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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 USA:

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+1 781 999 7750 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 Intended Use............................................................................................................................................................ 1 1.1 1.1.1 Contraindications ..................................................................................................................................... 1 Potential Adverse Effects of Mammography Systems on Health .................................................................... 2 1.2 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 Emergency Off Switches ...................................................................................................................................... 17 2.4 2.5 Interlocks ................................................................................................................................................................ 18 2.6 Compliance ............................................................................................................................................................ 18 2.6.1 Compliance Requirements .................................................................................................................... 18 2.6.2 Compliance Statements ......................................................................................................................... 20 Label Locations ..................................................................................................................................................... 21 2.7 MAN-05085-002 Revision 002 DRAFT v Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 3: System Controls and Indicators ________________________________________________23 3.1 System Power Controls ........................................................................................................................................ 23 Tubestand Controls and Indicators .................................................................................................................... 24 3.2 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 Perform the Functional Tests ............................................................................................................................... 32 4.3 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 Select Patient Screen ............................................................................................................................................. 48 5.3 5.3.1 About the Notices Tab ........................................................................................................................... 50 5.3.2 Open a Patient ......................................................................................................................................... 50 5.3.3 Add a New Patient ................................................................................................................................. 50 Edit the Patient Information .................................................................................................................. 51 5.3.4 5.3.5 Split the Patient Records ........................................................................................................................ 51 5.3.6 Delete a Patient ....................................................................................................................................... 53 Filters for Patients ................................................................................................................................... 53 5.3.7 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 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 5.4 vi DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 Print .......................................................................................................................................................... 66 5.7.3 6: Images ______________________________________________________________________69 6.1 Image Display Screen ........................................................................................................................................... 69 6.2 How to Set the Exposure Parameters ................................................................................................................. 70 Select the Image Acquisition Mode (Tomosynthesis Option) .......................................................... 70 6.2.1 Select the Exposure Mode ..................................................................................................................... 70 6.2.2 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 If the Image Is Not Accepted ................................................................................................................ 73 If the Image Is Accepted ........................................................................................................................ 73 6.5 How to Review the Images .................................................................................................................................. 74 Image Review Tools Tab ........................................................................................................................ 75 6.5.1 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 6.4.1 6.4.2 7: Accessories __________________________________________________________________83 7.1 How to Install Accessories on the C-Arm ......................................................................................................... 83 Patient Face Shields .............................................................................................................................................. 84 7.2 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 Routine Screening Paddles .................................................................................................................... 88 7.3.1 7.3.2 Contact and Spot Compression Paddles ............................................................................................. 89 7.3.3 Magnification Paddles ........................................................................................................................... 89 MAN-05085-002 Revision 002 DRAFT vii Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 Paddle Maintenance and Cleaning ...................................................................................................... 91 7.3.7 Paddle Shift.............................................................................................................................................. 92 7.3.8 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 Standard Workflow .............................................................................................................................................. 99 8.1 8.1.1 Preparation .............................................................................................................................................. 99 8.1.2 At the Gantry ........................................................................................................................................... 99 8.1.3 At the Acquisition Workstation .......................................................................................................... 100 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 Procedure for Needle Localization with Tomosynthesis .............................................................................. 103 8.2 8.3 9: Maintenance and Cleaning ___________________________________________________105 9.1 Cleaning ............................................................................................................................................................... 105 9.1.1 General Information About Cleaning ................................................................................................ 105 For General Cleaning ........................................................................................................................... 105 9.1.2 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 viii DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 Imaging System Technical Information ........................................................................................................... 138 A.6.1 Image Receptor ..................................................................................................................................... 138 A.6 Appendix B System Messages and Alert Messages ________________________________139 B.1 Error Recovery and Troubleshooting ............................................................................................................... 139 B.2 Types of Messages .............................................................................................................................................. 139 Fault Levels ........................................................................................................................................... 139 System Messages .................................................................................................................................. 140 B.3 UPS Messages ...................................................................................................................................................... 142 B.2.1 B.2.2 Appendix C Use of Mobile System ______________________________________________143 C.1 Conditions for Safety and Other Precautions ................................................................................................. 143 C.2 Specifications for Mobile Use ............................................................................................................................ 144 Shock and Vibration Limits ................................................................................................................. 144 C.2.1 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 MAN-05085-002 Revision 002 DRAFT ix Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 x DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide 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 MAN-05085-002 Revision 002 DRAFT xi Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 xii DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 MAN-05085-002 Revision 002 DRAFT xiii Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Table of Contents 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 ManagerSystem 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 MAN-05085-002 Revision 002 DRAFT xv Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 1: Introduction Chapter 1 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. MAN-05085-002 Revision 002 DRAFT Page 1 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 1: Introduction 1.2 1.3 1.4 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 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). 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. Page 2 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 1: Introduction 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, Fant 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 MAN-05085-002 Revision 002 DRAFT Page 3 Preview Copy-Generated May 30, 2018 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. Page 4 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 1: Introduction 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. 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. MAN-05085-002 Revision 002 DRAFT Page 5 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide 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 post-

processing 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 sites 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. User Profiles 1.7 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. Page 6 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 1: Introduction 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 1.9 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. 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. 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. MAN-05085-002 Revision 002 DRAFT Page 7 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide 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 manufacturers warranties shall extend to Hologics 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 Customers refusal to allow Hologic recommended Software upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a pre-

release 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. Page 8 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 1: Introduction 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. Warning Electricity Manufacturer Date of Manufacture This system transmits radio frequency (RF) energy (non-ionizing radiation) CautionRadiation Follow instructions for use Caution Catalog number Serial number Part number MAN-05085-002 Revision 002 DRAFT Page 9 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide 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. Page 10 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information Chapter 2 2.1 2:General Information System Overview Figure 1: 3Dimensions System Figure Legend 1. Tubestand (Gantry and C-arm) 2. Gantry 3. C-arm (Tube Arm and Compression Arm) 4. Universal Acquisition Workstation MAN-05085-002 Revision 002 DRAFT Page 11 Preview Copy-Generated May 30, 2018 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. 5. Compression Arm 6. Patient Handle 7. C-arm Control Panel Image Receptor Figure 2: C-arm Overview Page 12 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information 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. 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. MAN-05085-002 Revision 002 DRAFT Page 13 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide 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. Page 14 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information Warning:

The disk drives installed in this system are a Class I Laser Product. Prevent direct exposure to the beam. Hidden laser radiation exists if the case to a disk drive is open. Warning:

The bar code scanner installed in this system is a Class II Laser Product. Prevent direct exposure to the beam. Hidden laser radiation exists if the cover is opened. Warning:

Keep your full body behind the radiation shield during the exposure. Warning:

Do not move the C-arm while the system retrieves the image. Warning:

If a paddle touches possible infectious materials, contact your Infection Control Representative to remove contamination from the paddle. Warning:

Do not leave the patient unattended during the procedure. Warning:

Keep the hands of the patient away from all buttons and switches at all times. Warning:

Place each footswitch in a position where, when used, they remain in reach of the Emergency Off Switches. Warning:

Position the footswitches to prevent accidental operation by a patient or wheelchair. Warning:

To prevent a higher radiation dose to the patient, only put approved materials in the x-ray beam path. MAN-05085-002 Revision 002 DRAFT Page 15 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information Warning:

This system can be dangerous to the patient and the user. Always follow the safety precautions for x-ray exposures. Warning:

For exposures except magnification case studies, always use the Face Shield. Warning:

The Face Shield does not protect the patient from radiation. Warning:

Risk of entrapment. Make sure that the C-arm has 50 cm (20 inches) of clearance to any object during C-arm rotation. Do not use Auto Rotation when C-arm clearance is less than 50 cm (20 inches). Caution:

The system is a medical device and not a normal computer. Only make approved changes to the hardware or software. Install this device behind a firewall for network security. The computer virus protection or network security for this medical device is not supplied (for example, a computer firewall). The network security and anti-virus provisions are the responsibility of the user. Caution:

Do not turn off the Acquisition Workstation circuit breaker except in emergency. The circuit breaker can turn off the Uninterruptible Power Supply (UPS) and risk data loss. Caution:

Risk of data loss. Do not put any magnetic media near or on devices that create any magnetic fields. Caution:

Do not use any heat source (like a heating pad) on the image receptor. Caution:

To prevent possible damage from thermal shock to the Digital Image Receptor, follow the recommended procedure to turn off the equipment. Page 16 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information Caution:

The display is calibrated for compliance to DICOM standards. Do not make any brightness or contrast adjustments to the display. Caution:

Use the least possible amount of cleaning fluids. The fluids must not flow or run. Caution:

To prevent damage to the electronic components, do not use disinfectant sprays on the system. Note:

Hologic does not supply the Gantry power cable for some countries. If the power cable is not supplied, the installed cable must meet the following requirements and all local codes that apply: 3 conductor, 8 AWG (10 mm2) copper not more than 25 feet (7.62 meters) in length. 2.4 Emergency Off Switches The Emergency Off switches remove the power from the Gantry and the Acquisition Workstation Lift Mechanism (on the workstations that include that option). Do not routinely use the Emergency Off switches to turn off the system. Figure 3: Emergency Off Switch There are three Emergency Off switches, one on each side of the Gantry and one on the Acquisition Workstation. 1. To turn Off the Gantry and disable the Acquisition Workstation Lift Mechanism, press any of the Emergency Off switches. Functionality 2. To reset the Emergency Off switch, turn clockwise approximately one-quarter turn until the switch pops back out. MAN-05085-002 Revision 002 DRAFT Page 17 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information 2.5 Interlocks The 3Dimensions system has safety interlocks:

C-arm vertical movement and rotation are disabled when compression force is applied. A Service Engineer can configure the lockout force from 22 Newtons (5 pounds) to 45 Newtons (10 pounds). If the x-ray button or x-ray footswitch is released before the end of the exposure, the exposure stops and an alarm message is displayed. When in Tomo mode, the system does not allow an exposure if the Grid is in the x-

ray field (Tomosynthesis option). Mirror and Filter position flags also prevent x rays when the Light Field Mirror or the Filter Assembly is not correctly positioned. 2.6 Compliance This section describes the mammography system compliance requirements and the responsibilities of the manufacturer. 2.6.1 Compliance Requirements The manufacturer has the responsibility for the safety, reliability, and performance of this equipment with the following provisions:

The electrical installation of the room meets all requirements. The equipment is used according to the User Guide. The assembly operations, extensions, adjustments, changes, or repairs are performed only by authorized persons. The network and communication equipment is installed to meet IEC Standards. The complete system (network and communications equipment and the mammography system) must be in compliance with IEC 60601-1. Caution:

Medical Electrical Equipment needs special precautions about EMC and must be installed, put into service and used according to the EMC information provided. Caution:

Portable and mobile RF communications can affect medical electrical equipment. Caution:

The use of unauthorized accessories and cables can result in increased emissions or decreased immunity. To keep the isolation quality for the system, attach only approved Hologic accessories or options to the system. Page 18 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information Caution:

The Medical Electrical (ME) Equipment or ME System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, make sure that the ME Equipment or ME System operates correctly in this configuration. Caution:

This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the equipment or shielding the location. Caution:

Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment. Caution:

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Caution:

Based on ENCLOSURE PORT IMMUNITY to RF WIRELESS COMMUNICATIONS EQUIPMENT test level per IEC 60601-1-2 ed. 4, this device shows susceptibility to GMRS 460, FRS 460 transmission frequency. Provide a minimum separation of 30 cm between GMRS and FRS radios and the system. Caution:

This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. MAN-05085-002 Revision 002 DRAFT Page 19 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information 2.6.2 Compliance Statements The manufacturer states this device is made to meet the following requirements:

Medical Applied electromagnetic radiation equipment as to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005) and CAN/CSA-C22.2 No. 60601-1 (2008) CAN/CSA - ISO 13485-03 Medical Devices Quality Management Systems Requirements for Regulatory Purposes (Adopted ISO 13485:2003 second edition, 2003-07-15) CAN/CSA C22.2 NO. 60601-1-08 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-1:2005, third edition, 2005-12), includes Corrigendum 1:2011 EN 60601-1:2006 Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance ETSI EN 300 330-1: V1.3.1, and ETSI EN 300 330-2: V1.5.1: 2006Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz ETSI EN 301 489-1: V1.6.1, and ETSI EN 301 489-3: V1.8.1: 2008Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility

(EMC) standard for radio equipment and services FCC, 47 CFR Part 15, Subpart C, Section 15.225: 2009 FDA, 21 CFR [Parts 820, 900 and 1020]

IEC 60601-1 Ed. 3.0:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard:

Electromagnetic Compatibility Requirements and Tests IEC 60601-1-3 Ed. 2.0:2008 Medical Electrical Equipment Part 1-3: General Requirements for Basic Safety and Essential Performance Collateral Standard:

Radiation Protection in Diagnostic X-Ray Equipment IEC 60601-2-28 Ed. 2.0:2010 Medical Electrical Equipment - Part 2-28: Particular Requirements for the Basic Safety and Essential Performance of X-ray Tube Assemblies for Medical Devices IEC 60601-2-45 Ed. 3.0:2011 Medical Electrical Equipment Part 2-45: Particular Requirements for Basic Safety and Essential Performance of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices RSS-210: Issue 7, 2007 Radio Standards Specification Low-power License-exempt Radiocommunication Devices: Category I Equipment ANSI/AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance, includes amendment (2010) Page 20 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information 2.7 Label Locations Figure 4: Label Locations MAN-05085-002 Revision 002 DRAFT Page 21 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 2: General Information 1 Table 1: System Labels 2 3 Serialized Device 4 Gantry Nameplate System Model Electrical Shock Warning 5 8 Potential Equalization Terminal 6 Wheelchair Warning for Footswitch 7 Emergency Stop Switch Tomographic Mammography Detector 9 10 11 X-ray Device Warning Vendor-supplied X-ray Tube Serial Number 12 13 Acquisition Workstation Nameplate Compliance Technical Support Contact 14 Acquisition Workstation Lift Limit Page 22 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 3: System Controls and Indicators Chapter 3 3.1 3:System Controls and Indicators System Power Controls Figure 5: System Power Controls Figure Legend 1. Gantry Power Circuit Breaker 2. Emergency Off Switch (two on the Gantry, one on the Acquisition Workstation) 3. Acquisition Workstation Power Switch 4. Computer Power On/Reset Button 5. Uninterruptible Power Supply (UPS) Power Button MAN-05085-002 Revision 002 DRAFT Page 23 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 3: System Controls and Indicators 3.2 Tubestand Controls and Indicators Figure Legend 1. Rotation Angle Displays (each side) 2. C-arm Control Panels (each side) 3. Compression Device 4. Emergency Off Switches (each side) 5. Compression Handwheels 6. Gantry Control Panels (each side) 7. Footswitch 8. Tubehead Display Figure 6: Tubestand Controls and Indicators Page 24 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 3: System Controls and Indicators 3.2.1 Tubehead Display The Tubehead Display shows:

SID Filter Type

Collimator Setting

Paddle Position 3.2.2 Compression Device Controls and Display Figure 7: Tubehead Display Figure Legend 1. Manual Compression Handwheels 2. Paddle Shift Buttons 3. AEC Sensor Buttons 4. Compression Device Display 5. FAST Compression Mode Slide 6. Paddle Clamp The Compression Device Display shows:

AEC Sensor Position

Compression Force (displays 0.0 when force is less than 4 pounds)

Compression Thickness

Angle of the C-arm after rotation

(for 5 seconds) Figure 8: Compression Device Figure 9: Compression Device Display MAN-05085-002 Revision 002 DRAFT Page 25 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 3: System Controls and Indicators 3.2.3 C-Arm Control Panels There is a C-arm control panel on both the left side and right side of the C-arm. These buttons provide the Collimator and C-arm functions. Figure Legend 1. MLO Rotation 2. C-arm Zero 3. Light Field Lamp 4. Motor Enable 5. Collimator Override 6. Clockwise C-arm Rotation 7. C-arm Up and Down 8. Counterclockwise C-arm Rotation 9. Compression Up 10. Compression Down Figure 10: C-arm Control Panel 3.2.4 Gantry Control Panels Control panels on the Gantry provide additional access to C-arm functions. There is a C-

arm control panel on both the left side and right side of the Gantry. Figure Legend 1. Motor Enable 2. C-arm Zero 3. Clockwise C-arm Rotation 4. C-arm Up and Down 5. Counterclockwise C-arm Rotation Figure 11: Gantry Control Panel Page 26 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 3: System Controls and Indicators 3.2.5 Dual Function Footswitch Warning:

