Fluoro frame rate selection is common for both Frontal and Lateral plane.
Note: Use low fluoro frame rate as often as possible to reduce patient skin dose.
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Fluoro Frame Rate - Innova Digital Screen
Fluoro Frame Rate - Innova Central touch screen
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InnovaTM IGS 620,
InnovaTM IGS 630
7-4 Fluorostore
Use the [Store] button located on the TSSC (see Illustration Fluorostore - TSSC - Item 15) to enable storage and
looping display of the last 450 frames of the fluoro just performed.
In case of Biplane Fluoro, the last 450 frames will be stored for each plane (2 x 450 frames).
Fluorostore - TSSC
Depending on the Fluoro frame rate used, the Fluorostore function allows to store up to:
• 15 s of fluoro when performed at 30 fps.
• 60 s of fluoro when performed at 7.5 fps.
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• 120 s of fluoro when performed at 3.75 fps.

The stored images are added into the DL database as a new fluoro sequence.
The looping display starts automatically after the sequence is stored and enables better visualization of low
contrast objects by virtue of repeated display without repeat exposures to the patient.
The stored fluoro sequence has the same basic review capabilities (autoreview, Play/Pause...) as typically used for
Record sequence.
The fluoro sequence is shown in the sequence browser with a specific icon (see Illustration - Fluoro Sequence
icon) and has limited processing capabilities (measurements and quantifications are not allowed on such fluoro
images).
Fluoro Sequence icon
While the fluoro sequence is in review, a specific icon is displayed at the bottom right of the live display.
There are two ways to use the [Store] button:

On request Fluorostore:
• After each fluoro, the [Store] button blinks during 30 s. While the [Store] button is blinking, press the [Store]
button to manually store and play in loop the last 450 images of fluoro acquisition which was just performed.
Note: The [Store] button will stop blinking in case:
- A new acquisition, Fluoro or Record is started.
- End Exam is selected.
Auto Fluorostore:
• At any time but right after a fluoro, press on the [Store] button to activate the fluoro autostorage and loop
feature. The [Store] button will be permanently lit. Each following fluoro performed will be automatically stored
and displayed in loop until the [Store] button is manually switched Off.
Note:
– A specific icon is displayed on the left side of the live display during a fluoro performed in Auto
Fluorostore mode.
– The autostorage selection will automatically be deactivated at End Exam.
7-5 X-ray Timer
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InnovaTM IGS 620,
InnovaTM IGS 630
The X-ray TIME RESET button (Item 17 lower left corner) will blink and reset the X-ray timer.
This timer counts the cumulated time while the fluoro footswitch is depressed.
Note: For US only (Compliance to 21 CFR 10.20.32), this timer counts the total cumulated time while the Fluoro or
Record foot/hand switch is depressed.
With the expiration of 5 minutes of fluoro, an audible signal will occur during the exposure to indicate to the user to
reset the timer.
Press the button to reset the X-ray timer after the elapsed duration, or at any time, depending on local regulation.
At this time, the timer can be reset either at the tableside control or at the Innova Console.
Note: For US, the reset will be applied only for the plane where the timer expired.
For other countries, the reset will be applied for both planes simultaneously.
In case of continuous fluoro without interruption, X-ray will be terminated after 10 min and the error message
"Fluoro interrupted: reset Fluoro timer to continue" will be displayed.
Note: In Italy, after 10 min of cumulated X-rays, X-rays are disabled until the X-ray timer is manually reset.
7-6 Cumulated Time
It is reset to zero at end Exam. If the exam is resumed from an existing exam, the value is set to the total X-ray time
(Fluoro and Record) recorded in this exam.
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7-7 Image Rotation

The image displayed on each live display can rotate according to the angulation of the Frontal or Lateral gantry
axis (L, C and offset arms). In order to keep the "head up" display when the L-arm is positioned at 0° or 90°, a 90°
image rotation is performed when the image rotates more than +/- 45°. The 90° image rotation is not performed in
real time. Fluoro or Record hand/footswitches must be released first to activate the rotation.
IN CASE OF SYSTEM FAILURE, THE ROTATION OF THE IMAGE DISPLAYED ON THE LIVE
DISPLAY MIGHT NOT BE AUTOMATICALLY CORRECTED TO KEEP THE "HEAD UP"
DISPLAY WHEN THE L-ARM IS OUT OF 0° OR 90°. IN CASE SUCH CONDITION OCCURS,
AVOID TO START PROCEDURE WHICH REQUIRES A PERMANENT PATIENT "HEAD UP"
DISPLAY.
By default the [Image Rotation] key is active. Deselect the [Image Rotation] to prevent the image to automatically
rotate 90° when the L-Arm is moved more than +/- 45°. In such case, the image will be displayed "head up" only
when the L-Arm will be at 0°.
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InnovaTM IGS 620,
InnovaTM IGS 630
7-8 Patient Orientation

Patient Position on the DL
The Patient Position is the position of the patient on the table regardless of the imaging system. It is the
responsibility of the operator to select the correct patient position prior to any acquisition.
From the Patient Position pull down list, select the correct patient icon to match the current patient position on the
table.
This information is used by the system to correctly label patient orientation markers to avoid
misinterpretation of the image displayed for diagnostic purposes. It is also used by the 3D reconstruction
software to reconstruct the image in the correct orientation.
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Patient Position will automatically default to Head First Supine when the End Exam is selected.
Patient position in the exam room
The current selected patient position is displayed in the exam room on the live display.
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InnovaTM IGS 620,
InnovaTM IGS 630
Example: Patient is in Head First Supine Example: Patient is in Head First Prone
If the displayed patient position on the live monitor does not match the actual patient position in the exam room,
correct the patient position on the DL screen.
If the table is 180° rotated, an icon "180°" indicating the table rotation state will appear on the live monitor.
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The patient position relative to the table top does not change when the table is rotated so there is no need to
reselect a patient position on the DL screen.
However, the patient position relative to the imaging system is the opposite of the display (patient position display
shows his head under detector, while his feet are actually under the detector).
Note: the patient orientation markers (L, I, R) are described in the Patient Orientation markers section.
Patient position at start exam
When clicking on Start Exam, a display of the current selected patient position on the DL screen will alternate with
a question mark reminding the user to verify the correct patient position has been selected. This effect will stop
upon selecting a patient position from the list or after 30 seconds.
Question mark picture
Patient Orientation markers

Patient orientation is the orientation of the patient in the XR image.
The patient orientation is indicated by 1 to 3 direction letters located on the top, left and right edges of an x-ray
image in review or LIH. It is not indicated on live images. Right/Left, Superior/Inferior, Anterior/Posterior (R/L, S/I,
A/P).
The patient orientation markers correspond to the patient orientation in the image. It includes gantry and table
angulations, patient position on the table, and image transformations such as flips and rotations.
Patient orientation markers are part of the DICOM information and are transferred to a workstation which may have
the ability to display them.
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InnovaTM IGS 620,
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The following example is of a patient placed on the table supine, head first, frontal gantry in the PA position, lateral
gantry in Lateral position, and table position centered and not tilted.
Frontal plane:
1 Patient's right (R) is located on the left of the image

2 Patient's head (Superior) is located on the top of the image
3 Patient's left (L) is located on the right of the image
Lateral plane:
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1 Patient's anterior (A) is located on the left of the image

2 Patient's head (Superior) is located on the top of the image
3 Patient's posterior (P) is located on the right of the image
Additional patient directions appear when there are LAO/RAO and CRA/CAU angulations. The main direction of the
patient is indicated by the first letter. The potential secondary direction is indicated by the second letter and the
potential third direction, which is the least important, is indicated by the third letter.
For example, if there is some RAO/LAO angulation, and no CRA/CAU angulation, patient’s right/left and
anterior/posterior directions will be both indicated on the right and left of the image. Right/Left patient direction is
dominant if LAO<45°, Anterior/Posterior is dominant if LAO>45°.
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InnovaTM IGS 630
1 Patient's anterior (A) is the dominant direction because LAO>45° and the patient's right side (R) is also
viewed.
2 Patient's superior (S) is the dominant direction
3 Patient's left side (L) is the second dominant direction
4 Patient's anterior (A) direction is also viewed but it is the least important.
Superior/Inferior or Head/Feet display

By default, the Superior/Inferior patient direction is indicated by letters "S" and "I". However, there is a configuration
to display this direction with the letters "H" (Head) and "F" (Feet) instead. Contact your GE representative to
change this setting.
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Patient orientation display/transfer option
In the Preferences Tab on the DL screen, the "Patient Orientation Preferences" allows the display or not of the
patient orientation markers. This configuration is accessible at any time except during an acquisition.
When the configuration is set to "Yes", the patient orientation markers on acquired sequences or photos will be
displayed and transferred to workstations, for both planes.
When the configuration is set to "No", the patient orientation markers will not be displayed or transferred. If the
configuration is “No” and you need to retrieve the patient orientation of your acquired sequences, click on “Yes” and
re-launch the sequence or photo review. The markers will appear. If the sequence or photo without patient
orientation was already transferred to a workstation, they will need to be re-pushed.
Note: the change of display preference will not affect the images that are in the queue for transfer
Modification of Patient Orientation
If the patient position on the table was not selected properly, the patient orientation markers will be incorrect. In this
case, it is possible to manually annotate the images through the Modify Patient Orientation interface.
Select the sequence or photo to modify. To select multiple sequences or photos, press and hold the shift key while
selecting.
Right click on your selection then left click on the "Modify Patient Orientation" dialog box.
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InnovaTM IGS 620,
InnovaTM IGS 630
Right-click on multiple selection
The Modify Patient Orientation interface appears. This interface depends on the planes of acquisitions.
If only Frontal plane acquisitions or only Lateral planes acquisitions are selected:
Click on the box that matches the correct patient orientation for the selected images or the Clear Orientation box.
Click on Apply.
If Biplane acquisitions, or a mix of Frontal and Lateral plane acquisitions are selected:
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Click on the box for each plane that matches the correct patient orientation for the selected images, or the Clear
Orientation box. Click on Apply.
The change will apply to all frames in a sequence or photo, even if the patient orientation changes during the
acquisition.
Any sequence or photo that is in the queue for transfer cannot be modified.
If the sequence or photo containing incorrect patient orientation markers was already transferred, they will need to
be re-pushed.
7-9 Image Flip
It is the responsibility of the Operator to correctly verify the patient orientation by

confirming that it matches the information displayed on the live display.
For each plane, in case of image inversion selected, the and/or keys will be automatically highlighted and
a specific icon will be displayed below the and keys on the digital screen.
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InnovaTM IGS 620,
InnovaTM IGS 630
Image Flip - Innova Digital Screen
Three choices are possible:

: invert the image in horizontal: icon displayed.
: invert the image in vertical: icon displayed.
+ : invert the image in horizontal and vertical: icon displayed.
Image Flip can also be selected using the Image Flip button located in the Innova Central touch screen on the
Record tab or Fluoro tab.
Image Flip - Innova Central touch screen
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InnovaTM IGS 630
Image Flip invertion will be automatically removed at each Start Exam (default image flip settings at start exam =
no or flip selected).
The icon will be also displayed in the Geometry area (Item 1) of each live display and over any image
reviewed on each live or reference display (Item 1).
8 How to perform a Blended Roadmap Fluoroscopy Acquisition (Option)

Blended Roadmap overlays a vessel structure over the live subtracted Fluoroscopy.
Blended Roadmap can be used in monoplane or in biplane mode.
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InnovaTM IGS 620,
InnovaTM IGS 630
8-1 How to configure blended roadmap on one plane

• Select a substracted sequence and create the vessel image.
• Select Blended Roadmap mode.
• If needed, reposition Gantry/Table.
• Acquire the fluoro mask and if needed, register the vessel image and the mask using pixel shift.
• Enter Blended Roadmap mode and adjust the vessels and the landscape levels.
8-1-1 How to create the Vessel Image
1. Select a substracted sequence (substracted DSA, Bolus or subtracted 3D sequence).
2. Pause on the relevant frame.
3. Store a photo.
The vessel image used for Blended Roadmap must be a photo displayed on a reference display. It may come from
a frontal or lateral or biplane sequence depending on the mode you want to use Blended Roadmap in.
It is identified on the In-room Browser and on the DL console Photo Browser by the mask icon next to the photo
number.
In-room Browser Photo Browser
Note: If the photo was stored previously, double-click on it to display it on the reference.
Note: The quality of the vessel information displayed in blended roadmap depends on the quality of the created
vessel image.
8-1-2 How to enter / exit Blended Roadmap
To enter Blended Roadmap: after selecting the vessel image, select the Blend Frt or Blend Lat tab on:
• The Innova Digital console
DL Console blended roadmap frontal and lateral tabs
• The Innova Central touch screen, a submenu into the Fluoro mode.
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InnovaTM IGS 620,
InnovaTM IGS 630
• Or, from the NoSub Fluoro mode, press the Sub button on the Table Side Status Control (TSSC).
TSSC
Selecting any other fluoro tab than Blend Frt or Blend Lat, or pressing the Sub button on the Table Side Status
Control (TSSC) exits Blended Roadmap mode.
Note: The Sub button located on the TSSC toggles between NoSub Fluoro mode and the latest used Subtracted
Fluoro mode (Fluoro Roadmap, Blended Roadmap frontal, Blended Roadmap Lateral or Subtracted fluoro).
Blended roadmap must be the last used Subtracted Fluoro mode or the default Roadmap may be selected.
The state of each plane can be verified on reference displays. When a plane is in Blended Roadmap mode, the
label Blended Rdmp is displayed on its reference display.
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InnovaTM IGS 620,
InnovaTM IGS 630
Reference Display
Note: When trying to enter Blended Roadmap, an error message may pop up on the live display on which blended
roadmap is performed, in the following cases:
Error Message What is happening? What to do?

Selection Failed; select a subtracted Reference display is black, or displays Select a photo stored from a sub-
record photo. the IRB. stracted DSA, Bolus or substracted
3D sequence.
Photo displayed is not a sub DSA,
sub Bolus, or sub 3D photo.
Photo was stored from a zoomed se- Unzoom the sequence and store a
quence. new photo. Refer to FOV manage-
ment section if a zoom is needed on
the vessel sequence.
Selection Failed; original sequence Sequence where photo comes from is Acquire a new substracted DSA, Bo-
deleted. no more on the disk. lus or substracted 3D sequence.
Selection Failed; patient position mis- Current and photo patient positions Change the patient position set on
matched. are different. system and re-select Blended
Roadmap tab. If patient position is ac-
tually different from the one when ac-
quiring the substracted sequence, ac-
quire a new sequence.
Selection Failed; image flip mismatch- Current and photo flips are different. Change the image flip set on system
ed. and re-select Blended Roadmap tab.
Selection Failed; image rotation mis- Current and photo image rotations are Change the image rotation set on sys-
matched. different. tem and re-select Blended Roadmap
tab.
Blended roadmap not allowed. Move Lateral plane is parked. Move the lateral gantry to isocenter
the lateral gantry to isocenter. and re-select Blended Roadmap tab.
8-1-3 How to reposition the Gantry/Table

After selecting Blended Roadmap, the vessel image position and the current system positions are compared and if
needed, tools are provided to help repositioning of the gantry and the table back to where the vessel image was
acquired:
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InnovaTM IGS 620,
InnovaTM IGS 630
• If neither the gantry nor the table was moved, no specific action is required. Move to next step.
• If the gantry position has changed, the system automatically triggers the Send Angle function. Activate the Auto
Positioner joystick (top or bottom) to drive the gantry back to where the vessel mask was acquired.
• If the table position has changed, the system automatically displays the table repositioning tool. Manually adjust
the axis of the table until a check mark is displayed next to all axis.
Note: A check mark is displayed when within a range of 5 mm for longitudinal, lateral and vertical movement
and 0.3 degrees for rotation. However, the closer the displayed distance to move is to 0, the more accurate the
roadmap.
Need to reposition the Gantry Need to reposition the Table No repositioning needed
Note: Repositioning tools are displayed only on the live display on which blended roadmap is performed.
Note: Blended Roadmap Send Angles may fail or be cancelled, and an error message may pop up in the following
cases:
Error Message What is happening? What to do?

Send Angles stopped / not allowed. 30 s time-out. Exit and re-enter Blended Roadmap.
Restart Blended Rdmp to continue.
3D spin test started / Bolus start posi-
tion selection.
PA / LAT motion while system posi-
tion is being monitored.
Patient Position Change. Set the patient position correctly, exit
and re-enter blended roadmap.
8-1-4 How to acquire the mask and finetune the Registration

Blended roadmap uses a fluoro mask to remove unnecessary anatomy and to check repositioning accuracy.
The next step after repositioning is to acquire this fluoro mask.
Perform a fluoroscopy by pressing the fluoro footswitch; this is the mask acquisition phase. The fluoro icon
is displayed on the left side of the live display during fluoro to show that the displayed image is a live fluoroscopic
image.
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InnovaTM IGS 620,
InnovaTM IGS 630
AFTER ENOUGH FRAMES HAVE BEEN ACQUIRED FOR 1 OR 2 SECONDS, THE SYSTEM
AUTOMATICALLY STOPS THE ACQUISITION.
Release the fluoro footswitch. A "Vessel" icon is displayed on the left hand side of the live display, to
show that the system is ready for a Blended Roadmap acquisition, and the percent of vessel density.
Note: For this step of blended roadmap, the user can either press the proper footswitch of the plane on which
blended roadmap is being configured or the biplane footswitch.
LIH shows the subtraction between the fluoro mask and the vessel photo to verify the registration of the subtracted
roadmap.
See illustration below:
Sample image showing correct registration Sample image showing 5 mm misregistration
If neither the gantry nor the table was repositioned, and if the patient did not move, registration should not be
necessary.
IT IS UNDER THE USER’S RESPONSIBILITY TO ENSURE THAT THE REGISTRATION

BETWEEN THE FLUORO MASK AND THE VESSEL PHOTO IS SATISFACTORY FOR
CLINICAL PURPOSES. MISREGISTRATION COULD LEAD TO THE VESSEL MAP BEING
DISPLAYED INCORRECTLY AND COULD CAUSE POSSIBLE INJURY TO THE PATIENT.
Pixel shift is provided to improve the registration if it is needed. Pixel Shift is available from the:
• Innova Central touch screen joystick
• DL Keypad
• Remote Control
Horizontal, vertical and diagonal pixel shift is provided. If the pixel shift is held active during the registration, the size
of the shift will increase with time.
Note: It is not advised to modify the Landscape, Vessel or any other function while in the Pixel Shift phase as these
changes will not be apparent until fluoro is reinitiated and Pixel Shift may be aborted.
Note: During the registration phase, pressing the store photo button creates a photo of the LIH without subtraction
and deactivates pixel shift.
Note: If fluoro is activated too quickly without visually checking the registration, a message is displayed to remind
the user to check the registration. It is recommended to restart Blended Roadmap and verify the registration or this
message will continue to warn the user at every fluoro.
8-1-5 Blended Roadmap Acquisition
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Press the fluoro footswitch again to perform a Blended Roadmap acquisition. The fluoro mask is subtracted from
the displayed fluoro images to remove anatomy, and the selected vessels from the photo image are overlaid.
Note: During subtracted fluoroscopy, it is recommended not to move the tabletop, the gantry, change the Field of
View, the fluoro detail, the image flip settings, or insert or remove contour filters to avoid serious image quality
degradation.
Note: For this step of blended roadmap, the user can either press the proper footswitch of the plane on which
blend is being done or the biplane footswitch.
8-1-6 Landscape and Vessels Adjustment
The subtraction level between the live fluoro and the fluoro mask can be adjusted by selecting an appropriate
"Landscape" level in the Fluoro tab of the DL console, or by using the Table Side Status Control (TSSC) or the
Innova Central touch screen joystick.
The predefined LANDSCAPE values are: 0 (full subtraction), 30, 50, 70 and 100 (no subtraction)%.
Modification of Landscape level is available at any time during the Blended Roadmap only from the TSSC and
Innova Central touch screen joystick.
Note: In order to adjust the landscape level using the Innova Central touch screen joystick, press
Landscape/Vessels button on the Fluoro tab of the Innova Central touch screen. Move the joystick up or down to
adjust landscape.
The vessel density can be adjusted by selecting an appropriate "Vessels" level in the Fluoro tab of the DL console,
or by using the Innova Central touch screen joystick.
The predefined VESSELS values are: 0 (no vessels), 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100%.
Modification of Vessels level is available at any time during the Blended Roadmap from only the Innova Central
touch screen joystick.
Note: At 100% landscape the fluoro images are not subtracted. In this case vessel roadmap is not shown.
Note: In order to adjust the Vessels level by the Innova Central touch screen joystick, press
Landscape/Vessels button on the Fluoro tab of the Innova Central touch screen. Move the joystick left or right to
adjust vessel level.
Landscape and vessel density can be changed without fluoro. The display of percentages will update but not the
image until fluoro is reinitiated.
8-1-7 FOV Management in Blended Roadmap
The vessel image FOV is automatically adjusted to the Blended Roadmap settings (FOV selected at Blended
Roadmap entrance).
If a vessel photo is taken with a larger FOV than live fluoro, then the center part of the vessel image is used for
roadmapping.
Note: Do not change FOV after the fluoro mask acquisition or between subsequent blended roadmap runs,
because misregistration artifacts may occur (subtraction of images of different sizes). If FOV change is needed, exit
Blended Roadmap, change FOV, re-enter Blended Roadmap and acquire fluoro mask in the new FOV.
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InnovaTM IGS 620,
InnovaTM IGS 630
Vessel image Blended Roadmap image
If a vessel photo is taken with a smaller FOV than live fluoro, then the available vessel information does not extend
to the whole fluoro image:
Vessel image Blended Roadmap image
Note: In that case, the registration image looks like the following; the borders of the fluoro image appear
unsubtracted.
Sample image showing correct registration
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InnovaTM IGS 620,
InnovaTM IGS 630
8-2 How to use Blended Roadmap in biplane mode

1. Select a BIPLANE substracted sequence (e.g. DSA).
Frontal Lateral
2. Create a biplane vessel image, by pausing on the relevant injected frame and pressing Store button.
3. Configure Blended Roadmap mode on Frontal Plane:
• Click on Blend Frt tab.
• If needed, follow the instructions displayed on Frontal Live monitor to reposition the Frontal Gantry and/or Table.
• Acquire Fluoro Mask on Frontal plane by pressing fluoro footswitch .
• If needed, use pixel Shift to register Mask and DSA.

• Press fluoro footswitch to enter Blended Roadmap mode on Frontal.
• Release Fluoro footswitch.

4. Configure Blended Roadmap on Lateral plane:
• Click on Blend Lat tab.
• If needed, follow the instructions displayed on Lateral Live monitor to reposition the Lateral Gantry.
• Acquire Fluoro Mask on Lateral plane by pressing fluoro footswitch .
• If needed, use pixel Shift to register Mask and DSA.

• Press Biplane fluoro footswitch to enter Biplane Blended Roadmap mode.
5. Blended Roadmap in Biplane mode:
Frontal Lateral
Innova Digital 295

InnovaTM IGS 620,
InnovaTM IGS 630
Depending on your needs, switch between biplane and monoplane roadmap by pressing the relevant fluoro
footswitch.
If you press on footswitch… You get…
BIPLANE Roadmap
LATERAL Roadmap
FRONTAL Roadmap
Note: Vessel & Landscape levels are common for both planes.
Note: If you stop after Step 3, only monoplane blended roadmap will be available:
If you press on footswitch… You get…
FRONTAL Roadmap
LATERAL Fluoro No Sub
LATERAL Fluoro No Sub
FRONTAL Roadmap
Note: Steps 3 and 4 can be inverted: Lateral plane can be configured before Frontal plane.
Note: In case the angulations of the selected Biplane DSA are significantly different from the current angulations, it
may be difficult to use the autopositionner to reach the proper angulations needed for blended roadmap. In these
conditions, the message "Near collision, reposition gantry or table to continue Blended Roadmap" will be displayed.
Thus, if the angulations of the selected Biplane DSA are significantly different from the current angulations, It is
recommended to review the DSA sequence and to send the angulations to the gantry before starting the biplane
blended roadmap workflow.
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Note: Before starting blended roadmap mode, ensure there is no mismatch between the DSA and the fluoro, in
terms of image flip, image rotation, patient position and zoom.
Note: To exit Blended Roadmap in Biplane Mode, select any other fluoro mode.
9 How to perform a Roadmap Fluoroscopy Acquisition

Roadmap Fluoro can be activated from:
• The Innova Digital Screen by selecting the Roadmap tab in the Fluoro window.
• The Innova Central touch screen Innova main tab select the Fluoro tab and then press the Roadmap mode
button.
• The Table Side Status Control (TSSC) by pressing the Sub button (Item 13).
A Fl. Roadmap label is then displayed on the reference display.
Roadmap Fluoro - Innova Digital Screen
Roadmap Fluoro - Innova Central touch screen
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InnovaTM IGS 620,
InnovaTM IGS 630
Subtracted Fluoro - TSSC
- Perform a fluoroscopy depressing one of the fluoro footswitch (1, 2 or 3); this is the mask acquisition phase.
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The fluoro icon is displayed on the left side of the live display during fluoro to show that the
displayed image is a live fluoroscopic image.

After a short time, "Inject" flashes on the live display.
- Inject manually the contrast media to perform a roadmap run.
Note: In case the 7.5 fps fluoro is used, inject for at least 2 s to acquire enough frames. Doing so
will optimize the peak opacification phase of the mask acquisition.
- Release the fluoro footswitch.
A "Mask" icon is displayed on the left side of the live display to show that the fluoro mask was acquired.
- Depress again the fluoro footswitch. The displayed fluoro images are subtracted. The vessel roadmap should
be visible in white color.
- The subtraction level can be adjusted using the LANDSCAPE function. Select an appropriate "Landscape"
level in the fluoro window or use the "LANDSCAPE" button on the Table Side Status Control (TSSC).
THE FLUORO LANDSCAPE FEATURE AFFECTS ONLY THE BACKGROUND VISIBILITY OF

THE IMAGE. WHEN USING SUB FLUORO WITH LANDSCAPE, NEVER MOVE THE TABLE. IF
SO, INJECTED VESSELS WILL NOT MATCH ANYMORE WITH THE ANATOMY.
The predefined LANDSCAPE values are: 0, 30, 50, 70 and 100%.
A "Landscape" icon and the level value are displayed on the left side of the live display to
show the selected level of landscape.

- At 100% landscape the fluoro images are not subtracted, vessel roadmap is not visible.
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InnovaTM IGS 620,
InnovaTM IGS 630
- 0% landscape = full subtraction imaging.

Note: Modification of Landscape level is available at any time during the Roadmap time from the TSSC only.
DURING THE ROADMAP FLUOROSCOPY, IT IS HIGHLY RECOMMENDED TO NEVER MOVE

THE TABLETOP AND / OR THE GANTRY NOR CHANGE THE FIELD OF VIEW, THE FLUORO
DETAIL, THE IMAGE FLIP SETTINGS, INSERT OR REMOVE CONTOUR FILTERS. IF DONE
THE IMAGE QUALITY WILL BE SERIOUSLY DEGRADED.
Note: The mask is aborted when Roadmap mode is exited, or when "END EXAM" is activated or when another
protocol is selected.
Note: When the roadmap fluoro is deselected, the landscape function is disabled.
10 How to perform a Subtracted Fluoroscopy Acquisition

Subtracted Fluoro can be activated from:
• The Innova Digital Screen by selecting the Sub tab in the Fluoro window.
• The Innova Central touch screen Innova main tab select the Fluoro tab and then press the Sub mode button.
• The Table Side Status Control (TSSC) by pressing the Sub button (Item 13).
Note: The Sub button (Item 13) located on the TSSC toggles between Fluoro No Sub mode and either Sub or
Roadmap fluoro previously used mode:
• If Sub fluoro was used prior to No Sub fluoro, the TSSC button toggles between No Sub and Sub fluoro.
• If Roadmap fluoro was used prior to No Sub fluoro, the TSSC button toggles between No Sub and Roadmap
fluoro.
• If Blended Roadmap fluoro was used prior to No Sub fluoro, the TSSC button toggles between No Sub and
Blended Roadmap fluoro.
A Fluoro Sub label is then displayed on the reference display.
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InnovaTM IGS 620,
InnovaTM IGS 630
Subtracted Fluoro - Innova Digital Screen
Sub Fluoro - Innova Central touch screen
Innova Digital 301

InnovaTM IGS 620,
InnovaTM IGS 630
Subtracted Fluoro - TSSC
- Perform a fluoroscopy depressing one of the fluoro footswitch (1, 2 or 3).
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InnovaTM IGS 620,
InnovaTM IGS 630
The fluoro icon is displayed on the left side of the live display during fluoro to show that the
displayed image is a live fluoroscopic image.

After a short time (1 s when using 30 or 15 fps; 2 s when using 7.5 fps), the image displayed on the
live display switches automatically from No Sub to Sub.
- The subtraction level can be adjusted using the LANDSCAPE function. Select an appropriate "Landscape"
level in the fluoro window or use the "LANDSCAPE" button on the Table Side Status Control (TSSC).
THE FLUORO LANDSCAPE FEATURE AFFECTS ONLY THE BACKGROUND VISIBILITY OF

THE IMAGE. WHEN USING SUB FLUORO WITH LANDSCAPE, NEVER MOVE THE TABLE. IF
SO, INJECTED VESSELS WILL NOT MATCH ANYMORE WITH THE ANATOMY.
The predefined LANDSCAPE values are: 0, 30, 50, 70 and 100%.
A "Landscape" icon and the level value are displayed on the left side of the live display to
show the selected level of landscape.

- At 100% landscape the fluoro images are not subtracted, vessel roadmap is not visible.
- 0% landscape = full subtraction imaging.
Note: Landscape level can be modified at any time during Fluoro Roadmap from the TSSC only.
DURING THE SUBTRACTED FLUOROSCOPY, IT IS HIGHLY RECOMMENDED TO NEVER

MOVE THE TABLETOP AND / OR THE GANTRY NOR CHANGE THE FIELD OF VIEW, THE
FLUORO DETAIL, THE IMAGE FLIP SETTINGS, INSERT OR REMOVE CONTOUR FILTERS. IF
DONE THE IMAGE QUALITY WILL BE SERIOUSLY DEGRADED.
Note: The mask is aborted each time the fluoro footswitch is released.
Note: When the Subtracted fluoro is deselected, the landscape function is disabled.
Innova Digital 303

InnovaTM IGS 620,
InnovaTM IGS 630
11 Simultaneous Fluoro Sub / NoSub Display (Option)

Depending on system configuration, it is possible to display simultaneously the subtracted and non subtracted
fluoro images on the in-room monitor suspension.
The simultaneous Fluoro Sub / NoSub display can be activated from:
• The Innova Digital Screen by activating the Sub NoSub button located below the Landscape level selection in
the Roadmap tab of the Fluoro window.
• The Innova Central touch screen Innova main tab select the Fluoro tab and then press the Simultaneous
Display button.
Simultaneous Fluoro Sub / NoSub Display - Innova Digital Screen
Simultaneous Fluoro Sub / NoSub Display - Innova Central touch screen
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Note: Simultaneous Fluoro Sub / NoSub display selection is common for both Frontal and Lateral plane.
12 How to perform a Record Acquisition

• Dynamic mode: primary use for general cardiac procedures.
• InnovaBreezeTM (Bolus) mode: primary use for subtracted lower limbs arteriogram (available on Frontal plane
only).
The Record icon is displayed on the left side of the live display during Record acquisition to show that the
displayed image is a live image.
The Acquisition icon is displayed at the bottom of the control room console to show that a record
acquisition is in progress.
12-1 DSA Mode
• Select among "Abdomen, Chest, EP DoseSense, Head, Lower Limbs, Pediatrics, Upper Limbs, Vascular" from
the "Protocols". Double click on the protocol name to open it.
Then click on one procedure among the proposed choice.
Innova Digital 305

InnovaTM IGS 620,
InnovaTM IGS 630
As already described, protocol selection can also be performed from the Record tab or Fluoro tab of the Innova
Central touch screen.
In the "Vascular" anatomy, specific procedures are available such as:
"REC 2 fps-20 s, Fl 15 fps" to perform angio procedures using 15 fps fluoro.
"DSA 0.3 Focal Spot" to perform angio procedures using a fixed 0.3 focal spot.
Note: Because of the low available power on such small focal spot, use this procedure over
thin/low density areas.
"REC 0.6 Focal Spot" to perform angio procedures using a fixed 0.6 focal spot.
"REC 1.0 Focal Spot" to perform angio procedures using a fixed 1.0 focal spot.
Automatically the Application tab confirms the selected acquisition mode.
• In the Record window DSA tab, select the Frame Rate needed using the Frame rate pull down list between 0.5;
1; 2; 4 or 7.5 fps when Frontal or Lateral plane only is selected.
• In the Record window DSA tab, select the Frame Rate needed using the Frame rate pull down list between 0.5;
1; 2 or 4 fps when biplane is selected.
• Select the record duration and the frame rate for each of the 3 segments.
Note: If 7.5 fps is selected, do not select longer acquisition duration than 30 s in case the acquisition needs to be
burnt on a CD in order not to exceed the maximum storage capacity of the CD. A single run cannot be burnt on
more than one CD.
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• Select the needed Record Detail Level.
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InnovaTM IGS 620,
InnovaTM IGS 630
• Select injection parameters

Acquisition can be performed using either Manual or Automatic injection.
When Auto Inject is selected (injector automatically triggered by the Innova system), the
X-ray or Injection Delay must be set (or kept) at Zero on the injector unit. In order to prevent
any conflict between the injector unit and the Innova system, X-ray or Injection Delay must
only be selected from the Control Room Innova Console. Setting (or keeping) some X-ray or
Injection Delay on the injector unit itself could create some acquisition abort.
In case of Automatic injection selection, the injector is automatically triggered by the system.
When Auto Injection is selected, it is possible to preset an injection delay (X-ray then Injection start) or X-ray delay
(Injection then X-ray start) by opening the selected pull down list.
Click on the +/- field to open the Injection/X-ray delay edit window and add/remove new/existing values.
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To add a new value in the list, type the value and click on .
To delete an existing value, open the pull down list, select the value to remove and click on .
From this window, it is also possible to enter a new delay to use for the next acquisition. Just enter the value and
Innova Digital 309

InnovaTM IGS 620,
InnovaTM IGS 630
click OK to close the edit window and apply the new value. In this case, this new value will not be saved and added
to the list.
Note: New Injection or X-ray delay must be entered by step of 0.5 s only (i.e. 1 s, 1.5 s, 2 s...).
• Select the plane required to perform the acquisition: Frontal, Lateral or Biplane.
Note: Record frame rate, detail, injection parameters and plane selections can also be performed from the Record
subtab on Innova tab of the Innova Central touch screen using the Frame Rate, Detail, X-Ray Delay or Injection
Delay and Plane Select buttons.
Note: All record parameter selections are common for both Frontal and Lateral plane.
• Perform DSA acquisition
Depress and hold the hand/footswitch to initiate the acquisition.
Acquisition parameters are computed from the previous fluoro. In case of table/gantry motion, FOV change,
geometry modification... since the previous fluoro, the Record acquisition could be inhibited and a new Fluoro
required.
If such situation occurs, perform a short fluoro (2 s minimum) then depress the acquisition switch again.
Note: Always check the image quality at the beginning of the run before launching the injection (images shall not
be dark nor contain excessive saturation).
Note: If the expose trigger of the hand/footswitch is released during acquisition, X-ray and injection will stop.
In case of Manual injection, "Inject" will be displayed on the left side of the live display to inform when injection can
start.
- The Heat Units Information displayed are only estimations made by the system depending
on acquisition parameters computation. - The Heat Units Information are available from the
control room Innova Digital screen Heat Units window and from the reference display. At the
beginning of a DSA sequence, the system will automatically check the possibility of the
requested run. If the entire run duration is not possible because of thermal limitation (tube
too hot), then a 5-seconds long popup is displayed on the Frontal Live Display, informing
the user of the maximum possible run duration. If the user does not release the pedal, the
run starts and will end when reaching that duration. Before a Record acquisition is
performed, it is the responsability of the user to check the Heat Units informations.
Depending on the information displayed, the next Record acquisition may or may not be
completed as requested by the user.
Depending on acquisition parameters computation and available heat units, the system will display a Warning pop
up on the Frontal Live Display in case the requested run cannot be completed.
In this pop up, the computed available run time is displayed and a 5 seconds count down starts to let the user take
the decision to perform or not the acquisition, knowing that the run will be aborted before its completion.
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Note: In case of biplane acquisition, the displayed "Available Run Time" will refer to the X-ray tube which is the
most limited (the hotest).
Keep the hand/footswitch pressed to allow the run to start.
Release the hand/footswitch within 5 seconds (before count down reaches zero) to abort the acquisition.
Change acquisition parameters or wait for the X-ray tube to cool down to succeed in acquisition completion.
Note: Reaching X-ray tube thermal limit will interrupt the acquisition and require to wait for X-ray tube to cool down
or to modify acquisition parameters. Fluoro is always available. After reaching the thermal limits, the subsequent
DSA acquisition will have a 10 seconds access time.
12-2 Dynamic Mode
Note: Before performing the first Dynamic procedure after an angio procedure, check the Heat Units Status window
for heat units availability. It should be at least 50% for a diagnostic Dynamic case or 70% for an interventional
Dynamic case. The subsequent Dynamic procedures can be performed without any thermal limitation. Fluoroscopy
is always fully available.
• Select "Cardiac & Combo" from the "Protocols". Double click on the protocol name to open it.
Then click on one procedure among the proposed choice.
As already described, protocol selection can also be performed from both the Fluoro and Record subtabs of Innova
tab of the Innova Central touch screen.
In addition to specific protocols such as Coronaries, EP, Needle Placement, Pedia Cardiac, Pedia Cardiac Neonate
and Ventriculogram, two protocols labeled Cardiac 1 and Cardiac 2 can be modified at installation to better fit local
needs during cardiac procedures. Two other protocols labeled Combo 1 and Combo 2 can also be modified at
installation to access other angio acquisition modes needed for angiography and peripheral procedures.
Automatically the Acquisition tab confirms the selected acquisition mode.
• In the Record window Dynamic tab, select the Frame Rate needed using the Frame rate pull down list:
– In single plane mode: 15 or 30 fps.
– In biplane mode: 25 fps or 15 fps.
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• Select the needed Record Detail level.
• Select injection parameters.
Select Auto injection to automatically trigger the injector from the Innova system (for more detail, refer to Innova
Digital / How to perform a Record Acquisition / DSA Mode).
• Select the plane required to perform the acquisition: Frontal, Lateral or Biplane.
Note: Record frame rate, detail, injection parameters and plane selections can also be performed from the Record
subtab on Innova tab of the Innova Central touch screen using the Frame Rate, Detail, X-Ray Delay or Injection
Delay and Plane Select buttons.
Note: All record parameter selections are common for both Frontal and Lateral plane.
• Perform Cardiac acquisition
12-3 InnovaChaseTM Mode (Available on Frontal plane only)
• After selection of an angio protocol, select the Chase acquisition mode from the Current Application window
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located on the left side of the Innova Digital screen. If the selected protocol does not offer this choice, select
another protocol from the "Protocols".
• In the Record window, select the level of detail and injection parameters.
For more detail about injection parameters, refer to section Innova Digital / How to perform a Record Acquisition /
DSA Mode).
• Perform InnovaChaseTM acquisition
InnovaChaseTM Acquisition is available using only:
5 fps acquisition frame rate.
1.0 large focal spot.
Table top manual panning (non subtracted images).
The maximum record duration is limited to 90 s.
12-4 InnovaBreezeTM Mode (Option available on Innova IGS 630 Frontal plane only)
The Bolus Chasing acquisition mode is available on:
• the 30 cm Field of View only.
• the Omega V table.
12-4-1 Before You Start
12-4-1-1 On the Positioner
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Note: The Lateral gantry must be first moved into zone 1 (see Innova Positioner / Lateral Carriage Positioning) to
allow the Bolus acquisition.
• The L must be at plus or minus 90° (plus or minus 2°).
• The Pivot axis must be in PA (plus or minus 2° in CRA-CAU).
• The C-arc must be in PA (plus or minus 15° in RAO-LAO).
• The table-top must be centered (rotation is not allowed).
12-4-1-2 Patient Positioning
• To get the maximum patient coverage, position the patient so that the head is located at head end side of the
table top.
• Using fluoro, check that the patient is perfectly aligned with the table top/Digital Detector between Start and End
positions.
• Use proper accessories (Velcro straps...) to immobilize the legs/feet of the patient.
During the bolus acquisition, the table top will move between the Start and End positions at
high speed. Always check that all tubings (injector, pressure...) connected to the Patient will
be long enough and will have an extra length of at least 15 cm when the table will reach the
Start or End position. Failure to this recommendation could cause severe injury to the
Patient at punction location.
12-4-1-3 Anticollision Precaution
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Make sure to clear the area before launching the procedure to avoid any activation of the
anticollision system that would abort the X-ray acquisition and injection.
12-4-1-4 On the Innova Console
• After selection of an angio protocol, select the Bolus acquisition mode from the Current Application window
located on the left side of the Innova Digital screen. If the selected protocol does not offer this choice, select
another protocol from the "Protocols".
• If the table top is in the allowed range, the S/E/T button of the Table Control Panel lits.
Any protocol selection performed after the Start/End positions were memorized will lose
these positions.
• Select the acquisition parameters:
- Available frame rates at rest (when the table top does not move) are: 1 fps and 2 fps.
- Step length is fixed to 5 cm.
- Auto/Manual injection with X-ray/Injection Delay.
- Normal or Low Record Detail.
12-4-1-5 On the Control Panel

The Bolus Chasing mode must have been selected before the Start/End button can be used.
14 Bolus Start / End-Spin Test Rotation
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Note: Press once on the S/E/T button to store the Start position.
Press a second time on the S/E/T button to store the End position (there must be at least 30 cm between Start and
End positions).
Press a third time on the S/E/T button to reset (clear) the Start and End positions.
Note: A 15 minutes time out is allowed between:
- Memorization of Start and memorization of End position.
- Memorization of End position and beginning of bolus acquisition.
12-4-2 Making an Acquisition in Bolus Mode
12-4-2-1 On the Innova Console
• Select the Bolus Chase protocol and the appropriate acquisition parameters (refer to Innova Digital / How to
perform a Record Acquisition / InnovaBreezeTM Mode (Option available on Innova IGS 630 Frontal plane only)
/ Before You Start / On the Innova Console).
12-4-2-2 In the Examination Room
• In order to always get the maximum field coverage on the patient even using a small Field of View, move the
table top up to the end and keep the Digital Detector close to the patient.
• Move the table top to center the patient over the abdomen. The S/E/T button of the Control Panel must be ON
to allow to store the table position. Press the S/E/T button to memorize the table Start position. The S/E/T button
goes OFF.
• Correct centering is checked using fluoroscopy, from the abdomen to the feet.
Longitudinal movement is the only movement available. When the table top is moved more than 30 cm from the
Start position and is in the allowed range, the S/E/T button blinks.
• After centering over the feet, press the S/E/T button to memorize the table End position. The S/E/T button goes
OFF.
Note: From the time the Start position is memorized to the time the exposure switch is pressed all gantry axis are
locked except:
- Table Up/Down.
- Digital Detector Up/Down.
- Longitudinal table top.
Collimation, Contour Filters and Field of View selection are available until the exposure switch is pressed.
Fluoro is always available until the acquisition starts.
12-4-2-3 At the Console
Prep/Expose Handswitch Bolus Chasing Handswitch
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1 Table Speed
2 Bolus Button
• Press and hold the prep/expose Innova handswitch button.

