Manual Completo ACL Elite Ingles

Co v e r
ACL Elite/Elite Pro

ACL Elite/Elite Pro Operator's Manual • P/N 00018200232 • R01 • February, 2016
Manufacturer EU Authorized Representative

Headquarters Headquarters
Instrumentation Laboratory Company Instrumentation Laboratory SpA
180 Hartwell Road Viale Monza 338
Bedford, MA 01730-2443 U.S.A. 20128 Milan, Italy
Telephone: 1-781-861-0710 Telephone: 39-02-25221
Fax: 1-781-861-1908 Fax: 39-02-2575250
http://www.ilus.com http://www.il-italia.it
ACL Elite/Elite Pro Operator's Manual
Copyright © Instrumentation Laboratory, February, 2016
This publication and any and all materials (including software) concerning the products of the IL ACL Elite/Elite Pro
instrument are of proprietary nature and are communicated on a strictly confidential basis; they may not be
reproduced, recorded, stored in a retrieval system, transmitted or disclosed in any way and by any means whatsoever,
whether electronic, mechanical through photocopying or otherwise, without IL’s prior written consent.
Information contained herein is believed to be accurate. In any event, no responsibility, whether express or implied, is
assumed by IL for or in connection with the use thereof, or for infringement of any third party rights which might arise
therefrom, or from any representation or omissions contained therein. Information is subject to change and/or update
without notice.
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INRNo tic e
ACL ELITE/ELITE PRO TECHNICAL BULLETIN IMPORTANT INR NOTICE

INR FORMULA
INR = (PT Patient / PT Normal)ISI
PT PATIENT = Patient’s PT in seconds
PT NORMAL = Mean* of the Normal Range (on the ACL ELITE/ELITE PRO this is called the Reference Value)
ISI value = International Sensitivity Index from the current lot # of thromboplastin reagent being used.
To assure appropriate reporting of INR results, you must follow these steps:
1. Make sure instrument is in the READY mode. From the SET UP MENU select the LIQUIDS SUBMENU, then
select the appropriate THROMBOPLASTIN REAGENT (LIQUID ID) from the list in the left upper part of the
screen.
2. Select the PT TEST that uses this Thromboplastin reagent and click on ASSIGN VALUE.
3. Enter the ISI VALUE of the Thromboplastin Lot in use and select Confirm twice to enter value. Make sure
that all PT tests using the same Thromboplastin import the proper ISI assignment. Several PT TESTS using
the same Thromboplastin may be present such as PT extended, PT duplicate standard and PT duplicate
extended acquisition time. These tests will import the value from the standard test.
NOTE: The ISI value is specific for the lot number of prothrombin time reagent being used.
4. From the SET UP MENU select TESTS VIEW/DEFINE. Select the appropriate PT test and click on details.
5. Select CALCULATION SETUP and the instrument will show in the right part of the screen the selection of the
REFERENCE VALUE. This represents the Mean of Normal Population value in SECONDS, which is used
as the DENOMINATOR in the RATIO and INR CALCULATION.
6. Make sure that the value entered in this field represents the MEAN NORMAL POPULATION RANGE of the
local PT population. This value is editable and can be modified to reflect the laboratory established mean
normal range.
7. Confirm all PT Tests using the very same thromboplastin lot for Ratio/INR will be calculated using the same
value in seconds as the denominator (Mean Normal Population Range).
8. The instrument uses the following formula for RATIO CALCULATION.
RATIO CALCULATION = PATIENT PLASMA (seconds)

REFERENCE VALUE (seconds)
Reference Value means MEAN OF NORMAL POPULATION (seconds).

MEAN OF THE NORMAL POPULATION RANGE = Mean Normal PT Time = Mean of Patient Normal
Range in seconds as recommended in the CLSI Document C28-A, Vol. 15, No.4.
9. The INR will then be calculated as follows:
INR = (PT Patient/PT of Reference Value)ISI
Using the Reference Value feature the denominator used in the Ratio and INR calculation will accurately
reflect the Mean of Normal Population Range.
IMPORTANT WARNINGS:
l If the INR calculation is not properly setup, then erroneous patient results may be reported.
l If the product lot number changes, then the new ISI value from the package insert must be entered.
l In the ACL ELITE/ELITE PRO both screen and printout show/report Ratio and INR units separately
*or Geometric mean
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Contents
Cover i
INR Notice iii
Contents iv
Chapter 1 - General Information 13

1.0 Introduction 14
1.1 Product Use 14
1.2 Measured Parameters 15
1.3 Presentation of Results 16
1.4 Instrument Description and Operation 17
1.4.1 Summary 17
1.4.2 Main Hardware Components 18
1.4.3 Sample Tray 20
1.4.4 Reagent Area 22
1.4.5 Rinse/Waste Area 23
1.4.6 Sampling/Dispensing System 23
1.4.7 Loading and Analysis Area 27
1.4.8 Microprocessor and Electronics 33
1.4.9 Liquid Crystal Display (LCD) 33
1.4.10 Keyboard 34
1.4.11 Interface Connectors 35
1.4.12 Internal Cooling System 36
1.4.13 On-board Barcode Reader 37
1.4.14 External Barcode Scanner (Optional) 38
1.4.15 External Printer (Optional) 39
1.4.16 USB Port for All-In-One Utility 40
1.5 Additional Features 41
1.5.1 Standby Status 41
1.5.2 End of the Cycle 41
1.5.3 Power Loss 41
1.5.4 Setup and Utility Programs 41
1.5.5 Fault Detection 42
1.5.6 Color and Symbol Legend 42
1.6 Procedural Limitations 42
1.7 Certification 43
1.7.1 CE Certification 43
1.7.2 CSA Certification 43
1.7.3 CEI/IEC 61010-1 44
1.7.4 European Union Directive 2002/96/EC on Waste Electrical and Electrical Equipment
(WEEE) 44
1.8 Instrument Disposal 45
1.9 Symbols 45
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Contents
Chapter 2 - Installation 47
2.0 Introduction 48
2.1 Installation Requirements 48
2.1.1 Environmental Conditions 48
2.1.2 Space Requirements 49
2.1.3 Electrical Requirements 50
2.2 Instrument Delivery and Unpacking 52
2.3 Mounting Instrument Parts 53
2.4 Turning the System On 57
2.5 ACL – HOST Interconnect Cable 60
Chapter 3 - Analytical Operations 61

3.0 Introduction 63
3.1 Components and Use of the Operator Interface 63
3.1.1 Touch Screen 63
3.1.2 Numerical Keypad 64
3.1.3 Standard PC Keyboard 64
3.1.4 External Barcode Reader (optional on ACL ELITE) 65
3.1.5 Mouse - Port 2 65
3.1.6 Menus 65
3.1.7 Windows and Boxes 66
3.1.8 Key Screen Elements 66
3.1.9 A Special Window for Alarms and Errors 70
3.1.10 Screen Saver (Standby) 70
3.1.11 ACL ELITE/ELITE PRO Menu Structure 71
3.2 Sample Analysis 72
3.2.1 Sample Analysis Procedures - Summarized 73
3.2.2 Sample Analysis Modes 76
3.2.3 Materials Map 85
3.2.4 Analysis: Loadlist 88
3.2.5 Analysis: Session Report 93
3.2.6 Session Pause Conditions 97
3.2.7 Analysis: Pause / STAT Functions 98
3.2.8 Database View / Results List 102
3.2.8.1 Extract Icon 104
3.2.8.2 Sample Detail Icon 105
3.2.8.3 New Sample Icon (Tubes in Folder) 108
3.2.8.4 Delete Icon (Trash Can) 109
3.2.8.5 Printing results 110
3.2.8.6 Sending results to Host Computer 111
3.3 Quality Control 112
3.3.1 Analyzing QC Materials Using a Loadlist 113
3.3.2 Quality Control Setup 114
3.3.3 QC Result Review 117
3.3.4 QC – PLOT and STATISTICS 118
3.3.5 QC – CUMULATIVE RESULTS 120
3.3.6 QC – HOST COMMUNICATION 123
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3.3.7 QC – EXTRACT DATA 125

3.4 Calibration 127
3.4.1 Dedicated Calibration Procedure – Summary 128
3.4.2 Saving a Calibration – Summary 129
3.4.3 Dedicated Calibration – Details 129
3.4.4 Calibration – Review Calibrations 131
3.4.5 Factor Assay Calibration for Non-Parallelism Tests 136
3.4.6 Factor Assay Calibration for Parallelism Tests 141
3.4.7 Factor Assay Parallelism Results 141
3.5 Analytical Reference 143
3.5.1 Analytical Reference: SETUP 143
3.5.2 Analytical Reference: PLOT and STATISTICS 146
3.5.3 Analytical Reference: CUMULATIVE RESULTS 148
3.5.4 Analytical Reference: HOST COMMUNICATION 150
3.5.5 Analytical Reference: EXTRACT DATA 151
Chapter 4 - Setup and Utility 153

4.0 Introduction 155
4.1 SETUP 155
4.1.1 SETUP Submenu 155
4.1.2 Setup – TESTS – View/Define 156
4.1.3 Setup – TESTS – Sort Tests 158
4.1.4 Setup – TESTS – Interference Table 160
4.1.5 Setup – TESTS – Default Tests 162
4.1.6 Setup – TESTS – Reflex Tests 163
4.1.7 Setup – Multi-Tests - Profiles 167
4.1.8 Setup – Multi-Tests – Test Groups 170
4.1.9 Setup – Multi-Tests – Test Group Profiles 175
4.1.10 Setup – Multi-Tests – Sort Multi-Tests 178
4.1.11 Setup – Default Multi-Tests 179
4.1.12 Setup – LIQUIDS 180
4.1.13 Setup – INTERFACES – Host 188
4.1.14 Setup – INTERFACES – Printer 190
4.1.15 Setup – INTERFACES – Internal Barcode 191
4.1.16 Setup – INTERFACES – External Barcode – Optional 193
4.1.17 Setup – INTERFACES – Keyboard 194
4.1.18 Setup – INTERFACES – Network 194
4.1.19 Setup – INTERFACES – Modem 195
4.1.20 Setup – SYSTEM CONFIGURATION 195
4.1.21 Setup - SECURITY 197
4.1.22 Setup - Audible Alarms 201
4.1.23 Setup – DATE/TIME 202
4.1.24 Setup - UNITS 203
4.2 Setup – TESTS – Define 204
4.2.1 COPY TEST 206
4.2.2 Setup – TESTS DETAILS 207
4.2.3 Analysis – Loading Setup 213
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4.2.4 Calibration - Loading Setup 223

4.2.5 Acquisition Setup 233
4.2.6 Calculation Setup 235
4.2.6.1 None – No Algorithm 239
4.2.6.2 Trend Algorithm 239
4.2.6.3 Threshold Algorithm 240
4.2.6.4 Threshold/Second Derivative Algorithm 243
4.2.6.5 First Derivative Algorithm 247
4.2.6.6 Second Derivative Algorithm 250
4.2.6.7 Delta Algorithm 252
4.2.6.8 Additional Calculation Settings 256
4.3 UTILITY 265
4.3.1 UTILITY Submenu 265
4.3.2 UTILITY – Upgrade IL Library 266
4.3.3 UTILITY – Backup and Restore 267
4.3.4 UTILITY – Archive 270
4.3.5 UTILITY – SOFTWARE – Software Identification 271
4.3.6 UTILITY – SOFTWARE – Software Upload/Upgrade 272
4.3.7 UTILITY – Save Rotor Map 273
4.3.8 UTILITY – Save Trace File 275
4.3.9 UTILITY – Test/Material – Backup and Upload 276
4.3.10 Elite All-In-One Utility 278
Chapter 5 - Diagnostics and Maintenance 282

5.1 The DIAGNOSTIC Submenu 283
5.1.1 Priming 284
5.1.2 Cleaning 286
5.1.3 Maintenance 289
5.1.4 Temperature Control 291
5.1.5 Needles Position 292
5.1.6 Session Error History 293
5.1.7 File Error History 294
5.1.8 Logbook 295
5.1.9 Service (dimmed) 296
5.2 MAINTENANCE PROCEDURES 297
5.2.1 Introduction 297
5.2.2 Daily Preventive Maintenance 298
5.2.3 Weekly Preventive Maintenance 301
5.2.4 Biweekly Preventive Maintenance 303
5.2.5 Monthly Preventive Maintenance 304
5.2.6 As Needed Maintenance 305
5.2.7 Decontamination Procedure 312
5.3 Maintenance Table 314
Chapter 6 - Troubleshooting 316

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Contents
6.1 Failures, Alarms and Warnings 317

6.1.1 System Anomalies 318
6.1.2 REM (Rotor Exchange Module) Anomalies 322
6.1.3 Temperature Anomalies 324
6.1.4 Mechanical Anomalies 326
6.1.5 Acquisition Station Anomalies 328
6.1.6 Liquid Anomalies 329
6.1.7 Optics Anomalies 331
6.1.8 Operative Anomalies 332
6.1.9 Parsing and Loading Anomalies 333
6.1.10 Database Anomalies 334
6.2 Data Transmission Failure 334
6.3 Data Reduction Error Codes 335
6.3.1 Session Error Codes 336
6.3.2 Reaction Curve Error Codes 337
6.3.3 Calibration Error Codes 342
6.3.4 Analytical Reference Error Codes 346
6.3.5 QC Error Codes 350
6.3.6 Double Test Error Codes 352
6.3.7 Ratio and INR Error Codes 353
6.3.8 DMS Errors 355
6.3.9 Other Miscellaneous Errors 356
6.4 Classic Data Reduction Error 357
6.5 Sample ID Errors (Internal Barcode Reader) 358
6.6 Data Reduction Diagram for PT, APTT and TT 359
Chapter 7 - Assay and Instrument Specifications 360

7.2 Calculation of Results 367
7.2.1 Coagulometric Tests 369
7.2.2 Chromogenic Tests 377
7.3 Sample/Reagent Configuration and Specifications 380
7.3.1 Sample Requirements and Positions 380
7.3.2 Sample Positions in the Rotor (unused case) 383
7.3.3 Coagulometric Test Volumes 385
7.3.4 Chromogenic/405 Filter Test Volumes 387
7.3.5 Special Test Volumes 388
7.4 Data Processing Features, Parameters and Analytical Specifications 389
7.4.1 Flagging Limits 389
7.4.2 Results Format: VDU and Printer 392
7.4.3 Result Messages 393
7.4.4 Calibration Curve Slope (m) 394
7.4.5 Calibration Curve Intercept (q) 395
7.4.6 Ranges for Calibration Plasma Values 395
7.4.7 Reaction Times 396
7.4.8 Test Algorithms 399
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Contents
7.5 Assay Performance Characteristics 400

7.5.1 Assay Precision Performance, Linearity and Method Comparison Studies 400
7.5.2 Assay Calibration Stability 403
7.6 Analytical Limitations 404
7.6.1 Carryover 404
7.6.2 Cephalin: Needle Self-Conditioning 405
7.6.3 Lipemic Samples 405
7.7 Container Specifications 406
7.7.1 Primary Tubes 406
7.7.2 Cup and Reagent Containers 407
7.8 Instrument Specifications 408
7.8.1 Hardware and Operational Specifications 408
7.8.2 Dimensions 409
7.8.3 Database Specifications 409
7.9 Environmental Specifications 411
7.10 Electrical Specifications 412
7.11 HAZARDS 413
7.11.1 General Warnings 413
7.11.2 Shock Hazards 413
7.11.3 Electrical Hazards 413
7.11.4 Biohazards 414
7.11.5 Mechanical Hazards 414
Disclaimers 414
Bibliography 414
ADDENDUM: Method Comparison Studies 415
Chapter 8 - Sample Collection and Storage 423

8.1 Sample Collection 423
8.2 Plasma Handling 424
8.2.1 Plasma Separation 424
8.2.2 Plasma Transport 424
8.2.3 Plasma Storage 424
References 424
Chapter 9 - Parts and Expendables 425

9.1 Startup Kit 425
9.2 Order Information for Expendables 428
Chapter 10 - Warranty 429

10.1 Disclaimer Regarding Non-IL Brand Products 430
Chapter 11 - IL Worldwide Locations 431
Appendix A – Host Communication Protocol 441
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Contents

1.1 Purpose 444
2.0 General Description 445
2.1 Product Perspective 445
3.0 Specific Requirements 446
3.1 Protocol Specification 446
3.2 Low Level Interface 446
3.3 Data Link and Logical Layer 446
3.4 Sessions 446
3.4.1 Message Header and Message Terminator Records 447
3.5 Test Order Downloading 448
3.5.1 Receive Session from DMS 448
3.5.1.1 Test Request Message 450
3.5.1.2 Test Order Message 451
3.5.1.2.1 Patient Information Record 451
3.5.1.2.2 Test Order Record 453
3.5.2 Host Query 455
3.5.3 Test Request Message 457
3.5.4 Test Order Message 458
3.6 Rejected Test Order 459
3.7 Download Session Volumes 461
4.0 Test Results Uploading 462
4.1 Test Result Message 463
4.1.1 Patient Information Record 463
4.1.2 Test Order Record 465
4.1.3 Result Record 467
4.1.4 Comment Record 469
4.1.5 Error Codes 470
4.2 Upload Session Volumes 472
5.0 Not Supported Records 473
6.0 Transmission Abort 473
7.0 ELITE/ELITE PRO Test Codes 474
8.0 ELITE/ELITE PRO Supported Characters 478
8.1 Supported Characters for Sample ID 478
8.2 Supported Characters for Patient name, Department and Units 478
8.3 Supported Characters for delimiters 478
9.0 ELITE/ELITE PRO Supported Units 479
Appendix B - Bar Code Label Specification 480

1.1 Purpose 482
1.2 Definitions, Acronyms and Abbreviations 482
2.1 Supported Codes and Checksum type 483
2.2 Bar Code Symbol Specifications 483
2.3 Barcode Parameters 484
2.4 Barcode Label Positioning 485
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Contents
2.5 Decoder Zone Map 486

2.6 Barcode Label Dimensions 487
Appendix C – Special Test Procedures 488

1 APCR-V 490
2 Liquid Antithrombin 493
3 Anti-Xa 497
4 D-Dimer / D-Dimer High 500
5 D-Dimer 500 / D-Dimer 500 High 505
6 dRVVT Screen/Confirm 510
7 Factor Analysis 513
8 Chromogenic Factor VIII 518
9 Fibrinogen-C 522
10 Free Protein S 527
11 Heparin 531
12 Hepatocomplex 535
13 Homocysteine 539
14 Liquid Heparin 542
15 Plasminogen 545
16 Plasmin Inhibitor 549
17 Pro-IL-Complex 553
18 ProClot 557
19 Protein C 561
20 ProS 565
21 PS–ACT 569
22 SCT-Screen/Confirm 573
23 Thrombin Time (TT) 577
24 von Willebrand Factor Activity 580
25 von Willebrand Factor Antigen 584
Appendix D – Printout Examples 588

1 Analytical Reference – Cumulative Report 590
2 Analytical Reference – Plot and Statistics 591
3 Calibration Printout – PT Assay 592
4 Calibration Printout – Factor Assay 593
5 Calibration Replicate – Curve Details 594
6 File Error History 595
7 Liquid Setup 596
8 Logbook Report 597
9 Maintenance Report 598
10 Parallelism Cumulative Report 599
11 Parallelism Sample Report 600
12 Parallelism Detail Report 601
13 Profile Report 602
14 Quality Control Cumulative Report 603
15 Quality Control Plot and Statistics 604
16 Quality Control – Daily Printout 605
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Contents
17 Reflex Test Logics 606

18 Sample Report 607
19 Sample Report Cumulative 608
20 Session Error History Report 609
21 Temperature Report 610
22 Test Detail Report 611
Index 612
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Chapter 1 - General Information
1.0 Introduction 14
1.1 Product Use 14
1.3 Presentation of Results 16
1.4 Instrument Description and Operation 17
1.4.1 Summary 17
1.4.2 Main Hardware Components 18
1.4.3 Sample Tray 20
1.4.4 Reagent Area 22
1.4.5 Rinse/Waste Area 23
1.4.6 Sampling/Dispensing System 23
1.4.7 Loading and Analysis Area 27
1.4.8 Microprocessor and Electronics 33
1.4.9 Liquid Crystal Display (LCD) 33
1.4.10 Keyboard 34
1.4.11 Interface Connectors 35
1.4.12 Internal Cooling System 36
1.4.13 On-board Barcode Reader 37
1.4.14 External Barcode Scanner (Optional) 38
1.4.15 External Printer (Optional) 39
1.4.16 USB Port for All-In-One Utility 40
1.5 Additional Features 41
1.5.1 Standby Status 41
1.5.2 End of the Cycle 41
1.5.3 Power Loss 41
1.5.4 Setup and Utility Programs 41
1.5.5 Fault Detection 42
1.5.6 Color and Symbol Legend 42
1.6 Procedural Limitations 42
1.7 Certification 43
1.7.1 CE Certification 43
1.7.2 CSA Certification 43
1.7.3 CEI/IEC 61010-1 44
1.7.4 European Union Directive 2002/96/EC on Waste Electrical and Electrical Equipment (WEEE) 44
1.8 Instrument Disposal 45
1.9 Symbols 45
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1.0 Introduction Chapter 1 – General Information
1.0 Introduction
This manual contains the information necessary to operate, maintain and troubleshoot the
Instrumentation Laboratory ACL ELITE and ELITE PRO. Personnel responsible for operating and
maintaining the instrument should read and understand the material included here prior to using the
system. This manual should be kept near the instrument or in a suitable location for reference as
required.
This section of the manual contains general information about the ACL ELITE/ELITE PRO systems,
including use and measured parameters, description of the hardware modules as well as their function
and operation, methodology, additional features and procedural limitations. The description and use of
the ACL ELITE/ELITE PRO Operator’s Interface is addressed in separate sections of this manual.
ACL ELITE PRO system
1.1 Product Use

The IL ACL ELITE/ELITE PRO system is a fully automated, high productivity analyzer designed
specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. The
system provides results for both direct hemostasis measurements and calculated parameters.
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1.2 Measured Parameters Chapter 1 – General Information
1.2 Measured Parameters

The ACL ELITE/ELITE PRO system is used to perform the following tests:
Coagulometric Tests
l PT-FIB (Prothrombin Time and PT-Based Fibrinogen concentration)

l APTT (Activated Partial Thromboplastin Time)
l TT (Thrombin Time)
l Single Factors (VII, X, V, II, XII, XI, IX, VIII) (Parallelism for factors VIII, IX)
Absorbance Tests
l Antithrombin
l Heparin
l Protein C (Chromogenic)
l Plasmin Inhibitor
l Plasminogen
l Fibrinogen
Immunological Tests
l D-Dimer
l von Willebrand Factor – Activity and Antigen
l Free Protein S
Special Tests
l ProClot (clotting)
l Protein S
l Factor V Leiden
l Silica Clotting Screen and Confirm
l Pro-IL-Complex1
l Hepatocomplex1
l Homocysteine
Single Test or Multi-Tests
The user may program single or multiple tests on patient samples to be performed on a random access
basis. Refer to Chapter 4 - Setup and Utility on page 153 for additional information on this subject.
1This test is not available in all countries. Contact your local distributor for availability. Please refer to the library
installed on your system for the latest tests list.
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1.3 Presentation of Results Chapter 1 – General Information
Tests Groups
Some tests can be run together as a group, thus saving time when the number of samples to be analyzed
is relatively small. Following are some examples:
l PT-FIB/APTT
l PT-FIB/APTT/TT
l Fib-C/ AT/D-Dimer
Double Tests (Duplicate Testing)
The ACL ELITE/ELITE PRO offers the user the capability to set up double tests. Chapter 4.0 contains
information that allows you to set up double tests on the system.
1.3 Presentation of Results

The ACL system offers the following choices to display and print results of testing:
l s (seconds)
l R (Ratio)
l NR (Normalized Ratio)
l INR (International Normalized Ratio)
l % (Percent activity)
l U/mL (units/mL)
l mg/dL
l mg/L
l g/L
l ng/mL
l μg/mL
l μg/L
l μmol/L
l IU/mL (International Unit)
l User configurable unit
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1.4 Instrument Description and Operation Chapter 1 – General Information
1.4 Instrument Description and Operation

1.4.1 Summary
The ACL is a family of fully automated computer-controlled, microcentrifugal analyzers. The
ACL ELITE/ELITE PRO system incorporates a Liquid Crystal Display (LCD) unit that shows
the status of the instrument, permits the user to select desired procedures, and through the
use of menus and options guides the operator through these procedures. Information and
instructions are entered into the system either via the Touch Screen device or through a
standard PC keyboard or mouse.
When sample testing is initiated, the samples and reagents are sequentially pipetted into a
20-cuvette polystyrene rotor (loading process). A centrifugation process then mixes sample
and reagents. The mixing is carried out by a combination of rapid acceleration and braking
actions, which are effective in thoroughly mixing the liquids. Reaction measurements (data
acquisition) via the photometer are made while the rotor is spinning.
The ACL measures the parameters at 37 °C ± 1 °C (98.6 oF ± 1.8 oF), at an ambient

temperature from 15 °C to 32 °C (59 oF to 89 oF). However, if the ACL is in a temperature-
controlled environment where the ambient temperature is held constant, the measurements
are made within a narrower temperature range: 37 °C ± 0.25 °C.
The results are displayed on the LCD and optionally printed by the external printer, and/or
sent to a host computer. The ACL performs automatic calibration, offers a series of utility
programs for the operator and manages a complete quality control program.
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1.4.2 Main Hardware Components

The ACL ELITE/ELITE PRO analyzer includes several hardware components and modules,
which interact with each other to carry out the analytical process. This section contains
descriptions of those components and their functions as well as the operations that take
place during the analytical process.
The figure below highlights some of the main components of the ACL ELITE/ELITE PRO, as
viewed from the front of the system.
System – Components (ACL ELITE does not have Rotor Transport and Rotor Arm)
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The following items are addressed in this section:
l Section 1.4.3 – Sample Tray

l Section 1.4.4 – Reagent Area
l Section 1.4.5 – Rinse/Waste Area
l Section 1.4.6 - Sampling/Dispensing System
l Wash-Reference Emulsion
l Piston Block and Electrovalves
l Sampling Arm Assembly
l Sensors
l Section 1.4.7 – Loading and Analysis Area
l Rotors (reaction cuvettes)
l Rotor Housing and Rotor Transport*
l Rotor Holder and Rotor Loading
l Optical Measuring System (photometric and nephelometric)
l Rotor Waste Area
l Section 1.4.8 – Microprocessor and Electronics
l Section 1.4.9 – Liquid Crystal Display (LCD) Monitor
l Section 1.4.10 – Keyboard
l Section 1.4.11 – Interface Connectors
l Section 1.4.12 – Internal Cooling System
l Section 1.4.13 – On-board Barcode Reader
l Section 1.4.14 – External Barcode Scanner
l Section 1.4.15 – External Printer
l Section 1.4.16 – USB Port for All-In-One Utility
*Rotor Transport system is not available on the ACL ELITE.
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1.4.3 Sample Tray

The ACL autosampler system includes a rotating sample tray which contains:
l 40 x 14.2 mm diameter positions for cups and primary tubes and

l 10 x 23 mm diameter positions to hold accessory materials such as calibrators,
diluents, reagents vials, etc.
Optical sensors located around the tray verify that the tray is correctly positioned, and also
detect the presence of cups, tubes and vials.
Three different sample tray configurations can be used with the ACL system. Each is
appropriate for a different size of primary tubes: 3 mL, 5 mL and S11.5; all of them can be
used for 0.5, 2 or 4 mL cups.
l Short (3 mL) – Primary tube (13x75 mm)

l Tall (5 mL) – Primary tube (13x75 mm and/or 13x100 mm)
l Tall (S 11.5) – Sarstedt primary tube (11.5x66 mm) and/or (11.5x92 mm)
The dimensions mentioned above are all nominal values.
Sample Tray
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Sample Tray Location on the ACL
Additional Reagents Positions
The ten internal positions of the sample tray - A1 to A10 - are used to place materials such as
calibrators, diluents or reagents in a choice of containers such as 23 mm vials (10 mL fill
volume), 18 mm vials (4 mL fill volume) or cups. Adapters are needed for the 4 mL vials and
cups as seen in the picture below.
Normally, position A1 is reserved for a cup containing calibration plasma (normal pool) and
position A2 is reserved for a cup containing IL Factor Diluent, for use in the calibration
procedure and sample analysis.
Adapters for internal positions in the Sample Tray
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1.4.4 Reagent Area

The ACL ELITE reagent area consists of 8 reservoirs labeled R1 to R8 designed to hold
reagent containers. The ACL ELITE PRO has 4 additional non-stirred cooled positions
labeled R9 to R12. An area alongside the vial holes is designed to hold the vial caps while
the vials are in use.
Positions R1 to R4 (all models) and R9 to R12 (ACL ELITE PRO only) are maintained
between 10 - 16 °C by a Peltier effect regulator. Positions R1 to R4 are equipped with a
stirring mechanism.
Positions R5 to R8 are used for reagents at room temperature; these positions do not have a
stirring mechanism.
The reagents in positions R1 to R6 and R9 to R12 are aspirated with the internal (Reagent)
needle while the reagents placed in positions R7 and R8 are aspirated with the external
(Sample) needle.
Reagent Area - ACL ELITE
All reagent positions can hold 28 mm vials (16 mL fill volume). Smaller diameter vials require
the use of color-coded adapters.
Vial Adapters
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1.4.5 Rinse/Waste Area

The rinse/waste system of the ACL consists of a removable rinse cup reservoir positioned
between reagents positions R4 and R5, a plastic tube connected to the cup reservoir drains
the waste from the cup, and a waste container outside the analyzer (left side) collects the
waste.
The cup, which is always filled with Wash-R Emulsion, is used as a wash basin for the
dispensing needles between cycles; the liquid waste is then drained and collected in the
waste container on the outside of the analyzer for proper disposal.
Rinse/Waste System
1.4.6 Sampling/Dispensing System

The sampling/dispensing system of the ACL ELITE/ELITE PRO includes the following
components:
Wash-Reference Emulsion bottle
This is a plastic bottle containing 1000 mL of silicon emulsion, which is employed as a wash
solution and serves as the optical reference for the nephelometric channel. A sensor located
inside the bottle alerts the user when the liquid level falls below acceptable values. The cap
on the bottle is removed by lifting it straight up off the bottle.
Piston block and Electrovalves
Set against the back wall of the analyzer is an acrylic block with two cylinders each of which
has a stainless steel piston. Two electrovalves are connected to the pistons. The
electrovalves are electronically controlled and connect the pistons to the Wash-Reference
Emulsion bottle as well as to the two needles mounted on the sampling/dispensing arm.
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Sampling/Dispensing Arm Assembly
Two stainless steel needles, external (Sample) and internal (Reagent), are mounted on the
distal end of an arm, which is actuated radially by a stepper motor. Another stepper motor
moves the arm in the vertical plane through a worm screw. The combination of these two
movements allows the following operations:
l Aspiration of sample and/or reagent from their respective locations.

l Dispensing of sample and reagent into the inner and outer compartments of the
reaction cuvettes within the rotor.
l Washing of the needles in the waste/rinse station.
Sampling Dispensing System
Sensors
Two liquid level sensors connected to the needle block are used to detect the presence of
samples and reagents in the needles.
Through the liquid level sensors, the system monitors the presence of samples and liquid
materials (calibrators, deficient plasma, diluents, etc.) in the sample tray and reagents in the
original reagent vials located in the reagent area.
These liquid sensors are integrated into the ACL analytical cycles in such a way that their
operation does not affect the throughput of the system. For all analytical cycles the
verification by the sensors is done “in-line” during the loading phase. The sampling arm stops
24 of 617 L0018200232 R01

when the needle is just below the liquid surface to allow proper aspiration of the programmed
amount of liquid.
The liquid sensors become active at the start of each analytical cycle. The sequence of
sensor operations during a cycle is as follows:
l self-check
l liquid test
l washing
l final sensor self-check
l if applicable, reports sensor failures to be displayed in the LCD.
If Operators are warned of sample/reagent sensor failures: results of a sample for which the
system detected insufficient volume will appear with a warning. For Example, if the failure
was due to insufficient sample in a cup, the warning message will display “low level”. If all
sample containers in the sample tray are empty, the cycle will be aborted after the final self-
check. No other warnings appear on the monitor or on the printer.
Sampling Arm with sensor
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Any sensor failure warning due to self-check or to insufficient reagent will:
l disappear at the beginning of the loading phase

l appear during incubation/acquisition in case of self-check error or insufficient reagent
l remain up to the next loading phase in the following cycle.
Although the sensor test terminates as soon as an error is detected during the initial self-
check, the analytical cycle continues. In this case, the test results are given and a warning
appears in the status line indicating the sensor failure. No indications will be given about the
absence of samples and/or reagents.
The operator may view the warning condition by pressing the Warning icon. An equivalent
message will be printed out with the results.
NOTE: No additional amount of liquid (sample or reagent) is aspirated for the sensor
check.
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1.4.7 Loading and Analysis Area

The area of the analyzer where the reaction cuvettes are loaded and the analysis takes place
is located under the rotor holder cover in the center of the instrument, on the right side of the
reagent area. This area includes the reaction cuvettes (rotors) storage system and
mechanisms involved in the transport of these rotors, the plate where the rotor is placed
during loading and analysis (rotor holder), the hardware components responsible for ensuring
proper mixing of reagents and samples in the cuvettes and the optical system used to make
the analytical measurements. The rotor holder cover must be opened by pressing the rotor
cover icon, do not manually lift the cover to open.
Rotor
Rotor (reaction cuvettes)
The disposable reaction cuvettes, precision made of UV-transparent polystyrene, are

radially arranged in groups of 20. The 20-cuvette unit is called a rotor. Optical readings occur
in the outer portion of the rotor.
Each wedge-shaped cuvette contains two compartments, an inner one near the center to
hold the sample and/or reagent and an outer one that holds reagents only. A partial dam
between the compartments maintains the contents separately during the loading process; as
centrifugal action starts, the sample/reagent in the inside compartment flows over the dam to
mix with the contents in the outer compartment. The reaction and analysis take place within
the large, outside compartment while the rotor is spinning.
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Rotor Stack, Rotor Transport and Rotor Arm
Rotor stack - Before their use, rotors are stored in a stack that holds up to 12 rotors. The rotor
stack compartment, which may be accessed from the top of the analyzer on the right side,
can be filled at any time (continuous rotor loading) either manually (one rotor at a time) or
using a rotor refill tool (up to 10 rotors at a time). The rotor stack area is thermostatically
controlled in order to keep the rotors in a temperature range between 36 and 39 °C; the rotor
stack is insulated to help thermal-regulation. The instrument informs the Operator when the
Rotor Stack is empty on the ACL ELITE PRO.
Use of Rotor Refill Tool
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Feeding the Rotor Stack
Rotor Transport* – Below the rotor stack, a rotor transport slide mechanism moves the
bottom rotor out to make it available to the rotor arm mechanism.
Rotor Arm* – The robotic arm takes the rotor and inserts it into the rotor holder. This is the
area where the rotor will remain during the loading and analysis process. Once analysis is
completed, if the rotor is fully utilized (or if requested by the user), the rotor arm discards the
rotor into the rotor waste container.
Rotor Transport and Arm*
On the ACL ELITE rotors must be manually loaded from the storage area into the analysis
compartment. Press the “Open Lid” icon to raise/lower the analysis compartment cover.
Press the button on the center of the hub in the analysis compartment to properly seat and
remove the rotor. The analyzer will alert the operator when a rotor exchange is needed.
*Not Applicable on the ACL ELITE
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Rotor Holder and Rotor Loading
The rotor holder is an aluminum disk that holds the rotor in place during loading and analysis.
The rotor holder is thermostatically controlled to a temperature of 38.5 ± 0.5 °C to insure 37
°C inside the cuvette.
Rotor Holder Area
Rotor loading: as indicated above, the loading of sample and reagents into the reaction
cuvettes involves the action of the sampling/dispensing arm and needles.
Optical Measuring System
The Loading and Analysis area also houses the optical system for analysis on two channels:
nephelometric and absorbance.
Nephelometric channel: the light source for this channel is a light emitting diode (LED); the
light (λ = 660 nm) is directed to the reaction cuvettes in the rotor by a fiber optic system. The
scattered light is read at a 90° angle with respect to the incident beam using a solid state
detector located below the rotor holder.
Absorbance channel: the light source is a halogen lamp, from which the radiation is directed
to the reaction cuvettes in the rotor via a quartz optic fiber and a focusing system. The
selection of the wavelength for analysis is effected by a narrow-band interference filter
centered at λ = 405 nm.
The optical detector is mounted in the cover of the loading/analysis area; therefore the
readings are made at an 180° angle from the light beam.
The optical path width for the absorbance channel is 0.5 cm (cuvette height). The
absorbance values provided by the analyzer are normalized to 1 cm. These values are
30 of 617 L0018200232 R01

generally twice those ones obtained on other ACL models, for which the absorbance values
are not normalized and are thus exactly the ones obtained for the 0.5 cm cuvette path.
The halogen lamp can be replaced by accessing the area through a removable cover inside
the rotor waste area in the center of the instrument by an IL Service engineer.
Nephelometric and Absorbance Detection Systems
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Rotor Waste Area
The used rotors are automatically dropped into a waste container on the ACL ELITE PRO
system. On the ACL ELITE system rotors may be manually moved into the waste bin or
discarded immediately into a designated biohazard container per laboratory protocol. This
container is accessed from a door on the right front area of the analyzer for removal and
disposal of the used rotors, as seen in the figure below. The instrument informs the user
when the Rotor Waste is full.
WARNING: Cuvettes within the rotor are intended for use one time only. IL does not
recommend or support the re-use of previously used- washed cuvettes in a rotor.
Rotor Waste Access and Removal
In the waste area a switch (sensor) verifies the presence of the waste container.
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1.4.8 Microprocessor and Electronics

This ACL analyzer unit is built around three computer microprocessors. These
microprocessors control all actions of the analyzer: mechanical movements, aspiration and
dispensing of samples and fluids, acquisition and processing of data and operator interface
with input (keyboard) and output (monitor/printer) devices.
The electronics consist of printed circuit boards held together by a frame mounted behind the
front panel of the analyzer. Three of these boards are assigned to the microprocessor and
logic sections while the other three are used for the interface modules and the various
activation controls. These circuits and the sub-assemblies of the instrument are supported
by a switching power supply directly connected to the main power.
1.4.9 Liquid Crystal Display (LCD)

This module consists of a Liquid Crystal Display, 12-inch active matrix (LCD), which is fitted
with a Touch Screen function, allowing most operations to be carried out using the LCD.
The LCD guides the operator during the analytical process and displays calibrator data and
patient results. It is also used to display calibration curves and to perform several utility
programs, which are easily accessible through this input device.
The LCD screen system reproduces 256 colors, and shows numeric and alphanumeric
characters. The interaction with the operator is also made user friendly by the availability of
graphics and icons. The screen is divided into three areas:
l The upper section displays the submenus

l The central section displays menus, results, graph plots and instructional guidelines
l The lower section displays instruction icons.
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1.4.10 Keyboard
The ACL ELITE/ELITE PRO has a standard computer keyboard with mechanical keys that
allow the user to access the various operating modes of the instrument.
Although the instrument is equipped with and supports the English (US & UK) keyboard
layout, the ACL software itself also supports the following languages: German, French,
Spanish and Italian.
Keyboard
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1.4.11 Interface Connectors
All devices should be connected to the ACL Elite/Elite Pro before powering it ON.
Connecting a device to the instrument while it is running may result in the instrument not
detecting that device. In this case, you must reboot the instrument for detection. Some
devices, such as certain USB flash drives and some printers, do not require an instrument
reboot for detection.
The following interface connectors are located on the back of the instrument:
l RS-232 C Interface for Host (port 1) – The ACL ELITE/ELITE PRO contains an RS-
232C interface (DTE Standard) for the output of data to a central computer (Host) or a
personal computer. Communication to a host computer is via ASTM protocol.
l RS-232 C Interface for a serial mouse (port 2)
l USB ports (4 receptors) – The USB ports can be used for a mouse, printer, optional
external reagent barcode reader or memory device..
l Modem (port 4) not supported in this software release
l External Printer Output (port 5) – The ACL ELITE/ELITE PRO has an output for an
optional external printer. Two emulation protocols are available for printers: ESC/P2
(Epson like printers) and HP-PCL (for HP like Laser Printers). See USB Connector on
page 39.
l Standard PC keyboard (port 6)
The following interface connector is located on the front of the instrument:
l USB port (1 receptor) – For convenience, a fifth USB port is located on the front of
the instrument to use for backup, data store and load operations. See diagram in
Section 1.4.2 - Main Hardware Components on page 18.
All USB ports are interchangeable.
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Rear Panel and Fuse
1.4.12 Internal Cooling System

The cooling of the system is insured by the presence of fans mounted on the internal right
side of the analyzer. An air filter prevents dust from entering the system. To clean this air
filter, see Section 5.2.5 - Monthly Preventive Maintenance on page 304.
A two-level alarm warns the user when the internal temperature of the instrument rises above
damaging levels. The first level alerts the operator of the temperature rise and displays a
warning. The second level switches off the instrument.
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1.4.13 On-board Barcode Reader

The on-board barcode reader, a standard feature of the ACL ELITE/ELITE PRO, is located in
the sampling area as indicated in the figure below. A small window indicates its position. For
additional information on the use of the on-board barcode reader, refer to the following
sections:
l Section 3.1.4 - External Barcode Reader (optional on ACL ELITE) on page 65

l Section 4.1.15 - Setup – INTERFACES – Internal Barcode on page 191
l Section 4.1.16 - Setup – INTERFACES – External Barcode – Optional on page 193
l Appendix B - Bar Code Label Specification on page 480
The numeric and alpha-numeric readable codes are:
l Codabar
l Code 39
l Code 128
l Interleaved 2 of 5
When using barcoded sample tubes, it is important to position them in the sample tray such
that the labels are facing towards the outside of the sample tray. This will allow correct
reading of the labels by the on-board barcode reader.
On-Board Barcode Reader
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1.4.14 External Barcode Scanner (Optional)

The external barcode scanner is a standard item on the ELITE Pro and an optional feature of
the ACL ELITE. This barcode scanner is able to read the alphanumeric information on the
HemosIL reagent vials when the material map is displayed. The vial label includes the
following information used by the ACL ELITE/ELITE PRO:
l Last 4 digits of the lot number

l Lot number expiration date
l Material ID
The scanner is attached to one of the USB ports located on the backside of the analyzer.
Connect the scanner with the analyzer off and reboot the system. The scanner will become
active.
The scanner is automatically activated when the material map is displayed.
External Barcode Scanner
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1.4.15 External Printer (Optional)

The external printer is an optional feature. The printer can be connected using a parallel
connector or a USB port. Only one printer should be connected to the analyzer.
The printer must be connected and turned on before powering up the analyzer.
Parallel Connector
An external 80-column printer can be interfaced to the ACL ELITE/ELITE PRO.
The following emulation protocols can be used:
l ESC P2 – Typical Epson-like protocol.

l HP-PCL – Typical Hewlett Packard-like protocol for Inkjet and Laser printers..
USB Connector
The instrument supports USB 2.0 PCL5 compatible printers.
Connection of a USB printer is automatically detected.
External Printer
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1.4.16 USB Port for All-In-One Utility

You can use the USB port located on the front of the ACL Elite/Elite Pro for backup, data
store and load operations. See the diagram in Section 1.4.2 - Main Hardware Components
on page 18.
The instrument automatically detects USB storage devices at startup and when inserted into
the instrument.
When multiple USB storage devices are installed (i.e., flash drives, other remote storage
media) the instrument issues a message stating that only the first device detected is in use.
WARNING: To avoid infecting the instrument with a software virus, use only the
USB storage devices (flash drives) supplied with the instrument. These storage devices are
formatted to FAT* standard. The NTFS# standard is not supported.
USB Port on Front of Elite Instrument
*FAT = File Allocation Table. Format includes FAT, FAT32.

#NTFS = New Technology File System.
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1.5 Additional Features Chapter 1 – General Information
1.5 Additional Features

1.5.1 Standby Status
If the ACL ELITE/ELITE PRO is left ON for a period longer than 30 minutes without any
operator action, the system moves into the Standby status. The LCD screen is “Switched
off”. Pressing the Touch Screen reactivates the display and allows the system to resume
normal operation.
When the system enters the Standby status, the database is saved, all motors are
deactivated to reduce power consumption and the LED source is switched off. While the
instrument is in Standby an automatic priming cycle is performed every 30 minutes.
1.5.2 End of the Cycle

At the end of each analytical cycle, a beep signal notifies the operator that the cycle has
been completed.
1.5.3 Power Loss

The ACL Elite/Elite Pro Operator's Manual contains a non-volatile memory to retain the
database in the event of a power interruption. The instrument performs an automatic save of
the database which occurs with every exit from standby or when powering up the system.
Prior to shutting the unit off it is recommended the user log off before shutting the system
down
The instrument has an internal clock that keeps track of the date and time.
When power returns after an interruption, the instrument performs self-checks and displays
the “login” screen. Entering the main screen, two situations are possible:
1. The rotor holder temperature was within the acceptable range during the check. The
system is ready.
2. The rotor holder temperature was out of range. On the Main menu, the Warning icon on
the lower part of the screen is activated indicating that one or more temperatures are
out of range.
NOTE: Selecting the WARNING icon, a message may be displayed if temperatures

of the reagent cooling system, the rotor holder, the rotor transport and/or the rotor stack are
out of range.
1.5.4 Setup and Utility Programs

The instrument incorporates several utility programs that allow certain functions to be
changed or set according to the user’s needs. These programs also help in troubleshooting.
For additional information, refer to the following sections:
l Chapter 4 - Setup and Utility on page 153

l Chapter 6 - Troubleshooting on page 316
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1.6 Procedural Limitations Chapter 1 – General Information
1.5.5 Fault Detection

The system automatically monitors faults to ensure accuracy of sample data and proper
system performance. Fault monitoring includes display of alarms and warnings.
For additional information, refer to Chapter 6 - Troubleshooting on page 316.
1.5.6 Color and Symbol Legend

Certain situations concerning results and calibration parameters are displayed as follows:
l Black – Result within Normal range

l Violet – out of Normal range
l Red – out of Test range
l *** – result out of the Scale range, high, for the assay
l --- – result out of the Scale range, low, for the assay
l ? – No result is available for this ordered test
l * – More than one result is available for this test
For additional information, refer to the following sections:
l Section 3.2.2 - Sample Analysis Modes on page 76

l Chapter 7 - Assay and Instrument Specifications on page 360
Defined normal, test and scale range limits can be obtained by detailing the individual test
definitions in the system. Normal ranges must be entered by user.
1.6 Procedural Limitations

The operating range of the ACL ELITE/ELITE PRO is 15 to 32 °C (59 to 89 °F) and at up to 85% Relative
Humidity (not condensing). The system has been tested according to EN61010-1 to ensure no safety
hazards occur in the temperature range 5 - 40 °C (41 to 104 °F) and functional performance
characteristics resume when the instrument re-enters the range of 15 to 32 °C (59 to 89 °F).
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1.7 Certification Chapter 1 – General Information
1.7 Certification
1.7.1 CE Certification
The CE label on the back of the instrument indicates that the ACL ELITE/ELITE PRO
conforms to the European Directives as stated in IL Declaration of Conformity.
EU Directive
l IVD - 98/79/EC (27/10/1998) – Annex I and III
Applicable standards
EMC standards
l IEC 61326-1 – Electrical equipment for measurement, control and laboratory use -
EMC requirements
l IEC 61326-2-6 – In-Vitro diagnostic (IVD) - EMC requirements
l FCC Title 47 Part 15 Sub-part B
Safety standards
l IEC 61010-1, Third Edition – Safety requirements for electrical equipment for
measurement, control, and laboratory use
l IEC 61010-2-101, Second Edition – In-Vitro diagnostic (IVD) – Safety requirements
1.7.2 CSA Certification

The CSA label on the back of the instrument indicates that the Canadian Standards
Association (CSA) has certified the ACL ELITE/ELITE PRO to the applicable standards.
C US
Applicable standards
l CAN/CSA-C22.2 No. 61010-1

l CAN/CSA-C22.2 No. 61010-2-101
l UL Std. No. 61010-1
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1.7 Certification Chapter 1 – General Information
1.7.3 CEI/IEC 61010-1

The ACL ELITE/ELITE PRO instruments meet IEC 61010-1 Third Edition for the following:
l External surface temperature

l Flame resistance
l Fluid resistance
l Internal air flow and temperature
l Audible noise
l Product labeling
The ACL Elite/Elite Pro shipping crate complies with the International Safe Transit
Packaging Testing Procedure (ISTA).
1.7.4 European Union Directive 2002/96/EC on Waste Electrical and

Electrical Equipment (WEEE)
Instrumentation Laboratory is committed to meeting or exceeding the conditions of the

WEEE Directive and being a good environmental partner. In compliance with the WEEE
Directive, beginning with product shipped after August 13, 2005, all instruments are labeled
with the symbol shown above.
Disposing of this product correctly helps prevent potential negative consequences for the
environment and for human health. Recycling conserves natural resources.
Penalties may be applicable for incorrect disposal of this waste, in accordance with national
(European) legislation.
Please call your local Instrumentation Laboratory distributor for information regarding the
disposal of any end-of-life instruments.
Se also Section 1.8 - Instrument Disposal on the next page.
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1.8 Instrument Disposal Chapter 1 – General Information
1.8 Instrument Disposal

European Union Directive 2002/96/EC on Waste Electrical and Electrical Equipment
(WEEE)
See Section 1.7.4 - European Union Directive 2002/96/EC on Waste Electrical and Electrical Equipment
(WEEE) on the previous page.
1.9 Symbols
The following table displays the various symbols associated with the ACL ELITE/ELITE PRO:
Symbol Description
CE Mark
C
®
US
CSA Mark
Temperature Limitation
Use by
Manufacturer
Batch Code
Biological Risk
WARNING: Risk of Danger (IEC 61010-1)

Consult Accompanying Documents
CAUTION: Risk of Electrical Shock
NOTE. Important User Information
CAUTION: Mechanical Hazard
NOTE. Consult the documentation in all cases where this

symbol appears.
ATTENTION: Consult Instructions for Use
Catalog Number
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1.9 Symbols Chapter 1 – General Information
Symbol Description
SN Serial Number
In Vitro Diagnostic Device
Authorized Representative
Contains sufficient material for <n> tests
Protective Conductor Terminal - Earth (Ground)
Earth (Ground) Terminal
OFF (supply
ON (supply)
Bar Code Reader Hazard
End of Life Disposal (WEEE)
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Chapter 2 - Installation
2.0 Introduction 48
2.1 Installation Requirements 48
2.1.1 Environmental Conditions 48
2.1.2 Space Requirements 49
2.1.3 Electrical Requirements 50
2.2 Instrument Delivery and Unpacking 52
2.3 Mounting Instrument Parts 53
2.4 Turning the System On 57
2.5 ACL – HOST Interconnect Cable 60
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2.0 Introduction Chapter 2 – Installation
2.0 Introduction
This section contains all the information necessary for installing and setting up the ACL ELITE/ELITE
PRO system.
WARNING: The ACL ELITE/ELITE PRO system must only be installed by IL personnel or IL

authorized persons.
Before attempting the installation of the ACL ELITE/ELITE PRO system in the laboratory, inspect the
site with laboratory personnel to identify the desired location for the system and to insure that the
environment meets all the requirements for its successful installation.
2.1 Installation Requirements

The following sections detail the specific installation requirements for the ACL ELITE/ELITE PRO
system.
2.1.1 Environmental Conditions

The ACL Elite/Elite Pro functions correctly in an ambient temperature of 15° C to 32° C (59°
F to 89° F) with a relative humidity of 15% to 85% (non-condensing).
In accordance with the IEC regulations, no instrument failures occur in the presence of short-
term ambient temperatures as low as 5° C or as high as 40° C.
The ACL Elite/Elite Pro is compliant with IEC 60068-2-13 to 2000 meters. The instrument
should not be used at an altitude greater than 2000 meters.
The instrument should be placed in an area free from dust, fumes, vibrations and excessive
variations of temperature.
The heat generated by the instrument during normal operation is exhausted from the bottom,
on the rear-right and left side of the unit.
Sufficient space must be allowed around the instrument to permit circulation of air for
cooling. The instrument must be positioned so that a waste tube can be easily connected to
its left side. Allow at least 6 inches (15.24cm) of clearance on the sides, back, and top of the
analyzer to ensure proper cooling.
Leave sufficient room to quickly disconnect the power cord, if necessary.
According to IEC 61010-1, the maximum audible noise emission should be 80 dBA. The ACL
Elite/Elite Pro is compliant with IEC 61010-1 Third Edition.
See also Section 2.1.2 - Space Requirements on the next page.
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2.1 Installation Requirements Chapter 2 – Installation
Storage Conditions
Store the instrument and startup kit at 10°C to 30°C, and 15% to 85% relative humidity, non-
condensing.
Shipping Conditions
Ship the instrument and startup kit at 5°C to 40°C, and 15% to 85% relative humidity, non-
condensing.
2.1.2 Space Requirements

External dimensions of the analyzer are:
Height at display level 60 cm 23.6 inches

Height of analysis surface 33 cm 13 inches
Width (including LCD) 100 cm 39.4 inches
Depth 60 cm 23.6 inches
Weight 63 Kg 139 lbs.
The heat generated by the instrument during normal operation is exhausted from the bottom,
on the rear-right and left side of the unit.
Sufficient space must be allowed around the instrument to permit circulation of air for
cooling. The instrument must be positioned so that a waste tube can be easily connected to
its left side. Allow at least 6 inches (15.24cm) of clearance on the sides, back, and top of the
analyzer to ensure proper cooling.
If the operator wishes to work from a sitting position in front of the system, leg-space should
be provided under the front of the instrument.
See also Section 2.1.1 - Environmental Conditions on the previous page.
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2.1.3 Electrical Requirements

The instrument operates correctly with variations of ±10% on the nominal line voltage with
line frequencies of 50/60 Hz.
The instrument has a power supply that can operate from 100 to 240 V and it automatically
switches to the line voltage required.
WARNING: Check that the nominal line voltage in the laboratory is compatible with
the label on the rear of the instrument as shown in the table below. The electrical installation
of the room should comply with local, state or national requirements (including a power
supply circuit with independent grounding).
Values of line voltage for

Value as shown on the label
normal function
100 – 240 V 100, 110, 115, 120, 125 Vac ±10%
220, 230, 240 Vac ±10%
See also Section 7.10 - Electrical Specifications on page 412.
Power Consumption
Check that the line is capable of supplying 350 VA.
WARNING: The average power consumption is about 350 VA, but peak loads or
current surges may exceed this value when turning the instrument on.
Line Frequency
The instrument functions at 50/60 Hz line frequency.
The power cord provided with the system is specifically designed for use with the ACL
ELITE/ELITE PRO. No other cord should be substituted. The cord plugs into the socket as
shown in the figure below. The fuses are enclosed in the compartment to the right of the
socket. The power entry module and the ON/OFF switch are included.
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Power Socket and Fuse
Connectors
The instrument is provided with several connectors located on the back side.
Connectors
1. RS232C 1 (Host - Optional)

2. RS232C 2 (Serial Mouse)
3. USB Ports (4): Mouse, Printer, Memory device1 or Barcode reader
4. Modem (NS)
5. Parallel Printer (Optional)
6. Keyboard
NS = Not Supported in this software release.
1Available on units with Revised Computer Board. Only one device may be used at a time and it will be designated as
(USB0).
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2.2 Instrument Delivery and Unpacking Chapter 2 – Installation
2.2 Instrument Delivery and Unpacking

An IL-certified representative should unpack the boxes containing the ACL and accessories, visually
inspect them to verify that there has been no damage during shipping and handling. IL is not responsible
for damages resulting from any non IL-certified representative opening the boxes.
In case of damage notify the carrier and IL immediately.
Remove the box containing the rotors and the startup kit. Using the startup kit list included in the box,
confirm that all the shipping list components are present.
Remove the instrument and place it on the working surface.
Remove the adhesive tape used for transport from the various parts (covers, fan cover, etc.).
WARNING: Two persons should lift the instrument using the space below the unit at the front
and at the back as shown on the figure below.
Instrument carrying points
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2.3 Mounting Instrument Parts Chapter 2 – Installation
2.3 Mounting Instrument Parts

Waste tube
Connect the waste tube to the fitting on the bottom left hand side of the instrument. Cut the tube to
suitable length to fit into the waste container which must be situated below the instrument waste outlet
port, as shown in the figures below.
WARNING: The horizontal section of the tube should be kept as short as possible and the free
end should not be immersed in the liquid waste container. Waste volume is not monitored. Customer is
responsible to empty waste when full.
WARNING: The liquid waste from the instrument is to be considered contaminated and should
be disposed of according to the waste management procedures of the laboratory and in compliance with
local and state regulations.
Waste tube connection and waste container position
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Rinse, Sample and Reagent Accessories
l Verify that the rinse –waste reservoir is placed in its appropriate position.
l Fit the appropriate sample tray on its corresponding support.
l Fit the reagent adapters in their appropriate positions (if needed), as shown in the figure below.
Three color-coded reagent adapters are available for reagent positions R1 to R8 (ACL ELITE)
and R1 to R12 (ACL ELITE PRO):
l Gray – 10 mL vials requiring magnetic stirrer (R1 to R4 only). Place the magnetic
stirrers inside the reagent vials in reagent positions R1 to R4, if needed. Refer to
reagent package insert sheet for stir bar usage.
l Pink – 10 mL vials not requiring magnetic stirrer
l Green – 4 mL vials not requiring magnetic stirrer
l Blue vial adapters are used for the A1 through A10 positions on the sample tray. See sample
tray picture below.
Reagent Adapters for R1-R8 (ACL ELITE) and R1-R12 (ACL ELITE PRO) positions
Reagent Adapters for the Sample Tray A1-A10 positions
54 of 617 L0018200232 R01

Wash-Reference Emulsion
Place a 1-liter bottle of Wash-Reference Emulsion in the appropriate position at the back of the dilutor
block. Insert the aspiration tube. Make sure that the aspiration tube connector is properly connected to
the level-sensing device.
To replace the Wash-R bottle, see Section 5.2.6 - As Needed Maintenance on page 305.
Electrovalve-needle assembly
Verify that the two tubes from the dilutor electrovalve assembly to the needle block are tightly
connected.
NOTE: The tube from the left hand electrovalve fits into the lower needle connector and the right
hand tube fits into the upper needle connector.
Wash-Reference emulsion bottle and Electrovalve-needle assembly
55 of 617 L0018200232 R01

Positioning the touch-screen LCD display
Connect the LCD display to the appropriate fitting on the right side of the instrument, as shown in the
figure below.
Position of the LCD display
The monitor can be adjusted for left/right and up/down viewing angle.
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2.4 Turning the System On Chapter 2 – Installation
2.4 Turning the System On

Before turning the instrument on, check that the line voltage setting of the laboratory is in accordance
with the instrument label. Connect the instrument to the power supply and switch it on using the power
switch on the back panel.
Check that the Warning message “INCUBATION TEMPERATURE OUT OF RANGE” appears on the
screen display by accessing the WARNING icon. Check that the magnetic stirrers in the reagent vials
R1 and R4 are rotating (if needed).
Date/Time
Select Setup from the Main screen menu bar and click the Date/Time option. Choose the date format.
Set date and time. Press Confirm/Cancel to accept or ignore the changes. Refer to Section 4.1.23 -
Setup – DATE/TIME on page 202.
NOTE: The following error messages may appear in the File Error History at start up.
l Incubation temperature out of range – This error displays for approximately 15 minutes,
until the rotor holder has reached operating temperature. The error log may display various
temperature warnings that occur during the first 30 minutes after the system is turned on.
l Error: System Internal Error – This error may appear multiple times. It is caused by the
instrument trying to report a temperature value before true temperature acquisition has begun,
and does not interfere with normal instrument operations.
Needle Arm Assembly
Please refer to Section 5.1.5 - Needles Position on page 292.
Priming
Select Diagnostic from the main screen menu bar and click the Priming option.
The Priming screen is displayed during the priming cycle:
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Priming screen
During priming, check that the number of bubbles in the dilutor chambers are reduced to a minimum. If
necessary, pinch the chamber outlet tubes with your fingers while the piston is descending and release
them before the piston reaches bottom dead center. Repeat the priming cycle if necessary.
Check that there are no blockages or leaks in the fluid path and that the liquid is flowing smoothly from
the bottle to the dilutors and from the dilutors to the needles.
Check that the discharge of liquid from the rinse cup to the instrument outlet and then to the waste
container is not impaired.
WARNING: Warning: If the message “SENSOR FAIL” in the Warning area is displayed, the
priming cycle must be repeated.
Air Cooling System Check
Locate the ventilation filter holder on the right side of the instrument. Verify that the filter is clean and that
the two fans are operating properly.
Temperature Check
Wait until the INCUBATION TEMPERATURE OUT OF RANGE warning has disappeared and the Main
menu is displayed. Click the Diagnostic button in the menu bar and select the Temperature Control
option, which will open the Temperature Control screen. For details refer to Section 5.1.4 - Temperature
Control on page 291.
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Temperature Control screen
The temperature should be within the following ranges for each area:
l Rotor Holder – 38 to 39 °C
l Peltier* – 10 to 16 °C
l Rotor Transport – 34 to 40 °C (N/A ACL Elite)
l Rotor Stack – 34 to 40 °C
The temperature display is constantly refreshed showing a blinking effect on the display.
On-Board Barcode Reader
This is a standard feature for the ACL ELITE/ELITE PRO. Set up the On-Board Barcode Reader
according to the procedure described in Chapter 4 - Setup and Utility on page 153.
For additional information refer to Appendix B - Bar Code Label Specification on page 480.
Manufacturer’s Responsibility
The manufacturer is responsible for the defects having an impact on safety, reliability and performance
of the equipment only if:
l assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

manufacturer’s authorized personnel; and
l the electrical installation complies with national requirements; and
l the equipment is used in accordance with the instructions contained in this manual.
*ACL ELITE PRO will display Peltiers for R1 – R4 and R9 – R12.
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2.5 ACL – HOST Interconnect Cable Chapter 2 – Installation
2.5 ACL – HOST Interconnect Cable

The following table provides information regarding the wiring of the interconnection cable between the
ACL and a PC (Host).
ACL Side PC Side

Interface Type: DTE Interface Type: DTE
9 Pin Female Delta Connector 9 Pin Female Delta Connector
PIN DESCRIPTION PIN DESCRIPTION
1 N.C 1 N.C.
2 TXD 2 TXD
3 RXD 3 RXD
4 DTR 4 DSR
5 Signal GND 5 Signal GND
6 DSR 6 DTR
7 RTS 7 CTS
8 CTS 8 RTS
9 N.C. 9 N.C.
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Chapter 3 - Analytical Operations
3.0 Introduction 63
3.1 Components and Use of the Operator Interface 63
3.1.1 Touch Screen 63
3.1.2 Numerical Keypad 64
3.1.3 Standard PC Keyboard 64
3.1.4 External Barcode Reader (optional on ACL ELITE) 65
3.1.5 Mouse - Port 2 65
3.1.6 Menus 65
3.1.7 Windows and Boxes 66
3.1.8 Key Screen Elements 66
3.1.9 A Special Window for Alarms and Errors 70
3.1.10 Screen Saver (Standby) 70
3.1.11 ACL ELITE/ELITE PRO Menu Structure 71
3.2 Sample Analysis 72
3.2.1 Sample Analysis Procedures - Summarized 73
3.2.2 Sample Analysis Modes 76
3.2.3 Materials Map 85
3.2.4 Analysis: Loadlist 88
3.2.5 Analysis: Session Report 93
3.2.6 Session Pause Conditions 97
3.2.7 Analysis: Pause / STAT Functions 98
3.2.8 Database View / Results List 102
3.2.8.1 Extract Icon 104
3.2.8.2 Sample Detail Icon 105
3.2.8.3 New Sample Icon (Tubes in Folder) 108
3.2.8.4 Delete Icon (Trash Can) 109
3.2.8.5 Printing results 110
3.2.8.6 Sending results to Host Computer 111
3.3 Quality Control 112
3.3.1 Analyzing QC Materials Using a Loadlist 113
3.3.2 Quality Control Setup 114
3.3.3 QC Result Review 117
3.3.4 QC – PLOT and STATISTICS 118
3.3.5 QC – CUMULATIVE RESULTS 120
3.3.6 QC – HOST COMMUNICATION 123
3.3.7 QC – EXTRACT DATA 125
3.4 Calibration 127
3.4.1 Dedicated Calibration Procedure – Summary 128
3.4.2 Saving a Calibration – Summary 129
3.4.3 Dedicated Calibration – Details 129
3.4.4 Calibration – Review Calibrations 131
3.4.5 Factor Assay Calibration for Non-Parallelism Tests 136
3.4.6 Factor Assay Calibration for Parallelism Tests 141
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Chapter 3 – Analytical Operations
3.4.7 Factor Assay Parallelism Results 141

3.5 Analytical Reference 143
3.5.1 Analytical Reference: SETUP 143
3.5.2 Analytical Reference: PLOT and STATISTICS 146
3.5.3 Analytical Reference: CUMULATIVE RESULTS 148
3.5.4 Analytical Reference: HOST COMMUNICATION 150
3.5.5 Analytical Reference: EXTRACT DATA 151
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3.0 Introduction Chapter 3 – Analytical Operations
3.0 Introduction
This section describes the different procedures associated with sample analysis, calibration and quality
control (QC.) on the ACL ELITE/ELITE PRO System. Since these procedures require an interaction
between the operator and the ACL, this section begins with some general information about the
System’s Operator Interface (OI) for easy referral, as need arises.
3.1 Components and Use of the Operator Interface

The following sub-sections are intended to familiarize the operator with the Operator Interface (OI) items
used during the process of requesting and performing analytical operations, such as the data input
devices, menu items, buttons and icons. The ACL ELITE/ELITE PRO software tree is also included.
3.1.1 Touch Screen

The basic interaction with the ACL is done through menus that allow access to sets of
related functions (analysis, calibration, QC, set-up, diagnostics, etc.) and through the use of
dialogue or message boxes to input or retrieve information.
The main information input device for the user is the touch screen. To start an “enter” or “edit”
action, the operator touches the area to be edited. If the information to be entered is strictly
numerical, the editing is done directly on the keyboard or popup keypad (optional system
configuration). If the information requires alphanumeric characters, the input is done through
the external keyboard.
The editing action may be closed by pressing the Confirm or Cancel buttons.
Once confirmation is complete, the system performs an automatic check on the entered
value; if an erroneous entry is detected, the user is notified by means of dialogue boxes and
the editing action is reactivated. The touch screen supports auto-repeat functions in order to
make lists easier to scroll (e.g. sample lists, test lists, increase/decrease order).
The Main Database screen is divided into 3 main areas:
1. Status area: upper part of the screen which contains:
Instrument status Date and Time

Current user Software revision
IL logo
2. Working area: central area of the screen, which displays windows that contain data or
messages.
3. Toolbar area: bottom part of the screen, which contains a series of buttons for
immediate access to particular functions and easy access to specific commands. The
status of the buttons is dependent on the instrument status, but independent from the
type of information displayed in the working area.
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3.1 Components and Use of the Operator Interface Chapter 3 – Analytical Operations
NOTE: On the touch screen, any disabled object (menu, check-box, icon, or button)
is dimmed out and cannot be selected.
3.1.2 Numerical Keypad

The numerical keypad allows the operator to edit numerical data without using the standard
PC keyboard. The numerical keypad can be configured to automatically display when the
user starts an edit action. Refer to Section 4.1.17 - Setup – INTERFACES – Keyboard on
page 194.
The keypad allows the operator to visualize the edited string while editing is in progress. The
keypad automatically disappears when the Confirm or Cancel buttons are selected or the
editing action is implicitly closed.
The keypad displays the name of the field being edited as a window caption, and information
on the accepted range values; it also supports the date format.
When the numerical keypad is opened, the values shown in the fields are either the default or
the values previously entered. Use the arrow buttons to select the field to be edited.
3.1.3 Standard PC Keyboard

The main function of the PC keyboard is to enter and edit data in the alphanumeric fields.
The keyboard input is case sensitive.
To start the editing action, select the field to be edited. This is done by moving the cursor
from the current object (it may be the default object if the window was just opened) to the
chosen object by pressing [TAB] or [Shift] + [TAB].
To close the editing action, of the present text box, press [Enter] or select another active
object or move the cursor by pressing the [TAB] or [Shift] + [TAB] keys. In all cases,
closing the editing action causes the system to activate checks on the entered data and the
user is notified of any error condition by means of a dialogue box. If the editing action is
closed by touching a different area of the screen, the entered value will be changed to the
pre-existing one.
The editing action, of the present text box, may also be closed by pressing the [ESC] key
without activating any change; in this case the value returns to the pre-existing one.
Main and secondary menus may be selected using the keyboard. The menus are opened by
pressing [ALT] +underlined Character; selections within the menus are done using the
specific underlined character. Pressing the [ENTER] key allows access to the secondary
menus.
The keyboard function keys (F1 – F10) may also be used to activate the functions on the
bottom row of icons. Use [Ctrl] + F4 for keyboard log off.
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3.1.4 External Barcode Reader (optional on ACL ELITE)

The USB ports allow for the connection of an external hand held barcode reader. This device
can be used to identify reagents and indicate the placement of them onboard the system.
Please refer to Section 4.1.16 - Setup – INTERFACES – External Barcode – Optional on
page 193.
3.1.5 Mouse - Port 2

A serial mouse may be used as a pointing device in place of touching the screen. The USB
ports also provide the capability to connect a USB mouse to the analyzer.
3.1.6 Menus
A menu may be opened by selecting the appropriate area of the screen (touch or click with
the mouse) or using the keyboard: [ALT] + underlined letter.
The selection of menus to be opened may be done in all directions: up and down or right and
left.
The displayed items, which have a secondary menu, are identified with a marker (Ø).
Selecting a menu item, touching an external area, or pressing [ESC] from the standard
keyboard closes a menu.
NOTE: In any menu, an inactive item is dimmed out. selecting an inactive item does
not elicit a response; therefore, this method cannot be used to exit the menu.
See Section 3.1.11 - ACL ELITE/ELITE PRO Menu Structure on page 71 for the complete
menu structure.
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3.1.7 Windows and Boxes

Within the ACL screens, the data, information, or messages for the user are grouped or
contained in defined units of three different types:
l Standard window: usually a larger area which contains sets of related data which can
be edited by the user
l Dialogue box: a small area used to prompt the user to choose one of several options
(i.e. OK, Abort, Retry, Ignore, Cancel, Yes, No)
l Message box: an area used only to provide information
ICONS are often included in a message box. The table below lists all possible icons with
their corresponding meanings.
Icon Meaning
ERROR. Calls attention to high priority failures and fault messages.
WARNING. Delivers different kinds of messages, i.e. to warn the user of a “not
allowed/wrong” operation, or of problems/errors detected by the instrument
during or after an operation.
QUESTION. Requests confirmation by the user before starting an operation or

before canceling an action
INFORMATION. Offers general information. In some boxes, but not always, the
message is followed by a request for confirmation.
3.1.8 Key Screen Elements

Below are descriptions of the most significant items found within the ACL screens.
Instrument Status
Located in the upper part of the screen within the Status area, this item identifies the current
state of the instrument as one of the following:
l INIT (BOOT/START-UP): indicates that the instrument is performing startup

operations (Initializing)
l READY: indicates that there have been no errors detected, there are no analytical
operations in progress and the instrument is ready to start
l OPERATING: indicates that either an analytical function is in progress (i.e. calibration
or sample analysis) or a diagnostic function is being performed
l HOLD:identifies a system "pause" condition during an analytical session (i.e. STAT
request, no rotors, etc.)
l FAILURE:indicates that the system detected an internal mechanical malfunction
(devices, temperature control, etc.)
l STAND-BY:the status into which the instrument moves automatically after 30
minutes of inactivity. LCD display is switched off (screen saver); this extends LCD
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life. An orange LED indicates that the instrument is ON. Touching the screen or any
key on the keyboard will cause the instrument to exit from standby.
NOTE: When the instrument is in standby operation, every 30 minutes an

automatic priming cycle is performed. The consumption of Wash-R Emulsion is
approximately 0.9 mL (3 strokes per single piston dilutor – total of 6 strokes; each
single stroke of 0.15 mL).
l SERVICE: the status assumed when the Service functions are in use.
Check Boxes, Buttons and Icons
Buttons allow the user to select options, cause actions and get from one part of the software
to another. The buttons are positioned in different areas depending on the screen. Buttons
are identified with text that is self -explanatory of the action. Icons, which illustrate an
action, are defined below.
Check boxes allow the user to “mark” an item.
If a check box or button is in mutual exclusion with another check box or button, there is a
frame wrapping the two, along with “graphic” information.
ICONS
Icons can be found either in the middle Working Area of the screen or lining up in the Toolbar
Area at the bottom of the screen.
Below are two lists grouping the standard icons used throughout the ACL ELITE/ELITE
PRO, along with their associated commands. The first one includes the Window Icons found
in the screen’s Working Area, and the second one includes the Toolbar Icons found in the
screen’s Toolbar Area.
NOTES:
1. The same icon may have slightly different meaning depending on the screen where it
is found.
2. One or more of these may be disabled on a specific screen, indicated by a dimmed
representation. Its selection is ignored.
3. Active toolbar buttons for each specific screen and their actions are described within
the appropriate section of this manual.
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Table - Window Icons
Window Icons Command / Action
Confirm (dimmed if Edit action not allowed)
Cancel
Print
(Host) Transmit
Delete
Add item to the list
Remove an item from the list
Transfer an item from one list to another
Details
Information in different languages
New Sample
Extract Sample Data
Note
Patient Name
Patient Details
Save information
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Table - Toolbar Icons
Instrument Status
Toolbar Icons Commands / Actions
(Icon active)
STAT/Pause Operating
Pauses the system for stat or sample entry. Hold
Instrument Status Operating

Status of the operation in progress. Ready
Displays material map in Ready. Hold
Ready
Close/Open cover
Hold
Operating
STOP
Ready
Confirmation is required.
Hold
Reagent Map
Operating
Color changes depending upon the reagent map status.
Ready / Hold
QC
Operating
Press to view the most recent QC data. A red ! indicates a QC failure.
Failure
Operating
Database View
Ready
Return to the database view or “Main” screen.
Hold
Ready / Hold
Host Status
Operating
Host communication in process.
Failure
Ready / Hold
Warning
Operating
This icon indicates Warnings exist. Press to open the Warning List.
Failure
Log Out
Ready
Closes Databases & logs current operator off.
Failure
Confirmation is required.
Start or Resume Run. Ready / Hold
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3.1.9 A Special Window for Alarms and Errors

If an abnormal situation develops and causes an interruption during the progress of an
operation, the operator is informed through an alarm message in a specific message box.
This message box is displayed in front of all the other windows present in the working area.
After the operator confirms the message, the information about the alarm can be viewed in
this warning window.
Error conditions that do not affect the in-progress analytical session may be reviewed
accessing the "Session Error History". The operator is able to view a list of all the warnings
and error messages, sorted by time, which pertain to the last analytical session or to the one
in progress. The Session Error History is saved at the conclusion of each analytical session
so the errors can be checked between analytical sessions.
The "File Error History" window contains a list, sorted by time, of the last 100 alarms or error
conditions. The “Session Error History” and “File Error File History” windows are dynamically
updated when opened and must be closed before starting a new operation.
3.1.10 Screen Saver (Standby)

A screen blank is activated after 30 minutes of system inactivity, provided the ACL system
is in the READY status. The operator cannot modify this time. Any action performed on the
touch screen, through the keyboard or the bar code reader will reactivate the system.
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3.1.11 ACL ELITE/ELITE PRO Menu Structure
ANALYSIS QC CALIBRATION DIAGNOSTIC SETUP UTILITY
Multi Test Session

Calibrate Tests ► Upgrade IL Library
Single Test Session
Review Calibration Multi-Test ► Backup / Restore
Loadlist
Analytical Reference Liquids Archive
Session History
Interfaces ► Software ►
System Configuration Save Rotor Map
Security Save Trace
Audible Alarms Test / Material ►
QC Priming Date / Time Debug (dimmed)
Setup / Review Cleaning Units Testing (dimmed)
Maintenance
Temperature Control
Needles Position
Session Error History View / Define SW Identification
File Error History Sort Test SW Upgrade ►
Logbook Interference Table
Service (dimmed) Default Tests
Reflex Tests
Software Upgrade
SW Master ►
SW Slave ►
Profiles SW REM ►
Test Groups
Test Group Profiles
Sort Multi-Tests Backup
Default Multi-Test Upload
Upload
Upgrade
Host
Printer
Internal Barcode
External Barcode
Keyboard
Network (dimmed)
Modem (dimmed)
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3.2 Sample Analysis Chapter 3 – Analytical Operations
3.2 Sample Analysis

Section 3.2.1 and those that follow contain detailed descriptions of the screens, options and steps
involved in the sample analysis process on the ACL ELITE/ELITE PRO.
The system provides two modes for running samples: Single Test and Multi-Tests. Within each of
these a “session” is considered to be the total of all the individual test “runs”. For example, you are
using the PT-APTT PROFILE and have 20 samples to process. Each sample contains both tests. The
“Session” would therefore be composed of 4 test “Runs”; 2 runs for PT and 2 runs for APTT since the
maximum number of samples per run is 19 for the PT and APTT tests.
The system allows a variety of choices to enter the sample ID information into the system before
analysis, depending on the laboratory’s procedures and system setup. The Sample ID must contain a
minimum of 1 alphanumeric character. For users already familiar with the ACL Operator Interface,
Section 3.2.1 includes summarized sample analysis protocols to be followed depending on the mode of
sample ID entry.
This section contains the following procedures (sub section 3.2.1):
l Manual Sample ID Entry - Loadlist created before Analysis on the next page
l Manual Sample ID Entry – Loadlist created during Analysis on page 74
l Manual sample ID Entry –Loadlist created from Database menu on page 74
l Sample ID entry by barcodes - no connection to a host computer on page 75
l Sample ID entry by barcodes - connection to a host computer (Host Query mode) on page 75
l Sample ID entry by barcodes – connection to a host computer (Host Query mode) – Default
Mufti-test on page 75
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3.2.1 Sample Analysis Procedures - Summarized

Manual Sample ID Entry - Loadlist created before Analysis
1. Select Analysis.
2. Select Loadlist.
3. Select the desired (empty) Loadlist, click the details icon.
4. Click the Enter/Edit Sample ID button.
5. Type the Sample ID, use the ▼to move to the next position or Confirm when all
sample IDs have been entered.
6. If Default Tests are desired for the list, do not program tests for individual samples.
Click on the “Set Default Test” button.
7. Click the Program Test button to program individual tests
8. Program Tests/Multi-Tests on the sample by clicking the desired test selection in the
Test matrix. The selection will display in the Programmed test list. Corrections can be
made clicking the test selection again to deselect if the desired tests/PROFILES were
the same as the previous sample, click the Prev Prog button. Press the ▼to move to
the next loadlist position or Confirm when complete.
9. Click the Confirm button: Date and Time is associated to the Loadlist Number and the
system switches to the Loadlist screen.
10. Click the Confirm button: the system switches to the Main screen. The inserted
samples are displayed in the database.
11. Select Analysis; Multi-Tests or Single Test then desired test(s).
12. Click the Loadlist No. box and enter the loadlist number.
13. If tests were not previously ordered on the sample (step 6) or default tests are not
desired, click the Program Sample button. Select the test to be run and press the
▼to move to the next sample on the Loadlist or Confirm when complete.
14. Verify that the current test selection is the one of choice confirm the materials map and
click the Runner icon.
15. During Analysis the Session Report screen is shown. Test sequence is indicated.
From this screen the Material Map and the Error History are available.
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Manual Sample ID Entry – Loadlist created during Analysis
1. Select Analysis.
2. Select Multi-Tests Session or Single Test then desired test(s).
3. With cursor on the first tray position of the Loadlist, click the Program Sample button.
QC can be added by clicking on the Add QC button.
4. In the Sample Entry screen enter the Sample ID and select the Tests to be run.
5. Click the New Sample icon to enter the next position and enter the next Sample ID.
6. If tests to be run are the same as before, click the Prev. Prog. button; if they are
different, select new Tests.
7. Repeat steps 6 and 7 until all samples and tests are entered.
8. Click the Confirm button to accept the changes; the system switches to the Single
Test Pre-Analysis screen (if a single test was selected) or to the Multi-Tests Pre-
Analysis screen (if a Multi-Tests was selected).
9. The tray positions will be displayed in dark blue with the letter P (Pending).
10. Press the Store Loadlist button and enter in a loadlist number.
11. Once the samples are in the sample tray, confirm materials, click the Runner.
Manual sample ID Entry –Loadlist created from Database menu
1. Click the New Sample icon.

