Hologic Affirm Service Manual
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Hologic Affirm Service Manual

Breast biopsy guidance system
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Summary of Contents for Hologic Affirm

  • Page 3 Affirm ® Breast Biopsy Guidance System Service Manual For Software Versions 1.10/2.1 Part Number MAN-05754 Revision 002 August 2019...
  • Page 4 Hologic, Selenia, Dimensions, 3Dimensions, Affirm, 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.

  • Page 5: Table Of Contents

    Affirm Breast Biopsy Guidance System Service Manual Table of Contents Table of Contents List of Figures _________________________________________________________________ ix List of Tables __________________________________________________________________ xi 1: Introduction __________________________________________________________________1 Intended Use................................1 User Profiles................................1 1.2.1 Mammography Technologist ........................1 1.2.2 Radiologists, Surgeons ..........................1 1.2.3...
  • Page 6 3.9.1 Biopsy Control Module .......................... 42 3.9.2 Biopsy Guidance Module ........................42 3.9.3 Tabletop Stand for the Affirm System ....................43 3.9.4 Storage Case for the Lateral Arm ......................43 4: Calibration Procedures _______________________________________________________45 Required Tools and Equipment .......................... 45 Front Needle Guide Alignment ..........................
  • Page 7 Affirm Breast Biopsy Guidance System Service Manual Table of Contents Appendix B System Messages and Alerts _________________________________________69 Audible Alerts ............................... 69 Error Messages ..............................69 Acquisition Workstation Messages ........................71 Appendix C Hardware Range Calibration _________________________________________73 Hardware Range Calibration ..........................73 Appendix D Biopsy Device Evaluation Procedure _________________________________77 Introduction ................................

  • Page 9: List Of Figures

    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 ....................
  • Page 10 Affirm Breast Biopsy Guidance System Service Manual Table of Contents Figure 43: X-axis Reference Hole Locations and Y-axis Lead Screw Adjustment........... 73 Figure 44: Placing the Y-axis Dowel Pin ........................74 Figure 45: Hologic ASY-08307 Targeting Phantom ..................... 77 Figure 46: Biopsy Device Parameters - Standard Mount .................... 80 Figure 47: Additional Biopsy Device Parameters - Standard Mount ...............

  • Page 11: List Of Tables

    Table 5: Lateral Arm Calibration Target Coordinates List (in mm) ................52 Table 6: Calibrations ................................ 53 Table 7: Service Engineer Preventive Maintenance Schedule ................... 61 Table 8: Affirm System Audible Alerts ......................... 69 Table 9: Affirm System Error Messages ........................69 Table 10: Acquisition Workstation Messages ......................71 Table 11: Hologic Factory-Verified Biopsy Devices ....................

  • Page 13: 1: Introduction

    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. Intended Use Caution: Federal law restricts this device to sale by or on the order of a physician.

  • Page 14: Medical Physicist

    Additionally, the user manual is a guide for directions on how to use the system. All users must make sure that they receive training on correct operation of the system before use on patients. Hologic does not accept the responsibility for injury or damage from incorrect system operation. Quality Control Requirements Perform all Quality Control tests within the correct time frame.

  • Page 15: Warranty Statement

    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 pre- release or “as-is” basis. Technical Support Refer to the copyright page of this manual for contact information for product support.

  • Page 16: Symbols

    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...

  • Page 17: Descriptions Of Warnings, Cautions, And Notes

    Affirm Breast Biopsy Guidance System Service Manual Chapter 1: Introduction 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.

  • Page 19: 2: General Information

    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.

  • Page 20: How To Handle The Biopsy Guidance Module

    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.

  • Page 21: 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.

  • Page 22: Compliance

    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.

  • Page 23: Label Locations

    Affirm Breast Biopsy Guidance System Service Manual Chapter 2: General Information Label Locations Figure 4: Biopsy Guidance Module Label Location Figure 5: Lateral Arm Serial Number Label Location MAN-05754 Revision 002 Page 11...

