Hologic selenia dimensions User Manual
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Selenia Dimensions User Manual
Part Number MAN-01964
Revision 001
July 2010
Corporate Headquarters
35 Crosby Drive,
Bedford, MA 01730-1401 USA
Tel: +1.781.999.7300
Sales: +1.781.999.7453
Fax: +1.781.280.0668
www.hologic.com
Europe
(EU Representative)
Hologic NV
Leuvensesteenweg 250A
1800 Vilvoorde, Belgium
Tel: +32.2.711.4680
Fax: +32.2.725.2087
Refer to the corporate website for more facilities worldwide.
User Manual
Table of Contents
Table of Contents
List of Figures ix
List of Tables xi
Preface xiii
1.0 Intended Use ....................................................................................................................................... xiii
2.0 System Capabilities .............................................................................................................................. xiii
3.0 Users ................................................................................................................................................... xiii
4.0 Skills Needed for System Use .............................................................................................................. xiii
5.0 Training Requirements ......................................................................................................................... xiv
6.0 Quality Control Requirements ............................................................................................................. xiv
7.0 Hologic Cybersecurity Statement ......................................................................................................... xiv
8.0 Warnings, Cautions, and Notes ........................................................................................................... xiv
9.0 Terms and Definitions .......................................................................................................................... xv
10.0 International Symbols ........................................................................................................................ xvi
11.0 Document Standards ......................................................................................................................... xvi
Chapter 1—General Information 1
1.0 System Description .................................................................................................................................1
2.0 Safety Information .................................................................................................................................. 1
2.1 General Safety .................................................................................................................................. 1
2.2 Patient Safety ...................................................................................................................................3
2.3 Radiation Safety ............................................................................................................................... 4
2.4 Data Loss ......................................................................................................................................... 5
2.5 Equipment Damage .......................................................................................................................... 5
2.6 Emergency Off Switches ................................................................................................................... 5
2.7 Interlocks .........................................................................................................................................6
3.0 Compliance ............................................................................................................................................7
3.1 Compliance Requirements ...............................................................................................................7
3.2 Compliance Statements .................................................................................................................... 7
4.0 Label Locations ......................................................................................................................................8
Chapter 2—System Controls and Indicators 9
1.0 System Power Controls ........................................................................................................................... 9
2.0 Acquisition Workstation Controls and Display ...................................................................................... 10
2.1 Keyboard .......................................................................................................................................11
2.2 Bar Code Reader ............................................................................................................................11
2.3 Acquisition Workstation Touchscreen Display ............................................................................... 11
2.4 Preview Display .............................................................................................................................11
3.0 Tubestand Controls and Indicators ........................................................................................................ 12
3.1 C-arm Controls ............................................................................................................................... 13
3.2 Compression Device Controls and Displays ...................................................................................13
3.3 Tubehead Display ..........................................................................................................................14
3.4 Dual Function Footswitches ...........................................................................................................14
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4.0 How to Turn On the Selenia Dimensions ............................................................................................. 15
4.1 Preparation .................................................................................................................................... 15
4.2 Startup ........................................................................................................................................... 15
4.3 Log In ............................................................................................................................................ 16
5.0 Perform the Functional Tests ................................................................................................................ 17
6.0 How to Turn Off the System ................................................................................................................. 23
7.0 How to Remove All Power from the Acquisition Workstation .............................................................. 23
Chapter 3—The User Interface 25
1.0 Select the Function to Perform ............................................................................................................. 25
2.0 How to Perform the Quality Control Tasks ........................................................................................... 26
3.0 How to Select a Patient ........................................................................................................................ 27
3.1 How to Open a Procedure ............................................................................................................. 27
3.2 How to Add a New Patient ............................................................................................................ 28
3.3 How to Edit the Patient Information ............................................................................................... 28
3.4 How to Delete a Patient ................................................................................................................ 28
