User Guide
212 Pages
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Page 1
User Guide
MAN-10377-002 Revision 002
3Dimensions
Digital Mammography System
Digital Tomosynthesis System
User Guide
For Software Version 2.2.1
Part Number MAN-10377-002 Revision 002 May 2024
™
Product Support USA:
+1.877.371.4372
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+32 2 711 4690
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+852 37487700
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+1 800 264 073
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© 2024 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, 3Dimensions, 3D, 3D Mammography, 3DQuorum, Affirm, C-View, Dimensions, FAST Paddle, Genius, Genius AI, Hologic Clarity HD, I-View, ImageChecker, Quantra, 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/patent-information.
3Dimensions System User Guide
Table of Contents
Table of Contents List of Figures _________________________________________________________________ xi List of Tables _________________________________________________________________ xv 1: Introduction __________________________________________________________________1
1.1
1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10
1.11
1.12 1.13
1.14 1.15 1.16 1.17 1.18 1.19 1.20 1.21 1.22 1.23 1.24
Intended Uses ... 1 1.1.1 3Dimensions System Intended Use ... 1 1.1.2 Genius AI Detection Software Intended Use ... 2 1.1.3 Contraindications ... 2 Descriptions of Warnings, Cautions, and Notes ... 3 Intended User ... 3 Patient Target Group ... 4 Clinical Benefits... 4 Potential Adverse Effects of Mammography Systems on Health ... 4 System Capabilities... 4 About the Genius 3D Mammography Exam ... 5 More Information About Tomosynthesis ... 5 About C-View and Intelligent 2D Imaging Technologies ... 7 1.10.1 Warnings for C-View and Intelligent 2D Imaging Technologies... 7 1.10.2 Theory of Operation for C-View and Intelligent 2D Imaging Technologies ... 7 About 3DQuorum Software ... 9 1.11.1 Warning for 3DQuorum Software ... 9 1.11.2 Theory of Operation for 3DQuorum Software ... 10 About Genius AI Detection Software... 11 1.12.1 Warnings and Precautions for Genius AI Detection Software ... 11 User Profiles... 12 1.13.1 Mammography Technologist ... 12 1.13.2 Radiologist ... 12 1.13.3 Medical Physicist ... 12 Training Requirements ... 12 Quality Control Requirements ... 13 Where to Find the Installation Instructions ... 13 Where to Find Technical Description Information... 13 Warranty Statement ... 13 Technical Support ... 14 Product Complaints ... 14 Hologic Cybersecurity Statement ... 14 Antivirus Information ... 14 Symbols ... 14 Document Conventions ... 18
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2: General Information__________________________________________________________19 2.1 2.2 2.3 2.4 2.5 2.6
System Overview ... 19 2.1.1 C-Arm Overview ... 20 Safety Information ... 21 Warnings and Precautions ... 21 Emergency Off Switches ... 26 Interlocks ... 27 Compliance ... 27 2.6.1 Compliance Requirements ... 27 2.6.2 Compliance Statements... 29
3: System Controls and Indicators ________________________________________________31 3.1 3.2
3.3
System Power Controls ... 31 Tubestand Controls and Indicators ... 32 3.2.1 Tubehead Display ... 33 3.2.2 Compression Device Controls and Display ... 33 3.2.3 C-Arm Control Panels ... 34 3.2.4 Gantry Control Panels ... 34 3.2.5 Dual Function Footswitch ... 35 Universal Acquisition Workstation Controls and Displays ... 36
4: Startup, Functional Tests, and Shutdown _______________________________________37 4.1 4.2 4.3
4.4 4.5 4.6
How to Start the System... 37 Log In ... 40 Perform the Functional Tests... 42 4.3.1 Compression Functional Tests ... 43 4.3.2 C-Arm Movement Functional Tests ... 44 4.3.3 Collimation ... 51 4.3.4 Shifting Paddles ... 52 Emergency Off Switches Functionality ... 53 How to Turn Off the System ... 53 How to Remove All Power from the System ... 53