2. Enter the Sample ID.
3. Select the Test to be programmed.
4. Repeat steps 1, 2 and 3 until all samples are entered.
5. After programming the last sample, click the Confirm button. The system switches
back to the Main screen. The inserted samples are displayed and marked with a P (for
Pending); in the “Test Request” area the tests requested are marked with a ?.
6. Select Analysis.
7. Select Loadlist.
8. Click the Make Loadlist button.
9. Enter the Loadlist Number to start with (1-20), default is 1, and the Number of
samples per Loadlist (1-40), default is 40.
10. Click the Pending button (‘All’ or ‘Test’ selection). You may then select a certain “Date
and Time” range along with a “Sample ID” range.
11. An alternate method is to click on Mark Samples and select the Sample IDs from the
database of samples.
12. Click the Confirm button. The system switches back to the Loadlist screen showing
the Date and Time when the loadlist was saved.
13. Click the Confirm button. The system switches back to the Main screen.
14. Select Analysis.
16. Click the Loadlist No. box and enter a valid Loadlist number.
17. Once the samples are in the sample tray, confirm materials, press the Runner.
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Sample ID entry by barcodes - no connection to a host computer
1. Select Analysis.
3. Place the samples on the sample tray
4. Select Read Bar-codes and the instrument will create the loadlist using the barcode
reader.
5. Select first sample then Click Program Sample to select Test(s) to run.
6. Click the “>” button to move to the next position sample ID.
7. If tests to be run are the same as before, click the Prev.Prog. button; if they are
different, select a new Test. Repeat step 6 & 7 or when complete click the confirm
button.
8. Confirm Materials Map and press the Runner icon.
9. During Analysis the Session Report screen is available. Test sequence is indicated.
Sample ID entry by barcodes - connection to a host computer (Host Query

mode)
1. Select Analysis; Multi-Tests or Single Test then desired test(s).

2. Confirm the reagent map and Click the Runner icon (instrument will perform the Host
Query and proceed to the analysis).
3. During Analysis the Session Report screen is shown. Test sequence is indicated.
Sample ID entry by barcodes – connection to a host computer (Host Query

mode) – Default Mufti-test
1. Place barcoded samples on sample tray. From the main database screen click the
Runner icon. (Instrument will perform Host Query and proceed to the analysis).
NOTE: It is important to ensure the Reagent positions onboard the analyzer are
setup with the correct reagents placed for this option. Failure to do so may result in tests
running with an inappropriate reagent. Refer to Section 4.1.7 - Setup – Multi-Tests - Profiles
on page 167 (Profiles Details screen) to view the material map for the default PROFILE.
The ACL ELITE/ELITE PRO can process up to 40 samples in a single session (including
Reflex tests) programmed with a number of tests while optimizing cuvette positions within
the rotors. As positions on the sample tray become complete, new samples may be
substituted into these positions. This is accomplished using the Stat/Pause Icon. Reagents
and samples (from cups or original containers) are automatically aspirated and dispensed by
the needle arm. Rotors are loaded and discharged automatically providing a complete walk-
away system for the ACL ELITE PRO. The ACL ELITE will prompt the user when a new
rotor for analysis is required.
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3.2.2 Sample Analysis Modes

The sample analysis process is started from the Main screen by selecting Analysis on the
menu bar. The 2 options given on the Analysis screen for processing samples are MULTI-
TESTS and SINGLE TEST. In addition, the “Runner” icon on the main database will start a
run using the default Mufti-test setup.
l Multi-Tests: This option allows you to process multiple tests in a random access
fashion on the samples in the tray. The tests groupings are user defined and
configured under the Setup menu. The mufti-test grouping can be composed of one or
more single tests (PROFILE) or one or more tests groups (TEST GROUP PROFILE)
l Single Test: This option will configure the system to only process the single test
selected for analysis. If the samples on the tray have multiple tests programmed on
them, only the selected test will be analyzed and the unprocessed tests will remain
pending on a sample.
SINGLE TEST ANALYSIS Screen
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MULTI-TESTS ANALYSIS Screen
NOTE: The Current Multi-Test drop down menu will list the available PROFILES,
TEST GROUPS and TEST GROUP PROFILES in the order selected by the sort mufti-test
function
These 2 analysis screens contain multiple windows and associated buttons:
1. Top left area: the Current Multi-Tests or Single Test window displays the selection to be
run in the current analytical session. The selection can be changed by pressing the (>) button
on the right of the window and browsing though the displayed list; the decision must be
confirmed by pressing the same button again. The main objective of this screen is to activate
the Materials map, since the programming of the map is dependent on the Current selection
displayed.
The (…) displayed prior to the TEST GROUPS names have the following meaning.
Multi-Test Test Group – Grouping of tests that are run simultaneously during
the session.
Multi-Test Profile – User defined grouping of tests that are run sequentially
during the session.
Test Group Profile – Multi-Test session composed of combined TEST
GROUPS.
The Deselect Tests button (available when in the Multi-Tests Analysis Screen only) may be
clicked to open the Multi-Tests Details window. This screen allows the operator to deselect
running one (or more) of the tests, on all samples, included in the Multi-Tests.
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Clicking the Material List button at the bottom left of the screen opens the list of materials
required for the analysis.
Clicking the Materials Map button opens the Pre-Analysis: Material Status window as
shown below. For details, refer to Section 3.2.3 - Materials Map on page 85.
2. Middle area: the two windows in the middle of the Selected Pre-Analysis screen
(described on the previous pages ) contain the sample programming information. The round
circle on the left divided into 4 quadrants is used to select a region on the sample tray. The
current selected quadrant is displayed in yellow and highlighted. The window to the right
displays the status of the 10 samples within the selected quadrant. The color of the circle
provides information on the status of the sample. In addition to the color, the circle may
contain a letter or symbol that provides further details about the sample type. The following
table contains details about the colors and sample type letters.
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Color Status Symbol Status
Gray
Empty or
available + STAT
No test
Light Blue
programmed P Pending
Dark Blue
Programmed C Complete
Not
Lavender
Processing N Programmed
Sample
Complete
Processing
Green
Quality
Orange
Pending QC Control
Warning or
Yellow
Errors L Low Volume
Empty cup in Sample Not

position ? Identified
The circles will be colored and also will contain a symbol. Examples include:
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Clicking on a position circle will display the information about that sample.
#: Sample tray position
+: Sample Priority – Stat indicated by √
S: Status of Tests (P, C or N)
P - Pending: One or more tests is missing a result
C – Complete: All tests programmed on the sample have been analyzed
N – No Test: Sample ID has no tests ordered
F: Flags associated with that sample
Samples that are detected as short will be flagged with a yellowwith L. No further testing will
be performed on this sample position during this session. If the sample is replenished, the
sample must be moved to a different position on the tray if processing is desired in the
current session.
The small window on the top left Sample Tray Map enables the Read Bar Code button to be
displayed. The Loadlist No. window allows the operator to either create a new loadlist or
select a stored one. To create a new one enter the Loadlist number (1-20) not currently
defined for samples. Refer to Section 3.2.4 - Analysis: Loadlist on page 88 for loadlist
details. If you modify a loadlist, press the Store Loadlist button to save the changes.
The operator chooses how to program samples according to the desired sample ID entry
mode. Refer to Section 3.2.1 - Sample Analysis Procedures - Summarized on page 73.
Options include the following:
l Manual Entry into the “Analysis” menu

l Manual Entry in the “Loadlist” menu
l Manual Entry in the “Database” menu
l Use of barcoded samples, no connection with Host Computer
l Use of barcoded samples, connected, Host Query mode
Clicking the Read Bar Codes button activates rotation of the sample tray. During the
rotation the barcode reader and sample cup/tube position reader identify a cup/tube placed
on the tray along with sample identification by reading the bar codes. If barcoded samples
are present and barcodes are readable, their corresponding Sample IDs are displayed in the
large window. If a cup or tube is identified to be in place and the system is unable to read the
barcode label a warning of “Error in Sample Identification” is presented to the operator. If this
occurs, check the tube position to ensure the barcode label was properly oriented, then click
on the Read Bar Code button again. Bar Code read flags: (No_R) - Sample ID missing,
(Dpl) - duplicate Sample ID, (No_C) - truncated Sample ID, (Inv) - invalid Sample ID. A
label ID that cannot be read by the reader may be entered manually by selecting the Loadlist
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position and pressing the Edit Sample ID button. Refer to Section 6.5 - Sample ID Errors
(Internal Barcode Reader) on page 358 for barcode troubleshooting information.
The Loadlist button will display the status of the 20 Loadlists.
The Store Loadlist button will save the changes to the current list.
Clicking on the ADD QC button on the bottom of the screen will open the QC screen. Scroll
down the list and select the desired QC liquid to be processed in the current cup position.
Press the Confirm (√) to accept.
Clicking the Edit Sample ID button displays a window that allows the operator to type the
sample identification. For the Sample ID 1 to 16 alpha-numeric digits must be entered via the
standard keyboard or 1 to 16 numeric digits using the screen keypad. Use the ▼ to enter
additional IDs in subsequent positions on the sample tray.
Once all the ID numbers have been typed, clicking the Confirm button accepts all the IDs
and returns to the Selected Pre-Analysis Screen. To return to the Pre-Analysis Screen
without accepting the changes, click the Cancel button. The system does not allow the
same SampIe ID to be loaded twice; if this is attempted, a warning appears: Duplicated
Sample ID.
Clicking the Clear ID button deletes the selected Sample ID, leaving the space blank to
enter another Sample ID. No confirmation is requested.
Clicking the Program Sample button opens the window that allows you to program a new
sample.
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Program NEW SAMPLE
Within this screen the operator types the Sample ID (required field), and enters the Patient
Demographic information (optional) on the top half of the screen. If the sample is a Stat
sample, the Stat icon should be checked. The Test or the Multi-Tests (shown when in Multi-
Tests analysis mode) to run on the sample is ordered by clicking on the desired selection. If
you make a mistake, the scissors icon can be used to delete the test or Multi-Tests from this
sample or you can uncheck a selection box. Use the New Sample (tubes in folder) icon to
save this request and present a new (blank) order entry screen for your next sample. If the
current sample has the same test or PROFILE as the previous one, you can use the Prev.
Prog. Button. This sequence is repeated for all new samples.
After programming the last sample, click the (√) button. The system switches back to the
Single Test/Multi-Tests or TEST GROUP Pre-analysis screen.
The samples entered are displayed and marked with a P (Pending).
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Details for SAMPLE with Previous tests
Patient demographics: the upper portion of this window displays the patient demographic
information. The displayed fields that are editable fields include: Patient ID, Patient Name,
Department Name or Number (Dept.), Birth Date and Sex.
NOTE: The sample ID field must contain at least one alphanumeric character and it
cannot be changed once confirmed (√).
Loadlist and Position fields display the current Loadlist and position within the list for the
displayed sample.
Patient Details: clicking this icon allows access to additional fields, such as the Operator
Notes, the Physician’s name and the Entry Date.
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If the sample is a Stat sample, the Stat icon should be checked.
Status: the "status” associated with each sample is displayed in the Sample Data Screen:
l Trans. T = Transmitted and L = Local (Not Transmitted)

l Sample Status: (No test ordered [N]; Pending for at least one test [P]; Completed
[C]).
The tests programmed on the sample will be displayed in the center portion of the screen.
Pending tests will be indicated with a (?). Results for completed tests will be displayed.
Press the Detail Icon to view detailed information about the test (i.e. clot curve). To delete a
test that is either pending or completed on a sample, move the cursor to the test and press
the Trash (Delete) Icon.
Additional or repeat Tests to be run on the sample are ordered by clicking the Program Test
button. Use the New Sample (tubes in folder) icon to save this request and present a new
(blank) order entry screen for your next sample. This screen would be the one displayed in
option 1 above.To move to the next sample ID in the list use the (▼▲) to move down or up in
the list. Samples can be printed by pressing the Printer icon.
After programming the last sample, click the Confirm (√) button. The system switches back
to the Single Test/Multi-Tests or TEST GROUP Pre-analysis screen.
The samples entered are displayed and marked with a P (Pending).
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3.2.3 Materials Map

Pressing the Materials Map Button will display the Liquids necessary to do the testing for
this session.
The Materials map displays in a graphical format the liquid positions on the analyzer. The
Map shown above applies to the ACL ELITE PRO. The ACL ELITE does not have positions
(R9-R12), which are shown.
This screen displays the status of the reagents currently on-board the system, along with
other information. The color of the position circles can be:
Green – Volume of liquid in position is greater than warning limit and stability OK.
Orange – Volume of liquid in position is less than warning limit or either onboard or lot
number stability has expired.
Red – Analyzer detected a reagent shortage in this position.
NOTE: When you start or resume a run, the materials map is not checked for volume
status. The analysis will proceed regardless of the color of the reagent position. The colors
are only visual alerts to the user.
The operator is able to assess the situation of the ten Sample Tray positions and the
Reagent Tray positions. Clicking on one of the colored liquid positions will display details
about that liquid. This information includes:
l Liquid ID: The Name of the liquid assigned to this position

l Lot Number: Current lot number entered for the liquid in this position
l Liquid Level: The remaining volume of liquid in this position. This level is retained
from the last session for which this liquid was used. The system tracks the level by
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counting down the volume during the testing. The operator must enter the initial “start”
volume. This is generally done when a new bottle is placed on board or by the optional
barcode reader.
l Expiration Date:The lot number expiration date for this liquid. If this liquid is used
beyond the expiration date, the operator will be alerted with a warning in the Session
Error History list. The Expiration date is predefined in the Liquids screen.
l On Board Stability:The remaining time left for this liquid on board the analyzer. The
system tracks the time the bottle is on board the analyzer. The operator must start the
clock using the “Start Timer” button when a new bottle is placed on the analyzer. The
“Start Timer All” button will start the clock for all of the liquids displayed on the current
materials map. If a bottle is removed from the analyzer, the timer countdown may be
paused by pressing the “Pause Timer” button. When the bottle is returned back to the
analyzer the clock may be resumed by pressing the “Pause Timer” button. If this liquid
is used beyond the on board stability time, the operator will be alerted with the warning
“Material on board stability expired in position XX” in the Session Error History list.
The On Board Stability time is predefined in the Liquids screen. Expired stability will be
displayed in orange on the Materials Map.
NOTE: The use of the Liquid Level, Expiration Date and On Board Stability tracking
is optional. The operator can track these items offline and does not have to use the features
on board.
Three operations can be carried out on the Liquid Level settings:
l Set Volume allows manual volume update for the specific reagent position. Volume
entry less than 1mL should use a leading 0 (i.e. 0 .5).
l Reset single will update the volume of the selected reagent position to its default
value (predefined in the Liquids screen).
l Reset All will update all volumes of all reagent positions displayed on the current map
to the default values (predefined in the Liquids screen).
When the screen is activated, the system also checks and displays information about the
status of the rotor station, status of the waste, number of available cuvettes in the rotor and
the current volume of the Wash-Reference Emulsion. To start the session with an unused
rotor, the operator must check the Start with a New Rotor box.
Press the Confirm (√) to Accept the changes and return to the Pre-Analytical screen.
Pressing the Cancel (X) will discard any changes you made. Press the Runner icon and the
run will begin.
Liquid Details: This button will display the liquid setup screen for the current liquid position
selected. Refer to Section 4.1.12 - Setup – LIQUIDS on page 180.
The optional External Barcode Reader can be used to identify reagent placement and
validate the lot number and expiration date. When the material map is displayed, read the
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vial label using the reader. The lot number information and expiration is checked and the
position to place the reagent onboard the analyzer will blink. Place the vial in the designated
location. If the lot number or expiration dates are invalid the system will display a warning
box on the screen. You can configure the external barcode reader to automatically reset the
default volume and onboard stability for the vial when a label is read.
If the “Pause Timer” is checked for a reagent vial, when this vial is read with the external
barcode reader the “Pause Timer” will become unchecked. If the vial is then read a second
time at this point the volume and timer will be reset if these options are enabled under the
external barcode setup.
Refer to Section 4.1.16 - Setup – INTERFACES – External Barcode – Optional on page 193
for information on enabling the external barcode reader.
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3.2.4 Analysis: Loadlist

The Loadlist screen below can be accessed selecting Analysis from the Main screen menu
bar, and then the Loadlist option from the Analysis menu.
This screen gives the operator access to the information on the stored loadlists, by being
either blank or defined. Each of the defined stored loadlists (20 maximum) is identified with a
number, status and date/time.
Several options are available:
l Clear Single clears current highlighted single Loadlist. Clearing a Loadlist has no
impact on the samples in the database. The samples that were on the loadlist can still
be viewed and printed after a Loadlist is cleared.
l Clear All clears all defined Loadlists.
l Make Loadlist opens the loadlist creation screen.
l Clicking the Clear Single button in the Loadlist screen, displays a confirmation
window.
l Clicking the Clear All button on the bottom right of the screen, displays a confirmation
window.
l Clicking the Make Loadlist button opens the Make Loadlist screen.
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Loadlist can be created 4 ways:
1. Time Interval (Date/Time sample was entered into database)

2. Sample ID range
3. Marking or selecting Individual samples
4. Automatic List creation using a predefined Sample ID Prefix or Suffix
Once one of the four list criteria is chosen you then select which tests to include on the
loadlist. Clicking the Pending (all) button will search the database for all pending tests for
the group of samples chosen. Clicking the Pending (test selection) button will allow you to
scroll down the displayed test list and select the desired tests by pressing Select. If you
make a mistake you can remove a test by clicking on the Deselect button. The notation in
the Select column will then be removed.
Loadlist Creation Process
The first item to define at the top of the screen is the Loadlist Number to Start with. You
must enter in a value between 1-20 in this field. To the right of this field is the entry location
for the Number of Samples per loadlist. Enter in a value between 1-40.
You then select one of the 4 ways listed above to use for creating the loadlist.
1. Time Interval – Clicking All Time Interval will create the loadlist without respect to
the time that the samples were entered into the database. If you click on From To you
must enter in a Start Date/Time and End Date/Time.
2. Sample ID Range – Clicking All Samples will select all samples with no respect to
the Sample ID attached to it. If you click on From/To you must enter in a Starting
Sample ID and Ending Sample ID to include in the loadlist. Only samples within this
range will be placed on the loadlist.
3. If you click the Mark Samples button the following screen will appear.
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This screen will display all the samples along with their current status in the database.
You can scroll down the list and press Select to mark the current individual sample. If
you make a mistake, press the Deselect Single to remove the notation in the mark
column. Pressing Deselect All will remove the notation in the mark column for all
samples. When you are finished, press the Confirm (√) or Cancel (X) to return to the
previous screen.
4. Click the Autolist button to display the automatic loadlist creation screen. This
screen will allow you to create one or more loadlists. You can create the sample IDs
for the loadlist using a prefix or suffix.
On this screen you must enter in the number of loadlist you want to prepare. You can
create up to 20 loadlists; each loadlist will contain up to 40 samples. In the Fixed
String field, enter in a character string to attach to each sample ID. If you want to use
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the fixed string as a prefix, click on the Use as a prefix button. If you do not click on
this field, then the fixed string will be appended as a suffix to the ID.
The Variable string field will determine the maximum number of sample IDs to create.
If you select a variable string of 2, the maximum number of samples will be 99, if you
select 3 the maximum number will be 999. The starting number field will vary in length
depending upon the variable string field entry. The number you enter into the Starting
Number field will be used for the first sample. The remaining sample IDs will then
index by one after this value.
When you are finished, press the Confirm (√) or Cancel (X) to return to the previous screen.
NOTE: On this screen you determine the number of loadlist to prepare. On the
previous screen you entered in the loadlist number to start with along with the number of
sample IDs each loadlist will contain.
Once the Loadlist/Autoloadlist is created, you then program tests for the sample IDs on the
list. Select the Loadlist and then press the Detail Icon.
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The sample IDs on this loadlist will be displayed in the left hand column. You can change
the Sample IDs on the list by selecting a particular sample and pressing Edit Sample ID. If
you need to delete samples from the list you can use the Delete Sample ID or Delete All
Sample ID buttons.
To program or change the requested tests, select either a particular sample ID or the first one
on the list.
To program tests for the selected sample, Press the Program Sample button.
Click on the Prev. Prog to All button to program the previous tests request to ALL samples
on the loadlist. If you press the Prev. Prog button the previous tests will just be ordered on
the current highlighted sample only.
Click on the Set Default tests button to program the Default tests to all samples on the
loadlist.
Highlight a sample and click on the Detail button to view the current sample. This will
display the demographics along with the tests ordered and any completed results for the
sample.
To print a loadlist, click on the Printer Icon.
l Confirm or Cancel exits the screen; the system goes back to the previous screen.
ACTIVE BUTTONS at Bottom of Screen
l Open/Close opens or closes the rotor holder cover.

l Database View displays the Database View or Main Screen.
l Shutdown followed by a confirmation window Do you really want to shutdown
ACL? Yes closes the session, allowing the operator to log off and/or turn the system
off; No will cancel the operation.
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3.2.5 Analysis: Session Report

This screen is automatically displayed during a run.
This screen displays information about the status of the tests and samples for the analytical
runs performed on the system.
The top line displays the current test being analyzed and the current phase for the test (i.e.
loading, waiting, acquisition…)
The middle of the screen displays the 4 sample ring quadrants on the left and the 10 sample
cups included within the quadrant. Please refer to Section 3.2.2 - Sample Analysis Modes
on page 76 for details on sample position color codes and symbols.
The details (results) of a sample can be displayed by selecting the sample ring quadrant on
the left then selecting the desired cup position and clicking the Details button. If a sample is
complete the results will be displayed.
The Materials Map button will display the current reagent map for the session. Please refer
to Section 3.2.3 - Materials Map on page 85.
The Session Status button will display the Analysis Session report screen for all samples in
the current session.
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The Test Execution Status box displays information on the tests in the session. It displays
the tests that may be analyzed in this session along with the number of samples
programmed, number of reflex tests to be processed, and the number of samples actually
completed. TEST GROUPS are considered to be individual tests and display that way in the
box.
The Sample Status for the Session box on the right displays the samples to be processed in
this session. This box is divided into 5 columns:
l # Column: position on sample tray

l +: an ! in this column indicates the sample is designated a stat sample.
l Status: Displays the current status of this sample. The status can be indicated by the
following symbols
o Hourglass symbol: Sample is in process
o Clock symbol: Sample is in a waiting status
o Check Mark (√): Sample is finished being processed
l Short: This column will display a “low” indicator when a sample has been detected to
be short. A sample found to be low would stop all further testing on that sample.
l The sample ID column displays the sample IDs on the loadlist.
The Materials Map button will display the current reagent map for the session.
NOTE: The bottom row of Icons on the main screen contains one of a reagent bottle.
The color of the bottle indicates the status of the reagents in the map. If all the reagents
have levels above the warning volume the icon will be displayed in green. While testing is in
process if a reagent becomes low the bottle icon will turn orange. If a reagent runs out during
analysis the bottle icon turns red. Pressing the bottle icon will display the current reagent
map.
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When a reagent runs short during analysis the system will continue processing all other
tests. When testing is complete the system will display a message box with the following:
One or more reagents are insufficient to complete all samples. Do you want to Refill?
Press Yes to refill and then restart.
Press No to close the session.
If the Yes option is selected the operator should replenish the reagents that are short and
press the runner icon to restart the run.
If No is selected the system will end the current analytical session. The run can be restarted
later by selecting Analysis > Session History
The Restart this Session button will start the analysis again to process those samples with
a status of “Pending”. This can be useful if a reagent runs short during analysis.
The Session History Button will normally be dimmed out during analysis. If an error
condition occurs during the analysis the button will illuminate. The operator should make
note of the button status. When the button illuminates, the operator should press the button
to display the Session History List.
NOTE: Results (Patients, QC and Calibration) are initially saved in a temporary

database. The results are transferred to the permanent database when the system goes into
standby or the user logs off the system. If the system is turned off without logging off first
then results may not be available upon the system restart.
The list will display the Date and Time along with the Error that occurred.
The Printing option will print the Session Error History Report followed by a confirmation
window.
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Press the Confirm (√) button to return to the previous screen.
If the session has completed, you can return back to the Session History screen by
selecting Analysis from the Main screen menu bar and Session History from the Analysis
menu. This opens the Analysis: Session Report screen.

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3.2.6 Session Pause Conditions

The following conditions will place the ACL ELITE/ELITE PRO into a pause status during
analysis. If this occurs, the condition noted should be corrected. The run can then be
resumed by pressing the runner icon
ROTOR WASTE FULL (ELITE PRO Only)
When the rotor waste is full the instrument will beep and automatically pause.
To proceed the operator has to empty the rotor waste container and press the “runner” icon.
ROTOR STACK EMPTY (ELITE PRO Only)
When the rotor stack is empty, the instrument will beep and automatically pause.
To proceed the operator has to refill the rotor stack and press the “runner” icon.
REAGENT SHORT
A reagent shortage detected during analysis will place the system in the Hold condition at
the end of the session. At this time the operator has the option to refill the reagents and
resume the session.
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3.2.7 Analysis: Pause / STAT Functions

During a run the session status is presented showing the number of tests executed and
which test phase is in progress.
It is possible to pause the system during an analytical session using the Stat/Pause
“Ambulance” icon on the bottom left side of the screen.
When this icon is activated a message saying, “Do you really want to hold the session” will
be presented.
Pressing “NO” the session will proceed.
Pressing “YES” the session will pause at an appropriate time in the current session. You will
be notified when it is safe to proceed.
Stat samples cannot be executed during Automatic Host Transmission.
During the Hold state, you can perform the following on the system:
l Add Samples, both STAT and Routine

l Change Priority of a Sample from Routine to Stat
l Add Tests to a sample on the sample tray
l Add QC samples to the session
l Access the Materials Map to Refill reagents
l Substitute Samples on the sample tray. Completed samples indicated by a green cup
position circle (also noted by a C in “S” column) can be removed and replaced with a
new sample.
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The “Add Samples/Stats” screen displays the status of the samples on the tray.
The Status of the samples is displayed using colors and letters/symbols for the cup
positions. Refer to Section 3.2.2 - Sample Analysis Modes on page 76 for details on the
colors and symbols. The sample tray is divided into 4 quadrants of 10 sample positions
each. To change to a different quadrant simply click on the desired segment in the circle on
the left.
Barcode stat samples
Read Barcodes: This button will activate the sample bar code reader and read the sample
IDs on the tray. It will then display the samples IDs. No host query is performed during this
action. Non-barcoded sample IDs (except QC cups) may have to be re-identified if an aliquot
has not been aspirated from the sample cup. If you are not bi-directionally interfaced, after
reading the barcodes click on the desired sample position to display the sample-
programming screen. Enter the optional demographic information. To designate the sample
as a stat, click the Stat icon. Select the tests by clicking on the desired test box. To remove
a test from the programmed tests list click on the test name a second time. Use the down
arrow to proceed to the next sample position. When complete press the Confirm button.
Restart with BCR: This button can be selected if you are using host query and barcoded
samples. Click this button then press the Resume icon. The system will read the sample
IDs and query the host for the tests to process. This option is not recommended to be used
when a mix of barcoded and non-barcoded samples are present on the sample tray.
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Non-Barcoded stat samples
Programming Non-Barcoded Samples: Click on the desired sample position to display

the sample-programming screen.
To program your samples enter the Sample ID along with any of the other optional
demographic information. To designate the sample as a stat, click the Stat icon. Select the
tests by clicking on the desired test box. To remove a test from the programmed tests list
click on the test name a second time. If you have additional samples to program click on the
New Sample icon. If you are finished programming samples click on the Confirm button.
Press the Runner icon to start the analysis.
Enter/Edit Sample ID: This button allows you to manually enter an ID or edit one that is
displayed. Positions that cannot be edited will dim the button.
Clear ID: This button will clear an ID from a position on the sample tray. The position can
then be used to program a new sample onto the tray. This button will be dimmed if the
sample tray does not have positions in which the sample is complete. Completed samples
will be designated as a green cup position circle with the letter C. Samples with pending
tests to be completed will be designated as an orange cup position circle with the letter P.
Positions that cannot have the ID cleared will dim the button.
Program Sample: Opens the tests order screen. Refer to Section 3.2.2 - Sample Analysis
Modes on page 76 for details on this function.
Add QC Liquids: Displays the QC liquid list. Select the desired liquid and click on the
Confirm button to accept. The QC liquid will then be added to the samples on the tray.
Note: Do not click on the Restart with BCR button when QC is added to a list. Press the
Runner icon only to start the run.
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Once the Stat/New Samples have been programmed and added to the sample tray, the run
is restarted using the Runner icon.
NOTES:
l When the Stat/Pause icon is pressed, the system will display a message indicating
when it is safe to add/remove samples from the tray. Please wait for this message
to appear. This is an indication that the sample arm will not move toward the sample
tray.
l If a test is added but not contained in the Multi-Tests or Single Test presently running
the test will only be programmed.
l Default tests will be added to a sample when the next test in the run is started. Prior to
this the circle will be displayed in light blue with the status of N. After the next test in
the run is started the default tests will be added to the samples and circle will become
purple when processing occurs.
l If a test is contained in the Multi-Tests or Single Test presently running the test will
either interrupt the current session or be executed in a session after the current one.
The current session will be interrupted if the samples have not been pipetted. If the
stat interrupt occurs during a session whereby the reagent only is being pipetted, the
system will abort the run to process the stat. If you do not want to abort the current
run, wait until the unit begins pipetting sample before requesting the stat interrupt.
ACTIVE BUTTONS at the Bottom of Screen

off. No will cancel the operation.
l Confirm exits the screen; the system goes back to the previous screen.
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3.2.8 Database View / Results List

The main screen of the ACL ELITE/ELITE PRO is the database or results list. Up to 1000
sample IDs can be contained in the sample database. The database is handled in a first in
first out (FIFO) manner for all samples. When the database reaches 1000 samples the oldest
completed samples- transmitted to host, and not present on loadlist in use will be
permanently deleted. Each sample ID can reference up to 30 tests. Tests processed in
duplicate occupy a minimum of 3 test positions (1*st & 2nd results and mean).
The “Database View” at the top of the screen indicates whether you are viewing All
Samples or a Subset of the samples. A subset of the samples in the database is obtained
by Extracting results. If you are viewing a subset of the results and you wish to view all, you
must extract again and select the “All Samples” option.
Patient Records Count
The numeric values on the right of the screen (i.e. 147/540) indicate how many samples are
currently displayed in the database. If you extract, the first value indicates how many
samples were extracted and the second value indicates the total number of samples in the
entire database. When you are viewing “All Samples” the two values will be identical.
*Host transmission not checked if host interface is disabled.
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The results list has several columns:
l + indicates if the sample was run with a (STAT) priority attribute

l S Column indicates the status of the sample ID
l N means no tests are programmed on that sample ID
l P means one or more tests are missing a result
l C means that all tests have been run on the sample and it is considered
complete
l E column indicates errors are present on at least one test for the sample ID. Refer to
Section 6.3 - Data Reduction Error Codes on page 335.
l Sample ID column (max 16 characters). Each of the 1000 samples in the database
must have a unique Sample ID. Duplicate IDs are not allowed. If you need to re-use a
sample ID, you must delete the original one first. Highlight ID and click the trash can
icon to delete.
l Patient Name column (max 25 characters). Using the Identity Card icon this column
can be hidden. This will allow more tests to be displayed across the database screen.
l Test and Unit columns are defined (customized) in the sort test submenu in the Test
Set-up. Please refer to the Test Setup sections in Chapter 4 - Setup and Utility on
page 153. If a test has a ? in a column, then the result is pending for the sample. As
the test is completed, the ? will be replaced with the result. If the result is displayed
along with a “Snowflake” symbol, then there is more than one result available for that
particular test. Tests with errors will be noted instead of a result on the screen.
Highlight the sample and press the “detail” icon to view all the results
A result presented in black color means it is within the normal range.
A result presented in violet color means it is outside the normal range.
A result presented in red color means it is outside the test range.
A result presented as *** means it is outside the scale range high.
A result presented as --- means it is outside the scale range low.
The Instrument status line also displays the current User logged into the system and the
current revision of the software on the analyzer.
Several functions are available from the test results list:
Extract Results Detail Sample Icon
New Sample Delete Samples
Print Samples Transmit to Host
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3.2.8.1 Extract Icon
Using the Extract icon (Hand in File Drawer) it is possible to filter the database for
desired samples based on several criteria.
l Single Sample ID
l Sample ID From … To … (Use the Same number of Characters when defining
the From/To range that you normally have for the Sample ID)
l Patient ID
l Patient Name
l Loadlist Number
l All samples
l Entry Date From … To …
l Department
It is possible to combine the above Sample ID criteria with the result criteria checkbox
selections on the lower part of the screen.
l Completed / Pending
l Stat / Non Stat
l Transmitted / Not Transmitted
l Flagged / Not Flagged
NOTE: If you extract into a subset of the database, you must re-extract using
the “All Samples” checkbox to return the database to display all samples. New
samples entered into the database while you are in a subset may not be shown on the
database.
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3.2.8.2 Sample Detail Icon
Using the Details function (magnifying glass) additional information on the Sample and
Tests can be displayed. This information would include Demographic data, Results,
Errors and Reaction curves.
From the Sample Data screen the Patient Detail icon displays additional demographic
information.
From the Sample Data screen it is possible to view the reaction curve. Highlight the
desired test and press the Detail icon to view the curve.
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Warnings associated with the test results are displayed in the warning list. Please
review these and take appropriate action if necessary before reporting the results.
The Save icon allows you to save the “normalized data readings” for the curve. The
data can then be viewed using another software program (i.e. Microsoft Excel). The
curve as it is presented can be printed using the print icon. Warnings associated with
the results are displayed in the warning list.
The Clot/Reaction Curve displays the normalized data points recorded during the
acquisition phase. The “Y” axis displays the total reaction change divided into 5 points.
The reaction change is rounded to 2 decimal places; therefore samples with a small
amount of change may display duplicate points within the 5 that are displayed. Curves
for clotting assays typically will be presented in an “S” pattern. The curve is generally
composed of three sections: Baseline, Acceleration and Plateau.
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The Baseline readings start after any acquisition delay settings in the test definition.
During the baseline the sample and reagents are mixing and this continues until the clot
has begun to form. In the acceleration phase the clot continues to form resulting in an
increase in the optical readings. For a clotting based assay, once all the fibrinogen has
been converted to fibrin, the plateau has been reached and the reading stablizes.
Various algorithms are used by the system to select the actual clotting time. Some
examples of these include:
l First Derivative: time at which the maximum speed of clot formation is noted.
l Second Derivative: time at which the maximum change in speed (maximum
acceleration) of clot formation is noted.
l Threshold: time when a pre-set optical density value is reached.
l Threshold- 2nd Derivative: If the threshold reading is not met, then the system
will use the 2nd Derivative value.
When viewing clot curves some items you should make note of include:
l Shape of the curve (Flat curves may indicate no clotting).

l Long baselines indicate a prolonged clotting time.
l Range of the “Y” axis. A tight range may indicate no clotting or a low fibrinogen
value. Compare the questionable sample’s “Y” axis with one from a normal
sample. A wide range on the “Y” axis may indicate a high fibrinogen value.
l Continual rise in the Acceleration phase with no plateau indicates the sample
did not clot within the acquisition time.
l A drop in the plateau may indicate an unstable clot formation.
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3.2.8.3 New Sample Icon (Tubes in Folder)
Using the New Sample button it is possible to add a new sample to the database and
manually program tests on it. For details, refer to Program NEW SAMPLE on page
82.
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3.2.8.4 Delete Icon (Trash Can)
Using the Delete Icon it is possible to delete results using the following criteria.
l Single Sample ID
l Sample ID From … To …(Use the Same number of Characters when defining
l Patient ID
l Patient Name
l Loadlist Number
l All samples
l Department
It is possible to combine the above Sample ID criteria with the test criteria checkbox
l Stat / Non Stat
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3.2.8.5 Printing results
Using the Print Icon it is possible to Print results (two types of reports can be
generated: Cumulative and Sample Reports) using the following criteria.
l Single Sample ID
l Sample ID From … To ……(Use the Same number of Characters when defining
l Patient ID
l Loadlist Number
l All samples
l Patient Name
l Department
It is possible to combine the above Sample ID criteria with the test checkbox
selections in the lower part of the screen.
l Stat / Non Stat
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3.2.8.6 Sending results to Host Computer
Using the Host Icon it is possible to download test requests or transmit results using
the following criteria.
l Single Sample ID
l Sample ID From … To ……(Use the Same number of Characters when defining
l Patient ID
l Loadlist Number (1 through 20)
l All samples
l Patient Name
l Department
It is possible to combine the above Sample ID criteria with the test checkbox
l Stat / Non Stat
NOTE: If the liquid and/or Wash-R sensors are disabled, the system will not
automatically transmit the results to the host. At the end of each run, a warning
message will appear, instructing the operator to check the material and sample levels
to ensure there is sufficient residual volume in the containers. Once the check is
performed then the results can be manually transmitted to the host. When the sensors
are re-enabled, the auto transmission will resume.
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3.3 Quality Control Chapter 3 – Analytical Operations
3.3 Quality Control

This section contains all the information needed to perform analysis of quality control materials and
satisfy your laboratory’s quality control program requirements on the ACL ELITE/ELITE PRO System.
The first subsection presents a summarized procedure for those users already familiar with the ACL
ELITE/ELITE PRO system. Specific details about the screens, options, etc. are described later in the
step-by-step procedures.
l The QC Materials must be pre-defined in the Liquid Setup screen. Refer to Chapter 4 - Setup
and Utility on page 153.
l The QC Material target values must be pre-defined in the QC Setup screen. Refer to Chapter
4 - Setup and Utility on page 153.
l The QC Materials may run with patient samples during normal routine testing or alone as a
separate run. In the first case, refer to Section 3.2.1 - Sample Analysis Procedures -
Summarized on page 73. In the second case, follow the steps below.
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3.3.1 Analyzing QC Materials Using a Loadlist

This procedure will describe how to run QC on a loadlist without patient samples.
The loadlist can be saved and recalled each time that you need to run QC. Several different
loadlists can be configured on the system. Each loadlist could contain different QC
materials
1. Select Analysis.
2. Select Multi-Tests or Single Test.
3. Click on the Loadlist No. box. Enter a loadlist number (1-20). If you do not know which
loadlists are available, click on the “Loadlist” button to display the status of the 20
loadlists.
4. Position the cursor on the desired cup position on the sample tray. Click the Add QC
Liquid button.
5. Choose the control and click the Confirm (√) button.
6. Repeat the last two actions until all materials have been entered.
7. Click on the Store Loadlist button to save the loadlist.
8. Place the QC sample cups on the sample tray in the respective positions. Press the
Runner icon to begin the analysis.
NOTE: At the completion of the run, the completed loadlist will still be stored in
memory. If you do not delete it you can recall it the next time you need to run QC. In this
case you would not need to reprogram the sample tray positions.
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3.3.2 Quality Control Setup

The quality control process is started from the Main screen by selecting QC on the menu bar,
and selecting QC Setup/Review. This will open the QC Review screen shown.
Under the heading LIQUID ID, the window on the left side of this screen lists all control
materials that are configured in the Setup Liquids menu, while the Configured Test window in
the middle of the screen lists the tests that are associated with each material.
The QC statistics are reported on the right side of the screen:
l Unit
l Actual Mean
l Target Mean
l Actual SD
l Target SD
l Actual CV
l Results in Statistics (all points except omitted values)
l Results in Database (DB)
Clicking on the Show Enabled button will reduce the list of Liquids and display just the
Liquids that have been setup for QC analysis on the system. This is a toggle type button.
With the button not clicked you will always display all liquids. With the button clicked you will
display only the liquids previously setup.
Clicking the Confirm (√) button exits the screen and the system goes back to the Main
screen.

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The QC configuration must be entered into the QC Setup screen shown below. Select the
QC liquid in the left box then press the Setup button under the middle window.
The top of the screen displays the selected QC material (Liquid ID) and specific information
about it such as Expiration Date, Lot Number, plus a space for Notes.
The next step is to associate tests to the selected QC Liquid.
To do this, the operator highlights a test from the Enabled Tests list shown on the left
window then clicks on the Arrow icon under the window. This action causes the selected
test to move from the Enabled Tests list to the Configured Tests list shown in the middle
window. By repeating this sequence, the control material is associated with up to 15 tests.
To remove a test from the Configured Tests list, click the Scissors icon under the window.
This action opens first a confirmation window: Removing test removes all tests data…Do
you really want to remove the selected test? The Yes or No selection reminds the operator
that removing a test means removing all the results saved for that test.
Once the QC Liquid/Tests association is complete, the next step is to define the units, target
mean, target SD and the SD Range for all tests associated to the QC material.
Unit: for each test, the selection of units includes only the ones that are legitimate for that
test. Modifying a previously selected unit will not cause a change in Target Mean and SD
values. These would need to be updated if the unit type is changed.
Target Mean and Target SD: these fields accept any value, which is entered by touching
the field and using the external keyboard or the keypad on the screen.
SD Range: choose 1, 2 or 3 SD (Standard Deviations).
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If the QC Range Check box is activated, the control value before rounding is checked and
flagged if found to be outside the defined range. Patient results will not be flagged if only this
box is checked. See Section 7.4.2 - Results Format: VDU and Printer on page 392.
The Flag Patient Results check box can be activated only after the activation of the QC
Range Check box. If this box is checked and QC is out of range, then a flag will be noted on
patient samples processed until valid QC results are obtained for all QC materials defined for
the test.
The QC Range Check and Flag Patient Results check boxes can be activated by simple
touch, causing a check sign to appear.
The Clear Statistics button deletes, after confirmation, all the results of a particular Test -
QC Material combination.
WARNING: Changing the Lot number for a QC liquid under the Liquid Setup menu
will delete all previous QC results for that liquid.
Clicking the Printer icon, followed by a confirmation request Do you really want to print? Yes
allows the operator to print the test Setup. No will cancel the operation.
Clicking the Confirm button allows the operator to leave this screen and the system goes
back to the QC Review screen.

When there is an active association between a QC material and tests, the Plot and
Statistics, Cumulative Results and Host icons are active.
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3.3.3 QC Result Review

The Main Database screen has a QC Icon on the bottom row. This icon will display a
separate database of the last 100 QC results processed on the system. A red ! displays
across the icon if there is a QC failure on the system. Results outside 2SD will display in
blue, while those outside 3SD will display in Red. Results within their range will be
displayed in black. The exclamation point will remain on the icon until the QC failure is
cleared from the list. If all QC liquids and tests have no QC outliers the exclamation point
will not be displayed.
The database displays the following for the QC results: test, QC material, result, unit for
result, and any errors. The number of Results in the database is displayed in the “Results”
box on the top right. The Clear All and Clear Single buttons will remove the results from the
QC List, however they will still be displayed under the QC Plot and Cumulative result
options. The results on the database can be printed using the Print All QC or Print Today
QC buttons.
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3.3.4 QC – PLOT and STATISTICS

In order to open the QC Plot and Statistics window (shown below), press the Plot and
Statistics button located in the QC Review screen.
This screen displays both the Plot and the Statistics of a selected QC Material and test pair,
displayed at the top of the screen.
The window in the left side of the screen displays the following information, which is not
editable from this screen:
l Start Date
l End Date
l Unit
l Actual Mean
l Target Mean
l Actual SD
l Target SD
l Actual CV
l Results in Statistics (results for current selected date interval)
l Results in Database (DB) (all results for all dates)
The QC plot for a test with results can be viewed in the window on the right side of the
screen. The chart indicates Days on the X-axis, the unit and target mean on the left y-axis,
and the SD on the right y-axis.
The display covers an interval of 30 days; the default window displays the results for the last
30-day interval, but the operator may view earlier data and move about using the scroll bar.
The last 500 QC values per liquid and test can be displayed on the plot. The system will
retain the last 65,536 values for statistical calculations.
QC values will be displayed as follows on the graph:
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l Omitted values appear as a blue diamond symbol

l QC values out of SD range (1 or 2 SD) appear as a violet circle
l QC values out of 3 SD range appear as a red triangle
l Valid QC values appear as an asterisk
The statistical calculation is done using all results in database. To obtain the Statistics and
Plot for other selected intervals of time, click the Select Interval button and enter the
specific start and end date (dd.mm.yyyy or according to the date format selected in the
Date/Time configuration) to view results on the screen for the selected interval:
The new interval must be confirmed by clicking the Confirm button, which results in the
system going back to the QC Plot and Statistics screen, or not confirmed by clicking the
Cancel button (this applies only to the selected interval). The statistical results will be
updated based upon the selected interval.
Clicking the Printer icon, followed by a confirmation window Do you really want to print?
Yes allows the operator to print the plot; No will cancel the operation. Enter a “From … To”
date range interval to print results for a certain time interval. Selecting “All Results” will print
entire QC list for all dates.
Clicking the Cumulative Results button opens the QC Cumulative Results screen. Refer to
Section 3.3.5 - QC – CUMULATIVE RESULTS on the next page.
Clicking the Confirm button exits this screen and goes back to the QC Review screen.

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3.3.5 QC – CUMULATIVE RESULTS

Clicking the Cumulative Results button located in both the QC Plot and Statistics and the
QC Review screens opens the QC Cumulative Results screen:
The top portion of the screen displays the following: the selected QC material (Liquid ID), the
selected test (test ID), the date range (dd.mm.yyyy) and the time range (hh.mm). This
information cannot be edited on this screen.
The larger part of the screen is used to display the results obtained for the selected pair QC
material-test.
“F” column flag – A Q will appear in this field if there is a QC alert.
“S” column indicates the transmission status (L is local, T is transmitted).
“O” column means omitted, designated by a √ in this column.
Results are displayed using a list that can be scrolled vertically; the columns show the
numeric results in the configured unit and the date/time of the analysis. Values out of
programmed SD range (1 or 2 SD) will be displayed in violet and those values out of 3 SD
will be displayed in red.
There is also a column for notes, and columns for possible flags and warnings.
Further details about a single result, are accessible by clicking the Details icon, which opens
the QC Single Result Details screen:
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On this screen, the identity of the Liquid ID/Test ID pair is displayed on the first line of the
screen.
The windows in the left side of the screen display the QC sample curve, the measured units
and the calculated units.
Additional information about the displayed result is also viewable on the right side of the
screen:
l Transmission status (T: Transmitted to Host or L: Local when result has not been
transmitted to Host)
l Omission status (Yes or No)
l Analysis date and time
l Notes (if any)
l Warning list.
Clicking the Save icon allows you to save the results for future use. The action opens the
Type File Name screen.
After typing the name of the file and confirming the operation, the Operation in Progress
screen opens and the information is saved.
The curve save routine saves the raw data point readings and not the actual clot curve
display. The file name must have at least one alpha-numeric character and be named with a
“crv” extension (i.e. PTQC1.crv)
Clicking the Printer icon, followed by request for confirmation window Do you really want to
print? Yes allows the operator to print the single result; No will cancel the operation.
Clicking the Confirm button causes the system to go back to the QC Cumulative Results
screen.
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The operators may enter their own notes in the Insert Notes screen (shown below) that is
opened by clicking the Notes icon.
The free text note field allows the operator to key in up to 30 alphanumeric characters. Click
the Confirm button after entering the note to save it.
Clicking the Omit Result button allows the operator to permanently omit the selected result.
Before omitting it, confirmation is requested Omitting result…Do you really want to omit the
selected result? Yes or No selections are possible. When the result is omitted, a check will
appear in the O column beside the result and this result will not be included in the statistical
calculation. Omitted results will be displayed on the QC Plot as a blue “diamond” symbol.
You cannot recover a result once it has been omitted.
Clicking the Plot and Statistics button allows access to the QC Plot and Statistics scree.
Refer to Section 3.3.4 - QC – PLOT and STATISTICS on page 118.
Clicking the Host icon opens the QC Host Communication screen. Refer to Section 3.3.6 -
QC – HOST COMMUNICATION on the next page.
Clicking the Extract Results icon opens the QC Extract Data screen. Refer to Section 3.3.7
- QC – EXTRACT DATA on page 125.
Yes allows the operator to print the results; No will cancel the operation. Enter a “From … To”
date range interval to print results for a certain time interval. Selecting “All Results” will print
entire QC list for all dates.
Clicking the Confirm button saves any changes and returns back to the QC Review screen.

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3.3.6 QC – HOST COMMUNICATION

Clicking the Host icon found in both QC Cumulative Results and QC Review screens opens
the QC Host Communication screen:
The Host Communication configuration displayed on the screen is needed to decide which
type of QC results are to be sent and for what time interval.
The user first defines the date range, choosing between:
l “All range” (All range would include all results for the selected tests)
l “From…To…” (Specific Date range to send)
If the latter is selected, the starting date/time and the ending date/time must be defined.
The user can then select if data for a specific test or all tests should be transmitted by
choosing between the following options:
l “Single Test”
l “All Tests”
Once the date range and tests are chosen the user can then narrow down which results to
send from the following choices:
l Valid Results
l Invalid Results
l Not Numeric Results
l Out of Scale Results
l Omitted Results
l “Transmitted” or “Not Transmitted”
l “Flagged” or “Not Flagged”
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Touching the check box area close to the option makes the selections; a check mark
appears next to the choice. These options allow the user to group the transmitted results for
ease of handling: i.e. Valid and Not Flagged results. The second level options can also be
combined with them to transmit groups such as Valid and Not Flagged - but Omitted -
results.
Once the transmission criteria are defined, the transmission begins by clicking the Start
Communication button.
Clicking the Cancel button rejects the changes; the system goes back to either the QC
Cumulative Results screen or to the QC Review screen depending from which screen the
Host icon was pressed.

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3.3.7 QC – EXTRACT DATA

Clicking the Cumulative Results button from the QC Review screen opens the QC
Cumulative Results screen.
Clicking the Extract Results icon will open the QC Extract Data screen (shown below) that
is almost identical to the QC Host Communication screen.
Extracting QC will allow the user to display data for a particular date range. The date range
entered will impact the data displayed however it will not apply to QC Host Communication
or Printing. Each of these two additional functions has its own fields whereby you can limit
what is transmitted or printed.
The data configuration displayed on this screen is needed to decide which type of QC results
are to be extracted and at what time intervals. The Liquid ID/Test ID association is visible on
the upper part of the screen.
l “All range” (All range would include all results for the selected tests)
l “From…To…” (Specific Date range to send)
Once the date range and tests are chosen the user can then narrow down which results to
view from the following choices:
l Valid Results
l Invalid Results
l Omitted Results
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The selections are made by touching the check box area close to the option; a check mark
appears next to the choice. These options allow the user to group the extracted results for
ease of handling: i.e. Valid and Not Flagged results. The second level options can also be
combined with them to view groups such as Valid and Not Flagged - but Omitted - results.
Once the extraction criteria are defined, the process begins by clicking the Extract icon. The
cumulative data for the selected interval will be displayed. The statistical results are not
updated based upon the selected data. The statistics will be based upon the default interval
data.
l Clicking the Cancel button rejects the changes.

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3.4 Calibration Chapter 3 – Analytical Operations
3.4 Calibration
The ACL ELITE/ELITE PRO system requires that certain tests be calibrated either prior to or
simultaneously with sample analysis. If a test with a dedicated calibration is requested, and no
calibration curve exists in memory, a “missing calibration” warning will be displayed during the pre-
analytical check.
Although calibrations require the use of test-specific reagents and often other specific materials, the
calibration procedure is common to all tests.
This section contains all the information needed to calibrate assays on the ACL ELITE/ELITE PRO,
starting with a summarized procedure for those users already familiar with the ACL ELITE/ELITE PRO
system, followed by step-by-step procedures with specific details about the screens, options, etc.
Calibration Table characteristics by test
Test Dedicated In Session Each Rotor

PT #
Fib-PT Based #
Fibrinogen #
Factors* #
Antithrombin #
Heparin #
Homocysteine #
Protein-C #
Plasminogen #
Plasmin-Inhibitor #
ProClot #
Factor VIII Chrom. #
Free Protein S #
Pro S #
D-Dimer #
VWF (Ag & Activity) #
Dedicated means a separate session is initiated to perform a calibration. The session is initiated using
the calibration menu. The analyser will store the last executed calibration curve. The curve is viewable
under the calibration review submenu.
*Assays with Parallelism import the calibration from the same factor assay with a dedicated calibration mode.
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In session means the calibration is executed the first time together with samples and then saved.
Subsequent runs for the test in the same analytical session use the saved curve. For future analytical
sessions, if the calibrators are positioned on the sample tray the calibration will be executed, if not, the
previous calibration is used. The system will store the last five In-session calibrations per test. The
curves are visible using the calibration review menu. The last curve performed is active and in use.
Each Rotor means that every time a rotor is loaded with samples the calibration is executed as well.
The calibration material is required to be placed on the sample tray for each run. If multiple rotors are
processed within an analytical session, a calibration will be performed on each rotor.
3.4.1 Dedicated Calibration Procedure – Summary

1. Select Calibration from the Main screen menu bar and select Calibrate from the
Calibration submenu.
2. Scroll through the list of tests displayed in the Test to Calibrate window on the top right
side of the screen, and select the test to be calibrated.
3. Look at the left side window or Materials Map and make sure that you have on hand the
materials listed to perform the calibration for the test.
4. Press Start to begin the Pre-Analysis phase. The ACL ELITE/ELITE PRO will check
the presence of the required materials; if all required materials are present the
calibration run will begin.
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3.4.2 Saving a Calibration – Summary

At the end of the cycle the Calibration can be viewed prior to being saved. When the new
calibration is accepted the previous calibration will be deleted. For dedicated calibrations
only it is possible to compare results of the new calibration session with those of the
previous calibration before deciding to save it or not. For non-dedicated calibrations, the
system retains the last 5 calibrations in memory. The oldest is automatically canceled with
any new calibration run.
NOTE: Calibrations should be reviewed and accepted prior to the system going into
standby.
3.4.3 Dedicated Calibration – Details

The calibration process is started from the Main screen by selecting Calibration on the
menu bar and selecting Calibrate from the Calibration submenu. This will open the
Calibration Pre-Analysis screen:
The screen is divided into several areas:
Top right area: The Test to Calibrate window allows the user to scroll through the list of tests
displayed and choose the test to be calibrated. The list includes all the tests that require a
dedicated calibration.
Top left area: A large window displays the list of materials needed to perform the calibration
for the test selected in the Test to Calibrate window. For example, if a PT test is selected,
the Calibration Plasma, Factor Diluent and Thromboplastin will appear as required materials.
l If you are using a new lot of any of the materials press the Liquid Details button at the
bottom of the window and modify the appropriate lot number.
l If you are using a new lot of Calibration Plasma, press the Liquid Details button at the
bottom of the window and enter the new assigned value as shown on the Calibration
Plasma package insert sheet.
NOTE: For the PT calibration, the value entered for the cal plasma is 100.
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The window is divided into 4 columns with one row per Material. The information displayed is
the same as that entered when defining the material’s configuration:
l # – Number of the position assigned on the ACL Sample Tray (A1-10) or Reagent
Position (R#)
l Lot Number – Number of the specific lot
l Value – Assigned value for the FIRST Standard, as indicated on the package insert
sheet
Clicking the Materials Map button at the bottom of the window opens the Pre-Analysis:
Material Status screen:
This screen displays the status of reagents currently on-board the system, along with other
analyser information. Refer to Section 3.2.3 - Materials Map on page 85.
Clicking the Start button from the Materials Map starts the calibration run.

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3.4.4 Calibration – Review Calibrations

The Calibration Review process is started from the Main screen by selecting Calibration on
the menu bar, and selecting Review Calibration from the Calibration submenu. This will
open the Calibration Review screen:
This screen displays the recorded date and time of all the calibrations performed for each
enabled test.
l Dedicated Calibrations: The ACL will save the last calibration performed.
l In-Session Calibration: The ACL will save the last 5 calibrations. The most recent one
will be the active one in use.
Calibrations may be deleted by selecting the desired Test ID and Calibration date/time, then
clicking the Delete icon.
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Clicking the Details icon at the bottom of the screen opens the Calibration Data screen
(shown below).
This screen gives the user the ability to view at a glance the most important information
related to calibration runs:
l Name of the test (ID)

l Date and time when the calibration was performed
l Calibration curve
l Calibration Line Equation coefficients
l Errors (click the Error View button, see page 134)
l Warnings (click the Warning List button, see page 134)
l Mean value of the replicates, units of measure and CV%
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Clicking the Details icon displays information about each single replicate.
This screen allows the operator to review the clot formation curve (or the absorbance curve,
depending on the test) for each single replicate, along with the numeric value. For the clotting
test curves, the clotting point is also displayed.
Individual replicate values can be omitted by pressing the Omit Replicate button. The
selected replicate will be removed from the calculation of the mean. It will remain displayed
and will have a check in the Omit Column. You may omit multiple replicates, but must leave
at least one for the curve calculation.
The mean value for a calibration is calculated by averaging all replicate numeric values. The
replicate furthest from the mean is eliminated. The remaining replicates are then averaged.
This is the value used to construct the curve
The raw data for the level and replicates displayed may be saved using the Save icon. The
curve must be given a name. The .crv extension will automatically be added to the name.
l Database View displays the Database View or Main screen.

l Confirm exits the screen; the system goes back to the Calibration review screen.
WARNING: Changing the target value of a calibrator in the Liquid Setup screen after
a calibration is performed results in the stored calibration getting automatically updated to
reflect the new value. A warning message is presented informing the user the stored
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calibration will be updated. Calibration should still be executed for the test if the calibration
was never performed using this lot of calibrator.
Clicking the Confirm button will allow the operator to exit the screen and the system goes
back to the Calibration Data screen.
Clicking the Printer icon the calibration curve and the calibration data are printed. If the
curve is composed of multiple segments, you must print each segment individually. If the
printer icon is pressed while viewing the replicate curves, then the curve displayed will be
printed.
Clicking the Error Viewbutton opens the Error View screen (shown below).
Clicking the Warning List button opens the View Warnings screen:
Clicking the Confirm button exits the screens: the system goes back to the Calibration Data
screen.
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Table Number of calibration points used per test.
Calibration Standard Total Number of Number of Replicates Total Number of

Test
to be positioned Calibration Levels for each Level Calibration Points
PT 1 3 6 18
Fib-PT Based 1 3 6 18
Fib* 1 3/4 4 12
Factors# 2 6 1 6
Factors$ 1 6 2 12
AT 1 3 4 12
HEP 2 3 4 12
HEP Liquid 3 3 3 9
Homocysteine 1 4 3 12
P-C 1 3 1 3
PLG 1 3 1 3
FVIII Chr 1 3 1 3
P-I 1 3 1 3
ProClot 1 3 1 3
ProS 2 3 1 3
D-Dimer 1 3 4 12
VWF(Ag / Act) 1 4 4 16
*QFA uses 4 Levels and 4 Replicates, Fib-C uses 3 Levels.

#Two standards are used for Non-Parallelism Factor Assays calibration: the 100% is the Calibration Plasma as it is
(neat) and the Low Factor Calibration Plasma is the same calibration plasma diluted 1+15 with Factor Diluent (this
dilution has to be prepared manually by the operator). Factors with parallelism utilize Calibration plasma only.
$Factors with Parallelism tests defined will import the calibration from the same assay without the parallelism
dilutions. The calibration for this test will require 3 empty (0.5mL) cups during the calibration cycle which will be used
to prepare the Low Factor Calibration Plasma dilution.
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3.4.5 Factor Assay Calibration for Non-Parallelism Tests

This information is valid for all 8 factor assays (VII, X, V, II, XII, XI, IX and VIII*) when using
the IL tests library. The calibration curve for factors is divided into 3 segments:
1. High Curve: Prepared using Cal Plasma with levels at 100%, 50% and 25%.
2. Low Curve: Prepared using Low Cal F with levels ranging from 6.25%, 3.125% and
1.56%.
3. Middle segment connects the 25% from segment one and the 6.25% from segment
three.
Preparation of the Calibration standards
For factor assay calibration it is necessary to prepare two calibration standards:
100% is represented by the reconstituted Calibration Plasma; the specific assigned value
contained in the insert sheet of the calibration plasma needs to be used as the assigned
value for this material and the relative factor being tested.
Cal Low F (6.25%) is represented by the Calibration Plasma diluted 1 + 15 using Factor
Diluent. The assigned value is automatically calculated by the ACL ELITE/ELITE PRO from
the 100% value entered by the user. The standard is prepared by pipetting 20 µL Calibration
Plasma + 300 µL Factor Diluent into 0.5 mL cup. Mix well prior to use.
The 100% calibration plasma is required to obtain a valid calibration curve.
If the 100% calibration plasma material is not placed, a window will indicate the missing
materials. The options to abort or to continue are given. If the user chooses to continue,
sample analyses are performed although the calibration cannot be executed. Sample results
are calculated based on the previous calibration. Response and activity (%) values are
reported. If no stored calibration curve exists, the results will only be displayed in seconds.
If the 100% material does not give a valid result, the entire calibration is automatically
rejected. When reviewing the calibration, an error message is displayed. In addition, no
calibration curve or statistics will be displayed.
IL recommends that the 100% material be placed on the sample tray for each Factor
Analysis session.
The Cal Low F (6.25%) material is an optional material. It is used to obtain the Low and
Middle segments of the calibration curve.
Below is a summary of the 6 dilutions used by the ACL ELITE/ELITE PRO to perform a
Factor Assay calibration when all 3 segments are performed.
*Excludes Chromogenic Factor VIII.
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Dilution Ratio
Preparation
in %
100 Undiluted Calibration Plasma
Cal Plasma - Dilution done automatically by the ACL ELITE/ELITE
50
PRO
Cal Plasma - Dilution done automatically by the ACL ELITE/ELITE
25
PRO
Cal Low F - Manually prepared diluting the Calibration Plasma 1+15 with
6.25
Factor Diluent
3.12 Cal Low F - Dilution done automatically by the ACL ELITE/ELITE PRO
1.56 Cal Low F - Dilution done automatically by the ACL ELITE/ELITE PRO
3 Calibration segments: High, Middle and Low
The calibration curve for factor assays is composed by 3 segments:
High segment is obtained connecting the 100, 50 and 25 % points
Middle segment is obtained connecting the 25 and 6.25% points
Low segment is obtained connecting the 6.25, 3.12 and 1.56% points.
Factor Assay Calibration in the IL test library uses the criteria of the in-session calibration
mode. If the undiluted calibration plasma is present on the ACL ELITE/ELITE PRO sample
tray, the High segment calibration is performed during the analytical session.
If the undiluted calibration plasma is not present, the previous High calibration stored in
memory is used for calculation and reporting of results.
NOTE: Do not place the Low Cal F cup onboard the analyser without placing the Cal
Plasma cup
An analytical session is defined as beginning with the start of analysis and ending when the
instrument returns to Ready.
NOTE: All results processed on a calibration curve with an error in one segment will
be flagged with a warning “Invalid adjacent segment”.
High curve
In case the operator needs only the High curve, it is possible to perform the calibration only
using the undiluted calibration plasma.
The ACL ELITE/ELITE PRO will perform only 3 calibration points: 100%, 50 and 25%.
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Linearity varies from factor to factor but the instrument will always flag a result less than
60% of the lowest calibration point.
In case the lowest calibration point is 25 %, all results below 15 % will be flagged with a “C”
in the Error column and tagged with “Extrapolated Result” in the Test Details Warning List.
If a result is higher than 150 % of the highest calibration point value, a “C” will be displayed in
the Error column and “Extrapolated Result” will be shown in the Test Details Warning List.
For example, if the highest point of the calibration is 100 %; all results above 150% will be
flagged with a “C” and tagged with “Extrapolated Result”.
If the High curve is not valid (rejected), results on patients will be presented only in seconds.
If the High calibration curve is rejected but the 100% result is a valid result, the Low curve
and the Middle curve segments will be calculated.
If the 100% gives a non-valid result (i.e. error number xx), the High, Middle and the Low
curve will be rejected.
In both cases listed above the calibration should be repeated along with Quality Control and
patient samples.
It is possible that only two points (including the 100%) are valid and in this case the
instrument will present the "2 point cal” condition.
Low curve
If both High and Low segments are required, both segments must be calibrated at the same
time.
If the High curve is rejected due to a non-valid 100% result, the Low curve is rejected.
If the Low curve is rejected (invalid, non monotonic, etc.), the High and the Middle curve
segments can be considered valid. The Middle segment curve should be verified prior to
reporting the patient results.
It is possible that only two points (including the 6.25%) are valid and in this case the
instrument will present the "2 point cal” condition.
Any result outside its specified Test Range as defined in the test setup will be flagged with a
“C” in the Error column and “Outside Test Range” will be displayed in the Test Details
Warning List.
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Middle curve
The Middle curve will be calculated when both High and Low curve segments are calibrated
at the same time and both 25% and 6.25% points have produced valid results. “R2” value for
middle curve will always be 1.00 since it is composed of 2 points and therefore is a straight
line.
In case the High and Low segment do not produce a valid calibration (i.e. slope out of range),
if both results of the Middle curve segment are valid the Middle curve segment is calculated.
The Middle segment curve should be verified prior to reporting the patient results.
Any result outside its specified Test Range as defined in the test setup will be flagged with a
“C” in the Error column and “Outside Test Range” will be displayed in the Test Details
Warning List.
Non monotonic check
Another check done on calibration is called “Monotonic”.
This check verifies that the results obtained in seconds are proceeding in the same direction:
low to high or high to low.
If one of the points in seconds is not “monotonic”, the entire segment of the curve is flagged
and rejected.
If the High curve segment is found “non monotonic”, sample results will be calculated based
on the Middle or the Low curve segments if valid.
If the Low curve segment is found “non monotonic”, sample results will be calculated based
on the Middle or the High curve segments if valid.
For the two conditions above, the curve should be verified prior to reporting the patient
results.
If only the 100% calibrator is present and the error “non monotonic” is shown, the entire curve
will be rejected. In this case sample results will be calculated based on the previous
calibration curve. If a previous calibration curve is not present, only response values will be
reported.
Slope check
If the calibration slope exceeds the slope limit specifically defined for the segment, the
segment will be rejected with the Slope out of Range error message.
Samples run in this condition will be flagged with a “C” together with the message “Slope out
of Range”.
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R2 check
If the calibration R2 for a specific segment exceeds the R2 limit specifically defined for the
segment, the R2 will be presented in red and a “C” flag with the message “R2 out of Range”
will be presented together with patient sample results.
Flags on patient results
Several flags on patient results may be present and they are summarized in the following
table.
Flag Explanation
Out of Test Range =
result is displayed in Result is outside the Test Range for that specific test.
violet
When the result is greater than 150% of the highest calibration point
Extrapolated result or less than 60% of the lowest calibration point. Applies to high
curve or low curve.
Previous calibration Result is calculated using a previously stored calibration.
Invalid Adjacent
Calibration curve has a segment with an error.
Segment
Result is calculated if at least the High segment of the curve is
Slope out of Range
valid.
Result is calculated and an error message is shown (r2 out of
R2 out of Range
Range).
Response “non Result is calculated and an error message is shown (response “non
monotonic” monotonic”)
Recommendation
If the Low segment fails and results are obtained <25%, repeat the calibration, Quality
Control, and patient samples.
Since calibration can be run simultaneously with patient samples or a previously stored
calibration can be used, the operator should verify that all calibration segments are valid and
no calibration flags are present before validating any results.
For good laboratory practice, at least two (2) levels of controls should be run together with
patient samples.
If a calibration displays any flags, good laboratory practice suggests repeating the
calibration, Quality Control and patient samples.
In case of Factor VIII and/or IX, patient therapeutic treatment may be associated to sample
results. Perform the Low curve calibration, at the same time as the High curve calibration, to
cover factor concentrations down to the 1.56 % level.
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Stability of a stored calibration curve should be monitored by the use of at least two levels of
Quality Control materials each day of testing.
3.4.6 Factor Assay Calibration for Parallelism Tests

Factor assays for tests with parallelism import the calibration from the same factor test
defined without the parallelism dilutions. This master test is calibrated using the dedicated
calibration mode.
This information is valid for all factor assays with Parallelism when using the IL tests library.
The calibration curve for factors is divided into 3 segments:
l High Curve: Prepared using Cal Plasma with levels at 100%, 50% and 25%.
l Low Curve: Prepared using Low Cal F with levels ranging from 6.25%, 3.125% and
1.56%.
l Middle segment connects the 25% from segment one and the 6.25% from segment
three.
Calibration of the master test will require 3 empty(0.5mL) cups on the sample tray during the
calibration cycle. These cups will be used to automatically prepare the dilution of the Cal
Plasma for use as the Low Cal F.
Samples that are processed with the Factor Parallelism will process the samples at three
dilution levels: 100%, 50% and 25%.
3.4.7 Factor Assay Parallelism Results

Introduction
Factor Parallelism is a technique used to determine the influence or effect inhibitors have on
a sample’s Factor Assay activity result. The possible presence of an inhibitor and its effect
may be determined by assaying the Factor using a series of dilutions. The impact of the
dilutions on the factor activity can then be observed.
The purpose of the Parallelism function on the ACL ELITE / ELITE PRO is to assist with the
identification of an inhibitor in an easy, automated fashion. The Parallelism test mode is a
means to create operator definable dilutions. The
instrument will execute all dilutions, perform testing on the dilutions, and will provide
evaluation data on the results to assist in determining the presence of an inhibitor.
The software provides multiple checks of the data generated and provides the operator with
valuable information to assist in identifying the presence of an inhibitory pattern. Some of the
checks include comparison to the original undiluted result and precision data of the additional
dilutions.
Performing Factor Parallelism is an optional feature and if executed will provide an operator
definable Flag to alert the operator if a limit has been exceeded. If an inhibitor is suspected,
confirmatory testing is suggested.
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Results are obtained by running a series of dilutions of the sample similar to performing a
calibration. Samples run using factor parallelism will be analyzed at the 100%, 50% and
25% levels. On the cumulative report the results for all 3 dilutions will be reported as Dil 1
(100%), Dil 2 (50%) and Dil 3 (25%). Each of these levels may display the results in
seconds, % (Uncalculated) and Rec % (Recalculated). The recalculated results will be the
% uncalculated values multiplied by the dilution factor.
In addition to the individual results the system will perform calculations for the following:
l AVeCR% – Average of the three Corrected Results in % activity.

l CV-CR% – CV% of the three Corrected Results % values. When this value exceeds
the limit in the test setup the results will be displayed in red on the screen and an error
will print on the report.
l Slope – The slope for the 3 parallelism values is calculated. This slope should
coincide with that for the factor test calibration. In the test setup there is a user
definable minimum and maximum allowable Slope limit. When the recovered slope for
the samples is outside the limits in the test setup the results will be flagged in red and
the error “Slope out of range” will be printed.
l Int – This value is the intercept for the line based upon the 3 factor parallelism
dilutions. In the test setup there is a user definable minimum and maximum allowable
Intercept limit. When the recovered value for the samples is outside limits the results
will be flagged in red and the error “Intercept out of range” will be printed.
l R2 – This value is the correlation coefficient calculated using the seconds and the 3
factor parallelism dilution % values (uncorrected). In the test setup there is a user
definable minimum and maximum allowable R2 limit. When the recovered value for
the samples is outside the limits the results will be flagged in red and the error “R2 out
of range” will be printed.
Sample results with an error on any of the above units should be reviewed for the presence of
a possible factor inhibitor. Additional retesting including offline dilutions at higher levels
may be required to confirm any questionable results.
Example 1
l Laboratory Maximum Variance – ± 10% of the mean

l Concentrations – 100%50%25%
l Values – 54.7%51.5%46.4%
In the above example the results of 54.7% and 51.5%, have a mean of 53.1 with a 10%
agreement the range is 47.8% - 58.4%. If the results are outside that range another dilution
should be made, if they are within range they are close enough to report. If all points are
within 10% of their mean then the 100% concentration value should be reported as long as no
other flags are seen.
Parallelism’s sole purpose is to aide in the identification of inhibitors. In the case of an

inhibitor the answer reported should be the result obtained when 2 dilutions (CRs) agree
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3.5 Analytical Reference Chapter 3 – Analytical Operations
3.5 Analytical Reference

Analytical Reference (AR) is the name associated to a control material that is intended for use as a
general check of the system precision.
The AR results are handled just like the results for a Quality Control material. The plot and cumulative list
of results are both available for the AR. These results may be transferred to a host computer, printed or
archived.
3.5.1 Analytical Reference: SETUP

To Review the Analytical Reference results, from the Main screen select Calibration on the
menu bar, then select Analytical Reference from the Calibration submenu. This will open
the Analytical Reference Review screen:
This screen is similar to the QC Review screen.
The user may select the desired test from the list of enabled tests. The following statistics
are displayed, but cannot be edited, on the right side of the screen:
l Unit
l Actual and Target Mean
l Actual and Target SD
l Actual CV
l Results in Statistics and in Database (DB)
If the Mandatory AR Use box is checked then the system will check for the presence of the
Analytical Reference during the Pre-Analytical check. If the AR is required for any tests in
the session and it is not present the run will not proceed. Remove the check from the box to
disable the use of the Analytical Reference for all assays.
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If the Mandatory AR Use button is checked (enabled) and profiles are created the material
map for the profile will reflect the need for Cal Plasma. If the AR Use button is later disabled
the profiles that contain tests that use the AR will need to be deleted and re-created.
Clicking the Setup button opens the Analytical Reference Setup screen. See details in this
section.
Clicking the Plot and Statistics button opens the Analytical Reference Plot and Statistics
screen. See Section 3.5.2 - Analytical Reference: PLOT and STATISTICS on page 146.
Clicking the Cumulative Results button opens the Analytical Reference Data screen. See
Section 3.5.3 - Analytical Reference: CUMULATIVE RESULTS on page 148.
Clicking the Transfer to Host icon opens the AR Host Communication screen. See Section
3.5.4 - Analytical Reference: HOST COMMUNICATION on page 150.
Clicking the Confirm button exits the screen.