  • Page 25: 3: Installation, Verification, And Removal

    Installation, Verification, and Removal Chapter 3 Add Licensed Features Install the license(s) for the Affirm breast biopsy guidance system and/or optional Lateral Arm upright biopsy accessory. When installing a new licensed feature on a system, follow these steps in System (Service) Tools.
  • Page 26 Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal The System Tools Login screen opens. Login as a Service user and enter the appropriate password. Select Log In. Figure 6: System Tools Login screen The System Tools Welcome main screen opens.
  • Page 27 Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Navigate to the AWS > Licensing. The Licensing screen opens (see the following figure). Figure 8: System Tools > AWS > Licensing screen Generate a feature request file (xxxxxx.holx). This file includes all the features currently activated on the system and the MAC address of the computer.

  • Page 28: Unpacking

    If your Gantry system serial number is listed as 8100XXXXXXX and the last three digits is less than 488, check the C-arm housing for the presence of the Affirm system icon. If the icon is not present, install FMI Kit ASY-04074, C-Arm Upgrade for Affirm Breast Biopsy System, to prepare the Gantry to receive the Affirm system.

  • Page 29: Biopsy Guidance Module Components

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal 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.

  • Page 30: Biopsy Control Module Components

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Table 1: Components of the Biopsy Guidance Module Name Description Attachment Hooks Two on each side hold the Biopsy Guidance Module on the imaging system Gantry. Handles One on each side.

  • Page 31: Figure 8: Biopsy Control Module

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal for the user to perform the desired tasks. Motor Enable buttons (item 3) on either side of this module (and at the rear) activate motorized movement of the biopsy device.

  • Page 32: Installation Of The Main Components

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Installation of the Main Components 3.6.1 Install the Internal Gantry Biopsy Guidance Module Cables Refer to the imaging system Service Manual for the detailed removal instructions in the following procedure.

  • Page 33: Attach The Biopsy Guidance Module

    Slide the top hooks (item 2) of the Biopsy Guidance Module into the slots marked with the Affirm system icon (item 2A) on the front of the imaging system C-arm. Make sure the top and bottom hooks attach to the C-arm.

  • Page 34: Attach The Biopsy Control Module

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal 3.6.3 Attach the Biopsy Control Module The Biopsy Control Module attaches to either the left or right handle of the Biopsy Guidance Module. Figure Legend Lock Knob for the Articulating Arm...

  • Page 35: System Verifications

    Tilt or change the current angle of the Biopsy Control Module. Rotate the Lock Knob to lock the Biopsy Control Module in the new position. System Verifications Refer to the Affirm biopsy guidance system User Guide for information about the User Interfaces. MAN-05754 Revision 002...

  • Page 36: Confirm The Host Connection

    Chapter 3: Installation, Verification, and Removal 3.7.1 Confirm the Host Connection When the imaging system is On, logged in as Service, and the Affirm system cable connections are correct, the Home screen displays on the Biopsy Control Module. Figure Legend 1.

  • Page 37: Verify In Caltool

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal 3.7.2 Verify in CalTool For initial installations of the Affirm system or after adding the Lateral Arm upright biopsy accessory, do the following verification: Launch CalTool (CalTool.bat) from the normal location/directory. Click AdvancedForm.

  • Page 38: Biopsy Compression Paddles

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal 3.8.2 Biopsy Compression Paddles 5x5 cm Standard 6x7 cm Standard 5x5 cm Axillary 15 cm Lateral Arm Biopsy Paddle Biopsy Paddle Biopsy Paddle Biopsy Paddle* *The system automatically recognizes when a Lateral Arm is installed on the Biopsy Guidance Module.

  • Page 39: Figure 14: Installation Of The Needle Guide Holder On The Standard Device Mount

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Installation of the Needle Guide on the Standard Needle Guide Holder Insert the needle guide rods of the needle guide holder into the standard device mount (slide in from the bottom).

  • Page 40: Biopsy Device Adapter

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Removal of the Disposable Needle Guide Remove the biopsy device from the device mount. Pull the disposable needle guide away from the pin on the needle guide holder.