5: User Interface ________________________________________________________________55 5.1 5.2 5.3
Select Function to Perform Screen ... 55 About the Taskbar... 56 Select Patient Screen ... 59 5.3.1 About the Notices Tab ... 60 5.3.2 Open a Patient ... 61 5.3.3 Add a New Patient ... 61 5.3.4 Edit the Patient Information ... 61 5.3.5 Split the Patient Records ... 62 5.3.6 Delete a Patient ... 65 5.3.7 Filters for Patients ... 65 5.3.8 Refresh the Worklist ... 67
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5.4
5.5 5.6
5.7
5.3.9 Query the Worklist ... 67 5.3.10 Admin ... 67 5.3.11 Log Out ... 67 5.3.12 Advanced Workflow Manager ... 68 Procedure Screen... 68 5.4.1 How to Use the Implant Present Button... 70 5.4.2 How to Use the Paddle Shift Feature ... 70 5.4.3 Procedure Information Dialog Box ... 71 5.4.4 Add a Procedure ... 74 5.4.5 Add (or Remove) a View ... 76 5.4.6 Edit a View ... 77 5.4.7 Retrieve ... 77 5.4.8 Close a Patient ... 78 How to Access the Image Review Features ... 79 Output Groups ... 80 5.6.1 Select an Output Group ... 80 5.6.2 Add or Edit an Output Group ... 80 5.6.3 SmartSlices Output Groups... 81 5.6.4 Custom Output ... 82 On-Demand Outputs... 83 5.7.1 Archive ... 83 5.7.2 Export ... 84 5.7.3 Print ... 85
6: Imaging _____________________________________________________________________87 6.1 6.2
6.3
6.4
6.5
6.6
Image Display Screen ... 87 How to Set the Exposure Parameters ... 88 6.2.1 Select the Image Acquisition Mode (Tomosynthesis Option) ... 88 6.2.2 Select the Exposure Mode ... 88 6.2.3 How to Use the AEC Sensor ... 88 How to Acquire an Image... 89 6.3.1 Conventional Imaging Sequence of Events... 90 6.3.2 Tomosynthesis Imaging Sequence of Events ... 90 6.3.3 How to Accept a Rejected Image ... 91 6.3.4 How to Accept or Reject a Pended Image ... 91 6.3.5 Skin Line Brightness ... 91 How to Acquire an Image with an Implant ... 92 6.4.1 Implant Away from the Nipple ... 92 6.4.2 Implant Near the Nipple ... 93 6.4.3 Implant Displaced Views ... 95 6.4.4 Implant Brightness ... 96 How to Correct and Reprocess Implant Images ... 97 6.5.1 If the Image Is Not Accepted ... 97 6.5.2 If the Image Is Accepted ... 97 How to Review the Images... 98
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6.7 6.8
6.9
6.6.1 Image Review Tools Tab ... 99 6.6.2 Notices Tab ... 100 6.6.3 Other Image Review Tools ... 101 6.6.4 Projection Indicator ... 102 6.6.5 Slice Indicator ... 102 How to Send the Images to the Output Devices ... 102 I-View Software Contrast Enhanced 2D Images... 103 6.8.1 Tube Loading Indicator ... 106 6.8.2 How to Configure the Contrast Settings ... 107 Specimen Images... 108
7: Accessories _________________________________________________________________111 7.1 7.2
7.3
7.4 7.5
How to Install Accessories on the C-Arm... 111 Patient Face Shields ... 112 7.2.1 How to Install and Remove the Retractable Face Shield ... 112 7.2.2 How to Use the Retractable Face Shield ... 113 7.2.3 How to Install and Remove the Conventional Face Shield... 114 Compression Paddles ... 114 7.3.1 Routine Screening Paddles ... 116 7.3.2 Contact and Spot Compression Paddles ... 117 7.3.3 Magnification Paddles ... 117 7.3.4 Localization Paddles ... 118 7.3.5 Large Ultrasound Paddle... 118 7.3.6 How to Install and Remove a Compression Paddle ... 119 7.3.7 Paddle Maintenance and Cleaning ... 120 7.3.8 Paddle Shift... 120 7.3.9 FAST Compression Mode... 120 Magnification Stand... 122 7.4.1 How to Install and Remove the Magnification Stand... 122 Crosshair Devices... 124 7.5.1 How to Install and Remove the Localization Crosshair Device ... 124 7.5.2 How to Use the Localization Crosshair Device ... 125 7.5.3 How to Install and Remove the Magnification Crosshair Device ... 125 7.5.4 How to Align the Crosshair Device ... 126