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Clicking the Setup button in the Analytical Reference Review screen opens the Analytical
Reference Setup screen:
The selected test ID appears on the top of the screen; below it the operator can view the
following information:
l Unit
l Target Mean and SD
l Target SD
l SD Range
l Results in Database. 10, 100, 500, 1000 is selectable. Any change to the number of
results in the database will delete all AR results for this test.
l Note
Clicking the Clear Statistics button, followed by a confirmation window Clearing

Cumulative Results for this test? Yes clears the cumulative results; No will cancel the
operation.
Clicking the Confirm button saves the changes, while clicking the Cancel button rejects the
changes; in both cases the system goes back to the Analytical Reference Review screen.

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3.5.2 Analytical Reference: PLOT and STATISTICS

Clicking the Plot and Statistics button in the Analytical Reference Review screen opens
the AR Plot and Statistics screen.
This screen displays both the Plot and the Statistics for the selected test.
The following information is viewable, but not editable, on the far left side of the screen:
l Start and End Date

l Unit
l Actual and Target Mean
l Actual and Target SD
l Actual CV
l Results in Statistics and in the Database (DB), choices are 10, 100, 500 and 1000
viewable results.
The AR plot is displayed on the far right side of the screen; the axes on the chart indicate:
l X-axis = days
l left Y-axis = target mean and chosen units
l right y-axis = SD
The display covers an interval of 30 days; the default window displays the results for the last
30-day interval, but the operator may view earlier data and move about using the scroll bar.
The statistical calculation is done using all the results in the database. To obtain the
statistics for other selected intervals of time click the Select Interval button and enter the
specific start and end date (dd.mm.yyyy or according to the date format selected in the Date
and Time configuration) in the specific fields of the Select Interval screen.
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The new interval must be confirmed by clicking the Confirm button, which results in the
system going back to the AR Plot and Statistics screen, or not confirmed by clicking the
Cancel button (this applies only to the selected interval).
Yes allows the operator to print the test setup; No will cancel the operation.
Clicking the Cumulative Results button opens the Analytical Reference Data screen. Refer
to Section 3.5.3 - Analytical Reference: CUMULATIVE RESULTS on the next page.
Clicking the Confirm button allows the operator to leave this screen and go back to the AR
Review screen.

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3.5.3 Analytical Reference: CUMULATIVE RESULTS

Clicking the Cumulative Results button in either the Analytical Reference Review or the
Analytical Reference Plot and Statistics screen opens the Analytical Reference Data
screen:
In the upper part of the screen, the user views the selected Test ID. The larger part of the
screen is used to display the results obtained. Results can be displayed using the list that
can be scrolled vertically and horizontally; the columns show the numeric results in all
configured units and the date/time of the analysis.
There is also space for notes, and columns for flags and warnings. The operator may enter
his own notes by clicking the Note icon that opens the Insert Notes screen (similar to that on
the QC screen).
Clicking the Confirm button allows the operator to save the entered or modified note and to
exit this screen, going back to the AR Data screen.
Clicking the Omit Result button allows the operator to permanently omit the selected result.
Before omitting it, confirmation is requested Omitting result…Do you really want to omit the
selected result? Yes or No selections are possible. When the result is omitted, a check will
appear in the O column beside the result and this result will not be used in the statistical
calculation.
Clicking the Plot and Statistics button allows the operator to have access to the Analytical
Reference Plot and Statistics screen. Refer to Section 3.5.2 - Analytical Reference: PLOT
and STATISTICS on page 146.
Clicking the Host icon opens the AR Host Communication screen. Refer to Section 3.5.4 -
Analytical Reference: HOST COMMUNICATION on page 150.
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Clicking the Extract Results icon opens the AR Extract Data screen. Refer to Section 3.5.5
- Analytical Reference: EXTRACT DATA on page 151.
Clicking the Printer icon opens the AR Result Report screen with the various possibilities:
l ALL
l From … to
l Not numeric
l Out of scale
l Omitted
l Transmitted
l Not transmitted
l Flagged
l Not flagged
Clicking the Confirm button exits this screen and goes back to the Analytical Reference
Review screen.

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3.5.4 Analytical Reference: HOST COMMUNICATION

Clicking the Transfer to Host icon in the Analytical Reference Review screen opens the AR
Host Communication screen (similar to the QC functionality).
The Host Communication configuration displayed on this screen is needed to decide which
type of AR results are to be sent and at what time intervals they should be transferred to the
Host Computer.
l “All range”
l “From…To…”
The user can select also if a specific test data or all tests data should be transmitted
between the following options:
l “Single Test”
l “All Tests”
The user then makes a second-level choice from each of the following pairs:

l Omitted Results
Some second-level selections are also available:

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Touching the area close to the options makes the selections: a check mark appears next to
the choice. These options allow the user to group the transmitted results for ease of
handling, i.e. Not Numeric and Not Flagged results. The second level options can also be
combined with them to transmit groups such as Not Numeric and Not Flagged - but Omitted -
results. Once the extraction criteria are defined, clicking the Start Communication button
may activate the transmission.
Clicking the Cancel button rejects the changes and exits the screen.

3.5.5 Analytical Reference: EXTRACT DATA

Selecting Analytical Reference from the Calibration menu, then selecting Cumulative
Results and then clicking the Extract Results icon in the Analytical Reference Data screen
opens the AR Extract Data screen (similar to the QC functionality).
The data configuration displayed on this screen is needed to decide which type of AR results
are to be extracted and at what time intervals they are extracted.
l “All range”
l “From…To…”
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The user then makes a second-level choice from each of the following pairs

l Omitted Results
Some second-level selections are also available:

Touching the area close to the option makes the selections; a check mark appears next to
the choice. These options allow the user to group the transmitted results for ease of
handling, i.e. Not Numeric and Not Flagged results. The second level options can also be
combined with them to transmit groups such as Not Numeric and Not Flagged - but Omitted -
results. Once the extraction criteria are defined, clicking the Extract icon can activate the
extraction.
Clicking the Cancel button rejects the changes and exits from the screen.

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Chapter 4 - Setup and Utility

4.1 SETUP 155
4.1.1 SETUP Submenu 155
4.1.2 Setup – TESTS – View/Define 156
4.1.3 Setup – TESTS – Sort Tests 158
4.1.4 Setup – TESTS – Interference Table 160
4.1.5 Setup – TESTS – Default Tests 162
4.1.6 Setup – TESTS – Reflex Tests 163
4.1.7 Setup – Multi-Tests - Profiles 167
4.1.8 Setup – Multi-Tests – Test Groups 170
4.1.9 Setup – Multi-Tests – Test Group Profiles 175
4.1.10 Setup – Multi-Tests – Sort Multi-Tests 178
4.1.11 Setup – Default Multi-Tests 179
4.1.12 Setup – LIQUIDS 180
4.1.13 Setup – INTERFACES – Host 188
4.1.14 Setup – INTERFACES – Printer 190
4.1.15 Setup – INTERFACES – Internal Barcode 191
4.1.16 Setup – INTERFACES – External Barcode – Optional 193
4.1.17 Setup – INTERFACES – Keyboard 194
4.1.18 Setup – INTERFACES – Network 194
4.1.19 Setup – INTERFACES – Modem 195
4.1.20 Setup – SYSTEM CONFIGURATION 195
4.1.21 Setup - SECURITY 197
4.1.22 Setup - Audible Alarms 201
4.1.23 Setup – DATE/TIME 202
4.1.24 Setup - UNITS 203
4.2 Setup – TESTS – Define 204
4.2.1 COPY TEST 206
4.2.2 Setup – TESTS DETAILS 207
4.2.3 Analysis – Loading Setup 213
4.2.4 Calibration - Loading Setup 223
4.2.5 Acquisition Setup 233
4.2.6 Calculation Setup 235
4.2.6.1 None – No Algorithm 239
4.2.6.2 Trend Algorithm 239
4.2.6.3 Threshold Algorithm 240
4.2.6.4 Threshold/Second Derivative Algorithm 243
4.2.6.5 First Derivative Algorithm 247
4.2.6.6 Second Derivative Algorithm 250
4.2.6.7 Delta Algorithm 252
4.2.6.8 Additional Calculation Settings 256
4.3 UTILITY 265
4.3.1 UTILITY Submenu 265
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Chapter 4 – Setup and Utility
4.3.2 UTILITY – Upgrade IL Library 266

4.3.3 UTILITY – Backup and Restore 267
4.3.4 UTILITY – Archive 270
4.3.5 UTILITY – SOFTWARE – Software Identification 271
4.3.6 UTILITY – SOFTWARE – Software Upload/Upgrade 272
4.3.7 UTILITY – Save Rotor Map 273
4.3.8 UTILITY – Save Trace File 275
4.3.9 UTILITY – Test/Material – Backup and Upload 276
4.3.10 Elite All-In-One Utility 278
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4.0 Introduction Chapter 4 – Setup and Utility
4.0 Introduction
The intent of this section is to familiarize the ACL Elite/Elite Pro user with the items included in the Setup
and Utility portions of the Operator Interface. The understanding of the items and their proper use are
important in order to prepare the system for its optimal analytical operation, to handle data and to work
with the system software.
4.1 SETUP
4.1.1 SETUP Submenu
Clicking the SETUP button on the Main screen menu bar displays:
TESTS
l View/Define
l Sort Tests
l Interference Table
l Default Tests
l Reflex Tests
MULTI-TESTS
l Profiles
l Test Groups
l Test Group Profiles
l Sort Multi-Tests
l Default Multi-Tests
LIQUIDS
INTERFACES
l Host
l Printer
l Internal Barcode
l External Barcode
l Keyboard
l Network (dimmed) – Not Supported in this version
l Modem (dimmed) – Not supported in this version
SYSTEM CONFIGURATION
SECURITY
AUDIBLE ALARMS
DATE/TIME
UNITS
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4.1 SETUP Chapter 4 – Setup and Utility
4.1.2 Setup – TESTS – View/Define

This area of the software is used to define and view individual tests. The test library can
contain up to 300 tests; 200 reserved for IL applications and 100 reserved for customized
applications; up to 100 tests can be enabled (active) at the same time independent of the
mix. The default setting for all tests is disabled.
Selecting Tests from the Setup submenu, and then choosing View/Define opens the View
Tests screen:
Above the test list a rectangular box will show the number of tests present in the Library
Application. The box will show two numbers; the enabled tests followed by the total number
of tests.
The large window on the left of the screen displays a table of all the configured tests.
Each test is identified by an abbreviated name, Test ID, shown on the right side column. The
Test ID name can be customized in the test details screen. The Test ID must be unique for
each test.
The two columns to the left of the test names contain checks indicating whether each test is:
l Currently Enabled and ready to be run on the ACL

l An IL pre-defined test application.
NOTE: IL pre-defined tests were developed and tested specifically for use with
HemosIL® reagents and new supplies (i.e. rotors and wash-R) for use on the ACL™
Elite/Elite Pro. The proper performance of other reagents and supplies including washed
rotors has not been fully tested or verified, and the use of them may cause clinically
significant degradation of performance and results. IL does not assume any obligation or
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warranty engagement concerning precision and/or accuracy of the measurements or for any
damage to the instrument directly or indirectly resulting from the use of reagents,
consumables, and expendable supplies other than those sold by IL. All responsibility for
parameter development and validation of new or copied tests belongs to the user
alone.
The right side of the screen contains the following fields:
l TEST CODE
l TEST REVISION
l TEST CODE FOR HOST
l EXTENDED NAME
l CALIBRATION MODE
The information shown in these fields can be viewed but not edited from this screen. Several
buttons are found around these fields:
Clicking the Details icon opens the Test Details screen, which allows editing of the fields.
Refer to Section 4.2.2 - Setup – TESTS DETAILS on page 207.
Clicking the Printer icon, followed by a confirmation window Do you really want to print the
Test report? Yes allows the operator to print the Test Setup details of the selected test; No
cancels the operation.
Clicking the Enable/Disable button, followed by a confirmation window Yes/No, erases all
information related to the selected test from the Patient Database and the QC Database. If
the test is disabled, clicking the Enable/Disable button will enable it. Disabling a test will
delete all result data (patient, QC, calibration) for the test.
Clicking the Show Enabled check box allows the operator to view only the enabled tests
from the test table. When this checkbox is marked the list presented displays just the
enabled tests. This setting is saved when exiting from this screen and also at power off.
Clicking the Copy Test button opens the Copy Test screen. Refer to Section 4.2.1 - COPY
TEST on page 206.
Clicking the New Test button opens the New Test screen. Refer to Section 4.2.2 - Setup –
TESTS DETAILS on page 207.
Clicking the Delete icon, followed by a confirmation window, erases all setup details and
result data related to the currently selected test. IL locked tests cannot be deleted.

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4.1.3 Setup – TESTS – Sort Tests

This area of the software is used to sort the enabled tests.
Selecting Tests from the Setup submenu and choosing Sort Tests opens the Sort Tests
screen:
Sorting the tests defines the display order of the tests in the patient database, the order of
the tests list during programming and the order of the tests in the printouts.
The window on the left side of the screen displays a table of all currently enabled Tests; a
check mark to the left side of a test indicates that it is a Sorted Test.
The window on the right side of the screen displays the order in which the tests are sorted.
The Arrow and the Scissors icons at the bottom of the windows are used to create a sorted
list.
The default condition is to have the tests in both columns listed in alphabetical order.
The operator selects the tests from the sorted tests box and presses the scissors icon; the
tests are then removed from the right side window.
This operation is necessary because the tests cannot be moved up and down in the Sorted
Tests list.
The arrow is used to move a test from the left (enabled tests) list to the right (sorted) list in
the desired position.
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Tests are added below the cursor. If a mistake is made, the Scissors icon is used to remove
the test from the sorted list. No test can be added above the first test in the list.
Enabled tests that are not sorted will be printed and viewed after those tests that are sorted.
Clicking the Confirm button saves the changes and clicking the Cancel button rejects the
changes; in both cases the system goes back to the Database View screen.

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4.1.4 Setup – TESTS – Interference Table

Even though the ACL has been designed to minimize reagent carryover between tests, it
was found experimentally that performing an operation called “reagent priming” further
enhances the system performance for some tests. The Interference Table option is used to
activate this operation between test pairs.
Selecting Tests from the Setup submenu, and choosing Interference Table opens the
Interference Table screen shown below.
This screen contains three windows:
l TESTS WITH REAGENT PRIMING on the left side displays the list of tests
containing a preventive needle priming defined within their test setup.
l INTERFERING TESTS in the middle displays all tests that interfere with the current
test highlighted in the left window (Test with Reagent Priming).
l ENABLED TESTS on the right side displays all the enabled tests in the system.
If an interfering test is executed prior to a test with reagent priming defined, the reagent
priming cycle is executed before the first reagent dispensation.
The interference tests table is preset for IL-Predefined tests.
The Arrow and the Scissors icons at the bottom of the windows are used to add or remove a
test.
The steps to setup the interference tests table are as follows:
1. Select a test with Reagent Priming defined from the list in the left box.
2. Select the interfering tests that affect the highlighted test selected in step 1 from the
Enabled test box.
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3. Move the test selected in step 2 to the interfering test column using the arrow. Use the
scissors to delete a test from the center column.
At the bottom of this screen, clicking the Confirm button saves the changes; clicking the
Cancel button rejects the changes; in both cases the system goes back to the Main screen.
WARNING: After performing any software library upgrades it is important to check

the interference table especially if you have custom tests defined. Custom tests that
interfere with an IL Locked tests (tests with reagent priming defined) will no longer be linked
in the interference table. You will need to re-enter the interference.
Reagent Prime Defined Interfering Test Status after Upgrade

IL Locked Tests Custom Tests After upgrade – no link
Custom Tests IL Locked Tests After upgrade – still linked
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4.1.5 Setup – TESTS – Default Tests

The default tests are programmed on sample Ids without a test request from the internal
database or the Host.
If default test is enabled, a sample ID with no tests requested (status of N) will have the
selected default tests automatically programmed. If the tests are included in the selected
Multi-Tests or Single Tests session they will be processed.
The list on the left shows all enabled tests. The list on the right shows the tests selected as
default.
The Arrow and the Scissors icons at the bottom of the windows are used to add or remove a
test.
Select the tests to be added to the Default Tests list from the box on the left (Enabled Tests)
and press the Arrow key. The selected tests will move to the Default tests box.
The default tests can be disabled/enabled using the Enable Default Tests checkbox.
NOTE: Default tests are added to a sample after checking the database and
performing a host query. If neither of these checks result in tests being programmed on a
sample, then the default tests will be added. Default tests will not be added to a previously
run sample with completed results. The default tests will not be run if they are not included in
the current single test or multi-test session selected. For samples added during a
pause/STAT request the default tests will be added after the run is resumed if the criteria for
default tests are met.
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4.1.6 Setup – TESTS – Reflex Tests

The Reflex Tests allow the user to program and/or execute a test generated by a condition of
the master test. Reflex logics are applied one time on each sample. Additional logic
checking is not performed on results that originated on test orders from reflex test rules
Up to 60 rules can be defined. A rule is composed of 1 to 3 conditions. A condition may be

either numeric result based (on a specific unit) or dependent upon errors that occurred on the
master test (i.e. error 6, error 7, error 12, etc.).
Each rule can program and/or execute automatically up to 10 tests.
Clicking the Details icon when the cursor is on a specific rule displays all the conditions and
tests. All of these can be modified.
Moving the cursor using the up and down arrows, then clicking the Enable/Disable button
will select or deselect each single rule. When a rule is enabled a check mark appears close
to the rule number. If a rule is checked it will be applied. See .Section 4.1.20 - Setup –
SYSTEM CONFIGURATION on page 195 for general Reflex Rules activation.
Clicking the Delete icon deletes the rule.
Clicking the Print icon prints all the reflex rules.
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The Details icon opens the Reflex Rules Details window where you can view /edit the
conditions for the current reflex rule.
The upper window allows the insertion of the rule condition by pressing the Insert Icon.
To insert a rule, select the Insert Icon.
The reflex rule conditions window appears.
The test generating the reflex test can be chosen from the Test ID List.
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For the numeric results class use the appropriate Unit field to select which unit should be
checked by the rule.
Two classes of conditions are available: value- based on numeric results; error- based on the
error that occurred.
For the numeric results, the unit can be selected according to the test and the units defined in
the specific test setup.
Then select the Comparison in terms of >; =; < for the value entered above.
In the Value field, after checking the value check box, enter in the numerical value for
comparison. Press the green check to confirm and save the condition.
The second class includes the result error (data reduction errors), e.g. error 6, error 7, error
12, etc. Most errors are based upon the measured unit; therefore this unit should be used
when defining the logic. See Chapter 6 - Troubleshooting on page 316.
For the error conditions, it is possible to group multiple errors (up to 5) in a single rule by using
the Select icon.
Move the cursor on the error to be selected, and then press the Select button; a check mark
appears close to the selected errors. Press the green check to confirm and save the
condition.
Multiple conditions are checked using the “AND / OR” qualifiers.
Up to 3 conditions can be linked to the same rule using the AND/OR option.
If the AND option is selected, both selected conditions must be fulfilled to generate the reflex
test(s).
If the OR condition is selected, only one of the conditions must be fulfilled to generate the
reflex test(s).
The lower part of the Reflex Rules Details screen allows the reflex tests to be selected by
using the Arrow and Scissors icons.
Rules and conditions can be reviewed or deleted by pressing the Details or the Delete icons.
The Print icon prints all the relevant information for all rules and conditions stored.
Below are listed some possible examples of reflex rules. These rules do not represent any
particular clinical aspects but only possible selective examples.
Each customer should define his own reflex rules. For the reflex rules execution please refer
to Section 4.1.20 - Setup – SYSTEM CONFIGURATION on page 195.
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Reflex Rules examples
PT > 50 seconds then PT-e

PT (sec) = error 6 then PT-e
PT (sec) = error 7 then PT-e
APTT > 110 seconds then APTT-e
APTT (sec) = error 6 then APTT-e
APTT (sec) = error 7 then APTT-e
Fib-C > 600 mg/dL (or g/L) Fib-C H
Fib-C < 100 mg/dL (or g/L) Fib-C l
D-Dimer > 1050 ng/mL D-D h
VWF > 150 % VWF h
NOTE: Only one level of reflex logic checks is applied to each sample. No
additional reflex logic checks are applied to the results of tests that were added to a sample
from the first level of reflex logic checking.
The following table lists the reaction curve error codes along with the unit that should be used
when defining a reflex logic for that error.
Error
Code Definition Cause Reflex unit
5 Optical Failure ADC Saturation Measured
6 Not Coag First threshold not passed Measured
7 Coag Error Second threshold not passed Measured
8 Coag Error Delta time between thresholds is Measured
greater than the selected value
9 Coag Error Initial slope of the reaction curve Measured
is higher than the selected value
10 Coag Error Final Slope of the reaction curve Measured
is higher than the selected value
11 Final Delta Error Final delta of the reaction is Measured
higher than the selected value
12 Coag Error Maximum peak of the first Measured
derivative is below the selected
limit value
13 Coag Error Maximum peak of the second Measured
derivative is below the selected
limit value
14,30 Offset Error Offset value is outside limits Measured
31 Curve Delta Error Delta of reaction curve does not Measured
meet limit specified for test
32 Noisy Baseline Erratic reaction readings Measured
33 Noisy Reaction Erratic reaction readings Measured
45 & 46 Mean not Calculated One of the two test results is not Reported
valid (non numeric result)
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4.1.7 Setup – Multi-Tests - Profiles

This area of the software allows users to define and view their own choice of Multi-Tests
(Profiles or Test Group Profiles). Multi-Tests Profiles are composed of single tests and Test
Group Profiles are composed of test groups. Refer to Section 4.1.10 - Setup – Multi-Tests –
Sort Multi-Tests on page 178.
Up to 30 Multi-Tests profiles can be created (code numbers from 1 to 99). The same number
cannot be used for a mufti-test profile and a test group profile.
A mufti-test profile can contain a maximum of 20 tests. A test group profile can contain a
maximum of 20 test groups.
Selecting Mufti-test and Profiles from the Setup submenu and then choosing View/Define
opens the Profiles View screen shown below.
The order in which the tests are entered in the Profile is one of the major determinants of the
analysis sequence of the tests when the profile is utilized.
The window on the left side of the screen displays a list of Profiles defined, while the window
in the middle displays the individual tests in the Profile highlighted on the left.
Each Profile is assigned a unique numeric code (profile code: 1-99), and for each there is an
associated NOTE field. Notes can only be viewed on this screen.
The information shown for these fields can be viewed but not edited from this screen.
Several buttons are found near these fields:
Clicking the Details icon opens the Profiles Details screen, which allows editing of the
fields. Refer to Profiles Details screen on the next page.
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Clicking the Delete icon, followed by a confirmation window Do you want to delete the
current profile? Yes allows the operator to delete the selected profile; No will cancel the
operation.
Clicking the Print icon, followed by a confirmation window Do you really want to print the
current profile? Yes prints the selected profile setup; No will cancel the operation.
Clicking the New Profile button allows the operator to access the New Profile screen. Refer
to Profiles Details screen below.

Profiles Details screen
Clicking the Details icon opens the Profiles Details screen.
NOTE: If you want to define a NEW profile, click the New Profile button to open the
New Profile screen, which has blank fields to fill in. Since the purpose of the New Profile and
the Profiles Details screens is very similar, they have an identical design. when the fields are
completed in the New Profile screen, it becomes a Profiles Details screen.
Two fields in the top part of the screen display the Profile ID and the assigned Profile Code.
Two windows are located below: the window on the left displays all Enabled Tests and the
one on the right contains the tests that make up the selected profile. Tests with an in cup
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dilution or in-session calibration cannot be placed in a mufti-test profile, and must be run in
the Single Test mode.
The user defines the tests in the profile with the help of the Arrow and the Scissors icons to
add and delete the tests from the enabled tests window to the tests in profile window. The
NOTE field at the far right is open for the user to add desired comments (free text).
The materials map is automatically created as the tests are inserted according to the default
position defined in the Setup liquids. If a reagent’s default position for a profile’s material map
is already occupied by another reagent, the next available “like” position is then automatically
assigned. If all the positions in a particular area R1 to R4, R9 to R12 (ACL Elite Pro only), R7
to R8, A1 to A10 and R5 to R6, are occupied, the liquid cannot be placed and a message
warns the user that the test cannot be added to the profile
The large window in the bottom of the screen reports the information currently stored for this
profile in the Materials Map:
l Liquid ID: the name of the materials used to analyze the selected profile
l Position: the selected position (A1…A10 or R1…R8/12) for the specific liquid material
l Refrigerated: a check indicates that the selected liquid material must be kept at 15°C,
positions R1 to R4, R9 to R12 (ACL Elite Pro only)
l Stirred: a check indicates that the selected liquid material must be stirred by the
magnetic stir bar (positions R1 to R4)
l Needle: indicates which needle (sample or reagent) dispenses the selected material.
changes; in both cases the system goes back to the Profiles View screen.
The Globe icon allows modification of the profile names in the selected language.

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4.1.8 Setup – Multi-Tests – Test Groups

The Test Group is a combination of tests using the same wavelength, optical reference and
same acquisition cycle.
Test Groups are predefined by IL. A User can create a new test group when they are logged
in at the Lab Manager security level.
Selecting Multi-Tests from the Setup submenu, and then choosing Test Groups opens the
Test Groups screen, shown below.
The window on the left side of the screen displays a list of the current groups of tests, “Test
Groups ID”, while the window on the right side displays the individual tests in the highlighted
Group.
Each Test Group is assigned a numeric code, and on the right there is space to enter a
NOTE for each. Notes can be viewed but not defined on this screen.
Several buttons are located around these windows:
Clicking the Details icon allows the operator access to the Test Group Details screen. Refer
to the specific sections below.
Clicking the Print icon, followed by a confirmation window Do you really want to print Test
Group? Yes prints the test group setup; No will cancel the operation. For complete details it
is recommended the Test Groups and individual Tests parameters within the Test group be
printed.
Clicking the Confirm button saves the changes and the system goes back to the Main
screen.
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Test Group Details screen
Clicking the Details icon in the Test Group screen opens the Test Group Details screen
shown below.
The test group ID and code are displayed in the upper part of this screen; on the right there is
space for the user to enter notes.
The larger window on the left of the screen is used to describe the sequence of operations for
each of the tests included in the specific test group, while the smaller window on the right
lists the tests enabled.
Clicking the Materials Map button opens the Tests Materials Map screen. This screen is
used to check the number and the characteristics of the positions where the reagents for
these tests are located (refrigerated or not; mixed or not; use of sample or reagent needle).
Refer to Section 4.1.12 - Setup – LIQUIDS on page 180.
Clicking the Material Check button, displays the actions to be taken by the instrument when
a low liquid level is detected. The actions can only be changed after a test group is initially
saved.
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Clicking the Confirm button saves the changes and the system goes back to the Test
Group Details screen.

Creating a New Test Group
The user can create test groups when they are logged in at the Lab Manager level. When
creating a new group there are several items that need to be considered for tests to be
compatible in the group.
l A minimum of one test is required. Tests that require an in-session calibration or in-
cup dilution cannot be placed into a test group.
l The tests must utilize the same wavelength
l The tests must have similar Acquisition Setup settings. The actual acquisition time
does not have to be the same; however the mixing, ramp and inter-ramp settings must
be the same.
l The time to pipette the second test in the group must be less than the incubation time
for the first test.
l The test group can have one RP (Reagent Prime) and this occurs as the first aspiration
in the group.
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l The test group can have one CL (Clean) cycle at the end of the group
l The group can only have one Optical Reference and or Reference step.
l The material check screen can only be modified after a test group is saved.
Clicking the New Test Group button will opens a blank Test Group Detail screen.
l The Enable Max Samples Value box limits the number of samples in a run using this
group. For IL locked groups users can edit (lower) the value at the Lab Manager
security level if “timeout expired during loading” errors occur.
l The list of available tests is displayed in the Enabled Tests box. Highlight the desired
test and move the test into the group using the arrow icon. Repeat the step for all
desired tests in the group. You will notice that the steps for the second and all
subsequent tests that are added into the group are placed below the previous ones.
l Once all of the tests are placed into the group you then need to modify the sequence of
the pipetting steps. When you are doing this you need to consider items such as
grouping similar operations or moving pipetting steps so they occur during incubation.
l The next thing you need to consider is the incubation time clocks. For steps with a
“set timer” time constraint you need to have a “wait until timer expires” follow it. If you
have two simultaneous steps with “set timer” the system will respect the time for the
first step when it encounters the “wait until timer expires”. In this case the second
timer is ignored if both tests are run.
l Excessive optical reference steps must be deleted. The group only requires one.
Test Group ID: Enter an ID name for the group (8 alphanumeric characters)
Test Group Code: Enter a unique numeric value between 501 – 999.
Double Samples: A check in this box will initiate all testing to be performed in duplicate for
this group.
Notes: This field can be used for free text comments about the test group.
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Materials Map: Displays the material map for the group
Assign Step No.: Pressing this button displays a window that allows you to change the
step number for the current step highlighted.
Add Step: This button opens the window that allows you to program a new step for the
group.
For details on configuring this screen, refer to Section 4.1.2 - Setup – TESTS – View/Define
on page 156 and Section 4.2.3 - Analysis – Loading Setup on page 213.
Clicking the Confirm button saves the changes.
The following table contains a list of IL locked Test Groups and the tests contained within it.
Test Group Name Tests within Test Group

PT SP APTT SP, FIB, PT
RPT SYS APTTSYS, R-FIB, R-PT
HS+ SP APTT SP, FIB HS+, PT HS+
HS+ SYS APTTSYS, FIB HS+,PT HS+
ATDD FIB AT* , DD, DDh, FIB-C(g/L)
l Test Groups contain the standard and extended acquisition time tests for the PT,
APTT and PT based Fibrinogen except for the ATDDFIB which contains Clauss
Fibrinogen
l Test groups with the Underscore (_) designation contain the Fibrinogen reported in
mg/dL without the (_) the Fibrinogen is reported in g/L
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4.1.9 Setup – Multi-Tests – Test Group Profiles

This area of the software allows users to define and view their own choice of Test Groups to
be run in Multi-Tests analytical sessions.
Up to 30 Multi-Tests profiles can be created (code numbers from 1 to 99).
Each profile can contain a maximum of 20 tests combinations each. The actual maximum
number of tests you will be able to add will depend on the available reagent positions. A test
should only be included in one of the test groups of a test group profile. A Test Group Profile
should not contain two Test Groups which contain the same test. A test ID should only be
contained in one Test Group if the Test Group will be part of a Test Group Profile.
Selecting Mufti-test and Test Group Profiles from the Setup submenu and then choosing
New Test Group Profile opens the screen shown below.
The window on the left side of the screen displays a list of Test Groups defined, while the
window in the middle displays the tests groups in the current Profile.
Each Profile is assigned a Profile ID (8 alphanumeric characters max.), numeric code (profile
code: 1-99), and for each there is an associated NOTE field.
The user defines the tests groups in the profile with the help of the Arrow and the Scissors
icons to add and delete the groups from the left window to the right window. The NOTE field
at the far right is open for the user to add desired comments (free text).
The materials map is automatically created when the test groups are inserted according to
the default position of the Setup liquids. If the default position for a reagent is already
occupied by another reagent, the next available “like” position is then automatically
assigned. If all the positions in a homogeneous area R1 to R4, R9 to R12 (ACL Elite Pro
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only), R7 to R8, A1 to A10 and R5 to R6, are filled, the liquid cannot be placed and a
message warns the user that the tests group cannot be added to the profile
The large window in the bottom of the screen reports the information for this profile’s
Materials Map:
l Liquid ID: the name of the materials used to analyze the selected profile
l Position: the selected position (A1…A10 or R1…R12) for the specific liquid material
l Refrigerated: a check indicates that the selected liquid material must be kept at 15°C,
positions R1 to R4, R9 to R12 (ACL Elite Pro only)
l Stirred: a check indicates that the selected liquid material must be stirred by the
magnetic stir bar (positions R1 to R4)
l Needle: indicates which needle (sample or reagent) dispenses the selected material.
changes; in both cases the system goes back to the Profiles View screen.
The Globe icon allows language modification of the profile names.
If a Test Group profile needs to be modified after it is created and saved, the original test
group profile should be deleted and a new one created.
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Test Group Profiles Details screen
As mentioned above, any changes to be made to the fields shown in the Profiles View
screen are done through the Profiles Details screen, which opens by clicking the Details
button.
NOTE: Since the purpose of the New Profile and the Profiles Details screens is very
similar, they have an identical design. When the fields are completed in the New Profile
screen, it becomes a Profiles Details screen.
Clicking the Delete icon, followed by a confirmation window Do you want to delete the
current profile? Yes allows the operator to delete the selected profile; No will cancel the
operation.
Clicking the Print icon, followed by a confirmation window Do you really want to print the
current profile? Yes prints the selected profile setup; No will cancel the operation.

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4.1.10 Setup – Multi-Tests – Sort Multi-Tests

This area of the software is used to sort the test profiles defined in the system. Profiles,
Test Groups and Test Group Profiles that are not on the sorted list will not be visible as run
modes under Analysis. The operator only needs to sort the profiles, test groups and test
group profiles they will run.
Selecting Multi-Tests > Sort Multi-Tests from the Setup submenu opens the Sort Multi-
Tests screen, shown below.
The 3-windows on the left side of the screen list defined Profiles, Test Groups and Test
Group Profiles. A check mark on the left side of a defined item indicates that item is in the
Sorted Profile list.
The window on the right part of the screen displays all Sorted Profiles.
The Arrow and Scissors icons are used to sort profiles and groups. As the operator selects
the first entry and presses the Arrow icons, the profile/group is copied from one position to
another of the sorted profiles list in the right side window. If a mistake is made, the Scissors
icon is used to remove the profile from the sorted list. The profile is inserted below the cursor.
Profiles that are not sorted will not be visible on the Multi-Tests Analysis menu drop down
selection.
changes; in both cases the system goes back to the Main screen.

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4.1.11 Setup – Default Multi-Tests

The Default Multi-Tests Profile selection determines the tests that may be run and their
associated material map setup when a user activates a run using the “Runner” icon from the
main database screen.
Selecting Multi-Tests from the Setup submenu, and then choosing Default Mufti-test opens
the Test Groups screen, shown below.
The box on the left lists all of the Multi-Tests Profiles and Test Group Profiles created.
Select the desired Default selection from the list and move it to the column on the right using
the Arrow. If you want to change the selected Default Profile, use the scissor icon to
remove.
To Enable Default Multi-Tests place a check in the box. The desired tests to run still need
to be programmed on a sample even though the Default Mufti-test are enabled.
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4.1.12 Setup – LIQUIDS

This area of the software allows the user to define and view the setup for all the liquid
materials defined on the ACL Elite/Elite Pro. The system will store 300 liquids of which 200
are reserved for IL use and 100 are available for the operator to define.
Selecting Liquids from the Setup submenu opens the Liquid Setup screen.
A list of IL predefined liquids is already stored in the software.
This screen displays the characteristics of all the liquid materials currently configured in the
system.
l LIQUID ID: the short name of the liquid material. For Control liquids this ID can be all
numeric (1 to 10 characters). This is the control ID sent to the Host if the analyzer is
interfaced. All other liquids must be an alphanumeric ID
l EXTENDED NAME: the complete name of the liquid material (Max. 15 alphanumeric
characters)
l LOT No.: the lot number of the material. Modification of the lot number will
automatically delete the currently stored ISI value, if applicable for the reagent
l EXPIRATION DATE: the expiration date as it is shown on the vial label. It is possible
to use the expiration date as a function of the Reagent Map Warnings. See Section
3.2.3 - Materials Map on page 85.
l ON BOARD STABILITY: the stability as claimed in the insert sheet. It is possible to
use the on-board stability value for the real time stability timer as a function of the
Reagent Map Warnings. See Section 3.2.3 - Materials Map on page 85. Enter a
numeric value followed by h for hours and d for days.
l CURRENT VOLUME: quantity of liquid (in mL) remaining in the container depending
on the specific reagent used (non-editable from this screen)
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l ASSIGNED VOLUME: quantity of liquid (in mL) present in a new container before
starting the analytical session (default volume as defined on the product label)
l WARNING VOLUME: quantity of liquid (in mL) below which the material map position
and reagent map icon colors will change from green to orange. This field should be
filled in for all reagents to be monitored. Volumes less than 1 should be entered with a
leading 0 (i.e. 0.5)
l LIQUID TYPE: calibrator, control, reagent, solution
This screen also displays a “Used By” table showing the tests for which each material is
used. In this table, the user may also record the ISI values. For the Calibrators, the user may
enter the assigned value for the standard as reported in the product insert sheet.
ISI and Calibration Plasma assigned values can be inserted by clicking the Assign Value
button and entering the value using either the keyboard or the numerical keypad. The default
setting for all assignments is blanked out. The user must enter the calibrator values and ISI
value prior to running the analyzer. The calibrator value for the PT test run in the laboratory
should be set to 100. The ISI value is found on the PT reagent insert sheet and is lot specific
NOTES:
l Whenever the ISI value is modified, all the results will use the new ISI value to
calculate the INR. The ISI value entered must fall within the specified ISI range as
defined in the Liquid details for the PT reagent.
l The optional external barcode reader setup allows the operator to configure the system
to automatically reset the onboard stability and/or assigned volume whenever a vial
label is read. Respective data for these fields must be entered into the liquid setup for
this function to operate. Refer Section 4.1.16 - Setup – INTERFACES – External
Barcode – Optional on page 193 for more details.
l For the IL locked PT tests the ISI value entered for the primary PT test is automatically
imported into the secondary tests (i.e. extended (e) and double (d) tests). This option is
also available for custom (non-IL locked) PT tests. Refer to Section 4.2.6 - Calculation
Setup on page 235 for more details.
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ACL ELITE/ELITE PRO TECHNICAL BULLETIN IMPORTANT INR NOTICE

INR FORMULA
INR = (PT Patient / PT Normal)ISI
PT PATIENT = Patient’s PT in seconds
PT NORMAL = Mean* of the Normal Range (on the ACL ELITE/ELITE PRO this is called the Reference Value)
ISI value = International Sensitivity Index from the current lot # of thromboplastin reagent being used.
To assure appropriate reporting of INR results, you must follow these steps:
1. Make sure instrument is in the READY mode. From the SET UP MENU select the LIQUIDS SUBMENU, then
select the appropriate THROMBOPLASTIN REAGENT (LIQUID ID) from the list in the left upper part of the
screen.
2. Select the PT TEST that uses this Thromboplastin reagent and click on ASSIGN VALUE.
3. Enter the ISI VALUE of the Thromboplastin Lot in use and select Confirm twice to enter value. Make sure
that all PT tests using the same Thromboplastin import the proper ISI assignment. Several PT TESTS using
the same Thromboplastin may be present such as PT extended, PT duplicate standard and PT duplicate
extended acquisition time. These tests will import the value from the standard test.
NOTE: The ISI value is specific for the lot number of prothrombin time reagent being used.
4. From the SET UP MENU select TESTS VIEW/DEFINE. Select the appropriate PT test and click on details.
5. Select CALCULATION SETUP and the instrument will show in the right part of the screen the selection of the
REFERENCE VALUE. This represents the Mean of Normal Population value in SECONDS, which is used
as the DENOMINATOR in the RATIO and INR CALCULATION.
6. Make sure that the value entered in this field represents the MEAN NORMAL POPULATION RANGE of the
local PT population. This value is editable and can be modified to reflect the laboratory established mean
normal range.
7. Confirm all PT Tests using the very same thromboplastin lot for Ratio/INR will be calculated using the same
value in seconds as the denominator (Mean Normal Population Range).
8. The instrument uses the following formula for RATIO CALCULATION.
RATIO CALCULATION = PATIENT PLASMA (seconds)

REFERENCE VALUE (seconds)
Reference Value means MEAN OF NORMAL POPULATION (seconds).

MEAN OF THE NORMAL POPULATION RANGE = Mean Normal PT Time = Mean of Patient Normal
Range in seconds as recommended in the CLSI Document C28-A, Vol. 15, No.4.
9. The INR will then be calculated as follows:
INR = (PT Patient/PT of Reference Value)ISI
Using the Reference Value feature the denominator used in the Ratio and INR calculation will accurately
reflect the Mean of Normal Population Range.
IMPORTANT WARNINGS:
l If the INR calculation is not properly setup, then erroneous patient results may be reported.
l If the product lot number changes, then the new ISI value from the package insert must be entered.
l In the ACL ELITE/ELITE PRO both screen and printout show/report Ratio and INR units separately
*or Geometric mean
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NOTES: Whenever the Calibration Plasma target values are modified, the stored
calibrations for the tests are automatically updated and all future results will be calculated
according to the new assigned value.
A “Notes” field is available for the user to enter comments (free text).
Clicking the Details icon opens the Liquid Details screen that provides further details about
the selected material. Refer to Liquid Details screen on the next page .
Clicking the New Liquid button opens the New Liquid screen for the user to enter the
characteristics of a new material. Refer to New Liquid screen on page 186.
Clicking the Confirm button saves the changes made and clicking the Cancel button rejects
the changes.
Clicking the Print icon and confirming the selection the liquid report is printed.
Clicking the Show Enabled checkbox, the list of liquids on the left will be reduced to only
display the liquids used by the enabled tests.
If the Show Enabled box is checked, QC liquids will not be visible on the list. To view the
QC liquids remove the check in the box.
A warning window opens after a change is made in any field: Liquid parameters have been
changed. Do you want to save them before proceeding? The operator must select Cancel,
Yes or No.
l Cancel: The window is closed; the new value entered is displayed, but not yet saved.
l Yes: The window is closed and the changes are saved
l No: The window is closed, the changes entered are deleted and the previous saved
value is displayed
ACTIVE BUTTONS at the bottom of this screen

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Liquid Details screen
Clicking the Details button in the Liquid Setup screen opens the Liquid Details screen. This
allows access to further information about a selected liquid material:
The information in this screen can be viewed but not edited. The only exception is the
Default Position for the IL liquids only. The information provided in this screen is:
l Liquid ID (maximum 10 alphanumeric character ID)

l Liquid Code (valid numbers for user defined liquid is 501 – 999)
l LIQUID TYPE (calibrator, control, reagent, solution)
l EXTENDED NAME (maximum 15 alphanumeric character name)
l DEFAULT POSITION (Must coincide with following 3 selections)
l ACCESSING NEEDLE
l Sample: Valid for positions A1 – A10 and R 7, R 8
l Reagent: Valid for positions R1 – R6 and R9 – R12
l REFRIGERATED (checkbox)- Liquid must use Reagent needle and be placed in R1-
R4 or R9-R12 (ACL Elite Pro only)
l STIRRED (checkbox) – Liquid must use Reagent needle and be placed in Positions
R1- R4
l ISI Minimum and Maximum acceptable values for a Reagent
l IL LIQUID (available for IL use only)
changes.
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ACTIVE BUTTONS at the bottom of this screen are:

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New Liquid screen
Clicking the New Liquid button in the Liquid Setup screen opens the New Liquid screen.
This is the screen where the operator enters all information pertaining to a new liquid material
to be used on the ACL system, which will be displayed in other screens.
The following fields are “open” for the operator to enter the desired alphanumeric digits (fields
with the * are mandatory):
l LIQUID ID*: the abbreviated name of the material (10 characters). For Control liquids
only, this ID can be all numeric.
l EXTENDED NAME*: the complete name of the material (15 alphanumeric characters)
l LIQUID CODE*: the numeric code of the material (IL codes are reserved from 1 to 500;
user codes are from 501 to 999)
l LOT No.: the lot number of the material (8 characters).
l EXPIRATION DATE: the expiration date as it is shown on the vial label. The system
will monitor this date and alert the operator in the session error history screen when the
liquid date has expired.
l ASSIGNED VOLUME*: quantity of liquid (in mL) present in a new container before
starting the analytical session (default volume as declared on the product label).
Volumes less than 1 should be entered with a leading 0 (i.e. 0.5).
l WARNING VOLUME: quantity of liquid (mL) below which the material map position
and the reagent map icon colors will be changed from green to orange This field
should be filled in for all reagents to be monitored.
l ON BOARD STABILITY: the stability as it is claimed in the insert sheet. Time can be
entered using the following abbreviations: h=hours and d=days (i.e. 24h or 1d).
l ISI Value Minimum: If this liquid is defined as a Reagent the minimum acceptable ISI
value for the reagent can be entered.
l ISI Value Maximum: If this liquid is defined as a Reagent the maximum acceptable ISI
value for the reagent can be entered
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In the following fields the operator must make a choice among the given options:
l ACCESSING NEEDLE*: Sample, (external needle) can only aspirate from A1 to A10
and R7 and R8. The Reagent,(internal needle) can only aspirate from R1 to R6 and
from R9 to R12 (ACL Elite Pro only)
l DEFAULT POSITION*: A1 to A10 or R1 to R8 or (R9 to R12 on the ACL Elite Pro
only). Default position can be modified also for IL liquids, maintaining liquid
requirement characteristics (refrigeration, stirring, needle, etc.)
l LIQUID TYPE*: Calibrator, Reagent, Control, or Solution
In the following two areas the operator must “check” the checkbox if the liquid requires the
feature onboard (check = YES):
l REFRIGERATED (must use Reagent needle and positions R1 - R4 and R9 – R12)

l MIXED (must use Reagent needle and positions R1 – R4)
l IL LIQUID (dimmed)
Since only the first four positions of the Reagent Area (R1…R4) can be refrigerated and
mixed (on the ACL Elite Pro additional refrigerated only positions are located in the area from
R9 to R12), a warning window appears if the operator tries to define an improper setup (i.e. a
liquid is placed in position R5 and the operator checks the “Refrigerated” check box).
The warning reads:
“Invalid Liquid Setup. The specific liquid setup is invalid and cannot be stored. Please correct
setup before saving “
If the liquid material is an “IL predefined liquid”, another checkbox is automatically checked;
this checkbox cannot be edited, meaning that a “User Liquid” cannot be identified as an “IL
Liquid”.
changes; in both cases the system goes back to the Liquid Setup screen.
Clicking the Globe icon allows the user to modify the liquid ID and name in the selected
language.
ACTIVE BUTTONS at the bottom of this screen are:

l Shutdown followed by a confirmation window Do you really want to shutdown ACL?
Yes closes the session, allowing the operator to log off and/or turn the system off. No
will cancel the operation.
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4.1.13 Setup – INTERFACES – Host

This area of the software allows the user to define some characteristics of the
communication between the ACL Elite/Elite Pro and the Host Computer to which it is
interfaced. See Appendix A – Host Communication Protocol on page 441 for Host interface
specifications.
Selecting Interfaces from the Setup submenu and selecting Host opens the Host Setup
screen shown below.
Two fields in this screen allow the operator to define:
l BAUD RATE – Choices are: 2400, 4800, 9600, 19200 or 38400.

l AUTOMATIC DATA TRANSMISSION (TX) – Choices are: “Not Required”, “Patient
Samples” or “QC, AR and Patient Samples”.”
Selecting automatic data transmission, the transmission of results is done at the end of each
test run during the analytical session.
Other buttons in the screen are “checked” by the operator if the feature is desired (check =
YES):
l HOST QUERY
l DELETE AUTOMATICALLY AFTER TRANSMISSION (TX). Selecting automatic
deletion will not allow for re-transmission of results at a later time.
l UNIQUE INSTRUMENT ID (a digit between 1 and 99 can be defined)
Tests downloaded from the LIS that are disabled in the analyzer will not be displayed on the
database.
Clicking the Confirm button saves the changes and clicking the Cancel button reject the
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Refer to Appendix A – Host Communication Protocol on page 441 for additional information

on the host communication.
Refer to Section 2.5 - ACL – HOST Interconnect Cable on page 60 for details on the cable
pin configuration.
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4.1.14 Setup – INTERFACES – Printer

This area of the software allows the user to configure the ACL ELITE / ELITE PRO optional
external printer.
Selecting Interfaces from the Setup submenu and selecting Printer opens the Printer Setup
screen:
On the top part of the screen, the operator defines:
l PRINTED SAMPLES: Any tests just analyzed (regardless of sample status) or just
the Completed (sample status is complete)
l REPORT TYPE: Cumulative(multiple samples per page) or Sample Report (Single
Sample per page)
l PRINTER PROTOCOL: ESC/P2 (for Epson-like printers) or HP-PCL (for HP-like
printers)
l PAPER DIMENSION: A4 (210 x 297 mm.) or Letter (216 x 280 mm./ 8½ x 11 inches)
l PAPER FORMAT: Single sheet or Continuous sheet
A check in the Automatic Print-Out box indicates that this feature is desired.
Automatic Printout occurs at the end of each run within a rotor according to the
selected criteria (any analyzed, completed; cumulative or sample report).
The user defines the SAMPLE REPORT DATA area by pressing the Enable/Disable
button. Choices are: the Instrument Name, the Normal Ranges and Date/Time.
Clicking the Customize Header button allows further customization of the report by
providing 5 lines of 30 characters each of free text to the user as entered in the Custom
Header screen.
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On both screens - Printer Setup and Custom Header Setup, clicking the Confirm
button saves the changes and clicking the Cancel button rejects the changes; in both
cases the system goes back to the Printer Setup screen.

NOTE: The ACL ELITE/ELITE PRO support the use of a Parallel or USB connection
for the external printer. If the USB connection is used the printer must be connected and
turned on prior to the system being booted up. If the printer is turned off while the instrument
is on, the analyzer must be rebooted in order for printing to occur.
4.1.15 Setup – INTERFACES – Internal Barcode

This area of the software allows the user to configure the internal barcode reader used for
sample identification on the ACL ELITE/ELITE PRO system.
Selecting Interfaces from the Setup submenu and selecting Barcode opens the Barcode
Setup screen:
The first step is to activate the Internal Barcode Reader by checking the checkbox Internal
BCR enabled seen on top of the screen.
The four fields visible on the screen correspond to the four families of barcodes that may be
activated on the ACL along with their corresponding subtypes of barcodes.
For each field, the user must choose one of the options according to the laboratory’s needs,
as shown below.
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CODABAR Disabled
No Checksum
AIM Mod 16
NW7 Mod 11
NW7 Mod 16
CODE 39 Disabled
No Checksum
Mod 43
INTERLEAVED 2 OF 5 Disabled
No Checksum
USS Mod 10
OPCC Mod 10
CODE 128 Disabled

No Checksum

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4.1.16 Setup – INTERFACES – External Barcode – Optional
The external barcode reader is an option that allows the reagent vial barcodes to be read
when the material map is displayed. Click on the External BCR Enabled button to enable
the feature.
The Code 128 dropdown box provides two selections: Disabled, No Checksum
Reset Reagent Volume when Scanned: Checking this box will automatically reset the
reagent volume on the map to the default volume defined for the liquid.
Reset Timer when Scanned: Checking this box will automatically set the onboard stability
timer to the default value defined for the liquid. If the pause timer is checked for a reagent,
when the vial label is read it will uncheck the pause button. If the vial is read a second time,
the timer and volume will be reset. Onboard stability and default liquid volumes must be
defined for the two options listed above to be functional.
When the material map is displayed the external barcode reader is active. The external
barcode reader can be used to read the label on the reagents. The position to place the vial
onboard the system will blink. If the lot number Expiration date are invalid a warning
message will be displayed.
NOTES:
l The barcode device has been tested in accordance with EN60825-1 LED safety, and
has been certified to be under the limits of a Class 1 LED device.
l The scanner’s housing is not water-tight; therefore do not submerge the scanner in
water. The scanner housing and window should be cleaned with a soft cloth or facial
tissue dampened with water or a mild water based detergent. Do not clean the
scanner or window with alcohol or solvents.
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4.1.17 Setup – INTERFACES – Keyboard

This area of the software allows the user to configure the ACL ELITE/ELITE PRO standard
keyboard for the language used in the laboratory and to decide on the use of the on-screen
pop-up numerical keypad.
Selecting Interfaces from the Setup submenu, and selecting Keyboard opens the Keyboard
Setup screen.
The window in this screen selects:
l KEYBOARD TYPE:
English (UK), French, German, Italian, Spanish or USA (English).
l NUMERICAL KEYPAD
Disabled, All numerical fields, or All numerical fields and Sample ID
Clicking the Confirm button saves the changes and clicking the button reject the changes;
in both cases the system goes back to the Keyboard Setup screen.

4.1.18 Setup – INTERFACES – Network

Not supported in this Software Revision.
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4.1.19 Setup – INTERFACES – Modem

Not supported in this Software Revision.
4.1.20 Setup – SYSTEM CONFIGURATION

This area of the software allows the user to configure some of the system features of the
ACL ELITE/ELITE PRO.
Selecting System Configuration from the Setup submenu opens the System Configuration
screen:
This screen allows the user to select the preferred options for the following:
PATIENT DATABASE LISTING: defines the order of the patient samples in the database; 4
options are available.
1. Last sample entered manually is at the top

2. Last sample entered manually is at the end
3. Sample ID order Ascending
4. Sample ID order Descending
Options 1 and 2 are based upon date/time of sample entry and options 3 and 4 are based
upon the Sample ID alphanumeric sort.
QC/AR DATABASE LISTING: defines the order of the QC materials in the database: last
material entered is at the top or last entered is at the end.
REFLEX STATUS: if rules are defined in the Setup/Tests/Reflex Tests, three options are
available: Program Reflex only, Execute reflex before closing session, disabled. For
additional information refer to Section 4.1.6 - Setup – TESTS – Reflex Tests on page 163.
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l Program Reflex only: add the tests to the sample ID but do not execute the analysis.
Test will remain pending until executed in a subsequent session.
l Execute reflex before closing session: program tests and execute them during the
current session provided the tests are defined within the current profile session in use.
l Disabled: turn off ALL reflex programming and testing.
CURRENT LANGUAGE: English, French, German, Italian, or Spanish. Reboot the analyzer
after changing the language setup. Entries in the logbook, File Error and Session Error
history are not updated for entries prior to the language change date and time.
DEFAULT SCREEN: When the system boots up you can select from the following two
screens as the initial screen: Database View or Multi-Tests Pre-Analysis (pre-analysis of
last multi-test session is displayed).
LIQUID SENSOR checkbox: enable/disable the use of the sample and reagent probe liquid
level sensor.
Wash-R emulsion sensor checkbox: enable/disable the use of this sensor.
WARNING: If Liquid Sensors or the Wash-R Sensor are disabled both a warning
message and a flag on all sample results will be presented. If the Liquid Sensor is disabled
the operator must carefully monitor the volume of liquids and samples to ensure adequate
amounts are present for testing. The automatic host transmission of results is disabled
when the sensors are disabled. At the end of each session a pop up box will alert the
operator to confirm sufficient sample/reagent remains onboard the analyzer. After
confirmation of the volumes, the operator may initiate a manual upload of the results to the
host. When the sensor is re-enabled the host communication will automatically be re-
activated.
REM Enabled: enable/disable the use of the Rotor Exchange Module. Not applicable for the
ACL ELITE. When the REM is disabled the operator can use the system by manually
loading the rotors.

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4.1.21 Setup - SECURITY

This area of the software allows the Laboratory Manager to configure the privilege level for
the users (Supervisor or Operator) and define IDs and passwords for all personnel using the
ACL ELITE/ELITE PRO system.
Up to 99 users can be defined in the Security area.
The first operation to be performed by the Laboratory Manager is the definition of the level of
entry for the other two user groups.
The Laboratory Manager, using their password, will have access to the Lab Manager View
button.
NOTE: It is advisable upon installation of the system to enter a new Lab Manager ID
and password.
Clicking on the Lab Manager View button a screen where both Supervisor and Operator
access definition will appear.
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In this screen, for each menu/submenu, the level of entry can be defined by the Laboratory
Manager according to the specific laboratory needs.
LEVEL: From the drop down menu select the level to define: Supervisor, or Operator
NOTE: The Lab Manager must define the screen access levels available to both the
Supervisor and Operator. Defining no access at the supervisor level for a submenu does not
automatically exclude access at the operator level.
For each menu/submenu the Laboratory Manager has three basic options:
l No Access
l Access, View* only
l Access, Edit*
No Access means that it will not be possible to enter in a menu or submenu; the option will
be dimmed.
Access-View Only means that access is possible. The screens can be viewed but no
modification can be performed.
Access-Edit means that the access is possible and Edit capability is available (depending on
the type of screen).
*The V and E listed under the Environment column stand for View and Edit.
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Selecting the Details icon after choosing the menu/submenu the above screen will appear.
In the Access Mode box the Laboratory Manager can define the Access/No Access for the
specific menu/submenu.
If the Access option is chosen the Laboratory Manager can then define either View Only or
Edit capability for the selected menu/submenu.
Press the New User button from the main Security entry screen to define new users within
the system.
The next screen will appear.
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In this screen the following information needs to be entered.
USER NAME: type the user name (it must be unique). It is advisable to keep the name short
(minimum 3 and maximum 15 characters) as it will be used to log in to the system.
EXTENDED USER NAME: type the extended user name to differentiate between users.
(Maximum 20 characters)
LEVEL: the Laboratory Manager will define for each user the entry level:
l Lab Manager
l Supervisor
l Operator
PASSWORD: the new user’s password.
CONFIRM PASSWORD: re-enter the same password for confirmation.
Password has to be minimum 3 and maximum of 9 characters.
When logging onto the system User Name and Password will be required.
It is recommended that when the system is not in use to log-out (using the key icon) requiring
the next user to log-in.
When using the Security/Password system, all-important operations are logged into the
Logbook. See Chapter 5 - Diagnostics and Maintenance on page 282.
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4.1.22 Setup - Audible Alarms

The audible alarms setup screen allows for labs to enable/disable the alarm sounding for
various system conditions.
Selecting Audible Alarms from the Setup menu opens the following screen:
Three non configurable alarm sounds are defined, referred to as: A, B, C. The audible alarms
can be enabled/disabled for the following conditions:
l END OF ANALYTICAL SESSION (Alarm A)

l HOLD STATUS (Alarm B): This condition occurs during a stat interrupt when the
current test in process is complete
l FAILURE STATUS (Alarm C): System error condition encountered
l INSUFFICIENT REAGENT (Alarm B): Reagent Shortage during the analytical
session
l INSUFFICIENT WASH-REFERENCE EMULSION (Alarm B): Wash-Reference
bottle is empty
l QC OUTSIDE SD RANGE (Alarm B): Alert when a QC failure occurs on the system
l MISSING MATERIAL/CALIBRATION BEFORE ANALYSIS STARTS (Alarm B):
Missing material observed during pre-analytical check
l MISSING MATERIAL/MISSING SAMPLES (Alarm B): Missing material or samples
observed during pre-analytical check
l ROTOR RE-USE (Alarm B): Physical cuvette map for the rotor does not match the
logical map, operator must enter or confirm cuvette positions
Move the cursor to the desired Audible Alarm Condition and press the DeSelect button to
enable/disable the alarm for this condition.
If the alarm is enabled it will sound at a 60 second interval for up to one hour.
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4.1.23 Setup – DATE/TIME

This area of the software allows the user to configure the format of the Date and to set the
current Date and Time for use on all appropriate screens and printouts of the ACL Elite/Elite
Pro system.
Selecting Date/Time from the Setup submenu opens the Date and Time screen:
DATE FORMAT: in this field the user chooses among the following options:
l dd.mm.yyyy (European style)

l mm.dd.yyyy (US style)
In order to set date and time, two numeric fields are available.
changes.

WARNING: Changing date to a prior date may impact the result (Patient, QC,
Calibration & AR) database FIFO operation. Results processed on dates furthest from the
current system date will be the first ones to be automatically deleted.
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4.1.24 Setup - UNITS

This area of the software allows the user to configure the units used for temperature on the
ACL ELITE/ELITE PRO system.
Selecting Units from the Setup submenu opens the Units screen:
The TEMPERATURE UNIT field has the following options: °C or °F.
changes; in both cases the system goes ack to the Main Screen.

