Hologic Affirm User Manual
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Hologic Affirm User Manual

Breast biopsy guidance system
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Summary of Contents for Hologic Affirm

  • Page 3 User Guide For Software Version 1.8 Part Number MAN-04068 Revision 002 June 2016...

  • Page 5: Table Of Contents

    3.1.4 Attach the Biopsy Control Module ......................14 Installation and Removal of Accessories ......................15 3.2.1 Biopsy Compression Paddles ........................15 3.2.2 Biopsy Device Holder..........................16 3.2.3 Needle Guides ............................17 3.2.4 Tabletop Stand for the Affirm System ....................18 MAN-04068 Revision 002...
  • Page 6 Affirm Breast Biopsy Guidance System User Guide Table of Contents Removal of Main Components ........................... 19 3.3.1 Biopsy Control Module ..........................19 3.3.2 Biopsy Guidance Module ........................19 4: User Interface - Biopsy Control Module ________________________________________21 Biopsy Control Module Screens .......................... 21 4.1.1 Home Screen ..............................
  • Page 7 Affirm Breast Biopsy Guidance System User Guide Table of Contents Appendix A: System Specifications ______________________________________________53 Affirm System Measurements ..........................53 Biopsy Guidance Module ............................ 53 Biopsy Control Module ............................53 Appendix B: System Messages and Alerts _________________________________________55 Audible Alerts ............................... 55 Error Messages ..............................

  • Page 9: List Of Figures

    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: Label Location ..............................
  • Page 10 Affirm Breast Biopsy Guidance System User Guide Table of Contents Figure 41: Admin Screen Showing QAS Test ....................... 45 Figure 42: Device Field in the Biopsy Tab ........................46 Figure 43: Affirm Biopsy Guidance Module ........................ 53 MAN-04068 Revision 002...

  • Page 11: List Of Tables

    Table 4: The C-arm Stereo Mode Button ........................32 Table 5: How to Select the C-Arm Stereo Mode ......................33 Table 6: Radiologic Technologist Preventive Maintenance Schedule............... 49 Table 7: Affirm System Audible Alerts ......................... 55 Table 8: Affirm System Error Messages ........................55 MAN-04068 Revision 002...

  • Page 13: 1: Introduction

    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.

  • 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 wrong system operation. Quality Control Requirements Perform all Quality control tests within the correct time frame.

  • Page 15: Warranty Statement

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

  • Page 16: Descriptions Of Warnings, Cautions, And Notes

    Affirm Breast Biopsy Guidance System User Guide 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 17: 2: General Information

    Biopsy Control Module A compatible biopsy device attaches to the biopsy guidance module device mount. During a procedure, motors in the Affirm system move the biopsy device in X and Y directions. Z-axis movement is manual. 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.

  • Page 18: 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 19: 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.

  • Page 20: 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 21: 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 Label Locations...

  • Page 23: 3: How To Install Or Remove The System

    Affirm Breast Biopsy Guidance System User Guide Chapter 3: How to Install or Remove the System Chapter 3 How to Install or Remove the System Installation of Components 3.1.1 Biopsy Guidance Module Components The Biopsy Guidance Module installs on the front of the C-arm of the Selenia Dimensions system.

  • Page 24: Biopsy Control Module Components

    Affirm Breast Biopsy Guidance System User Guide Chapter 3: How to Install or Remove the System Table 1: Components of the Biopsy Guidance Module Name Description Cable Connects to the Selenia Dimensions system to bring power to the Affirm system.

  • Page 25: 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 Selenia Dimensions C-arm. Make sure the top and bottom hooks attach to the Selenia Dimensions C-arm.

  • Page 26: Attach The Biopsy Control Module

    Affirm Breast Biopsy Guidance System User Guide Chapter 3: How to Install or Remove the System 3.1.4 Attach the Biopsy Control Module The Biopsy Control Module attaches to either the left or right handle of the Biopsy Guidance Module. Figure Legend...

  • Page 27: Installation And Removal Of Accessories

    Affirm Breast Biopsy Guidance System User Guide Chapter 3: How to Install or Remove the System Adjust the Bracket Height Release the Attachment Bracket Lock (see the previous figure, item 5). Slide the bracket to the required height. Push the Attachment Bracket Lock into the locked position.

  • Page 28: Biopsy Device Holder

    Affirm Breast Biopsy Guidance System User Guide Chapter 3: How to Install or Remove the System 3.2.2 Biopsy Device Holder To install a biopsy device holder: Align the holes (top and bottom) in the holder with the guide pins on the mount.

  • Page 29: Needle Guides

    Affirm Breast Biopsy Guidance System User Guide Chapter 3: How to Install or Remove the System 3.2.3 Needle Guides Always use sterile techniques when you use Needle Warning: Guides during the patient procedures. It is important to install the device correctly. Be sure...

  • Page 30: 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 Selenia Dimensions C-arm.

  • Page 31: Removal Of 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 Selenia Dimensions C-arm: Disconnect the Biopsy Guidance Module Cable from the Selenia Dimensions C-arm.