Place each footswitch in a position where, when used, they remain in reach of the Emergency Off Switches. Warning:

Position the footswitches to prevent accidental operation by a patient or wheelchair. To use the footswitch:

1. Press the footswitch to actuate. 2. Release the switch to stop the movement. Figure Legend 1. C-arm Down 2. C-arm Up 3. Compression Down 4. Compression Up Figure 12: Dual Function Footswitch MAN-05085-002 Revision 002 DRAFT Page 27 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 3: System Controls and Indicators 3.3 Universal Acquisition Workstation Controls and Displays Note Hologic configures some systems to meet specific requirements. Your system configuration may not have all the options and accessories included in this manual. Figure 13: Universal Acquisition Workstation Controls and Displays Figure Legend 1. Height Adjustment Switch 2. Keyboard (in drawer) 3. Bar Code Scanner 4. Control Monitor 5. Fingerprint Scanner*

6. Emergency Off Switch*

7. Image Display Monitor 8. X-ray Activation Button*

9. Compression Release Button 10. CD/DVD Drive 11. USB Ports 12. Acquisition Workstation Power Switch 13. Computer Power On/Reset Button 14. Uninterruptible Power Supply (UPS) Power Button 15. X-ray Footswitch

*A = series II UAWS layout; B = series I UAWS layout Note The controls for the Universal Acquisition Workstation installed in a mobile environment are the same as the controls for the Universal Acquisition Workstation. Page 28 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Chapter 4 4.1 4:Startup, Functional Tests, and Shutdown How to Start the System Note If the system remains on overnight, restart the system daily to guarantee best performance. 1. Make sure that there are no obstructions to C-arm movement or to the view of the Operator. 2. Make sure that all three Emergency Off switches are in the reset position (unpushed). Figure 14: Turn to Reset the Emergency Off Switches 3. Make sure that the Gantry circuit breaker is in the ON position. 4. If the UPS was turned OFF, press the UPS power button to apply power to the UPS

(see the following figure). Figure Legend 1. Acquisition Workstation Power Switch 2. Computer Power On/Reset Button 3. UPS Power Button Figure 15: Universal Acquisition Workstation Power Buttons 5. Turn ON the Acquisition Workstation power switch (see the previous figure). MAN-05085-002 Revision 002 DRAFT Page 29 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 6. Press the computer power button (see the previous figure). The computer powers on and the Startup screen opens on the Acquisition Workstation control monitor. The Gantry then automatically powers on. Figure 16: Startup Screen Note The Startup screen includes a Shutdown button that turns off the system, and a Reboot button that restarts the system. Note The system can require between five minutes and fifteen minutes to prepare for image acquisition. The wait time depends on the detector power configuration. A timer in the Taskbar displays the wait time before the system is ready. Do not acquire clinical or QC images unless the System Status Icon indicates that the system is Ready. Page 30 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4.2 Log In 1. Select the Log In button on the Startup screen. 2. The Select an Operator (Log In) screen opens and shows a list of Manager and Technologist user names. If necessary, select the Show All button to list the Service, Applications, and Physicist user names. 3. Choose an operator by selecting the applicable user name. Figure 17: Select an Operator (Log In) Screen MAN-05085-002 Revision 002 DRAFT Page 31 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4. Type in your password and select Log In.

-OR-

Validate your fingerprint by pressing your finger in the fingerprint scanner. Note Most of the unique, repeatable fingerprint information is from the pad of the finger, not the fingertip. Flat finger placement as shown in the left image results in fast and accurate fingerprint identification. Correct operation Incorrect operation Note If Quality Control tasks are due, the Select Function to Perform screen opens. You can perform the quality tasks or you can select Skip. 4.3 Perform the Functional Tests To make sure that the controls operate correctly, do the Functional Tests as part of your monthly visual checklist. Make sure that all buttons work correctly (Gantry and C-arm control panels, left and right sides). Figure Legend 1. MLO Rotation 2. C-arm Zero 3. Light Field Lamp 4. Motor Enable 5. Collimator Override 6. Clockwise C-arm Rotation 7. C-arm Up and Down 8. Counterclockwise C-arm Rotation 9. Compression Up 10. Compression Down Figure 18: C-arm Control Panel (left side shown) Page 32 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Note C-arm vertical movement and rotation are disabled when compression force is applied. A Service Engineer can configure the lockout force from 22 Newtons (5 pounds) to 45 Newtons (10 pounds). 4.3.1 Compression Functional Tests Table 2: Compression Tests Functional Test Press a Compression Down button:

The compression brake engages. The light field lamp illuminates. The compression device lowers. Note When you press the Compression Down button, the compression brake remains engaged until the Compression Release button is pressed. Compression down movement stops:

When you release the button.

When you reach the Down Force limit.

When you reach the lower travel limit. Press a Compression Up button:

The Compression Device moves toward the top. Note The Compression Up button does NOT release the Compression Brake. Compression up movement automatically stops:

When you release the button.

When you reach the upper travel limit. Function Compression Down Compression Up MAN-05085-002 Revision 002 DRAFT Page 33 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4.3.2 C-Arm Movement Functional Tests C-Arm Up and Down Movement Function C-arm Up Table 3: C-arm Up and Down Movement Functional Test Press the C-arm Up button.

C-arm movement stops when the button is released.

C-arm movement stops when the C-arm reaches the upper travel limit.

C-arm vertical movement and rotation are disabled when compression force is applied. A Service Engineer can configure the lockout force from 22 Newtons (5 pounds) to 45 Newtons (10 pounds). Page 34 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 Function C-arm Down 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Table 3: C-arm Up and Down Movement Functional Test Press the C-arm Down button.

C-arm movement stops when the button is released.

C-arm movement stops when the C-arm reaches the lower travel limit.

C-arm vertical movement and rotation are disabled when compression force is applied. A Service Engineer can configure the lockout force from 22 Newtons (5 pounds) to 45 Newtons (10 pounds). MAN-05085-002 Revision 002 DRAFT Page 35 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown C-Arm Rotation Function Counterclockwise C-arm Rotation Table 4: C-arm Counterclockwise Rotation Functional Test Press the Counterclockwise C-arm Rotation button (item 1) to start counterclockwise C-arm rotation. C-arm movement stops when the switch is released. To fine-tune the C-arm rotation in one degree segments, hold the button down for a second, then let go quickly. Repeat as necessary. Left Panel Right Panel Page 36 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Function Table 5: C-arm Clockwise Rotation Functional Test Clockwise C-arm Rotation Press the Clockwise C-arm Rotation button (item 1) to start clockwise C-arm rotation. C-arm movement stops when the switch is released. To fine-tune the C-arm rotation in one degree segments, hold the button down for a second, then let go quickly. Repeat as necessary. Left Panel Right Panel MAN-05085-002 Revision 002 DRAFT Page 37 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Function C-arm Rotation Switch Table 6: C-arm Rotation Switch Functional Test Push the C-arm Rotation switch away from you to move the C-arm toward you. Pull the C-arm Rotation switch toward you to move the C-arm away from you. C-arm movement stops when the switch is released. Page 38 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown C-Arm Automatic Rotation (Auto-Rotate) Warning:

Risk of entrapment. Make sure that the C-arm has 50 cm (20 inches) of clearance to any object during C-arm rotation. Do not use Auto Rotation when C-arm clearance is less than 50 cm (20 inches). Note To stop the C-arm automatic rotation movement, press any button or the Emergency Stop switch. Motor Enable C-arm Zero Press the Motor Enable button and a Rotation button at the same time to enable auto-rotation movement clockwise or counterclockwise. Press the Motor Enable button and the C-arm Zero button at the same time. Release the buttons. The machine beeps and the C-arm returns automatically to the zero position. Table 7: Automatic C-arm Counterclockwise Rotation Function Automatic Counterclockwise C-arm Rotation Functional Test Press the Motor Enable button (item 1) and the Counterclockwise C-arm Rotation button (item 2) at the same time. Release the buttons. The machine beeps and the C-arm moves automatically counterclockwise. Left Panel Right Panel MAN-05085-002 Revision 002 DRAFT Page 39 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Table 8: Automatic C-arm Clockwise Rotation Function Automatic Clockwise C-

arm Rotation Functional Test Press the Motor Enable button (item 1) and the Clockwise C-arm Rotation button (item 2) at the same time. Release the buttons. The machine beeps and the C-

arm moves automatically clockwise. Left Panel Right Panel Page 40 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown MLO Automatic Rotation Function Automatic Tubehead Rotation to Zero Position Table 9: Automatic MLO Rotation Functional Test Position the C-arm at an angle greater than 15 degrees. Press the MLO Rotation button (item 1). The Tubehead moves automatically to the zero position. The Compression Arm stays in its angled position. Press the MLO Rotation button again to return the Tubehead to its original position. Left Panel Right Panel MAN-05085-002 Revision 002 DRAFT Page 41 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4.3.3 Collimation Function Collimator Override Light Field Lamp Table 10: C-arm Collimation Functional Test The Collimator Override button changes the collimation through the different x-ray fields. Press the Light Field Lamp button to show the x-ray field, then press the Collimator Override button to select an x-

ray field. For compression paddles: Press the Light Field Lamp button to see the x-ray field for two minutes. For localization paddles: Press the Light Field Lamp button to see the x-ray field for the configured amount of time. The default time for biopsy or needle localization paddles is ten minutes. Press the Light Field Lamp button again to turn off the light field lamp. The light field lamp automatically illuminates with the start of the Compression Down movement. Page 42 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4.3.4 Shifting Paddles Note Most paddles can be used with the Shifting Paddle function. The large 24 x 29 cm Frameless Screening Paddle, the large 24 x 29 cm SmartCurve system paddle, and the Magnification paddles are not compatible with the Shifting Paddle function. Use the 18 x 24 cm Frameless Screening Paddle to test the Shifting Paddle function. Function Paddle Shift Table 11: Shifting Paddle Functional Test The 18 x 24 cm Screening Paddle moves approximately 2.5 cm into the left, center, or right position. While compression is applied, you cannot move the paddle. The collimator is programmed to follow the position of the paddle. To test this function:

1. Install the 18 x 24 cm paddle in the Compression Device. 2. Select a view. 3. Use the Paddle Shift buttons on the Procedure screen to override the position. 4. Verify that the paddle automatically moves to the new position. 5. Turn on the light field lamp. 6. Confirm that the collimator position matches the paddle position. 7. Repeat this procedure for the other paddle positions. MAN-05085-002 Revision 002 DRAFT Page 43 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4.4 Emergency Off Switches Functionality There are three Emergency Off switches, one on each side of the Gantry and one on the Acquisition Workstation. 1. To turn Off the Gantry and disable the Acquisition Workstation Lift Mechanism, press any of the Emergency Off switches. 2. To reset the Emergency Off switch, turn clockwise approximately one-quarter turn until the switch pops back out. Figure 19: Emergency Off Switch Functionality 4.5 4.6 How to Turn Off the System 1. Close any open patient procedures. Refer to Close a Patient on page 62. 2. From the Select Patient screen, select the Log Out button. 3. From the Startup screen, select the Shutdown button. 4. Select Yes in the confirmation dialog box. How to Remove All Power from the System See the following figure for illustrations of the buttons and switches referenced in the following procedures. Figure Legend 1. Acquisition Workstation Power Switch 2. Computer Power On/Reset Button 3. UPS Power Button Figure 20: Universal Acquisition Workstation Power Buttons If your system includes the UPS, press the UPS button (item 3). To remove all power from the system:

1. Turn off the system. 2. 3. Turn OFF the acquisition workstation power switch (item 1). 4. Unplug the acquisition workstation power cable from the AC outlet. 5. Turn OFF the Gantry circuit breaker. 6. Turn OFF the Facility Mains circuit breaker. Page 44 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface Chapter 5 5.1 5:User Interface Select Function to Perform Screen After login, the Select Function to Perform screen opens. This screen shows the quality control tasks that are due. Note The Select Patient screen opens when no quality control tasks are scheduled to be done. Figure 21: An Example Select Function to Perform Screen To Complete a Scheduled Quality Control Task:

1. Select a Quality Control task from the list. 2. Select the Start button. Follow the messages to complete the procedure. (The Start button is not available for all types of tests.)

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Select the Mark Completed button to mark the status of this procedure as finished. Select Yes to confirm the selected procedure is completed. 3. Select End QC. MAN-05085-002 Revision 002 DRAFT Page 45 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface To Proceed Without Completing All Scheduled Quality Control Tasks:

If all Quality Control tasks are not completed at this time, select the Skip button. Note If you select the Skip button, the Select Patient screen opens. Refer to Select Patient Screen on page 48 for information about this screen. If you select the Admin button, the Admin screen opens. Refer to Admin Screen on page 111 for information about this screen. Note Quality Control tasks are available to complete at any time. Select the Admin button then the Quality Control button to access the list of Quality Control tasks. 5.2 About the Taskbar The taskbar at the bottom of the screen displays additional icons. Select the icon to access information or perform system tasks. Figure 22: Taskbar Table 12: Taskbar Menus Description Information Icon Menu Select the Information icon to display a menu. This section of the taskbar flashes a yellow color when an alarm exists. Select Acknowledge All to stop the flashing indication. Select Manage Alarms to display and close any open alarms. Current User Name Select the user name section of the taskbar to display the Users Menu. Log Out returns you to the Startup screen. My Settings lets you select user settings and workflow preferences. Print sends the displayed patient list to a connected printer. Output Device Icons Select any output device icon to display the Manage Queues screen. This screen displays the status of jobs in the queue, job information for the selected output, and allows you to filter the queue display. The number on the icon shows the number of jobs that remain in the queue. 1 2 3 Page 46 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 4 5 3Dimensions System User Guide Chapter 5: User Interface Table 12: Taskbar Menus Description Notices Icon Menu Select the Notice icon to display the Patients with Unviewed Notices screen. The number on the icon shows the number of patients with Unviewed Notices. System Status Icons Select the Tubehead icon to display a menu. When the detector and generator are ready for use, a green checkmark appears next to the tubehead icon. If the Tubehead icon is red with a number next to it, the system needs to wait the number of minutes shown before the next image can safely be taken. Clear All Faults deletes all fault messages. X-ray Tube, 0 Degrees puts the tubehead at zero degrees of rotation for the next exposure. X-ray Tube, -15 Degrees puts the tubehead at -15 degrees of rotation for an exposure. X-ray Tube, +15 Degrees puts the tubehead at +15 degrees of rotation for an exposure. System Diagnostics accesses Subsystem settings. System Defaults opens the Gantry Defaults screen to set the Compression and Generator default values. About displays information about the Acquisition Workstation (refer to About Screen on page 113). MAN-05085-002 Revision 002 DRAFT Page 47 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.3 Select Patient Screen Figure 23: Select Patient Screen Item Table 13: The Select Patient Screen Description 1. Quick Search Search the selected tab for the Patient Name, Patient ID, or Accession #. Page 48 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 Item 2. Tabs 3. Buttons 3Dimensions System User Guide Chapter 5: User Interface Table 13: The Select Patient Screen Description Scheduled tab shows the scheduled procedures. In Progress tab shows the procedures not complete. The tabs at the top of the screen are configurable. A user with the correct permissions can delete tabs and create new tabs.

Completed tab shows the completed procedures.

Current User tab shows the procedures for the current operator.

Reject tab shows the procedures with rejected views. Pend tab shows the procedures with pending views.

All tab shows all procedures for all users.

Notices tab shows the patients with unviewed notices by default. Refer to About the Notices Tab on page 50 for complete information.

QC tab shows the Quality Control procedures.

Enterprise tab is displayed if you have the Advanced Workflow Manager on page 56. This tab shows the procedures acquired on all compatible networked systems. Figure 24: Enterprise Tab Many functions are accessed from this screen by selecting a particular button:

Open: Open the selected patient.

New: Add a new patient refer to Add a New Patient on page 50.

Edit: Edit the patient information refer to Edit the Patient Information on page 51. Split: Remove the images from a procedure or a patient and move the images to a different procedure or patient refer to Split the Patient Records on page 51.

Delete: Delete the selected patient refer to Delete a Patient on page 53.

Refresh Worklist: Update the Scheduled Patient Worklist information Filter: Use a Patient Filter refer to Filters for Patients on page 53. refer to Refresh the Worklist on page 55.