  • Page 41: Lateral Arm And Lateral Arm Accessories

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal 3.8.6 Lateral Arm and Lateral Arm Accessories Warning: Be careful when working with the Lateral Arm. Bumping or jarring the Lateral Arm can affect system accuracy, cause patient injury, or cause equipment damage.
  • Page 42 Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Table 3: Components of the Lateral Arm Name Description Scale On each side of the Lateral Arm. Yellow scale is for right lateral needle approach. Blue scale is for left lateral needle approach. Use the top scale to position the carriage.

  • Page 43: Figure 18: Left Needle Approach Of Lateral Arm (Blue)

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal The Lateral Arm can be mounted to the left or the right side of the Biopsy Guidance Module to permit a lateral needle approach from either direction. Determine the desired approach before mounting the Lateral Arm and install the Biopsy Control Module on the opposite side from the desired approach.

  • Page 44: Figure 20: Installing Lateral Arm Stand Over Image Receptor

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Lateral Arm Warning: Clean the Lateral Arm before and after every use (refer to For General Cleaning on page 62). Installation of the Lateral Arm Make sure that the C-arm is set to 0 degrees.

  • Page 45: Figure 21: Removing The Needle Guide Holder From The Standard Device Mount

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal On the Affirm system, remove the needle guide holder used on the standard device mount. Figure 24: Removing the Needle Guide Holder from the Standard Device Mount Determine the direction of approach of the biopsy device (left or right side of the Biopsy Guidance Module).

  • Page 46: Figure 22: Installing Lateral Arm To Device Mount

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Attach the Lateral Arm to the Biopsy Guidance Module (see the following figure). Align the top and bottom guide holes on the Lateral Arm (item 1 in the following figure) to the top and bottom pins on the device mount on the Biopsy Guidance Module.

  • Page 47: Figure 23: Lateral Arm Mounting Side Selection Screen

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal On the Biopsy Control Module, select the correct Lateral Arm Mounting Side button for the side the Lateral Arm is mounted on. Figure 26: Lateral Arm Mounting Side Selection Screen On the Biopsy Control Module, select OK to confirm that the Lateral Arm Stand is installed.

  • Page 48: Figure 24: Attaching Blue Needle Guide Holder To Needle Guide Rods (Left Needle Approach)

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Installation of the Needle Guide on the Lateral Arm Needle Guide Holder Make sure that the Lateral Arm is attached to the correct side of the Biopsy Guidance Module for the desired direction of approach.

  • Page 49: Figure 26: Installing Disposable Needle Guide On Needle Guide Holder (Lateral Arm)

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Slide the disposable needle guide (item 1) over the pin on the end of the needle guide holder (item 2). Figure Legend 1. Disposable Needle Guide 2. Needle Guide Holder...

  • Page 50: Figure 28: Locked And Unlocked Positions Of Device Mount Lever

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Using the Carriage Position Indicator and the upper scale, set the Carriage position to 220 mm. Note Setting the Carriage Position Indicator at 220 mm provides a safe distance from the breast to attach the biopsy device.

  • Page 51: Figure 30: Lock Levers In Fully Locked Position

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Removal of Device the Mount Flip the device mount lever up to unlock the device mount. Slide the device mount off the Lateral Arm. Biopsy Device Follow the directions supplied by the manufacturer to install or remove the biopsy device and adapter.

  • Page 52: Figure 31: Scales And Positioning For X-Stop And Carriage

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal X-Stop The X-Stop is an accessory that stops movement of the Carriage and the device mount along the Lat X axis. The X-Stop Position Indicator is used to position the X-Stop along the bottom scale of the Lateral Arm.

  • Page 53: Figure 32: Installing X-Stop On Lateral Arm

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal Installation of X-Stop Make sure that the X-Stop lever is fully in the unlocked (up) position. Slide the X-Stop onto the Lateral Arm on the same side as the Lateral Arm mount.

  • Page 54: Removal Of The Main Components

    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. To remove the Biopsy Guidance Module from the imaging system C-arm: Disconnect the Biopsy Guidance Module Cable from the C-arm.

  • Page 55: Tabletop Stand For The Affirm System

    The Affirm system Tabletop Stand is not for mobile applications. To place the Affirm biopsy system on the optional stand, refer to the following figure. Move the device mount and needle guide to the highest upper position as shown in Disconnect the biopsy guidance module cable from the imaging system C-arm.

