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
USA: +1.877.371.4372
Europe: [phone]
Asia: [phone]
Australia: [phone]
All Other: [phone]
Email: [email protected]

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 v
DRAFT Preview Copy-Generated May 30, 2018
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

3Dimensions System User Guide
Table of Contents
vi MAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
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

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 vii
DRAFT Preview Copy-Generated May 30, 2018
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

3Dimensions System User Guide
Table of Contents
viii MAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
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

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 ix
DRAFT Preview Copy-Generated May 30, 2018
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

3Dimensions System User Guide
Table of Contents
xMAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
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

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 xi
DRAFT Preview Copy-Generated May 30, 2018
List of Figures
Figure 1: 3Dimensions™ System ...................................................................................................................................11
Figure 2: C-arm Overview..............................................................................................................................................12
Figure 3: Emergency Off Switch Functionality............................................................................................................17
Figure 4: Label Locations................................................................................................................................................21
Figure 5: System Power Controls .................................................................................................................................. 23
Figure 6: Tubestand Controls and Indicators ..............................................................................................................24
Figure 7: Tubehead Display ...........................................................................................................................................25
Figure 8: Compression Device .......................................................................................................................................25
Figure 9: Compression Device Display.........................................................................................................................25
Figure 10: C-arm Control Panel ..................................................................................................................................... 26
Figure 11: Gantry Control Panel....................................................................................................................................26
Figure 12: Dual Function Footswitch............................................................................................................................ 27
Figure 13: Universal Acquisition Workstation Controls and Displays ....................................................................28
Figure 14: Turn to Reset the Emergency Off Switches................................................................................................29
Figure 15: Universal Acquisition Workstation Power Buttons .................................................................................29
Figure 16: Startup Screen................................................................................................................................................30
Figure 17: Select an Operator (Log In) Screen..............................................................................................................31
Figure 18: C-arm Control Panel (left side shown).......................................................................................................32
Figure 19: Emergency Off Switch Functionality.......................................................................................................... 44
Figure 20: Universal Acquisition Workstation Power Buttons .................................................................................44
Figure 21: An Example Select Function to Perform Screen........................................................................................ 45
Figure 22: Taskbar............................................................................................................................................................46
Figure 23: Select Patient Screen......................................................................................................................................48
Figure 24: Enterprise Tab................................................................................................................................................ 49
Figure 25: Add Patient Screen........................................................................................................................................50
Figure 26: Split Patient Records Screen.........................................................................................................................51
Figure 27: Select the Correct Procedure to Split Patient Records..............................................................................52
Figure 28: Filter Tab in the Patient Filter Screen..........................................................................................................53
Figure 29: Procedure Screen........................................................................................................................................... 56
Figure 30: Paddle Shift Buttons......................................................................................................................................58
Figure 31: Procedure Info Dialog Box...........................................................................................................................58
Figure 32: Add Procedure Dialog Box .......................................................................................................................... 59
Figure 33: Add View Screen........................................................................................................................................... 60
Figure 34: Edit View Screen............................................................................................................................................61
Figure 35: Output Groups Field..................................................................................................................................... 63
Figure 36: An Example Custom Output Group...........................................................................................................64
Figure 37: Select the Images for Export ........................................................................................................................65
Figure 38: Export Dialog Box .........................................................................................................................................66
Figure 39: Print Screen ....................................................................................................................................................67
Figure 40: Image Display Screen....................................................................................................................................69
Figure 41: Exposure In Progress ....................................................................................................................................71
Figure 42: Exposure Complete.......................................................................................................................................71

