Affirm Guidance System User Guide Rev 003 July 2021

Affirm

®

Breast Biopsy Guidance System

User Guide

For Software Versions 1.11 and 2.2

Part Number MAN-06411-002 Revision 003 July 2021

Product Support USA:

+1.877.371.4372

Europe:

+32 2 711 4690

Asia:

+852 37487700

Australia:

+1 800 264 073

All Other:

+1 781 999 7750

Email:

[email protected]

© 2020-2001 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, 3Dimensions, Affirm, ATEC, Brevera, Dimensions, Eviva, Selenia, 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.

Affirm Breast Biopsy Guidance System User Guide Table of Contents

Table of Contents List of Figures _________________________________________________________________ ix List of Tables __________________________________________________________________ xi 1: Introduction __________________________________________________________________1 1.1 1.2

Intended Use... 1 User Profiles... 1 1.2.1 Mammography Technologist ... 1 1.2.2 Radiologists, Surgeons ... 1 1.2.3 Medical Physicist ... 2 1.3 Training Requirements... 2 1.4 Quality Control Requirements ... 2 1.5 Where to Find Technical Description Information... 2 1.6 Warranty Statement ... 3 1.7 Technical Support ... 3 1.8 Product Complaints ... 3 1.9 Hologic Cybersecurity Statement ... 3 1.10 Symbols ... 4 1.11 Descriptions of Warnings, Cautions, and Notes ... 5

2: General Information___________________________________________________________7 2.1 2.2 2.3 2.4 2.5 2.6

System Overview ... 7 How to Handle the Biopsy Guidance Module... 8 Safety Information ... 9 Warnings and Precautions... 9 Compliance ... 10 2.5.1 Compliance Requirements ... 10 Label Locations ... 11

3: Installation, Verification, and Removal _________________________________________13 3.1 3.2 3.3

3.4

Biopsy Guidance Module Components ... 13 Biopsy Control Module Components ... 15 Installation of the Main Components... 16 3.3.1 Attach the Biopsy Guidance Module ... 16 3.3.2 Attach the Biopsy Control Module ... 17 Installation and Removal of Accessories ... 18 3.4.1 Biopsy Compression Paddles... 18 3.4.2 Needle Guide ... 18 3.4.3 Biopsy Device Adapter ... 20 3.4.4 Biopsy Device ... 20 3.4.5 Lateral Arm and Lateral Arm Accessories ... 21

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Affirm Breast Biopsy Guidance System User Guide Table of Contents

3.5 3.6

3.7 3.8

System Verifications ... 36 3.5.1 Confirm the Host Connection ... 36 Removal of the Main Components ... 37 3.6.1 Biopsy Control Module... 37 3.6.2 Biopsy Guidance Module ... 37 Tabletop Stand for the Affirm System ... 38 Storage Case for the Lateral Arm ... 39

4: User Interface - Biopsy Control Module ________________________________________41 4.1

Biopsy Control Module Screens ... 41 4.1.1 Home Screen... 41 4.1.2 Target Guidance Screen ... 42 4.1.3 Jog Mode Screen... 46 4.1.4 Select Target Screen ... 48

5: Biopsy ______________________________________________________________________51 5.1

5.2

5.3 5.4 5.5

5.6 5.7 5.8

Biopsy Views ... 51 5.1.1 Add a Biopsy View ... 52 5.1.2 Edit a Biopsy View ... 54 C-Arm Stereo Modes ... 55 5.2.1 C-Arm Rotation in the C-Arm Stereo Modes... 55 5.2.2 How to Select the C-Arm Stereo Mode for Image Acquisition ... 57 Biopsy Tab... 58 5.3.1 Biopsy Options ... 59 Stereotactic 2D Lesion Targeting ... 62 5.4.1 Verify the Position of the Biopsy Device ... 63 Lesion Targeting with Tomosynthesis Guidance ... 64 5.5.1 Verify the Position of the Biopsy Device ... 65 5.5.2 Project Targets on Post-Fire Scout Image ... 65 Lesion Targeting Using Multi-Pass ... 66 Post Biopsy ... 70 Printing Stereo Pair Images ... 70

6: Quality Control ______________________________________________________________71 6.1 6.2