Query Worklist: Search for a patient in the Modality Worklist refer to Query the Worklist on page 55.

Admin: Access the Admin Screen refer to Admin Screen on page 111.

Log Out: Exit the system refer to Log Out on page 55. MAN-05085-002 Revision 002 DRAFT Page 49 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.3.1 About the Notices Tab After selecting the Notices tab from the Select Patient screen, a list of the Patients with Notices is shown. The default value for the list is patients with Viewed and Unviewed Notices. You can change the value to show patients with Viewed Notices or patients with Unviewed Notices. Select Open to access the Procedure screen for the selected patient. 5.3.2 Open a Patient 1. Select a tab to show the desired list of patients. 2. Select a patient from the list. The Open button becomes active. 3. Select Open to access the Procedure screen for that patient. 5.3.3 Add a New Patient 1. In the Select Patient screen, select the New button. The Add Patient screen opens. Figure 25: Add Patient Screen 2. Enter the new patient information and select a procedure. 3. Select the Open button. The Procedure screen for the new patient opens. Page 50 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.3.4 Edit the Patient Information 1. 2. 3. Select OK to the Update Successful message. In the Select Patient screen, select the patient name then select the Edit button. In the Edit Patient screen, make changes then select the Save button. 5.3.5 Split the Patient Records The Split function lets you move images when you acquired the images in the wrong procedure or the wrong patient. Note You cannot split images for protected patients. Note Archived patient records still need correction on PACS or other archive systems after using the Split function. Figure 26: Split Patient Records Screen In the Select Patient screen, select the patient. Images Acquired in the Wrong Procedure 1. 2. Select the Split button. The Split Patient Records screen opens. 3. Select the images to move. If all images are being moved, select Select All. MAN-05085-002 Revision 002 DRAFT Page 51 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 4. Select your search criteria (for example, Patient Name or Accession Number) using the drop-down menu below the images. 5. Enter the same patient information and select the Search button (the magnifying glass). If you want to archive the images, select Archive. 6. When the Patient name appears, select the correct procedure for the images. 7. 8. Select Split, then select OK to the Split Successful message. Images Acquired in the Wrong Patient 1. In the Select Patient screen, select the patient that has the images that need to be moved. 2. Select the Split button. The Split Patient Records screen opens. 3. Select the images to move. If all images are being moved, select Select All. 4. Select your search criteria (for example, Patient Name or Accession Number) using the drop-down menu below the images. 5. Enter the search criteria and select the Search button (the magnifying glass). 6. When the Patient name appears, select the correct procedure. Figure 27: Select the Correct Procedure to Split Patient Records 7. If all images are being moved and you want to delete the incorrect patient from the Patient List, check Delete Empty. If you want to archive the images, select Archive. 8. 9. Select Split, then select OK to the Split Successful message. Page 52 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.3.6 Delete a Patient Note Reclamation normally removes the requirement to delete patients manually. Refer to About Reclamation on page 110. In the Select Patient screen, select one or more patients. 1. 2. Select the Delete button. 3. When the confirmation prompt is shown, select Yes. Note The Technologists do not have permissions to delete patients. 5.3.7 Filters for Patients After selecting the Filter button in the Select Patient screen, the Patient Filter screen for the selected patient list opens. Figure 28: Filter Tab in the Patient Filter Screen MAN-05085-002 Revision 002 DRAFT Page 53 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface Filter Tab Use the Filter tab to change the filter options for the patient list. When you select or cancel an option, the change shows in the Results area of the screen. Note You must have Manager level access to save these new filters to the selected tab in the Select Patient screen. (Refer to Other Functions of the Filter Tab on page 54.) Note When you select a line in the results list then select the Open button, the Procedure screen for the selected patient opens. Other Functions of the Filter Tab The Filter tab allows users with access privileges to add, change, or delete tabs in the Select Patient screen. Refer to the following table. Table 14: Filter Tab Options (Require Access Privileges) Change the current patient filter parameters. Create a new tab for the Select Patient screen. Delete a tab from the Select Patient screen. 1. Select a tab on the Select Patient screen. 2. Select the Filter button. 3. Select the filter options. 4. Select the Save button. 5. Make sure the name of the tab you selected is in the name box. 6. Select OK. 1. Select a tab on the Select Patient screen. 2. Select the Filter button. 3. Select the filter options for the tab. 4. Select the Save As button. 5. Enter a new name for the tab. 6. Select OK. 1. Select a tab on the Select Patient screen. 2. Select the Filter button. 3. Select the Delete button. 4. Select Yes in the confirmation dialog box. Page 54 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface Columns Tab Use the Columns tab to add more search options (for example, Age, Gender, Notices) to the filtered list. The options show as columns in the results area. To add more columns to a filtered list, select the Columns tab then select the options. Note You must have Manager level access to save these new columns to the patient filter. Note When you select a line in the results list then select the Open button, the Procedure screen for the selected patient opens. Order Tabs Button Select the Order Tabs button to change the order of the patient list tabs. 5.3.8 Refresh the Worklist Select the Refresh Worklist button to update the Scheduled patient list from the Modality Worklist Provider. 5.3.9 Query the Worklist Select the Query Worklist button to search the Modality Worklist Provider for a patient or a list of patients. There are two methods to enter the query information:

KeyboardType the query information into one or more fields. The scheduled procedure is displayed, and the patient is added to the local database. All fields to query are configurable. The default fields are Patient name, Patient ID, Accession Number, Requested Procedure ID, and Scheduled Procedure Date. Bar Code ScannerScan the bar code for the configured query field. The scheduled procedure is displayed, and the patient is added to the local database. The field in which the bar code scanner scans is configurable. The default query field can be the Patient ID, Accession Number, or Requested Procedure ID. 5.3.10 Admin Select the Admin button to access the Admin screen and the system administration functions. Refer to System Administration Interface on page 111 for more information. 5.3.11 Log Out Select the Log Out button to exit the system and return to the Startup screen. MAN-05085-002 Revision 002 DRAFT Page 55 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.3.12 Advanced Workflow Manager The Advanced Workflow Manager is a workflow engine that allows compatible Hologic systems to communicate and exchange images with each other. The Advanced Workflow Manager keeps track of all patients, procedures, and images acquired on all systems within an Advanced Workflow Manager cluster. In addition, the Advanced Workflow Manager synchronizes notices and provides images to all systems within the cluster. Systems with Advanced Workflow Manager show the Enterprise tab on the Select Patient Screen on page 48. This tab lists the procedures acquired on all systems within an Advanced Workflow Manager cluster. 5.4 Procedure Screen Figure 29: Procedure Screen Page 56 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface Item Table 15: The Procedure Screen Description 1. Image Status The view icon shows the current selected view. Implant Present buttonselect when the patient has an implant. Accept buttonselect to accept the image. Reject buttonselect to reject the image. Pend buttonselect to save the image for future review. Select the Generator tab to adjust the exposure techniques for the procedure. Select the Tools tab to review the images. Select the Biopsy tab to create targets. Select the Contrast tab to perform I-View 2D Contrast procedures. Many functions are accessed from this screen by selecting a particular button:

Add Procedure: Add a new patient. Add View: Add a new view. Edit View: Assign a different view to an image. Archive/Export: Send images to an output. Print: Print images. Retrieve: Query the configured devices with the current patient information. Paddle Shift: Bypass the default paddle position for the selected view. Close Patient: Exit the patient and procedure. Trash Can: Delete a view. Select a tab to show the thumbnail views or the thumbnail images for that procedure. 2. Tabs 3. Buttons 4. Thumbnails 5.4.1 How to Use the Implant Present Button The Implant Present button is above the Accept button on the Procedure screen. This button applies special implant processing to the implant and implant displaced views, and changes the "Implant Present" DICOM tag in the image header. When this button is selected, a check mark appears on the button. Select the Implant Present button for both implant and implant displaced views before you acquire the image. Note The Implant Present button is automatically selected if any procedure tabs contain an ID view. MAN-05085-002 Revision 002 DRAFT Page 57 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.4.2 How to Use the Paddle Shift Feature Refer to Paddle Shift for information about the Paddle Shift feature. 1. In the Procedure screen, select an unexposed thumbnail image view. The paddle moves to the default position for that view. 2. Select a paddle shift button to bypass the default paddle position for the selected view. The paddle moves to the new position. Figure 30: Paddle Shift Buttons 5.4.3 Procedure Name Procedure Information Dialog Box To show procedure information, select the Procedure Information button located below the Delete View (trash can) button. The Procedure Info dialog box opens with the following information:

Accession Number Dose Information (each Breast and Cumulative) For procedures that contain no exposed views, select the Delete Procedure button to remove the selected procedure from the patient. Select Return to Procedure to exit the dialog box. Procedure Status Procedure Start and End Date and Time Page 58 DRAFT Figure 31: Procedure Info Dialog Box MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.4.4 Add a Procedure 1. To add another procedure, select the Add Procedure button on the Procedure screen to access the Add Procedure dialog box. Figure 32: Add Procedure Dialog Box 2. Use the drop-down menus to select the type of procedure to add. 3. The current Accession Number is automatically used. To use a different Accession Number, deselect the "Inherit Accession Number" check box and enter the desired number. 4. Select the OK button. A new tab is added with the thumbnail views for the procedure that was selected. Available Procedures The table that follows shows the major groups of procedures that are available on the system. Note Some procedures in the list show only when the system is licensed for that procedure. Procedure Conventional Combo Tomo TomoHD ComboHD Table 16: Procedure Groups Description Digital mammography (2D) imaging only Digital mammography (2D) and breast tomosynthesis imaging Breast tomosynthesis imaging only Breast tomosynthesis imaging and a generated 2D image Digital mammography (2D) and breast tomosynthesis imaging and a generated 2D image Biopsy that uses stereotactic targeting Stereo Biopsy Tomo Guided Biopsy Biopsy that uses tomosynthesis targeting Specimen 2D Contrast Specialized specimen imaging Contrast enhanced digital imaging MAN-05085-002 Revision 002 DRAFT Page 59 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.4.5 Add (or Remove) a View To Add a View 1. Select the Add View button to access the Add View screen. Note Depending on the license settings for your system, you may see different tabs. View Modifiers ID = Implant Displaced RL = Rolled Lateral RM = Rolled Medial RI = Rolled Inferior RS = Rolled Superior NP = Nipple in Profile AC = Anterior Compression IMF = Infra-Mammary Fold AX = Axillary Tissue Figure 33: Add View Screen 2. Select the tab, then select the view. You can select a maximum of three View Modifiers from the right panel of the screen. 3. Select the Add button. A thumbnail image of each selected view is added in the bottom panel of the screen. To Remove a View To remove a single view from the added list: select the view then select the trash can icon. To remove all views from the added list: select the Clear button. Page 60 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.4.6 Edit a View Use the Edit View screen to assign a different view to an image. Figure 34: Edit View Screen In the Procedure screen, select an exposed thumbnail image view. 1. 2. Select the Edit View button. 3. Select the view from the screen. You can select a maximum of three View Modifiers. See the figure The Add View Screen on page 60 for a description of the View Modifiers. 4. Select Save, then select OK to the Update Successful message. Note The Edit View screen for biopsy procedures shows different View Modifiers. Refer to the Affirm System User Guide. 5.4.7 Retrieve Select the Retrieve button to query the configured devices with the current patient information. The Retrieve button performs the same function as the Query Retrieve button in the Admin screen. MAN-05085-002 Revision 002 DRAFT Page 61 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.4.8 Close a Patient Select the Close Patient button. If images were acquired, a Close Procedure dialog box opens. Select one of the following options:

Close Procedure Complete: Closes the procedure and puts the procedure in the Completed tab. Close Procedure In Progress: Closes the procedure and puts the procedure in the In Progress tab. Close Procedure Discontinue: Closes the procedure and puts the procedure in the All tab. A dialog box opens and you must select the reason the procedure was discontinued from a list or add a new reason. Return To Procedure: Returns to the procedure. If there are images marked as Pend, a dialog box opens with the following options:

Accept All and Close Complete Close Procedure In Progress Return to Procedure If MPPS is activated, procedure status information is sent to the output devices when you select Complete or Discontinue. You can also click and hold the tab above the thumbnail images to resend a message about the procedure status during the procedure. A Procedure Action dialog box opens with buttons to resend a status or to return to the procedure. 5.5 How to Access the Image Review Features Select the Tools tab on the Procedure screen to access the image review features. Refer to Image Review Tools Tab on page 75 for information. Page 62 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.6 Output Groups The accepted images are sent automatically to the output devices in the selected Output Group. The system configuration controls if the images are sent after a patient is closed or after the image is accepted. Note Tomosynthesis images are not sent to a print device in the selected Output Group. You can print selected tomosynthesis images from the Print screen. 5.6.1 Select an Output Group Figure 35: Output Groups Field Select an output device group like PACS, Diagnostic Workstations, CAD devices and printers from the Output Groups drop-down list in the Procedure screen. Note Images are not sent if an Output Group is not selected. 5.6.2 Add or Edit an Output Group Note The configuration of Output Groups occurs during installation, but you can edit existing groups or add new groups. To add a new Output Group:

1. Access the Admin screen. 2. Select the Manage Output Groups button. 3. Select the New button, enter the information, then select the output device(s). 4. Select Add, then select OK in the Update Successful message. 5. You can select any group to set as the default. To edit an Output Group:

1. Access the Admin screen. 2. Select the Manage Output Groups button. 3. Select the Edit button, then make the changes. 4. Select Save, then select OK in the Update Successful message. MAN-05085-002 Revision 002 DRAFT Page 63 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 5.6.3 Custom Output The Custom Output option lets you make an output group from the Procedure screen. The custom group that you make stays as the Custom option until another custom group is made. To Make a Custom Group from the Procedure screen:

1. 2. In the Procedure screen, select Custom from the Output Groups drop-down menu. In the Output Group screen, select from the list of available devices, then select OK. Figure 36: An Example Custom Output Group 5.7 On-Demand Outputs The On-Demand Outputs are Archive/Export or Print. You can manually Archive, Export, or Print the currently opened patient until the procedure is closed. When you select an On-Demand Output button, you have the option to send images from the patient that is open to any of the configured output devices. 5.7.1 Archive 1. Select the Archive/Export button. 2. Select the procedure or views in the On Demand Archive screen:

Select All button selects all items that show in this screen. Clear button deselects items that are selected in this screen. Rejected button shows rejected views for this patient. Priors button shows previous procedures and views for this patient. Page 64 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 3. Select a storage device:

Select the Device List button and make your selection from the options in the Storage Device drop-down menu.

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Select an output group from the Output Group drop-down list. 4. Select the Archive button to send the selected images to the selected archive. Note Use the Manage Queue utility in the taskbar to review the archive status. 5.7.2 Export 1. Select the Archive/Export button (on the right side of the Procedure screen). 2. Select the images to export, then select the Export button. Figure 37: Select the Images for Export MAN-05085-002 Revision 002 DRAFT Page 65 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface 3. In the Export dialog box, select the target from the drop-down menu of media devices. Figure 38: Export Dialog Box To anonymize patient data, select Anonymize To select a folder on your local systems for storage of your selections and to select the Export types, select Advanced. 5.7.3 4. Select the Start button to copy the selected images to the selected device. Print 1. From the Procedure screen, select the Print button to show the Print screen. See the figure The Print Screen on page 67 to prepare your print data. 2. Select the film format from the film format area of the screen. 3. Select a thumbnail image. 4. Select the image mode (Conventional, Projection, or Reconstruction). The C-View button shows if the system is licensed for C-View imaging. 5. Select the print preview area (item 16) in the Print screen. The image that shows in this area is the image that prints on the film. 6. To put other images on the same multiformat film, repeat steps 3 through 5. 7. To print a different film format of the same images, select the New Film button (item 12), then complete steps 2 through 6. 8. Use the buttons in the top left area of the Print screen (item 1 through item 6) to hide or show patient data, markings and annotations, and to change the orientation of the image. 9. Select the Print button to print your films. Page 66 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 5: User Interface Figure 39: Print Screen Figure Legend 1. Show or hide patient data. 2. Show or hide markings and annotations. 3. Show or hide targets in images from a biopsy. 4. Print the image from a dorsal perspective. 5. Print the image from a ventral perspective. 6. Reverse (mirror) the image. 7. Go to previous or next tomosynthesis slice or projection (Tomosynthesis option). 8. Select Conventional, Projection, or Reconstruction views (Tomosynthesis option). The C-View button shows if the system is licensed for C-View imaging. 9. Select the printer options. 10. View Thumbnail images. 11. Select the film format (number of tiles). 12. Create a new film. 13. Delete a film. 14. Delete an image from a film. 15. Step through the film pages. 16. Print preview area. 17. Print Conventional (and C-View images, if system is licensed) with the default setup. 18. Print tomosynthesis images (slices or projections) Tagged for Print (Tomosynthesis option). 19. Return the Print screen to default settings. 20. Open the Properties screen. 21. Show the printer IP address, AE Title, Port and capability for True Size print. 22. Start the print process. 23. Return to the Procedure screen. MAN-05085-002 Revision 002 DRAFT Page 67 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images Chapter 6 6.1 6:Images Image Display Screen After you make an exposure, the acquired image opens on the Image Display monitor. Patient and procedure information can be displayed on the screen. To turn the information on or off, go to the Tools tab in the Procedure screen and select the Patient Information button. Figure 40: Image Display Screen Figure Legend 1. Patient information and exam date 2. Exposure information, including:

Exposure techniques

Patient dose

C-arm angle

Compression thickness and force

Facility and technologist information MAN-05085-002 Revision 002 DRAFT Page 69 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.2 6.2.1 How to Set the Exposure Parameters Select the Image Acquisition Mode (Tomosynthesis Option) Standard Enhanced

For routine Tomosynthesis screening procedures For diagnostic Tomosynthesis views Warning:

Enhanced acquisition mode with combo mode imaging (DM + BT) can produce radiation dose that is higher than the MQSA screening limit of 3.0 mGy and therefore should only be used in diagnostic evaluation. 6.2.2 Select the Exposure Mode Use the Automatic Exposure Control modes (AEC) to let the system control the exposure techniques. AEC modes are available from 20-49 kV.

