21 Section 4-1. User Manual DRT-MAN-104

Notice
Notice
Thank you very much for purchasing RMF-2000, made by DRTECH. All of us in DRTECH are
always striving to manufacture our equipment with the highest quality.
The contents in this manual offer instruction on general information and safety; installation
and use; and maintenance of the system and are based on the standard specification of the
system. The contents in this manual are subject to change without any notice due to changes
of specification, components, or appearance related to improvement of performance and
quality of the system.
This manual contains important information to use the system. The user have to read this
manual carefully to secure the safety of both the patient and the user and perform the
operation and maintenance of the system appropriately. Keep this manual in a place you can
find for future reference.
For any question about this manual and the system, call DRTECH staff.
 Manufacturer: DRTECH Corp.

 Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-Daero 541beon-gil,
Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea.
 Phone: +82-31-730-6805
 Fax: +82-31-730-6899
 E-mail: drtech@drtech.co.kr
 Homepage: http://www.drtech.com
Full Field Digital Mammography i

Copyright
Copyright
Copyright © DRTECH. All rights reserved.
Copying, using, or distributing of any contents in this manual, in whole or in part, without prior
written consent of DRTECH is strictly prohibited according to copyright law.
is a trademark of DRTECH.
All the information in the manual are reliable by DRTECH. DRTECH is trying the best to provide
good service to the customers. If you find any incorrect information, typo, or item to improve,
please send it back to us (drtech@drtech.co.kr) to improve the accuracy and usefulness of the
manual.
The information in this manual is subject to change without any notice due to improvement of
performance and quality of the system. You can visit our homepage (http:/drtech.co.kr) and
see the version history about this manual.
@ Copyright 2019, DRTECH
ii Full Field Digital Mammography

Warranty and Responsibility
Warranty and Responsibility

 The manufacturer is not responsible for the failure due to the use of products of third
parties.
 The manufacturer is not responsible for the failure or the damage due to installation,
relocation, modification, or repair performed by other than the person appointed by the
manufacturer.
 The manufacturer is not responsible for any accident or damage to the equipment resulted
from failing to observe any warning, caution, notice, or operation instruction in this manual.
 The manufacturer is not responsible for the failure or the damage due to natural disasters,
such as fire, earthquake, flood, lightning, etc.
 The manufacturer is not responsible for incorrect environment or result of diagnosis.
 The manufacturer is not responsible for the failure or the damage resulted from using the
equipment to other than its original purpose.
Full Field Digital Mammography iii

Revision History
Revision History
Revision Number Date Changes Notes
1.0 Jun. 2020 Newly published
iv Full Field Digital Mammography

Contents
Contents
Notice ....................................................................................................................... i
Copyright.................................................................................................................... ii
Warranty and Responsibility ......................................................................................iii
Revision History .........................................................................................................iv
Contents ......................................................................................................................v
1. General Information ........................................................................................ 1
1.1 Scope of Usage ............................................................................................................. 1
1.2 User ............................................................................................................................. 1
1.3 Training Program ........................................................................................................... 1
1.4 Information Security ...................................................................................................... 1
1.5 Manual Users ................................................................................................................ 2
1.6 Rules of Notation........................................................................................................... 3
1.7 Manual Layout .............................................................................................................. 4
1.8 Warning Signs ............................................................................................................... 5
1.9 Terms and Abbreviations................................................................................................ 6
1.10 Composition.................................................................................................................. 7
1.11 Labels and Symbols ....................................................................................................... 9
1.11.1 System Labels ................................................................................................... 9

1.11.2 Component Labels............................................................................................. 9
1.11.3 Symbols in Labels.............................................................................................10
2. Safety and Regulation ................................................................................... 13
2.1 General Safety Management .........................................................................................13
2.2 Patient Safety Management ..........................................................................................14
2.3 Electric Safety Management ..........................................................................................16
2.4 Mechanical Safety Management ....................................................................................17
2.5 Fire and Explosion Safety Management..........................................................................17
2.6 Radiological Safety Management ...................................................................................18
Full Field Digital Mammography v

Contents
2.7 Electromagnetic Compatibility .......................................................................................19
2.8 Safety Measures...........................................................................................................20
2.8.1 Emergency Stop Switch ....................................................................................20

2.8.2 Interlock..........................................................................................................22
2.9 Observation of the Standards........................................................................................22
2.10 Safety Symbols ............................................................................................................23
3. System Components and Functions ............................................................... 25
3.1 Components of the Gantry............................................................................................25
3.1.1 Components of the C-arm.................................................................................26

3.1.2 Components of the Column and the Base ..........................................................32
3.1.3 Components of the Foot Switches .....................................................................34
3.2 Components of the Workstation ....................................................................................35
3.2.1 Switch Set .......................................................................................................36
4. System Hardware Operation.......................................................................... 37
4.1 Preparation..................................................................................................................37
4.2 Turning On/Off the Power of the System .......................................................................38
4.2.1 Turning On the Power.......................................................................................38

4.2.2 Turning Off the Power ......................................................................................39
4.2.3 Test of System Operation..................................................................................42
5. Usage of System Accessories ......................................................................... 49
5.1 Face Shield ..................................................................................................................49
5.1.1 Attachment and Detachment of the Face Shield .................................................49
5.2 2D Crosshair Device .....................................................................................................50
5.2.1 Attachment and Detachment of the 2D Crosshair Device ....................................50
5.3 Magnification Stand......................................................................................................51
5.4 Compression Paddle .....................................................................................................52
5.4.1 Routine Screen Paddle......................................................................................52

5.4.2 Localization Paddle ...........................................................................................52
5.4.3 Small Breast and Implant Paddle.......................................................................53
5.4.4 Magnification Paddle ........................................................................................54
5.4.5 Spot Paddle .....................................................................................................54
5.4.6 Attachment and Detachment of the Compression Paddles...................................55
5.4.7 Compression Paddle Shift .................................................................................56
vi Full Field Digital Mammography

Contents
6. Procedure for Clinical Examination................................................................ 57
6.1 Turning On the Power of the System .............................................................................57
6.2 Selecting and Starting the Examination..........................................................................58
6.3 Preparation of Gantry ...................................................................................................60
6.4 Arranging the Position of the Patient..............................................................................60
6.5 Compression ................................................................................................................61
6.6 Selecting Exposure Mode ..............................................................................................62
6.7 Proceeding the Examination ..........................................................................................63
6.7.1 Exposure to X-rays ...........................................................................................63

6.7.2 Displaying the Images on the Acquisition Window ..............................................63
6.7.3 Acquiring Another Image ..................................................................................63
6.8 Finishing the Examination .............................................................................................63
6.9 Shutting Down the System............................................................................................64
6.10 Cleaning and Replacing Accessories of the System .........................................................64
7. Workstation Operation .................................................................................. 65
7.1 System Login ...............................................................................................................65
7.2 Patient Information Management ..................................................................................66
7.2.1 Information on Worklist Screen .........................................................................66

7.2.2 Patient Search..................................................................................................67
7.2.3 Detail Search ...................................................................................................67
7.2.4 Adding New Patient ..........................................................................................67
7.2.5 Editing Patient Information ...............................................................................68
7.2.6 Deleting Patient Information .............................................................................70
7.2.7 DICOM Storage Manager ..................................................................................71
7.2.8 Network Management.......................................................................................72
7.2.9 Switching ID Account........................................................................................73
8. Image Acquisition.......................................................................................... 75
8.1 Going into the Acquisition Mode ....................................................................................75
8.2 Exam Mode Screen.......................................................................................................75
8.2.1 X-ray Indicator .................................................................................................76

8.2.2 Setting Up the X-ray Exposure Condition............................................................77
8.2.3 Gantry Display and Adjustment .........................................................................78
8.2.4 Editing Procedure .............................................................................................79
8.2.5 View Position Screen ........................................................................................80
Full Field Digital Mammography vii

Contents
9. Exam List Management.................................................................................. 85
9.1 Exam List Screen..........................................................................................................85
9.2 Editing Patient Information ...........................................................................................86
9.3 Deleting Patient Information. ........................................................................................87
9.4 Importing Patient Image Data.......................................................................................88
9.5 Exporting Patient Image Data .......................................................................................89
9.6 Merging Patient Image Data .........................................................................................90
9.7 Editing Study Information List .......................................................................................91
9.8 Deleting Study Information List .....................................................................................92
9.9 Exporting Study Information List ...................................................................................93
9.10 Sending Study Information List .....................................................................................94
9.11 Review and Acquisition .................................................................................................94
10. Review Mode.................................................................................................. 95
10.1 Review Screen .............................................................................................................95
10.2 Image Layout Tool .......................................................................................................96
10.3 Image Control Tool.......................................................................................................97
10.4 Annotation Tool............................................................................................................98
10.5 Image Tool ..................................................................................................................99
10.5.1 Reprocessing ................................................................................................. 100

10.6 DICOM Tool ............................................................................................................... 101
11. User Setup ................................................................................................... 103
11.1 Gantry User Setup...................................................................................................... 103
11.1.1 Gantry Setting................................................................................................ 104

11.1.2 Overlay Setup ................................................................................................ 105
11.1.3 W/L Length(Sensitivity) Setup......................................................................... 106
12. Exposure Mode ............................................................................................ 107
12.1 Manual mode ............................................................................................................. 107
12.1.1 General Information ....................................................................................... 107

12.1.2 Influence under Different Parameter Values ..................................................... 107
12.1.3 Implants........................................................................................................ 108
12.2 AEC mode.................................................................................................................. 108
12.2.1 General Description of AEC ............................................................................. 108
viii Full Field Digital Mammography

Contents
13. Image Processing and Display..................................................................... 111
13.1 Original Image ...........................................................................................................111
13.2 Processed Image........................................................................................................111
13.2.1 TruivewART....................................................................................................111
13.2.2 TruviewM .......................................................................................................111
14. Localization Examination............................................................................. 115
14.1 Safety Notice..............................................................................................................115
14.2 Definition ...................................................................................................................116
14.3 Procedure Preparation ................................................................................................116
14.4 Image Acquisition Procedure .......................................................................................117
14.5 Completion ................................................................................................................118
15. Sanitation and Preventive Maintenance ...................................................... 119
15.1 Cleaning and Washing ................................................................................................119
15.1.1 Cleaning the System .......................................................................................120

15.1.2 Cleaning the Monitor ......................................................................................120
15.1.3 Cleaning the Keyboard and Mouse...................................................................120
15.1.4 Cleaning the Examination Room ......................................................................120
15.2 Disinfection ................................................................................................................120
15.2.1 Disinfecting the Compression Paddle ...............................................................121
15.3 Recommended Detergents and Disinfectants................................................................122
15.3.1 Recommended Detergents ..............................................................................122

15.3.2 Recommended Disinfectants ...........................................................................122
15.4 Preventive Maintenance Schedule................................................................................123
15.5 Disposal of the System ...............................................................................................124
16. Administration Massages............................................................................. 125
16.1 Error Recovery and Troubleshooting ............................................................................125
16.2 Types of messages and alert messages........................................................................125
16.2.1 Fault levels.....................................................................................................125

16.2.2 Alert Messages ...............................................................................................125
17. Specifications............................................................................................... 127
17.1 Classification ..............................................................................................................127
17.2 Environment for Use and Storage ................................................................................127
Full Field Digital Mammography ix

Contents
17.3 Input Power............................................................................................................... 128
17.4 Specifications per Unit ................................................................................................ 128
17.4.1 X-ray Generator ............................................................................................. 128

17.4.2 X-ray Tube and Output ................................................................................... 128
17.4.3 X-ray Beam Filtration ...................................................................................... 129
17.4.4 X-ray Source Assembly Specifications and Location .......................................... 129
17.4.5 Anti-scatter grid ............................................................................................. 130
17.4.6 C-arm............................................................................................................ 131
17.4.7 Compression .................................................................................................. 131
17.4.8 Collimation Size and Light Field Indication ....................................................... 132
17.4.9 Image Receptor ............................................................................................. 132
17.4.10 Others ........................................................................................................... 133
17.4.11 Dose to the patient of operation...................................................................... 134
17.5 Specifications for X-ray Beam Measurement and Calibrations ........................................ 134
17.5.1 Environment of Operation............................................................................... 134

17.5.2 Calibrations.................................................................................................... 135
17.6 Specifications of Acquisition Workstation ..................................................................... 135
17.7 Dimension ................................................................................................................. 136
17.7.1 Dimensions of the System Unit ....................................................................... 136

17.7.2 Dimensions of the Acquisition Workstation....................................................... 137
17.8 Protect from Radiation................................................................................................ 138
18. Appendix A................................................................................................... 140
18.1 Guidance and Manufacturer's Declaration .................................................................... 140
18.1.1 Electromagnetic Emissions.............................................................................. 140

18.1.2 Electromagnetic Immunity .............................................................................. 141
18.2 Open Sources Used in This System.............................................................................. 142
x Full Field Digital Mammography

1. General Information
This chapter explains the purpose of the system, user needs, and the rules of notation in this
manual.
1.1 Scope of Usage

This system is used for mammographic screening diagnosis.
RMF-2000 acquires digital mammographic images for diagnosis of the breast cancer. RMF-
2000 is designed to be used in the same clinical application for 2D screening mammographic
systems. The screening examination exposes X-rays to the left and the right breasts of the
patient to acquire images. Also, the RMF-2000 can be used to additional precision diagnosis
for breasts.
The user of this manual has to read the manual carefully and familiarize him/herself to the
contents before operating, maintaining, or repairing the equipment. Keep this manual in a
place you can find easily for future reference.
1.2 User
Only the trained users, such as doctors/radiologists, QA technicians, or doctors like surgeons
and physicians can operate the system.
All the users of this system have to be professionally trained of medical knowledge and skills in
radiation protection, safety rules, and safety of patients.
Through the manual, the user has to be thoroughly familiarized with the instruction of
operation and safety before operating the system. If a user fails to be familiar with the
instruction of operation and safety, it can result in injury to the user or a patient.
1.3 Training Program

DRTECH is not responsible for any injury or damage due to inappropriate operation of the
system.
Every user of the system has to be trained properly before an actual use of the system to a
patient. For more information about a proper training program, call the DRTECH staff. DRTECH
is carrying on a professional training program for every technician, doctor, or specialist, who
might use this system.
1.4 Information Security

RMF-2000 includes a hard disk drive which saves personal information of patients for medical
use. In several countries, this type of system can be under regulations about process of
personal information and distribution of the data.
Full Field Digital Mammography 1

RMF-2000 User Manual
It is strongly recommended to protect patient files from accessing except those who are to
treat the patients. Accessing the RMF-2000 application is protected with a password. This
password is confirmed in the initial phase of the installation.
The administrator of this system must set up user IDs for every user before operation. Each
and every user must input his/her own name and password to access the system.
It is a duty for every user to prevent accessing the application and the patient data.
1.5 Manual Users

Based on the scope of operation and usage of this system, DRTECH categorizes the manual
users as below. The user in each category must read this manual carefully and operate the
system only as much as the scope of operation allowed to his/her category.
Table 1-1 Manual Users
Category Scope of Operation
Users who actually operate the system. Do Not perform anything that is
not allowed to operators.
Operator  Specialists of acquisition and check of the images.
 Authorized system managers.
 Radiologists.
Users who manage the system in software and hardware, such as in
system operation, creation and edit of the program, regular check-up,
maintenance, etc. Do Not perform anything that is not allowed to
Maintenance staffs maintenance staffs.
 Maintenance specialists.
 Specialists with medical knowledge and conducting tests on the
system for quality assurance.
Users, who belong to DRTECH and perform services on the system,

including diagnosis of failure, repair of modules, and replacement of
Service managers. components.
 Service managers, who install the system, configures it, and finding
defects in the setting and calibration.
Direction
To operate or maintain the system, each and every type of users have to pass the training
program about the system, provided by DRTECH.
2 Full Field Digital Mammography

1.6 Rules of Notation

Rules of notation are the rules for symbols, punctuation marks, and notation used in this
manual.
The following rules of notation are used to help the users of the system:
Table 1-2 Rules of Notation
Notation Description
Used to mark references.