Note: Except in case of emergency, this button must NOT be released during the entire Bolus acquisition.
• The table is automatically positioned at the Start position (Abdomen).
Note: In order to optimize the acquisition, the table will always stop 5 cm further than the memorized Start position.
Special attention is required regarding the length of cables, pipes, catheter... connected to the patient. These
devices must be long enough to follow the total table motion safely.
• The Mask sequence is performed at a fixed frame rate, from the Abdomen to the feet. Two trial shots are
performed at low dose (about 25% of nominal dose) prior to each mask acquisition. The table then returns to the
Start position and "Depress Bolus button" is displayed in the Status area.
• On the Bolus Chasing handswitch: depress and release the Bolus button (See Illustration above).
• The X-ray Run begins.
The injection begins after the programmed delay.
• Use the Table Speed button of the Bolus Chasing handswitch to follow the contrast media.
Note: In case of image pasting needed after the Bolus acquisition, adapt the table movement to ensure that the
central horizontal strip of the acquired images is always well opacified. Ideally, the contrast agent should be visible
on at least 75% of the image. If necessary, proceed to separate acquisition for each leg.
• Increase or decrease the speed of the table by pressing more or less firmly on the button.
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1 Table stopped (button released)

2 Maximum speed (button fully pressed)
• When the table speed button is released, the table stops on the next Mask position. Images are then acquired at
the frame rate at rest.
• To optimize the last acquisition, the table will stop at 4 cm maximum further than the memorized End position.
• To stop the X-ray Run:
- Release the prep/expose Innova handswitch button at any time or,
- Press then release the Bolus button on the Bolus Chasing handswitch after the table has reached its stop
position.
Note: Until the Bolus Chase protocol is exited or the S/E/T button is depressed to clear the Start and End
memorized positions, the system is still ready to perform another identical bolus acquisition.
A 15 minutes time out will automatically clear both memorized table positions if no action is perform on the system
after the completion of the bolus.
12-5 Innova 3D / Innova CT Modes (Options available on Frontal plane only)
12-5-1 Application Description
Depending on system configuration, two 3D Spin modes can be available.
Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the
physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
Innova CT is intended for imaging bone and soft tissues as well as other internal body structures.
Innova 3D / Innova CT images should not be used on its own for diagnosis or treatment but
always in complement of 2D images (live or recent recorded images).
The 3D reconstruction is carried out on the Advantage Workstation and allows reconstructions from a single 200°
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(approximate) Spin acquired at a frame rate of 30 or 50 fps.

All reconstructed 3D models can have 5123 resolution. A 2563 resolution mode is also available when faster
reconstructions are needed.
3D models produced can be visualized on the Advantage Workstation using the Volume Viewer software.
The Volume Viewer software offers the ability to:
• Manipulate the 3D model around all three axes.
• Perform distance, and volume measurements.
• Navigate inside vessels (with Navigator option).
• Display MPVR (Multi Planar Volume Reconstruction) cross-sections: axial, sagittal, coronal and oblique
cross-sections.
• Detect vessels and remove un-wanted structures from the image.
12-5-2 3D Spin Acquisition
Note: The Lateral gantry must be first moved into zone 1 (see Section Innova Positioner / Lateral Carriage
Positioning) to allow the 3D or 3DCT acquisition.
The 3D Spin Acquisition is available using any of the Field of View (FOV) sizes available on the system.
The 3D Spin Acquisition procedure is performed in two steps:
• 3D calibration acquisition using the helix phantom for definition of volume reference points (to be performed
once every six months).
Two levels of information message are displayed:
– 6 months-15 days: "3D Calibration near to expire. Call Service to perform 3D Calibration".
– After 6 months: "3D Calibration out of date. Call Service to perform 3D Calibration".
3D acquisition and reconstruction are still allowed.
A small "*" will be displayed left to the reconstruction date of the 3D model on the Advantage Workstation.
• Acquisition of patient images using a specific 200° (approximate) rotation protocol around the patient.
12-5-2-1 3D Spin Images Acquisition
• In Innova 3D mode, the rotation is performed at 40°/s, at a frame rate of 30 fps, providing approximately 150
views in a 5 s acquisition.
• In Innova CT mode, 3 rotation speeds are available: 40°/s, 28°/s and 16°/s, with an increased frame rate of 50
fps, providing approximately 250, 350 or 600 views respectively. Using more views allows to improve the
visualization of bones and soft-tissues.
Note: As the source images are acquired during the 3D spin, several detector and processing corrections are
applied and tuned to optimize resulting 3D image consistency during reconstruction. This process may result in
the presence of certain anomalies visible while reviewing the source images. The potential anomalies may
include a horizontal line or contrast change across the middle of an image and/or image-to-image contrast
oscillations. In general these anomalies are generated by rapid corrections taking place to account for the
presence of raw radiation within the Field of View during the spin. The degree of visibility of these anomalies will
depend on several factors related to the patient, system and geometry of the spin. These anomalies appear
solely in the 2D spin image and allow for an improved display of the 3D model.
12-5-2-2 Patient Positioning
Using fluoro in PA and Lateral projections, properly center the region of interest (ROI) at isocenter.
Special attention must be paid to the patient immobilization during the 3D Spin acquisition
sequence. Any patient motion during the fast rotation of the gantry could injure the patient.
It is advised, particularly if the patient is not anaesthetized, to use appropriate restraining
devices to completely immobilize the patient (head, arms, legs) in order to keep the patient,
and so the region of interest, perfectly still throughout the acquisition sequence. Any
patient motion will also reduce the quality of the images and the 3D reconstruction.
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Use appropriate collimation to limit patient radiation and cut raw radiation.
Note: Because contour filter blades can create artifacts on 3D models, blades are automatically parked as soon as
a 3D acquisition mode is selected.
12-5-2-3 Scatter Management
Scattered radiation is inherent to all X-ray acquisitions. To reduce the impact over 3D reconstruction, use horizontal
collimation that decreases the amount of scatter on the detector. When such collimation exceeds 10% of the FOV
length, this enables the possibility to activate a dedicated pre-processing algorithm for scatter reduction on AW
side.
Scatter reduction will be most beneficial in the case of:

• Brain imaging with the soft tissue protocol.
• Abdominal imaging with large FOV.
Note: When collimating before the 3D spin, make sure that the anatomical structure you are interested in is still
present in the Field of View.
12-5-2-4 On the Innova Digital Screen
For an Innova 3D acquisition, select the 3D acquisition mode in the Acquisition Mode tabs area. If the selected
protocol does not offer this choice, select another angio protocol from the Protocols.
For an Innova CT acquisition, select the 3DCT acquisition mode in the Acquisition Mode tabs area.
Select the acquisition parameters:

• Subtraction setting (Sub / NoSub)
• Rotation speed (selection available only in Innova CT from the Innova Console or the optional Innova Central
touch screen).
• Auto/Manual injection with X-ray Delay.
• Normal/Low Record detail.
In the case of vessel, or perfusion imaging, use appropriate injection parameters (volume,
rate, delay) in order that vessels are properly opacified during the entire image acquisition
phase.
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12-5-2-5 Making an acquisition in 3D Spin

As soon as the 3D or 3DCT mode is selected, the S/E/T button starts to blink on the right side of the Control Panel
and the message "Ready for Spin Test" is displayed at bottom left of the live display.
Press and hold the S/E/T button (14):

• The gantry moves from its current position to the End of rotation position.
• All gantry axes are reinitialized and the detector moves to maximum SID (119 cm/46.8").
• The gantry performs its test rotation at 15°/s from End to Start position.
Some specific protocols ("Soft Tissues", and "Innova CT High Resolution" in category
"Head") are set by default for a reduced SID (108 cm, 42.5") for 3DCT acquisition performed
at 16 or 28°/s to optimize the visibility of soft tissues or small structures in the brain. When
using these, or other protocols set for a reduced 3DCT SID, take extra care of centering the
table top laterally to avoid collision during the gantry test rotation.
Make sure to clear the area before launching the procedure to avoid any activation of the
anticollision system that would abort the X-ray acquisition and injection.
Special attention must be paid to select the appropriate 3D spin mode for the current exam
(Innova 3D mode versus Innova Subtracted 3D mode) to avoid: - Unnecessary retake,
causing extra X-ray dose and injection to patient (when Innova 3D mode is selected instead
of Innova Subtracted 3D), - Or mechanical hazard to clinical staff arising from unexpected
gantry movement (when Innova Subtracted 3D mode is selected instead of Innova 3D).
At the end of the test rotation, the S/E/T button goes Off and the message "Ready. Clear rotation area" is displayed
on the live display.
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Note: From the beginning of the Test Rotation, all table and gantry axes are locked. Pressing on the S/E/T button
after the completion of the Test Rotation will abort the 3D Spin set up and free all table and gantry axes. If needed,
the patient can be repositioned. A new Test Rotation is then required.
Press and hold the prep/expose Innova handswitch button:
Note: Except in case of emergency, this button must NOT be released during the entire 3D Spin
acquisition.
• The injection starts.
• The X-ray run begins after the programmed delay.
• The gantry rotates at the selected speed.
When the gantry reaches the End position, X-rays are stopped and the S/E/T button starts to blink again; the
system is ready for a new 3D Spin acquisition (new Test Rotation must be performed first).
In order that the 3D spin acquisition can be reconstructed at any time, all calibration data needed for the 3D
reconstruction is saved with the images in the same DICOM sequence.
12-5-3 Image Network
After the 3D Spin acquisition is completed, the acquired images are automatically transferred to the Advantage
Workstation.
Note: 3D images will always be sent to a predefined selected 3D remote host (AW workstation) and to other
selected host(s).
The status of the 3D sequence in the DL Sequence Browser will change to sent only after successful completion of
the 3D sequence data transfer to all the selected host(s).
12-5-4 3D Image Reconstruction
As soon as all acquired images are received at the Advantage Workstation, the 3D reconstruction is started
automatically.
Note: For detailed information on the use of the reconstruction software, refer to the Innova 3D XR Operator
Manual.
12-5-5 3D Model Display
The 3D model of vessels and/or interventional devices can be analyzed using a range of 3D analysis tools
including:
• MIP (maximum intensity projection).
• Volume Rendering.
• MPVR (multi-planar volume reconstruction).
• Axial, sagittal, coronal and oblique cross-sections.
• Electronic scalpel and 3D shutter.
• Distance and volume measurements.
• Navigator (endovascular-like).
• Customized screen layouts for Innova 3D and Innova CT.
Default Advantage Workstation screen layout for Innova 3D
Left screen Right screen
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MIP VR Sagittal
Oblique Axial Coronal
Default Advantage Workstation screen layout for Innova CT
Left screen Right screen

Oblique Axial MIP
Sagittal Coronal
3D image Cross-section
12-5-6 3D Image Archiving

The 3D model is saved as a DICOM object, and as such can be archived onto a CD or DVD medium, or a USB
drive. This model can later be reviewed on any Advantage Workstation with the Volume Viewer software.
Additionally, the user can archive the spin acquisition on PACS, then at any time later retrieve and reconstruct a 3D
model from it.
Archiving of "screen capture" images that are created from the 3D model is also possible on a PACS.
12-5-7 3D Quick Guide
12-5-7-1 3D Acquisition
• By moving the patient on the tabletop, and or the tabletop itself, Isocenter the anatomy of interest, perform
frontal and lateral fluoroscopies to check and adjust the position.
• When using the 30 cm FOV, use appropriate collimation to avoid raw radiation, which can degrade the 3D
image.
• Use collimator blades as required, but as the 3D image might be slightly smaller than 2D image, make sure to
keep an appropriate margin by NOT collimating too tightly.
• For optimum vessel contrast, injection should be as selective as possible.
• Vessels should be completely opacified from the beginning of the spin until the end.
– X-ray delay: If a DSA series is available, use the "scale" button on the DL keypad to display the time line and
measure the delay between injection start and vessel completely filled. Enter this delay as X-ray delay.
– Injection parameters: select volume and flow rate such that the injection duration is equal to the
above-computed X-ray delay plus rotation duration of 5 seconds.
– As a guideline, injection parameters should be equal or inferior to the one used for an unsubtracted 3D.
Subtracted 3D enables automatic bone removal, one can expect same vessel segmentation and visibility
with volume of contrast product inferior to the one used for a no sub 3D.
• Any patient motion during gantry rotation will degrade the 3D image quality (streaks, blurring). Inform the patient
about the gantry rotation. Ask patient not to move and not to breathe. In case of cerebral procedure, ask patient
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to close his/her eyes during the Spin acquisition. In case of general anesthesia, if possible, stop the respirator.
• For intracranial vascular studies, it is recommended to use the 20 cm FOV to avoid the presence of skull in the
3D image. This simplifies the 3D processing on the AW as there is no manual manipulation needed to remove
the skull.
12-5-7-2 3D reconstruction
• 3 modes are available to reconstruct 3D Spin images:
– To get optimum spatial resolution, reconstruct the 3D Spin using the "512" 3D volume size.
– To speed up the reconstruction keeping a very good spatial resolution, use the "Fast 512" 3D volume size to
reconstruct the 3D Spin. Reconstruction time is about 50% compared to "512" with a spatial resolution
slightly lower.
512 Fast 512
– In case of large amount of images to reconstruct or to get the shortest reconstruction time, reconstrut the 3D
Spin using the "256" 3D volume size. Reconstruction time is about 12% (8 time less) compared to "512" with
the lowest spatial resolution.
• Reconstruction filters
– Vascular: primary choice is None, Bone filter enhances 3D vessel sharpness but increases noise in
cross-section.
– Bones: primary choice is Sharp filter.
– Low, Medium or High smoothing filter is to be used only in 256 to average the noise and increase contrast
visibility in soft tissues.
• For 512 reconstruction in the abdomen, do not use "Sharp" if your main interest is to look at Volume Rendering
images (and not to look at cross-sections).
• For the abdomen, 256 reconstruction might be a good option if your main interest is to look at Volume
Rendering images:
– Faster reconstruction time.
– Less noise in the Volume Rendering images.
• For Volume Rendering purposes, 512 Low Smooth and 256 Bone seem almost equivalent, so 256 Bone is
recommended (because much faster than 512 Low Smooth).
• How to control the "noise" in a 3D Volume Rendering image:
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12-5-7-3 3D display
• When looking at a 3D image, keep in mind that it is a reconstructed image which may also contain
reconstruction artifacts. Always compare a 3D image with other patient data in case unexpected structures are
discovered.
• When using scalpel, select only the 3D images you are working on, otherwise black areas will be created in
cross-sections.
• A fast way to isolate and display a ROI is to use the Sphere Shutter (adjust shutter diameter as required) or the
Box Shutter.
• On cross-section images, a large slice thickness (between approximately 5 mm and a few centimeters)
improves vessel visibility.
• Influence of "VR Opacity" on the 3D image.
512 Bone, Opacity 30% 512 Low Smooth, Opacity 60%
A Higher VR Opacity will provide smoother vessels, but will also increase the visibility of undesired structures
(bone, etc).
512 None, Opacity 60% 256 Bone, Opacity 60%
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512 None, Opacity 30% 256 None, Opacity 30%
256 High Smooth, Opacity 60%
• When performing measurements, it is better to drop points on a cross-section of minimal thickness than on a 3D
view. For measuring vessel diameter, the cross-section must be orthogonal to the vessel.
• How to create a cross-section orthogonal to a vessel:
– The wrong way to do it:
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Oblique cross-section
which is not necessarily
orthogonal to the vessel
axis (because in 3D the
vessel is not necessarily
parallel to the plane of
the screen).
MIP or VR image
– A right way to do it:
MIP or VR image
1st Oblique cross- 2nd Oblique cross- Oblique cross-
section parallel to section perpendicu- section orthogonal
the vessel axis lar to the vessel ax- to the vessel axis
is
• Reminder: How to measure a distance in V V

– When in Volume Viewer, there are two ways to measure a distance:
– When "projection (2D)" is selected, points are dropped in a plane and result refers to the distance between
these points in the same plane.
– When "from volume (3D)" is selected, points are dropped in the space along a virtual line. Points are
dropped at the intersection of these virtual lines with any anatomy found. Result refers to the distance
between these 2 points which can be located in different planes.
– The same visual distance between both points can display two completely different results.
- "2D" displays the length of the segment visualized on the image
- "3D" displays the length of the segment drawn in the space. In fact, the 3D segment is going from the small
vessel located on the front of the image to the large vessel located in the background of the image. This
oblique segment is much longer than it seems.
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Recommendation is to use a cross section view to measure a distance.

In case the measurement is performed on a 3D view, using "projection (2D)" will give the exact
length of the segment visualized.
13 How to select an Acquisition Mode

Depending on system configuration, several Record acquisition modes can be available for each protocol listed in
the Protocols.
As previously explained, a Record acquisition can be performed using either the DSA, Dynamic, Chase, Bolus, 3D
or 3DCT mode.
After a protocol was selected in the Protocols, look at the Acquisition Mode tabs located at the top of the Record
Parameter window of the Innova Digital Screen to see which Record acquisition modes are available,
and, using the mouse, click on the Record acquisition mode needed to perform the next acquisition.
All Record parameters are automatically set and the Innova system is ready to acquire using the selected mode.
14 How to review a Sequence/Photo

14-1 Sequence/Photo Viewer
Note: If you have an active patient's exam started (seen by the "Ready" displayed at top right corner of Digital
screen), you can only review the sequences that have been acquired on the current patient.
• Click on the [Patients] tab. This brings the PATIENT BROWSER.
• Select the patient you want to review by clicking on it once.
• Click on the [Exams] tab. This brings the EXAM BROWSER of the patient you have selected.
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Exam Browser
If there is more than one Exam available for the patient, both of them can be reviewed from the Sequence Browser.
To activate this function, highlight the desired exams to review by holding down the Control key and clicking on
them with the mouse.
• Select the exam you want to review and double click on it. This brings up the SEQUENCE BROWSER window
and automatically launches the review of first sequence.
Sequence Browser
• In the SEQUENCE/PHOTO BROWSER window, double click on any sequence/photo that you wish to review.
The Sequence name is displayed on the image in the upper right corner during review
The Review icon is displayed on the left side of the live display as soon as the review is launched to
show that the displayed image in review was previously recorded.
Specific icons , , , are also displayed at the bottom right of the live display to show that the
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displayed image is either a previously recorded or stored fluoroscopic image reviewed in Play or Paused mode
(review in loop or frozen image).
If there are no Sequences acquired at this time, the Browser will be blank. As each Record Sequence is stored to
the digital disk, a new icon will appear with the number of the sequence.
During an exposure, a message will appear "Acquisition in Progress" on the Digital console.
A single click on a Sequence/Photo icon only activates it for other processing. The icon will be highlighted to
indicate that it has been selected. Selection can be for the following:
1. Name - Each Sequence/Photo can be named up to 8 characters. A menu window will open displaying a
predefined list. Adding or deleting from this list is allowed. Sequence naming can be performed during Fluoro or
Record acquisition.
2. Delete - this will delete the Sequence/Photo from the digital disk. It can not be retrieve after the OK for deletion
has been accepted. Multiple sequences/photos can be deleted at a time by holding down the Control key and
clicking on each icon with the mouse. If a Sequence/Photo is deleted from a list, the numbering of the other
ones is not changed.
3. Network - this will start the transfer of the Sequence/Photo to the Network. Multiple sequences/photos can be
networked at a time by holding down the Control key and clicking on each icon with the mouse. Sequence
network can be initiated during Fluoro or Record acquisition.
If the Sequence/Photo icon has a Yellow box around it, this indicates that this is the Sequence/Photo that is
presently being reviewed.
Review of the Sequence/Photo can be accomplished by using the Keypad, Remote control or the Digital console
and mouse. None of these are active during an exposure.
In case of a biplane acquisition, a double line, showing each Frontal and Lateral gantry angulation, will be
displayed in the Sequence/Photo browsers.
In case of frame mismatch due to a frame loss failure during a biplane acquisition, the biplane recorded sequence
will be automatically converted into two single plane sequences, Frontal and Lateral.
Two separate sequence icons will be displayed into the Sequence Browser, one for the Frontal acquisition, the
other one for the Lateral acquisition.
Because these two sequences are issued from the same biplane acquisition, they will have the same sequence
number.
They can be reviewed/processed/networked as single plane sequences.
Note: Because at least one frame is missing on one plane, the acquisition timing is not always kept between these
two sequences. Therefore, the Frontal frame number "N" might show an image acquired at a time different from the
Lateral frame number "N".
Do not use the acquisition timing of such "false" biplane sequence as reference.
In some case of acquisition abort on one plane during a biplane acquisition, the total number of acquired frames
will be smaller on one plane compared to the other. In such case, a unique sequence icon will be displayed in the
Sequence Browser but the biplane review will not be allowed. Frontal and Lateral sequence will have to be
reviewed separately.
Note: Depending on system configuration, only one monitor could be available in control room to review a biplane
sequence or photo. In such case, the Frontal plane will always be selected by default when the review will be
launched.
Plane selection for review is available on the DL Keypad (Items 23/24/25) and DL Remote Control (Item 6).
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DL Keypad plane selection
Remote Control plane selection
Note: Reviewing images at frame rates higher than acquisition frame rates will cause some frames been skipped
during display.
Photo Browser
• In the PHOTO BROWSER window, double click on any photo that you wish to review.
The photo name is displayed on the image in the upper right corner during review.
If there are no Photos stored at this time, the Browser will be blank. As each Photo is stored to the digital disk, a
new icon will appear with the number of the sequence. During an exposure, a message will appear "Acquisition in
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InnovaTM IGS 630
Progress" on the Digital console. A single click on a Photo icon only activates it for other processing. The icon will
be highlighted to indicate that it has been selected. Selection can be for the following:
1. Name - Each Photo can be named up to 8 characters. A menu window will open displaying a predefined list.
Adding or deleting from this list is allowed. Photo naming can be performed during Fluoro or Record acquisition.
2. Delete - this will delete the Photo from the digital disk. It can not be retrieve after the OK for deletion has been
accepted. Multiple Photos can be deleted at a time by holding down the Control key and clicking on each icon
with the mouse. If a Photo is deleted from a list, the numbering of the other ones is not changed.
3. Network - this will start the transfer of the Photo to the Network. Multiple sequences/photos can be networked at
a time by holding down the Control key and clicking on each icon with the mouse. Photo network can be
initiated during Fluoro or Record acquisition.
If the Photo icon has a Yellow box around it, this indicates that this is the Photo that is presently being reviewed.
Review of the Photo can be accomplished by using the Keypad, Remote control or the Digital console and mouse.
None of these are active during an exposure.
15 How to End an Exam

When all Fluoro and Record acquisitions are no longer required, select END EXAM in the upper right corner of the
SEQUENCE BROWSER screen or on Innova Central touch screen.
After this:
1. No exposures can be made.
2. The READY message will disappear.
3. The image graphics on the live and reference display are erased.
4. The image monitor will be blank.
At this time, any patient's images can be viewed on the Digital.
If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting system and DICOM MPPS is
enabled, the End Exam notification is sent to that system using "MPPS Completed" message.
If the Innova system is connected to a Dicom Dose Structured Report Receiving system and some exposures is
taken, the Dose Information will be exported to that system at End Exam.
16 How to Abort an Exam

If DICOM MPPS is enabled in Innova, when a wrong exam is started and need to be aborted, select ABORT EXAM
in the upper right corner of the SEQUENCE BROWSER screen.
After this:
1. No exposures can be made.
2. The READY message will disappear.
3. The image graphics on the live and reference display are erased.
4. The image monitor will be blank.
At this time, any patient's images can be viewed on the Digital.
If the Innova system is connected to a Patient Monitoring/Scheduling/Reporting system, the Abort Exam notification
is also sent to that system using "MPPS Discontinued" message.
If the Innova system is connected to a Dicom Structured Dose Report Receiving system and some exposures is
taken, the Dose Information will be exported to that system at Abort Exam.
17 Stenosis Analysis (Option)

Stenosis Analysis (SA) application allows for an estimation of distances (for instance vessel size at the Stenosis
position) and a Stenosis ratio by a trained user. It can be used to help an experienced physician assess lesion
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lengths.
THE STENOSIS ANALYSIS FUNCTION IS A REFERENCE TOOL ONLY AND IS NOT

INTENDED AS A MEANS OF MAKING A DIAGNOSIS.
While the SA calculations take into account all available information, it should be kept in mind that these results are
provided only as estimates to help the diagnosis, not as reliable measurements. In particular, the results are not
robust to a number of factors including (but not restricted to) the followings:
• Mistake on the effective distance between the object to measure and the table top leading in the entry of an
inaccurate value for the automatic calibration.
• Use of autocalibration on images acquired in full lateral view.
• Mistake on the effective size of the catheter (error in the entry, error on the catheter labeling) or other user
inputs (points clicked).
• Significant error (more than +/- 4 cm) on the location of the artery above the table (in case of autocalibration on
some systems).
• Catheter and vessel not in a same plane parallel to the detector plane.
• Measurement of objects in an axis not parallel to the detector plane.
• Bad positioning of catheter contours when using catheter calibration.
• Bad positioning of vessel edges.
• Conic deformation of X-ray beam when calibrating on or measuring objects not centered in the image.
• Exceptional failures in the positioner geometry measurement system.
• Patient motion during the sequence or between sequences.
• Vessel geometry affected by temporary changes (spasm, over-sizing due to medication…).
Therefore, special care should be taken when using the application in a diagnostic or interventional context -
displayed results should be confronted to other sources of information - including (but not restricted to) personal
assessment of practitioner and visual check - before taking a decision based on the data.
To get analysis results expressed in mm, Stenosis Analysis can be performed using either the autocalibration or
the catheter calibration. In case of use of catheter calibration, the empty catheter and the vessel to analyse must be
present in the same sequence.
The empty catheter must be in the vessel to analyse and at the same level as the lesion to
quantify, else the measurement results displayed will be wrong. See Innova Digital /
Stenosis Analysis (Option)/ Calibrating on a Catheter Diameter.
Note: Before starting acquisition, exit the Stenosis Analysis (SA) application to have access to the display of the
X-ray technique factors on the INNOVA Digital Screen.
17-1 Analysis Limitations
The software will not allow analysis under the following conditions:
• Image type is not the original acquired image (i.e. photos cannot be used to perform an analysis).
• Some functionalities only work in the following conditions:
– Stenosis quantification can be used on Dynamic, subtracted DSA, subtracted Bolus and subtracted 3D
images only (not available on InnovaChaseTM, 3D/3DCT images and Cardiac images acquired using a Field
of View larger than 20 cm).
Multi-segments and Distance Measurement functionalities are always available.
Note: Stenosis quantification and Distance measurement cannot be performed on fluoro image: Fluoro LIH and
fluoro sequence created using the Fluorostore function. In such case, a pop up will be displayed and the
application will fail.
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InnovaTM IGS 630
17-2 Stenosis Analysis at a Glance

Using the Stenosis Analysis application to calculate stenosis size involves the activities summarized below.
• Select Study Image.
• In case of catheter calibration:
Review patient loops and select two image-frame:
– The one that most clearly shows the empty catheter
– The one that most clearly shows the stenosis of interest.
Calibrate System to Catheter Diameter.
Here you tell the system what size of catheter you are using, and then place 2 points within the
catheter to define the section for diameter detection.
The system uses the known catheter diameter to calculate screen pixels per millimeter.
This metric is used later in calculating stenosis size.
• Stenosis Quantification; available for Dynamic, subtracted DSA, subtracted Bolus and subtracted 3D images
only (not available on InnovaChaseTM, 3D/3DCT images and Cardiac images acquired using a Field of View
larger than 20 cm).
Place 2 points or more within the vessel from the proximal to the distal part of the stenosis to define the section
for automatic detection. The system determines the narrowest lesion width compared to the reference diameter,
and then calculates stenosis percentages.
• In case of automatic calibration:
Enter object to table top distance as requested or use default proposed value (15 cm for Cardiac image; 8 cm
for Angio image).
• System calculates stenosis and displays report; available for Dynamic, DSA, Bolus and subtracted 3D modes
only.
You'll be given the option of saving the results electronically. When the report is saved electronically, it's added
in the Photo Browser as a normal photo.
17-3 Performing Stenosis Analysis
• Once need for analysis has been established, select the desired sequence from the SEQUENCE BROWSER
and begin playback.
• Review the images that most clearly show the stenosis of interest (and the catheter if needed).
• Click the Stenosis Analysis button on the SEQUENCE BROWSER to start the analysis.
If the review was launched in single plane mode, either Frontal or Lateral, the Stenosis Analysis application will
start on the selected plane for review.
If the review was launched in biplane mode, the Stenosis Analysis application will start on the Frontal plane.
The Stenosis Analysis button can be selected while in a review or paused mode.
If selected during a review, it will stop and then:
• The Stenosis Analysis icon will appear on the left side of the live display indicating that Stenosis Analysis is
active.
• The selected image and the Stenosis Analysis toolbar will appear on the flat panel.
Note: Any X-ray acquisition will exit the Stenosis Analysis application.
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Stenosis Analysis Button
Stenosis Analysis Window
17-4 Reference Description for Stenosis Analysis Toolbar
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InnovaTM IGS 620,
InnovaTM IGS 630
The functions provided by the Stenosis Analysis Toolbar are:
1 Autocalibration
2 Catheter Calibration
3 Stenosis Quantification
4 Show/Hide Results
5 Hide Contours
6 Show Real Contours
7 Show Real and Ideal Contours
8 Multi Segments
9 Measure Distance
10 Zoom Image
11 Store Photo
12 Exit
17-5 Calibrating on a Catheter Diameter

Calibration measures the pixel size at the vessel plane perpendicular to the X-ray beam by using a catheter as a
calibration device.
The user gives the external diameter of the catheter, which is supplied by the manufacturer (usually in French), and
then indicates a portion of the catheter visible on the image.
The system automatically detects the external diameter of the catheter and computes the calibration factor for this
acquisition and its associated accuracy. The calibration factor is reliable for all objects located at the same plane
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(+/- 1.5 cm) as the catheter and for all the images acquired with the same geometric parameters of the X-ray
system.
The catheter calibration can be performed on cardiac images or non-subtracted digital angiographic images. If in
subtracted mode, the application will switch automatically to non-subtracted mode when clicking on the catheter
calibration button. Automatic catheter detection may not work on subtracted frames.
The imprecision displayed below the calibration factor is the estimated confidence interval around the result
returned by the application (in %).
For example, if you get a calibration factor of 0.1 mm/pixel with an imprecision of 10%, it means that the real factor
is between 0.09 mm/pixel and 0.11 mm/pixel.
17-6 How to achieve an accurate catheter calibration
• Select a frame where the catheter is completely empty: no contrast media and no guide-wire or any kind of tool.
Guide Line:
Always calibrate on a completely empty catheter
Watch the imprecision percentage displayed in the calibration result box: if higher than 20%, select another
frame and redo the calibration in order to get the lowest imprecision as possible.
• Enter the exact size of the catheter used.
The catheter must be at the same distance from the detector than the vessel to be measured.
A difference in distance of 5 cm may cause a 5% error in the vessel dimension. The catheter
must be as close as possible to the vessel to be measured in the image.
Reject those, which do not fit the external edges of the catheter.
• Select a catheter segment long enough (at least 2 cm on the screen) in the straight section of the catheter.
• Examine carefully the traced contours.
• Steps to calibrate a catheter
• Click on the icon for Catheter Calibration (2) on the Stenosis Analysis Toolbar.
The Input the Catheter Size dialog box appears.
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InnovaTM IGS 630
A preloaded 10 lines catheter list is available from the Catheter list.

Default catheter names are between "Standard 3 French and Standard 9 French".
In the Input the Catheter Size dialog box, select one of the existing catheters from the catheter list, and click on the
OK dialog button. To quit the dialog box without any change, click Cancel.
• If you do not find a catheter in the list with the appropriate size, define your own catheter and add it to the
catheter list. Just enter the name of the new catheter in the Catheter Name field, specify the catheter size in
either one of the two Catheter Size fields, and click on the Save Catheter dialog button. The minimum and the
maximum value that can be saved for a catheter is 3 F (1 mm) and 9F (3 mm), respectively. Both size fields are
synchronized.
• It is also possible to use a catheter size without saving it. Enter the catheter size into the Catheter Size box and
click OK.
• To delete a catheter from the list, select the intended catheter in the Catheter list and click on the Delete
Catheter dialog button.
• To sort the catheter list by catheter name or catheter size in ascending or descending order, click on one of the
dialog box located on top of the list, either Catheter Name or Size.
Note: To get the mm measurement of a catheter, divide the catheter French size by 3. Example: a 6 F catheter
divided by 3 = 2 mm.
Note: The catheter list is sorted by catheter size from the smallest (3 F) to the largest (9 F).
In all cases, you should ensure that the calibration was performed using the appropriate catheter size by checking
the Object Size displayed in the calibration result box at anytime a sequence is calibrated
Stenosis Analysis application shall only be used with catheter between 3 and 9 French (1-3
mm). Also, depending of the manufacturer, the given product catheter size may not be
accurate, else the measurement results displayed will be wrong. In such case, you may
possibly want to customize your catheter sizes. In all cases, it is recommended to check the
displayed catheter size before accepting the calibration results.
• Place two points within the catheter, as close as possible to the end but not on a curve, to define the section for
diameter detection.
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• The system automatically finds and displays the catheter edges. The "Confirm the catheter detection" message
appears.
BEFORE ACCEPTING ANY CALIBRATION BY CLICKING ON OK, IN THE "CALIBRATION

RESULTS" POP-UP WINDOW, ALWAYS DOUBLE-CHECK CATHETER SIZE DISPLAYED IN
THE "CALIBRATION RESULT" GREY BOX, ON THE DL SCREEN.
THE AUTOMATIC EDGE DETECTION PROGRAM WILL SHOW THE DETECTED BORDER OF
THE CATHETER. YOU SHALL CHECK THAT THE EDGES BEING DISPLAYED ARE
MATCHING THE CATHETER BORDER BEFORE ACCEPTING THE CALIBRATION RESULTS.
IF THE MATCHING IS NOT ACCURATE, PLEASE CANCEL AND RESTART A NEW
CALIBRATION.
17-7 Stenosis Quantification (available for Dynamic, subtracted DSA, Bolus and
The basic principles of this functionality are the automatic detection of the vessel edges in a selected portion of the
artery, then the quantitative measurement of the vessel length and diameters along the selected segment.
The application is able to quantify vessels up to 5 mm on Cardiac images acquired on Dynamic mode with FOV
less than or equal to 20 cm and vessels up to 50 mm on subtracted DSA, Bolus and subtracted 3D images.
The contrast media used to differentiate the vessels from the patient background must be radio-opaque (iodine) so
that vessels appear as dark structures with respect to the background. Quantification is not applicable on
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InnovaTM IGS 630
radio-transparent opacification (CO2).

The user has the option of placing only two points to start the automatic detection. For a tortuous vessel or one that
is very close to another one, more points will increase the precision on the stenosis vessel path.
• Pick the image that best shows the area of interest.
The user shall select the frame containing the vessel to be quantified before clicking on the Stenosis Analysis
button in the SA toolbar.
• From the Stenosis Analysis Toolbar, click on the Stenosis Quantification button (3).
Guidelines appear in the dialog area, left of the screen:
• Place two or more points within the vessel from the proximal to the distal part of the stenosis to define the
section for automatic detection. Double click the last point to start the calculation and get the results. To move a
point, drag it with left mouse button. To delete a selected point, press the Delete key.
Note: The ability to accurately measure a vessel can be hindered by:
• The presence of a stent or guiding catheter in the vessel.
• A calibration or quantification performed on edge or corner of the image (conic deformation of X-ray) can
degrade the accuracy by up to 7.5%.
17-7-1 In case of Auto-calibration
• If the image is not calibrated, the Auto-calibration dialog box opens asking you to enter the "object to table top
distance".
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The goal of auto-calibration is to allow the software to compute the pixel size in a given image without using any
kind of reference object. Auto-calibration is entirely based on the known geometry of the imaging system. The
only parameter that the user has to specify is the Object to Tabletop distance defined as being the shortest
distance between the center of the object to be measured and the top of the table.
As opposed to catheter calibration, auto-calibration is available only after a region of interest has been defined
in the image. It means that auto-calibration can be launched only after vessel contours or segments are drawn
in the image.
Calibration results are automatically saved at the sequence level. If you launch the application on a previously
calibrated sequence, the calibration information will also be loaded as well as the sequence itself.
Enter the object (vessel) to table top distance or use the default value (15 cm for Cardiac image; 8 cm for Angio
image), then click OK to get results in metric units.
THE OBJECT (VESSEL) TO TABLE TOP DISTANCE IS DEFINED FROM THE TOP OF THE
TABLE TOP AND NOT FROM THE TOP OF THE MATTRESS. IF THE DISTANCE ENTERED
DIFFERS FROM THE ACTUAL DISTANCE, THE RESULTING MEASUREMENTS WILL BE
INACCURATE OF ABOUT 1% PER CENTIMETER OF DIFFERENCE.
In case a new auto-calibration is needed, after points were dropped, it is always possible to launch it manually
pressing on the Auto-calibration icon (1) on the Stenosis Analysis toolbar.
Upon completion of auto-calibration, Stenosis Analysis report is displayed with the computed results.
Notes: To accurately measure a vessel, note the followings:
• Input the correct distance the anatomy is from the table top.
• The greater the gantry angulation towards a lateral position, the higher the imprecision result will be. Avoid
using Auto-calibration for lateral images; use catheter calibration instead.
• Always take into account the imprecision displayed with each measurement.
17-7-2 In case of Catheter Calibration
IN CASE OF USE OF CATHETER CALIBRATION, THE QUANTIFICATION MEASUREMENTS

SHALL ONLY BE TAKEN INTO ACCOUNT WHEN THE CATHETER USED FOR CALIBRATION
AND THE QUANTIFIED VESSEL ARE IN THE SAME PLANE, PLANE THAT SHALL BE
PARALLEL TO THE FLAT PANEL DETECTOR. ANY OTHER CASES WILL LEAD TO
UNDERESTIMATED IMPRECISION.
Note: The ability to accurately measure a vessel can be hindered by a table panning between frame used for
catheter calibration and frame used for quantification (increase the risk of catheter and vessel not in the same
plane).
Situations such as described above will result in additional inaccuracy that will not be taken into account by the
algorithm. So, the percentage of imprecision linked to results will be underestimated and will not reflect reality.
17-8 Stenosis Quantification Results (available for Dynamic, subtracted DSA, Bolus and
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InnovaTM IGS 620,
InnovaTM IGS 630
Stenosis Quantification Results Box
Vessel Profile Box
The Results Box displays results of stenosis quantification and their imprecision.
The imprecision displayed after each measurement is the estimated confidence interval around the result returned
by the application (in mm).
For example, if you get a Reference Diameter of 2 mm ± 0.2 mm, it means that the real reference diameter is
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between 1.8 mm and 2.2 mm.

The Vessel Profile Box shows the detected vessel diameters in mm versus the distance in mm along the vessel
path from the beginning of the vessel portion. The profile corresponds to the vessel portion between the first and
the last point entered by the user.
Once the calculation is finished and the results are displayed, you have several options on how to modify the
results. In the Profile box, click and drag on any line to modify the placement. The edge detection of the vessel will
be drawn in yellow. It will fill in where the vessel is over or under sized.
STENOSIS ANALYSIS SHALL NEVER BE TAKEN AS LITERAL PROOF, BUT SHALL BE

DOUBLE CHECKED BY THE PHYSICIAN. STENOSIS ANALYSIS IS A REFERENCE TOOL
ONLY AND IS NOT INTENDED AS A MEANS OF MAKING A DIAGNOSIS.
• Decide if the Reference segment is placed in the best area to represent the normal vessel size. If not, from the
vessel profile, grabbing the black dot, move the segment to the desired area. Do the same with the stenosed
segment representing the tightest lesion narrowing.
• Move the same way the lesion length segments (proximal and distal) to best represent the area of interest.
• Other modifications can be done to the drawing using the Stenosis Analysis Toolbar.
• Show/Hide Results (4) will remove and redisplay the Result and Profile windows.
• Hide Contours (5) will remove the vessel drawing temporarily. By clicking on icon (6) or (7), the drawing will be
returned.
• Show Real Contours (6) displays only the stenosis contours and will redisplay the vessel drawing if removed
with Hide Contours.
• Show Real and Ideal Contours (7) displays the stenosis contours and the plaque area and will redisplay the
vessel drawing if removed with Hide Contours.
Note: Hide and show the contours to visually verify the adequation between the edges detected and the actual
vessel shape.
• To edit stenosis contour, right-click on any part of the contour. A line of seven crosses will appear on the edited
contour area. Grab and move any points within this area to modify the contour. Double click with left button to
confirm your modification. Each side of the stenosis can be edited separately.
• Zoom Image (10) will enlarge the image to double size in both directions. Click on it again to go back to the
normal display.
• Store Photo (11) will save the SA results as a photo image in the Photo Browser. You will be asked to select
whether this is a Pre- or Post- Interventional frame, and you might indicate the concerned region of interest,
which will be displayed at the bottom of the taken photo.
• Exit (12) will close the Stenosis Analysis window. No Stenosis Quantification results will be saved except by
using the Store Photo function.
17-9 Measure Distance
Distance Measurement is used to obtain up to 7 length only between two points and their ratio.
Click on the Measure Distance button (9) to activate the function.
Measuring a length:
• Position the cursor at the beginning for the first point and click. Move the mouse and draw the line to the second
point and click. A length will be displayed.
• A maximum of 7 lengths can be displayed with their ratio relative to the first length measured taken as
reference.
Note: The objects to measure may not be in a plane perpendicular to the X-ray beam. Then, foreshortening in the
length measurement may happen. The software is not able to detect or correct foreshortening. It is the user
responsibility to interpret the results of the Distance Measurement function.
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InnovaTM IGS 620,
InnovaTM IGS 630
WHEN DRAWING A SEGMENT ON AN UNZOOMED FRAME, THE USER SHALL ENSURE HE

DOESN'T MAKE AN ERROR OF MORE THAN 1 PIXEL FOR EACH POINT DEFINED.
The imprecision being displayed for each segment take into account a 1 pixel error for each click, no more. Also,
when the distance is displayed in pixels, it is always displayed based on the non-zoomed image, even if zoomed.
Note: The Ratio between the segments is computed without taking into account the imprecision link to calibration
or user error when clicking points. If the user error is at max 1 pixel for each segment, Ratio imprecision is less than
10.5% starting with 20 pixels segments. User shall be very careful with Ratio results taking into account smaller
segments.
17-10 Multi Segments
Clicking on the Multi Segments Icon (8) will allow to drop more than 2 points and to display the total length between
the first and last point.
ENSURE THAT THE MEASURED OBJECT IS IN THE SAME PLANE AS THE CATHETER,
PARALLEL TO THE DETECTOR AND TAKE INTO ACCOUNT THE IMPRECISION FOUND
AROUND THE CALIBRATION FACTOR.
Note: Only one Multi-segments can be displayed at a time.
17-11 Innova OneTouchQA (option available on the optional Innova Central touch
screen)
Using the Review Tab of the Innova Central touch screen located at table side, it is also possible to launch the
Stenosis Analysis application.
From the Review tab, select Stenosis Analysis (SA) to enter the application.
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The most useful functions are available to quantify a vessel or measure a distance.
Note: Only Autocalibration is available at table side. In case of catheter calibration required, perform the calibration
from the control room console.
Launch the transfer of the image displayed on the live display in the Innova Central touch screen.
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InnovaTM IGS 620,
InnovaTM IGS 630
After the completion of the transfer, the central part of the image appears on the Innova Central touch screen.
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And the displayed Region Of Interest (ROI) is visualized on the live display.
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InnovaTM IGS 620,
InnovaTM IGS 630
Use the Innova Central touch screen joystick to roam the image:
• Tilt the joystick left/right to see further left/right (the viewport moves left/right, the image moves toward right/left).
• Tilt the joystick up/down to see further up/down (the viewport moves up/down, the image moves down/up).
The location of the ROI visualized on the live display always matches the image displayed on the Innova Central
touch screen.
Use the Zoom/Roam functions to better visualize and center the part of vessel to quantify.
The Zoom button on the Innova Central touch screen switches zoom state on both images, Innova Central touch
screen and live display.
Drop points apart of the stenosis to quantify from proximal to distal by just touching the vessel (at least 2 points
must be dropped).
All dropped points can be deleted by using the Delete All Points button.
One single point can be selected by just touching it, moved by just dragging it or deleted by pressing on the Delete
Selected Point button.
After all points are dropped, press on the OK button to launch the quantification.
After completion of the quantification, results are displayed on the live display.
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InnovaTM IGS 620,
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The image can be zoomed using the Zoom button and roamed using the Innova Central touch screen joystick.
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InnovaTM IGS 620,
InnovaTM IGS 630
The Calibration Result window can be hidden by pressing on the Show/Hide calibration button.
Note: The Stenosis Quantification Results and Vessel Profile windows cannot be hidden.
Vessel diameters along the vessel can be moved by using the Move Diameter button.
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Select the diameter which needs to be moved by selecting either "Reference", "At Stenosis", "Lesion Start" or
"Lesion End".
The selected diameter is highlighted on the live display. Tilt the Innova Central touch screen joystick right/left to
move the selected diameter. When the optimum position is found, select another diameter or press the Move
Diameter button again to end diameter movement.
As for Stenosis Quantification, launch the transfer of the image displayed on the live display in the
Innova Central touch screen.

