Hologic Brevera User manual

Brevera®
Breast Biopsy System
User Guide
Models BREV100, BREV200
Part Number MAN-04303-002
Revision 006
May 2019

© 2018 - 2019 Hologic, Inc. Printed in the USA. This manual was originally written in English.
Hologic, Brevera, CorLumina, ATEC, Eviva, and associated logos are trademarks and/or registered trademarks of Hologic, Inc.,
and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product
names are the property of their respective owners.
This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patents.
Technical Support
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Asia: [phone]
Australia: [phone]
All Other: [phone]
Email: [email protected]

Brevera Breast Biopsy System User Guide
Table of Contents
MAN-04303-002 Revision 006 v
Table of Contents
List of Figures _________________________________________________________________ xi
List of Tables _________________________________________________________________xiii
1: Introduction __________________________________________________________________1
1.1 Preface ......................................................................................................................................................................1
1.2 Indications for Use..................................................................................................................................................1
1.3 Contraindications....................................................................................................................................................1
1.4 Essential Performance ............................................................................................................................................ 1
1.5 System Capabilities.................................................................................................................................................2
1.6 User Profiles.............................................................................................................................................................3
1.6.1 Mammography Technologist.................................................................................................................. 3
1.6.2 Radiologists, Surgeons.............................................................................................................................3
1.6.3 Medical Physicist ...................................................................................................................................... 3
1.7 Where to Find the Installation Instructions......................................................................................................... 3
1.8 Where to Find Technical Description Information.............................................................................................3
1.9 Warranty Statement................................................................................................................................................ 4
1.10 Technical Support ................................................................................................................................................... 4
1.11 Product Complaints................................................................................................................................................ 4
1.12 Hologic Cybersecurity Statement.........................................................................................................................4
1.13 Where to Obtain Copies of the Manuals.............................................................................................................. 5
1.14 Terms and Definitions............................................................................................................................................ 5
1.15 Descriptions of Warnings, Cautions, and Notes ................................................................................................5
2: General Information___________________________________________________________7
2.1 System Overview....................................................................................................................................................7
2.2 Safety Information ..................................................................................................................................................8
2.3 Warnings and Precautions.....................................................................................................................................8
2.4 Interlocks................................................................................................................................................................ 14
2.5 Compliance............................................................................................................................................................14
2.5.1 Compliance Requirements ....................................................................................................................14
2.5.2 Compliance Statements .........................................................................................................................15
2.6 Symbols ..................................................................................................................................................................16
2.7 Label Locations .....................................................................................................................................................19
3: Components, Controls, and Indicators __________________________________________21
3.1 System Components............................................................................................................................................. 21
3.1.1 Imaging Cabinet Components..............................................................................................................25
3.1.2 Suction Canister Components .............................................................................................................. 26
3.1.3 Biopsy Device Components ..................................................................................................................27

Brevera Breast Biopsy System User Guide
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3.2 System Connections..............................................................................................................................................31
3.2.1 Power and Network Connections ........................................................................................................32
3.2.2 Footswitch Connection ..........................................................................................................................33
3.2.3 Device Driver and Remote Control Connections...............................................................................33
3.2.4 Suction Canister Connections ...............................................................................................................34
3.2.5 Biopsy Needle Connections ..................................................................................................................34
3.3 Controls and Indicators........................................................................................................................................37
3.3.1 Imaging Panel Controls and Indicators...............................................................................................37
3.3.2 Mode Controls and Biopsy Device Arm and Fire Controls..............................................................38
3.4 How to Lock and Unlock a Caster......................................................................................................................39
3.5 How to Move the Console ...................................................................................................................................39
3.6 How to Start the System.......................................................................................................................................40
3.6.1 Log In........................................................................................................................................................41
3.7 How to Shut Down the System...........................................................................................................................41
3.7.1 How to Remove All Power from the System......................................................................................41
4: User Interface - Imaging Display_______________________________________________43
4.1About the Taskbar.................................................................................................................................................43
4.2 The Select Patient Screen......................................................................................................................................44
4.2.1 How to Change the Language ..............................................................................................................45
4.2.2 How to Open a Patient...........................................................................................................................45
4.2.3 How to Add a Patient ............................................................................................................................46
4.2.4 How to Edit the Patient Information ...................................................................................................47
4.2.5 How to Delete a Patient .........................................................................................................................48
4.2.6 The Patient Filter Screen ........................................................................................................................48
4.2.7 How to Refresh the Worklist.................................................................................................................50
4.2.8 How to Query the Worklist...................................................................................................................50
4.3 The Procedure Screen...........................................................................................................................................50
4.3.1 How to Select a Procedure.....................................................................................................................52
4.3.2 How to Add a Procedure.......................................................................................................................52
4.3.3 How to Access the Review Mode Screen ............................................................................................52
4.3.4 How to Access the Image Enhancement Tools...................................................................................52
4.3.5 How to Access the Filter Info................................................................................................................52
4.3.6 How to Access the Reimage Feature....................................................................................................53
4.3.7 How to Close a Patient...........................................................................................................................53
4.4 How to Use the Output Set..................................................................................................................................53
4.4.1 How to Select an Output Set .................................................................................................................53
4.4.2 How to Add or Edit an Output Set ......................................................................................................53
4.4.3 How to Use the On-Demand Outputs .................................................................................................54
4.4.4 How to Do the Gain Calibration...........................................................................................................58
5: User Interface - Technologist Display __________________________________________59
5.1 Technologist Display Screens and Modes .........................................................................................................59