“”
i.e.) Refer to “Ch. 1 General Information.”
Used to emphasize the items for GUI, such as menus and buttons.
Bold
i.e.) Click the STOP button.
Used to list several menus or buttons sequentially.

>
i.e.) Click the STOP > AUTO button.
Used to sort items parallel or organize them systematically.
Used to organize procedures in the order.
Used to identify components in figures or explain them.
Used to explain the sequential movements in figures in the order.

1.7 Manual Layout

The manual layout is the layout where the contents of this manual, including passages and
images, are organized effectively.
The following manual layout is used to help the users of the system:
Figure 1-1 Manual Layout

Table 1-3 Items of Manual Layout
No. Name No. Name
1 Logo 5 Table
2 Figure 6 Page number
3 Figure caption 7 Chapter
4 Table caption

1.8 Warning Signs

They are the signs to help the users understand the severity of injury to the user or damage
to the system which can occur in each case of system operation and maintenance. Each sign
means different severity.
The following warnings are used to help the users of the system:
 Danger sign
Danger
Failure to observe the instructions with this sign can lead to serious
accidents, which result in death or severe injury to the user or the patient.
The user must observe the instructions with Danger sign.
 Warning sign
Warning
Failure to observe the instructions with this sign can lead to accidents,
which result in chance of death or severe injury to the user or the patient.
The user must observe the instructions with Warning sign.
 Caution sign
Caution
Failure to observe the instructions with this sign can lead to accidents,
which result injury to the user or the patient. The user must observe the
instructions with Caution sign.
 Notice sign
Notice
Failure to observe the instructions with this sign can lead to accidents, which result in partial
or whole damage to the program or data in the system and lead to loss of property. The
user must observe the instructions with Notice sign.
 Important sign
Important
This sign shows the instructions the user needs to observe. The user must observe the
instructions in Important sign.

 Note sign
Note
This sign shows the instructions the user needs to see. The user must observe the
instructions in Note sign.
1.9 Terms and Abbreviations

The following list is about the terms and abbreviations frequently used in this manual:
Item Description
ACR American College of Radiology
AEC Automatic Exposure Control
DICOM Digital Imaging and Communication in Medicine
EMC Electromagnetic Compatibility
IEC International Electro-technical Commission
MQSA Mammography Quality Standards Act
PACS Picture Archiving and Communications System
RF Radio Frequency
RIS Radiology Information System
ROI Region Of Interest

1.10 Composition
This manual is composed of total 20 chapters. Brief introduction of each chapter is like below:
 Chapter 1 General Information
This chapter provides the instruction for scope of usage and system users; information
security and manual users; rules of notation and manual layout; terminology abbreviations;
composition of the manual and system labels to operate the system.
 Chapter 2 Safety and Regulation

This chapter provides the instruction for safety management, safety measures, safety
symbols, and items for observation of the standards to operate the system.
 Chapter 3 System Components and Functions
This chapter provides the instruction of the components and functions of the gantry and
the workstation.
 Chapter 4 System Hardware Operation
This chapter provides the instruction of the hardware performance test to operate the
system.
 Chapter 5 Usage of System Accessories
This chapter provides the instruction for system accessories: face shield, 2D crosshair
device, and compression paddle.
 Chapter 6 Procedure for Clinical Examination
This chapter provides the procedure to use the system for clinical examination step by step.
 Chapter 7 Workstation Operation

This chapter provides the instruction for system login and patient information management.
 Chapter 8 Image Acquisition
This chapter provides the instruction for image acquisition procedure and the image
acquisition window.
 Chapter 9 Exam List Management
This chapter provides the instruction for the exam list window.
 Chapter 10 Review Mode

This chapter provides the instruction for the review window.
 Chapter 11 User Setup
This chapter provides the instruction for the configuration of the gantry, overlay, and
windows.
 Chapter 12 Exposure Mode
This chapter provides the instruction for the manual exposure mode and the auto exposure
mode.
 Chapter 13 Image Processing and Display
This chapter provides the instruction for image procession.

 Chapter 14 Localization Exam
This chapter provides the instruction for the process of 2D localization exam.
 Chapter 15 Sanitation and Preventive Maintenance
This chapter provides the instruction for cleaning, disinfection, preventive maintenance
schedule of the system, and disposition of the waste.
 Chapter 16 Administration Massages
This chapter provides the instruction for administration messages displayed during
operation.
 Chapter 17 Specifications
This chapter provides the instruction for the specifications of the system including system
class, environment for use and storage, input power, system unit specifications, acquisition
workstation specifications, size and external measurements.
 Chapter 18 Appendix A
This chapter provides the instruction for guidance and manufacturer's declaration and the
open sources used for the system.

1.11 Labels and Symbols

System labels and component labels are shown with the meaning of the symbols in the labels
in this section.
1.11.1 System Labels
The system symbols are found at the rear side of the system.
Figure 1-2 System Labels for Exportation.
1.11.2 Component Labels
Figure 1-3 Collimator Label
Figure 1-4 Tube Label

Figure 1-5 Generator Label
Figure 1-6 Compression Paddle Label
Figure 1-7 Magnification Stand Label
Figure 1-8 Crosshair Label
Figure 1-9 Radiation Shield Label
Figure 1-10 Applied Part Label (at Bucky and Face shield)
1.11.3 Symbols in Labels
Item Description
Alternating Current

Item Description
Direct Current
General Danger sign
Type B Applied Part (No electrical contact with patient according to

IEC 60601-1)
Follow the instruction of the manual.
Name and Address of Manufacturer
Date of Manufacture
Serial Number
Authorized Representative in the European Community
Directive 2012/19/EC on waste electrical and electronic equipment

(WEEE)
Call the manufacturer about disposal of the system.
Radioactive

Left blank intentionally

2. Safety and Regulation
This chapter provides safety instructions every user must be familiarized with to protect the
safety and the system before use. Read the instructions very carefully and then use the
system appropriately to keep the safety of the user and the patient and prevent loss of
property.
The manufacturer is not responsible for any accident due to inappropriate operation of the
system as a result of failure to familiarize the safety instructions of this manual.
2.1 General Safety Management
Warning
 Before using this system, the user must check on each items below:
 Is every component connected properly?
 Is every component normally operational when the power is applied
to the system?
 Is there any patient or user in the laboratory when the power is
applied to the system?
 Only authorized users can operate this system. It can be dangerous to
the patient and the user if the instructions about safety exposure
factors, operational instruction, and maintenance schedule are not fully
informed.
 The user of the system must be familiarized with the basic structure
and functions of the system.
 The user of the system must be familiarized with emergencies that
can occur in using the system.
 The user of the system must solve or improve the known problem of
the system before operation. The user of the system must prepare for
the service engineer to perform maintenance to prevent any accident.
 If an error message appears while using the system, the system can be
inoperable. When the error message appears, call the service center.
 If there is any electric or mechanical failure, stop using the system
immediately. Failures can be displayed on screen or noticed with an
alarm.
 In case you need to connect the system with another equipment, ask
an expert of the manufacturer of the equipment.
 All the accessories must be certified by the IEC Standard (Data
Processing Devices: IEC 60950 and Medical Devices: IEC 60601-1).
 In case of connecting accessories to the I/O part of the signal, IEC
60601-1-1 must be observed.
 In case the system or paddles of the system touched a contagious
object, ask the infection staff to the instruction to get rid of the
contamination.

Caution
 Do not spray any liquid or aerosol. It can permeate the system.

 It can cause damage to electric or mechanical parts inside the
system.
 In case the system was exposed to water, moisture, or any other
foreign substance, turn the power of the system immediately and
call a DRTECH staff.
 In case a trace of oil leakage is spotted, stop the operation of the
system immediately and call a DRTECH staff.
 Do NOT pull or push the system. It can break the balance of the system
and cause accidents.
 This system is a medical equipment, not a PC. Do not modify its
hardware or software to another that is not authorized.
 Protection from viruses or network security for the medical device
(i.e. PC firewall) is not provided.
 It is a responsibility of the user to provide the network security and
the anti-virus software.
 Do not obstruct the vent from ventilation. The system can be overheat
due to improper or insufficient air conditioning.
 Always give enough space for ventilation to the system.
2.2 Patient Safety Management

For patient’s safety, observe following safety instructions.
Danger
Do not perform any examination on the patient in case the examination

can endanger the patient.
Warning
 Special care is needed when the patient is pregnant, has a change to be

pregnant, or is breastfeeding her child.
 Examinations on the following types of patients have to be carefully
done. If needed, someone has to accompany with and help the patient.
 Aged patients
 Patients with high blood pressure
 Patients with heart problem
 Patients with cardiovascular disease
 Patients with disability
 Do not leave any other equipment nor object around perimeter of the
system a patient is being examined with.
 Objects prohibited to install or leave near the patient in an
examination: A workstation, hard-copy printouts, etc.
 Keep the buttons and the switch of the system away from being
touched or pushed by the patient.
 Keep the passage for the moving parts of the system clear from the

patient's costume or other medical appliance, such as a wheelchair.

 Restrict access to the system according to local regulations on radiation
protection.
 If the exposure value for AEC increases, increase the patient dose to
high level. If the exposure value for AEC decreases, increase noises for
the image or lower the image quality.
Caution
 During the examination, the user must keep visual contact with the
patient and communicate vocally.
 Once the patient is in position for a test, the user has to protect
him/herself from the radiation behind a radiation shield or in a
protection room and control the exposure with a workstation.
 If the patient has long hair, fix it in a hair net during the examination.
Before the examination, remove the accessories the patient is wearing,
including a necklace, etc.
 To reduce unnecessary discomfort for the patient, inform the patient in
advance that compression and decompression of a breast can cause
discomfort and pain. Inform the patient of this and try to shorten the
minimum time for acquiring the image under compression of the breast.
 To make sure of safe operation of the system, the compression system
has a brake to keep the compression paddle from dropping in case of
power loss. In case of power loss during compression of the breast does
not affect the compression force. Using the compressor manual knob,
lift the compression paddle gently and detach the patient from the
system.
 To minimize the chance of injury to the patient during decompression
mode, stop the upward movement of compression paddle when the
downward force exceeds 3 daN.
 If any anomaly was found out of the patient or the system, move the
patient to a safe place immediately, shut the system down, and perform
safety check on the system.

Note
The following are a list of potential risks in mammography:

 Possible injuries, such as:
 Excessive compression of the breast,
 Irritation on skin, abrasion, or stab wound,
 Infection
 Irradiation, such as:
 Excessive exposure to X-rays,
 Or electrocution, including:
 Electric shock.
2.3 Electric Safety Management

High voltage electricity passes through the power unit at the lower part of the system. A
serious accident such as electric shock can occur if any part of the body touches the system
when the power is on.
The high voltage unit of the system is protected with a cover. However, to prevent any
accident which may occur related to parts with electric danger, the user must observe the
followings:
Warning
 According to IEC 60601-1, this medical equipment conforms with Class

1, Type B applied parts for protection against electric shock.
 This system must be used in an environment which fulfills all the
requirements of IEC safety standard.
 Do not arbitrarily remove the safety cover from the system. Removal of
the safety cover may lead to electric shock due to the high voltage
inside the system.
 Irregular power supply leads to abnormal operation or shutdown of the
system which can result in injury to the patient and/or the user. Make
sure to install the system with a stable power source.
 Make sure that the ground cable is properly connected to the ground
terminal in conformity with the relevant laws on medical equipment.
Improper ground connection can lead to electric shock.
 The system and the workstation should be grounded to the same
protective ground terminal.
 To sustain the quality of isolation of the system, attach only authorized
accessories and options to the system. Only authorized personnel can
change the connection of the system.
 Before cleaning the system, make sure to disconnect the power source.

2.4 Mechanical Safety Management

To prevent any accident which may occur related to parts with mechanical danger, the user
must observe the followings:
Warning
Avoid getting parts of body or the costume stuck in between moving parts
of the system. There are danger signs labeled on the parts where there is
a chance for the user or the patient to be stuck or hit during the operation
of the system.
Caution
 To prevent injuries from being stuck or hit, be careful not to have any
part of body entangled with, hit by, or stuck in the system during the
movement of the system with the motor system (such as in movement
to preset position) or without it.
 To prevent injuries from dropping parts or components, be careful in
handling every system parts and components. Always take care of
handling them and follow appropriate procedures to use them.
 Be aware of the danger to be stuck during the installation of the
components.
2.5 Fire and Explosion Safety Management

To prevent fire and explosion, the user must observe the followings:
Danger
This system is not explosion-proof. Under exposure to inflammable or

explosive gas, NEVER operate the system. It can explode.
Warning
 In case of fire, shut down the entire system immediately and disconnect
the power.
 Make sure to use only carbon-dioxide extinguishers to put out the
fire.
 Do not operate the system in danger of explosion. This system was not
designed for use in explosive environments and does not meet the
AP/AGP standards.

2.6 Radiological Safety Management

To minimize the exposure to X-rays of patients, doctors, radiologic technologists, nurses and
other clinical staffs, everyone must observe the followings:
This system observes IEC 60601-1-3, Standards of Protection for diagnostic use of X-rays.
Warning
 Acquire the mammogram image correctly to prevent the patient from

excessive exposure to X-rays.
 Always use the face shield only except for the examination using the
magnification paddle.
 The bar code reader of the system is a Class II Laser Product. Refrain
from direct exposure to the beam. There can be exposure of the residue
of Laser radiation when the cover is open.
 To prevent unintended exposure to X-rays, the user must observe the
followings:
 All the safety instructions MUST be observed before exposure to X-
rays.
 Do not push the hand switch for exposure to X-rays by mistake while
the system is turned on.
 For maximum protection against X-ray exposure, the hand switch for X-
ray exposure must be pushed behind radiation shield during the
exposure. Keep distance of at least 2 meters between the workstation
with the radiation shield and the focal point and the beam of X-ray.

2.7 Electromagnetic Compatibility

Electromagnetic Compatibility (EMC) is the operability with a certain amount of tolerance for
electromagnetic interference (EMI) from other devices or systems without generating EMI
back to the devices or systems.
For secure EMC, observe following safety instructions.
Warning
 Do not bring electromagnetic wave generators, such as cellphones,

receivers, toys with RC controllers, etc. into the room where the system
is installed. Electromagnetic wave from those objects can cause system
malfunction.
 If someone came to the room with them, ask him/her to turn off the
objects.
 Applying this system to patients with “implantable pacemaker” or
“implantable cardioverter defibrillator,” the user must inform the patient
of the possibility that the “implantable pacemaker” or the “implantable
cardioverter defibrillator” can malfunction due to radiation of continuous
X-ray pulse to the implants.
 Try to avoid direct radiation of X-rays to the “implantable
pacemaker” or the “implantable cardioverter defibrillator” during the
operation of the system. Also, try to shorten the time for radiation to
the patient with either of those devices.

