Hologic PCB01647 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
Technical Support
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All Other: +1 781 999 7750
Email: BreastHealth.Support@hologic.com
© 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.
3Dimensions System User Guide
Table of Contents
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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Retrieve .................................................................................................................................................... 61
5.4.7
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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Localization Paddles .............................................................................................................................. 90
7.3.4
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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Enable and Set the Default Height ................................................................................................................... 120
10.9
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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Test the System after Travel .............................................................................................................................. 148
C.6
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
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Table of Contents
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
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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
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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
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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
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Chapter 1: Introduction
Chapter 1
1.1 Intended Use
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.
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.
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Chapter 1: Introduction
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
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
Genius™ 3D Mammography™ is the brand name of a Hologic 3D Mammography™
exam, and may not be available in all markets.
®
3D Mammography™ system, and has a 2D and 3D™ image set. The 2D image
®
3D Mammography™ system.
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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
papers/breastimaging/.
http://www.hologic.com/en/learning-center/white-
Chapter 1: Introduction
.
.
.
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 breastcancer 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
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3Dimensions System User Guide
Chapter 1: Introduction
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.
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1.6 About C-View and Intelligent 2D
Note
Intelligent 2D™ may not be available in all regions. Contact your sales representative
for information
1.6.1 C-View and Intelligent 2D Software
The C-ViewTM and Intelligent 2DTM software uses image data available from a breast
tomosynthesis acquisition to generate one digital mammogram (2D) per breast
tomosynthesis acquisition. The generated 2D image is created without the need for an
additional digital mammography exposure. The generated 2D image is designed to
appear similar to, and serve the same purpose as, a digital mammogram (2D) when used
as part of a screening study employing tomosynthesis. The C-View or Intelligent 2D
image is interpreted in combination with a breast tomosynthesis image set and is not
intended to be used without the accompanying breast tomosynthesis images to make a
clinical decision or diagnosis.
3Dimensions System User Guide
Chapter 1: Introduction
1.6.2 C-View and Intelligent 2D Warnings
Warning:
Do not make a clinical decision or diagnosis from the C-View or Intelligent
2D images without reviewing the accompanying tomosynthesis image set.
Use the C-View or Intelligent 2D generated 2D images in the same way you would use
conventional digital mammography (2D) when performing a screening study employing
tomosynthesis.
• While reviewing the C-View or Intelligent 2D images for items or areas of interest,
compare to a prior digital mammogram (2D) if priors exist and then review the
related tomosynthesis images carefully.
• Carefully examine the entire tomosynthesis image set before making a clinical
decision.
Warning:
The appearance of a C-View or Intelligent 2D generated 2D image may differ
from that of a conventional digital mammography (2D) image, just as 2D film
and digital mammography (2D) images from different vendors may look
different.
Users should ensure they are adequately trained and are familiar with the appearance of
C-View and Intelligent 2D generated 2D images before using them in conjunction with
tomosynthesis image sets.
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Chapter 1: Introduction
1.6.3 C-View and Intelligent 2D Theory of Operation
Overview
The C-View and Intelligent 2D software is an image processing application for postprocessing the pixel data from tomosynthesis data, captured on a Hologic tomosynthesis
imaging system, into a digital mammography (2D) image. The C-View or Intelligent 2D
generated 2D image can be used in place of a digital mammogram (2D) as part of a
screening study employing tomosynthesis.
The C-View and Intelligent 2D software processes tomosynthesis data to generate 2D
images which are designed to appear similar to and serve the same purpose as a digital
mammogram (2D) when used as part of a screening study employing tomosynthesis.
Configuration
The C-View and Intelligent 2D software has no user-configurable settings that influence
the appearance of the resulting generated 2D images. C-View and Intelligent 2D images
are produced in either DICOM Breast Tomosynthesis Image object format, as a single
thick slice, or DICOM Digital Mammography Image object format. The site PACS
administrator, in consultation with Hologic connectivity engineers, can select the output
format most appropriate for the site’s IT infrastructure and workstations. Each C-View or
Intelligent 2D image DICOM header contains the information needed to differentiate it
from any accompanying conventional 2D image(s) or tomosynthesis image sets in the
same view. An annotation (“C-View” or "Intelligent 2D") will also be burned to the
generated 2D image pixel data.