Manual

AEC: Auto-Time The user selects the kV, Focal Spot, and Filter. The system The user selects the kV, mAs, Focal Spot, and Filter.

AEC: Auto-kV selects the mAs. The user selects the Focal Spot. The system selects the kV, mAs, and Filter (Rhodium).

AEC: Auto-Filter The user selects the Focal Spot. The system selects the kV, mAs, and Filter. 6.2.3 How to Use the AEC Sensor The AEC Sensor has seven manual positions and an automatic position. The manual positions start at the chest wall edge (position 1) and reach toward the nipple edge

(position 7). The automatic position selects two regions within an area that extends from the chest wall to the nipple. Use the plus (+) and minus (-) keys on the Compression Device or in the AEC Sensor area of the screen to change the sensor position. You can select Auto AEC to allow the system to calculate the best exposure for the breast. Page 70 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.3 How to Acquire an Image Refer to Clinical Procedures on page 99 for information about clinical procedures. 1. Select a view from the thumbnail views at the bottom of the Procedure screen. 2. Press and hold the x-ray button and/or the x-ray footswitch for the full exposure. During the exposure:

The System Status bar shows the radiation symbol and a yellow background (see the following figure). Figure 41: Exposure In Progress An audible tone continues to sound during the exposure The audible tone is a continuous sequence of tones. The tone sounds during the entire combo acquisition from the initiation of the exposure to the end of the conventional view. There is no interruption of the audible tone between breast tomosynthesis and conventional digital mammography exposures. Do not release the exposure switch during the audible tone. 3. When the tone stops and the System Status bar shows Standby (see the following figure), release the x-ray button and/or the x-ray footswitch. Figure 42: Exposure Complete MAN-05085-002 Revision 002 DRAFT Page 71 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 4. When the x-ray is finished, the image appears on the Image Display monitor. The Procedure screen automatically changes to the Tools tab. Select one of the following options to complete the acquisition:

Accept the image. The image transmits to output devices with all attributes. Reject the image. When the dialog box opens, select the reason for rejecting the image. The Image Display screen closes. You can repeat the rejected view, or select another view. If you select Reject, an "X" appears on the thumbnail image. Pend the image. The image saves for future review. If you select Pend, a question mark "?" appears on the thumbnail image. Figure 43: Marked Images in a Procedure 5. Repeat steps 1 through 4 for each view. Note A manager user can configure the system to Auto-Accept or Auto-Pend new images. 6.3.1 Conventional Imaging Sequence of Events 1. Review the image after the exposure and add a comment, if necessary. 2. Accept, Reject, or Pend the image. A thumbnail image replaces the thumbnail view in the Case Study area of the screen. Note A manager user can configure the system to Auto-Accept or Auto-Pend new images. 6.3.2 Tomosynthesis Imaging Sequence of Events 1. Wait for the image reconstruction to complete. 2. Review the projection images for motion. 3. Accept, Reject, or Pend the images. A thumbnail image replaces the thumbnail view in the Case Study area of the screen. Note A manager user can configure the system to Auto-Accept or Auto-Pend new images. Page 72 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.3.3 How to Accept a Rejected Image If a rejected image is better than the new image, you can retrieve and use the old image. Select the thumbnail image on the Procedure screen to review the image, then Accept the image. 6.3.4 How to Accept or Reject a Pended Image To accept or reject a Pended image, select the Pended thumbnail image, then select the Accept button or the Reject button. Note A manager user can configure the system to Auto-Accept or Auto-Pend new images. 6.4 How to Correct and Reprocess Implant Images You must correct the image if you acquire an implant or an implant displaced view without the Implant Present button activated. 6.4.1 If the Image Is Not Accepted Select the Implant Present button on the Procedure screen to indicate an implant exists. A check mark appears on the button and the image reprocesses. 6.4.2 If the Image Is Accepted 1. Select the image. 2. Select the Implant Present button on the Procedure screen to correct the image. A check mark appears on the button and the image reprocesses. 3. Select the Accept button to accept the changes. Note The corrected image is sent automatically to the selected output devices if the system is set to send images when the Accept button is selected. MAN-05085-002 Revision 002 DRAFT Page 73 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.5 How to Review the Images Review of the images involves use of the thumbnails, image review tools, and display modes. Figure 44: Tools Tab (Tomosynthesis option shown) Figure Legend Image Review Tools - refer to Image Review Tools Tab on page 75. Image Display Modes - refer to Display Modes on page 77. 1. 2. 3. Thumbnail Views and Thumbnail Images. Select any thumbnail image to display that image on the Image Display monitor. Page 74 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.5.1 Image Review Tools Tab The Tools tab in the Procedure screen provides the image review tools. A check mark appears on an active tool. Figure Legend 1. The Zoom tool magnifies a section of the image. 2. The Ruler tool measures the distance between two points. 3. The Crosshair tool displays a crosshair on the Image Display screen. 4. The Demetalizer tool for processing tomosynthesis images that contain metal objects. 5. The Window/Level tool changes the brightness and contrast. 6. The Window/Level Fine Adjustment tool allows the entry of specific window and level values. 7. The LUT Selection tool scrolls through available Window/Level settings for a displayed image with LUTs attached. 8. The AEC button displays the AEC Sensor areas used for the exposure calculation. The sensor areas display on the Image Display screen. Figure 45: Image Review Tools 9. The Patient Information button activates the patient information display. 10. The Auto-Hanging button automatically hangs the currently selected study in a 4-up configuration. 11. The Auto-Pairing button turns off auto-pairing for the currently selected image in a multi-up configuration. 12. The SNR/CNR button calculates the signal-to-noise ratio and contrast-to-noise ratio on the ACR Phantom. 13. The Fit-to-Viewport button fits the image within the image tile. 14. The True Size button displays the image in the actual size of the breast. 15. The View Actual Pixels button displays the image in full resolution. 16. The Multi-Up Display button selects the number of tiles to display. 17. The Image Tile Advance button sets the active Multi-Up tile. 18. The Invert Image tool changes blacks to whites and whites to black. 19. The Mirror button reverses (mirrors) the image. 20. The Tag for Print button tags the projection or reconstruction images of a tomosynthesis image to print later. MAN-05085-002 Revision 002 DRAFT Page 75 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.5.2 Notices Tab The tools on the Notices tab allow you to mark and annotate images and send notices about the displayed image or procedure. The Notice Output Groups drop-down menu at the bottom of the tab allows you to select the destination for the Notices. Figure 46: Tools on the Notices Tab Figure Legend 1. The Oval tool draws an oval marking on the image. 2. The Ruler tool measures the distance between two points. 3. The Freehand tool draws a freehand marking on the image. 4. The Text tool adds a text note to the image without a marking. 5. The Arrow tool draws an arrow marking on the image. 6. The Markings tool shows or hides markings and annotations on an image. 7. The Send Notice tool sends a notice for the current image to the selected destination. 8. The Send All Notices tool sends all notices for all images in the opened procedure to the selected destination. 9. The Viewed tool changes the Patient Notices status to viewed. Page 76 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.5.3 Other Image Review Tools Other Tabs Comments: Add comments to an image. Service: Mark an image for service use. ROI: Draw a Region of Interest on the Image Display monitor. Cine: Show a series of images as a movie (Tomosynthesis option). Exposure Index The Exposure Index is an image quality guide. When the Exposure Index indicates the red or yellow area, review the selected image for noise and decide whether to reacquire the image. Figure 47: Exposure Index Display Modes Use the buttons in the Display Modes area of the screen to select the type of view to show on the Image Display monitor. You can change between conventional, generated 2D, projections, and reconstructions to show the combination images. Figure 48: Display Modes Figure Legend 1. Conventional button shows conventional images. 2. Generated 2D button shows a conventional 2D image generated from the acquired tomographic image. 3. Projections button shows the 15 projection images. 4. Reconstructions button shows reconstructed slices. MAN-05085-002 Revision 002 DRAFT Page 77 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.5.4 Slice Indicator The Slice Indicator on the Image Display monitor shows only on tomographic reconstructions. Figure Legend 1. Up and Down arrows let you change between slices that contain a lesion target and slices that are tagged for printing. 2. Up and Down arrows let you change between slices that contain notices. 3. H (anatomical reference to head direction) 4. Slices that contain targets or are tagged for printing. 5. Slices that contain notices. 6. Scroll bar moves through the slices of the reconstruction. 7. F (anatomical reference to foot direction) Figure 49: Slice Indicator 6.6 How to Send the Images to the Output Devices You can send the images to output devices or use the Archive/Export function to copy images to temporary storage media. Refer to Output Groups on page 63 and On-Demand Outputs on page 64 for instructions. Page 78 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.7 How to Use I-View 2D Contrast 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. Select the Contrast tab to access the I-ViewTM 2D Contrast (CE2D) function. Figure 50: I-View 2D Contrast Screen 2. Set the contrast settings. For more information, refer to How to Set the Contrast Defaults on page 119. Note When you set contrast information, it appears in the DICOM header of the images. MAN-05085-002 Revision 002 DRAFT Page 79 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 3. To begin the contrast dose and start the timer, select the Start (arrow) button. The timer begins in the Waiting Period, which appears with a yellow background. Note You can adjust the default length of time for the Waiting Period and Optimal Imaging Period phases of the timer. Refer to How to Set the Contrast Defaults on page 119. Figure 51: I-View 2D Contrast Screen, Waiting Period Note The timer function does not allow you to stop the timer, only to start and reset it. The timer stops only when you exit the patient procedures. After the Waiting Period, the timer begins the Optimal Imaging Period, which appears with a green background. Page 80 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 4. Acquire the images during the Optimal Imaging Period. After you acquire an image, a marker will appear below the timer. Figure 52: I-View 2D Contrast Screen, Optimal Imaging Period 5. Select the low and high exposure buttons to acquire both low and high energy images. Low: Conventional low-energy image Sub: Contrasted, subtracted image Low Sub: Shows both the low and sub screen images side-by-side in a split screen. Caution:

Using I-View 2D Contrast increases the recovery time the machine needs before more images are acquired. When the x-ray tube status icon appears red recommended wait time is shown. This wait time lets the x-ray tube temperature decrease to avoid damage that can void the x-ray tube warranty. Always make sure

, a that the x-ray tube status icon is green procedure. If the x-ray tube status icon turns red during a procedure, complete the procedure quickly using the minimum number of exposures. before starting an I-View 2D Contrast MAN-05085-002 Revision 002 DRAFT Page 81 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 6: Images 6.7.1 How to Configure Contrast Settings 1. From the Contrast tab, select the Configure Contrast button to edit the contrast settings. The Contrast Information dialog box opens. Figure 53: I-View 2D Contrast Information 2. Use the drop-down menus to select the appropriate settings. 3. Enter data for the Contrast Concentration Per Body Weight field or the Amount of Contrast Agent field. The other field automatically populates with the correct information. 4. Click Save & Close. Page 82 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories Chapter 7 7:Accessories The system can perform screening or diagnostic applications with specified accessories. This chapter describes how to use all possible system accessories. Note Hologic configures some systems to meet specific requirements. Your system configuration may not have all the options and accessories included in this manual. 7.1 How to Install Accessories on the C-Arm The Retractable Face Shield, Magnification Stand, and Localization Crosshairs are installed in slots on the C-arm. The slots have labels with icons to indicate the accessory that attaches in the slot. Each accessory has two lines. Align the accessory with the related line on the C-arm. When the hook on the accessory is at the correct depth, the second, thinner line aligns with the line on the C-arm. The next sections contain installation instructions for each accessory. Figure 54: C-arm Accessories Figure Legend 1. Slot for Retractable Face Shield (Tomosynthesis option) or the Affirm breast biopsy guidance system (biopsy option) 2. Slot for 1.8x Mag Stand and Localization Crosshairs 3. Slot for 1.5x Mag Stand MAN-05085-002 Revision 002 DRAFT Page 83 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.2 Patient Face Shields The Face Shield keeps the head and face of the patient away from the x-ray field during the examination. Inspect the shield each day before use. Warning:

The Face Shield must be attached for all exposures except magnification case studies. Warning:

The Face Shield does not protect the patient from radiation. 7.2.1 How to Install and Remove the Retractable Face Shield To install the Retractable Face Shield:

1. Completely extend the Face Shield to the outer position. 2. Align the hooks of the Face Shield with the mounting slots on the C-arm, indicated by a face shield icon. 3. Put the hooks on both sides of the Face Shield into the mounting slots on the C-arm. The Unlock Lever (see item 1 in the following figure) is in the Up position. 4. Push the Face Shield to the down and locked position. The Unlock Lever is in the Down position when the Face Shield locks. Figure 55: Align the Retractable Face Shield on the C-arm To remove the Retractable Face Shield:

1. Press and hold the Unlock Lever (see item 1 in the previous figure) in the Up position. 2. Lift the Face Shield from the slots and remove from the C-arm. Page 84 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018

3Dimensions System User Guide Chapter 7: Accessories 7.2.2 How to Use the Retractable Face Shield Note Before you make an exposure, make sure the Face Shield is completely extended or completely retracted. To extend the Face Shield, pull the Face Shield away from the C-arm until the device latches in the outer position. To retract the Face Shield:

1. Press a Latch Release (see item 2 in the figure Face Shield Operation on page 85one on each side). 2. Push the Face Shield toward the C-arm until the device stops. Figure 56: Face Shield Installation Figure 57: Face Shield Operation MAN-05085-002 Revision 002 DRAFT Page 85 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.2.3 How to Install and Remove the Conventional Face Shield Figure 58: How to Install the Conventional Face Shield To install the Conventional Face Shield:

1. Carefully put the tab ends of the Face Shield (item 1 in the previous figure) into the slots at the front of the tubehead mount. 2. Slide the Face Shield on the tubehead mount until the Face Shield locks. To remove the Conventional Face Shield:

1. Pull the sides of the Face Shield in a horizontal direction (away from the tubehead). 2. Remove the Face Shield. Page 86 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.3 Compression Paddles Note Some paddles are optional and may not be included with your system. The system can identify each paddle and automatically adjust the collimator. Available accessories depend on your system configuration. Table 17: Available Accessories Accessory 2D/BT 2D Screening Routine Screening Paddles 18 x 24 cm 24 x 29 cm Small Breast 18 x 24 cm SmartCurve 24 x 29 cm SmartCurve Contact and Spot Compression Paddles 10 cm Contact 15 cm Contact 7.5 cm Spot Contact Frameless Spot Contact Magnification Paddles 7.5 cm Spot Mag 10 cm Mag 15 cm Mag Localization Paddles 10 cm Rectangular Open 15 cm Rectangular Open 10 cm Perforated 15 cm Perforated 10 cm Mag Perforated Loc 10 cm Mag Localization 15 cm Large Ultrasound Ultrasound Paddle Patient Face Shield Magnification Stand Localization Crosshair Device Magnification Crosshair Device