2.8 Safety Measures

To avoid incomplete acquisition of an image or cessation of exposure, use the emergency stop
switch only in case it is absolutely needed to prevent injury.
Emergency power-off switch cut the power to the gantry and standardized mammogram
workstation system forcibly. Do not use the emergency power-off switch in a normal situation.
 Emergency stop switch
 Interlock
2.8.1 Emergency Stop Switch
Locations of the emergency stop switches are shown below:
Figure 2-1 Locations of Emergency Stop Switches
Warning
The user of the system must be aware of the location and the usage of the
emergency stop switches.

2.8.1.1 How to Activate the Emergency Stop Switch
This section explains how to activate the emergency stop switch and releasing it.
When the system is needed to stop immediately due to anomalies during operation, push the
emergency stop switch to shut down the system.
1 In case of emergency, push the emergency stop button immediately.
2 Pushing the emergency stop switch holds the switch pushed.
Figure 2-2 Activation of the Emergency Stop Switch
Important
The system cannot be restarted before the emergency stop switch is released.
2.8.1.2 How to Release the Emergency Stop Switch from Activation
After all the causes of emergency were solved and no further sign of anomaly was found, turn
the emergency stop switch clockwise and release the emergency stop.
 Once the emergency is solved, turn the emergency stop switch clockwise.
Figure 2-3 Release of the Emergency Stop Switch
Important
The system cannot be restarted before the emergency stop switch is released.

2.8.2 Interlock
RMF-2000 is equipped with safety interlocks.
 In case the compression is displayed to exceed 3 daN (6.7 lb), the vertical movement and
rotation movement of the C-arm is deactivated.
 Releasing the X-ray button before the exposure has been done, the system stops exposure
and displays a warning message.
 In case of Magnification Mode, the system does not allow any grid in X-ray field
(tomosynthesis option).
 In case the light field mirror or the filter mirror is not aligned, the mirror interlock and the
filter interlock block X-ray exposure.
2.9 Observation of the Standards

This system observes the following standard.
Standards Standards Standards Title Version

No.
No. Organization
Medical electrical equipment - EC 60601-1:

IEC 60601- IEC Part 1: General requirements for 2005+AMD1:2012 CSV
1
1 basic safety and essential
performance
Medical electrical equipment - IEC 60601-1-2:2014

Part 1-2: General requirements
for basic safety and essential
IEC 60601- IEC
2 performance - Collateral
1-2
Standard: Electromagnetic
disturbances - Requirements and
tests
Medical electrical equipment - IEC 60601-1-3:

Part 1-3: General requirements 2008+AMD1:2013 CSV
IEC 60601- for basic safety and essential
3 IEC
1-3 performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
Medical electrical equipment - IEC 60601-2-45:

Part 2-45: Particular requirements 2011+AMD1:2015 CSV
for basic safety and essential
IEC 60601- IEC
4 performance of mammographic
2-45
X-ray equipment and
mammographic stereotactic
devices
IEC Medical device software - IEC

5 IEC 62304 Software life cycle processes 62304:2006+AMD:2015
CSV
IEC Medical devices - Part 1: IEC 62366-1:2015

IEC 62366-
6 Application of usability
1
engineering to medical devices

Standards Standards Standards Title Version

No.
No. Organization
CEN-CENELEC Medical devices - Application of EN ISO 14971:2012

EN ISO
7 risk management to medical
14971
devices
2.10 Safety Symbols

Following symbols are used in this system to do with the safety of the user and the patient.
Item Description
Follow all the instructions in the manual to operating the system

safe.
Power to the system can be cut off by pushing the emergency stop
switch.
Suitable for Type B applied parts according to IEC 60601-1.
Only suitable for direct current (DC).
A ground terminal.
Every terminal to connect to the outside conductor to protect the

system from electronic shock.
X-rays are about to radiate or in radiation.


3. System Components and Functions
3.1 Components of the Gantry
Figure 3-1 Components of the Gantry

Table 3-1 Components of the Gantry
No. Name
1 C-arm
2 Column
3 Base
4 Foot switches

3.1.1 Components of the C-arm
Figure 3-2 Components of the C-arm

Table 3-2 Components of the C-arm
No. Name Description
Equipped with the buttons including movement of the

1 C-arm gantry key C-arm, operation of collimator, and automatic
compressor unlock.
2 Manual compression knob Manually moves the compressor vertically.
Holds the magnification stand during magnified

3 Magnification stand holder
acquisition.
Compression paddle shift

4 Moves the compression paddle horizontally.
lever
Displays C-arm rotation angle, thickness of the

5 C-arm display compressed breast, and compression force to the
breast.
Keeps the face and hair of the patient from the

6 Face shield
passage of X-rays.
7 Compression paddle clamp Serves as the receptacle of the compression paddle.
8 Compression paddle Compresses the breast of the patient.
Supports the breast of the patient and covers the

9 Bucky
image detector.

3.1.1.1 Gantry Key
Moves the C-arm, operates the collimator, and automatically unlocks the compressor.
Figure 3-3 Components of the Gantry Key

Table 3-3 Components of the Gantry Key
Adjusts the size of the X-rays and the light field.

1 Collimation size toggle (toggling from 24x30 to 18x24 to 10x24 to 18x24
(Tube Small Focal Spot) to 8x8 then returns to 24x30)
2 Collimator lamp Turns on/off the collimator lamp.
Lift up & down/ Moves the C-arm vertically and rotates it

3
Rotation cw & ccw clockwise/counter clockwise.
4 Preset Moves to next preset position.
Automatically releases the compression paddle after X-

5 Auto decompression
ray radiation.
6 0 degree Rotates the C-arm back to 0° position.

3.1.1.2 C-arm Display
Displays the rotation angle of the C-arm, the thickness of the compressed breast, and the
compression force to the breast.
Figure 3-4 Components of the C-arm Display

Table 3-4 Components of the C-arm Display
1 Compression force ranges from 3daN to 30 daN.
2 C-arm angle rotates from 0° to 180°.
The breast thickness can be adjusted between 10 mm

3 Compression thickness
and 300 mm.

3.1.1.3 Manual Compression Knob
Can move the compression paddle manually up and down. To lower the compression paddle,
turn the knob clockwise. To raise the paddle, turn the knob counter clockwise.
3.1.1.4 Compression Paddle Clamp
Used to replace the compression paddle. To release current compression paddle, push flip the
clamp lock with your hand. Once a new compression paddle is inserted, release your hand out
of the clamp.

3.1.1.5 Compression Paddle Shift Lever
Turning down the compression paddle shift lever enables the compression paddle to move to
left or right from the center. Set the compression paddle to desired position and release the
shift lever. The lever turns up automatically to its original position.

3.1.1.6 Bucky
The image receptor consists of the detector, the grid, and the breast support, all in one piece.
Figure 3-5 Bucky
Caution
Do not try to detach the detector forcibly from the image receptor.

3.1.2 Components of the Column and the Base
Figure 3-6 Components of the Column and the Base

Table 3-5 Components of the Column and the Base
Moves the C-arm vertically, rotates it clockwise/counter

1 Column gantry key
clockwise, and performs Preset.
When activated in an emergency, each button

2 Emergency Stop Switch disconnects the power from the moving parts of the
gantry and shuts down the system.
The power must be supplied from the power outlet on

3 System Power Cable
the wall during the examination.
Displays C-arm rotation angle, thickness of the

compressed breast, and compression force to the
4 Base Display breast.
Works as same as the C-arm display of the C-arm.

Emergency Stop Switch
There are totally three emergency stop switches. Two of them are on the right and the left
side of the gantry, one on each side. The last one is in the workstation.
When activated in an emergency, each button disconnects the power from the moving parts of
the gantry and shuts down the system.
Figure 3-7 Activation of the Emergency Stop Switch
Caution
 When returning from the emergency

Turning the emergency switches clockwise by 90° releases and resets
them, so that the system can resume operation. To restart the system,
push the power button in the workstation.
Figure 3-8 Release of the Emergency Stop Switch

3.1.3 Components of the Foot Switches
Moves the C-arm or the compression paddle vertically.
Figure 3-9 Components of the Foot Switches

Table 3-6 Components of the Foot Switches
1 Lift up/down Moves the C-arm vertically.
2 Compressor up/down Moves the compression paddle vertically.
Warning
 To prevent pushing the foot switches accidentally, keep the switches

away from the patient and the C-arm.
 In case of the patient with on a wheelchair, keep the switches away
from the wheelchair.

3.2 Components of the Workstation
Figure 3-10 Components of the Workstation

Table 3-7 Components of the Workstation
1 Radiation shield Protects the user from the radiation.
Displays the system status and image information captured

2 Monitor
from the patient for the user.
Consists of the emergency stop switch, the system power

3 Switch set button, the auto decompression button, and the exposure
button.
4 Exposure switch Controls the exposure to X-rays.
5 Mouse Interacts with the monitor and selects items on the monitor.
6 Keyboard Controls the software.
7 PC Runs the software and saves the data.

8 UPS Supports stable power source to the system during a blackout.
Exposure hand switch

9 Controls the exposure to X-rays.
(Optional)
3.2.1 Switch Set
Consists of the emergency stop switch, the system power button, the auto decompression
button, and the exposure button.
Figure 3-11 Components of the Switch Set

Table 3-8 Components of the Switch Set
When activated in an emergency, the switch

1 Emergency Stop Switch disconnects the power from the moving parts of the
gantry and shuts down the system.
Turns on and off the system. When turned on, it turns

2 Power On/Off switch
on the LED lamp in the button.
In case of emergency due to excessive compression of

3 Compressor release switch the breast, it automatically lifts the compression paddle
to release the breast.
4 Exposure switch Serves as the button for exposure to X-rays.

4. System Hardware Operation
4.1 Preparation
1 Make sure all the emergency stop switches are released to normal positions.
Note
There are three emergency stop switches in total, each of them is on both side of the
gantry and in the workstation. If the switches are pushed, release and reset them by
turning them clockwise by 90°.
2 Make sure the system power cable is properly connected to the power outlet on a wall.
3 Make sure both the passage of the moving parts of the C-arm and the view from the user
to the system are clear. If there is any object in those passages, get rid of it.
4 Make sure to path for the patient is cleared without any object.
Warning
In case of a patient on a wheelchair, keep the foot switches and cables

away from the wheelchair.

4.2 Turning On/Off the Power of the System
4.2.1 Turning On the Power
1 Push the system power button on the switch set of the workstation. The LED light is on in
the system power button and the monitor displays the log-in screen. Also, the C-arm
display of the C-arm and the base display of the lower body are turned on.
2 With the keyboard and the mouse, input the user ID and password and click the Login
button. The worklist screen is displayed.
Note
There are three icons to click on the lower part of the login screen.
 Shut Down: Shuts down the system.
 Reboot: Reboots the system.
 Information: Shows system information.

4.2.2 Turning Off the Power
4.2.2.1 Turning Off the Power with the Workstation
On the login screen, click the Shut down icon. On the pop-up Notice window which says, “Do
you want to Shutdown System and Software?”, click OK to turn off the program. Or you can
also turn off the program by clicking the power icon on lower left of the screen in Worklist
mode.
Push the system power button on the switch set. On the pop-up Notice window which says,
“Do you want to Shutdown System and Software?”, click OK to turn off the program.
As the power is gone, the LED lamp in the system power button is turned off.

4.2.2.2 Turning Off the Power in Case of Emergency
Emergency stop switches are on both sides of the gantry stand and on the switch set of the
workstation. When the emergency stop switch is activated, the switch disconnects the power
from the moving parts of the gantry and shuts down the system.
Resuming the System Operation after Emergency Stop
1 Release and reset the emergency stop switch by turning it clockwise by 90°.
2 Push the system power button on the workstation one more time to restart the program.

Caution
If the system fails to restart, call the DRTECH service center.
In Case of Shut Down due to Blackout
In case of blackout, the power to the moving parts of the system is disconnected. It leads to
cessation of compression by the compression paddle.
 Turn up the manual compression knob and lift the compression paddle to release the breast
of the patient.
 Or you can release the breast of the patient by pushing the auto compressor release button
on the switch set and letting the compression paddle lift automatically.

4.2.3 Test of System Operation
4.2.3.1 Upward/Downward Movement of the C-arm
You can control the movement with the gantry key on the left and the right side of the C-arm
or the one on either side of the stand. The foot pad on the foot switch also controls vertical
movement of the C-arm.
 On the foot switches, push the C-arm UP/DOWN to move the C-arm UP and DOWN.
 On the gantry key, push the LIFT UP/LIFT DOWN button to move the C-arm following the
button.
 The C-arm stops moving when the button is released.
 The C-arm stops moving at the limit of vertical movement.
Note
The Limit of vertical movement of the C-arm ranges from 700 ±30 mm to 1400 ±30 mm.

4.2.3.2 Rotation of the C-arm
You can control the movement with the gantry key on the left and the right side of the C-arm
or the one on either side of the stand.
 Push the button to rotate the C-arm clockwise or counter clockwise.
 The C-arm stops moving when the button is released.
 The C-arm stops moving at the limit of rotation.
Note
 To rotate the C-arm, do it roughly with the Preset button or 0 DEGREE button and then
use the ROT CW/CCW button on the gantry key to rotate it more accurately.
 The Limit of rotation of the C-arm ranges from -180° ±5° to +180° ±5°.

4.2.3.3 Preset Positioning
 Moves to the preset position of the system.
 The preset angle for the acquisition of the mammographic image in MLO view is ±45°. The
exposure angle is ±30°.
4.2.3.4 0° Positioning
 The tube head of the C-arm moves to 0° position.
 According to the setting of the breast support position, the head automatically moves
upward or downward.

4.2.3.5 Operation of the Manual Compression Knob
 Turning down one of the knobs at either side of the C-arm turns on the collimator lamp and
lowers the compression unit.
 Turning up one of the knobs at either side of the C-arm lifts the compression unit.
Note
 In following cases, the compression unit stops lowering:

 when the knob is not turned,
 when the compression force reached the maximum limit of 30 daN, or
 when the thickness of the compressed breast reached the minimum limit of 10 mm.
 In following cases, the compression unit stops lifting:
 when the knob is not turned,
 when the thickness of the compressed breast reached the maximum limit of 300 mm.

4.2.3.6 Auto Decompression
This button automatically releases the breast from compression after the X-rays have been
radiated.
Note
 If the Auto Decompression LED was set On, the LED lamp is also turned on.
 The compression paddle moves away up to 150 mm from the breast support.
4.2.3.7 Collimator Lamp
The timing for turning on and off the lamp is set up during the initial system setting. However,
the collimator lamp button enables to turn on and off the lamp regardless of the setting. Each
time you push this button, the lamp goes on and off.
Note
When the compression paddle lowers, the collimator lamp is automatically turned on.

4.2.3.8 Collimator Size Toggle
This button changes the collimator size through various sizes of X-ray field. Push the collimator
lamp button to display the X-ray field and push the collimator size button to choose the size of
the X-ray field.
Note
Each time you push this button, the size of the field toggles from 24x30 to 18x24 to 10x24
to 18x24 to 8x8, then back to 24x30, sequentially.


5. Usage of System Accessories
This chapter provides the instructions to use the accessories for the system. These accessories
can perform screening or diagnosis application.
5.1 Face Shield

Protects the face, head, hair, and ears from exposure to the X-rays. Check the face shield
before use on a daily basis.
Warning
 Whenever the X-rays are radiated, the face shield must be attached to
the system.
 However, the face shield does not provide absolute protection from the
X-rays.
5.1.1 Attachment and Detachment of the Face Shield
To Attach the Part to the System
As shown in the figure, push the face shield along the rail above the display at the C-arm until
the shield is mechanically fixed to the structure.
To Detach the Part from the System
To the opposite direction of the attachment, pull the face shield carefully along the rail until
the shield is detached.