3.5 How to Use a Patient Filter ............................................................................................................ 29
3.6 How to Refresh the Worklist .......................................................................................................... 29
3.7 How to Query the Worklist ........................................................................................................... 30
3.8 About the Admin Button ................................................................................................................ 30
3.9 How to Log Out ............................................................................................................................ 30
4.0 The Procedure Screen .......................................................................................................................... 31
4.1 How to Set the Exposure Parameters .............................................................................................. 31
4.2 How to Use the Implant Present Button ......................................................................................... 32
4.3 How to Acquire an Image .............................................................................................................. 32
4.4 How to Add or Remove a View ..................................................................................................... 33
4.5 How to Add a Procedure ............................................................................................................... 34
4.6 How to Edit a View ....................................................................................................................... 34
4.7 How to Close a Procedure ............................................................................................................. 35
5.0 How to Access Image Review Features ................................................................................................ 35
6.0 How to Use the Output Sets ................................................................................................................. 35
6.1 How to Select an Output Set ......................................................................................................... 35
6.2 How to Add or Edit an Output Set ................................................................................................. 35
7.0 How to Use the On-Demand Outputs .................................................................................................. 36
7.1 How to Archive ............................................................................................................................. 36
7.2 How to Print .................................................................................................................................. 37
7.3 How to Export ............................................................................................................................... 38
8.0 How to Use the Paddle Shift Feature .................................................................................................... 38
9.0 About the Taskbar ................................................................................................................................ 39
Chapter 4—The Images 41
1.0 Introduction ......................................................................................................................................... 41
1.1 Conventional Sequence of Events .................................................................................................. 41
1.2 Tomosynthesis Sequence of Events (Tomosynthesis option) ........................................................... 41
2.0 How to Review the Images .................................................................................................................. 42
2.1 The Image Review Tools Tab ......................................................................................................... 43
2.2 Other Image Review Tools ............................................................................................................ 44
2.3 How to Correct and Reprocess Implant Images .............................................................................. 45
3.0 Send the Images to the Output Devices ................................................................................................ 45
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Chapter 5—How to Use the Accessories 47
1.0 Introduction .......................................................................................................................................... 47
2.0 How to Install Accessories on the C-arm .............................................................................................. 47
3.0 The Patient Face Shields .......................................................................................................................48
3.1 How to Install or Remove the Conventional Face Shield ................................................................48
3.2 How to Install or Remove the Retractable Face Shield .................................................................... 49
3.3 How to Use the Retractable Face Shield .........................................................................................50
4.0 Compression Paddles ...........................................................................................................................51
4.1 Routine Screening Paddles ............................................................................................................. 51
4.2 Contact and Spot Compression Paddles ......................................................................................... 51
4.3 Localization Paddles ...................................................................................................................... 52
4.4 Magnification Paddles ....................................................................................................................52
4.5 How to Install or Remove a Compression Paddle ........................................................................... 53
4.6 Maintenance and Cleaning ............................................................................................................53
4.7 Paddle Shift .................................................................................................................................... 53
4.8 FAST Compression Mode ............................................................................................................... 54
5.0 Magnification Stand ..............................................................................................................................55
5.1 How to Install and Remove the Magnification Stand ......................................................................55
6.0 Crosshair Devices .................................................................................................................................56
6.1 How to Install and Remove the Localization Crosshair Device .......................................................56
6.2 How to Use the Localization Crosshair Device .............................................................................. 56
6.3 How to Install and Remove the Magnification Crosshair Device .................................................... 57
6.4 How to Align the Crosshair Device ................................................................................................ 57
Chapter 6—Clinical Procedures 59
1.0 Standard Workflow ...............................................................................................................................59
2.0 Example Screening Procedure ..............................................................................................................60