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MAN-05085-002 Revision 002 DRAFT Page 87 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories Note On the 2D screening system, only use the 7.5 cm Spot Contact Paddle for compression thickness calibration. Note The 24 x 29 cm frameless screening paddle, the 24 x 29 cm SmartCurve system paddle, the magnification paddles, and the localization paddles are NOT compatible with the paddle shift function. 7.3.1 Routine Screening Paddles 18 x 24 cm Frameless Screening Paddle 24 x 29 cm Frameless Screening Paddle Small Breast Frameless Paddle SmartCurve System Paddles Warning:

The SmartCurve system paddles do not meet the IEC 60601-2-45 standards for minimum range of movement that require the paddle to compress to 10 mm. To ensure adequate compression of very small or very thin breasts, use the standard flat screening paddle. 18 x 24 cm SmartCurve System Frameless Screening Paddle 24 x 29 cm SmartCurve System Frameless Screening Paddle Note The SmartCurve system paddles may not be suitable for patients with very small breasts. If the breast cannot be properly immobilized or compressed due to the curvature of the paddles, use the standard flat screening paddles. Page 88 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories Note The SmartCurve system paddles are not recommended for cleavage views, rolled views, or mosaic views of very large breasts. Use the standard flat screening paddles for these views. Note The SmartCurve system paddles accommodate most breast sizes. Due to the curvature of the paddles, some patients who would use the smaller standard flat paddle may be more easily positioned using the larger SmartCurve paddle. Note SmartCurve system paddles are not compatible with FAST Compression mode. 7.3.2 Contact and Spot Compression Paddles 10 cm Contact Frameless Paddle 15 cm Contact Frameless Paddle 7.5 cm Spot Contact Frameless Paddle Spot Contact Frameless Paddle 7.3.3 Magnification Paddles 7.5 cm Spot Magnification Paddle 10 cm Magnification Paddle 15 cm Magnification Paddle Note You cannot acquire Tomosynthesis images with the Magnification paddles. MAN-05085-002 Revision 002 DRAFT Page 89 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.3.4 Localization Paddles 10 cm Rectangular Opening Localization Paddle 15 cm Rectangular Opening Localization Paddle 10 cm Magnification Localization Paddle 10 cm Perforated Localization Paddle 15 cm Perforated Localization Paddle 10 cm Magnification Localization Perforated Paddle 7.3.5 Large Ultrasound Paddle 15 cm Large Ultrasound Paddle Page 90 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.3.6 How to Install and Remove a Compression Paddle See the figure How to Install a Compression Paddle on page 91 to install a Compression Paddle:

1. Hold the front of the paddle with one hand in front of the Compression Device. 2. Tilt the paddle (between 30 and 45 degrees), then put the rear of the paddle on the groove in the rear of the Compression Device (item 1). 3. Slide the paddle along the groove until the slots on the top of the paddle are under the locks on the Paddle Clamp (item 2). 4. Compress the Paddle Clamp (item 3) with your free hand. 5. Rotate the paddle up (item 4), then release the Paddle Clamp to lock the paddle. Figure 59: How to Install a Compression Paddle See the figure How to Remove the Compression Paddle on page 91 to remove the Compression Paddle:

1. Hold the paddle with one hand while you use the free hand to compress the Paddle Clamp to release the lock (item 1). 2. Lower the paddle (item 2) and remove the paddle from the Compression Device

(item 3), then release the Paddle Clamp. Figure 60: How to Remove a Compression Paddle 7.3.7 Paddle Maintenance and Cleaning Clean the paddles after each use. Refer to Maintenance and Cleaning on page 105 for cleaning instructions. MAN-05085-002 Revision 002 DRAFT Page 91 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.3.8 Paddle Shift The system allows most paddles to move to the left or right of the center position. The feature helps small-breast examinations with lateral views. When a lateral view is selected, the system automatically moves the collimator for the selected paddle position. 7.3.9 Note The 24 x 29 cm frameless screening paddle, the 24 x 29 cm SmartCurve system paddle, and the magnification paddles are NOT compatible with the paddle shift function. FAST Compression Mode About FAST Compression Mode The Fully Automatic Self-adjusting Tilt (FAST) Compression Mode is for use when the composition of the breast tissue does not allow uniform compression across the complete breast with a flat compression paddle. For these patients, not enough compression can cause an image to appear to be out of focus at the anterior region from both involuntary motion and not enough compression. The FAST Compression mode used with this type of breast provides these features:

More uniform compression, from the chest wall to the nipple Maximum patient comfort, because over compression at the chest wall is prevented Reduced motion artifacts, because the compression is more effective When the FAST Compression mode is selected, the paddle automatically tilts when compression is applied. The paddle starts at the flat position until some compression force is applied. The paddle then tilts until its maximum angle is reached. The FAST Compression mode does not require excessive compression, but you must use enough compression to prevent the movement of the breast. You should use a consistent amount of compression, especially for related left and right views. The FAST Compression mode may not be best for breasts that are equal or symmetrical in thickness from the chest wall to the anterior area of the breast. Note Only the 18 x 24 cm Frameless Screening Paddle and the 24 x 29 cm Frameless Screening Paddle are compatible with FAST Compression Mode. Note The system beeps when FAST Compression Mode is engaged but is not compatible with the current paddle. Page 92 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories How to Use the FAST Compression Mode Slide To engage FAST Compression Mode, push the slide (from either side) until the "F" is visible and the slide clicks into position. Figure 61: The FAST Compression Mode Slide 7.4 Magnification Stand The Magnification Stand has a breast platform and an abdominal shield. When the Magnification Stand is installed, the grid automatically retracts and the x-ray exposure techniques are set to the Magnification default values. Only use the Magnification paddles when the Magnification Stand is installed (refer to Magnification Paddles on page 89). 7.4.1 How to Install and Remove the Magnification Stand Figure 62: Installation of the Magnification Stand MAN-05085-002 Revision 002 DRAFT Page 93 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories To Install the Magnification Stand 1. Remove the Face Shield (refer to Patient Face Shields on page 84). 2. Remove the compression paddle (refer to How to Remove the Compression Paddle on page 91). 3. Move the Compression Device completely to the top. 4. Hold the stand on each side just below the black buttons, item 4. Do not press the black buttons. Note The black buttons are used only when removing the Magnification Stand. Note There are two sets of mounting slots for the Magnification StandOne set is for 1.8x, and the other set is for 1.5x. See numbers 2 and 3 in the figure C-arm Accessories on page 83. 5. Align the thick black lines on the Magnification Stand with the thick black lines on the C-arm. When these lines meet, the hooks of the Magnification Stand align to the mounting slots on the C-arm. See item 1 in the previous figure. 6. Put the hooks of the Magnification Stand into the C-arm slots. Slide the Magnification Stand down, until the thin black lines on the Magnification Stand and the black line of the C-arm meet. See item 2 in the previous figure. 7. The locking pins slide into holes and lock the device. You hear an audible click. Note If the Magnification Stand is not installed correctly, there is an indicator with a red shaft which protrudes. See item 3 in the previous figure. When the stand is installed correctly, the indicator is retracted. To Remove the Magnification Stand 1. Remove the Magnification paddle. 2. Hold the handles of the Magnification Stand and press the black buttons. 3. Lift and remove the device from the C-arm. Page 94 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories Crosshair Devices 7.5 7.5.1 How to Install and Remove the Localization Crosshair Device Figure 63: Installation of the Localization Crosshair Device To Install the Localization Crosshair Device 1. Remove the face shield (refer to Patient Face Shields on page 84). 2. Move the Compression Device below the mounting slots, indicated by a crosshair icon. See item 2 in the figure C-arm Accessories on page 83. 3. Hold the crosshair device by the handles and align the thick lines on the device with the line on the C-arm. Compress the release levers. 4. Put the hooks into the C-arm slots. 5. Slide the hooks toward the bottom until the thin black lines on the crosshair meet the black line on the C-arm. 6. Release the levers. The locking pins slide into holes and lock the device in position. To Remove the Localization Crosshair Device 1. Compress the release levers. 2. Lift the frame toward the top and remove the hooks from the C-arm slots. MAN-05085-002 Revision 002 DRAFT Page 95 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.5.2 How to Use the Localization Crosshair Device 1. The crosshair device rotates to the left or right of the tubehead. Rotate the device away from the x-ray beam during the exposure acquired with the localization paddle. 2. When you rotate the device back to the front for use, make sure the rotation continues until the device clicks into position. 3. Turn on the light field lamp. 4. Rotate the two crosshair knobs until the shadow on the breast matches the crosshairs on the image that identifies the suspect lesion. 7.5.3 How to Install and Remove the Magnification Crosshair Device Figure 64: How to Install and Remove the Magnification Crosshair Device To Install the Magnification Crosshair Device 1. Remove the face shield (refer to How to Install and Remove the Conventional Face Shield on page 86). 2. Align the Magnification Crosshair Device with the tubehead. 3. Slide the crosshair device on the rails on each side of the tubehead that are used by the Conventional Face Shield. Make sure the device locks into position. Install the remaining magnification devices. 4. To Remove the Magnification Crosshair Device 1. Hold the sides of the device. 2. Pull the device toward you and remove from the tubehead. Page 96 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 7: Accessories 7.5.4 How to Align the Crosshair Device Note If the crosshair light rectangle appears skewed to the opening in the paddle, perform this alignment procedure. Install the rectangular localization paddle. 1. 2. Loosen the adjustment lock screw on the bottom of the Crosshair Device. 3. Put a piece of white paper on the image receptor to make the shadows of the crosshairs easier to see. 4. Move the localization paddle approximately 6 cm above the image receptor. 5. Turn on the light field. 6. Rotate the Crosshair Device until the rectangle of light aligns with the opening in the localization paddle. 7. Tighten the adjustment screw. MAN-05085-002 Revision 002 DRAFT Page 97 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 8: Clinical Procedures Chapter 8 8:Clinical Procedures Warning:

C-arm movement is motorized. Warning:

Keep the hands of the patient away from all buttons and switches at all times. Warning:

Place each footswitch in a position where, when used, they remain in reach of the Emergency Off Switches. Warning:

Position the footswitches to prevent accidental operation by a patient or wheelchair. 8.1 8.1.1 Standard Workflow Preparation 1. Select a patient from the worklist, or manually add a new patient. 2. 3. Select the output device set if a different or additional device is needed. 4. 5. Select the first view. Identify the required procedures. Install the paddle. 8.1.2 At the Gantry 1. Set C-arm height and rotation angle. 2. Make sure the light field illuminates the correct area. 3. Position the patient and compress the breast. MAN-05085-002 Revision 002 DRAFT Page 99 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 8: Clinical Procedures 8.1.3 At the Acquisition Workstation 1. Set the exposure technique. 2. Acquire the image. 3. Release the patient. 4. Preview the image. Look at the Exposure Index to make sure that the exposure is within acceptable range. 5. You can use the Window/Level tool or other image review options during image preview. 6. Accept, Reject, or Pend the image. 7. Perform the Acquisition cycle as required for the requested procedures. 8. 9. Make sure that the patient is safely away from the system after you complete the If necessary, add an additional view or procedure. examination. 10. Close the procedure. 8.2 Screening Procedure Example Figure 65: Example of a Screening Procedure Screen Page 100 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 8: Clinical Procedures 8.2.1 Position the Patient 1. Lift or lower the breast platform for the patient. 2. Move the tubehead to the projection angle. 3. Move the patient to the C-arm. 4. Position the patient as required. 5. Put the arm or hand of the patient on the Patient Handle or against the side of the body. 6. Tell the patient to keep away from system controls. 7. Compress the breast. When possible, use the footswitch controls to provide hands-free compression control and C-arm height adjustment. Use the light field lamp as necessary to see the x-ray field. Apply compression slowly. As necessary, stop and make the adjustments to patient position. Use the handwheels for final compression. 8.2.2 Set the Exposure Techniques Select the exposure techniques for the procedure. Refer to How to Set the Exposure Parameters on page 70 for information. 8.2.3 Acquire the Exposure 1. Confirm that all exposure factors are set correctly. 2. If the system does not display Ready in 30 seconds, verify that the accessories are correctly installed and the paddle is locked into position. When the generator status displays Ready, the system is ready for exposure. Warning:

This system can be dangerous to the patient and the user. Always follow the safety precautions for x-ray exposures. MAN-05085-002 Revision 002 DRAFT Page 101 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 8: Clinical Procedures 3. Press and hold the x-ray button and/or the x-ray footswitch for the full exposure. During the exposure:

A System Message with the radiation symbol and a yellow background is displayed (see the following figure) An audible tone continues to sound during the exposure The behavior of the audible tone during a combo exposure has changed to avoid early releases of the x-ray button and/or the x-ray footswitch by users. The audible tone is now a continuous sequence of tones. The tone sounds during the entire combo acquisition from the initiation of the exposure to the end of the conventional view. There is no interruption of the audible tone between breast tomosynthesis and conventional digital mammography exposures. Do not release the exposure switch during the audible tone. Figure 66: Exposure In Progress 4. When the tone stops and the System Message shows Standby (see the following figure), you can release the x-ray button and/or the x-ray footswitch. Figure 67: Exposure Complete 5. Release the compression device. If the automatic release feature is set, the compression device automatically lifts after the exposure. Page 102 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 8.3 3Dimensions System User Guide Chapter 8: Clinical Procedures Procedure for Needle Localization with Tomosynthesis 1. Install a Localization Paddle, and install the Crosshair Device at the Tubehead. Be sure that the crosshair guides are out of the x-ray field. 2. Open a new procedure with a Tomo or TomoHD view for your approach. 3. Position the patient and apply compression. 4. Acquire a Tomo Scout. Make sure that the ROI is visible inside the Localization Paddle opening. If not, reposition the patient and repeat. 5. Note the Compression Thickness, and note the thickness of the excess tissue through the opening of the Localization Paddle. 6. Scroll through the reconstruction slices to identify where the lesion is best seen. Note the slice number (each slice is 1 mm in thickness). 7. Place the Acquisition Workstation crosshair on the lesion. 8. To find the coordinates for the Gantry Crosshair Device, scroll through the reconstructions until you can identify the alpha numeric coordinates. 9. Calculate the needle depth:

Value Breast Compression Thickness

(+) Thickness of the tissue through the opening of the paddle

(-) Slice number where the lesion is found

(+) Optional distance past the ROI for the wire

(=) Needle depth of the localization wire Example 50 mm

+ 7 mm

- 30 mm

+ 5-15 mm 32 42 mm 10. Turn on the collimator light and align the Crosshair Device at the Tubehead to match the Acquisition Workstation crosshair. 11. Position and insert the needle. 12. Move the Crosshair Device guides out of the x-ray field. 13. Acquire another Tomo image to be sure that the needle is in the correct location. To calculate if a correction is necessary, compare the slice number of the point of the needle and the slice number of the lesion. 14. Insert the guide wire through the needle, and then remove the needle, if desired, leaving the wire in position. 15. If desired, complete the following steps:

a. Acquire a Conventional or Tomo view to be sure of correct wire placement. b. Take the orthogonal view to document wire or needle placement (either in Tomo or conventional). 16. Only add one view icon at a time for orthogonal views to remove the possibility of paddle shift due to possible minimal compression. MAN-05085-002 Revision 002 DRAFT Page 103 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 8: Clinical Procedures Example: Calculating Needle Depth with Tomosynthesis In this example, use the values from the table on the previous page and refer to the following figure. Calculate the needle depth from the tissue skin line (item 1) rather than from the localization paddle (item 9). Insert the needle a minimum of 27 mm (breast compression

+ bulging tissue). Figure 68: Calculating needle depth Item Description Thickness of the tissue through the opening of the localization paddle Thickness measured from the localization paddle to the lesion Lesion slice number (the slice number where lesion is best seen (clearest)) 30 mm 1 2 3 4 5 Thickness measured from the detector to the lesion Slice number 1 6 Needle 7 8 9 10 Lesion Advancing the needle 5 - 15 mm more than the lesion (optional) Localization paddle Thickness of the breast compression from the detector (0 mm) to the localization paddle (50 mm in this example) Example 7 mm 5 - 15 mm 50 mm Page 104 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 9: Maintenance and Cleaning Chapter 9 9:Maintenance and Cleaning Cleaning 9.1 9.1.1 General Information About Cleaning Before each examination, clean and use a disinfectant on any part of the system which touches a patient. Give the attention to the paddles and the image receptor. Caution:

