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Hologic Affirm User Manual
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Hologic Affirm User Manual

Hologic Affirm User Manual

Prone biopsy system
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User Guide
MAN-10818-004 Revision 001

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Summary of Contents for Hologic Affirm

  • Page 1 User Guide MAN-10818-004 Revision 001...
  • Page 3 Affirm ® Prone Biopsy System User Guide For Software Version 1.0 Part Number MAN-10818-004 Revision 001 August 2023...
  • Page 4 © 2023 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, Affirm, ATEC, Eviva, and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
  • Page 5 Affirm Prone Biopsy System User Guide Table of Contents Table of Contents List of Figures _________________________________________________________________ xi List of Tables _________________________________________________________________ xv 1: Introduction __________________________________________________________________1 Intended Use................................1 1.1.1 Indications for Use............................ 1 1.1.2 Contraindications ............................. 1 Essential Performance ............................1 System Capabilities ..............................
  • Page 6 Affirm Prone Biopsy System User Guide Table of Contents Patient Platform Controls ............................ 25 Acquisition Workstation Controls ........................26 4: Startup, Functional Tests, and Shutdown _______________________________________27 How to Start the System ............................27 4.1.1 Log In................................ 28 Functional Tests..............................29 4.2.1...
  • Page 7 Affirm Prone Biopsy System User Guide Table of Contents 6: User Interface - Biopsy Control Module ________________________________________57 Biopsy Control Module Screens .......................... 57 6.1.1 Home Screen ............................57 6.1.2 About the Taskbar for the Biopsy Control Module ................58 6.1.3 Target Guidance Screen .........................
  • Page 8 Affirm Prone Biopsy System User Guide Table of Contents Equipment Drape Set ............................95 9.4.1 Symbols ..............................97 Accessory Cart ............................... 98 9.5.1 Pad Hangers ............................98 9.5.2 Paddle Holders ............................99 10: Sample Clinical Sequences __________________________________________________101 10.1 Example Stereotactic Biopsy Procedure ......................101 10.2 Example Tomography Biopsy Procedure ......................
  • Page 9 Affirm Prone Biopsy System User Guide Table of Contents Gantry Technical Information ........................... 135 A.4.1 C-arm ..............................135 A.4.2 Compression System ..........................136 A.4.3 Biopsy Guidance Module ........................136 A.4.4 X-ray Tube ............................. 136 A.4.5 X-ray Beam Filtration and Output ..................... 136 A.4.6...
  • Page 10 Affirm Prone Biopsy System User Guide Table of Contents Appendix G: Ancillary Parts for Biopsy __________________________________________159 Hologic Factory-Verified Biopsy Devices ......................159 Appendix H: Technical References ______________________________________________161 Electromagnetic Compatibility ......................... 161 Appendix I: Forms ____________________________________________________________165 QAS Test Checklist ............................. 165 Geometry Calibration ............................
  • Page 11 Affirm Prone Biopsy System User Guide Table of Contents List of Figures Figure 1: Affirm Prone Biopsy System ..........................9 Figure 2: C-arm Overview .............................. 10 Figure 3: Emergency Off Switch Functionality ......................15 Figure 4: Label Locations ..............................18 Figure 5: System Power Controls ..........................
  • Page 12 Affirm Prone Biopsy System User Guide Table of Contents Figure 43: Biopsy Arm Angles of Rotation ........................73 Figure 44: Directional Movement for the X, Y, Z Axes ....................74 Figure 45: Biopsy Tab ..............................75 Figure 46: Function Buttons and Data on the Biopsy Tab ..................76 Figure 47: Multi-Pass Options ............................
  • Page 13 Affirm Prone Biopsy System User Guide Table of Contents Figure 88: Alignment of Markings on the C-arm with the C-arm Cradle .............. 148 Figure 89: Mouse Holder (2) and Keyboard Tray Lock Knob (1) ................149 Figure 90: Set the Lock Knob to Locked Position ...................... 149 Figure 91: Release the Lock Knobs on the Monitors ....................
  • Page 15 Table 16: Radiologic Technologist Manager—System Tools Functions ..............127 Table 17: Maximum mA as a Function of kV ......................137 Table 18: System Messages ............................140 Table 19: Hologic Factory-Verified Biopsy Devices ....................159 Table 20: Electronic Emissions ............................. 161 Table 21: Electromagnetic Immunity Part 1 ....................... 162 Table 22: Electromagnetic Immunity Part 2 .......................
  • Page 17 Patient cannot remain in a prone position during the entire procedure. Essential Performance The essential performance requirements of the Affirm prone biopsy system is as defined in IEC-60601-2-45: 2005. These include: accuracy of loading factors, automatic control system, imaging performance, missed tissue at chest wall side, breast compression device, linearity of air kerma over limited intervals of loading factors, and reproducibility of the X-radiation output.
  • Page 18 Affirm Prone Biopsy System User Guide Chapter 1: Introduction System Capabilities The Affirm prone biopsy system is a tomosynthesis-capable mammography system for performing breast biopsies on patients lying in the prone position. The system localizes suspicious lesions, as determined through prior mammographic examinations, using either stereotactic or tomosynthesis techniques.
  • Page 19 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 20 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. 1.10 Technical Support Refer to the copyright page of this manual for contact information for product support.