2.1 How to Position the Patient ............................................................................................................60
2.2 Set the Exposure Techniques ..........................................................................................................60
2.3 How to Acquire the Exposure ......................................................................................................... 61
2.4 How to Automatically Store the Image ...........................................................................................61
2.5 How to Accept a Rejected Image ................................................................................................... 61
2.6 How to Accept or Reject a Pended Image ...................................................................................... 61
Chapter 7—Maintenance and Cleaning 63
1.0 General Information ............................................................................................................................. 63
1.1 For General Cleaning ..................................................................................................................... 63
1.2 To prevent Possible Injury or Equipment Damage ..........................................................................64
2.0 Acquisition Workstation .......................................................................................................................65
2.1 How to Clean the Preview Display .................................................................................................65
2.2 How to Clean the Touchscreen Display ......................................................................................... 65
2.3 How to Clean the Keyboard ........................................................................................................... 65
2.4 How to Clean the Fingerprint Reader ............................................................................................. 65
Chapter 8—System Administration Interface 67
1.0 How to Use the Admin Screen ............................................................................................................. 67
2.0 How to Use the System Tools ...............................................................................................................70
2.1 The Radiologic Technologist Manager ........................................................................................... 70
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Appendix A—Specifications 73
1.0 Product Measurements ......................................................................................................................... 73
1.1 Tubestand (Gantry with C-arm) ...................................................................................................... 73
1.2 Acquisition Workstation ................................................................................................................ 74
2.0 Operation and Storage Environment .................................................................................................... 75
2.1 General Conditions for Operation ................................................................................................. 75
2.2 Storage Environment ...................................................................................................................... 75
3.0 Acquisition Workstation Technical Information ................................................................................... 75
4.0 Electrical Input ..................................................................................................................................... 76
4.1 Tubestand ...................................................................................................................................... 76
4.2 Acquisition Workstation ................................................................................................................ 76
5.0 Tubestand Technical Information ......................................................................................................... 76
5.1 C-arm ............................................................................................................................................ 76
5.2 Compression ................................................................................................................................. 77
5.3 X-ray Tube ..................................................................................................................................... 77
5.4 X-ray Beam Filtration and Output .................................................................................................. 78
5.5 X-ray Collimation .......................................................................................................................... 79
5.6 Light Field Indication ..................................................................................................................... 79
5.7 X-ray Generator ............................................................................................................................. 79
6.0 Imaging System Technical Information ................................................................................................. 79
6.1 Image Receptor ............................................................................................................................. 79
Appendix B—The System Messages and Alert Messages 81
1.0 Error Recovery and Troubleshooting .................................................................................................... 81
2.0 Types of Messages and Alert messages ................................................................................................. 81
2.1 Fault Levels ................................................................................................................................... 81
2.2 System Messages ........................................................................................................................... 82
List of Addenda 83
Index 85
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List of Figures
List of Figures
Figure 1-1: Selenia Dimensions .................................................................................................................... 1
Figure 1-2: Label Locations........................................................................................................................... 8
Figure 2-1: System Power Controls ............................................................................................................... 9
Figure 2-2: Acquisition Workstation Controls and Displays ........................................................................ 10
Figure 2-3: Tubestand Controls and Indicators............................................................................................ 12
Figure 2-4: C-arm Controls ......................................................................................................................... 13
Figure 2-5: Compression Device................................................................................................................. 13
Figure 2-6: Compression Display................................................................................................................ 13
Figure 2-7: Tubehead Display..................................................................................................................... 14
Figure 2-8: Dual Function Footswitches...................................................................................................... 14
Figure 2-9: The Startup Screen.................................................................................................................... 15
Figure 2-10: How to Log In......................................................................................................................... 16
