Hologic 3Dimensions User manual

3Dimensions™
Digital Mammography System
Digital Tomosynthesis System
User Guide
For Software Version 2.0
Part Number MAN-05085-002
Revision 002
May 2018

© 2017-2018 Hologic, Inc. Printed in the USA. This manual was originally written in English.
Hologic, 3Dimensions, 3D, 3D Mammography, Affirm, C-View, Dimensions, FAST Paddle, Genius, I-View, Selenia, SmartCurve,
and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States
and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective
owners.
This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.
Technical Support
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Australia: [phone]
All Other: [phone]
Email: [email protected]

3Dimensions System User Guide
Table of Contents
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Table of Contents
List of Figures _________________________________________________________________ xi
List of Tables _________________________________________________________________ xv
1: Introduction __________________________________________________________________1
1.1 Intended Use............................................................................................................................................................1
1.1.1 Contraindications .....................................................................................................................................1
1.2 Potential Adverse Effects of Mammography Systems on Health ....................................................................2
1.3 System Capabilities.................................................................................................................................................2
1.4 About the Genius 3D Mammography Exam ...................................................................................................... 2
1.5 More Information About Tomosynthesis............................................................................................................3
1.6 About C-View and Intelligent 2D.........................................................................................................................5
1.6.1 C-View and Intelligent 2D Software ......................................................................................................5
1.6.2 C-View and Intelligent 2D Warnings ....................................................................................................5
1.6.3 C-View and Intelligent 2D Theory of Operation.................................................................................. 6
1.7 User Profiles.............................................................................................................................................................6
1.7.1 Mammography Technologist.................................................................................................................. 6
1.7.2 Radiologist................................................................................................................................................. 6
1.7.3 Medical Physicist...................................................................................................................................... 7
1.8 Training Requirements ..........................................................................................................................................7
1.9 Quality Control Requirements..............................................................................................................................7
1.10 Where to Find the Installation Instructions.........................................................................................................7
1.11 Where to Find Technical Description Information.............................................................................................7
1.12 Warranty Statement................................................................................................................................................ 8
1.13 Technical Support ...................................................................................................................................................8
1.14 Product Complaints................................................................................................................................................8
1.15 Hologic Cybersecurity Statement......................................................................................................................... 8
1.16 Symbols ....................................................................................................................................................................9
1.17 Descriptions of Warnings, Cautions, and Notes ..............................................................................................10
1.18 Document Conventions ....................................................................................................................................... 10
2: General Information__________________________________________________________11
2.1 System Overview..................................................................................................................................................11
2.1.1 C-Arm Overview ....................................................................................................................................12
2.2 Safety Information ................................................................................................................................................13
2.3 Warnings and Precautions...................................................................................................................................13
2.4 Emergency Off Switches ...................................................................................................................................... 17
2.5 Interlocks................................................................................................................................................................18
2.6 Compliance............................................................................................................................................................18
2.6.1 Compliance Requirements ....................................................................................................................18
2.6.2 Compliance Statements .........................................................................................................................20
2.7 Label Locations .....................................................................................................................................................21

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3: System Controls and Indicators ________________________________________________23
3.1 System Power Controls ........................................................................................................................................23
3.2 Tubestand Controls and Indicators ....................................................................................................................24
3.2.1 Tubehead Display...................................................................................................................................25
3.2.2 Compression Device Controls and Display ........................................................................................25
3.2.3 C-Arm Control Panels............................................................................................................................26
3.2.4 Gantry Control Panels............................................................................................................................26
3.2.5 Dual Function Footswitch .....................................................................................................................27
3.3 Universal Acquisition Workstation Controls and Displays............................................................................28
4: Startup, Functional Tests, and Shutdown _______________________________________29
4.1 How to Start the System.......................................................................................................................................29
4.2 Log In......................................................................................................................................................................31
4.3 Perform the Functional Tests...............................................................................................................................32
4.3.1 Compression Functional Tests..............................................................................................................33
4.3.2 C-Arm Movement Functional Tests.....................................................................................................34
4.3.3 Collimation ..............................................................................................................................................42
4.3.4 Shifting Paddles ......................................................................................................................................43
4.4 Emergency Off Switches Functionality..............................................................................................................44
4.5 How to Turn Off the System ...............................................................................................................................44
4.6 How to Remove All Power from the System ....................................................................................................44
5: User Interface________________________________________________________________45
5.1 Select Function to Perform Screen ......................................................................................................................45
5.2 About the Taskbar.................................................................................................................................................46
5.3 Select Patient Screen .............................................................................................................................................48
5.3.1 About the Notices Tab ...........................................................................................................................50
5.3.2 Open a Patient.........................................................................................................................................50
5.3.3 Add a New Patient .................................................................................................................................50
5.3.4 Edit the Patient Information..................................................................................................................51
5.3.5 Split the Patient Records........................................................................................................................51
5.3.6 Delete a Patient .......................................................................................................................................53
5.3.7 Filters for Patients...................................................................................................................................53
5.3.8 Refresh the Worklist...............................................................................................................................55
5.3.9 Query the Worklist .................................................................................................................................55
5.3.10 Admin ......................................................................................................................................................55
5.3.11 Log Out ....................................................................................................................................................55
5.3.12 Advanced Workflow Manager .............................................................................................................56
5.4 Procedure Screen...................................................................................................................................................56
5.4.1 How to Use the Implant Present Button..............................................................................................57
5.4.2 How to Use the Paddle Shift Feature...................................................................................................58
5.4.3 Procedure Information Dialog Box ......................................................................................................58
5.4.4 Add a Procedure.....................................................................................................................................59
5.4.5 Add (or Remove) a View .......................................................................................................................60
5.4.6 Edit a View ..............................................................................................................................................61