3Dimensions System User Guide
Table of Contents
xii MAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
Figure 43: Marked Images in a Procedure....................................................................................................................72
Figure 44: Tools Tab (Tomosynthesis option shown) .................................................................................................74
Figure 45: Image Review Tools......................................................................................................................................75
Figure 46: Tools on the Notices Tab ..............................................................................................................................76
Figure 47: Exposure Index ..............................................................................................................................................77
Figure 48: Display Modes ...............................................................................................................................................77
Figure 49: Slice Indicator.................................................................................................................................................78
Figure 50: I-View 2D Contrast Screen ...........................................................................................................................79
Figure 51: I-View 2D Contrast Screen, Waiting Period ..............................................................................................80
Figure 52: I-View 2D Contrast Screen, Optimal Imaging Period ..............................................................................81
Figure 53: I-View 2D Contrast Information..................................................................................................................82
Figure 54: C-arm Accessories .........................................................................................................................................83
Figure 55: Align the Retractable Face Shield on the C-arm........................................................................................84
Figure 56: Face Shield Installation.................................................................................................................................85
Figure 57: Face Shield Operation...................................................................................................................................85
Figure 58: How to Install the Conventional Face Shield ............................................................................................86
Figure 59: How to Install a Compression Paddle........................................................................................................91
Figure 60: How to Remove a Compression Paddle.....................................................................................................91
Figure 61: The FAST Compression Mode Slide...........................................................................................................93
Figure 62: Installation of the Magnification Stand ......................................................................................................93
Figure 63: Installation of the Localization Crosshair Device .....................................................................................95
Figure 64: How to Install and Remove the Magnification Crosshair Device...........................................................96
Figure 65: Example of a Screening Procedure Screen ...............................................................................................100
Figure 66: Exposure In Progress ..................................................................................................................................102
Figure 67: Exposure Complete.....................................................................................................................................102
Figure 68: Calculating needle depth............................................................................................................................104
Figure 69: Admin Screen...............................................................................................................................................111
Figure 70: System Tab of the About (the Acquisition Workstation) Screen...........................................................113
Figure 71: Licensing Tab of the About Screen............................................................................................................114
Figure 72: Enable Auto-Hanging and Auto-Pairing .................................................................................................115
Figure 73: Enable Multi Line Procedure Tabs............................................................................................................116
Figure 74: My Settings Button in the Admin Screen.................................................................................................116
Figure 75: Console Tab of the Edit Operator Screen .................................................................................................117
Figure 76: Height Adjust Control Panel......................................................................................................................117
Figure 77: Desired Console Height and Current Console Height Fields ...............................................................117
Figure 78: Set Image Auto Disposition .......................................................................................................................118
Figure 79: I-View 2D Contrast Default Settings.........................................................................................................119
Figure 80: Preferences Button in the Admin Screen..................................................................................................120
Figure 81: Console Tab of the System Preferences Screen........................................................................................120
Figure 82: Height Adjust Control Panel......................................................................................................................121
Figure 83: Desired Console Height and Current Console Height Fields ...............................................................121
Figure 84: System Tools Button....................................................................................................................................122
Figure 85: System Tools Screen....................................................................................................................................122
Figure 86: Remote Logon Screen for Service Tools ...................................................................................................124
Figure 87: Service Tools Welcome Screen...................................................................................................................125

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 xiii
DRAFT Preview Copy-Generated May 30, 2018
Figure 88: Create Image Report Parameters ..............................................................................................................125
Figure 89: Create Image Report ................................................................................................................................... 126
Figure 90: Archive Button.............................................................................................................................................126
Figure 91: Multi Patient On Demand Archive Screen .............................................................................................. 127
Figure 92: Export Screen ............................................................................................................................................... 128
Figure 93: Tubestand (Gantry with C-arm) Measurements.....................................................................................129
Figure 94: Universal Acquisition Workstation Measurements ...............................................................................130
Figure 95: Mobile Universal Acquisition Workstation Measurements ..................................................................131
Figure 96: UPS LCD Display ........................................................................................................................................142
Figure 97: Keyboard Tray Lock Knob......................................................................................................................... 146
Figure 98: Keyboard Tray Lock Knob......................................................................................................................... 146
Figure 99: Tray Lock Release from Locked (A) to Unlocked (D) ............................................................................146
Figure 100: Swivel Lock Knobs for Image Display Monitor on Mobile Universal Acquisition Workstation...147
Figure 101: Tray Lock Release from Locked (A) to Unlocked (D) ..........................................................................147
Figure 102: Swivel Lock Knobs for Image Display Monitor on Mobile Universal Acquisition Workstation...148