8: Clinical Procedures __________________________________________________________127 8.1
8.3
Standard Workflow ... 127 8.1.1 Preparation ... 127 8.1.2 At the Gantry ... 128 8.1.3 At the Acquisition Workstation ... 129 Screening Procedure Example... 129 8.2.1 Position the Patient ... 130 8.2.2 Set the Exposure Techniques... 130 8.2.3 Acquire the Exposure ... 131 Procedure for Needle Localization with Tomosynthesis ... 132
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9: Maintenance and Cleaning ___________________________________________________135 9.1
9.2
Cleaning ... 135 9.1.1 General Information About Cleaning ... 135 9.1.2 For General Cleaning ... 135 9.1.3 To Prevent Possible Injury or Equipment Damage... 136 9.1.4 Acquisition Workstation... 136 Maintenance ... 138 9.2.1 Preventive Maintenance Schedules ... 138 9.2.2 About Reclamation ... 140
10: System Administration Interface _____________________________________________141
10.1 Admin Screen ... 141 10.2 About Screen ... 143 10.2.1 Licensing Tab ... 144 10.3 Change the User Language Preference ... 145 10.4 Set Auto-Hanging and Auto-Pairing ... 145 10.5 Set Multi Line Procedure Tabs ... 146 10.6 Enable and Set the Height Memory ... 147 10.7 Enable and Set the Default Height ... 149 10.8 Set Auto-Accept and Auto-Pend Images ... 151 10.9 Set the Contrast Defaults ... 152 10.10 Set Genius AI Detection Software Preferences ... 153 10.11 System Tools ... 155 10.11.1 System Tools for the Radiologic Technologist Manager ... 156 10.11.2 Remote Access to Image Reports ... 157 10.12 Archive Tool ... 160
Appendix A Specifications _____________________________________________________163 A.1
A.2
A.3 A.4
A.5
Product Measurements ... 163 A.1.1 Tubestand (Gantry with C-Arm) ... 163 A.1.2 Acquisition Workstations ... 164 Operation and Storage Environment ... 165 A.2.1 General Conditions for Operation... 165 A.2.2 Storage Environment ... 166 Radiation Shield ... 166 Electrical Input ... 166 A.4.1 Tubestand ... 166 A.4.2 Acquisition Workstation... 167 Tubestand Technical Information... 167 A.5.1 C-Arm... 167 A.5.2 Compression ... 168 A.5.3 X-ray Tube ... 169 A.5.4 X-ray Beam Filtration and Output ... 169 A.5.5 X-ray Collimation ... 171 A.5.6 Light Field Indication ... 171
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A.6
A.5.7 X-ray Generator... 171 Imaging System Technical Information ... 172 A.6.1 Image Receptor ... 172
Appendix B System Messages and Alert Messages ________________________________173 B.1 B.2
B.3
Error Recovery and Troubleshooting ... 173 Types of Messages ... 173 B.2.1 Fault Levels... 173 B.2.2 System Messages ... 174 UPS Messages ... 176
Appendix C Use of Mobile System ______________________________________________177 C.1 C.2
C.3
C.4 C.5 C.6
Conditions for Safety and Other Precautions ... 177 Specifications for Mobile Use ... 178 C.2.1 Shock and Vibration Limits ... 178 C.2.2 Coach Environment ... 178 Electrical Input ... 179 C.3.1 Gantry... 179 C.3.2 Acquisition Workstation ... 179 Prepare the System for Travel ... 180 Prepare the System for Use ... 182 Test the System after Travel ... 183 C.6.1 Mobile System Controls and Functional Tests ... 183 C.6.2 Quality Control for Mobile Systems ... 183
Appendix D Dose Information _________________________________________________185 D.1 D.2
EUREF Dose Tables ... 185 EUREF CNR Table ... 186
Appendix E List of Licenses and Accessories _____________________________________187 Glossary of Terms _____________________________________________________________189 Index ________________________________________________________________________191