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4.2 Setup – TESTS – Define Chapter 4 – Setup and Utility
4.2 Setup – TESTS – Define

This area of the software is used to view and define tests.
WARNING: After defining a new or copied test, the test settings should be printed and verified to
confirm correct entry. IL assumes no responsibility for the performance of non-IL locked tests on the
analyzer. Each laboratory must verify and confirm the validity and results of the user defined tests
definitions.
Selecting Tests from the Setup submenu and then choosing View/Define opens the View Tests screen:
On top of the test list a rectangular box will show the number of tests present in the Library Application.
The box will show two numbers: the enabled tests and the total number of tests. The system can store
100 user defined and 200 IL locked tests.
The large window on the left of the screen displays a table of all configured tests. Each test is identified
by an abbreviated name, Test ID, shown on the right side column. Both columns to the left of the test
names contain checks to indicate whether each test is:
l currently Enabled and ready to be run on the ACL ELITE/ELITE PRO

l an IL pre-defined Locked test.
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WARNING:
l IL pre-defined tests were developed and tested specifically for use with HemosIL reagents
and IL supported supplies for use on the ACL™ Elite/Elite Pro.
l The proper performance of other reagents and supplies has not been fully tested or verified,
and the use of them may cause clinically significant degradation of performance and results.
IL does not assume any obligation or warranty engagement concerning precision and/or
accuracy of the measurements or for any damage to the instrument directly or indirectly
resulting from the use of reagents, consumables (new or washed), and expendable supplies
other than those sold by IL.
l All responsibility for parameter development and validation of new or copied tests
belongs to the user alone.
The right side of the screen contains the following fields:
l TEST CODE
l TEST REVISION
l TEST CODE FOR HOST
l EXTENDED NAME
l CALIBRATION MODE
The information shown in these fields can be viewed but not edited from this screen. Several buttons are
found around these fields:
Clicking the Details icon opens the Test Details screen which allows editing of the fields. Refer to
Section 4.2.2 - Setup – TESTS DETAILS on page 207.
Clicking the Printer icon followed by a confirmation window “Do you really want to print?” Yes allows
the operator the choice to print the Test Setup of the selected test; No will cancel the operation.
Clicking the Enable/Disable button followed by a confirmation window Yes/No, erases all information
related to the selected test from the Patient Database and the QC Database. If the test is disabled,
clicking the Enable/Disable button will enable it.
The test database can contain up to 300 tests; 200 reserved for IL applications and 100 reserved for
customized applications; up to 100 tests can be enabled (active) at the same time.
Clicking the Show Enabled check box allows the operator to view only the enabled tests from the test
table. When this checkbox is marked the list presented is relative to the enabled tests. This information
is saved exiting from this screen and also at power off.
Clicking Delete erases only the open tests (customized); IL predefined tests cannot be deleted.
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4.2.1 COPY TEST

Clicking the Copy Test button opens the Copy Test screen.
The upper field indicates the “Test to be Copied”; the list contains all the tests present in the
test database.
The NEW TEST ID field allows the operator to name the new test (8 characters maximum).
This is a mandatory field.
The EXTENDED NAME field allows the operator to name the new test with a more detailed
name (15 characters maximum).
The TEST CODE FOR HOST represents the numeric code for the Host communication
(four characters).
The TEST CODE is a unique numeric field (four characters maximum). This is a mandatory
field. The acceptable test code range for Non-IL locked tests is between 501 and 999.
The TEST REVISION helps the operator to keep track of the changes in the application. The
number must be keyed in manually (4 characters maximum).
The Confirm/Cancel button saves or rejects the changes and the system returns to the
View Test screen.
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4.2.2 Setup – TESTS DETAILS

The Test Details screen is shown below. For new tests the fields will be blank, while those
for copied tests will contain the settings from the original test that was copied.
In the new test details the following information is accessible.
TEST ID – 8 characters
l Editable for all tests including the IL predefined tests.

l Must be unique for each test.
l Used for ordering tests as well as reviewing results (i.e. TEST ID column).
l Printed in the cumulative report.
l At least one alpha-numeric character is mandatory.
TEST CODE – 3 characters
l Editable in an open test but not in the IL locked tests.

l Available numbers for the open assays are from 501 to 999.
EXTENDED TEST NAME – 15 characters
l Editable in the IL and open test.

l Printed in the sample report.
l At least one alpha-numeric character is mandatory.
TEST CODE FOR HOST – 4 characters (editable)
l Editable for all tests.

l Represents the Code for Host transmission.
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TEST REVISION – 4 characters
l Editable in an open test.

l Format is from 0.00 to 99.99.
CALIBRATION MODE – One of the following options may be selected:
l None: No calibration is needed for this test.

l One time per session: This test does not have a dedicated calibration cycle; the
calibration is performed with the analytical session and can be stored and used for
further analysis.
l Each rotor: This test does not have a dedicated calibration cycle; the calibration is
performed for each analytical session within the rotor. The previous calibration can be
reviewed but cannot be used for further analysis.
l Dedicated: This test has a dedicated calibration cycle and the calibration can be
stored.
IMPORT CALIBRATION – One of the following options may be selected:
l None: No calibration import is needed for this test

l Test List dropdown: If it is necessary to import a calibration, choose the test from the
displayed test list. Only the tests enabled with a calibration defined will appear.
IMPORT RAW DATA FROM – The following options may be selected:
l None: This test does not import raw data from any other test.
l Test List dropdown: If it is necessary to import the raw data, choose the test from the
displayed test list. All tests are displayed.
Select Ranges from the test setup screen to modify the unit reporting option, the ranges for
the selected unit and the scale of the Y-axis of the reaction curves.
The IL Test box indicates this test is locked with minimal user modifications allowed when
the box is checked.
The Parallelism ( // ) box indicates parallelism is defined for this test when the box is
checked.
NOTE: When defining a new test the Ranges should be entered after all of the
subsections (Analysis, Calibration, Acquisition and Calculation) of the test setup are
defined.
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The Range and Units table contains the following information.
l Show in sample list – If the unit has been checked (Yes) the selected unit is
displayed in the patient database and printed.
NOTE: This setting has no impact on transmission of results to a Host

system. All units for a test are always transmitted regardless of the setting in this
checkbox.
l Correction parameters – If any correction factor is applied to a specific unit, an
asterisk will appear.
l Result Unit – Units that are available in the selected test (from 1 to 4).
l Normal Range – Defines the normal range for each unit. Minimum and Maximum
values can be typed in. The normal range is used to flag patient results. On the screen,
the results are displayed in black when within the Normal Range; the results are
displayed in violet when outside the Normal Range; on the printout an asterisk will be
printed (close to the results out of normal range).
l Test Range – Defines the test range for each unit (i.e. Linearity Range). Minimum and
Maximum values cannot be edited in IL test applications but can be edited in the
customized applications. The test range is used to flag patient results. Values outside
the Test Range are displayed in red; on the printout these results will be in bold print.
l Scale Range – Numerical reporting range for the test. Numerical values outside the
scale range high are presented as asterisks (***), and values outside the range low are
presented as dashes (---). Minimum and Maximum values cannot be edited in the IL
test applications but can be edited in the customized applications.
l Reaction Curve Graph – Defines the Y-axis of the reaction curve (minimum and
maximum values). If fields are left blank, the system will auto-scale based on the raw
data obtained.
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The Reference Value is entered in the Calculation Setup. Refer to Section 4.2.6 -
Calculation Setup on page 235 for more details.
The value is used for R (Ratio) and INR calculation for the tests.
This value is the denominator of the R and INR calculation and it should represent the mean
normal population time for the selected test.
The reference value for the standard test can be automatically imported into the secondary
related tests. For example, the PT (standard test) reference value will be automatically
imported into the Pte, PTd and Pted (secondary) tests. The automatic import is built into the
IL locked tests. For non-IL locked tests this feature can be used if the tests are configured to
do so. Refer to Section 4.2.6 - Calculation Setup on page 235 for more details.
Clicking on the Unit Correction button it is possible to correct result units based on a
mathematical equation.
The calculated units for the tests can be corrected on this screen (i.e. %, R, INR, g/L,
mg/dL, U/mL, etc.), while the primary units (i.e. seconds, delta, absorbance, etc.) can be
corrected in the Calculation Setup screen (page 236). Test results for IL locked tests that
have correction parameters entered for the primary (measured) unit will display “Lab
correlation applied” in the warning list box when the clot curve is displayed.
Up to 3 intervals of corrections based on the result range can be activated.
The correction is represented by the following formula:
Y = mX + q
where “m” represents the slope and “q” the intercept on the Y axis.
X is the original result and Y is the corrected results.
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Minimum and Maximum Interval values represent the range of unit where the correction is
expected to be active. The values for these fields should be positive numbers within the test
range for the selected test.
For “m” and “q” coefficients both positive and negative value coefficients can be entered.
Correction Parameter (when not defined by IL in the IL Locked Test Applications) definitions
used are the responsibility of the laboratory personnel.
WARNING: Modification of the correction parameters for calculated units on the IL

Locked Tests (i.e. D-Dimer High) is not recommended. A message box will display to alert
the user if they attempt to change the settings.
The recommended sequence of operations when a new test is created is the following.
1. Analysis: Loading setup

2. Calibration: Loading setup
3. Acquisition setup
4. Calculation setup
5. Ranges setup
WARNING: When a new application is defined please consider that major changes

to the Analysis step setup (i.e. adding or removing steps), the Calibration step setup (i.e.
adding or removing calibration points) and the Acquisition setup (i.e. change in acquisition
time) will erase all the Calculation setup conditions. This is done to prevent conditions of
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possible test inconsistencies. For this reason it is important to ensure the Analysis loading,
Calibration Loading and Acquisition Setup is correct before defining the Calculation Setup.
It is advisable before any change is done to an open test either new or copied, to print the
parameters in order to have a reference to use when re-entry of calculation setup is needed.
When a new application is defined please consider that minor changes to the Analysis step
setup (i.e. change of a liquid name or volume in an existing step) and the Calibration step
setup (i.e. change of a liquid name or volume in an existing step) will not erase the
Calculation setup conditions.
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4.2.3 Analysis – Loading Setup

Analysis: Loading Setup screen flow
Click a box in the diagram to jump to the corresponding screen description.
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Clicking the Analysis: Loading Setup button allows the user to editorial the reagents and
sample setup in the trays during analysis.
This screen is used to define all the steps needed to carry out the analysis.
Test ID: in this field the test Id previously defined is displayed. This field is present in all
screens of the test setup.
EMPTY CUPS ON OUTER RING STARTING FROM POSITION NUMBER: this field is
used only when it is necessary to place an empty (0.5mL) cup on the sample tray for pre-
dilution purposes.
Calibration Points Replicates: view field only; defined in calibration setup.
Double Samples checkbox: check this box to run tests in duplicate mode. Checking of the
mean value is enabled under Calculation Setup
Step: this is the order of the execution of the analysis step by step.
Add button: this button is used to define in detail all the steps of the analysis. A single step
is the action of aspirating/dispensing liquids. A step can be carried out by the sample needle
the reagent needle or by both needles. The final result of a step is the completion of a scope.
NOTE: Cuvette volume for a reaction must be no less than 150ul and no greater than
250ul.
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Several scopes can be selected:
l Optical Reference (Wash-R Emulsion) to be used with both 660 nm and 405 nm
channel definitions.
l Reference (in Absorbance tests) to be used with 405 nm channel definition only.
l Sample
l Sample a (activated sample as in APCR-V test)
l Sample 1, 2, 3 (For use with factor parallelism)
l Analytical Reference
l Analytical Reference a (activated analytical reference as in APCR-V test)
The Arrow/Scissors icons add or delete a possible scope.
List of “possible scope” presented in this screen is only an example; real selections of
possible scopes are indicated in the text above.
Once the scope is defined, it is necessary to define which needle will be used to
aspirate/dispense the liquids.
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The Parametersbutton for entering the Sample or Reagent line opens the Step Setup
Parameters window.
The Loading parameters for the Sample and Reagent needle can be defined as No Loading,
No Dilution, In Line Dilution or In Cup Dilution.
NOTES:
l A head volume of 10 microliters is always automatically added to each total step

condition both on the sample line as well as on the reagent line for all three conditions:
No Dilution, In Line Dilution and In Cup Dilution.
l All liquid volumes should be entered as microliter volumes.
l Wash cycle aspiration is 130 ul of Wash-R per cycle.
No Loading: No aspirating/dispensing of liquid occurs in this step.
No Dilution: the liquid is aspirated and dispensed as it is without any dilution. The following
fields must be entered.
l Liquid ID: choose from the liquid list

l Volume: enter the volumes in microliters (minimum 10; maximum = 140)
In Line Dilution: a diluent and the sample are aspirated one after the other and dispensed
together. The following fields must be entered.
l Diluent Liquid ID: choose the diluent liquid from the list
l Diluted Liquid ID: choose the liquid to be diluted from the list
l Volume: enter the volumes for each liquid in microliters (minimum single liquid=2;
maximum total volume is 140).
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In Cup Dilution (Sample needle only): diluent and sample are dispensed in an empty
(0.5mL) cup when a very high dilution is needed. This option is not available for the reagent
needle as this needle cannot aspirate/dispense in the sample tray area.
l Pre-dispensed Liquid ID: choose the diluent from the liquid list*
l Diluent Liquid ID: choose the diluent from the liquid list*
l Diluted Liquid ID: choose the liquid to be diluted from the list (i.e. plasma)
l Volume: enter the volumes in microliters (minimum single liquid=2; minimum total cup
volume=150; maximum total cup volume is 250).
The Washing field must be entered if a wash cycle is needed after each cup dilution is
completed. The value refers to the number of cycles and the range is 1-5.
The position of the empty (0.5mL) cup in the sample tray is defined by checking the Inner
Ring (A1- A10) or Outer Ring checkbox.
WARNING: When a low volume sample needs to be dispensed, it is advisable to

use the In Line Dilution option or the In Cup Dilution option. It is not recommended to
dispense a low sample (below 10 microliters) alone without any diluent/buffer.
Intermediate Rinse checkbox: if checked, the needle is dipped in the waste/rinse reservoir
to wash the exterior of the probe. This action is recommended when low volumes are used.
Wash R. checkbox: if checked, the needles are washed in the rinse before starting the next
step. Must be activated to run washing between loading.
Washing between loading: defines how many rinse cycles are performed between any
sample line loading or between any reagent line loading. The minimum is 0 and the maximum
is 5.
Washing at step completion: defines how many rinse cycles are performed at the end of
the loading phase for both the sample line and reagent line for this step. The minimum is 0
and the maximum is 5.
Timing constraint: some steps can be more critical on timing than others. For these it is
necessary to define a time interval that must be honored in the defined step(s).
None: the following step is executed immediately after the completion of the present
liquid dispensation.
Step length: it is possible to define the time interval within which a single step must
be completed. The loading time is included in the total step length. The system will
*When a highly diluted sample is required, the diluent must be added in two phases. The diluent used in the first phase
is called "pre-dispensed liquid". The diluent used in the second phase, together with the sample, is called "diluent
liquid".
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wait for the remainder of the step length time if loading is complete before the time
limit elapses. Mixing will occur after the step length time expires.
Delay at Completion: after loading of the liquids in the step, a fixed delay is added;
loading time is not included within the Delay at Completion time. No mixing occurs
before starting the delay timer.
Step length and Delay at Completion are always applied to a single step definition
only
Set timer: at the end of the loading phase of the defined step, a TIMER is set for a
certain amount of seconds; this timer will be used across the next loading step(s)
(i.e.: the Cephalin step incubation time in the APTT test has to wait for the step of the
Calcium Chloride). Subsequent steps, up to a Wait timer step, are executed
immediately, only the timer is set.
Wait until timer is expired: the loading step is executed after the time of a
previously SET TIMER step expires (i.e.: the CaCl2 step in the APTT test has to
close the timer previously opened).
NOTE: Set Timer and Wait until timer is expired are used when a timer
spans across several steps (minimum of two). In this case the time will go across
multiple steps. When Set Timer is defined in one step, a subsequent step must have
a Wait until timer is expired condition in order to close the timer opened previously.
Both conditions of Set Timer and Wait until timer is expired have to be used in one
application definition.
Time in seconds for the timing constraint field can be defined from 1 to 999 seconds (0
means disabled).
Mixing area: In the current step, if it is necessary to mix the contents of the rotor cuvette,
the ramp checkbox must be checked.
The following fields must be filled in.
Centrifugation Time: rotor may spin from 1 second to 999 seconds. If the value 0 is input,
the rotor will not spin.
Inter-ramp Interval: if the rotor is stopped after the first acceleration, this interval must be
defined. The minimum is 1 second and the maximum is 10 seconds. If 0 is input, no inter-
ramp will occur.
The Confirm/Cancel button leaves the screen saving or rejecting the changes and the
system goes back to the Main screen.
As soon as one step is entered, the details button becomes active and it can be pressed to
review and edit the fields.
The Delete icon can be used to delete a step in the analysis sequence.
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CLEANING
From the Analysis: Loading Setup Screen, press the Cleaning button to display the
Cleaning Setup screen.
This screen is used to define the liquid and its volume used for cleaning the reagent line and
the sample line.
When the cleaning procedure is defined, it is carried out after the last step of the test cycle.
Liquids can be defined as Diluent Liquid Id and/or Diluted Liquid ID which means that it
is possible to use a single solution or to dilute the solution with another liquid.
The total volume has to be within 10-140 microliters, independent from Diluent Liquid only,
Diluted Liquid only, both Diluent and Diluted Liquids.
Cycles no.: this is the number of the cycles (minimum 1 – maximum 5). If 0 is entered no
cleaning is performed.
Perform Sequentially: if checked, one line (sample needle line) is cleaned before the other
line (reagent sample needle); if not checked, the cleaning is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion in number of
cycles at the end of the cleaning cycle (minimum 1 - maximum 5).
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REAGENT PRIMING
From the Analysis: Loading Setup screen, press the Reagent Priming button to display the
Reagent Priming Setup screen.
This screen is used to define the liquid and its volume to be used for reagent priming for the
reagent line and/or the sample line.
When the reagent priming procedure is defined, it is carried out at the beginning of the test
cycle (before the first step).
When Reagent Priming is defined, the interfering tests that will trigger the prime need to be
activated using the Interference Table. See Section 4.1.4 - Setup – TESTS – Interference
Table on page 160.
Washing at startup defines the washing done by the Wash-R Emulsion in number of cycles
at the beginning of the reagent priming cycle.
Liquids can be defined as Diluent Liquid ID and Diluted Liquid ID which means that it is
possible to use a single solution or to dilute the solution with another liquid.
Cycles no.: this is the number of the cycles (minimum 1 – maximum 5). If 0 is entered, no
reagent priming is performed.
Before and after the reagent priming, a wash (using the Wash-R emulsion) procedure can
take place; a number can be defined (minimum 1- maximum 5).
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Perform Sequentially: if checked, one line (sample needle line) is primed before the other
line (reagent needle line); if not checked, the reagent priming is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion and number of
cycles at the end of the reagent priming cycle (minimum 1 - maximum 5).
The Confirm/Cancel button leaves the screen saving or rejecting the changes done and the
MATERIALS CHECK
Once all the liquids are configured, it is possible to define whether the instrument checks for
the presence of the liquid container during the pre-analytical check.
If a liquid is selected to be checked, you can define what actions to take if the liquid
becomes low during the analysis.
The check in pre-analysis option defines if the analysis may start even if the liquid is not
present (optional presence). This applies to materials in positions A1 – A10 on the sample
tray.
If the liquid is marked as mandatory, the analysis cannot start without it and the options of
Check and Continue or Abort are presented after the pre-analysis checks.
If the liquid is not marked as mandatory, the analysis can start without it and the Continue
option is also presented after the pre-analysis checks allowing the analysis to continue
without a specific liquid.
The Check Selected Row box is used to define the liquid as mandatory. This option can
only be used for the liquids positioned in A1 to A10 (auxiliary sample tray positions).
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The available actions of the system when a liquid is low are as follows:
l Abort test: in some cases the presence of the liquid is required to complete the
session (i.e. calibration): if the liquid is low, the session will be aborted. Samples and
reagents pipetted into the rotor prior to the shortage will not be analyzed.
l Complete possible and signal: in this case if the liquid becomes low during the
session, the samples that had sufficient liquid aspirated and dispensed will be
completed; while those, after the low reagent condition was detected, will be kept on
hold and the system will warn the user. Tests after the low condition remain pending.
The run can be restarted by refilling the reagents after session completion
l Just signal: The instrument will only advise the operator that a liquid is low but it will
continue to perform all pipetting operations.
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4.2.4 Calibration - Loading Setup

Calibration: Loading Setup screen flow
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Click the Calibration: Loading Setup button to editorial the liquids (reagents, calibrators)
setup in the trays during the test calibration.
This screen is used to define all the steps needed to carry out a calibration.
Test ID: in this field the test Id previously defined is displayed. This field is present in all the
screens of the test setup.
EMPTY CUPS ON OUTER RING STARTING FROM POSITION number: this field is
used only when it is necessary to place an empty cup (0.5 mL) on the sample tray for pre-
dilution purposes.
Calibration Points Replicates: the maximum number of replicates is 6. Since the

calibration must be performed on a single rotor, the total number of usable rotor cuvettes is
18; the possible combinations (standard levels/replicates) are as follows: 2 levels and 3, 4,
5, 6 replicates; 3 levels and 3, 4, 5, 6 replicates; 4 levels and 3, 4 replicates; 5 levels and 3
replicates; 6 levels and 3 replicates.
The Delete icon can be used to delete a step in the calibration sequence.
Add button: this button is used to define in detail a step of the calibration. A single step is the
action of aspirating/dispensing liquids. A step can be carried out by the sample needle the
reagent needle or by both needles. The final result of a step is the completion of a scope.
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Step: this is the order of the execution of the calibration run.
Several scopes can be selected:
l Optical Reference (Wash-R Emulsion) to be used with both 660 nm and 405 nm
channels definition.
l Reference (in Absorbance tests) to be used with 405 nm channel definition only.
l Sample
l Standard (1-2-3-4-5-6)
l All (only if all steps have the same conditions)
The Arrow/Scissors icons add or delete a step.
Once the scope is defined, it is necessary to define which needles will be used to
aspirate/dispense the liquids in the step.
The Loading type for the needle of the sample line may be defined; here is the definition of
the Sample and/or Reagent line.
No Loading: This line does not aspirate/dispense liquid in this step.
No Dilution: The liquid is aspirated and dispensed as it is.
In Line Dilution: A diluent and the sample are aspirated one after the other and dispensed
together.
In Cup Dilution: Diluent and sample are dispensed in an empty cup when a very high
dilution is needed.
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The Parameters button for either the Sample or Reagent line opens the step setup
parameters window.
No Dilution: The liquid is aspirated and dispensed as it is. The following fields must be
entered:
l Liquid ID: choose from the liquid list

l Volume: enter the volumes in microliters (minimum=10; maximum=140)
In Line Dilution: A diluent and the liquid are aspirated one after the other and dispensed
together. The following fields must be entered:
l Diluent Liquid ID: Choose the diluent from the liquid list.
l Diluted Liquid ID: Choose the liquid to be diluted from the list (i.e. cal plasma).
l Volume: Enter the volumes in microliters (minimum single liquid=2; maximum total
volume is 140).
"In Cup dilution" option (Sample Probe option only) dilutes the material in an empty 0.5mL
cup prior to loading into a cuvette on the rotor. Used when a high dilution ratio of material is
required. The following fields must be entered:
l Pre-dispensed Liquid ID: Choose the diluent from the liquid list.*
l Diluent Liquid ID: Choose the diluent from the liquid list.*
l Diluted Liquid ID: Choose the liquid to be diluted from the list (i.e. cal plasma)
l Volume: Enter the volumes in microliters (minimum single liquid=2; minimum total
volume=150; maximum total volume is 250).
*In case a highly diluted sample is required, the diluent must be added in two phases. The diluent used in the first
phase is called "pre-dispensed liquid". The diluent used in the second phase, together with the sample, is called
"diluent liquid".
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The In Cup Dilution option is not available for the reagent needle as this needle cannot
aspirate/dispense in the sample tray area.
NOTE: A head volume of 10 microliters is always automatically added to each total

step condition both on the sample line as well as on the reagent line for all three conditions:
No Dilution, In Line Dilution and In Cup Dilution.
The Washing field must be entered if a wash cycle is needed after each cup dilution is
completed. The value refers to the number of cycles and the range is 1-5. Each wash cycle
rinses with 130ul of Wash-R.
The position of the empty cup (0.5mL) in the sample tray is defined by checking the Inner
Ring or Outer Ring checkbox. Standard dilutions must use the Outer Ring.
The Confirm/Cancel button leaves the screen saving or rejecting the changes.
WARNING: When a low volume sample needs to be dispensed, it is advisable to

use the In Line Dilution option or the In Cup Dilution option. It is not recommended to
dispense a low sample (below 10 microliters) alone, without any diluent/buffer.
Intermediate Rinse checkbox: If it is checked, the needle is dipped in the waste/rinse

reservoir to rinse the exterior of the probe. This action is recommended in case of low volume
use.
Wash R. checkbox: If it is checked, the needles are washed in the rinse before starting the
next step.
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Washing between loading: Defines how many rinse cycles are performed between any
sample line loading or between any reagent line loading. The minimum is 0 and the maximum
is 5. Each wash cycle rinses with 130ul of Wash-R.
Washing at step completion: It is possible to define how many rinse cycles are to be
performed at the end of loading phase for both sample line or reagent line. The minimum is 0
and the maximum is 5. Each wash cycle rinses with 130ul of Wash-R.
Timing constraint: Since some steps can be more critical than others, it is necessary to
define some time interval that must be honored in the defined steps.
None: The following step is executed immediately after the completion of the present liquid
dispensation.
Step length and Delay at Completion are always applied to a single step definition only.
Step length: It is possible to define the time interval within which a single step must be
completed. The loading time is included in the total step length. for example, the loading of
the substrate in the AT test: activation time must be respected because it is a critical step in
the reaction.
Delay at Completion: After loading of the liquids in the step, a fixed delay is added; loading
time is not included within the Delay at Completion time. No mixing occurs before starting
the delay timer.
NOTE: Set Timer and Wait until timer is expired are used when a time has to
include several steps (minimum of two). In this case the time will go across multiple steps.
When Set Timer is defined in one step, a subsequent step must have a Wait until timer is
expired condition in order to close the timer opened previously. Both conditions of Set
Timer and Wait until timer is expired have to be used in one application definition.
Set timer: At the end of the loading phase of the defined step, a TIMER is set for a certain
amount of seconds; this timer will be used across the next loading steps (i.e.: the Cephalin
step incubation time in the APTT test has to wait for the step of the Calcium Chloride).
Subsequent steps, up to a Wait Timer step, are executed immediately, only the timer is set.
Wait until timer is expired: The loading step is executed when the time of a previously
SET TIMER step expires (i.e.: the CaCl2 step in the APTT test has to close the timer
previously opened).
Time in seconds for the timing constraint field can be defined from 1 to 999 seconds (0
means disabled).
Mixing area: If in the current step is necessary to mix the contents of the rotor cuvette, the
ramp checkbox must be checked.
The following fields must be filled in.
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Centrifugation Time: Rotor may spin from 1 second to 999 seconds. If the value 0 is input,
the rotor will not spin.
Inter-ramp Interval: If the rotor is stopped after the first acceleration, this interval must be
defined. The minimum is 1 second and the maximum is 10 seconds. If 0 is input, no inter-
ramp will occur.
The Confirm/Cancel button leaves the screen saving or rejecting the changes.
As soon as one step is entered, the details button becomes active and it can be pressed to
review and edit the fields.
CLEANING
From the Calibration Loading Setup screen, press the Cleaning button to display the
Cleaning Setup screen.
This screen is used to define the liquid and its volume to be used to clean the reagent and
sample lines.
When the cleaning procedure is defined, it is carried out after the last step of the test cycle.
Liquids can be defined as Diluent Liquid ID and/or Diluted Liquid ID which means that it
is possible to use a single solution or to dilute the solution with another liquid.
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Cycles no.: This is the number of cycles (minimum 1 - maximum 5). If 0 is entered, no
cleaning is performed.
After the cleaning, a wash (using the Wash-R emulsion) procedure can take place: a cycle
number can be defined (minimum 1 - maximum 5).
Perform Sequentially: If checked, the sample needle line is cleaned before the reagent line;
if not checked, the cleaning is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion in number of
cycles at the end of the cleaning cycle (minimum 1- maximum 5). Each wash cycle rinses
with 130ul of Wash-R.
REAGENT PRIMING
From the Calibration: Loading Setup screen, press the Reagent Priming button to display
the Reagent Priming Setup screen.
This screen is used to define the liquid and its volume to be used for reagent priming for the
reagent and/or sample lines.
When the reagent priming procedure is defined, it is carried out at the beginning of the test
cycle (before the first step).
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When Reagent Priming is defined, the interfering tests that will trigger it need to be activated
using the Interference Table. See Section 4.1.4 - Setup – TESTS – Interference Table on
page 160.
Washing at startup defines the washing done by the Wash-R Emulsion in number of cycles
at the beginning of the reagent priming cycle.
Liquids can be defined as Diluent Liquid ID and Diluted Liquid ID which means that it is
possible to use a single solution or to dilute the solution with another liquid.
The total volume has to be within 10-140 microliters, independent of Diluent Liquid only,
Cycles no.: This is the number of the cycles (minimum 1 - maximum 5). If 0 is entered, no
reagent priming is performed.
Perform Sequentially: If checked, the sample line is primed before the reagent line; if not
checked, the reagent priming is performed at the same time.
Washing at completion defines the washing done by the Wash-R Emulsion and number of
cycles at the end of the reagent priming cycle (minimum 1 - maximum 5). Each wash cycle
rinses with 130ul of Wash-R.
MATERIALS CHECK
Once all the liquids have been configured, it is possible to define whether the instrument
checks for the presence of the liquid, and also what action to take if the liquid volume is low.
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If a liquid is selected to be checked, you can define what actions to take if the liquid
becomes low during the analysis.
The check in pre-analysis option defines if the analysis may start if the liquid is not present
(optional presence).
If the liquid is marked as mandatory, the analysis cannot start without it and the message
Check and Continue or Abort is presented after the pre-analysis checks.
If the liquid is not marked as mandatory, the analysis can start without it and the Continue
option is presented after the pre-analysis checks allowing the analysis to continue without a
specific liquid.
The check selected row box is used to define the liquid as mandatory.
The Check Selected Row option can only be used for the liquids positioned in A1 to A10
(auxiliary sample tray positions).
The available actions of the system when a liquid is low are as follows:
l Abort test: In some cases the presence of the liquid is required to complete the
session (i.e. calibration); if the liquid is short, the session will be aborted.
l Complete possible and signal: In this case if the liquid becomes low during the
session, the samples that had sufficient liquid aspirated and dispensed will be
completed; while those, after the low reagent condition was detected, will be kept on
hold and the system will warn the user (tests after the low condition will remain
pending).
l Just signal: The instrument will only advise the operator that a liquid is low but it will
continue to perform all pipetting operations.
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4.2.5 Acquisition Setup

Click the Acquisition: Setup button to open the screen to view or edit the data acquisition
settings for the test.
This screen is used to define all the acquisition parameters.
The acquisition profile is represented in the following drawing.
Each mixing Ramp is fixed at 0.4 seconds.
Inter-Ramp Interval, Delay Time and Acquisition Time are defined according to the
application.
In general terms clotting reactions always have an Inter-Ramp Interval while chromogenic
and latex reactions do not use Inter-Ramp Interval.
If the Ramp checkbox is checked, the other parameters can be entered.
First mixing ramps (ramp up and down) are set at 0.8 seconds total.
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INTER-RAMP INTERVAL: time in seconds between the two ramps (0 means no inter-
ramp; or 1 to 10 seconds defines the time between the two ramps).
Second ramp up after the inter-ramp interval and before the acquisition delay is set at 0.4
seconds.
ACQUISITION DELAY: time where no data points are recorded during the acquisition (1-
60). If 0 is entered, no delay is considered.
SAMPLING RATE: interval between the data points in milliseconds (50 to 1000
milliseconds in 50 millisecond interval)
ACQUISITION TIME: time used to read the reaction (1-1200 seconds)
SPEED: 600 or 1200 rpm
ACQUISITION CHANNEL: 405 (Absorbance) or 660 (nephelometric) nm.
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4.2.6 Calculation Setup

Calculation: Setup screen flow
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Click the Calculation: Setup button to editorial the data calculation settings for the test.
This screen is used to define all the steps needed to manage the raw data (calibration and
analysis).
Test ID: in this field the test Id that has been previously defined is displayed. This field is
present in all screens of the calculation setup.
Normalization: two criteria may be selected: S/R * 100 or 2 * log (R/S). the first algorithm is
commonly used for the clotting assays, while the second is mostly used for chromogenic
assays. S means the value (in mV) of the sample and R means the value (in mV) of the
Wash-R emulsion (for S/R*100) and also the Optical Reference (for 2 * log (R/S)).
Scope: Defines the calculation for all the steps defined in the loading step setup:
l Optical Reference (Wash-R Emulsion)

l Reference (in Absorbance tests)
l Sample, Sample a (activated sample as in the APCR-V test)
l Analytical Reference, Analytical Reference a (activated analytical reference as in
the APCR-V test)
l ALL
Ratio: Select the fformula used to calculate the Ratio. Available options are:
l None (No ratio calculation performed)

l R = S / Ref. Value (Enter Reference Value in Field on right)
l R = S / Std 1
l R = S / Std 2
l R = S / Std 3
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Import Ref Value from: Select either None or a test from the drop down list.
The reference value entered for the primary test is automatically imported into the secondary
tests (i.e. extended (e) and double (d) tests). This value is the denominator of the R and INR
calculation and should represent the geometric mean of the normal population time for the
selected test.
Normalized Ratio: Select the formula from the drop down list.
l None (no calculation performed)

l INR = R^ISI
l NR = R(S) / Ref (Enter Reference Value in Field on right)
Import ISI Value from: Select either None or a test from the drop down list.
The ISI value entered for the primary test is automatically imported into the secondary tests
(i.e. extended (e) and double (d) tests).
Algorithm Type – Seven selections are available:

None, Trend Algorithm, Threshold, Threshold/Second Derivative, First Derivative, Second
Derivative and Delta.
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Once the Algorithm type has been selected the Define Parameters screen can be accessed
to define the calculation of the selected Algorithm Type. To clear parameter settings for a
test select the Delete Parameters button.
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4.2.6.1 None – No Algorithm
No algorithm is applied. Only the raw data will be available.
4.2.6.2 Trend Algorithm
Selecting Trend the following selections are possible:
Two Smoothings can be selected in terms of number of points.
The reaction curve can be analyzed in two areas: the First Part (Offset and/or Min)
and the Final Part (Final and/or Max). Number of points to calculate the Offset/Final
value or determine the Min/Max for the two curve areas can be defined.
Presented Units
The available units for the Trend algorithm are the first part of reaction curve
Offset/Minimum and the Final/Maximum for the final part of the curve.
Curve Checks
The Check Saturation checkbox activates a monitor on the reaction curve readings to
ensure they are within the hardware optical limit.
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4.2.6.3 Threshold Algorithm
Selecting Threshold the following selections are possible:
Two smoothings can be selected in terms of number of points: 1st Smooth and 2nd
Smooth.
Smoothings are calculated using the moving average mean criteria; the criteria to
calculate the moving average mean is defined by the number of points (degree) used to
calculate the new smoothed values.
Delta Check defines the minimum acceptable delta for the normalized data reaction
curve.
The reaction curve can be analyzed in two areas: the First Part (Offset or Min) and
the Final Part (Final or Max). Number of points to calculate the Offset/Final value or
determine the Min/Max for the two parts of the curve can be defined.
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Pressing the Threshold Parameters button will display the following window
The 1° Threshold Parameters window allows you to set the following parameters.
Threshold Search Direction provides the option to search for the threshold value in
the Forward (starting from the beginning of the reaction) or Backward (starting from
the end of the reaction and moving toward the beginning) direction.
Threshold Mode allows selection of Absolute (total) or % of Curve to calculate the

threshold.
1st Threshold defines where the clot time should be taken; a numerical value should
be entered. The threshold represents a fix change in turbidity from the initial offset of
the reaction curve.
Backwards Threshold Settings settings not applicable for this algorithm.
Presented Units
Time in seconds (calculated against the first threshold) is in general the presented unit,
other units such as the Initial Reaction Offset/Minimum and the Final/Maximum part
of the reaction can be chosen.
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Curve Checks
2nd Threshold defines where one of the checks on the clot curve should be taken; a
numerical value should be entered. This value is used as a verification that a real
clotting curve is present.
In general the second threshold is used to discriminate between real clotting curves
and noisy or unstable clot curves or low Fibrinogen.
Delta Time is used to check bi-phasic curves; it represents the difference in seconds
between 1st and 2nd thresholds.
Initial Slope checks for non-phasic curves. It represents the initial slope of the
reaction curve at the beginning of the acquisition time. If the minimum slope check is
not met an error will be generated.
Primary Unit Correction
Accessing the Correction Parameters window it is possible to set value corrections

based on the reaction.
Correction Parameters are applied here on the primary unit.
Three correction intervals can be defined and a corresponding slope (m) and intercept
(q) value can be entered.
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The correction is represented by the formula Y = mX + q where “m” represents the

slope and “q” the intercept on the Y axis.
Minimum and Maximum Interval values represent the result range where the correction
is applied.
For “m” and “q” coefficients both positive and negative value coefficients can be
entered.
4.2.6.4 Threshold/Second Derivative Algorithm
1st and 2nd Derivative calculation in terms of number of points to be used.
Five smoothings can be selected in terms of number of points: 1st Smooth, 2nd
Smooth and 3rd Smooth is used for the raw data; the 4th and 5th Smoothings are
used for the First Derivative.
The reaction curve can be analyzed in two areas: the First Part (Offset/Min) and the
Final Part (Final/Max). Number of points used to calculate the Offset/Final values or
determine the Min/Max for the two curve areas can be defined.
curve.
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Presented Units
Time in seconds (calculated from the first threshold or the maximum peak of the
second derivative) is usually the presented unit. Other available units include the First
Part Offset/Minimum and the Final Part Final/Maximum values.
Pressing the Threshold Parameters button displays the following window:
The Threshold Search Direction provides the option to search for the threshold value
in the Forward (starting from the beginning of the reaction) or Backward (starting from

threshold.
be entered. The threshold represents a fixed change in turbidity from the initial offset of
the reaction curve.
Click on the Backwards Threshold Settings box to enable calculation from the end of
acquisition time moving backwards to the beginning.

threshold.
Value field defines where the clot time should be taken; a numerical value should be
entered. The threshold represents a fixed change in turbidity from the initial offset of
the reaction curve.
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Curve Check
Accessing the Curve Check Parameters window it is possible to make the following
selections.
numerical value should be entered. This value is used as verification that a real clot
curve is present.
In general the second threshold is used to discriminate between real clot curves and
noisy, unstable clot curves or low Fibrinogen.
Delta Time is used to check bi-phasic curves; it represents the difference in seconds
between two thresholds. In case the delta time is not met the raw data will be analyzed
using the Second Derivative criteria
Initial Slope checks for non-phasic curves. It represents the initial slope of the reaction
curve at the beginning of the acquisition time. Number of points and slope value can be
entered. If the slope check is not met the raw data will be analyzed using the Second
Derivative criteria.
1st and 2nd Derivative can be enabled and minimum acceptable delta limits defined.
Noise Check 1 – If enabled, the system will determine the clot time searching
backwards through the data curve for a value that is a percentage of the curve delta.
The desired percentage is entered in the Percent field. The delta between the original
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time (time or threshold) and the backward calculation time is determined. The Max
Time Delta value is the maximum allowable time delta between the two values.
Noise Check 2 – If enabled the system seeks the next maxima value or time starting
from the original value or time. If there is no further drop in the normalized data curve
then the local maxima value and time will equal the original.
In the Points field enter the minimum number of points the curve must fall in order for
the local maxima to be considered a true peak. The Min Peak Delta is the percentage
of the overall delta of the curve the local max value must exceed in order for it to be
considered a true peak. The Min Decrease is the minimum difference in signal
(absolute) for the local maxima to be considered a true peak.
Click on Coagulation Location Check button to activate. If enabled the system will
check the coagulation point to ensure it falls within the Percent of the total curve delta.

Three Correction Intervals can be defined and a corresponding slope (m) and intercept

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Minimum and Maximum Interval values represents the result range where the
correction is applied.
entered.
4.2.6.5 First Derivative Algorithm
Selecting First Derivative the following selections are possible:
1st Derivative calculation in terms of number of points to be used.
It represents the velocity of the reaction and can be used as criteria to find the clotting
point searching for the maximum peak of the first derivative.
Smooth and 3rd Smooth are used for the raw data; the 4th and the 5th Smoothings
are used for the First Derivative.
Final Part (Final/Max). Number of points used to calculate the Offset/Final values or
determine the Min/Max for the two curve areas can be defined.
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curve.
Presented Units
Time in seconds is usually the presented unit. Other available units include the First
Part Offset/Minimum and the Final Part Final/Maximum values.


is applied.
entered.
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Curve Check
selections.
First Derivative limit checks in terms of absolute value to be used to verify that a
proper clot is occurring.
First Part – the initial turbidity check value of the reaction versus the value.
Second Derivative – enter the number of points to use and check limit value to verify
that a proper clot is occurring.
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4.2.6.6 Second Derivative Algorithm
1st Derivative is calculated using number of points entered. The 1st derivative is the
velocity of the reaction
2nd Derivative is calculated using number of points entered. The 2nd derivative is the
acceleration of the reaction and can be used to find the clotting point searching for the
maximum peak of the second derivative.
Smooth and 3rd Smooth are used for the raw data; the 4th and the 5th Smoothings
are used for the First Derivative.
Final Part (Final/Max). Number of points to be used to calculate the average or
determine the Min/Max for the first and final parts can be defined.
curve.
Presented Units
Time in seconds (calculated on the maximum peak of the second derivative) is the
usual presented unit. Other available units include the First Part Offset/Minimum and
Final Part Final/Maximum Reaction part values
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Curve Checks
1st Derivative defines the minimum acceptable limit for the 1st derivative.
Second Derivative value defines when the maximum peak of the second derivative
should give a result as time in seconds; a numerical value should be entered.

(q) can be entered.

Minimum and Maximum Interval values represents the result range where the
correction is applied.
entered.
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4.2.6.7 Delta Algorithm
Two smoothings (1st and 2nd) can be selected in terms of number of points.
Final Part (Final/Max). Number of points to be used to calculate the average or
determine the Min/Max for the first and final parts can be defined.
Delta Check is the minimum acceptable delta for the normalized curve data.
Presented Units
Delta is in general the presented unit, other units such as the offset/Minimum and the
final/Maximum of the reaction can be chosen.
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Curve Checks
selections.
1st Threshold defines where one of the checks on the clot curve should be taken; a
curve is present. The threshold represents a fix change in turbidity from the initial offset
of the reaction curve.
Offset Min checks the reaction to see if the offset value is less than this value. If the
offset is less than the value the response is failed.
The Check Saturation checkbox activates a control on the reaction curve readings to
curve is present. The second threshold is used to discriminate between real clot
curves and noisy or unstable clot curves or low Fibrinogen.
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Delta Time checks bi-phasic curves; it represents the difference in seconds between
two thresholds.
Initial Slope checks non-phasic curves; it represents the initial slope of the reaction
curve at the beginning of the acquisition time. Number of points and slope value can be
entered (numerical values).
Final Slope checks non-phasic curves; it represents the final slope of the reaction
curve at the end of the acquisition time. Number of points and slope value can be
entered (numerical values).
First Part checks the initial reaction to be sure it has not exceeded the value entered
(turbid reaction)
Max / Final checks if the final reaction is turbid or not. Maximum absorbance reading
minus the final absorbance reading cannot exceed this limit.
Pressing the Threshold Parameters button will display the following window
The Threshold Search Direction provides the option to search for the threshold value
in the Forward (starting from the beginning of the reaction) or Backward (starting from

threshold.
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be entered. The threshold represents a fixed change in turbidity from the initial offset of
the reaction curve.
Backwards Threshold Settings – settings not applicable for this algorithm.
Correction Parameters
Correction Parameters allows you to set primary unit corrections based on the
reaction.
(q) can be defined.

is applied.
entered.
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4.2.6.8 Additional Calculation Settings
These include the Mean, Checks, Parallelism Setup, Acq. Data Checks and
Calibration Setup.
Calculate Mean: determines mean value if “Duplicate” analysis is performed
Check Mean: flags the duplicate values when they exceed the mean by the entered
value. This unit is represented in % variation for the selected unit.
Pressing the Checks button displays the Analytical Reference Checks screen.
Limits to flag the Analytical Reference and/or the Analytical Reference Activated

(ARa) values can be defined.
The check is done in % versus the measured value of the Analytical Reference.
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Options for the AR/ARa values can be chosen from the following selections:
l Reference Value – value manually entered by the operator

l Std 1 – against the first calibration standard point
l Std 2 – against the second calibration standard point
l Std 3 – against the third calibration standard point
Pressing the Acq. Data Checks button displays the following screen
Raw Data Checks
Click the box to select the Baseline By Moving SD. In the Points field enter the
number of raw data points to use. The Segment field allows you to enter the portion of
the total curve time.
Click the box to select the Curve Sequence. In the Curve Type field select either
Max follows Min or Min follows Max.
Click the box to select the Spike Removal. In the Percent field enter the minimum
deviation (1-99%) from the curve sequence for a point to be considered a spike. In the
Limit field enter the maximum number of spikes allowed.
Normalized Data Checks
Click the box to select the Baseline SD. In the Points field enter the number of data
points to use. In the Max SD field enter the maximum allowable Standard Deviation
used to establish whether the baseline is smooth or not
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Derivative Checks
Click the box to select the Normalized Signal to ensure the reported clot time
coincides with the curve sequence selection.
Click the box to select the 1st Derivative Boundary check. This will ensure the 2nd
derivative max peak occurs before (in time) the 1st derivative max peak.
Parallelism Setup
Please refer to Section - Parallelism Setup on page 262 for details.
Selecting the Calibration Setup button displays the Calibration Setup screen.
Algorithm Type: 7 options are available: None, Trend Algorithm, Threshold,

Threshold/Second Derivative, First Derivative, Second Derivative, and Delta.
Define Parameters: This option in Calibration Setup has the same selections as for
the test calculation setup. See Section 4.2.6 - Calculation Setup on page 235.
Delete Parameters: Used to delete the defined parameters for the selected Algorithm
type.
Response type: the measured unit is displayed in this field
Check CV checkbox: if the user wants to flag the CV of the calibration replicates, this
checkbox should be selected.
Outlier checkbox: if checked, the outlier result is automatically discarded in the

calibration calculation for each calibration level.
The instrument calculates the mean, discards the furthest value from the mean, then a
new mean is recalculated using the remaining points.
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Dilution Ratio %: to be defined according to the calibration loading setup (up to two
decimals may be entered).
CV: when a minimum of three replicates is configured, the field can be filled in with the
maximum acceptable CV% value. When the obtained CV% value is higher than the
defined limit, the specific calibration standard point is flagged.
Final Unit: Represents the calculated unit of the calibration. The unit can be selected
from a list including: mg/dL, g/L, %, ng/mL, U/mL, ug/L, umol/L, IU/mL, %, mg/mL,
ug/mL.
New Unit: If a unit different from those included in the list is desired, the user can
configure a custom unit by typing it in this field (up to 8 characters).
Calibration Curve Setup: pressing this button displays the Calibration Curve setup
screen.
This screen aims to define the mathematical relation between X (measured unit) and Y
(calculated unit).
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Normalization of X and Y axis: X and Y can be recalculated according to the

selected options.
l X (as it is)
l R= X/Std Z (Z = selected from the standards defined in the calibration.)
And for the Y:
l Y (as it is)
l R= Y/Std Z (Z = selected from the standards defined in the calibration.)
Correct with AR in analysis checkbox: the AR result in the run is used to modify the
calibration curve (it represents a single point calibration); all patient results will be
calculated on the basis of the modified calibration, if the checkbox is checked. This
option is valid only for the dedicated calibration sessions and only for the calibration
unit.
Correct Ratio with 100% Std: if the checkbox is activated, the Ratio (and
consequently the INR) is calculated using for the denominator the 100% as it is
obtained from the modification of the calibration curve.
Extrapolated Result
The Extrapolated Result function is automatically executed. It is not visible on any

screen and cannot be modified by the operator. When a result exceeds 150% of the
highest calibration point or is below 60% of the lowest calibration point, it will be
flagged if this option is enabled.
Define as Mandatory: defines which calibration points are mandatory.
The calibration curve can use multiple functions to better interpolate the calibration
standards.
The curve can be divided into three different segments and different functions may be
applied to each of them.
In order to define the segments, it is necessary to define start and end points that
correspond to the standards previously defined. For example Factor Assays use 3
segments to cover the entire range.
The end point of the first segment corresponds to the start point of the second; the end
point of the second segment corresponds to the start point of the third.
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Calibration Curve (X) and (Y) axis functions:
1 X Y
2 1/X 1/Y
3 X2 Y2
4 ln (X) ln /Y)
5 ln [ln (X)] ln [ln (Y)]
6 log (X) log (Y)
7 log [log (X)] log [log (Y)]
8 eX eY
9 10X 10Y
q' checkbox: when checked, it is possible to force the curve to pass through the
desired calibration point standard. If multiple segments have been defined, the q' must
correspond to the interconnection point between two segments (end of one segment -
start of the other segment).
Calibration Curve Checks
A different slope range flag can be attributed to the different calibration curve
segments. Limit is from –99999 to +99999.
If the curve is not divided into segments, only the first line must be filled in.
If the slope is outside of the given range, an error is presented.
A different r2 flag can be attributed to different calibration curve segments. If the r2

value is lower than the given limit presented (format is x.xxxx), a flag is displayed.
If the curve has not been divided into segments, only the first line must be filled in.
Clicking the Confirm button saves the changes; clicking the Cancel button rejects the
changes; in both cases the system goes back to the View Tests screen.

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Parallelism Setup
Selecting the Parallelism setup button allows definition of the checks used for factor
assays with parallelism.
Three dilutions can be performed on each sample. The Dilution Ratio % displays the
dilution percentage used on the system.
The results for the Parallelism can be selected for display and printouts in various units
using the following checkboxes.
l CR %: the system will take the results in seconds for each dilution; convert
these results to % activity by reading it off the calibration curve, then multiply
the results by the dilution factor.
l Ave CR%: the average of the 3 CR% results.
l CV-CR% : the CV of the CR% results.
Slope*: If enabled, a minimum and maximum acceptable value for the slope of the line
based on the 3 dilution values can be entered. Results outside these limits will be
flagged “out of range” and printed in bold.
Intercept*: If enabled, a minimum and maximum acceptable value for the intercept of
the line based on the 3 dilution values can be entered. Results outside these limits will
be flagged “out of range” and “results printed in bold.
R2: If enabled, a minimum and maximum acceptable value for the R2 for the linear
regression line (seconds vs. uncorrected % recovery) based on the 3 dilution values
*To enable and enter values you must be at the Lab Manager level.
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can be entered. Results outside these limits will be flagged “out of range” and results
printed in bold.
Maximum % Variance: Maximum allowable difference between the recalculated

results. This check is determined by comparing dilution result 1 to dilution result 2 and
also comparing dilution result 2 and dilution result 3.
Maximum % CV: Maximum allowable CV% for the recalculated results.
Pressing the Units button will display the available units for parallelism. You can
select four of the units to display and print.
Highlight the desired unit and press the Show in Sample List. A check will be placed
in the left hand column. These units will display on the screen and be printed. Up to 4
units can be selected.
Available units include:
l AVECR% – Average of the recalculated results in %

l CV-CR% – CV of the recalculated results in %
l Slope – Slope of the parallelism line
l INT – Intercept of the parallelism line
l r2 – Correlation of the parallelism line based upon the results versus the dilution
%. This is determined using linear regression analysis.
For Slope and INT you must enter a range to report and flag these units.
Results for factor parallelism can be printed in 3 ways:
1. Sample Report – This report will include 4 of the following selected by the user:
a. Ave CR%
b. CV CR%
c. Slope
d. Int. (Intercept)
e. r2
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2. Cumulative Report – This report will include:
a. 1st dilution , 2nd dilution and 3rd dilution results expressed in seconds (s),
percent (%) and the corrected result in % (CR%). Note: For IL locked tests the
1st dilution is 100%, 2nd dilution is 50% and the 3rd dilution is the 25%.
b. Ave CR%
c. CV CR%
d. Slope
e. Int. (Intercept)
f. r2
3. Parallelism Detail Report – This report will include everything that is included on the
cumulative report for a sample along with a list of the errors associated with the
sample.
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4.3 UTILITY Chapter 4 – Setup and Utility
4.3 UTILITY
The Utility portion of the ACL Elite/Elite Pro software groups all functions related to saving data and
handling the ACL software. For ease of use:
Section 4.3.1 shows the Utility submenu.
Sections 4.3.2 and higher are labeled as the items in this submenu.
4.3.1 UTILITY Submenu

This group of functions can be accessed from the Main screen by pressing the UTILITY
button on the menu bar:
Section 4.3.2 – UPGRADE IL LIBRARY
Section 4.3.3 – BACKUP/RESTORE
Section 4.3.4 – ARCHIVE
Section 4.3.5 – SOFTWARE IDENTIFICATION
Section 4.3.6 – SOFTWARE UPGRADE
l SW Master Upload-Upgrade
l SW Slave Upload-Upgrade
l SW REM Upload-Upgrade
Section 4.3.7 – SAVE LAST ROTOR map
Section 4.3.8 – SAVE TRACE
Section 4.3.9 – TESTS / MATERIALS
l Backup/Upload
Section 4.3.10 – Elite All-In-One Utility
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4.3.2 UTILITY – Upgrade IL Library

This utility is used to upgrade the IL tests library.
Follow the instructions indicated on the screen.
The screen indicates to insert the USB storage device (flash drive) containing the IL Library
Upgrade into a USB port and press continue. See Section 1.4.16 - USB Port for All-In-One
Utility on page 40 for location of the USB port.
At the end of the IL Library Upgrade all modifications are listed on the screen.
The modifications that occurred can also be printed on a report.
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4.3.3 UTILITY – Backup and Restore

Use this screen to backup or restore the system configuration settings and the patient data
stored on the instrument.
WARNINGS:
l To avoid infecting the instrument with a software virus, use only the USB storage
devices (flash drives) supplied with the instrument. These storage devices are
formatted to FAT* standard. The NTFS# standard is not supported.
l You can back up an ACL Elite and restore it to an ACL Elite Pro. However you cannot
backup an ACL Elite Pro and restore it to an ACL ELite.
NOTE: For all Backup and Restore operations, the Elite All-In-One Utility flash drive
is used as the storage device. The Elite All-In-One Utility maintenance programs cannot be
accessed from the ELITE User Interface.
Data is backed up to and restored from the aclbckup file located in the root directory of the
All-In-One Utility USB storage device.
Patient data includes the following:
l Patient demographic information

l Sample IDs
l Patient test results
l Clot curves
Configuration settings includes the following:
l Host
l Printer
l Barcode, internal and external
l Keyboard
l Tests, including QC, default and reflex tests
l Profiles
l Test groups
l Liquids
l Interference table
l Analytical Reference settings
*FAT = File Allocation Table. Format includes FAT, FAT32.

#NTFS = New Technology File System.
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Creating a Backup File
WARNINGS:
l Each time the instrument performs a backup, it creates a backup file named
aclbckup (not case-sensitive, with no extension). If a file named aclbckup
currently exists on the All-In-One Utility USB storage device (root directory),
the instrument will overwrite this file during the backup operation.
l To prevent loss of data, IL recommends moving the previous backup file from
the USB storage device to another permanent storage media or computer, and
to rename the backup file with the date and instrument serial number.
1. Connect the All-In-One Utility storage device to one of the USB ports located on the
front or rear of the instrument.
2. Select Utility > Backup / Restore in the Elite menu bar.
3. Select Backup on the Backup/Restore screen.
4. When the backup operation completes, move the backup file from the All-In-One Utility
USB storage device to another permanent storage device or computer, and append the
date and instrument serial number to the backup filename.
Restoring a Backup File
NOTE: In order to prevent loss of data it is important to understand the following

types of restore options available on the ACL ELITE:
l Configuration Restore – Restores only the instrument configuration settings.

This operation does not restore patient data, and will overwrite the existing
configuration settings on the instrument. The filename of the backup file to
restore must be: aclbckup (no extension).
l Full Restore – Restores both instrument configuration settings and patient
data to the analyzer. This operation overwrites existing configuration settings
and patient results on the instrument. The filename of the backup file to restore
must be: aclbckup (no extension).
1. Copy the backup file you want to restore to the All-In-One Utility USB storage device
and rename it to aclbckup (not case-sensitive, with no extension).
2. Connect the All-In-One Utility storage device with the aclbckup backup file to one of
the USB ports located on the front of the instrument.
3. Select Utility > Backup / Restore in the Elite menu bar.
4. Select the appropriate button on the Backup/Restore screen.
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Backup – Saves both patient data and the instrument configuration settings.
View Backup Date – Displays the date when backup file was created.
Configuration Restore – Restores only the instrument configuration settings. This

operation does not restore patient data, and will overwrite the existing configuration settings
on the instrument. The filename of the backup file to restore must be: aclbckup (no
extension).
Full Restore – Restores both instrument configuration settings and patient data to the
analyzer. This operation overwrites existing configuration settings and patient results on the
instrument. The filename of the backup file to restore must be: aclbckup (no extension).
Storage Media – Displays the USB storage device where the aclbckup backup file resides.
Green check (√) – Closes the screen.
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4.3.4 UTILITY – Archive

This utility is used to copy/transfer data to an external storage media.
Four checkboxes allow selection of the set of data to be copied/transferred.
l PATIENT DATA (Sample Entry date range is selectable)*

l QC DATA (date range, QC liquid, and tests are selectable)
l AR DATA (date range and tests are selectable)
l CAL DATA (tests are selectable)
*Patient data is archived based upon the sample entry date and not the date the sample was
analyzed.
Enabling the checkbox Remove Data After Archive will delete the selected data for
completed samples from the ACL database.
To start the archiving procedure, press the START button.
The file name created by the instrument is composed of two letters and six numerical
characters: the two letters identify the kind of selection made by the operator (CD =
Calibration Data, QC = Quality Control, PD = Patient Data, AR = Analytical Reference), the
numbers correspond to the date when this operation is carried out (ddmmyy). The file
extension is .000. These files are viewable using common programs capable of reading text
data.
The Data archived includes the following: test name, patient name with related
demographics, results, flags and calibration curve parameters, depending on the selection
made.
WARNING: Archived data cannot be restored back to the ACL Elite/Elite Pro. The
data can be viewed using a standard computer capable of viewing text data.
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4.3.5 UTILITY – SOFTWARE – Software Identification

Selecting the Utility button on the menu bar and selecting Software Identification opens
the SW Identification screen.
The following information can be viewed but not edited on this screen:
l MASTER SW IDENTIFICATION
l SLAVE SW IDENTIFICATION
l REM SW IDENTIFICATION (Not available on the ACL Elite)
l IL TEST LIBRARY
The Confirm button leaves the screen and the system goes back to the Main screen.
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4.3.6 UTILITY – SOFTWARE – Software Upload/Upgrade

Follow this procedure to upload/upgrade the instrument software.
1. From the Main screen, log out of the user interface. Select the key icon at the bottom
right side of the screen. Select Yes to the prompt: Are you sure?
2. Power OFF the instrument.
3. Insert the USB drive that contains the updated software release into the USB port
located on the front side of the instrument.
4. Power ON the instrument.
5. After a few minutes, select one of the following options when prompted by the
instrument:
Press Y if you want to install an empty database.
Press N if you want to maintain the current database.
WARNING: Pressing Y will delete all data and user input settings from
the database. IL recommends pressing N
6. When the software upgrade is complete, follow the prompts to power OFF the
instrument and remove the USB drive.
7. You can now power ON the instrument log onto the system.
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4.3.7 UTILITY – Save Rotor Map

Selecting the Utility button on the menu bar and selecting Save Rotor Map, opens the Save
Last Rotor screen shown below.
This utility is used to save the analysis raw data to an external storage media.
The system retains the raw data for all testing performed for the last 31 days.
The user can type the file name and select the file format by checking the appropriate
checkbox.
DAT files are only compatible for use with the Windows Research Program.
NOTE: The DAT file is only available if one test (up to 19 samples maximum) is
executed on the rotor. If more tests are executed on the same rotor the DAT file option can
not be used.
NOTE: IL recommends saving data to TXT files. TXT files are ASCII files
compatible with text editors and spreadsheets (i.e., MS-Word or MS-Excel).
A maximum of 8 characters can be used for file name. Do not enter the filename extension
when entering a file name. The extension will automatically be added depending upon the
checkbox selected (TXT or DAT).
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The file name format is: RMdxxhyy
l xx = day of the month the run was performed

l yy = hour of the day the run was performed*
Insert the media to save the file to and press Continue.
The Cancel button will exit to the main screen.
*If multiple runs are performed within the hour selected, all runs will be saved. A run time stamp separates the various
run data. The end of run time is used for the time stamp.
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4.3.8 UTILITY – Save Trace File

This utility is used to save all the operations performed by the instrument.
This utility is used for troubleshooting purposes in case a software defect may appear (i.e.
database error, system lockups, etc.).
The system saves up to 31 trace files, one for each day for the past 31 days
Type the file name using the following format: Trace_XX.txt. Using a file name already
saved will overwrite the previous file.
XX is the day of the month you want to save the trace on.
For example, to save the trace for the 10th day type: Trace_10.txt
In case the system may need to be rebooted, the trace file can still be performed after
restarting the analyzer.
Select available storage media for your system
NOTE: The trace file will only monitor internal software or database errors. A trace
file does not include information about abnormal results.
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4.3.9 UTILITY – Test/Material – Backup and Upload

This feature allows single material and test definitions to be saved and uploaded.
Selecting the Backup option from the menu displays the following screen:
The Test/Material drop down box allows you to select a material ID, Test ID or Test Group
to backup.
The Test/Material list below the selection will then display either the material IDs, Tests or
Test Group based upon the above selection.
In the Filename box enter the filename (8 characters maximum with no extension needed)
Select desired storage media available for your system
Press the Confirm button to start the backup or the Cancel button to exit the screen.
Selecting the Upload option from the menu displays the following Upload Test/Material
screen.
NOTE: Only user defined Materials, Tests and Test Groups can be backed up.
Users cannot backup IL defined Materials, Tests and Test Groups.
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Select Test/Material from the drop down box.
A check in the Overwrite box will cause the new information uploaded to replace the
information currently defined in the system.
Enter the Filename of the Material or test to be uploaded (8 characters maximum with no
extension needed).
Select desired storage media available for your system
Press the Confirm button to start the backup or the Cancel button to exit the screen.
NOTE: After uploading Test Groups verify the “Max Sample Value” is set correctly
for the uploaded test groups in the Test Group Definition screen.
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4.3.10 Elite All-In-One Utility

Procedures in this section:
l Comparison: Elite All-In-One Utility versus Elite UI

l Using the DOS All-In-One Utility
l A. Perform Hard Drive Maintenance
l B. Perform Database Backup
l C. Perform Database Restore
l D. Perform Rotor Map Extraction
l E. Perform Trace (Log) File Extraction
l F. EXIT to DOS prompt
The ACL Elite/Elite ProAll-In-One Utility is a set of DOS-based programs contained on a

USB flash drive, an accessory that comes with the ACL Elite/Elite Pro instrument.
The All-In-One Utility is completely standalone, and separate from the Elite application.
Comparison: Elite All-In-One Utility versus Elite UI
Variations of the operations contained in the Elite All-In-One Utility can be performed through
the Elite user interface. The variations are described in the following table:
Operation Elite All-In-One Utility Elite UI

Hard Drive Checks and repairs file system errors None.
Maintenance on the hard disk, and then defragments
the disk.
Database Performs a full database backup to file Performs a full database backup to
Backup database.zip located in the DB folder file aclbckup located on the All-In-
on the All-In-One Utility flash drive. One Utility flash drive (root directory).
See Section 4.3.3 - UTILITY –
Backup and Restore on page 267.
Database Restores the full database from the Option to restore the full database or
Restore database.zip file located in the DB the configuration settings (only) from
folder on the All-In-One Utility flash the aclbckup file located on the All-
drive. In-One Utility flash drive (root
directory).
Rotor Map Backs up all the rotor map files stored Backs up a single, user-selected
Extraction on the system to file RotorMap.zip in rotor map file to a .dat1 or .txt file. See
the RotorMap folder on the All-In-One Section 4.3.7 - UTILITY – Save Rotor
Utility flash drive. Map on page 273.
Trace (Log) Backs up all the trace (log) files stored Backs up a single, user-selected
File on the system to file LogFile.zip in the trace (log) file on the instrument to a
Extraction Log folder on the All-In-One Utility flash .txt file.
drive.
Exit to DOS Opens the DOS command line. None.
prompt
1.dat file = File that contains data in text or binary format.
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NOTE: IL recommends saving data to TXT files. TXT files are ASCII files
compatible with text editors and spreadsheets (i.e., MS-Word or MS-Excel).
Using the DOS All-In-One Utility
1. Exit the Elite application and power off the system.

2. Plug the All-In-One Utility flash drive into one of the USB ports. Make sure there are no
other flash drives connected to the instrument.
3. Power on the Elite system.
4. After some initial DOS screens appear, the following DOS Utilities List screen
displays:
Elite All-In-One Utility Functions (V01.00):
A. Perform Hard Drive Maintenance

B. Perform Database Backup
C. Perform Database Restore
D. Perform Rotor Map Extraction
E. Perform Trace (Log) File Extraction
F. EXIT to DOS prompt
5. Refer to one of the following sections for further instructions.
A. Perform Hard Drive Maintenance
This utility checks for and repairs file system errors on the hard disk, and then defragments
the hard disk.
1. Select A. Perform Hard Drive Maintenance from the DOS Utilities List screen.
2. No further action is required.
3. When this maintenance is finished, a message states: Hard Drive Maintenance is
completed.
4. After completion, the DOS Utilities List screen reappears.
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B. Perform Database Backup
This utility performs a full database backup to file database.zip in the DB folder on the All-In-
One Utility flash drive. This action overwrites the existing database.zip file in the DB folder,
if it exists.
1. To prevent loss of data, rename any existing database.zip in the DB folder, or copy it
to another secure location.
2. Select B. Perform Database Backup from the DOS Utilities List screen.
3. Follow the prompts.
4. The system notifies you when backup is complete.
C. Perform Database Restore
This utility restores the full database from the database.zip file that resides in the DB folder
on the All-In-One Utility flash drive. This action overwrites all the database files on the Elite
system.
1. Select C. Perform Database Restore from the DOS Utilities List screen.
3. The system notifies you when the full restore is complete.
NOTE: To restore only the instrument configuration settings (omit patient data) see
Section 4.3.3 - UTILITY – Backup and Restore on page 267.
D. Perform Rotor Map Extraction
This utility copies all the rotor map files stored on the system to file RotorMap.zip and in the
RotorMap folder on the All-In-One Utility flash drive. This action overwrites the existing
RotorMap.zip file in the RotorMap folder, if it exists.
1. Select D. Perform Rotor Map Extraction from the DOS Utilities List screen.
3. The system notifies you when all the rotor map files have been extracted.
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E. Perform Trace (Log) File Extraction
This utility backs up all the trace (log) files stored on the system to file LogFile.zip in the Log
folder on the All-In-One Utility flash drive. This action overwrites the existing LogFile.zip file
in the Log folder, if it exists.
1. Select E. Perform Trace (Log) File Extraction from the DOS Utilities List screen.
3. The system notifies you when all the trace (log) files have been extracted.
F. EXIT to DOS prompt
This utility exits the Elite All-In-One Utility.
1. Select F. EXIT to DOS prompt from the DOS Utilities List screen.
2. The DOS screen displays the following information that pertains to the DOS command
line:
l At this time you can execute DOS (FreeDOS) commands.

l The C: drive refers to the USB drive.
l The D: drive refers to the Elite system hard drive.
3. When you are finished entering DOS commands, power off the instrument.
4. After the instrument shuts down, remove the All-In-One Utility flash drive.
5. Before rebooting the instrument remove the All-In-One Utility flash drive, if necessary.
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Chapter 5 - Diagnostics and Maintenance

5.1 The DIAGNOSTIC Submenu 283
5.1.1 Priming 284
5.1.2 Cleaning 286
5.1.3 Maintenance 289
5.1.4 Temperature Control 291
5.1.5 Needles Position 292
5.1.6 Session Error History 293
5.1.7 File Error History 294
5.1.8 Logbook 295
5.1.9 Service (dimmed) 296
5.2 MAINTENANCE PROCEDURES 297
5.2.1 Introduction 297
5.2.2 Daily Preventive Maintenance 298
5.2.3 Weekly Preventive Maintenance 301
5.2.4 Biweekly Preventive Maintenance 303
5.2.5 Monthly Preventive Maintenance 304
5.2.6 As Needed Maintenance 305
5.2.7 Decontamination Procedure 312
5.3 Maintenance Table 314
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5.0 Introduction Chapter 5 – Diagnostics and Maintenance
5.0 Introduction
The purpose of this section is to familiarize the ACL ELITE/ELITE PRO user with the software-driven
diagnostics procedures that are performed automatically by the system at the operator’s request.
Through the ACL diagnostics programs, the user can access the error history and logbooks of the
system as well as perform checks on key hardware items.
In addition, this section contains all necessary information to perform Preventive Maintenance
procedures, and thus keep the ACL ELITE/ELITE PRO in top functional condition.
5.1 The DIAGNOSTIC Submenu

The Diagnostic submenu can be accessed from the Main screen by pressing the DIAGNOSTIC button
on the menu bar:
l PRIMING
l CLEANING
l MAINTENANCE
l TEMPERATURE CONTROL
l NEEDLES POSITION
l SESSION ERROR HISTORY
l FILE ERROR HISTORY
l LOGBOOK
l SERVICE (dimmed). Only accessible to Service
The following sections contain details about each of the items in the Diagnostic submenu.
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5.1 The DIAGNOSTIC Submenu Chapter 5 – Diagnostics and Maintenance
5.1.1 Priming
INSTRUCTIONS to perform a PRIMING CYCLE

(from the READY status)
1. Click the Diagnostic button on the Main menu bar.

2. Select Priming from the Diagnostic menu.
The ACL starts a priming cycle, washing needles and pistons.
Duration: approximately 50 seconds.
The Priming feature of the Diagnostics menu allows the operator to perform an automatic
priming cycle on the ACL in order to wash the loading module’s pistons and needles. This
priming cycle can only be activated if the system is in the Ready mode.
The priming cycle must be performed at the following times:
l beginning of a working day or a shift

l end of a working day or a shift
l when the ACL has been OFF for a prolonged period of time
l after replacement of the Wash-Reference Emulsion bottle
In order to perform a priming cycle, click the Diagnostic button on the Main menu bar and
select the Priming option from the Diagnostic submenu to open the Priming screen:
The window in this screen displays a bar that moves during the cycle activation to show the
elapsed time, for a total of approximately 50 seconds.
The two piston dilutors will move up and down priming the tubing line with an approximate
consumption of 6 mL of Wash-R Emulsion (20 strokes per single piston dilutor – total of 40
strokes; each single stroke of 0.15 mL).
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l Stop followed by a confirmation window Do you really want to stop the current
operation? OK confirms the choice and Cancel cancels the operation.
NOTE: When the instrument is in standby, an automatic priming cycle is performed

every 30 minutes. The consumption of Wash-R Emulsion is approximately 0.9 mL (3 strokes
per single piston dilutor – total of 6 strokes; each single stroke of 0.15 mL).
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5.1.2 Cleaning
INSTRUCTIONS to perform a CLEANING CYCLE

(from the READY status)
Before starting the cleaning cycle, prepare the IL Cleaning Agent-Hypochlorite P/N
0009832700 diluted 1:8 (1 part cleaning agent +7 parts water) and place in reagent position
R6 (for the reagent line) and reagent position R7 (for the sample line). This material is also
referred to as Dilute Clean B.
1. Click the Diagnostic button on the Main menu bar.

2. Select Cleaning from the Diagnostic menu
The ACL starts a cleaning cycle for the reagent and sample needles.
Duration: dependent upon the cycle configuration.
The Cleaning feature of the Diagnostic menu allows the operator to perform an automatic
deep cleaning of the ACL needles using selected cleaning solutions, followed by rinse
cycles using the Wash-Reference Emulsion. Before starting the cycle, the cleaning
solutions must be placed in reagent position R6 for the reagent line and reagent position R7
for the sample line.
NOTE: The recommended cleaning solution is freshly prepared IL Cleaning Agent

P/N 0009832700 Hypochlorite diluted 1:8 (1 part cleaning agent +7 parts water). This
material is often referred to as Dilute Clean B.
In order to perform a cleaning cycle, click the Diagnostic button on the Main menu bar and
select the Cleaning option from the Diagnostic submenu to open the Cleaning screen shown
below. Note: This procedure may only be started when the ACL is in the READY status.
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In this screen the operator may define the configuration of the cleaning operation:
l VOLUME - volume in microliters of cleaning solutions (positions R6 and R7) to be

used in each single cycle to clean the reagent and the sample lines: default is 130
microliters. Minimum volume is 0 and maximum volume is 130 microliters.
Recommended setting is 130ul.
l CYCLES No. - the number of cleaning cycles using the cleaning solutions (same for
both lines); default is 3 cycle. Range for number of cycles performed is 0 to 5.
Selecting 0 no cycles will be executed. Recommended setting is 3 cycles
l WASHING AT COMPLETION - number of rinse cycles (defined for each line) using
Wash-Reference Emulsion; default is 5 cycles. Range for number of washes
performed is 0 to 5. Selecting 0 no cycles will be executed. Recommended setting is 5
cycles.
At a minimum either the sample, reagent or both lines need to be defined prior to pressing
“Start” for the cleaning cycle to be performed.
CLEANING PROCEDURE
Materials needed:
l 4 glass vials (10 mL volume; diameter 23 mm)

l 16 mL of Cleaning Agent P/N 0009832700 (diluted 1:8)*
l 16 mL of Factor Diluent (P/N 0009757600)
*IL Cleaning Agent - Hypochlorite (P/N 0009832700) diluted 1:8 (1 part Cleaning Agent plus 7 parts Water)
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Dilute the Cleaning Agent. Place 8ml of the freshly prepared solution in position R6 and R7
using 2 of the 10mL glass vials indicated above, Press Start
After the cycle is complete with Cleaning solution, replace the vials with a second set filled
with 8mL of Factor Diluent and Start the clean cycle a second time.
After the cleaning cycle is complete with Factor Diluent, perform a system priming cycle.
Repeat priming two times.
When the cleaning cycle executes a window opens displaying a bar that moves to show the
elapsed time of the procedure.
If the liquids are not in the appropriate positions, the cycle will automatically abort and an
error window will appear.
Clicking the Cancel button leaves the screen.
l Stop stops the cleaning procedure.

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5.1.3 Maintenance
The Maintenance subsection of the Diagnostic menu allows the user to access and record
dates related to the performance of specific maintenance operations. This is meant to keep
track of the frequency with which the instrument is maintained and for troubleshooting
purposes.
For information about Maintenance Procedures and recommended frequency guidelines,

refer to Section 5.2 - MAINTENANCE PROCEDURES on page 297.
To open the Maintenance screen, click the Diagnostic button on the Main menu bar and
select the Maintenance option from the Diagnostic submenu:
The large window that occupies most of the screen displays a list of the suggested
maintenance operations along with their recommended frequency in days.
Operation Days (Frequency)

CLEANING CYCLE 1
RINSE WASTE RESERVOIR 7
CLEAN OPTICAL SENSORS AND WINDOWS 14
CLEAN AIR FILTER 28
Next to the Maintenance/Operation column there are three other columns containing the
following information relative to each procedure:
LAST DATE: the date does not need to be typed in after performance of a specific operation.
clicking the Date button causes today’s date to appear automatically. Items displayed in red
indicate that the maintenance is past the listed frequency and is overdue. Maintenance is
tracked by date and will become overdue when the date changes after the indicated number
of days. If a run is processed with maintenance overdue, the Session Error History button
will illuminate to alert the operator, and the results will be flagged. The alert icon will also be
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illuminated when maintenance is due. The Clear button clears the date which disables
maintenance tracking.
DAYS: This number cannot be edited; it is the IL-recommended frequency in days with
which this procedure should be performed.
NOTE icon opens the Insert Notes screen for entry of free text (26 characters maximum can
be printed).
Clicking the Confirm button saves changes in the Notes screen. clicking the Cancel
button rejects the changes; in both cases the system goes back to the Main screen.
Clicking the Printer button, followed by a confirmation window Do you really want to print?
Yes/No, prints the maintenance list.

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5.1.4 Temperature Control

Through the Temperature Control option of the Diagnostic submenu the operator is able to
check if the temperatures of the system are within their acceptable ranges. This is a real-
time update screen and the display will flicker as the temperatures are constantly updating.
Clicking the Diagnostic button on the Main menu bar and selecting Temperature Control
opens the Temperature Control screen:
The window in this screen contains 3 columns:
l DEVICE – Indicates the areas that are checked.

l NORMAL RANGE (°C) – Indicates the acceptable range for each device:
o Rotor holder – 38-39 °C (100.4 - 102.2 °F)
o Peltier – 10-16 °C (50-60.8 °F)
o Rotor transport* – 34 40 °C (93.2-104.0 °F)
o Rotor stack – 34-40 °C (93.2-104.0 °F)
l TEMPERATURE – °C or °F according to the selected Units in Setup. indicates the

actual temperature in the area.
*Used to monitor Base of Rotor Stack in ACL ELITE.
Yes/No, prints the temperature list report.
Clicking the Confirm button exits the screen and the system goes back to the Main screen.
NOTE: The system will automatically shutdown if the internal Temperature exceeds
75 °C. This automatic shutdown error will not be recorded in the File Error History.

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5.1.5 Needles Position

The Needles Position option of the Diagnostic submenu is used to center the needles as
needed or after changing or removing the needle block.
The needle position has to be verified with the rotor cover open, therefore press the
Open/Close Cover button to open the Rotor cover. Install alignment tool.
Clicking the Diagnostic button on the Main menu bar and selecting Needles Position
causes a very quick self-initialization. After a reminder to open the cover, the arm moves
over the rotor holder area.
The Raise/Lower Arm button will raise/lower the arm over the rotor holder area.
The Rotate button will move the rotor holder 90° (1/4 turn).
If the needles position procedure has to be carried out, the needle adjustment tool must be
placed on the rotor holder. For details on this operation, refer to Positioning the Needle on
page 308.
Remember to remove the tool at the end of the procedure.
Clicking the Stop button, followed by a confirmation window Do you really want to stop the
current operation? OK the system goes back to the main screen; Cancel will cancel the
operation.
In order to verify the needle centering with the rotor cover closed, repeat the operation
described in Section 5.2.6 - As Needed Maintenance on page 305.

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5.1.6 Session Error History

Any error or alarm occurring during an analytical session is recorded in the system.
Up to 200 errors can be stored in the error file. The file is handled automatically using the first
in first out approach.
If the user wants to view the errors and alarms while the session is active, clicking the
Diagnostic button on the Main menu bar and then selecting the Session Error History
option will open the Session Error History screen:
The window in this screen contains descriptions of all the errors and warnings that occurred
during the current session along with the date and time. The latest error or warning appears
at the top of the list.
Yes/No, prints the error list.
As soon as a new session starts, the previous session errors are automatically erased and
the permanent errors are transferred to the File Error History database.

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NOTE: If the language on the system is changed entries in the log prior to the
change will remain in the original language. New entries in the log after the change will be in
the new language
5.1.7 File Error History

The ACL ELITE/ELITE PRO software records, stores and displays all the errors and
warnings that occurred since the system was first turned on.
Up to 100 errors can be stored in the error file. The file is handled automatically using the first
in first out approach.
The error history may be viewed in the Error File History screen (shown below), which opens
by first clicking the Diagnostic button on the Main menu bar and then selecting File Error
History from the Diagnostic submenu.
This screen displays error code number and descriptions of the errors/ warnings along with
the date and time when they occurred. The latest error or warning appears at the top of the
list.
Yes/No, prints the error list.
Clicking the Clear button followed by a confirmation window deletes all the messages in the
file. Available at the IL-Service Level only.
the new language
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5.1.8 Logbook
The ACL ELITE/ELITE PRO software records, stores and displays information on all the
actions performed on the system since it was first turned on.
Actions traced in the Logbook are all the conditions in which an operator decision is taken.
for example, a Liquid entry, a change in assigned value, a modification in the setup and/or in
the configuration, etc. are recorded.
Up to 200 messages can be stored in the logbook file. The file is handled automatically using
the first in first out approach.
The logbook may be viewed in the Logbook screen, which opens by first clicking the
Diagnostic button on the Main menu bar and then selecting Logbook from the Diagnostic
submenu.
This screen displays descriptions of all the actions and the login level along with the date and
time when they occurred. The latest action appears at the top of the list.
l DATE/TIME – Date and time when the action occurred

l LEVEL – Password level
l USER NAME – User
l ACTION – Description of the action performed
l NOTE – User editable field for comments
Clicking the Notes button the operator is allowed to enter comments for each logbook
message. (26 characters maximum)
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Yes/No, prints the logbook records.
the new language

5.1.9 Service (dimmed)

This section is not accessible at the user level.
The procedures listed in the Service section of the software are to be performed only by
trained IL Service Engineers and therefore are not included in this Operator’s Manual.
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5.2 MAINTENANCE PROCEDURES Chapter 5 – Diagnostics and Maintenance
5.2 MAINTENANCE PROCEDURES

5.2.1 Introduction
The ACL is a precision instrument. In order to keep it in functional condition IL recommends
that a trained operator, at the minimum frequency specified, carry out the following
operations.
WARNINGS:
l The instrument should be decontaminated before performing any maintenance

procedure and/or service. Section 5.2.7 - Decontamination Procedure on page 312.
l While performing maintenance procedures, the operator should wear protective
clothing and gloves to prevent direct contact with items potentially contaminated with
blood. Hands should also be washed immediately after gloves are removed and before
leaving the laboratory. Please refer to local and state regulations for disposal of
potentially hazardous material.
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5.2.2 Daily Preventive Maintenance

The following checks and procedures should be performed on the ACL before starting the
daily testing or once per shift.
NOTE: IMPORTANT. The ACL will perform optimally if it is left ON at all times. The
complex electronic circuit is most reliable if the number of ON/OFF cycles is kept to a
minimum. Leaving the instrument in the Standby mode guarantees minimum power
consumption and maximum readiness for operation at any time. For additional information
refer Section 1.5.1 - Standby Status on page 41.
Check Wash-Reference Emulsion
The Wash Reference Emulsion bottle is fitted with a liquid level sensor that, reports in real
time the amount of solution left in the bottle (mL). This sensor also produces a warning to
alert the operator when the solution in the bottle is insufficient for additional testing.
If the sensor is switched off in the Setup Configuration option, the operator must check that
the level of liquid in the bottle is at least 1.5 to 2 cm from the bottom.
If the level is lower, replace the Wash-Reference Emulsion bottle with a full one and perform
the priming procedure before using the system for testing. Refer to Waste tube on page 53.
NOTE: At a level of 2 cm, there is enough solution to perform testing in one or two
more rotors (taking into account the bottle dead volume).
Check Liquid Waste Container
Check the level of the liquid waste container and empty if necessary. Also verify visually
that the waste flows freely into the container. For correct installation, please refer to Chapter
2 - Installation on page 47.
WARNING: The liquid waste of the instrument should be considered a source of

contamination and should therefore be discarded following the laboratory’s waste
procedures, in compliance with the local regulations. Please refer to local and state
regulations for disposal of potentially hazardous material.
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Needle Cleaning Procedure
1. Prepare fresh IL Cleaning Agent-Hypochlorite (diluted 1:8).