Do not use any hot source (like a heating pad) on the image receptor. Be careful with the compression paddles. Inspect the paddles. Replace the paddle when you see damage. 9.1.2 For General Cleaning Use a lint-free cloth or pad and apply a diluted dishwashing liquid. Caution:

Use the least possible amount of cleaning fluids. The fluids must not flow or run. If more than soap and water is required, Hologic recommends any one of the following:

10% chlorine bleach and water with one part commercially available chlorine bleach

(normally 5.25% chlorine and 94.75% water) and nine parts water Commercially available isopropyl alcohol solution (70% isopropyl alcohol by volume, not diluted) 3% maximum concentration of hydrogen peroxide solution After you apply any of the above solutions, use a pad and apply a diluted dishwashing liquid to clean any parts which touch the patient. Warning:

If a paddle touches possible infectious materials, contact your Infection Control Representative to remove contamination from the paddle. Caution:

To prevent damage to the electronic components, do not use disinfectant sprays on the system. MAN-05085-002 Revision 002 DRAFT Page 105 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 9: Maintenance and Cleaning 9.1.3 To Prevent Possible Injury or Equipment Damage Do not use a corrosive solvent, abrasive detergent, or polish. Select a cleaning/disinfecting agent that does not damage the plastics, aluminum, or carbon fiber. Do not use strong detergents, abrasive cleaners, high alcohol concentration, or methanol at any concentration. Do not expose equipment parts to steam or high temperature sterilization. Do not let liquids enter the internal parts of the equipment. Do not apply cleaning sprays or liquids to the equipment. Always use a clean cloth and apply the spray or liquid to the cloth. If liquid enters the system, disconnect the electrical supply and examine the system before returning it to use. Caution:

Wrong cleaning methods can damage the equipment, decrease imaging performance, or increase the risk of electric shock. Always follow instructions from the manufacturer of the product you use for cleaning. The instructions include the directions and precautions for the application and contact time, storage, wash requirements, protective clothing, shelf life, and disposal. Follow the instructions and use the product in the most safe and effective method. Page 106 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 9: Maintenance and Cleaning 9.1.4 Acquisition Workstation How to Clean the Image Display Screen Avoid touching the display screen of the Image Display monitor. Use care when cleaning the outer surface of the LCD screen. Always use a clean, soft, lint-free cloth to clean the display area. Microfiber cloths are recommended. Never use a spray or flow a liquid on the display. Never apply any pressure to the display area. Never use a detergent with fluorides, ammonia, alcohol, or abrasives. Never use any bleach. Never use any steel wool. Never use a sponge with abrasives. There are many commercially available products to clean LCD displays. Any of the products free of the ingredients described above and used according to the directions of the manufacturer can be used. How to Clean the Touchscreen Display Use a window or glass cleaning product to clean the Touchscreen display. Apply the cleaning product to a cloth, then clean the Touchscreen display. Do not apply the cleaning product to the display without the cloth. How to Clean the Keyboard Wipe the surfaces with a CRT wipe. If necessary, clean the keyboard with a vacuum. If liquids enter the keyboard, contact Technical Support for a replacement. How to Clean the Fingerprint Scanner Caution:

To protect the Fingerprint Scanner:

Do not apply any liquid product directly on the Fingerprint Scanner window.

Do not use products that contain alcohol.

Never put the Fingerprint Scanner under liquid.

Never apply any pressure to the Fingerprint Scanner window with abrasive material.

Do not push the Fingerprint Scanner window. To clean the Fingerprint Scanner window, do one of the following:

Apply the adhesive side of cellophane tape, then remove the tape. Apply a product with ammonia base to a cloth, and clean the Fingerprint Scanner window. MAN-05085-002 Revision 002 DRAFT Page 107 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 9: Maintenance and Cleaning 9.2 9.2.1 Maintenance Preventive Maintenance Schedules Table 18: User Preventive Maintenance Recommended Frequency Maintenance Task Description Clean & disinfect paddle Clean & disinfect breast platform Visually inspect all paddles for damage Detector Flat Field Calibration *

Artifact Evaluation *

Phantom Image *

Signal to Noise / Contrast to Noise Measurements *

Geometry Calibration

(Tomosynthesis Option) *

Compression Thickness Indicator *

Visual Checklist *

Compression *

Each Use x x x Weekly Biweekly Monthly Bimonthly Semiannually x x x x x x x x

* Refer to Quality Control Manual Page 108 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 9: Maintenance and Cleaning Table 19: Service Engineer Preventive Maintenance Maintenance Task Description Recommended Frequency Semiannually Annually Clean and Inspect the Gantry and Acquisition Workstation Inspect the radiation shield for chips, cracks, breaks, and for tight attachments. Check all primary power connections Check interlocks, safety and limit switches Inspect/Lubricate C-arm C-arm / Verify all C-arm buttons Verify C-arm and Rotational Calibration Replace Breast Platform Filter Verify Compression Force Calibration Verify Compression Thickness Calibration Inspect LED Collimator Lamp for dust and dirt Clean & lubricate collimator, and worm screws Perform Rotational Brake verification Verify X-ray Field / Light Field Calibration Verify kV Calibration and Tube Current Calibration Check HVL Evaluation Verify Target Dose Verification Verify AEC Exposure Compensation 2D Perform System Resolution Test *

Perform Phantom Image Quality Evaluation *

Perform Image Artifact Evaluation *

Backup Acquisition Workstation files Evaluate UPS Performance Status/ Batteries Status Backup all Calibration Data x x x x x x x x x x x x x x x x x x x x x x x x

* Refer to Quality Control Manual MAN-05085-002 Revision 002 DRAFT Page 109 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 9: Maintenance and Cleaning 9.2.2 About Reclamation Reclamation is an automatic function that makes disk space available for storing newly acquired images. Configurable parameters let a given number of images collect before reclamation starts and older images are removed from the system. Page 110 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface Chapter 10 10:System Administration Interface 10.1 Admin Screen This section describes the functions available in the Admin screen. To access all the functions in this screen, log in to the system as a user with administrator, manager, or service permissions. Refer to the table on the following page for descriptions of the Admin screen functions. Note Depending on the license settings for your system, you may see different buttons. Group Operators Procedures Figure 69: Admin Screen Table 20: Admin Screen Functions Button Function Manage Operators Add, delete or change Operator information. My Settings Procedure Editor Procedure Order Change the procedure list order. Change the information for the current Operator. Add or Edit the procedures, or change the view order for each user. View Editor Set the default view order for a procedure and edit individual views. Contrast Access the contrast enhanced digital mammography functionality. MAN-05085-002 Revision 002 DRAFT Page 111 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface Group Button Function Table 20: Admin Screen Functions Quality Control Quality Control Select a Quality Control task to perform or mark completed. QC Report Test Patterns Reject and Repeat Report Create a QC Report. Select and send the test patterns to output devices. Create a Reject and Repeat Report. System System Tools The Interface for Service for the configuration of and identification of problems in the Acquisition Workstation. Set the Gantry default values. System Defaults System Diagnostics Shows the status of all subsystems. Preferences About Exposure Report Create a radiation Exposure Report. Set the system preferences. Describes the system. Refer to About Screen on page 113. Biopsy Devices QAS Lists available biopsy devices. Access the QAS Needle Test screen. Lateral QAS Access the Lateral QAS Needle Test screen. Connectivity Query Retrieve Query the configured devices. Import Import the data from a DICOM source. Manage Output Groups Incoming Log Archive Add, delete, or edit output groups. Shows log entries for images that do not import during manual import or DICOM store. Send local studies to networked storage or export to removable media devices. You must have permission to access all features. The permission level controls the functions you can change. Page 112 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.2 About Screen The About screen provides information about the machine, such as system level, IP address, and Gantry serial number. This type of data can be useful when you are working with Hologic to resolve a system issue or configure the system. To access the About screen, select About from the System group in the Admin screen. Note You can also access the About screen through the Taskbar. Select the Tube Icon then select About. Figure 70: System Tab of the About (the Acquisition Workstation) Screen There are five tabs on the About screen:

System Tab (default) - lists system configuration information Licensing Tab - lists the Hologic-licensed options installed on this machine Institution Tab - lists the name and address of the organization assigned to this machine Copyright Tab - lists the copyrights of Hologic and third-party software installed on this machine UDI Tab - lists the unique device identifier(s) of this machine MAN-05085-002 Revision 002 DRAFT Page 113 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.2.1 Licensing Tab The Licensing tab of the About screen shows all the licenses installed on your 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. Figure 71: Licensing Tab of the About Screen 10.3 Change the User Language Preference In the Operators group of the Admin screen, select My Settings. Users can set the language on the user interface to automatically change to their individual preference when logging in. 1. Note You can also access My Settings through the taskbar. Select the User Name area then select My Settings in the pop-up menu. 2. The Users tab of the Edit Operator screen opens. From the Locale field, select a language from the drop-down list. 3. Select Save, then select OK to the Update Successful message. The user interface changes to the selected language. Page 114 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.4 Set Auto-Hanging and Auto-Pairing In the Operators group of the Admin screen, select My Settings. To set the system for Auto-Hanging and Auto-Pairing of images:

1. Note You can also access My Settings through the Taskbar. Select the User Name area then select My Settings in the pop-up menu. 2. The Edit Operator screen opens. Select the Workflow tab. Select the Auto-Hanging check box to show a prior study in 4-up mode automatically. Select the Auto-Pairing check box to show a prior view in multi-up mode next to a newly captured image. Figure 72: Enable Auto-Hanging and Auto-Pairing 3. Select Save, then select OK to the Update Successful message. 10.5 Set Multi Line Procedure Tabs You can set the operator preferences to display more of the procedure name in the top of the procedure tabs. To change the procedure tabs from a single line of text to multiple lines of text:

1. Note You can also access My Settings through the Taskbar. Select the User Name area then select My Settings in the pop-up menu. In the Operators group of the Admin screen, select My Settings. 2. The Edit Operator screen opens. Select the Workflow tab. MAN-05085-002 Revision 002 DRAFT Page 115 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 3. Select the Use Multi Line Procedure Tabs check box. Figure 73: Enable Multi Line Procedure Tabs 4. Select Save, then select OK in the Update Successful message. 10.6 Enable and Set the Height Memory Users can enable and set the acquisition workstation height to automatically change to their individual preference when logging in. To enable and set the height adjust memory:

1. In the Operators group of the Admin screen, select My Settings. Figure 74: My Settings Button in the Admin Screen Note You can also access My Settings through the Taskbar. Select the User Name area then select My Settings in the pop-up menu. 2. In the Edit Operator screen, select the Console tab. Page 116 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 3. To enable the height adjust memory, select the radio button to the right of the "Auto-

Height adjustment on login" field. A check mark appears. (To disable the height adjust memory, clear the radio button.) Figure 75: Console Tab of the Edit Operator Screen 4. Use the UP and DOWN buttons on the height adjust control panel to set the desired height (see the following figure). Figure 76: Height Adjust Control Panel 5. The Desired console height field displays the height as it is now positioned. The Current console height field displays the most recently saved height. (See the following figure.) To save your desired height setting, select Apply. Figure 77: Desired Console Height and Current Console Height Fields 6. Select Save, then select OK to the Update Successful message. MAN-05085-002 Revision 002 DRAFT Page 117 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.7 Set Auto-Accept and Auto-Pend Images A manager user can configure the system to automatically accept or automatically pend new images. 1. In the System group of the Admin screen, select Preferences. The System Preferences screen opens. 2. Select the Image Auto Disposition tab. 3. Use the drop-down menus to select the auto disposition for each type of image. Select Manual to manually accept, reject, or pend each newly acquired image. Select Accept to automatically accept newly acquired images. Select Pend to automatically pend newly acquired images. Figure 78: Set Image Auto Disposition 4. Select Save, then select OK to the Update Successful message. Page 118 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.8 How to Set the Contrast Defaults A manager user can configure the default timer periods and the default contrast information. Set the Default Timer Periods 1. From the Procedures group in the Admin screen, select the Contrast button. Figure 79: I-View 2D Contrast Default Settings 2. Choose the plus (+) or minus (-) buttons to change the Minutes and Seconds for the Waiting Period and Optimal Imaging Period. 3. Select Save. Your selections appear as the default timer settings on the Contrast tab. Set the Default Contrast Information 1. From the Procedures group in the Admin screen, select the Contrast button. 2. Select one or more Contrast agents, Entry routes, and Concentration. See the previous figure. 3. Select Save. Your selections appear as the default options in the Contrast Information dialog box. MAN-05085-002 Revision 002 DRAFT Page 119 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.9 Enable and Set the Default Height A manager can set the acquisition workstation to automatically return to a default height when a user logs out. To enable and set the default height:

1. In the system group of the Admin screen, select Preferences. Figure 80: Preferences Button in the Admin Screen In the System Preferences screen, select the Console tab. 2. 3. To enable the default height, select the radio button to the right of the "Auto-Height adjustment on logout" field. A check mark appears. (To disable the default height option, clear the radio button.) Figure 81: Console Tab of the System Preferences Screen Page 120 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 4. Use the UP and DOWN buttons on the height adjust control panel to set the desired height (see the following figure). Figure 82: Height Adjust Control Panel 5. The Desired console height field displays the height as it is now positioned. The Current console height field displays the most recently saved height. (See the following figure.) To save your desired height setting, select Apply. Figure 83: Desired Console Height and Current Console Height Fields 6. Select Save, then select OK to the Update Successful message. MAN-05085-002 Revision 002 DRAFT Page 121 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.10 System Tools The Radiologic Technologist Managers and users with Service permissions can access the System Tools utility. The System Tools utility contains the configuration information about the system. To access the utility, select System Tools from the System group in the Admin screen. Figure 84: System Tools Button 10.10.1 System Tools for the Radiologic Technologist Manager Figure 85: System Tools Screen Page 122 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface Table 21: Radiologic Technologist ManagerSystem Tools Functions Section Getting Started AWS Screen Functions About: The introduction to the service tool. FAQ: List of common questions. Glossary: List of terms and descriptions. Platform: List of directories, software version numbers, and system software statistics. Shortcuts: List of Windows shortcuts. Connectivity: List of Installed Devices. Film & Image Information: Create an Image Report*. Create a QC Report. (*You can also access this report from a remote computer. Refer to Remote Access to Image Reports on page 124.) Licensing: List of Installed Licenses. User Interface: Change the options in the Software application. Internationalization: Select the local language and culture. Troubleshooting AWS: Allows for download of images. Computer: System Management and Network Information. Log: Change the event record options. Backups: Control the backups for the system. MAN-05085-002 Revision 002 DRAFT Page 123 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 10.10.2 Remote Access to Image Reports Access image reports via a remote computer networked to the system. This function can be useful for sites that do not permit USB downloads of reports directly from the system. Follow these steps to access image reports from a remote computer. You must log in to the System Tools as a Manager-level user for this procedure. 1. Get the IP Address for the system you want to access. You can get the IP Address from your IT administrator or from the system. From the system, go to Select Patient Screen > Tube Icon on Taskbar > About > System Tab > IP Address. Write down the IP Address. 2. Using an internet browser on your remote computer, navigate to http:// [IP address]/Hologic.web/MainPage.aspx. Use the IP Address from step 1. 3. The Service Tools Logon screen opens. Type a Manager-level user name and password, and then click Submit. Figure 86: Remote Logon Screen for Service Tools Page 124 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 4. The Service Tools Welcome screen opens. Go to AWS > Film & Image Information >

Create Image Report. Figure 87: Service Tools Welcome Screen 5. Select the parameters for the report and click Generate. Figure 88: Create Image Report Parameters MAN-05085-002 Revision 002 DRAFT Page 125 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 6. The report shows on the screen. Scroll to the bottom of the report and select either Click to Download (html) or Click to Download (csv) for the file download type. Click Save when prompted. Figure 89: Create Image Report 7. Select a folder on the computer, and then click Save. 8. Log out from Service Tools when finished. 10.11 Archive Tool The archive feature in the Admin screen lets you:

Send local studies to an archive. Export studies to removable media.