  • Page 21 "OFF" (power) "ON" (power) "OFF" for part of the equipment "ON" for part of the equipment Discard electrical and electronic equipment separately from standard waste. Send decommissioned material to Hologic or contact your service representative. Dangerous Voltage Manufacturer Date of Manufacture...
  • Page 22 Affirm Prone Biopsy System User Guide Chapter 1: Introduction Symbol Description Alternating current Follow operating instructions Follow the User Guide Caution Fragile, handle with care Temperature limit Humidity limitation Do not immerse in any liquid No pushing No stepping on surface...
  • Page 23 Affirm Prone Biopsy System User Guide Chapter 1: Introduction 1.14 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 25 5. Accessory Cart 3. C-Arm 6. High Voltage Generator Note A radiation shield is not provided with the Affirm prone biopsy system. Note The Acquisition Workstation has wheels for ease of positioning only. The system is NOT a mobile unit.
  • Page 26 Affirm Prone Biopsy System User Guide Chapter 2: General Information 2.1.1 C-Arm Overview Figure 2: C-arm Overview Figure Legend 1. Compression Arm 2. Biopsy Arm 3. Biopsy Device 4. Tubehead 5. C-arm Rotation Handle 6. Biopsy Control Module Display 7. Control Handle 8.
  • Page 27 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 28 Keep a 1.5 meter safe distance between the patient platform and the acquisition workstation. WARNING! Only trained Service Engineers authorized through Hologic can open any of the panels. This system contains lethal voltages. WARNING! The user must correct problems before the system is used. Contact an approved service representative for preventive maintenance.
  • Page 29 Affirm Prone Biopsy System User Guide Chapter 2: General Information Warning: Keep your full body behind the radiation shield during the exposure. Warning: Do not move the C-arm while the system retrieves the image. Warning: If a paddle touches possible infectious materials, contact your Infection Control Representative to remove contamination from the paddle.
  • Page 30 Affirm Prone Biopsy System User Guide Chapter 2: General Information Caution: The system is a medical device and not a normal computer. Only make approved changes to the hardware or software. Install this device behind a firewall for network security. The computer virus protection or network security for this medical device is not supplied (for example, a computer firewall).
  • Page 31 • The network and communication equipment is installed to meet IEC Standards. The complete system (network and communications equipment and the Affirm Prone Biopsy System) must be in compliance with IEC 60601-1. MAN-10818-004 Revision 001 Page 15...
  • Page 32 Caution: Changes or modifications not expressly approved by Hologic could void your authority to operate the equipment. Caution: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
  • Page 33 Affirm Prone Biopsy System User Guide Chapter 2: General Information 2.6.2 Compliance Statements The manufacturer states this device is made to meet the following requirements. IEC: • IEC 60601-1: 2005 - Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance •...
  • Page 34 Affirm Prone Biopsy System User Guide Chapter 2: General Information Label Locations Figure 4: Label Locations Page 18 MAN-10818-004 Revision 001...
  • Page 35 Affirm Prone Biopsy System User Guide Chapter 2: General Information Table 1: System Labels MAN-10818-004 Revision 001 Page 19...
  • Page 37 Affirm Prone Biopsy System User Guide Chapter 3: System Controls and Indicators Chapter 3 System Controls and Indicators System Power Controls Figure 5: System Power Controls Figure Legend 1. Uninterruptible Power Supply (UPS) Power/Reset Button 2. Isolation Transformer Power Switch 3.
  • Page 38 Affirm Prone Biopsy System User Guide Chapter 3: System Controls and Indicators C-Arm Controls Figure 6: C-arm Controls and Displays Figure Legend 1. Emergency Off (E-Stop) Switch 2. Manual Compression Adjust Knob 3. Control Handle 4. Biopsy Control Module Touch Screen Display 5.
  • Page 39 Affirm Prone Biopsy System User Guide Chapter 3: System Controls and Indicators 3.2.1 Biopsy Arm Controls Figure 7: Biopsy Arm – Detailed View Figure Legend 1. Biopsy Device Mount Knob 2. Manual Needle Advance/Retract Knobs 3. Biopsy Control Module Touch Screen Displays 4.
  • Page 40 Affirm Prone Biopsy System User Guide Chapter 3: System Controls and Indicators 3.2.2 Control Handle Controls Button Function C-arm Translate (horizontal plane) C-arm Up C-arm Down System Lock Figure 8: Control Handle -- Detailed View Patient Platform Up Patient Platform Down 3.2.3...
  • Page 41 Affirm Prone Biopsy System User Guide Chapter 3: System Controls and Indicators Patient Platform Controls Figure 10: Patient Platform Controls Figure Legend 1. Patient Platform Up 2. Patient Platform Down 3. Task Light On/Medium/Low/Off 4. Patient Platform Up Limit (Full Height)
  • Page 42 Affirm Prone Biopsy System User Guide Chapter 3: System Controls and Indicators Acquisition Workstation Controls Figure 11: Acquisition Workstation Controls Figure Legend 1. Control Monitor 9. CD/DVD Drive 2. Image Display Monitor 10. Emergency Off/X-ray Activation Remote 3. Keyboard A. Power On Light 4.
  • Page 43 Affirm Prone Biopsy System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Chapter 4 Startup, Functional Tests, and Shutdown How to Start the System Note See the figure System Power Controls on page 21 for the locations of power buttons.