6.3

Required Quality Control Procedures ... 71 QAS Test ... 71 6.2.1 QAS Test for Standard Needle Approach ... 72 6.2.2 QAS Test for Lateral Needle Approach ... 75 Geometry Calibration ... 78 6.3.1 Geometry Calibration Procedure... 78

7: Care and Cleaning____________________________________________________________79 7.1 7.2 7.3

General Information ... 79 Preventive Maintenance Schedule ... 79 Service Preventive Maintenance Schedule ... 81

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7.4

For General Cleaning ... 82 7.4.1 How to Clean the Biopsy Control Module Screen ... 82 7.4.2 To Prevent Possible Injury or Equipment Damage ... 83

Appendix A: System Specifications ______________________________________________85 A.1 A.2 A.3 A.4 A.5

Affirm System Measurements ... 85 Lateral Arm Measurements ... 86 Biopsy Guidance Module ... 87 Lateral Arm ... 87 Biopsy Control Module ... 87

Appendix B: System Messages and Alerts _________________________________________89 B.1 B.2 B.3

Audible Alerts ... 89 Error Messages ... 89 Acquisition Workstation Messages ... 91

Appendix C: CNR Correction for Biopsy __________________________________________93 C.1 C.2

CNR Correction for Stereotactic 2D Biopsy ... 93 C.1.1 AEC Table 0 (Standard Stereotactic 2D Biopsy Dose) ... 93 CNR Correction for Biopsy Under Tomosynthesis Option ... 93 C.2.1 AEC Table 0 (Tomosynthesis Option: Standard Tomo Dose) ... 93

Appendix D: Forms_____________________________________________________________95 D.1 D.2

QAS Test Checklist ... 95 QAS Test Checklist for the Lateral Arm ... 96

Appendix E: Ancillary Parts for Biopsy ___________________________________________97 E.1 E.2

Hologic Factory-Verified Biopsy Devices ... 97 Wire Localization Needle Guides ... 98

Glossary of Terms ______________________________________________________________99 Index ________________________________________________________________________101

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Affirm Breast Biopsy Guidance System User Guide Table of Contents

List of Figures Figure 1: Affirm Biopsy System on the Selenia Dimensions Mammography System ... 7 Figure 2: How to Lift the Biopsy Guidance Module ... 8 Figure 3: How to Store the Biopsy Guidance Module ... 8 Figure 4: Biopsy Guidance Module Label Location ... 11 Figure 5: Lateral Arm Serial Number Label Location... 11 Figure 6: Biopsy Guidance Module ... 13 Figure 7: Biopsy Control Module ... 15 Figure 8: Installation of the Biopsy Guidance Module ... 16 Figure 9: Attachment of the Biopsy Control Module... 17 Figure 10: Installation of the Needle Guide Holder on the Standard Device Mount ... 19 Figure 11: Installation of the Needle Guide on the Standard Needle Guide Holder ... 19 Figure 12: Attaching a Biopsy Device Adapter to the Device Mount (Standard) ... 20 Figure 13: Lateral Arm Components... 21 Figure 14: Left Needle Approach of Lateral Arm (Blue) ... 23 Figure 15: Right Needle Approach of Lateral Arm (Yellow) ... 23 Figure 16: Installing the Lateral Arm Stand over the Image Receptor ... 24 Figure 17: Removing the Needle Guide Holder from the Standard Device Mount ... 25 Figure 18: Installing the Lateral Arm on the Device Mount ... 26 Figure 19: Selection Screen for the Lateral Arm Mounting Side ... 27 Figure 20: Attaching the Blue Needle Guide Holder to the Needle Guide Rods (Left Needle Approach) ... 28 Figure 21: Attaching the Yellow Needle Guide Holder to the Needle Guide Rods (Right Needle Approach).. 28 Figure 22: Installing a Disposable Needle Guide on a Needle Guide Holder (Lateral Arm) ... 29 Figure 23: Carriage Lever Locked and Unlocked Positions ... 30 Figure 24: Locked and Unlocked Positions of Device Mount Lever... 30 Figure 25: Installing Device Mount onto Lateral Arm Carriage ... 31 Figure 26: Attaching the Biopsy Device Adapter to the Device Mount (Lateral Arm) ... 32 Figure 27: Lock Levers in Fully Locked Position... 33 Figure 28: Scales and Positioning for the X-Stop and Carriage ... 34 Figure 29: Installing the X-Stop on the Lateral Arm ... 35 Figure 30: Home Screen on the Biopsy Control Module ... 36 Figure 31: Affirm System Tabletop Stand ... 38 Figure 32: Lateral Arm and Storage Case ... 39 Figure 33: Home Screen ... 41 Figure 34: Target Guidance Screen ... 42 Figure 35: Target Guidance Screen for Lateral Arm ... 43 Figure 36: Green Differential Cells ... 44 Figure 37: Yellow and Red Cells ... 44 Figure 38: Alert Sounds Are Audible... 45 Figure 39: Alert Sounds Are Muted ... 45 Figure 40: Jog Mode Screen ... 46 Figure 41: Jog Mode Screen for Lateral Arm... 47 Figure 42: Select Target Screen... 48

