Affirm V1.8 User Guide Upright with Lateral Arm Upright Biopsy Accessory Rev 001 May 2016

User Guide with the optional Lateral Arm Upright Biopsy Accessory for Software Version 1.8

Part Number MAN-04739-002 Revision 001 May 2016

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 1.3

Preface ... 1 Intended Use... 1 User Profiles... 1 1.3.1 Mammography Technologist ... 1 1.3.2 Radiologists, Surgeons ... 1 1.3.3 Medical Physicist ... 2 1.4 Training Requirements... 2 1.5 Quality Control Requirements ... 2 1.6 Where to Find Technical Description Information... 2 1.7 Warranty Statement ... 3 1.8 Technical Support ... 3 1.9 Product Complaints ... 3 1.10 Hologic Cybersecurity Statement ... 3 1.11 Descriptions of Warnings, Cautions, and Notes ... 4

2: General Information___________________________________________________________5 2.1 2.2 2.3 2.4 2.5 2.6 2.7

System Overview ... 5 How to Handle the Biopsy Guidance Module... 6 Safety ... 7 Warnings and Precautions... 7 Compliance ... 8 2.5.1 Compliance Requirements ... 8 Symbols ... 9 Label Locations ... 10

3: Installation, Verification, and Removal _________________________________________11 3.1 3.2 3.3

3.4

Biopsy Guidance Module Components ... 11 Biopsy Control Module Components ... 13 Installation of Main Components ... 14 3.3.1 Attach the Biopsy Guidance Module ... 14 3.3.2 Attach the Biopsy Control Module... 15 Installation and Removal of Accessories ... 16 3.4.1 Biopsy Compression Paddles ... 16 3.4.2 Needle Guide... 16 3.4.3 Biopsy Device Adapter ... 18 3.4.4 Biopsy Device ... 19 3.4.5 Installation and Removal of Lateral Arm and Accessories ... 20

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Affirm Breast Biopsy Guidance System User Guide Table of Contents

3.5

3.6

3.7 3.8

System Verifications ... 34 3.5.1 Confirm the Host Connection ... 34 3.5.2 Confirm the Biopsy Connections ... 34 Removal of Main Components ... 36 3.6.1 Biopsy Control Module ... 36 3.6.2 Biopsy Guidance Module ... 36 Tabletop Stand for the Affirm System ... 37 Storage Case for Lateral Arm ... 38

4: User Interface - Biopsy Control Module ________________________________________39 4.1

Biopsy Control Module Screens ... 39 4.1.1 Home Screen ... 39 4.1.2 Target Guidance Screen ... 40 4.1.3 Jog Mode Screen ... 44 4.1.4 Select Target Screen ... 46

5: Biopsy ______________________________________________________________________49 5.1

5.2

5.3 5.4 5.5

5.6 5.7 5.8

Biopsy Views ... 49 5.1.1 How to Add a Biopsy View ... 49 5.1.2 How to Edit a Biopsy View... 50 C-Arm Stereo Modes ... 51 5.2.1 C-Arm Rotation in the C-Arm Stereo Modes ... 51 5.2.2 How to Select the C-Arm Stereo Mode for Image Acquisition... 53 Biopsy Tab... 54 5.3.1 Biopsy Options ... 55 Stereotactic Lesion Targeting ... 57 5.4.1 Verify the Position of the Biopsy Device ... 58 Lesion Targeting with Tomosynthesis Guidance ... 59 5.5.1 Verify the Position of the Biopsy Device ... 60 5.5.2 Project Targets on Post-Fire Scout Image ... 60 Lesion Targeting with Multi-Pass ... 60 Post Biopsy ... 63 Printing Stereo Pair Images ... 64

6: Quality Assurance ____________________________________________________________65 6.1

6.2

The QAS Test ... 65 6.1.1 QAS Test for Standard Needle Approach ... 65 6.1.2 QAS Test for Lateral Needle Approach ... 67 Geometry Calibration ... 70 6.2.1 Geometry Calibration Procedure ... 70