Workflow
As with any imaging study, the technologist selects the patient and identifies the type of
imaging procedure that will be done. For an exam with C-View or Intelligent 2D images,
the process of imaging the subject and completing the study is all that is necessary. The
C-View and Intelligent 2D software itself operates with no direct human intervention.
1.7 User Profiles
1.7.1 Mammography Technologist
• Meets all requirements that apply to the location in which the Mammography
Technologist operates.
• Completed training on the mammography system.
• Has training in mammography positions.
• Knows how to operate a computer and its peripherals.
1.7.2 Radiologist
• Meets all requirements that apply to the location in which the Radiologist operates.
• Knows how to operate a computer and its peripherals.
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1.7.3 Medical Physicist
• Meets all requirements that apply to the location in which the Medical Physicist
operates.
• Knows about mammography.
• Has experience with digital imaging.
• Knows how to operate a computer and its peripherals.
1.8 Training Requirements
In the United States, users must be Registered Radiologic Technologists meeting criteria
to perform mammography. The mammography users must meet all applicable MQSA
personnel requirements under FDA guidelines for conventional and digital
mammography.
The user has options available for training, which include but are not limited to:
• Onsite applications training by a Hologic Clinical Services Specialist
• Onsite on the job training also known as peer training
Additionally, the user manual is a guide for directions on how to use the system.
3Dimensions System User Guide
Chapter 1: Introduction
All users must make sure that they receive training on correct operation of the system
before use on patients.
Hologic does not accept the responsibility for injury or damage from incorrect system
operation.
1.9 Quality Control Requirements
Facilities in the United States must use the Quality Control Manual to create a Quality
Assurance and Quality Control program. The facility must create the program to meet
the requirements of the Mammography Quality Standards Act or to be accredited by
ACR or another accreditation body.
Facilities outside the United States can use the Quality Control Manual as a guide to
create a program to meet the local standards and regulations.
1.10 Where to Find the Installation Instructions
Installation instructions are available in the Service Manual.
1.11 Where to Find Technical Description Information
Technical description information is available in the Service Manual.
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Chapter 1: Introduction
1.12 Warranty Statement
Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by
Hologic is warranted to the original Customer to perform substantially in accordance
with published product specifications for one (1) year starting from the date of shipment,
or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital
imaging mammography x-ray tubes are warranted for twenty-four (24) months, during
which the x-ray tubes are fully warranted for the first twelve (12) months and are
warranted on a straight-line prorated basis during months 13-24; iii) replacement parts
and remanufactured items are warranted for the remainder of the Warranty Period or
ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are
warranted to conform to published specifications for a period ending on the expiration
date shown on their respective packages; v) licensed Software is warranted to operate in
accordance with published specifications; vi) Services are warranted to be supplied in a
workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through
its manufacturer and such manufacturer’s warranties shall extend to Hologic’s
customers, to the extent permitted by the manufacturer of such non-Hologic
Manufactured Equipment. Hologic does not warrant that use of Products will be
uninterrupted or error-free, or that Products will operate with non-Hologic authorized
third-party products. These warranties do not apply to any item that is: (a) repaired,
moved, or altered other than by Hologic authorized service personnel; (b) subjected to
physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained,
or operated in any manner inconsistent with applicable Hologic specifications or
instructions, including Customer’s refusal to allow Hologic recommended Software
upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a prerelease or “as-is” basis.
1.13 Technical Support
Refer to the copyright page of this manual for contact information for product support.
1.14 Product Complaints
Report any complaints or problems in the quality, reliability, safety, or performance of
this product to Hologic. If the device has caused or added to patient injury, immediately
report the incident to Hologic. (See the copyright page for contact information.)