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5.4.7 Retrieve ....................................................................................................................................................61
5.4.8 Close a Patient......................................................................................................................................... 62
5.5 How to Access the Image Review Features ......................................................................................................62
5.6 Output Groups......................................................................................................................................................63
5.6.1 Select an Output Group.........................................................................................................................63
5.6.2 Add or Edit an Output Group .............................................................................................................. 63
5.6.3 Custom Output .......................................................................................................................................64
5.7 On-Demand Outputs............................................................................................................................................64
5.7.1 Archive.....................................................................................................................................................64
5.7.2 Export....................................................................................................................................................... 65
5.7.3 Print ..........................................................................................................................................................66
6: Images ______________________________________________________________________69
6.1 Image Display Screen........................................................................................................................................... 69
6.2 How to Set the Exposure Parameters.................................................................................................................70
6.2.1 Select the Image Acquisition Mode (Tomosynthesis Option) .......................................................... 70
6.2.2 Select the Exposure Mode .....................................................................................................................70
6.2.3 How to Use the AEC Sensor ................................................................................................................. 70
6.3 How to Acquire an Image....................................................................................................................................71
6.3.1 Conventional Imaging Sequence of Events.........................................................................................72
6.3.2 Tomosynthesis Imaging Sequence of Events......................................................................................72
6.3.3 How to Accept a Rejected Image..........................................................................................................73
6.3.4 How to Accept or Reject a Pended Image........................................................................................... 73
6.4 How to Correct and Reprocess Implant Images...............................................................................................73
6.4.1 If the Image Is Not Accepted ................................................................................................................73
6.4.2 If the Image Is Accepted ........................................................................................................................73
6.5 How to Review the Images.................................................................................................................................. 74
6.5.1 Image Review Tools Tab........................................................................................................................75
6.5.2 Notices Tab.............................................................................................................................................. 76
6.5.3 Other Image Review Tools....................................................................................................................77
6.5.4 Slice Indicator..........................................................................................................................................78
6.6 How to Send the Images to the Output Devices...............................................................................................78
6.7 How to Use I-View 2D Contrast ......................................................................................................................... 79
6.7.1 How to Configure Contrast Settings.................................................................................................... 82
7: Accessories __________________________________________________________________83
7.1 How to Install Accessories on the C-Arm .........................................................................................................83
7.2 Patient Face Shields ..............................................................................................................................................84
7.2.1 How to Install and Remove the Retractable Face Shield...................................................................84
7.2.2 How to Use the Retractable Face Shield.............................................................................................. 85
7.2.3 How to Install and Remove the Conventional Face Shield ..............................................................86
7.3 Compression Paddles...........................................................................................................................................87
7.3.1 Routine Screening Paddles....................................................................................................................88
7.3.2 Contact and Spot Compression Paddles ............................................................................................. 89
7.3.3 Magnification Paddles ...........................................................................................................................89