Figure 2-11: C-arm Controls (left side shown) ............................................................................................. 17
Figure 2-12: Power Buttons ........................................................................................................................ 23
Figure 3-1: An Example Select Function to Perform Screen ......................................................................... 25
Figure 3-2: An Example Gain Calibration Screen ........................................................................................ 26
Figure 3-3: How to Select a Patient............................................................................................................. 27
Figure 3-4: How to Add a New Patient ....................................................................................................... 28
Figure 3-5: The Filter Tab in the Patient Filter Screen .................................................................................. 29
Figure 3-6: An Example Generator Tab in the Procedure Screen ................................................................. 31
Figure 3-7: The Add View Screen ............................................................................................................... 33
Figure 3-8: The Add Procedure Dialog Box ................................................................................................ 34
Figure 3-9: The Edit View Screen................................................................................................................ 34
Figure 3-10: The Print Screen ..................................................................................................................... 37
Figure 4-1: The Preview Screen .................................................................................................................. 41
Figure 4-2: The Tools Tab in the Procedure Screen ..................................................................................... 42
Figure 4-3: Marked Images in a Procedure.................................................................................................. 42
Figure 4-4: Image Review Tools.................................................................................................................. 43
Figure 4-5: Image Review Tabs ................................................................................................................... 44
Figure 4-6: Icons Available on the Notices Tab........................................................................................... 44
Figure 4-7: The Exposure Index .................................................................................................................. 44
Figure 5-1: C-arm Accessories .................................................................................................................... 47
Figure 5-2: How to Install the Conventional Face Shield............................................................................. 48
Figure 5-3: How to Align the Retractable Face Shield on the C-arm............................................................ 49
Figure 5-4: Installation ................................................................................................................................ 50
Figure 5-5: Operation ................................................................................................................................. 50
Figure 5-6: How to Install a Compression Paddle ....................................................................................... 53
Figure 5-7: How to Remove the Compression Paddle ................................................................................. 53
Figure 5-8: The FAST Compression Mode Slide .......................................................................................... 54
Figure 5-9: Installation of the Magnification Stand ...................................................................................... 55
Figure 5-10: How to Attach the Localization Crosshair Device ................................................................... 56
Figure 5-11: How to Install and Remove the Magnification Crosshair Device ............................................. 57
Figure 6-1: Screening Example, Conventional Procedure ............................................................................ 60
Figure 8-1: The Admin Screen .................................................................................................................... 68
Figure A-1: Tubestand Dimensions ............................................................................................................. 73
Figure A-2: Acquisition Workstation Dimensions........................................................................................ 74
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List of Tables
Table 2-1: C-arm Functional Tests ...............................................................................................................17
Table 3-1: Taskbar Menus ........................................................................................................................... 39
Table 8-1: Admin Screen Functions ............................................................................................................. 69
Table 8-2: Radiologic Technologist Manager—Service Tools Functions.......................................................71
Table A-1: mA Setting as a Function of kV...................................................................................................78
Table B-1: System Messages ........................................................................................................................82
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Preface
1.0 Intended Use
The Hologic Selenia® Dimensions® Digital Breast Tomosynthesis System generates digital
mammographic images that can be used for screening and diagnosis of breast cancer. The
Selenia Dimensions system is intended for use in the same clinical applications as Full Field
Digital Mammography systems for screening mammograms. Specifically, the Selenia
Dimensions system can be used to acquire two-dimensional full field digital mammograms
and three-dimensional tomosynthesis mammograms. The screening examination will consist
of a two-dimensional image set or a two-dimensional and tomosynthesis image set. The
Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
2.0 System Capabilities
The system provides the user interfaces for the performance of screening and diagnostic
mammograms:
• Conventional mammography with a digital image receptor equivalent in size to large
mammography film.
• Tomosynthesis scan with a digital image receptor equivalent in size to large
mammography film (Tomosynthesis option).
• Conventional digital mammogram and tomosynthesis scan during one compression
(Tomosynthesis option).
User Manual
Preface
Intended Use
3.0 Users
• A Technologist to acquire and review images
• A Technologist with the manager
• A system administrator to enable permissions
• A Medical Physicist to perform the Quality Control tests
• A Radiologist can use the system with a Technologist
• The service personnel to install the system, set the site system configurations and
calibrations, and find faults
4.0 Skills Needed for System Use
You must know how to do the following:
• Perform the trackball operations, like click, drag, and/or select
• Perform the touchscreen operations
• Select from menus
• Type information in text fields
• Select the options in the screens
• Select the entries from drop-down lists
• Use scroll bars
permissions to perform the Quality Assurance
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Training Requirements
5.0 Training Requirements
Hologic™ does not accept the responsibility for injury or damage from wrong system
operation.