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Affirm Breast Biopsy Guidance System User Guide Table of Contents

Figure 43: Select Target Screen for Lateral Arm ... 49 Figure 44: Biopsy Tab in the Add View Screen ... 52 Figure 45: Stereo (-) and Stereo (+) View Modifiers ... 53 Figure 46: Edit (Biopsy) View Screen ... 54 Figure 47: Stereo Mode... 56 Figure 48: C-arm Mode ... 56 Figure 49: System Status Icon ... 57 Figure 50: System Status Menu ... 57 Figure 51: System Defaults Screen ... 57 Figure 52: The Biopsy Tab ... 58 Figure 53: Function Buttons and Data on the Biopsy Tab (Standard Needle Approach) ... 59 Figure 54: Function Buttons and Data on the Biopsy Tab (Lateral Needle Approach) ... 59 Figure 55: Multi-Pass Options ... 66 Figure 56: Four Offset Target Points Established Around Center Target Point ... 67 Figure 57: 3 mm Spacing of Offset Points ... 67 Figure 58: 5 mm Spacing of Offset Points ... 67 Figure 59: Single Point Target Selected ... 68 Figure 60: Single Point Target Deselected ... 68 Figure 61: Multi-Pass Target Selected ... 68 Figure 62: Multi-Pass Target Deselected... 68 Figure 63: Biopsy Order of Target Sets ... 69 Figure 64: Biopsy Order of a Three Offset Target... 69 Figure 65: Biopsy Order of a Four Offset Target ... 69 Figure 66: Biopsy Order of a Five Offset Target ... 69 Figure 67: Stereo Pair Print Screen ... 70 Figure 68: QAS Button on the Admin Screen... 72 Figure 69: QAS Test Info Dialog Box... 73 Figure 70: Device Field in the Biopsy Tab ... 73 Figure 71: Lateral QAS Button on the Admin Screen ... 75 Figure 72: Lateral QAS Test Info Dialog Box ... 76 Figure 73: Device Field in the Biopsy Tab ... 76 Figure 74: Affirm Biopsy Guidance Module ... 85 Figure 75: Lateral Arm ... 86

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Affirm Breast Biopsy Guidance System User Guide Table of Contents

List of Tables Table 1: Components of the Biopsy Guidance Module ... 14 Table 2: Components of the Biopsy Control Module... 15 Table 3: Components of the Lateral Arm ... 22 Table 4: How to Use the Sound Button ... 45 Table 5: The C-arm Stereo Mode Button ... 56 Table 6: How to Select the C-Arm Stereo Mode ... 57 Table 7: Required Procedures ... 71 Table 8: Radiologic Technologist Preventive Maintenance Schedule... 79 Table 9: Radiologic Technologist Preventive Maintenance Schedule... 80 Table 10: Service Engineer Preventive Maintenance Schedule ... 81 Table 11: Affirm System Audible Alerts ... 89 Table 12: Affirm System Error Messages ... 89 Table 13: Acquisition Workstation Messages ... 91 Table 14: Hologic Factory-Verified Biopsy Devices ... 97 Table 15: Wire Localization (Loc) Needle Guides ... 98

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Affirm Breast Biopsy Guidance System User Guide 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.