  • Page 56: Figure 34: Lateral Arm And Storage Case

    Affirm Breast Biopsy Guidance System Service Manual Chapter 3: Installation, Verification, and Removal the equipment and to maintain accuracy, always store the Lateral Arm and its components in its case. Figure 37: Lateral Arm and Storage Case Page 44 MAN-05754 Revision 002...

  • Page 57: 4: Calibration Procedures

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Calibration Procedures Chapter 4 This chapter describes the tools and procedures required to perform the Biopsy subsystem calibrations. The Guidance Hardware calibrations do not involve imaging and can be implemented by using CalTool.

  • Page 58: Front Needle Guide Alignment

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Description Image Part Number Z-axis Calibration Tool TLS-02432 Biopsy Device with Holder Disposable Needle Guide (14-guage) Lateral Arm Stand ASY-09644 Lateral Arm Biopsy Paddle ASY-05205 Lateral Arm QAS Phantom...

  • Page 59: Alignment For Standard Approach

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures 4.2.1 Alignment for Standard Approach Required Tools/Equipment • X-ray and Light Field Size Adjust Fixture (TLS-01063) • Biopsy Device with Holder • Needle Guide (14-gauge) • Needle (14-gauge) Procedure Install the Needle Guide on the front Needle Guide mount.

  • Page 60: Biopsy Guidance Hardware

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Procedure Attach the biopsy device (with holder) to the removable mount oriented for left-side installation on the Lateral Arm. That is, make sure that the device needle is near the blue needle guide mount rail cap.

  • Page 61: Stx Calibration

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Procedure Inspect the calibration phantom for damage. Select Admin > Quality Control > Technologist tab > Geometry Calibration procedure on the Acquisition Workstation. Select Start. Follow the instructions on the screen and take the predefined exposure. Do not change the preselected techniques.

  • Page 62: Table 4: Calibration Target List

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Accept the image. For the following steps, use the zoom and/or magnification feature to enlarge the target area. Accept the target. Select the next stereo pair, and repeat steps 3 through 8 for the next four exposures.

  • Page 63: Stx Calibration For Lateral Approach

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures 10. When the 12 exposures are complete, rotate the C-arm to 0°. A message on the Acquisition Workstation is displayed to complete the following procedure: • Attach the 5 x 5 cm Standard Biopsy Paddle in the Compression Device and lift the paddle.

  • Page 64: Table 5: Lateral Arm Calibration Target Coordinates List (In Mm)

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Slide the Lateral Arm X-Stop and the Lateral Arm carriage to move to the Lat X position in the Lateral Arm Calibration Target List (see the following table). The Biopsy Control Module shows that you have reached the target.

  • Page 65: Biopsy Calibration Interaction

    The QAS Test Perform the Quality Assurance Standard (QAS) Test procedure to make sure of accurate alignment and performance of the needle guidance system when you use the Affirm biopsy system with the Selenia Dimensions or 3Dimensions mammography system. Log into the system as a Service User.

  • Page 66: Qas Test For Standard Needle Approach

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures 4.7.1 QAS Test for Standard Needle Approach Prerequisites and Required Equipment • Remove all paddles • Install the Affirm System • Have available a QAS Phantom (ASY-06255) Caution: If you use a QAS Needle Phantom, do not extend the needle unless it is attached to the Biopsy Guidance Module and the module is installed on the C-arm.

  • Page 67: Figure 36: Qas Test Info Dialog Box

    Install the QAS Phantom. (If the QAS Phantom uses a needle, fully extend the needle.) In the Info dialog box, select OK. On the QAS screen, select the Biopsy tab. Make sure that Affirm system QAS appears in the Device field. Figure 40: Device Field in the Biopsy Tab Attach the QAS Phantom.

  • Page 68: Qas Test For Lateral Needle Approach

    If the targeting coordinates are not within ± 1 mm, contact Technical Support. Do not try to adjust the system. Do not perform any biopsy procedure with the Affirm system until Technical Support indicates the system is ready for use.