Make sure that you receive training on the Selenia Dimensions before use on patients.
Hologic training programs address MQSA training regulations for any Technologist or
Physician.
Refer to this manual for directions on how to use Selenia Dimensions.
6.0 Quality Control Requirements
The facilities in the United States must use the Quality Control Manual to create a Quality
Assurance and Quality Control program. The facility must create the program to meet the
requirements of the Mammography Quality Standards Act or to be accredited by ACR or
another accreditation body.
The facilities outside the United States can use the Quality Control Manual as a guide to
create a program to meet the local standards and regulations.
7.0 Hologic Cybersecurity Statement
Hologic continuously tests the current state of computer and network security to examine
possible security problems. When necessary, Hologic provides the updates to the product.
For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic
Internet site.
8.0 Warnings, Cautions, and Notes
Descriptions of Warnings, Cautions, and Notes used in this manual:
WARNING! Procedures that you must follow accurately to prevent
possible serious injury or death.
Warning: Procedures that you must follow accurately to prevent injury.
Caution: Cautions point out procedures that you must follow accurately to
prevent the damage to equipment, loss of data, or damage to files in
software applications.
Note… Notes indicate additional information.
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9.0 Terms and Definitions
ACR American College of Radiology
AEC Automatic Exposure Control
Annotations Graphic or text marks on an image to indicate an area of interest.
Collimator Device at the x-ray tube to control the area of the receptor
Combo Procedure An image acquisition procedure for which the system takes
Conventional Mammography Single projection x-ray images of views for screening and
Diagnostic Workstation Softcopy workstation for diagnoses from digital images.
DICOM Digital Imaging and Communications in Medicine
Gantry A part of the Selenia Dimensions that has the Detector,
Grid Element within the Digital Image Receptor that reduces
HIS Hospital Information System
HTC™ High Transmission Cellular Grid
Image Receptor Assembly of x-ray detector, x-ray scatter reduction grid,
MQSA Mammography Quality Standards Act
Notice Annotations and comments per image communicated
PACS Picture Archiving and Communications System. A
Pend A mark on the image to indicate the Technologist is not
Projection Images The group of x-ray images for tomosynthesis taken at
RIS Radiology Information System
ROI Region of Interest
SID Source to Image Distance
Tomosynthesis An imaging procedure which combines a number of
UPS Uninterruptible Power Supply
User Manual
Preface
Ter ms an d Definitions
that is exposed.
a conventional mammography image and a tomosynthesis
scan during a single patient compression (Tomosynthesis
option).
diagnostic purposes.
Generator and x-ray Source, Positioning/Compression,
Power Distribution, and Accessories Subsystems.
scatter radiation during the exposure.
and carbon fiber cover.
between Diagnostic Review Workstations, Technologist
Workstations, and Acquisition Workstations.
computer and network system for the transfer and archive
of digital medical images.
positive about the image quality. Pended images must be
Accepted or Rejected before the procedure is closed.
different projection angles through the breast
(Tomosynthesis option).
projections taken at different angles. The tomosynthesis
images can be reconstructed to show planes or slices
within the object (Tomosynthesis option).
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Preface
International Symbols
10.0 International Symbols
This section describes the International Symbols on the Selenia Dimensions.
Potential Equalization
terminal
Protective Earth
terminal
Off Power disconnected from the main power source.
On Power connection to the main power source.
Off
On
WEEE
Dangerous Voltage Identifies an area of possible lethal voltage.
Manufacturer
Connection for a conductor different from the Protective
Earth for a direct connection between two or more pieces
of electrical equipment.
For the connection of the line cord ground or ground
cable of the equipment and there is no other purpose.
Only a part of the equipment is disconnected from the
main power source.