  • Page 44 Affirm Prone Biopsy System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Note The system can require between five minutes and fifteen minutes to prepare for image acquisition. The wait time depends on the detector power configuration. A timer in the Taskbar displays the wait time before the system is ready.
  • Page 45 Affirm Prone Biopsy System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Functional Tests 4.2.1 Compression Functional Tests Table 2: Compression Tests Function Functional Test Compression Apply Press a Compression Apply button: The Compression Paddle moves toward the image •...
  • Page 46 Affirm Prone Biopsy System User Guide Chapter 4: Startup, Functional Tests, and Shutdown 4.2.2 C-arm Movement Functional Tests Table 3: C-arm Tests Function Functional Test C-arm Up Press a C-arm Up button: The C-arm moves up. • C-arm up movement stops: When the button is released.
  • Page 47 Affirm Prone Biopsy System User Guide Chapter 4: Startup, Functional Tests, and Shutdown Emergency Off Switches Functionality There are three Emergency Off switches, one on each side of the Gantry and one on the Acquisition Workstation. 1. To turn Off the Gantry and disable the Acquisition Workstation Lift Mechanism, press any of the Emergency Off switches.
  • Page 49 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Chapter 5 User Interface - Control Monitor Select Function to Perform Screen Figure 15: Select Function to Perform Screen After login, the Select Function to Perform screen opens. This screen shows the Quality Control tasks that are due.
  • Page 50 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor To proceed without completing all scheduled Quality Control tasks: If all Quality Control tasks are not completed at this time, select the Skip button. Note If you select the Skip button, the Select Patient screen opens. Refer to Select Patient Screen on page 36 for information about this screen.
  • Page 51 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Table 5: Taskbar Menus Description Menu System Status Icons Select the System Status (Table) icon to display a menu. When the detector and generator are ready for use, a green check mark appears next to the System Status icon.
  • Page 52 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Select Patient Screen Figure 16: Select Patient Screen Page 36 MAN-10818-004 Revision 001...
  • Page 53 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Table 6: The Select Patient Screen Item Description 1. Quick Search Search the local database for the Patient Name, Patient ID, or Accession number. 2. Tabs The filter tabs at the top of the screen are configurable. A user with the correct permissions can delete tabs and create new tabs.
  • Page 54 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.3.2 Add a New Patient Figure 17: Add Patient Screen 1. In the Select Patient screen, select the New button. The Add Patient screen opens. 2. Enter the new patient information and select a procedure.
  • Page 55 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.3.5 Filters for Patients After selecting the Filter button in the Select Patient screen, the Patient Filter screen for the selected tab opens. Figure 18: Filter Tab in the Patient Filter Screen Filter Tab Use the Filter tab to change the filter options for the patient list.
  • Page 56 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Other Functions of the Filter Tab The Filter tab allows users with access privileges to add, change, or delete tabs in the Select Patient screen. Refer to the following table.
  • Page 57 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.3.6 Refresh the Worklist Select the Refresh Worklist button to update the Scheduled patient list from the Modality Worklist Provider. 5.3.7 Query the Worklist Select the Query Worklist button to search the Modality Worklist Provider for a patient or a list of patients.
  • Page 58 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Procedure Screen Figure 19: Procedure Screen Page 42 MAN-10818-004 Revision 001...
  • Page 59 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Table 8: The Procedure Screen Item Description 1. Image Status The view icon shows the current selected view. Implant Present button—select when the patient has an implant.
  • Page 60 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Figure 20: Add Procedure Dialog Box 2. Use the drop-down lists to select the type of procedure to add. 3. Type an Accession Number or select the Inherit Accession Number check box to use the current number.
  • Page 61 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.4.3 Add a View To add a view: 1. Select the Add View button to access the Add View screen. Note Depending on the license settings for your system, you may see different tabs.
  • Page 62 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.4.4 Edit a View Use the Edit View screen to assign a different view to an image. Figure 22: Edit View Screen To edit a view: 1. In the Procedure screen, select an exposed thumbnail image.
  • Page 63 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.4.6 Procedure Info To show procedure information, select the Procedure Information button located below the Delete View (trash can) button. The Procedure Info dialog box opens with the following information: •...
  • Page 64 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.4.7 Close a Patient Select the Close Patient button. If images were acquired, a Close Procedure dialog box opens. Select one of the following options: Close Procedure Complete: Closes the procedure and puts the procedure in the Completed tab.
  • Page 65 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Output Groups The accepted images are sent automatically to the output devices in the selected Output Group. The system configuration controls if the images are sent after a patient is closed or after the image is accepted.
  • Page 66 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.7.3 Custom Output The Custom Output Group option lets you make an output group from the Procedure screen. The custom output group that you make stays as the Custom option until another custom output group is made.
  • Page 67 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor On-Demand Outputs The On-Demand Outputs are Archive/Export or Print. You can manually Archive, Export, or Print the currently opened patient until the procedure is closed. When you select an On-Demand Output button, you have the option to send images from the patient that is open to any of the configured output devices.
  • Page 68 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.8.2 Export 1. In the Procedure screen, select the Archive/Export button. The On Demand Archive screen opens. 2. Select the images to export, then select the Export button.
  • Page 69 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor 5.8.3 Print 1. From the Procedure screen, select the Print button to open the Print screen. See the figure The Print Screen on page 54 to prepare your print data.