After the completion of the transfer, the central part of the image appears on the Innova Central touch screen.
If needed, zoom and roam the same way as for Stenosis Quantification by using the Innova Central touch screen
joystick.
Drop points (at least two) by touching the image displayed on the Innova Central touch screen. All points or
selected point can always be deleted.
Select a point by touching it and drag it in the image to move it.
Press the OK button to end the drawing.
If needed, select one of the preloaded Object to table top distance from the pull down list.
Select the Contours key and then one of the predefined displays from the pull down list. This
function is only available after a Stenosis Quantification has been performed.
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InnovaTM IGS 620,
InnovaTM IGS 630
When possible, allows to toggle between Sub and NoSub image display.
When available, allows to display or not the calibration result window.
During a vessel quantification, allows to move the "Reference" or "At Stenosis" or "Lesion Start" or
"Lesion End" vessel diameter.

Allows to zoom/unzoom images displayed on the Innova Central touch screen and live display.
During stenosis quantification, the image displayed on the Touch Screen can be roamed by using the Innova
Central touch screen joystick.
After In-room Stenosis Analysis is launched, it is always possible to launch the review of the selected sequence or
of another one from the control room console. In such case, the pop up below is displayed:
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InnovaTM IGS 620,
InnovaTM IGS 630
Click on "Cancel" to continue the in-room Stenosis Analysis application.

Click on "Exit" to exit from the in-room Stenosis Analysis application. Double click again on the sequence to review
in the Sequence Browser to launch the review.
While In-room Stenosis Analysis is on going, it is also possible to continue the analysis from the control room. Click
the "Stenosis Analysis" button on the Control room. The pop up below is displayed:
Click on "Cancel" to continue the in-room Stenosis Analysis application.

Click on "Exit" to exit from the in-room Stenosis Analysis application.
Click on "Switch" to switch the Stenosis Analysis application on the Control room console to continue the analysis.
18 Ventricular Analysis (Option)

Ventricular Analysis (VA) is an application designed for analyzing and quantifying the left ventricle (LV). The user
can perform two types of quantification: Global Ejection Fraction (GEF) analysis and Wall Motion (WM) analysis.
The output of the Global Ejection Fraction quantification provides the user with information on left ventricle volumes
and the ejection fraction. This set of information gives the user a good idea about how well the entire left ventricle is
functioning.
From the results of Wall Motion analysis, the user can estimate the adequacy of blood supply to each distinct
region of the left ventricle.
In addition to these two major functions, a "Multi-segments" feature allows to draw a multi-segment line to estimate
segments lengths.
VENTRICULAR ANALYSIS IS ONLY AN ESTIMATION TOOL, AND IS NOT INTENDED AS A

MEANS OF MAKING A DIAGNOSIS.
Note: Ventricular quantification and Distance measurement cannot be performed on a fluoro image such as Fluoro
LIH or a fluoro sequence created using the Fluorostore function. A message will be displayed and the application
will fail.
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InnovaTM IGS 620,
InnovaTM IGS 630
Note: Before starting acquisition, exit the Ventricular Analysis (VA) application to have access to the display of the
X-ray technique factors on the INNOVA Digital Screen.
Contrast media
For ventricular analysis to be successful, the contrast media injected in the left ventricle should have enough
volume to fill the entire ventricle during multiple cardiac cycles and to visualize the end diastolic and end systolic
phases of the cycles.
Quantification
Based on the end-diastolic and end-systolic contour of the left ventricle defined manually by the user, Ventricular
Analysis provides a means to perform Wall Motion (WM) and Global Ejection Fraction (GEF) calculations. Wall
Motion analysis is built upon the Sheehan's centerline method. Global Ejection Fraction analysis provides results
calculated with both the Simpson's rule method and the Dodge-Sandler Area-Length method.
18-1 Ventricular Analysis at a glance
Using the Ventricular Analysis application involves the five activities summarized below.
1. Select study image.
Review patient LV-gram.
2. Launch Ventricular Analysis application.
The VA application can be launched while in review or paused.
3. Select two frames and manually draw LV contour:
The one that most clearly shows the end of Diastolic contour.
The one that most clearly shows the end of Systolic contour.
4. Generate the Global Ejection Fraction and Wall Motion report.
On application request, enter the object to tabletop distance (or use default value) to perform the automatic
calibration. The distance entered shall be determined from the center of the measured object to the top plane of
the table without mattress.
5. Save the GEF and WM report.
When the report is saved, it is added in the Photo Browser as a standard photo.
18-2 Performing Ventricular Analysis
1. Once need for analysis has been established, select the desired sequence from the SEQUENCE BROWSER
and begin playback.
2. Review the images that most clearly show the end of Diastolic and end of Systolic contours.
3. Click the Ventricular Analysis button on the SEQUENCE BROWSER to start the analysis.
If the review was launched in single plane mode, either Frontal or Lateral, the Ventricular Analysis application
will start on the selected plane for review.
If the review was launched in biplane mode, the Ventricular Analysis application will start on the Frontal plane.
The Ventricular Analysis button can be selected while in a review or paused mode.
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InnovaTM IGS 620,
InnovaTM IGS 630
If selected during a review, it will stop and then:

• The Ventricular Analysis icon will appear on the left side of the live display indicating that Ventricular Analysis is
active.
• The selected image and the Ventricular Analysis toolbar will appear on the flat panel.
Note: Any X-ray acquisition will exit the Ventricular Analysis application.
18-3 Reference description for Ventricular Analysis Tool Menu
The functions provided by the Ventricular Analysis tool menu are:
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InnovaTM IGS 620,
InnovaTM IGS 630
1 Auto-calibration select to manually launch a new autocalibration

2 Draw Diastole select to start to draw End-Diastolic Contour
3 Delete Diastole select to delete the Diastolic contour
4 Draw Systole select to start to draw End-Systolic Contour
5 Delete Systole select to delete the Systolic contour
6 Show/Hide contours select to show/hide graphics/reports already performed on the image
7 Generate GEF report select to launch the Global Ejection Fraction report
8 Generate WM report select to launch the Wall Motion report
9 Multi-segments select to draw a multi-segment line and get length measurements
10 Store photo select to save the image/graphic/report as a standard photo
11 Exit select to exit from the Ventricular Analysis application
18-4 Draw Diastolic Contour

Using the Play/Pause and/or Next/Previous Frame keys and/or Shuttle Knob, select the frame which most clearly
shows the end of Diastolic contour.
Click on the icon Draw Diastole (2) on the Ventricular Analysis tool menu.
Following the instructions in the hint window, enter the points of the diastolic contour by clicking with the left mouse
button. The LV diastolic contour shall contain at least 3 points.
Each point entered is represented by a yellow cross.
The application builds up the LV diastolic contour by connecting the user-specified LV edge points using a bicubic
spline interpolation. The diastolic contour is represented by a red curve.
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To edit a point already entered, move over the point, click on it, and drag it to the correct position with the left
mouse button kept pressed.
To insert a new point in the contour, click on the contour with the left mouse button.
To delete a selected point, press the Delete key on the keyboard.
If you do not get an acceptable curve using the editing functions, the Delete Diastole (3) allows you to
easily delete and redraw the curve.

During the modifications, the contour is updated real-time in the screen.
To end the drawing, double-click the last point or any point of the contour, or click on the Draw Diastole button. The
contour becomes thinner (Draw Diastole button OFF).
To insert a new point to the contour, click on it with the left mouse button. The contour becomes active again (Draw
Diastole button ON).
To modify the location of any point after finishing the curve, click on the point with the left mouse button, and drag it
to the right place. The contour becomes active again (Draw Diastole ON).
When you finish with the modifications, press Draw Diastole again (OFF).
The LV contour is automatically saved at the sequence level. It means that if you already drew a contour in the
past, then launching Ventricular Analysis again later on that same sequence will display the frame selected in the
viewer with the LV contour drawn on it.
It is possible to change the frame during the diastolic contour edition. The diastolic frame will be the one on which
the contour edition is finished.
18-5 Draw Systolic Contour
As for the Diastolic contour, using the Play/Pause and/or Next/Previous Frame keys and/or Shuttle Knob, select the
frame which most clearly shows the end of Systolic contour.
Note: The Systolic frame must be selected in the same heart cycle as the Diastolic frame to preserve the best
result accuracy.
Click on the icon Draw Systole (4) on the Ventricular Analysis tool menu.
Follow the same process to draw/edit/delete the Systolic contour.

The Systolic contour is represented by a blue curve.
After the Systolic contour is ended by double clicking on it or clicking again on the Draw Systole button, both
Diastolic and Systolic contours connected with the 100 equidistant chords are displayed.
Click on Show/Hide contours (6) to display or not the Diastolic and/or Systolic contour.
It is possible to change the frame during the systolic contour edition. The systolic frame will be the one on which the
contour edition is finished.
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InnovaTM IGS 620,
InnovaTM IGS 630
18-6 Global Ejection Fraction Analysis

The GEF analysis uses two different methods for estimating Left Ventricular (LV) volumes: the Simpson's Rule and
the Dodge-Sandler Area-Length Method. Both methods aim at modeling the left ventricle in 3D, based on the
accurate determination of the LV border on the diastolic and the systolic frame. Both methods also require the
determination of the long axis of the LV.
Ventricular Analysis uses linear correction formulas with coefficients varying between X-ray systems so as to
counterweight the errors exhibited by the mathematical models during the 3D modeling process.
Note: These two methods are validated for LV acquired in RAO 30° angulation. So, if the sequence was not
acquired in RAO 30° +/- 10°, or with a CRA or CAU angulation greater than 10°, or with more than 5° difference
between the end of Diastolic and end of Systolic frame, a warning message about the loss of result accuracy will be
displayed.
Simpson's Rule Method
Simpson's Rule is based on the idea that the volume of an object can be determined by "cutting" the object into thin
"slices", measuring the volume of each slice and summing the volumes of all slices. Simpson's Rule is applied to
the left ventricle by slicing it into "discs" along the long axis, as shown in the illustration below. The area of each
disc is calculated and multiplied by the disc's thickness to determine its volume.
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Dodge's method
The left ventricle is approximated by a prolate ellipsoid with its long axis in the 30° RAO projection. The calculation
of the volume of a prolate ellipsoid only requires knowledge of the length of the longest axis and the area of the
ellipse. The axis of revolution length is the long axis of the LV. The computation of the ellipse area is based on the
mechanical tracing of the LV projection border.
After both end of Diastolic and Systolic contours are drawn, click on Generate GEF report (7) on the
Ventricular Analysis tool menu.

If needed, the Auto-calibration dialog box opens asking you to enter the "object to table top distance".
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InnovaTM IGS 620,
InnovaTM IGS 630
The goal of auto-calibration is to allow the software to compute the pixel size in a given image without using any
kind of reference object. Auto-calibration is entirely based on the known geometry of the imaging system. The only
parameter that the user has to specify is the Object to Tabletop distance defined as being the shortest distance
between the center of the object to be measured and the top of the table.
As opposed to catheter calibration, auto-calibration is available only after a region of interest has been defined in
the image. It means that auto-calibration can be launched only after LV contours or segments are drawn in the
image.
Calibration results are automatically saved at the sequence level. If you launch the application on a previously
calibrated sequence, the calibration information will also be loaded as well as the sequence itself.
Enter the object (heart) to table top distance or use the 15 cm default value, then click OK to get results in metric
units.
THE OBJECT (HEART) TO TABLE TOP DISTANCE IS DEFINED FROM THE TOP OF THE
TABLE TOP AND NOT FROM THE TOP OF THE MATTRESS. IF THE DISTANCE ENTERED
DIFFERS FROM THE ACTUAL DISTANCE, THE RESULTING VOLUMES WILL BE
INACCURATE OF ABOUT 3% PER CENTIMETER OF DIFFERENCE.
In case a new auto-calibration is needed, it is always possible to launch it manually pressing on the Auto-calibration
icon (1) on the Ventricular Analysis toolbar.
Upon completion of auto-calibration, centerline computation and GEF quantification, the GEF report is displayed
with the computed results.
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InnovaTM IGS 620,
InnovaTM IGS 630
The GEF analysis results report includes the report header, patient and exam information, the Diastolic and
Systolic image, and the results table.
The results table provides the end diastolic, end systolic and stroke volumes of the left ventricle computed in two
ways (Dodge's method and Simpson's method). These volumes are provided in both ml and ml/m² (normalized by
the body surface area. Patient weight and height must be entered). Also, the table contains the Global Ejection
Fraction value expressed in %.
If the sequence has not been calibrated for Ventricular Analysis, then the resulting units of ml or ml/ m² are not
displayed. In this case, only percentage values appear.
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InnovaTM IGS 620,
InnovaTM IGS 630
The volumes displayed are calculated from the following equation:

Vcorrected = A * Vmeasured + B
The Vmeasured is the volume in ml resulting directly from the Dodge's and Simpson's methods. Because these
methods overestimate the actual left ventricle volumes, the coefficients A (slope) and B (intercept) are applied to
obtain the actual volume Vcorrected in ml, which is the volume displayed in the Results table.
The Global Ejection Fraction (GEF) is calculated as the ratio of the End diastolic and End systolic volumes.
IF THE SEQUENCE HAS NOT BEEN CALIBRATED FOR VENTRICULAR ANALYSIS, THIS
CORRECTION IS NOT APPLIED, WHICH LEADS TO A LESS ACCURATE VALUE OF THE
GEF.
If you hide the GEF report by pressing again the Generate GEF report button, you will see both Systolic and
Diastolic contours in the image connected with the 100 equidistant chords.
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InnovaTM IGS 620,
InnovaTM IGS 630
In case you are not satisfied by results delivered in the GEF report:
1. Hide the current GEF report by pressing again the Generate GEF report button.
2. Modify the position of the existing points on the Diastolic or Systolic contour, add new points, or delete the
contours and draw new ones.
3. Press the Generate GEF Report button. (If requested, perform auto-calibration.)
The new GEF report appears in the screen.
Before exiting the GEF report, click on Store Photo (10) to save the report in the Photo Browser as a
standard photo.
18-7 Wall Motion Analysis
Wall Motion Analysis analyzes the wall motion dynamics of the left ventricle using the Sheehan's centerline
method. This method computes the lengths and locations of 100 chords equally spaced between the user-defined
heart contours.
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InnovaTM IGS 620,
InnovaTM IGS 630
According to the Sheehan's centerline method, each chord is drawn perpendicular to the centerline which is
constructed midway between the End- Diastolic (ED) and the End-Systolic (ES) contour. The length of the chord
represents the wall motion at a given location of the ventricle contour. The value will be negative if, at a given point
of the contour, the ES contour is located outside the ED contour.
Since the heart size varies from patient to patient, the absolute extent of motion will vary even in normal hearts of
different size. To normalize for heart size, each chord length is divided by the length of the ED perimeter. The
normalized chord data can then be standardized.
This is done by subtracting from each chord the average of a group of normal patients (called the normal mean),
and dividing the result by the standard deviation from the normal mean for that chord.
Note: This method is validated for LV acquired in RAO 30° or LAO 60° angulations. So, if the sequence was not
acquired in RAO 30° +/- 10° or LAO 60° +/- 10°, or with a CRA or CAU angulation greater than 10°, or with more
than 5° difference between the end of Diastolic and end of Systolic frame, a warning message about the loss of
result accuracy will be displayed.
After both end of Diastolic and Systolic contours are drawn, click on Generate Wall Motion report (8) on
the Ventricular Analysis tool menu.

If needed, the Auto-calibration dialog box opens asking you to enter the "object to table top distance" (refer to GEF
analysis for Auto-calibration procedure).
Upon completion of auto-calibration, centerline computation and Wall Motion quantification, the Wall Motion report
is displayed with the computed results.
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InnovaTM IGS 620,
InnovaTM IGS 630
The Wall Motion analysis report includes a report header, patient and exam information, a heart graph, a standard
deviation graph, and a results table.
The Heart graph field (top right of the WM report) contains the Systolic and Diastolic contours previously drawn by
the user, together with the corresponding RAO/LAO values. Also, the 100 chords representing the current wall
motion of the left ventricle are displayed (current patient chords).
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InnovaTM IGS 620,
InnovaTM IGS 630
To gather precise and relevant information on hypokinesia and hyperkinesia in different ROIs, study the Standard
deviation graph and the Results table.
The standard deviation graph (bottom left of the WM report) shows the normalized wall motion as a function of
chord number, based on Wall Motion computation.
In the case of hypokinesia, the normalized wall motion is a negative value. For hyperkinesia, the normalized wall
motion is positive.
Left ventricle with normalized motion between -2 and +2 can be considered as normal.
The Results table field (bottom right of the WM report) contains a table with the results of Wall Motion Regional
analysis.
The results provide information about the impact on the wall motion of the three main coronary arteries (LAD, RCA,
and CFX) affected with single or multiple diseases. Also, the chord interval is specified for each vessel ROI in the
'Chord #' column. The chord interval associated with a main coronary territory is different in the case of RAO 30°
+/- 10° and LAO 60° +/- 10° acquisition. The table below shows the chord intervals for each ROI in both cases.
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InnovaTM IGS 630
CHORD INTERVALS ASSOCIATED WITH DIFFERENT CORONARY TERRITORIES
Region of Interest (ROI) Chord interval for RAO 30° Chord interval for LAO 60°
CFX single 10 - 80 19 - 67
CFX multiple 10 - 80 19 - 67
LAD single 10 - 66 50 - 67
LAD multiple 10 - 58 50 - 67
RCA single 51 - 80 38 - 74
RCA multiple 59 - 80 38 - 74
The 'Hypokin. SD' column displays the average of hypokinesia severity in standard deviation unit in a certain ROI. If
the average of the hypokinesia value is lower than -2, then it is displayed in bold. Negative values in this column
refer to hypokinesia. Wall motion is considered normal, if it is between -2 and +2.
For each ROI, the '% Total LV contour' column displays what percentage of the entire length of the left ventricle
contour can be characterized with hypokinesia outside the [-2;+2] range.
For each ROI, the 'Hyperkin. op. ROI SD' column displays the possible hyperkinesia compensation in the opposite
ROI. It corresponds to a significant hyperkinesia if it is positive and outside the range [-2; +2].
If you hide the WM report by pressing again on the Generate WM report button, you will see both Systolic and
Diastolic contours in the image connected with the 100 equidistant chords.
In case you are not satisfied by results delivered in the WM report:
1. Hide the current WM report by pressing again the Generate WM report button.
2. Modify the position of the existing points on the Diastolic or Systolic contour, add new points, or delete the
contours and draw new ones.
3. Press the Generate WM Report button. (If requested, perform auto-calibration.)
The new WM report appears in the screen.
Before exiting the WM report, click on Store Photo (10) to save the report in the Photo Browser as a
standard photo.
18-8 Multi Segments
Click on the icon Multi-segments (9) on the Ventricular Analysis tool menu to draw a link made of multiple
segments (multi-segments) on a single frame of a sequence, and to estimate the length of the segments.
Note: Only one Multi-segments can be displayed at a time.
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InnovaTM IGS 620,
InnovaTM IGS 630
Following the instructions in the Hint window, enter the points of the multi-segment by clicking with the left mouse
button.
Before you place the first point, you can perform frame navigation using the Play/Pause or Next/Previous Frame
keys or Shuttle Knob functions.
The adjacent points of the multi-segments can be as close as you want from each other. However, remember that
the smaller the distance between the points is, the higher the imprecision will be.
While creating the multi-segments, you can edit any of the points already entered. Move over a point, the pointer
will change to a crosshair cursor, and then click and drag with the left mouse button to the intended position.
Also, you can insert points between two points already entered. Move over the intended position on the segment
line (the pointer will change to a crosshair cursor), and click with the left mouse button.
Double-click the last or any existing point to indicate that the multi-segment is finished.
To draw a new multi-segment on the selected frame, repeat the above procedure.
Before exiting, click on Store Photo (10) to save the image with measurements in the Photo Browser as a
standard photo.
After all analysis are performed and all images/graphics/reports saved, click on the Exit icon
(11) to exit the Ventricular Analysis application.
19 StentViz (Option)
The StentViz application is designed to enhance the visibility of a stent placed during an interventional Cardiac
procedure. Additionally, StentViz may help the cardiologist assess the correct deployment of the stent in the vessel.
If a stent was already placed, it may also be used to verify the positioning of a new balloon before the deployment
of the second adjacent stent, or before re-dilatation of the stent.
The result is shown on the static image below detailing the enhanced image image quality and contrast of the stent.
There are two StentViz images displayed on the reference display. One where the full guidewire is displayed and a
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InnovaTM IGS 620,
InnovaTM IGS 630
second where the portion of the guidewire between the balloon marker-balls has been subtracted. The subtracted
guidewire is intended to ease the visualization of the stent.
There are four different displays the image will be divided depending on the original direction the vessel was
imaged.
Note: This application is restricted to heart anatomy only and can be launched only on images acquired using the
automatic StentViz workflow described below.
The success of the StentViz application might be altered by the poor quality of the images (high noise level…), the
type of balloon used (low marker radio-opacity), the radio-opacity of the guidewire, and or high radio-opacity
structures in the vicinity of the markers.
Note: The StentViz resulting photo is a recomputed image. Always associate it with the original recorded sequence
for interpretation.
19-1 Automatic StentViz Workflow
To launch the StentViz application acquisition to image a deployed stent the following is required:
1. Deflate the balloon and leave it in position inside the stent. StentViz will detect and focus on both markers of the
balloon and on the guidewire to perform the image processing.
2. A cardiac related protocol needs to be selected. On DL console or on the Innova Central touch screen (option),
select Dynamic and then StentViz to launch the application. An icon will be displayed on Live monitor to indicate
the StentViz acquisition mode is set for the next single dynamic acquisition.
The message “READY FOR STENT VIZ” is displayed at the bottom left of the Live monitor in the Status area.
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InnovaTM IGS 620,
InnovaTM IGS 630
DL record acquisition console
Innova Central touch screen Record Tab
StentViz acquisition mode icon
3. Perform a short Record acquisition centered on the display stent and deflated balloon. A "Stop X-Ray" blinking
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InnovaTM IGS 620,
InnovaTM IGS 630
message will be displayed on the Live monitor when enough frames are acquired. You can release the pedal at
this stage.
The acquired sequence is stored in the DL Sequence browser with a specific default "Pre-StentViz" label.
"Pre-StentViz" sequence displayed on Live monitor
4. At the end of acquisition, StentViz processing is automatically launched. The message "STENT VIZ IN
PROGRESS" is displayed at the bottom left of the Live monitor in the Status area. The typical processing time is
less than 10 seconds. Because image processing is performed in the background, fluoro, record, review and
image processing are always available.
5. At the end of StentViz processing time, the message "STENT VIZ IN PROGRESS" is replaced by "STENT VIZ
PHOTO READY" at the bottom left of the Live monitor and the resulting image is automatically displayed on the
reference display as a photo showing the stent with enhanced image quality and contrast. As for other photos,
this photo is stored in the DL Photo browser with a specific default "StentViz" label.
StentViz photo displayed on Reference monitor
Note: In case of biplane sequence, the automatic StentViz workflow is launched on frontal sequence only. The
lateral sequence is to be processed manually.
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InnovaTM IGS 620,
InnovaTM IGS 630
Note: In case of fluoro or record acquisition, or image review in progress at the completion of the StentViz
processing, the resulting photo is displayed only at the end of the fluoro or when the review switches to Pause
mode.
Note: The next Dynamic acquisition will be performed without StentViz processing. In case a new StentViz
acquisition is required, reselect the StentViz button on the DL Console or Innova Central touch screen (option).
19-2 Manual StentViz Workflow
If the StentViz processing is not successful, StentViz can be manually launched on previously acquired StentViz
sequence:
1. Select the StentViz native sequence (labeled “Pre-StentViz”) and launch the review. Zoom the image and center
it on the stent. This will increase the sucess rate and decrease the processing time.
2. Launch StentViz through the “StentRefine” button from the DL sequence browser on the control room console,
the DL remote control using the Menu key, or from the Innova Central touch screen (Option) using Review
menu or the SmartNav menu.
Note: In case of biplane sequence, select the Frontal or Lateral sequence before selecting "StentRefine" button.
DL sequence browser
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Innova Central touch screen Review Tab
DL remote control - Menu
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InnovaTM IGS 620,
InnovaTM IGS 630
Smart Nav menu
3. Refer to steps 4 and 5 of Automatic StentViz Workflow.

19-3 StentViz Best Practice
• Before performing the StentViz short record acquisition, perform fluoroscopy to:
– Verify that the balloon has only 2 markerballs. StentViz will fail if the balloon shows 1 or 3 markers.
– Verify that there is only one pair of markers in the image. StentViz will fail if 2 balloons are in the same
image.
– Management of stent positioning to insure overlap: in case 2 adjacent stents are required and the first one is
already deployed, position the balloon with the second non deployed stent next to the first one.
– Verify that the pair of markers and the stent are in the same vessel and/or as close as possible to each
other. The closer the stent is to the markers, the sharper the stent will be displayed on the StentViz resulting
image.
– Verify that the markers are not super-imposed to highly radio-opaque objects (like metallic staples, guidewire
tip or injected catheter).
– Verify that the stent is radio-opaque. The more radio opaque the stent is the higher the StentViz image
quality will be.
• During the StentViz short record acquisition:
– Make sure that the markers are visible in every frame.
– Do not move the balloon during the StentViz acquisition.The only allowable motion is from anatomy.
– Do not move the table or gantry during the StentViz acquisition.
19-4 StentViz User Messages
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InnovaTM IGS 620,
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Location Message Description
Live and Refer- StentViz already running. Restart it The previous StentRefine or StentViz post-processing is
ence monitor manually later still running
This is not an eligible sequence for The sequence selected for the StentRefine post-
StentRefine processing has not been acquired using a StentViz
workflow
Not enough frames. Reselect The acquired sequence or selected sequence does not
StentViz to proceed have enough frames for StentViz post-processing.
Redo StentViz acquisition and wait until "X-Ray Stop" is
displayed.
StentViz failure, apply zoom and StentViz processing has failed.

launch StentRefine Select the StentViz native sequence (labeled "Pre-
StentViz") and launch the review.
Zoom on the sequence and center it on the stent.
Launch StentViz through the "StentRefine" button.
20 Remote Control
1 Cancel 13 Previous Sequence

2 Menu 14 Exam Loop (Collage / In-Room Browser)
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InnovaTM IGS 620,
InnovaTM IGS 630
3 Brightness/Contrast Selection 15 Next Sequence

4 Send Angle 16 SUB/No Sub Selection / Roam / IRB
5 Pixel Shift Selection 17 Faster Review / Contrast + / Pixel Shift Up / Roam / IRB
6 Plane Selection 18 Mask Selection to select another mask if needed / Roam / IRB
7 Zoom 19 Backward Review / Brightness - / Pixel Shift Left / Roam / IRB
8 Store Photo 20 Enter Key
9 Recall Photo 21 Forward Review / Brightness + / Pixel Shift Right / Roam / IRB
10 Previous Image 22 Previous Sequence / Roam / IRB
11 Play / Pause 23 Next Sequence / Roam / IRB
12 Next Image 24 Slower Review / Contrast - / Pixel Shift Down / Roam / IRB
20-1 Collage / In-Room Browser

From the Remote Control, press on the Exam Loop key (key 14 on Remote Control Illustration) to activate and
display the In-Room Browser (IRB) on the reference display.
Note: An image review must be started first to allow the IRB activation and display.
The IRB can also be activated from the Exam Loop key of the Sequence Browser, the Exam Mode key of the DL
keypad or the In-Room Browser key of the Innova Central touch screen.
376 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Sequence thumbnails are displayed first with their original sequence number; photo thumbnails are then displayed
with a dedicated photo icon and their original photo number.
In case of biplane sequence or photo, a double thumbnail is shown with gantry angles of each plane for better
understanding.
A thick horizontal white line separates sequences and photos.
Note: In case of multiple exams performed on a Patient, sequences of each exam are displayed first (a thin
horizontal white line separates each exam), then, after the thick white line, photos of each exam are displayed (a
thin white line also separates each exam).
Once the IRB is displayed on the reference display, use the Exam Loop key to switch focus either on the IRB or on
the live display. Refer to the highlighted label in side panel of both IRB or live displays to visualize where the focus
is located.
Innova Digital 377

InnovaTM IGS 620,
InnovaTM IGS 630
Focus on live display
Focus on IRB
Note: The IRB will stay displayed on the reference display even when the focus is on the live display.
The IRB will be removed only in case of Start/End Exam or Store/Recall photo.
It will not be possible to activate or take focus on the IRB during a Stenosis quantification of acquisition.
When the focus is on the IRB, use one of the eight Remote Control arrows to select the sequence or photo to
review.
A dedicated icon shows the selected thumbnail:
After selection, press on the Remote Control Enter key to launch the review.
A dedicated icon shows the sequence in review:
378 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Note: The thumbnail selection can also be performed using the DL keypad joystick. Press also on the DL keypad
Enter key to launch the review.
A small arrow is displayed in the bottom right corner of the IRB to indicate that more than 16 thumbnails are
available (see 1).
Use the Remote arrow keys to scroll and see the other available thumbnails.
While focus is on the IRB, the 6 blue keys of the Remote Control (or equivalent functions on the DL keypad) can be
used without exiting focus from the IRB.
Any other processing function activation (Zoom, Pixel Shift...) will automatically switch focus on the live display.
In case of photo thumbnail selection and Enter key pressed, the selected photo will replace the IRB on the
reference display and the system will react as if a Recall photo was activated.
Press on Exam Loop again to re-display the IRB when the photo is not needed anymore.
20-2 Send Angle
From the Remote Control, press on the Send Angle key (see Illustration Remote Control) to send to the
Autopositioner the gantry/SID position of the selected/reviewed image/photo. Angles sent to autopositioner are
displayed and high-lighted on the live display until the next move of the gantry.
Activate and move the Autopositioner joystick Up to move the gantry to match the angulation of the selected
image/photo.
21 DL Keypad
Innova Digital 379

InnovaTM IGS 620,
InnovaTM IGS 630
1 Reset Brightness and Contrast to Default Values 14 Edge Enhancement / Pixel Shift / Roam Adjustment
2 Contrast Adjustment 15 Zoom
3 Brightness Adjustment 16 Edge Enhancement Filter Selection
4 Start and Stop Review within a Sequence 17 Auto Archive Mode Selection
5 Review Next Image 18 Shuttle Knob for Image Review
6 Review Next Sequence 19 Monitor Pattern
7 Store Photo 20 Exam Mode (Collage / In-Room Browser)
8 Recall Photo 21 Time Scale ON/OFF Control
9 Review Previous Image 22 Show/Hide Image Infos
10 Review Previous Sequence 23 Biplane Selection
11 SUB/No Sub Selection 24 Lateral Plane Selection
12 Mask Selection to select another mask if needed 25 Frontal Plane Selection
13 Pixel Shift Selection
Note: The monitor pattern is not available while in review or under Ready for exam status (exam in progress).
• To display the pattern on both live and reference displays, press the blank (19) button.
• To remove the pattern:
1. Creating a new patient and starting the exam will blacken both screens.
2. Starting a review on any sequence will remove the pattern from the live display.
3. Recalling a photo will remove the pattern from the reference display.
21-1 Edge Enhancement Filter Selection
380 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Edge Enhancement can be used to sharpen or smooth the image content. A range of filter values is available and
permits to obtain different image looks. By default, the edge filter used during acquisition is applied during DL
review. This default edge enhancement value can be changed.
The following procedure should be followed to adjust the desired level of edge enhancement for Cardiac/DSA no
Sub/Bolus/Chase/DSA/Innova 3D/Innova 3DCT acquisitions:
• Load the sequence to be reviewed.
• Press the "Edge Enhancement Filter Selection" and select the preferred filter setting for the type of acquisition
reviewed.
• Apply the same number as the filter selected to the "Customer Sharpness Sensitivity" parameter in the
acquisition protocol (ask Applications Specialist).
22 Dose Information Record

The following dose information are recorded at exam level and represent the accumulation of both Frontal and
Lateral plane:
1 Fluoro time (h:min:s) - Frontal/Lateral/Total

2 Dose (mGy) - Frontal/Lateral/Total
3 Total DAP (Gy.cm2) - Frontal/Lateral/Total
4 Record DAP (Gy.cm2) - Frontal/Lateral/Total
5 Fluoro DAP (Gy.cm2) - Frontal/Lateral/Total
When starting a new exam these fields are empty.

During exam the dose information are displayed on reference display (Dose, TotalDAP and Total Fluoro time).
During exam these dose information are not updated in the exam browser.
Dose information related to the current procedure is stored into the database after each record acquisition and at
the end of the exam.
In case of system failure requiring a reset during a procedure, dose related to fluoro
acquisitions performed after the last record acquisition is lost.
If a reset is needed during a procedure requiring fluoro only, all patient dose information are entirely lost. A way to
estimate the cumulated patient skin dose (worst case) in Gy is obtained by multiplying the estimated performed
fluoro time in minutes by 0.1.
e.g. for a performed fluoro time of 60 min, the estimated cumulated patient skin dose is: 60 x 0.1 = 6 Gy.
A way to estimate the cumulated DAP (Dose Area Product) in Gray.cm² (worst case) is by multiplying the estimated
performed fluoro time in minutes by 0.1 and further multiplied by 100.
e.g. for a performed fluoro time of 60 min, the estimated DAP is: 60 x 0.1 x 100 = 600 Gy x cm²
Always end any exam by using the "End Exam" key located on the top of the DL flat panel in
order to save all dose information related to the exam.
At "End exam", the actual dose information are recorded and displayed on the appropriate fields in the exam
browser.
Doing a start exam on an already performed exam will update the dose information on the reference display with
the values previously recorded at exam level.
Innova Digital 381

InnovaTM IGS 620,
InnovaTM IGS 630
23 How to Check or Reset the ECG signal (Option)

The icon is used as a visual update of the status of the ECG signal. Waveform & detected peaks are sent in real
time during all kinds of acquisition modes to the AW. When the ECG is enabled and well received (i.e. status is
Online), the ECG data will be automatically stored in the DICOM header of the corresponding sequence for the
following record modes: DSA, Dynamic mode, unsubtracted Innova 3D and Innova CT.
Click on the ECG icon on top of the Innova DL screen to display the beats per minute and to reset the R-wave peak
to peak detection
There are 4 possible ECG status modes, which will be displayed on the DL and the live display (Offline, Stabilizing,
Online and No Trigger).
23-1 ECG icon indication on the DL by color and on the live display
Offline (White and grayed out):

No ECG signal is received or there is no active exam.
382 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Stabilizing (yellow):
A signal is received, and the system is "learning" the ECG.
The algorithm detecting the peaks needs a period of 10 seconds to analyze the waveform (polarity, amplitude, etc.)
before being able to trigger.
An hour glass will be displayed during the stabilization phase.
Online (green):
A signal is received and the system is delivering triggers.
Innova Digital 383

InnovaTM IGS 620,
InnovaTM IGS 630
No Trigger (orange):
A signal is received but the system is not capable of delivering a trigger.
23-2 ECG icon indication on the live display

23-2-1 Status "Online"
384 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
The system is receiving the signal, the current BPM are displayed.
23-2-2 Status "Stabilizing"
The hourglass will be displayed during the stabilization phase.

23-2-3 Status "No Trigger"
Innova Digital 385

InnovaTM IGS 620,
InnovaTM IGS 630
The "- -" will be displayed if there is no R – Peak detection or there is noise in the signal.
Note: Always refer to the hemodynamic or electrophysiology system as the prime reference for the status of the
patient’s ECG, not the Innova system.
23-2-4 Status "Offline"
No ECG signal is received, the ECG line is black, there is no ECG indication
If the ECG signal is lost:
In most situations, check the hemodynamic monitor verifying there is no electrode failure. Once that is confirmed,
perform a reset of the R-peak detection to try to recover the signal.
386 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
There are some situations that the ECG waveform analyzer will be 'lost'.
Examples:
• Noise cannot be differentiated from a regular signal and will try to detect peaks.
• When peaks are detected at a frequency greater than 300 BPM, the display of the BPM value will be
">300BPM" until the frequency is less.
• If the polarity of the signal is changing, it is probable that no peak will be detected.
• If the signal is too noisy: false peaks may be detected.
• If the signal amplitude is increasing: false peaks may be detected.
• If the signal amplitude is decreasing: no peak may be detected.
24 How to Check the Disk Space

Click on the Disk Space icon on top of the Innova Digital screen to display the available Disk Space on each
Frontal and Lateral plane.
Innova Digital 387

InnovaTM IGS 620,
InnovaTM IGS 630
25 How to Check the Heat Unit Informations

Click on the Heat Units icon on top of the Innova Digital screen to display the estimated exposures and run time
available.
388 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
26 How to Delete
Note: Before to delete any data from the Innova Digital, always check that all data was successfully pushed and
available on the AW Workstation.
26-1 How to delete a Patient
Innova Digital 389

InnovaTM IGS 620,
InnovaTM IGS 630
Patient Browser
Delete Patient
• Click on the [Patients] tab at top left of DL screen to select the PATIENT BROWSER. By a simple click; select
the patient(s) you want to delete.
Note: You can select multiple patients:
390 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
• Using <Shift> + left mouse button for contiguous patients.

• Using <Control> + left mouse button for non-contiguous patients.
• While holding the [Control] key, click on the [Delete] key.
• The pop-up "Confirm Delete Patient" will appear.
• Select [Cancel] key to cancel deletion.
• Select [OK] or press the <Enter> key to confirm deletion.
Note: If not all of the sequences of a patient have been pushed/archived, another pop-up "Patient 'Last Name' was
not sent to network/archived yet. Confirm delete patient?" will appear. Select [OK] (or press the <Enter> key) to
confirm deletion.
Select [Cancel] key to cancel deletion.
• After a delete is done, the PATIENT BROWSER will be updated and redisplayed.
26-2 How to delete an Exam
• Click on the [Patients] tab at top left of DL screen to select the PATIENT BROWSER. Select a single patient by
a simple click.
– Click on the [Exams] tab to select the EXAM BROWSER. The Exam Browser window appears.
– Select on the exam(s) to be deleted.
Note: You can select multiple exams:
• Using <Shift> + left mouse button for contiguous exams.
• Using <Control> + left mouse button for non-contiguous exams.
• While holding the [Control] key, click on the [Delete] key.
• The pop-up "Confirm Delete Exam" will appear.
Note: If not all of the sequences of an exam have been pushed/archived, another pop-up "Exam from date
'DD-MMM-YYYY' was not sent to network/archived yet. Confirm delete exam?" will appear. Select [OK] (or press
the <Enter> key) to confirm deletion.
• After a delete is done, the EXAM BROWSER will be updated and redisplayed.
26-3 How to delete a Sequence

a simple click.
• Click on the [Exams] tab to select the EXAM BROWSER Select a single exam by a simple click.
• Click on the [Sequences] tab. The SEQUENCE BROWSER window appears.
• Click on the sequence to be deleted.
Note: In case of a biplane sequence, both Frontal and Lateral sequence will be deleted at the same time.
Note: You can select multiple sequences:
• Using <Shift> + left mouse button for contiguous icons.
• Using <Control> + left mouse button for non-contiguous icons.
• While holding the [Control] key, click on [Delete] key. The message "Confirm Delete Selected Sequence(s)"
appears.
Innova Digital 391

InnovaTM IGS 620,
InnovaTM IGS 630

Note: If one of the sequences has not been pushed/archived, another pop-up "Sequence was not sent to
network/archived yet. Confirm delete sequence?" will appear. Select [OK] (or press the <Enter> key) to confirm
deletion.
• After selection has been done, the SEQUENCE BROWSER will be updated and redisplayed.
26-4 How to delete a Photo
a simple click.
• Click on the [Exams] tab to select the EXAM BROWSER Select a single exam by a simple click.
• Click on the [Photos] tab. The PHOTO BROWSER window appears.
• Click on the photo to be deleted.
Note: In case of a biplane photo, both Frontal and Lateral photo will be deleted at the same time.
Note: You can select multiple photos:
• Using <Shift> + left mouse button for contiguous icons.
• Using <Control> + left mouse button for non-contiguous icons.
• While holding the [Control] key, click on [Delete] key. The message "Confirm Delete Selected Photo(s)"
appears.
Note: If one of the photos has not been pushed/archived, another pop-up "Photo was not sent to network/archived
yet. Confirm delete photo?" will appear. Select [OK] (or press the <Enter> key) to confirm deletion.
• After a selection is made, the PHOTO BROWSER will be updated and redisplayed.
27 How to Network Images to a Workstation, Archive Stations

You can manually or automatically transfer, exams, sequences or photos to one or several hosts (workstation,
PACS...).
Note: In order to optimize data security, it is strongly recommended to always work in Auto Archive mode.
27-1 Auto Archive
The Auto Archive button on the Digital keypad activates the auto transfer of sequences or photos as they are
acquired.
Auto Archive is active when the button is illuminated. If a manual transfer is desired, a single push of the illuminated
Auto Archive button will deactivate the Auto Archive transfer.
392 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Alternatively, it is possible to preset the Auto Archive to ON or OFF by default in the Browser. By default, the Auto
Archive is set to ON. The update will require a system restart.
Note: Transfer will pause when there is a fluoro, record or review in progress.
27-2 How to configure and select a Host
• Click on the [Net] button at the top of the DL screen. The NETWORK QUEUE appears:
Innova Digital 393

InnovaTM IGS 620,
InnovaTM IGS 630
• Click on the [Select Host] button. This opens the host configuration screen. The tabs MPPS and Worklist will
be displayed if the MPPS and Worklist is enabled.
• Select the Image tab to create or modify Image hosts.