5.2 2D Crosshair Device

The 2D crosshair device is only used to 2D mammograms for localization.
5.2.1 Attachment and Detachment of the 2D Crosshair Device
To Attach the Part to the System
From the rear of the tube head, push the device forward of the system along the rail above
the display at the C-arm until the device is mechanically fixed to the structure.
To Detach the Part from the System
To the opposite direction of the attachment, push the device carefully backward of the system
along the rail until the device is detached.

5.3 Magnification Stand
Attach the magnification stand to the holder at the C-arm. Magnification on the bottom side is
x 1.5 and on the top side, it is x 1.8.
When attached, the grid of the bucky is automatically pushed away from the radiation field.
Caution
The system is inoperable when the grid is moving.

5.4 Compression Paddle

Some of the paddles below are optional and can be excluded from the original package of the
system. The system can recognize each type of the paddles and adjust the collimator
accordingly.
Caution
Before use, check each paddle for damage. If the paddle is damaged,
replace it immediately with a new one.
 Any paddle with a sharp edge (edges) or a rough surface can harm the
breast of the patient. Also it can impede accurate diagnosis because it is
difficult to assure the image quality with damaged paddles.
 It is recommended to replace the paddles regularly.
 The system can only use the paddles provided by DRTECH. The system
does not recognize images with paddles from other manufacturers and
DRTECH cannot guarantee the safety of the patient.
5.4.1 Routine Screen Paddle
Type Description Print Image
24x30 Screening Paddle  Basic type of the

compression paddles. This
paddle can use the
maximum range of
detector effective area.
 Size: 24 cm (d) x 30 cm
(w)
 Weight: Approx. 1 kg
 This compression paddle

is used to acquire the
18x24 Screening Paddle mammographic images of
a part of the detector
effective area for the
examination.
 Can move to the left or
the right to acquisition of
axillary images, including
MLO mammograms.
 Size: 18 cm (d) x 24 cm
(w)
 Weight: Approx. 0.9 kg
5.4.2 Localization Paddle

 The compression
paddle type for
mammogram for
localization.
 Equipped with needle
holes.
 Marked with
Localization Paddle coordinates which help
localization.
 Keeps from X-ray
penetration and
recognizable in the
mammographic
images.
the right to acquisition
of axillary images,
including MLO
mammograms.
 Size: 18 cm (d) x 24
cm (w)
5.4.3 Small Breast and Implant Paddle
 This compression
paddle is for
compressing the breast
avoiding the breast
implant during the
acquisition of the
Small Breast and Implant
mammographic image.
Paddle
 Also used to patients
with small breasts that
cannot be compressed
accurately with other
paddles.
the right to acquisition
of axillary images,
including MLO
mammograms.
 Size: 10 cm (d) x 24
cm (w)

5.4.4 Magnification Paddle
paddle is used to
acquire magnified
mammographic
images.
Magnification Paddle  Can be used for
acquisition of images
with both x 1.5 and x
1.8 magnification.
 Like the spot paddle,
this compresses and
acquires the
mammographic image
of a spot from the
breast.
 Size: Longer than 10
cm (d) x 10 cm (w)
5.4.5 Spot Paddle
Spot Paddle paddle is for
compressing and
acquiring the
mammographic image
of a spot from the
breast.
 Size: Longer than 8cm
(d) x 8cm (w)
 Weight: Approx. 0.6kg

5.4.6 Attachment and Detachment of the Compression Paddles
Attaching/detaching the compression paddles forcibly can lead to damage to the paddle or
malfunction of the clamp. Make sure to attach and detach the paddles in the right order.
5.4.6.1 Attachment of the Compression Paddle
1 Tilt the paddle to 30°-43° and hang it against the slot at the back on the bottom of the
compressor unit.
2 Open up and hold the clamp of the compressor unit manually.
3 Raise the paddle.
4 Release the clamp so the clamp hold is fixed to the slot on the paddle.
5.4.6.2 Detachment of the Compression Paddle
1 Open up and hold the clamp of the compressor unit manually.
2 Lower the paddle as shown in the figure.
3 Release the clamp hold from the slot on the paddle and detach the paddle.

5.4.7 Compression Paddle Shift
Turning down the compression paddle shift lever enables the compression paddle to move to
left or right from the center. Set the compression paddle to desired position and release the
shift lever. The lever turns up automatically to its original position.
Note
The lateral view helps examining small breasts. The collimator moves automatically to the
selected paddle position.

6. Procedure for Clinical Examination
Warning
 C-arm is moving during the examination. Be careful.

 Always keep every button and switch away from the hands of the
patient.
 To prevent pushing the foot switches accidentally, keep the switches
away from the patient and the C-arm.
 In case of a patient on a wheelchair, keep the foot switches and cables
away from the wheelchair.
6.1 Turning On the Power of the System

1 Push the system power button on the switch set of the workstation.
The LED light is on in the system power button and the monitor displays the log-in screen.
Also, the C-arm display of the C-arm and the base display of the lower body are turned on.
2 With the keyboard and the mouse, input the user ID and password and click the Login
button. The worklist screen is displayed.

6.2 Selecting and Starting the Examination
Selecting the Examination from the Worklist
In case of the scheduled examination which data can be found in HIS/RIS, double click your
mouse on the name of the patient in the worklist. The exposure mode is initiated.
Or
Click the Acquisition button at bottom right of the worklist screen. The exposure mode is
initiated.
Selecting the Examination without a Worklist
In case of the examination that was not scheduled and cannot be found in the worklist, you
can create a new item manually.
1 On the bottom left, click the Add icon. A registration window for a New Patient appears.

2 Fill all the needed fields.
3 Click Add icon at the bottom of the window to register the information of the new patient
to the worklist.
4 Click the Acquisition icon at the center of the bottom of the window. The exposure mode
is initiated.
Warning
 To prevent any mismatch between patient data or displaying any patient

information which is wrong, make sure to check the patient
identification information before every examination.
 To prevent any unintended exposure to the X-rays or additional
acquisition, make sure to check the patient identification information
and examination history before every examination.

6.3 Preparation of Gantry

Prepare the gantry and arrange the affected part of the patient for examination.
1 Install the compression paddle. Install the compression paddle considering the size of the
patient’s breast.
2 Install the face shield. Protects the face, head, hair, and ears from exposure to the X-rays.
Note
When attached to the magnification stand, do not install any face shield.
3 Set the rotation angle of the C-arm and move it to the appropriate position to get a desired
image.
4 Check the imaging protocols and types of the view. According to the paddle that is installed,
check the protocol.
Basic imaging protocols in the exposure mode are RCC, LCC, RMLO, and LMLO. Switch to a
protocol you want to acquire the mammographic images in.
After the protocol is set, you can maneuver the acquisition and additional acquisition of
mammographic images as well as the type of the view in the protocol.
Note
Before every examination, make sure that the protocol and the type of the view were
correctly selected to avoid the chance of misdiagnosis.
6.4 Arranging the Position of the Patient
Caution
 To prevent the head of the patient from hitting the tube and avoid
exposure of unnecessary body parts to the X-rays, arrange the patient
to the right spot.
 Make sure all the unwanted objects, such as earrings and necklaces,
have been removed from the patient so that you can prevent them from
interfering your view during the examination. Also, make sure that the
patient’s hair was arranged and fixed at the back of the head of the
patient.
 To prevent sudden and unintended activation of control buttons for
operation of the system, guide the hands of the patient to the hand rest
of the gantry.
 Explain the importance of maintaining the posture to the patient so that
the patient tries to minimize the movement of the body during the
acquisition of the images.
1 Use the lift to place the detector suitable for the height of the patient.
2 Control the C-arm until it rotates to the necessary angle.
3 Put the breast onto the center of the image receptor.
4 Try not to have the breast wrinkled on the image receptor.

5 If possible, arrange the nipple to face forward.
6 Guide the hands of the patient to the hand rest.
7 With the centering lamp, check the size of the field and check if any object, such as the
patient’s hair, earrings, etc., blocks the passage of the X-rays to the breast.
8 Check the type of the view matches the angle of the C-arm.
6.5 Compression
To prevent decreasing the quality of the images and the quantity of the X-ray radiation, it is
very important to compress the breast appropriately. If the compression force is below 3 daN,
it is prohibited to expose the breast to the X-rays under the AEC auto mode.
Caution
To prevent the breakage of the breast implant, use manual compression

and apply only minimum compression that is necessary for the examination
to a patient with a breast implant.
1 Push the compressor down paddle on the foot switch to compress the breast.
2 With one of the compression manual knobs at each side of the compression paddle holder,
you can control the compression manually.
3 Compress the breast until the breast is tightly stretched on the image receptor.

6.6 Selecting Exposure Mode

Select the auto mode or the manual mode in the exposure mode.
Click the AEC icon to select the auto mode and click the Manual icon to select the manual
mode.
Auto Mode Selected
Basic AEC sub mode for the system is selected. According to the needed quality of the image
and the allowed radiation dose for each examination, you can select one of the following AEC
sub modes on the list of the scroll:
 AEC +: Provides high contrast to noise ratio (CNR) for the images acquired from increased
dose.
 AEC: Provides average CNR for the images with average dose.
 AEC -: Provides low CNR for the images with reduced dose.
Manual Mode Selected
Check the thickness of the compressed breast on the compressor display of the gantry. The
manual mode can be used for the patients whose breast cannot be compressed with the
pressure of 3 daN, because the patient has a breast pain or has just taken a breast surgery.
Warning
The minimum compression force recommended in the manual mode to

avoid decreasing of the quality of the images or acquiring useless images is
3 daN. In case of failure to observe this warning:
 The treatment can be delayed.
 Additional exposure to the X-rays can be needed.
 The breast can be exposed to too much X-rays.
 The radiation of X-rays can be inefficient.

6.7 Proceeding the Examination
6.7.1 Exposure to X-rays
After all the parameters for the examination is properly selected and the patient is ready,
1 Push the X-ray Exposure on the switch set of the workstation. On the X-ray indicator of
the display, the exposure is displayed.
2 Press and hold the X-ray Exposure button until the signal lamp for shutting down the
exposure ( ) and the alarm sounds.
Note
In case of the premature release of the X-ray exposure button before the signal lamp for
exposure available ( ) is turned on, the preparation sequence is canceled and the
compressor unit decompresses the breast.
Caution
To prevent the acquisition of incomplete image, do not release the X-ray

exposure button until the whole imaging sequence is complete.
6.7.2 Displaying the Images on the Acquisition Window
After the exposure to X-rays, the processed image is displayed on the exposure mode of the
workstation.
Check if the type of the image is correct and change it, if needed. Proceed necessary tasks.
6.7.3 Acquiring Another Image
As soon as the window displays the processed image, the system is ready for next round of
exposure. Repeat the steps above.
6.8 Finishing the Examination
Releasing the Compressor
Turn up the Compressor Release switch. If the auto compressor release is set, the
compressor unit lifts automatically after the exposure. After the examination, move the patient
away from the system safely.
Image Quality Check
Check every image to decide if its quality is enough to diagnose. Use the quality check feature
of the system to check images, if needed.
Printing the Images

The image on the viewer can be printed by clicking the Print icon.
Sending the Images
On the viewer, click the Send icon to send the image to the storage server in the hospital.
Finishing the Examination
To finish current examination, click the Close Study icon at the lower right of the exposure
mode. Once the auto print is activated, a pop-up window for print preview appears.
6.9 Shutting Down the System

Click the Power icon at the lower left of the workstation screen. Main power to the system is
cut off and it shuts down.
Note
 It is recommended to shut the system down when the business hour is over.
 Turning off the power to the switch set of the workstation also turns off the main power
to the system. In this case, the main system is disconnected to the workstation.
However, the network between the workstation and the server is still operational.
 Click the power icon at the lower left of the workstation screen to cut off the main power
to the system and shut it down.
6.10 Cleaning and Replacing Accessories of the System

Clean the compression paddle, the breast support, the face shield, and the compressor unit
(For the details of cleaning, refer to Ch. 15 Sanitation and Preventive Maintenance).
Detach the compression paddle and the face shield if it is needed to replace them for the next
examination.
Caution
To prevent contagion between patients, it is essential to clean the entire

system thoroughly on a regular basis. Clean and disinfect all the surfaces
that can be contaminated while using, including the surfaces that directly
contact the patients. Clean and wash every part that contacts the patient in
between every examination.

7. Workstation Operation
7.1 System Login

When the workstation is booted, it shows the login screen as shown below.
Input the user ID and password and click the Login button to log into the workstation.
1 Login Use the saved user information to log in.
2 Information Displays system software version information.
3 Reboot Reboots the workstation PC.
4 Shut Down Shuts the system down.
Note
You can also reboot the system using the power switch on the switch set.
While the workstation is turned on, it is not rebooted when you push the power switch on
the switch set.

7.2 Patient Information Management

Patient information can be added, modified, deleted, and searched on the worklist screen.
Generally it shows the information of every patient whose examination is scheduled on the day.
Linked to the HIS/RIS system, this system shows the list of the patients who are downloaded
from the HIS/RIS system on the worklist.
7.2.1 Information on Worklist Screen
1 Search/Detail search Goes to the patient search/detail search screen.
2 Worklist Patient list for exam
3 Detector temperature Displays detector temperature
4 HDD Capacity Displays the storage capacity of the HDD.
Retries server query for the worklist, checks the data

5 Network management transfer status, confirms data sent to the print server,
and checks each server status.
6 System shutdown/Reboot Shuts down the software and restarts it.
7 Editing worklist Adds, edits, deletes and imports the worklist.
8 Acquisition Goes to the acquisition screen.
9 User ID Goes to the ID account and user setup screen.

7.2.2 Patient Search
Input the patient ID, patient name, accession number in the search field above the worklist
and click the Search ( ) to find the patient to examine.
7.2.3 Detail Search
Inputs and selects detailed information of a patient to search the patient.
1 Click the Detail Search button above the worklist. Detail Search screen appears at the
center on the worklist.
2 To find the patient, input or select detailed field information on the advanced search screen.
Note
There are fields to input and select such as patient ID, patient name, accession number,
gender, and period. For the period field, you can select it manually by clicking dates on the
calendar.
3 To select a patient on the worklist, click the OK button.
7.2.4 Adding New Patient
You can add a new patient with no scheduled exam and no entry on the worklist directly to
the worklist.

1 On the bottom left, click the + Add icon. New Patient screen appears.
2 Click the Auto Create button. A patient ID is automatically given to the patient.
3 Fill all the needed fields.
4 Click Add button at the bottom of the window to register the information of the new
patient to the worklist.
Note
 To save the patient information, you must input the patient ID and patient name.
 To move onto the exposure mode, click the Acquisition button on the lower center of
the screen.
7.2.5 Editing Patient Information
You can edit the patient information that you directly added to the worklist.

1 On the worklist, select the patient whose information you want to edit and click Edit button
on the lower left of the screen. Edit Patient screen appears.
2 Edit the field information you want to change.
3 To save the change, click the Edit button on the bottom of the Edit Patient screen.
Note
To cancel the change, click the Cancel button.