  • Page 70 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Figure 27: Print Screen Figure Legend 1. Show or hide patient data. 13. Delete a film. 2. Show or hide markings and annotations. 14. Delete an image from a film.
  • Page 71 Affirm Prone Biopsy System User Guide Chapter 5: User Interface - Control Monitor Printing Stereo Pair Images When you select a stereo pair from the thumbnail images in the Print screen, the image mode buttons change. • Select the -15 button to show that stereo image in the display area.
  • Page 73 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module Chapter 6 User Interface - Biopsy Control Module Biopsy Control Module Screens 6.1.1 Home Screen Figure 29: Home Screen Figure Legend 1. Patient Name 2. Biopsy Control Module Version Number 3.
  • Page 74 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module 6.1.2 About the Taskbar for the Biopsy Control Module The taskbar at the bottom of the screen shows additional information about the C-arm and the system.
  • Page 75 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module 6.1.3 Target Guidance Screen The Target Guidance screen is the main screen for 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 76 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module Colored Cells in the Screens Green Cells When all Differential 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 77 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module Select Target Screen The Select Target screen allows the user to select a different target for biopsy guidance or to move to one of the home positions.
  • Page 78 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module Jog Mode Screen The Jog Mode screen allows the user to manually overwrite the targeting coordinates of the Biopsy Control Module. The arrow buttons in the Jog Mode screen change the Jog value of each of the coordinates.
  • Page 79 Affirm Prone Biopsy System User Guide Chapter 6: User Interface - Biopsy Control Module AEC Adjust Screen The AEC Adjust screen allows the user to select the AEC Sensor positions. The AEC Sensor has five manual positions and an automatic position.
  • Page 81 Affirm Prone Biopsy System User Guide Chapter 7: Images Chapter 7 Images Image Display Screen Figure 35: Image Display Screen After you make an exposure, the acquired image opens on the Image Display monitor. The image is always oriented with the chest wall at the top of the screen and the nipple pointing down.
  • Page 82 Affirm Prone Biopsy System User Guide Chapter 7: Images 7.1.1 Conventional Imaging Sequence of Events • Review the image after the exposure and add a comment, if necessary. • Accept or Reject the image. A thumbnail image appears in the Case Study area of the screen.
  • Page 83 Affirm Prone Biopsy System User Guide Chapter 7: Images How to Acquire an Image Refer to Sample Clinical Sequences on page 101 for information about clinical procedures. 1. On the Control Handle, press the System Lock button to lock the C-arm. (The system does not allow x-rays unless the System Lock button is on.)
  • Page 84 Affirm Prone Biopsy System User Guide Chapter 7: Images 5. When the x-ray is finished, the image opens on the Image Display monitor. The Procedure screen automatically changes to the Tools tab. Select one of the following options to complete the acquisition: •...
  • Page 85 Affirm Prone Biopsy System User Guide Chapter 7: Images How to Review the Images Review of images involves use of the thumbnails, image review tools, and display modes. Figure 38: Tools Tab Figure Legend 1. Image Review Tools - refer to The Image Review Tools Tab on page 70.
  • Page 86 Affirm Prone Biopsy System User Guide Chapter 7: Images 7.4.1 The Image Review Tools Tab The Tools tab in the Procedure screen provides the image review tools. A check mark appears on an active tool. Figure Legend 1. The Zoom tool magnifies a section of the image.
  • Page 87 Affirm Prone Biopsy System User Guide Chapter 7: Images 7.4.2 Other Image Review Tools Other Tabs • Comments: Add comments to an image. • Service: Mark an image for service use. • ROI: Draw a Region of Interest on the Image Display monitor.
  • Page 88 Affirm Prone Biopsy System User Guide Chapter 7: Images 7.4.3 Slice Indicator The Slice Indicator shows only on tomographic reconstructions. Figure Legend 1. Up and Down arrows let you change between slices that contain a lesion target and slices that are tagged for printing.
  • Page 89 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Chapter 8 Biopsy Biopsy Approach The system has the capability to do biopsies from a standard needle approach or a lateral needle approach. When a standard needle approach is not optimal, the lateral needle approach allows the needle to enter the breast parallel to the breast platform and perpendicular to the Compression arm.
  • Page 90 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Biopsy Coordinate System Positive and negative directional movements are in relation to the breast platform. The X direction is the medial-lateral axis (chest wall) with the positive direction to the right of the breast platform.
  • Page 91 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Biopsy Views When performing a 2D biopsy procedure, the biopsy guidance system requires stereo views. Stereo views are images taken at +15° and -15° angles. Collectively, these two images are called a stereo pair. The word "stereo" in the biopsy procedures refers to the +15°...
  • Page 92 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy 8.4.1 Biopsy Options 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 biopsy device (item 9), the targets (item 10), and the needle position (item 11).
  • Page 93 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Move Z-Target Positive moves the final position of the needle away from the Breast Platform and the graphic of the lesion downward. The values for the safety margins change accordingly. Move Z-Target Negative moves the final position of the needle toward the Breast Platform and the graphic of the lesion upward.
  • Page 94 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy 11. Status Indicators show the distance information: The distance from the needle tip (post fire) to the breast platform. • • The distance of the target from the center of the aperture.
  • Page 95 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Note The target that shows on the Target Guidance screen of the Biopsy Control Module is the last target created. The target or target set that shows on the Select Target screen is the last target or target set sent to the Biopsy Control Module.