If user clicks on the [Add] button, empty host parameter fields will be displayed for the new host.
394 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
All fields will have to be filled in to create a new host.

The Host Label field is limited to 20 characters.
The Network Address field is limited to 15 characters and the user will only be able to enter numbers (0-9) and dots
(.).
The Port Number field is limited to 5 characters and the user can only enter numbers (0-9).
The AE Title field is limited to 16 characters.
If Storage Commitment option not enabled, the ‘Archive Station’ radio buttons will be disabled.
If Storage Commitment option is enabled, the ‘Archive Station’ radio buttons will be enabled.
Initial state of radio buttons:
• For Archive Station "No" is selected by default
• For 512 transfer of images there will be no default selection.
If the user checks ‘yes’ for the ‘Archive Station’ option, the ‘Storage Commitment’ edit fields will be enabled and, if
they are empty, they will be filled in automatically with the same values as the storage host.
[Verify] button allows checking if the network connection is alive between the Innova system and the remote host.
Innova Digital 395

InnovaTM IGS 620,
InnovaTM IGS 630
By pressing [Save] button and if all fields are filled in, the new host will be added to the list in the left window.
User can select the 3D reconstruction host (if 3D option is selected).
User can set the auto push option. 'Yes' is selected by default. If automatic push behavior is not required, this
parameter is to be selected as ‘No’. It requires a system restart to update changes made to this setting.
From the available host(s) list in the left window, the user can select one or several hosts by clicking on its/their
name with the left mouse button.
In case of several hosts selected, use the Up and Down buttons to prioritize the transfer. The hosts may also be
dragged up or down to change their priority. Transfer is performed to the host from first line of the list to last bottom
line of the list.
At the bottom of each Patients/Exams/Sequences/Photos Browser, the selected host(s) is (are) displayed in priority
order from left to right.
396 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Host set in the system for 3D acquisition network is labeled with "3D" written after the host name).
Note: Whatever be the priority of the 3D host in the host list, a 3D acquisition is always networked first. Host set as
archive station is labeled "host name*" (small star written after the host name).
• Click [Exit] to return to the Network Queue.

27-3 How to Network Patient
• Click on the [Patients] tab on the top of the DL flat panel to go to the PATIENT BROWSER.
• Click on the patient(s) to be transferred.
Note: You can select multiple patients:
– Using <Shift> + left mouse button for contiguous selection of patients.
– Using <Control> + left mouse button for non-contiguous selection of patients.
• Click on the [Network] button on the right of the DL screen.
Innova Digital 397

InnovaTM IGS 620,
InnovaTM IGS 630
• Wait for the images to arrive on the remote host.
27-4 How to Network Exam

• Select a patient and click on the [Exams] tab. The EXAM BROWSER appears.
• Click on the exam(s) to be transferred.
Note: You can select multiple exams:
– Using <Shift> + left mouse button for contiguous selection of exams.
– Using <Control> + left mouse button for non-contiguous selection of exams.
• Click on the [Network] button on the right of the DL screen.
• Wait for the images to arrive on the remote host.
27-5 How to Network Sequence / Photos

• Select a patient and click on the [Exams] tab on the top of the DL screen to go to the EXAM BROWSER.
• Select an exam and click on the [Sequences/Photos] tab on the top of the DL flat panel to go to the
SEQUENCE/PHOTOS BROWSER.
• Click on the sequence(s)/photo(s) to be transferred.
Note: You can select multiple sequences/photos:
– Using <Shift> + left mouse button for contiguous selection of sequences/photos.
– Using <Control> + left mouse button for non-contiguous selection of sequences/photos.
• Click on the [Network] button on the right of the flat panel.
398 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
27-6 How to check the status of Network Image operations

CASE 1: If the Network status at Patient Browser is FAILED, then place the mouse over the FAILED status.
If the tool-tip displays: "Failure occurred during image transferring. See Exam tab for more details."
Go to the EXAM Browser of that Patient.

If any Exam displays Network status as "FAILED", place the mouse over the FAILED status.
If the tool-tip displays "Failure occurred during image transferring. See Sequences/Photos tab for more details."
Go to the SEQUENCE and PHOTO Browser of that Patient - Exam.

If any Sequence or Photo displays Network Status as "FAILED", place the mouse over the FAILED status.
Follow the tool-tip instructions to recover the error.
CASE 2: If the Network status at Patient Browser is INFORMATION, then place the mouse over the
Innova Digital 399

InnovaTM IGS 620,
InnovaTM IGS 630
INFORMATION status.
CASE 2.1: If the tooltip indicates "There is no image host configured" then, configure and select an Image push
host. Refer 26-2 How to configure and select a Host
CASE 2.2: If the tooltip indicates "There are unsent images. Manual push is required" then, go to Exams tab.
In the Exams tab, click on the network status for the exam with "Information" status.
If the tooltip indicates “There are unsent images” then, go to Sequences and Photos tab.
Manually push the unsent Images.
CASE 2.3: If Tooltip indicates "Patient is under exam", it implies that the exam is ongoing.
400 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
CASE 3: If the Network status at Patient Browser is SENDING, then place the mouse over the SENDING status.
If the tool-tip indicates: "Sending Images is under way" then, image push is underway. Need to wait for the network
operation to end.
CASE 4: If the Network status at Patient Browser is ARCHIVING, then place the mouse over the ARCHIVING
status.
If the tool-tip indicates: "Archiving Images is under way" then, image archival is underway. Need to wait for the
network operation to end.
CASE 5: If the Network status at Patient Browser is COMPLETED, then place the mouse over the COMPLETED
status.
If the tooltip indicates "Images have been transferred successfully" then, it implies successful transfer of all images
for the selected patient.
27-7 Network Queue Management

• Click on the [Net] button at the bottom of the DL screen to open the SENDING or (if any) ARCHIVING queue.
Innova Digital 401

InnovaTM IGS 620,
InnovaTM IGS 630
27-7-1 SENDING/ARCHIVING Queues
The Network queue contains the following columns:

• Patient Name.
• 'Acqu. Plane :' will contain the type of plane:
– "MONOPLANE FRT" for frontal only sequences and photos.
– "BIPLANE FRT" for frontal planes of biplane sequences and photos.
– "MONOPLANE LAT" for lateral only sequences and photos.
– "BIPLANE LAT" for lateral planes of biplane sequences and photos.
• Item type (patient, exam, sequence or photo).
• Item number will show its number according to its type.
• Host Label will show the name of the destination host.
• Status will contain the transfer status (Pending, Active or Failed):
– PENDING: waiting to be processed.
402 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
– ACTIVE: the item is currently being transferred.

– FAILED: when transfer of item failed to the host or one of the hosts. In this case the item remains in the
queue. It is removed from the queue only by use of the Delete Selected button. It can also return in the
queue with PENDING status by use of the Retry Failed Button.
Note: Successfully transferred items are removed from the Network Queue.
When a biplane item is sent to the network (from the sequence or photo Browser, or using auto-push), two jobs are
submitted (one for each plane), thus two independent rows will be displayed on the Network Queue, with
independent status.
Each plane of a biplane sequence/photo in the Network Queue can be selected independently from the other
plane, and all the actions related to the selection (i.e. "delete all selected") will be applicable only to the selected
plane.
27-7-2 SENDING/ARCHIVING Queues Functions
• Delete Selected: Remove the selected item from the queue. This function is available only on items with
PENDING or FAILED status.
• Clear Pending: Remove all PENDING items from the queue, after completion of the ACTIVE item transfer.
• Retry Failed: Return all items with FAILED status to the active part of the queue; their status is changed to
PENDING.
• Retry Selected: Allow to resend selected items with PENDING status (neither successfully pushed nor failed) in
case of communication problem.
• Abort: Immediately abort the current ACTIVE task.
• Select Host: Give access to configuring different host(s).
28 How to use Worklist

The worklist option allows to retrieve the patient demographic information from a worklist provider.
The worklist option can be enabled by GE Service personnel only.
If the worklist option is enabled, the patient browser will look as follows:
Innova Digital 403

InnovaTM IGS 620,
InnovaTM IGS 630
28-1 How to configure and select a Worklist host
• Click on the [Net] tab of DL Screen. The NETWORK QUEUE appears.

• Click on the [Select Host] button.
This opens the window with different tabs to configure the hosts.
Note: The tab MPPS is displayed, only if MPPS is enabled.

Selecting the Worklist tab of Host Configuration screen, the user can configure the Worklist host.
404 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Only one Worklist host can be configured.

By pressing [Save] button if all fields are filled in, the new host will be saved.
User can modify the host configuration details of the existing host.
User can DELETE the host by clicking the [Clear] and [Save] button in the given order.
User can set the automatic retrieve of Worklist at boot. 'Yes' is selected by default. Changing this parameter would
require a system restart.
Innova Digital 405

InnovaTM IGS 620,
InnovaTM IGS 630
28-2 Retrieving the worklist

Go to Patient Browser.
If Worklist option is enabled, the patient Browser will be split horizontally and displays Worklist Browser in the
bottom.
If the worklist option is not present, the patient list will be full screen and none of the worklist buttons is seen.
The three worklist specific buttons are:

• [Refresh]: retrieves the worklist from the worklist provider.
• [Settings/Search]: opens the settings definition window.
• [Add to database]: allows creating patients/exams in the Innova database from the items selected in the
worklist.
406 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
Pressing the [Refresh] button on the patient Browser retrieves the worklist.
While the query is in progress, the system remains fully available for other operations.
During the query, the [Refresh] button toggles to [Cancel Query], allowing canceling the query in progress.
If the query fails, the last successful query result remains displayed.
The worklist can be sorted by patient name or by scheduled start date and time by clicking on the header row.
28-3 Worklist settings configuration

The worklist settings is configured from the [Settings/Search] button.
Three matching criteria are available:

• Modality worklist,
• Scheduled exam date,
Innova Digital 407

InnovaTM IGS 620,
InnovaTM IGS 630
• Patient information (optional).
The system will retrieve items that satisfy the criteria defined in all three boxes. In the "Date" area, only one item
can be selected.
The "Modality Worklist" criteria and the "Date" criteria are stored persistently on the system. The patient criterion is
stored as long as the system is not re-booted.
MODALITY WORKLIST
One or both or none of the checkboxes may be selected
• This room: The scheduled system's DICOM AE-Title matches the local dicom AE-Title.
• This modality: The modality of the scheduled procedure step is "XA", X-ray angiography.
• Leaving both checkboxes unchecked: Selecting this will have the effect of bypassing the scheduled system
selection criteria, since it will always match.
• Both checkboxes checked: The scheduled system's DICOM AE-Title and the modality of the scheduled
procedure step will be used for filtering.
Note: This selection must be used when a GE Mac-Lab is used to retrieve the worklist.
Note: To see the local system's AE-Title, select Service from the Browser. In Service User Interface, choose
configuration application, then DICOM.
DATE
Any date: Selecting this will have the effect of bypassing the date selection criteria, since it will always match.
From ... to: Enter the selected dates in the following format: 01-Jan-2001.
PATIENT SEARCH
Multiple matching criteria can be defined in this area.
For the last name and first name, the query will match if the name in the worklist provider contains the given name.
E.g.: querying for "John" will return "John", "Johnson" ...
The tab key navigates between the fields.
[Refresh now] button
This has the same effect as [Apply] + [Refresh].
[Apply] button
The window is closed. The settings definition is saved.
[Cancel] button
All edits are discarded. The window is closed.
408 Innova Digital

InnovaTM IGS 620,
InnovaTM IGS 630
28-4 Creating Innova patients from worklist

Creating Innova patients from the worklist can be done by:
• Clicking on the [Add to database] button.
• Double clicking a line from the worklist Browser.
• Dragging a line from the worklist Browser into the patient Browser.
IN CASE SOME PATIENT/EXAM INFORMATION OF THE PATIENT TO BE IMPORTED

ALREADY EXISTS IN THE INNOVA DATABASE, BUT BELONGS TO ANOTHER
PATIENT/EXAM, A POP UP WINDOW WILL BE DISPLAYED TO WARN USERS ABOUT THE
“RISK OF PATIENT/EXAM DATA/IMAGES MIX”.
Three scenarios can occur:
1 – Same patient information but different exam information.
2 – Different patient information but same exam information.

3 – Same patient information with study information belonging to another patient.
Case 1: The patient has only one scheduled procedure step:

• Selecting the patient line or the scheduled procedure step line has the same effect. If creates the patient with
Innova Digital 409

InnovaTM IGS 620,
InnovaTM IGS 630
one exam in the database.
Case 2: The patient has more than one scheduled procedure step:
• To create one exam from each procedure step, select and import each procedure step individually.
• . Selecting and importing the patient line or a group of scheduled procedure steps will import the first procedure
step.
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Importing items from the worklist will open the patient and exam info screen, pre-filled with the information from the
worklist provider.
To ease the patient identification in Review Stations and Archive Stations, the patient demographic information is
not editable if it was created from the worklist (patient last and first name, patient ID, date of birth, other patient
identification and sex). If editing is required, it should be done on the worklist provider, then the worklist should be
refreshed and the patient re-imported.
29 Modality Performed Procedure Step (MPPS)

Innova System MPPS, together with the Innova System Worklist functionality, provides customers with a
bi-directional interface between the Patient Monitoring/Scheduling/Reporting System and the Innova system.
Demographic information is retrieved seamlessly from the Patient Monitoring/Scheduling/Reporting System to the
Innova system previous to the examination, while X-ray acquisition information is sent to the Patient
Monitoring/Scheduling/Reporting System once the examination is completed.
29-1 How to configure and select a MPPS host
• Click on the [Net] button at the top of the DL screen.
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This opens the window to configure the hosts. The tabs MPPS and Worklist is displayed if MPPS and Worklist is
enabled.
Selecting the MPPS tab of Host Configuration screen, the user can configure the MPPS host.
Only one MPPS host can be configured.
By pressing [Save] button if all fields are filled in, the new host will be saved.
A [Verify] button allows checking if the network connection is alive between the Innova system and the remote
host.
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User can modify the host configuration details of the existing host.
User can DELETE the host by clicking the [Clear] and [Save] buttons in the given order.
29-2 How to send MPPS

MPPS will be sent automatically by the system.
At Start Exam, the initial MPPS message is sent over the network. At End Exam or Abort Exam, the final MPPS
message is sent over the network.
This message contains all patient demographic, dose related and exam related information.
29-3 How to check status of MPPS transfers
In the Patient and Exam Browser, the Network status will also consolidate the MPPS transfer status.
If the tool-tip displays: "Failure occurred during MPPS transferring. See Exam tab for more details."
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InnovaTM IGS 630
Steps to Resend MPPS:

Only Failed MPPS can be resent.
For resending failed MPPS, right-click on the selected Patient or Exam and click "Resend Failed MPPS".
Resend Failed MPPS from Patient Browser:
Resend Failed MPPS from Exam Browser:
status.
If the tooltip indicates "MPPS data has been transferred successfully" then, it implies successful transfer of all
MPPS for the selected patient.
29-4 How to integrate MPPS with Mac-Lab/CardioLab and Carddas system

In case the Innova system is connected to a Mac-Lab/CardioLab patient monitoring/scheduling/reporting or
Carddas patient scheduling/reporting system, the benefit is the automatic and complete X-ray documentation within
the Patient Monitoring/Scheduling/Reporting System. X-ray exam information is saved as part of the patient record
and report of the Patient Monitoring/Scheduling/Reporting System.
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THE EXAM STARTED ON INNOVA SYSTEM MUST ALWAYS BE THE EXAM THAT IS ACTIVE
ON THE PATIENT MONITORING/SCHEDULING/REPORTING SYSTEM. STARTING ANOTHER
EXAM ON INNOVA SYSTEM WILL LEAD TO FAILING THE EXPORT OF THE EXAM DOSE
AND DATA.
MAKE SURE THAT THE EXAM IS PROPERLY CLOSED BY PRESSING THE [END EXAM or
ABORT EXAM] BUTTON ON THE INNOVA SYSTEM BROWSER SCREEN. PRESSING THE
[END EXAM or ABORT EXAM] BUTTON WILL ACTIVATE THE AUTOMATIC TRANSFER OF
THE EXAM DATA. IF THE INNOVA SYSTEM IS RE-STARTED WITHOUT PROPERLY
CLOSING THE EXAM, THE EXAM DATA WILL NOT BE AUTOMATICALLY TRANSFERRED.
EACH TIME AN EXAM IS ENDED ON INNOVA SYSTEM, THE X-RAY INFORMATION OF THE
RECENTLY PERFORMED EXAM IS SENT TO THE PATIENT
MONITORING/SCHEDULING/REPORTING SYSTEM.
If the patient information is not populated on the Patient Monitoring/Scheduling/Reporting system, or the study is
not activated on the Patient Monitoring/Scheduling/Reporting system, it will be impossible to retrieve on Innova the
patient demographics via the Worklist. Therefore, a new patient and exam must be created manually on Innova.
At the end of this unscheduled exam, the X-ray exam information will be integrated in the patient record of
Mac-Lab/CardioLab and Carddas.
29-4-1 Known limitations with Mac-Lab/CardioLab system
The 'Cine Dose', 'Fluoro Dose', 'Total Dose' and 'Cine Frames' fields is not displayed in the Dose Report of
Mac-Lab/CardioLab. The user may get these values from the information displayed on the Innova screens. The
user can also find these values in the Dicom Dose Structured Report document that will be available in the Dose
Report Receiving station.
30 How to Network Dicom Structured Dose Report (Dose SR) to Dose SR

Receiving stations
Automatically Dose SR transfers, happens to one or several hosts (workstation, PACS...) configured.
30-1 How to configure and select a Dose SR host
• Click on the [Net] button at the top of the DL screen. The NETWORK QUEUE appears.
This opens the window to configure different hosts. The tabs MPPS and Worklist is displayed if MPPS and Worklist
is enabled.
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Select the Dose SR tab of Host Configuration screen to create or modify Dose SR hosts.
If the user clicks on the 'Add' button, empty host parameter fields will be displayed for the new host.
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If Storage Commitment workflow is not enabled, the ‘Archive Station’ radio buttons will be disabled.
If Storage Commitment workflow is enabled, the ‘Archive Station’ radio buttons will be enabled.
Initial state of radio buttons: For Archive Station "No" is selected by default.
If the user checks ‘yes’ for ‘Archive Station’ option, the ‘Storage Commitment’ edit fields will be enabled and, if they
are empty, they will be filled in automatically with the same values as the storage host.
By pressing [Save] button and if all fields are filled in, the new host will be added to the list in the left window.
From the available host(s) list in the left window, user can select one or several host by clicking on its/their name
with the left mouse button.
In case of several hosts selected, use the Up and Down buttons to prioritize the transfer. The hosts may also be
dragged up or down to change their priority. Transfer is performed to host from first line of the list to last bottom line
of the list.
• Click [Exit] to return to the Network Queue.

30-2 How to Network Dicom Structured Dose Reports
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InnovaTM IGS 620,
InnovaTM IGS 630
Dicom Structured Dose Reports (Dose SR) is a standard medium defined by DICOM to convey dose information. It
is structured document [a tree of information] containing X-ray and dose information. It is driven by Safety and
Regulatory guidelines [IEC Edition3].
Transfer of Dose SR is mandatory in the system.
Optionally if storage commitment option is enabled, upon successful Dose SR transfer the system will request for
archival of the Dose SR's sent to the selected Dose Archive Stations.
In the Browser, when END or ABORT EXAM is clicked, DICOM Dose SR is automatically sent to all the configured
Dose SR SCP(s), if any acquisition [fluoro or record] was taken during the study, irrespective of the acquisition
being stored or pushed or deleted.
Note: ABORT EXAM will be enabled only if MPPS is enabled.
Dose SR has the dosage information of the exam performed, cumulated at every Performed Procedure Step level.
Run information (consolidated and not per frame) is provided for all fluoros, fluorostores and record acquisitions
[i.e, for every irradiation event] acquired for a Performed Procedure Step in Dose SR object
The reference to all images (record or fluoro acquisitions) that is acquired during the exam [in-between START and
END EXAM] is also included in the Dose SR object.
For the fluoro acquisitions, though the pixel data is not stored in system, Dose SR includes the available dose
values and irradiation event UID s associated with the fluoro image.
30-3 How to check the status of Dose SR transfers
In the Patient and Exam Browser, the Network status will also consolidate the Dose SR transfer status.
If the tool-tip displays: "Failure occurred during Dose Report transferring. See Exam tab for more details."

Steps to Resend Dose SR:

Successful and Failed Dose SR’s can be resent.
For resending Dose SR’s, right-click on the selected Patient or Exam and click "Resend Dose Report".
Resend Dose Report from Patient Browser:
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Resend Dose Report from Exam Browser:
status.
If the tooltip indicates "Dose Report has been transferred successfully" then, it implies successful transfer of all
Dose Reports for the selected patient.
30-4 How to integrate Dose SR with AW system

In case the Innova system is connected to a AW system in which Reporting Tool is installed, Innova can be
configured to transfer Dose SR automatically to AW system. The report can be viewed using the Reporting Tool in
AW.
1. Add AW as a new Data Transfer host in Dose SR tab.
2. Select AW as a destination host in Dose SR tab.
3. Test the connection to AW system. In DL Browser, go to the NET tab, click the [Select Host] button.
Click on Dose SR tab.
a. Highlight the remote host in the left side window.
b. Click on the [Verify] button. A message box is displayed indicating the successful Echo to AW host.
30-4-1 Known limitations with AW Reporting Tool display
1. It could be possible that for DAP value’s <10-3 or >107, values displayed in the report are inconsistent with
Innova value displayed with AW Reporting Tool 2.8 and before. Reporting Tool 2.9 to be installed to overcome
the problem.
2. In the Reporting Tool, click on [Options] button In Display options window, set Decimal places to "4".
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3. Restart AW.
31 Innova Screens Image Display
Live Display Frontal
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Live Display Lateral
Displayed on left side of the live display to show that the displayed image
is a live fluoroscopic image.
Displayed on left side of the live display to show that the displayed image
is a recorded image.
Displayed on left side of the live display during a fluoro performed in Auto
Fluorostore mode.
Displayed on live display to show that the displayed image is the frozen
last fluoroscopic image.
Displayed on live display to show that the displayed image, previously

recorded, is reviewed.
Displayed on left side of the live display to show that a mask is available
for the Roadmap fluoro.
Displayed on the left side of the live display to show the system is in
Blended Roadmap and the selected percentage of vessel visibility
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InnovaTM IGS 620,
InnovaTM IGS 630
Displayed on left side of the live display to show the selected level of 30%
landscape for Subtracted or Roadmap fluoro.
Displayed at the bottom right of the live display to show that the displayed
image is a previously recorded image reviewed in Play mode Forward
image is a previously recorded image reviewed in Play mode Backward
image is a previously recorded image reviewed in Pause mode (frozen
image)
image is a previously stored fluoroscopic image reviewed in Play mode
Forward nominal speed (review in loop)
Forward half speed (review in loop)
Forward high speed (review in loop)
Backward nominal speed (review in loop)
Backward half speed (review in loop)
Backward high speed (review in loop)
image is a previously stored fluoroscopic image reviewed in Pause mode
(frozen image)
Displayed on left side of the live display to show that an ECG signal is be-
ing detected
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Reference Display
Displayed on the right side of the right side of the reference display to
show that disk space is still available.
Displayed on the right side of the right side of the reference display to
show that disk starts to be full.
Blinking icon displayed on the right side of the reference display to show
that disk is nearly full.
Displayed on the right side of the reference display to show that disk is full.
Displayed on the right side of the reference display to show that at least
50% of the heat units are still available in the X-ray tube.
Displayed on the right side of the reference display to show that available
heat units in the X-ray tube are between 30% and 50%.
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InnovaTM IGS 620,
InnovaTM IGS 630
Blinking icon displayed on the right side of the reference display to show
that available heat units in the X-ray tube are below 30%.
Displayed on the right side of the reference display to show that the maxi-
mum heat units are reached in the X-ray tube.
Displayed on the right side of the reference display to show that the Fluoro
is ready (enabled).
Displayed on the right side of the reference display to show that the Fluoro
is not available (disabled).
Displayed on the right side of the reference display to show that the
Record is ready (enabled).
Displayed on the right side of the reference display to show that the
Record is not available (disabled).
Note: Fluoro and Record techniques are linked to the plane selected. If the Frontal plane is selected, techniques
are displayed only on the Frontal Reference Display. In case of Biplane selection, techniques are displayed on both
Frontal and Lateral Reference Displays.
Note: 30/25 fps displayed in the Fluoro Frame rate field means that Biplane Fluoro is performed at 25 fps and
Single Plane Fluoro is performed at 30 fps.
Live and reference displays are managed independently, so, in some cases, it is possible to display images from
two different exams of the same patient.
It is possible to display one frontal and one lateral review at the same time on both live
displays. To distinguish this case from a review of a biplane sequence, it is necessary to
check seq Id consistency on both live displays.
There is a delay between Photo storage and Photo display. In case of X-ray started before the Photo is displayed,
use Recall Photo to display the last stored Photo.
31-1 Technique factors display accuracy
The relative variation between actual and displayed high voltage (in kV unit) is within [0%; 0.07%].
The relative variation between actual and displayed tube current (in mA unit) is within [+/- 5%].
31-2 Dose Estimation
Error on dose estimation is within +/- 35 % interval in accordance with the international safety standard for Dose
Rate and Total Dose and which is valid down to 100 mGy for dose and 6 mGy/min for dose rate.
Error on Dose Area Product (DAP) estimation is within +/-30 % interval in accordance with Switzerland legislation
which is valid down 2.5 Gy.cm² for DAP.
Compliance is tested with acquisition or duration longer than 3 seconds.
The estimation of the total dose (cumulated Air Kerma) (mGy) delivered to the patient per plane is continuously
displayed and updated on the reference display. On the live display, is the ratio (in percentage) of the actual Total
Dose of the Dose Threshold value set within the protocol. The Dose Threshold value and a gauge icon visualizing
the Dose percentage of the Threshold are displayed during acquisition. After the Dose Threshold value is reached
on a plane, the value corresponding to that plane is displayed in reverse video. Once the Dose Threshold reaches
twice the set Dose Threshold value, on a plane, a warning icon is displayed on the corresponding live display next
to gauge icon.
Display prior to the predefined Dose Threshold value being reached:
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Live Display Reference Display
Display after the predefined Dose Threshold value is reached:
Display after the predefined Dose Threshold value has been exceeded (above 100%):
Display on live display after double of the predefined Dose Threshold value has been reached:
Live Display
Possible states of the gauge icon depending on the actual Total Dose ratio to the Dose Threshold value.
0% of Threshold 101-125% of Threshold
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InnovaTM IGS 620,
InnovaTM IGS 630
1-25% of Threshold 126-150% of Threshold
76-99% of Threshold >200% of Threshold
100% of Threshold
Dose Threshold values are set in each anatomy protocol. The default Dose Threshold values are:
• 1 Gy Threshold for Pediatric protocols
• 2 Gy Threshold for Neuro protocols
• 3 Gy Threshold for others
The Dose Threshold value of each protocol can be configured to any of the following values:
• 0.5 GY
• 1 GY
• 2 Gy
• 3 Gy
• 4 Gy
• 5 Gy
If you want to change Dose Threshold level for any of the protocols, contact your GE Healthcare Representative.
31-3 Monitor Pattern
On the DL keypad, a dedicated key (19) can be used to check the in-room/control room monitors.
Note: The monitor pattern is not available while in review or under Ready for exam status (exam in progress).
• To display the pattern on both live and reference displays, press the blank (19) button.
• To remove the pattern:
1. Create a new patient and start the exam will blacken both screens.
2. Start a review of any sequence will remove the pattern from the live display.
3. Recall a photo will remove the pattern from the reference display.
31-3-1 Monitor Contrast Adjustment Check
The Contrast Adjustment Tool is used to set monitor brightness and contrast levels. They are correctly adjusted
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InnovaTM IGS 620,
InnovaTM IGS 630
when the 5% square inside of the black or white squares is visible. If this is not visible, brightness and contrast may
need to be readjusted. Monitor changes are to be performed only by service.
1 Contrast Adjustment Tool 1

2 Contrast Adjustment Tool 2
31-4 Stopwatch
The Stopwatch when selected on the Innova Central touch screen has the capabilities of Start, Pause, Restart the
timer and Exit the function. Exit will abort the stopwatch and remove the display from the reference display's lower
left corner. Reclicking on Stopwatch button will close the window but leave the stopwatch displayed in the mode it
was last using.
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InnovaTM IGS 620,
InnovaTM IGS 630
After the Stopwatch button is pressed:

• Press on Start/Stop to start or stop the counting.
• Press on Reset to restart the counting from 0.
• Press on Stopwatch button again to hide/show the sub menu and keep counting.
• Press on Exit Stop Watch to close the sub menu and erase the display.
31-5 Electronic Shutter
When collimated, an electronic shutter can be automatically applied around the image area to optimize its esthetic
during Fluoro or Record acquisition, or during Review.
On the left side of the Innova Digital Screen, in the Image Display area, a Shutter button, activated by default,
allows to display or not the electronic shutter during acquisition (Fluoro or Record).
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The electronic shutter is always displayed several millimeters larger than the image area to keep the collimator
blades always visible during Fluoro or Record acquisition.
Note: In case collimator blades are moved during an acquisition, the electronic shutter displayed in review and
pushed will correspond to the largest position of the blades.
Using the Shutter button located on the DL Keypad it is possible to activate or not the electronic shutter in review.
Note: Shutter button on DL keypad and on Digital screen are activating and deactivating the electronic shutter
simultaneously on both lateral and frontal plane.
In review, the electronic shutter is applied as close as possible to the image area to hide the collimator blades
completely.
Note: Only images acquired with electronic shutter can be reviewed with or without electronic shutter. For images
acquired without electronic shutter the Keypad’s Shutter button is inactive.
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InnovaTM IGS 620,
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26 Show/Hide the electronic shutter in review
THE OPERATOR'S ATTENTION IS DRAWN TO ALWAYS CHECK THE COLLIMATOR BLADE

EDGES ARE VISIBLE (NOT HIDDEN BY ELECTRONIC SHUTTER) BY CHECKING FOR A
SHARP TRANSITION BETWEEN THE ELECTRONIC SHUTTER EDGE AND THE COLIMATOR
BLADE EDGE. FAILURE TO CONTROL MAY LEAD TO NOT VISUALIZE EXPOSED
ANATOMY.
If a collimator blade edge is not visible, then the operator is recommended to:
For Record: Review the last acquired sequence with electronic shutter disabled to check for collimator blades
positions.
For Fluoro: Stop the ongoing fluoro then disable the electronic shutter for the next acquisitions to check for
collimator blades positions.
For both cases: If the blades are not in their place, disable the electronic shutter using the Shutter button located
on the left side of the Innova Digital Screen, prior performing the next Fluoro or Record acquisition.
Note: When reviewing a stored fluoro, it is not possible to remove the electronic shutter. In case of electronic
shutter failure during fluoro, clinical data may be hidden by the electronic shutter and will be permanently lost.
Always refer to Recorded images on which electronic shutter can be disabled in review for diagnostic purpose.
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TM
Chapter 9 - InnovaSpin (Option available on Frontal plane only)
Note: The Lateral gantry must be first moved into zone 1 (see Section Innova Positioner / Lateral Carriage
Positioning) to allow the InnovaSpin acquisition mode.
The InnovaSpin option allows to perform an acquisition while the gantry rotates around its horizontal axis (pivot).
Rotation from RAO to LAO can be performed at up to 40°/s.
Rotation from LAO to RAO can be performed at up to 30°/s.
To prevent any collision during the rotation a test rotation at 10°/s must be performed first.
Time for gantry to speed up and slow down is included in the rotation trajectory.
1 Safety Recommendations
1. Secure the patient on the table using appropriate restraints to prevent any motion during the gantry rotation.
2. Explain the procedure to the patient and ask him not to move during the gantry rotation
3. Clear the rotation area to prevent any collision during the rotation
4. In case of any problem during the rotation, releasing the exposure footswitch will activate the emergency break
of the gantry.
2 Acquisition Procedure and Timing

• Before selecting the InnovaSpin mode, select a protocol in Cardiac or InnovaChaseTM acquisition mode.
• Position the region of interest (ROI) at isocenter. The table top shall not be rotated.
• Using the auto positioner on the Table Side Status Control (TSSC), select Operator F then one of the 7
predefined rotation trajectories.
– Angles and speed of rotation can be checked on the lower left corner of the live display.
– "Spin" is displayed on the right side of the reference display.
– "Ready for Spin Test" is displayed in the status area of the live display.
– TEST button on the TSSC flashes.
• Press and hold the Test button. During Test rotation, perform short fluoros to check that the ROI is well
isocentered.
– "Spin Test in Progress" is displayed in the status area of the live display.
– Gantry first moves from current position to end of spin position. Manual motion of the table is allowed (except
table rotation).
– Then, gantry moves from end of spin to start of spin position (this phase is the safety test rotation). No
manual gantry or table motion is allowed.
– When the start position is reached, the Test button goes OFF and can be released. "Ready. Clear Rotation
Area" is displayed in the status area of the live display.
Note:
- The Test button must be pressed within 30 seconds after the trajectory was selected. In case of longer time,
reselect the trajectory to reactivate the Test button.
- The test rotation is valid for 5 minutes. After this time, the InnovaSpin mode will be aborted.
• Press on the exposure footswitch. X-ray starts and Test button goes ON. Perform injection as usual.
• When contrast media starts to appear on the image, press once on the Test button to start the gantry rotation.
– Test button goes OFF.
– At the end of the rotation, the gantry motion is stopped and X-ray can still be performed until the exposure
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footswitch is released
• Releasing the exposure footswitch will exit from the InnovaSpin mode. "Cardiac" or "Chase" is displayed back
on the reference display.
Note: If you choose to keep shooting X-ray once the InnovaSpin is finished, some gantry vibrations might occur
and be visible on the image depending on the trajectory performed.
3 Trajectories Settings
Spin trajectories are preloaded in the Innova system.
However, gantry Start position, End position and rotation speed can be modified for each trajectory.
If needed, contact your GE Healthcare Representative for any trajectory modification.
4 User Messages
Information and error messages are displayed in the status and Error Message areas located at the bottom of the
live display.
Message What is happening?
"SELECTION NOT ALLOWED, ACQUISITION IS IN • You tried to enter spin mode with an X-ray switch
PROGRESS" appears in error area. pressed. This in not allowed.
or
• You tried to reselect a trajectory with an X-ray switch
pressed. This is not allowed.
"SELECTION NOT ALLOWED, RELEASE TEST BUT- • You tried to enter spin mode with Test button-
TON" appears in error area. pressed. This is not allowed.
or
• You tried to reselect a trajectory with Test button-
pressed. This is not allowed.
"SELECTION NOT ALLOWED, TABLE IS ROTATED" You tried to enter spin mode with Table rotated. This is
appears in error area. not allowed.
"RECORD ACQUISITION NOT ALLOWED, SPIN TEST You tried to perform a record during test phase. This is
IS IN PROGRESS" appears in error area. not allowed.
"RELEASE FLUORO SWITCH FOR SPIN ACQUISI- You tried to select a new spin position during a fluoro
TION" appears in error area. acquisition. This is not allowed.
"RELEASE TEST BUTTON FOR SPIN ACQUISITION" After test phase completed, you tried to start acquisition
appears in error area. with test button already pressed. This is not allowed.
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InnovaTM IGS 630
"SPIN SETUP ABORTED, RESELECT TRAJECTORY" You got out of spin mode before performing spin acqui-
appears in error area. sition.
This can happen if:
• There was a user gantry or a table motion between
end and start position during test phase.
or
• There was a collision between end and start position
during test phase.
or
• You exited operator "F".
or
• You selected a new protocol.
or
• 5 minutes has been elapsed after a spin test.
"SPIN ACQUISITION ABORTED, RESELECT TRA- You stopped acquisition during Spin acquisition.
JECTORY" appears in error area. There is no error or status message and you cannot se-
lect the F operator: You tried to select InnovaSpin mode
but other than a Cardiac or the InnovaChaseTM protocol
is selected. This is not allowed.
"SEND ANGLES NOT ALLOWED, SPIN IS IN You selected Send Angles during Spin test or Spin ac-
PROGRESS" appears in error area. quisition.
"READY FOR SPIN TEST" appears in status field. You just entered Spin mode.
"SPIN TEST IN PROGRESS" appears in status field. Spin safe test is running.
"READY. CLEAR ROTATION AREA" appears in status You are ready to start acquisition then launch Spin.
field.
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Chapter 10 - Innova Positioner
1 How to move the Table/Gantry

Depending on system configuration, a Smart Box or Smart Handle can be used to activate all table and gantry axis.
These user interfaces are installed on the table accessory rails. If needed, they can be moved all along the rails.
Using the Frontal or Lateral Plane motion selection button, it is possible to move the Frontal or Lateral gantry
independently.
When both Frontal and Lateral Plane motion are selected, both Frontal and Lateral gantry can be moved
simultaneously.
1-1 Omega Smart Box
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1 Table Panning: Press down first, then pan

2 Frontal and/or Lateral Pivot and C-Arc Gantry Motion: Press down first, then tilt
3 Table Control Up/Down; Motorized Longitudinal Tabletop: Press down first, then tilt
4 Frontal or Lateral Detector Lift Control: Press down first, then tilt
5 Patient Contouring (Option)
6 Frontal L-Arm and Lateral Carriage Control: Squeeze first, then tilt
7 Frontal Plane motion select
8 Lateral Plane motion select
9 A 3 positions black switch is located under the Smart Box to adapt the gantry and table directions
to the location of the Box.
Depending on the location of the Smart Box, either on the right or left side of the table, slide the
black switch toward the table head end side to be correctly oriented.
Position the black switch in intermediate position if the Smart Box is installed at foot end side of
the table. In this case, gantry C-Arm and Pivot are reversed.
10 Rail Fixation Release
Note: In case of collision between two mechanical parts or with the patient, activating a collision sensor (see
Innova Positioner / Collision Sensors), the anti-collision software stops the gantry. Release the enable trigger and
press it again. Gantry motion will automatically reverse to clear the collision. After the collision was cleared, call
Service in case the gantry moves permanently at low speed.
In case of collision between two mechanical parts or with the patient, without activation of a collision sensor, the
anti-collision software progressively slows down the gantry motion. An audible signal is activated and the visual
gantry display located at the bottom left of the live display is highlighted. The command of the gantry or table must
be released to prevent any collision.
1-2 Smart Handle
Innova Positioner 435

InnovaTM IGS 620,
InnovaTM IGS 630
1 Table Control Up/Down; Motorized Longitudinal Tabletop: Press down first, then tilt
2 Frontal and Lateral Detector Lift Control: Press down first, then tilt
3 Frontal C-Arc and/or Lateral Pivot Gantry Motion: Press Gantry Enable first, then press button
right or left
4 Table Panning / Frontal Pivot and/or Lateral C-Arc Gantry Motion: Press respective Enable first,
then rotate
5 Patient Contouring (Option)
6 Frontal L-Arm and Lateral Carriage Control: Squeeze first, then tilt
7 Frontal Plane motion select
8 Lateral Plane motion select
9 A 2 positions black switch is located under the Smart Handle to adapt the gantry and table direc-
tions to the location of the Handle.
Depending on the location of the Smart Handle, either on the right or left side of the table, slide
the black switch toward the table head end side to be correctly oriented.
10 Rail Fixation Release

InnovaTM IGS 620,
InnovaTM IGS 630
11 Table and Gantry Enable Release (short or long button can be configured at installation to enable
either the table or the gantry)
Note: In case of collision between two mechanical parts or with the patient, activating a collision sensor (see
Innova Positioner / Collision Sensors), the anti-collision software stops the gantry. Release the enable trigger and
press it again. Gantry motion will automatically reverse to clear the collision. After the collision was cleared, call
Service in case the gantry moves permanently at low speed.
In case of collision between two mechanical parts or with the patient, without activation of a collision sensor, the
anti-collision software progressively slows down the gantry motion. An audible signal is activated and the visual
gantry display located at the bottom left of the live display is highlighted. The command of the gantry or table must
be released to prevent any collision.
1-3 Manual L-Arm Positioning
Use the L-Arm rotational brake release (1) to manually position the L-Arm. The brake release is located on a
handle at the upper end of the L-Arm. Press one or both side buttons on the handle to release the brakes and
manually position the L-Arm.
You can freely move the L-Arm to its limits in either direction. A built-in hard stop limits travel.
Note: The brake release allows manual positioning of the L-Arm only. In case of failure of the L-Arm brake, it is still
possible to overcome the L-Arm brake by pushing manually on the L-Arm with sufficient strength so as to clear the
patient as needed in case of emergency situation.
1-4 Additional Table Panning Handle

Press the switch located at the top of the handle to release the longitudinal and lateral tabletop brakes; the tabletop
can be moved manually.