7.2.6 Deleting Patient Information
You can delete the worklist you directly added.
1 On the worklist, select the patients you want to delete and click Delete button on the
lower left of the screen. Information screen appears to confirm deleting selected patients.
Note
To delete multiple patients on the worklist, select them on the list and click the Delete
button on the lower left of the screen.
2 Click the YES button at the bottom and the selected patients are deleted from the worklist.
Note
To cancel the deletion, click the No button.

7.2.7 DICOM Storage Manager
Can check the data transfer to DICOM storage and print status. Also makes it possible to retry
tasks and deletes some or all items on the list.
1 On the lower left of the worklist screen, click the Storage ( ) Icon. DICOM Storage
Manager screen appears.
2 To check the transfer status to DICOM, click the Storage on the upper left. To check the
printer status, click the Print.
Note
 Function of the buttons at the bottom of the screen

 Retry: Resends the data in case of failure.
 Delete: Deletes an item on the list.
 Delete All: Deletes a whole list.
 Close: Closes the DICOM Storage Manager screen.

7.2.8 Network Management
Checks the AET(AE-Title), IP, Port and the usage for each server.
There is page by page information on Worklist, Storage, MPPS, and Print. The selected server
can be set up manually or automatically.
Note
For more information on server settings, refer to the service manual and the installation
manual.

7.2.9 Switching ID Account
Through another ID, you can login easily without going back to the login page.
1 On the upper right of the worklist screen, click the admin button. IDs which logged in
before appear.
2 Click an ID to login with.
3 A column for password appears.
4 Input the password and click the OK button. The current user is changed. To cancel the
change, click the Cancel button.


8. Image Acquisition
8.1 Going into the Acquisition Mode
From the Worklist to the Acquisition Mode
 Select a patient to acquire images from the worklist and click the button to move onto
the acquisition mode.
 Or, click the patient twice on the worklist. It also moves to the acquisition mode.
From the New Patient Screen to the Acquisition Mode
 On the bottom of the New Patient screen, click the Acquisition button to go to the
acquisition mode.
8.2 Exam Mode Screen
 View Position: Displays the area for acquisition.

 Gantry Status: Displays the paddle and the
collimator size.
 X-ray Indicator: Displays the radiation phase by
phase.
 Displays heating unit and detector temperature.
1 System Control
 Exposure Mode: Selects Manual and AEC.
 Adjusts the tube voltage (kV) and tube current
(mA).
 Displays filter change information and focus
information.
 Displays the compression force, thickness, and


rotation information.
2 Image Viewer Shows the patient image.
Image Editing Tools: Can be configured for tools in

3 Tools
need.
Displays patient information including patient ID,

4 Patient Information
patient name, birthday, and procedure.
 Sets a proper view position for each procedure.

 Adds, deletes, and edits the acquisition position.
View Position Image
5  Rejects/Repeats the acquired image.
Thumbnail
 Shows the acquired image as a thumbnail.
 Checks the transfer and print status.
6 Send/Print Prints a selected image/ Sends the image via PACS.
7 Suspend/Close Study Waits while acquisition/Completes the acquisition.
8.2.1 X-ray Indicator
Indicates the radiation phase by phase.
No. Symbol Description
1 System ready
2 Exposure ready
3 Radiating
4 Resting (deactivated) after radiation

8.2.2 Setting Up the X-ray Exposure Condition
You can select AEC mode and manual mode. In Manual mode, you can select the parameters.
In manual mode, the parameters (kV, mA) for exposure

1 Manual mode can be selected.
To select AEC mode, click the AEC (Auto Exposure

Control) button.
 AEC +: Provides high contrast to noise ratio (CNR) for
the images acquired from increased dose.
2 AEC mode
 AEC: Provides average CNR for the images with
average dose.
 AEC -: Provides low CNR for the images with reduced
dose.
To adjust kV (tube voltage) value in manual mode, click

3 kV (tube voltage) the desired value or click the <> buttons below the
numbers until desired value is chosen (25 kV-39 kV).
To adjust mAs (tube current) value in manual mode, click

4 mAs (tube current) the desired value or click the <> buttons below the
numbers until the desired value occurs (1 mA-500 mAs).

8.2.3 Gantry Display and Adjustment
Selects the filter: between Ag (silver) and Rh

1 Filter
(rhodium)
Displays the magnification automatically according to

2 Magnification
the attached breast support.
Shows the current focal spot.

 Large: In case that the magnification stand is not
3 Focal spot attached.
 Small: In case that the magnification stand is
attached.
4 Compression force The force currently compressing the breast.
Thickness of the breast which is currently under

5 Compression thickness
compression.
6 C-arm rotation angle Current C-arm rotation angle

8.2.4 Editing Procedure
You can edit the procedure on the worklist.
1 On the patient information, click the Procedure icon. The Edit Procedure screen appears
at the center of the acquisition screen.
2 Click the Changing Procedure to select the procedure to edit.
3 Click the OK button to save the change. To cancel, click the Cancel button.

8.2.5 View Position Screen
Enables addition, deletion, edit, rejection, and repeat of view position and displays acquired
images as thumbnails.
8.2.5.1 Adding View Position
You can add new view positions.
1 On the right side of the Exam Mode screen, click the Add (+) icon. The Add View
Position screen appears.
2 Click the position to add. The selected view position is added to the List of view position
box at the bottom of the Add View Position screen.
Note
 To add another view position (A):

Click the position to add and click + icon ( ) at the lower right of the Add View
Position screen. The selected view position is added to the View Position List box.
 To remove a view position from the List of view position box (B):
Click the position to delete and click the bin icon ( ) at the lower right of the Add
View Position screen.
 Total 20 view positions can be added.
3 To save the added view positions, click the Add button at the lower center of the screen.
8.2.5.2 Deleting View Position
The thumbnail of view position can be deleted.
1 Click the thumbnail to delete and click the Delete (-) icon above the thumbnail.
2 An information screen appears to confirm deletion.

3 Click the Yes button to delete the selected thumbnail of view position. To cancel it, click
the No button.
8.2.5.3 Editing View Position
You can edit view positions.
1 Click the thumbnail to change.
2 Click the Edit ( ) icon above the thumbnail. The Edit View Position screen appears.
3 Click the view position to change and click the Edit button on the bottom of the screen.
The view position is changed. To cancel, click the Cancel button.

8.2.5.4 Repeat/Reject
Select Reject to delete a mistaken image. Select Repeat to retry acquisition.
1 Select and click the thumbnail to reject or repeat.
2 Above the thumbnail, click the Repeat icon or the Reject icon. A column for password
appears.
3 Input the password and click the OK button. The Reject Code screen appears.
4 From the Reject Reason List, select a relevant reason and click the OK button. The
mistaken image is deleted. To cancel, click the Cancel button.

Note
 To cancel Reject,
Undo it by double clicking the Reject button above the image.
8.2.5.5 Edit Tool Shortcut Icon Setup
Frequently used Edit Tools can be placed in the top pane of the screen.
1 On the upper right bar of the screen, click the Edit Tool button. The Tool screen appears.
Note
 Click the V icon on the selection pane, the function panel list appears.
 Image Layout Panel: Defines image viewer layout.
 Image Control Panel: Selects, enlarges, and edits the image and adjusts windowing.
 Annotation Panel: Annotation indicated on images.
 Image Panel: Recovers the image, applies the parameters for image procession, and
copying the image.
 DICOM Panel: Transfer, print, additional storage, and DICOM Header viewer.
2 Select desired panel to choose necessary tools. The Edit Tool icon for the selected panel
appears.
3 Select and click the icon of the tool to register a shortcut. The selected icon in the tool
panel appears in the selection pane.
4 Repeat steps 2 and 3 to select all the required icons and click the OK button on the bottom
of the selection pane. Registered shortcut icons of Edit Tool appear at the top pane of the
screen.

Note
A total of 12 slots for shortcut icons are available.

9. Exam List Management
Manages the patient and exam information of finished acquisition and sends the acquired
images to PACS and other storage media.
9.1 Exam List Screen
1 Search/Detail search Patient Search
2 Patient list Patient list whose acquisition is done.
 Edit: Editing patient information.

 Delete: Deleting patient information.
Patient list  Import: Importing images from external media.
3
Edit/Delete/Import/Export/Merge  Export: Exporting patient images to extra
storage media (CD, DVD, or External Drive).
 Merge: Moves images among the worklist.
4 Review Shows the acquired image on review screen.
5 Acquisition Goes to acquisition for additional acquisition.
6 Image list Saved image list
 Edit: Editing study information.

 Delete: Deleting study information.
Study list
7  Export: Exporting study information to extra
Edit/Delete/Export/Send
storage media (CD, DVD, or External Drive).
 Send: Sending the image to PACS.

8 Study list Information list for finished exam.
9.2 Editing Patient Information

You can edit the patient information whose examination is finished.
1 On the worklist, select the patient whose information you want to edit and click Edit icon
on the bottom of the worklist. Edit Patient screen appears at the center of the screen.
2 Edit the patient information field you want to change.
3 Click the OK button. Patient information is changed and saved. To cancel, click the Cancel
button.

9.3 Deleting Patient Information.

You can delete the worklist which examination is finished.
1 On the worklist, select the patient you want to delete and click Delete icon on the bottom
of the worklist. A column for Password appears at the center of the screen.
2 Input the password and click the OK button. The selected list is deleted. To cancel, click
the Cancel button.

9.4 Importing Patient Image Data

Images acquired externally from other equipment can be imported.
1 On the worklist, select the patient whose image data you want to import and click Import
icon on the bottom of the worklist. Import screen appears at the center of the screen.
2 Click the Folder Path icon and select a patient image file from the source folder.
3 Click the OK button. Selected image data of the patient is imported. To cancel, click the
Cancel button.

9.5 Exporting Patient Image Data

Patient images can be exported to extra storage media (CD, DVD, or External Drive).
1 On the worklist, select the patient whose image data you want to export and click Export
icon on the bottom of the worklist. Export screen appears at the center of the screen.
2 Set up each parameter.
Note
 In case you select the storage for drive type, it leads to set up path, image format, and
inclusion of RAW. Also, there are settings of each overlay for user marker, information,
and annotation.
 In case you select the CD/DVD for drive type, it leads to set up Media and inclusion of
Viewer or RAW. Also, there are settings of each overlay for user marker, information, and
annotation.
 Overlay: As the user overlay option that will be overlaid in the image, it configures each
of user marker, formation, and annotation.
3 Click the Start button. Selected patient information if exported. To cancel, click the Delete
button. When export is done, click the Close button.

9.6 Merging Patient Image Data

To move the patient image from the worklist, select multiple patients with the Ctrl key and
click the Merge icon on the bottom of the worklist. The images can be moved.
1 On the bottom of the worklist, click the Merge icon. Merge screen appears at the center
of the screen.
2 Input patient name or patient ID in one of the two search columns on top of the Merge
screen and click the search icon. Or click the patient whose image you want to merge from
the worklist. On the bottom of the screen, the images of the selected patients are displayed.
3 Click > button or < button to move the image to merge to the selected direction.
4 Click the OK button. Image merging is finished. To cancel it, click the Cancel button.

9.7 Editing Study Information List

You can edit the study information list.
1 On the study information list, select the list which information you want to edit and click
Edit icon on the bottom of the study information list. Edit Study screen appears at the
center of the screen.
2 Edit the study information field you want to change.
3 Click the OK button. Study information is changed and saved. To cancel, click the Cancel
button.

9.8 Deleting Study Information List

You can delete the study information list which examination is finished.
1 On the study information list, select the list which information you want to delete and click
Delete icon on the bottom of the study information list. A column for Password appears
at the center of the screen.
2 Input the password and click the OK button. The selected list is deleted. To cancel, click
the Cancel button.

9.9 Exporting Study Information List

Study image data can be exported to extra storage media (CD, DVD/ External Drive).
1 On the study list, select the image data you want to export and click Export icon on the
bottom of the study list. Export screen appears at the center of the screen.
2 Set up each parameter.
Note
 In case you select the storage for drive type, it leads to set up path, image format, and
inclusion of RAW. Also, there are settings of each overlay for user marker, information,
and annotation.
 In case you select the CD/DVD for drive type, it leads to set up Media and inclusion of
Viewer or RAW. Also, there are settings of each overlay for user marker, information, and
annotation.
3 Click the Start button. The selected list is sent. To cancel, click the Delete button. When
export is done, click the Close button.

9.10 Sending Study Information List

Sends the selected study information list to the Picture Archiving and Communication System
(PACS).
1 Select the study list to send to the PACS. Click the Send icon on the bottom of the screen
to send the list immediately.
1 Study list to send File list to send
 Retry: Retries to send.

 Delete: Deletes selected list.
2 Function button
 Delete All: Deletes all the list to send.
 Close: Closes the window.
9.11 Review and Acquisition

To show the acquired image on the review screen, click the Review button.
For additional acquisition, click the Acquisition button to go to the acquisition mode.

10. Review Mode
10. Review Mode
Checks the acquired image and modifies the additional image if annotation is needed.
10.1 Review Screen
 Partial View: Defines the image viewer layout.

 Image Control: Selects, enlarges, and edits the
image and adjusts windowing.
 Annotation: Annotation indicated on images.
1 Image Edit Tool  Image: Recovers the image, applies the
parameters for image procession, and copying the
image.
 DICOM: Transfer, print, additional storage, and
DICOM Header viewer.
 Shows the image on screen.

2 Image Viewer  Displays the information of patient, exam, operator,
and acquisition with text overlay.
Displays patient/study information. Patient ID, patient

3 Patient/Study Information
name (gender), birthday, and procedure.
 Rejects the acquired image.

View Position Image
4  Changes the view position of the acquired image.
Thumbnail
 Checks the transfer and print status.
5 Print/Send Prints and sends the image.
6 Close Closes the review screen.

10.2 Image Layout Tool

Selects the image layout displayed on the image viewer screen.
1 1x1 ( ) Displays one image.
Displays two images, one at the right and the other at

2 1x2 ( )
the left.
3 1x4 ( ) Displays four images horizontally.
4 2x2 ( ) Displays four images.
5 Time ( ) Displays images acquired before.
6 Custom ( ) Displays two images selected by the user.
7 CC ( ) Displays the LCC and the RCC images left and right.
8 MLO ( ) Displays the LMLO and the RMLO images left and right.
9 RCC MLO ( ) Displays the RCC and the RMLO images left and right.
10 LCC MLO ( ) Displays the LCC and the LMLO images left and right.
Displays two images, one at the top and the other at

11 2x1 ( )
the bottom.
Aligns the nipple positions in the images of the left and

12 Nipple ( )
the right.

10. Review Mode
10.3 Image Control Tool

Selects the image displayed on the image viewer screen.
1 Select ( ) Selects the viewer.
2 Zoom ( ) Enlarges the image.
Displays a moving image to facilitate comparative

3 PAN ( )
analysis of a certain spot.
4 Fit ( ) Displays a fitted image to the viewer.
5 W/L ( ) Adjusts the Window Width and Window Level.
6 Mag Z ( ) Enlarges the zoom-in image even more.
7 1:1 ( ) Displays magnified images to the original image size.
8 ROI W/L ( ) Adjusts the brightness of ROI in the image
Reverses white and black parts in the image upon each

9 Invert ( )
click. (White to black, black to white)
10 Left 90 ( ) Displays the image rotated 90° CCW.
11 Right 90 ( ) Displays the image rotated 90° CW.
12 Horizontal ( ) Displays the image enlarged horizontally.
13 Vertical ( ) Displays the image enlarged vertically.