  • Page 69: Figure 38: Admin Screen Showing Lateral Arm Qas Test

    Affirm Breast Biopsy Guidance System Service Manual Chapter 4: Calibration Procedures Procedure On the Acquisition Workstation, from the Select Patient screen, select the Admin button. On the Admin screen, select the Lateral QAS button. Figure 41: Admin Screen Showing Lateral Arm QAS Test...

  • Page 70: Figure 39: Lateral Qas Test Info Dialog Box

    Install the Lateral Arm assembly and the Lateral Arm QAS Phantom on the left side of the Affirm system. In the Info dialog box, select OK. On the QAS screen, select the Biopsy tab. Make sure that Affirm Lateral QAS appears in the Device field. Figure 43: Device Field in the Biopsy Tab Press and hold a right or left Motor Enable button pair on the Biopsy Control Module.

  • Page 71: Dose Calibration

    12. Repeat steps 10 and 11 for all unexposed views for that approach side. 13. Move the Lateral Arm assembly to the right side of the Affirm system. Repeat steps 4 through 12. 14. At the Acquisition Workstation, select the End QC button.

  • Page 73: 5: Care And Cleaning

    Check compression lockout operation. Verify the Affirm system alignment to the C-arm. Verify the Needle Guide alignment. Verify the Affirm system locks in position on the C-arm. Verify the ID sensors correctly identify the Affirm system when installed. Install software/ firmware upgrades if required and if under warranty/contract.

  • Page 74: For General Cleaning

    Caution: Use the least possible amount of cleaning fluids. The fluids must not flow or run. If more than soap and water is required, Hologic recommends any one of the following: • 10% chlorine bleach and water with one part commercially available chlorine bleach (normally 5.25% chlorine and 94.75% water) and nine parts water...

  • Page 75: To Prevent Possible Injury Or Equipment Damage

    Affirm Breast Biopsy Guidance System Service Manual Chapter 5: Care and Cleaning 5.2.2 To Prevent Possible Injury or Equipment Damage Do not use a corrosive solvent, abrasive detergent, or polish. Select a cleaning/disinfecting agent that does not damage the plastics, aluminum, or carbon fiber.

  • Page 77: Appendix A System Specifications

    Affirm Breast Biopsy Guidance System Service Manual Appendix A: System Specifications System Specifications Appendix A Appendix A Affirm System Measurements Figure 44: Affirm Biopsy Guidance Module A. Height 37.1 cm (14.6 inches) B. Width 37.8 cm (14.9 inches) C. Depth 35.6 cm (14 inches)

  • Page 78: Lateral Arm Measurements

    Affirm Breast Biopsy Guidance System Service Manual Appendix A: System Specifications Lateral Arm Measurements Figure 45: Lateral Arm A. Height 24.4 cm (9.6 inches) B. Width (Biopsy Device Mount 53.0 cm (20.9 inches) and Needle Guide extended toward Lateral Arm Mount) C.

  • Page 79: Biopsy Guidance Module

    Affirm Breast Biopsy Guidance System Service Manual Appendix A: System Specifications Biopsy Guidance Module Accuracy of Biopsy Guidance maximum deviation: 1 mm in either direction of target coordinate Module Combined Accuracy of Biopsy maximum deviation: 2 mm in either direction of target coordinate...

  • Page 81: Appendix B System Messages And Alerts

    Affirm Breast Biopsy Guidance System Service Manual Appendix B: System Messages and Alerts System Messages and Alerts Appendix B Appendix B Audible Alerts Table 8: Affirm System Audible Alerts Activity Frequency Duration Repeats? At Power Up: 250 ms Any Needle position within the...
  • Page 82 If the message continues to display, contact Technical Support. Selftest Error Disconnect the Affirm Biopsy Guidance Module cable from the imaging system. Reconnect the Affirm Biopsy Guidance Module cable to the imaging system. If the message continues to display, contact Technical Support. Stuck Switch Fault Disconnect the Biopsy Control Module cable from the Biopsy Guidance Module.