InnovaTM IGS 620,
InnovaTM IGS 630
1 Omega Table 2 Table Panning Handle
1-5 Table Side Status Control (TSSC)

InnovaTM IGS 620,
InnovaTM IGS 630
1 Frontal Collimator or Contour Filter Blades Con- 10 Emergency Stop

trol
2 Lateral Collimator or Contour Filter Blades Con- 11 Anatomic/Machine Mode Selection
trol
3 Autopositioner Control 12 Positioner Enable/Disable: Activate this button to
disable all table/gantry axis commands (button
light ON). Press again on this button to reactive
all table/gantry axis commands (button light
OFF).
The Positioner Enable/Disable
button only enables/disables commands from

the Smart Box/Handle and Table Side Status
Control. It does not enable/disable table top
brakes commands from the Fluoro/Record
footswitch or the Table Panning handle.
4 Frontal Detector Field of View Selection 13 Subtracted Fluoro Selection
5 Lateral Detector Field of View Selection 14 Bolus Start/End-Spin Test Control
6 Collimator Selection: light is Off 15 Fluorostore
or
Contour Filter Selection: light is On
7 Lateral X-Ray Tube Lift: Press and hold Enable 16 Table Lateral and Longitudinal Brakes Release
first in the middle of the button, then press right
or left
8 Autopositioner Operator Selection 17 X-Ray Timer Reset
9 Room Light Control 18 Table Rotation Brakes Release
Note: In case a second TSSC is used in control room, all commands driving any gantry motorized axis are disabled
(i.e.: Autopositioner, gantry Test rotation).
In case of Emergency, press the Emergency Button (10). All Gantry and table motions will stop.
To reset, press the RESET Button at TSSC underside.

InnovaTM IGS 620,
InnovaTM IGS 630

1-6-1 General description
The Tableside Cart is delivered with two accessory rails, each designated to hold up to two GE Healthcare Table
Side User Interface (TSUI). Depending on the configuration, the Tableside Cart can be installed with one or two
accessory rails.
1 Tableside Cart configuration with one accessory rail

2 Tableside Cart configuration with two accessory rails
There are four configurations of the Tableside Cart with one accessory rail. The approximate height from the floor
to the rail for these four configurations is the following:
• 75.5 cm (29.7 in)
• 82 cm (32.3 in)
• 98 cm (38.6 in)

InnovaTM IGS 620,
InnovaTM IGS 630
• 104.5 cm (41.2 in)

There are two configurations of the Tableside Cart with two accessory rails. The approximate height from the floor
to the rail for these two configurations is the following:
• Bottom rail: 75.5 cm (29.7 in) Top rail: 98 cm (38.6 in)
• Bottom rail: 82 cm (32.3 in) Top rail: 104.5 cm (41.2 in)
Contact your GE Service Representative for any mechanical modification.
Handles located on the front and on each side allow moving the Tableside Cart in any direction.
Two brakes located on the front side of both front wheels, can be used to immobilize the Tableside Cart when
needed.
1-6-2 Environmental working conditions
Because the TSUI’s cables are connected to the table, the Tableside Cart must remain near the table at a distance
of 2 or 3 m around the table base, depending on the cable lengths.
If one of the TSUIs mounted on the Tableside Cart has a cable length of 3 m (118 in), the Tableside Cart must
remain at a maximum distance of 2 m around the table base.
If all the TSUIs mounted on the Tableside Cart have a cable length of 4 m (157.5 in), the Tableside Cart must
remain at a maximum distance of 3 m around the table base.
1-6-3 How to move the Tableside Cart
Release first both front wheel brakes by lifting up the brake command. Then use the frontal handle or handles on
each side of each accessory rail to move the Tableside Cart in any direction.
When the Tableside Cart is positioned at the proper location, push down the brake command located in front of
each of the frontal wheels to immobilize the Tableside Cart.

InnovaTM IGS 620,
InnovaTM IGS 630
1 Brake released
2 Brake engaged
3 Handles used to move
1-6-4 Table Side User Interfaces on the Tableside Cart

The Tableside Cart is designed such that the TSUIs are clamped on its rails exactly the same manner as they are
clamped on the table accessory rails.
BEFORE USING THE TSUIs ON THE TABLESIDE CART, BE SURE THEY ARE WELL
CLAMPED ON THE RAILS. FAILURE TO DO SO MAY LEAD TO STAFF INJURY DUE TO
TSUIs FALLING.
ALWAYS ENSURE THE SWITCH SIDE CONFIGURATION OF THE SMART BOX IS

CONSISTENT WITH THE POSITION OF THE CART. FAILURE TO DO SO MAY RESULT IN
PATIENT OR STAFF INJURY DUE TO UNCONTROLLED MOTION.
When using the Smart Box on the Tableside Cart to move the gantry or the table, keep the
Tableside Cart accessory rails parallel to the table accessory rails or to the Tabletop end.
When using the Smart Handle on the Tableside Cart to move the gantry or the table, keep
the Tableside Cart accessory rails parallel to the table accessory rails.
1-6-5 Cable Routing
The cable routing on the Tableside Cart is designed to avoid TSUIs cables hanging down from the rails or lying on
the floor.
Two cable strips are used for tying TSUI cables on the Tableside Cart and four cable winders are used for winding
the TSUI cables to minimize the cables lying on the floor .

InnovaTM IGS 620,
InnovaTM IGS 630
1 Cable winder
2 Cable tie
ALWAYS ENSURE THE TSUI CABLES FROM THE TABLESIDE CART ARE NEVER IN A
LOCATION WHERE PATIENT OR STAFF COULD TRIP. USE THE FOUR CABLE WINDERS TO
REDUCE THE MINIMUM LENGTH OF THE TSUI CABLES LYING ON THE FLOOR.
1-6-6 Safety mechanism
The shape and size of the front and side handles is designed to avoid unexpected table and gantry motion due to
an unwanted activation of the TSUI in case of collision between the Tableside Cart and other equipment.

InnovaTM IGS 620,
InnovaTM IGS 630
Wheels are designed to prevent any unexpected X-ray pedal activation and to roll over any TSUI cables.
1-7 Error Management

In case of dysfunction detected either in the Control Panel, Smart Handle or Smart Box, the Frontal Field of View
display and the Autopositioner Operator selection display windows located on the Control Panel will start flashing.
(In some cases, the flashing may start up to 5mn after the dysfunction started).
The two windows are used to display an error code in order to help your GE Service Representative solve the
problem.
Please, note this error code before calling GE Service.
The windows will display information as follows:
- for the first 5 seconds: error code flashes
- for the next 10 seconds: steady initial display, and so on.
THIS TYPE OF DYSFUNCTION MAY CAUSE UNEXPECTED GANTRY MOTION AND RESULT
IN SEVERE INJURY TO THE PATIENT OR PEOPLE AROUND THE GANTRY.
AS SOON AS THE ERROR CODE IS DISPLAYED ON THE CONTROL PANEL (TSSC), YOU MAY TERMINATE
YOUR EXAM WITH CAUTION AND MUST REPORT TO YOUR GE SERVICE REPRESENTATIVE
IMMEDIATELY.
1-8 Remote Stand (Option)
The Remote Stand is installed in the control room by your GE Service Engineer. It is used to mount the Smart Box,
TSSC and Smart Handle (either Smart Box or Smart Handle can be used at a time) in the control room allowing
movement of the gantry and table remotely. The Remote Stand can be configured to have the main column either
to the left or right side of the rail arms. The direction will be selected based on the position it is mounted on the
counter to make the controls easily accessible to the user but not extending beyond the counter surface. It is
important that the stand and controls are always in a position that the patient and equipment are clearly visible and
the view unobstructed to the operator. Keep the surrounding area free of objects that could fall on the controls and
cause an uncontrolled motion.
DO NOT ATTEMPT TO MODIFY THE INSTALLATION OR CONFIGURATION OF THE REMOTE

STAND. TO DO SO, MAY RESULT IN SEVERE PATIENT OR STAFF INJURY DUE TO AN
UNCONTROLLED MOTION. CONTACT YOUR GE SERVICE REPRESENTATIVE FOR ANY
MODIFICATION.
The following user interfaces can be installed:
• Smart Box
• Table Side Status Control (TSSC)
• Smart Handle

InnovaTM IGS 620,
InnovaTM IGS 630
The Remote Stand is equipped with a knob to lock or unlock the rotation of the two arms:
• Turning the knob counter clockwise will unlock the arms and allow rotation around the axis of the stand. Adjust
the position of the arms as needed.
• Turning the knob clockwise will lock the rotation of the arms and hold them in the desired position.
Note: Do not use the joysticks of the Smart Box / Smart Handle or TSSC to move the stand.
ALWAYS ENSURE THAT THE ROTATION OF THE REMOTE STAND IS LOCKED BY PULLING
ON ITS ARM BEFORE USING THE EQUIPMENT. FAILURE TO DO SO MAY RESULT IN
SEVERE PATIENT OR STAFF INJURY DUE TO AN UNCONTROLLED MOTION.
1-9 Omega Cable Holder
The cable holder for the Omega Table encloses and guides the Table Side User Interface (TSUI) cables during the
table movements and thereby protects the cables from entangling and getting cut during table movements.
• The cables in the center sheath divides to left and right sides rails accessories.
• It can be opened to selectively add or remove cables.
• It can be removed for cleaning.
THE CABLE HOLDER WILL BE EFFECTIVE ONLY WHEN THE SHEATH IS PROPERLY
INSTALLED AS PER THE OM INSTRUCTIONS.
DO NOT LEAVE ANY TSUI OR GROUNDING CABLES OUTSIDE THE SHEATH WHEN CMD IS
IN USE.
DO NOT TRY TO ROTATE TABLE BEYOND 90 DEG. WITHOUT FOLLOWING INSTRUCTIONS.
MAKE SURE NO OBJECT LIES UNDER THE TABLE, WHICH THE CABLES COULD GET
CAUGHT INTO.
The following TSUI cables shall always be routed through the Cable Holder when installed on the table rail.
• Table Side Status Control (TSSC)
• Smart Box
• Table Panning Device (TPD)

InnovaTM IGS 620,
InnovaTM IGS 630

• In-room 3D Mouse
• Ground wire from table
• Injector (Mark V Table Mounted)
1-9-1 How to swap TSUIs
When side sheath option is used, follow below instructions to swap accessories:
• Unhook the accessory cable from rail hook.
• Remove the side sheath zipper; take only the desired cable out from the internal strap and button it back, then
close the zipper.
• Move the accessory to the other side.

• Route the cable in the other side sheath. Make sure it is going through the internal strap, and close the zipper.
• Hook the extra length cable in the rail hook to prevent sagging.
When Cable Holder mechanism is used, follow the below instructions:
• Unhook the accessory cable from rail hook.
• Remove the cable with ferrule from the Cable Holder mechanism, and move the accessory to the other side.
• Tag the ferrule in the other side Cable Holder mechanism.

InnovaTM IGS 620,
InnovaTM IGS 630
• Open the flap in the middle sheath, and move the cable to the other side; button the flap back.
1-9-2 How to Rotate the Table beyond 90 deg. when Cable Holder is in use
DO NOT TRY TO ROTATE TABLE BEYOND 90 DEG. WITHOUT FOLLOWING INSTRUCTIONS.
Note: Table shall be rotated up to 90 deg. without any change in setup.
• Remove all ferrules from both side Cable Holder (with Cable Holder option); or unhook from the rails the two
hooks of the side sheath (with side sheath option).
• Remove central hook of middle sheath from cover plate.

InnovaTM IGS 620,
InnovaTM IGS 630
• When the table is rotated back to its home position, make sure that all ferrules and hooks are placed back into
their original positions.
1-9-3 How to Use with Remote Stand
WHEN USING THE REMOTE STAND, ALWAYS RELEASE THE CABLE LOOPS OF THOSE
CABLES ON THE REMOTE STAND OR THE CABLES WILL BE TOO SHORT TO LIE ON THE
FLOOR.
IF, AFTER USING THE REMOTE STAND, THE DEVICES ARE BROUGHT BACK TO THE
TABLE RAIL, THE EXTRA CABLE LENGTH MUST BE LOOPED AGAIN TO AVOID CABLES
GETTING CAUGHT.
• If all the devices are moved to the remote stand, the sheath can be left on the cables.
• If only some devices are moved to the cart, the cables of those devices should be taken out of the sheath.
1-9-4 How to Remove and Install the Sheath
1-9-4-1 Detaching the Sheath
• Remove the side sheath zipper, unbutton the internal straps and take the cables out.
• Unhook the side sheath from the rail
• Remove the center sheath and middle sheath zippers to remove the center sheath.
• Unhook the sheath metal holder from the two supports.

InnovaTM IGS 620,
InnovaTM IGS 630
1-9-4-2 Attaching the Sheath

• Collect all the cable self-laminated label marks together, and make sure cables are twist-free.
• Keep label marks at the start of the center sheath, and close sheath zipper.
• Button the center sheath flap at the top.

• Follow cable looping procedure in case extra length cables are found outside the center sheath.
Side Sheath Attaching:
• Attach the side sheath zipper with the center sheath.
• Put the cables inside the internal straps, and close the side sheath zipper.
• Mount the side sheath hooks on the channel block of rail.
1-9-5 How to Loop the Extra Cable Length

InnovaTM IGS 620,
InnovaTM IGS 630
Once the center sheath is installed, the extra length of cables coming out of it has to be managed through cable tie
and holder.
• Use the cable tie to group cables on rest point bracket. Provide extra length of ~120mm from cable tie to the
center sheath end.
Note: In case of shortage of length of cables, adjust the cables in the center sheath to accommodate for extra
length requirement
• Use cable tie and holder to carry the loop of cables inside the rest point board.
• Confirm all TSUI connections are good; Close the rest point board with cover.
2 Collimator Control
Select the Collimator function from the TSSC button: light is Off.
The collimator is controlled automatically when operator selects a Field of View on the TSSC.
The collimator may also be operated manually at the TSSC.
There is a permanent safety mechanism which ensures automatically for the operator that the X-ray beam will
never expose patient body areas which are not displayed on the monitor (SID and FOV tracking).

InnovaTM IGS 620,
InnovaTM IGS 630
1 Not Used
2 Not Used
3 Not Used
4 Auto-Collimation
5 Lateral Blades Closed
6 Lateral Blades Open
7 Longitudinal Blades Open
8 Longitudinal Blades Closed
Auto-Collimation:
The auto-collimation button (4) provides the means to quickly open collimator blades to maximum selected field
size. When the button is pressed, the corresponding LED in the collimator joystick is ON. As soon as the collimator
blades are manually moved in the FOV, the LED goes OFF.
There are two ways to visualize the location of the collimator blades:
• While performing fluoro:
Move the collimator joystick to visualize and position real time the collimator blades over the selected anatomy.
• Out of fluoro:
Move the collimator joystick to visualize and position virtual lines displayed over the Last Image Hold (LIH) or
over any image in review on the live display.
Note: Virtual lines displayed represent the current location of the collimator blades and may not match, in case
of gantry or table motion, with the anatomy of an image previously acquired.
These virtual lines are displayed just few seconds over the image each time the collimator blades are moved
either manually using the collimator joystick or either automatically when changing the gantry SID or detector
FOV.
Note: There is always a short delay between the time the collimator blades move and the time the position of
the virtual collimation lines is updated on the image. If X-ray is performed before the position of the virtual
collimation lines stabilizes, the X-ray beam might not perfectly match the area shown by the virtual collimation
lines.
Recommendation: wait for the virtual collimation lines to stabilize before performing fluoro or record
acquisition.
Gantry informations linked to the acquired image and displayed in the bottom right corner of the live display are
removed during the few seconds the virtual collimator lines are displayed.
Note: Collimator blades can be moved during DSA, Chase and Cardiac Record acquisitions. Collimator blades
controls are disabled during Bolus and 3D Record acquisitions to allow further successful image reconstruction.
2-1 Contour Filter Control
Select the Contour Filter function from the TSSC button: light is On.

InnovaTM IGS 620,
InnovaTM IGS 630
1 Left Contour Filter Blade Selection (not used on Innova IGS 620)
2 Right Contour Filter Blade Selection (not used on Innova IGS 620)
3 Central Contour Filter Blade Selection (not used on Innova IGS 620)
4 Auto Parking Positioning
5 Moving Inside the Field
6 Moving Outside the Field
7 Rotation Control Clock Wise
8 Rotation Control Counter Clock Wise
Any combination in simultaneous blades selection is available.

Blade selection button lit when selected.
Note: Contour filter blades cannot be moved during any Record acquisition.
3 Auto Positioning
The Auto Positioner stores gantry angulations only, either Frontal or Lateral or Biplane, following the active plane
selection on the Smart Box/Smart Handle.
3-1 Auto Positioning Control
The Auto Positioning control allows storing and recalling gantry positions.
It gives access to 9 users. 7 positions can be stored and recalled for each user.
3 Auto Position Selector

8 User Selector
3-2 Auto Position Selector

InnovaTM IGS 620,
InnovaTM IGS 630
1 Move Lateral gantry towards parking: Press down first, then tilt left
2 Move Lateral gantry towards isocenter: Press down first, then tilt right
3 7 memorized Gantry Positions
4 To reach preselected position (1 by 7): Press down first, then tilt up
5 Move all Frontal and/or Lateral gantry axis to 0° (Home position): Press down first, then tilt down
6 Press to store the position
To store a position:
• Move the gantry in the position to store.
• Using the User Selector (button 8), select an operator number.
• Using the Auto Position Selector (button 3), select a position number. The button light goes On.
• Press the store icon (button 6) to store the gantry position, the light of the position number goes Off then On
again to show that the storage is performed.
Note: If no storage action is performed within 30 s after the position number was selected, the light of the position
number will automatically goes Off. In such case, reselect the position number prior to storage action.
To recall a position:
• Using the User Selector (button 8), select an operator number.
• Using the Auto Position Selector (button 3), select a position number. The button light goes On and the gantry
position previously stored is displayed in reversed video on the live display.
• Using the Auto Positioning joystick, press down first then tilt the joystick Up or Down to move the gantry to the
previously stored position. At the end of the motion, the information "Position Reached" appears in the lower left
corner of the live display.
3-3 Park/Iso Function
The Park/Iso function is activated by using the autopositioner joystick. This aligns the Frontal and Lateral gantry to
get optimum clearance and unrestricted motion, then drives the Lateral gantry from the isocenter position to the
parking position (or reverse).
When the Park/Iso function is activated, the following sequence of events occurs:
• Lateral X-ray tube and both Detectors are moved to max SOD and SID.
• Frontal Pivot moves to 0°.
• Frontal C-Arc moves to approximately 25°.
• L-Arm moves to approximately -16°.
• Lateral Pivot moves to 0°.

InnovaTM IGS 620,
InnovaTM IGS 630
• Lateral C-Arc moves to 90°.

• Lateral carriage moves towards parking (or iso) position.
• At the end of the Lateral carriage motion, all Frontal gantry axis move back to 0°.
Note: The Lateral carriage motion stops as soon as the Park/Iso command is released. Activate the command
again to resume the carriage motion.
It is always possible to manually move the Lateral carriage and the Lateral pivot axis.
Lateral Carriage Positioning
4 Lateral Carriage Positioning

There are several zones in which the Lateral carriage can be located.
Each of these zones has an impact on the behavior of the system.
• Lateral carriage located within a range of 20 cm apart of the Iso (so called zone 3): all frontal and Lateral gantry
axis are allowed; X-rays are available on both plane (see further Innova Positioner / Lateral Plane Off Iso).
• Lateral carriage moved towards Parking position (towards Patient head) within a range of 20 cm to 180 cm from
Iso (so called zone 2): all Frontal and Lateral gantry axis are forbidden; X-rays are inhibited on Lateral plane, but
still available on Frontal plane.
• Lateral carriage moved towards Parking position within a range 180 cm to 300 cm from Iso (so called zone 1):
all Frontal gantry axis are allowed; X-rays are available on Frontal plane. Acquisition modes such as Bolus (on
Innova IGS 630 only), 3D or 3DCT are available.
"Frontal Plane Only" is displayed at the bottom left of the live display when the Lateral carriage reaches 180 cm

InnovaTM IGS 620,
InnovaTM IGS 630
from the ISO.

Note: The full parking position is located at 300 cm from the isocenter (depending on room configuration,
parking position could be located closer from isocenter).
IF LATERAL CARRIAGE IS MOVED TO PARKING POSITION, IT SHOULD NOT BE PUSHED

FURTHER MANUALLY, AS IT CAN RUN TO LIMIT-SWITCH PREVENTING LATERAL GANTRY
FROM OPERATING. IF LATERAL PLANE DOES NOT BOOT BECAUSE OF LIMIT-SWITCH
SITUATION, LATERAL CARRIAGE NEEDS TO BE MANUALLY PUSHED TOWARDS ISO TO
UNLOCK IT.
5 Lateral Plane Off Iso

From the isocenter position (ISO), when the Lateral plane is selected on the Smart Box or Smart Handle, it is
possible to move the Lateral carriage within a range of 20 cm apart of the ISO (zone 3) using the L-Arm Control
located at the top of the Smart Box/Smart Handle.
Squeeze first the L-Arm Control to activate the Enable, then tilt the joystick Up/Down to move the Lateral carriage.
After a dead zone apart of the position at rest, a variable speed is applied to the carriage to move it slowly or fast.
The more the joystick is tilted, the faster the Lateral carriage moves.
Fluoro and Record are available on each plane in this +/- 20 cm range.
When the Lateral gantry is Off Iso, the anti collision software is still active but collision
could occur when both gantry are very close one from the other. Keep visual focus on both
Frontal and Lateral gantry when working in such position (Lateral gantry moved 20 cm
towards parking (Patient head)).
6 Digital Detector Housing Controls

Frontal Detector Lateral Detector
1 Up Detector Control (Frontal only) 4 Digital Detector

2 Down Detector Control (Frontal only) 5 Removable Grid
3 Emergency Back-out Button 6 Anti-Collision Belt
6-1 Up/Down Control

Lower or raise the Frontal Digital Detector by pressing either of the two Up/Down controls (See Illustration).

InnovaTM IGS 620,
InnovaTM IGS 630
6-2 Emergency Back-Out

Raise (only) the Digital Detector by pressing one of the Emergency Back-Out buttons located on the Digital
Detector (See Illustration).
Note: This control must be used only:
1. To clear a collision Level 2 (see Innova Positioner / Collision Sensors) by allowing a 2.5 cm additional SID
course.
2. To move away the Digital Detector from the patient in case of gantry failure.
3. In case of SID failure. Use this button to bring the Digital Detector to its highest position to still allow X-ray.
6-3 InnovaSense patient contouring (Option available on Frontal plane only)
InnovaSense patient contouring incorporates implementation of advanced capacitive sensiting technology.
The system in this mode is aware of location of the patient and can dynamically adapt the receptor distance to
position receptor safely in proximity to the patient.
The Frontal Digital Detector housing is surrounded by a capacitive sensor ring (1) to prevent as much as possible
collision with the patient.
With these sensors, the gantry can rotate at up to 20°/s.

These sensors are active as soon as a gantry enable trigger is depressed.
NARROW AND SMALL HUMAN OBJECTS (I.E. NOSE) ARE MORE DIFFICULT TO DETECT
BY THE SENSORS. SO IT IS RECOMMENDED TO TURN PATIENT'S HEAD TO THE LEFT OR
RIGHT AND TO REDUCE GANTRY SPEED WHEN IN THE VICINITY OF THE PATIENT'S
HEAD.
When InnovaSense patient contouring is activated (Item 5 on Smart Box/Smart Handle), the Digital Detector

InnovaTM IGS 620,
InnovaTM IGS 630
always stays at a constant safe distance from the patient while the gantry is moved in any direction. At the end of
the motion, keeping the gantry enable pressed, will move the detector down for even closer positioning (stops at
few cm from patient).
The Digital Detector will also move Up/Down in response to the table movement providing a smart system
response.
With InnovaSense patient contouring activated, bringing the detector at its highest position will prevent it to
automatically move down during a table Up/Down motion and /or longitudinal tabletop motorization.
When using the AutoPositioner, the Digital Detector will automatically move Up/Down during gantry motion to stay
at safe distance from the Patient. There is a button provided to activate or disable this function (Item 5).
IN CASE OF PROCEDURE THAT INVOLVES THE USE OF SMALL INVASIVE

OBJECTS/DEVICES (I.E. BIOPSY OR OTHER NEEDLES) OR OBJECTS MADE OF
NON-CONDUCTIVE MATERIALS (PLASTIC... I.E. OXYGEN MASK) WHICH PROJECT OUT
FROM THE PATIENT SKIN SURFACE, THE INNOVASENSE PATIENT CONTOURING MUST
BE DISABLED (ITEM 5) PRIOR MOVING THE GANTRY EITHER MANUALLY OR WITH THE
AUTOPOSITIONER; THESE OBJECTS/DEVICES BEING TOO SMALL AND/OR NOT
DETECTED BY THE CAPACITIVE SENSORS. USE THE "NEEDLE PLACEMENT" PROTOCOL
LOCATED EITHER IN THE ABDOMEN OR CARDIAC ANATOMY WHICH AUTOMATICALLY
DISABLES THE INNOVASENSE PATIENT CONTOURING FUNCTION. FAILURE TO THIS MAY
CAUSE SEVERE PATIENT INJURY IN CASE THE DETECTOR HITS THE INVASIVE
OBJECT/DEVICE.
A "Needle Placement" protocol, located in the "Cardiac" and "Abdomen" anatomy automatically disables the
InnovaSense patient contouring function and forbids its activation.
Such protocol must be selected prior to start any procedure that involve the use of small invasive objects/devices
which project out from the patient skin surface.
Note: When using an Angio protocol (located out of the "Cardiac" anatomy, the InovaSense/Patient Contouring
function is automatically disabled at each new protocol selection or end of exam activation.
Note: Manual control of the Digital Detector is available at any time.
ALTHOUGH INNOVASENSE PATIENT CONTOURING FUNCTION DYNAMICALLY ADAPTS

THE RECEPTOR DISTANCE, THE USER IS ADVISED AT ALL TIMES TO VISUALLY GUIDE
AND CONTROL THE OPTIMAL RECEPTOR POSITIONING. THIS IS SPECIFICALLY
IMPORTANT WHILE POSITIONING THE RECEPTOR NEAR SMALL HUMAN ANATOMIES
SUCH AS NOSE, HEAD ETC.; NEAR OBJECTS MADE OF NONCONDUCTIVE MATERIAL
SUCH AS OXYGEN MASK AND NEAR AREA WHERE A PUNCTURE NEEDLE IS POSITIONED
IN THE PATIENT BODY.
THE RECEPTOR WILL NOT AUTOMATICALLY MOVE OUT OF THE WAY DURING MANUAL
PANNING UNLESS GANTRY ENABLE IS PRESSED.
7 Collision Sensors
The sensor pads surrounding the X-ray tube and Digital Detector contain pressure-sensitive collision sensors.
There is one level of collision detection for the X-ray tube sensor (see Innova Positioner / Collision Sensors / Level
1), and there are two levels for the Digital Detector sensor (see Innova Positioner / Collision Sensors / Level 1 and
Innova Positioner / Collision Sensors / Level 2).

InnovaTM IGS 620,
InnovaTM IGS 630
1 Digital Detector Sensor 3 Frontal Gantry Sensor

2 Collimator Sensor 4 Lateral Gantry Sensor
7-1 Level 1
During normal operation, Level 1 sensors activate immediately upon sensor detection of collision.
Activation:
When Level 1 collision sensors are activated, corresponding parts of the visual gantry display located on the left
side of the live display are highlighted and flashing. An audible signal is activated. Motions and drives for the
positioner and the table stop.
Clearing Procedure:
After a Level 1 collision sensor activates, remove the obstruction to allow the sensor to clear itself automatically. If
you are unable to remove the obstruction and the system must be driven to clear the sensor, perform the following
procedure:
1. Release the Smart Handle or Smart Box motion enable button. Press the button again, and the system
automatically backs out of the collision.
a. Collimator collision clearing. If you are clearing a collimator collision, then during collimator backout, the
system retraces the motion that preceded the collision.
b. Digital Detector collision clearing. If you are clearing a Digital Detector collision, the system first attempts to
raise the Digital Detector along its motion axis. If this is not successful, the system retraces the motion that
preceded the collision along the remaining axes.
2. If the collision remains after the backward motion, you can resume the positioner movement by releasing and
pressing the Motion Enable Trigger.

InnovaTM IGS 620,
InnovaTM IGS 630
Note: In case the table top is under collision and the collision cannot be cleared as described above, such collision
can be cleared by moving manually the table top in longitudinal or lateral direction or by manually rotating it.
Note: In case of collision sensor failure, messages such as "...Press Tube front plate to reinit" or "...Press Detector
front plate to reinit" will be permanently displayed on the Innova console at system boot. In such case, press once
on the specified sensor to reinitialize it.
7-2 Level 2 (Digital Detector only)
Level 2 detection is a back-up for Level 1 detection. The Level 2 collision sensor on the Digital Detector is activated
if sensor detection continues beyond the normal and expected machine stopping distance.
Activation:
When the Level 2 collision sensor is activated, the Status Display indicator list and an audible signal is activated. All
motions and drives for the gantry and the table are disabled.
Clearing Procedure:
1. Level 2 prohibits powered motions; therefore, you must clear the sensor manually or press the Digital Detector
emergency backout button (see Innova Positioner / Digital Detector Housing Controls).
2. Once you remove the obstruction or clear Level 2 using the backout button, all motions and drives are restored.
THE COLLISION SENSORS ARE NOT INTENDED TO BE A SUBSTITUTE FOR CAREFUL

EQUIPMENT OPERATION. WHEN POSITIONING THE EQUIPMENT, BE SURE THE
EQUIPMENT PATH IS CLEAR BEFORE STARTING A MOTION, CAREFULLY OBSERVE THE
MOVING PARTS, AND STOP THE MOTION BEFORE MAKING ANY CONTACT. THE
SENSORS ARE PROVIDED FOR ADDED PROTECTION IN CASE OF INADVERTENT
CONTACT, AND ARE NOT TO BE RELIED ON AS THE USUAL MEANS FOR STOPPING THE
MOTION. IMPROPER EQUIPMENT POSITIONING COULD RESULT IN SERIOUS INJURY OR
EQUIPMENT DAMAGE.
8 Skin Spacer
Depending on country regulation (e.g.: as required in USA and New Zealand), the Skin Spacer must be installed
over the X-ray tube cover on each plane.
Innova IGS 620 with Skin Spacer Innova IGS 620 without Skin Spacer
Innova IGS 630 with Skin Spacer Innova IGS 630 without Skin Spacer

InnovaTM IGS 620,
InnovaTM IGS 630
When the Skin Spacer is installed over the X-ray tube cover, particular attention must be taken when moving the
table down, especially during patient loading/unloading phase.
With the Skin Spacer installed, do not stop the table too close to the spacer (keep about 5
cm in between) when loading the patient on the table.
Doing so will prevent the table top to collide with the Skin Spacer due to its flexibility.
9 Innova Central touch screen
The purpose of the Innova Central touch screen is to bring an easy and direct access from table side to most
commonly used functionalities related to the acquisition, image review, electrophysiology and Intra Vascular
Ultrasound.
A joystick is used to navigate in some of the functionalities.
A reset button located under the Innova Central touch screen (left side) allows to reinitialize it in case it hangs or
does not respond properly.
9-1 Innova Central touch screen Installation
The primary location of the Innova Central touch screen, connected at table base, is at table side. It can also be
installed on a cart, on an articulated arm or just placed on a table.
To install the Innova Central touch screen at table side, pull the handle located underside, position it over the table
accessories rail and release the handle.
Note: Before using the Innova Central touch screen, make sure it is well secured on the table accessories rail.
9-2 Innova Central touch screen Menus
At the bottom of the Innova Central touch screen, permanent buttons are always available whatever menu is
selected.

InnovaTM IGS 620,
InnovaTM IGS 630
Depending on configuration, on the top of the Innova Central touch screen, tabs give access to acquisition, image
review, electrophysiology and intra vascular ultrasound dedicated screens.
When a small joystick is displayed on a button, it indicates that the Innova Central touch screen joystick needs to
be used to interact in the selected function. For example, when Recall Sequence is selected, move the joystick
right/left to visualize the next/previous sequence.
9-2-1 X-Ray tab
9-2-1-1 Record tab
This screen gives access to the most used Record acquisition parameters as well as protocols and image flip
selection.
Label Description
Protocols Allows to select an acquisition protocol within an anato-
my.
Image Flip Allows to flip the Frontal and Lateral image in horizontal
or/and vertical.
End Exam Allows to close the current exam.
X-Ray Lock Interrupts the system from taking exposures when Fluoro
or Record is no longer required.
Plane select Allows to select either the Frontal, Lateral or both planes
to perform X-ray.
Record Mode Allows to select one of the available acquisition mode.

InnovaTM IGS 620,
InnovaTM IGS 630
3D Spin Speed Depending on system configuration, allows to select

among three 3D gantry rotation speed.
X-ray Delay Allows to set the delay between Injection and X-ray.
Detail Allows to select among Normal or Low Record detail.
Frame Rate / Duration Allows to select a Record acquisition frame rate and the
Record duration.
Subtraction Enables subtraction.
Injection Delay Allows to set the delay between X-ray and injection.
9-2-1-2 Fluoro tab
Label Description
Protocols Allows to select an acquisition protocol within an anato-
my.
Image Flip Allows to flip the Frontal and Lateral image in horizontal
or/and vertical.
End Exam Allows to close the current exam.
X-Ray Lock Interrupts the system from taking exposures when Fluoro
or Record is no longer required.
No Sub Selects Non-Subtracted fluoro mode.

InnovaTM IGS 620,
InnovaTM IGS 630
Sub Selects Subtracted fluoro mode.

Roadmap Selects Roadmap fluoro mode.
Blended Rdmp Frontal Selects Blended Roadmap fluoro mode on the Frontal
plane.
Blended Rdmp Lateral Selects Blended Roadmap fluoro mode on the Lateral
plane.
Detail Allows to select among Normal or Low Fluoro detail.
Frame Rate Allows to select a fluoro acquisition frame rate.
Simultaneous Display Enables Simultaneous Display.
Landscape / Vessels Allows to set the landscape and vessel values with the
joystick.
9-2-1-3 Review tab

All basic review and display functions are directly available from this screen. When the In-Room Browser is
activated, all images acquired during the procedure can easily be reviewed using the Innova Central touch screen
joystick. For angio processing, Mask select and Pixel Shift are directly accessible.
Label Description

InnovaTM IGS 620,
InnovaTM IGS 630
Send Angles Send to the TSSC autopositioner gantry angles from:

• The image in review on the live display.
• The sequence or photo selected in the In-Room
Browser.
Time Scale Displays/Hide a time line under the image in review on
the live display.
Stenosis Analysis Allows to launch the Stenosis Analysis application.
StentViz Enables StentViz function.
Plane Select Allows to select either the Frontal, Lateral or both planes
for review.
Zoom Activates/Desactivates the Zoom function:
• When active, move joystick up/down, right/left to roam
the image.
Filter Allows to set the edge enhancement filter level.
Cancel Cancels the last Pixel Shift, Brightness/Contrast, Filter...
selection. Brings the image back to previous settings.
Brightness Contrast Enables the Brightness/Contrast adjustment:
• When enabled, move joystick up/down to adjust
Brightness and right/left to adjust Contrast.
Mask Select Activates/Desactivates the Mask Select function:
• When active, move joystick right/left to modify mask
selection.
Subtraction Toggles between Sub and NoSub mode when in image
review.
Pixel Shift Activates/Desactivates the Pixel Shift function:
• When active, move joystick up/down and/or right/left
to pixel shift.
9-2-2 AW tab
These functions of the Innova Central touch screen are described in the InnovaTM Vision, InnovaTM TrackVision,
InnovaTM EPVision, InnovaTM HeartVision OM.
9-2-3 MLab tab
9-2-3-1 Mac-Lab tab

InnovaTM IGS 620,
InnovaTM IGS 630
Label Description
Study > Emergency Begins a new study, bypassing the patient demographic
input. The patient information is set as follows:
• Last Name: Timestamp
• First Name: No Name
• MRN: Timestamp
Study > Close Closes the current Mac-Lab study in progress.
• Yes/No confirmation on the Innova Central touch
screen.
• No confirmation from the Mac-Lab application.
Labels Labels a selected blood pressure channel ART, PA,
VEN, PV, LA, RA, AO, RV, VC, SP, LV, or PCW.
12 Lead Prints a Real-Time 12 lead. Also adds 12-Lead event to
the log.
Scale Scales all pressures to 25, 50, 100, or 200 mmHg as se-
lected.
P1 Selects blood pressure channel 1 in the Real-Time win-
dow.
P2 Selects blood pressure channel 2 in the Real-Time win-
dow.

InnovaTM IGS 620,
InnovaTM IGS 630
Measure Measures the current active pressure. The pressure

measurement is displayed in the Review and Log win-
dows.
Measure All Measures all displayed pressures. The pressure mea-
surements are displayed in the Review and Log win-
dows.
Zero Sets the selected pressure to zero for calibration.
Zero All Sets all displayed pressures to zero for calibration.
Sweep Up Increases the scroll/sweep speed in the active window to
the next scroll/sweep speed value up in the list.
Sweep Down Decreases the scroll/sweep speed in the active window
to the next scroll/sweep speed value down in the list.
Update Saves about 10 seconds of signal data in the Review
window (the actual time of data saved is dependant on
the number of channels displayed). A corresponding en-
try appears in the Log (green time-stamp).
Switch Video Toggles the video signal sent to the monitor in the proce-
dure room.
Stopwatch • Open: Opens a new stopwatch on the Real-Time win-
dow.
• Close: Closes the stopwatch opened above.
• Reset: Resets the time on the stopwatch to 0:00.
Start/Stop Stopwatch Starts or stops the stopwatch.
9-2-3-2 CardioLab tab

InnovaTM IGS 620,
InnovaTM IGS 630
Label Description
Close Study Closes the current Mac-Lab study in progress.
• Yes/No confirmation on the Innova Central touch
screen.
• No confirmation from the CardioLab application.
Mark Creates a new note at the current time with the Mark text
in the Event Log.
12 Lead Prints a Real-Time 12 lead. Also adds 12-Lead event to
the log.
Pace Switches the pacing settings to the highlighted channel
poles.
Page Up Changes the display of the Real-Time window up one
page.
Page Down Changes the display of the Real-Time window down one
page.
Gain Up Increases the gain for the selected ECG, intracardiac, or
high-level input channels.
Gain Down Decreases the gain for the selected ECG, intracardiac, or
high-level input channels.
Auto Save Enables/Disables the automatic saving option.

InnovaTM IGS 620,
InnovaTM IGS 630
Manual Save Starts/Stops saving the signals in the Real-Time window.

Sweep Up Increments the scroll/sweep speed in the active window
to the next scroll/sweep speed value up in the list.
Sweep Down Decreases the scroll/sweep speed in the active window
to the next scroll/sweep speed value down in the list.
Update Saves about 10 seconds of signal data in the Review
window (the actual time of data saved is dependant on
the number of channels displayed). A corresponding en-
try appears in the Log (green time-stamp).
Switch Video Toggles the video signal sent to the monitor in the proce-
dure room.
Image Freeze Freezes an image in the CardioImage window.
Permanent Buttons:
Label Description
Auto Injection
In Room-Browser Activates/Desactivates the Collage/In-Room Browser
function:
• Move joystick up/down, right/left to select the se-
quence/photo to review.
• Press on top of joystick to launch the review of the se-
lected sequence/photo.
Recall Sequence Brings focus back on live display:
• Press on top of joystick to Play/Pause the review.
• Move joystick right/left to review next/previous se-
quence when in Play; next/previous frame when in
Pause.
Recall Photo Displays on the reference display the last stored photo.
Store Photo Saves on disk the image displayed on live display and
displays this image on reference display.
Emergency Save Immediately starts saving signals in the Real-Time win-
dow to the optical disk. Also saves as much data as pos-
sible from memory.
Stat Vitals Performs a Stat Vitals measurement. The current HR,
SPO2, RR, temperature, Inspired CO2, and Expired CO2
are recorded as-is from the Status area into the Log win-
dow.
Stopwatch
9-3 Innova Central touch screen customization

InnovaTM IGS 620,
InnovaTM IGS 630
The Innova Central touch screen (Option) provides the possibility to control many applications of different
modalities, and many types of procedures performed by users with different preferences; but users need just a few
of these functionalities during a specific type of examination.
Innova Central touch screen customization enables to collect the frequently used functionalities to one single
surface based on the user preferences or the type of intervention. It means that you are able to copy the frequently
used Innova Central touch screen buttons to one single location, and use only this surface during the examination
without navigating through the different pages of the Innova Central touch screen.
The following section describes step by step how you can customize Innova Central touch screen. Please be aware
that the customization mode is available only out of exam, for safety reasons. During the examination you can use
the created favorite pages.
9-3-1 Location of the customized pages (Favorites tab)
Innova Central touch screen has a specific tab page called Favorites tab, which is indicated with a star icon. You
can collect your preferred functionalities under different favorite sub-tabs. After the system installation, Favorites
tab has one single sub-tab, which contains a short description about the usage of customization feature.
9-3-2 Creation and renaming of Favorites sub-tabs

You have the possibility to create a new favorite sub-tab with the help of the following steps:
1. Tap and hold your finger on the sub-tab area of the touch screen: entering to edit mode is indicated by the
animation. After animation has finished, a menu will be displayed.

InnovaTM IGS 620,
InnovaTM IGS 630
2. Select the Add new tab item from the displayed list: a virtual keyboard is opened.
3. Enter the name of the new favorites sub-tabs, and press the [OK] button. The new favorites sub-tab with the
given name will be created.

InnovaTM IGS 620,
InnovaTM IGS 630
9-3-3 How to populate Favorite sub-tabs

You can put any buttons from any configured modalities to a selected favorites sub-tab with the help of the
following actions.
1. Tap and hold your finger on the button which you would like to add to a favorite sub-tab. After the animation is
finished, a dialog is displayed where you can select the name of the favorite sub-tab from the available list.
2. Select the name of the Favorite sub-tab where you want to copy the button with the help of the pager arrows,
and press the [OK] button. The selected control functionality will be copied to the selected Favorite sub-tab.
3. Repeat the previous actions until you collect all functionalities you need for your examination.
Please be aware that a single functionality can be placed only once in a favorites sub-tab (functionalities cannot be
duplicated inside a single favorites sub-tab). The functionalities coming from different modalities can be simply
distinguished with the help of the colored stripe and caption of the buttons. Each modality has one specific color
that can also be found on the bottom left corner (colored squares) of the corresponding Tab:
• Purple: Innova / Record
• Green: Innova / Review
• Beige: Innova / Fluoro
• Yellow: AW
• Cyan: MLab
• Red: Volcano s5i

InnovaTM IGS 620,
InnovaTM IGS 630
9-3-4 Button arrangement on a favorite sub-tab or between tabs

Innova Central touch screen customization provides some advanced features to create the best arrangement of the
sub-tabs on a comfortable way. When you tap and hold your finger on a button of a favorites sub-tab, a menu is
displayed after the animation is finished, which provides the following functionalities:
• Move within tab: Move the selected button inside the current sub-tab
• Copy to: Copy the selected button to another favorites sub-tab
• Move to: Move the selected button to another favorites sub-tab
• Delete button: Delete the selected button from the current sub-tab
• Cancel

InnovaTM IGS 620,
InnovaTM IGS 630
9-3-4-1 Move a button inside the current tab

When you select the Move within tab item from the menu, a specific screen is displayed, where icons show the
positions where you can move the selected button.