Figure 90: Archive Button Page 126 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 1. From the Connectivity group in the Admin screen, select the Archive button. The Multi Patient On Demand Archive screen opens. 2. To search for a patient, enter at least two characters in the Search parameters area and select the magnifying glass. A list of patients that match the search criteria is displayed. Figure Legend 1. Search parameters 2. Patient List area 3. Patients To Be Archived area 4. Add selection in the Patient List area to the Patients To Be Archived area 5. Remove the selection from the Patients To Be Archived area Figure 91: Multi Patient On Demand Archive Screen To Archive:

1. Select the patients and the procedures to archive. Select patients from the patient list, or do a search with the search parameters

(item 1) and select patients from the search results. Note The Select All button (on the right side of the screen) selects all the patients in the Patient List area. The Clear button (on the right side of the screen) clears selections. Select the procedures for each patient. Select the Down Arrow (item 4) on the screen to move the selected patients to the Patients To Be Archived area (item 3). Select the Up Arrow (item 5) on the screen to remove the selected patients from the Patients To Be Archived area (item 3). MAN-05085-002 Revision 002 DRAFT Page 127 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Chapter 10: System Administration Interface 2. Select a storage device. Select an option from the Store Device drop-down menu.

-OR-

Select the Group List button, then select an option. 3. Select the Archive button. The list in the Patients To Be Archived area copies to the selected archive devices. Note Use the Manage Queue utility in the taskbar to review the archive status. To Export:

1. Select the patients and the procedures to export. Select patients from the patient list, or do a search with one of the search parameters (item 1) and select patients from the search results. Note The Select All button (on the right side of the screen) selects all the patients in the Patient List area. The Clear button (on the right side of the screen) clears selections. Select the procedures for each patient. Select the Down Arrow (item 4) on the screen to move the selected patients to the Patients To Be Archived area (item 3). Select the Up Arrow (item 5) on the screen to remove the selected patients from the Patients To Be Archived area (item 3). 2. Select the Export button. 3. In the Export dialog box, select the Target from the drop-down menu of media devices. Figure 92: Export Screen 4. Select other options, if necessary:

Anonymize: to anonymize patient data. Advanced: to select a folder on your local system to keep the selections, and also to select the Export types. 5. Select the Start button to copy the selected images to the selected device. Page 128 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications Appendix A Appendix A Specifications A.1 Product Measurements A.1.1 Tubestand (Gantry with C-Arm) Figure 93: Tubestand (Gantry with C-arm) Measurements A. B. C. D. Height Width Width Depth Weight 223 cm (87.8 inches) 66 cm (26 inches) 173 cm (68 inches) 138 cm (54.25 inches) Maximum of 400 kg (882 pounds) MAN-05085-002 Revision 002 DRAFT Page 129 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.1.2 Acquisition Workstations Universal Acquisition Workstation Figure 94: Universal Acquisition Workstation Measurements A. B. C. Width (maximum) with optional articulated display arm extended Width (maximum) with standard display arm Depth (maximum) with keyboard tray extended and optional articulated display monitor arm Depth (maximum) with keyboard tray extended and standard display arm Height (nominal) Weight (maximum) 136 cm (53.4 inches) - series I UAWS 128 cm (50.3 inches) - series II UAWS 94.0 cm (36.9 inches) - series I UAWS 107 cm (42.0 inches) - series II UAWS 122 cm (48.4 inches) - series I UAWS, rotated to the side 115 cm (45.1 inches) - series II UAWS, rotated to the side 83.6 cm (32.9 inches) - series I and II UAWS 219 cm (86.1 inches) after August 2017 204 cm (80.3 inches) before September 2017 209 kg (460 pounds) Page 130 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications Acquisition Workstation for Mobile Use Figure 95: Mobile Universal Acquisition Workstation Measurements A. B. C. Width (maximum) with mobile display arm Depth (maximum) with keyboard tray extended Height (maximum) Weight (maximum) 100 cm (39.5 inches) - series I UAWS 107 cm (42.0 inches) - series II UAWS 85 cm (33.5 inches) 180 cm (71 inches) 179 kg (395 pounds) A.2 Operation and Storage Environment A.2.1 General Conditions for Operation Temperature Range 20 C (68 F) to 30 C (86 F) Relative Humidity Range 20% to 80% without condensing moisture MAN-05085-002 Revision 002 DRAFT Page 131 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.2.2 Storage Environment Gantry Temperature Range 10 C (14 F) to 40 C (104 F) Relative Humidity Range 10% to 90% without condensing moisture

(Put in a package for storage in a building.) X-ray Detector Temperature Range Maximum rate of temperature change Relative Humidity Range 10 C (50 F) to 30 C (86F) indefinitely 10 C (50 F) to 35C (95 F) for a maximum of 12 hours Less than 10 C (50 F) per hour 10% to 80% without condensing moisture

(Put in a package for storage in a building.) Acquisition Workstation Temperature Range Relative Humidity Range 10 C (14 F) to 40 C (104 F) 10% to 90% without condensing moisture

(Put in a package for storage in a building.) A.3 Radiation Shield Radiation Shield Lead (Pb) equivalent 0.5 mm lead for x ray energy to 35 kV A.4 Electrical Input A.4.1 Tubestand Mains Voltage Mains Impedance Mains Frequency 200/208/220/230/ 240 VAC 10%

Maximum line impedance not to exceed 0.20 ohms for 208/220/230/240 VAC, 0.16 ohms for 200 VAC 50/60 Hz 5%

Average Current over 24 Hours Peak Line Current

< 5 A 4 A (65 A maximum for < 5 seconds) Page 132 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.4.2 Acquisition Workstation Mains Voltage Mains Frequency Power Consumption Duty Cycle (Standard Acquisition Workstation) Overcurrent Protection 100/120/200/208/220/230/240 VAC 10%

50/60 Hz 5%

< 1000 watts 10% ~ 6 minutes per hour or 2 minutes on, 18 minutes off 8A A.5 Tubestand Technical Information A.5.1 C-Arm Rotation Range Conventional Mammography:

+195 +3/0.5 to 0 0.5 to 155 +0.5/3 Tomosynthesis option:

+180 0.5 to 0 0.5 to 140 0.5 Absolute Angular Position Rotation Acceleration Rotation Deceleration accurate to 0.5 18/s2 +18/-9%

18/s2 +18/-9%

Rotational Positioning Angular Velocity 18/s 25%

Note The angular velocity is the average of the velocity of the tube arm rotating clockwise between 0 and 90 or rotating counterclockwise between 90 and 0. The angular velocity does not include the time to accelerate from zero velocity and decelerate to zero velocity. Source-to-Image Distance (SID) Patient Support (non-magnification) Vertical Position Lower Limit Vertical Position Upper Limit 70.0 cm 1.0 cm (27.6 inches 0.4 inches)

(Focus position deviation is 5 mm) 70.5 cm +5.1/-0 cm (27.75 inches +2.0/-0 inches) 141 cm +0/-17.8 cm (55.5 inches +0/-7.0 inches) MAN-05085-002 Revision 002 DRAFT Page 133 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.5.2 Compression Manual Compression Force Motorized Compression Pre-Compression Force Full Range Compression Force Dual Mode Compression Compression Controls Compression Release Automatic Compression Release Down Motion Variable Speed Compression Force Display Compression Force Display Accuracy Compression Thickness Display Compression Thickness Accuracy Breast Tomosynthesis Compression Thickness Compression Paddles Page 134 DRAFT Maximum of 300 N (67.4 pounds) Functions in three operating modes:

Pre-compression, Full-Range, Dual Compression. User selectable through software. 15 pounds to 30 pounds (67 to 134 N), motorized 20 pounds to 40 pounds (89 to 178 N), motorized Provides Pre-Compression force upon first activation of compression switch; then, if switch is activated within 2 seconds, the force is increased incrementally for each additional switch activation, up to the user selected full compression force. Up/Down controls on both sides of C-arm and on 2-position footswitch (Motorized). Handwheel on both sides of Compression Device (Manual). Manual Motorized Release controlled by push-buttons on both sides of the C-arm. User selectable automatic release mode raises Compression Device upon exposure termination. 4.2 cm/s 15% (1.66 inches/s 15%) Two LCDs on the Compression Device show the compression force through the range of 18 N to 300 N in 1 N increments (4 pounds to 67 pounds in 1 pound increments). 20 N (4.5 pounds) Two LCDs on the Compression Device measure compression thickness in 0.1 cm increments. The display is visible from both sides of the patient. 0.5 cm (0.2 inches) for thicknesses between 0.5 cm and 15 cm (5.9 inches) Standard resolution tomosynthesis Maximum: 24 cm (restricted by compression device geometry) High resolution tomosynthesis Maximum: 15 cm (restricted by DICOM limitations) Compression Paddles are transparent. The paddles are composed of polycarbonate resin or the equivalent. With compression applied, paddle deflection from a plane parallel to the patient support surface shall be less than or equal to 1.0 cm. MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.5.3 X-ray Tube Focal Spot Tube Voltage Anode Material X-Ray Window Tube leakage test conditions Large (0.3 mm) Nominal Small (0.1 mm) Nominal 20 kV to 49 kV Tungsten Beryllium 0.63 mm 49 kVp, 2.0 mA A.5.4 X-ray Beam Filtration and Output Filtration Five-position filter wheel:

Position 1: Rhodium, 0.050 mm 10%

Position 2: Aluminum, 0.70 mm (nominal) (Tomosynthesis option) Position 3: Silver, 0.050 mm 10%

Position 4: Copper, 0.3mm Position 5: Lead (provided for servicing) kV/mA Range Table 22: Maximum mA Setting as a Function of kV kV 20 21 22 23 24 25 26 27 28 29 30 31 LFS mA SFS mA 100 110 110 120 130 130 140 150 160 160 170 180 30 30 30 30 30 40 40 40 40 40 50 50 MAN-05085-002 Revision 002 DRAFT Page 135 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications Table 22: Maximum mA Setting as a Function of kV kV 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 LFS mA SFS mA 190 200 200 200 190 180 180 180 170 170 160 160 150 150 150 140 140 140 50 50 50 50 50 50 50 50 mAs Steps (Table 1, default) 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, 25, 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5, 60, 62.5, 65, 67.5, 70, 75, 80, 85, 90, 95, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340, 360, 380, 400, 420, 440, 460, 480, 500 Attenuation of Carbon Fiber Image Receptor Magnification Platform

< 0.3 mm Al

< 0.3 mm Al Page 136 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.5.5 X-ray Collimation Collimation Fields 7.0 cm x 8.5 cm 10 cm x 10 cm 15 cm x 15 cm 18 cm x 24 cm 18 cm x 29 cm (Tomosynthesis option) 24 cm x 29 cm A.5.6 Light Field Indication Light Field to X Ray Congruency Within 2% of SID A.5.7 X-ray Generator Type Rating Electrical Power Capacity kV Range kV accuracy mAs Range mAs Accuracy mA Range Constant Potential High Frequency Inverter 7.0 kW, maximum (isowatt), 200 mA at 35 kV 9.0 kW maximum 20 kV to 49 kV in 1 kV increments 2%, over range 20-49 kVp 3.0 mAs to 500 mAs in Manual Mode mAs (8 mAs minimum in AEC Mode)

(10% + 0.2 mAs) 10 mA to 200 mA, Large Focal Spot 10 mA to 50 mA, Small Focal Spot MAN-05085-002 Revision 002 DRAFT Page 137 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix A: Specifications A.6 Imaging System Technical Information A.6.1 Image Receptor Fluid Ingress Deflection Active Imaging Area DQE Conventional Mammography DQE (Tomosynthesis option) Dynamic Range and Linearity Uniformity No fluid from accidental spillage on the Image Receptor may seep inside. Does not exceed 1.0 mm at maximum compression. Not less than 23.3 cm by 28.5 cm (9.2 inches x 11.2 inches) Not less than 50% at 0.2 lp/mm Not less than 15% at the Nyquist limit Not less than 30% at 0.2 lp/mm Not less than 15% at the Nyquist limit Detector Subsystem response is linear with linearity of 0.999 over a dynamic range of 400:1 in x-ray exposure. Detector Subsystem can correct pixel-to-pixel gain variations. For conventional mammography procedures, the uniformity of flat field image response of the detector shall be no greater than 2% after gain calibration is applied over an exposure range of 0.5 mR to 200 mR. Page 138 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix B: System Messages and Alert Messages Appendix B Appendix B System Messages and Alert Messages B.1 Error Recovery and Troubleshooting Most faults and alert messages are cleared without result to your workflow. Follow the instructions on the screen or fix the condition then clear the status from the Taskbar. Some conditions require a system restart or indicate that more action is necessary (for example, to call Hologic Technical Support). This appendix describes the message categories and your actions to return the system to normal operation. If errors repeat, contact Hologic Technical Support. B.2 Types of Messages B.2.1 Fault Levels Prevents an exposure from starting (yes/no) Each Message has a particular set of the following characteristics:

Aborts an exposure in progress (yes/no) Displays a message to the user on the Acquisition Workstation (yes/no) May be reset by the user (yes/no) May be reset automatically by the system (yes/no) Displayed Messages All displayed messages will be shown in the users selected language. Any message which aborts an exposure or prevents an exposure from starting will always display a message directing the users actions required to proceed. Additional Message Information Technical information about the message is available in the log file. Some messages always show as a critical fault (a system restart is necessary). These messages result from a condition which prevents an exposure, and which cannot be reset by the user or the system. MAN-05085-002 Revision 002 DRAFT Page 139 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix B: System Messages and Alert Messages B.2.2 System Messages When the following system messages show, do the step shown in the User Action column to clear the message and allow the next exposure. Table 23: System Messages Icon Message User Action Paddle is moving No action needed. Sending notice No action needed. Invalid use of Magnification Stand You selected a tomographic view with the Magnification Stand installed. Select a non-tomographic view.

(Tomosynthesis option) Face shield is not secured Fully extend or fully retract the Face Shield. (Tomosynthesis option) Invalid use of compression paddle Remove the Magnification Stand or install the Magnification Paddle. Paddle position does not match selected view Shift the Paddle to the correct location for the selected view. Compression is less than 4.5 cm during calibration Move the Compression Paddle higher than 4.5 cm to complete the calibration procedure. FAST compression is engaged Disengage FAST compression and install a paddle designated for this mode. License is missing Invalid detector calibration A license is necessary to use this feature or function. (This message is for your information only. There are no user actions.) Install the Magnification Stand for Small Focal Spot calibration. Remove the Magnification Stand to do Large Focal Spot calibration. Page 140 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix B: System Messages and Alert Messages Table 23: System Messages Icon Message User Action Invalid geometry calibration Repeat the geometry calibration before you try to take an exposure. (Tomosynthesis option) Configuration file is missing Applies to Service Personnel. Waiting for Detector No action needed. System in Test Mode Applies to Service Personnel. Tube needs to be manually positioned (move to 0 degrees) Rotate the C-arm to 0 degrees. Tube needs to be manually positioned (move to -15 degrees) Tube needs to be manually positioned (move to 15 degrees) Rotate the C-arm to -15 degrees. Rotate the C-arm to +15 degrees. The Emergency Stop switch has been engaged. Turn the Emergency Off switch one-quarter turn to reset the switch. Compression too low for tomo reconstructions. Move the Compression Paddle higher than 0.5 cm to take tomography exposures. MAN-05085-002 Revision 002 DRAFT Page 141 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix B: System Messages and Alert Messages B.3 UPS Messages Note The User Guide for the UPS is supplied with the system. Refer to the UPS User Guide for complete instructions. The LCD in the UPS shows the power status. Figure Legend 1. UPS Mode 2. UPS Load 3. UPS Efficiency 4. UPS Battery level Figure 96: UPS LCD Display If the UPS battery expires, the Mode icon changes as shown. Contact your service representative to replace the battery. Page 142 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix C: Use of Mobile System Appendix C Appendix C Use of Mobile System This appendix describes the system installed in a mobile environment. C.1 Conditions for Safety and Other Precautions An acceptable, stable, clean VAC power source is required to make sure that the system meets all its performance specifications. Where available, shore power correctly supplied to the system provides the best performance. If a mobile power generator is used, you must keep the specifications for input power during all load conditions. Warning:

The radiation shield is not approved for mobile use and is not provided. The coach manufacturer must provide adequate shielding. Caution:

When shore power is unavailable, mobile power sources that provide equivalent performance may be employed. (Refer to Specifications for Mobile Use on page 144.) Proper system function and performance can only be ensured if continuous true sinusoidal VAC power is supplied per the system power input specifications and loading characteristics. Intermittently, the power source must provide 65 Amps at 208 VAC for a minimum of 5 seconds, and 4 Amps maximum continuous otherwise. This load must be supported once every 30 seconds. In the event of shore or mobile power service interruption, the UPS must be capable of providing the operational power described above for a minimum of 4 minutes. Acquisition Workstation and Gantry power must be fed on separate dedicated circuits. The use of an uninterruptible power supply with active line conditioner is recommended on each power circuit. Accordingly, all ancillary mobile coach power should be distributed by other circuits. The electrical installation must be verified to meet system power input specifications and IEC 60601-1 safety requirements after initial installation and upon each relocation of the mobile coach. Caution:

The temperature and humidity inside the vehicle must be maintained at all times. Do not allow environmental conditions to exceed stated specifications when the unit is not in use. Caution:

Voltages cannot change by more than 10% when the x-ray unit or other equipment

(for example, heating or air conditioning) is operated. MAN-05085-002 Revision 002 DRAFT Page 143 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix C: Use of Mobile System Caution To avoid image artifacts from occurring:

Care should be exercised not to locate or park the mobile coach near sources of high power (such as power transmission lines and outdoor transformers).