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List of Figures Figure 1: 3Dimensions™ System ... 19 Figure 2: C-arm Overview ... 20 Figure 3: Emergency Off Switch Functionality ... 26 Figure 4: System Power Controls ... 31 Figure 5: Tubestand Controls and Indicators ... 32 Figure 6: Tubehead Display ... 33 Figure 7: Compression Device ... 33 Figure 8: Compression Device Display... 33 Figure 9: C-arm Control Panel ... 34 Figure 10: Gantry Control Panel ... 34 Figure 11: Dual Function Footswitch ... 35 Figure 12: Universal Acquisition Workstation Controls and Displays ... 36 Figure 13: Turn to Reset the Emergency Off Switches... 37 Figure 14: Universal Acquisition Workstation Power Buttons ... 37 Figure 15: Windows 10 Login Screen ... 38 Figure 16: Startup Screen ... 39 Figure 17: System Log In Screen ... 40 Figure 18: C-arm Control Panel (left side shown) ... 42 Figure 19: Emergency Off Switch Functionality ... 53 Figure 20: Universal Acquisition Workstation Power Buttons ... 53 Figure 21: An Example Select Function to Perform Screen ... 55 Figure 22: Taskbar... 56 Figure 23: Select Patient Screen... 59 Figure 24: Enterprise Tab ... 60 Figure 25: Add Patient Screen ... 61 Figure 26: Split Patient Records Screen... 62 Figure 27: Select the Correct Procedure to Split Patient Records ... 64 Figure 28: Filter Tab in the Patient Filter Screen... 65 Figure 29: Procedure Screen ... 68 Figure 30: Paddle Shift Buttons... 70 Figure 31: Procedure Info Dialog Box ... 71 Figure 32: Genius AI Detection Tab ... 73 Figure 33: Add Procedure Dialog Box ... 74 Figure 34: Add View Screen ... 76 Figure 35: Edit View Screen... 77 Figure 36: Output Groups Field ... 80 Figure 37: Example of the Output Device Settings ... 81 Figure 38: An Example Custom Output Group... 82 Figure 39: Select the Images for Export ... 84 Figure 40: Export Dialog Box ... 84 Figure 41: Print Screen ... 85 Figure 42: Image Display Screen (SmartSlices option shown) ... 87 MAN-10377-002 Revision 002
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Figure 43: Exposure In Progress ... 89 Figure 44: Exposure Complete ... 89 Figure 45: Marked Images in a Procedure ... 90 Figure 46: Comparison of Standard Brightness and Reduced Brightness ... 91 Figure 47: Comparison of Standard Brightness and Reduced Brightness ... 96 Figure 48: Tools Tab (Tomosynthesis option shown) ... 98 Figure 49: Image Review Tools ... 99 Figure 50: Tools on the Notices Tab ... 100 Figure 51: Exposure Index ... 101 Figure 52: Display Modes ... 101 Figure 53: Projection Indicator ... 102 Figure 54: Slice Indicator (SmartSlices option shown)... 102 Figure 55: I-View Software 2D Contrast Screen... 103 Figure 56: I-View Software 2D Contrast Screen, Waiting Period ... 104 Figure 57: I-View Software 2D Contrast Screen, Optimal Imaging Period ... 105 Figure 58: I-View Software 2D Contrast Information ... 107 Figure 59: Procedure Screen for Specimens ... 108 Figure 60: Specimen Imaging Screen... 109 Figure 61: C-arm Accessories ... 111 Figure 62: Align the Retractable Face Shield on the C-arm... 112 Figure 63: Face Shield Installation ... 113 Figure 64: Face Shield Operation ... 113 Figure 65: How to Install the Conventional Face Shield ... 114 Figure 66: Installation of a Compression Paddle ... 119 Figure 67: How to Remove a Compression Paddle... 119 Figure 68: The FAST Compression Mode Slide ... 121 Figure 69: Installation of the Magnification Stand ... 122 Figure 70: Installation of the Localization Crosshair Device ... 124 Figure 71: How to Install and Remove the Magnification Crosshair Device... 125 Figure 72: Example of a Screening Procedure Screen ... 129 Figure 73: Exposure In Progress ... 131 Figure 74: Exposure Complete ... 131 Figure 75: Calculating needle depth... 133 Figure 76: Admin Screen ... 141 Figure 77: System Tab of the About (the Acquisition Workstation) Screen... 143 Figure 78: Licensing Tab of the About Screen... 144 Figure 79: Enable Auto-Hanging and Auto-Pairing ... 145 Figure 80: Enable Multi Line Procedure Tabs ... 146 Figure 81: My Settings Button in the Admin Screen ... 147 Figure 82: Console Tab of the Edit Operator Screen ... 147 Figure 83: Height Adjust Control Panel... 148 Figure 84: Desired Console Height and Current Console Height Fields ... 148 Figure 85: Preferences Button in the Admin Screen ... 149 Figure 86: Console Tab of the System Preferences Screen... 149 Figure 87: Height Adjust Control Panel... 150