  • Page 83: Acquisition Workstation Messages

    Icon Message User Action Affirm cable is not connected Connect the Affirm system cable to the side of the Gantry. Affirm is not locked Lock each side of the Affirm system. BCM cable is not connected Connect the Biopsy Control Module cable to the side of the Affirm system.

  • Page 85: Appendix C Hardware Range Calibration

    Affirm Breast Biopsy Guidance System Service Manual Appendix C: Hardware Range Calibration Hardware Range Calibration Appendix C Appendix C Hardware Range Calibration Perform these procedures when you replace components in the Biopsy Guidance Module or you cannot reach points specified in the STX calibration.
  • Page 86 Affirm Breast Biopsy Guidance System Service Manual Appendix C: Hardware Range Calibration Jog the Y-axis towards the rear of the Breast Platform until the Y-axis lead screw is visible (see previous figure). Place the dowel pin in the center hole in the top of the Y-axis Component Mount (see following figure).
  • Page 87 Affirm Breast Biopsy Guidance System Service Manual Appendix C: Hardware Range Calibration Determine the maximum X-axis encoder count by moving the X carriage to the left mechanical limit (as viewed from the front of the Biopsy Guidance Module). With the carriage at the mechanical limit, use the Biopsy Control Module function "Set Xlimit...

  • Page 89: Appendix D Biopsy Device Evaluation Procedure

    Affirm system Service Manual and User Guide, as well as the procedures in the User Guide of any biopsy device that is used with the Affirm system. These procedures provide step-by-step instructions for validating biopsy devices for use with the Affirm system.

  • Page 90: Hologic Factory-Verified Biopsy Devices

    Whether you add a new (or edit an existing) biopsy device, keep each parameter within the valid range as stated in the following table. If you believe that a parameter for your device is outside the valid range, contact Hologic Technical Support desk for guidance on how to proceed.

  • Page 91: Table 12: Biopsy Device Parameters (See Also Following Four Figures)

    Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Table 12: Biopsy Device Parameters (see also following four figures) Measurement Description Valid Range (in mm) Aperture (AP) Opening of the biopsy device 0 to 50.0 Dead Space (DS) Distance from needle tip to opening-edge 0 to 20.0...
  • Page 92 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Figure 49: Biopsy Device Parameters - Standard Mount Page 80 MAN-05754 Revision 002...
  • Page 93 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Figure 50: Additional Biopsy Device Parameters - Standard Mount MAN-05754 Revision 002 Page 81...

  • Page 94: Needle Validation Process

    Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Figure 51: Biopsy Device Parameters - Front Edge for Lateral Arm Figure 52: Biopsy Device Parameters - Body Size for Lateral Arm D.2.2 Needle Validation Process Note All manual jogs in the following procedure are performed from the Biopsy Control Module Target Screen, not from the Service Screen.
  • Page 95 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Install the QAS needle in the extended position. At the Biopsy Control Module, select a Home position and press and hold the front and back Motor Enable buttons.
  • Page 96 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Configure a New Biopsy Needle Obtain Needle Specifications Record the following technical information from the biopsy device manufacturer: Needle Name ______________________________ Aperture ______________________________mm Dead Space ______________________________mm Diameter (convert the needle...
  • Page 97 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Measure the Front Edge (FE) parameter with the device in the extended (or post-fire) position. Install the fired device in the holder, and place the holder upside down on a flat surface.
  • Page 98 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Calculate New Needle Parameters Open the same procedure used earlier with the QAS needle. Select the same stereo pair acquired earlier. Select the new Device from the list.
  • Page 99 Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Validate Needle Open the same procedure used earlier with the QAS needle and select the previously acquired stereo pair. Select the Device from the list. Select Resend Target.

  • Page 100: Configuring The Wire Localization Needle

    The following table provides the part numbers of the wire localization (loc) needle guides. These items can be ordered by either calling 1.877.371.4372 and following the prompts for parts, emailing at Parts@hologic.com, or contacting your local Hologic dealer (outside of the USA).

  • Page 101: Wire Localization Parameters

    Wire Localization Parameters Keep each parameter within the valid range as stated in the following table. If you believe that a parameter for your device is outside the valid range, contact Hologic Technical Support desk for guidance on how to proceed.