2. Place 8 mL in 2 empty 10mL vials.
3. Place the filled vials in reagent positions R6 and R7.
4. For more detailed information please refer to Section 5.1.2 - Cleaning on page 286.
5. Click the Diagnostic button on the Main menu bar and select the Cleaning option of
the Diagnostic submenu to display the Cleaning screen.
6. In this screen the operator defines the configuration of the cleaning operation,
according to the needs of the instrument. Refer to Section 5.1.2 - Cleaning on page
286.
7. Clicking the Start button starts the cleaning cycle and opens a window displaying a bar
that moves to show the elapsed time of the procedure.
8. Repeat this procedure substituting the dilute Clean B with Factor Diluent.
9. At the completion of the Cleaning cycles perform a system Priming. Repeat priming
two times.
Perform Priming Procedure
The priming procedure is used to flush the liquid flow path of the system, thus ensuring
removal of sample or reagent residues that may accumulate during sample analysis. The
priming procedure is an effective way to maintain the ACL’s needle assembly and the rinse
reservoir in good working condition.
The ACL automatic priming procedure should be performed at the beginning of each day/shift
and at the end of each working day.
Click the Diagnostic button on the Main Menu bar and select the Priming option from the
Diagnostic submenu. The Priming screen opens with a message “Priming in progress” and
priming begins immediately. When the dispenser system finishes flushing the sample and
reagent needles, the instrument returns automatically to the Main menu. For additional
details, refer to Section 5.1.1 - Priming on page 284.
Important: While the priming cycle is in progress, the operator should visually inspect three
items:
l The number of bubbles in the dilutor chamber is reduced to a minimum. If bubbles are
still present, pinch the chamber outlet tubes while the piston is descending and release
before the piston reaches the bottom dead center. Repeat the priming cycle as needed
until all bubbles are gone.
l There are no blockages or leaks in the liquid flow path and the liquid is flowing
smoothly from reservoir to dilutors and from dilutors to needles.
l There is free flow of the liquid waste from the washing chamber to the instrument outlet
tube and then to the waste container.
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Empty Rotor Waste
1. To access the container with the used rotors, open the small door on the front of the
analyzer body, to the right of the reagent area. Grab the handle of the container and pull
outwards to remove it.
2. Properly discard the used rotors found in the rotor waste container.
Location of Rotor Waste and Rotor Waste Container
WARNING:
l Rotors contain potentially contaminated materials; discard and incinerate used rotors
according to the proper local regulations.
l Do not return a partially used rotor to the rotor preheater.
NOTE: A partially used rotor may be left in the rotor housing. A 24-hour
timer is set when a new rotor is introduced. After 24-hours the user will be prompted
to enter the open cuvette positions for subsequent runs in the rotor. In order to
remove a rotor from the rotor holder, press the Open/Close icon to open the rotor-holder
cover and manually retrieve the rotor, making sure not to spill its contents while transporting
it to the waste container. Close the rotor holder cover by pressing the Open/Close icon on
the screen. A partially used rotor may be placed back on the rotor housing to use the
remaining cuvettes. Prior to placing a rotor back on the analyzer, the last used cuvette in the
rotor should be filled with 200ul of Wash –R.
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5.2.3 Weekly Preventive Maintenance

Weekly preventive maintenance for the ACL consists of cleaning all the key instrument
areas that normally come in contact with sample and reagents and therefore accumulate
residues that will, if allowed to build up, impair the instrument functionality and affect test
results.
The parts to clean are:
l General instrument external surface cleaning, includes autosampler and rotor holder
area.
l The rinse reservoir.
General Instrument External Surfaces Cleaning Procedure
Wipe down all exposed surfaces of the analyzer body, the inside of the sample tray
compartment and the new rotor compartment (excluding the analysis area) using a cloth
moistened with 0.1 N Hydrochloric Acid (HCl) solution (IL Cleaning Solution P/N
0009831700). Rinse using a cloth moistened with distilled water. Wipe dry.
Cleaning of Sample Spillage
In case of sample spillage in the auto-sampler or in the analysis compartment, it may be

necessary to clean the cup/tube sensor and the two optical paths in the analysis area.
1. Cup/Tube sensor inside the sample tray area: Wipe the two vertical faces of the
sensor using a clean cloth or cotton tip applicator soaked in a 0.1 N HCl solution. Spills
in the rotor compartment should be clean using dilute (1:8) cleaning agent P/N
0009832700. Follow with distilled water and dry with a clean cloth or cotton tip
applicator.
2. Optical paths in the analysis area: Refer to Section 5.2.4 - Biweekly Preventive
Maintenance on page 303.
WARNING: If you suspect that infectious samples have been tested on the system,
refer to Section 5.2.7 - Decontamination Procedure on page 312 and proceed with the
appropriate decontamination procedure, if needed.
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Rinse Reservoir Cleaning Procedure
Follow the steps below to clean the rinse reservoir:
1. Click the Diagnostic button on the Main menu bar and select Needles Position. This
will cause the needle arm to move to the top of the rotor holder.
2. Remove the rinse reservoir, wash it thoroughly with a 0.1N HCl solution (Clean A) and
rinse it with distilled water.
NOTE: For additional cleaning/decontamination you may substitute 0.625%

Bleach solution - HemosIL® Cleaning Agent PN 0009832700 (Clean B) diluted 1:8 with
distilled water in place of the 0.1 N HCl solution. Rinse well with distilled water to
remove all residual cleaning material.
3. Return the rinse reservoir to its position. Perform a needle alignment procedure. Refer
to Section 5.1.5 - Needles Position on page 292. After the alignment check, press the
STOP icon and confirm with OK. The needle arm goes back to the home position into
the waste rinse reservoir. The instrument returns to the Ready State.
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5.2.4 Biweekly Preventive Maintenance

The rotor holder and the optical path components found in the analysis area must be cleaned
every two weeks under normal instrument use.
Reboot the analyzer
1. Log off the system.

2. Turn the power off.
3. Wait 15 seconds then turn the power back on.
4. Allow the system to perform the normal boot up.
Rotor Holder and Optical Path Cleaning Procedure
1. Press the Open/Close Rotor icon to open the rotor holder cover.
2. Proceed as follows using the figure below as a reference:
Cleaning the Optical Path
3. Using a cotton tip applicator moistened with distilled water, clean all 20 holes in the
rotor holder and the surface of the channel sensor. Use a clean, dry cotton tip
applicator to remove all moisture from these areas. The cotton swab should not be
pushed down below the rotor holder assembly
4. Clean the LED sensor surface (under the rotor holder) and the LED fiber optic surface
using a cotton tip applicator moistened with distilled water. Use a clean, dry cotton tip
applicator to dry these areas well.
5. Using a cotton tip applicator moistened with distilled water, clean the halogen lamp
fiber outlet below the rotor holder and the chromogenic channel sensor filter surface
mounted in the rotor holder cover, as seen in the figure above.
6. Use a clean, dry cotton tip applicator to dry the areas after cleaning.
7. Press the Open/Close Rotor icon to close the rotor holder cover.
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5.2.5 Monthly Preventive Maintenance

Checking and Cleaning the Air Filter
1. In order to clean the analyzer air filter, it must first be removed from its location on the
right side of the instrument. Insert a finger in the holder slot; pull up and slide the filter
out (see figure below).
Removing the Fan Filter
2. Check the filter. if it is dirty or blocked, clean it with compressed air or by washing it in
water and blowing it dry.
3. If the filter appears damaged, it should be replaced.
4. Do not place a wet filter back into the analyzer position.
5. Insert the clean or new filter back in its holder.
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5.2.6 As Needed Maintenance

Procedures in this section:
l Replacing the Wash-R Bottle

l Waste Line Cleaning Procedure
l Replacing the Needle
l Positioning the Needle
l Replacing the Halogen Lamp
l Bleaching the Waste Line
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Replacing the Wash-R Bottle
A sensor is placed inside the one-liter bottle of Wash-Reference Emulsion when it is

installed on the instrument. When the level of Wash-R emulsion falls below acceptable
values, the instrument alerts you to replace the Wash-R bottle.
To install or replace the Wash-R Emulsion bottle:
1. Unscrew the cap from a new bottle of Wash-R. Remove the inner seal. Then screw
the cap back onto the full bottle and set it aside.
2. Lift to remove the Wash-R sensor/cap from the empty bottle while it is still installed on
the instrument. Pull the cap straight up. Do not twist it off. To avoid
contamination, do not place the sensor/cap on top of the instrument.
3. Lift the empty bottle up and out of the instrument.
4. Place the full bottle of Wash-R onto the instrument with the cap oriented to the left
side.
5. Unscrew and remove the cap from the full bottle of Wash-R.
6. Place the sensor into the full bottle of Wash-R and secure the cap on top of the bottle.
7. Verify that neither the tubing nor the cable is crimped.
8. Prime instrument and ensure there are no bubbles in diluter syringes. See Section
5.1.1 - Priming on page 284.
Positioning the Wash-Reference emulsion bottle
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Waste Line Cleaning Procedure
This procedure is performed to prevent formation of clots or to clean any possible blockages
(due to clotting) in the waste line. The frequency with which this procedure should be done
depends on the daily workload; once a day may be necessary for heavy sample loads and
less frequently for lighter loads.
Materials required:
l 20 mL plastic syringe
l 20 cm PVC tube, 4 mm ID, 6 mm OD (This tube dimensions must be such that it will fit
onto the syringe on one end and into the waste line at the other end.)
l 20 mL distilled water
l Container for the distilled water
Preparation
Remove the needle from the plastic syringe (if necessary) and fit the PVC tube on the end on
the syringe. Fill the syringe with distilled water.
Procedure
1. Click the Diagnostic button on the Main menu bar and select Needles Position for
the Diagnostic submenu. This will cause the arm to move to the top of the rotor holder.
2. Remove the rinse reservoir and clean it if necessary. Refer to Section 5.2.3 - Weekly
Preventive Maintenance on page 301.
3. Insert the free end of the PVC tube into the waste line (hole in the rinse reservoir area).
Carefully inject the distilled water into the waste line and check that the liquid flows
from the external waste line of the instrument to the waste container.
4. Repeat the procedure several times to ensure removal of any potential blockage.
5. Replace the rinse reservoir. Click the Stop icon and confirm it with OK; the arm goes
back to waste position and ACL returns to the Ready Status.
Replacing the Needle
The needle is considered an expendable item that will require periodic replacement to assure
quality results
1. Press the Open/Close Rotor Cover icon to open the rotor cover.
2. Click the Diagnostic button on the Main menu bar and select Needles Position from
the Diagnostic submenu. The needle arm moves over the rotor holder.
3. Label the two tubes that connect to the needle assembly (i.e. top and bottom).
4. Loosen the white knob on the back of the needle, disconnect the tubing, disconnect
the sensor cable and remove the needle block.
5. Insert the new needle block, connect the sensor cable, connect the two tubes and
position the block higher than the arm top surface.
6. Follow the needle positioning procedure as described in the next section.
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Positioning the Needle
The procedure to reposition or adjust the ACL sampling/dispensing needles is necessary in

the following situations:
l Periodic alignment check

l After having dismantled the needles block for cleaning or decontamination of the
needles
l After having changed the needles block
Procedure
1. In order to verify needle centering with the cover open, press the Open/Close Rotor
Cover icon to open the rotor cover.
2. Insert the “needle alignment tool” (a special tool in the shipping kit) into the rotor holder
with side A facing up. Refer to the figures on following pages.
the Diagnostic submenu. An Open Cover? Yes/No screen will display if you did not
open the cover beforehand. Click Yes to open the cover. The needle arm moves over
the rotor holder.
4. Loosen the white knob on the back of the needle arm and move the needle block (or
insert a new one) so that its top surface is higher than the arm top surface.
5. Click the Raise/Lower Arm button to lower the arm to the rotor holder over the tool.
6. Adjust the height of the needle block so that the needles touch the upper surface of the
tool and confirm that the two needles match the two white reference dots on the tool
surface.
7. Tighten the needles using the white arm knob, making sure that the position has not
changed after the tightening.
8. Click the Raise/Lower Arm button to raise the arm.
9. Remove the tool and insert an ACL rotor; manually push the center of the rotor snap to
fit the rotor properly.
10. Click the Raise/Lower Arm button to lower the arm and verify that the needles enter
the rotor holes (cuvette position 1) without touching the edges of the holes.
11. Click the Raise/Lower Arm button to raise the arm.
12. Click the Rotate button to move the rotor to the next position (cuvette 6 of the rotor)
and repeat the same procedure (as for cuvette position 1).
13. Repeat as above for cuvettes position number 11, 16 and 1.
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14. If the centering of the needles is correct, as shown in examples A and B of the Needle
Alignment figure, proceed to the next step. If the needles are not centered, correct the
position.
15. Remove the rotor manually.
16. Click the Stop icon and confirm it with OK.
17. The arm returns to the waste rinse reservoir position.
18. In order to verify the needle centering with the cover closed, click the Diagnostic
button and select again Needles Position.
19. The needles arm moves over the rotor holder.
20. Verify that needles are contained in the rotor cover holes.
21. Press STOP and confirm and the arm returns to the waste reservoir position.
22. Perform a Priming cycle. See Section 5.1.1 - Priming on page 284.
NOTE: The alignment of the needles may not be identical for the four tested rotor
cuvettes. If a needle does not enter the rotor port/ports or if the sample needle is positioned
to the right of the center in any one cuvette (as in example C of the figure below), the needles
must be re-adjusted in the cuvette where it is furthest to the right, and the entire procedure
must be repeated.
Needle Positioning Tool: Top view
Needle Positioning Tool: Side view
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Needles Alignment
Replacing the Halogen Lamp
This operation should be done by an IL Representative Service Engineer.
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Bleaching the Waste Line
Material needed:
l 20 mL syringe with tubing attached

l Tubing – 20 cm PVC, 4 mm ID, 6 mm OD
l 20 mL of freshly prepared 0.625% Bleach solution - HemosIL® Cleaning Agent PN
0009832700 diluted 1:8 with distilled water (1 part cleaning agent plus 7 parts distilled
water). (Clean B)
l Approximately 2 Liters of distilled water
l Clamp
Procedure
the Diagnostic submenu. This will cause the arm to move to the top of the rotor holder.
2. Remove the rinse reservoir and clean thoroughly with clean solution and rinse with
distilled water.
3. Clamp off the External Waste Tubing from the side of the ACL ELITE/ELITE PRO.
4. Fill the 20 mL syringe with fresh 0.625% Bleach solution (HemosIL Cleaning Agent PN
0009832700 diluted 1:8 with distilled water).
5. With the Waste/Rinse reservoir still out of the instrument, insert the syringe into the
hole at the bottom of the reservoir and slowly push the 0.625% bleach solution through
the waste tubing being careful that the bleach solution does not overflow into the well.
6. Let bleach solution sit in the waste line for 15 minutes.
7. Unclamp the Waste Line.
8. Flush with approximately 1 Liter of distilled water.
9. Perform the Needle Cleaning procedure. See Section - Needle Cleaning Procedure on
page 299.
10. Place fresh reagents on the instrument and process controls.
11. Problems that may be resolved by this “as needed” waste line bleaching:
l Waste not flowing properly due to a clot stuck in the line that will not dislodge by
flushing with distilled water.
l High or low control recovery. There may be a blockage in the waste line
causing insufficient cleaning of the needles due to a backup in the rinse/waste
reservoir.
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5.2.7 Decontamination Procedure

Introduction
This section describes the procedure to be used to clean or decontaminate the ACL
ELITE/ELITE PRO, prior to shipping a unit or either as a general precaution to prevent and
eliminate potential bacterial contamination, or after using the system to test a highly
infectious sample (i.e. from known or suspected Australia Antigen positive and/or HIV
positive subjects, etc.).
WARNING: If spillage of a sample should occur during the course of normal system
use, clean the affected areas following the procedure in Section - Cleaning of Sample
Spillage on page 301.
The decontamination of the ACL system includes cleaning of the instrument surfaces and all
parts which have been in contact with the samples or used rotors. The disinfecting agent
used to perform the decontamination is a freshly prepared 1:8 dilution of IL Cleaning Agent
P/N 98327-00, which is a solution of sodium hypochlorite with a concentration of less than
0.625% of available chlorine. The 1:8 diluted solution is prepared by mixing 1 part Cleaning
Agent with 7 parts of distilled water.
WARNING: Use only IL Cleaning Agent (P/N 98327-00) diluted 1:8 with distilled
water (1 part cleaning agent with 7 parts distilled water).
CAUTION: The use of undiluted IL Cleaning Agent may cause corrosion of metal

parts.
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Decontamination procedure
Materials required
l 2 glass vials (23 mm diameter, 10 mL maximum volume)

l Prepare approximately 16 mL of diluted Cleaning Agent solution (mix 1 part of IL
Cleaning Agent and 7 parts distilled water; e.g. 2 mL of Cleaning agent and 14 mL of
distilled water)
1. Load the ACL reagent position R6 and R7:
l Reagent position R6 – Place the glass vial filled with 8 mL of diluted Cleaning
Agent solution
l Reagent position R7 – Place the glass vial filled with 8 mL of diluted Cleaning
Agent solution
2. Select Diagnostic, then select Cleaning.

3. Press Start.
4. At the end of the cleaning cycle the ACL returns to the cleaning screen.
5. Replace the Clean solution with Factor Diluent and repeat the procedure.
6. Press the Cancel button to return to the main screen.
7. Refer to section Section 5.1.2 - Cleaning on page 286 for further details on the
cleaning cycle.
8. Remove the vials in position R6 and R7.
9. Perform a Priming cycle. Repeat priming two times.
10. Replace the external waste tube and the waste container.
NOTES:
l The discarded items must be placed in an appropriate container for further disposal,
according to proper state and local regulations.
l In case of suspected severe contamination, replace the tubing and discard the old one
in an appropriate container for further disposal, according to proper state and local
regulations
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5.3 Maintenance Table Chapter 5 – Diagnostics and Maintenance
5.3 Maintenance Table

Frequency Maintenance Procedure
Daily l Perform a Needles cleaning procedure.

l At the beginning and at the end of each working day or shift, carry out a priming
cycle.
l Empty, if necessary, the liquid waste container.
l Empty the rotor waste container.
l Check level of Wash-R solution and replace if needed.
Weekly l Clean instrument by wiping down all external surfaces.

l Rinse/waste reservoir cleaning & probe alignment.
Bi Weekly l Reboot the System

l Clean Rotor Holder/Optical path area:
o Halogen lamp optic fiber surface
o LED sensor
o LED fiber optic surface
o 20 holes of the rotor holder
4 Weeks l Clean the air filter
Annual l Replace the air filter.

l Replace the sample and reagent tubing.
l Replace the liquid waste tubing.
l Replace the needle block (minimum interval).
l Replace the rinse waste reservoir
As Needed l Waste line cleaning.

l Needle replacement and alignment.
l Hard drive maintenance.
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5.3 Maintenance Table Chapter 5 – Diagnostics and Maintenance
ACL ELITE/ELITE PRO Serial Number: Month:
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Daily
Needles Cleaning
Priming Cycle - start of shift/day
Priming Cycle - end of shift/day
Empty Liquid and Rotor Waste Containers
Check Wash-R Level
Weekly
Clean external surfaces
(weekly or as needed)
Rinse Waste Reservoir Clean /Probe Align
Bi-Weekly
Reboot the System
Clean Rotor Holder and Optical Path
Monthly
Clean Air Filter
As Needed
Waste Line Cleaning
Needles Replacement
Hard Drive Maintenance
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Chapter 6 - Troubleshooting

6.1 Failures, Alarms and Warnings 317
6.1.1 System Anomalies 318
6.1.2 REM (Rotor Exchange Module) Anomalies 322
6.1.3 Temperature Anomalies 324
6.1.4 Mechanical Anomalies 326
6.1.5 Acquisition Station Anomalies 328
6.1.6 Liquid Anomalies 329
6.1.7 Optics Anomalies 331
6.1.8 Operative Anomalies 332
6.1.9 Parsing and Loading Anomalies 333
6.1.10 Database Anomalies 334
6.2 Data Transmission Failure 334
6.3 Data Reduction Error Codes 335
6.3.1 Session Error Codes 336
6.3.2 Reaction Curve Error Codes 337
6.3.3 Calibration Error Codes 342
6.3.4 Analytical Reference Error Codes 346
6.3.5 QC Error Codes 350
6.3.6 Double Test Error Codes 352
6.3.7 Ratio and INR Error Codes 353
6.3.8 DMS Errors 355
6.3.9 Other Miscellaneous Errors 356
6.4 Classic Data Reduction Error 357
6.5 Sample ID Errors (Internal Barcode Reader) 358
6.6 Data Reduction Diagram for PT, APTT and TT 359
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6.0 Introduction Chapter 6 – Troubleshooting
6.0 Introduction
Following the Maintenance guidelines described in Chapter 5 - Diagnostics and Maintenance on page
282 is of paramount importance to keep the ACL ELITE/ELITE PRO system in good working order and
to minimize instrument failures.
In the event of a malfunction, the ACL automatically notifies the user of the situation through a system of
warnings and alarms. With the help of built-in system checks and the guidelines offered in this section,
the user would be able to resolve most of the problems that may arise.
6.1 Failures, Alarms and Warnings

The following general definitions apply to the types of messages that the ACL ELITE/ELITE PRO
displays in case of system problems:
l A WARNING, displayed in the form of a yellow icon on the bottom part of the screen,
announces a problem to the user. Clicking on the icon allows viewing of text that describes
the problem. As a general rule, the instrument may continue to be used with some limitations,
depending on the problem.
l An ALARM warns the user of a problem that needs immediate attention. Some system sub-
functions and operations will still be available. If the failure persists after the operator switches
the instrument off and on again (in case this is suggested), the problem should be referred to a
Service Engineer.
l A FAILURE message indicates a problem serious enough to prevent further use of the
instrument and requires the intervention of a Service Engineer.
All Warnings, Alarms and Failures are grouped in the following categories depending on the their origin.
Each group is addressed in the sections indicated below:
l Section 6.1.1 – System anomalies

l Section 6.1.2 – REM (Rotor Exchanger Module) anomalies
l Section 6.1.3 – Temperature anomalies
l Section 6.1.4 – Mechanical anomalies
l Section 6.1.5 – Acquisition station anomalies
l Section 6.1.6 – Liquids anomalies
l Section 6.1.7 – Optics anomalies
l Section 6.1.8 – Operative anomalies
l Section 6.1.9 – Parsing and loading anomalies
l Section 6.1.10 – Database anomalies
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6.1 Failures, Alarms and Warnings Chapter 6 – Troubleshooting
6.1.1 System Anomalies

Failures
System Anomalies – Failures

Error Message Possible Explanation Remedial Action
ACL thermal shut Temperature inside the analyzer is Contact Service.
down higher than 75 °C. The instrument
shuts down automatically.
ACL shut down The output current of the +5 V supply Contact Service.
is higher than 11 A. The instrument
shuts down automatically.
Hard disk failure Problem with the controller or Contact Service.
damaged hard disk .
RAM memory failure BIOS finds RAM problem. Contact Service.
Full Hard disk The hard disk is full. Contact Service.
Opening File Missed critical opening file. Reload the main software. If the
failure persists, contact Service.
File length alarm Wrong length of a critical file. Reload the main software. If the
File read alarm Missed reading of a critical file. Reload the main software. If the
File write alarm Missed writing of a critical file. Reload the main software. If the
File close alarm Missed closing of a critical file. Reload the main software. If the
Exhausted memory Exhausted master memory. Reload the main software. If the
Error opening Error while opening a window on the Reload the main software. If the
window master. failure persists, contact Service.
Master manager Error on the master error manager. Reload the main software. If the
error failure persists, contact Service.
Unexpected internal Unexpected internal message on the Reload the main software. If the
message master. failure persists, contact Service.
Internal sending Internal sending failed on the master. Reload the main software. If the
failed failure persists, contact Service.
Queue/semaphore Error while creating a queue or Reload the main software. If the
creating error semaphore on the master. failure persists, contact Service.
Driver installation Error while installing. Reload the main software. If the
Timer allocation Error while allocating timer on master. Reload the main software. If the
Internal library error Internal error in the library on master. Reload the main software. If the
318 of 617 L0018200232 R01

System Anomalies – Failures

Len parse error Error in the message length from Reload the main software. If the
master to slave. failure persists, contact Service.
Subtype parse error Error in the message code (subtype) Reload the main software. If the
from master to slave. failure persists, contact Service.
Type parse error Error in the message code (type) from Reload the main software. If the
Invalid parameter Error in the parameter message from Reload the main software. If the
Database failure Major error in the database handling. Reload the main software. If the
Coded SW failure Major error in code handling. Reload the main software. If the
Alarms
System Anomalies – Alarms

Slave communication Master and slave do Reload the main software. If the failure
failure not communicate. persists, contact Service.
A/D converter failure Periodic error while Reload the main software. If the failure
handling the ADC. persists, contact Service.
Slave code absent Missing slave code. Reload the main software. If the failure
persists, contact Service.
Slave download error Failed loading the Reload the main software. If the failure
slave code. persists, contact Service.
Check DB error Consistency error in Reload the main software. If the failure
the data base. persists, contact Service.
Check parameters Error in consistency of Reload the main software. If the failure
error the parameters. persists, contact Service.
Error Code 1019 Internal system out of If this occurs during the initial 30 minutes of
specification startup, allow time for temperatures to stabilize
Warnings
System Anomalies – Warnings

ACL thermal warning* The temperature Switch the system off, wait a few seconds and
inside the analyzer is switch it back on.
higher than 60°C. If the error persists, contact Service.
319 of 617 L0018200232 R01


REM communication Missing Switch the system off, wait a few seconds and
error (N/A on the ACL communication with switch it back on.
ELITE) REM. Either the If the error persists, contact Service.
software is missing or
REM is not working.
REM command error Command not Switch the system off, wait a few seconds and
executed correctly. switch it back on.
(N/A on the ACL If the error persists, contact Service.
ELITE)
REM download error Download not Switch the system off, wait a few seconds and
(N/A on the ACL executed correctly. switch it back on.
ELITE) If the error persists, contact Service.
DB restoring Error Failure to restore Switch the system off, wait a few seconds and
database. switch it back on.
If the error persists, contact Service.
DB backup Error Failure to backup Switch the system off, wait a few seconds and
database. switch it back on.
File open warning Missed opening a Switch the system off, wait a few seconds and
non-critical file. switch it back on.
File length warning Incorrect length of a Switch the system off, wait a few seconds and
non-critical file. switch it back on.
File read warning Missed reading a non- Switch the system off, wait a few seconds and
critical file. switch it back on.
File write warning Missed writing a non- Switch the system off, wait a few seconds and
File close warning Missed closing a non- Switch the system off, wait a few seconds and
No space on external The data storage Replace with another data storage device.
media. device inserted into
the USB port is full.
External media in use External storage Wait until process finishes before removing the
media is being used device. Then insert the USB storage media
by another process. into the USB port.
Too many flash Multiple USB storage devices have been
(thumb) drives detected. Please remove one. See Section
1.4.16 - USB Port for All-In-One Utility on page
40.
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Printer fail **# Printer is not Check printer and connection.
connected or not
working.
Paper end No more paper in Reload printer paper.
printer.
Internal BCR failure The internal barcode Switch the system off, wait a few seconds and
reader is not working. switch it back on.
Reload the main software. If the error persists,
contact Service.
* Thermal Fail
This warning indicates the instrument is overheating internally which may have an effect on
the temperature of the measuring chamber. The reason may be a clogged air filter
obstructing the airflow in and out of the analyzer. Check the air filter on the right side of the
analyzer; clean or replace it as necessary following the instructions in Chapter 5 -
Diagnostics and Maintenance on page 282. Make sure that there is free airflow and that the
ambient air temperature is below 35°C.
NOTE: The ACL ELITE/ELITE PRO works optimally when the ambient temperature
is in the range of 15 to 32 °C, and does not fail in the range of 10 to 40 °C.
If cleaning the air filter does not resolve the warning and the ambient temperature is within
limits, contact Service.
** Printer Fail
If the printer does not produce a printout due to a printer failure, the results may be viewed on
the monitor. Results transmitted via the RS232 C data link (if connected and enabled) are
also correct.
In order to troubleshoot the printer, verify that the paper is correctly loaded. Also verify that
the proper transmission protocol has been selected in the ACL ELITE/ELITE PRO Setup
(ESCP2 or PCL), and that the printer supports the selected emulation protocol.
# The actual error displayed will vary depending upon the submenu where the request was
made. If the failure persists, contact Service.
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6.1.2 REM (Rotor Exchange Module) Anomalies
NOTE: The ACL ELITE does not issue REM anomalies.
Failures
REM Anomalies – Failures

REM elect fail REM electrical failure. Please logout. Switch the system off, wait a
few seconds and switch it back on. If the error
REM voltage out of REM voltage out of Please logout. Switch the system off, wait a
range range. few seconds and switch it back on. If the error
REM vertical alarm Robotic vertical arm Verify that there is no obstruction interfering
motor failure. with movement. If there is no obstruction, but
the error persists, the system may be used in
the manual mode by disabling the REM. If the
error persists, contact Service.
REM horizontal alarm Robotic horizontal Verify that there is no obstruction interfering
arm motor failure. with movement. If there is no obstruction, but
REM transport alarm Transport motor Verify that there is no obstruction interfering
failure. with movement. If there is no obstruction, but
REM CPU failure REM CPU failure. Verify that there is no obstruction interfering
with movement. If there is no obstruction, but
REM arm EM fault Arm EM failure. The system may be used in the manual mode
by disabling the REM. If the error persists,
contact Service.
REM arm EM driver Arm circuit failure. The system may be used in the manual mode
fault by disabling the REM. If the error persists,
contact Service.
REM transport EM Transport EM failure. The system may be used in the manual mode
contact Service.
REM transport EM Transport circuit The system may be used in the manual mode
driver fault failure. by disabling the REM. If the error persists,
contact Service.
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REM Anomalies – Failures

REM stack EM fault Stack EM failure. The system may be used in the manual mode
by disabling the REM. If the error persists,
contact Service.
REM stack EM driver Stack circuit failure. The system may be used in the manual mode
contact Service.
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6.1.3 Temperature Anomalies

Alarms (also see notes at the end of this table)
Temperature Anomalies – Alarms

Thermal power off Power circuit is off. Please logout. Switch the system off, wait a
Incubation Incubation Allow 30 minutes after powering on to allow
temperature out of temperature out of temperature stabilization. If the error persists,
range at startup range after power on. contact Service.
Incubation Incubation Message may appear for a few seconds if the
temperature out of temperature out of rotor cover has been left open. If the warning
range range during normal persists after the rotor cover has been closed
operation for several minutes, contact Service.
Peltier out of range at Peltier temperature Wait 30 minutes after turning power on. If the
startup out of range after warning persists, contact Service.
power on. Although the reagent refrigeration is not
See Note 1, below. working correctly, the system may continue to
be used as long as the reagents are left on the
analyzer only for the time required for the
testing.
Peltier out of range Peltier temperature If the warning persists, contact Service.
out of range during Although the reagent refrigeration is not
normal operation. working correctly, the system may continue to
See Note 1, below. be used as long as the reagents are left on the
analyzer only for the time required for the
testing.
Transport out of range Transport temperature Wait 30 minutes after turning power on. If the
at startup. out of range at startup. warning persists, contact Service.
(N/A on the ACL See Note 2, below. In the meantime, although the thermal
ELITE) regulation of the rotor transport is not operating
correctly, the system may be used.
Transport out of range Transport temperature If the warning persists, contact Service.
(N/A on the ACL out of range. In the meantime, although the thermal
ELITE) See Note 2, below. regulation of the rotor transport is not operating
Stack out of range at Rotor stack Wait 30 minutes after turning power on. If the
startup temperature out of warning persists, contact Service.
range at startup. In the meantime, although the thermal
See Note 2, below. regulation of the rotor stack is not operating
Stack out of range Rotor stack If the temperature is out of range the system
temperature out of may be used provided QC. is processed
range. during the session and the results are within
See Note 2, below. established limits. If the error persists, contact
Service.
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Temperature Anomalies – Alarms

Note 1
Peltier Temperature Temperature is Select DIAGNOSTIC from the Main Menu, and
out of Range outside the 10-16°C then select TEMPERATURE CONTROL.
range. If the monitor displays ------ or **** for the
Peltier, the temperature may be very high or
very low. The instrument may continue to be
used provided that the reagents are left on
board only for the duration of the testing, and
are refrigerated afterwards. Contact Service.
If the monitor displays a temperature value
from 4 to 12 °C for the Peltier, the system is
fully operational and precautions need to be
taken. However, the Service Engineer should
be called to rectify the situation.
If the monitor displays a low temperature value
(from 20 to 36 °C), check that the ambient
temperature is not higher than 32 °C. If the
problem is not corrected, contact Service.
Note: As noted above, a high
temperature may be caused by dirty
filters or ambient temperatures outside
the optimal operational range.
Note 2
Transport or Stack Temperature is Select DIAGNOSTIC from the Main Menu, and
Temperature out of outside the 36-39°C then select TEMPERATURE CONTROL.
Range range. If the monitor displays ------ or **** for the
transport or stack temperatures and the
instrument has been properly warmed up,
contact Service.
If the monitor displays a high temperature
value (from 36 to 50 °C), check the air filter and
ambient conditions as indicated in Section
6.1.1 - System Anomalies on page 318. If the
problem is not corrected, contact Service.
If the monitor displays a low temperature value
(from 20 to 36 °C), check that the instrument
has been properly warmed up and that the
ambient temperature is higher than 15 °C. If
the problem is not corrected, contact Service.
Note: The system is fully operational
even when the pre-heater temperature
is out of range, unless the message
“INCUBATION TEMP OUT OF RANGE”
appears at the start of analysis.
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6.1.4 Mechanical Anomalies

Alarms
Mechanical Anomalies – Alarms

Autosampler alarm Autosampler problem. Please logout. Switch the system off, wait a
Rotor alarm Rotor holder problem. Please logout. Switch the system off, wait a
Horizontal motor Horizontal motor arm Please logout. Switch the system off, wait a
alarm problem. few seconds and switch it back on. If the error
Vertical motor alarm Vertical motor arm Please logout. Switch the system off, wait a
problem. few seconds and switch it back on. If the error
Reagent dilutor alarm Reagent dilutor Please logout. Switch the system off, wait a
Sample dilutor alarm Sample dilutor Please logout. Switch the system off, wait a
Cover alarm Rotor cover problem. Please logout. Switch the system off, wait a
Warnings
Mechanical Anomalies – Warnings

Autosampler warning Autosampler Please logout. Switch the system off, wait a
intermittent problem. few seconds and switch it back on. If the error
Rotor warning Intermittent problem Verify that there is no obstruction interfering
with rotor holder. with movement. If the error persists, contact
Service.
Horizontal motor Intermittent problem Verify that there is no obstruction interfering
warning with horizontal motor with movement. If the error persists, contact
arm. Service.
Vertical motor warning Intermittent problem Verify that there is no obstruction interfering
with vertical motor with movement. If the error persists, contact
arm. Service.
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Mechanical Anomalies – Warnings

Reagent dilutor Intermittent problem Verify that there is no obstruction interfering
warning with reagent dilutor. with movement. If the error persists, contact
Service.
Sample dilutor Intermittent problem Verify that there is no obstruction interfering
warning with sample dilutor. with movement. If the error persists, contact
Service.
Cover warning Intermittent problem Verify that there is no obstruction interfering
with rotor cover. with movement. If the error persists, contact
Service.
Stirrer fail Magnetic stirrer not The system may be used without reagent
working. stirring. In this case the reagent should be well
mixed before each run. If the error persists,
contact Service.
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6.1.5 Acquisition Station Anomalies

Failures
Acquisition Station Anomalies – Failures

Acquisition timeout Acquisition running for Switch the system off, wait a few seconds and
alarm more than 30 minutes. switch it back on. If the error persists, contact
Service.
Warnings
Acquisition Station Anomalies – Warnings

Acquisition start error Home position not Verify that there is no obstruction interfering
found at start. with movement. If the error persists, switch the
system off, wait a few seconds and switch it
back on. If the error persists, contact Service.
Acquisition sync error Home position not Verify that there is no obstruction interfering
found during with movement. If the error persists, switch the
acquisition. system off, wait a few seconds and switch it
adc int error Unexpected ADC Log out, switch the system off, wait a few
interruption seconds and switch it back on. If the error
Cuv int error Unexpected cuvette Log out, switch the system off, wait a few
interruption seconds and switch it back on. If the error
Acq centrifuge error Rotor holder blocked Verify no obstruction exists. Log out, switch the
system off, wait a few seconds and switch it
Acq tx error Unable to Transmit Log out, switch the system off, wait a few
data seconds and switch it back on. If the error
Acq rot fail error Rotor fail Log out, switch the system off, wait a few
seconds and switch it back on. If the error
Acq opt ref error Optical reference fail Log out, switch the system off, wait a few
seconds and switch it back on. If the error
Acq ref error Reference emulsion Log out, switch the system off, wait a few
fail seconds and switch it back on. If the error
Acq cover open error Cover open during Verify that the rotor cover is closed. If the cover
acquisition is closed, but the error persists, please logout.
Switch the system off, wait a few seconds and
switch it back on. If the error persists, contact
Service.
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6.1.6 Liquid Anomalies

Alarms
Liquid Anomalies – Alarms

Flush short Reference Emulsion Verify the Wash-R bottle liquid level. If the
not present. liquid level is low, replace with a new bottle. If
sufficient liquid is present, the user may
temporarily disable the Wash-R sensor. It is
then the operators' responsibility to verify the
Wash-R level. If the error persists with the
sensor enabled, contact Service.
Warnings
Liquid Anomalies – Warnings

Flush warning Reference Emulsion Verify the Wash-R bottle liquid level. If the
below 100 mL level. liquid level is low, replace with a new bottle. If
sufficient liquid is present, the user may
temporarily disable the Wash-R sensor. It is
then the operators' responsibility to verify the
Wash-R level. If the error persists with the
sensor enabled, contact Service.
Sample liquid sensor External needle If the sensor is disabled, it is the operator's
off (sample) sensor responsibility to verify appropriate liquid levels.
disabled. If the error persists with the sensor enabled,
contact Service.
Reagent liquid sensor Internal needle If the sensor is disabled, it is the operator's
off (reagent) sensor responsibility to verify appropriate liquid levels.
disabled. If the error persists with the sensor enabled,
contact Service.
Sample liquid sensor External needle If the sensor is disabled, it is the operator's
fail (sample) circuit responsibility to verify appropriate liquid levels.
sensor error. If the error persists with the sensor enabled,
contact Service.
Reagent liquid sensor Internal needle If the sensor is disabled, it is the operator's
fail (reagent) circuit responsibility to verify appropriate liquid levels.
sensor error. If the error persists with the sensor enabled,
contact Service.
Sample short in Insufficient sample in An insufficient sample level was detected. If
position xxx position xxx. using a tube transfer the remaining sample to
a sample cup and repeat the test. If sufficient
sample is present, but the error persists,
contact Service.
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Liquid Anomalies – Warnings

Cleaning not Cleaning not If the error appeared during an analysis, check
performed performed due to the cleaning material level and perform a
insufficient or no cleaning cycle. If sufficient material is present,
cleaning solution but the error persists, contact Service.
present.
Material onboard Timer for a material Replace the material and reset the onboard
stability expired in onboard has expired. timer.
position “XX” This material will be
displayed in orange
on the material map.
Liquid “id” short A specific non- An insufficient material level was detected.
mandatory liquid “id” Make sure that the material level is sufficient. If
is absent or in sufficient material is present, but the error
insufficient amount. persists, contact Service.
Mandatory Liquid “id” A specific mandatory An insufficient material level was detected.
short liquid “id” is absent or Make sure that the material level is sufficient. If
in insufficient amount. sufficient material is present, but the error
Flush/Optic Channel Problem with Check the level of the Reference Emulsion in
Error Reference Emulsion the bottle. If the level is lower than 1 cm,
dispensing replace the bottle with a new one. Mix by
gentle inversion before placing in the
instrument.
Check that the Reference Emulsion was
correctly dispensed into the rotor cuvettes for
the rotor in the analysis cycle. The positions of
the Reference Emulsion depend on the test.
See Chapter 7 - Assay and Instrument
Specifications on page 360 for further details.
If the Reference Emulsion bottle is in place
and it has sufficient liquid, check that the fluidic
path is free of obstructions.
Note: A quick way to check the fluidic
path is to remove the needle assembly
from the sample arm. Using a beaker to
collect the liquid, perform an automatic
PRIMING cycle and check that the
liquid is coming out of both needles.
Remember to perform a NEEDLES
POSITION ADJUSTMENT after this
check. Refer to Chapter 5 - Diagnostics
and Maintenance on page 282.
Check that the LED is ON.
If the LED is ON, perform the optic path
cleaning as described in the Chapter 5 -
Diagnostics and Maintenance on page 282.
If none of the above resolves the problem,
contact Service.
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6.1.7 Optics Anomalies

Warnings
Optics Anomalies – Warnings

Halogen lamp fail Halogen lamp is not Please logout. Switch the system off, wait a
working. few seconds and switch it back on. The
system may be used without the halogen lamp
for clotting-based tests only. If the error
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6.1.8 Operative Anomalies

Warnings
Operative Anomalies – Warnings

Waste full Rotor waste is full. Empty the rotor waste container. If the error
persists after emptying the container, contact
Service.
Waste open Rotor waste cover is Close the rotor waste container door. If the
open. error persists after this action, contact Service.
No rotors (REM No more rotors in the Refill the rotor stack. If the error persists after
active) rotor stack. this action, contact Service.
No rotors No more rotors in the Refill the rotor stack. If the error persists after
(REM not active) rotor stack. this action, contact Service.
Rotor station empty No more rotors in the Refill the rotor stack. If the error persists after
rotor stack. this action, contact Service.
Rotor refill Only one or two rotors Refill the rotor stack. If the error persists,
left in the rotor stack. contact Service.
Cover open during Rotor cover was Close rotor cover. If the error persists contact
loading / incubation opened during the Service.
loading or incubation
operation.
Time out expired Time out not met Max Sample limit in test group set to high,
during loading during loading. lower limit by one. Repeat run. If the error
No test to perform No test to perform Check the programmed tests in the database
programmed in the match the tests in the mufti-test session. Verify
database and after that the connection to the host is working
host query. properly. If they are both OK, contact Service.
? No tests performed Verify the presence of necessary liquids. If they
due to missing liquids. are all on-board, contact Service.
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6.1.9 Parsing and Loading Anomalies

Warnings
Parsing and Loading Anomalies – Warnings

Parsing error xxx Error found in the Verify the test definition setup is accurate and
parameters during complete. Switch the instrument off, wait a few
loading. seconds and switch it back on. If the error
Run error xxx Error found during the Log out, switch the instrument off, wait a few
run. seconds and switch it back on. If the error
Session error xxx Error found during the Log out, switch the instrument off, wait a few
session. seconds and switch it back on. If the error
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6.2 Data Transmission Failure Chapter 6 – Troubleshooting
6.1.10 Database Anomalies

Warnings
Database Anomalies – Warnings

Database warning Patient database at Remove data from the database
95% or higher.
Database full Patient database at Remove data from the database
100%.
6.2 Data Transmission Failure

The error Data Transmission is displayed when there has been an error in the transmission of the data
over the RS232 C interface.
Attempt to re-transmit the data as follows:
1. Select SETUP from the Main Menu, select INTERFACE STATUS to view the Data
Transmission characteristics to the Host Computer
2. Select Data Transmission connection (ACL-computer)
3. Repeat the transmission from the Database.
If the fault persists, contact Service. For additional information please refer to Appendix A –
Host Communication Protocol on page 441.
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6.3 Data Reduction Error Codes Chapter 6 – Troubleshooting
6.3 Data Reduction Error Codes

Any error that occurs during the data reduction process will be reported as a code number. The following
subsections describe all the error code numbers and their meanings. Possible sources for the errors,
identified by letter codes, are shown as flags according to the following list:
Error Code Abbreviation Priority

Data reduction Errors R 1 (Highest)
Temperature Errors T 2
Instrument Errors (i.e. Sensor error) E 3
Calibration Errors C 4
Analytical Reference Errors A 5
QC Errors Q 6
Parallelism Errors P 7
Errors on Algorithms, ratio, Ranges… W 8
Material Errors ((i.e. expiration) M 9 (Lowest)
Error Codes, that will not generate a valid result, are represented by an Error Number.
The Error Number is presented instead of a valid result.
Error codes that will generate a result plus an additional flag are indicated with a message that explains
the error.
Results with more than one error display the highest priority error.
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6.3.1 Session Error Codes

Error 1 - No flush/optical error
Meaning No flush/optical error

Cause Nephelometric optical reference channel out of range (above 4.0 V or
below 1.5 V).
Flags Cycle aborted
Results No results in database.
Remedial Action Replace Reference Emulsion bottle and clean optics.
Error 2 - Optical error
Meaning Optical error

Cause Absorbance optical reference channel out of range (above 9.5 V or
below 5.0 V).
Flags Cycle aborted
Remedial Action Clean optics.
Error 3 - No flush
Meaning No flush
Cause Absorbance channel Reference Emulsion out of range (above 3.5 V or
below 0.0 V).
Flags Cycle aborted
Error 4 - Optical failure
Meaning Optical failure

Cause Acquisition data check (signal above 10 V).
Flags Cycle aborted
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6.3.2 Reaction Curve Error Codes
WARNING: For any sample, if you are unsure about the result after reviewing the
error code and clot curve, it is recommended the sample be rerun using an alternate method.
Error code - 5
Meaning Optical failure

Cause ADC saturation (signal above 9.5 V at the end of the clotting curve).
Flags R
Results Error 5 instead of the result.
Remedial Action Possible high Fibrinogen concentration. Dilute the sample 1:1 with
factor Diluent and repeat the test if possible.
Error code – 6 *
Meaning Not coag

Cause First threshold not passed.
Flags R
Remedial Action Sample does not clot within the acquisition time. Repeat the test in
extended acquisition time.
Error code – 7 *
Meaning Coag error

Cause Second threshold not passed.
Flags R
Remedial Action Sample clot curve is noisy and does not give a normal clot signal within
the acquisition time. Repeat the test in extended acquisition time.
Error code - 8
Meaning Coag error

Cause Delta time between the two thresholds is higher than the selected
value.
Flags R
Remedial Action Possible non-phasic clotting curve. Review the clot curve. Possible
sample interference with the clotting reaction.
*See Section 6.4 - Classic Data Reduction Error on page 357 for more details.
337 of 617 L0018200232 R01

Error code - 9
Meaning Coag error

Cause Initial slope of the reaction curve is higher than the selected value.
Flags R
Remedial Action Possible bi-phasic clotting curve. Review the clot curve. Possible
sample interference with the clotting reaction.
Error code - 10
Meaning Coag error

Cause Final slope of the reaction curve is higher than the selected value.
Flags R
Remedial Action Unstable plateau of the clotting curve. Review the clot curve. Possible
sample interference with the clotting reaction. Repeat the test in
Error code - 11
Meaning Final delta error is a check that the curve is not dropping too much after
reaching its maximum reading
Cause Final delta of the reaction curve (maximum abs reading – final abs.
reading) is higher than the selected value.
Flags R
Remedial Action If this is a nephelometric reaction, it may be an indication of an
unstable plateau in the clotting curve. Review the clot curve. Possible
sample interference with the clotting reaction. Repeat the test in
If this is an absorbance test, it may be an indication of an absorbance
value outside the specified limit.
Error code - 12
Meaning Coag error

Cause Maximum peak of the first derivative is below the selected limit value.
Flags R
Remedial Action First derivative peak is not significant enough to indicate a real clotting
reaction point. Review the clot curve. Repeat the test in extended
acquisition time.
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Error code – 13
Meaning Coag error

Cause Maximum peak of the second derivative is below the selected limit
value.
Flags R
Remedial Action Second derivative peak is not significant enough to indicate a real
clotting reaction point. Review the clot curve. Repeat the test in
Error code - 14
Meaning Offset error (delta algorithm)

Cause Offset value is greater than “First part” value defined in calculation
setup section of test definition or below scale range low limit.
Flags R
Remedial Action Review the clot reaction curve “Y” axis scale to determine if value is
low or high (turbid). Rerun Sample.
Error code - 30
Meaning Offset error (delta algorithm)

Cause Offset of the initial part of the curve is below the selected limit value.
Flags R
Remedial Action Initial reaction turbidity is relatively low. Review the clot reaction curve.
Check integrity of reagents, and make sure no bubbles are present
Error code - 31
Meaning Minimum Curve Delta not met

Cause The total delta of the reaction curve is less than the limit specified in the
test setup. (Reaction curve is flat, and clot formation may not have
occurred)
Flags R
Remedial Action Review the curve and rerun the sample. Sample may have an
extended clotting time.
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Error 32 or 33 - Noisy Baseline/Reaction Curve
Meaning Reaction curve baseline readings are erratic

Cause Interference in reaction readings
Flags R
Results
Remedial Action Review Curve and repeat sample
Error code - 70
Meaning Curve Sequence Error

Cause Reaction curve not in correct sequence
Flags on samples R
Cal Results Error 70 instead of the result.
Remedial Action Check sample, and rerun. Sample may have an extended clotting
time. Clot Curve not available.
Error code - 71
Meaning Too Many Spikes Error

Cause Reaction curve has excessive reading spikes
Flags on samples R
Remedial Action Review the curve, check sample, and rerun. Sample may have an
extended clotting time. Invalid result.
Error code - 72
Meaning Baseline SD Error

Cause Baseline SD reading is greater than limit
Flags on samples R
extended clotting time. Invalid result.
340 of 617 L0018200232 R01

Error code - 73
Meaning SyX Value greater than Maximum SD

Cause Linear regression SyX value exceeds limit
Flags on samples R
extended clotting time .Invalid result.
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6.3.3 Calibration Error Codes

Error code - 15
Meaning No cal - Insufficient data (curve with a single segment)

Cause Less than 2 calibration standards gave valid results in the specific
curve segment.
Flags on samples C – No cal - insufficient data
Remedial Action Invalid result. Review the reaction curve. Repeat the calibration with
freshly prepared materials.
Error code - 16
Meaning Invalid curve - Insufficient data (curve with more than one segment)
Cause Less than 2 calibration standards gave valid results.
Flags on samples C – Invalid curve - insufficient data
Remedial Action Invalid result. Review the reaction curve. Repeat the calibration with
Error code - 17
Meaning Lower No. of standards

Cause A number of standards points are less than the ones defined in the
setup.
Flags on -samples C – n-1 Standard points
Remedial Action Invalid results. Review the reaction curve. Repeat the calibration with
Error code - 18
Meaning No cal - No mandatory standards

Cause A mandatory calibration standard does not give a valid result (single
curve segment).
Flags C – no cal no Standard
Remedial Action Invalid curve. Review the reaction curve. Repeat the calibration with
342 of 617 L0018200232 R01

Error code - 19
Meaning Invalid curve segment - No mandatory standards

Cause A mandatory calibration standard does not give a valid result (curve
with more than one segment).
Flags on samples C – invalid curve no Standard
Remedial Action Invalid curve. Review the reaction curve. Repeat the calibration with
Error code - 20
Meaning Invalid standards replicates

Cause One or more of the replicates for a defined calibration standard does
not give a valid result.
Flags on samples C– invalid Standard n
Cal Results Error 20. Mean is flagged. CV is shown flagged (in red).
Remedial Action Invalid standard. Review the reaction curve. Repeat the calibration with
Error code - 21
Meaning CV not shown – Insufficient replicates

Cause One or more of the replicates for a defined calibration standard does
not give a valid result. CV cannot be calculated (replicates below or =
2).
Flags on samples C – Insufficient replicates
Cal Results Error 21. CV is not shown.
Remedial Action Invalid standard. Review the reaction curve. Repeat the calibration with
Meaning Invalid replicate

Cause One replicate for a defined calibration standard does not give a valid
result.
Flags C – Invalid replicates
Results Error 22. Mean value is flagged.
0Remedial Action Invalid replicate. Review the reaction curve. Repeat the calibration with
343 of 617 L0018200232 R01

Error code - 23
Meaning CV out of range

Cause CV of the replicates higher than the selected limit.
Flags on samples C – CV out of range
Cal Results Error 23. CV is flagged.
Remedial Action Result out of range. Review the reaction curve. Repeat the calibration
with freshly prepared materials.
Error code - 24
Meaning No cal - slope out of range

Cause The slope of the curve (curve composed by a single equation) is out of
the defined range (single segment).
Flags on samples C – No Calibration: slope out of range
Cal Results Error 24. Calibration curve not displayed.
Remedial Action Review the reaction curve. Repeat the calibration with freshly prepared
materials.
Error code - 25
Meaning Invalid curve - slope out of range

Cause One of the slopes of the curve (curve composed by several segments)
is out of the defined range.
Flags on samples C – Invalid segment - slope out of range
Cal Results Error 25. Calibration curve is displayed.
materials.
Error code - 26
Meaning R2 R2 out of range

Cause R2 The R2 of the calibration is outside the selected limit.
Flag on samples C - R2 out of range
Cal Results Error 26. Calibration curve is displayed. R2 value is flagged.
materials.
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Error code - 27
Meaning No Calibration - No valid curve

Cause The calibration curve does not have any valid segment.
Flags on samples No Calibration – no valid curve
Cal Results Error 27. Calibration curve is not presented.
materials.
Error code - 28
Meaning Curve non monotonic

Cause Invalid calibration due to a result not in sequence compared to the
other calibration points.
Flags on samples C – invalid segment
Cal Results Error 28. Non monotonic curve.
Remedial Action Repeat calibration.
Error - Extrapolated data
Meaning Extrapolated data.

Cause Test result is above 150% as compared to the highest calibration
standard or below 60% as compared to the lowest calibration standard.
Flags on samples C - Extrapolated result.
Cal Results None
Remedial Action None
Error – Invalid Adjacent Segment (Factor Assays)
Meaning One Segment of Calibration Curve contains an error.

Flags on samples C – Invalid Adjacent Segment
Remedial Action Review results before reporting. Repeat any samples if the results are
suspicious.
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6.3.4 Analytical Reference Error Codes

Error - AR invalid
Meaning AR invalid (using Reference Value for Ratio/INR calculation)

Cause AR does not give a valid result.
Flags on samples A – AR invalid
AR Results AR is flagged with an R that indicates the specific Error code number.
Remedial Action Review the reaction curves. Repeat the test with freshly prepared
materials.
Error - AR out of range
Meaning AR out of range (using Reference Value for Ratio/INR calculation)

Cause AR gives a result out of range.
Flags on samples A – AR out of range
AR Results AR is flagged in blue.
materials.
Error - AR invalid
Meaning AR invalid (AR used as reference for Ratio/INR calculation)

Cause AR does not give a valid calculated result.
Flags on samples A – AR invalid. Ratio/INR on samples is not presented
AR Results AR is flagged.
materials.
Meaning AR out of range (AR used as reference for Ratio/INR calculation)

Cause AR gives a result out of range.
Flags on samples A – AR out of range. Ratio/INR on samples is not presented
materials.
346 of 617 L0018200232 R01

Meaning AR out of range (compared to a Calibration standard)

Cause AR does not have a valid Ratio result.
Flags on samples A – AR out of range, Ratio/INR on samples is not presented
AR Results AR has no ratio calculated.
materials.
Error - AR not checked
Meaning AR not checked (compared to a Calibration standard not defined)

Cause AR not checked.
Flags on samples A – AR not checked. Ratio/INR is given on samples
materials.
Meaning AR out of range (no check on AR selected)

Cause AR gives an invalid result.
Flags on samples none
materials.
Error - Ara invalid
Meaning Ara invalid (check on Ara selected)

Cause Ara is invalid.
Flags on samples A - ARa invalid
ARa Results ARa flagged.
Remedial Action Repeat the test with freshly prepared materials.
Error - Ara out of range
Meaning Ara out of range (check on Ara selected)

Cause Ara is out of range.
Flags on samples A - ARa is cut of range
ARa Results ARa is presented in blue.
347 of 617 L0018200232 R01

Error - Ara invalid
Meaning Ara invalid (check on Ara not selected)

Cause Ara invalid.
ARa Results ARa flagged.
Error - AR invalid
Meaning AR invalid (Ratio defined versus one Calibration Standard)

Cause AR gives an invalid calculated unit.
Flags on samples A – AR invalid. Ratio/INR is presented on samples
materials.
Meaning AR out of range (Ratio defined versus one Calibration Standard)

Cause AR gives a calculated out of range result.
Flags on samples A – AR out of range. Ratio/INR is presented on samples.
AR Results AR is calculated and presented in blue.
materials.
Error - AR invalid
Meaning AR invalid (No check on AR is selected)

Cause AR gives an invalid result.
materials.
348 of 617 L0018200232 R01

Meaning AR out of range (Check on AR is selected)

Cause AR gives an out of range result.
Flags on samples A – AR out of range. Ratio/INR are not given if AR is defined for
Ratio/INR calculation
materials.
Meaning AR out of range (Check on AR is selected on Calibration standard)

Cause AR gives an out of range result.
Flags on samples A - AR out of range. Ratio/INR are given but flagged
materials.
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6.3.5 QC Error Codes

Error - QC Invalid
Meaning QC not valid (Check QC – Not selected)

Cause QC gives a non-valid result.
Flags on samples No flag on samples
QC Results QC result is not displayed and the specific code number is presented.
materials.
Error - QC Invalid
Meaning QC not valid (Check QC -selected, flag samples - not selected)

materials.
Error - QC out of range
Meaning QC out of range (Check QC - selected, flag samples - not selected)

Cause QC gives a result out of range.
QC Results Flagged with QC Invalid and appear in violet or red.
materials.
Error - QC invalid
Meaning QC invalid (Check QC - selected, flag samples - selected)

Flags on samples Q – QC Invalid, Flag on samples is present
materials.
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Error - QC out of range
Meaning QC out of range (Check QC - selected, flag samples - selected)

Cause QC gives a result out of range.
Flags Q – QC out of range flag on samples is present
Results QC result is flagged in violet or red
materials.
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6.3.6 Double Test Error Codes

Error code - 45
Meaning Mean not calculated (No check selected on mean)

Cause One of the two tests is not valid (non numeric result).
Results Error 45. Mean is not displayed.
materials.
Error code - 46
Meaning Mean not calculated (Check selected on mean)

Cause One of the two results is not valid.
Flags on samples W – Mean not calculated. Flag on samples
Results Error 46. Mean is not displayed.
materials.
Error - Mean out of range
Meaning Mean out of range (Check selected on mean)

Cause One of the two results is out of normal range or linearity range.
Flags on samples W -- Mean is flagged on samples
Results Mean is presented in relation to the violated result range.
materials.
Error - Mean out of range
Meaning Duplicate out of range (Check selected on mean)

Cause Difference between Replicates exceeds limit
Flags on samples W - Mean is flagged on samples
Results Mean is flagged in violet.
materials.
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6.3.7 Ratio and INR Error Codes

Error code – 52/53/54/55/56/59/60/62/63/65
Meaning Ratio calculation error (i.e. Ratio for PT, APTT, TT, etc.)
Cause One of the results needed for the calculation is not valid.
Flags on samples W - Ratio calculation error. Flag on samples
Results Error 52 = Sample
Error 53 = Standard
Error 54 = AR
Error 55 = Sa
Error 56 = ARa
Error 59 = AR invalid
Error 60 = Standard invalid
Error 62 = Sample invalid
Error 63 = Reference invalid*
Error 65 = ARa invalid
materials.
Error code - 50
Meaning Ratio : S or Sa out of range (i.e. Ratio for APCR-V)

Cause S or Sa out of normal range.
Flags on samples W – Ratio: S, Sa out of range.
Results Error 50. Ratio is not calculated.
materials.
Error code - 58
Meaning NR: AR or ARa out of range (i.e. NR for APCR-V)

Cause AR or ARa out of range.
Flags on samples W – R: AR, ARa out of range.
Results Error 58. Ratio is not calculated.
materials.
*Reference Value is set to 0.
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Error code - 57/64/66
Meaning NR error
Cause Ratio not available to calculate the NR
Flags on samples W – NR error.
Results Error 57 = Ratio not found.*
Error 64 = AR Ratio invalid.
Error 66 = AR Delta invalid.
materials.
*Reference Value is set to 0.
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6.3.8 DMS Errors

DMS = Document Management System on the host.
Error message Possible explanation

Data base full More than 1000 Sample IDs in the DMS. Sample IDs must be deleted
to allow space for programming.
More than 30 tests Trying to program test # 31 for a sample. Tests must be deleted to allow
programmed per space for programming.
sample
Duplicated sample ID A duplicate sample ID has been entered when editing a loadlist.
Duplicate sample ID must be deleted.
Control ID already ID already used for a QC material. Sample ID must be changed.
used
Control ID already ID already used for another patient sample. Sample ID must be
used for patient changed.
Invalid range One of the two IDs in the selected range does not exist.
selection
Sample ID not found ID requested does not exist in the database.
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6.3.9 Other Miscellaneous Errors

Unidentified sample in Sample in loadlist has no associated ID
position X
Check sample tray Material is missing from the sample tray.
Low Sample was found missing during aspiration or liquid level detection
check.
Test X is not Test does not have a calibration associated with it.
calibrated
Added sample in A sample that was not in the previous loadlist was found during the
position X sample tray check.
Timeout Expired Incubation time exceeded. Lower Max Sample value in Test group.
During loading
Used rotor Rotor is partially used. Enter the unused cuvette positions (open the
rotor cover to check the first available empty cuvette number).
Load rotors Rotor is insufficient to perform the requested analysis. Add more rotors
to the rotor stack.
AR out of range NP out of range (± 9% for PT, ± 15% for APTT or ± 20% for FIB-PT
based).
QC out of range QC material out of range according to the selected SD limit in the QC
setup.
Generic Acquisition Check LED/Halogen Lamp to ensure they are on. Call service if
Error problem persists
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6.4 Classic Data Reduction Error Chapter 6 – Troubleshooting
6.4 Classic Data Reduction Error

Error appears when there are anomalies in the data generated during the clotting of the sample. The
number that accompanies the error - 6, 7 or 13 - refers to the criteria algorithm that detected the problem.
For additional details, refer to the diagram in Section 6.6 - Data Reduction Diagram for PT, APTT and TT
on page 359.
Error 6
Failing Criteria Possible Explanation

The clot curve does not The sample may not have clotted during the acquisition time, or the variation in
pass the first threshold the turbidity is insufficient to trigger the reading of the clotting point.
before the end of the Run it in extended acquisition time.
acquisition time.
Coag Error 7

The clot curve passes the The sample may not have clotted during the acquisition time, or the variation in
first threshold, but not the the turbidity is insufficient to trigger the reading of the clotting point.
second threshold, before Run it in extended acquisition time.
the end of the acquisition
time.
Error 13

When the initial slope of The reaction curve may not be a real clotting curve, likely indicating a curve that
the reaction curve is too exhibits an unusual biphasic shape.
high, the criteria used to
decide the clotting point
is the Maximum of the
Second Derivative. If the
limit of the Maximum of
the Second Derivative is
not passed, it means that
the acceleration of the
reaction is not significant
enough.
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6.5 Sample ID Errors (Internal Barcode Reader) Chapter 6 – Troubleshooting
6.5 Sample ID Errors (Internal Barcode Reader)

When using barcoded samples and sample identification is done with the ACL internal barcode reader,
the following errors may be generated:

No_R Sample ID missing
Dpl Duplicated Sample ID
No C Truncated Sample ID
Inv Invalid Sample ID
If any of these errors occur, the operator may enter the sample ID manually into the system.
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6.6 Data Reduction Diagram for PT, APTT and TT Chapter 6 – Troubleshooting
6.6 Data Reduction Diagram for PT, APTT and TT
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Chapter 7 - Assay and Instrument Specifications

7.2 Calculation of Results 367
7.2.1 Coagulometric Tests 369
7.2.2 Chromogenic Tests 377
7.3 Sample/Reagent Configuration and Specifications 380
7.3.1 Sample Requirements and Positions 380
7.3.2 Sample Positions in the Rotor (unused case) 383
7.3.3 Coagulometric Test Volumes 385
7.3.4 Chromogenic/405 Filter Test Volumes 387
7.3.5 Special Test Volumes 388
7.4 Data Processing Features, Parameters and Analytical Specifications 389
7.4.1 Flagging Limits 389
7.4.2 Results Format: VDU and Printer 392
7.4.3 Result Messages 393
7.4.4 Calibration Curve Slope (m) 394
7.4.5 Calibration Curve Intercept (q) 395
7.4.6 Ranges for Calibration Plasma Values 395
7.4.7 Reaction Times 396
7.4.8 Test Algorithms 399
7.5 Assay Performance Characteristics 400
7.5.1 Assay Precision Performance, Linearity and Method Comparison Studies 400
7.5.2 Assay Calibration Stability 403
7.6 Analytical Limitations 404
7.6.1 Carryover 404
7.6.2 Cephalin: Needle Self-Conditioning 405
7.6.3 Lipemic Samples 405
7.7 Container Specifications 406
7.7.1 Primary Tubes 406
7.7.2 Cup and Reagent Containers 407
7.8 Instrument Specifications 408
7.8.1 Hardware and Operational Specifications 408
7.8.2 Dimensions 409
7.8.3 Database Specifications 409
7.9 Environmental Specifications 411
7.10 Electrical Specifications 412
7.11 HAZARDS 413
7.11.1 General Warnings 413
7.11.2 Shock Hazards 413
7.11.3 Electrical Hazards 413
7.11.4 Biohazards 414
7.11.5 Mechanical Hazards 414
Disclaimers 414
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Chapter 7 – Assay and Instrument Specifications
Bibliography 414
ADDENDUM: Method Comparison Studies 415
361 of 617 L0018200232 R01

7.0 Introduction Chapter 7 – Assay and Instrument Specifications
7.0 Introduction
This section includes specifications related to many assays performed on the ACL ELITE/ELITE PRO
system, as well as specifications related to the instrument and its accessory items.
The following abbreviations are used throughout this section:
APCR-V Activated Protein HEP Heparin

C Resistance - Factor V test PI Plasmin Inhibitor
AT Antithrombin D-D h D-Dimer high
PLG Plasminogen FPS Free Protein S
PCX Pro-IL-Complex*
HPX Hepatocomplex* SCT Silica Clot Time
PCL ProClot VWF von Willebrand Factor
PC Protein C F8 chr H/L Factor VIII chromogenic High/Low
Pro S Protein S DP Deficient Plasma
FIB-C Fibrinogen Clauss AR Analytical Reference
FIB-C h Fib Clauss High
FIB-C l Fib Clauss Low
NOTE: The ACL ELITE/ELITE PRO and the ACL8, 9 and 10000 use identical analytical
systems. Reagents, Calibrators, Controls and their assigned values are interchangeable between the
two systems.
The information provided in this section is organized as follows:
Section 7.1 – Measured Parameters

Section 7.2 – Calculation of Results
7.2.1 – Coagulometric Tests
7.2.2 – Chromogenic Tests
Section 7.3 – Sample/Reagent Configuration and Specification
7.3.1 – Sample Requirements and Positions
7.3.2 – Sample Positions in the Rotor
7.3.3 – Coagulometric Test Volumes
7.3.4 – Chromogenic Test Volumes
7.3.5 – Special Test Volumes
Section 7.4 – Data Processing Features, Parameters and Analytical Specifications
7.4.1 – Flagging Limits
7.4.2 – Results Format: VDU and Printer
7.4.3 – Dealing with Result Messages
7.4.4 – Calibration Curve Slope (m)
7.4.5 – Calibration Curve Intercept (q)
*Not currently available in the U.S.
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7.0 Introduction Chapter 7 – Assay and Instrument Specifications
7.4.6 – Ranges for Calibration Plasma Values

7.4.7 – Reaction Times
Coagulometric and Special Tests
Chromogenic Tests
7.4.8 – Test Algorithms
Section 7.5 – Assay Performance Characteristics
7.5.1 – Assay Precision Performance, Linearity and Method Comparison Studies
7.5.2 – Assay Calibration Stability
Section 7.6 – Analytical Limitations
7.6.1 – Carryover
Assaying a contaminating sample
Assaying a contaminated sample
7.6.2 – Cephalin: needle self-conditioning
7.6.3 – Lipemic Samples
Section 7.7 – Container Specifications
7.7.1 – Primary Tubes
7.7.2 – Cup and Reagent Containers
Section 7.8 – Instrument Specifications
7.8.1 – Hardware and Operational Specifications
7.8.2 – Dimensions
7.8.3 – Data Bases Specifications
Section 7.9 – Ambient Specifications
Section 7.10 – Electrical Specifications
Section 7.11 – Hazards
7.11.1 – General Warning
7.11.2 – Shock Hazards
7.11.3 – Electrical Hazards
7.11.4 – Biohazards
7.11.5 – Mechanical Hazards
Addendum – Method Comparison Studies
NOTE: Please refer to the individual test definitions in the Setup menu on the analyzer for the
latest test library settings for each assay.
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7.1 Measured Parameters Chapter 7 – Assay and Instrument Specifications
7.1 Measured Parameters

This section describes some of the parameters measured by the ACL ELITE/ELITE PRO assays to
determine the test results. The tests are grouped according to their common methodology. A brief
explanation of the methods is given. Please refer to the current library in the analyzer for the latest
settings.
Some of these parameters may also be one of the reporting units used by the ACL, such as “seconds” for
the coagulometric tests. All measurements are used in the internal calculation of test results, either
related to calibration curves or processed in various ways to report other useful parameters as described
in Section 7.2 - Calculation of Results on page 367.
All parameters are measured on the ACL ELITE/ELITE PRO at 37°C ± 1°C, provided the ambient
temperature is kept within the range of 15°C to 32°C.
COAGULOMETRIC TESTS: PT, APTT, TT, Factors, Pro-IL-Complex*,

Hepatocomplex*,SCT, ProClot, and Pro S
The ACL monitors clot formation by light scatter (LS), measuring the time (t) expressed in seconds (s)
required to reach a selected point in the clot formation curve.
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FIBRINOGEN (PT-Based)
This Fibrinogen test is based on clot monitoring measurements as it records the light scattered before
and after the formation of the clot and calculates the difference between the two readings (delta light
scatter = ∆LS).
CHROMOGENIC and LATEX TESTS: Antithrombin, Heparin, Homocysteine, Plasmin

Inhibitor, Plasminogen, Protein C (Chromogenic), D-Dimer,vWF and Free Protein S
The ACL monitors photometrically the color development of the reaction, and calculates the difference
between the light absorbed at the beginning of the reaction and the light absorbed at a defined point
during the reaction (∆OD).
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FIBRINOGEN-C, FIBRINOGEN- QFA
The Fibrinogen photometry tests measure the time (sec) required for a pre-defined absorbance change to
occur. The time is then related to Fibrinogen concentration.
Fibrinogen-C results above 600 mg/dL (6 g/L) can be reflexed to the FIB-C h (high test). Fibrinogen QFA
is linear to 1000 mg/dL (10 g/L) and has no High test. Fibrinogen C results below 100 mg/dL (1 g/L) can
be reflexed to the FIB-C l (low test), while FIB QFA results below 150mg/dL (1.5 g/L) can be reflexed to
the FIB QFA L (low test).
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7.2 Calculation of Results Chapter 7 – Assay and Instrument Specifications
7.2 Calculation of Results

This section describes the ACL choices for calculation of results from the parameters measured for each
test. Some parameters are reported directly, such as “seconds” for the coagulometric tests. For other
tests, such as the chromogenic ones, the results are calculated based on the fit of optical measurements
to calibration curves, built by performing similar measurements on calibrators. The ACL offers unit result
choices for many of the tests, as it is capable of using the basic measurements for one sample and
processing them in different ways to derive several other values which are clinically significant (i.e.
ratios).
The table below summarizes the tests, the ACL measured parameters and the result formats that can be
reported by the ACL. The choice of the reported results is dependent on the instrument and analytical
conditions (i.e. pre-calibration, presence of AR in the run, units selection) as seen in the table below.
Tests Measured parameters Reported Results

PT Seconds s, %, R or INR
FIB (PT-based) Delta Light Scattering mg/dL or g/L
APTT Seconds s, R
Silica Clotting Time Seconds S, offset, final
TT Seconds S, R
Single Factor Seconds s, %
Antithrombin D O. D. %
Heparin, Liquid Heparin D O. D. U/mL
Homocysteine D O. D umol/L
Plasminogen D O. D. %
Plasmin Inhibitor D O. D. %
Pro-IL-Complex* Seconds s, %, R or INR
Hepatocomplex* Seconds s, %, R or INR
ProClot Seconds s, %, R
FIB-C, QFA Seconds mg/dL or g/L
Protein C (Chromogenic) D O. D. %
Protein S Seconds s, %
Free Protein S D O. D. %
VWF D O. D. Offset#, Max, %
F8 Chromogenic High/Low D O. D. %
D-Dimer D O. D. ng/mL, Offset#
APCR-V Seconds (S and Sa) s, R or INR

#Initial average absorbance reading for the reaction.
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Test Normal Plasma (AR) in run Stored calibration Not calibrated

PT with AR s, %, R, INR * s, R/INR *
(Correct ON) without AR seconds seconds
PT with AR s, %, R, INR * seconds
(Correct OFF) without AR seconds, % ** seconds
Fibrinogen with AR mg/dL, g/L test must be
without AR calibrated
APTT with AR this test does not seconds, Ratio
without AR require calibration seconds **
TT with AR this test does not seconds, Ratio
without AR require calibration seconds **
Silica Clotting Time this test does not seconds
require calibration
Antithrombin % , D OD D OD
Heparin U/mL, D OD D OD
Plasmin Inhibitor %, D OD D OD
Plasminogen % , D OD D OD
Protein C Chromogenic % , D OD D OD
D-Dimer ng/mL, D OD D OD
F8 Chromogenic H/L % , D OD calibrated each run
Free Protein S % , D OD D OD
Homocysteine U/mL, D OD D OD
Factors s, % seconds
ProClot s , %, R seconds
Fib-C s, mg/dL or g/L seconds
Pro S s,% calibrated each run
Pro-IL-Complex *** s, %, INR seconds
Hepatocomplex *** s, %, INR seconds
APCR-V # this test does not seconds (s and sa),
require calibration R, NR
* Thromboplastin ISI value is entered in Liquid setup