Only a part of the equipment is connected to the main
power source.
Symbol that indicates separate removal for electrical and
electronic equipment.
Date of Manufacture
11.0 Document Standards
When prompted to add text, enter the text written in monospaced fo nt exactly as
shown.
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Chapter 1—General Information
1.0 System Description
Legend for Figure1-1
1. Gantry
2. C-arm
3. Acquisition Workstation
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Chapter 1—General Information
System Description
2.0 Safety Information
Read and understand this manual before you use the system. Keep the manual available
during the patient procedures.
Always follow all the instructions in this manual. Hologic does not accept the responsibility
for injury or damage from wrong system operation. Hologic can arrange for training at your
facility.
The Selenia Dimensions has protective devices, but the Technologist must understand how
to safely use the system. The Technologist must remember the health hazards of x-rays.
2.1 General Safety
The Selenia Dimensions system is classified as CLASS I, TYPE B APPLIED PART, IPX0,
permanently connected equipment, continuous operation with short term loading per IEC
60601-1. There are no special provisions to protect the system from flammable anesthetics
or ingress of liquids.
WARNING! Lethal voltages exist inside of this system. Do not open any
Figure 1-1: Selenia Dimensions
of the panels.
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WARNING! Per North American electrical safety requirements, you
WARNING! Do not use the electrical equipment near flammable
Warning: This device contains dangerous material. Return to Hologic all
Warning: The user or the service personnel must correct problems before
must use a Hospital Grade receptacle to provide a correct
Ground.
anesthetics.
material removed from service.
the system is used.
Warning: The user must arrange for preventive maintenance by an
authorized service representative.
Warning: If a paddle touches possible infectious materials, call your
Infection Control Representative for decontamination
instructions.
Caution: The system is a medical device and not a normal computer. Do not
make changes to the hardware or software that are not authorized.
Install this device behind a firewall for network security. The
computer virus protection or network security for this medical device
is not provided (for example, a computer firewall). The network
security and anti-virus provisions are the responsibility of the user.
Caution: Only use the approved accessories with this equipment. The failure to
follow this caution can cause errors and possible data loss.
Note… Hologic does not provide the Gantry power cable for some countries. If
the power cable is not provided, the installed cable must meet the
following requirements and all local codes that apply: 3 conductor, 8
2
AWG (10 mm
) copper not more than 25 feet (7.62 meters) in length.
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2.2 Patient Safety
WARNING! After power failure, remove the patient from the system
WARNING! To keep the isolation quality for the system, attach only
WARNING! Keep a 1.5 meter safe distance between the patient and
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Safety Information
before you apply power.
approved accessories or options to the system. Only the
authorized personnel can make changes to the
connections.
any non-patient devices.
Non-patient system components (like the Workflow
Manager, the diagnostic review workstation, or the hard
copy printer) must not be installed in the Patient Area.
1.5m
Warning: Never leave the patient during the procedure if in contact with
the mammography system.
Warning: Keep the hands of the patient away from all buttons and
switches at all times.
Warning: The C-arm movement has drive motors.
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Warning: You increase the patient dose to high levels if you increase the
Warning: Put both footswitches away from the patient and C-arm area to
Warning: Control the access to the equipment according to local
2.3 Radiation Safety
AEC exposure adjustment setting. You increase the image noise
or decrease image quality if you decrease the AEC exposure
adjustment setting.
prevent any accidental footswitch use. When the patient has a
wheelchair, put the footswitches away from the area.
regulations for radiation protection.
WARNING! This x-ray system can be dangerous to the patient and the
user. Always follow the safety precautions for x-ray
exposures.
Warning: For exposures except magnification case studies, always use the
Face Shield.
Warning: The Face Shield does not protect from radiation.
WARNING! The disk drives installed in this system are a Class I Laser
Product. Prevent direct exposure to the beam. Hidden
laser radiation exists if the case to a disk drive is open.