14 Crop ( ) Crops a part of the image and displays it.
15 WWL Res. ( ) Returns to the original image.
10.4 Annotation Tool

Annotates the image with graphics and texts. Also measures angle and length of objects in the
image.
1 Rectangle ( ) Shows a rectangle on the image.
2 Circle ( ) Shows a circle on the image.
3 Angle ( ) Shows a protractor to measure angle on the image.
4 Ruler ( ) Shows a ruler to measure length on the image.
5 Text ( ) Inputs texts on the image.
6 User Mark ( ) Inputs user marks on the image.
Shows average pixel value and standard deviation of

7 ROI M. ( )
the ROI.
8 Cross ( ) Shows a cross on the image.
Marks two spots on the image and shows the distance

9 Ruler Cal. ( )
between them.

10. Review Mode
10 Delete ( ) Deletes selected annotation.
Hides or reveals the annotation on the image viewer.

11 Hide ( )
Clicking the icon toggles activation and deactivation.
12 Arrow ( ) Shows an arrow on the image.
Shows the ROI position value (width and height) on

13 ROI Pos ( )
the image.
10.5 Image Tool

Recovers the image, applies the image processing parameters, and copies the image.
1 Reset ( ) Resets the image.
Selects and adjusts the parameters of the acquired

2 Re-Pro. ( )
image for post-processing.
3 Copy ( ) Copies the image.

10.5.1 Reprocessing
Applies the post-processed image which parameters for acquisition was selected or adjusted
after acquisition.
 Select: Selects the viewer.

 Zoom: Magnifies the image X times (available for
two viewers at the same time).
 Pan: Displays moving images (available for two
viewers at the same time, moves the two images
1 Viewer Tool identically, makes it easy to compare and read a
certain spot).
 Fit window: Displays a fitted image to the viewer.
 WWL: Adjusts the brightness of the image
 WWL Reset: Resets the adjusted brightness of the
image.
 Apply Param.: Applies parameter values adjusted by

users.
Apply Parameter / Save  Save Default Param.: Applies default parameter
2 Default Parameter / Reset / values.
Close
 Reset: Reset.
 Close: Saves and closes Reprocessing.
Adjusts image parameter values.
 Latitude
 Contrast
3 Parameter  Sharpness
 Brightness
 Frequency
 Fat Suppression

10. Review Mode

 Truview ART application
4 IPP list Image Processing Parameter file list.
Divides the processed image into two copies.

5 Image View
Click and select an image to apply.
10.6 DICOM Tool

Transfers the image, prints it, and exports it to additional storage, and displays DICOM Header
viewer.
1 Send ( ) Sends the image immediately.
2 Print ( ) Prints the image.
3 Export ( ) Exports the image to additional external storage.
Shows the DICOM Header information of the acquired

4 Header ( )
image.


11. User Setup
11. User Setup
11.1 Gantry User Setup

User setup for the gantry, the overlay and windowing.
1 On the upper right of the worklist screen, click the admin button.
2 Click the User Setting button. User Setting screen appears.
3 Select an item to setup (among Gantry, Overlay, W/L sensitivity). The setting screen for
each appears.

11.1.1 Gantry Setting
Available to set up the values for compression force, lamp timing, compression auto
decompression, decompression height, lift movement speed, rotation speed, view position
angle, position functions of the gantry.
 Sets up primary compression limit following

procedures.
 Beeps when reached the primary limit.
1 Compression maximum force
 setup category: normal acquisition, acquisition for
localization, and acquisition for breasts with
implants.
Sets up duration of collimator lamp light following

procedures.
2 Lamp time
 setup category: name/family name and acquisition
for localization.
3 Auto release Sets up when using the auto compressor release.
Adjusts compressor release height.

4 Auto release height  setup category: normal acquisition and magnified
acquisition.
Lift speed
5 Selects speed (slow, normal, fast).
Rotation speed
View position angle

6 Sets up MLO angle.
MLO angle
7 Positioning Selects position. Auto and mirror position.
To save the change, click the Save button. Not to save the change, click the Cancel button.

11. User Setup
11.1.2 Overlay Setup
Can set up information fields displayed on screen during acquisition or review. Also sets up
location of these information fields.
1 To save the change, click the OK button.
2 Set up the arrangement and font size of the overlaid information.

Note
 Edit ( ): edits each field.

 Up/Down ( ): changes the order of each field.
3 To save the change, click the Save button. To cancel, click the Cancel button.
11.1.3 W/L Length(Sensitivity) Setup
Sets up the image sensitivity during acquisition or review. Sensitivity level changes with
horizontal/vertical movement of the mouse.
Note
 Window Level Length: Decides the sensitivity of window level change.

 Up/Down: Decides the brightness level of the window.
 Left/Right: Decides the brightness of the window in a level.
To save the change, click the Save button. To cancel, click the Cancel button.

12. Exposure Mode
12. Exposure Mode
12.1 Manual mode
12.1.1 General Information
Considering that auto exposure mode is available and it can fulfill the necessity for digital
mammography, use of the manual mode is not recommended. However, it should only be used
when there is a specific need including measurement of physical parameter for quality control.
In manual mode, the following exposure parameters can be selected:
 Anode track/filter combination: Tungsten (W) track / Rhodium (Rh) filter, Silver (Ag) filter
 Tube voltage peak (kVp): 25-39 kV with W/Rh, W/Ag
 Current-time product per exposure (mAs) within the limits of the maximum peak power and
exposure times.
12.1.2 Influence under Different Parameter Values
The tables below mimicking the AEC operation should be a good start for the selection of
parameters. See Table 1 and Table 2 for recommended parameters according to breast type
and thickness.
 The influence of high voltage (kV) is not simple due to the presence of characteristic
radiation and filters with discontinuities (k-edge). However, increase of the high voltage
also increases the emission efficiency and the tube yield. It increases the dose to the
patient and reduces the quantum noise. Difference of only 1-2 kV may produce significant
changes.
 Increasing the current-time product through the tube (mAs) increases proportionally the
amount of x- ray photons. It improves the contrast to noise ratio. It also increases the dose
to the patient. To be effective in changing the image properties, a change by more than 2
steps (i.e. 25% in dose) is required, and 3 steps (40% in dose) more significant.
A difference in image contrast resulting from a selection of track/filter and tube voltage (kV)
may be compensated by changing image processing, and, in particular, contrast windowing.
• Table 1 Suggested Manual Techniques - No implant
Compressed With MagStand (magnification

With Bucky (contact view):
breast view):
thickness
(mm) Target/Filter kVp mAs Target/Filter kVp mAs
< 20 W/Rh 25 32 W/Rh 27 32
20-35 W/Rh 26 50 W/Rh 28 63
35-50 W/Rh 27 80 W/Rh 29 90
50-60 W/Rh 28 80 W/Rh 30 100
60-70 W/Rh 28 100 W/Rh 30 125

Compressed With MagStand (magnification

With Bucky (contact view):
breast view):
thickness
(mm) Target/Filter kVp mAs Target/Filter kVp mAs
70-80 W/Rh 29 140 W/Rh 34 125
> 80 W/Rh 30 180 W/Rh 35 125
12.1.3 Implants
Automatic Implant mode is recommended for acquisition of breasts with implants. Manual
mode may also be used. The suggested acquisition parameters for implants can be used as an
alternative to the Automatic Implant mode, particularly when acquiring the images without
displacing the implants.
When the implant is displaced and not visible, other AEC modes can be used.
Table 2 contains suggested parameters for image acquisition depending on breast thickness.
• Table 2 Suggested Manual Techniques for Acquisition of Breast with Implant
Breast Thickness Exposure Parameters

(mm) Track / Filter kV mAs
< 32 W/Rh 26 45
32-40 W/Rh 27 56
40-50 W/Rh 28 71
50-60 W/Rh 28 10
60-70 W/Rh 29 12
70-80 W/Rh 29 16
> 80 W/Rh 30 20
12.2 AEC mode

The AEC modes of the system automatically determine all technique factors in response to the
breast properties as analyzed during a pre-exposure.
The AEC intends to optimize the quality of images while maintaining the dose to the breast as
low as possible for this image quality, taking into account the available technical capability.
It has been designed to optimize image quality for the examination of breasts with a
radiological thickness between 20 mm (0.8 inch) and 80 mm (3.15 inches).
12.2.1 General Description of AEC
When an AEC mode of operation is selected, the system takes full control of the quality and
quantity of X-rays by automatically setting the exposure parameters:
 Anode track: Tungsten (W).

12. Exposure Mode
 Filter: Rhodium (Rh), Silver (Ag)
 Tube High Voltage value (kVp),
 Current time product per exposure (mAs).
The AEC mode can be used for contact views or magnification views.
In AEC mode, a pre-exposure is performed to determine the X-ray attenuation properties of

the breast.
Based on accepted statistics of breast thickness and composition, the track, filter and kVp
selected by the AEC will generally be the same as used during the pre-exposure.
However, for breasts with specific properties a change in anode/filter/kV values may be
necessary between pre-exposure and exposure. This change is fully automatic; it may
generate an additional delay between pre-exposure and exposure.
The image resulting from the pre-exposure is analyzed, and an automatic algorithm with a
provision to exclude the pectoral muscle detects and measures the most attenuating glandular
18x24 mm area in the image (longer dimension parallel to the longer dimension of the
detector).
Figure 1 Position of the AEC Search Zone in the Field of View (FOV)
The average of this area is used for calculation of “radiological thickness” or “PMMA-radiation
thickness.” The value results in PMMA thickness. Under the same X-ray condition, transmission
level is also equal. This radiological thickness is the exclusive input to the automatic selection
of the exposure parameters, so that the resulting X-ray beam maximizes the contrast to noise
ratio (CNR) in the corresponding area relative to the dose delivered to the breast. Since this
area is the densest in the breast, the CNR in the other areas of the breast will be equal to or
higher than the target value of the AEC in all areas of the image.

Then, depending on the selected AEC mode and the PMMA-radiation thickness of the breast in
the area determined from the pre-exposure, the desired dose to the detector is selected.
Finally, the tube current (mAs) value required to reach this detector dose value for the
radiological (PMMA-radiation) thickness is computed and set together with the other technique
factors and the exposure performed.
Note that thickness of the compressed breast is not a factor to consider when deciding
technical factors of main exposure in AEC mode.
The CNR vs. AGD optimization computations drove to specific values of tube voltage and dose
to the detector in response to the measured PMMA-radiation thickness. The resulting high
voltage values are constant vs. PMMA-radiation thickness for each anode track/filter
combination:
The image contrast is set by the track/filter kV combination and the image noise by the target
dose to the detector. The combination of the image contrast and noise provides the desired
CNR.

13. Image Processing and Display
13.1 Original Image

The image acquired directly from the detector after X-ray radiation is sent to the workstation
and is not displayed on viewer. The original image is saved in DICOM format for later use.
13.2 Processed Image

The image process includes application of TruviewART and TruviewM to the original image.
The processed image is saved in DICOM format for reading.
13.2.1 TruivewART
TruviewART improves the sharpness of the image.
Note
For more information on TruviewART, please refer to the articles below:

 KJ. Chae, JM. Goo, SY. Ahn, JY. Yoo, SH Yoon Application of Deconvolution Algorithm of
Point
 Spread Function in Improving Image Quality: An Observer Preference Study on Chest
Radiography, Korean Journal of Radiology, 2018
13.2.2 TruviewM
As the main image process, TruviewM facilitate the reading of mammograms. TruviewM
consists of the sub-procedures like below:
Background Masking
Masks the background other than the breast area in black to help reading of the image.
Tissue Equalization
Equalizes the gray scale all over the breast by reducing the difference of thickness between
tissues inside the breast and near the skin which is generated from compression.
Sharpness Enhancement
Intensifies the sharpness of edges inside the breast and adjusts the sharpness.
Brightness Control
Adjusts overall brightness of the breast image.

Fat Suppression
Adjusts the contrast between fat tissues and mammary gland tissues inside the breast.
13.2.2.1 Adjustable Parameters in TruviewM
Paramete Rang
Description
r e
Adjusts general thickness of the breast (gray scale): As the value

becomes bigger, the thickness also increases.
Latitude 1-15
Adjusts overall contrast of the image: As the value becomes bigger, the
contrast also increases.
Contrast 0-100
Stresses the edge sharpness of the tissues inside the breast: As the
Sharpness 0-20
value becomes bigger, the sharpness also increases.

Paramete Rang
Description
r e
Adjusts the brightness of the breast in the image: As the value becomes
bigger, the brightness of the breast in the image also increases.
Brightness 0-50
Adjusts the difference between fat tissues and mammary gland tissues
inside the breast, As the value becomes bigger, the difference also
increases.
Fat-
Suppressio 1-30
n
Adjusts the volume of the mammary gland tissues inside the breast: As
Penetration 1-20
the value becomes smaller, the volume increases.

Paramete Rang
Description
r e

14. Localization Examination
The System provides optional tools to perform a Localization examination:
 Localization Paddle including a coordinate system marking.
 Crosshair Unit including metallic wires which may be positioned in the field of view: It is
used during localization procedures, to target a position for the introduction of a needle or
to position a marker for a tangential view.
 Manual Compression knobs allow the wires to be moved on the X and Y axes.
 Refer to Chapter 5 Usage of System Accessories for mounting instructions of the crosshair
device, standard face shield and paddles.
Note
These tools are intended to be used with the standard face shield, to keep the patient’s face
out of the X-ray beam during the radiation.
14.1 Safety Notice
Caution
To prevent injuries from being stuck or hit, be careful not to have any part
of body entangled with, hit by, or stuck in the system during the movement
of the system with the motor system (such as in movement to preset
position) or without it.
Caution
 Elevation and rotation movements are enabled when the displayed

compression force is less than 3 daN. Where possible, make sure the
compression force is greater than 3 daN before starting the localization
procedure. If compression less than 3 daN must be used, take great
care to prevent unwanted gantry movements when a needle is inserted
in the breast, to avoid damaging the breast tissue.
 If the patient moves during the localization procedure or compression
thickness (thickness of the breast under compression) changes, the
procedure should be started again from the beginning in order to
guarantee the accuracy of the localization.

Note
To avoid damaging the equipment due to the paddle colliding with the crosshair during
motorized decompression, do not use the MagStand in combination with the crosshair
device.
Note
Place the foot switch so that the patient cannot reach it accidentally during positioning or
imaging and inadvertently decompress the breast.
Note
 Always bear in mind the needle's height and insert it to a depth such that it will not
pierce through the breast nor touch the Bucky. This way you will avoid damaging the
breast and/or the breast support.
 For views that do not require the patient to stand, the patient must be seated in a biopsy
chair; the chair must provide good support to the patient’s back and arms.
 Auto decompression is automatically turned off when a Localization protocol is set.
 The default centering light duration is 5minutes.
14.2 Definition
 Physical and Electronic Crosshair: The X-ray image of the cross superposed on the
breast image will be named "physical crosshair" in the rest of this chapter, to distinguish it
from the "electronic crosshair" that can be displayed on the image on the monitor.
 Physical Crosshair Images: X-ray image: exposure
 Light Image: Turn the collimator light on.
 Target: The inserting target of the needle in the breast.
 Insertion point: Entry point for the needle on the skin of the breast
 Image target: X-ray image of the target
14.3 Procedure Preparation

1 Prepare the standard face shield if it is not in place. Insert the crosshair device.
2 Use the Manual Compression Knob to move the X and Y axes as much as necessary to
be sure that the cross wires are positioned out of the field of view.
3 Insert the localization paddle.
4 Switch localization protocol on acquisition mode.
5 Compress the patient’s breast.
Note
Compression is limited to 12 daN with a localization protocol.