InnovaTM IGS 620,
InnovaTM IGS 630
By selecting an allowed location (displayed with green or blue arrows) you can put the button to an empty position
or you can swap two buttons. (Red icon means a position which is not allowed for the given button.)
9-3-4-2 Arrange buttons between tabs
You can arrange buttons between favorites sub-tabs by copying or moving them to another tab. To do this, you
have to select the Copy to or Move to item from the menu.
When you select Copy to or Move to item, a dialog window is displayed to enable selecting the new location of the
button.

InnovaTM IGS 620,
InnovaTM IGS 630
Select the name of the sub-tab where you want to copy or move the button with the help of the pager arrows, and
press the [OK] button. The selected button will be copied or moved to the first free position of the selected tab.
9-3-4-3 Delete a button from the current tab
You can remove a button from the favorites sub-tab by selecting the Delete button item from menu. Before the
button is removed a confirmation dialog is displayed. Answer the question of the dialog according to your needs.

InnovaTM IGS 620,
InnovaTM IGS 630
9-3-5 Advanced features to manage Favorites sub-tabs

If you populated more than one Favorites sub-tabs and tap and hold your finger on a sub-tab, an extended menu
list is displayed to allow sub-tab management.

InnovaTM IGS 620,
InnovaTM IGS 630
The following additional functionalities are available in the extended sub-tab management menu:
• Move tab: change the order of tabs
• Delete all buttons: delete the content of the selected sub-tab
• Delete current tab: delete the selected sub-tab
9-3-5-1 How to change the tab order
Select the Move tab item of the menu: a dialog window will be displayed where you can chose where you want to
insert the selected sub-tab page (before another tab, or at the end of the tab page by selecting at the end).

InnovaTM IGS 620,
InnovaTM IGS 630
9-3-5-2 How to delete the content of a favorite sub-tab

Select the Delete all buttons item of the menu. A confirmation dialog will be displayed, where you can approve the
content deletion of the selected sub-tab.

InnovaTM IGS 620,
InnovaTM IGS 630
The approval of content deletion will result in an empty favorites sub-tab, which you can populate again according
to your preferences.
9-3-5-3 How to delete a Favorites sub-tab
Select the Delete current tab item of the menu. A confirmation dialog will be displayed where you can approve the
deletion of the selected sub-tab.
9-4 Smart Nav
The Smart Nav Menu can be displayed on the Reference monitor in 2 monitors configuration or on the Live 2
monitor in 3 monitors configuration. It provides an easy access to system functionalities.
Smart Nav can be opened In Room by pressing the [Menu] button on either the Innova Central touch screen or the
DL remote control, or in the Control Room by pressing the [Menu] button on the DL keypad. The user can open
Smart Nav with a long press of the Innova Central touch screen joystick button.
An Icon is displayed at the bottom right of the screen when functionalities are applicable to the lateral plane or to
the biplane.

InnovaTM IGS 620,
InnovaTM IGS 630
Function applicable on the Frontal Function applicable on the lateral Function applicable on the biplane
plane plane
9-4-1 Navigation and function selection through the Menu

In order to navigate, select an application or function, and control a functionality in Smart Nav, you can either use
the Innova touch screen joystick or the DL remote control arrows or the DL keypad joystick.
• On the Innova Central touch screen:
– Perform a Left, Up or Down movement of the joystick to navigated in the menu.
– Perform either a right movement of the joystick, or a short press on the joystick button to access a sub menu.
– Press the joystick button to select a function or application.
• DL remote control:
– Use the Left, Up or Down arrows to navigated in the menu.
– Either use the right arrow or a press "enter" to access a sub menu.
– Press "enter" to select a function or application.
• DL Keypad:
– Perform a Left, Up or Down movement of the joystick to navigated in the menu.
– Perform either a right movement of the joystick or press enter to access a sub menu.
– Press "enter" to select a function or application.
This logo indicates that the selected item is a sub menu.
This logo indicates that the selected item triggers an application or functionality.
9-4-2 Functions descriptions

• Select StentRefine to enable the StentRefine access (Menu will be hidden).
• Select Filter in order to choose a filter to apply. Use the touch screen joystick, the remote control arrows or the

InnovaTM IGS 620,
InnovaTM IGS 630
DL keypad joystick to select the filter to apply on the sequence. Press on the touch screen joystick button or on
enter on either the remote control or the DL keypad to exit the function.
The state of Menu will change. Select Validate to keep the performed modification. Select Reset to reset the
sequence to its initial state.
The number of the filter is displayed on the Live 1.
• Select Time Scale to display or erase the time scale.
Note that StentRefine is present if StentViz option is available on the system.

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 11 - Alarm Systems

1 Alarm management
On Innova systems, an embedded alarm system informs operators that there is either a potential hazard or an
actual hazard.
The alarm system is fully functional and operational after system is ready for use.
The alarm system indicates technical alarm condition with the display of an error message containing the level of
priority.
The level of priority is indicated by the addition of "!" for Low priority, "!!" for Medium priority, "!!!" for High priority at
the beginning of the error message.
• ! Low priority indicates that operator awareness is required.
• !! Medium priority indicates that prompt operator response is required.
• !!! High priority indicates that immediate operator response is required.
The alarm error message is always displayed on live displays in exam room and in control room.
If more than one alarm is active at one time, the alarm error messages are displayed successively with a 10
seconds period.
2 Alarm Message Format

Each alarm message is formatted on the following pattern:
[ Priority ] [ Risk ] [ Impacted Functionality ] [ Instruction ] [ Index ]
Alarm priority Risk System impacted Recommended in- Alarm index

functionality struction
!! Patient fall risk. Gantry/Table lock Handle patient with (2.7)
failed. care.
The alarm index displayed at the end of the error message refers to the alarm description in this section of the
Operator Manual and in the Alarm Messages window available from the Utilities key located on top of the Innova
Digital screen.
3 Alarm System Performances

The alarm management in the Innova system is implemented among the different components of the system.
The following table gives the maximum latency between the time an alarm condition is detected by the system and
the time the alarm message is displayed on monitors.
Innova system functions Nominal display latency Maximum display latency

Gantry / Table motion 1s 5s
482 Alarm Systems

InnovaTM IGS 620,
InnovaTM IGS 630
X-Ray / Auto-injection 1s 3s
Alarm system not functional 3s 5s
4 Degraded Mode of the Alarm Management

In case of communication problem between internal components of the system, only the functions related to the
Gantry/Table motions remain available to the operator, Gantry/Table alarm are then not displayed.
When an internal communication problem is detected, the alarm message "!! Collision/patient fall risk. Alarm
system failure. Move with care. (2.1)" is displayed on monitors and console.
5 List of Alarm Messages

The following tables give the list of all alarm messages of the Innova systems along their detailed description
recommended corrective instructions.
If alarm persists contact your Field Service Representative.
In- Alarm message Corrective actions Description

dex
3.1 !!! Collision risk. Protocol Check patient contouring activation state. Upon the selection of a pro-
change failed. Check patient Reselect protocol. tocol, patient contouring
contouring Reset system to recover. control error. Risk of colli-
sion between the detector
and thin materials, e.g. nee-
dles. InnovaTraceTM sensors
do not detect small invasive
object.
3.2 !!! Risk of resuscitation delay. Clear potential collision and reach CPR posi- A collision occurred during
Auto CPR failure. Move manually tion manually. automatic CPR motion. The
system can not reach the
CPR position by itself.
Unknown gantry or table po-
sition. Risk of uncontrolled
collision. Automatic CPR
motion is disabled.
A failure of one table axis
prevents the table to reach
the CPR position by itself.
2.1 !! Collision/patient fall risk. Move Gantry with caution. Communication problem de-
Alarm system failure. Move with Secure the Load/Unload patient procedure. tected inside Innova system.
care Reset the system. Gantry and Table alarms
cannot be displayed. Risk of
patient fall if patient load/
unload procedure is in
progress. Risk of collision
with the patient or by-
standers.
Alarm Systems 483

InnovaTM IGS 620,
InnovaTM IGS 630
2.2 !! Collision risk. Detector lift Reset system to recover. Detector lift brake failure de-
brake failure. Reset system tected at system boot or re-
set. Risk of uncontrolled de-
tector lift down motion. De-
tector lift commands are dis-
abled after five consecutive
detections.
2.3 !! Collision risk. Table position Continue on going procedure with care. Unknown table position.
failure. Move with care Risk of uncontrolled colli-
sion. All frontal and lateral
gantry axes move at half
speed.
2.4 !! Extra dose risk. Acquisition Release exposure switch. The frame rate used during
frame rate error. Reselect proto- Reselect the protocol and restart the acqui- acquisition does not match
col sition. the requested frame rate.
Patient skin dose may be
higher than expected (up to
four time to nominal).
2.5 !! Extra dose risk. Spectral filtra- Stop acquisition and resume. Error detected in spectral fil-
tion failure. Restart acquisition If problem persists, terminate promptly on tration selection.
going procedure. Image quality may not be
optimal and patient skin
dose may be higher (up to
four times nominal).
2.7 !! Patient fall risk. Gantry/table Verify that Gantry and Table motion are dis- One of the Gantry or Table
lock failed. Handle patient care- abled. brake has not been activat-
fully Handle patient with care. ed after a Gantry/Table dis-
able command. One of the
frontal or lateral gantry axis
is not locked. Table longitu-
dinal or lateral axis is not
locked. Risk of patient fall in
case of accidental table or
gantry command during pa-
tient load / unload.
2.8 !! Patient fall risk. Gantry/Table Stop Gantry/Table motion then resume. Gantry/Table disable com-
lock failed. Repeat lock command not available during
mand an ongoing motion, a 3D, a
Spin Cardiac or a Bolus ac-
quisition. Risk of patient fall
in case of accidental table or
gantry command during pa-
tient load / unload.
2.9 !! Patient fall risk. Tabletop Handle patient with care. Longitudinal/lateral brakes
brakes failure. Handle patient cannot be activated any-
carefully more. Risk of patient fall
during patient load / unload.
2.10 !! System lock up risk. Long time Reset system before the end of the day. System was not reset for 30
without reset. Reset system consecutive days. A reset of
the system is needed to
eliminate a growing risk of
system lock up.
484 Alarm Systems

InnovaTM IGS 620,
InnovaTM IGS 630
2.11 !! Extra dose risk. Detector fail- Terminate promptly ongoing procedure to Error detected in detector
ure. Secure patient secure patient. X-rays will be inhibited after power supply. Image quality
the end of the current procedure. may not be optimal and pa-
tient skin dose may be high-
er (up to four times nomi-
nal).
2.12 !! Patient fall risk. Immediately Move back immedialety the table in horizon- One of the table brakes has
move table back to horizontal tal position. Handle the patient with care. been detected as defective.
Risk of patient fall due to a
table brake failure and un-
controlled motion of the ta-
ble top.
2.13 ! Hidden anatomy risk. Deselect Stop on going Fluoro or Record. Deselect The electronic shutter posi-
auto-shutter and resume electronic shutter using the Shutter button tion is not accurate and clini-
on the Innova Digital Screen and resume cal data may be hidden.
procedure.
2.14 !! Collision risk. Anti collision Continue on going procedure with care. Unknown gantry or table po-
failure. Move with care sition. Risk of uncontrolled
collision. All gantry and table
axis move at reduced
speed. Auto-Positioning and
automatic CPR are dis-
abled.
2.15 !! Exam interruption risk if power Contact immediately GE service for repair of Undercharged UPS batter-
is lost. UPS failure. Call Service the UPS. ies or UPS failure. Risk that
the exam is interrupted and
the Innova system suddently
unavailable in case of main
power failure.
1.1 !! Collision risk. Collision detec- Continue on going procedure with care. Gantry emergency stop fail-
tion failure. Move with care ure or bumper sensor fail-
ure. Risk of patient collision.
All frontal and lateral gantry
axes move at half speed.
1.2 !! Collision risk. L-Arm clutch Continue on going procedure with care. Gantry clutch failure detect-
failure. Move with care ed. Risk of staff injury in
case of collision with by-
!! Collision risk. LP Carriage
stander by L-arm or LP Car-
clutch failure. Move with care
riage movement. All frontal
and lateral gantry axes
move at half speed.
1.3 ! Extra dose risk. Cumulated Cumulated dose displayed is not accurate; The cumulated dose dis-
Dose not accurate. Reset system do not use this information in patient played might be less than
records. the cumulated dose deliv-
Reset System. ered to the patient.
1.4 ! Extra dose risk. Spectral filtra- Stop acquisition and resume. Error in spectral filtration se-
tion failure. Restart acquisition If problem persists, terminate on going pro- lection. Image quality may
cedure. not be optimal and patient
skin dose may be higher (up
to twice nominal).
Alarm Systems 485

InnovaTM IGS 620,
InnovaTM IGS 630
1.5 ! Over injection risk. Injection Reset Innova system and reinitialize injector. Automatic injection failure
stop failure. Reset system If problem persists, use manual injection. detected. Injector did not
stop the injection as expect-
ed.
1.6 !! Unintended motion risk. Mo- Continue with caution. Smart Handle / Smart Box /
tion command failure. Move Secure the Load/Unload patient procedure. TSSC not fully operational.
carefully Risk of unintended motion
due to loss of command pro-
tection.
1.7 ! Unintended motion risk. Check Verify on footswitch/console hand switch are Record foot / hand switch
exposure switches are released released. permanent activation is de-
Correct and reset system to recover. tected by the system con-
trol. Risk of unintended mo-
tion during 3D, Spin Cardiac
or Bolus acquisition.
1.8 ! Unused X-ray risk. Injector un- Stop acquisition if started. Automatic Injection failure
available. Use manual injection Reinitialize injector and resume or select detected. Injector got dis-
manual injection. armed before automatic in-
jection start.
1.9 !!! 3 min before X-Ray inhibit. Terminate promptly current operation to se- System will be shut downed
UPS low. Secure patient cure patient. 3 min after the first message
is displayed. Less than 20 s
!!! 2 min before X-Ray inhibit.
prior system shutdown after
UPS low. Secure patient
last message is displayed.
UPS low. Secure patient
!!! System near to be shut down.
UPS low. Exit exam
1.10 !!! 3 min before X-Ray inhibit. Terminate promptly current operation to se- The X-ray tube is not cooled
Tube cooling failure. Secure pa- cure patient. anymore. X-rays are
tient stopped 3 min after the first
message is displayed.
Tube cooling failure. Secure pa-
tient
Tube cooling failure. Secure pa-
tient
486 Alarm Systems

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 12 - Large Display Monitor Option

1 General Description
The Large Display Monitor is a monitor with a resolution of 3840 x 2160 pixels for display of the Innova images and
external devices images in the exam room and provides the capability to arrange the images per preference
through the Innova Central touch screen.
2 System Components
2-1 Basic Components
• A large display cabinet in the technical room.
• A large display monitor in the exam room.
• A suspension in the exam room.
• A set of video source devices either in the exam or control room.
• A table side interface for controlling the display (Innova Central touch screen).
2-2 Option
• A large display monitor to replicate images from the exam room.
• A set of parts to have HD 2MP and HD 8M output.
• A set of video source devices either in the exam or control room.
3 Safety recommendations
THE WORKING POSITION WITH THE LARGE DISPLAY MONITOR OPTION IS TWO METERS
MAXIMUM FROM THE MONITOR.
For Innova signals, the images can be reduced to 75% of the native resolution. It is estimated that the image is still
readable at 75% for a working distance of two meters or less.
DURING THE CRITICAL PHASES OF AN INTERVENTION, A LAYOUT THAT CONTAINS THE

INNOVA IMAGES AT 100% SHOULD BE USED.
IMAGE RESIZING: THE LARGE DISPLAY MONITOR ALLOWS RESIZING OF THE IMAGES
(ZOOM, SHRINK). THE USER SHOULD PAY ATTENTION WHEN DOING A DIAGNOSTIC OR A
TREATMENT ON OVER ESTIMATED VESSELS/STENOSIS.
THE USER SHOULD PAY ATTENTION THAT ALL THE IMAGES ON THE LARGE DISPLAY
MONITOR OPTION DISPLAYS THE SAME PATIENT INFORMATION TO AVOID DATA
MISMATCH.
4 Connection of external devices

For the following modalities, the Large Display Monitor provides a connection, ensures a frequency match and
equivalent image quality:
• Innova
• Mac-Lab / CardioLab / ComboLab / SpecialsLab
Note: Mac-Lab / CardioLab / ComboLab / SpecialsLab do not support the Real-Time Scrolling feature when
used with the Large Display Monitor. Use the standard sweeping waveform display mode.
• Volcano s5i
• AW
Large Display Monitor Option 487

InnovaTM IGS 620,
InnovaTM IGS 630
• CA1000
• Vivid E9
FOR THE OTHER MODALITIES, THE LARGE DISPLAY MONITOR ONLY PROVIDES A
CONNECTION BUT DOES NOT ENSURE AN EQUIVALENT IMAGE QUALITY AND A
FREQUENCY MATCH.
If there is a degradation of the signal on the Large Display Monitor that prevents the use of the modality image, use
the original monitor of the modality.
If the frequency of the signal does not match the frequency of the allocated input port of the Large Display Monitor,
use the original monitor of the modality.
5 How to control the Large Display Monitor

The Innova Central touch screen provides an interface to control the Large Display Monitor.
Use this interface to select layouts and manage them into groups. A group is a set of layouts. Before using the
Large Display Monitor during exams or procedures, it is possible to create and store groups dedicated to each
specific type of examination.
Please be aware that the joystick of the Innova Central touch screen is not controlling the Large Display Monitor.
On the 'Large Display' tab, the function of the joystick remains to control the Innova functions.
5-1 How to Manage Groups

The Groups are managed from the Innova Central touch screen. Press the ‘Large Display’ tab on the Innova
Central touch screen in order to have access to the group management. Tap on the "Groups" button to display the
list of saved groups.
Select a group by tapping on it in the groups list.
Find the name of the selected group displayed in the upper left corner of the 'Large Display' tab.
488 Large Display Monitor Option

InnovaTM IGS 620,
InnovaTM IGS 630
Note: Five groups can be displayed at the same time in the group list . The user may navigate using up and down
arrow in order to access to the whole group list.
5-1-1 How to Create a New Group
Press ‘Manage Groups’, then ‘Create new group’.
5-1-1-1 Group naming

Enter the name of the new group. The name of the group should contain between 1 and 16 characters.
Each group should have a unique name.
Once the name is entered, press ‘OK’ to go to the Starter group selection screen.

InnovaTM IGS 620,
InnovaTM IGS 630
5-1-1-2 Selecting a starter group

Select a predefined group of example layouts in the category that most resembles the modality of the user.
A new group can be created by selecting the 'New Empty Group' and selecting layouts that have been predefined.
After choosing the starter group, the selected group's layouts will appear.
5-1-1-3 Composing a group

On this screen you may perform the following actions:
• Add a new layout to the group: tap on an empty layout box to add a new layout.

InnovaTM IGS 620,
InnovaTM IGS 630
After tapping on the 'Assign new layout' box, a new page will appear with all the video inputs that are available.
Tap each video input to be displayed in the layout and a corresponding green outline will appear.
Selecting too many inputs at a time could cause the layout filter to return 0 matches. Reduce the number of
video inputs to widen the search.
Once the selection is done, press on "Apply Filter".
All layouts that respect the filtering criteria will be displayed.

InnovaTM IGS 620,
InnovaTM IGS 630
Use the right and left arrow in order to navigate among pages of proposed layouts. An indicator shows to the user
the number of pages and which one is currently displayed.
5-1-1-4 Advanced Filtering
To utilize the advanced filtering function, tap on the 'Advanced' button.
The advanced filtering is divided into:
• Contain: allows the user to define if this video input is to be considered when searching for matching layouts.
Selections are:
– Include: a check mark will be displayed on the input button.
– Exclude: an "X" will be displayed on the input button.
– Not relevant: displays nothing and will search for any layout that might apply.
• Size: allows the user to define the size of the video input that will be displayed on the layout. Selections are:

InnovaTM IGS 620,
InnovaTM IGS 630
– Small: 75% of the original size or smaller.

– Normal: image is the original matrix size.
– Large: over 100% of the normal size.
– Not relevant: will search for any layout that might apply.
• Vertical Position: allows the user to define where the video source will be positioned in the layout. Selections
are:
– Top: anywhere on the top of the layout.
– Bottom: anywhere on the bottom of the layout.
• Horizontal Position: allows the user to define where the video source will be positioned in the layout. Selections
are:
– Left: anywhere on the left of the layout.

InnovaTM IGS 620,
InnovaTM IGS 630
– Right: anywhere on the right of the layout.

Repeat this operation for all the desired video inputs. Once the filters are selected, tap on the 'Apply Filter' button to
display all the matching layouts. Tap on any of the layouts to add to the group.
After creating a group, tap on the 'Save Group' button and return to the mail screen of the groups available.
5-1-2 How to Modify a selected Group
Press the ‘Groups’ button on the bottom of the Innova Central touch screen.
Press ‘Manage Groups’.
Select the group to modify.
Select ‘Edit selected group’ option.
The selected group's layouts will appear allowing the user to add, move or delete any layouts.

InnovaTM IGS 620,
InnovaTM IGS 630
To move a layout in a group:

• Select the layout.
• Use the right and left arrow in order to move the layouts.
• Tap the “X” to delete the layout.
• Tap “Save Group” to save the modifications.
5-1-3 How to Modify the name of the selected layout
Select the group to rename.
Select ‘Edit selected group name’ option.
Type in the new name for that group with the soft keyboard.

InnovaTM IGS 620,
InnovaTM IGS 630
Tap ‘OK’.
5-1-4 How to Delete a selected Group
Select the group to delete.
Select ‘Delete selected group’ option.
Confirm the warning message to finalize the delete process.

InnovaTM IGS 620,
InnovaTM IGS 630
5-2 How to change the Large Display Monitor layout
IT IS NOT POSSIBLE TO CHANGE THE LAYOUT DURING THE X-RAY ACQUISITION. IF A

CHANGE IS ATTEMPTED ON THE LAYOUT DURING X-RAY, A POP-UP MESSAGE WILL
APPEAR TO NOTIFY THAT THIS ACTION IS NOT POSSIBLE.
Outside the acquisition, it is possible to select another layout by tapping the desired layout. To select a layout from
another group, press the ‘Groups’ button. Select the desired group. All the layouts from this group will appear.
Select the desired layout by tapping on it.
Use the paging buttons to navigate among layouts within the selected group.
The page indicator informs which page is currently displayed.
5-3 How to Identify Innova monitors
On the Large Display Monitor, the Innova images can be recognized by the specific labeling:
• The Frontal Live 1 image, and its possible duplicate, is defined by a medium blue horizontal line at the top of the
image.
• The Frontal Live 2 image, and its possible duplicate, is defined by a medium blue horizontal line at the top of the
image.
• The Frontal Reference image is defined by a light blue horizontal line on the top.
• The Frontal Reference duplicate image is defined by a light blue full border.
• The Lateral Live 1 image, and its possible duplicate, is defined by a medium orange horizontal line at the top of
the image.
• The Lateral Live 2 image, and its possible duplicate, is defined by a medium orange horizontal line at the top of
the image.
• The Lateral Reference image is defined by a light blue horizontal line on the top.
• The Lateral Reference duplicate image is defined by a light blue full border.
On the Innova Central touch screen, the rectangles representing the Innova inputs could be identified by the
specific labeling:
• The Frontal Live 1 image, and its possible duplicate, is represented by a medium blue rectangle.
• The Frontal Live 2 image, and its possible duplicate, is represented by a medium blue rectangle.

InnovaTM IGS 620,
InnovaTM IGS 630
• The Frontal Reference image, and its possible duplicate, is represented by a light blue rectangle.
• The Lateral Live 1 image, and its possible duplicate, is represented by a medium orange rectangle.
• The Lateral Live 2 image, and its possible duplicate, is represented by a medium orange rectangle.
• The Lateral Reference image, and its possible duplicate, is represented by a light orange rectangle.
5-4 How to Identify the presence/absence of signal

When the device is not connected to the Large Display Monitor, the "No Signal" message appears on the Large
Display Monitor.
5-5 How to recognize availability of the Large Display Monitor

InnovaTM IGS 620,
InnovaTM IGS 630
A notification message appears if the connection between the Large Display Monitor and the Innova Central touch
screen is not established or is being established. Until the connection is not properly set up, the Large Display
Monitor cannot be controlled.
6 Second Large Display Monitor (Replica) (Option)

When a second Large Display Monitor is installed on the wall, both Large Display Monitors display the same layout.
The image of the optional Large Display Monitor is a replica of the image of the Large Display Monitor located in
the exam room. This second monitor has similar performance as the Large Display Monitor of the exam room.

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 13 - Monitor Suspension

1 LCD Monitor Suspensions
1-1 6 or 8 LCD Monitors Suspension
The Innova IGS 620, Innova IGS 630 can be delivered with 6 or 8 LCD monitors suspension.
The LCD Monitor Suspension comes fully installed and pre-cabled, suspended by a Suspension Arm. For your
operational needs, no additional features need to be considered.
1-2 Large Display Monitor Suspension
1-2-1 Standard use
500 Monitor Suspension

InnovaTM IGS 620,
InnovaTM IGS 630
The Innova IGS 620, Innova IGS 630 can be delivered with a Large Display Monitor suspension.
The Large Display Monitor suspension is delivered with one Large Display Monitor and two 19" monitors mounted
to the back of the suspension to use in case of a degraded mode of the Large Display Monitor.
The Large Display Monitor suspension comes fully installed and pre-cabled, suspended by a suspension Arm. For
your operational needs, no additional features need to be considered.
The Large Display Monitor suspension can receive cover sheets in order to preserve the sterility of the
environment.
Tool clips may be added on the cover sheets to avoid slippage during usage.
Please refer to the picture below for mounting:
These tool clips can be purchased at the following manufacturers:
Manufacturer Link Manufacturer reference

Farnell www.farnell.com 708-1558
Farnell www.farnell.com 155-25-22
Springmasters www.springmasters.com 80112BP, 80112WP, 80112
Monitor Suspension 501

InnovaTM IGS 620,
InnovaTM IGS 630
Toolclip www.toolclip.com 108, 108V, 2-B, 2-BV, FB-FXL

Terry tool - 80-28-3
Buckandhickman www.buckandhickman.com/find/keyw 8165009028
ord-is-tool+clips/product-is-103026
1-2-2 Degraded Mode
FOR INNOVA IGS 620, INNOVA IGS 630 IN CASE OF AN LCD FAILURE, ROTATE YOUR
SUSPENSION TO ACCESS THE BACKUP FRONTAL MONITORS FIXED ON THE BACK.
THEN MOVE THE LATERAL CARRIAGE TOWARD THE PARKING POSITION IN ORDER TO
DISABLE X-RAY ON THE LATERAL PLANE. CHECK DAILY THAT THE BACKUP MONITORS
ARE WORKING PROPERLY AND DISPLAYING IMAGES.
For Innova IGS 620, Innova IGS 630, the Frontal Live 1 and Frontal Reference displays will be fixed on the back of
the suspension.
If Simultaneous Fluoro Sub / NoSub Display option is installed on the Innova IGS 620, Innova IGS 630, the Frontal
Live and Frontal Live 2 monitors will be fixed on the back of the suspension.
Rotation in case of Large Display Monitor failure:
The rotation of the suspension in case of LCD failure can be done in one direction only depending on the room
configuration. The rotation angle is 180°, if it cannot be reached, rotate the suspension in the opposite direction.

InnovaTM IGS 620,
InnovaTM IGS 630
The label fixed on the handles indicates to the user the presence of backup monitors located at the back of the
suspension.
THE USER IS RESPONSIBLE OF ASSURING MINIMUM CLEARANCE RADIUS OF 850 MM

AROUND THE LARGE DISPLAY MONITOR IN ORDER TO ALLOW THE ROTATION IN
DEGRADED MODE.
IN A CASE WHERE THE LARGE DISPLAY MONITOR IS ACCIDENTALLY TURNED OFF, THE
BACK-UP MONITORS WILL STILL BE ON AND SHOULD BE USED.
1-3 Third party Monitor Suspension

The Innova IGS system can be associated with a monitor suspension purchased, provided and installed by the
customer or a third party supplier of his choice. Refer to the third party monitor suspension instructions for use
before any use.
In case of a Large Display Monitor mounted on a third party monitor suspension, the two 19" backup monitors for
the Large Display Monitor degraded mode can be mounted at the back of the suspension or on an additional
suspension (refer to Monitor Suspension / LCD Monitor Suspensions / Large Display Monitor Suspension /
Degraded Mode and Safety and Regulatory / General Safety / Be Sure the Equipment is Functioning Before each
Use / Large Display Monitor suspension).
1-4 Precautions
The installation, connection, removal and repair of all components must be performed by qualified, licensed
technicians only.
Ceiling mounted systems must be installed properly. Failure to follow the instructions provided may lead to
potentially hazardous and unstable condition of the system.
This products must be serviced with manufacturer-approved, original replacement parts only. Failure to follow this
recommendation will void the manufacturer's warranty and will release the manufacturer from liability and warranty
claims!
When installing and adjusting the LCD Monitor Suspension System and/or associated components, or performing
any works on the system, make sure to cut off all electrical supply of the entire system - hazardous condition!
The suspension arm is under constant spring tension. When installing or removing components to or from the
system, always move suspension arm slowly up to its upper stop (upper maximum hub)! Otherwise, when
disconnecting components from the system, suspension arm may jump upwards, causing damage or injury.
The Manufacturer can not be held liable for unauthorized modifications made to the system, or use of the system
for unintended purposes. Since improper modifications may impair proper operation, safety, or reliability of the

InnovaTM IGS 620,
InnovaTM IGS 630
system, all modifications need to be authorized by the Manufacturer in writing.

Avoid all Collisions with other Equipment or Walls, Ceiling, etc. Severe Damage may occur!
In case of Collision or Damage, immediately stop Operation of System.
Disconnect Power Supply immediately!!
Do not post Persons under System, nor walk underneath the System!
Inform Manufacturer immediately!
Do not use System in humid surroundings.
Do not open Covers, Cable Channels, etc.! Hazardous!
1-5 Operation
Note: The suspension arm contains GAS SPRINGS. These springs, or rather the gas inside, react to temperature
by extending or contracting, thus slightly changing their spring range.
Therefore, extensive temperature differences may affect the Suspension Arm performance. Please let the gas
springs adjust to your room climate, before you have the balance of your Suspension Arm adjusted. Even 10°
Celsius will have a (small) effect. Allow Suspension Arm to "accommodate" ca. 12 hours.
Swing System in all desired directions. Avoid harsh movements. Do not turn more than 350° - System is blocked at
360° to avoid Cable torque.
Upward movement is easier if you swing System outwards (away from point of Suspension Arm fixation) before
you lift the System.
Downward movement is easier if you swing System inwards (towards point of Suspension Arm fixation) before you
lower the System.
1-6 Cleaning
Use soft tissues and warm water only.
1-7 Periodic Maintenance
On a regular basis (min. annually), have a technician check screws and cables of System for security.
Please refer to Service Manual for LCD Monitor Suspension (2384065-100) for all necessary Measurements and
Specification.
Note: System is designed for a life time of 10 (ten) years. After 10 years, exchange of System is strongly
recommended.
2 In-Room AW LCD Monitor (Option)

2-1 LCD Holder General Description
The Advantage Workstation Display is used for displaying information about the patient health status during
surgery, or operation. The display is attached through a holder to the Monitor suspension, which supports VESA
(100 x 100 hole) standard displays.
2-2 LCD Holder
The display holder can be attached to the following monitor suspensions:
• 3 Monitor Suspension systems: 2353620*
• 4 Monitor Suspension systems: 2353621*
* These monitor suspensions are designed and pre-cabled for LCD Holder
The following illustration shows how the LCD Holder looks like.

InnovaTM IGS 620,
InnovaTM IGS 630
2-3 Suggested LCD Monitor Models

The suggested LCD monitors are the following:
Monitor Name Dimension (W x H x D) Weight

NEC 1990SXi 19" 41.2 x 33.7 x 8 cm 8.5 kg
EIZO GmbH 19100 19" 42.2 x 34.8 x 9.5 cm 10.7 kg
It is also possible to mount a different ECG or AW Monitor type like the above but its weight must be between 21 kg
and 35 kg, width max of 50 cm and depth max of 59 cm, for LCD display the weight must be between 8 kg and 9 kg
and it should use VESA standard (100 x 100 mm, 4 hole) connection interface.
2-4 Operating Instructions
The Holder is designed to rotate and tilt its Display to achieve optimal view angle for the user.
By grasping the side of the LCD Display, it can be easily moved (rotated / tilted) to the convenient viewing position
within its range. To prevent damage to the LCD Display or other equipment, care should be taken to be sure that
the LCD Display motion has stopped before releasing and the motion should be made smoothly and slowly.

InnovaTM IGS 620,
InnovaTM IGS 630
The ranges for the movements:
Parameter LSL USL U/M

Tilting of LCD backward (0° 30 120 degrees
means vertical position)
Tilting of LCD forward (0° 5 25 degrees
means vertical position)
Rotation of LCD 90 358 degrees
Note: All AW Display's operation is described in a separate document, which is shipped as User Guide for the
display.
2-5 Periodic Maintenance
In order to assure continued safe performance of this equipment, a periodic maintenance program must be
established. It is the owner's responsibility to arrange for this service.
Annual maintenance is required on the various components of the LCD Holder. The detailed procedures are given
in the Service Manual 2373127-100 or 2373132-100 available from representative of GE Healthcare.
A maintenance checklist - PMS Data Record Form attachment No. F3907 for the LCD Holder is provided in this
Operating Manual as a guide to typical maintenance tasks.
2-6 Qualified Service
Safe equipment performance also requires the use of service personnel specially trained on medical apparatus.
GE Healthcare, and its associates, maintain a word-wide organization of stations from which skilled service may be
obtained. If desired, arrangements can usually be made to have preventive and/or emergency service performed
on a contract basic.
A GE representative will be glad to discuss this plan.
2-7 User Service and Maintenance
Cleanliness is a prime rule in maintaining equipment.
At least once a month, external metallic surfaces and exposed tracks, should be wiped to remove any foreign
material that may have accumulated.

InnovaTM IGS 620,
InnovaTM IGS 630
If the tracks are wiped with a cloth slightly moistened with oil, sufficient lubrication will be provided to insure smooth
operations and to protect again rust. Enameled surfaces should be cleaned using a clean cloth moistened slightly
with a good mild cleaner and polish acceptable for such use.
Aside from routine maintenance, any abnormal noise, vibration or unusual performance should be reported
immediately to a GE Healthcare representative.
Before calling for service, however, be sure the equipment is being operated in accordance with the foregoing
instructions.
2-8 PMS Data Record Attachment for LCD Holder
DATE OF INSPECTION INSPECTOR

LCD HOLDER WITH LCD DISPLAY TYPE: NEC1850X ( ) NEC1880SX ( ) NEC1980SXi ( ) OTHER ( )
SERIAL NUMBER_______________
CHECK ( ) AFTER COMPLETING MARK (N/A) IF NOT AP-
PLICABLE
PERIODIC MAINTENANCE RECORD COMMENTS, NOTES,

ETC...
1. LCD Holder
• Check tightness of mounting bolts
2. Mounted Display
• Check tightness of mounting bolts
3. Electrical System
• Check the line voltage
• Check condition of cables
– Inspect for wear
– Inspect for "hang up"
– Check tightness of ties
• Check cable drape
– Clean and lube drape track
• Check cable concealments (if used)
– Check cable routing
– Check cable clamps
– Lubricate cables
– Clean cables and springs
4. General Cleaning
• Clean exterior
• Touch up painting
2-9 Functional Check of LCD Holder

It is not mandatory to record these data if no special request exists.
RECORD YOUR DATA

InnovaTM IGS 620,
InnovaTM IGS 630
Check, AW Display NEC1850X _________, AW Display NEC1880SX __________,

Other _______________________________.
1.
• Rotate left _________ lbs. (________ kgs)
• Rotate right ________ lbs. (________ kgs)
2.
• Tilt up __________ lbs. (________ kgs)
• Tilt down ________ lbs. (________ kgs)

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 14 - Cathlab Frontiers Solutions (Option)

1 General Application Description
The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic
X-ray systems and imaging / data medical devices used in interventional and surgical cath lab environments and
cleared for commercial distribution.
The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that
simplify the end-to-end clinical workflow in the cath lab by implementing:
(1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image
information between the angiographic X-ray systems and the imaging / data medical devices,
(2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray
systems user interface,
(3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE
angiographic X-ray systems.
EXCEPT FOR THE INTERCONNECTIONS THROUGH STANDARDIZED SW AND HW
INTERFACES (LIKE DICOM), ALL ASSOCIATIONS OF THE GE ANGIOGRAPHIC X-RAY SYSTEM WITH A 3RD
PARTY IMAGING/DATA MEDICAL DEVICE MUST BE APPROVED FOR USE BY THE MANUFACTURER
GEHC.
Cathlab Frontiers Solutions is the common name for the following system option:
• The Integrated Vivid E9 solution (Vivid E9 System: BT' 12 version).
2 Integrated Vivid E9 solution (Option)

The Integrated Vivid E9 solution (option) with the 6VT-D (4D TEE) probe, provide access to GE's cardiovascular
ultrasound system designed for cardiac 4D imaging. By displaying the Vivid E9 system output on Innova IGS
system Large Display Monitor, the system simplifies the end-to-end clinical workflow for electrophysiology and
structural heart procedures like (but not limited too):
• TAVI/TAVR – Transcatheter Aortic Valve Implantation / Transcatheter Aortic Valve Repair
• ASD - Atrial Septum Defect closure
• MV - Mitral Valve repair / Mitral Valve clip
• LAA - Left Atrial Appendage closure.
The Large Display Monitor provides a connection for Vivid E9 system that ensures a frequency match and
equivalent image quality with Vivid E9 monitor.
The Vivid E9 system is depicted in the following picture:
For a complete description of the Vivid E9 systems and the 6VT-D (4D TEE) probe refer to the following User
Manuals:
• Vivid E9 User Manual - GA092907.
Cathlab Frontiers Solutions (Option) 509

InnovaTM IGS 620,
InnovaTM IGS 630
• TEE probes User Manual - KZ192871.

2-1 System Setup
During the clinical procedures the Vivid E9 system with the 6VT-D (4D TEE) probe will be positioned either on the
left or on the right side of the patient head area, at a distance which permits comfortable access of the TEE probe
towards the patient (transesophageal access). The Vivid E9 operator is standing between the equipment and the
patient head. The patient head area positions are shared with the anesthesiology equipment and operator, and the
interventional cardiologist and/or surgeons.
During the X-Ray procedure, the Innova IGS system movements are also limiting the Vivid E9 positions around the
head area, and a dedicated back out path has to be cleared for Vivid E9 park position.
The Vivid E9 has 3 types of connection cables:
• Power
• Network
• Large Display Monitor image link called Vivid E9 linkset cable
The power and the network connection cables belong to the Vivid E9. They shall be disconnected from the wall
access sockets and roll up to Vivid E9 cable hooks before moving the equipment out of the exam room.
The LDM image link cable should be disconnected from the back of the Vivid E9 and needs to be protected when
not in use.
The Vivid E9 linkset cable has the following end (including an EMC foam that needs to be used all the time):
It is important to prevent any damage of the Vivid E9 linkset cable. To do so:

• Avoid stepping on or pulling out the cable when the Vivid E9 is operational and connected to the Large Display
Monitor.
• Roll up the Vivid E9 linkset cable and store it on the wall mounted cable hook when the Vivid E9 is not in use.
Make sure you insert the EMC foams in the Vivid E9 image linkset cable end.
2-2 Safety recommendations
The Vivid E9 system supports the use of a 4D Transesophageal Echocardiography (TEE) probe, the 6VT-D (4D
TEE) probe, that is used during all phases of the above mentioned clinical procedures.
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ACCIDENTAL WITHDRAWAL OF A TEE PROBE MAY CAUSE DEEP SOFT TISSUE INJURY.
THE USER SHOULD MINIMIZE THE RISK OF THE INJURY BY: - LOCKING THE WHEELS OF
THE VIVID E9 SYSTEM WHILE IT IS IN USE - LOCKING THE INNOVA IGS SYSTEM AND
TABLE MOTIONS WHEN NO MOVEMENT IS NEEDED - TAKING SPECIFIC CARE WHEN
MOVING THE GANTRY AND/OR TABLE TO PREVENT THE ACCIDENTAL WITHDRAWAL OF
THE 6VT-D (4D TEE) PROBE.
Since the Vivid E9 system is used in the vicinity of the patient, it may accidentally collide with Innova IGS Gantry
and/or Table.
ACCIDENTAL ENTRAPMENT, PINCH, OR CRUSH OF USERS BETWEEN THE VIVID E9 AND

THE INNOVA IGS SYSTEMS MAY CAUSE MUSCULOSKELETAL INJURIES. THE USER
SHOULD MINIMIZE THE RISK OF THE INJURY BY REMOVING THE VIVID E9 SYSTEM FROM
THE VICINITY OF THE INNOVA IGS SYSTEM WHEN PERFORMING QUICK GANTRY
MOVEMENTS, INNOVA SPIN OR 3D ROTATIONAL SPIN.
2-3 Procedure specific layouts
Using the Innova Central touch screen, you can select from the predefined Large Display Monitor layouts as
described in the previous sections of this Operator Manual. However, it is possible to further optimize the layouts to
fulfill all the needs of the clinical procedure (fully customized input types, sizes, and positions). Contact the GE
Service Office for your country to ask support for further layout customization.
Note: When selecting or configuring the needed layout, the Vivid E9 system is using the US #2 video input of the
Large Display Monitor.
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Chapter 15 - Quality Assurance Program (QAP)

1 Introduction
1-1 What is QAP?
QAP stands for "Quality Assurance Program" which is the application that makes an assessment of the Innova
System image quality.
QAP is non-proprietary.
1-2 How to launch QAP?
QAP can be accessed via the Service User Interface (SUIF). To access SUIF, click on the Utilities button at the
top left of the Innova Digital screen.
Users must then click on Quality Assessment button in Navigation Area and follow QAP instructions on screen.
1-3 Web Pages

Once the QAP home page appeared, the user must choose a plane (frontal or lateral) from the Application Toolbar.
QAP on Frontal and Lateral cannot be performed simultaneously, but one after the other. To get the result, QAP
should be executed for both planes.
After choosing a plane, the user must follow the instructions and go through the different pages until he/she gets
the Image Quality status.
Start Page
Acquisition Page
512 Quality Assurance Program (QAP)

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1-4 Status
When all images have been acquired and processing is finished, the application displays a status:
Quality Assurance Program has been completed successfully

Image quality is optimal.
Quality Assurance Program has failed
Image quality is not optimal
Please run the application again or call GE Service
Quality Assurance Program could not be done
Internal Error
Please call GE Service. If this is the first time you run QAP after a software installation, you have to
run it on both planes to get the result.
1-4-1 Other System Measurements

This section is intended to provide specific recommendations to physicists or persons in charge of testing the
system and its operation (e.g. for dose level measurement).
1-4-2 Recommendation #1
You need to open the SUIF Home Page and click on "System Parameters" button in the selection tree to be able to
display the Last Acquisition Parameter values. To access Service User Interface (SUIF), click on the "Service"
button in the DL Browser.
1-4-3 Recommendation #2
Refer to the "Innova 2121-IQ, 3131-IQ Biplane Cardiovascular Imaging System, Innova IGS 620, Innova IGS 630"
Service Manual to find HHS Procedures recommended for dose measurement.
1-4-4 Use of metallic phantoms
In our systems, the X-ray parameters are controlled by an automatic exposure control device that ensure the
optimal image quality by modifying the tube voltage, current and exposure pulse width as needed for the given
patient thickness.
For Dynamic modes, at the beginning of each acquisition and in case of positioning changes during acquisition the
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control device is designed to provide a fast and stable convergence for anatomical tissues.
For DSA mode, the control device is designed to provide a single and accurate prediction of DSA technique, based
on the previous fluoro technique and other parameters.
However, for both Dynamic and DSA modes, these optimal responses are not ensured when the Field of View is
covered by other materials, in particular, strange behavior may occur when metallic phantoms are imaged.
Some of the standard physics measurements are performed using metallic (copper and/or aluminum) phantoms for
simulating patient attenuation.
These are selected in such a way that the total X-ray absorption of the phantom is similar to an average patient.
However, since the atomic numbers of the metal phantoms are much higher than the ones of the elements in a real
patient, the response they give to tube voltage variations is very different. In practice it means that metallic
phantoms are more sensitive to voltage adjustments than the real anatomies.
As a consequence for Dynamic mode, when the exposure control device tries to regulate for a metal phantom, it
may overreact and produce oscillating techniques (the displayed kV and mA values may periodically increase and
decrease). Such oscillations are normal in the presence of metal phantoms, and they do not occur when real
anatomy is in the field.
As a consequence for DSA mode, when the exposure control for DSA tries to regulate for a metal phantom, it may
overreact and produce higher techniques than intended for clinical use. Such higher techniques are normal in the
presence of metal phantoms when the difference in kVp between the selected kVp for the DSA sequence and the
previous fluoro s higher than approximatively 10 kVp, and they do not occur when real anatomy is in the field or
when the mentioned kVp difference is smaller.
In order to avoid these effects we suggest the usage of water, plexiglas or anatomical phantoms, which are much
closer to real tissues in X-ray absorption properties.
Figure: example of relative response of water, plexiglas (PMMA) and a metallic phantom to tube voltage (kVp).
Simulation based on: IPEM: Institute of Physics and Engineering in Medicine, Report 78 Catalog of Diagnostic
X-ray Spectra and Other Data K Cranley, B.J. Gilmore, G.W.A Fogarty and L. Desponds.
1-5 Display of the IEC pattern

This shall be used when checking for artifacts for the conformance with the DIN V 6868-57. On the DL:
1. Open SUIF -> Quality Assurance -> Display Check.
2. Click on IEC Pattern, it will display 1024 x 1024 IEC pattern on all monitors.