  • Page 96 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Lesion Targeting in a 3D Biopsy Procedure Lesion targeting in a 3D™ biopsy procedure requires system licenses for tomosynthesis biopsy. Note Make sure that the biopsy device is out of the imaging area.
  • Page 97 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy 8.6.1 Lateral Needle Approach Use a lateral needle approach when it is apparent that the lesion is not reachable with a standard needle approach or is close to the breast platform.
  • Page 98 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy 8.6.3 Project Targets on Post-Fire Scout Image To project targets from the pre-fire tomosynthesis target (scout) onto the post-fire tomosynthesis target (scout), follow these steps: 1. Select the pre-fire tomosynthesis target (scout) thumbnail. The image shows in the bottom half of a 2-Up screen on the Image Display monitor.
  • Page 99 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy Note Make sure that the biopsy device is out of the imaging area. Note The overall targeting accuracy is equal to the combined targeting accuracy of the Biopsy Arm Controller 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 100 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy 6. Select how far the offset target points are automatically generated from the center target point - 2 mm, 3 mm (the default), 4 mm, or 5 mm. Figure 49: 3 mm Spacing of Offset Points...
  • Page 101 Affirm Prone Biopsy System User Guide Chapter 8: Biopsy 8. The biopsy order of the target points is as follows: • The number displayed at the bottom right of the crosshairs circle indicates the order between target sets. The first target is labeled "1", the second is "2", and so on.
  • Page 103 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Chapter 9 Accessories Maximum Comfort Package General instructions for installation and use are given in the table below. For specific instructions for using the Arm Through accessories, see the table Installation of the Arm Through Max Comfort Package on page 89.
  • Page 104 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Table 9: Installation and Use of the Maximum Comfort Package Step What the step looks like 6. Adjust the footrest. a. Pull and hold the knob on the footrest. b. Adjust the footrest: Rotate the footrest and pull out or push in to the desired position.
  • Page 105 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Table 10: Installation of the Arm Through Maximum Comfort Package Step What the step looks like 1. Select the Arm Through accessories. item 1 Aperture • • item 2 Aperture cushion 2.
  • Page 106 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Table 11: Use of the Arm Through Maximum Comfort Package Step What the step looks like 1. Position the patient on the patient platform. 2. Position the arm of the patient on the arm support and lock the support into position.
  • Page 107 Affirm Prone Biopsy System User Guide Chapter 9: Accessories 9.2.1 How to Install or Remove a Paddle How to install a paddle: 1. Move the compression mechanism away from the breast platform. 2. Hold the paddle in one hand with the flat compression side facing the image receptor.
  • Page 108 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Biopsy Devices and Components 9.3.1 Needle Guides Warning: Always use sterile techniques when you use needle guides during the patient procedures. Warning: It is important to install the device correctly. Be sure to insert the needle through the needle guides.
  • Page 109 Affirm Prone Biopsy System User Guide Chapter 9: Accessories 9.3.2 Biopsy Device Adapter To install a biopsy device adapter: 1. Align the outer holes in the biopsy device adapter (item 1) with the guide pins on the device mount. 2. Align the middle hole in the biopsy device adapter with the mount screw (item 2).
  • Page 110 Affirm Prone Biopsy System User Guide Chapter 9: Accessories 9.3.3 Biopsy Device Warning: Always apply the device safety and cock the biopsy device before you install the device on the biopsy device mount. Figure 62: Attach the Biopsy Device 1. Turn the biopsy device knob to move the biopsy device mount fully back.
  • Page 111 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Equipment Drape Set The Drape Set is used to prevent fluids from contaminating portions of the C-arm. The Drape Set consists of three sections: • drape for the breast platform (with a clear plastic pocket to cover the paddle mount) •...
  • Page 112 Affirm Prone Biopsy System User Guide Chapter 9: Accessories 4. Attach the paddle on the paddle mount over the clear plastic pouch section of the drape (item 3). 5. Place the drape section for the biopsy device mount over the biopsy device mount (item 4).
  • Page 113 Affirm Prone Biopsy System User Guide Chapter 9: Accessories 10. Install the clear cover (item 7) over the control panel. 11. To use a lateral needle approach, the biopsy device mount drape can be divided into two sections. Separate the drape at the perforation between the biopsy device and the paddle (item 8).
  • Page 114 Affirm Prone Biopsy System User Guide Chapter 9: Accessories Accessory Cart 9.5.1 Pad Hangers The system is equipped with four aperture pads. The accessory cart includes two hooks (pad hangers) to hang the pads. To install the pad hangers: A mounting bracket is affixed to the inside of the accessory cart. The pad hangers are installed in the two outer mounting holes on the mounting bracket (see the following figure).
  • Page 115 Affirm Prone Biopsy System User Guide Chapter 9: Accessories 9.5.2 Paddle Holders The system is equipped with four paddles. The accessory cart includes a paddle holder for each of the paddles. To install the paddle holders: Slide the paddle holders over the narrow sides of the cart. The pockets of the paddle holders go inside the cart (see the following figure).
  • Page 117 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences Chapter 10 Sample Clinical Sequences 10.1 Example Stereotactic Biopsy Procedure MAN-10818-004 Revision 001 Page 101...
  • Page 118 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences 10.2 Example Tomography Biopsy Procedure Page 102 MAN-10818-004 Revision 001...