1.1

Intended Use Caution: United States federal law restricts this device to sale by or on the order of a physician. The Affirm® breast biopsy guidance system is an optional accessory for the Selenia® Dimensions® and 3Dimensions™ digital mammography and digital tomosynthesis systems. Its function is to localize lesions accurately in the breast in three dimensions. It is intended to provide targeting guidance for interventional procedures such as biopsy, presurgical localization, or treatment devices.

1.2

User Profiles

1.2.1

Mammography Technologist

1.2.2

•

Meets all requirements that apply to the location in which the Mammography Technologist operates.

• • • • •

Completed training on the mammography system.

•

Understands sterile procedures.

Has training in mammography positions. Understands stereotactic breast biopsy procedures. Understands how to operate a computer and its peripherals. Can lift 20 pounds to shoulder height with two hands (necessary for upright stereotactic systems).

Radiologists, Surgeons • • • • • •

Meets all requirements that apply to the location in which the Physician operates. Understands stereotactic breast biopsy procedures. Understands how to operate a computer and its peripherals. Understands sterile procedures. Gives local anesthesia. Understands basic surgical procedures for core biopsy.

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Affirm Breast Biopsy Guidance System User Guide Chapter 1: Introduction

1.2.3

1.3

Medical Physicist •

Meets all requirements that apply to the location in which the Medical Physicist operates.

• •

Understands mammography.

•

Understands how to operate a computer and its peripherals.

Has experience with digital imaging.

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.

1.4

Quality Control Requirements Perform all Quality Control tests within the correct time frame.

1.5

Where to Find Technical Description Information Technical description information is available in the Service Manual.

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1.6

Warranty Statement Except as otherwise expressly stated in the Agreement: i) Equipment manufactured by Hologic is warranted to the original Customer to perform substantially in accordance with published product specifications for one (1) year starting from the date of shipment, or if Installation is required, from the date of Installation (“Warranty Period”); ii) digital imaging mammography x-ray tubes are warranted for twenty-four (24) months, during which the x-ray tubes are fully warranted for the first twelve (12) months and are warranted on a straight-line prorated basis during months 13-24; iii) replacement parts and remanufactured items are warranted for the remainder of the Warranty Period or ninety (90) days from shipment, whichever is longer; iv) consumable Supplies are warranted to conform to published specifications for a period ending on the expiration date shown on their respective packages; v) licensed Software is warranted to operate in accordance with published specifications; vi) Services are warranted to be supplied in a workman-like manner; vii) non-Hologic Manufactured Equipment is warranted through its manufacturer and such manufacturer’s warranties shall extend to Hologic’s customers, to the extent permitted by the manufacturer of such non-Hologic Manufactured Equipment. Hologic does not warrant that use of Products will be uninterrupted or error-free, or that Products will operate with non-Hologic authorized third-party products. These warranties do not apply to any item that is: (a) repaired, moved, or altered other than by Hologic authorized service personnel; (b) subjected to physical (including thermal or electrical) abuse, stress, or misuse; (c) stored, maintained, or operated in any manner inconsistent with applicable Hologic specifications or instructions, including Customer’s refusal to allow Hologic recommended Software upgrades; or (d) designated as supplied subject to a non-Hologic warranty or on a prerelease or “as-is” basis.

1.7

Technical Support Refer to the copyright page of this manual for contact information for product support.

1.8

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. (Refer to the copyright page for contact information.)

1.9

Hologic Cybersecurity Statement Hologic continuously tests the current state of computer and network security to examine possible security problems. When necessary, Hologic provides the updates to the product. For Cybersecurity Best Practices documents for Hologic products, refer to the Hologic Internet site at www.Hologic.com.

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Affirm Breast Biopsy Guidance System User Guide Chapter 1: Introduction

1.10

Symbols This section describes the Symbols on this system. Potential Equalization terminal

Protective Earth terminal

"On" and "Off" (power) for the computer and display.

Discard electrical and electronic equipment separately from standard waste. Send decommissioned material to Hologic or contact your service representative. Manufacturer

Date of Manufacture

Catalog number Serial number Caution

Follow operating instructions

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1.11

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.