3Dimensions System User Guide
Table of Contents
MAN-05085-002 Revision 002 xv
DRAFT Preview Copy-Generated May 30, 2018
List of Tables
Table 1: System Labels ....................................................................................................................................................22
Table 2: Compression Tests............................................................................................................................................33
Table 3: C-arm Up and Down Movement....................................................................................................................34
Table 4: C-arm Counterclockwise Rotation..................................................................................................................36
Table 5: C-arm Clockwise Rotation...............................................................................................................................37
Table 6: C-arm Rotation Switch .....................................................................................................................................38
Table 7: Automatic C-arm Counterclockwise Rotation..............................................................................................39
Table 8: Automatic C-arm Clockwise Rotation ...........................................................................................................40
Table 9: Automatic MLO Rotation ................................................................................................................................ 41
Table 10: C-arm Collimation ..........................................................................................................................................42
Table 11: Shifting Paddle ................................................................................................................................................43
Table 12: Taskbar Menus ................................................................................................................................................46
Table 13: The Select Patient Screen................................................................................................................................48
Table 14: Filter Tab Options (Require Access Privileges)........................................................................................... 54
Table 15: The Procedure Screen .....................................................................................................................................57
Table 16: Procedure Groups...........................................................................................................................................59
Table 17: Available Accessories ..................................................................................................................................... 87
Table 18: User Preventive Maintenance......................................................................................................................108
Table 19: Service Engineer Preventive Maintenance ................................................................................................ 109
Table 20: Admin Screen Functions.............................................................................................................................. 111
Table 21: Radiologic Technologist Manager—System Tools Functions.................................................................123
Table 22: Maximum mA Setting as a Function of kV ...............................................................................................135
Table 23: System Messages........................................................................................................................................... 140
Table 24: 2D Dose (EUREF).......................................................................................................................................... 149
Table 25: BT Dose (EUREF) ..........................................................................................................................................149
Table 26: CEDM Dose (EUREF)................................................................................................................................... 150

3Dimensions System User Guide
Chapter 1: Introduction
MAN-05085-002 Revision 002 Page 1
DRAFT Preview Copy-Generated May 30, 2018
1: Introduction
Read all this information carefully before operating the system. Follow all warnings and
precautions as stated in this manual. Keep this manual available during procedures.
Physicians should tell patients about all potential risks and adverse events described in
this manual with respect to the operation of the system.
Note
Hologic configures some systems to meet specific requirements. Your system
configuration may not have all the options and accessories included in this manual.
1.1 Intended Use
Caution: Federal law restricts this device to sale by or on the order of a physician.
The Hologic®3Dimensions™ system is indicated to generate digital mammographic
images that can be used for screening and diagnosis of breast cancer. The 3Dimensions
(2D or 3D) system is intended for use in the same clinical applications as a 2D
mammography system for screening mammograms. Specifically, the 3Dimensions
system can be used to generate 2D digital mammograms and 3D mammograms. Each
screening examination may consist of:
•a 2D FFDM image set
- OR -
•a 2D and 3D image set, where the 2D image can be either an FFDM or a 2D
image generated from the 3D image set
The 3Dimensions system may also be used for additional diagnostic workup of the
breast.
Note
In Canada and Singapore, Tomosynthesis is not approved for screening, and must be
used in conjunction with a 2D image (either a FFDM image or 2D image generated from
the 3D image set).
Contrast Enhanced Digital Mammography
Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing
indication for diagnostic mammography with the 3Dimensions system. The CEDM
application shall enable contrast enhanced breast imaging using a dual energy technique.
This imaging technique can be used as an adjunct following mammography and/or
ultrasound exams to localize a known or suspected lesion.
1.1.1 Contraindications
There are no known contraindications.
Chapter 1

3Dimensions System User Guide
Chapter 1: Introduction
Page 2 MAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
1.2 Potential Adverse Effects of Mammography Systems on
Health
Below is a list of the potential adverse effects (such as complications) associated with the
use of the device (these risks are the same as for other screen-film or digital
mammography systems):
•Excessive breast compression
•Excessive x-ray exposure
•Electric shock
•Infection
•Skin irritation, abrasions, or puncture wounds
1.3 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).
1.4 About the Genius 3D Mammography Exam
The Genius™ 3D Mammography™ exam (also known as Genius™ exam) is acquired on
a Hologic®3D Mammography™ system, and has a 2D and 3D™ image set. The 2D image
can be either an acquired 2D image or a 2D image generated from the 3D™ image set.
The Genius™ exam is only available on a Hologic®3D Mammography™ system.
Genius™ 3D Mammography™ is the brand name of a Hologic 3D Mammography™
exam, and may not be available in all markets.