Warning: The bar code reader installed in this system is a Class II Laser
Product. Prevent direct exposure to the beam. Hidden laser
radiation exists if the cover is opened.
Warning: You must keep your complete body behind the radiation shield
for the time of the exposure for maximum protection from x-ray
exposure.
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2.4 Data Loss
Warning: Do not move the C-arm while the system retrieves the image.
Caution: Never turn off the Acquisition Workstation Circuit Breaker except in
emergency. The circuit breaker can turn off the Uninterruptible Power
Supply (UPS) and risk data loss.
Caution: Do not put any magnetic media near or on devices that create any
magnetic fields, because stored data can be lost.
2.5 Equipment Damage
Caution: Do not put any heat source on the image receptor.
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Safety Information
Caution: To minimize possible damage from thermal shock to the Digital Image
Receptor, follow the recommended procedure to turn off the
equipment.
Caution: Do not make any brightness or contrast adjustments to the display
unless the SMPTE test pattern is on the screen.
Caution: Use the least possible amount of cleaning fluids. The fluids must not
flow or run.
Caution: Do not spray disinfectant on the system, because the moisture can
enter the system and damage the electronic components.
2.6 Emergency Off Switches
The Emergency Off switches remove the power from the Gantry. Do not normally use the
Emergency Off switches to turn off the system. See Chapter 2, page 23 for complete
information.
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2.7 Interlocks
The Selenia Dimensions has safety interlocks:
• The C-arm vertical drive and rotation is disabled when 45 Newtons (10 pounds) or
greater of compression force is displayed.
• If the x-ray button is released before the end of the exposure, the exposure stops and an
alarm message appears.
• When in Tomo mode, the system does not allow the Grid in the x-ray field
(Tomosynthesis option).
• Mirror and Filter interlocks prevent the x-ray exposure when the Light Field Mirror or the
Filter is not aligned.
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3.0 Compliance
This section describes the mammography system compliance requirements and the
responsibilities of the manufacturer.
3.1 Compliance Requirements
The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:
• The electrical installation of the room meets all requirements.
• The equipment is used according to Instructions for Use.
• The assembly operations, extensions, adjustments, changes, or repairs are performed
only by authorized persons.
• The network and communication equipment must be installed to meet IEC Standards.
The complete system (network and communications equipment and Selenia Dimensions
Mammography System) must be in compliance with IEC 60601-1 and IEC 60601-1-1.
3.2 Compliance Statements
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Compliance
The manufacturer states this device is made to meet the following requirements:
• CAN/CSA ISO 13485:2003
• EN 60601-1:1990 +A1+A11+A12+A2+A13 Medical Electrical Equipment—General
Requirements for Basic Safety and Essential Performance
• FDA, 21 CFR [Parts 820, 900 and 1020]
• IEC 60601-1:1988 +A1+A2:1995 +A13:1996 Medical Electrical Equipment—General
Requirements for Safety
• IEC 60601-1-1:2000-12 Medical Electrical Equipment—Collateral Standard: Safety
Requirements for Medical Electrical Systems
• IEC 60601-1-2:2001 Medical Electrical Equipment—Collateral Standard:
Electromagnetic Compatibility for Medical Electric Systems
• IEC 60601-1-3:1994 Medical Electrical Equipment—Collateral Standard: Requirements
for Radiation Protection in Diagnostic X-ray Equipment
• IEC 60601-1-4:1996 +A1:1999 Medical Electrical Equipment—Collateral Standard:
Programmable Electrical Medical Systems
• IEC 60601-2-7:1998 Medical Electrical Equipment—Particular Requirements for the
Safety of High-Voltage Generators of Diagnostic X-ray Equipment
• IEC 60601-2-28:1993-03 Medical Electrical Equipment—Particular Requirements for the
Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis
• IEC 60601-2-32:1994 Medical Electrical Equipment—Particular Requirements for the
Safety of Associated Equipment of X-ray Equipment
• IEC 60601-2-45:2001 Medical Electrical Equipment—Particular Requirements for the
Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices
• UL 60601-1: Medical Electrical Equipment, Part 1—General Requirements for Safety
• CAN/CSA: Medical Electrical Equipment Part 1: C22.2 No. 601.1–M90—General
Requirements for Safety
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Chapter 1—General Information
Label Locations
4.0 Label Locations
Figure 1-2: Label Locations
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Chapter 2—System Controls and Indicators
Chapter 2—System Controls and Indicators
1.0 System Power Controls
User Manual
System Power Controls
Figure 2-1: System Power Controls
Legend for Figure 2-1
1. Gantry Power Circuit Breaker
2. Emergency Off Switch (two on the Gantry, one on the Acquisition Workstation)
3. Acquisition Workstation Power Circuit Breaker
4. Computer Power Button
5. UPS Power Button
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Chapter 2—System Controls and Indicators
Acquisition Workstation Controls and Display
2.0 Acquisition Workstation Controls and Display
Figure 2-2: Acquisition Workstation Controls and Displays
Legend for Figure2-2
1. Trackball
2. Scroll Wheel
3. Compression Release
4. Emergency Off Switch
5. Fingerprint Reader
6. X-ray Button (one on each side)
7. Touchscreen Display
8. Keyboard (in drawer)
9. CD/DVD Drive
10. Bar Code Reader
11. LED for Preview Display Power
12. Preview Display
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Chapter 2—System Controls and Indicators
Acquisition Workstation Controls and Display
2.1 Keyboard
Use the keyboard in the front drawer of the Acquisition Workstation for data entry.
2.2 Bar Code Reader
Use this device for data entry from bar codes for patient or procedure records.
2.3 Acquisition Workstation Touchscreen Display
Use the Touchscreen or trackball to select items.
2.4 Preview Display
See the images on the Preview Display.
User Manual
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Chapter 2—System Controls and Indicators
Tubestand Controls and Indicators
3.0 Tubestand Controls and Indicators
Legend for Figure2-3
1. The Rotation Angle Displays (each side)
2. The C-arm Controls (each side)
3. The Compression Device
4. The Patient Handles (each side)
5. The Emergency Off Switches (each side)
6. The Compression Handwheels
7. The Patient Face Shield
8. The Tubehead Display
9. The Footswitches
Figure 2-3: Tubestand Controls and Indicators
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3.1 C-arm Controls
AE
C
P
O
S
I
TIO
N
The C-arm Controls provide the
Collimator and C-arm functions.
See Section 5.0, page 17.
User Manual
Chapter 2—System Controls and Indicators
Tubestand Controls and Indicators
Figure 2-4: C-arm Controls
3.2 Compression Device Controls and Displays
Legend for Figure2-5
1. Manual Compression Handwheels
2. Paddle Shift Buttons
3. AEC Buttons
4. Compression Device Display
5. The FAST Compression Mode Slide
6. Paddle Clamp
Figure 2-5: Compression Device
The Display on the compression
device shows:
• AEC Sensor Position
• Compression Force (displays 0.0
when force is less than 4 pounds)
• Compression Thickness
• Angle of C-arm after rotation (for
10 seconds)
Figure 2-6: Compression Display
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COMPRESSION
C-ARM
Chapter 2—System Controls and Indicators
Tubestand Controls and Indicators
3.3 Tubehead Display
The Tubehead Display shows:
•SID
• Filter Type
• Collimator Setting
• Paddle Position
SID: 70 cm Rh
Coll: 24x29 C
3.4 Dual Function Footswitches
Warning: Put both footswitches away from the patient and C-arm area to
prevent any accidental footswitch use. When the patient has a
wheelchair, put the footswitches away from the area.
To use the footswitches:
1. Press the footswitch to actuate.
2. Release the switch to stop the
movement.
Legend for Figure2-8
1. C-arm Down
2. C-arm Up
3. Compression Down
4. Compression Up
Figure 2-7: Tubehead Display
Figure 2-8: Dual Function Footswitches
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