  • Page 102: Validate The Wire Localization Needle

    Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure D.3.3 Validate the Wire Localization Needle Record the following information from the wire localization needle manufacturer. For needle diameter, convert the needle gauge listed by the manufacturer into millimeters.

  • Page 103: Calculate And Confirm The New Wire Localization Needle Parameters

    Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Record the body size measurement. Unless otherwise specified by the manufacturer, use 10.0 mm. Body Size (BO) =_____________mm The body size measurement is the distance between the wire loc needle and the bottom of the needle guide.

  • Page 104: Adjust The Needle Length On The Acquisition Workstation

    Affirm Breast Biopsy Guidance System Service Manual Appendix D: Biopsy Device Evaluation Procedure Read the Z Diff from the Biopsy Control Module. This number is added to the previously entered Length in the Acquisition Workstation Biopsy menu in the next procedure.

  • Page 105: Appendix E Field Replaceable Units (Frus)

    Affirm Breast Biopsy Guidance System Service Manual Appendix E: Field Replaceable Units (FRUs) Field Replaceable Units (FRUs) Appendix E Appendix E Biopsy Control Module - Field Replaceable Units Table 15: Recommended FRUs - Biopsy Control Module (BCM) Description Part Status / Notes...

  • Page 106: Biopsy Guidance Module - Field Replaceable Units

    Affirm Breast Biopsy Guidance System Service Manual Appendix E: Field Replaceable Units (FRUs) Biopsy Guidance Module - Field Replaceable Units Table 16: Recommended FRUs - Biopsy Guidance Module (BGM) Description Part Status / Notes Number Left Handle FAB-05730 Returnable Handle Latch (LH)

  • Page 107: Lateral Arm - Field Replaceable Units

    Affirm Breast Biopsy Guidance System Service Manual Appendix E: Field Replaceable Units (FRUs) Table 16: Recommended FRUs - Biopsy Guidance Module (BGM) Description Part Status / Notes Number Stop, Front Y-axis FAB-08012 Non-Returnable Slide Guide Linear Ball Rail MME-01176 Non-Returnable...

  • Page 108: Table 18: Recommended Frus - Lateral Arm Carriage Assembly

    Affirm Breast Biopsy Guidance System Service Manual Appendix E: Field Replaceable Units (FRUs) Table 17: Recommended FRUs - Lateral Arm Assembly Description Part Number Status / Notes WHEEL, V-GUIDE, SHIELD .584BORE+.0/- MME-01543 Non-Returnable .00003X.1575BORE+/- .002X.584ODX.250WIDE+.0/-.004, ST STL BEARING,FLANGED 2-110-0063 Non-Returnable...

  • Page 109: Accessories - Field Replaceable Units

    Affirm Breast Biopsy Guidance System Service Manual Appendix E: Field Replaceable Units (FRUs) Table 22: Recommended FRUs - Lateral Arm Device Mount Single Position Assembly Description Part Number Status / Notes ASSY, ALA DEVICE MOUNT, SINGLE ASY-09440 Non-Returnable POSITION SHAFT, ALA DEVICE MOUNT...

  • Page 111: Glossary Of Terms

    Affirm Breast Biopsy Guidance System Service Manual Glossary of Terms Stereotactic Procedure Glossary of Terms A type of examination that allows stereotactic views at the Acquisition Workstation. Affirm System The breast biopsy guidance system for the Selenia Stereotactic View Dimensions and 3Dimensions imaging systems...

  • Page 113: Index

    Affirm Breast Biopsy Guidance System Service Manual Index Index general information • 7 adjustment host connection verification • 24 biopsy control module position • 23 bracket height • 23 control module position • 23 Affirm system storage • 43 information attach general •...
  • Page 114 Affirm Breast Biopsy Guidance System Service Manual Index removal biopsy control module • 42 biopsy guidance module • 42 device mount, lateral arm • 37 lateral arm • 32 needle guides, lateral arm • 35 X-Stop • 40 remove biopsy control module • 42 biopsy guidance module •...

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