1.15 Hologic Cybersecurity Statement
Hologic continuously tests the current state of computer and network security to
examine possible security problems. When necessary, Hologic provides the updates to
the product.
For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic
Internet site at www.Hologic.com
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.
1.16 Symbols
This section describes the Symbols on this system.
Symbol Description
Type B Applied Part
Potential Equalization terminal
Protective Earth terminal
"OFF" (power)
"ON" (power)
Discard electrical and electronic equipment separately from standard
waste. Send decommissioned material to Hologic or contact your service
representative.
3Dimensions System User Guide
Chapter 1: Introduction
Warning Electricity
Manufacturer
Date of Manufacture
This system transmits radio frequency (RF) energy (non-ionizing
radiation)
Caution—Radiation
Follow instructions for use
Caution
Catalog number
Serial number
Part number
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Chapter 1: Introduction
1.17 Descriptions of Warnings, Cautions, and Notes
Descriptions of Warnings, Cautions, and Notes used in this manual:
WARNING!
The procedures that you must follow accurately to prevent possible
dangerous or fatal injury.
Warning:
The procedures that you must follow accurately to prevent injury.
Caution:
The procedures that you must follow accurately to prevent damage to equipment,
loss of data, or damage to files in software applications.
Note
Notes show additional information.
1.18 Document Conventions
When prompted to add text, enter the text printed in monospaced font exactly as
shown.
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3Dimensions System User Guide
Chapter 2: General Information
Chapter 2
2.1 System Overview
2:General Information
Figure 1: 3Dimensions™ System
1. Tubestand (Gantry and C-arm)
2. Gantry
3. C-arm (Tube Arm and Compression Arm)
4. Universal Acquisition Workstation
Figure Legend
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3Dimensions System User Guide
Chapter 2: General Information
2.1.1 C-Arm Overview
Figure Legend
1. Tube Arm
2. Patient Face Shield
3. Compression Device
4. Image Receptor
5. Compression Arm
6. Patient Handle
7. C-arm Control Panel
Figure 2: C-arm Overview
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2.2 Safety Information
Read and understand this manual before you use the system. Keep the manual available
during the patient procedures.
Always follow all the instructions in this manual. Hologic does not accept the
responsibility for injury or damage from incorrect system operation. Hologic can
schedule training at your facility.
The system has protective devices, but the Technologist must understand how to safely
use the system. The Technologist must remember the health hazards of x rays.
2.3 Warnings and Precautions
This system is classified as CLASS I, TYPE B APPLIED PART, IPX0, permanently
connected equipment, continuous operation with short term loading per IEC 60601-1.
There are no special provisions to protect the system from flammable anesthetics or
ingress of liquids.
3Dimensions System User Guide
Chapter 2: General Information
WARNING!
Risk of electric shock. Only connect this equipment to supply mains
with Protective Earth.
WARNING!
For North American electrical safety requirements, use a Hospital
Grade receptacle to supply a correct Ground.
WARNING!
Electrical equipment used near flammable anesthetics can cause an
explosion.
WARNING!
To correctly isolate the system, attach only approved accessories or
options to the system. Only approved personnel can change the
connections.
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Chapter 2: General Information
WARNING!
Keep a 1.5 meter safe distance between the patient and any non-patient
devices.
Do not install non-patient system components (like the Workflow
Manager, a diagnostic review workstation, or a hard copy printer) in
the Patient Area.
WARNING!
Only trained Service Engineers authorized through Hologic can open
any of the panels. This system contains lethal voltages.
WARNING!
The user must correct problems before the system is used. Contact an
approved service representative for preventive maintenance.
WARNING!
After power failure, remove the patient from the system before you
apply power.
Warning:
This device contains dangerous material. Send decommissioned material to
Hologic or contact your service representative.
Warning:
C-arm movement is motorized.
Warning:
You increase the patient dose to high levels when you increase the AEC
exposure adjustment. You increase the image noise or decrease image quality
when you decrease the AEC exposure adjustment.
Warning:
Control the access to the equipment according to local regulations for
radiation protection.
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