  • Page 119 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences 10.3 Example Sequence of Operation Step Where this action is done At the Acquisition Workstation, select the patient name, procedure, and output (if desired). MAN-10818-004 Revision 001 Page 103...
  • Page 120 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences Step Where this action is done Protect the system with equipment drapes. Install the biopsy paddle. Page 104 MAN-10818-004 Revision 001...
  • Page 121 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences Step Where this action is done Position the patient, the patient platform, and the C-arm. Compress the breast. Acquire the image. MAN-10818-004 Revision 001 Page 105...
  • Page 122 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences Step Where this action is done On the Acquisition Workstation, target the lesion then accept the target to transmit it to the Biopsy Control Module. Make sure that the device mount is moved fully back.
  • Page 123 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences Step Where this action is done Enable the Biopsy Control Module motor to move the biopsy device to the X and Y positions. Use the knobs to manually move the biopsy device close to the breast.
  • Page 124 Affirm Prone Biopsy System User Guide Chapter 10: Sample Clinical Sequences Step Where this action is done Insert a biopsy marker (if desired). Acquire post-biopsy images (if desired). Release compression. Lower the patient platform. Apply pressure to the biopsy site as needed.
  • Page 125 Affirm Prone Biopsy System User Guide Chapter 11: Quality Control Chapter 11 Quality Control MQSA has no requirements for interventional procedures (such as breast biopsy). If your facility is ACR accredited for breast biopsy, refer to the 1999 ACR Stereotactic Breast Biopsy Quality Control Manual on how to do quality control.
  • Page 126 Affirm Prone Biopsy System User Guide Chapter 11: Quality Control 11.2 How to Access Quality Control Tasks There are two ways to access the Quality Control Tasks. • After logging in, the Select Function to Perform screen appears. This screen lists the quality tasks that are due.
  • Page 127 Affirm Prone Biopsy System User Guide Chapter 11: Quality Control • From the Admin screen, select one of the following buttons: QAS, Quality Control, or Test Patterns. All Quality Control Tasks can be accessed this way at any time. MAN-10818-004 Revision 001...
  • Page 128 Affirm Prone Biopsy System User Guide Chapter 11: Quality Control 11.3 QAS Test Each day that the system is used, do this test one time to confirm the system accuracy. Record the results in the QAS Test Checklist on page 165.
  • Page 129 4. Install the QAS Phantom. (If the QAS Phantom uses a needle, fully extend the needle.) 5. In the Info dialog box, select OK. 6. On the QAS screen, select the Biopsy tab. Make sure that Affirm QAS appears in the Device field.. Figure 67: Device Field in the Biopsy Tab 7.
  • Page 130 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 131 Affirm Prone Biopsy System User Guide Chapter 11: Quality Control 11.4 Gain Calibration Note Allow the system to warm up for at least 30 minutes before doing the Gain Calibration. 1. Select the Admin button on the Acquisition Workstation Control monitor, then select the Quality Control button from the Admin screen.
  • Page 132 Affirm Prone Biopsy System User Guide Chapter 11: Quality Control 11.5 Geometry Calibration Note It is important to clean the Geometry Calibration paddle and the surface of the digital image receptor before starting the calibration procedure. 1. Select the Admin button on the Acquisition Workstation Control monitor, then select the Quality Control button from the Admin screen.
  • Page 133 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 134 Affirm Prone Biopsy System User Guide Chapter 12: Care and Cleaning 12.1.3 How to Clean the Biopsy Control Module Screen There are many commercially available products to clean LCD screens. Make sure the product that you select is free of strong chemicals, abrasives, bleach, and detergents that contain fluorides, ammonia, and alcohol.
  • Page 135 To reduce potential for contamination and equipment damage, protect the equipment with drapes during biopsy procedures. See the following figure for the areas on the Affirm prone biopsy system that require protection. Warning: Protect the equipment to guard against fluids entering the system.
  • Page 136 Affirm Prone Biopsy System User Guide Chapter 12: Care and Cleaning 12.3 Preventive Maintenance Schedule for the User Table 13: Operator Preventive Maintenance Schedule Each Maintenance Task Description Daily Weekly Semiannually Clean the Biopsy Paddle with a disinfectant after use.* Clean the Breast Platform with a disinfectant after use.*...
  • Page 137 Affirm Prone Biopsy System User Guide Chapter 12: Care and Cleaning 12.4 Preventive Maintenance Schedule for Service Table 14: Service Engineer Preventive Maintenance Recommended Frequency Maintenance Task Description Semiannually Annually Clean and inspect the Gantry, Detector, and Acquisition Workstation Check all primary power connections...
  • Page 139 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface Chapter 13 System Administration Interface 13.1 The Admin Screen To access all functions in this screen, log in to the system as a user with administrator, manager, or service permissions.
  • Page 140 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface Table 15: Admin Screen Functions Section Button Name Function Quality Control Quality Control Select a Quality Control task to perform or mark completed. QC Report Create a QC Report.
  • Page 141 The About Screen The About screen provides information about the machine, such as system level, IP address, and serial number. This type of data can be useful when working with Hologic to configure the system or resolve a system issue.
  • Page 142 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface 13.3 Change the User Language Preference Users can set the language on the user interface to automatically change to their individual preference when logging in. 1. In the Operators group of the Admin screen, select My Settings.