** Only in case R = S/AR
*** Not currently available in the U.S.
# ar is required for NR calculation
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7.2.1 Coagulometric Tests

PT (Prothrombin Time)
PT is measured in seconds. if Normal Plasma (ar) or a calibration curve is run, the ACL can
perform different calculations in order to report results in other formats: % activity, R (ratio
using AR) or INR (International Normalized Ratio).
In the example below, the (100% calibrator) is measured at 11 seconds (R=1), the 50%
dilution of Calibration Plasma measured at 15 seconds (R=1.36) and the 25% dilution is
measured at 21 seconds (R=1.9).
The Calibration Plasma (100% calibrator) value - in seconds - is used as denominator to

calculate the Ratio (R).
100% NP : 11 s → 11 ÷ 11 = 1 (R)
50% NP : 15 s → 15 ÷ 11 = 1.36 (R)
25% NP : 21 s → 21 ÷ 11 = 1.9 (R)
NOTES:
l If the PT test is run with “Correct with AR in Analysis” selected, the Analytical
Reference value in seconds is used to modify the calibration curve. The modified
curve is used for the calculation of the sample value.
l If the PT test is run with “Correct with AR in Analysis” not checked, the Calibration
Plasma value in the original calibration curve (100% point) is used for the calculation of
the sample value.
l Recalibrate the PT test when the lot of Wash-R or rotor lot (alpha character) changes.
l For more details, refer to Chapter 4 - Setup and Utility on page 153.
l Result as % activity: – The prothrombin activity of the sample is expressed as %
calculated from the calibration curve based on the R-value.
369 of 617 L0018200232 R01

l Result as R – R is the ratio between the sample value in seconds and the value in
seconds for either the AR, the Reference Value or one of the calibration standards (see
note above).
Sample APTT/TT in seconds

R (ratio) =
AR or Reference Value or Calibration Standard (in seconds)
l Result as INR: is the R-value normalized according to the ISI (Sensitivity Index). to
obtain this value, the ISI must be entered in the ACL software.
INR = RISI
APTT, TT
APTT and TT are measured in seconds. These tests do not require calibration. Normal
Plasma may be placed along with the samples in each analysis run, or a reference value
may be stored in the software. For additional information, refer to Chapter 4 - Setup and
Utility on page 153 (Test Setup).
seconds for AR or a Reference Value.
Sample APTT/TT in seconds

R (ratio) =
AR or Reference Value (in seconds)
APCR-V
This test is measured in seconds. Sa is the “activated time” and S is the “base time”.
l Result as R – R is the ratio between the value in seconds for Sa and the value in
seconds for S.
S in seconds
R (ratio) = a
S in seconds
l Result as NR – NR is the normalized ratio, the sample ratio value divided by the
Normal Plasma (AR) ratio value.
Sample Ratio value
NR =
AR Ratio value
370 of 617 L0018200232 R01

FACTORS
Factors are measured in seconds; the ACL also calculates the % activity based on a
calibration curve.
The calibration curves for Factor assays are composed of three segments: one High Curve
segment with higher concentration calibrators; one Low Curve segment with lower
concentration calibrators and one Medium segment which connects the high curve 25 %
calibration point with the Low curve 6.25% calibration point.
The Calibration Plasma (100% calibrator) value - in seconds - is used as the denominator to
calculate the Ratio (R).
For the High Calibration Curve segment:
100% NP : 40 s → 40 ÷ 40 = 1 (R)
50% NP : 50 s → 50 ÷ 40 = 1.25 (R)
25% NP : 60 s → 60 ÷ 40 = 1.50 (R)
The curve is constructed with Ratios (from seconds) on the x-axis and % Activity on the y-
axis, using a log-log scale.
For the Low Calibration Curve segment:
6.25% NP (log = 0.80) : 70 s → 70 ÷ 40 = 1.75 (R)
3.12% NP (log = 0.50) : 80 s → 80 ÷ 40 = 2.00 (R)
1.56% NP (log = 0.20) : 90 s → 90 ÷ 40 = 2.25 (R)
371 of 617 L0018200232 R01

The MEDIUM SEGMENT connects the 25% and the 6.25% points.
l Result as % activity – For the whole range of Multilinear Calibration Curve the ratio
between the sample value in seconds and the Calibration Plasma 100% value in
seconds is calculated and then used to read the value of Activity from the calibration
curve.
Refer to Section 3.4 - Calibration on page 127 for preparation of 6.25% dilution used to
calibrate low curve.
NOTES:
l All samples run for factor analysis are automatically diluted (x5) by the ACL system
during the analysis.
l Factors VIII and IX using either HemosIL SynthASil or HemosIL SP reagent can be
processed in the Parallelism mode. The system will perform 3 dilutions (100%, 50%
and 25%) on these samples.
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Pro-IL-Complex*
Pro-IL-Complex is measured in seconds; the ACL also calculates the % Activity based on a
calibration curve.
Below are some typical calibration data and a graphical example of a Pro-IL-Complex
calibration curve – 25% - 6.25 segment.
Ratio values are calculated using the 100% Standard as denominator. Therefore the
Calibration plasma must be placed on the sample tray when the Pro-IL-complex calibration is
run.
100%NP:40s→40 ÷ 40=1
25%NP (log = 1.40):65s→65 ÷ 40=1.63(log = 0.21)
12.5%NP (log = 1.10):95s→95 ÷ 40=2.4(log = 0.38)
6.25%NP (log = 0.80): 150s→150 ÷ 40=3.75(log = 0.57)
The 100% - 25% segment is constructed with Ratios (from seconds) on the
x-axis and 1/% Activity on the y-axis, using a linear scale.
The 25% - 6.25% segment is constructed with Ratios (from seconds) on the
x-axis and % Activity on the y-axis, using a log-log scale.
The sample activity is obtained by calculating the ratio between the sample value in seconds
and the 100% Calibration Plasma in seconds. This value is then read off of the calibration
curve to obtain the value of % Activity.
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HEPATOCOMPLEX*
Hepatocomplex is measured in seconds; the ACL also calculates the % Activity based on a
calibration curve.
Below are some typical calibration data and a graphical example of a Hepatocomplex
calibration curve.
100% NP : 18 s → 18 ÷ 18 = 1 (R)
50% NP : 27 s → 27 ÷ 18 = 1.5 (R)
25% NP : 36 s → 36 ÷ 18 = 2 (R)
The Calibration curve is constructed with Ratio on the x-axis and 1/Activity on the y-axis, on
a linear scale.
The sample activity is obtained by calculating the ratio between the sample value in seconds
and the 100% Calibration Plasma in seconds. This value is then read off of the calibration
curve to obtain the value of %
374 of 617 L0018200232 R01

Silica Clotting Time – Screen and Confirm
SCT is measured in seconds. These tests do not require calibration. Normal Plasma may be
placed along with the samples in each analysis run, or a reference value may be stored in the
software. For additional information, refer to Chapter 4 - Setup and Utility on page 153 (Test
Setup).
seconds for a Reference Value.
Sample screen result in seconds
Screen R (ratio) =
Mean of Screen Normal Range (in seconds)
Sample confirm result in seconds
Confirm R (ratio) =
Mean of Confirm Normal Range (in seconds)
Sample screen ratio
Normalized SCT (ratio) =
Sample confirm ratio
ProClot
ProClot is measured in seconds; the ACL also calculates the ProClot % Activity based on a
calibration curve.
Below are some typical calibration data and a graphical example of ProClot calibration curve.
100% NP : 165 s → 165 ÷ 60 = 2.75 (R)
50% NP : 120 s → 120 ÷ 60 = 2.0 (R)
0% NP : 60 s → 60 ÷ 60 = 1.0 (R)
The calibration curve is constructed with squared Ratio on the x-axis and Activity on the y-
axis, on a linear scale.
The sample activity is obtained using the squared Ratio (calculated using the sample value
in seconds and 0% calibrator value in seconds) to read the % Activity off the calibration
curve.
375 of 617 L0018200232 R01

FIBRINOGEN (PT-Based)
The ACL records the light scattered before and after the formation of a clot and calculates
the difference (∆LS) between the two readings.
The ACL calculates the fibrinogen value of the sample in mg/dL using a calibration curve.
The curve correlates the fibrinogen concentration of 3 calibrators with their ∆LS Ratios.
Below is some typical fibrinogen calibration data and the calibration curve constructed with
them.
Cal. Conc. (mg/dL) Delta LS Ratio (R)
300 60 60 ÷ 60 = 1
150 30 30 ÷ 60 = 0.5
75 15 15 ÷ 60 = 0.25
The Calibration curve is constructed with Ratio on the x-axis and Fibrinogen concentration
on the y-axis, on a linear scale.
The ACL calculates the ratio between the fibrinogen sample values (in delta LS) and the first
point of Calibration Plasma (in delta LS) to obtain the corresponding value in mg/dL from the
calibration curve.
376 of 617 L0018200232 R01

7.2.2 Chromogenic Tests

Antithrombin, Plasmin Inhibitor, Plasminogen,
Protein C (Chromogenic), Homocysteine
For these chromogenic tests, the ACL measures the difference between the light absorbed
at the beginning and at a defined point during the reaction (∆OD). The % activity of the
sample is calculated from a calibration curve built with 3 calibrators of known activity and
measured ∆OD. Below are examples of calibration curves for Antithrombin, Plasmin Inhibitor
Plasminogen and Protein C.
Heparin, Liquid Heparin
For Heparin, the ACL calculates the concentration of the samples in U/mL based on a
calibration curve. The calibration curve is built with 3 calibrators of known concentration and
measured ∆OD.
An example of a Heparin Calibration Curve is shown below.
377 of 617 L0018200232 R01

NOTE: For Antithrombin and Heparin, the delta OD is measured throughout the
reaction acquisition time of 30 seconds. For Plasmin Inhibitor, Plasminogen and Protein C
(Chromogenic) the acquisition time is 60 seconds.
D-Dimer
For the D-Dimer test, the ACL measures the difference between the light absorbed at the
beginning and at a defined point during the reaction (∆OD). The concentration of D-Dimer in
the sample, in ng/mL, is calculated from a calibration curve constructed by correlating the
calibrator’s delta OD values and their respective concentrations in ng/mL.
In case of patient results higher than 1050 ng/mL, the test can be rerun using the D-Dimer
high (D-D h) test which has a linearity from 1000 to 5250 ng/mL.
NOTE: The D-Dh test should only be run on patients with a D-Dimer sample
concentration greater than 1000 ng/mL.
An example of D-Dimer Calibration curve is shown below:
378 of 617 L0018200232 R01

Free Protein S
For the Free Protein S test, the ACL measures the difference between the light absorbed at
the beginning and at a defined point during the reaction (∆OD). The concentration of Free
Protein S in the sample, in %, is calculated from a calibration curve constructed by
correlating the calibrator’s delta OD values and their respective concentrations in %. The
calibration curve for the Free Protein S is constructed of 3 segments:
Segment 1:100% to 50%
Segment 2:50% to 25%
Segment 3:25% to 12.5%
An example of Free Protein S Calibration curve is shown below:
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7.3 Sample/Reagent Configuration and Specifications Chapter 7 – Assay and Instrument Specifications
7.3 Sample/Reagent Configuration and Specifications

7.3.1 Sample Requirements and Positions
The following tables indicate the materials that must be placed on the ACL ELITE/ELITE
PRO sample tray in order to perform each test, along with their respective positions. The
tables group the different types of tests.
In the Tables, Ax indicates the material map positions on the sample tray for positions A1 to
A10 to be used for Calibrators, Diluents, Buffer, Deficient Plasma, etc. The default positions
are defined in the Setup submenu of the ACL ELITE/ELITE PRO software.
For details, refer to Chapter 4 - Setup and Utility on page 153 and Appendix C – Special Test
Procedures on page 488.
COAGULOMETRIC TESTS
Positions
Test
Ax Ax Ax Ax 1-40
PT-FIB CAL Normal Factor
Pool Diluent
PT-FIB Normal Samples

Pool
APTT Normal Samples

Pool
TT Normal Samples
Pool
PT-FIB/APTT Normal Samples

Pool
SCT Normal Samples

Pool
FACTORS Normal Factor Diluted Normal Deficient Samples

(Calibration + Pool (100%) Diluent Pool* (6.25%) Plasma
Analysis)
DOUBLE TESTS
Positions
Test
Ax Ax Ax Ax 1-40
DOUBLE TEST Normal Samples

(PT-FIB, APTT, TT) Pool
Normal Pool = Calibration Plasma
*Diluted Normal Pool is prepared by placing 300ul of Factor Diluent + 20ul of Calibration Plasma in a 0.5mL cup. Mix
cup well prior to use.
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CHROMOGENIC and SPECIAL TESTS
Positions
Test
Ax Ax Ax Ax 1-40
AT Normal Factor Empty Empty Empty Cups
Calibration Pool Diluent Cup Cup Positions
1-12
AT Factor 1 – 20;
Analysis Diluent Empty Cups
Positions 21-
40
AT * Normal Factor Empty Empty
Calibration Pool Diluent Cup Cup
AT* Factor 1 - 40
Analysis Diluent
Heparin Empty Cup Calibrator Calibrator Working Dil.
Calibration
Heparin Working Dil. 1 – 40
Analysis
PI Normal Diluted 1 - 40
Pool Buffer
PLG Normal Factor substrate 1 - 40
Pool Diluent
PCX Cal.** Normal Factor DP # Empty
Pool Diluent cups
PCX Anal.** DP # 1 - 40
HPX Cal.** Normal Factor Empty DP #
Pool Diluent cups
HPX Anal.** DP # 1 - 40
PCL Normal Working Protein C Empty 1 - 40
Pool Diluent DP # Cup
FIB-C Normal Factor
Cal. Pool Diluent
FIB-C Factor 1 – 40
Anal. Diluent
PS Normal PS Activated PS 50% Std. 1 - 40
Pool DP # DP #
PC Normal Diluted Substrate 1 - 40
Pool Diluent
FPS Normal Factor Empty
Cal. Pool Diluent Cups
FPS Factor 1 - 40
Anal. Diluent
F8 chr H Normal Empty Empty F8 Chr 1 – 20;
Cal/Anal. Pool Cup Cup Buffer Empty Cups
Positions 21-
40
381 of 617 L0018200232 R01

Positions
Test
Ax Ax Ax Ax 1-40
F8 Chr L Empty Empty Diluted F8 Chr 1 – 20;
Cal/Anal. Cup Cup Normal Pool Buffer Empty Cups
Positions 21-
40
vWF Cal Normal Factor Empty vWF Buffer
Pool Diluent Cups
vWF Anal. Factor vWF Buffer
Diluent
D-Dimer Calibrator Buffer Factor
Calibration Pool Diluent
D-Dimer Buffer 1 - 40
Analysis
APCR-V Normal Factor V 1 - 40
Pool DP #
The Normal Pool can either be the IL Calibration Plasma or a laboratory’s pooled plasma.
* Liquid Antithrombin
** not currently available in the U.S.
# = Deficient Plasma
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7.3.2 Sample Positions in the Rotor (unused case)

The following table indicates, for each different test (or test combination in the case of double
tests), the positions occupied in the rotor by the materials needed to perform the assay. A
maximum of 19 samples are used.
Reference Optical
TEST Cal Curve NP Samples
Emulsion Reference
PT-FIB Cal. 100% 1-6 19
50% 7-12
25% 13-18
PT /APTT 1 2 - 19 20
SCT 1 - 19 20
TT 1 2 - 19 20
FACTOR 100% 1 7 - 19 20
(Cal+Anal) 50% 2
25% 3
6.25% 4
3.12% 5
1.56% 6
FACTOR 1 - 19 20
Analysis
DOUBLE 1 2 - 19 20
TEST
(PT-FIB,
APTT, TT)
Liquid - AT 100% 2-5 14 1
Cal. 50% 6-9
25% 10-13
Liquid - AT 2-9 20 1
Analysis
AT Cal. 100% 2-5 14 1
50% 6-9
25% 10-13
AT. 2 - 19 20 1
Analysis
Heparin 0.8 2-5 14 1
Calibration 0.4 6-9
0.0 10-13
Heparin 2 - 19 20 1
Analysis
PI / PLG 100% 2 5 - 19 20 1
50% 3
0%4
PCX 25% 5-8 17
Cal * 12.5% 9-12
6.25% 13-16
100% 1-4
PCX 1 – 19 20
Analysis *
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Reference Optical
TEST Cal Curve NP Samples
Emulsion Reference
HPX 100% 1-4 13
Cal * 50% 5-8
25% 9-12
HPX* 1 - 19 20
Anal.
PCL 100% 1 4 - 19 20
50% 2
0% 3
FIB-C 150% 2-5 14 1
Cal. 100% 6-9
50% 10-13
FIB-C 2 - 19 20 1
Anal.
PROTEIN-S 100% 1 4 - 19 20
50% 2
0% 3
PROTEIN-C 100% 2 5 - 19 20
50% 3
0% 4
FPS Cal. 100% 2-4 14 1
50% 5-7
25% 8-10
12.5% 11-13
FPS 2 - 19 20
Analysis
F8 Chr H/L 100% 2 5-19 20 1
Cal./Anal. 50% 3
25% 4
vWF Cal. 100% 2-5 18 1
50% 6-9
25% 10-13
12.5% 14-17
vWF Anal. 2 - 19 20 1
D-Dimer Cal. 1000 2 - 5 14 1
ng/mL 500 6 - 9
250 10 - 13
D-Dimer 2 - 19 20 1
Anal
APCR-V 1 3 - 10 (s) 19
and 11-18
2 (Sa)
In the chromogenic cycles, the Reference Emulsion serves as a check to

verify complete washing between samples and from rotor to rotor.
* Not currently available in the U.S.
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7.3.3 Coagulometric Test Volumes

The following tables summarize the sample and reagent volumes aspirated and dispensed
for each coagulometric test, including “head” volumes.
PT-FIB Cal
100%, PT-FIB
APTT & SCT TT
50% Analysis
25%
Sample Head 10 µL/sample 10 µL/sample 10 µL/sample 10 µL/sample
0
0
Sample Dispensed 50 µL 50 µL 53 µL 75 µL
25 µL
12.5 µL
Diluent Head --
10 µL/sample
10 µL/sample
Diluent Dispensed --
25 µL
37.5 µL
Reagent Head 10 µL 10 µL/sample 10 µL reagent 50 µL
10 µL per sample per rotor
10 µL 50 µL CaCl /rotor
2
Reagent Dispensed 100 µL 100 µL 53 µL reagent 75 µL
100 µL 50 µL CaCl
2
100 µL
NOTE: Conditioning of the needle for cephalin (APTT). When the APTT based
test is proceeded by a cycle using thromboplastin - PT, Factors of Extrinsic Pathway, Pro-
IL-Complex*, Hepatocomplex* and Protein S, the internal needle aspirates 90 µL of cephalin
or Clean A followed by an 80 µL air bubble. The cephalin or Clean A is then dispensed into
the waste reservoir. This step is repeated three times.
385 of 617 L0018200232 R01

l NP is the abbreviation for Normal Plasma.

l Std. is the abbreviation for standard used during in-session calibration.
** Std 4 to be prepared manually (20ul Cal plasma + 300ul factor diluent).
Standards for Single Factor assays
For Single Factor assays of the Extrinsic and Intrinsic Pathways, the Standards are as
indicated below:
HIGH CURVE segment LOW CURVE segment

1st Standard 100% 6.25%
2nd Standard 50% 3.12%
3rd Standard 25% 1.56%
The MEDIUM SEGMENT connects the 25% and the 6.25% points.
386 of 617 L0018200232 R01

7.3.4 Chromogenic/405 Filter Test Volumes

The following table lists the tests that use the 405nm filter on the ACL ELITE/ELITE PRO.
Details for each test can be either viewed on the screen or printed. The test information can
be obtained under the Setup, Tests, View Define menu. Once you highlight the test you can
either print the information by pressing the print Icon or you can press the detail Icon to view
the test.
The test volumes can be found in the Analysis Setup and Calibration Setup for each test*.
See Section 4.2.3 - Analysis – Loading Setup on page 213 and Section 4.2.4 - Calibration -
Loading Setup on page 223. The volume listed defined for each test do not include any
header volumes. The head volumes are as follows:
l Sample Head – 10ul/Sample

l Reagent Head – 10ul/cuvette when pipetted along with the sample (i.e. APTT
Cephalin).
l Reagent Head – 50ul/rotor when pipetted by itself into the rotor (i.e. APTT CaCl).
Chromogenic/405 filter Channel Tests

Test Abbreviation Test Name Test Code Number
PLG Plasminogen 212
PI Plasmin Inhibitor 213
PC Protein C 214
F8 Chr H Chromogenic VIII High 220
D-D D-Dimer 250
AT Anti-Thrombin 200
AT* Anti-Thrombin Liquid 199
HepXa Heparin-UHF 210
Hep Liq Liquid Heparin 218
Fib-C Fibrinogen Clauss 202
Fib QFA Fibrinogen QFA 290 (g/L), 294 (mg/dL)
vWF Von Willebrand Factor 400
Free PS Free Protein S 160
*Refer to the test library installed for the latest test detail information.
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7.3.5 Special Test Volumes

The following table list the Special tests on the ACL ELITE/ELITE PRO. Details for each
test can be either viewed on the screen or printed. The test information can be obtained
under the Setup, Tests, View Define menu. Once you highlight the test you can either print
the information by pressing the print Icon or you can press the detail Icon to view the test.
The test volumes can be found in the Analysis Setup and Calibration Setup for each test*.
See Section 4.2.3 - Analysis – Loading Setup on page 213 and Section 4.2.4 - Calibration -
Loading Setup on page 223. The volume listed defined for each test do not include any
header volumes. The head volumes are as follows:
l Sample Head – 10ul/Sample

l Reagent Head – 10ul/cuvette when pipetted along with the sample (i.e. APTT
Cephalin).
l Reagent Head – 50ul/rotor when pipetted by itself into the rotor (i.e. APTT CaCl).
Special Tests
Test Abbreviation Test Name Test Code Number
APCR-V Activated Protein C Resistance 225
HCY, HCYh Homocysteine 180 / 181
SCT-S, SCT-C SCT Screen/Confirm 155 / 156
PCX# Pro-IL Complex 150
HPX# Hepatocomplex 151
P-ClotSP Proclot SP 153
PS Protein S 159
*Refer to the test library installed for the latest test detail information.
#Not currently available in the U.S.
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7.4 Data Processing Features, Parameters and Analytical Chapter 7 – Assay and Instrument Specifications
Specifications
7.4 Data Processing Features, Parameters and Analytical Specifications

7.4.1 Flagging Limits
When results are outside acceptable limits, Low or High, the ACL flags them by displaying
them as --- / *** respectively or in a different color. There are three types of results that are
flagged in this manner:
1. Test results outside the instrument numeric reading scale capabilities

2. Linearity of calibration curves outside acceptable limits
3. Percent CV (%CV) for calibration cycles outside relative acceptable limits.
NOTE: Refer to the Calculation setup parameters for the most current limits on each
test. See Section 4.2.6 - Calculation Setup on page 235.
1. Tests Results Outside the Instrument Reading Scale Capabilities
These limits are imposed by the instrument electro-mechanical capabilities they are not
necessarily the same as the limits of the assay range.
NOTE: Check the Instrument settings and package insert included with the assay’s
reagents to obtain information about the range and the limitations of the assay.
The table below provides examples, for some common tests, which results are displayed in
black and which results are outside the limits and therefore displayed in red. Refer to the
current library installed on your system for the latest settings for all tests.
TEST Red Black Red --- / ***

PT < 15% 15-150% > 150% <0 - >500%
Fibrinogen < 40 mg/dL 40-800 > 800 <0 - >3000
< 0.4 g/L mg/dL mg/dL mg/dL
0.4-8.0 g/L > 8.0 g/L <0 - >30 g/L
Factors < 1% 1-150% > 150% <0 ->900%
Lyophilized < 15% 15-150% > 150% <0 ->900%
Antithrombin
Liquid < 15% 15-150% > 150% <0 ->900%
Antithrombin
PI < 10% 15-150% > 150% <0 ->500%
PLG < 10% 15-150% > 150% <0 ->500%
PC < 15% 15-150% > 150% <0 ->500%
Heparin <0.1 U/mL 0.1-1 U/mL > 1 U/mL <0 ->90 U/mL
Liquid Heparin <0 IU/mL 0 – 2.0 IU/mL >2.0 <-0.2->2.5
IU/mL IU/mL
Homocysteine <4.5 umol/L 4.5-30 N/A <2.4->30
umol/L umol/L
Pro-IL-Complex* < 4% 4-150% > 150% <0 ->900%
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Specifications
TEST Red Black Red --- / ***

Hepatocomplex* < 8% 8-120% > 120% <0 ->500%
ProClot < 10% 10-150% > 150% <0 ->500%
Protein S < 10% 10-150% > 150% <0 ->500%
FIB-C < 60 mg/dL 60-550 >550 <0 ->900 mg/dL
< 0.6 g/L mg/dL mg/dL <0 ->9.0 g/L
0.6-5.5 g/L >5.5 g/L
FIB QFA < 150 mg/dL 150-1000 >1000 <150 ->1200
< 1.5 g/L mg/dL mg/dL mg/dL
1.5 - 10 g/L >10.0 g/L <1.5 ->12.0 g/L
Free Protein S < 10 % 10- 140% > 140% <0 ->999%
F8 Chr H < 10 % 10- 120% > 120% <0 ->500%
F8 Chr L <0% 0- 10% > 10% <0 ->500%
SCT S/C <6.640 s 24 – 35 s >247.5 s <0 - >300
vWF < 10% 10- 150% > 150% <0 ->999%
D-Dimer <200 ng/mL 200-1050 >1050 <0 ->9999
ng/mL ng/mL ng/mL

- - - / *** Represents the operating limit of the system (scale range)
2. Linearity of calibration curves outside acceptable limits
The most reliable results are obtained when the linearity coefficient r2 of a calibration curve is
close to 1.000. The instrument flags r2 values outside respective acceptable limits. For
example, if a test had the acceptable limit set as > 0.980, results outside the limit would
display as:
l r2 < 0.980 - displayed in red

l 0.980 < r2 ≤ 1.000 - displayed in black
390 of 617 L0018200232 R01

Specifications
3. Percent CV (%Coefficient of Variation) for calibration cycles
When the calibration replicates %CV values are greater than programmed acceptable limits,
they are flagged in red. The table below lists the acceptable limits for each test. Refer to test
library for latest settings on all tests.
NOTE: For PT and Fibrinogen, calibrations are considered acceptable by the system
if the %CV is no more than 1% higher than the limit and the r2 is within the acceptable limits.
TEST Calibrator %CV limit

PT NP (100%) 1.5
NP (50%) 2.0
NP (25%) 2.0
FIB NP (100%) 8.0
NP (50%) 12.0
NP (25%) 12.0
Lyophilized AT NP (100%) 8.0
NP (50%) 6.0
NP (25%) 4.0
Liquid AT NP (100%) 8.0
NP (50%) 6.0
NP (25%) 4.0
Heparin Std 1 (100%) 8.0
Std 2 (50%) 6.0
Std 3 (25%) 4.0
Heparin Liquid Std 1 (100%) 5.0
Std 2 (40%) 5.0
Std 3 (0%) 5.0
Homocysteine Std 1 (100%) Not Defined
Std 2 (50%) Not Defined
Std 3 (25%) Not Defined
Std 4 (8.33%) Not Defined
HPX* NP (100%) 1.5
NP (50%) 2.0
NP (25%) 6.0
PCX* NP (100%) 2.0
NP (25%) 3.0
NP (12.5%) 4.0
NP (6.25%) 6.0
FIB-C NP (150%) 1.5
NP (100%) 2.0
NP (50%) 2.5
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Specifications
TEST Calibrator %CV limit

FIB QFA NP (150%) 5
NP (100%) 5
NP (50%) 5
NP (25%) 5
FPS NP (100%) 8
NP (50%) 8
NP (25%) 8
NP (12.5%) 20
vWF NP (100%) 5
NP (50%) 5
NP (25%) 7
NP (12.5%) 10
D-Dimer Cal 1 (1000 ng/mL) 4.0
Cal 2 (500 ng/mL) 6.0
Cal 3 (250 ng/mL) 10.0
7.4.2 Results Format: VDU and Printer

The format used to display and print numerical fields is dependent upon the value obtained.
The format cannot be changed. The following rules are used:
Value Range Format Example

X<1 x.yyy (3 decimal places) Concentration (U/mL)
1 ≤ x < 10 x.yy (2 decimal places) Time
10 ≤ x < 100 xx.y (1 decimal place) Activity
X ≥ 100 Xxx (or greater, depending on field size) Concentration (mg/dL)
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Specifications
7.4.3 Result Messages

The table below contains result messages that appear on the VDU or printer. This table
contains a list of the common messages that may appear on the ACL ELITE/ELITE PRO in
place of results, ordered by test, along with an explanation and suggestions to obtain a
numerical result.
General Messages Table
TEST MESSAGE Possible Explanation

PT Error 6 The sample does not clot within the programmed acquisition time.
Read the sample in Extended Time
Error 7 Fibrinogen< 60 mg/dL
Clotted sample analyzed
Normal plasma Normal Plasma out of range with respect to the reference data
value displayed (range ± 9% of the reference value). Results are flagged
in violet depending on calculation setup.
FIB *** on the The FIB value exceeds the high scale range limit.
sample Dilute the sample 1:2 with Factor DIL for high samples and repeat.
value > 800 Dilute the sample 1:2 to fit into the instrument operating range.
mg/dL on the
sample, in red
Normal Plasma Normal Plasma out of range (Range ± 20% of the reference value).
value displayed
in violet
Error 10 the clot may not be completely stabilized. Read the sample in the
Extended Acquisition Time
No FIB is given Light scatter exceeds the maximum readable limit of the amplifier.
for the sample. 1. Analysis mixture is very turbid and initially exceeds the readable
limit.
2. During clot formation the curve exceeds the readable limit.
Dilute the sample 1:2. to fit into the instrument operating range and
multiply results by 2.
APTT Error 6 The sample does not clot within the maximum end time. Read the
sample in Extended Acquisition Time
Error 7 - Fibrinogen < 60 mg/dL
- Clotted sample analyzed
Normal Plasma Normal Plasma out of range with respect to the reference data
value displayed (range ± 15% of the reference value).
in violet Results are flagged depending on calculation setup.
TT Error 6 The sample does not clot within the acquisition time. Read the
sample in Extended Acquisition Time
Error 7 - Fibrinogen < 60 mg/dL
- Already clotted sample
Normal Plasma Normal Plasma out of range with respect to the reference data
value displayed (range ± 20% of the reference value). Results are flagged
in violet depending on calculation setup.
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Specifications
7.4.4 Calibration Curve Slope (m)

The table below lists the expected slopes (m) for the calibration lines.
TEST Range of slope m

PT 0 - 0.2
FIB - mg/dL,(g/L) 0 – 1000, (0 – 10)
Factors 100% - 25% -20 – 0
25% - 6.25% -30 – 0
6.25% - 1.56% -30 – 0
Antithrombin (Lyophilized & Liquid) -2000 – 0
Homocysteine Not Defined
Plasmin Inhibitor -2000 – 0
Heparin -200 – 0
Liquid Heparin -50 –- -10
Plasminogen 0 – 1000
Pro-IL-Complex* -12 – 0
25%-6.25% segment
Pro-IL-Complex* 0 - 0.17
100%-25% segment
Hepatocomplex* 0 - 0.35
ProClot 0 – 200
FIB-C -10 – 0
PC 0 – 1000
Protein-S 0 – 10
Free Protein S 0 – 1000
vWF: Ag 0 – 1000
D-Dimer 0 – 6000

Refer to current test library in system for latest settings.
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Specifications
7.4.5 Calibration Curve Intercept (q)

In tests that require calibration (PT-FIB, Factors, Chromogenic Tests and Special Tests),
the calibration curve is best fitted to the measured points such that the first point (first
dilution) lays on the calibration line.
The following graphs illustrate the situation before and after the fitting to the first point.
The equation for a line is: Y = mX + q
Therefore: q = Y - mX
The graph displayed uses this first intercept “q”, as seen below.
The curve is then transported so it passes through the first point, and a new intercept q’ is
calculated:q’ = Y’ - mX’
The sample results for these calibrated tests are calculated from this new calibration curve,
which has an identical slope to the original one, but a different intercept.
7.4.6 Ranges for Calibration Plasma Values

Before analyzing samples, the ACL ELITE/ELITE PRO requires the user define the
corresponding value of the Calibration Plasma for each test. This is done in the Liquid setup
area of the software. For details refer to Chapter 4 - Setup and Utility on page 153.
When this area is accessed, a default value is displayed; the user enters the corresponding
value for the lot of Calibration Plasma in use.
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Specifications
7.4.7 Reaction Times

This section contains information about the different timings within the reactions for each
test measured by the ACL ELITE/ELITE PRO, including the details of the data acquisition
process. The tests have been divided into two groups which are treated separately:
Coagulometric/Special tests and Chromogenic tests.
COAGULOMETRIC TESTS and SPECIAL TESTS
The following diagram represents the general reaction for a Coagulometric and a Special
test:
The table below shows the specific reaction times for coagulometric and special test. Please
refer to the individual tests on the system for more details.
NOTES: Related to table below:
l BLANKING TIME = RAMP + INTER-RAMP INTERVAL (seconds)

l TOTAL ACQUISITION TIME = BLANKING TIME + ACQUISITION TIME (seconds)
or BLANKING TIME + DELAY + ACQUISITION TIME (seconds)
l EXTENDED time is available for PT-FIB, APTT and TT in single and double tests
mode.
COAGULOMETRIC Blank. Time Acq. time per point Acq. time Total Acq. time
TESTS (sec) (msec) (sec) (sec)§
PT/FIB Calibration* 4 100 58 62
PT/FIB Analysis*
(single, double)
standard 4 100 58 62
extended 4 150 165 169
APTT
(single, double)*
standard 4 100 115 119
extended 4 250 245 249
SCT S/C 4 250 245 245
TT 2 mL
extended 2 150 165 167
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Specifications
COAGULOMETRIC Blank. Time Acq. time per point Acq. time Total Acq. time
TESTS (sec) (msec) (sec) (sec)§
TT 5 mL
extended 4 150 165 169
TT 8 mL
extended 4 150 165 169
FACTORS
Extrinsic Pathway
Calibration + Analysis 4 150 165 169
FACTORS
Intrinsic Pathway
Calibration + Analysis 4 150 165 169
FACTORS
Ext.Pathway Analysis 4 150 165 169
FACTORS
Int.Pathway Analysis 4 150 165 169
*Check individual test definitions in the system for specific values.
Blank. time
SPECIAL Acq. time per point Acq. time Total Acq. time
(sec)
TESTS (msec) (sec) (sec)
Ramp, delay
Pro-IL-Complex # 4 + 20 250 275 299
Hepatocomplex # 4 200 220 224
ProClot 4 + 20 250 275 299
Protein-S 4 200 220 224
APCR-V 4 200 220 224
# Calibration and Analysis; not currently available in the U.S.
CHROMOGENIC TESTS
The following diagram represents the reaction for a 405 nm chromogenic assay:
The table below summarizes the reaction times:
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Specifications
Blank. time Acq. Time Total

CHROMOGENIC Acq. Time
(sec) per point Acq. Time
TESTS (sec)
Ramp, delay (msec) (sec)
Antithrombin 1 100 30 31
Liquid Antithrombin 1 50 20 21
Heparin 1 100 30 31
Liquid Heparin 0 100 60 60
Homocysteine 1 250 300 301
Plasminogen 1 100 60 61
Plasmin Inhibitor 1 100 60 61
Protein C (Chromogenic) 0 100 90 90
Fibrinogen-C 1 100 90 91
Fibrinogen QFA 1 100 90 91
Factor VIII (Chromogenic) 1 100 120 121
vWF : Antigen 1 250 300 301
Free Protein S 1 250 300 301
D-Dimer 2 250 300 303
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Specifications
7.4.8 Test Algorithms

The following table shows the algorithms that relate the Y-axis and X-axis for the parameter
measurements done on the ACL ELITE/ELITE PRO.
TEST CORRELATION Y X
PT Linear 1/Activity Ratio
FIBRINOGEN Linear C (mg/dL or g/L) Ratio
FACTORS Log Activity Ratio
AT, PLG, PC, PI Linear Activity ∆OD
HEPARIN Linear C (U/mL) ∆OD
Liquid Heparin Log/Log IU/mL ∆OD
Homocysteine Log umol/L ∆OD
PRO-IL-Complex* Log/Log Activity R
(25%-12.5%-6.25%)
PRO-IL-Complex* Linear 1/Activity R
(100% -25%)
HEPATOCOMPLEX* Linear 1/Activity R
PROCLOT Quadratic Activity R2
FIBRINOGEN C or QFA Log-Log/Log C (mg/dL or g/L) seconds
PROTEIN-S Linear Activity seconds
D-DIMER Linear 1/C (ng/mL) ∆OD
VWF Linear Activity ∆OD
Free Protein S Linear Activity ∆OD
* Not currently available in all countries.
399 of 617 L0018200232 R01

7.5 Assay Performance Characteristics Chapter 7 – Assay and Instrument Specifications
7.5 Assay Performance Characteristics

7.5.1 Assay Precision Performance, Linearity and Method Comparison
Studies
This section contains information about the analytical precision performance for selected
assays on the ACL ELITE/ELITE PRO. The tables displayed below include data obtained
during performance studies (for the purpose of system evaluation) conducted by or for
Instrumentation Laboratory. Please refer to the reagent package insert included in the
reagent kit for the latest performance specifications.
The data presented should be used as an example of typical precision performance for the
selected assays on the ACL ELITE/ELITE PRO.
Precision studies
The table below shows the within-run precision data obtained for 2 or 3 levels of controls,
during studies performed at IL on an ACL ELITE/ELITE PRO for the following IL reagents.
Within Run Precision
Within run precision assessed over multiple runs (10) using multiple levels of control plasma
gave the following results:
Precision Performance
Reagent Control Level n Mean %CV

Antithrombin Normal 30 112.3 2.33
(%) Abnormal 1 30 58.3 3.23
Abnormal 2 30 25.7 3.42
APCR-V Level1 40 0.98 1.82
(Normalized Ratio) Level 2 40 0.62 1.96
APTT-SP Normal 60 29.3 1.27
(seconds) Abnormal 1 60 49.2 0.98
Abnormal 2 60 61.3 1.72
D-Dimer Level 1 90 263 6.54
(ng/mL) Level 2 90 673 3.00
Factor VII (%) with Normal 40 78.9 3.32
PT-Fibrinogen Abnormal 1 40 55.7 3.01
Abnormal 2 40 24.4 4.04
Factor VIII (%) with Normal 40 77.0 8.39
APTT-SP Abnormal 1 40 84.0 6.67
Abnormal 2 40 39.2 6.67
Fibrinogen-C Normal 80 269.3 3.20
(mg/dL) Low Fibrinogen 80 97.2 2.09
Heparin 0.85 LMW Heparin 30 0.8 2.02
(U/mL) Low Heparin 30 0.3 4.33
High Heparin 30 0.7 2.65
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Reagent Control Level n Mean %CV

Plasmin Inhibitor Normal 50 110 1.21
(%) Abnormal 1 50 68.4 2.52
Abnormal 2 50 35.3 3.82
Plasminogen Normal 50 106.2 2.78
(%) Abnormal 1 50 69.2 2.94
Abnormal 2 50 31.3 3.31
ProClot (%) Normal 80 83.0 3.71
APTT-SP Abnormal 80 48.6 5.12
Protein -C Normal 40 95.4 1.68
(%) Abnormal 1 40 51.1 1.77
Abnormal 2 40 22.8 3.31
PT Normal 60 12.8 1.30
(seconds) Abnormal 1 60 19.2 1.75
Abnormal 2 60 29.1 2.07
PT-FIB Normal 90 243.0 7.06
(mg/dL) Low Fibrinogen 90 106.4 7.14
TT 8 mL Normal 90 17.9 3.39
(seconds) Heparin sample 90 22.8 3.57
Linearity Studies
Reagent No. of Levels Slope Intercept r Sample Range

Antithrombin 7 0.94 5.958 0.999 14-140
(%)
D-Dimer 10 0.97 6.229 0.998 56-1192
(ng/mL)
Factor VII (%) with 9 1.01 -4.036 0.997 1.9-132
PT-Fibrinogen
Factor VIII (%) 9 0.87 -0.508 1.000 2.3-127.5
with APTT-SP
Fibrinogen-C 7 1.10 -25.713 0.999 91-528
(mg/dL)
Heparin 7 0.97 -0.007 0.999 0.00-1.07
(U/mL)
Plasmin Inhibitor 7 0.94 6.677 0.997 0-115
(%)
Plasminogen 7 0.95 3.500 0.994 0-137
(%)
ProClot (%) 8 0.92 -0.129 1.000 0-171
APTT-SP
Protein -C 7 1.04 -0.338 1.000 0.5-173.5
(%)
PT 6 0.96 0.565 1.000 12-35
(seconds)
PT-Based Fibrinogen 9 0.95 15.621 0.997 0-567
(mg/dL)
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Method Comparison Studies
In method comparison studies evaluating citrated plasma samples, the ACL ELITE/ELITE
PRO results were similar to the predicate device’s (ACL9000) results as supported by the
summary of linear regression statistics below. The graphs are reported in the Addendum at
the end of this chapter.
No. of
Reagent Slope Intercept r Sample Range
Sample Levels
Antithrombin 48 1.08 -3.031 0.995 14-125
(%)
APCR-V 57 0.97 0.021 0.993 0.457-1.105
(Normalized Ratio)
APTT-SP 54 1.04 -1.471 0.998 27.5-96.2
(seconds)
D-Dimer 46 0.91 86.596 0.996 56-1083
(ng/mL)
Factor VII (%) with 48 1.02 -2.605 0.996 2.4-170
PT-Fibrinogen
Factor VIII (%) with 47 0.96 0.6184 0.990 0.96-199.2
APTT-SP
Fibrinogen-C 54 1.10 -14.032 0.998 74-766
(mg/dL)
Heparin 50 1.03 -0.002 0.996 0.00-1.21
(U/mL)
Plasmin Inhibitor 57 0.91 8.642 0.990 49.6-125.0
(%)
Plasminogen 57 0.99 3.525 0.989 18.4-150.8
(%)
ProClot (%) 54 0.98 1.912 0.995 10.7-199.1
APTT-SP
Protein -C 52 1.10 -5.781 0.998 22-317
(%)
PT 52 1.07 -0.838 0.999 10.4-25.1
(seconds)
PT-Based Fibrinogen 51 0.93 35.038 0.990 49.7-844.7
(mg/dL)
Thrombin Time-8 mL 54 1.01 1.010 0.998 15.5-43.5
(seconds)
Please refer to the end of this chapter for the Method Comparison Graphs.
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7.5.2 Assay Calibration Stability

Calibration stability studies were done at IL with a full range of controls in order to determine
the minimum amount of time that a calibration curve can be used for each assay. The results
for some of the assays on the ACL ELITE and ELITE PRO are shown in the table below.
TEST Calibration Stability

Factor II 5 days
Factor V 5 days
Factor VII 5 days
Factor VIII 5 days
Factor IX 5 days
Factor X 5 days
Factor XI 5 days
Factor XII 5 days
Fibrinogen-C 5 days
Antithrombin 5 days
Liquid Antithrombin 30 days
Heparin 5 days
Plasminogen 5 days
Plasmin Inhibitor 5 days
These time intervals should be used as guideline only. Use of Quality Control materials is
the best determinant of stability in your laboratory.
403 of 617 L0018200232 R01

7.6 Analytical Limitations Chapter 7 – Assay and Instrument Specifications
7.6 Analytical Limitations

7.6.1 Carryover
Studies performed on all members of the ACL family have shown sample carryover to be
less than 0.5% by volume.
In most cases, the inaccuracy contributed by the carryover factor is well within the expected
imprecision of the method; therefore, it is not statistically or clinically significant. The
condition and cleanliness of the sample probe are key factors in minimizing carryover.
The following exception cases were found to be statistically significant, although not
clinically significant (the amount of contamination will not shift an abnormal sample result
into the normal range):
1. When testing a plasma sample (PT or APTT) from a patient with a severe Factor
Deficiency (factor < 10%) immediately after a normal sample.
2. When testing an unusually high heparinized sample (> 10 U/mL) or samples from patients
undergoing aggressive factor replacement therapy, immediately after a normal sample.
Assaying a Sample treated with Hepzyme
Samples treated with Hepzyme should be processed in a separate run and not together with
untreated samples. After the run is complete a Cleaning cycle should be performed to rinse
out any residual Hepzyme material within the probe. Refer to Section 5.1.2 - Cleaning on
page 286. Processing Hepzyme treated samples in this mode will minimize residual
Hepzyme from contaminating subsequent non-treated samples. Instrumentation Laboratory
has not performed validation studies as it relates to the use of Hepzyme treated samples
with the HemosIL reagent line.
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7.6 Analytical Limitations Chapter 7 – Assay and Instrument Specifications
7.6.2 Cephalin: Needle Self-Conditioning

The reagent aspirating/dispensing needle does its own “self-conditioning” prior to using the
cephalin reagent.
When a test which uses cephalin is preceded by a cycle using thromboplastin (i.e. PT,
Single Factors of the Extrinsic Pathway, Pro-IL-Complex*, Hepatocomplex* or Protein-S),
the following procedure is repeated three times before aspirating the cephalin:
l Internal needle aspirates 90 µL of reagent or Clean A, followed by an 80 µL air bubble.

l Liquid is discarded into the waste reservoir.
7.6.3 Lipemic Samples

If a lipemic sample is tested on the ACL ELITE/ELITE PRO, the turbidity caused by the
lipemia may interfere with the fibrinogen measurement that is done by light scattering.
Lipemic specimens should preferably be cleared before testing on the ACL. However, since
studies have shown that there is a linear relationship between turbidity and fibrinogen values,
a correction factor has been introduced in the calculation of fibrinogen results based on the
initial offset of the sample in order to compensate for lipemic interference.
405 of 617 L0018200232 R01

7.7 Container Specifications Chapter 7 – Assay and Instrument Specifications
7.7 Container Specifications

7.7.1 Primary Tubes
The ACL ELITE/ELITE PRO sample tray accepts several kinds of primary tubes, in different
sizes and filling volumes, as specified in the table below.
Primary glass Anticoagulant Drawn Blood Total Volume

tube size (mm) Volume (mL) Volume (mL) (mL)
13 x 75 - Type a 0.50 4.5 5.0
13 x 75 - Type b 0.35 3.15 3.5
13 x 64 0.30 2.7 3.0
11.5 x 64 0.30 2.7 3.0
11.5 x 92 0.50 4.5 5.0
13 x 100 0.50 4.5 5.0
Type a
For drawn blood volumes of 4.5 mL (nominal value), the ACL can aspirate plasma with
tolerances of +10 to -20%.
For maximum sample collection (4.5 mL + 10%), the ACL can aspirate the correct amount of
sample if the hematocrit is ≤ 70%.
Type b
For drawn blood volumes of 3.15 mL (nominal value), the ACL can aspirate plasma with
tolerances of +10 to -20%.
For maximum sample collection (3.15 mL + 10%), the ACL can aspirate the correct amount
of sample if the hematocrit is ≤ 70%.
NOTE: The specifications above may be affected by the following variables:
l Lot and manufacturer variations of internal tube diameter.

l Time remaining to expiration date (level of vacuum decreases close to the end of the
tube life).
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7.7 Container Specifications Chapter 7 – Assay and Instrument Specifications
7.7.2 Cup and Reagent Containers

The following charts detail the specifications for the sample cups and reagent containers that
may be used on the ACL ELITE/ELITE PRO.
Sample Tray
Container
Volume Diameter Usable Volume Usable Volume
Type
Positions 1-40 Positions A1-A10
Sample Cup 0.5 mL 14 mm 0.4 mL In cup dilution only
Sample Cup 2 mL 14 mm 1.8 mL 1.9 mL
Sample Cup 4 mL 14 mm 3.8 mL 3.9 mL
Reagent Vial 4 mL 18 mm NA 3.6 mL
Reagent Area
Container
Volume Diameter Usable Volume Usable Volume
Type
Stirred Reagents Non-Stirred Reagents
Reagent Vial 10 mL 23 mm 8.3 mL 9.4 mL
Reagent Vial 16 mL 28 mm 13.2 mL 14.1 mL
NOTE: The reagent vials partially filled with PT-FIB and APTT reagents may be
topped with fresh reagent ONLY IF the reagent in the vial is still within the on-board stability
at 15 °C and the ratio between old reagent and fresh reagent does not exceed 1:2
(suggestion is to use one part of old reagent plus two parts of new reagents).
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7.8 Instrument Specifications Chapter 7 – Assay and Instrument Specifications
7.8 Instrument Specifications

7.8.1 Hardware and Operational Specifications
Temperature of the reagent reservoirs
10 - 16 °C
Temperature of the analysis area
37 ± 1 °C at ambient temperatures from 15 to 32°C
Coagulometric channel light source
Light emitting diode, λ=660 nm
Chromogenic channel light source
Halogen lamp, λ=405 nm w/filter
Chromogenic channel optical path
0.5 cm
Analytical cuvettes
Rotor units contain 20 cuvettes each
Number of rotors in rotor stack
12 maximum
Sample trays available:
1. For cups and primary tubes (13x75 mm - 5 mL & 13x64 mm - 3 mL)
2. For cups and primary tubes (13x100 mm - 5 mL)
3. For cups and Sarstedt primary tubes (11.5x64 mm - 5 mL and 11.5x92 mm - 3 mL)
Sample tray adapters
For 4 mL reagent containers and cups
Reagent containers
4 mL, 10 mL and 16 mL vials, cups
Reagent reservoir adapters
For 10 mL vial with stirrer (gray)
For 10 mL vial w/o stirrer (pink)
For 4 mL vial w/o stirrer (green)
Stirrer magnet reagent R1-R4
Size - 10x5 mm diameter; rotation speed - 250 rpm
Sample/reagent dispensing
Stainless steel pistons contained in an acrylic structure
Waste tube
PVC, 12 mm diameter
Cooling fans
two, with five blades and dust filter
Fuses
Two, T 6.3 A (for 100-240 Vac nom.)
PC keyboard
Standard
408 of 617 L0018200232 R01

Monitor
12.1” color LCD, with touch screen
Interface for data transmission to Host
RS 232C
Additional interfaces
One for optional Barcode Scanner
One for optional External Printer
Instrument structure
Expanded polyurethane designed for direct mounting of internal elements
7.8.2 Dimensions
Total height 60 cm
Height of analysis surface 33 cm
Width 100 cm
Depth 60 cm
Weight 63 Kg
7.8.3 Database Specifications

The table below provides specifications related to the maximum size of all Databases
included in the ACL ELITE/ELITE PRO software.
Description Maximum Size Type of Handling

N° of Patient IDs in Data Base 1000 FIFO
Number of Tests per Patient * 30 N/A
Number of Reaction Curves in Patients Data Base 800 FIFO
Number of Results in Each Single QC file 500 FIFO
Total number of QC Results in each Statistic file 65536 FIFO
Number of Reaction Curves in QC Data Base 200 FIFO
Total Number of QC Materials 50 N/A
Number of IL QC Materials 30 N/A
Number of Customized QC Materials 20 N/A
Number of Tests for each Single QC Material 20 N/A
N° of QC results in QC Data base 100 FIFO
Number of Results in AR Data Base 10-50-100- Selectable
500-1000
Number of Reaction Curves in AR Data Base 100 FIFO
Total Number of Operators 100 N/A
Total Number of Profiles 30 N/A
Number of Tests in a Single Profile 20 N/A
Total Number of Tests in the Library 300 N/A
Number of IL Tests in the Library 250 N/A
Number of Customized Tests in the Library 100 N/A
Total Number of Test Groups 60 N/A
Number of IL Test Groups 30 N/A
409 of 617 L0018200232 R01

Description Maximum Size Type of Handling

Number of Customized Test Groups 30 N/A
Number of Tests in a Single Test Group 6 N/A
Total Number of Materials (Liquids) in the Data Base 300 N/A
Number of IL Materials (Liquids) in the Data Base 200 N/A
Number of Customized Materials (Liquids) in the 100 N/A
Data Base
Number of Definable Loadlist 20 N/A
Number of Sample IDs in a Loadlist 40 N/A
Number of Steps used in a Test Application 30 N/A
Number of Materials (Liquids) used in a Test 36 N/A
Application
Number of Reflex Rules 60 N/A
Number of Criteria in each Single Reflex Rule 3 N/A
Number of Tests that can be generated by each 10 N/A
Single Reflex Rule
Number of Calibrations for Dedicated Session 1 FIFO
Number of Calibrations for In Session and In Run 5 FIFO
Number of Messages in the Session Error History 200 FIFO
Number of Messages in the File Error History 100 FIFO
Number of Messages in the Logbook 200 FIFO
Number of Messages in the Trace file Up to 1.4 MB Automatic
* Test in duplicate count for 3 results (first result, second result and mean)
FIFO = First In First Out
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7.9 Environmental Specifications Chapter 7 – Assay and Instrument Specifications
7.9 Environmental Specifications

The ACL ELITE/ELITE PRO pertains to the following class of instruments:
CATEGORY II
POLLUTION DEGREE 2
USE Indoors
The following ambient conditions apply to the ACL ELITE/ELITE PRO:
Ambient conditions for transport and storage
Temperature 5 - 40 °C
RH Maximum 95%, non-condensing
Functional ambient conditions
RH 15 - 85%, non-condensing
BP 500 to 1060 mbar
Altitude Maximum 2000 meters
Safety limit ambient conditions
RH Maximum 85%, non-condensing
BP 500 to 1060 mbar
Altitude Maximum 2000 meters
411 of 617 L0018200232 R01

7.10 Electrical Specifications Chapter 7 – Assay and Instrument Specifications
7.10 Electrical Specifications

FREQUENCY 50 and 60 Hz (nominal)
Frequency range 50/60 Hz
VOLTAGE 100 V to 240 V
Voltage tolerance ± 10%
Power Consumption Estimated 350 Watts
Fuses 2 x T 6.3 A
See also Section 2.1.3 - Electrical Requirements on page 50.
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7.11 HAZARDS Chapter 7 – Assay and Instrument Specifications
7.11 HAZARDS
7.11.1 General Warnings
The ACL ELITE/ELITE PRO analyzer can be used with a main voltage of 100 to 240 VAC
(50/60 Hz). An automatic power supply unit is provided with the instrument which allows the
use of the local 100-240 V power supply.
The analyzer must be plugged into a grounded power outlet.
In order to allow proper cooling around the analyzer, allow at least 15 cm (6 inches) of
clearance on the sides, back and top of the unit.
The ACL ELITE/ELITE PRO has been tested and found to comply with national and
international EMC and RFI requirements. These requirements are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
clinical/laboratory environment. This instrument generates, uses and can radiate radio
frequency energy. If harmful interference is produced as a result of installation and use other
than that recommended by the manufacturer, the user will be required to correct the
interference at his own expense.
See Section 1.9 - Symbols on page 45.
7.11.2 Shock Hazards

Operators and maintenance personnel of the ACL ELITE/ELITE PRO analyzer are urged to
follow sound electrical safety practices when using the instrument. Although all exposed
metal parts of the analyzer are at ground potential (0 volts), it should never be touched with
one hand while the other hand is touching a plumbing fixture, radiator, AC operated device or
other grounded object.
7.11.3 Electrical Hazards

1. Turn the analyzer OFF and unplug it from the power outlet before opening the body of
the analyzer, replacing components, and/or attempting any repairs.
2. Do not operate the analyzer in an atmosphere containing explosive gases, as the
components of the analyzer may generate sparks.
Earth Ground – Identifies an Earth Ground terminal.
Protective Ground – Identifies any GND terminal intended for

connection to an external GND conductor.
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7.11 HAZARDS Chapter 7 – Assay and Instrument Specifications
7.11.4 Biohazards
Since the ACL is used to work with products derived from human blood, all operator-
accessible parts of the analyzer should be considered potentially bio-hazardous. For this
reason, gloves and protective clothing must be worn during system operation.
When carrying sample trays loaded with samples, exercise caution to avoid spillage of
samples. Also avoid spilling fluids on the analyzer, and clean immediately if this occurs.
Inspect the surface of the analyzer frequently for visible spills and decontaminate if
necessary following the instructions in Chapter 1 - on page 1.
Follow the recommendations given in Section 5 for preventive and routine maintenance of
the instrument.
For additional information, refer to CLSI M29-A4: Protection of Laboratory Workers from
Occupationally Acquired Infections: Approved Guidelines, 4th Edition, 2014.
Instrumentation Laboratory complies with the Directive 2002/96/EC of the European

Parliament on Waste, Electrical and Electrical equipment (WEEE) . For instructions on End
of Life Disposal please contact your local distributor for further details.
7.11.5 Mechanical Hazards

The operator should pay attention to the moving parts of the instrument during normal
operation.
In particular the sample tray area should be accessed only in Ready state or using the STAT
(Pause) function to avoid mechanical hazard due to the needles arm movement.
Disclaimers
Instrumentation Laboratory, Inc. (IL) is responsible for the safety and electrical performance
of this equipment if and only if:
l Assembly operations, extensions, adjustments, modifications or repairs are carried

out by persons authorized by IL;
l The electrical installation of the room complies with the local, state or national
requirements (including a power supply circuit with independent grounding);
l The equipment is used in accordance with the instructions contained in this manual.
Bibliography
For additional information, refer to CLSI M29-A4: Protection of Laboratory Workers from
Occupationally Acquired Infections: Approved Guidelines, 4th Edition, 2014.
414 of 617 L0018200232 R01

ADDENDUM: Method Comparison Studies Chapter 7 – Assay and Instrument Specifications
ADDENDUM: Method Comparison Studies
NOTE: Analytical performance for the ACL 8/9/10000 and ELITE/ ELITE PRO are comparable.
Antithrombin (%)
APC Resistance V (Normalized Ratio)
415 of 617 L0018200232 R01

APTT-SP (Seconds)
D-Dimer (ng/mL)
416 of 617 L0018200232 R01

Factor VII (%) with PT-Fibrinogen
Factor VIII (%) with APTT-SP
417 of 617 L0018200232 R01

Fibrinogen-C (mg/dL)
Heparin (U/mL)
418 of 617 L0018200232 R01

Plasmin Inhibitor (%)
Plasminogen (%)
419 of 617 L0018200232 R01

ProClot (%) with APTT-SP
Protein-C (%)
Protein S (%)
420 of 617 L0018200232 R01

PT (Seconds)
PT-Based Fibrinogen (mg/dL)
421 of 617 L0018200232 R01

Thrombin Time - 8 mL (Seconds)
422 of 617 L0018200232 R01

Chapter 8 - Sample Collection and Storage
8.0 Introduction
Given the importance of coagulation tests in making diagnostic and therapeutic decisions, it is essential
to follow a detailed procedure for the collection and transport of blood specimens as well as for the
preparation of plasma used for these tests. Many variables such as the type of anticoagulant, the
storage of the sample, and the type of container used to draw blood will have an effect on the analytical
results.
The general procedures described below - which concern the collection of human blood samples from the
patient, their transport from the collection site to the laboratory, and their handling and storage in the
laboratory - are considered standard for any coagulation test.
8.1 Sample Collection

Venous blood must be drawn with minimal stasis using a plastic syringe or a vacuum filled test tube, as
recommended by CLSI Document H21.
For all tests concerning control of hemostasis, with the exception of the platelet count, the preferred
anticoagulant is trisodium citrate at the concentration recommended in CLSI Document H21, using a
ratio of 1 volume of citrate to 9 volumes of blood.
The correct concentration of the anticoagulant is of utmost importance for precision of the results. The
Document mentioned above must be referenced when adjustments to the citrate concentration are
required.
423 of 617 L0018200232 R01

8.2 Plasma Handling Chapter 8 – Sample Collection and Storage
8.2 Plasma Handling

8.2.1 Plasma Separation
The samples should be centrifuged at 2500 g for 15 minutes as soon as possible after
collection.
Hemolysis must be avoided during collection and centrifugation of the sample due to the
presence of red cells, which have phospholipid surfaces with thromboplastin activity that will
affect clotting times.
8.2.2 Plasma Transport

For recommendations on transporting plasma, please refer to CLSI Document H21.
8.2.3 Plasma Storage

For recommendations on storage of plasma, please refer to CLSI Document H21.
References
1. CLSI Document (latest revision) Collection, Transport and Processing of Blood
Specimens for Coagulation Testing and General Performance of Coagulation Assays.
2. ECCLS Vol. No. 1 Standard for Specimen Collection
3. CLSI Document (latest revision). Procedure for the Collection of Diagnostic Blood
Specimens by Venipuncture.
424 of 617 L0018200232 R01

Chapter 9 - Parts and Expendables
9.0 Introduction
This section contains information about the expendable materials that are available for use with the ACL
ELITE/ELITE PRO System. These items may be ordered from IL or its representative whenever they are
needed using the catalog numbers as shown in the table in Section 9.2 - Order Information for
Expendables on page 428. Many of these items are shipped in the “Startup Kit” included with the ACL
ELITE/ELITE PRO system, as indicated in Section 9.1 - Startup Kit below.
9.1 Startup Kit

The following expendable materials are contained in the Startup Kit that is shipped with the ACL
ELITE/ELITE PRO System:
Sample Trays
Three sample tray configurations are available. The startup kit includes one tray with conversion
adaptors. The user chooses the desired system configuration between the Short and Tall configuration.
Trays for the Sarstedt tubes must be ordered separately.
Tray type Used fo2qr

Short Primary tube, 3 or 3.5 mL total volume (13x75 mm)
Tall Primary tube, 5 mL total volume (13x75 or 13x100 mm)
S 11.5 Sarstedt type tube, 3 mL (11.5x66 mm) or 5 mL (11.5x92 mm)
Sample Tray Adapters
l For plastic cups - 4 pieces

l For 4 mL glass vials - 6 pieces
Reagent Vial Adapters
l For 10 mL vials, reagents requiring magnetic stirring (gray) - 4 pieces

l For 10 mL vials, reagents not requiring magnetic stirring (pink) - 6 pieces
l For 4 mL vials, reagents not requiring magnetic stirring (green) - 4 pieces
Magnetic Stirrers
l For reagent stirring - one package containing 6 pieces
Small Sample Cups
l 0.5 mL sample cups - one package containing 1000 pieces
425 of 617 L0018200232 R01

9.1 Startup Kit Chapter 9 – Parts and Expendables
Large Sample Cups
l 2.0 mL sample cups - one package containing 1000 pieces
Diluent/Buffer/Reagent Cups
l 4.0 mL cups, with labels - one package containing 100 pieces
Diluent/Buffer/Reagent Glass Vials
l 10 mL glass vials - one package containing 10 pieces
Block and Probes Assembly
l Assembly consisting of an acrylic block with the sample and reagent needles and their
associated liquid sensors
Sample and Reagent Tubing
l 1.5 meter piece of tubing to be cut and used as needed
Insertion Tool for Sample and Reagent Tubing
l Tool to be used when replacing sample and reagent tubing
Wash-R Emulsion
l 1-liter bottle of Wash Emulsion
Waste/Rinse Reservoir
l Reservoir for needle wash and rinse
Waste Bottle
l 5-liter bottle to collect ACL waste
Waste Tubing
l 1.5 meter piece of tubing to be used for collection of liquid waste
Adjustment Tool for Aspiration/Dispensing Needles
l Tool to be used to adjust the position of the needles in the arm
Rotors
l 20-Cuvette Rotors - package containing 100 pieces
Rotor Insertion Tool
l Tool used to insert rotors into the system
426 of 617 L0018200232 R01

9.1 Startup Kit Chapter 9 – Parts and Expendables
Rotor Waste Container
l Removable container used inside the system to hold the used rotors
Molded Air Filter
l One air filter for the analyzer body
Fuses 6.3 AT
l 2 fuses for the system
Power Cord
l The power cord included with the system is compatible with 100-115 V or 220-240 V.
Host Computer Cable
l Cable to connect the optional host computer
Software System Kit
l Kit containing the main system software
Test Library Kit
l Kit containing the test library software
Operator’s Manual
l Operator’s Manual for the use of the ACL ELITE/ELITE PRO system
Two-Button mouse pointing device
External Barcode Reader
l Standard with ACL ELITE PRO Only
Compliance Certificate
l Specific system compliance certificate
427 of 617 L0018200232 R01

9.2 Order Information for Expendables Chapter 9 – Parts and Expendables
9.2 Order Information for Expendables

Catalog # Pieces in
Item Description
Number Package Unit
0018110898* Sample Tray for 13x75 & 13x100 mm, (5 mL) tubes 1
0018181285 Sample Tray for Sarstedt 11.5x66 mm (3 mL) & 11.5x92 mm (5 mL) tubes 1
0019076400 Sample Tray adapter for plastic cup 4
0019076300 Sample Tray adapter for 4 mL vials 6
0018181265 Adapter for 10 mL reagent vials with magnetic stirring (gray) 4
0019076200 Adapter for 10 mL reagent vials without magnetic stirring (pink) 6
0019076100 Adapter for 4 mL reagent vials without magnetic stirring (green) 4
0009746606 Magnetic Stirrer 6
0018924100 Glass Vials, 10 mL 10
0006799200 Sample Cups, 0.5 mL 1000
0005575100 Sample Cups, 2 mL 1000
0006799400 Sample Cups, 4 mL 100
0006800000 Rotors- 20 cuvettes 100
0018181277 Rotor Refill Tool 1
0018110897 Rotor Waste Container 1
0018110843 Block Probe Assembly 1
0018103941 Needles Adjustment Tool 1
0007328901 Sample and Reagent Tubing, 1.5 meters long 1
0018181272 Sample and Reagent Tubing Extractor Tool 1
0018105769 Waste Reservoir, for needles wash 1
0018105769 Liquid Waste Bottle 1
0009909503 Waste Tube, 1.5 m 1
0018181271 Air Filter, molded 1
0006893102 Fuses 6.3 AT 2
0020002400 Wash/Reference Emulsion, 1 liter 1
0009757600 Factor Diluent (100mL) 1
0009831700 IL Test Cleaning Solution (Clean A) 1
0009832700 IL Test Cleaning Agent (Clean B) 1
0018420238 Host Computer Cable (9 pin – 9 pin) 1
0018200232 Operator’s Manual, English version 1
*Sample tray included in start-up kit.
428 of 617 L0018200232 R01

Chapter 10 - Warranty
10.0 Introduction
IL declares to the original Purchaser that each instrument manufactured and/or sold by IL shall be free
from defects in material workmanship and, under normal and proper use conditions, warrants it for a
period of one year from installation and no more than 13 months from the shipping date.
IL's obligation is limited to repairing, replacing or modifying (at IL's undisputed judgment) at IL's factory -
or elsewhere - the material whose defects have been verified, on condition that the Purchaser has
informed IL of any defects found within 8 days from receipt or from discovery in case of defects which
may not be identified in the normal inspection.
Damages caused by or connected to transport are excluded. Transport to and from IL’s Factory will be at
Purchaser's charge and risk and shall be paid also for reshipment.
These replacements, repairs or alterations will in no case determine extension to the above specified
warranty period.
This warranty does not cover those parts which deteriorate or which are considered consumables or
those parts or items which by their nature are normally required to be replaced periodically consistent
with normal maintenance (including without limitation lamps, and tubes).
Those instruments or accessories, which are supplied by IL but are not of IL manufacture will only
benefit from the warranty conditions offered by the manufacturer.
It's also understood that, following the purchase and delivery of the instrument, the Purchaser shall be
deemed liable for any losses, damages or complaints concerning persons or things incurred by the use or
misuse of the instrument on behalf of the Purchaser, his employees, co-operators or others.
IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the
measurements as well as for any damage to the instrument directly or indirectly resulting from the use of
reagents and/or consumables different from those produced by IL specifically for its own instruments on
the same properly tested.
Warranty will not apply to those defective instruments or materials showing defects or damage arising
from the following causes:
a. Insufficient or negligent care by the Purchaser.
b. Insufficient or negligent maintenance by the Purchaser in relation to the instructions contained in the
manuals prepared by IL for this purpose, tampering or alterations of the instruments or in any case
intervention or repairs made by any person not duly authorized by IL.
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10.1 Disclaimer Regarding Non-IL Brand Products Chapter 10 – Warranty
c. Misuse due to carelessness, negligence or inexperience.
d. Employment of materials under heavier conditions than those for which they had been designed and
manufactured and use of the same in combination with incompatible or dangerous products.
e. Non-observance of regulations relative to installation, power supply and operation of the instruments
(with particular regard to the regulations for accident prevention).
10.1 Disclaimer Regarding Non-IL Brand Products

IL brand reagents, consumable and expendable supplies (including, for example, wash reference
emulsion and rotors) were developed specifically for the ACL's centrifugal, nephelometric clot detection
system. IL's ACL system products are tested to assure proper performance when using plasma samples
in accordance with the collection protocol described in Chapter 8 - Sample Collection and Storage on
page 423. Each lot of IL brand ACL reagents is tested against these criteria. Verification of other brands
of reagent or supplies to ascertain their suitability for the ACL's methodology or their level of performance
on the IL ACL instruments is not performed. The use of non-IL brand reagents or supplies for testing
which is not done in accordance with IL protocols may cause a clinically significant degradation of
performance and results.
IL does not assume any obligation or warranty engagement concerning precision and/or accuracy of the
measurements as for any damage to the instrument directly or indirectly resulting from the use of
reagents, consumables and expendable supplies different from those produced by IL.
THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED. PURCHASER AGREES THAT THERE IS NO WARRANTY OR
MERCHANTABILITY AND THAT THERE ARE NO OTHER REMEDIES OR WARRANTIES,
EXPRESSED OR IMPLIED, WHICH EXTEND BEYOND THE CONTENTS OF THIS AGREEMENT.
No agent or employee of IL is authorized to extend any other warranty or to assume for IL any liability
except as above set forth.
IL does not test other manufacturer reagents to ascertain their suitability for the ACL's methodology or
their level of performance on the IL ACL instruments.
ACL Warranty
The following items are considered as consumable parts:
l Fluidic Tubing
l Sample Probe
430 of 617 L0018200232 R01

Chapter 11 - IL Worldwide Locations
For locations not listed in this topic, visit the IL International website at http://international.werfen.com.
IL Locations Listed in this Topic
l Instrumentation Laboratory Headquarters
l Werfen Corporate Headquarters
US, Canada, Latin America, and South America
l Brazil l Mexico
l Canada l Uruguay
l Columbia l USA
Pacific Region
l Australia l Japan
l China l South Korea
l Hong Kong l Thailand
l India
Europe, Middle East, Africa
l Austria l Lithuania
l Belgium l Netherlands
l Czech Republic l Poland
l France l Portugal
l Germany l Russia
l Hungary l Spain
l Italy l United Kingdom
431 of 617 L0018200232 R01

Chapter 11 – IL Worldwide Locations
Instrumentation Laboratory Headquarters

Instrumentation Laboratory
180 Hartwell Road
Bedford, MA 01730
USA
Phone: 781-861-0710
Website: www.ilus.com
Werfen Corporate Headquarters

Werfen Espana
Plaça d'Europa 21-23 - L'Hospitalet de Llobregat
08909 Barcelona
Spain
Phone: +34-93-4010101
Website: www.werfen.com
432 of 617 L0018200232 R01

US, Canada, Latin America, and South America

Brazil
Werfen Brasil
Avenida Tambore, 267
Edificio Canopus – Torre Sul – 25° andar
06460-000, Alphaville – Barueri – SP, BRASIL
Phone: + 55 11 41543337
Website: br.werfen.com
Canada
Instrumentation Laboratory (Canada) Ltd.

155 East Beaver Creek, Unit 24,
Suite 882 Richmond Hill
Ontario L4B 2N1
Canada
Phone: 800-552-2025 x6115
Fax: 800-732-3675
Columbia
Werfen Colombia
Calle 100 N° 8A - 55 Torre C Oficina 602
World Trade Center
Bogotá
Colombia
Phone: +57 1 6167513
Mexico
Werfen IL Mexico
Lago Victoria No. 80
11520 - Col. Granada D.F.
Mexico
Phone: +52-55-5262-1760
Fax: +52-55-5262-1763
Website: mx.ilwerfen.com
433 of 617 L0018200232 R01

Uruguay
Werfen Uruguay
Dr. Alfredo Navarro 3136
11600 - Montevideo
Uruguay
Phone: +5982-481-81-33
Fax: +5982-481-81-33
USA
Instrumentation Laboratory
180 Hartwell Road
Bedford, MA 01730
USA
Phone: 781-861-0710
434 of 617 L0018200232 R01

Pacific Region
Australia
Werfen Australia Pty. Limited

59-61 Dickson Ave.
Artarmon, NSW 2064
Australia
Phone: +61-2-9098-0200
China
Werfen China
Building B18B. Universal Business Park
#10, Jiiuxianqiao Middle Rd. Chaoyang District
Beijing, PRC
Phone: +86-10-5975-6055
Website: cn.werfen.com
Hong Kong
Werfen Hong Kong

31st Floor, No. 88 Hing Fat Street
Causeway Bay, Hong Kong
Phone: 852-2683-9500
India
Werfen India
Office No. 271-274, Aggarwal Millenium Tower - II, Plot no. E-4
Netaji Subhash Place, Pitampura
New Delhi - 110034
INDIA
Phone: +91-11-49029550
Fax: +91-11-49029567
Website: www.il-india.com
Japan
Werfen Japan
1-3-30 Mita, Minato-ku
Tokyo 108-0073 Japan
Phone: +81 3 5419 1301
Fax: +81 3 5419 1302
Email: info@il-japan.jp
Website: jp.werfen.com
435 of 617 L0018200232 R01

South Korea
Werfen Korea
101 Nashil Bldg. 48, Nonhyeon-ro 105-gil
Gangnam-gu (604-1 Yeoksam-dong)
135-907 Seoul, South Korea
Phone: +82-2-571-2207
Website: kr.werfen.com
Thailand
PCN Healthcare Co., Ltd.