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3. Once the tests are finished, close the window using the cross on right top corner.
2 Parameter monitoring
2-1 The parameters that are monitored are
• Electronic Noise
• Row Correlated Noise
• Brightness Uniformity
• Signal to Noise Ratio uniformity
• Bad Pixels
• Noise Power Spectrum
• Conversion Factor
• Modulation Transfer Function
• Resolution uniformity
• Dynamic Range Linearity
• Dynamic Range Accuracy
• Contrast to noise ratio
• Contrast
2-2 Frequency
QAP shall be run on a periodic timeline going from every week to at least every month.
Logs will be automatically retrieved by OnLine-Center.
3 Quality criteria
Comparing the current values to typical values monitored with optimal image quality makes the Pass/Fail status.
This is made using the 6-sigma methodology.
4 Material
In order to perform QAP, you need the QAP Suitcase, which contains:
• The flat-field phantom (20 mm Al):
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• The QAP phantom holder + the QAP round insert:

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Chapter 16 - User Quality Control (QC) Mode

User Quality Control Mode (QC Mode) is a set of equipment controls and quality tools on imaging equipment
intended for hospital medical physicists.
Note: Depending on the system configuration and country where the system is used, this feature may not be
available.
1 How to launch QC Mode (not intended for clinical use)

QC Mode can be accessed via the Service User Interface (SUIF). To access SUIF, click on the Utilities button at
the top left of the Digital System Screen.
Utilities button
Click on the Quality Assessment button in Navigation Area and then click on Enable QC Mode.
QC Mode Launch
Once QC Mode is launched, it is only possible to create, edit or delete phantom examinations. A phantom
examination is an examination with "phantom" written in the Patient Last Name field.
All the options linked to the QC Mode are available by clicking on them on the left pane. A detailed description of
these options follows below.
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QC Mode SUIF
Note: If the SUIF disappears, it can be displayed by clicking on the Utilities button, then the Service button.
2 X-Ray Control Parts Test

The X-ray Control Parts Test provides the means to measure the product performance as defined in IEC
60601-2-43 and as listed below:
• Half-value layer
• Dose reproducibility
• mA linearity
• kVp, mA, pulse width accuracy
• X-ray tube output measurement
For accuracy tests of Cumulative Air Kerma (CAK) and Dose Area Product (DAP) displays, exit QC Mode.
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Frontal X-Ray Control Parts Test Lateral X-Ray Control Parts Test
Note: Lateral X-Ray Control Parts Test and Frontal X-Ray Control Parts Test are respectively available on left pane
for the lateral plane and the frontal plane.
In the X-Ray Control Parts Test of QC Mode, the patient safety functions like Dose Monitoring and Patient Dose
Limiter are disabled. The operator of the equipment does not have patient Dose related information (CAK and
DAP).
In this test, the user can set a parameter value:
• With a value in the range as displayed on right.
• From the list of preselected values.
2-1 Detector Lead Blocker
The user can protect the digital detector by using the Detector Lead Blocker against excessive radiation.
Detector Lead Blocker
The Detector Lead Blocker is a large heavy plate with dimensions almost equal to the dimensions of the detector. It
is introduced in front of the detector by sliding it instead of the anti-scatter grid. It can be found in the X-ray beam
accessories suitcase. It is part of the Quality control suite case (IEC tool...). Please check with your Service
Representative for the location of this suitcase (e.g.: Technical Room).

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X-ray beam accessories suitcase
2-2 X-Ray Tube Heat Units Available

The system may be used with several irradiations that may decrease the X-Ray tube Heat Units Available (HUA). It
is possible to experience waiting time to recover HUA sufficient to continue.
3 "For Processing" Images

"For Processing" images are defined as "unprocessed images". "For Processing" pixel values are encoded with a
LUT that is as follows:
• Pixel value format is a linear relationship up to a pixel value of 224.
• For larger pixel value, the relationship is the following:
"For Processing" pixel value = 2×square root (Linear pixel value × 224) – 224, rounded to an integer value.
The FluoroStore enables the storage of the fluoroscopic images. Make sure to press the Store button of the TSSC
in order to let the system automatically store all the fluoroscopic acquisitions performed during the current test.
After pressing it, the Store button must light up with the yellow color.
The instructions displayed on the SUIF allow performing the test. Some actions need to be performed in the DL
console (selection of a Protocol, selection of acquisition parameters, click on End Exam).

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"For Processing" Image Test
"For Processing" images are stored as raw images available for export:
• In the format 1024*1024*12/16 bits, encoded in little endian (4 unused high bits)
.
• With the filenames IQC_YearMonthDay_HourMinuteSecond_Plane_<ImageNumber>.raw
(the part ImageNumber corresponds to 4 digits).
Note: All the raw images from a given acquisition will have the same date in file name.
32 raw images at maximum (the last frames) are stored for radioscopy or radiography acquisitions.
To export these images, please refer to the SFTP mechanism section.
Note: Beware the images are automatically deleted after a system reboot.
4 "For Presentation" Images

"For Presentation" images are defined as "processed images" and necessary to confirm compliance to quality
standards. They allow also evaluating the display system (printer or monitor).
The "For Presentation" images are the DICOM images already available in clinical mode.
The FluoroStore enables the storage of the fluoroscopic images. Make sure to press the Store button of the TSSC
in order to let the system automatically store all the fluoroscopic acquisitions performed during the current test.
After pressing it, the Store button must light up with the yellow color.
The instructions displayed on the SUIF allow performing the test. Some actions need to be performed in the DL
console (selection of a Protocol, selection of acquisition parameters, click on End Exam).

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"For Presentation" Image Test
The maximum capacity of storage is equal to 450 images per run.
5 Calibration inputs for fields in the DICOM Dose SR: Update Calibration
Factor
Calibration inputs for fields in the DICOM Dose SR can be filled by clicking on Update Calibration Factor in the
SUIF.
Follow the instructions displayed on the SUIF to update the calibration factor with its associated parameters
(uncertainty, date, responsible party and protocol) to report the new values in the DICOM Dose SR.
The Dose Calibration Factor is a value provided by the user which allows to obtain estimated real-world value by
multiplying this factor with the recorded dose and DAP in the DICOM Dose SR.
The new values will be populated in the further DICOM Dose SR generated on the equipment.
All the fields are mandatory except the Calibration Protocol.
Update Frontal Calibration Factor Update Lateral Calibration Factor
Note: The items "Update Lateral Calibration Factor" and "Update Frontal Calibration Factor" are respectively
available on left pane for the lateral plane and the frontal plane: the calibration parameters can be different for each
plane.
6 Protocol Export
6-1 Electronic documentation available
This tool provides means to export through SFTP mechanism, along with the date of configuration of the protocols:

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• Factory Default protocol files and Current protocol files in xml format.
• A text file containing the system configuration parameters in text format (“sysconfigFile.txt”).
• The most recent protocol modification history file in xml format (if any).
To access the Protocol Export user interface in User QC Mode, click on the Protocol Export link.
The instructions mentioned in the Protocol Export user interface page allow connecting to the SFTP server.
Protocol Export
6-2 SFTP mechanism

Secure File Transfer Protocol (SFTP) is a secure form of File Transfer Protocol (FTP), which enables the data
access and data transfer over a secure shell (SSH) connection.
SFTP requires that the client user must be authenticated by the server and the data transfer must take place over a
secure channel (SSH).
When using SSH the entire login session, including transmission of password, is encrypted and therefore very
secure.
6-2-1 Pre-requisite for the remote device and the user's firewall
1. The remote device (where SFTP server is installed) is connected to the hospital network.
2. An SFTP Server is running on the remote device with the following configurations:
– Configured to accept username and password based authentication.
– Shall be listening on the standard SSH port (the port number 22 is proposed by default but can be changed
on the user interface).
– Server shall support SSHv2.
3. If there are firewall(s) in between the system and the remote device, make sure that firewall is configured to
allow SSH and SFTP protocols.
6-2-2 To connect to the SFTP server and transfer the file(s)
Some details on the SFTP server are required to connect:

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• SFTP server IP address.

• User Name.
• Password.
After configuring the SFTP server details, click on the Export button to establish the connection with SFTP server.
If the SFTP connection to the server cannot be established, a message box is displayed to indicate the connection
failure.
Note: In case of failure, please check the current parameters. If problem persists, please contact your IT
administrator to check the configuration.
On account of the successful connection with the SFTP server, select the files from the SFTP transfer application
and click on Export button. To select multiple files at a time, use CTRL key with the file selection.
The SFTP transfer status is indicated via appropriate success/failure messages.
All the files will be exported in the root folder of the remote device.
7 Protocol Comparison
It is possible to compare 2 protocols among all the protocols (Factory or Current).
To access to the Protocol Comparison tool:
• Click on Protocol Comparison Tool (at the left of the SUIF in User QC Mode).
• Select 2 protocols on the 2 separate screens.
• Click on Compare.
Protocol Comparison Tool
After clicking on Compare, a window appears and displays the two protocols previously selected..
All the parameters linked to each protocol are displayed and the differences are highlighted in different colors.
The Protocol Comparison window shall be closed by the user before exiting the Protocol Comparison test.
8 Access to DICOM Dose SR

Additionally to automatic export of DICOM Dose SR to preselected Dose SR host(s) upon exam closure, it is

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possible to export manually the DICOM Dose SR by following the instructions displayed on the SUIF.
Refer to chapter Innova Digital / How to Network DICOM Dose Structured Report (Dose SR) to Dose SR Receiving
stations.
DICOM Dose SR Export
9 How to exit QC Mode?

To exit QC Mode, click on Exit QC Mode and reboot the system. The reboot must be performed manually.
Exit QC Mode
Even if the SUIF QC Mode is closed, the system is still in QC Mode: restart the system.
In this state (QC Mode SUIF closed), the system allows a limited access to data: only phantom examinations are
available, and the creation of clinical patient examination is impossible.
Note: Refer to section Innova System / Vascular Control Interface Module for the description of the procedure to

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restart the system.

InnovaTM IGS 620,
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Chapter 17 - ILinq User Guide

1 Introduction
iLinq is a GE Service offering that is available on most diagnostic imaging equipment. iLinq brings direct,
interactive communications and other advanced Service features to GE Healthcare customers via an InSite
connection directly on the diagnostic imaging equipment itself.
The main focus of the iLinq release is the "Contact GE" feature. This functionality lets you request help from the
experts in GE's OnLine Center directly from the equipment's console. GE's technical experts in the OnLine Center
are informed of your request, and respond to your call.
The advantages of contacting GE in this manner are:
1. You stay in front of the console, and enter your request by simply pushing a few buttons.
2. You do not need to remember any specific instructions like telephone number, systemID reference, etc.
3. All your iLinq requests are treated as top priority calls. You will receive an electronic acknowledgement within a
few minutes, confirming the request. GE's OnLine center will call you shortly after to confirm job status.
4. The OnLine experts get your request for help directly via an electronic alert mechanism.
5. As your request comes in, the equipment automatically sends key technical info, like error logs, to the OnLine
experts so they can analyze system operation without delay.
6. The OnLine experts can also communicate electronically, sending information back to you directly on the
equipment.
FOR OPTIMAL PERFORMANCE AND RELIABILITY OF THE iLinq CONNECTION, A

BROADBAND CONNECTION (ISDN, VPN, NHS) IS STRONGLY ADVISED.
2 Starting ILinq
To access the iLinq features, click on the iLinq button on the DL Browser screen of your GE equipment. This is
located under the "Utilities" icon.
The iLinq main screen will appear.
If your GE equipment does not have the iLinq licenses installed, contact your local GE Service representative for
details on how to get it. iLinq is activated remotely, via the InSite connection, and does not require any manual step
or access to the equipment.
It is from this main screen that you select which iLinq feature to use.
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1 Applications Self Help

2 Contact GE
3 Community
4 Messages
5 Virtual Assist
6 Online Tutorial
7 iLinq Help
8 Close
3 Features
3-1 Applications Self Help
Clicking on button (1) opens a new window:
Solutions: Use this to access answers to most commonly asked questions.

Quick Steps: Not applicable on this product.
Education and Tip TV: This provides access into the GEHC Online Training & Education information.
Accessories: This provides access into the GEHC Accessories Online Catalog.
3-2 Contact GE
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Contact GE: Use this to ask questions to applications specialists or to send a problem report directly to the Online
Center.
Phone Number: Provides the phone number to call Online Center.
3-3 Community
GE Community: This provides access to the GE Community web site. The site allows you to network with your
peers in the GE on-line community and provides you with the latest information at your operator console. For
certain areas of this site, users are required to register via the GE Single Sign On to access this community. Single
Sign-on requires an e-mail address to register.
Modality Neighborhood: This provides access to the modality neighborhood web site corresponding to your
equipment type. This feature provides access to latest information related to your equipment type. The content
varies by modality.
eFlex Trial: This provides access to the eFlexTrial web site. This feature provides access to a list of available
packages for your type of imaging equipment. Please note that not all imaging equipment will have products
available through eFlexTrial. You can select the software package, try it free for a limited time and buy it directly
from the operator console. To download a package, you need to provide login information. If you don't have this
login information, please go to the GE Community web site to register and to set up your username and password.
You can get to the GE Community web site by selecting the Community button on the left side of the page and
clicking on the GE Community link in the submenu.
Clinical Cases: This provides a sample of cases that you may be interested in performing. These clinical cases
are selected by other technologists and are updated on a regular basis. This feature provides clinical cases only
related to your imaging equipment.
3-4 Messages
Current Messages: A list of your current messages appears, the most recent messages listed first. You may need
to scroll down to see all the messages.
Saved Messages: Access to your saved messages.
3-5 Virtual Assist

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Tip Virtual Assist: Allows a Customer to be remotely trained by an Application Specialist or the On Line Center.
The Customer will need to initiate a TVA session. Before starting the session, the Customer shall agree with the
stated conditions that appear in a pop up message. To agree, the Customer will need to press the Accept button. If
the Customer does not agree or does not want to initiate a session, the Cancel button shall be pressed.
The remote User connects to the system by providing a Customer-defined password to watch and take control over
the system standard inputs, that is, the mouse and the keyboard.
The Customer may change the password that the remote User needs to enter by pressing the Change Session
Password button.
Once connected, the remote User will not be dependent on the Customer for any activity.
This feature does not impact regular clinical applications, and the Customer can disconnect the remote User at any
time from the console.
Notice: Depending on local regulation, patient consent might be required to autorize any GE Healthcare
support to access his/her demographic information prior the launch of the TVA program.
Note: The performances of the system may be degraded during a TVA session. The announced performances do
not apply in this mode.
Service Virtual Assist: Allows an Online Engineer to remotely perform service actions that would normally be
available from the DL desktop, using the standard inputs, that is, the mouse and the keyboard. The Customer will
need to initiate a TVA session. Before starting the session, the Customer shall agree with the stated conditions that
appear in a pop up message. To agree, the Customer will need to press the Accept button. If the Customer does
not agree or does not want to initiate a session, the Cancel button shall be pressed.
The Customer may change the password that the remote User needs to enter by pressing the Change Session
Password button.
The remote User must provide a Customer-defined password for the session to be successfully established.
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Once connected, the remote User will not be dependent on the Customer for any activity.
This feature does not impact regular clinical applications, and the Customer can disconnect the remote User at any
time from the console.
Notice: Depending on local regulation, patient consent might be required to autorize any GE Healthcare
support to access his/her demographic information prior the launch of the SVA program.
3-6 Online Tutorial
The OnLine Tutorial button (6) will provide the user with a detailed tutorial on how to use the iLinq application and
all it's functionality.
3-7 Help
The Help button (7) will provide you with a summary text explaining how to use iLinq.
3-8 Close
The Close button (8) will close all iLinq screens and return you to the Browser.

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Chapter 18 - Advantage Workstation (AW) Configuration (Option)

1 Introduction
- The Advantage Workstation (AW) delivered for the Innova system is loaded with a specific
software to allow Innova image review and processing. - Subtracted images acquired on the
Innova system can be visualized in Sub mode or reprocessed only on the AW delivered for
the Innova system. - Innova images networked to any other workstation/PACS... can be
reviewed only in No Sub mode.
2 Helpful Information
All general information and information about Patient List Browser and Viewer can be found in the AW OM
corresponding to the AW version installed.
• AW VS5/VS6: 5396335-1xx, Revision 2
• AW VS4: 5307751-1xx, Revision 4
3 In-Room Monitor Display

The video of the In-Room monitor can be switched ON or OFF from the remote button located in control room.
1 Video ON/OFF
532 Advantage Workstation (AW) Configuration (Option)

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Chapter 19 - Diamentor M4 KDK (Option)

1 Introduction
1-1 General description of the Diamentor M4 KDK
Note: This option is not available for China.
The DIAMENTOR M4 KDK dosimeter assists Radiology personnel in giving additional informative values of a
patient's exposure during an examination. To meet regulatory requirements based on the international safety
standards IEC 60601-2-43:2000 and/or 21 CFR 1020.32 (k), use as reference the exposure dose displayed on the
DL console, live or reference display.
4 parameters are available:
• The Cumulative Dose (while not in loading state).
• The Dose Area Product (while not in loading state).
• The Dose Rate (while in loading state).
• The Dose Area Product Rate (while in loading state).
In addition to these dosimetric indications, the irradiation time is also available on the Diamentor M4 KDK main and
secondary display.
Units available:
• Dose: mGy.
• DAP (Dose Area Product): cGy.cm², µGy.m², Gy.cm².
• Dose Rate: mGy/s.
• Dose Area Product Rate: cGy.cm²/s, µGy.m²/s, Gy.cm²/s.
Note: The ‘Cumulative dose’ and ‘Dose’ is the ‘Cumulative Air Kerma (CAK)’ and the ‘Dose rate’ is the ‘Air Kerma
Rate (AKR)’.
To record the Dose, DAP, Dose Rate, and DAP Rate, a double ionization chamber is fixed at the output of the
X-ray tube collimator. There is a cable connecting the chamber to the main unit.
One or two secondary displays connected to the main control unit and fixed on the monitor boom display the dose
information in the X-ray Room.
One ionization chamber can be connected to the main unit to record the Dose, DAP, Dose Rate, and DAP Rate of
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one X-ray tubes.

An optional printer can be connected to the main unit to enable dose report printing on labels.
When the CAK reaches 10 Gy, the Diamentor M4 KDK displays OL (Overload). To avoid
information loss, before the CAK reaches 10 Gy (e.g. 5 Gy), write down (or print) the CAK
value and reset the Diamentor M4 KDK. Repeat this operation as many times as needed to
avoid the 10 Gy limit. At the end of the patient exam, add all written (or printed) values to
estimate the exam CAK value.
When an optional Diamentor M4 KDK is installed on the system, the values displayed on the DL console, live or
reference monitor may be different from the Diamentor M4 KDK values since they are based on the internal
dosimetric indications of the system.
1-2 Dose Measurement at Interventional Reference Point
A Diamentor is a device that displays dose values measured at a fixed distance of the focal point.
The interventional reference point is defined as the point on the reference axis, 15 cm from the isocenter, in the
direction of the focal point.
The following table presents the different possible Interventional Reference Point distances:
Chamber/Patient Distance (CPD) and Source/Chamber Distance (SCD) must be set at the following values
depending on the detector size :
System Flat Panel SOD (cm) Reference point dis- CPD SCD
(Source Object Dis- tance from source (in (in cm) (in mm)
tance) cm)
Innova IGS 620 20 x 20 72 57 (72-15) 30 270

Frontal
Innova IGS 630 30 x 30 72 57 (72-15) 26 307

Frontal
Innova IGS 620 Lat- 20 x 20 71 56 (71-15) 29 270

eral
Innova IGS 630 Lat- 30 x 30 71 56 (71-15) 25 307

eral
2 Operating Controls and Indicators

2-1 Diamentor M4 KDK, front view
534 Diamentor M4 KDK (Option)

InnovaTM IGS 620,
InnovaTM IGS 630
1. Digital display.
2. <Reset> key to reset to zero the dose area product and entrance dose readings as well as the time and to quit
the setup menu without saving the modified settings. Secondary displays connected are also reset.
Depending on the setup menu configuration, <Reset> will also initiate a printout; refer to Diamentor M4 KDK
(Option) / System Configuration (Setup Menu). In addition, the key is used to terminate entry of the
chamber-patient distance without saving the new value.
3. key: cursor control key used in the setup menu (up) and to enter the Chamber-Patient Distance.
4. <Enter> key to access submenus of the setup menu and to enable the Chamber-Patient Distance entry mode.
5. key: cursor control key used in the setup menu (down), to enter the Chamber-Patient Distance and to display
the calibration menu.
6. Contrast adjustment .
7. <Print> key to initiate a printout and to quit the setup menu, saving the modified settings. In addition, the key
is used to terminate entry of the Chamber-Patient Distance, saving the new value.
2-2 Diamentor M4 KDK, top view

InnovaTM IGS 620,
InnovaTM IGS 630
1. Chamber connection B.
2. High-voltage fuse for ionization chamber (20 mA, slow-blow).
3. Chamber connection A.
4. Power switch.
5. Power input fuse.
6. Power input.
7. Nameplate (on rear panel).
8. <Test> button to perform a Diamentor M4 KDK (Option) / Performing a Measurement / Constancy Check of the
device.
9. Serial interface for connection of a printer or PC.
10.2 connectors for secondary displays.
Symbols as marked on the equipment
| power on
power off
contrast adjustment
brightness adjustment (secondary display)
up
down
AC voltage
3 Performing a Measurement
3-1 Constancy Check
Check the device performance every day, before putting the Diamentor M4 KDK into operation.
1. Turn on the device and wait for the display to illuminate.
2. Press the <Test> button 2.

InnovaTM IGS 620,
InnovaTM IGS 630
Power switch 1 and <Test> button 2
The test screen will be displayed (Illustration Test screen). When no problem is found, the message "Test passed"
appears briefly afterwards. The test screen clears automatically after approx. 3 seconds.
Test screen
Note: This test is meant to check the stability of the electrical calibration. For this purpose a test charge is injected
to the amplifier input (deviation +/-1 %) and the resulting gain is compared with the factory calibration.
The percentage deviation is indicated for each channel. Deviations of +/-5 % are admissible (message: Test
passed). When the deviation exceeds +/ 5 %, the message "Test failed" appears (confirm message with <Print>).
In the second case, repeat the test. Should the "Test failed" message be displayed again, the Diamentor M4 KDK
must be repaired before it can be used again.
3-2 Measurement
When the device has passed the test, the measured values will be shown in the selected format as soon as
radiation is detected.
A filter or tubus placed between chamber and patient will reduce the dose area product and
entrance dose relevant for the patient. In this situation the Diamentor M4 KDK will display
dose area product and entrance dose values which are too high. According to national
regulations in Germany (1), however, it is sufficient to record the measuring value and the
filter or tubus in use for reconstruction of the radiation exposure level. Should the system
be permanently used with the filter or tubus, it is recommended to recalibrate the Diamentor
M4 KDK.
(1) Ask your competent authority about the regulatory situation.
3-2-1 Note on warm-up time
The device requires a minimum warm-up period of 15 minutes before a measurement can be performed, because
the leakage is very high during this time. As the leakage changes in the beginning, it would not make sense to
perform the zero adjustment within the first 15 minutes. The leakage has a strong effect only on measurements
with small measuring values and long measuring times. Therefore, measurements with high values and short times

InnovaTM IGS 620,
InnovaTM IGS 630
can be taken earlier.

See Diamentor M4 KDK (Option) / System Configuration (Setup Menu) / Zero adjustment for further details.
1. Press the <Print> key (Item 2) to obtain a printout of the measured value, if you have not selected the AUTO
PRINT mode.
2. Then, before performing the next measurement, reset the display to zero with the <Reset> key (Item 1).
3. If you are in the AUTO PRINT mode, the measurement will be automatically documented when you press
<Reset>.
Diamentor M4 KDK, <Print> and <Reset> keys
4. Having performed all measurements, turn off the Diamentor M4 KDK.

3-2-2 Chamber-Patient Distance
The Diamentor M4 KDK calculates the value of the entrance dose in the patient plane from the value measured in
the chamber plane.
The value is calculated according to the following formula:
DPat = Dose in patient plane

Dcha = Dose in chamber plane
SCD = Source-Chamber Distance
CPD = Chamber-Patient Distance
The Source-Chamber Distance depends on the X-ray unit and the installation of the measuring chamber. It must be
set once during installation of the Diamentor M4 KDK in the Corrections menu (See Diamentor M4 KDK (Option) /
System Configuration (Setup Menu) / Source-Chamber Distance). The Chamber-Patient Distance may vary
between measurements. Therefore, the value is set immediately before a measurement.
The Diamentor M4 KDK accepts Chamber-Patient Distances in the range of (0 ... 199) cm.
The entry mode for the Chamber-Patient Distance is enabled simply by pressing the <Enter> key.
When you are in this mode, a digit of the Chamber-Patient Distance will appear in reverse video, indicating that it
can be changed. You change the value with the / keys.
With the <Enter> key, you confirm the new value and activate the digit to the left which now appears in reverse
video. When you have entered the correct value, press <Enter> again to exit the entry mode and save the value.
Pressing the <Reset> key disables the entry mode for the Chamber-Patient Distance. Changes are not saved; the

InnovaTM IGS 620,
InnovaTM IGS 630
previous Chamber-Patient Distance will be retained.

Pressing the <Print> key disables the entry mode for the Chamber-Patient Distance, but changes will be saved.
As the value of the Chamber-Patient Distance directly influences the measuring result of the entrance dose
according to the above formula, the accuracy of the measuring result depends strongly on the accuracy of the
Chamber-Patient Distance
Should the Chamber-Patient Distance vary considerably during a measurement, it is recommended to divide the
measurement into several single measurements if a very accurate measurement result is needed. For each of
these measurements you can set the correct Chamber-Patient Distance. Between measurements you must reset
the display to zero, and after the last measurement the results from the single measurements must be summed up
manually.
4 System Configuration (Setup Menu)

4-1 Some Basic Facts
The setup menu is used to perform some basic device adjustments. These settings are saved to the memory and
will not be lost when the device is switched off (See Diamentor M4 KDK (Option) / System Configuration (Setup
Menu) / Factory Settings). You can quit the setup menu at any time without saving the adjustments just made by
pressing the <Reset> key. If you wish to save the new settings, use the <Print> key to quit the menu. The setup
menu includes four submenus. The overview below shows the contents of each of the menus. The operating steps
are described on the following pages.
The device does not accept implausible entries.
Display (Submenu):
• Selection of the display format (independently for the Diamentor M4 KDK and the secondary display).
• Adjustment of the bar graph limits.
• Selection of the filter depth.
• Activation of the display test.
• Enabling/disabling the time display.
• Selection of the display resolution.
Date & Time (Submenu):
• Entry of date and time of day. Correction (Submenu):
• Initiating the zero adjustment.
• Entry of the chamber temperature.
• Entry of the chamber ambient pressure.
• Entry of the correction factor.
• Entry of the focus chamber distance.
Printer (Submenu):
• Entry of the printer control commands.
Language:
• English, German, Spanish, Italian, French.
Dose area product Unit:
• Selecting the unit for dose area product measurement: cGy.cm², µGy.m², Gy.cm².
RS232:
• Printer, PC or unassigned.

InnovaTM IGS 620,
InnovaTM IGS 630
Print Mode:
• AUTO ON/OFF (initiate an automatic printout with <Reset>: yes/no).
4-2 Factory Settings
The device is delivered with the following factory settings:
Display format (1-4-5):
[D-d] [E-e] [D-d] [E-e] [D-d] [E-e]
Bar graph limits (1-4-6):
low = 0 and high = 3600 cGy.cm²/s
Filter depth (1-4-7):
3
Time (1-4-8):
ON
Display test (1-4-10):
N/A
Date & Time (1-4-11):
Is set to the date & time in Germany
Zero adjustment (1-4-12):
N/A
Chamber temperature (1-4-13):
20 °C
Air pressure (1-4-13):
1013 hPa
Correction factor (1-4-13):
1
Init code (1-4-15):
<000> <000> <000> <000>
Paper feed (1-4-15):
<009> <010> <000> <000>
Note: This is the printer setup for the STAR printer DP8340S (PTW ordering number L991096). This is also the
default setting even if the Diamentor M4 KDK is delivered without a printer.
Language (1-4-4):
English
Dose area product unit (1-4-17):
µGy.m²
RS232 (1-4-18):
Computer
Note: If the Diamentor M4 KDK is delivered with a printer, this option is set to "Printer".
Print mode (1-4-19):

InnovaTM IGS 620,
InnovaTM IGS 630
AUTO OFF
4-3 Displaying the Setup Menu
• Press or and, keeping either key depressed, push <Enter> to display the setup menu. (If you press the
<Enter> key first, the Diamentor M4 KDK changes to the mode for entry of the Chamber-Patient Distance).
Setup menu
4-4 Selecting the Language

Before proceeding for further adjustments, you should first select the language.
• Using one of the cursor keys, move the cursor to "Language" and press <Enter>.
• Select English, German, Spanish, Italian or French and press <Enter>.
From now on the texts are displayed in the selected language and you can proceed to make further adjustments. In
order to save the language selection, however, you must exit the setup menu with <Print>.
4-5 Selecting the Display Format (Display Submenu)
On the Diamentor M4 KDK as well as on the secondary displays the measured values can be shown either on one
line or on two lines. When only a single line is used, the bar graph expands accordingly.
The following parameters can be selected independently for display on the left on each line of the Diamentor M4
KDK and the two secondary displays:
• [DFP] display of the dose area product.
• [EFD] display of the entrance dose.
• [dfp] display of the dose area product rate.
• [efd] display of the entrance dose rate.
• [D-d] automatic switching: display of the dose area product rate while radiation is detected
<--> display of the dose area product if no radiation is detected.
• [E-e] automatic switching: display of the entrance dose rate if radiation is detected
<--> display of the entrance dose if no radiation is detected.
• [ ] no measuring value.
In the first square brackets to the right of "Display" you choose the measuring value to appear in the first display
line of the Diamentor M4 KDK, in the second square brackets to choose the value for the second display line of the
Diamentor M4 KDK.
If you choose [ ] (= no measuring value) for the second display line, you get a full-size bar graph.
The measuring values selectable in the third up to the sixth square brackets are used for the configuration of the
secondary displays Diamentor SD.
For option [DFP], [dfp] and [D-d], the dose area product or the dose area product rate, respectively, is displayed in
the display area to the left. In the display area to the right you will see the measuring value for the fluoroscopy time.
The line is labeled with a "D:" in the left margin of the Diamentor M4 KDK but it is labeled with an "A:" on the
display of the Diamentor SD.

InnovaTM IGS 620,
InnovaTM IGS 630
For option [EFD], [efd] and [E-e], the measuring value for the entrance dose rate, respectively, is displayed in the
display area to the left. In the display area to the right you will see the current chamber-patient distance. The line is
labeled with a "E:" in the left margin.
Using the cursor key , select "Display" and press <Enter>.
The Display submenu will be shown (Illustration Display menu).
Display menu
1 - Parameter for 1st line on Diamentor display

2 - Parameter for 2nd line on Diamentor display
3 - Parameter for 1st line on secondary display 1
4 - Parameter for 2nd line on secondary display 1
5 - Parameter for 1st line on secondary display 2
6 - Parameter for 2nd line on secondary display 2
The six pairs of brackets to the tight of "Display" represent the 6 lines to choose from Illustration Display Menu.
• Press <Enter> (the cursor starts flashing on the first bracket), then press one of the cursor keys repeatedly until
you reach the correct parameter.
– [DFP] display of the dose area product
– [EFD] display of the entrance dose
– [dfp] display of the dose area product rate
– [efd] display of the entrance dose rate
– [D-d] automatic switching: display of the dose area product rate while radiation is detected
<--> display of the dose area product if no radiation is detected.
– [E-e] automatic switching: display of the entrance dose rate if radiation is detected
<--> display of the entrance dose if no radiation is detected.
– [ ] no measuring value.
• Press <Enter> to move the next bracket.
• Proceed in the same manner for all other brackets.
• When finished, you can continue adjusting other device settings, or you can quit the submenu and the setup
menu with <Reset> (selections will be lost) or with <Print> (selections will be saved).

InnovaTM IGS 620,
InnovaTM IGS 630
Example
1 - Measuring unit for the first line (display area to the left)
2 - Measuring unit for the second line (display area to the left)
3 - Measuring unit for the first line (display area to the right)
4 - Measuring unit for the second line (display area to the right)
5 - Fluoroscopy time
6 - Chamber-Patient Distance
7 - Bar graph for the dose area product rate
8 - Entrance dose
9 - Dose area product
4-6 Bar Graph Limits (Display Submenu)
The length of the bar graph corresponds to the dose area product rate. If the measured dose area product rate is
below the low limit, the bar graph will not deflect. If the measured value reaches the high limit, the bar graph
deflects to full scale. The bar graph starts flashing when the dose area product rate exceeds the high limit.
Note: The fact that the reading exceeds the high limit is indicated only by the bar graph flashing.
The bar graph scale is linear. Limits can be adjusted in the range between 0.000 cGycm²/s and 30,000 cGycm²/s.
The following limitations must be observed: (max. - min.) > 1 cGycm²/s; min. > 0.8 max.
• Call up the Display menu.
• Using the cursor keys, select "Bargraph limits" and press <Enter>.
• Using the cursor keys, adjust the first digit of the low limit, or press <Enter> to access the second digit.
4-7 Filter Depth (Display Submenu)
The Diamentor M4 KDK calculates the dose area product rate on the basis of the change of the dose area product
over a period of time T between approx. 0.6 and 6 seconds. The time T automatically adapts to the radiation pulse
frequency of the X-ray device, allowing the dose area product rate to be indicated even in the presence of pulsed
fluoroscopy.
The chain of dose area product rate values determined in this manner are sent through a digital filter with
adjustable filter depth for further smoothing before being displayed.
Major signal changes exceeding 12.5 % pass this filter undelayed. Minor changes build up in dependance of the
selected filter depth:
0 = filter off T = 60 ms (fixed)

InnovaTM IGS 620,
InnovaTM IGS 630
1 = filter off residual noise for pulsed fluoroscopy approx. 9 %
5 = filter off residual noise for pulsed fluoroscopy approx. 9 % / 5 setting time to 90 %
approx. 5 x 2.3 x T
9 = filter off residual noise for pulsed fluoroscopy approx. 9 % / 9 setting time to 90 %
approx. 9 x 2.3 x T
4-8 Time (Option)

The fluoroscopy time determined by the Diamentor M4 KDK, both in continuous and pulsed mode, is equivalent to
the difference in time between beginning and end of the fluoroscopic sequence. In the pulsed mode, the time
includes the pauses, if these are shorter than 0.6 s.
If, in pulsed mode, pauses longer than 0.6 s occur, the fluoroscopy time determined by the Diamentor M4 KDK may
not be identical with the duration of the fluoroscopic sequence.
For this reason, the fluoroscopy time readout can be disabled in the Diamentor M4 KDK display Setup menu.
4-9 Sensitivity (Display Submenu)
You can choose between two sensitivity levels for the Diamentor M4 KDK display:
• Low sensitivity:
The display resolution for the dose area product is fixed at 0.1 cGycm².
The maximum DAP value that can be displayed is 99999.9 cGycm².
The display resolution for the dose area product rate is fixed at 0.1 cGycm²/s.
• High sensitivity:
The display resolution for the DAP begins at 0.01 cGycm².
If the sum of the DAP values measured in both channels reaches 9999.99 cGycm², the display resolution
changes to 1 cGycm².
With this resolution, the maximum DAP value that can be displayed is 999999 cGycm².
The display resolution for the dose area product rate is 0.01 cGycm²/s until the instantaneous value of the
added sum of the DAP rate values measured in both channels exceeds 9999.99 cGycm²/s.
If the instantaneous value of the added sum of the DAP rate measuring values exceeds 9999.99 cGycm²/s, the
display resolution changes to 1 cGycm²/s.
The same applies, when the display unit selected at the Diamentor M4 KDK is not cGycm².
The selected sensitivity is valid for the Diamentor M4 KDK display as well as for the secondary displays Diamentor
SD which can be connected.
The sensitivity does not affect the displayed entrance dose (rate).
4-10 Display Test (Display Submenu)
With the display test option you initiate a performance test of the digital display. The test ends automatically after
approx. 40 seconds.
• Call up the Display menu.
• Using the cursor keys, select "Display Test" and press <Enter>.
4-11 Date & Time (Date & Time Menu)
• In the Setup menu, move the cursor to "Date & Time" and press <Enter>.
The Date & Time menu appears.
• Move the cursor to Date or Time and press <Enter>.
• Using the cursor keys, adjust the first digit of the date or the time and press <Enter>.

InnovaTM IGS 620,
InnovaTM IGS 630
• Adjust the other digits in the same manner. The internal clock does not stop while the menu is being displayed.
The Diamentor adopts the new time as soon as you quit the menu with <Print>.
Date & Time menu
4-12 Zero Adjustment (Corrections Menu)

High resolution of the charge is an important requirement in the measurement of the entrance dose. Consequently,
inevitable leakage currents of the chamber, chamber cable and amplifier have an influence on the measuring result
of the Diamentor M4 KDK. In order to obtain correct measurement results, the zero adjustment must be performed
with an unirradiated chamber and with great care.
Fluctuations in the leakage currents of the Diamentor M4 KDK are particularly strong in the first 15 minutes after
turning the device on. Therefore, you should allow for a warm-up period of at least 15 minutes before performing
the zero adjustment.
If you need measuring values with very little leakage during a long-term measurement, it is recommended to repeat
the zero adjustment after a warm-up period of four hours and then leave the Diamentor M4 KDK turned on (over
night).
The zero adjustment should be repeated if the ambient temperature or humidity changes.
• In the setup menu, move the cursor to "Corrections" and press <Enter>.
The Corrections menu appears and the cursor flashes on "Zero instrument".
• Press <Enter> to initiate the zero adjustment procedure.
If the system displays the message "Off-set current out of range. Confirm with PRINT" at the
end of the procedure, the system could not be zeroed.
Corrections menu
4-13 Chamber Temperature, Air Pressure and Correction Factors (Corrections Menu)
Before putting the Diamentor into operation, the chamber temperature and air pressure for air density correction
must be specified. If there are radiation absorbing parts between the patient and the chamber (such as the patient
couch), the corresponding correction factor must be entered as well.
• Display the Corrections menu.
• Using the cursor keys, select one of the menu items and press <Enter>.
• Using the cursor keys again, adjust the first digit and confirm it with <Enter>.
• Proceed in the same manner to adjust all other digits.

InnovaTM IGS 620,
InnovaTM IGS 630
Adjustment ranges:
temperature (0 ... 70) °C
air pressure (500 ... 1500) hPa
correction factor 0.000 ... 9.999
The air density correction factor is calculated by the following formula:
PO = 1013 hPa
tO = 20 °C
t = actual temperature
P = actual air pressure
You can set only one correction factor for the Diamentor M4 KDK. As both measuring chambers form a unit, the
installation is the same for both chambers (under-table tube or over-table tube). Therefore, it would not make sense
to set different correction factors for the two chambers.
4-14 Source-Chamber Distance
The Diamentor M4 KDK calculates the value of the entrance dose in the patient plane from the value measured in
the chamber plane.
The values are calculated according to the following formula:
DPat = Dose in patient plane

Dcha = Dose in chamber plane
SCD = Source-Chamber Distance
CPD = Chamber-Patient Distance
The Source-Chamber Distance depends on the X-ray unit and the installation of the measuring chamber. It must be
set once during the installation of the Diamentor M4 KDK in the Corrections menu.
The Chamber-Patient Distance may vary between measurements. Therefore, the value is set immediately before a
measurement (See Diamentor M4 KDK (Option) / Performing a Measurement / Measurement / Chamber-Patient
Distance).
As the Source-Chamber Distance directly affects the measuring result, you should set the value as precise as
possible to avoid errors.
4-15 Printer Control (Printer Menu)
Via the printer menu you can make all adjustments required to control the printer.
The table below shows the adjustments for the recommended printers.
• In the setup menu, move the cursor to "Printer" and press <Enter>.
The Printer Setup menu appears.
Printer menu

InnovaTM IGS 620,
InnovaTM IGS 630
Printer Left mar- Init code Paper feed

gin
STAR DP8340S <02> <000> <000> <000> <000> <009> <010> <000> <000>
COSYS LP2042 <06> <027> <081> <063> <000> <001> <012> <010> <000>
ELTRON COMPANION PLUS <06> <094> <080> <094> <080> <001> <094> <080> <000>
4-16 Entering the Label Headline

• Display the printer menu.
• Move the cursor to "H" and press <Enter>.
• Using the cursor keys, select the first character (numbers and letters) and press <Enter>.
• Proceed in the same manner to select the other characters.
You may enter a headline of up to 36 characters.
Setup menu (repeated)
4-17 Dose Area Product Unit

Different radiological units for dose area product reading can be selected: cGy.cm², mGy.m², Gy.cm².
• Display the Setup menu.
• Move the cursor to "Dose Area Product Unit" and press <Enter>.
• Using the cursor keys, select one of the units.
Note: The unit of the entrance dose is always mGy, irrespective of the unit set for the dose area product.
4-18 RS232 Interface (SERIAL port 9)
A printer or a PC can be connected to the serial port 9. In the RS232 menu, make the appropriate choice: "Printer",
"Computer", " " (port not assigned).
• Move the cursor to "RS232" and press <Enter>.
• Using the cursor keys, select one of the choices.
4-19 Print Mode
You can select an AUTO PRINT mode in which the Diamentor M4 KDK will automatically document the
measurement result when you delete it with <Reset> (AUTO ON).
• Move the cursor to "Print Mode" and press <Enter>.