7: Care and Cleaning____________________________________________________________71 7.1 7.2

General Information ... 71 Preventive Maintenance Schedule ... 71

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7.3

For General Cleaning ... 72 7.3.1 How to Clean the Biopsy Control Module Screen ... 73 7.3.2 To Prevent Possible Injury or Equipment Damage ... 73

Appendix A: System Specifications ______________________________________________75 A.1 A.2 A.3 A.4 A.5

Affirm System Measurements ... 75 Lateral Arm Measurements ... 76 Biopsy Guidance Module ... 77 Lateral Arm ... 77 Biopsy Control Module ... 77

Appendix B: System Messages and Alerts _________________________________________79 B.1 B.2

Audible Alerts ... 79 Error Messages ... 80

Appendix C: CNR Correction for Biopsy __________________________________________81 C.1 C.2

CNR Correction for Stereotactic Biopsy ... 81 C.1.1 AEC Table 0 (Standard Stereotactic Biopsy Dose) ... 81 CNR Correction for Biopsy Under Tomosynthesis Option ... 81 C.2.1 AEC Table 0 (Tomosynthesis Option: Standard Tomo Dose) ... 81

Appendix D: Forms_____________________________________________________________83 D.1 D.2

QAS Test Checklist ... 83 QAS Test Checklist for the Lateral Arm ... 84

Glossary of Terms ______________________________________________________________85 Index _________________________________________________________________________87

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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 ... 5 Figure 2: How to Lift the Biopsy Guidance Module ... 6 Figure 3: How to Store the Biopsy Guidance Module ... 6 Figure 4: Biopsy Guidance Module Label Location ... 10 Figure 5: Lateral Arm Serial Number Label Location... 10 Figure 6: Biopsy Guidance Module ... 11 Figure 7: Biopsy Control Module ... 13 Figure 8: Installation of the Biopsy Guidance Module ... 14 Figure 9: Attachment of the Biopsy Control Module... 15 Figure 10: Installing Needle Guide Holder on Standard Device Mount... 17 Figure 11: Installing Disposable Needle Guide on Standard Needle Guide Holder... 17 Figure 12: Attaching a Biopsy Device Adapter to Device Mount (Standard) ... 18 Figure 13: Lateral Arm Components... 20 Figure 14: Left Needle Approach of Lateral Arm (Blue) ... 22 Figure 15: Right Needle Approach of Lateral Arm (Yellow) ... 22 Figure 16: Installing Lateral Arm Stand over Image Receptor ... 23 Figure 17: Removing the Needle Guide Holder from the Standard Device Mount ... 24 Figure 18: Installing Lateral Arm to Device Mount ... 25 Figure 19: Lateral Arm Mounting Side Selection Screen ... 25 Figure 20: Attaching Blue Needle Guide Holder to Needle Guide Rods (Left Needle Approach) ... 27 Figure 21: Attaching Yellow Needle Guide Holder to Needle Guide Rods (Right Needle Approach)... 27 Figure 22: Installing Disposable Needle Guide on Needle Guide Holder (Lateral Arm) ... 27 Figure 23: Carriage Lever Locked and Unlocked Positions ... 28 Figure 24: Locked and Unlocked Positions of Device Mount Lever... 28 Figure 25: Installing Device Mount onto Lateral Arm Carriage ... 29 Figure 26: Attaching Biopsy Device Adapter to Device Mount (Lateral Arm) ... 30 Figure 27: Lock Levers in Fully Locked Position... 31 Figure 28: Scales and Positioning for X-Stop and Carriage... 32 Figure 29: Installing X-Stop on Lateral Arm ... 33 Figure 30: Home Screen on the Biopsy Control Module ... 34 Figure 31: Biopsy Options Area Using Standard Needle Approach ... 35 Figure 32: Biopsy Options Area Using Lateral Needle Approach ... 35 Figure 33: Affirm System Tabletop Stand ... 37 Figure 34: Lateral Arm and Storage Case ... 38 Figure 35: Home Screen ... 39 Figure 36: Target Guidance Screen ... 40 Figure 37: Target Guidance Screen for Lateral Arm ... 41 Figure 38: Green Differential Cells ... 42 Figure 39: Yellow and Red Cells ... 42 Figure 40: Alert Sounds Are Audible... 43 Figure 41: Alert Sounds Are Muted ... 43 Figure 42: Jog Mode Screen ... 44 MAN-04739-002 Revision 001