Bangkok 10700
Thailand
Phone: +66 2 881 2800-3 (4 lines)
Fax: +66 2 881 2804
Website: http://international.werfen.com
Email: pisit@pclholding.com
Email: nipon@pclholding.com
436 of 617 L0018200232 R01

Europe, Middle East, Africa

Austria
Werfen Austria
Tillmanngasse 5
1220 Vienna
Austria
Phone: 43-1-2565800 0
Fax: 43-1-2565800-88
Website: at.werfen.com
Belgium
Werfen Benelux
Excelsiorlaan 48-50 bus 8
1930 Zaventem (Brussels)
Belgium
Phone: +32-2-7252052
Fax: +32-2-7212409
Website: benelux.werfen.com
Czech Republic
Werfen Czech s.r.o

Pocernicka 272/96
108 00 - Praha 10
Czech Republic
Phone: +420-246090931
Fax: +420-246090935
Website: cz.werfen.com
France
Werfen France
88-94 rue André Joineau
93310 Le Pré Saint Gervais
France
Phone: +33-1-82308600
Fax: +33-1-82308601
Website: fr.werfen.com
437 of 617 L0018200232 R01

Germany
Werfen GmbH
Klausnerring 4
D-85551 Kircheim
Germany
Phone: +49-89-909070
Fax: +49-89-90907112
Website: de.werfen.com
Hungary
Werfen Hungary KFT

Montevideo u 2/c
H-1037 Budapest
Hungary
Phone: +36-1-882-7310
Fax: +36-1-882-7319
Website: hu.werfen.com
Italy
Instrumentation Laboratory SpA
V.le Monza 338
20128 Milan
Italy
Phone: +39-02-25-22-1
Fax: +39-02-25-75-250
Website: it.werfen.com
Lithuania
Werfen Lithuania
Savanoriu 281A
50128 Kaunas
Lithuania
Phone: +370-37-313201
Fax: +370-37-313159
Website: lt.werfen.com
438 of 617 L0018200232 R01

Netherlands
Werfen B.V.
Brugsteen 6
4815 PL Breda
Netherlands
Phone: +31-76-548-0100
Fax: +31-76-5480102
Website: benelux.werfen.com
Poland
Werfen Polska Sp. z o.o.

Wolinska 4
03-699 Warszawa
Poland
Phone: +48-22-3361840
Fax: +48-22-3361850
Email: pfik@werfen.com
Website: www.comesa.pl
Portugal
Werfen Portugal
Rua do Proletariado, 1 - Quinta do Paizinho
2790-138 Carnaxide, Lisboa
Portugal
Phone: +351-21-4247300
Website: pt.werfen.com
Russia
Werfen IL Russia
Dmitry Ulyanov Street, 31
Moscow, Russia 117447
Phone: +7-499-271-9615
Email: office@instlab.ru
Website: ru.ilwerfen.com
Spain
Werfen Espana
Plaça d'Europa 21-23 - L'Hospitalet de Llobregat
08909 Barcelona
Spain
Phone: +34-93-4010101
439 of 617 L0018200232 R01

United Kingdom
Werfen United Kingdom

Kelvin Close – Birchwood Science Park
Warrington, Cheshire WA3 7PB
United Kingdom
Phone: +44-1925-81-0141
Fax: +44-1925-82-6708
Website: uk.werfen.com
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Appendix A
ACL Elite/Elite Pro
Host Communication Protocol
Revision 2.5
November 2011
441 of 617 L0018200232 R01

Appendix A - Host Communication Protocol
Revision Table
Revision Date Comments

December 07-2002 Added transmission examples
Specified ASTM field numbers
Add Notes for information
Total number of pages
Reviewed Test Codes
December 16-2002 Review some Notes
April 2004 Error code update
December 2005 ELITE/ELITE PRO update
January 2010 ELITE/ELITE PRO updated test list and errors
November 2011 ELITE/ELITE PRO updated test list
442 of 617 L0018200232 R01

Appendix A - Host Communication Protocol
Contents

1.1 Purpose 444
2.1 Product Perspective 445
3.0 Specific Requirements 446
3.1 Protocol Specification 446
3.2 Low Level Interface 446
3.3 Data Link and Logical Layer 446
3.4 Sessions 446
3.4.1 Message Header and Message Terminator Records 447
3.5 Test Order Downloading 448
3.5.1 Receive Session from DMS 448
3.5.1.1 Test Request Message 450
3.5.1.2 Test Order Message 451
3.5.1.2.1 Patient Information Record 451
3.5.1.2.2 Test Order Record 453
3.5.2 Host Query 455
3.5.3 Test Request Message 457
3.5.4 Test Order Message 458
3.6 Rejected Test Order 459
3.7 Download Session Volumes 461
4.0 Test Results Uploading 462
4.1 Test Result Message 463
4.1.1 Patient Information Record 463
4.1.2 Test Order Record 465
4.1.3 Result Record 467
4.1.4 Comment Record 469
4.1.5 Error Codes 470
4.2 Upload Session Volumes 472
5.0 Not Supported Records 473
6.0 Transmission Abort 473
7.0 ELITE/ELITE PRO Test Codes 474
8.0 ELITE/ELITE PRO Supported Characters 478
8.1 Supported Characters for Sample ID 478
8.2 Supported Characters for Patient name, Department and Units 478
8.3 Supported Characters for delimiters 478
9.0 ELITE/ELITE PRO Supported Units 479
443 of 617 L0018200232 R01

1.0 Introduction Appendix A - Host Communication Protocol
1.0 Introduction
1.1 Purpose
This document is a guide to integrate a Laboratory Information Management system with the
Instrumentation Laboratory ELITE/ELITE PRO family instruments using the ASTM (American Society
for Testing and Materials) specification to transfer information between clinical instruments and
computer systems.
ASTM specification E-1394-91 Standard Specification for Transferring Information between Clinical
instruments and Computer Systems and E-1381-91 Standard Specification for the Low Level Protocol to
transfer Messages between Clinical Laboratory Instruments and Computer Systems have been used as
standard to develop ELITE/ELITE PRO Host Communication Protocol.
Specification E-1394 defines the logical layer of ASTM standard; all significant information for
ELITE/ELITE PRO instruments application can be found in chapters Specific Requirements and
following.
Specification E-1381 refers to low level protocol; significant information for ELITE/ELITE PRO family
instruments application can be found later on in this document.
444 of 617 L0018200232 R01

2.0 General Description Appendix A - Host Communication Protocol
2.0 General Description

2.1 Product Perspective
Communication sessions with host computer can be started on ELITE family instruments by operator
request or automatically at session completion. If the operator requires a manual download session, the
instrument will open communication with the host computer that will provide transmission of all test
orders. If the operator requires an upload session, the instrument will transmit a subset of sample results
(identified by the user) stored in the instrument patient, QC or Analytical Reference databases.
If the instrument is properly configured, automatic downloading or uploading sessions can be started by
ELITE/ELITE PRO instrument. Automatic downloading will occur at session start if host query is
configured. In this condition the instrument will request test orders for specific sample IDs recognized on
the sample tray.
The second condition will occur, if automatic uploading has been requested, at session completion.
In case the communication session is not generated from the instrument, any host computer message is
ignored.
All information received by the host computer must be associated with a Sample ID which is the primary
key of the database. In addition to programmed tests a certain amount of information can be associated
with a Sample ID (patient data) and stored in ELITE/ELITE PRO database. This information is optional.
The sample ID is the primary key to access information in the database. If the checks fail, any
downloading operations will be aborted. See Section 3.5 - Test Order Downloading on page 448
At most 1000 samples can be stored in ELITE/ELITE PRO database; each sample can have a
maximum of 30 tests associated (double tests are considered as 3 tests). The system behavior when
these limits are exceeded is explained in the paragraph Test Order Downloading.
If 1000 samples are present in the database, the FIFO (First In First Out) will not accept additional
samples during a manual download.
The test ordering operation, to identify the type of ordered test, by host computer must refer to a
computer code that is instrument specific. Refer to Section 3.5 - Test Order Downloading on page 448
for further details, and also to Section 7.0 - ELITE/ELITE PRO Test Codes on page 474.
NOTE: For the downloading, the Host should send to the ELITE/ELITE PRO string information
in single frame (single line) during the transmission, or up to 240 bytes maximum during the
transmission.
445 of 617 L0018200232 R01

3.0 Specific Requirements Appendix A - Host Communication Protocol
3.0 Specific Requirements

3.1 Protocol Specification
3.2 Low Level Interface
Low level interface conforms to ASTM specification E-1381-91. The following characteristics are
supported and are configurable by Operator Interface:
Baud Rate 2400, 4800, 9600, 19200, 38600

Character Length 8 bit
Parity No parity
Stop Bits 1
3.3 Data Link and Logical Layer

For the Data Link and Logical Layer the ASTM specification E-1381-91 has been maintained as a
reference. Protocol limits and constraints are those declared by the standard.
To mention some of them, the data part of the frames exchanged between the instrument and the host
computer should be done as single frame. As a consequence during transmission sessions specific
routines provide the ability to divide large records into multiple frames and during a reception session
they re-build partial frames in a single record. The application level has no evidence of this mechanism.
According to ASTM standard the following characters cannot be part of data records: <SOH>, <STX>,
<ETX>, <EOT>, <ENQ>, <ACK>, <DLE>, <NAK>, <SYN>, <ETB>, <LF>, <DC1>, <DC2>, <DC3>,
<DC4>.
Timeout and retry logic are those specified by the standard; the Low Level Clinical Message State
Diagram representing the implemented automatic is the reference.
In interrupt request status the instrument accept remote EOT.
3.4 Sessions
There are two types of sessions that the instrument handles with the ASTM interface: the test orders
download and the test results upload. These sessions can be initiated by the operator or automatically
activated by the instrument.
When the user/operator requests a download operation (Receive Command), the instrument will send a
request to the host for available test orders (all) or for test orders requested for specific samples, and the
host will answer with the test orders available for the instrument.
Test results upload (Transmit Command) are initiated by the user or automatically by the instrument at
the same way. The host is not allowed to transmit unsolicited messages, any type of inquiries or test
orders not explicitly required by the instrument.
446 of 617 L0018200232 R01

3.4 Sessions Appendix A - Host Communication Protocol
3.4.1 Message Header and Message Terminator Records

Following ASTM specification, each type of transaction between the instrument (DTE) and
the host computer (DCE) has two common records that are the Message Header record and
the Message Terminator record. These records open and close data transmission between
ELITE/ELITE PRO instruments and host computer.
Their fields are described in the following:
Message Header Record

Record Type ID Always set to ‘H’
Delimiter Definition The 5 ASCII characters composing this field define the
type of delimiters that will be used in the following
records. See Section 8.3 - Supported Characters for
delimiters on page 478 (Appendix A).
Message Control ID Not provided
Access Password Not provided
Sender Name or ID Set to ‘ACL9000’ when transmitting to host or receiving.
As an option, the ability to identify univocally the
instrument by means of an extension to the instrument
name is also supported: the name syntax becomes
‘ACL9000-xx’ where xx is a two digit code in the range
01-99.
The extension to the instrument name is user
configurable in the set-up environment.
The instrument ID is always ACL9000 independently from
the model; ELITE/ELITE PRO.
Sender Street Address Not provided
Reserved Fields Not provided
Sender Telephone Number Not provided
Characteristics of Sender Not provided
Receiver ID Must be set to ‘ACL9000’ when receiving from host.
Depending on the instrument set-up, the ability to identify
univocally the instrument by means of the extension to the
instrument name is also supported: the name syntax
becomes ‘ACL9000-xx’ where xx is a two digit code in the
range 01-99.
If the ID is different from the expected one, the session is
interrupted.
Comment or special Instructions Not provided
Processing ID Always set to ‘P’ meaning Production
Version No. Set to the current ASTM standard version = ‘1’
Date and Time of Message Format is yyyymmddhhmmss
Example of message sent from the ELITE/ELITE PRO :
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
Example of message sent from Host:
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
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3.5 Test Order Downloading Appendix A - Host Communication Protocol
Message Terminator Record

Record Type ID Always set to ‘L’
Sequence Number Always set to ‘1’
Termination Code Set to ‘N’ for normal termination and to ‘E’ for abnormal termination while
transmitting to host; not considered for received data
Example of Terminator:
L|1|N<CR>
3.5 Test Order Downloading

Test order downloading is used to request test orders available on the host and to have them on the
instrument. This operation can be obtained in two ways: manually opening a download session from the
Document Management System (DMS) environment or enabling on the instrument the host query
function.
In the first case the host will have to transmit to the instruments all pending test requests; in the second
case the instrument will automatically require specific information for the samples placed on the sample
tray and without any test requests.
Details for both modalities are explained in Receive Session from DMS and Host Query paragraphs.
3.5.1 Receive Session from DMS

The operator manually initiates the test order download from the Document Management
System (DMS) environment. The host will provide to the instrument all available test
requests. The host can send zero or more test orders in one or more messages, but all
messages will be part of the same transmission session.
During a transmission session more test orders can be required for the same sample. The
host sends usually all test orders for which it has not yet received results even if they have
been previously transmitted.
ELITE/ELITE PRO instruments will process each received test order to validate fields
supported; some information will be extracted from the received record while other
information will be ignored. Only test orders related to patient samples are considered, if the
required sample ID does not exist in the patient database and the required sample ID is not
used in the QC database, a new record is created. If the database is full, the transmission
session will be aborted.
If the test orders are for a sample already existing in the sample data base, the new orders
will be added to the existing tests but all tests already ordered or performed will remain
unchanged.
If a test order with more than the maximum number of programmable tests is sent, the
request is rejected. The limit is 30 single tests or 10 double tests.
448 of 617 L0018200232 R01

If the test order is not recognized as one of those supported by ELITE/ELITE PRO family
instruments, it is rejected. The instrument will inform the host computer using a record
containing the list of rejected test orders.
During a downloading session the listed error conditions can be detected, the associated
instrument behavior and actions are listed as well:
Error Condition Action User Message

Sample ID used in the QC data base Abort communication Sample ID already used
in the QC data base
Bad Sample ID (long, unsupported Abort communication Invalid Sample ID
characters)
Data Base full Abort communication Patient Data Base is full
Patient record has no associated test Abort communication Not identified sample ID
order record for patient data
Test order has no associated patient Abort communication No patient record for
record ordered tests
Instrument Identifier different from Abort communication Invalid instrument
ACL9000 or extended name identifier
Too many test requests for the same Reject test order -
sample ID
Unknown test request Reject test order -
Bad Test Reject test orders
Illegal record format Abort communication Incorrect record format in
host messages
All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host
computer a message with the reason for transmission interruption while a message is
presented to the user on the instrument. When transmission abort is not implied, at
transmission completion one or more records will follow with an indication of rejected test
orders. See Section 3.6 - Rejected Test Order on page 459 (Appendix A).
Information rejected is typically unknown test requests or test requests exceeding the
sample record size in ELITE/ELITE PRO Data Management System. It must be observed
that if any of this information is rejected, it does not imply that all sample data have been
rejected.
The set of legal test requests are normally stored while the illegal requests for the same
sample ID will be rejected.
It also must be underscored that ELITE/ELITE PRO limits the size of handled records
(independently from the record type supported by ASTM) to 1024 byte during downloading
session.
449 of 617 L0018200232 R01

NOTE: For the downloading the Host should send to the ELITE/ELITE PRO string
information in single frame (single line) during the transmission or up to 240 bytes maximum
during the transmission.
3.5.1.1 Test Request Message
The Test Request Message is used by ELITE/ELITE PRO to start the test order
download session. It is composed from a Message Header record, a Request
Information record and a Message Terminator record. The Request Information record
requests from the host ALL test orders available for the specific instrument.
Following the ASTM specification the fields composing the Request Information are
described in the following:
Request Information Record

Record Type ID always set to ‘Q’
Sequence Number as defined by the standard set to ‘1’ when query
is sent
Starting Range ID Number set to the string ‘ALL’
Ending Range ID Number not provided
Universal Test ID not provided
Nature of Request Time Limit not provided
Beginning request Results Date not provided
and Time
Requesting Physician Name not provided
User Field #1 not provided
Request Information Status Code always set to ‘O’ (requesting test orders and
demographics only)
An example for the complete message (composed by header message, request

information record and message terminator record) is given by:
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|ALL||||||||O<CR>
L|1|N<CR>
450 of 617 L0018200232 R01

3.5.1.2 Test Order Message
To answer the ELITE/ELITE PRO Test Request Message, the host computer sends
the Test Order Message. It contains the records specifying which tests are being
requested for each specified sample. The host computer may answer with one or more
message; each one contains one or more test order specifications. The test order
specification consists of a Patient Information record followed by one or more Test
Order records.
The host can send for the same sample ID a Patient Information record followed by
many Test Order records or, for each test to be ordered, a pair composed by the Patient
Information record followed the Test Order record.
Comment Record messages during downloading operations are ignored by

ELITE/ELITE PRO.
3.5.1.2.1 Patient Information Record
The fields characterizing this record are specified in the following:
Patient Information Record

Record Type ID Must be ‘P’
Sequence Number Must begin with ‘1’ and then must increment
by one for each new Patient Information
record
Practice Assigned Patient ID Ignored
Laboratory Assigned Patient ID Stored, if available, as a string in the Patient
ID field of the sample record.
No checks are performed for this field and
the string will be truncated to 15 characters.
Patient ID #3 Ignored
Patient Name Stored, if available, as a unique string in the
‘name’ field of sample record considering
only the first two sub fields in this data field
(second and first name). The string will be
truncated to 30 characters. If a character not
supported is found, the patient name and all
the other strings in the same patient record
will be ignored. See Section 8.3 - Supported
Characters for delimiters on page 478
(Appendix A).
Mother’s maiden Name Ignored
Birth date Stored, if available. The data will be
converted and displayed in the following in
according to ELITE/ELITE PRO supported
format.
Expected format, conforming to ASTM
standard, is YYYYMMDD
Patient Sex Stored if available. Allowed characters are
‘M’, ‘m’, ‘F’, ‘f’, ‘U’, ‘u’; any other character is
interpreted as ‘U’.
451 of 617 L0018200232 R01


Patient Race-Ethnic Origin Ignored
Patient Address Ignored
Reserved Field Ignored
Patient Telephone Number Ignored
Attending Physician ID Ignored
Special Field #1 Ignored
Special Field #2 Ignored
Patient Height Ignored
Patient Weight Ignored
Patient’s Known or Suspected Ignored
Diagnosis
Patient Active Medications Ignored
Patient’s Diet Ignored
Practice Field #1 Ignored
Practice Field #2 Ignored
Admission and Discharged Dates Ignored
Admission Status Ignored
Location Stored if available as a free string in the
‘department’ field of sample record. The
string will be truncated to 30 characters. See
Section 8.3 - Supported Characters for
delimiters on page 478 (Appendix A).
Nature of Alternative Diagnostic Ignored
Code and Classifiers
Alternative Diagnostic Code and Ignored
Classifiers
Patient Religion Ignored
Marital Status Ignored
Isolation Status Ignored
Language Ignored
Hospital Service Ignored
Hospital Institution Ignored
Dosage Category Ignored
452 of 617 L0018200232 R01

3.5.1.2.2 Test Order Record
Test Order Record

Record Type ID Must be ‘O’ (letter)
Sequence Number Must begin with ‘1’ and then must increment by one for each
new test order record for the same patient
Specimen ID This is the ELITE/ELITE PRO sample ID; the field must be less
than or equal to 15 characters and must be consistent with
rules on sample ID (ID already in use for QC database are not
legal). Non conforming sample IDs will cause an abort of the
download process. See Section 8.3 - Supported Characters
for delimiters on page 478 (Appendix A).
Instrument Ignored
Specimen ID
Universal Test ID The field is composed of 4 parts; only the Manufacturer’s
Code component is used as a 4 character code (user
configurable on board); unknown test ID will be rejected.
Priority If the field contains in any of the sub fields the S char the
sample ID will be considered a priority sample; any additional
flag will be ignored. If the field does not contain the S char or it
is empty, the sample will be identified as a routine sample.
Requested/Ordered Ignored
Date and Time
Specimen Ignored
Collection Date and
Time
Collection End Ignored
Time
Collection Volume Ignored
Collector ID Ignored
Action Code Ignored
Danger Code Ignored
Relevant Clinical Ignored
Information
Date/Time Ignored
Specimen
Received
Specimen Ignored both fields
Descriptor
Ordering Physician Stored if available as a free string in the ‘physician’ field of
sample record. The string will be truncated to 30 characters.
See Section 8.3 - Supported Characters for delimiters on
page 478 (Appendix A).
Physician’s Ignored
Telephone Number
User Field No. 1 Ignored
User Field No. 2 Ignored
Laboratory Field Ignored
No. 1
453 of 617 L0018200232 R01

Test Order Record

Laboratory Field Ignored
No. 2
Date/Time Results Ignored
Reported or Last
Modified
Instrument Charge Ignored
to Computer
System
Instrument Section Ignored
ID
Report Types Set to O (letter); other codes will cause records rejection
Reserved Field Ignored
Location of Ward of Ignored
Specimen
Collection
Hospital Ignored
Information Flag
Specimen Service Ignored
Specimen Ignored
Institution
An example for a complete test ordering is given by:
Example of download without patient name:
NOTE: Separators are always expected from Host and are always
transmitted independently from the information contained in the string.
454 of 617 L0018200232 R01

3.5.2 Host Query

Host query is automatically activated by the instrument each time the system is properly
configured. Beginning the pre-analysis phase of a single test or profile or test group, one or
more samples have no type of test requests associated.
The instrument will send, using the requested information record, the sample IDs requiring
test programming and will accept only test orders for those sample IDs. The instrument will
accept for the queried samples any test orders independently by the type of test which will
be executed in the starting session.
The mechanism supported by ASTM requires sending to the host a Request Information
record for each sample ID or sending to the host a range of queried sample IDs. The
mechanism supported by ELITE/ELITE PRO is the first option, so will be independent of the
sorting system used by instrument or host computer on the samples.
As a consequence the instrument will send a query for the first sample, will wait for the host
information and will send later a new query for the next samples (if any). All the host query
sessions will be organized in this manner.
Because the instrument is asking for information regarding a specific sample ID, it will reject
any type of information associated with different sample IDs.
The host will provide to the instrument all available test requests. The host can send zero or
more test orders in one or more messages, but all messages will be part of the same
transmission session. During a transmission session more test orders can be required for
the same sample.
ELITE/ELITE PRO will process each received test order validating the fields that
ELITE/ELITE PRO supports; some information will be extracted from the received record
while other information will be ignored.
If the test order is not recognized as one of those supported by ELITE/ELITE PRO it will be
rejected. The instrument will inform the host computer using a record containing the list of
rejected test orders.
Host Query is only performed if the Sample ID is not located in the database for the ACL
system.
During a download session the listed error conditions can be detected, the associated
ELITE/ELITE PRO action is listed as well:

Sample ID used in the QC data base Abort communication Sample ID already used
in the QC data base
Bad Sample ID (long, unsupported Abort communication Invalid Sample ID
characters)
Data Base full Abort communication Patient Data Base is full
455 of 617 L0018200232 R01


Patient record has no associated test Abort communication Not identified sample ID
order record for patient data
Test order has no associated patient Abort communication No patient record for
record ordered tests
Instrument Identifier different from Abort communication Invalid instrument
ACL9000 or extended name identifier
Too many test requests for the same Reject test order -
sample ID
Unknown test request Reject test order -
Bad Test Reject test orders -
Illegal record format Abort communication Incorrect record format in
host messages
All abort conditions imply that ELITE/ELITE PRO family instruments will send to the host
computer a message with the reason of transmission interruption while a message is
presented to the user on the instrument. When transmission abort is not implied, at
transmission completion one or more records will follow with an indication of rejected test
orders. See Section 3.6 - Rejected Test Order on page 459 (Appendix A).
Information rejected is typically unknown test requests or test requests exceeding the
sample record size in ELITE/ELITE PRO Data Management System. It must be observed
that if any of this information is rejected, it does not imply that all the sample data have been
rejected. The set of legal test requests are normally stored while the illegal requests for the
same sample ID will be rejected.
It also must be underscored that ELITE/ELITE PRO limits the size of handled records
(independently from the record type supported by ASTM) to 1024 byte during downloading
session.
NOTE: If the Sample ID is not present at the Host level during the Host Query, the
Host will return only the Header and the terminator.
H|\^&||||||||ACL9000||P|1|20021205123956<CR>
L|1|N<CR>
NOTE: If the Host requests a test that is disabled on the ELITE/ELITE PRO, the
test will not be programmed on the ELITE/ELITE PRO and a reject message of this type will
be returned back to the Host.
C|1|I|UKNOWN_T|PatientID^0080|I<CR>
456 of 617 L0018200232 R01

3.5.3 Test Request Message

The Test Request Message is used by ELITE/ELITE PRO to require information for each
specific sample that has no test orders in the instrument database. It is composed from a
Message Header, a Request Information and a Message Terminator record.
The Request Information record requests in this case information for one specific ID at time.
The ASTM protocol limits the number of Request Information records to one. As a
consequence the instrument will wait for the host answer before sending a second Request
Information record for a second sample.
Following the ASTM specification the fields composing the Request Information are
described in the following.
Request Information Record

Record Type ID always set to ‘Q’
Sequence Number as defined by the standard set to ‘1’ when query is
sent
Starting Range ID Number set to the specific sample ID to require information
on; the meaningful component is the second one
Ending Range ID Number not provided
Universal Test ID not provided
Nature of Request Time Limit not provided
Beginning request Results Date and not provided
Time
Requesting Physician Name not provided
Request Information Status Code always set to ‘O’ (requesting test orders and
demographics only)
An example for the complete message (composed by header message, request information
record and message terminator record) is given by:
H|\^&|||ACL9000|||||||P|1|19960210103227<CR>
Q|1|^S001^||||||||O<CR>
L|1|N<CR>
Answer from Host:
H|\^&||||||||ACL9000||P|1|19960210103256<CR>
P|1||||ROSSI^MARIO^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|S001||^^^0001|||||||||||^| DR. VERDI |||||||||O||||||<CR>
O|2|S001||^^^0002|||||||||||^||||||||||O||||||<CR>
L|1|N<CR>
457 of 617 L0018200232 R01

3.5.4 Test Order Message

As an answer to the ELITE/ELITE PRO Test Request Message the host computer sends
the Test Order Message. It contains the records specifying which tests are being requested
for the queried Sample ID.
See Section 3.5.1.2 - Test Order Message on page 451 (Appendix A) for details.
458 of 617 L0018200232 R01

3.6 Rejected Test Order Appendix A - Host Communication Protocol
3.6 Rejected Test Order

At completion of download operations, or at completion of the download operation for a single sample in
the host query mechanism, ELITE/ELITE PRO can transmit a message to inform host computer about
rejected test orders and samples or about the reasons for transmission interrupt.
The Rejected Test Order Message consists of a Message Header record followed by one or more
Comment records and completed by the Message Terminator Record. A comment record will be
transmitted for each rejected information.
It must be observed that if no legal information has been received, the download process is interrupted
and the rejected test order message will signal the reason for the interruption. If the download process
has been completed normally, the possible following rejected test order message will report no legal test
orders.
Comment Record structure is described in the following table:
Comment Record Structure

Record Type ID Always set to ‘C’
Sequence Number Must begin with ‘1’ and then it will increment by one for each new comment
record
Comment Source Always set to ‘I’ (as ASTM: clinical instrument system)
Comment Text This field indicates the reason of the test order rejection. It is a string with two
components, each one can assume the reported values:
Rejection Reason:
BAD_TEST: the transmitted test code is invalid
QC_MA_ID: the specified ID is already used as a material in the QC data
base
BAD_S_ID: the specified ID is invalid
WRONG_ID: the host is sending information for a sample ID different from
the expected one
PDB_FULL: patient data base is full
M_TEST_E: more tests than expected
UKNOWN_T: unknown test requested
INSTR_ID: invalid instrument identifier
NO_TESTS: no test ordered for patient record
NO_PATIE: no patient record for ordered test
BAD_RECO: incorrect record format
Identification: This string contains the identification of the sample causing the
problem; if a test order caused the problem the sample ID and test ID are
transmitted sequentially. The character used to separate the rejection reason,
and the two strings used for the identification field is ‘|‘.
Lacking information will be signaled as “UNKNOWN”.
If BAD_RECO is the reason of the rejection the field will contain the record
number and the field number caused the failure.
Comment Type Always set to ‘I’ (as ASTM: instrument flag comment)
To summarize the possible values for the rejection reason and identification fields are reported in the
following table:
459 of 617 L0018200232 R01

3.6 Rejected Test Order Appendix A - Host Communication Protocol
Transmission Identification: Identification:

Rejection Reason
Interrupted first sub_field second sub_field
QC_MA_ID yes sample ID (causing the problem) UNKNOWN
BAD_S_ID yes sample ID (causing the problem) UNKNOWN
PDB_FULL yes sample ID (causing the problem) test_ID
NO_TESTS yes UNKNOWN UNKNOWN
NO_PATIE yes sample ID (causing the problem) test_ID
INSTR_ID yes UNKNOWN UNKNOWN
M_TEST_E no sample ID test ID (causing the problem)
UNKWOWN_T no sample ID test ID (causing the problem)
BAD_TEST no sample ID test ID (causing the problem)
BAD_RECO yes Record No. (debug purpose) Field No. (debug purpose)
An example for a complete rejection phase is given by:
H|\^&|||ACL9000|||||||P|1|19982110103227<CR>
C|2|I|M_TEST_E|SMP01 ^000|I<CR>
C|2|I|BAD_TEST|SMP01 ^000|I<CR>
L|1|N<CR>
460 of 617 L0018200232 R01

3.7 Download Session Volumes Appendix A - Host Communication Protocol
3.7 Download Session Volumes

Approximate data volumes for download sessions is provided as a guide for estimating the time required
completing typical sessions. System latencies (both in ELITE/ELITE PRO and host computer) are not
considered.
The minimal session would occur if the host has no test orders available for ELITE/ELITE PRO. In this
condition ELITE/ELITE PRO sends the test request message, the host would respond with a message
containing no test orders (only message header and message terminator record). In conditions in which
the host has test orders for the instrument, the estimated data volume is:
Test Request Message = Message Header (41) +17 + Message Terminator Record (6) = 64
Test Order Message = Message Header (41)

+ Number of patient records (82 + 55 *number of ordered test)
+ Message Terminator Record (6)
Test Order Rejected = Message Header (41)

+ 41 * number of rejected records
+ Message Terminator Record (6)
So considering the following situation: the host has 50 sample IDs to be download, each one with 4
tests, consider 10 rejected records the data volume can be estimated in:
Test Request Message = 64

Test Order Message = 41+ 50 (82 + 55 *4) + 6 = 15147
Test Order Rejected = 41 + (41 * 10) + 6 = 457
Total = 15668 characters
At 9600 “baud rate” and with no system overhead it would take approximately 17 seconds and
considering a system efficiency of 60% it becomes about 27 seconds.
All estimations have been done using the maximum expected length for string fields.
461 of 617 L0018200232 R01

4.0 Test Results Uploading Appendix A - Host Communication Protocol
4.0 Test Results Uploading

Test Result Uploading allows transmission of results of the tests performed on ELITE/ELITE PRO to the
host computer. Results, related to patient, QC samples and Analytical Reference materials, are
transmitted on explicit user request or automatically at session completion.
In the first case the user must require the transmission command in the DMS or in the QC or in the AR
environment, select the patient samples or QC samples or AR set of data to be transmitted (in according
with one of the supported selection criteria) and start operation.
In the second case the transmission will happen automatically at session completion and the instrument
will provide to upload patient and/or QC samples data and/or AR data.
The type of data to be transferred during an automatic upload session depends upon the instrument set-
up (the automatic data transmission can be set to “patient samples only” or “QC and patient samples” or
“QC and AR patient samples”). If upload is manually requested, all data are transmitted independently
from the transmission flag. If transmission is performed automatically at session completion, the
instrument will upload for patient samples all the data available for the sample IDs just analyzed and will
upload, for QC data, the results just obtained.
From a general point of view the automatic data transmission of the patient samples is equivalent to the
manual data transmission, requested in DMS, of patient samples belonging to a specific load-list. While
the automatic data transmission of the QC data or AR data is equivalent to the manual data
transmission, requested in QC database or AR database, or the data in a specified interval for the QC
material present in the load-list.
Considering that ELITE/ELITE PRO fills the strings used for Sample ID, department and patient name
with space characters (to align data); the host computer must ignore space characters on the right of
these fields.
If uploading is completed successfully for patient, QC samples and AR data, the transmission flag
associated to the single record will be updated from ‘L’ to ‘T’ (transmitted).
It must also be noted that on the ELITE/ELITE PRO, modifications to sample data already transmitted
(such as adding of a new test result or modifications of sample data) cause the transmission flag to
change from ‘T’ to ‘L’. It does not apply to QC or AR data because the only modification the user can
request on these data is to omit or to clear statistic. The effect of omit operation is to exclude the data
from the statistic but the data is not modified.
Modifications in the set-up values and note field do not modify the transmission status of QC data and
AR data.
While transmission is in progress the user will be updated on the number of the sample being
transmitted.
ELITE/ELITE PRO does not accept inquiries for test results.
462 of 617 L0018200232 R01

4.1 Test Result Message Appendix A - Host Communication Protocol
4.1 Test Result Message

The Test Result Message is used by ELITE/ELITE PRO to transmit any available test results for a
sample. All available test results will be transmitted for patient samples even if data have been already
transmitted partially.
The message consist of a Message Header record, a Patient Information record, one or more pair Test
Order records followed by one or more Results records (depending upon the number of available test
results and the number of results for each specific test).
The Result record can be completed with a Comment record containing flags associated to the executed
test.
Tests are uploaded using the same sorting used on board. The complete set of available test results is
globally uploaded to the host computer independently by the set of results defined as to show in the
sample list.
In some conditions, depending by the instrument status (i.e. calibrated, not calibrated, AR used, etc.)
only a subset of the results supported by the test will be transmitted to the host computer.
The Message Terminator record completes the transmitted data.
The same structure is used also to upload QC and AR data. In the following paragraphs any differences
in the way to treat patient, QC and AR data will be underlined.
4.1.1 Patient Information Record

This information is transmitted to the host only if available on the instrument. The Patient
Information structure is:

File Type Patient Sample QC Sample or AR
Record Type ID Must be ‘P’ must be ‘P’
Sequence Number Must begin with ‘1’ and then must begin with ‘1’ and
must increment by one for each then must increment by
new Patient Information record one for each new Patient
Information record
Practice Assigned Patient ID Not provided not provided
Laboratory Assigned Patient Provided if defined as a string not provided
ID containing up to 15 characters.
Patient ID #3 Not provided not provided
Patient Name Provided if known as a single not provided
string containing up to 30
characters
Mother’s Maiden Name Not provided not provided
Birth date Provided if known as a single not provided
string without any checks
Patient Sex Provided if known as a single not provided
character
463 of 617 L0018200232 R01


File Type Patient Sample QC Sample or AR
Patient Race-Ethnic Origin Not provided not provided
Patient Address Not provided not provided
Reserved Field Not provided not provided
Patient Telephone Number Not provided not provided
Attending Physician ID Not provided not provided
Special Field #1 Not provided not provided
Special Field #2 Not provided not provided
Patient Height Not provided not provided
Patient Weight Not provided not provided
Patient’s Known or Suspected Not provided not provided
Diagnosis
Patient Active Medications Not provided not provided
Patient’s Diet Not provided not provided
Practice Field #1 Not provided not provided
Practice Field #2 Not provided not provided
Admission and Discharged Not provided not provided
Dates
Admission Status Not provided not provided
Location Provided if known as a 30 not provided
characters free string
Nature of Alternative Not provided not provided
Diagnostic Code and
Classifiers
Alternative Diagnostic Code Not provided not provided
and Classifiers
Patient Religion Not provided not provided
Marital Status Not provided not provided
Isolation Status Not provided not provided
Language Not provided not provided
Hospital Service Not provided not provided
Hospital Institution Not provided not provided
Dosage Category Not provided not provided
464 of 617 L0018200232 R01

4.1.2 Test Order Record

Test Order Record:

File Type Patient Sample QC Sample or AR data
Record Type ID Must be ‘O’ Must be ‘O’
Sequence Number Must begin with ‘1’ and then Must begin with ‘1’ and then
must increment by one for must increment by one for
each new test order record for each new test order record
the same patient for the same patient
Specimen ID Provided, is the ELITE/ELITE Provided, is the ELITE/ELITE
PRO sample ID. See Section PRO QC material ID for QC
8.3 - Supported Characters for data; or is the ‘AR’ keyword
delimiters on page 478 for AR data. See Section 8.3
(Appendix A). - Supported Characters for
delimiters on page 478
(Appendix A).
Instrument Specimen ID Not provided Not provided
Universal Test ID The field is composed of 4 The field is composed of 4
parts, only the Manufacturer’s parts; only the
Code component is used as a Manufacturer’s Code
4 character code (host codes component is used as a 4
are user configurable on character code (host codes
board). are user configurable on
board).
Priority Provided if set as a ‘S’ char for Not provided
priority samples.
Requested/Ordered Not provided Not provided
Date/Time
Specimen Collection Date Not provided Not provided
and Time
Collection End Time Not provided Not provided
Collection Volume Not provided Not provided
Collector ID Not provided Not provided
Action Code Not provided Set to ‘Q’
Danger Code Not provided Not provided
Relevant Clinical Information Not provided Not provided
Date and Time Specimen Not provided Not provided
Received
Specimen Descriptor Not provided both fields Not provided both fields
Ordering Physician Provided, if available, as a Not provided
string containing up to 30
chars
Physician’s Telephone Not provided Not provided
Number
User Field #1 Not provided Not provided
User Field #2 Not provided Not provided
Laboratory Field #1 Not provided Not provided
Laboratory Field #2 Not provided Not provided
465 of 617 L0018200232 R01

Test Order Record:

Date/time Results Reported or Not provided Not provided
Last Modified
Instrument Charge to Not provided Not provided
Computer System
Instrument Section Not provided Not provided
Report Type Set to F Set to F
Reserved Field Not provided Not provided
Location of Ward of specimen Not provided Not provided
Collection
Hospital Information Flag Not provided Not provided
Specimen Service Not provided Not provided
Specimen Institution Not provided Not provided
466 of 617 L0018200232 R01

4.1.3 Result Record

The fields characterizing this record are specified in the following table.
A result record is send to the host computer for each available test result. For double tests all
available single values will be transmitted to the host computer (no mean values). Each
result record will contain one of available test results.
Result Record
Sequence Number Must begin with ‘1’ and then Must begin with ‘1’ and then
must increment by one for must increment by one for
each result record for the each result record for the
same patient test record for same patient test record for
the same patient record the same patient record
Universal Test ID The field is composed of 4 The field is composed of 4
parts, only the Manufacturer’s parts, only the Manufacturer’s
Code component is used as a Code component is used as a
4 character code (host codes 4 character code (host codes
are user configurable on are user configurable on
board). board).
Data or Measurement Value The field contains the The field contains the
obtained numeric value or obtained numeric value or
qualitative message (Error qualitative message (Error
xx). All numerical results are xx). All numerical results are
sent. * sent. *
Units Provided if the previous field Provided if the previous field
is a numeric value; is a free is a numeric value; is a free
string (maximum number of string (maximum number of
characters is 8). See Section characters is 8). See Section
9.0 - ELITE/ELITE PRO 9.0 - ELITE/ELITE PRO
Supported Units on page Supported Units on page 479
479 (Appendix A). (Appendix A).
Reference range Not provided Not provided
Result Abnormal Flag Not provided Not provided
Nature of Abnormality Flag Not provided Not provided
Result Status Set to ‘F’ Set to ‘F’
Data of Change in Instrument Not provided Not provided
Normative Values or Units
Operator Identification Not provided Not provided
Date/Time Test Started Not provided Not provided
467 of 617 L0018200232 R01

Result Record
Date/Time Test Completed Execution time, string of the Execution time, string of the
type YYYYMMDDHHMMSS type YYYYMMDDHHMMSS
Instrument Identification Not provided Not provided
* Specific ranges must be set at the Host level.
468 of 617 L0018200232 R01

4.1.4 Comment Record

The Comment record allows integration of the transmitted test results with possible error
messages.
One or more comment records can follow the result records. Fields characterizing this record
are specified in the following.
Comment Record
Record Type ID set to ‘C’
Sequence Number must begin with ‘1’ and then must increment by one
for each comment record
Comment Source set to ‘I’
Comment Text this field specifies the instrument errors (see table) as
a numeric code (3 characters) plus the associated
message
Comment Type set to ‘I’
469 of 617 L0018200232 R01

4.1.5 Error Codes

TEMPERATURE WARNING
ROTOR STACK TEMPERATURE Out of Range = 41,
SLIDER TEMPERATURE Out of Range = 43,
REAGENT TEMPERATURE Out of Range = 45,
INCUBATION TEMPERATURE Out of Range = 49,
MECHANICAL WARNING
AUTOSAMPLER WARNING = 50,
ROTOR MOTOR WARNING = 51,
HORIZONTAL MOTOR WARNING = 52,
VERTICAL MOTOR WARNING = 53,
REAGENT DILUTOR WARNING = 54,
SAMPLE DILUTOR WARNING = 55,
PHOTOMETRIC COVER WARNING = 56,
STIRRER1_FAIL = 57,
STIRRER2_FAIL = 58,
STIRRER3_FAIL = 59,
STIRRER4_FAIL = 60,
LIQUID WARNING
LIQUID_SENSOR OFF (SAMPLE) = 73,
LIQUID_SENSOR OFF (REAGENT) = 74,
LIQUID_SENSOR_FAIL (SAMPLE) = 75,
LIQUID_SENSOR_FAIL (REAGENT) = 76,
MATERIAL_SHORT = 77,
MANDATORY_MATERIAL_SHORT = 78,
FLUSH_PRE_WARNING = 79,
FLUSH WARNING = 80,
CLEANING_NOT_PERFORMED = 83,
MISCELLANEOUS WARNING
COVER_OPEN_DURING_LOADING_OR_INCUBATION = 86,
TIMEOUT_EXPIRED_DURING_LOADING = 87,
ERRORS ON RESPONSE
OUTSIDE SCALE RANGE LOW = 98
OUTSIDE HIGH = 99
SATURATION_ERROR = 205,
FIRST_THRESHOLD_ERROR = 206,
SECOND_THRESHOLD_ERROR = 207,
DELTA_ERROR = 208,
INITIAL_SLOPE_ERROR = 209,
FINAL_SLOPE_ERROR = 210,
FINAL_REACTION CURVE ERROR = 211,
FIRST_DERIVATIVE_ERROR = 212,
SECOND_DERIVATIVE_ERROR = 213,
FIRST_PART_REACTION CURVE ERROR = 214,
470 of 617 L0018200232 R01

ERRORS ON CALIBRATION CURVES

INSUFFICIENT_STANDARD POINTS IN ONE_SEGMENT = 215,
INVALID CURVE INSUFFICIENT DATA = 216,
NUMBER OF_STANDARD OUT OF RANGE = 217,
INVALID_TRANSLATION_OR_MANDATORY_STANDARD = 219,
INVALID_STD_INSUFFICIENT_REPLICATES = 220,
INSUFFICIENT_REPLICATES = 221,
INVALID_REPLICATES = 222,
CV_OUT_OF_RANGE = 223,
SLOPE OUT OF RANGE: INVALID CALIBRATION CURVE = 225,
R2_OUT_OF_RANGE = 226,
NOT MONOTONIC CURVE = 228,
ERRORS ON ANALYTICAL REFERENCE, QC, RATIO AND NORMALIZED

RATIO
AR_INVALID = 229,
AR_OUT_OF_RANGE = 230,
AR_NOT_CHECKED = 233,
DUPLICATE OUT OF RANGE = 239,
QC_INVALID = 240,
QC_OUT_OF_RANGE = 242,
RATIO_CALCULATION_ERROR = 249,
RATIO_CALCULATION_ERROR: S/Sa out of range = 250,
NORMALIZED RATIO ERROR: AR/Ara out of range = 251,
NORMALIZED RATIO: CALCULATION ERROR = 252,
STD_NOT_FOUND = 253,
AR_NOT_FOUND = 254,
ACTIVATE SAMPLE NOT_FOUND = 255,
ARa_NOT_FOUND = 256,
RATIO_NOT_FOUND = 257,
AR_OUT_OF_RANGE = 258,
AR_NULL = 259,
STD_NULL = 260,
SAMPLE_NULL = 262,
REF_NULL = 263,
AR_RATIO_ NULL_ = 264,
ACTIVATED_AR NULL_ = 265,
NULL_DIFFERENCE = 266,
Out of range indications referring to normal or test ranges are not transmitted to the host
computer. The * symbol (outside ) is presented only on the Cumulative and Sample Reports.
An example for a complete test uploading sequence is given by:
Sample
H|\^&||||||||ACL9000||P|1|19982110134700<CR>
P|1||PTNT1||BLU^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|SMP01||^^^0001|S||||||||||^|DR. VERDI|||||||||O||||||<CR>
R|1|^^^0001|12.8|||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<CR>
P|2||PTNT1||Gialli^^^^||19391127|M|||||||||||||||||DEP 1||||||||||<CR>
O|1|SMP10||^^^0001|S||||||||||^|DR. VERDI|||||||||O||||||<CR>
R|1|^^^0001|14.5|s||||F||||19960119114215|<CR>
C|1|I|31^ Invalid for QC |I<CR>
L|1|N<CR>
471 of 617 L0018200232 R01

4.2 Upload Session Volumes Appendix A - Host Communication Protocol
QC
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
P|1||||||||||||||||||||||||||||||||||<CR>
O|1|Normal C.||^^^0001|||||||Q||||^||||||||||F||||||<CR>
L|1|N<CR>
AR
H|\^&|||ACL9000|||||||P|1|20021205123956<CR>
P|1||||||||||||||||||||||||||||||||||<CR>
O|1|AR||^^^0001|||||||Q||||^||||||||||F||||||<CR>
L|1|N<CR>
4.2 Upload Session Volumes

Approximate data volumes for upload sessions is provided as a guide for estimating the time required to
complete typical sessions. Obviously, system latencies (both in ELITE/ELITE PRO and host computer)
are not considered.
The minimal session would occur if ELITE/ELITE PRO has no test results to be transmitted; no data is
sent and the data volume is zero.
In conditions in which the ELITE/ELITE PRO has results to be transmitted, the data volume can be
estimated on the Test Order and Test Result record size base.
Test Order Message = Message Header (41)

+ Number of patient records (82 + Results) + Message Terminator Record (6)
Results = number of ordered test (55 + 60*number of test result + 56* number of error messages)
Consider the following situation: ELITE/ELITE PRO has 50 sample IDs to be uploaded each with 4
tests, each test with 3 results and each test with 2 flags, the data volume can be estimated in:
Test Result Message = 41+ 50 (82 + 4(55 + 60*3 + 56*2)) + 6

Total = 69547 characters
At 9600 “baud rate” and with no system overhead it would take approximately 73 seconds and
considering a system efficiency of 60% it becomes about 116 seconds.
472 of 617 L0018200232 R01

5.0 Not Supported Records Appendix A - Host Communication Protocol
5.0 Not Supported Records

The Scientific record and the Manufacturer Information record are not supported by ELITE/ELITE PRO
protocol.
As a consequence the instrument ignores any type of information they contain.
6.0 Transmission Abort

The download or upload transmission session can be interrupted for an explicit user request detected on
the instrument, because the host computer is not responding or because the host computer required
interruption of the transmission process.
Further, as reported above, the download process can be interrupted because an illegal sample Identifier
has been received. Instrument behavior in this particular condition was defined in and Reject Test
Orders.
ELITE/ELITE PRO family instruments behavior in each of the listed conditions is described in the
following:
Condition Action
ELITE/ELITE PRO operator ELITE/ELITE PRO will signal the end of transmission to the host and will
requested stop download discard any following messages. The host must consider the interrupt
process request.
It must be emphasized that ELITE/ELITE PRO will signal the transmission
interruption with a message that is a rejected test order message if any
information has been rejected or with a message header plus a message
terminator record if no information has been rejected.
ELITE/ELITE PRO operator ELITE/ELITE PRO will complete the message in progress with the message
requested stop upload terminator and will not transmit any further test results.
process
Host computer is not During download and upload transmission sessions, operation by
responding ELITE/ELITE PRO is stopped. If download was in progress, no rejected test
messages will be transmitted.
A message will inform the user that the transmission has been interrupted:
“Host Computer not responding”
Host computer required EOT Both during download and upload sessions, operation by ELITE/ELITE
PRO is stopped. If download was in progress, no rejected test messages
will be transmitted.
It must be emphasized that the host computer must request the
transmission interruption with a message composed by a message header
plus a message terminator record.
A message will inform the user that the transmission has been interrupted:
“Host Computer required interrupt transmission”
Incorrect record format Transmission/reception is aborted and the user is informed: “Incorrect
format in host messages”
473 of 617 L0018200232 R01

7.0 ELITE/ELITE PRO Test Codes Appendix A - Host Communication Protocol
7.0 ELITE/ELITE PRO Test Codes

Test codes are user definable. Codes from 1 to 500 are assigned to IL pre-defined tests. Codes greater
than 500 are assigned to the user definable tests. IL Library proposes the default test codes reported in
the following table. Current library installed on the system may have tests not found in this list
Test ID Extended Test Name

Test Code Test Code for host
(8 char. max) (15 char. max)
001 0001 PT PT
002 0002 PT e PT Extended
003 0003 PT d PT Double
004 0004 PT ed PT Ext. Db.
009 0009 PT HS + PT PLUS
010 0010 PT HS + e PT PLUS Extended
011 0011 PT HS + d PT PLUS Double
012 0012 PT HS + ed PT PLUS Ext. Db.
013 0013 R-PT Recombipl-PT
014 0014 R-PTe Recombipl-PTex
015 0015 PTRP-8 PT-RPT 8
016 0016 PTRPe-8 PTe-RPT 8
017 0017 PTRPd-8 PTd-RPT 8
018 0018 PTRPed-8 PTed-RPT 8
023 0023 R-PT d Rec-PT Double
024 0024 R-PT ed Rec-PT Ext Db
025 0025 FIIRP-8 Factor II-RP 8
026 0026 FVRP-8 Factor V-RP 8
027 0027 FVIIRP-8 Factor VII-RP 8
028 0028 FXRP-8 Factor X-RP 8
030 0030 FIB_ FIB (PT)
031 0031 FIB FIB (PT)
032 0032 FIB e_ FIB (PT e)
033 0033 FIB e FIB (PT e)
034 0034 FIB d_ FIB (PT d)
035 0035 FIB d FIB (PT d)
036 0036 FIB ed_ FIB (PT ed)
037 0037 FIB ed FIB (PT ed)
046 0046 FIB HS+_ FIB (PT PLUS)
047 0047 FIB HS+ FIB (PT PLUS)
048 0048 FIB HS+e_ FIB (PLUS e)
049 0049 FIB HS+e FIB (PLUS e)
050 0050 FIB HS+d_ FIB (PLUS db)
051 0051 FIB HS+d FIB (PLUS db)
052 0052 FIB+ed_ FIB (PLUS ed)
053 0053 FIB+ed FIB (PLUS ed)
054 0054 R-FIB_ Recombipl-FIB
474 of 617 L0018200232 R01


055 0055 R-FIB Recombipl-FIB
056 0056 R-FIBe_ Recombipl-FIBex
057 0057 R-FIBe Recombipl-FIBex
058 0058 FIBRP 8 Fib RecombiPT8
059 0059 FIBRP_8 Fib_ RecombiPT8
060 0060 FIBRPe 8 Fibe RecombiPT8
061 0061 FIBRPe_8 Fibe_RecombiPT8
062 0062 FIBRPd 8 Fibd RecombiPT8
063 0063 FIBRPd_8 Fibd_RecombiPT8
064 0064 FBRPed 8 Fibed RecombPT8
065 0065 FBRPed_8 Fibed_RecombPT8
074 0074 R-Fibd_ Recombipl-FIBd
075 0075 R-Fibd Recombipl-FIBd
076 0076 R-Fibed_ Recombipl-FIBed
077 0077 R-Fibed Recombipl-FIBed
084 0084 APTT-SP APTT-SP
085 0085 APTT-SPe APTT-SP Ext.
086 0086 APTT-SPd APTT-SP Db.
087 0087 APTTSPed APTT-SP Ext.Db.
092 0092 APTTSYS APTT SynthASil
093 0093 APTTSYSe APTT SynthASile
094 0094 APTTSYSd APTT SynthASild
095 0095 APTTSSed APTTSynthASiled
096 0096 APTTSYF APTT SynthAFax
097 0097 APTTSYFe APTT SynthAFaxe
098 0098 APTTSYFd APTT SynthAFaxd
099 0099 APTTSFed APTT SynthAFaxed
102 0102 FVIII SF FVIII SynthAFax
107 0107 FIX SF FIX SynthAFax
112 0112 FXI SF FXI SynthAFax
113 0113 FXII SYS FIXII SynthASil
117 0117 FXII SF FXII SynthAFax
120 0120 TT-5 TT - 5
121 0121 TT e-5 TT Ext. 5
122 0122 TT d-5 TT Dbl. 5
123 0123 TT ed-5 TT Ext. Dbl. 5
124 0124 TT-8 TT - 8
125 0125 TT e-8 TT Ext. 8
126 0126 TT d-8 TT Dbl. 8
127 0127 TT ed-8 TT Ext. Dbl. 8
128 0128 TT-2 TT - 2
129 0129 TT e-2 TT Ext. 2
475 of 617 L0018200232 R01


130 0130 TT d-2 TT Dbl. 2
131 0131 TT ed-2 TT Ext. Dbl. 2
150 0150 PCX Pro-IL-Complex
151 0151 HPX Hepatocomplex
153 0153 P-ClotSP Pro-Clot SP
155 0155 SCT-S SCT Screen
156 0156 SCT-C SCT Confirm
160 0160 Free PS Free Protein S
161 0161 Pro S Protein S
162 0162 VWFACT VWF Activity
175 0175 ThP-A ThromboPath A
176 0176 ThP-B ThromboPath B
180 0180 HCY Homocysteine
181 0181 HCY h HCY High
199 0199 AT* Antithr. Liquid
200 0200 AT Antithr. In cup
201 0201 FIB-C_ Fib. Clauss
202 0202 FIB-C Fib. Clauss
203 0203 FIB-C l_ Fib. Clauss low
204 0204 FIB-C l Fib. Clauss low
205 0205 FIB-C h_ Fib Clauss high
206 0206 FIB-C h Fib. Clauss high
208 0208 HEP LMW Heparin LMW
210 0210 HEP UHF Heparin UHF
212 0212 PLG Plasminogen
213 0213 PL-IN Plasmin Inhib.
214 0214 P-C Protein C
218 0218 Liq Hep Liquid Heparin
219 0219 Anti-Xa Liq Anti-Xa
220 0220 F8 Chr H F8Chr High
221 0221 F8 Chr L F8Chr Low
225 0225 APCR V APCR V
229 0229 DD500 DDimer 500
230 0230 DD500h DDimer 500 High
250 0250 D-Dimer D-Dimer
251 0251 D-Dh D-Dimer high
275 0275 F8SP-P FVIII SP Par
276 0276 F9SP-P FIX SP Par
290 0290 QFA QFA
291 0291 QFA L QFA L
292 0292 QFA L_ QFA L_
294 0294 QFA_ QFA_
476 of 617 L0018200232 R01


302 0302 FVIII SP F VIII - SP
303 0303 F8vf-SP FVIII-SP nVWF
304 0304 F8vf-SS FVIII-SS nVWF
305 0305 FVIII SS FVIII SynthASil
306 0306 F8 SS-P FVIII SS Par
307 0307 F8vfSS-P FVIII-SS-P nVWF
308 0308 F8vfSP-P FVIII-SP-P nVWF
312 0312 FIX SP F IX - SP
315 0315 FIX SS FIX SynthASil
316 0316 F9 SS-P FIX SS Par
322 0322 FXI SP F XI - SP
325 0325 FXI SS FXI SynthASil
332 0332 FXII SP F XII - SP
336 0336 FVII PT F VII - PT
340 0340 FVII HSP F VII - HS Plus
343 0343 R FVII FVII RecombPT
350 0350 FX PT F X – PT
354 0354 FX HSP F X - HS Plus
357 0357 R FX FX RecombPT
360 0360 FV PT F V - PT
364 0364 FV HSP F V - HS Plus
367 0367 R FV FV RecombPT
370 0370 FII PT F II - PT
374 0374 FII HSP F II - HS Plus
377 0377 R FII FII RecombPT
400 0400 VWF:Ag vWF Antigen
401 0401 vWF:AgH vWF Antigen Hig
412 0412 dRVVT S dRVVT Screen
413 0413 dRVVT C dRVVT Confirm
414 0414 PS-ACT Protein S Act
477 of 617 L0018200232 R01

8.0 ELITE/ELITE PRO Supported Characters Appendix A - Host Communication Protocol
8.0 ELITE/ELITE PRO Supported Characters

8.1 Supported Characters for Sample ID
The ASCII set of characters considered is in the decimal range 32 to 126, because a Sample ID can be
accepted only if it contains at least one character different from a space.
8.2 Supported Characters for Patient name, Department and Units

The ASCII set of characters considered in the decimal range 32 to 255.
8.3 Supported Characters for delimiters

! “ # $ %
& ‘ ( ) *
+ / : ; =
@ [ \ ] ^
_ { | } ~
ASCII character 127 is not allowed as delimiter.
NOTE: Separators are always expected from Host and are always transmitted independently
from the information contained in the string.
478 of 617 L0018200232 R01

9.0 ELITE/ELITE PRO Supported Units Appendix A - Host Communication Protocol
9.0 ELITE/ELITE PRO Supported Units

Unit Abbreviation
Time S
Activity %
Ratio R
International Normalized Ratio INR
NR
Concentration mg/dL
g/L
ng/mL
U/mL
mg/L
mmol/L
IU/mL
mg/L
ug/mL
Delta Optical Absorbance D Abs
Delta D (D ASCII code is 7F)
Activated Sample Sa Sa (Hex code EC)
Curve behavior Offset
Min
Max
Final
User defined free string containing up to 8 chars
NOTE: For duplicate (d) and extended duplicate (ed) tests only the individual replicate results are
sent to the host system. The mean value is not sent from the ACL ELITE/ELITE PRO system. This
applies to all sample types including patient, QC and Analytical reference.
479 of 617 L0018200232 R01

Appendix B
ACL Elite/Elite Pro
Bar Code Label Specification
480 of 617 L0018200232 R01

Appendix B - Bar Code Label Specification
Contents

1.1 Purpose 482
1.2 Definitions, Acronyms and Abbreviations 482
2.1 Supported Codes and Checksum type 483
2.2 Bar Code Symbol Specifications 483
2.3 Barcode Parameters 484
2.4 Barcode Label Positioning 485
2.5 Decoder Zone Map 486
2.6 Barcode Label Dimensions 487
481 of 617 L0018200232 R01

1.0 Introduction Appendix B - Bar Code Label Specification
1.0 Introduction
In the following sections the characteristics of the bar code labels that can be read with the internal
scanner installed on ACL ELITE/ELITE PRO family instruments are described.
1.1 Purpose
Purpose of this document is to give indication of the scanner characteristics in terms of readable codes,
identify the requirements the barcode labels must satisfy and define constraints in terms of label
positioning within ACL ELITE/ELITE PRO instrument.
1.2 Definitions, Acronyms and Abbreviations

l Near Distance – The nearest distance that a scanner can accurately digitize a given bar code.
l Far Distance – The farthest distance that a scanner can accurately digitize a given bar code.
l Scan Width – The length of the widest bar code that can be successfully interpreted by the
scanner.
l Quiet Zone – The blank area located just before and just after the bar space pattern.
482 of 617 L0018200232 R01

2.0 General Description Appendix B - Bar Code Label Specification
2.0 General Description

The scanner is a fixed mount CCD bar code scanner with integrated decoder for easy integration into the
ACL ELITE/ELITE PRO instruments
The following mean features are available with the internal scanner:
l High scan rate per second (100 is the standard)

l Flexible scan trigger configurations
l Decoder configurable for high security
l Scan voting to ensure bar code data integrity
l Ease of configuration through RS-322 interface
2.1 Supported Codes and Checksum type

Code Type Checksum Type Data Digits
Code 128 No checksum up to 15
Code 39 Modulus 43 up to 15
No Checksum up to 15
Interleaved 2 of 5 USS - Modulus 10 up to 15
OPCC - Modulus 10 up to 15
No checksum up to 15
Codabar AIM - Modulus 16 with start/stop digits up to 15
NW7 - Modulus 11 up to 15
NW7 - Modulus 16 with start/stop digits up to 15
No Checksum up to 15
2.2 Bar Code Symbol Specifications

All bar code symbols have to satisfy the appropriate AIM Uniform Symbology Specification.
In particular the following characteristics have to be considered:
l Background substrate: the barcode symbol should be printed on a material type which is
reflective and has a matte (not glossy) finish. A background diffuse reflectance of at least 70%
to 80% is suggested for optimum contrast.
l Ink color and type: the ink type must be compatible with 660 nm LEDs used in the scanner.
The barcode symbols inked bars should not exceed 10% reflectance at 660 nm which is being
used for reading, whether printed with black ink or colored ink.
l Voids and Specks: the code has to be printed clearly, free of voids, specks, blemishes and
lines which could “fool” the scanner.
l Definition: the bars in the barcode symbols should be well defined. Their edges should not be
rough or fuzzy, so that bar and spaces have the proper widths intended for the used barcode
symbology used. Definition should be sharp and consistent.
l Tolerance: the ratio of the widths and spaces in a barcode symbol must conform to the
appropriate AIM barcode specifications and can cause problems if not correct throughout the
barcode. Problems can occur if bar edges are smeared or rough, or when they exhibit voids.
483 of 617 L0018200232 R01

2.3 Barcode Parameters Appendix B - Bar Code Label Specification
2.3 Barcode Parameters

Parameters have to be considered in that context are:
l Density (bar code): refers to the number of characters in a linear inch of bar code.
l Ratio: refers to the ratio of the nominal wide element width to the nominal narrow element
width.
In order to ensure a good bar code reading (in addition to that indicated in Section 2.2 - Bar Code Symbol
Specifications on the previous page, Appendix B), the parameters above mentioned should be as
follows:
l Density: not less 10 Mils

l Ratio: not less 2.5
These values are valid for all the above mentioned bar code types.
The relationship between reading distances, scan width and bar code density are displayed in the
following:
Scan Width Scan Width Density

Near Distance Far Distance
(near distance) (far distance) (bar code)
63.5 mm 114.5 mm 101.6 mm 152.4 mm 7.5 MIL
(161.29’’) (290.83’’) (258.064’’) (387.096’’)
34.3 mm 130.3 mm 82.3 mm 178.3 mm 13 MIL
(87.122’’) (330.962’’) (209.042’’) (452.882’’)
In Section 2.5 - Decoder Zone Map on page 486 (Appendix B) the attached drawing defines the “decoder
zone map” for the data displayed above. The displayed graph has been experimentally obtained from the
OEM vendor because the scanner equipped for the IL requirements does not have standard optics.
484 of 617 L0018200232 R01

2.4 Barcode Label Positioning Appendix B - Bar Code Label Specification
2.4 Barcode Label Positioning

The drawings in Section 2.5 and Section 2.6 of Appendix B define the barcode label dimensions and
identify constraints in positioning labels on Vacutainers#. The 13x75 Vacutainers have been considered.
The proposed barcode label dimensions and positioning apply to all sample tray models.
The following measurements are reported:
Barcode label feature Dimension

Maximum label length (global label size) 52.6 mm
(2.071”)
Maximum barcode length (printed area) 39.6 mm
(1.559”)
Quiet zone (white area before and after the printed area) 6.35 mm
(0.256”)
Label position (it is identified as the label edge measured starting from the Vacutainer 58 mm (2.283”)
lower edge)
#Vacutainer is a registered trademark of Becton Dickinson.
485 of 617 L0018200232 R01

2.5 Decoder Zone Map Appendix B - Bar Code Label Specification
2.5 Decoder Zone Map
.27
PCB
1.35
FRONT OF SCANNER
5.10
5.94
3.24
7.00
486 of 617 L0018200232 R01

2.6 Barcode Label Dimensions Appendix B - Bar Code Label Specification
2.6 Barcode Label Dimensions
487 of 617 L0018200232 R01

Appendix C
ACL Elite/Elite Pro
Special Test Procedures
Revision 6
488 of 617 L0018200232 R01

Appendix C - Special Test Procedures
Contents
1 APCR-V 490
2 Liquid Antithrombin 493
3 Anti-Xa 497
4 D-Dimer / D-Dimer High 500
5 D-Dimer 500 / D-Dimer 500 High 505
6 dRVVT Screen/Confirm 510
7 Factor Analysis 513
8 Chromogenic Factor VIII 518
9 Fibrinogen-C 522
10 Free Protein S 527
11 Heparin 531
12 Hepatocomplex 535
13 Homocysteine 539
14 Liquid Heparin 542
15 Plasminogen 545
16 Plasmin Inhibitor 549
17 Pro-IL-Complex 553
18 ProClot 557
19 Protein C 561
20 ProS 565
21 PS–ACT 569
22 SCT-Screen/Confirm 573
23 Thrombin Time (TT) 577
24 von Willebrand Factor Activity 580
25 von Willebrand Factor Antigen 584
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1 APCR-V Appendix C - Special Test Procedures
1 APCR-V
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1. Materials Needed
APCR-V Reagent Kit Cat. No. 20008700

Calibration Plasma Cat No. 20003700
APCR-V Reagent Kit Configuration

Kit Contents Stability Preparation
2 x 4mL APTT Reagent 1 Month at 2-8 °C Mix Thoroughly
1 Week at 15-25 °C before Use
8 hours at 15 °C on ACL
**Note: Do Not Freeze
2 x 4 mL Factor V Reagent Plasma 8 hours at 15-25 °C Add 4.0 mL H2 O.

24 hours at 2-8 °C Swirl, let sit for 30
3 months at -20 °C in original vial min at
15 - 25 °C.
(Thaw at 37 °C and mix before use. Do
Not Refreeze) Invert. Do Not
Shake!
2 x 2 mL APC CaCl2 8 hours at 15-25 o C Add 2.0 mL H2 O.

Note: Default position on the analyzer is 5 Days at 2-8 o C Swirl, let sit for 30
R7 (APC Ca Act) 3 months at -20 o C in original vial min at
15 - 25°C.
(Do Not Refreeze)
Invert. Do Not
Shake!
2 x 2 mL CaCl2 1 Month at 2-8 °C Mix Thoroughly

Note: Default position on the analyzer is 1 Week at 15-25 °C before Use
R8 (APC CaCl2) 3 Days at 15 °C on ACL
2 x 1 mL APC Control Plasma Level 1 6 hours at 15-25 °C Add 1.0 mL H2 O.

3 months at -20 °C original vial min at
15 - 25 °C.
Shake!
2 x 1 mL APC Control Plasma Level 2 6 hours at 15-25 °C Add 1.0 mL H2 O.

3 months at -20 °C in original vial min at
15 - 25 °C.
Shake!
2. Enabling the Test in the Analyzer
1. Select Setup > Tests > View/Define.

2. Click on the Show Enabled button to display all the tests.
3. Scroll down the test list and highlight the APCR-V Test. Click on the Enable/Disable button to enable
the test. A check mark will appear in the Enabled test column for this test.
4. Select the green check (√) to save and return to Database screen.
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3. Editing the Test Reference Range/Cutoff

2. Scroll down the list, highlight the APCR-V test, and press the Detail Icon.
3. Scroll down to the row for desired reporting units, and click on the Ranges button.
4. Enter in the Min and Max values for the normal range.
5. The reaction curve min and max may also be set. If the values are unknown, clear the min and max to
zoom the curve display to full scale.
4. Setting up Liquid Positions
The liquid positions for APTT Reagent, Factor V Reagent Plasma, APC/CaCl2 and CaCl2 are automatically
assigned when the test is placed in a profile or run as a single assay. Refer to the Materials Map for placement
when running the assay. See Section 3.2.3 - Materials Map on page 85.
5. Setting up QC
Prior to setting up QC ranges the QC material first needs to be defined. Verify that your system has the
appropriate QC liquid defined The APCR-V test can utilize the following control materials to verify assay
performance:
l APC Control Plasma Level 1

l APC Control Plasma Level 2
On the ACL ELITE/ELITE PRO these liquids are defined in the Setup > Liquids menu. Refer to Section
4.1.11 - Setup – Default Multi-Tests on page 179 for detailed instructions.
1. Select QC > QC Review and Setup.

2. Scroll down the Liquid ID list and select the appropriate QC liquid. Press the Setup button to define.
3. Configure the tests from the Enabled tests list. Define the Units, Target Mean, Target SD and SD range
for the test. If the Mean and SD is not known, then initially leave it set to zero. Once the ranges are
known, then you can re-define and click on the QC Range check button for control result flagging.
4. Refer to the Section 3.3 - Quality Control on page 112 for details on QC setup.
6. Sample Processing
Citrated plasma centrifuged from nine parts freshly drawn venous blood collected in one part trisodium citrate.
Frozen samples should be thawed at 37°C for 15 minutes. Centrifuge the plasma prior to testing. Samples
should be analyzed within 2 hours.
Results are reported in either seconds or a Ratio of the Seconds. The ratio is calculated as follows:
APCR-V = APTT (with APC) / APTT (without APC)
Each laboratory should establish its own normal cutoff value for the ratio.
Refer to the HemosIL™ APC™ Resistance V package insert sheet for a procedure to establish the cut-off
value.
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2 Liquid Antithrombin Appendix C - Special Test Procedures
2 Liquid Antithrombin
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1. Materials Needed
Liquid Antithrombin Kit Cat. No. 20002500

HemosIL Calibrator Cat. No. 20003700
HemosIL Normal Unassayed Control* Cat. No. 20003120
HemosIL Normal Assayed Control Cat No. 20003110
HemosIL Low Abnormal Unassayed Control* Cat. No. 20003220
HemosIL Low Abnormal Assayed Control Cat. No. 20003210
HemosIL High Abnormal Unassayed Control* Cat. No. 20003320
HemosIL High Abnormal Assayed Control Cat. No. 20003310
Special Test Control Level 1 Cat. No. 20011000
Factor Diluent Cat. No. 09757600
Cleaning solution (Clean A) Cat. No. 09831700
Liquid Antithrombin Reagent Kit Configuration

4 x 4mL Factor Xa Reagent Until Expiration when not opened and stored at 2-8 °C Invert to mix before
5 weeks in original vial at 2-8 °C 2 Days on ACL, use.
when opened
2 x 2 mL Chromogenic Until Expiration when not opened and stored at 2-8 °C Invert to mix before
Substrate 5 weeks in original vial at 2-8 °C use.
2 Days on ACL, when opened

3. Scroll down the test list and highlight the AT* Test. Click on the Enable/Disable button to enable the
test. A check mark will appear in the Enabled test column for this test.

2. Scroll down the list, highlight the AT* test, and press the Detail Icon.
3. Scroll down to the row for units in % and click on the Ranges button.
*Not available in all countries.
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4. Entering in the Calibrator concentration
1. Select Setup > Liquids.

2. Scroll down the Liquid ID column and highlight Cal Plasma.
3. Scroll down the Used by column and highlight the AT* test.
4. Click on the Assign Value button, and enter in the value for the Calibrator. This value can be found on
the Cal Plasma package insert.
The liquid positions for the Cal Plasma, Factor Xa, Chromogenic Substrate, Factor Diluent and Clean A are
automatically assigned when the test is placed in a profile or run as a single assay. Refer to the Materials Map
for placement when calibrating or running the assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The AT* test can utilize the following control materials to verify assay
performance:
l Normal Control Plasma

l Abnormal Chromogenic Control Plasma Level 1
l Abnormal Chromogenic Control Plasma Level 2

for the test. If the Mean and SD range is not known, then initially leave it set to zero. Once the ranges
are known, then you can re-define and click on the QC Range check button for control result flagging.
7. Calibrating the Assay
All reagents, calibrators must be reconstituted according to directions and allowed to sit for 30 minutes prior to
calibration.
1. Select Calibration > Calibrate.

2. From the calibrate screen, select the AT* test from the drop down menu in the Test to Calibrate window.
3. Confirm the necessary liquids are in place according to the Material Map.
4. Place 2 empty 0.5 mL sample cups in the appropriate “A” positions according to the Material Map.
5. Press the Run key to begin the calibrate cycle.
6. When the calibration is complete the graph and cal curve data will be visible. If the curve data is
acceptable, click on the check to accept the use of the curve.
495 of 617 L0018200232 R01

Linearity: 10 – 150 % activity
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3 Anti-Xa Appendix C - Special Test Procedures
3 Anti-Xa
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1. Materials Needed
Liquid Anti Xa Reagent Kit Cat. No. 0020302600

Heparin Calibrators Cat. No. 0020300600
LMW Heparin Controls Cat. No. 0020300200
UF Heparin Controls Cat. No. 0020300300
Cleaning Solution(Clean A) Cat. No. 0009831700
Cleaning agent (Clean B) Cat. No. 0009832700
Anti-Xa Reagent Kit Configuration

5 x 3mL Anti FXa Substrate 1 month at 2-8°C – original vial Invert to mix prior to use.
3 Days at 15°C on ACL ELITE/ELITE PRO
5 x 2.5mL Anti FXa Reagent 1 month at 2-8°C – original vial Invert to mix prior to use.

3. Scroll down the test list and highlight the Anti-Xa test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the Anti-Xa test, and press the Detail Icon.
3. Scroll down to the row for units in IU/mL and click on the Ranges button.
5. The reaction curve min and max may also be set. If the desired values are unknown, clear both the min
and the max to zoom curve display to full scale.

2. Scroll down the Liquid ID column and highlight HepCal3 .
3. Scroll down the Used by column and highlight the Anti-Xa test.
4. Click on the Assign Value button, and enter in the value of 2.0. HepCal 1 and HepCal 2 values are
automatically calculated and do not need to be entered.
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The liquid positions for the Hep Cals(1,2,3), AnFXaRgt, and AnFXaSub are automatically assigned when the
test is calibrated, placed in a profile or run as a single assay. Refer to the Materials Map for placement when
calibrating or running the assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The Anti-Xa test can utilize the following control materials to verify assay
performance:
l LMW Heparin Control

l UF Heparin Control

Heparin Calibrators must be reconstituted according to directions and allowed to sit for 30 minutes prior to
calibration.