InnovaTM IGS 620,
InnovaTM IGS 630
• Using the cursor keys, select one of the options.
5 Maintenance
The measures provided by the M4 KDK are determined by Calibration factors.
A maintenance of the M4 KDK is necessary every two years to ensure calibration factors are valid (i.e. measures
are accurate).
If your equipment is maintained by GE Healthcare, this maintenance will be performed during a periodic
maintenance.
If your equipment is maintained by a service provider other than GE Healthcare, a request should be made to your
service provider to perform this maintenance or, alternatively, you may request a preventive maintenance from your
local GE Healthcare service provider.
6 Restrictions
The values recorded by the Diamentor M4 KDK are accurate as required by the International Standards in the
following working conditions:
• Temperature within 10 to 40 °C.
• Field of views not smaller than the smallest Field of view available with collimator blades wide opened.

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 20 - Maintenance Schedule

In order to obtain continued safe performance of this X-ray equipment, a periodic maintenance program must be
established. It is the owner's responsibility to supply or arrange for this service.
Periodic Maintenance requirements detailed in the System Service Manual are listed in the following table.
In case of third party monitor suspension, refer to the manufacturer’s maintenance instructions and periodicity.
Sub- Check Job Card Periodicity

assembly
6M 1Y 2Y 3Y 5Y
Frontal Lock/Unlock CHK0085 x
Gantry check
Emergency CHK0087 x
Back Out
check
Frontal CHK0088 x
Gantry Anti-
Collision
check
TSSC Emer- CHK0086 x
gency Stop
Button check
Frontal CHK0090 x
Gantry cali-
bration check
Quick Appli- CHK0095 x
cation check
Grid detection PM0050 x
check
Lateral Lateral CHK0092 x
Gantry Gantry Anti-
Collision
check
Lateral CHK0093 x
Gantry cali-
bration check
Lateral PM0064 x
Gantry rail
cleaning
Grid detection PM0050 x
check
Maintenance Schedule 549

InnovaTM IGS 620,
InnovaTM IGS 630
Omega Table Table calibra- CHK0091 x

tion check
Table Rota- PM0071 x
tion Brake
Plate cleaning
Table Lateral PM0094 x
Brake Plate
cleaning
Table moving CHK0179 x
protective
earth cables
check
Check the - x
Tabletop on
both sides in
fully longitudi-
nal position to
ensure no
cracks or
damages are
present
550 Maintenance Schedule

InnovaTM IGS 620,
InnovaTM IGS 630
C1 Frontal DL fans PM0060 x

Cabinet cleaning
RTAC fan PM0060 x
cleaning
DL battery re- PM0058 x
placement (2
years)
System back SW0188, see x
up for sys- sections 3.1 &
tems with 21 3.2
& 31 cm de-
tectors (DL9)
tems with 21 3.2
& 31 cm de-
tectors
(DL9-2)
tems with 21 3.2
& 31 cm de-
tectors
(DL9EB)
RTAC battery PM0059 x
swap (2
years)
Jedi fan diag- PM0037 x
nostic
Jedi RAM KV PM0029 x
board re-
placement (5
years)
KV accuracy PM0038 x
C1 Lateral RTAC fans PM0060 x
Cabinet cleaning
RTAC battery PM0059 x
swap (2
years)
Jedi fan diag- PM0037 x
nostic
Jedi RAM KV PM0029 x
board re-
placement (5
years)
KV accuracy PM0038 x
C2 Cabinet Cabinet fan PM0033 x
cleaning

InnovaTM IGS 620,
InnovaTM IGS 630
Console Quick monitor CHK0096 x

calibrations
check
Frontal Digital Conditioner PM0051 x
Detector Flush & Fill
Conditioner PM0053 x
liquid level
check
Lateral Digital Conditioner PM0051 x
Detector Flush & Fill
Conditioner PM0053 x
liquid level
check
Frontal X-Ray Tube chiller PM0073 x
Tube Chiller pump assy
swap (3
years)
Tube chiller PM0075 x
check
Lateral X-Ray Tube chiller PM0073 x
Tube Chiller pump assy
swap (3
years)
Tube chiller PM0075 x
check
Frontal Colli- Collimator PM0036 x
mator Fans Check
Lateral Colli- Collimator PM0036 x
mator Fans Check
Frontal X-Ray 70°C Security CHK0060 x
Tube
70°C Sensor PM0056 x
Check
Lateral X-Ray 70°C Security CHK0060 x
Tube
70°C Sensor PM0056 x
Check

InnovaTM IGS 620,
InnovaTM IGS 630
3 kVA UPS 3 kVA UPS DR0994 x

Eaton Power-
ware 9130
Battery re-
placement
(For System
without Fluoro
UPS: every
1.5 years)
3 kVA UPS DR0994 x
Eaton Power-
ware 9130
Battery re-
placement
(For System
with Fluoro
UPS: every 3
years)
CE Power Emergency CHK0075 x
Distribution Power off
Box (EPO) check
CE PDB PM0066 x
breakers
check (with
fluoro UPS)
CE PDB PM0065 x
breakers
check
(without fluoro
UPS)
UL Power Emergency CHK0075 x
Distribution Power off
Box (EPO) check
UL PDB PM0068 x
breakers
check (with
fluoro UPS)
UL PDB PM0067 x
breakers
check
(without fluoro
UPS)

InnovaTM IGS 620,
InnovaTM IGS 630
Fluoro Unin- Fluoro UPS CHK0080 x

terruptible Functional
Power Supply Check
(UPS) Option
Fluoro UPS CHK0174 x
CE by GEHC CHK0176
(every year) CNF0227
CHK0175
CHK0080
Fluoro UPS CHK0128 x
UL by GEHC CHK0132
(every year) CNF0176
CHK0131
CHK0080
Frontal Diamentor CAL0087 x
Dosemeter calibration -
(1 year)
Lateral Diamentor CAL0087 x
Dosemeter calibration -
(1 year)
Radiation Rad shield Vendor x
shield sus- suspension
pension check

InnovaTM IGS 620,
InnovaTM IGS 630
Large Display Large Monitor PM0072 x

Monitor Manager Fan
Cleaning
Large Display CAL0132 x
Monitor Cali-
bration (every
6 months)
Large Display CHK0134 x
Option func-
tional check
(every 6
months)
Large Display (For 56" Mon- x
Monitor Lmax itor)
Check CHK0135
3 kVA Large DR0994 x
Display Moni-
tor Battery re-
placement
(For System
without Fluoro
UPS: every
1.5 years)
3 kVA Large DR0994 x
Display Moni-
tor Battery re-
placement
(For System
with Fluoro
UPS: every 3
years)
Suspension Mavig Sus- CHK0094 x
pension
Monitor Sus- PM0069 x
pension Rail
Cleaning

InnovaTM IGS 620,
InnovaTM IGS 630
Frontal Image ABC Stabi- CHK0063 x

Quality lization point
check
Bad Pixel Service User x
Interface
(SUIF)
Pixel Gain SUIF x
Conversion SUIF x
Factor
mRmAs SUIF x
Fluoro Tapers SUIF x
IQST SUIF x
QA check SUIF x
Lateral Image ABC Stabi- CHK0063 x
Quality lization point
check
Bad Pixel Service User x
Interface
(SUIF)
Pixel Gain SUIF x
Conversion SUIF x
Factor
mRmAs SUIF x
Fluoro Tapers SUIF x
IQST SUIF x
QA check SUIF x
3D Spin 3D spin cali- CAL0104 x
bration
Augmented CAL0129 x
calibration
Quick 3D CHK0051, x
check section 4.2

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 21 - Appendix - Technical Publications

1 System Line Voltage
Nominal Voltage Frequency Power consumption Type of power input
Nominal Peak Without Fluoro With Fluoro UPS
(at 125 kV, 100 UPS
ms, 640 mA)
380 V + 10% 50 Hz or 60 Hz (+ 60 kVA 150 kVA 3~ 3N~
3 Hz)
400 V + 10%
415 V + 10%
480 V + 10% 60 Hz (+ 3 Hz)
2 System Line Voltage - Options

Option Nominal Frequency Nominal Power Type of power input
Voltage consumption
LDM 100-120 V / 50 Hz or 60 Hz (+ 3 3 kVA Single phase
220-240 V Hz)
AW 100-127 V / 50 Hz or 60 Hz 11 A / 5.5 A Single phase
200-240 V
3 System Line Current Specifications

Max Line Impedance for feeder line between Generator cabinet and Hospital
V 380 400 420 440 460 480
Ohms 0.09 0.096 0.102 0.108 0.114 0.12
Technique factors that constitute the maximum line current condition is 100 kV, 1000 mA.
Hospital feeder line protection:
• 480V 3~ or 3N~ 60 Hz PDB configuration: circuit breaker, rating 150 A.
• 380/400/415V 3~ or 3N~ 50/60 Hz PDB configuration: circuit breaker, rating 80 A.
4 Generator Rating and Duty Cycle

4-1 High Voltage Generator Classification for Japan
Standard model name

IRF-1000-150
4-2 Generator rating in primary contacted mode

Primary contacted mode is a discontinuous mode where X-ray pulses are obtained through kV pulses.
• Peak power: 100 kW.
Appendix - Technical Publications 557

InnovaTM IGS 620,
InnovaTM IGS 630
• Average power: 3.2 kW avg.

• kV range: from 40 kV to 125 kV.
• mA range: from 10 mA up to 1000 mA.
4-3 Generator rating in gridded mode
Gridded mode is a discontinuous mode where X-ray pulses are obtained through tube current pulses with
permanent kV. Tube current pulses are obtained with the grid function which is responsible to cut tube mA on
cathode side.
• Peak power: 48 kW.
• kV range: from 60 kV to 120 kV.
• mA range: from 1 mA to 400 mA.
4-4 Generator duty-cycle
Generator can be used continuously as long as average power limitations described above are satisfied.
4-5 Minimum mAs
• 2 µAs in fluoro.
• 0.00325 mAs in record.
5 System: Maximum deviation of kVp and mA actual parameters from the

displayed parameters (during exposure)
• kVp = +/-10%.
• mA = +/-20%.
To measure kVp use an external HV-voltage divider in parallel with the tube (for example Machlett Dynalizer) and
measure the low-voltage output with a digital voltmeter (for example a Fluke 47).
To measure mA use the mid-point of the generator and correct by removing the generator bleeder current (contact
Service for more information).
6 System: Nominal Tube Current at Maximum kVp

• In Fluoroscopy
– Innova IGS 620: Maximum Tube current is 26.9 mA average (111.1 mA peak) for a tube voltage of 120 kV.
– Innova IGS 630: Maximum Tube current is 26.7 mA average (111.1 mA peak) for a tube voltage of 120 kV.
• In Cardiac record
– Maximum Tube current is 400 mA peak for a tube voltage of 120 kV in gridded mode.
– Maximum Tube current is 625 mA peak for a tube voltage of 120 kV in non gridded mode.
• In DSA record
– Maximum Tube current is 640 mA peak with a tube voltage of 125 kVp.
7 System: Nominal Tube Voltage Range when mA is Maximum

• In Fluoroscopy
– Innova IGS 620: Tube current is maximum at: 31.5 mA average, 130 mA peak in the tube voltage range of:
60 - 100 kV.
558 Appendix - Technical Publications

InnovaTM IGS 620,
InnovaTM IGS 630
– Innova IGS 630: Tube current is maximum at: 31.2 mA average, 130 mA peak in the tube voltage range of:
60 - 100 kV.
• In cardiac record
– Tube current is maximum at: 938 mA peak with a tube voltage of 80 kV in non gridded mode.
– Tube current is maximum at: 400 mA peak in tube voltage range of 80 - 120 kV in gridded mode.
• In DSA record
– Tube current is maximum at: 1000 mA peak with a tube voltage of: 80 kVp.
8 System: Maximum Power

• In Fluoroscopy:
– Innova IGS 620: Maximum power is 3.2 kW average (13.3 kW peak) with 120 kV, 26.9 mA average.
– Innova IGS 630: Maximum power is 3.2 kW average (13.3 kW peak) with 120 kV, 26.7 mA average.
• In Dynamic record, in gridded mode, maximum power is 48 kW peak with 120 kV, 400 mA peak.
• In Dynamic record, in non gridded mode, maximum power is 65 kW peak with 100 kV, 650 mA peak.
• In DSA record, maximum power is 80 kW peak with 100 kV, 800 mA peak.
Note: 0.1 s exposure time is in the range of DSA record exposure time.
9 System: Maximum mA at nominal tube voltage

French Quality Control: performance parameters for radiography in DSA mode with 100 ms pulse width:
kV mA max
Focal Spot 1 50 290
70 630
125 640
Focal Spot 0.6 50 169
70 313
125 267
Note: Measured on one pulse.
Appendix - Technical Publications 559

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 22 - Appendix - Radiation Safety Tutorial

1 Warning
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR. UNLESS
MEASURES OF PROTECTION ARE STRICTLY OBSERVED. THOUGH THIS EQUIPMENT IS

BUILT TO THE HIGHEST STANDARDS OF ELECTRICAL AND MECHANICAL SAFETY, THE
USEFUL X-RAY BEAM BECOMES A SOURCE OF DANGER IN THE HANDS OF THE
UNAUTHORIZED OR UNQUALIFIED OPERATOR. EXCESSIVE EXPOSURE TO X-RADIATION
CAUSES DAMAGE TO HUMAN TISSUE. THEREFORE, ADEQUATE PRECAUTIONS MUST BE
TAKEN TO PREVENT UNAUTHORIZED OR UNQUALIFIED PERSONS FROM OPERATING
THIS EQUIPMENT OR EXPOSING THEMSELVES OR OTHERS TO ITS RADIATION. BEFORE
OPERATION, PERSONS QUALIFIED AND AUTHORIZED TO OPERATE THIS EQUIPMENT
SHOULD BE FAMILIAR WITH THE RECOMMENDATIONS OF THE INTERNATIONAL
COMMISSION ON RADIOLOGICAL PROTECTION, CONTAINED IN ANNALS NUMBER 26 OF
THE ICRP, AND WITH APPLICABLE NATIONAL STANDARDS.
2 Learning objective
Increase your knowledge and help you develop safe work habits. Quick overview of X-ray radiation and dose
through a simple explanation of the equipment, technology and to discuss the different techniques available to
reduce dose.
3 Teaching points
• Radiation dose is a natural consequence of x-ray imaging.
• Displayed Dose Parameters.
• Effects of ionizing radiation on humans.
• Dose reduction measures for the patient.
• Dose reduction measures for the staff.
• Pediatrics Case.
• Legal Provisions.
4 Radiation dose is a natural consequence of x-ray imaging

• Images are created by the interaction of x-rays with materials.
• During this interaction x-rays leave some energy in the patient.
– Energy at the Image Detector is about 100 to 1000 less than energy entering the pa-
tient.
• Absorbed dose = mean energy imparted by the x-ray beam per unit mass at a point in
the tissue.
• Air Kerma = mean energy imparted to air.
– Usual way of reporting radiation dose.
– Compared to actual Skin dose, the Air Kerma differs material absorption of dose (a
few % effect) and do not include backscatter from underlying tissue (a 10-40% effect).
560 Appendix - Radiation Safety Tutorial

InnovaTM IGS 620,
InnovaTM IGS 630
5 Displayed Dose Parameters

5-1 Cumulated Air Kerma
• Air Kerma is cumulated over the

course of exam and displayed.
– By standard, it is determined for
a fixed distance to the x-ray
tube for isocentric C-arm
(Interventional Reference Point
or Patient Entrance Reference
Point).
• The cumulated Air Kerma is relat-
ed to the patient skin dose to some
extent:
– The reference point is only an
"average" representation of the
patient skin location.
– The accumulation is performed
over all gantry angulations and
Live display Reference display table positions.
1: Focal Spot
2: Reference Point
3: Isocenter
A: 57 cm on Innova monoplane units.
B: 15 cm
5-2 Cumulated Dose Area Product (DAP)

• DAP is the product of Air Kerma and exposed area and is cumulated over the course of exam and displayed.
– By nature, it is independent of distances to the focal spot.
• The cumulated DAP is related to the patient skin dose to some extent:
– DAP should be more representative of long-term risk (stochastic risk).
– The accumulation is performed over all gantry angulations and table positions.
– Several guidance levels based on DAP.
Appendix - Radiation Safety Tutorial 561

InnovaTM IGS 620,
InnovaTM IGS 630
Live display Reference display
1: Focal Spot
S: Surface of Area
AK: Air Kerma
DAP: Dose (Air Kerma) Area Product
6 Effects of ionizing radiation on humans

6-1 Deterministic effects
• Table describes several possible effect to the patient skin/hair for different approximate range of Skin Dose
estimate.
• Skin Dose estimate is not equal to cumulated Air Kerma.
• Approximate 3/5 ratio between Skin Dose estimate and cumulated Air Kerma.
– Due to gantry/table movements and different distance.
– From SIR-CIRSE recommendation: Stecker MS, Balter S, Towbin RB, et al. Guidelines for patient radiation
dose management. J Vasc Interv Radiol 2009 20 (7 suppl) S263 – S273.
Summary of tissue reactions from single-delivery Radiation Dose to Skin
Approximate Range Reactions

(Gy)

InnovaTM IGS 620,
InnovaTM IGS 630
0 to 2 • None Expected
2 to 5 • Transient erythema/epilation
Above 5 • Erythema/epilation transient or permanent

• Possible Moist desquamation, dermal athrophy above 10 Gy
For full table, refer to S. Balter et al. Fluoroscopically Guided Interventional Procedures: A
Review of Radiation Effects on Patients' Skin and Hair Radiology 254(2) 2010.
6-2 Stochastic effects

• Absorbed doses lower than deterministic threshold may increase natural risks of cancer or mutations.
• This risk is stochastic i.e. is a random effect. Within "linear non threshold hypothesis" the same collective dose
will generate the same number of pathologies regardless of the number of persons who receive it (100 mSv to
1000 persons each is equivalent to 10 mSv to 10 000 persons each, or to 1 mSv to 100 000 persons).
• Pediatrics patients are at greater risk with stochastic effects compared to adult, due to their longer potential life
and increased sensitivity to such effects.
7 Dose reduction measures for the patient

7-1 List
Several dose reduction means (non-exhaustive):
• Select the appropriate protocol.
• Appropriate use of Equipment distances (SID: Source to Image Distance, Table position).
• Change Gantry angulations during procedure.
• Minimize Sequence duration.
• Use of LIH (Last Image Hold).
• Adjust collimation without radiation.
• Select largest FOV with small exposed area with collimation.
• Select a lower dose rate:
– Use as low Frame rate as possible.
– Select Low detail vs Normal detail (~50% less dose).
– Have protocols preselected with lower dose setup (AutoEx preferences/fluoro dose strategy).
7-2 Appropriate protocols
• Select the appropriate protocol by target or anatomy:
– Use setup with the lowest value compatible with the medical requirement.
– Specific pediatric protocol available with Low detail setup.
– EP protocols (EP, EP + Mapping) specifically set to further low-dose setup.
– Changes in default values, protocols names and order of appearance (by alphabetical order) can be made in
protocol by Service or Application specialist.

InnovaTM IGS 620,
InnovaTM IGS 630
7-3 Equipment distances and angulations

• Use of Equipment distances (SID: Source to Image Distance, Table position):
– Minimize distance between patient, Image detector.
– Maximize between Patient and X-ray tube.
– Use Skin Spacer.
– Keep distance between detector and patient at minimum, can be facilitated with auto contouring option
(InnovaSense
).
• Use of Gantry angulations during procedure:
– Change angulations during the procedure, to avoid to cumulate dose on the same patient area.
7-4 Sequence duration, Last Image Hold
• Sequence duration:
– Minimize Radiation time, use the X-ray timer indications.
– The X-ray timer flashes and emits an audible signal after 5 minutes of X-ray time.

InnovaTM IGS 620,
InnovaTM IGS 630
• Use of LIH (Last Image Hold):

– LIH provides an image in between the live fluoro images to use as a reference image and eliminates the
need for extended fluoro exposures.
– Further reducing the need for additional fluoro exposure can be facilitated by storing the last frames (up to
450) of the fluoro sequence with the fluorostore .
7-5 Virtual collimation

Adjust collimation without radiation (Virtual Collimation):
• Enables positioning of collimator blades without irradiation.
• Means to visualize the virtual position of collimator blades by lines displayed over the live display image
(regardless if there is an image, a LIH or nothing).
• Uses the regular joystick for positioning the collimator blades.
7-6 FOV selection

Select largest FOV with small exposed area with collimation:
• When compatible with medical requirements for anatomy and/or tool(s) visibility at the current viewing distance
to the display monitors.
• The dose rate is increased at smaller FOV to provide increased visibility from both magnification effect and
reduced noise content.
• Collimating within the FOV decreases the overall exposure.
Lower dose can be achieved by using less magnified view, using a larger FOV with some collimation inside as
appropriate.

InnovaTM IGS 620,
InnovaTM IGS 630
FOV: Field of View
Example from the "Dose to patient" section, for Innova IGS 620, RDL+, Balanced Dose/IQ, 7.5 fps, Normal, at 20
cm patient size (PMMA cm). Refer to this Operator Manual section to find the data corresponding to your system
configuration.
7-7 AutoExposure preferences, Normal/Low setting
Lower dose rate:
• Select Low detail vs Normal detail (at tableside or console) when compatible with medical requirements for
anatomy and/or tool(s) visibility.
• Have protocols preselected with lower dose setup (AutoEx preferences).
– About 50% less Air Kerma rate in Low versus Normal, except at max fluoro dose limits (limits explained in
next section).
Example from the "Dose to pa-

tient" section of the Operator Man-
ual, for Innova IGS 620, 15 fps,
Balanced IQ/Dose, 20 cm FOV, at
20 cm patient size (PMMA cm).
Refer to this Operator Manual
section to find the data corre-
sponding to your system configu-
ration.
: Low
: Normal
Note: SmartIQ is offered on monoplane systems only.

Note: Depending on country regulations, some of the choice may not be available (e.g. only RDLx choices in

InnovaTM IGS 620,
InnovaTM IGS 630
Germany)
Lower dose rate selectable within a large range.
Choice of AutoEx preference to be preset in protocol by Service or Application specialist.
7-8 Frame Rate
Lower dose rate:
• Use as low Frame rate as possible (at tableside or console) compatible with medical requirements for the image
refresh rate (versus anatomy and/or tool(s) movements or changes).
• Have protocols preselected with lower dose setup (fluoro dose strategy).
Pulsed fluoroscopy with a choice of frame rate: 30 fps, 15 fps, 7.5 fps, 3.75 fps.
2 Options provided on Innova’s (to be preset within protocols by Service or Application Specialist).
Example from the "Dose to pa-

tient" section, for Innova IGS 620,
RDL Plus, Normal, 20 cm FOV, at
20 cm patient size (PMMA cm).
FOV: Field of View

Max Dose Reduction: Dose rate drops directly with fluoro frame rate.
Balanced IQ/Dose: Maintains static object detectability, noise appearance. Based on perception experi-
ment (Case Western University, OH, from the D.L. Wilson group).
7-9 Fluoro limit

Selecting fluoro limit "Low" and lower frame rates minimizes dose.
Highest reference dose (mGy/min) for For Autoexposure preference: IQ For Autoexposure preference: IQ
Fluoro settings Plus, RDL Plus, SmartIQ Standard, RDL Standard
Balanced IQ/Dose Max Dose Reduc- Balanced IQ/Dose Max Dose Reduc-
tion tion
30 fps Normal < 87.6 < 87.6 < 87.6 < 87.6
15 fps Normal < 87.6 < 43.8 < 87.6 < 43.8
7.5 fps Normal < 43.8 < 21.9 < 43.8 < 21.9
3.75 fps Normal < 21.9 < 21.9 < 21.9 < 21.9
30 fps Low < 87.6 < 87.6 < 43.8 < 43.8
15 fps Low < 87.6 < 43.8 < 43.8 < 21.9

InnovaTM IGS 620,
InnovaTM IGS 630
7.5 fps Low < 43.8 < 21.9 < 21.9 < 21.9
3.75 fps Low < 21.9 < 21.9 < 21.9 < 21.9
• Dose Limit in fluoro can be lowered when reducing frame rate (up to 4x) and using a different fluoro frame rate
strategy (up to 2x).
• Two main different ways – main difference is on the Low detail management for the standard AutoEx
preferences which are set lower than the regular ones (up to 2x).
7-10 Threshold
Display prior to the predefined Dose Threshold value being reached: • Watch the dose display and apply
dose reduction means as appropri-
Live display Reference display
ate.
– The display changes above the
predefined threshold.
• Other recommendations exist for
procedural dose warning.
– eg Values above 5 Gy indicates
that the patient should have
clinical follow-up for determinis-
tic radiation-induced injury
Display after the predefined Dose Threshold value has been exceeded (SIR-CIRSE recommenda-
(above 100%): tions).
Live display Reference display – eg. Use 500 Gy*cm2 as signifi-
cant radiation threshold
(SIR-CIRSE).
– eg. Use 3000 mGy as first noti-
fication, then each further addi-
tional 1000 mGy (SIR-CIRSE).
– eg. Use first notification 3000
mGy, then second one at 6000
mGy (ACR).
Display on live display after double of the predefined Dose Threshold SIR-CIRSE recommendation: Stecker
value has been reached: MS, Balter S, Towbin RB, et al.
Guidelines for patient radiation dose
management. J Vasc Interv Radiol
2009 20(7 supp) S263-S273.
ACR recommendation: Mahdevappa,
M, Detorie, N. How to prepare for the
joint commission's sentinel event poli-
cy pertaining to prolonged fluo-
roscopy. American College of Radiol-
ogy. The Medical Physics Consultant
2008 601-603.
8 Dose reduction measures for the staff

InnovaTM IGS 620,
InnovaTM IGS 630
• Minimize patient dose.

– Staff dose related to the patient dose scattered X-
rays mostly come from the patient dose entry
points.
• Be as far as possible.
– Radiation decreases as the inverse square of dis-
tance.
• Minimize your time near radiation sources when pos-
sible.
• Use radiation shield:
– Wear your personal ones.
– Position these between you and the patient dose
entry location, or locate yourself behind shields
whenever possible.
– Do not stay in the procedure room when your at-
tendance at tableside in not needed.
• Monitoring.
– Wear your personal dosimeter.
9 Pediatrics Case
The Innova IGS system is specifically designed to minimize radiation exposure while providing good image quality
for the intended pediatric and adult patients. Exposure to ionizing radiation is of particular concern in pediatric
patients as younger patients are more radiosensitive than adults and have a longer potential lifetime for the effects
of radiation exposure to manifest as cancer. Thus, the use of equipment and exposure settings designed for
pediatric patients are different from the ones used for adult patients.
9-1 Dose-related parameters default values
Depending on the anatomical region and patient’s age, a set of imaging system settings are categorized by
protocols. Pediatric protocols are optimized in terms of dose and temporal resolution.
Dose-related parameters default values of adult vs. pediatric protocols
Dose-related para- Adult Pediatric cardiac Pediatric cardiac Pediatric angio pro-
meters protocol protocol for tocols
neonates
Dose Threshold 2 or 3 Gy 1 Gy 1 Gy 1 Gy
Fluoro detail Normal* Low Low Low
Fluoro FPS 15 fps** 15 fps 30 fps 15 fps
Dynamic detail Normal* Low Low Low
Dynamic FPS 15 fps** 15 fps 30 fps 15 fps
DSA detail Normal N/A N/A Low
AutoExposure (Fluoro, Mostly SUIF AutoEx- RDL+ RDL+ RDL+
record Angio, record posure***
Cardiac)

InnovaTM IGS 620,
InnovaTM IGS 630
* Few adult protocols have Fluoro or Dynamic detail default value at Low (a non-exhaustive example is Dose
Limited protocols).
** Few adult protocols have Fluoro or Dynamic FPS default value different from 15.
*** Most adult protocols take the AutoExposure set in the Service User Interface (SUIF), but few adult protocols
have a defined AutoExposure (a non-exhaustive example is Dose Limited protocols defined at RDL+).
In addition to the dose-related default values, the system is able to optimize temporal resolution for pediatric
patients. The system also adapts a smaller ROI in dynamic fluoroscopy and in dynamic record, based on the exam
type (Angio or Cardiac) and the patient type (Adult or Pediatric). These correspond to attributes of a patient
protocol, and are set according to its usage. Further, there is a minimal spectral filtration of 0.1 mm for pediatric
protocols due to a higher radiosensitivity.
9-2 List of pediatric protocols
For pediatrics imaging, select a protocol on the system console under the "Pediatrics" category, or where the name
contains "Pedia". For details concerning how to select a protocol on the system console, please refer to section:
Innova Digital / How to select an Acquisition Protocol.
List of available pre-configured pediatric protocols by category:
Type of procedure Protocol name Category

Angio procedure Pedia Abdomen Pediatrics
Pedia Cerebral
Pedia Chest
Pedia Lower Limbs
Pedia Upper Limbs
Cardiac procedure Pedia Cardiac
Pedia Cardiac Neonate
In case of adult protocol selected while the patient’s age is below the "Pediatrics limit age threshold", the following
events are trigged at start exam:
• An informative popup is displayed on the DL.
• A message is displayed on live monitors.
Both recommend using a pediatric protocol for young patients.
Note 1: The "Pediatrics limit age threshold" is editable before the start of an exam in the Preferences tab on the DL
screen. It is used to set the maximum patient age defined for pediatrics. The range is from 0-21 years of age.
Note 2: The patient’s age is calculated from his date of birth or his age if it has been modified in the Patient exam
information screen.
Further to using pediatric protocols, also consider the application of:
• For infants up to 1 year old, remove the anti-scatter grid from acquisitions performed at Field Of View smaller
than 20 cm.
• Use collimation to the specific area of interest.
• When possible, use a gonad shield.
Note: Dose rate for pediatrics are automatically reduced as the system senses a small patient thickness from the
dose signal to the detector.
9-3 Dose settings for pediatrics in Innova IGS systems
Innova products are designed to automatically set the optimal X-ray technique parameters (kVp, mAs, focal spot
size, and spectral filtration) for a variety of operational modes, e.g. fluoroscopy, DSA, and digital cardiac record.

InnovaTM IGS 620,
InnovaTM IGS 630
For this, an equivalent patient thickness (EPT) is determined based on the dose signal to the detector and the
technique values used for that exposure, and then the optimized technique parameters are set for the next
exposure using the patient thickness value and predetermined look-up tables (or “trajectories”) designed to give an
appropriate image quality for the lowest possible patient entrance dose.
For each available acquisition setting there are two trajectory tables: normal and low detail, giving two dose curves
versus EPT. The dose ratio of normal and low is 2 in case of fluoroscopy, at 20 cm PMMA. The "dose" is defined
here as the Air Kerma rate delivered by the X-ray equipment.
Predefined procedure protocols contain the default settings for clinical procedures, e.g. for pediatric protocols,
default detail and frame rate levels are low. Default low detail provides a dose reduction of a factor of 2 in case of
pediatrics compared to adult default; default low frame rates results in further dose reduction.
See an example of patient dose dependence on patient thickness in case of fluoroscopy with 30 pulses per second
on figure below (further values for other pulses per second settings and other settings are given in Operator
Manual for 20 cm PMMA thickness).
Air Kerma rates at IRP with RDL 30 fps fluoroscopy

Air Kerma rate
(mGy/min)
PMMA thickness (cm)

Low
Normal
Air Kerma rates at the interventional reference point (IRP) in case of fluoroscopy with 30 pulses per second, normal
and low detail Receptor Dose Limited (RDL) settings in FOV20, measured using phantoms with different thickness
on Innova IGS 630.
10 Electrophysiology (EP) Exam Case

Electrophysiology (EP) exams often require long fluoro times and are often less demanding in object visualization,
allowing in these cases to have radiation dose rate set to lower values compared to other exam types.
• Select an appropriate protocol when long fluoro times are expected for an EP exam. Use a protocol with the
lowest dose rate value compatible with the medical requirement. Several protocols are pre-set to lower radiation
dose rate, refer to the list of available protocols with "EP" in their name or category name.
• When compatible with medical requirement, apply the means presented in previous chapters to minimize dose:
– Monitor cumulative dose,

InnovaTM IGS 620,
InnovaTM IGS 630
– Appropriate use of Equipment distances,

– Minimize Sequence duration,
– etc.
11 Legal Provisions
• In many countries or states, by means of rules, guidelines or regulations, lawmakers have contributed to
improving radiation protection for patients and medical personnel.
• On an international level, guidelines are laid down by the International Commission on Radiological Protection
(ICRP). Many of the rules, guidelines or regulations are governed by the ALARA concept (As Low As
Reasonably Achievable), meaning the production of a diagnostically relevant image at minimum possible dose.
• The material presented in this tutorial contains ways to improve radiation safety on Innova’s but is not deemed
to be exhaustive, read the Radiation Safety section for more details. Local legal provisions also prevails over the
ways presented in this document when applicable.

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 23 - Glossary
1 Acronyms in use
Acronym Defi- Comment Generic Standards Unit Medical appli- System com-
nition cation ponent
2D 2 Dimensional X
Application
3D 3 Dimensional X
Application
ABC Automatic X
Brightness Con-
trol
AE-Title Application Enti- X
ty Title
ALARA As Low As Rea- X
sonably Achiev-
able
AW Advantage X
Workstation
CAU Caudal X
CCD Coupled X
Charged Device
CD Compact Disk X
CDROM CD Read Only X
Memory
CFR Code of Federal X
Regulations
CFX Circumflex X
artery
CISPR Comité Interna- X
tional Special
des Perturba-
tions
Radioélectrique
s
cm centimeter X
CPD Chamber-Pa- X
tient Distance
CPR Cardiac Pul- X
monary Resus-
citation
CRA Cranial X
CSA Canadian Stan- X
dards Associa-
tion
Glossary 573
InnovaTM IGS 620,
InnovaTM IGS 630
CT Computed To- X
mography (or
equivalent ap-
plication)
DAP Dose Area X
Product
DFP Digital Flat Pan- X
el
DICOM Digital Imaging X
and COmmuni-
cations in Medi-
cine
DL Digital Leader X
DQE Detective Quan- X
tum Efficiency
DSA Digital Subtract- X
ed Angiography
DVD Digital Versatile X
Disc
DVD+R DVD Record- X
able
DVD+RW DVD X
ReWritable
ECG ElectroCardioG- X
raphy
ED End-Diastolic X
EEP Electrical and X
Electronic Prod-
uct
EFUP Environment-Friend- X
ly Use Period
EMC Electro Magnet- X
ic Compatibility
EP Electro Physiol- X
ogy
ES End-Systolic X
F french X
FDA Food and Drug X
Administration
FNR Fluoro Noise X
Reduction
FOV Field of View X
fps Frame Per Sec- X
ond
574 Glossary
InnovaTM IGS 620,
InnovaTM IGS 630
GE General Electric X
GEF Global Ejection X
Fraction
GEHC General Electric X
HealthCare
GEMS General Electric X
Medical Sys-
tems
Gy gray X
HHS Department of X
Health and Hu-
man Services
HRE High Radiation X
Exposures
HUA Heat Unit Avail- X
able
HVL Half Value Lay- X
er
ICRP International X
Commission on
Radiological
Protection
ID IDentifier X
IEC International X
Electrotechnical
Commission
II Image Intensifi- X
er
IPEM Institute of X
Physics and En-
gineering in
Medicine
IQ Image Quality X
IRB In-Room Brows- X
er
IRP Interventional X
Reference Point
ISO Isocenter X
J joule X
kg kilogram X
kVp kilovolt peak X
LAD Left Anterior X
Descending
artery
Glossary 575
InnovaTM IGS 620,
InnovaTM IGS 630
LAO Left Anterio X

Oblique
LC L-C gantry X
LCD Liquid Crystal X
Display
LED Light Emitting X
Diodes
LIH Last Image X
Hold
LP L-P gantry X
LV Left Ventricle X
m meter X
mA milliAmpere X
mAs milliAmpere X
second
min minute X
MIP Maximum Inten- X
sity Projection
ml millilitre X
mm millimeter X
MPVR Multi Planar X
Volume Recon-
struction
MRI Magnetic X
Resonnance
Imagery
MTF Modulation X
Transfer Func-
tion
PA Posterio Anteri- X
or
PACS Picture Archiv- X
ing and Com-
munication Sys-
tems
PBB PolyBrominated X
Biphenyl
PBDE PolyBrominated X
Diphenyl Ether
PC Personal Com- X
puter
PDB Power Distribu- X
tion Box
576 Glossary
InnovaTM IGS 620,
InnovaTM IGS 630
PDF Portable Docu- X

ment Format
PIM Pre Installation X
Manual
PM Periodic Mainte- X
nance
PMMA PolyMethyl- X
MethAcrylate
PMS X
QAP Quality Assur- X
ance Program
RAO Right Anterio X
Oblique
RCA Right Coronary X
Artery
RDL Receptor Dose X
Limited
REC Record X
RF Radio Frequen- X
cy
ROI Region Of Inter- X
est
RTAC Real Time Ac- X
quisition Con-
troller
s second X
SA Stenosis Analy- X
sis
SCD Source- X
Chamber Dis-
tance
SCPT Secondary Cap- X
ture
SID Source to Im- X
age Distance
SNR Signal to Noise X
Ratio
SUB Subtraction X
SUIF Service User In- X
terface
SVA Service Virtual X
Assist
TFT Thin-Film Tran- X
sistors
Glossary 577
InnovaTM IGS 620,
InnovaTM IGS 630
TSSC Table Side Sta- X

tus Control
TSUI Table Side User X
Interface
TVA Training Virtual X
Assist
UDI Unique Device X
Identifier
UL Underwriter's X
Laboratories,
Inc.
UPS Uninterruptible X
Power Supply
US United State X
USA United States of X
America
VA Ventricular X
Analysis
VCIM Vascular Con- X
trol Interface
Module
VESA Video Electron- X
ics Standards
Association
VR Volume Ren- X
dering
WEEE Waste Electric, X
Electronic
Equipment
WM Wall Motion X
XA X-ray Angiogra- X
phy
578 Glossary
InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 24 - Importer Offices of GE Healthcare

AUSTRALIA
GE Healthcare Australia Pty Ltd
Building 4B, 21 South Street
Rydalmere NSW 2116 Australia
Tel: 1800 659 465
INDONESIA (ID)
PT GE Operations Indonesia
Gedung BRI II, Lantai 27
Jl. Jenderal Sudirman No. 44-46
Jakarta Pusat 10210
Indonesia
NEW ZEALAND
GE Healthcare Limited
8 Tangihua Street
Auckland, NEW ZEALAND
Tel: 0800 659 465
TURKEY (TR)
Ithalatci : GE Medical Systems Türkiye Ltd. Sti
Esentepe Mah. Harman Sok. No: 8 Sisli – Istanbul / Turkiye
Importer Offices of GE Healthcare 579

InnovaTM IGS 620,
InnovaTM IGS 630
Chapter 25 - Revision History
Part / Rev Date Reason for Change
5719150-1-1EN February 2016 Initial release of direction 5719150-1-1EN.

rev 1
5719150-1-1EN September 2018 Second release of direction 5719150-1-1EN.

rev 2
580 Revision History

© 2018 General Electric Company, All Rights Reserved.
GE Medical Systems SCS
283, rue de la Minière
78530, Buc
FRANCE
www.gehealthcare.com

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InnovaTM IGS 620,

InnovaTM IGS 630

WARNING: BEFORE USING THIS SYSTEM

RECOMMENDATIONS PROVIDED IN THIS MANUAL.

SERIOUS INJURY TO THE PATIENT, TO THE OPERATOR OR TO OTHER PERSONS.

            

       

1 Using This Module 27

Chapter 3 - Safety and Regulatory 31

1-9 Patient Confidentiality 44

6-3 Suspensions Cleaning 65

1 Indications for Use 67

5-2-5 Receptor Dose Limited Standard 85

6-1 Mode of Operation 128

Chapter 5 - Radiation Safety 218

1 How X-ray Radiation is created and the "Dose" concept 218

7-2 Spectral Filtration 227

1 Imaging Chain 230

1 General Description 236

4-5 Innova Imaging 242

1 Guidelines for the best usage of the system 249

7-7 Image Rotation 275

12-5-2 3D Spin Acquisition 319

17-10 Multi Segments 344

26-2 How to delete an Exam 391

31-2 Dose Estimation 424

1 Safety Recommendations 431

1 How to move the Table/Gantry 434

1-9-4-2 Attaching the Sheath 449

9-3-4 Button arrangement on a favorite sub-tab or between tabs 472

1 Alarm management 482

1 General Description 487

5-1-3 How to Modify the name of the selected layout 495

1 LCD Monitor Suspensions 500

1 General Application Description 509

2-2 Safety recommendations 510

1 How to launch QC Mode (not intended for clinical use) 517

7 Protocol Comparison 524

4 System Configuration (Setup Menu) 539

Chapter 21 - Appendix - Technical Publications 557

1 System Line Voltage 557

4-5 Minimum mAs 558

9-2 List of pediatric protocols 570

1 Acronyms in use 573

Chapter 25 - Revision History 580

2 Printing this Module

Click on the PRINT button:

3 Electronic Operator Manual

Symbol indicating that the Instruction For Use (Operator

Chapter 3 - Safety and Regulatory

Safety and Regulatory 31

Essential Performance IEC standard reference Comments

32 Safety and Regulatory

1-1-4-2 Electromagnetic Emission

1-1-4-3 Electromagnetic Immunity

Safety and Regulatory 33

34 Safety and Regulatory

Portable and mobile RF communications equip-

where P is the maximum output power rating of