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

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List of Tables Table 1: Components of the Biopsy Guidance Module ... 12 Table 2: Components of the Biopsy Control Module... 13 Table 3: Hologic Factory-Verified Biopsy Devices... 19 Table 4: Components of the Lateral Arm ... 21 Table 5: How to Use the Sound Button ... 43 Table 6: The C-arm Stereo Mode Button ... 52 Table 7: How to Select the C-Arm Stereo Mode ... 53 Table 8: Radiologic Technologist Preventive Maintenance Schedule... 71 Table 9: Radiologic Technologist Preventive Maintenance Schedule... 72 Table 10: Affirm System Audible Alerts ... 79 Table 11: Affirm System Error Messages ... 80

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Affirm Breast Biopsy Guidance System User Guide Chapter 1: Introduction

Chapter 1 Introduction 1:

1.1

Preface Read all of this information carefully before installation and operation. 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.

1.2

Intended Use Caution: 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® digital mammography system. 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.

1.3

User Profiles

1.3.1

Mammography Technologist

1.3.2

•

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.

• •

Gives local anesthesia.

Understands stereotactic breast biopsy procedures. Understands how to operate a computer and its peripherals. Understands sterile procedures. Understands basic surgical procedures for core biopsy.

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1.3.3

1.4

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 wrong system operation.

1.5

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

1.6

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

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1.7

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.

1.8

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

1.9

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.

1.10

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.

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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 mammography 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 system moves separately from the Compression Arm to permit the acquisition of stereotactic and tomosynthesis images for targeting. The types of images you can acquire are contingent on your Selenia Dimensions system licensing. Refer to the Selenia Dimensions 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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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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2.3

Safety Read and understand this manual before you use the system. Keep this manual available during the patient exams. 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 site. The system has protective devices, but the Technologist must understand how to safely operate 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: Do not use this equipment if any faults or problems are detected. Warning: The user must schedule preventive maintenance by an approved Service Engineer.

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

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:

• •

Page 8

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

Symbols This section describes the International 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

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2.7

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 system. A lock lever (see the following figure, item 8) secures the module in position. A cable (item 7) connects to the side of the Selenia Dimensions C-arm for operation of the biopsy guidance system.

Figure 6: Biopsy Guidance Module

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

Table 1: Components of the Biopsy Guidance Module #

Page 12

Name

1

Attachment Hooks

2

Handles

3

4

Biopsy Device Advance/Retract Knobs Slide Rail

5

Needle Guide Holder

6

Device Mount

7

Cable

8

Lock Lever

9

Receptacle

Description Two on each side hold the Biopsy Guidance Module on the Selenia Dimensions Gantry. One on each side. Hold both handles to lift the Biopsy Guidance Module. Rotate either knob to move the biopsy device along the slide rail.

Holds the biopsy device mount and provides the track for manual biopsy device movements. Holds the disposable needle guide through which the biopsy needle is inserted. (This front needle guide is removed when the Lateral Arm is installed.) Holds the biopsy device adapter to which the biopsy needle is attached. Moves along the slide rail when a biopsy device advance/retract knob is rotated. Connects to the Selenia Dimensions system to supply power to the Biopsy Guidance Module. One on each side. Engage the two levers to lock the Biopsy Guidance Module in position and onto the Selenia Dimensions system C-arm. Accepts the cable from the Biopsy Control Module.

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