14.4 Image Acquisition Procedure
Note
 In order to perform an accurate Localization procedure, make sure to read lesion

coordinates and place the electronic crosshair correctly, then to position the cross wires
on the determined coordinates.
 Before Localization procedure, check the alignment of crosshair projection.
 Do not forget to remove the wire to the parking position before acquisition.
1 Acquire an image.
2 Remain the breast under compression.
3 Click the Cross button. The button to display a set of electronic crosshair in the acquired
image.
4 Use the mouse to position the intersection of the electronic crosshair over the center of the
target.
5 Read the relative position of the graduations on the paddle (X and Y axes) if the localization
paddle with rectangular hole was used on screen.
Note
In case the perforated localization paddle is used,

Check the coordinate of the hole where the electronic crosshair is located, as shown in (4, j)
of the following figure.
6 Use Zoom, Fit to Breast or Fit to Screen as required for the best visualization of the area. If
the graduations can not be seen in the zoomed view after the electronic crosshair has been
positioned, reduce the zoom to display the graduations.
7 Turn the collimator light on.
8 Use the knobs on the crosshair device to move the wires into the correct position.
Note
 The goal is to superpose the image of the physical crosshair with the electronic crosshair.
 If needed, perform another acquisition to verify the correct position of the physical
crosshair.
9 To insert the needle, first anesthetize the insertion point if required. Turn on the collimator
light, then place the needle tip at the intersection of the shadow of the cross wires at skin
level and insert the needle.

 With the needle in place, make sure that the shadow of the cross wires coincides with
the hub of the needle.
10 Use the knobs on the crosshair unit to move the cross wires out of the field of view.
11 Perform another acquisition to verify correct needle position.
12 Use the manual compression knob to decompress slowly and carefully remove the
breast from the breast support.
13 Support the breast and turn the gantry arm through 90 degrees.
14 Perform another acquisition to check for correct depth.
15 If correct depth of the needle or correct location of the hook wire is secured, let the patient
come out the system.
14.5 Completion
1 You can now annotate the images and/or apply measurements.
2 Click the Print icon to print each required image.
3 Push the image to review workstation.
4 In the Operator Preferences menu, turn AutoPush and AutoPrint back on if needed for
routine mammography.

15. Sanitation and Preventive Maintenance
This chapter provides the instructions for regular sanitation and preventive maintenance
procedures to keep the patients’ health and the system condition.
Preventive maintenance includes daily check-ups, regular tests, replacement of the

consumables and other components subject to regular replacement.
Warning
The user must follow the local hygiene regulations to prevent contagion of
diseases.
Caution
Perform sanitary maintenance on every part and component that can

contact the user or the patient at least at the beginning and the end of the
business hour every day, as well as in between every examination.
Note
 Regular check-ups on and replacement of certain parts requires special skills (which
requires special tools or involves a risk). In case the preventive maintenance task
requires special skills, DRTECH performs the task for a surcharge on the service.
 For the details on preventive maintenance, call the DRTECH staff.
15.1 Cleaning and Washing

This section provides the instructions to get rid of the contaminant physically according to the
purpose of the use of the system.
After using the system, clean the system and the examination room. If a janitor is supposed to
perform this task, inform him/her enough of the safety instructions in advance.
Warning
 Make sure to turn off all the power of the system and cut the power to
the wall. Cleaning the system while the power is supplied to it can lead
to malfunction of the system and/or cause an accident. Invasion of
liquid such as water or detergent into the system can cause electric
shock.
 Do not pour nor spray any liquid such as water or detergent on the
floor. Invasion of liquid into the cable can lead to malfunction of the
system and/or cause an accident.
 Do not use detergent that can cause damage to the system while
cleaning, because it is too strong, abrasive, or based of highly
concentrated alcohols.
 To prevent injury and/or damage to the system, do not perform steam-
cleaning nor high temperature disinfection on the system.
 In case the invasion of liquid into the system is detected, let the
qualified service staff inspect the system before use.

Caution
 Do not apply cleaner sprays or other liquids directly to the system.

According to the instructions of the manufacturer, use clean cloth wet
with the cleaner spray or liquid to clean the system.
 To prevent damage to the system, keep the perimeter of control
buttons and moving parts dry from the liquids.
 Every part of the system is sensitive to mechanical damage. Be careful
not to hit the system with cleaning instruments by mistake while
cleaning it.
 Do not apply any corrosive substance to the surface of the system. For
example, do not use methanol to clean the system, regardless of the
concentration.
 Also, do not use any cleaning product which contains solutions such as
benzene or most kinds of stain removers.
15.1.1 Cleaning the System
Wet a piece of clean soft cloth with neutral detergent and wipe out any stain on the system.
 Dilute the neutral detergent to the concentration the manufacturer specified.
 Wet a piece of clean soft cloth with the diluted detergent solution and squeeze it to get rid
of abundant solution.
 After wiping out the stain, wipe the spot one more time with dry cloth.
15.1.2 Cleaning the Monitor
It is important to keep the monitor clean, free from any dust or fingerprint on it.
Caution
The front panel of the monitor can be easily damaged. Be very careful to
hit or scratch the monitor by mistake during the examination, the cleaning,
or any other task near the system. Only use microfiber cloth wet with
water to clean the monitor.
15.1.3 Cleaning the Keyboard and Mouse
Keep the liquid cleaning products from invading into the keyboard or the mouse while cleaning.
15.1.4 Cleaning the Examination Room
Vacuum-clean all the dust in the room. When you wipe the floor, make sure to squeeze the
mop or the cleaning cloth not to drip.
15.2 Disinfection
When disinfecting parts or whole of the system, follow the lead of the infection control staff of
the clinic or the hospital.

Commonly known disinfection procedure eliminates most types of pathogens, viruses,

mycobacteria, fungi and phytobacteria. However, the procedure does not thoroughly kill all the
bacteria to the spore level.
Warning
 To prevent contagion, disinfect every surface touched by the user and

the patient thoroughly between examinations all the time.
 Before disinfection, turn off the power of the system. Disinfecting the
system, while it is still turned on, can cause malfunction and lead to an
accident. Liquid products including disinfectants can get into the system
and cause a short circuit leading to electric shock.
 Do not pour or spray disinfectants directly onto the system. Liquid
products can invade the system and cause system malfunction or an
accident.
 After disinfection, make sure to let all the air out of the room before
restarting the system. Any inflammable gas staying in the room can
cause ignition or explosion.
Caution
Do not use the disinfectants listed below. These types of disinfectants can
cause damage to the system. In case of damage to the system due to the
use of inappropriate disinfectants, optimal performance of the system and
safety of the user and the patient cannot be guaranteed.
 Disinfectants highly corrosive to metal and rubber (i.e., chlorine-based
disinfectants).
 Disinfectants warned not to use on metal, plastics, rubber, and coatings.
 Disinfectants which can invade the system (i.e., formalin gas or other
disinfectant sprays).
To prevent irritation to the skin, always rinse the surface, which might
contact the user or the patient later, with clean water and dry with dry and
soft cloth after using the disinfectants.
15.2.1 Disinfecting the Compression Paddle
Before each examination, make sure to inspect the compression paddle visually. In case of
damage to the paddle, replace it immediately.
In case of contact of the paddle to any source of infection, ask the infection staff to the
instruction to get rid of the contamination.

15.3 Recommended Detergents and Disinfectants

It is an obligation of the user to use detergents and disinfectants to the system without any
damage to it.
Warning
To use the system in maximum efficiency and safety, make sure to observe
all the instructions of the manufacturer of the detergents and/or the
disinfectants, including the instructions on the ways of mixing, storage and
application of the products; allowed time of contact to the system,
requirements for cleaning and disinfection and protection gears; expiration
date and disposal of the products, etc.
Caution
Use dry clean cloth to dry the surface after disinfection.
15.3.1 Recommended Detergents
 Recommended detergents: Water or Water with ethyl alcohol (concentrated up to 96%).
 Targets for the detergents: All covers, all compression paddles, accessories, the detector,
the monitor, the mouse, and the keyboard.
15.3.2 Recommended Disinfectants
 Recommended disinfectants: 10% bleach and water dilution or 3% hydrogen peroxide and
water dilution.
 Targets for the disinfectants: All compression paddles, the breast support, and the face
shield.

15.4 Preventive Maintenance Schedule

It is essential to perform preventive maintenance to the system to secure safety and
performance. It is an obligation of the user to prepare and perform preventive maintenance to
the system.
Preventive maintenance includes daily check-ups, regular tests, replacement of the

consumables and other components subject to regular replacement. Regular check-ups on and
replacement of certain parts requires special skills (which requires special tools or involves a
risk). In case the preventive maintenance task requires special skills, DRTECH performs the
task for a surcharge on the service.
Recommended Schedule
Tasks Every
Every Every Every six
Upon use other
week month months
week
Cleaning and disinfection of the

●
compression paddle
Cleaning and disinfection of the

●
breast support
Visual inspection of all paddles

for damage ●
*Detector Flat Field Calibration ●
*Artifact Evaluation ●
*Phantom Image ●
*Signal to Noise / Contrast to

●
Noise Measurements
*Compression Thickness
●
Indicator
*Visual Checklist ●
*Geometry Calibration ●
*Compression ●
Refer to the Quality Control Manual for the items with an asterisk (*).

15.5 Disposal of the System

Prior to the disposal of the system, its component, or parts, call the DRTECH staff.
In case of disposal of the system conducted by any person other than a technician authorized
by the user or DRTECH, it can cause pollution of the environment.
Caution
This system or any part/component of this system must be classified as

industrial waste and disposed appropriately. In case of disposal of the
system, it must be conducted by an authorized waste disposal company
and in compliance with local regulations which are applicable. For more
information, call the DRTECH staff.

16. Administration Massages
16. Administration Massages
16.1 Error Recovery and Troubleshooting

Most fault and alert messages are cleared without result to your workflows. Follow thd
instructions on the screen or correct the condition then clear the status from the LCD monitor
and Gantry. Some conditions require a system restart or indicate that more action is necessary.
This chapter describes the message categories and your actions to return the system to
normal operation. If errors repeat, contact DRTECH Field Engineer.
16.2 Types of messages and alert messages
16.2.1 Fault levels
There are two fault levels : Warning, Error
1 Warming Faults
• Release through the software or communications commands.
• Cancel an exposure that is in progress
• Prevent the start of a new exposure
2 Error Faults
• Not release through the software or communications commands.
• Cancel an exposure that is in progress
• Prevent the start of a new exposure
16.2.2 Alert Messages
Alert Messages are routine messages that can prevent an exposure. An Alert message remains
active until the required action is complete or the condition does not exist.


17. Specifications
17. Specifications
This chapter provides the instructions for the specifications of the installed and operational
system related to the usage information for the user. For more information on pre-installation,
shipping, storage, installation and maintenance, refer to the chapter of the service manual
relevant to each subject.
17.1 Classification
Items Description
Protection type against electric shock Class 2 X-ray device for mammography
Protection degree against electric shock Type B applied parts
Water ingress protection IPX1 for the system and the foot switch
Way to disinfect No disinfection, cleaning only
Usability in an oxygen-rich environment Not usable in an oxygen-rich environment
Duty type Continuous duty
17.2 Environment for Use and Storage
Items Description
Temperature +10 °C - +35 °C

(Recommended: +20 °C - +28 °C )
Environment for (Rate of change: < 15 ˚C (59 ˚F)/hour)
use
Humidity 20% - 75% (non-condensing)
Pressure 700 - 1060 hPa
Temperature -10 ℃ to +40 ℃

Gantry
(In a building as packed)
+5 ℃ to +40 ℃, Direct detector type

-10 ℃ to +40 ℃, Indirect detector
Environment for
type
storage/shipping Detector
(Rate of change: < 15 ˚C (59
˚F)/hour)
(In a building as packed)
Humidity 0% - 80% (non-condensing)
Pressure 500 - 1060 hPa

17.3 Input Power
Items Description
Rated input voltage 200-240 Vac ±10%
Rated input frequency 50/60 Hz ±5%
Power rating 8.1 kVA
17.4 Specifications per Unit
17.4.1 X-ray Generator
Items Description
Input voltage 200-240 Vac (±10%), single phase, 50/60 Hz
Min. 35 A service recommended for 5 kW

Input current
operation
 Output voltage range: 20 kV to 40 kV

 Polarity Positive, grounded cathode X-ray tube
 Accuracy: Within 1% of programmed values
Output voltage
 Reproducibility: <0.5%
 Settling time: <10 ms
 Ripple: ≤1%
Output current range 10 mA to 200 mA
 5 kW at 0.1 second loading time

Output power
 Max. 30 W average power
Maximum mAs 600 mAs
Exposure timer 5 ms-10 seconds
Within 2% of programmed values measured after

Accuracy
mA rises to stable DC level
Reproducibility <0.5%
Settling time <10 ms
17.4.2 X-ray Tube and Output
Items Description
Target Tungsten (W)
kVp / mAs 49 kV

17. Specifications
Items Description
 Large (0.3 mm)

Focal spot
 Small (0.1 mm)
X-ray Window Beryllium, 0.5 mm
Max. 150 W
17.4.3 X-ray Beam Filtration
Items Description Thickness (E.g.)
Position 1 Rhodium 0.05 mm (0.8 mm Al (28 kV/HVL 0.52 mm Al)
Position 2 Silver 0.05 mm (0.9 mm Al (28 kV/HVL 0.56 mm Al)
17.4.4 X-ray Source Assembly Specifications and Location
This tube is an anode-grounded rotating anode tube with a focal track made of respectively
Tungsten(W). In compliance with IEC 60336 (2005), it has two focal spots, of which the
nominal values are 0.3 and 0.1. The target angle(s) with respect to the specified reference
axis are:
Items Description
Small focal spot 0.1 / 10°
Large focal spot 0.3 / 16°
Source to Image Distance (SID)
The direct focal distance is fixed, with a value of 660 mm.