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Figure 88: Desired Console Height and Current Console Height Fields ... 150 Figure 89: Set Image Auto Disposition ... 151 Figure 90: I-View Software 2D Contrast Default Settings ... 152 Figure 91: Automatic Selection for Genius AI Case Processing ... 153 Figure 92: Enable User Selection for Genius AI Case Processing... 153 Figure 93: User Selection for Genius AI Detection Software Case Processing ... 154 Figure 94: System Tools Button ... 155 Figure 95: System Tools Screen ... 156 Figure 96: System Tools Login Screen... 157 Figure 97: System Tools Welcome Screen ... 158 Figure 98: Create Image Report Parameters ... 158 Figure 99: Download the Image Report... 159 Figure 100: Archive Button ... 160 Figure 101: Multi Patient On Demand Archive Screen ... 160 Figure 102: Export Screen ... 162 Figure 103: Tubestand (Gantry with C-arm) Measurements ... 163 Figure 104: Universal Acquisition Workstation Measurements ... 164 Figure 105: Mobile Universal Acquisition Workstation Measurements ... 165 Figure 106: UPS LCD Display ... 176 Figure 107: Keyboard Tray Lock Knob (Right or Left Side)... 180 Figure 108: Tray Lock Release from Locked (A) to Unlocked (D) ... 180 Figure 109: Swivel Monitor Lock Knobs on the Mobile Universal Acquisition Workstation (series I) ... 181 Figure 110: Swivel Monitor Lock Knobs on the Mobile Universal Acquisition Workstation (series II) ... 181 Figure 111: Tray Lock Release from Locked (A) to Unlocked (D) ... 182 Figure 112: Swivel Monitor Lock Knobs on the Mobile Universal Acquisition Workstation (series I) ... 182 Figure 113: Swivel Monitor Lock Knobs on the Mobile Universal Acquisition Workstation (series II) ... 182
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List of Tables Table 1: Compression Tests ... 43 Table 2: C-arm Up and Down Movement ... 44 Table 3: C-arm Counterclockwise Rotation... 46 Table 4: C-arm Clockwise Rotation ... 46 Table 5: C-arm Rotation Switch ... 47 Table 6: Automatic C-arm Counterclockwise Rotation ... 49 Table 7: Automatic C-arm Clockwise Rotation ... 49 Table 8: Automatic MLO Rotation ... 50 Table 9: C-arm Collimation ... 51 Table 10: Shifting Paddle ... 52 Table 11: Taskbar Menus ... 56 Table 12: The Select Patient Screen ... 59 Table 13: Filter Tab Options (Require Access Privileges) ... 66 Table 14: The Procedure Screen ... 69 Table 15: Procedure Groups ... 75 Table 16: Output Groups for 3DQuorum Software ... 81 Table 17: Output Device Settings for 3DQuorum Software ... 81 Table 18: Conventional 2D Imaging ... 94 Table 19: Tomosynthesis Imaging ... 94 Table 20: Contrast Enhanced Imaging ... 94 Table 21: Available Accessories ... 115 Table 22: User Preventive Maintenance... 138 Table 23: Service Engineer Preventive Maintenance ... 139 Table 24: Admin Screen Functions ... 142 Table 25: Radiologic Technologist Manager-System Tools Functions ... 156 Table 26: Maximum mA Setting as a Function of kV ... 169 Table 27: System Messages ... 174 Table 28: 2D Dose (EUREF) ... 185 Table 29: BT Dose (EUREF) ... 185 Table 30: CEDM Dose (EUREF) ... 186 Table 31: Licenses and Accessories ... 187
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Chapter 1: Introduction
Chapter 1 Introduction 1:
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. Note The features shown in this manual may not be available in all regions. Contact your Hologic representative for information.