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Affirm Breast Biopsy Guidance System User Guide Chapter 2: General Information

Chapter 2 General Information 2:

2.1

System Overview The Affirm breast biopsy guidance system attaches to the C-arm of the Selenia Dimensions system or the 3Dimensions system. The Affirm biopsy system has two main components:

• •

Biopsy Guidance Module Biopsy Control Module

A compatible biopsy device attaches to the biopsy guidance module device mount. During a standard needle approach procedure, motors in the Affirm system move the biopsy device in X and Y directions. Z-axis movement is manual. The optional Affirm Lateral Arm Upright Biopsy Accessory installs on the biopsy guidance module to enable lateral needle approach procedures. When using the lateral arm accessory, X-, Y-, and Zaxis movement is the same as for standard needle approach. The C-arm is positioned at 0° and the biopsy device is positioned the same way as in a standard needle approach. Then the needle is manually advanced into the breast along its own X-axis, referred to as “Lat X.” The Tube Arm on the Selenia Dimensions and 3Dimensions systems moves separately from the Compression Arm to permit the acquisition of 2D and tomosynthesis images for targeting. The types of images you can acquire are contingent on your imaging system licensing. Refer to the imaging system User Guide for complete information about that system. The types of biopsies you can perform are contingent on your Affirm system licensing. To see all your installed licenses, go to Licensing in System Tools. Figure Legend 1. Biopsy Guidance Module 2. Biopsy Control Module

Figure 1: Affirm Biopsy System on the Selenia Dimensions Mammography System

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Affirm Breast Biopsy Guidance System User Guide Chapter 2: General Information

2.2

How to Handle the Biopsy Guidance Module Caution: To prevent damage or alignment problems with the Needle Guidance Stage, be careful when you move the Biopsy Guidance Module. Caution: The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure to have a secure grip on the handles. Only lift the Biopsy Guidance Module with the handles.

Figure 2: How to Lift the Biopsy Guidance Module When the Biopsy Guidance Module is not in use, put the device on its back.

Figure 3: How to Store the Biopsy Guidance Module

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Affirm Breast Biopsy Guidance System User Guide Chapter 2: General Information

2.3

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. Do not connect this equipment to any system or component not described in this manual. A combination of components must have the data to validate the safety of the patient, personnel, and the environment. Any additional certification becomes the responsibility of the user.

2.4

Warnings and Precautions WARNING! After power failure, remove the patient from the system before you apply power. Warning: You make x rays when you use the procedures in this manual. Warning: C-arm movement is motorized. Warning: The Tube Arm movement is motorized. Warning: Only qualified users can use this system. Warning: Only physicians and providers trained in percutaneous biopsy procedures can use this system. Warning: Do not use this equipment if any faults or problems are detected.

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Affirm Breast Biopsy Guidance System User Guide Chapter 2: General Information

Warning: The user must schedule preventive maintenance by an approved Service Engineer. Warning: The user or a Service Engineer must correct problems before the system is used. 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. Caution: To prevent damage or misalignment, be careful when you move the Affirm system.

Caution: The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure to have a secure grip on the handles. Note The system does not have any parts that are serviced by the user.

2.5

Compliance This section describes the system compliance requirements and the responsibilities of the manufacturer.

2.5.1

Compliance Requirements The manufacturer is responsible for the effects of safety, reliability, and performance of this equipment, with the following provisions:

• •

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The equipment is used in accordance with the User Guide. Assembly operations, extensions, re-adjustments, modifications, or repairs are performed by authorized persons only.

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2.6

Label Locations

Figure 4: Biopsy Guidance Module Label Location

Figure 5: Lateral Arm Serial Number Label Location

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Affirm Breast Biopsy Guidance System User Guide Chapter 3: Installation, Verification, and Removal

Chapter 3 Installation, Verification, and Removal 3:

3.1

Biopsy Guidance Module Components The Biopsy Guidance Module installs on the front of the C-arm of the Selenia Dimensions and 3Dimensions systems. A lock lever (see the following figure, item 8) secures the module in position. A cable (item 7) connects to the side of the C-arm for operation of the biopsy guidance system.

Figure 6: Biopsy Guidance Module

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