  • Page 143 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface 13.4.1 System Tools for the Radiologic Technologist Manager Figure 73: System Tools Screen Table 16: Radiologic Technologist Manager—System Tools Functions Section Screen Functions Getting Started About: The introduction to the service tool.
  • Page 144 IP Address. 2. Using an internet browser on your remote computer, navigate to http:// [IP address]/Hologic.web/MainPage.aspx. Use the IP Address from step 1. 3. The Service Tools Logon screen opens. Type a Manager-level user name and password, and then click Submit.
  • Page 145 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface 5. Select the parameters for the report and click Generate. Figure 76: Create Image Report Parameters 6. The report shows on the screen. Scroll to the bottom of the report and select either Click to Download (html) or Click to Download (csv) for the file download type.
  • Page 146 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface 13.5 Archive Tool The archive feature in the Admin screen lets you: Send local studies to an • archive. Export studies to removable • media. Figure 78: Archive Button 1.
  • Page 147 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface To Archive: 1. Select the patients and the procedures to archive. • Select patients from the patient list, or do a search with the search parameters (item 1) and select patients from the search results.
  • Page 148 Affirm Prone Biopsy System User Guide Chapter 13: System Administration Interface To Export: 1. Select the patients and the procedures to export. • Select patients from the patient list, or do a search with one of the search parameters (item 1) and select patients from the search results.
  • Page 149 Affirm Prone Biopsy System User Guide Appendix A: Specifications Appendix A Specifications Appendix A Product Measurements Figure 81: Gantry and Generator Dimensions Gantry/Patient Platform Dimensions Height 107 cm (42 inches) Width 229 cm (90 inches) Depth with C-arm 178 cm (70 inches)
  • Page 150 Affirm Prone Biopsy System User Guide Appendix A: Specifications Figure 82: Acquisition Workstation Dimensions Acquisition Workstation Dimensions Height 138.4 cm (54.5 inches) Overall Height Range 138.4 cm (54.5 inches) to 179.1 cm (70.5 inches) Height Range (floor to 71.1 cm (28 inches) to 111.8 cm (44 inches)
  • Page 151 Affirm Prone Biopsy System User Guide Appendix A: Specifications A.2.2 General Conditions for Transport and Storage Temperature Range 10 °C (50 °F) to 35 °C (95 °F) Relative Humidity Range 10 to 80%, not packaged for outdoor storage Electrical Input A.3.1...
  • Page 152 Affirm Prone Biopsy System User Guide Appendix A: Specifications A.4.2 Compression System Manual Compression Force 300 N (67.4 lb) maximum Motorized Compression Force 62.3 N (14.0 lb) minimum 200 N (45.0 lb) maximum A.4.3 Biopsy Guidance Module Accuracy of Biopsy Arm Controller...
  • Page 153 Affirm Prone Biopsy System User Guide Appendix A: Specifications kV/mA Range Table 17: Maximum mA as a Function of kV LFS mA LFS mA A.4.6 X-ray Generator Type Constant potential, three-phase, high frequency inverter Rating 7.0 kW (large focus) maximum, mid focus 4.08 KW(120 mA...
  • Page 154 Affirm Prone Biopsy System User Guide Appendix A: Specifications A.4.7 Image Receptor Technical Information Dimensions Height 33 cm (13 inches) Width 21.5 cm (8.46 inches) Depth 10 cm (3.94 inches) Weight 7.3 kg (16 pounds) Imaging Area 14 cm x 12 cm Effective Field of View 12.4 cm x 10.2 cm at the Breast Platform...
  • Page 155 Taskbar. Some conditions require a system restart or indicate that more action is necessary (for example, to call Hologic Technical Support). This appendix describes the message categories and your actions to return the system to normal operation. If errors repeat, contact Hologic Technical Support.
  • Page 156 Affirm Prone Biopsy System User Guide Appendix B: System Messages and Alerts B.2.2 System Messages When the following system messages show, do the step shown in the User Action column to clear the message and allow the next exposure. Table 18: System Messages...
  • Page 157 Affirm Prone Biopsy System User Guide Appendix B: System Messages and Alerts Table 18: System Messages Icon Message User Action An E-Stop has been pressed When safe, turn the Emergency Off switch one-quarter turn to reset the switch. Tube needs to be manually Manually rotate the C-arm to 0 degrees.
  • Page 158 Affirm Prone Biopsy System User Guide Appendix B: System Messages and Alerts Table 18: System Messages Icon Message User Action Compression too low for tomo Move the Compression Paddle to greater reconstructions than 0.5 cm. Compression is less than 4.5 cm...
  • Page 159 Use in a Mobile Environment Appendix C General Information This appendix describes the Affirm prone biopsy system installed in a mobile environment. Conditions for Safety and Other Precautions An acceptable, stable, clean VAC power source is required to make sure that the system meets all its performance specifications.
  • Page 160 Affirm Prone Biopsy System User Guide Appendix C: Use in a Mobile Environment Caution To avoid image artifacts from occurring: • Do not locate or park the mobile coach near sources of high power (such as power transmission lines and outdoor transformers).
  • Page 161 Affirm Prone Biopsy System User Guide Appendix C: Use in a Mobile Environment 6. Put the C-arm cradle into position under the C-arm. Confirm that the cradle is correctly seated on the circular mounting block. Figure 84: Set the C-arm Cradle 7.