3Dimensions System User Guide
Chapter 1: Introduction
MAN-05085-002 Revision 002 Page 3
DRAFT Preview Copy-Generated May 30, 2018
1.5 More Information About Tomosynthesis
The Hologic Selenia Dimensions system received FDA approval for the Hologic
Tomosynthesis option on 11 Feb 2011 (refer to PMA number P080003). This FDA
approval applies to screening and diagnostic imaging. More information is available
from the FDA website at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080003.
The Generated 2D option (C-View) in conjunction with Tomosynthesis received FDA
approval on 16 May 2013 (refer to PMA number P080003 S001). More information is
available from the FDA website at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080003S001.
A list of scientific publications about Breast Tomosynthesis is available from the Hologic
website. The majority of the studies were done with the commercially released Hologic
Selenia Dimensions Tomosynthesis system. See the publication at
http://www.hologic.com/sites/default/files/Tomo-Bibliography-Rev-13.pdf.
The Hologic website has several white papers and summary cards about breast imaging
publications. See the documents at http://www.hologic.com/en/learning-center/white-
papers/breastimaging/.
Independent publications have examined Hologic Selenia Dimensions Tomosynthesis
systems in population-based screening sequences in Europe. Results consistently show a
significant increase in invasive cancer detection rate at the same time as a reduction in
false positives. The following publications are recommended.
Integration of 3D digital mammography with tomosynthesis for population breast-
cancer screening (STORM): a prospective comparison study.
Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P,
Bricolo P, Fantò C, Valentini M, Montemezzi S, Macaskill P.
Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25.
http://www.ncbi.nlm.nih.gov/pubmed/23623721
Prospective trial comparing full-field digital mammography (FFDM) versus
combined FFDM and tomosynthesis in a population-based screening programme
using independent double reading with arbitration.
Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN,
Jahr G, Krager M, Hofvind S.
Eur Radiol. 2013 Aug;23(8):2061-71. doi: 10.1007/s00330-013-2820-3. Epub 2013 Apr 4.
http://www.ncbi.nlm.nih.gov/pubmed/23553585

3Dimensions System User Guide
Chapter 1: Introduction
Page 4 MAN-05085-002 Revision 002
DRAFT Preview Copy-Generated May 30, 2018
Comparison of digital mammography alone and digital mammography plus
tomosynthesis in a population-based screening program.
Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN,
Jahr G, Krager M, Niklason LT, Hofvind S, Gur D.
Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.
http://www.ncbi.nlm.nih.gov/pubmed/23297332
Two-view digital breast tomosynthesis screening with synthetically reconstructed
projection images: comparison with digital breast tomosynthesis with full-field
digital mammographic images.
Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi
M, Hofvind S, Gullien R.
Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24
http://www.ncbi.nlm.nih.gov/pubmed/24484063
Breast Cancer Screening Using Tomosynthesis in Combination With Digital
Mammography
Sarah M. Friedewald, MD1; Elizabeth A. Rafferty, MD2; Stephen L. Rose, MD3,4;
Melissa A. Durand, MD5; Donna M. Plecha, MD6; Julianne S. Greenberg, MD7; Mary K.
Hayes, MD8; Debra S. Copit, MD9; Kara L. Carlson, MD10; Thomas M. Cink, MD11;
Lora D. Barke, DO12; Linda N. Greer, MD13; Dave P. Miller, MS14; Emily F. Conant,
MD15
JAMA. 2014;311(24):2499-2507. doi:10.1001/jama.2014.6095
http://jama.jamanetwork.com/article.aspx?articleid=1883018
IMPORTANT:
Hologic strongly recommends that users make themselves familiar with local or
regional regulations. These regulations could impose restrictions on the different types
of clinical use. Because the regulations could evolve and change over time, periodic
review is recommended.