17.4.5 Anti-scatter grid
When performing examinations in contact view, the breast support contains a reciprocating
anti-scatter grid (Potter-Bucky device).
This grid is positioned with the septa parallel to the chest wall side for compatibility with
angulated operation (such as tomosynthesis). For this reason, the movement of the grid has
very small amplitude (< 2 mm) to preserve the capability to image the region close to the
chest wall of the patient.
A special speed-law has been designed to perform a satisfactory erasure of the grid lines in
spite of this short amplitude.
Items Description
 Linear focused grid designed particularly for

Type mammography.
 Graphite interspaced
Material of the absorbing strips Pb
Composite covers Carbon fiber
Focusing distance f0 = 660 mm
Strip frequency 41L/CM
Grid ratio 3.5 : 1

17. Specifications
17.4.6 C-arm
Items Description
 Unit: degree (°)

Rotation range  Range: -180° - +180° ±5°
 Accuracy: ≤ ±1°
Rotation speed n/s
Source-to-image distance (SID) 660 mm ±6.6 mm
 Unit: mm
Patient support (non-magnification)  Range: 700±30 mm - 1400±30 mm
 Accuracy: ≤ ±30 mm
17.4.7 Compression
Items Description
3-stepped compression motor speed

 Before compression force < 4 N
Speed
 After compression force ≥ 4 N
 Manual compression movement
 Unit: mm
 Min. height: < 10 mm / Max. height: 300±5
mm
Thickness
 Auto release default height: 120 mm
 Balance: | Left – Right | < 5 mm
 Unit: daN
 Min. display: 3 daN
Motorized compression force
 Max. display: 20 daN
 Accuracy: ≤ ±2 daN
 Unit: daN
Manual compression force  Max. display: 30 daN
 Compression moving distance per turn: 4 mm
C-arm angle
 Unit: degree (°)
Display  Min. display: 0
 Max. display: 180
 Accuracy: ≤ ±2°

Items Description
Compression thickness
 Unit: mm
 Min. display: < 10 mm
 Max. display: 300 mm
Compression force
 Unit: daN
 Max. display: 30 daN
 24x30 Screening Paddle

 18x24 Screening paddle
 Localization paddle
Paddle
 Small and implant 10x24 paddle
 Spot paddle
 Magnification paddle
17.4.8 Collimation Size and Light Field Indication
Items Description
 24x30 cm (default)
 18x24 cm (18x24 screening option)
 18x24 cm (localization option)
Collimation position  10x24 cm (10x24 small breast and implant

option)
 9x14 cm (8x8 spot option)
 18x24 cm tube small focal spot (10x10
magnification option)
Light field to X-ray difference Chest wall, right, left and nipple side < SID 2%
17.4.9 Image Receptor
Items Description
 Field of View (FOV) of the Digital Detector:

RSM 2430TD 24x30 cm.
 Digital detector technology: amorphous silicon

17. Specifications
Items Description
matrix with CsI scintillator.
 Detector elements pitch: 76 μm
 Image size (in pixels): X=3840 Y=3072
24x30 cm.
 Digital detector technology: IGZO matrix with
RSM 2430TDP CsI scintillator.
24x30 cm.
 Digital detector technology: amorphous silicon
RSM 2430UD matrix with a-Se direct.
24x30 cm.
 Digital detector technology: IGZO matrix with
RSM 2430UDP a-Se direct.
17.4.10 Others
Items Description
Exposure parameter (kV, mAs) selection

Automatic Exposure Control (AEC)
depending on AEC
Average Glandular Dose (AGD)

Calculation method: Dance et al, 2011
calculation
 Type: Manual/motor-driven adjustable force.

Compression device  Display of C-arm angle, breast compression
force and thickness
 C-arm angle
Display information on gantry base  Compression force
 Compression thickness
Weight ≤ 300 kg

17.4.11 Dose to the patient of operation
The radiation dose to the patient is determined, displayed and recorded using two quantities:
the Entrance Surface Area Kerma (ESAK) and the Average Glandular Dose (AGD, also known
as Mean Glandular Dose, MGD) at the patient’s skin.
Entrance Surface Air Kerma
This quantity will also be designated as “ESAK” “ESE”. It is an air kerma measured in Gy and
its subunits. ESAK is computed using the re-calibrated model on the plane of contact of the
compression paddle to the breast without considering back scattering from the breast. The
position of this plane is determined from the position of the compression paddle. If no
compression paddle is in place, a default thickness of 45 mm is taken.
Half Value Layer (HVL)
Beam HVL is calculated in re-calibrated model using the same method as in (1).
Average Glandular Dose (AGD)
Average Glandular Dose (AGD, also known as Mean Glandular Dose, MGD) is the quantity
recognized globally as the best radiation quantity for describing the radiation dose to the
patient. AGD is computed by the following formula, multiplying the entrance air kerma and
normalized glandular dose coefficients associated with it.
AGD=K*g*c*s
Where K is the entrance surface air kerma (ESAK). The factor “g”, “c” and “s” are taken from
the publications of Professor David Dance.
The values of "g" and "c" are obtained by interpolation from the values corresponding to the
next neighbor PMMA thickness and HVL values in each table of this publication.
17.5 Specifications for X-ray Beam Measurement and

Calibrations
The following information completely defines the X-ray parameters used in the system.
Measuring instruments used for measuring in particular air kerma, kVp, HVL etc. must be
declared compatible with these specifications by their manufacturers, and certified by
corresponding calibration certificates.
17.5.1 Environment of Operation
Items Description
Anode material Tungsten
Anode angle to chest wall 24° (Large focal spot), 18° (small focal spot)
Irremovable filtration (tube window) 0.5 mm Be

17. Specifications
Items Description
Additional Filter (filter parallel to the

50 μm Rh with W (Tungsten) anode
image receptor)
Upper foil negligible
Operating kV-ranges W/Rh: 25-35 kV
17.5.2 Calibrations
During calibration, the dosimeter is mounted on the support presented with the system.
Depending on the type of the dosimeter, it can be mounted on the support directly or on the
medium support given by the manufacturer.
Position of the Reference Point for the Following Measurement
 On the axis through the middle of the chest wall side of the detector
 60 mm from the chest wall edge
 642.5 mm from the focal spot
The Calibrations Based on Air Kerma Measurement
Air kerma and HVL calibration for patient entrance air kerma and average glandular dose
display.
 The measurements are performed in the following conditions:
 the compression paddle (3 mm polycarbonate) is present and positioned immediately

after the tube /collimator output window.
 W/Rh 28kV(100mAs) for large and small focal points and primitive beam, additional
aluminum filter for less than 0.6 mm to check HVL.
 The detector conversion factor (relation between dose and digital values) is calibrated
using 28 kV, W/Rh, without compression paddle, with the dosimeter and 2mm Al filter on
tube side.
The dosimeters used for calibration of the system must be accurate within ± 5% in all
conditions described above.
The thickness of the Al foils used for calibration of the HVL model must be accurate within ±
5%.
The high voltage closed-loop regulation specific to the system incorporates a high accuracy
internal reference meter (voltage divider) which is factory-adjusted and sealed. It cannot be
adjusted on site.
17.6 Specifications of Acquisition Workstation
Items Description
Operating system Windows 10 64 bit

Items Description
Computer memory Min. 4 GB RAM
HDD Capacity Min. 1 TB
Display Min. 1920x1080
Network interface Gigabit Ethernet (GbE)
Lead Glass Pb equivalent: 0.8 mm lead for 35 kV
Console software Needed to update
Weight ≤ 200 kg
17.7 Dimension
17.7.1 Dimensions of the System Unit

17. Specifications
17.7.2 Dimensions of the Acquisition Workstation

17.8 Protect from Radiation

The experiment according to the regulations for radiation protection was conducted as follows.
For the Signification Zone of occupancy, it can be confirmed that the shielding against X-rays
was confirmed as a result of the experiment.
Although this apparatus incorporates a high degree of certain protections against x-radiation
other than the useful beam, no feasible design of equipment can provide complete protection
from all potential injury. Nor can any feasible design force the operator to take adequate
precautions to prevent the possibility of any persons carelessly exposing themselves or others
to radiation.
It is important that anyone having anything to do with x-radiation be properly trained and fully
knowledgeable about the recommendations of the National Council on Radiation Protection
and Measurements as published in NCRP Reports available from NCRP Publications, 7910
Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International
Commission on Radiation Protection.

17. Specifications

18. Appendix A
18.1 Guidance and Manufacturer's Declaration
18.1.1 Electromagnetic Emissions
Electromagnetic Emissions
This system is intended for use in the electromagnetic environment specified below. The
customer or the user of this system should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions This system uses RF energy only for its

internal functions. Therefore, its RF
Group 1 emissions are low and it is not likely to
CISPR 11 cause interference with nearby electronic
equipment.
RF emissions
Class A
CISPR 11
This system is suitable for use in all
Harmonic emissions establishments except for domestic
Not applicable establishments and those directly
IEC 61000-3-2 connected to the public low-voltage power
supply network that supplies buildings used
Power fluctuations/flicker
for domestic purposes.
emissions Not applicable
IEC 61000-3-3
Do not use cables or parts other than those specified for use
with this system. If cables and parts other than those specified
Note
for use with this system are used, the emission performance
may be affected.

18. Appendix A
18.1.2 Electromagnetic Immunity
Electromagnetic Immunity
This system is intended for use in the electromagnetic environment specified below. The
customer or the user of this system should ensure that it is used in such an environment.
IEC 60601 Electromagnetic environment -

Immunity test Compliance level
test level guidance
Electrostatic Floors should be wood, concrete, or

±8 kV contact ±8 kV contact ceramic tile. If floors are covered
discharge (ESD)
±15 kV air ±15 kV air with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
3 V/m 3 V/m
80 MHz -2.7 GHz 80 MHz -2.7 GHz
Radiated RF RMF-2000 is appropriate for use in
80% of 80% of
IEC 61000-4-3 Amplitude Amplitude professional medical environment.
Modulation (AM) Modulation (AM)
at 1 kHz at 1 kHz
RF
communication
device immune 28 V/m Max. 28 V/m Max. The RF communication device is
to proximity 385-5,785 MHz 385-5,785 MHz used more than 30 cm apart from
fields (in compliance (in compliance the entire RMF-2000 system
with Table 9, IEC with Table 9, IEC including cables specified by
60601-1-2) 60601-1-2) DRTECH.
IEC 61000-4-3
±2 kV for power ±2 kV for power

supply lines supply lines
Electrical fast The mains power quality should
±1 kV for ±1 kV for comply with the requirements for a
transient/burst input/output lines input/output lines typical commercial or hospital
IEC 61000-4-4 (100 kHz (100 kHz environment.
repetition repetition
frequency) frequency)
±1 kV differential ±1 kV differential The mains power quality should

Surge mode mode comply with the requirements for a
IEC 61000-4-5 ±2 kV common ±2 kV common typical commercial or hospital
mode mode environment.
3V 3V
0.15-80 MHz 6 V 0.15-80 MHz 6 V
in ISM bands in ISM bands
between 0.15 between 0.15
Conductive RF and 80 MHz 80% and 80 MHz 80% The strength of RF field in the
magnetic fields of Amplitude of Amplitude frequency range higher than 150
Modulation (AM) Modulation (AM) kHz~80 MHz, the strength of the RF
IEC 61000-4-6 field is smaller than 3 V
at 1 kHz. at 1 kHz.
Power supply and Power supply and

I/O line I/O line

Electromagnetic Immunity
< 0% of UT < 0% of UT
(Decrease of > (Decrease of >
100% of UT) 100% of UT)
In 0.5 cycles In 0.5 cycles
0 °, 45 °, 90 °, 0 °, 45 °, 90 °,
135 °, 180 °, 135 °, 180 °,
225 °, 270 °, 225 °, 270 °, The mains power quality should
Voltage dips,
315 ° 315 ° comply with the requirements for a
short
interruptions 0% of UT 0% of UT typical commercial or hospital
and voltage (Decrease of (Decrease of environment. If continuous operation
variations on 100% of UT) 100% of UT) of this system is required during a
power supply power outage, it is recommended
In 1 cycles In 1 cycles
input lines that an uninterruptible power supply
70% of UT 70% of UT or batteries be used with the system
IEC 61000-4-11 (Decrease of > (Decrease of > power source.
30% of UT) 30% of UT)
In 30 cycles In 30 cycles
< 0% of UT < 0% of UT
(Decrease of > (Decrease of >
100% of UT) 100% of UT)
In 5 seconds In 5 seconds
Power
frequency Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic of a
30 A/m 30 A/m
magnetic field typical location in a typical
commercial or hospital environment.
IEC 61000-4-8
UT is the AC main voltage prior to application of the test level.

Do not use cables and parts other than those used for the current system.
Caution
If cables and parts other than those used for the current system are used,
the immunity may be affected.
18.2 Open Sources Used in This System

The software of this system included software products which copyrights are allowed to use by
GPL/ LGPL/GPLv2/OpenSSL/CPOL.
You can get the complete set of relevant source codes for three years as of the last launching
of this system, by sending an e-mail via following address. xxxxxxx@drtech.com
If you want to have the complete set of corresponding source codes in a physical media, such
as a CD-ROM, there can be extra charge for distribution of the source.
Also, you can find a copy of the source at http://opensource.drtech.com. Everyone can get the
information on the open sources here.
Source/Lib URL License
Boost : 1.69 http://www.boost.org/LICENSE_1_0.txt BSD, MIT

18. Appendix A
Source/Lib URL License
dcmtk 3.6.4 https://dicom.offis.de/evaluation.php.en BSD
jsoncpp http://jsoncpp.sourceforge.net/LICENSE MIT

0.10.7
libiconv http://www.gnu.org/licenses/ GNU GPL

1.1.15
libpng : http://www.libpng.org FREE SW

1.6.36
libtiff : http://download.osgeo.org/libtiff/tiff-4.0.10.tar.gz FREE SW

4.0.10
libxml2 : http://www.apache.org/licenses/LICENSE-2.0 MIT

v2.9.9
openssl : https://www.openssl.org/source/license.html OpenSSL,

1.1.1
zlib : 1.2.11 SSLeay


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Notice

 Manufacturer: DRTECH Corp.

Full Field Digital Mammography i

@ Copyright 2019, DRTECH

ii Full Field Digital Mammography

Warranty and Responsibility

 The manufacturer is not responsible for incorrect environment or result of diagnosis.

Full Field Digital Mammography iii

Revision Number Date Changes Notes

1.0 Jun. 2020 Newly published

iv Full Field Digital Mammography

Warranty and Responsibility ......................................................................................iii

Revision History .........................................................................................................iv

1. General Information ........................................................................................ 1

1.1 Scope of Usage ............................................................................................................. 1

1.2 User ............................................................................................................................. 1

1.3 Training Program ........................................................................................................... 1

1.4 Information Security ...................................................................................................... 1

1.5 Manual Users ................................................................................................................ 2

1.6 Rules of Notation........................................................................................................... 3

1.7 Manual Layout .............................................................................................................. 4

1.8 Warning Signs ............................................................................................................... 5

1.9 Terms and Abbreviations................................................................................................ 6

1.11 Labels and Symbols ....................................................................................................... 9

1.11.1 System Labels ................................................................................................... 9

2. Safety and Regulation ................................................................................... 13

2.1 General Safety Management .........................................................................................13

2.2 Patient Safety Management ..........................................................................................14

2.3 Electric Safety Management ..........................................................................................16

2.4 Mechanical Safety Management ....................................................................................17

2.5 Fire and Explosion Safety Management..........................................................................17

2.6 Radiological Safety Management ...................................................................................18

Full Field Digital Mammography v

2.7 Electromagnetic Compatibility .......................................................................................19

2.8 Safety Measures...........................................................................................................20

2.8.1 Emergency Stop Switch ....................................................................................20

2.9 Observation of the Standards........................................................................................22

2.10 Safety Symbols ............................................................................................................23

3. System Components and Functions ............................................................... 25

3.1 Components of the Gantry............................................................................................25

3.1.1 Components of the C-arm.................................................................................26

3.2 Components of the Workstation ....................................................................................35

3.2.1 Switch Set .......................................................................................................36

4. System Hardware Operation.......................................................................... 37

4.2 Turning On/Off the Power of the System .......................................................................38

4.2.1 Turning On the Power.......................................................................................38

5. Usage of System Accessories ......................................................................... 49

5.1 Face Shield ..................................................................................................................49

5.1.1 Attachment and Detachment of the Face Shield .................................................49

5.2 2D Crosshair Device .....................................................................................................50

5.2.1 Attachment and Detachment of the 2D Crosshair Device ....................................50

5.3 Magnification Stand......................................................................................................51

5.4 Compression Paddle .....................................................................................................52

5.4.1 Routine Screen Paddle......................................................................................52

vi Full Field Digital Mammography

6. Procedure for Clinical Examination................................................................ 57

6.1 Turning On the Power of the System .............................................................................57

6.2 Selecting and Starting the Examination..........................................................................58

6.3 Preparation of Gantry ...................................................................................................60