2. From the calibrate screen, select the Anti-Xa test from the drop down menu in the Test to Calibrate
window.
Linearity: Up to 2.0 IU/mL
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4 D-Dimer / D-Dimer High Appendix C - Special Test Procedures
4 D-Dimer / D-Dimer High
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1. Materials Needed
D-Dimer Reagent Kit Cat. No. 20008500

D-Dimer Bi-level Control kit Cat. No. 20008610
D-Dimer Reagent Kit Configuration

4 x 3mL Latex Reagent 1 Month at 2-8°C Add 3.0 mL H2 O.
1 Day on ACL at 15 o C Swirl, let sit for 30 min at15 - 25o .
**Note: Do Not Freeze Invert. Do Not Shake!
3 x 9 mL Reaction 1 Month at 2-8°C Ready to use.

Buffer 1 Day on ACL at 15 o C Invert to mix prior to placing vial on
instrument
2 x 1mL D-Dimer 1 Month at 2-8°C Add 1.0 mL H2 O.

Calibrator 3 Days at 15-25°C Swirl, let sit for 30 min at 15 - 25°C.
2 Months at –20°C Invert. Do Not Shake!
**Freeze and thaw only 1 time. Avoid foam formation.
Thaw at 37°C & mix prior to use.
D-Dimer Controls
5 x 1.0 mL Low D-Dimer 1 Month at 2-8°C Add 1.0 mL H2 O.
Control 3 Days at 15-25°C Swirl, let sit for 30 min at 15 - 25°C.
Approximate Level: 2 Months at –20°C Invert. Do Not Shake!
Border line value
**Freeze and thaw only 1 time.
5 x 1.0 mL High D- 1 Month at 2-8°C Add 1.0 mL H2 O.

Dimer Control 3 Days at 15-25°C Swirl, let sit for 30 min at 15 - 25°C.
Approximate Level: 2 Months at –20°C Invert. Do Not Shake! Avoid foam formation.
Abnormal value

3. Scroll down the test list and highlight the D-Dimer Test. Click on the Enable/Disable button to enable
4. Repeat the above step for the D-D h test (D-Dimer High assay).
501 of 617 L0018200232 R01


2. Scroll down the list, highlight the D-Dimer test, and press the Detail Icon.
3. Scroll down to the row for units in ng/mL and click on the Ranges button.
1. Setup > Liquids

2. Scroll down the Liquid ID column and highlight D-D Cal.
3. Scroll down the Used by column and highlight the D-Dimer test.
4. Click on the Assign Value button, and enter in the value for the D-Dimer Calibrator. This value can be
found on the package insert included in the kit.
The D-Dh (D-Dimer High) test uses the calibration curve for the regular D-Dimer test. It is not necessary to
enter in the calibrator value into the D-D h test.
The liquid positions for the D-D Cal, D-Dimer Latex, Buffer reagent and Factor Diluent are automatically
502 of 617 L0018200232 R01

6. Setting up the Autorerun feature
The D-Dimer assay is linear from 200 to 1050 ng/mL. The ACL ELITE/ELITE PRO system can rerun patient
samples that exceed the 1050ng/mL limit using the D-Dimer high test. This will increase the linearity of the
assay 5-fold up to 5250 ng/mL. Values above 5250 ng/mL from the D-D h (D-Dimer high) test will need manual
dilution (1:25 or 1:125) with factor diluent and repeated using the D-Dimer test. Multiply the printed results by 5,
25 or 125 (depending upon the number of dilution steps performed) to correct for the dilution. Do Not run the D-
Dimer high test on samples with a D-Dimer less than 1000 ng/mL
1. Setup > Tests > Reflex Tests.

2. Define a new Reflex rule for the following:
3. If D-Dimer > 1050 > Add test D-Dh (D-Dimer High).
4. Refer to Section 4.1.6 - Setup – TESTS – Reflex Tests on page 163 for detailed instructions on setting
up Reflex rules.
5. To Enable the reflex testing: Setup > System Configuration.
6. The drop down menu for Reflex Status provides 3 choices:
l Program Test only
l Execute before closing session
l Disabled
7. Select either option 1 or 2 to enable the programming and/or testing.
7. Setting up QC
appropriate QC liquid defined. The D-Dimer test can utilize the following control materials to verify assay
performance:
l Low Dimer Control

l High Dimer Control

503 of 617 L0018200232 R01

calibration.

2. From the calibrate screen, select the D-Dimer test from the drop down menu in the Test to Calibrate
window.
Linearity: 200 – 1050 ng/mL
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5 D-Dimer 500 / D-Dimer 500 High Appendix C - Special Test Procedures
5 D-Dimer 500 / D-Dimer 500 High
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1. Materials Needed
D-Dimer 500 Reagent Kit Cat. No. 20301000*

D-Dimer Bi-level Control kit Cat. No. 20008610
D-Dimer Reagent Kit Configuration

4 x 3mL Latex Reagent 1 Month at 2-8°C Add 3.0 mL H2 O.
1 Day on ACL at 15 o C Swirl, let sit for 30 min at15 - 25o .
**Note: Do Not Freeze Invert. Do Not Shake!
3 x 9 mL Reaction 1 Month at 2-8°C Ready to use.

Buffer 1 Day on ACL at 15 o C Invert to mix prior to placing vial on
instrument
2 x 1mL D-Dimer 1 Month at 2-8°C Add 1.0 mL H2 O.

Calibrator 3 Days at 15-25°C Swirl, let sit for 30 min at15 - 25°C.
2 Months at –20°C Invert. Do Not Shake!
**Freeze and thaw only 1 time. Avoid foam formation.
D-Dimer Controls
5 x 1.0 mL Low D-Dimer 1 Month at 2-8°C Add 1.0 mL H O.
2
Control 3 Days at 15-25°C Swirl, let sit for 30 min at 15 - 25°C.
Approximate Level: 2 Months at –20°C Invert. Do Not Shake!
Border line value
5 x 1.0 mL High D- 1 Month at 2-8°C Add 1.0 mL H2 O.

Dimer Control 3 Days at 15-25°C Swirl, let sit for 30 min at 15 - 25°C.
Approximate Level: 2 Months at –20°C Invert. Do Not Shake! Avoid foam formation.
Abnormal value

3. Scroll down the test list and highlight the DD500 Test. Click on the Enable/Disable button to enable the
4. Repeat the above step for the DD500h test (D-Dimer 500 High assay).
*Check with your local ACL distributor for availability in your country.
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2. Scroll down the list, highlight the D-Dimer test, and press the Detail Icon.
3. Scroll down to the row for units in ng/mL and click on the Ranges button.
1. Setup > Liquids

2. Scroll down the Liquid ID column and highlight DD500 Cal.
3. Scroll down the Used by column and highlight the DD500 test.
4. Click on the Assign Value button, and enter in the value for the DD500 Calibrator. This value can be
found on the package insert included in the kit.
The DD500h (D-Dimer 500 High) test uses the calibration curve from the D-Dimer-500 test. It is not necessary
to enter in the calibrator value into the DD500h test.
The liquid positions for the DD500 Cal, DD500 Latx, DD500 Bufr reagents and Factor Diluent are automatically
507 of 617 L0018200232 R01

The DD500 assay is linear from 453 to 2283 ng/mL. The ACL ELITE/ELITE PRO system can rerun patient
samples that exceed the 2283ng/mL limit using the DD500h test. This will increase the linearity of the assay 5-
fold up to 11413ng/mL. Values above 11413 ng/mL from the DD500h (DDimer500 high) test will need manual
dilution (1:25 or 1:125) with factor diluent and repeated using the DD500 test. Multiply the printed DD500
results by the manual dilution factor to correct for the dilution. Do Not run the DD500h (DDimer 500 high) test
on samples with a D-Dimer less than 2283 ng/mL.
1. Setup > Tests > Reflex Tests.

2. Define a new Reflex rule for the following:
3. If DD500 > 2283 add test DD500h (D-Dimer 500 High).
up Reflex rules.
l Program Test only
l Disabled
7. Select either option 1 or 2 to enable the programming and/or testing.
7. Setting up QC
appropriate QC liquid defined. The D-Dimer test can utilize the following control materials to verify assay
performance:
l Low Dimer Control

l High Dimer Control

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calibration.

2. From the calibrate screen, select the DD500 test from the drop down menu in the Test to Calibrate
window.
Linearity: 435 – 2283 ng/mL
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6 dRVVT Screen/Confirm Appendix C - Special Test Procedures
6 dRVVT Screen/Confirm
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1. Materials Needed
dRVVT Screen Reagent Kit Cat. No. 0020301500

dRVVT Confirm Reagent Kit Cat. No. 0020301600
LA Positive Control Cat. No. 0020012500
LA Negative Control Cat. No. 0020012600
Cleaning Agent Cat. No. 0009832700
dRVVT Screen/Confirm
10 x 2mL dRVVT Screen 24 Hours onboard the analyzer at 15-25°C in Remove vial from refrigerate,
Reagent the original vial* Add 2.0 mL.
10 x 2mL dRVVT Confirm 15 days at 2-8°C in the original vial Swirl, let sit for 30 min at 15 –
Reagent *Note: Do Not freeze 25°C.
Invert. Do Not Shake!

3. Scroll down the test list and highlight the dRVVT* Test. Click on the Enable/Disable button to enable
* dRVVT S is the Screen assay and dRVVT C is the Confirm assay.

2. Scroll down the list, highlight the desired dRVVT test, and press the Detail Icon.
3. Scroll down to the row for units in seconds (S) or ratio (R) and click on the Ranges button.
The liquid positions for the dRVVT Reagent are automatically assigned when the test is run as a single assay.

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6. Results
The following procedure should be used to calculate the dRVVT Screen and dRVVT Confirm ratios:
l For each new lot of dRVVT Screen and dRVVT Confirm kit a new Normal Range may need to be
determined according to local and state regulations.
l Determine the Mean of each Normal Range in seconds.
l The mean of each normal range will be used as a constant denominator in the calculations of ratios.
dRVVT Screen
l Screen Ratio = Patient Screen results (seconds) / Mean of Screen Normal Range (seconds)
dRVVT Confirm
l Confirm Ratio = Patient Confirm results (seconds) / Mean of Confirm Normal Range (seconds)
l Normalized dRVVT Ratio = Screen Ratio / Confirm Ratio
The final result should be expressed as the Normalized dRVVT Ratio.
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7 Factor Analysis Appendix C - Special Test Procedures
7 Factor Analysis
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This protocol is setup for the FXII SP test. All factors are processed the same way on the ACL ELITE/ELITE
PRO, therefore these guidelines can be used to run any clotting factor test on the analyzer. Ordering
information for the materials needed to run additional factor tests is located at the end of the document.
1. Materials Needed
Factor XII Deficient Plasma Cat. No. 20011200

APTT SP# Cat. No. 20006300
# Kit can also be run using other APTT formulations.

* Not available in all countries.
Factor Analysis Reagent Kit Configuration

5 x 1mL Factor XII Deficient 4 Hours at 2 - 8°C Add 1.0 mL H2 O.
Plasma original vial Swirl, let sit for 30 min at 15 - 25°C.
5 x 9mL APTT Reagent 1 Month at 2-8°C Shake for 15 seconds or Vortex for 5 seconds
5 Days at 15 o C on ACL before use.
5 x 8mL Calcium Chloride 1 Month at 2-8°C Ready for Use
5 x 1mL Factor XII Deficient 4 Hours at 2 - 8°C Add 1.0 mL H2 O.

Plasma original vial Swirl, let sit for 30 min at 15 - 25°C.

3. Scroll down the test list and highlight the FXII SP Test. Click on the Enable/Disable button to enable the

#Kit can also be run using other APTT formulations.
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2. Scroll down the list, highlight the FXII SP test, and press the Detail Icon.

3. Scroll down the Used by column and highlight the FXII SP test.
NOTES:
l The FXII SP assay is Calibrated Once per Session onboard the ACL ELITE/ELITE PRO. The test
calibration occurs during the analysis cycle. The test cannot be calibrated under the Calibration Menu.
l Factor assays with parallelism tests utilize a Dedicated calibration and are calibrated under the
Calibration menu. These include FVIII and FIX for APTT SP and SynthASil.
The liquid positions for the Cal Plasma, Cal Low F, FXII Def, Factor Diluent, APTTSP and APTT CaCl2 are
automatically assigned when the test is run as a single assay. Refer to the Materials Map for placement when
running the assay. See Section 3.2.3 - Materials Map on page 85.
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6. Setting up QC
appropriate QC liquid defined. The FXII SP test can utilize the following control material to verify assay
performance:

l Special Test Control Level 2

calibration.
Non Parallelism Factor Assays
Calibration is performed during the Analysis Run for FXII SP. The Calibration utilizes 2 calibrators: Cal Plasma
and Cal Low F. The Cal Low F is a 1:16 dilution of the cal plasma. This is prepared by mixing 20µL of Cal
Plasma with 300µL of Factor diluent in a 0.5mL cup. When the ACL ELITE/ELITE PRO sees both of these
calibrators onboard during its pre-analytical check it will do a complete calibration curve. The calibration curve
will cover between 100% down to 1.56% activity.
If the ACL detects only the Cal Plasma onboard during the pre-analytical check, then it will execute a
calibration and construct a curve from 100% down to 25% activity. Low results below 25% will be extrapolated
from the curve. In either case the calibration curve will be stored and utilized again on subsequent runs if during
the pre-analytical check for FXII SP the instrument does not detect the presence of the Cal Plasma in position
A1.
NOTE: Do not place the Low Cal F onboard without having Cal Plasma onboard as well.
Calibration for the tests with Factor Parallelism are defined as “dedicated” and performed using the Calibration
Menu. These tests include FVIII and FIX for APTT SP and SynthASil.
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Expected Values: 50 – 150 % activity
9. Ordering information for Factor Assays
APTT Based Factors
Factor VIII Deficient Plasma Cat. No. 20011800

Factor IX Deficient Plasma Cat. No. 20011900
Factor XI Deficient Plasma Cat. No. 20011300
Factor XII Deficient Plasma Cat. No. 20011200
PT Based Factors
Factor II Deficient Plasma Cat. No. 20012200

Factor V Deficient Plasma Cat. No. 20011500
Factor VII Deficient Plasma Cat. No. 20011700
Factor X Deficient Plasma Cat. No. 20010000
Clotting Reagents
APTT SP Cat. No. 20006300

APTT Lyophilized Silica Cat. No. 08468710
SynthasIL Cat. No.20006800
PT - Fib Cat. No. 09756710
PT- Fib HS PLUS Cat. No. 08469810
RecombiPlasTin 2G Cat. No.20002950(8mL) or 20003050(20mL)
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8 Chromogenic Factor VIII Appendix C - Special Test Procedures
8 Chromogenic Factor VIII
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1. Materials Needed
Electrachrome Factor VIII Cat. No. 49730503

Cleaning Solution (Clean A) Cat. No. 09831700
Reagent Kit Configuration

2 x 3mL Factor Reagent 12 Hours at 2 - 8°C Add 3.0 mL H2 O.
original vial Swirl, let sit for 30 min at15 - 25°C.
30 days at -70°C Invert. Do Not Shake!
1 x 6mL Factor VIII Chromogenic 1 Month at 2-8°C Add 6.0 mL H2 O.

Substrate Reagent original vial Swirl, let sit for 30 min at15 - 25°C.
1 x 24mL Factor VIII Buffer 1 Month at 2-8°C (after Working buffer: dilute 2 mL Buffer with
diluting) 18 mL H2 O.

3. Scroll down the test list and highlight the F8 Chr H / F8 Chr L Test. Click on the Enable/Disable button
to enable the test. A check mark will appear in the Enabled test column for this test. You can select to
run either the High test, Low test or both. The selected test must be run in single test mode and cannot
be placed in a profile.

2. Scroll down the list, highlight the F8 Chr H / F8 Chr L test, and press the Detail Icon.
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3. Scroll down the Used by column and highlight the F8 Chr H / F8 Chr L test.
The liquid positions for the Cal Plasma, Cal Low F, F8 Chr Buf, F8 Chr Act, F8 Chr Sub, Clean A, and Factor
Diluent are automatically assigned when the test is run as a single assay. Refer to the Materials Map for
placement when running the assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The F8 Chr test can utilize the following control material to verify assay
performance:


7. Calibrating the Assay (performed each rotor during analysis)
All reagents and calibrators must be reconstituted according to directions and allowed to sit for 30 minutes prior
to calibration.
The Cal Low F is a 1:16 dilution of the cal plasma.
This is prepared by mixing 20µL of Cal Plasma with 300µL of Factor diluent in a 0.5mL cup.
This calibrator is used for the F8 Chr L (Low Chromogenic Factor VIII) test.
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NOTE: When the assay is run 2 empty (0.5 mL) cups for calibration will be required in the displayed “A”
positions on the tray along with one empty (0.5 mL) cup for each sample. The empty cups in the sample
position should be placed starting with position 21. One cup per patient sample needs to be placed.
Expected Values: 50 – 150 % activity
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9 Fibrinogen-C Appendix C - Special Test Procedures
9 Fibrinogen-C
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1. Materials Needed
Fibrinogen-C Reagent Kit (2mL) Cat. No. 20301100

QFA Thrombin Reagent Kit (2mL) Cat. No. 20301800
Low Fibrinogen Control Cat. No. 20004200
Fibrinogen-C Reagent Kit Configuration

10 x 2mL Bovine Thrombin Reagent 3 Days at 2-8°C Add 2.0 mL H2 O.
8 hours at 15°C on ACL Swirl, let sit for 30 min at 15 - 25°C.
1 Month at 20°C original vial Invert. Do Not Shake!
Fibrinogen QFA Reagent Kit Configuration

10 x 2mL Bovine Thrombin 7 Days at 2-8°C Let vial sit 15 min at 20-25°C
Reagent 6 days onboard system at 20- Add 2.0 mL H2 O.
25°C Swirl, let sit for 30 min at 20 -
25°C.
NOTES:
l The Fib Clauss test is designated as Fib-C (g/L) and Fib-C_ (mg/dL)
l The QFA Fib test is designated as QFA (g/L) and QFA_ (mg/dL)

3. Scroll down the test list and highlight the desired Fib Test. Click on the Enable/Disable button to enable
the desired Fib-C or QFA test. A check mark will appear in the Enabled test column for this test.
4. Repeat the above step for the desired Fib-C h test (Fib Clauss High assay) and the Fib-C l (Fib Clauss
Low assay) and/or the QFA L (QFA Low).
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2. Scroll down the list, highlight the desired Fib test, and press the Detail Icon.
3. Scroll down to the row for units in g/L or mg/dL and click on the Ranges button.
6. Repeat the above steps for the desired Fib-C h test (Fib Clauss High assay) and the Fib-C l (Fib Clauss
Low assay) and/or QFA L (QFA Low).

2. Scroll down the Liquid ID column and highlight Cal Plasm
3. Scroll down the Used by column and highlight the desired Fib-C or QFA test
4. Click on the Assign Value button, and enter in the value for the Cal Plasma. This value can be found on
The Fib-C h (Fib Clauss High) and the Fib-C l (Fib Clauss Low) tests use the calibration curve for the regular
Fib Clauss test. The QFA L test uses the calibration from the QFA test. It is not necessary to enter the
calibrator value into these additional tests.
The liquid positions for the Cal Plasm, FIB/QFA Thr., Factor Diluent, and Clean A are automatically assigned
when the test is placed in a profile or run as a single assay. Refer to the Materials Map for placement when
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The Fib-C assay range is from 70 - 700 mg/dL (0.7 – 7.0g/L). The system can rerun samples that exceed the
lower and upper range using the Fib Clauss Low and High tests. The Fib-Clauss Low test range is 30-700
mg/dL (0.3 – 7.0g/L) and the Fib Clauss high test range is 70-1100mg/dL (0.7-11 g/L). The QFA_ test assay
range is 150 to 1000mg/dL (1.5 – 10g/L). The system can rerun samples that are below the lower limit using the
QFA L test. The test range for the QFA_Low test is 30 – 150 mg/dL (0.3 – 1.5g/L).
1. Setup > Tests >Reflex Tests.

2. Define Reflex rules for the Fib test(s) used in your laboratory. For Example,
l If Fib-C > 700 mg/dL add test Fib-C h_ (Fib Clauss High)
l If Fib-C < 70 mg/dL add test Fib-C l_ (Fib Clauss Low)
l If QFA < 150 mg/dL add test QFA L_ (Fib QFA Low)
3. If using g/L instead of mg/dL the above equations use the test ID without the underscore (i.e. Fib C and
QFA) and enter the values in g/L.
up Reflex rules.
l Program Test only
l Disabled
7. Select desired option to enable the programming and/or testing.
7. Setting up QC
appropriate QC liquid defined.

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calibration.

2. From the calibrate screen, select the desired Fib-C/QFA test from the drop down menu in the Test to
Calibrate window.
3. Confirm the necessary liquids (Fib-C/QFA Thr., Factor Diluent and Clean A) are in place according to
the Material Map.
Assay Ranges:
Fib-C 70 – 700 mg/dL 0.7 – 7.0 g/L

Fib-C l 30 – 700 mg/dL 0.3 – 7.0 g/L
Fib-C h 70 – 1100 mg/dL 0.7 – 11.0 g/L
QFA 150 – 1000 mg/dL 1.5 – 10.0 g/L
QFA L 30 – 150 mg/dL 0.3 – 1.5 g/L
NOTES:
l Tests with underscore in the test ID (i.e. Fib-C_) indicate the test is defined in mg/dL. Test ID without
the underscore (i.e. Fib-C) indicate the test is defined in g/L.
l Samples should be processed using the standard test first. If results exceed the standard test assay
range then the respective low/high Fib test should be used.
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10 Free Protein S Appendix C - Special Test Procedures
10 Free Protein S
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1. Materials Needed
Free Protein S Reagent Kit Cat. No. 20002700

HemosIL Calibration Plasma Cat. No. 20003700
HemosIL Normal Assayed Control* Cat No. 20003110
Free Protein S Reagent Kit Configuration

3 x 2mL Anti PS Until Expiration when not opened Invert to mix before use. Do Not Shake!
Latex Reagent and stored at 2-8°C Avoid Foam Formation!
1 Month at 2-8°C ,1 Week on ACL,
when opened
3 x 4 mL C4BP Latex Post Reconstitution: Add 1 vial of C4BP Buffer into Latex, swirl
1 Month at 2-8°C gently 20 seconds
1 Week on ACL Let sit for 30 min at
15 - 25°C.

3. Scroll down the test list and highlight the Free PS Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the Free PS test, and press the Detail Icon.
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3. Scroll down the Used by column and highlight the Free PS test.
The liquid positions for the Cal Plasma, Anti PS Latex, C4BP Latex reagent and Factor Diluent are
automatically assigned when the test is placed in a profile or run as a single assay. Refer to the Materials Map
for placement when calibrating or running the assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The Free PS kit can utilize the following control materials to verify assay
performance:

l Special Test Control Plasma Level 2

calibration.

2. From the calibrate screen, select the Free PS test from the drop down menu in the Test to Calibrate
window.
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Linearity: 10 – 135 %
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11 Heparin Appendix C - Special Test Procedures
11 Heparin
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1. Materials Needed
Heparin Reagent Kit Cat. No. 20009400

Low Heparin Control Plasma Cat. No. 20004000
High Heparin Control Plasma Cat. No. 20004100
Cleaning Solution (Clean A)# Cat. No. 09831700
Heparin Reagent Kit Configuration

1 x 4mL Chromogenic Substrate (Hep 3 Months at 2-8°C Add 4.0 mL H2 O.
Sub) 7 Days at 15°C original vial Swirl, let sit for 30 min at 15 - 25°C.
Invert.
1 x 5 mL Factor Xa Reagent (Hep_F 3 Months at 2-8°C Add 5.0 mL H2 O.

(Xa) 7 Days at 15°C original vial Swirl, let sit for 30 min at 15 - 25°C.
Invert.
1 x 3 mL Antithrombin 3 Months at 2-8°C original Add 3.0 mL H2 O.

vial Swirl, let sit for 30 min at 15 - 25°C.
Invert.
1 x 8mL Buffer 3 Months at 2-8°C original Dilute 1:10 (1 part Buffer + 9 parts
vial H2 O)
Prepare the reagents as directed above, then prepare the working reagents for the Heparin assay after the
reagents above have reconstituted and stabilized (30 minutes)
Heparin Working Reagent Preparation

Working Buffer (Hep 7 Days at 2-8°C Add 1.0 mL Antithrombin to 24.0 mL of Diluted Buffer
W.D.) 7 Days at 15°C
0.8 Calibrator Add 1.0 mL of 0.8 U/mL diluted Heparin* to 1 vial of

Lyophilized Cal Plasma
0.0 Calibrator Add 1.0 mL of H2 O to a vial of Cal Plasma, let sit 30

minutes
#Clean A is used for the automatic clean cycle incorporated into the Heparin assay test definition.
*0.8 Heparin Calibrator Preparation
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Dilution
Stock Heparin Concentration Dilution Ratio
(to create a 20 U/mL heparin standard)
25,000 units/mL Step 1: 100 µL heparin +2.4 mL water 1:25
Step 2: 100 µL of Step 1 dilution + 4.9 mL water 1:50
10,000 units/mL Step 1: 100 µL heparin + 900 µL water 1:10
5,000 units/mL Step 1: 100 µL heparin + 400 µL water 1:5
1,000 units/mL 100 µL of heparin + 4.9 mL water 1:50
50 units/mL 1.0 mL heparin + 1.5 mL water 1:2.5
Dilute 100 µL of the 20 U/mL heparin prepared above with 2.4 mL of the recommended water. This will result in
a 0.8 U/mL solution of heparin. Use 1.0mL of this solution to dilute one vial of Cal Plasma.
NOTE: There are 2 Heparin assays defined within the ACL ELITE/ELITE PRO.
1. Hep UHF – Unfractionated Heparin

2. Hep LMW

3. Scroll down the test list and highlight the desired Heparin Test. Click on the Enable/Disable button to
enable the test. A check mark will appear in the Enabled test column for this test.

2. Scroll down the list, highlight the desired Heparin test, and press the Detail Icon.
3. Scroll down to the row for units in U/mL and click on the Ranges button.

2. Scroll down the Liquid ID column and highlight HEPCAL 0.8.
3. Scroll down the Used by column and highlight the desired Heparin test.
4. Click on the Assign Value button, and enter in the value for the Calibrator (0.8).
5. Do Not enter a cal value for the HEPCAL 0.0 (zero heparin calibrator)
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The liquid positions for the HEP W.D., HEP_F(Xa), HEP Sub, Cleaning A, HepCal 0.0 and HEPCal 0.8 are
automatically assigned when the test is either calibrated or run as a single assay. HEPCal 0.0 and HEPCal
0.8 are only needed during the calibration cycle. Refer to the Materials Map for placement when running the
assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The Heparin test can utilize the following control materials, for Unfractionated
Heparin testing only, to verify assay performance:
l Low Heparin Control Plasma

l High Heparin Control Plasma

calibration.
The Heparin assay utilizes the dedicated Calibration mode and therefore is calibrated under the Calibration
menu.
Empty cups for the calibration must be placed onboard the analyzer as follows:
l Hep UHF test – Position A1

l Hep LMW test – Position A1
The Hep UHF and the Hep LMW tests do not need empty cups during analysis.
Linearity: 0 – 1.0 U/mL
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12 Hepatocomplex Appendix C - Special Test Procedures
12 Hepatocomplex
The Hepatocomplex kit not available in all countries.
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1. Materials Needed
Hepatocomplex Reagent Kit Cat. No. 09758710

PCX/HPX Thromboplastin diluent Cat. No. 08469600
Hepatocomplex Reagent Kit Configuration

5 x 7mL Rabbit Until Expiration when not Add 7mL of PCX/HPX Thromboplastin diluent,
Calcium opened and stored at 2-8°C Swirl, let sit for 30 min at 15 - 25°C.
Thromboplastin 5 days in original vial at 2-8°C Invert. Do Not Shake!
8 Hours on ACL, when opened
5 x 3 mL Bovine Until Expiration when not Add 3.0 mL CLSI Type II water.
Plasma opened and stored at 2-8°C Swirl, let sit for 30 min at 15 - 25°C.
24 hours in original vial at 2- Invert. Do Not Shake!
8°C, when opened
5 days stability at -20°C
**Note: Do Not Re-Freeze

3. Scroll down the test list and highlight the HPX Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the HPX test, and press the Detail Icon.
3. Scroll down to the row for desired unit and click on the Ranges button.
4. Enter in the Min and Max values for the range.
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4. Entering in the Reagent ISI value

2. Scroll down the Liquid ID column and highlight the Rabbit Calcium Thromboplastin (HPX Thromb.)
3. Scroll down the Used by column and highlight the HPX test
4. Click on the Assign Value button, and enter in the ISI value. This value can be found on the
Hepatocomplex package insert.

2. Scroll down the Liquid ID column and highlight Cal Plasma
3. Scroll down the Used by column and highlight the HPX test
The liquid positions for the Cal Plasma, HPX Plasma, HPX Thromb (Rabbit Ca Thromboplastin) , and Factor
Diluent are automatically assigned when the test is calibrated or run in a profile or as a single assay. Refer to
the Materials Map for placement when calibrating or running the assay. See Section 3.2.3 - Materials Map on
page 85.
7. Setting up QC
appropriate QC liquid defined. The HPX test can utilize the following control materials to verify assay
performance:

l Abnormal Control Plasma Low/Level 1
l Abnormal Control Plasma High/Level 2

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calibration.

2. From the calibrate screen, select the HPX test from the drop down menu in the Test to Calibrate
window.
4. Place 2 empty 0.5 mL sample cups in the appropriate “A” positions (A3 and A4) according to the Material
Map.
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13 Homocysteine Appendix C - Special Test Procedures
13 Homocysteine
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1. Materials Needed
Homocysteine Reagent Kit Cat. No. 20007800

Homocysteine Controls Cat. No. 20007900
Homocysteine Reagent Kit Configuration

2 x 9 mL Buffer 2 months at 2-8°C in the original vial Invert to mix before use
8 Hours at 15°C onboard
Do Not Freeze
4 x 2 mL Reductant 2 months at 2-8°C in the original vial Invert to mix before use
Do Not Freeze
2 x 2 mL Enzyme 2 months at 2-8°C in the original vial Invert to mix before use
Do Not Freeze
2 x 2.5mL Conjugate 2 months at 2-8°C in the original vial Invert to mix before use
Do Not Freeze
2 x 2 mL SAH Latex Reagent 2 months at 2-8°C in the original vial Add 2.0 mL H2 O.
8 Hours at 15°C onboard Swirl, let sit for 30 min at 15 - 25°C.
Do Not Freeze Invert. Do Not Shake!
2 x 1 mL Calibrator 2 months at 2-8°C in the original vial Invert to mix before use
Do Not Freeze

3. Scroll down the test list and highlight the HCY Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the HCY test, and press the Detail Icon.
3. Scroll down to the row for units in umol/L and click on the Ranges button.
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2. Scroll down the Liquid ID column and highlight HCY Calibrator.
3. Scroll down the Used by column and highlight the HCY test.
4. Click on the Assign Value button, and enter in the value for the Calibrator.
The liquid positions for the HCY Cal , HCY Buffer, HCY Red, HCY Enz, HCY Conj. And HCY Latex are
6. Setting up QC
appropriate QC liquid defined. The Homocysteine test utilizes the following control material to verify assay
performance:
l Homocysteine Controls

calibration.
The Homocysteine assay utilizes the dedicated Calibration mode and therefore is calibrated under the
Calibration menu. In addition to the reagents, 3 empty 0.5mL cups will need to be placed in the designated A
positions on the sample tray
Linearity: 4.5 to 30 umol/L
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14 Liquid Heparin Appendix C - Special Test Procedures
14 Liquid Heparin
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1. Materials Needed
Liquid Heparin Reagent Kit Cat. No. 0020300100

Heparin Calibrators Cat. No. 0020300600
LMW Heparin Controls Cat. No. 0020300200
UF Heparin Controls Cat. No. 0020300300
Cleaning Solution(Clean A) Cat. No. 0009831700
Cleaning agent (Clean B) Cat. No. 0009832700
Liquid Heparin Reagent Kit Configuration

5 x 3mL Chromogenic Substrate 1 month at 2-8°C – original vial Invert to mix prior to use.
5 x 2.5mL Factor Xa Reagent 1 month at 2-8°C – original vial Invert to mix prior to use.

3. Scroll down the test list and highlight the LiqHep test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the LiqHep test, and press the Detail Icon.
3. Scroll down to the row for units in IU/mL and click on the Ranges button.

2. Scroll down the Liquid ID column and highlight HepCal3 .
3. Scroll down the Used by column and highlight the LiqHep test.
4. Click on the Assign Value button, and enter in the value of 2.0. HepCal 1 and HepCal 2 values are
automatically calculated and do not need to be entered.
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The liquid positions for the Hep Cals, LHepFXa, and LHepSub are automatically assigned when the test is
calibrated, placed in a profile or run as a single assay. Refer to the Materials Map for placement when
6. Setting up QC
appropriate QC liquid defined. The LiqHep test can utilize the following control materials to verify assay
performance:
l LMW Heparin Control

l UF Heparin Control

Heparin Calibrators must be reconstituted according to directions and allowed to sit for 30 minutes prior to
calibration.

2. From the calibrate screen, select the Liq Hep test from the drop down menu in the Test to Calibrate
window.
Frozen samples should be quickly thawed at 37°C. Gently mix the plasma prior to testing. Samples should be
analyzed within 2 hours.
Linearity: Up to 2.0 IU/mL
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15 Plasminogen Appendix C - Special Test Procedures
15 Plasminogen
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1. Materials Needed
Plasminogen Reagent Kit Cat. No. 20009000

Plasminogen Reagent Kit Configuration

2 x 2mL Chromogenic Substrate 3 Months at 2-8°C original vial Add 2.0 mL H2 O.
7 Days at 15°C original vial Swirl, let sit for 30 min at 15 - 25°C.
6 Months at -20°C original vial Mix before use.
2 x 2.5 mL Streptokinase 3 Months at 2-8°C original vial Add 2.5 mL H2 O.

7 Days at 15°C original vial Swirl, let sit for 30 min at 15 - 25°C.

3. Scroll down the test list and highlight the PLG Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the PLG test, and press the Detail Icon.
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3. Scroll down the Used by column and highlight the PLG test.
NOTES:
l The PLG assay is Calibrated Once per Session onboard the ACL ELITE/ELITE PRO.
l The test calibration occurs during the analysis cycle.
l The test cannot be calibrated under the Calibration Menu.
The liquid positions for the Cal Plasma, Streptokinase (PLG Strept) and Chromogenic substrate (PLG Sub) are
automatically assigned when the test is run. The test can be run in the Single Test or Profile mode on the
analyzer. Refer to the Materials Map for placement when running the assay. See Section 3.2.3 - Materials Map
on page 85.
6. Setting up QC
appropriate QC liquid defined. The PLG test can utilize the following control materials to verify assay
performance:

l Abnormal Chromogenic Control Plasma Level 1and 2

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calibration.
Calibration is performed during the Analysis Run for PLG. The calibration curve will be saved and utilized again
on subsequent runs if, during the pre-analytical check for PLG, the instrument does not detect the presence of
the Cal Plasma in position A1.
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16 Plasmin Inhibitor Appendix C - Special Test Procedures
16 Plasmin Inhibitor
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1. Materials Needed
Plasmin Inhibitor Reagent Kit Cat. No. 20009200

Plasmin Inhibitor Reagent Kit Configuration

1 x 4mL 5 Days at 2-8°C original vial Add 4.0 mL H2 O.
Chromogenic 5 Days at 15°C original vial Swirl, let sit for 30 min at 15 - 25°C.
Substrate
2 x 2.5 mL Plasmin 5 Days at 2-8°C original vial Add 2.5 mL Diluted Buffer.
Reagent 5 Days at 15°C original vial Swirl, let sit for 30 min at 15 - 25°C.
2 x 9mL Buffer Undiluted Buffer: Until Expiration when not Dilute as needed 1:10 by adding 1
(Buffer must be opened and stored at 2-8°C part Buffer + 9 part H2 O
diluted prior to use) Diluted Buffer: 24 Hours at 15°C

3. Scroll down the test list and highlight the PL-IN Test (test no. 213). Click on the Enable/Disable button
to enable the test. A check mark will appear in the Enabled test column for this test.

2. Scroll down the list, highlight the PL-IN test, and press the Detail Icon.
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3. Scroll down the Used by column and highlight the PL-IN test.
NOTES:
l The PL-IN assay is Calibrated Once per Session onboard the ACL ELITE/ELITE PRO.
The liquid positions for the Cal Plasma, PI Buffer, PI Plasmin, and Chromogenic substrate (PI Sub) are
automatically assigned when the test is run. The test can be run in the Single Test or Profile mode on the
analyzer. Refer to the Materials Map for placement when running the assay. See Section 3.2.3 - Materials Map
on page 85.
6. Setting up QC
appropriate QC liquid defined. The PL-IN test can utilize the following control materials to verify assay
performance:

l Abnormal Chromogenic Control Plasma Level 1and 2

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calibration.
Calibration is performed during the Analysis Run for PL-IN. The calibration curve will be saved and utilized
again on subsequent runs if, during the pre-analytical check for PL-IN, the instrument does not detect the
presence of the Cal Plasma in position A1.
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17 Pro-IL-Complex Appendix C - Special Test Procedures
17 Pro-IL-Complex
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1. Materials Needed
Pro-IL-Complex Reagent Kit Cat. No. 09758810

PCX/HPX Thromboplastin diluent Cat. No. 08469600
Pro-IL-Complex Reagent Kit Configuration

5 x 7mL Bovine Until Expiration when not Add 7mL of PCX/HPX Thromboplastin diluent,
Calcium opened and stored at 2-8°C Swirl, let sit for 30 min at 15 - 25°C.
Thromboplastin 5 days in original vial at 2-8°C Invert. Do Not Shake!
8 Hours on ACL, when opened
5 x 3 mL Bovine Until Expiration when not Add 3.0 mL CLSI Type II water.
Plasma opened and stored at 2-8°C Swirl, let sit for 30 min at 15 - 25°C.
24 hours in original vial at 2- Invert. Do Not Shake!
8°C when opened
5 days stability at -20°C
**Note: Do Not Re-Freeze

3. Scroll down the test list and highlight the PCX Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the PCX test, and press the Detail Icon.
3. Scroll down to the row for desired unit and click on the Ranges button.
4. Enter in the Min and Max values for the range.
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4. Entering in the Reagent ISI value

2. Scroll down the Liquid ID column and highlight the Bovine Calcium Thromboplastin (PCX Thromb.).
3. Scroll down the Used by column and highlight the PCX test.
4. Click on the Assign Value button, and enter in the ISI value. This value can be found on the Pro-IL-
Complex package insert.

3. Scroll down the Used by column and highlight the PCX test.
The liquid positions for the Cal Plasma, PCX Plasma, PCX Thromb (Bovine Ca Thromboplastin) , and Factor
Diluent are automatically assigned when the test is calibrated or run in a profile or as a single assay. Refer to
the Materials Map for placement when calibrating or running the assay. See Section 3.2.3 - Materials Map on
page 85.
7. Setting up QC
appropriate QC liquid defined. The PCX test can utilize the following control materials to verify assay
performance:

l Abnormal Control Plasma Low/Level 1
l Abnormal Control Plasma High/Level 2

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calibration.

2. From the calibrate screen, select the PCX test from the drop down menu in the Test to Calibrate
window.
4. Place 3 empty 0.5 mL sample cups in the appropriate “A” positions (A3, A4 and A6) according to the
Material Map.
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18 ProClot Appendix C - Special Test Procedures
18 ProClot
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1. Materials Needed
ProClot Reagent Kit Cat. No. 08468310

ProClot Diluent Cat. No. 08468600
APTT SP# Cat. No. 20006300
ProClot Reagent Kit Configuration

4 x 1mL Protein C Deficient 4 Hours at 15-25°C Add 1.0 mL H2 O.
Reagent 7 Days at - 20°C in the Swirl, let sit for 30 min at 15 - 25°C.
original vial Invert. Do Not Shake!
4 x 1.5 mL Protein C Activator 15 Days at 2-8°C Add 1.5 mL H2 O.

(Protac®) 60 Days at - 20°C in the Swirl, let sit for 30 min at 15 - 25°C.
Protein C Working Diluent 8 Hours at 2-8°C Mix 4.3 Parts of ProClot Diluent with 1 Part
Protein C Activator
5 x 9mL APTT Reagent 1 Month at 2-8°C Shake for 15 seconds or Vortex for 5 seconds
5 Days at 15 o C on ACL before Use
5 x 8mL Calcium Chloride 1 Month at 2-8°C Ready for Use
2 x 1 mL Protein C Control 4 Hours at 15-25°C Add 1.0 mL H2 O.

Plasma 7 Days at - 20°C in the Swirl, let sit for 30 min at 15 - 25°C.

3. Scroll down the test list and highlight the ProClotSP Test. Click on the Enable/Disable button to enable

#Kit can also be run using APTT-Lyophilized silica.
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2. Scroll down the list, highlight the ProClotSP test, and press the Detail Icon.

3. Scroll down the Used by column and highlight the ProClotSP test.
NOTES:
l The ProClot assay is Calibrated Once per Session onboard the ACL ELITE/ELITE PRO.
l The Calibration under analysis utilizes an empty cup for the calibration. Therefore the test must be run
as a single test and cannot be run in the profile mode.
The liquid positions for the Cal Plasma, Protein C Deficient, Working Diluent, APTTSP and APTT CaCl are
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6. Setting up QC
appropriate QC liquid defined. The ProClotSP test can utilize the following control materials to verify assay
performance:

l Abnormal Control Plasma Level 1
l Protein C Control Plasma – packaged in reagent kit

calibration.
Calibration is performed during the Analysis Run for ProClot. The calibration curve will be saved and utilized
again on subsequent runs if during the pre-analytical check for Pro-Clot the instrument does not detect the
presence of the Cal Plasma in position A1.
The Calibration during analysis requires an empty cup to be placed in position A2 on the sample tray.
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19 Protein C Appendix C - Special Test Procedures
19 Protein C
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1. Materials Needed
Protein C Reagent Kit Cat. No. 20300500

Protein C Reagent Kit Configuration

2 x 2.5mL Chromogenic 3 Months at 2-8°C Add 2.5 mL H2 O.
Substrate 7 Days at 15°C original Swirl, let sit for 30 min at 15 - 25°C.
vial Invert.
2 x 2.5 mL Protein C 3 Months at 2-8°C Add 2.5 mL H2 O.

Activator 7 Days at 15°C original Swirl, let sit for 30 min at 15 - 25°C.
vial Invert.
1 x 8mL Diluent Store at 2-8°C in original Mix 1 Part of Diluent with 9 Parts Water. Mix
vial before use.

2. Click on the Show Enabled button to display all the tests
3. Scroll down the test list and highlight the P-C Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the P-C test, and press the Detail Icon.
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3. Scroll down the Used by column and highlight the P-C test.
NOTES:
l The P-C assay is Calibrated Once per Session onboard the ACL ELITE/ELITE PRO.
The liquid positions for the Cal Plasma, PC Activ., PC Sub., and Pchrom Dil are automatically assigned when
the test is run as a single assay. Refer to the Materials Map for placement when running the assay. See
Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The P-C test can utilize the following control materials to verify assay
performance:

l Special Test Control Plasma Level 1and 2

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calibration.
Calibration is performed during the Analysis Run for P-C. The calibration curve will be saved and utilized again
on subsequent runs if, during the pre-analytical check for P-C, the instrument does not detect the presence of
the Cal Plasma in position A1.
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20 ProS Appendix C - Special Test Procedures
20 ProS
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1. Materials Needed
HemosIL ProS Reagent Kit Cat. No. 20002800

Prot S Ctrl (included in ProS Reagent Kit) Cat. No. 20002830
ProS Reagent Kit Configuration

3 x 3mL Protein S Reagent 2 Days at 2-8°C Add 3.0 mL H2 O.
4 Hours at 15°C on board Swirl gently, let sit for 30 min at 15
#15 Days at –20°C original 25°C.
vial Invert. Do Not Shake!
No stirring required
6 x 1 mL Protein S Deficient After Reconstitution: Add 1.0 mL H2 O.

Plasma 4 Hours at 15°C original vial Swirl gently, let sit for 30 min at 15 -
#7 Days at –20°C 25°C.
2 x 1 mL Protein S Control 4 Hours at 15-25°C original Add 1.0 mL H2 O.

Plasma vial Swirl, let sit for 30 min at 15 - 25°C.
# 7 Days at –20°C

3. Scroll down the test list and highlight the ProS Test. Click on the Enable/Disable button to enable the
*For use in selected countries.

#Frozen reagent and plasmas should be thawed at 37°C and gently mixed before. Before freezing they can be
aliquoted using plastic tubes and stoppers. DO NOT REFREEZE.
566 of 617 L0018200232 R01

3. Editing the Test Reference Range

2. Scroll down the list, highlight the ProS test, and press the Detail Icon.
5. Scroll down to the row for units in seconds (s) and click on the Ranges button.

3. Scroll down the Used by column and highlight the ProS test.
5. DO NOT enter any value for ProS 50% C.
NOTES:
l The ProS assay must be Calibrated One Time per Session.

l The test cannot be calibrated under the Calibration Menu but you can view the calibration report after
analysis run.
The liquid positions for the Cal Plasma, ProS 50% C (Cal Plasma diluted 1:1 with Protein S Def Plasma),
Protein S Reagent, Protein S Deficient Plasma and Factor Diluent are automatically assigned when the test is
run as a single assay. Refer to the Materials Map for placement when calibrating or running the assay. See
Section 3.2.3 - Materials Map on page 85.
567 of 617 L0018200232 R01

6. Setting up QC
appropriate QC liquid defined. The ProS test can utilize the following control materials to verify assay
performance:

l Low Abnormal Control Plasma
l High Abnormal Control Plasma
l Protein S Control Plasma – packaged in reagent kit

calibration.
The ProS assay must be Calibrated One Time per Session. The test calibration occurs during the analysis
cycle. The test cannot be calibrated under the Calibration Menu but you can view the calibration report after
analysis run.
Frozen samples should be thawed at 37°C for 15 minutes. Centrifuge the plasma prior to testing.
568 of 617 L0018200232 R01

21 PS–ACT Appendix C - Special Test Procedures
21 PS–ACT
569 of 617 L0018200232 R01

1. Materials Needed
HemosIL PS-ACT Reagent Kit Cat. No. 0020302000

Cleaning Agent Cat. No. 0009832700
PS–ACT Reagent Kit Configuration

3 x 2 mL Protein S Reagent 24 Hours at 2-8°C Add 2.0 mL H2 O.
8 Hours at 15°C on board Swirl gently, let sit for 30 min at 15 -
25°C.
3 x 2 mL Protein S Deficient After Reconstitution: Add 2.0 mL H2 O.

Plasma 3 Hours at 20-25°C original Swirl gently, let sit for 30 min at 15 -
vial 25°C.
3 x 6 mL Calcium Reagent 8 Hours at 20-25°C on board Liquid, Invert to mix prior to use

3. Scroll down the test list and highlight the PS-ACT Test. Click on the Enable/Disable button to enable
3. Editing the Test Reference Range

2. Scroll down the list, highlight the PS-ACT test, and press the Detail Icon.
*For use in selected countries.
570 of 617 L0018200232 R01


3. Scroll down the Used by column and highlight the PS-ACT test.
5. DO NOT enter any value for PS-A50%Cal.
The liquid positions for the Cal Plasma, PS-A 50% Cal (Cal Plasma diluted 1:1 with Protein S Def Plasma),
PS-A Rgt, PS-ADefPl, PS-A CaRgt and Factor Diluent are automatically assigned when the test is run. Refer
to the Materials Map for placement when calibrating or running the assay. See Section 3.2.3 - Materials Map
on page 85.
6. Setting up QC
appropriate QC liquid defined. The PS-ACT test can utilize the following control materials to verify assay
performance:

l Low Abnormal Control Plasma
l High Abnormal Control Plasma

571 of 617 L0018200232 R01

calibration.

2. From the calibrate screen, select the PS-ACT test from the drop down menu in the Test to Calibrate
window.
572 of 617 L0018200232 R01

22 SCT-Screen/Confirm Appendix C - Special Test Procedures
22 SCT-Screen/Confirm
573 of 617 L0018200232 R01

1. Materials Needed
Silica Clotting Time Reagent Kit Cat. No. 20004800

SCT-Screen/Confirm Reagent Kit Configuration

3 x 5mL SCT Screen 20 Days at 2-8°C – Add 50 uL of mixed SCT Confirm reagent to one vial of
Reagent Original vial SCT Screen reagent.
5 Days at 15 o C on Invert to mix before use.

ACL

3 x 5 mL SCT Confirm 20 Days at 2-8°C – Invert to mix before use.
Reagent Original vial
5 Days at 15 o C on
ACL

3 x 10 mL SCT CaCl2 20 Days at 2-8 o C – Invert to mix before use.
Original vial

3. Scroll down the test list and highlight the SCT-S / SCT-C Test. Click on the Enable/Disable button to
enable the test. A check mark will appear in the Enabled test column for this test.
574 of 617 L0018200232 R01


2. Scroll down the list, highlight the SCT-S / SCT-C -V test, and press the Detail Icon.
3. Scroll down to the row for desired reporting units, and click on the Ranges button.
5. The reaction curve min and max may also be set. If the values are unknown, clear the min and max to
zoom the curve display to full scale.
The liquid positions for SCT Screen, SCT Confirm and SCT CaCl2 are automatically assigned when the test is
placed in a profile or run as a single assay. Refer to the Materials Map for placement when running the assay.
See Section 3.2.3 - Materials Map on page 85.
5. Setting up QC
appropriate QC liquid defined. The SCT Screen/Confirm test can utilize the following control materials to verify
assay performance:
l HemosIL Normal Unassayed Control

l HemosIL Normal Assayed Control
l HemosIL Low Abnormal Unassayed Control
l HemosIL Low Abnormal Assayed Control

for the test. If the Mean and SD is not known, then initially leave it set to zero. Once the ranges are
known, then you can re-define and click on the QC Range check button for control result flagging.
575 of 617 L0018200232 R01

Freezing of the plasma releases residual platelet phospholipids which can shorten the SCT screen clotting
times. Double centrifuge or filter plasma through a 0.2micron filter to remove platelets before freezing.Frozen
samples should be thawed at 37°C for 15 minutes. Centrifuge the plasma prior to testing. Samples should be
SCT Screen
The patient sample result in seconds is divided by the Mean of the SCT Screen normal range.
Patient Screen results (in seconds)

Screen Ratio =
Mean of Screen Normal Range (in seconds)
SCT Confirm
The patient sample result in seconds is divided by the Mean of the SCT Confirm normal range.
Patient Confirm results (in seconds)

Confirm Ratio =
Mean of Confirm Normal Range (in seconds)
The ratio result from the SCT Screen is divided by the ratio result from SCT Confirm.
Screen Ratio
Normalized SCT Ratio =
Confirm Ratio
Interpretation
The final result should be expressed as the Normalized SCT Ratio:
ACL ELITE/ELITE PRO Ratio > 1.20 indicates Lupus Anticoagulant is present
If ratio ≤ 1.20 and SCT Screen and SCT Confirm clotting times are prolonged, then mixing studies should be
performed to investigate factor deficiencies or inhibitors. If the mixing test is still prolonged, it indicates that
some anticoagulant other than LA may be present in the test plasma.
Each laboratory should establish its own normal cutoff value for the ratio. Refer to the HemosIL™ Silica
Clotting Time package insert sheet for a procedure to establish the cut-off value.
576 of 617 L0018200232 R01

23 Thrombin Time (TT) Appendix C - Special Test Procedures
23 Thrombin Time (TT)
577 of 617 L0018200232 R01

1. Materials Needed
Thrombin Time Reagent Kit Cat. No. 09758515

Thrombin Time Reagent Kit Configuration

4 x 2, 5 or 8mL Bovine 15 Days at 2-8°C original Add 2.0 / 5.0 or 8.0* mL Diluted Diluent.
Thrombin# vial Swirl, let sit for 30 min at 15 - 25°C.
8 Hours at 15°C onboard Invert. Do Not Shake!
ACL
1 x 9mL Diluent 1 month after preparation at Dilute necessary amount 1:5 using 1 part
15-25 o C Diluent + 4 part H2 O.

3. Scroll down the test list and highlight the TT$ Test. Click on the Enable/Disable button to enable the

2. Scroll down the list, highlight the TT-# test, and press the Detail Icon.
The liquid positions for the Cal Plasma, and Thrombin Reagent (TT Thr.) are automatically assigned when the
test is run as a single assay. Refer to the Materials Map for placement when running the assay. See Section
3.2.3 - Materials Map on page 85.

#For Heparin Therapy: 2.0 mL, Screening Test: 5.0 or 8.0mL reconstitution.
$Refers to reconstitution volume 2, 5, or 8mL. Select the appropriate test based upon your reconstitution volume for
the Thrombin Reagent.
578 of 617 L0018200232 R01

5. Setting up QC
appropriate QC liquid defined. The TT tests can utilize the following control materials to verify assay
performance:

579 of 617 L0018200232 R01

24 von Willebrand Factor Activity Appendix C - Special Test Procedures
24 von Willebrand Factor Activity
580 of 617 L0018200232 R01

1. Materials Needed
vWF Activity Reagent Kit Cat. No. 20004700

VWF Reagent Kit Configuration

2 x 4.5mL Latex 1 month at 2-8°C Pour entire contents of 1 vial of Buffer into Latex
Reagent 3 days onboard bottle.
analyzer Cap, Swirl for 20 seconds.
**Note: Do Not Freeze Allow to sit at room temperature for 25-30 minutes.
Invert to mix prior to use.
2 x 4.5 mL Buffer

3. Scroll down the test list and highlight the VWFACT Test. Click on the Enable/Disable button to enable

2. Scroll down the list, highlight the VWFACT test, and press the Detail Icon.
581 of 617 L0018200232 R01


3. Scroll down the Used by column and highlight the VWFACT test.
The liquid positions for the Cal Plasma, VWFACT Latex and Factor Diluent are automatically assigned when
the test is calibrated, placed in a profile or run as a single assay. Refer to the Materials Map for placement
when calibrating or running the assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The VWFACT test can utilize the following control materials to verify assay
performance:

l Normal Control

Recommended controls are Normal and the Special Test controls levels 1 & 2.
Cal Plasma must be reconstituted according to directions and allowed to sit for 30 minutes prior to calibration.

2. From the calibrate screen, select the VWFACT test from the drop down menu in the Test to Calibrate
window.
582 of 617 L0018200232 R01

Linearity: 10 – 150 % (VWFACT)
583 of 617 L0018200232 R01

25 von Willebrand Factor Antigen Appendix C - Special Test Procedures
25 von Willebrand Factor Antigen
584 of 617 L0018200232 R01

1. Materials Needed
vWF Activity Reagent Kit Cat. No. 20002300

VWF Reagent Kit Configuration

2 x 3 mL Latex 3 month at 2-8°C – original vial Invert to mix prior to use.
Reagent 1 week at 15°C on ACL ELITE/ELITE Avoid foam formation in reagent when
PRO mixing.
2 x 4 mL Buffer 3 month at 2-8°C – original vial Invert to mix prior to use.

1 week at 15°C on ACL ELITE/ELITE Avoid foam formation in reagent when
PRO mixing.

3. Scroll down the test list and highlight the VWF:Ag Test. Click on the Enable/Disable button to enable

2. Scroll down the list, highlight the VWF:Ag test, and press the Detail Icon.
585 of 617 L0018200232 R01


3. Scroll down the Used by column and highlight the VWF:Ag test.
The liquid positions for the Cal Plasma, VWF:AgBuf, VWF:AgLx and Factor Diluent are automatically
assigned when the test is calibrated, placed in a profile or run as a single assay. Refer to the Materials Map for
placement when calibrating or running the assay. See Section 3.2.3 - Materials Map on page 85.
6. Setting up QC
appropriate QC liquid defined. The VWFACT test can utilize the following control materials to verify assay
performance:

l Normal Control

Recommended controls are Normal and the Special Test controls levels 1 & 2.
586 of 617 L0018200232 R01

Cal Plasma must be reconstituted according to directions and allowed to sit for 30 minutes prior to calibration.

2. From the calibrate screen, select the VWF:Ag test from the drop down menu in the Test to Calibrate
window.
3. Confirm the necessary liquids are in place according to the Material Map. The calibration will require 3
empty 0.5 mL sample cups.
Frozen samples should be quickly thawed at 37°C. Gently mix the plasma prior to testing. Samples should be
Linearity: 10 – 150 % (VWF Antigen)
High Samples that exceed 150 % can be reprocessed using the VWF:AgH test. This assay dilutes the sample
and extends the linearity by a factor of 4 (40 – 600 %). The VWF:AgH test should only be used for samples that
initially had a confirmed result that exceeded the linear range for the VWF:Ag test.
587 of 617 L0018200232 R01

Appendix D
ACL Elite/Elite Pro
Printout Examples
588 of 617 L0018200232 R01

Appendix D - ACL Elite/Elite Pro Printout Examples
Contents
1 Analytical Reference – Cumulative Report 590

2 Analytical Reference – Plot and Statistics 591
3 Calibration Printout – PT Assay 592
4 Calibration Printout – Factor Assay 593
5 Calibration Replicate – Curve Details 594
6 File Error History 595
7 Liquid Setup 596
8 Logbook Report 597
9 Maintenance Report 598
10 Parallelism Cumulative Report 599
11 Parallelism Sample Report 600
12 Parallelism Detail Report 601
13 Profile Report 602
14 Quality Control Cumulative Report 603
15 Quality Control Plot and Statistics 604
16 Quality Control – Daily Printout 605
17 Reflex Test Logics 606
18 Sample Report 607
19 Sample Report Cumulative 608
20 Session Error History Report 609
21 Temperature Report 610
22 Test Detail Report 611
589 of 617 L0018200232 R01

1 Analytical Reference – Cumulative Report Appendix D - ACL Elite/Elite Pro Printout Examples
1 Analytical Reference – Cumulative Report
590 of 617 L0018200232 R01

2 Analytical Reference – Plot and Statistics Appendix D - ACL Elite/Elite Pro Printout Examples
2 Analytical Reference – Plot and Statistics
591 of 617 L0018200232 R01

3 Calibration Printout – PT Assay Appendix D - ACL Elite/Elite Pro Printout Examples
3 Calibration Printout – PT Assay
592 of 617 L0018200232 R01

4 Calibration Printout – Factor Assay Appendix D - ACL Elite/Elite Pro Printout Examples
4 Calibration Printout – Factor Assay
593 of 617 L0018200232 R01

5 Calibration Replicate – Curve Details Appendix D - ACL Elite/Elite Pro Printout Examples
5 Calibration Replicate – Curve Details
594 of 617 L0018200232 R01

6 File Error History Appendix D - ACL Elite/Elite Pro Printout Examples
6 File Error History
595 of 617 L0018200232 R01

7 Liquid Setup Appendix D - ACL Elite/Elite Pro Printout Examples
7 Liquid Setup
596 of 617 L0018200232 R01

8 Logbook Report Appendix D - ACL Elite/Elite Pro Printout Examples
8 Logbook Report
597 of 617 L0018200232 R01

9 Maintenance Report Appendix D - ACL Elite/Elite Pro Printout Examples
9 Maintenance Report
598 of 617 L0018200232 R01

10 Parallelism Cumulative Report Appendix D - ACL Elite/Elite Pro Printout Examples
10 Parallelism Cumulative Report
599 of 617 L0018200232 R01

11 Parallelism Sample Report Appendix D - ACL Elite/Elite Pro Printout Examples
11 Parallelism Sample Report
600 of 617 L0018200232 R01

12 Parallelism Detail Report Appendix D - ACL Elite/Elite Pro Printout Examples
12 Parallelism Detail Report
601 of 617 L0018200232 R01

13 Profile Report Appendix D - ACL Elite/Elite Pro Printout Examples
13 Profile Report
602 of 617 L0018200232 R01

14 Quality Control Cumulative Report Appendix D - ACL Elite/Elite Pro Printout Examples
14 Quality Control Cumulative Report
603 of 617 L0018200232 R01

15 Quality Control Plot and Statistics Appendix D - ACL Elite/Elite Pro Printout Examples
15 Quality Control Plot and Statistics
604 of 617 L0018200232 R01

16 Quality Control – Daily Printout Appendix D - ACL Elite/Elite Pro Printout Examples
16 Quality Control – Daily Printout
605 of 617 L0018200232 R01

17 Reflex Test Logics Appendix D - ACL Elite/Elite Pro Printout Examples
17 Reflex Test Logics
606 of 617 L0018200232 R01

18 Sample Report Appendix D - ACL Elite/Elite Pro Printout Examples
18 Sample Report
607 of 617 L0018200232 R01

19 Sample Report Cumulative Appendix D - ACL Elite/Elite Pro Printout Examples
19 Sample Report Cumulative
608 of 617 L0018200232 R01

20 Session Error History Report Appendix D - ACL Elite/Elite Pro Printout Examples
20 Session Error History Report
609 of 617 L0018200232 R01

21 Temperature Report Appendix D - ACL Elite/Elite Pro Printout Examples
21 Temperature Report
610 of 617 L0018200232 R01

22 Test Detail Report Appendix D - ACL Elite/Elite Pro Printout Examples
22 Test Detail Report
611 of 617 L0018200232 R01

Index
% Barcode 37-38
Barcode Label Specifications 480
%CV 391 Beep 41
Biohazards 414
Bleaching the Waste Line 311
A
Absorbance Channel 30 C
Absorbance Tests 15
Acquisition Delay 234 Cal Low F 136
ACQUISITION DELAY 234 Calculation of Results 367
Acquisition Setup 233 Calculation Settings
Acquisition Station Anomalies 328 Additional Calculation Settings 256
Acquisition Time 396 Delta Algorithm 252
adapters 54 First Derivative Algorithm 247
Adapters 21 No Algorithm 239
ADD QC 81 Second Derivative Algorithm 250
Air Filter 304 Threshold Algorithm 240
Alarms 42, 317, 319 Threshold/Second Derivative Algorithm 243
Acquisition Station 328 Trend Algorithm 239
Database 334 Calculation Setup 235-236
Liquid 329 Calibration 127
Mechanical 326 Calibration Curve Intercept 395
Operative 332 Calibration Curve Limits 390
Optics 331 Calibration Curve Setup 258
Parsing and Loading 333 Calibration Curve Slope 394
REM 322 Calibration Error Codes 342
System 318 Calibration Loading Setup 223-224
Temperature 324 Calibration Plasma Values 395
Algorithm 237, 258 Calibration Replicates 224
Algorithms, Test 399 Calibration Stability 403
All In One Utility 278 Carryover 404
Ambient Cephalin 405
Specifications 411 Certification 43
Ambient Conditions 48 WEEE 44
Ambulance 98 Check Mark 68
Analytical Reference 143 Chromogenic Tests 365, 377
Analytical Reference Error Codes 346 Clean Air Filter 304
Archive 270 Cleaning 219, 229, 286
Audible Alarms 201 Clock 94
Autolist 90 Clot/Reaction Curve 106
Coagulometric tests 364, 369
Coagulometric Tests 15
B Color Codes 93
Comparison Studies 415
Backup 267
Connectors 51
Backup Test and Material 276
Cooling System 36
Bar Code
Copy Tests 206
Reader 46
Cuvettes 32
612 of 617 L0018200232 R01

Index
D Internal Barcode Reader 358

Miscellaneous 356
Data Reduction QC 350
APTT 359 Ratio and INR 353
Diagram 359 Reaction Curve 337
Error Codes 335 Sample ID 358
Error, Classic 357 Session 336
PT 359 Expiration Date 86
Data Transmission Failure 334 External Barcode 193
Database 195 External Barcode Reader 86
Database Anomalies 334 Extract 104
Database Specifications 409
Database View 102
Date/Time 202 F
Dead Volume 407
Factor Assay 136
Decimal places 392
Failure 317
Decontamination 297, 312
Data Transmission 334
Dedicated 127
FAILURE 66
Default Multi-Tests 179
Fault Detection 42
Default Tests 92, 162
Fibrinogen - PT based 365
Delete 109
File Error History 294
Delta Algorithm 252
Filter 58, 304
dilutor 55
First Derivative 107
Dimensions 409
First Derivative Algorithm 247
Disclaimer 430
Flush/Optic Channel Error 330
Disclaimers 414
Fuse 51
Display 33
Disposal 45
DMS 448, 462 H
Errors 355
Double Test Error Codes 352 Halogen Lamp 31
Halogen Lamp Replacement 310
Hardware Components 18
E HAZARDS 413
Header volumes 385
Each Rotor 128
High curve 137
Electrical Hazards 413
HOLD 66
Electrical Requirements 50
Host 111, 188, 448
Electrical Specifications 412
HOST 60
Electronics 33
Host Communication Protocol 441
Environmental Conditions 48
Hourglass 79
Errors
Humidity 42
Analytical Reference 346
Calibration 342
Coag Error 7, Data Reduction 357 I
Data Reduction 335
Data Reduction, Classic 357 ICONS 67
DMS 355 Immunological Tests 15
Double Test 352 In Cup Dilution 217, 225
Error 6 357, 393 In Line Dilution 216, 225
Error 7 393 In Session 128
Error 8 357 INR 210
Errors 10 393 Installation 47
Installation Requirements 48
613 of 617 L0018200232 R01

Index
Instrument Cleaning 301 Portugal 439

Instrument Description and Operation 17 Russia 439
Instrument Status 66 South Korea 436
Inter-ramp Interval 229 Spain 432, 439
INTER-RAMP INTERVAL 234 Thailand 436
Interface Connectors 35 United Kingdom 440
INTERFACES 188 Uruguay 434
Interference Table 160 USA 432, 434
Intermediate Rinse 217, 227 Werfen Corporate Headquarters 432
Internal Barcode 191 Logbook 295
ISI 181, 237, 537, 555 LOT Symbol 45
Low Curve 138
K
M
Keyboard 34, 36, 64, 194
Maintenance 297
Bi-Weekly 303
L Daily 298
Monthly 304
Latex tests 365
Schedule 314
LCD 33
Weekly 301
Library 266
Maintenance - As Needed 305
Line Frequency 50
Maintenance menu 289
Linearity 401
Maintenance Procedures
Lipemic Samples 405
Bleaching the Waste Line 311
Liquid Anomalies 329
Check Liquid Waste Container 298
Liquid Sensor 196
Check Wash-Reference Emulsion 298
Liquid Sensors 24
Clean Air Filter 304
Liquid Waste Container 298
Clean Needle 299
LIQUIDS 180
Clean Waste Line 307
Loading and Analysis Area 27
Decontamination 312
Loading Setup 213
Empty Rotor Waste 300
Loadlist 88
Optical Path Cleaning 303
Locations, IL Offices 431
Positioning the Needle 308
Australia 435
Priming 284, 299
Austria 437
Reboot Analyzer 303
Belgium 437
Replace Halogen Lamp 310
Brazil 433
Replace Needle 307
Canada 433
Replacing the Wash-R Bottle 306
China 435
Rotor Holder Cleaning 303
Columbia 433
Make Loadlist 88
Czech Republic 437
Materials Check 221, 231
France 437
Materials Map 85
Germany 438
Mean 256
Hong Kong 435
Measured Parameters 15
Hungary 438
Mechanical Anomalies 326
IL Corporate Headquarters 432
Mechanical Hazards 414
India 435
Menus 71
Italy 438
Method Comparison 402
Japan 435
Method Comparison Studies 415
Lithuania 438
Microprocessor 33
Mexico 433
Middle Curve 139
Netherlands 439
Miscellaneous Errors 356
Poland 439
614 of 617 L0018200232 R01

Index
Mixing 218, 228 Power Loss 41

Modem 195 Precision 400
Mouse 65 Presentation of Results 16
Multi-Tests 76, 167 Primary Unit Correction 242, 246, 248, 251
Priming 57
In STANDBY 285
N Procedure 284, 299
Printer 39, 190
Needle Alignment 292
Printer Fail 321
Needle Cleaning 299
Printing Results 110
Needle Replacement 307
Product Use 14
Nephelometric Channel 30
Profiles 167
Network 194
Profiles Details screen 168
New Liquid 186
Program Sample 82, 92
New Sample 108
New User 199
No Algorithm 239 Q
Noise Check 1 245
Noise Check 2 246 QC Error Codes 350
Non-IL Brand Products 430 Quality Control 112
Normal Range 42, 103, 208
Normalization 236
Normalized Ratio 237 R
Numerical Keypad 64
R2 check 140
Ramp 233
O Ratio 210, 236
Ratio and INR Error Codes 353
Omit Replicate 133 Reaction Curve Error Codes 337
On Board Stability 86, 180 Reaction Time 396
Operative Anomalies 332 Read Barcodes 99
Optical Measuring System 30 Reagent Area 22
Optical Path 30 Reagent Positions 21
Optical Path Cleaning 303 Reagent Priming 220, 230
Optical Reference 225 Reagent Vials 407
Optics Anomalies 331 Reboot Analyzer 303
Reference 225
Reference Value 210
P Reflex 195
Reflex Tests 163
Parallel Printer 36
REM 196
Parallelism 135, 141
REM Anomalies 322
Parallelism Results 141
Replacing the Wash-R Bottle 306
Parsing and Loading Anomalies 333
Reports 588
Parts 428
Restart BCR 99
Passwords 197
Restart Session 95
Patient Demographics 83
Restore 267
Patient Details 83, 105
Result Messages 393
Pause 97
Results 102, 389
Pause Timer 86
Results Calculation 367
Performance 400
Rinse Reservoir Cleaning 302
Piston Block and Electrovalves 23
Rinse/Waste 23
Plasma Handling 424
Rotor 27, 300
Positioning the Needle 308
Rotor Arm 28-29
Power Consumption 50
Rotor Holder 30
615 of 617 L0018200232 R01

Index
Rotor Holder Cleaning 303 Hardware 408

Rotor Refill Tool 28 Instrument 408
Rotor Stack 28 Operational 408
Rotor Transport 28-29 STAND-BY Status 41, 66
Rotor Waste 32, 300 Start Timer 86
Rotor Waste Area 32 Startup Kit 425
STAT 98
stirrers 54
S Subset 102
Symbols 45
Sample Analysis 72
System Anomalies 318
Sample Collection 423
Alarms 319
Sample Cups 407
Warnings 319
Sample Database 102
System Configuration 195
Sample Detail 105
Sample ID Errors 358
Sample Spillage 301 T
Sample Status 84, 94
Sample Tray 20 Target Values 183
Samples 380, 383 temperature 59
Sampling Rate 234 Temperature 17, 42
Sampling/Dispensing Arm Assembly 24 Symbol 45
Save Rotor Map Temperature Anomalies 324
Rotor Map 273 Temperature Display 291
Save Trace 275 Test Group Profiles 175
Scale Range 42, 103 Test Groups 170
Scope 236 Test Range 103
Second Derivative 107 Test volumes 388
Second Derivative Algorithm 250 Test Volumes 385, 387
Security 197 Tests
Sensor 24 Special 488
Serial Number 46 Tests Details 207
Service 296 Tests Setup 204
Session Error Codes 336 Thermal Fail 321
Session Error History 293 Threshold 107
Session History 95 Threshold- 2nd Derivative 107
Session Report 93 Threshold Algorithm 240
Setup Tests 156 Threshold/Second Derivative Algorithm 243
Shock Hazards 413 Thumb Drive 40
Short 94 Timing constraint 217, 228
Single Test 76 Touch Screen 33, 63
Slope check 139 Trans 84
Software Identification 271 Trend Algorithm 239
Software Tree 71 TT 359
Software Upgrade 272
Sort Multi-Tests 178
Sort Tests 158 U
Space Requirements 49
Unit Correction 210
Special Test Procedures 488
Units 203
Special Tests 15
USB Ports 51
Specifications
USB Storage Device 40
Database 409
Utilities
Dimensions 409
Archive 270
Electrical 412
Backup/Restore 267
616 of 617 L0018200232 R01

Index
Elite All In One Utility 278

Save Rotor Map 273
Save Trace File 275
Software Identification 271
Software Upload, Upgrade 272
Submenu 265
Test/Material - Backup and Upload 276
Upgrade IL Library 266
Warning 317
Warnings 319
Warranty 429
Wash-Reference Emulsion 23, 55, 298
Replacing 306
Wash R. checkbox 227
Waste Line Bleaching 311
Waste Line Cleaning 307
Waste tube 53
WEEE Certification 44
617 of 617 L0018200232 R01

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ACL Elite/Elite Pro

Manufacturer EU Authorized Representative

Copyright © Instrumentation Laboratory, February, 2016

ii of 617 L0018200232 R01

ACL ELITE/ELITE PRO TECHNICAL BULLETIN IMPORTANT INR NOTICE

RATIO CALCULATION = PATIENT PLASMA (seconds)

Reference Value means MEAN OF NORMAL POPULATION (seconds).

INR = (PT Patient/PT of Reference Value)ISI

*or Geometric mean

iii of 617 L0018200232 R01

INR Notice iii

Chapter 1 - General Information 13

iv of 617 L0018200232 R01

Chapter 3 - Analytical Operations 61

v of 617 L0018200232 R01

3.3.7 QC – EXTRACT DATA 125

Chapter 4 - Setup and Utility 153

vi of 617 L0018200232 R01

4.2.4 Calibration - Loading Setup 223

Chapter 5 - Diagnostics and Maintenance 282

Chapter 6 - Troubleshooting 316

vii of 617 L0018200232 R01

6.1 Failures, Alarms and Warnings 317

Chapter 7 - Assay and Instrument Specifications 360

viii of 617 L0018200232 R01

7.5 Assay Performance Characteristics 400

Chapter 8 - Sample Collection and Storage 423

Chapter 9 - Parts and Expendables 425

Chapter 10 - Warranty 429

Chapter 11 - IL Worldwide Locations 431

Appendix A – Host Communication Protocol 441

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1.0 Introduction 444

Appendix B - Bar Code Label Specification 480

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2.5 Decoder Zone Map 486

Appendix C – Special Test Procedures 488

Appendix D – Printout Examples 588

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17 Reflex Test Logics 606

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Chapter 1 - General Information

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ACL ELITE PRO system

1.1 Product Use

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1.2 Measured Parameters

l PT-FIB (Prothrombin Time and PT-Based Fibrinogen concentration)

Single Test or Multi-Tests

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Double Tests (Duplicate Testing)

1.3 Presentation of Results

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1.4 Instrument Description and Operation

The ACL measures the parameters at 37 °C ± 1 °C (98.6 oF ± 1.8 oF), at an ambient

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1.4.2 Main Hardware Components

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