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7.3.4 Localization Paddles ..............................................................................................................................90
7.3.5 Large Ultrasound Paddle.......................................................................................................................90
7.3.6 How to Install and Remove a Compression Paddle ..........................................................................91
7.3.7 Paddle Maintenance and Cleaning ......................................................................................................91
7.3.8 Paddle Shift..............................................................................................................................................92
7.3.9 FAST Compression Mode......................................................................................................................92
7.4 Magnification Stand..............................................................................................................................................93
7.4.1 How to Install and Remove the Magnification Stand........................................................................93
7.5 Crosshair Devices..................................................................................................................................................95
7.5.1 How to Install and Remove the Localization Crosshair Device.......................................................95
7.5.2 How to Use the Localization Crosshair Device ..................................................................................96
7.5.3 How to Install and Remove the Magnification Crosshair Device....................................................96
7.5.4 How to Align the Crosshair Device .....................................................................................................97
8: Clinical Procedures___________________________________________________________99
8.1 Standard Workflow ..............................................................................................................................................99
8.1.1 Preparation ..............................................................................................................................................99
8.1.2 At the Gantry...........................................................................................................................................99
8.1.3 At the Acquisition Workstation..........................................................................................................100
8.2 Screening Procedure Example...........................................................................................................................100
8.2.1 Position the Patient...............................................................................................................................101
8.2.2 Set the Exposure Techniques...............................................................................................................101
8.2.3 Acquire the Exposure...........................................................................................................................101
8.3 Procedure for Needle Localization with Tomosynthesis ..............................................................................103
9: Maintenance and Cleaning ___________________________________________________105
9.1 Cleaning ...............................................................................................................................................................105
9.1.1 General Information About Cleaning................................................................................................105
9.1.2 For General Cleaning ...........................................................................................................................105
9.1.3 To Prevent Possible Injury or Equipment Damage..........................................................................106
9.1.4 Acquisition Workstation......................................................................................................................107
9.2 Maintenance.........................................................................................................................................................108
9.2.1 Preventive Maintenance Schedules....................................................................................................108
9.2.2 About Reclamation...............................................................................................................................110
10: System Administration Interface_____________________________________________111
10.1 Admin Screen ......................................................................................................................................................111
10.2 About Screen........................................................................................................................................................113
10.2.1 Licensing Tab ........................................................................................................................................114
10.3 Change the User Language Preference............................................................................................................114
10.4 Set Auto-Hanging and Auto-Pairing ...............................................................................................................115
10.5 Set Multi Line Procedure Tabs ..........................................................................................................................115
10.6 Enable and Set the Height Memory..................................................................................................................116
10.7 Set Auto-Accept and Auto-Pend Images.........................................................................................................118
10.8 How to Set the Contrast Defaults .....................................................................................................................119

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10.9 Enable and Set the Default Height ...................................................................................................................120
10.10 System Tools........................................................................................................................................................ 122
10.10.1 System Tools for the Radiologic Technologist Manager.................................................................122
10.10.2 Remote Access to Image Reports .......................................................................................................124
10.11 Archive Tool ........................................................................................................................................................126
Appendix A Specifications _____________________________________________________129
A.1 Product Measurements ......................................................................................................................................129
A.1.1 Tubestand (Gantry with C-Arm)........................................................................................................ 129
A.1.2 Acquisition Workstations.................................................................................................................... 130
A.2 Operation and Storage Environment ...............................................................................................................131
A.2.1 General Conditions for Operation......................................................................................................131
A.2.2 Storage Environment ...........................................................................................................................132
A.3 Radiation Shield..................................................................................................................................................132
A.4 Electrical Input .................................................................................................................................................... 132
A.4.1 Tubestand ..............................................................................................................................................132
A.4.2 Acquisition Workstation......................................................................................................................133
A.5 Tubestand Technical Information..................................................................................................................... 133
A.5.1 C-Arm.....................................................................................................................................................133
A.5.2 Compression .........................................................................................................................................134
A.5.3 X-ray Tube ............................................................................................................................................. 135
A.5.4 X-ray Beam Filtration and Output .....................................................................................................135
A.5.5 X-ray Collimation .................................................................................................................................137
A.5.6 Light Field Indication........................................................................................................................... 137
A.5.7 X-ray Generator ....................................................................................................................................137
A.6 Imaging System Technical Information...........................................................................................................138
A.6.1 Image Receptor ..................................................................................................................................... 138
Appendix B System Messages and Alert Messages________________________________139
B.1 Error Recovery and Troubleshooting...............................................................................................................139
B.2 Types of Messages ..............................................................................................................................................139
B.2.1 Fault Levels ...........................................................................................................................................139
B.2.2 System Messages ..................................................................................................................................140
B.3 UPS Messages...................................................................................................................................................... 142
Appendix C Use of Mobile System ______________________________________________143
C.1 Conditions for Safety and Other Precautions .................................................................................................143
C.2 Specifications for Mobile Use............................................................................................................................144
C.2.1 Shock and Vibration Limits................................................................................................................. 144
C.2.2 Coach Environment.............................................................................................................................. 144
C.3 Electrical Input .................................................................................................................................................... 145
C.3.1 Gantry ....................................................................................................................................................145
C.3.2 Acquisition Workstation......................................................................................................................145
C.4 Prepare the System for Travel...........................................................................................................................146
C.5 Prepare the System for Use................................................................................................................................147

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C.6 Test the System after Travel ..............................................................................................................................148
C.6.1 Mobile System Controls and Functional Tests .................................................................................148
C.7 Quality Control Tests .........................................................................................................................................148
Appendix D Dose Information _________________________________________________149
D.1 EUREF Dose Tables ............................................................................................................................................149
Glossary of Terms_____________________________________________________________151
Index ________________________________________________________________________153