  • Page 33: 4: User Interface - Biopsy Control Module

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module Chapter 4 User Interface - Biopsy Control Module Biopsy Control Module Screens 4.1.1 Home Screen The Home screen shows the name or initials of the user who logs in and any error messages.

  • Page 34: Target Guidance Screen

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module 4.1.2 Target Guidance Screen The following figure shows the main screen of the Biopsy Control Module. This screen shows the current position of the biopsy device, the selected target coordinates and the Cartesian difference between the two positions.

  • Page 35: Figure 12: Target Guidance Screen

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module Figure 12: Target Guidance Screen Figure Legend Go to the Jog Mode screen Go to the Select Target screen Go to the previous screen Target Information Switch between C-Arm Mode or Stereo Mode (when the system is set for Manual C-Arm Stereo Mode).

  • Page 36: Figure 13: Green Differential Cells

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module Colored Cells in the Screens Green Cells When all Diff cells are green, the biopsy device is in the correct position for the selected target. When the biopsy device is fired, the target is at the center of the aperture of the device.

  • Page 37: Figure 15: Alert Sounds Are Audible

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module The Sound Button The Sound button is enabled when there is a system fault. When the Sound button displays, you can control system sounds related to alarms and motor movements of the biopsy device.

  • Page 38: Jog Mode Screen

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module 4.1.3 Jog Mode Screen This screen allows the user to manually overwrite the targeting coordinates of the Biopsy Guidance Module. The arrow buttons in the Jog Mode screen change the Jog value of the X and Y coordinates.

  • Page 39: Figure 17: Jog Mode Screen

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module Figure 17: Jog Mode Screen Figure Legend Change Y-axis Jog value in negative direction Change X-axis Jog value in negative direction Change Y-axis Jog value in positive direction...

  • Page 40: Select Target Screen

    Affirm Breast Biopsy Guidance System User Guide Chapter 4: User Interface - Biopsy Control Module 4.1.4 Select Target Screen This screen allows the user to select a different target for biopsy guidance or to move to one of the Home positions. The buttons in the Select Target screen allow the user to go to the previous screen (item 1), go to the Target screen (item 2), or go to the Left or Right Home Position (item 3 or item 6).

  • Page 41: 5: Biopsy

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Chapter 5 Biopsy Biopsy Views When used with the Selenia Dimensions stereotactic system, biopsy procedures require stereo views, which are images taken at +15° and -15° angles. Collectively, these images are called a stereo pair.

  • Page 42: How To Edit A Biopsy View

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Select the Biopsy tab. Select the view, then select a View Modifier from the right panel of the screen. Note The Biopsy Stereo and Tomosynthesis View Modifiers show only when the system has licenses for tomosynthesis and biopsy.

  • Page 43: C-Arm Stereo Modes

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy C-Arm Stereo Modes Acquire the stereo images in either the Auto C-arm Stereo Mode or the Manual C-arm Stereo Mode. Make the C-arm Stereo Mode selection at the Acquisition Workstation...

  • Page 44: Figure 21: Stereo Mode

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy In Manual C-Arm Stereo Mode In Manual C-arm Stereo Mode, the C-arm Stereo Mode button shows on the Target Guidance screen. The default is Stereo Mode. See the table that follows for a description of the button function.

  • Page 45: How To Select The C-Arm Stereo Mode For Image Acquisition

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy 5.2.2 How to Select the C-Arm Stereo Mode for Image Acquisition Table 5: How to Select the C-Arm Stereo Mode 1. Select the System Status icon. Figure 23: System Status Icon 2.

  • Page 46: Biopsy Tab

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Biopsy Tab Figure Legend Target Function Buttons Biopsy Options Area Figure 26: The Biopsy Tab When you select the Biopsy tab, the Biopsy Options appear. The Biopsy Options area of the screen shows information about the targets and the biopsy device installed on the system.

  • Page 47: Biopsy Staging

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy 5.3.1 Biopsy Staging The buttons in the Biopsy Options area communicate target information to the Biopsy Control Module. The area on the right side of the buttons shows the selected target and biopsy device.
  • Page 48 Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Device shows the name of the attached biopsy device that was selected from the related drop-down list. Warning: Patient injury can occur if the device you select in the Biopsy tab is not the device that is installed on the system.

  • Page 49: Stereotactic Lesion Targeting

    Yellow warns of being near the safety limit. • Note To make a target active for the Affirm system, select a target icon from the target set and click the Resend button. Stereotactic Lesion Targeting Note You can use the Zoom tool (in the Tools tab or View Actual Pixels button) to magnify the area of interest in an image.

  • Page 50: Verify The Position Of The Biopsy Device

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Select the Create Target button to save the target. The active target set automatically transmits to the Biopsy Control Module with the creation of each new target. Repeat this procedure to create multiple targets (a maximum of six).