Brevera Breast Biopsy System User Guide
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6: Imaging System Modes _______________________________________________________65
6.1 X-ray Mode ............................................................................................................................................................65
6.2 No X-ray Mode......................................................................................................................................................65
6.3 Single Chamber Mode.......................................................................................................................................... 66
7: Biopsy ______________________________________________________________________69
7.1 Set Up the System .................................................................................................................................................69
7.2 Connect the Device Driver and the Biopsy Supplies .......................................................................................69
7.3 Pre-Procedure System Check ..............................................................................................................................75
7.4 Prepare for Image Acquisition ............................................................................................................................ 76
7.5 Attach the Introducer to the Biopsy Device ......................................................................................................77
7.6 Attach a Biopsy Device Adapter to the Biopsy Guidance System .................................................................78
7.6.1 Using the System with Stereotactic (STX) Guidance .........................................................................78
7.7 Attach the Biopsy Device to the Biopsy Device Adapter ................................................................................78
7.8 Performing a Biopsy and Acquiring Real-time Images...................................................................................79
7.8.1 When the Twelve Chambers of the Tissue Filter Contain Cores .....................................................81
7.8.2 Lavage and Aspirate .............................................................................................................................. 82
7.8.3 Conclude Tissue Acquisition ................................................................................................................82
7.8.4 Deploying a Biopsy Site Marker........................................................................................................... 83
7.8.5 Remove the Biopsy Device Adapter ....................................................................................................83
7.9 Conclude the Procedure....................................................................................................................................... 84
7.10 How to Change the Biopsy Needle Between Procedures ...............................................................................85
7.11 How to Change the Biopsy Needle During Troubleshooting ........................................................................86
8: The Images __________________________________________________________________89
8.1 Introduction...........................................................................................................................................................89
8.2 How to Review the Images..................................................................................................................................89
8.2.1 How to Tag an Image.............................................................................................................................90
8.2.2 The Review Mode Screen ...................................................................................................................... 91
8.2.3 Image Enhancement Tools ....................................................................................................................92
8.2.4 The Filter Info and Comments Screen ................................................................................................. 93
8.2.5 How to Reimage .....................................................................................................................................94
8.3 Send the Images to the Output Devices.............................................................................................................94
9: System Administration Interface_______________________________________________95
9.1 The Admin Screen ................................................................................................................................................ 95
9.2 How to Use the System Tools .............................................................................................................................97
9.2.1 The System Tools Screen .......................................................................................................................98
10: Maintenance, Cleaning, and Disinfecting ______________________________________99
10.1 General Information ............................................................................................................................................. 99
10.1.1 For General Cleaning ............................................................................................................................. 99
10.1.2 For Disinfecting.......................................................................................................................................99
10.1.3 To Prevent Possible Injury or Equipment Damage..........................................................................100

Brevera Breast Biopsy System User Guide
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10.2 Component Specific Cleaning and Disinfection.............................................................................................100
10.2.1 How to Clean and Disinfect the Console Exterior Surfaces............................................................100
10.2.2 How to Clean and Disinfect the Device Driver and Remote Control............................................101
10.2.3 How to Clean and Disinfect the Tissue Filter Drawer.....................................................................101
10.2.4 How to Clean the Imaging Display....................................................................................................101
10.2.5 How to Clean the Technologist Display............................................................................................102
10.2.6 How to Clean the Footswitch..............................................................................................................103
10.2.7 Cleaning Schedule ................................................................................................................................103
10.3 Preventive Maintenance.....................................................................................................................................104
10.3.1 Vacuum Line Assembly.......................................................................................................................104
10.3.2 Device Driver ........................................................................................................................................105
10.3.3 Footswitch..............................................................................................................................................106
10.3.4 Power Cord............................................................................................................................................106
10.3.5 Preventive Maintenance Schedule for the User................................................................................107
10.3.6 Preventive Maintenance Schedule for the Service Engineer...........................................................108
Appendix A: System Specifications _____________________________________________109
A.1 Product Measurements ......................................................................................................................................109
A.1.1 Console...................................................................................................................................................109
A.1.2 Device Driver ........................................................................................................................................110
A.1.3 Biopsy Needle .......................................................................................................................................110
A.2 Operation and Storage Environment ...............................................................................................................110
A.2.1 General Conditions for Operation......................................................................................................110
A.2.2 Storage Environment............................................................................................................................110
A.3 Electrical Input ....................................................................................................................................................111
A.4 Classification........................................................................................................................................................111
A.5 Console Technical Information .........................................................................................................................112
A.5.1 General Information.............................................................................................................................112
A.5.2 Network Environment.........................................................................................................................112
A.6 X-ray Tube Technical Information....................................................................................................................112
A.6.1 X-Ray Generator ...................................................................................................................................112
A.6.2 Disposal..................................................................................................................................................112
A.7 Imaging System Technical Information...........................................................................................................113
A.7.1 Image Receptor .....................................................................................................................................113
Appendix B: Troubleshooting __________________________________________________115
B.1 Error Recovery and Troubleshooting...............................................................................................................115
B.2 Types of Messages and Alert Messages...........................................................................................................115
B.2.1 Fault Levels............................................................................................................................................115
B.2.2 System Messages ..................................................................................................................................116
B.3 System Restart .....................................................................................................................................................116
B.4 Troubleshooting During Setup .........................................................................................................................116
B.5 Troubleshooting During a Procedure ..............................................................................................................119

Brevera Breast Biopsy System User Guide
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Appendix C: Brevera Compatible Components and Accessories ____________________123
C.1 Hologic Factory-Verified Compatible Components and Accessories ......................................................... 123
Appendix D: Owner’s Record___________________________________________________125
D.1 Brevera Breast Biopsy System with CorLumina Imaging Technology .......................................................125
Index ________________________________________________________________________127