1.1
Intended Uses Caution: United States federal law restricts this device to sale by or on the order of a physician.
1.1.1
3Dimensions System Intended Use The Hologic® 3Dimensions™ system generates 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 and the 3D image set can be viewed as either 1-mm 3D slices or 6-mm 3D SmartSlices.
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).
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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.
1.1.2
Genius AI Detection Software Intended Use Genius AI® Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and asymmetries) and calcifications while reading DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam. Intended user population Intended users of Genius AI Detection software are MQSA qualified interpreting physicians. For users of Hologic review workstations, training on image review tools related to Genius AI Detection software is provided in the workstation User Guide. For other workstations, the user is expected to be trained based on materials provided by the workstation vendor. Intended patient population The device is intended to be used in the population of women undergoing screening mammography.
1.1.3
Contraindications There are no known contraindications.
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1.2
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.
1.3
Intended User Qualified, technically-trained personnel position the patient and operate the device (such as a mammography technologist), calibrate the device (such as a medical physicist), and interpret the image produced by the device (such as a radiologist).
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1.4
Patient Target Group Asymptomatic patients who are at average risk or at higher-than-average risk for breast cancer require breast cancer screening imaging. Those patients who may have symptoms related to breast cancer or abnormal findings on a screening exam also need diagnostic imaging using the same or similar modalities. Qualified, medically-trained personnel will decide based on shared decision making with the patient and, in some cases, the provider whether a radiographic examination is indicated based on patient age, patient health, and physical condition.
1.5
Clinical Benefits Population based mammography screening is the best method for detecting breast cancer before symptoms occur and is the only modality that has been proven to reduce mortality.
1.6
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):
1.7
•
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:
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•
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).
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1.8
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 a 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.
1.9
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 breastcancer screening (STORM): a prospective comparison study. Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fantò C, Valentini M, Montemezzi S, Macaskill P. Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25.
http://www.ncbi.nlm.nih.gov/pubmed/23623721
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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 Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.
http://www.ncbi.nlm.nih.gov/pubmed/23297332 Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24
http://www.ncbi.nlm.nih.gov/pubmed/24484063 Breast Cancer Screening Using Tomosynthesis in Combination With Digital Mammography Sarah M. Friedewald, MD1; Elizabeth A. Rafferty, MD2; Stephen L. Rose, MD3,4; Melissa A. Durand, MD5; Donna M. Plecha, MD6; Julianne S. Greenberg, MD7; Mary K. Hayes, MD8; Debra S. Copit, MD9; Kara L. Carlson, MD10; Thomas M. Cink, MD11; Lora D. Barke, DO12; Linda N. Greer, MD13; Dave P. Miller, MS14; Emily F. Conant, MD15 JAMA. 2014;311(24):2499-2507. doi:10.1001/jama.2014.6095
http://jama.jamanetwork.com/article.aspx?articleid=1883018 IMPORTANT: Hologic strongly recommends that users make themselves familiar with local or regional regulations. These regulations could impose restrictions on the different types of clinical use. Because the regulations could evolve and change over time, periodic review is recommended.
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1.10
About C-View and Intelligent 2D Imaging Technologies Note Intelligent 2D™ imaging technology may not be available in all regions. Contact your sales representative for information. 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 synthesized 2D image is created without the need for an additional digital mammography exposure. The synthesized 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.
1.10.1 Warnings for C-View and Intelligent 2D Imaging Technologies 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 synthesized 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 synthesized 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 synthesized 2D images before using them in conjunction with tomosynthesis image sets.
1.10.2 Theory of Operation for C-View and Intelligent 2D Imaging Technologies Overview
MAN-10377-002 Revision 002
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