  • Page 51: Verify The Position Of The Biopsy Device

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Use the scroll wheel to scroll through the slices of the tomosynthesis target (scout) to find the best view of the lesion. Click on the lesion. • A dash appears in the Slice Indicator beside the selected slice.

  • Page 52: Lesion Targeting Using Multi-Pass

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Lesion Targeting Using Multi-Pass Note The overall targeting accuracy is equal to the combined targeting accuracy of the Biopsy Control Module and the biopsy device. When using the biopsy device, the maximum deviation from the target coordinate will not be more than 2 mm from either side.

  • Page 53: Figure 29: Four Offset Target Points Established Around Center Target Point

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Select the number of offset target points (three, four, or five) you require around the center target point. Figure 29: Four Offset Target Points Established Around Center Target Point Note Keep in mind that the center target point is included in the total target points.

  • Page 54: Figure 32: Single Point Target Selected

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy The crosshairs pattern for the target changes when the target is selected or deselected. See the following figures. Figure 32: Single Figure 33: Single Figure 34: Multi-Pass Figure 35: Multi-Pass...

  • Page 55: Post Biopsy

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy • The order within a Multi-Pass target starts at the center target point. After the center target point, the order moves to the 12 o'clock position and continues counter-clockwise through the offset points. See the following figures.

  • Page 56: Printing Stereo Images

    Affirm Breast Biopsy Guidance System User Guide Chapter 5: Biopsy Printing Stereo Images When you select a stereo pair from the thumbnail area of the Print screen, the image mode buttons change. See the Selenia Dimensions system User Guide for instructions on use of the Print screen.

  • Page 57: 6: Quality Assurance

    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. Make sure the Affirm system is installed correctly and all paddles are removed. On the Acquisition Workstation, from the Select Patient screen, select the Admin button.
  • Page 58 Affirm Breast Biopsy Guidance System User Guide Chapter 6: Quality Assurance On the QAS screen, select the Biopsy tab. Make sure that Affirm QAS appears in the Device field. Figure 42: Device Field in the Biopsy Tab Attach the QAS Phantom. (If the QAS Phantom uses a needle, fully extend the needle.)

  • Page 59: Geometry Calibration

    Affirm Breast Biopsy Guidance System User Guide Chapter 6: Quality Assurance Geometry Calibration Geometry calibration is required semiannually. Perform this calibration using the Geometry phantom supplied with the system. 6.2.1 Geometry Calibration Procedure Inspect the calibration phantom for damage. Select Admin > Quality Control > Technologist tab > Geometry Calibration procedure on the Acquisition Workstation.

  • Page 61: 7: Care And Cleaning

    Inspect the Biopsy Paddle for damage before use. Inspect the calibration Phantom for damage. Inspect all cables for wear and damage before use. Make sure that the Affirm system locks in position. Make sure that the Needle Guides are installed correctly before use.

  • Page 62: 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 63: To Prevent Possible Injury Or Equipment Damage

    Affirm Breast Biopsy Guidance System User Guide Chapter 7: Care and Cleaning 7.3.2 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 65: Appendix A System Specifications

    Affirm Breast Biopsy Guidance System User Guide Appendix A: System Specifications Appendix A System Specifications App endix A Affirm System Measurements Figure 43: 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 67: Appendix B: System Messages And Alerts

    Affirm Breast Biopsy Guidance System User Guide Appendix B: System Messages and Alerts Appendix B System Messages and Alerts App endix B Audible Alerts Table 7: Affirm System Audible Alerts Activity Frequency Duration Repeats? At Power Up: 250 ms Any Needle position within the...
  • Page 68 If the message continues to display, contact Technical Support. Selftest Error Disconnect the Affirm Biopsy Guidance Module cable from the Dimensions system. Reconnect the Affirm Biopsy Guidance Module cable to the Dimensions 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 69: Appendix C: Cnr Correction For Biopsy

    Affirm Breast Biopsy Guidance System User Guide Appendix C: CNR Correction for Biopsy Appendix C CNR Correction for Biopsy App endix C CNR Correction for Stereotactic Biopsy Note System default setting is AEC Table 0 for imaging under stereotactic biopsy mode.

  • Page 71: Appendix D: Forms

    Affirm Breast Biopsy Guidance System User Guide Appendix D: Forms Appendix D Forms App endix D QAS Test Checklist Date Tech X Diff Y Diff Z Diff Pass/Fail MAN-04068 Revision 002 Page 59...

  • Page 73: Glossary Of Terms

    Affirm Breast Biopsy Guidance System User Guide 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 system...

  • Page 75: Index

    Affirm Breast Biopsy Guidance System User Guide Index Index general information - 5 adjustment Hologic technical support - 49 biopsy control module position - 15 home screen - 21 bracket height - 15 control module position - 15 Affirm system storage - 18...
  • Page 76 Affirm Breast Biopsy Guidance System User Guide Index select target screen - 28 skills needed - 1 specifications - 53 stereo biopsy mode C-arm rotation - 31 stereo views - 29 stereotactic lesion targeting - 37 system description - 5...

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