Make sure that any mobile power generator, uninterruptible power system

(UPS), or voltage stabilizer is at least 3 meters (10 feet) from the closest point of the image detector travel. C.2 Specifications for Mobile Use The following system specifications are for mobile use only. For all other specifications, refer to the section Specifications on page 129. C.2.1 Shock and Vibration Limits Vibration Limit Shock Limit C.2.2 Coach Environment Operation Environment Temperature Range Relative Humidity Range Maximum of 0.30 G (2 Hz to 200 Hz), measured at the point where the system mounts to the coach. Maximum of 1.0 G (1/2 sine pulse), measured at the point where the system mounts to the coach. An air ride coach suspension is recommended. 20 C (68 F) to 30 C (86 F) 20% to 80% without condensing moisture Non-operating/Transit Environment Temperature Range 10 C (50 F) to 35 C (95 F) for a maximum of 12 hours Maximum Rate of Temperature Change 10 C (50 F) to 30 C (86 F) indefinitely

<10 C/hr. Relative Humidity Range 10% to 80% without condensing moisture Page 144 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix C: Use of Mobile System C.3 Electrical Input C.3.1 Gantry Mains Voltage Mains Impedance Mains Frequency Average Current over 24 Hours Peak Line Current C.3.2 Acquisition Workstation Mains Voltage Mains Frequency Power Consumption 200/209/220/230/ 240 VAC 10%

Maximum line impedance not to exceed 0.20 ohms for 208/220/230/240 VAC, 0.16 ohms for 200 VAC 50/60 Hz 5%

< 5 A 4 A (65 A maximum for 3 seconds) 100/120/200/ 208/220/230/ 240 VAC 10%

50/60 Hz 5%

< 1000 watts MAN-05085-002 Revision 002 DRAFT Page 145 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix C: Use of Mobile System C.4 Prepare the System for Travel Before travel, perform these steps:

1. Rotate the C-arm to 0 degrees (CC position). 2. Lower the C-arm to its lowest position. 3. Turn off the system through the user interface. 4. Place the mouse in the keyboard tray. 5. Lock the keyboard tray (see the following figures):

a. Close the tray. b. Find the knob under the tray. c. Turn the knob 90 until the knob fits into the lock. Position A in the following figure shows the locked position. Figure 97: Keyboard Tray Lock Knob Figure 98: Keyboard Tray Lock Knob Figure 99: Tray Lock Release from Locked (A) to Unlocked (D) Page 146 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix C: Use of Mobile System 6. If using the mobile Universal Acquisition Workstation, lock the swivel display using the knobs provided (see the following figure). Figure 100: Swivel Lock Knobs for Image Display Monitor on Mobile Universal Acquisition Workstation 7. Lower the work surface to the minimum height. 8. Remove all system accessories. 9. Put all accessories in a safe storage area. C.5 Prepare the System for Use 1. Unlock the keyboard tray:

a. Find the knob under the tray. b. Pull the knob down. c. Turn the knob 90. This position keeps the latch open. Position D (in the following figure) shows the unlocked position. Figure 101: Tray Lock Release from Locked (A) to Unlocked (D) MAN-05085-002 Revision 002 DRAFT Page 147 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix C: Use of Mobile System 2. Pull the tray out, if needed. 3. If using the mobile Universal Acquisition Workstation, unlock the swivel display (see the following figure). Figure 102: Swivel Lock Knobs for Image Display Monitor on Mobile Universal Acquisition Workstation C.6 Test the System after Travel C.6.1 Mobile System Controls and Functional Tests Perform the Controls and Functional Tests. Refer to Perform the Functional Tests on page 32. Compression Up/Down Compression Release C-arm Rotation C-arm Up/Down Collimator Override Light Field Lamp Shifting Paddle System Emergency Off Switches C.7 Quality Control Tests Refer to your quality control manual for quality system checks. Page 148 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix D: Dose Information Appendix D Appendix D Dose Information D.1 EUREF Dose Tables Notes This information is only applicable for the European Union. The following values are for the default dose tables. The following tables show typical dose values when operating the system in 2D and in BT imaging modes. The tables follow the procedures given in the European guidelines for quality assurance in breast cancer screening and diagnosis, Fourth edition: section 2a.2.5.1 Dosimetry, and Appendix 5: Procedure for determination of average glandular dose. Phantom 2.0 cm PMMA 3.0 cm PMMA 4.0 cm PMMA 4.5 cm PMMA 5.0 cm PMMA 6.0 cm PMMA 7.0 cm PMMA Phantom 2.0 cm PMMA 3.0 cm PMMA 4.0 cm PMMA 4.5 cm PMMA 5.0 cm PMMA 6.0 cm PMMA 7.0 cm PMMA cm 2.1 3.2 4.5 5.3 6 7.5 9 cm 2.1 3.2 4.5 5.3 6 7.5 9 Table 24: 2D Dose (EUREF) Filter Anode kV EUREF dose (mGy) 25 26 28 29 31 31 34 W W W W W W W 0.05 mm Rh 0.05 mm Rh 0.05 mm Rh 0.05 mm Rh 0.05 mm Rh 0.05 mm Ag 0.05 mm Ag 0.55 0.75 1.05 1.42 2 2.7 3.1 Table 25: BT Dose (EUREF) Filter Anode kV EUREF dose (mGy) 26 28 30 31 33 36 42 W W W W W W W 0.7 mm Al 0.7 mm Al 0.7 mm Al 0.7 mm Al 0.7 mm Al 0.7 mm Al 0.7 mm Al 1 1.15 1.5 2.00 2.5 3.9 5.15 MAN-05085-002 Revision 002 DRAFT Page 149 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Appendix D: Dose Information Phantom 2.0 cm PMMA 3.0 cm PMMA 4.0 cm PMMA 4.5 cm PMMA 5.0 cm PMMA 6.0 cm PMMA 7.0 cm PMMA cm 2.1 3.2 4.5 5.3 6 7.5 9 Table 26: CEDM Dose (EUREF) kV Filter Anode EUREF dose (mGy) 26/45 26/45 28/45 29/49 31/49 32/49 33/49 W W W W W W W 0.05/0.3 mm Rh/Cu 0.05/0.3 mm Rh/Cu 0.05/0.3 mm Rh/Cu 0.05/0.3 mm Rh/Cu 0.05/0.3 mm Rh/Cu 0.05/0.3 mm Ag/Cu 0.05/0.3 mm Ag/Cu 0.83 1.1 1.6 2.1 3.0 4.1 4.7 Page 150 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 11:Glossary of Terms ACR American College of Radiology AEC Automatic Exposure Control Annotations Markings on an image to indicate an area of interest. BT Breast Tomosynthesis. An imaging procedure that provides information about the breast in three dimensions CEDM Contrast Enhanced Digital Mammography Collimator A device at the x-ray tube to control the x-ray beam exposure area. Conventional Mammography Single projection x-ray images of views for screening and diagnostic purposes C-View A licensed Hologic feature where a digital mammography (DM) image is generated from data acquired during a breast tomosynthesis (BT) scan DICOM Digital Imaging and Communications in Medicine DM Digital Mammography (2D) EMC Electromagnetic Compatibility FAST Paddle Fully Automatic Self-adjusting Tilt Paddle 3Dimensions System User Guide Glossary of Terms FDA Food and Drug Administration (in the United States) Grid An element within the Digital Image Receptor that reduces scatter radiation during the exposure Image Receptor Assembly of the x-ray detector, x-ray scatter reduction grid, and carbon fiber cover Intelligent 2D A licensed Hologic feature where a high-

resolution digital mammography (DM) image is generated from data acquired during a high resolution breast tomosynthesis (BT) scan I-View A licensed feature for 2D Contrast Enhanced Digital Mammography MPPS Modality Performed Procedure Step MQSA Mammography Quality Standards Act Notice Annotations and comments per image communicated between Diagnostic Review Workstations, Technologist Workstations, and Acquisition Workstations PACS Picture Archiving and Communications System. A computer and network system that transmits and archives digital medical images. Pend The action taken on an image to mark the image if the Technologist is not positive about the image quality (pended images must be Accepted or Rejected before the procedure is closed) MAN-05085-002 Revision 002 DRAFT Page 151 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Glossary of Terms Projection Image One of a group of breast tomosynthesis images taken at different projection angles and used to produce the final reconstructed image Reclamation Automatic removal of patient images and related information to allow storage of new patient image acquisitions RF Radio Frequency ROI Region of Interest SID Source to Image Distance Tomosynthesis An imaging procedure that combines a number of breast images taken at different angles. The tomosynthesis images can be reconstructed to show focal planes (slices) within the breast. UDI A United States Food and Drug Administration program for Unique Device Identification (UDI). For more information about UDI, go to http://www.fda.gov/MedicalDevices/DeviceRegulationa ndGuidance/UniqueDeviceIdentification/UDIBasics/de fault.htm. UPS Uninterruptible Power Supply USB Universal Serial Bus Page 152 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Index Index 2 2D contrast - 79 2D contrast settings - 82, 119 A about (acquisition workstation) screen - 113 accept images - 71, 73, 118 accept rejected images - 73 accessories - 83 compression paddles - 87 crosshair devices - 95 face shields - 84 install on C-arm - 83 magnification stand - 93 acquire images - 71, 101 acquisition modes - 70 Acquisition Workstation about (acquisition workstation) screen - 113 maintenance - 107 add new patient - 50 procedure - 59 view - 60 admin screen - 111 about (acquisition workstation) screen - 113 admin button - 55 functions - 111 remote access to image reports - 124 alerts - 139 archive - 64 auto-hanging, auto-pairing - 115 Automatic Exposure Control buttons - 25 Sensor position - 25 auto-rotation - 39, 41 C calibrations, perform - 45 C-arm auto-rotation - 39, 41 controls and indicators - 24, 26 displays - 25 rotation and movement - 34 slots for accessories - 83 cine tab - 77 circuit breaker Gantry - 23 clinical procedures - 99 close patient - 62 procedure - 62 collimator override - 42 programmed to paddle - 87 columns tab - 55 comments tab - 77 compression controls and displays - 25 FAST compression mode - 92 paddles - 87 release - 101 specifications - 134 compression force, range - 25 computer power button - 23 contact paddles - 89 contrast procedures - 79 contrast settings - 82, 119 controls C-arm - 26, 27 collimator override - 42 compression - 27 compression brake - 33 footswitches, AWS - 27 Gantry Tubestand - 24 handwheels - 25 indicators - 23 light field lamp - 42 system - 23 conventional face shield, install - 86 custom output - 64 cybersecurity statement - 8 D data loss - 13 delete patient - 53 display MAN-05085-002 Revision 002 DRAFT Page 153 Preview Copy-Generated May 30, 2018 3Dimensions System User Guide Index clean - 107 compression force - 25 preview image - 69 thickness - 25 types of images selection - 77 window level - 75 dose information - 149 EUREF dose tables - 149 E edit patient information - 51 user information - 46 view - 61 Emergency Off Switch - 17, 23, 24 functional test - 32 export - 65, 126 exposure parameters - 70 sequence - 101 techniques, set - 70 F face shield - 84 FAST compression mode - 92 faults - 139 filter tab - 54 other functions - 54 filter, information options - 53 fingerprint scanner - AWS - 31 footswitches, AWS - 27 function, select to perform - 45 functional tests - 32 Emergency Off Switch - 17, 44 G generator tab, set techniques - 70 H Hologic technical support - 105 I images accept - 71, 73, 118 Page 154 DRAFT acquisition mode - 70 output options - 78 preview - 69 reject - 71 remote access to image reports - 124 review - 74 review tools - 62, 75 store - 71, 118 Implant Displaced views - 60 Implant Present button - 57 indicators - 23 install compression paddles - 91 conventional face shield - 86 localization crosshair device - 95 magnification crosshair device - 96 Magnification Stand - 93 retractable face shield - 84 Intelligent 2D - 5 international symbols - 9 I-View - 79 I-View settings - 82, 119 L label locations - 21 laser film printer, isolation requirements - 13 licenses - 114 light field lamp use - 101 localization crosshair device align - 97 install and remove - 95 use - 96 localization paddles - 90 Log In - 31 fingerprint scanner - 31 Log Out - 55 M magnification crosshair device, install and remove

- 96 magnification paddles - 89 Magnification Stand - 93 install and remove - 93 maintenance MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018 general - 105 manage alarms - 46 notices - 46 output groups - 63 messages and alerts - 139 MLO rotation - 41 mobile system QC tests - 148 safety - 143 specifications - 144 test after travel - 148 My Settings icon - 46 N needle localization - 103 Notices tab - 77 O On/Off button - 23 on-demand outputs - 64 open patient procedure - 50 output devices custom output - 64 manage output groups - 46 output groups - 78 taskbar icons - 46 output groups, manage - 78 output groups, select - 63 outputs, on-demand - 64 P paddle shift - 43, 58 paddle shift buttons - 25 paddles compression - 89 install - 91 remove - 91 shift - 25, 43, 58 shift to new position - 58 SmartCurve paddle - 87, 88 patient add - 50 close - 62 3Dimensions System User Guide Index delete - 53 edit information - 51 face shield - 84 filter - 53 open - 50 position - 101 pended image, accept or reject - 73 permissions, by user group - 122 power button - 23 prerequisites for system use - 6 preview image screen - 69 print - 66 procedure screen - 56 procedures add - 59 close - 62 Q quality control requirements - 7 quality control tasks, perform - 45 query worklist - 55 R radiation safety - 13 reject images - 71 remote access to image reports - 124 remove compression paddles - 91 conventional face shield - 86 localization crosshair device - 95 magnification crosshair device - 96 Magnification Stand - 93 retractable face shield - 84 view - 60 requirements quality control - 7 skills needed - 6 training - 7 retractable face shield install - 84 use - 85 review images - 74 rejected image - 73 ROI tab - 77 MAN-05085-002 Revision 002 DRAFT Page 155 Preview Copy-Generated May 30, 2018 turn off system - 44 turn on system - 29 Log In - 31 startup - 29 U uninterrupted power supply - 142 user interface - 45 user profiles - 6 users menu - 46 V view add - 60 edit - 61 W warnings, cautions and notes - 13 defined - 10 window level - 75 workflow, standard - 99 worklist, query - 55 X x-ray acquire image - 101 collimated fields - 42 indicators - 101 3Dimensions System User Guide Index S safety data loss - 13 equipment damage - 13 general information - 13 radiation - 13 screening acquire the image - 101 screens add new patient - 50 add view - 60 admin - 111 filter patient information - 53 preview image - 69 query - 55 Select Function to Perform - 45 select exposure parameters - 70 output groups - 63 send images to outputs - 78 Shifting Paddle system - 43, 58 SmartCurve paddle - 87, 88 specifications - 129 electrical - 132 spot compression paddles - 89 statement, cybersecurity - 8 system administration - 111 capabilities - 2 description - 11 messages - 140 power controls - 23 ready - 101 status icons - 46 T tabs filter, column - 54 taskbar - 46 technical support - 8 tools, image review - 75 training requirements - 7 tubehead, display - 25 tubestand, controls and indicators - 24 Page 156 DRAFT MAN-05085-002 Revision 002 Preview Copy-Generated May 30, 2018