  • Page 162 Affirm Prone Biopsy System User Guide Appendix C: Use in a Mobile Environment 8. Use the height tool to lock the biopsy arm in position. Place the tool on the tube arm between the biopsy arm and the tubehead. Make sure to use the hook and loop strap for extra support.
  • Page 163 Affirm Prone Biopsy System User Guide Appendix C: Use in a Mobile Environment 9. Put the footswitch into the footswitch channels in the C-arm cradle and secure with the hook and loop strap. Caution: Make sure that the footswitch cord is positioned safely to prevent damage from being compressed between the C-arm and the C-arm cradle.
  • Page 164 Affirm Prone Biopsy System User Guide Appendix C: Use in a Mobile Environment 11. Continue pressing the C-arm Translate button and adjust the C-arm as needed while lowering the patient platform into the C-arm cradle. The marking on the C-arm aligns with the support bracket on the C-arm cradle.
  • Page 165 Affirm Prone Biopsy System User Guide Appendix C: Use in a Mobile Environment 16. Close and lock the keyboard tray. Figure 89: Mouse Holder (2) and Keyboard Tray Lock Knob (1) Figure 90: Set the Lock Knob to Locked Position 17.
  • Page 166 C-arm Up and Down • Patient Platform Up and Down • Patient Platform Up Limit C.6.2 Quality Control Tests After Travel Perform the Quality Control tests as recommended for the non-mobile Affirm prone biopsy system. Page 150 MAN-10818-004 Revision 001...
  • Page 167 Affirm Prone Biopsy System User Guide Appendix D: Dose Conversion Tables for the Medical Physicist Appendix D Dose Conversion Tables for the Medical Appendix D Physicist MAN-10818-004 Revision 001 Page 151...
  • Page 168 Affirm Prone Biopsy System User Guide Appendix D: Dose Conversion Tables for the Medical Physicist (Tomosynthesis Option) Page 152 MAN-10818-004 Revision 001...
  • Page 169 Affirm Prone Biopsy System User Guide Appendix D: Dose Conversion Tables for the Medical Physicist (Tomosynthesis Option) MAN-10818-004 Revision 001 Page 153...
  • Page 171 Affirm Prone Biopsy System User Guide Appendix E: CNR Correction for Biopsy Appendix E CNR Correction for Biopsy Appendix E CNR Correction for Stereotactic Biopsy E.1.1 AEC Table 0 (Standard Stereotactic Biopsy Dose) Compression Thickness CNR Correction Factor 2.0 cm 0.71...
  • Page 173 Affirm Prone Biopsy System User Guide Appendix F: Technique Tables Appendix F Technique Tables Appendix F Recommended Technique Table for Stereotactic Procedures Compressed Breast Fatty Breast Normal Breast Dense Breast Thickness (mm) MAN-10818-004 Revision 001 Page 157...
  • Page 174 Affirm Prone Biopsy System User Guide Appendix F: Technique Tables Recommended Technique Table for Tomosynthesis Procedures Compressed Breast Fatty Breast Normal Breast Dense Breast Thickness (mm) Page 158 MAN-10818-004 Revision 001...
  • Page 175 Affirm Prone Biopsy System User Guide Appendix G: Ancillary Parts for Biopsy Appendix G Ancillary Parts for Biopsy Appendix G Hologic Factory-Verified Biopsy Devices Table 19: Hologic Factory-Verified Biopsy Devices Manufacturer Description Model Hologic Affirm QAS Needle ASY-03949 Hologic ATEC...
  • Page 177 Affirm Prone Biopsy System User Guide Appendix H: Technical References Appendix H Technical References Appendix H Electromagnetic Compatibility This section provides information about the electromagnetic compatibility of system per IEC 60601-1-2. Table 20: Electronic Emissions Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 178 Affirm Prone Biopsy System User Guide Appendix H: Technical References Table 21: Electromagnetic Immunity Part 1 Electromagnetic Immunity – Part 1 The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 179 Affirm Prone Biopsy System User Guide Appendix H: Technical References Table 22: Electromagnetic Immunity Part 2 The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 180 Affirm Prone Biopsy System User Guide Appendix H: Technical References Table 23: Separation Distances for RF Equipment Recommended Separation Distances for Portable and Mobile RF Communications Equipment and the system The system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 181 Affirm Prone Biopsy System User Guide Appendix I: Forms Appendix I Forms Appendix I QAS Test Checklist Date Tech X Diff Y Diff Z Diff Pass/Fail MAN-10818-004 Revision 001 Page 165...
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  • Page 183 Affirm Prone Biopsy System User Guide Appendix I: Forms Geometry Calibration MAN-10818-004 Revision 001 Page 167...
  • Page 184 Affirm Prone Biopsy System User Guide Appendix I: Forms (This page is intentionally left blank.) Page 168 MAN-10818-004 Revision 001...
  • Page 185 Affirm Prone Biopsy System User Guide Appendix I: Forms Gain Calibration MAN-10818-004 Revision 001 Page 169...
  • Page 187 Affirm Prone Biopsy System User Guide Glossary of Terms Glossary of Terms Source to Image Distance Standard Needle Approach American College of Radiology Biopsy device approach that is parallel to the plane of compression and perpendicular to the imaging plane.
  • Page 188 Affirm Prone Biopsy System User Guide Glossary of Terms X-axis Refers to the horizontal plane across the biopsy window. When the Needle Guidance Stage moves left of the reference point, the movement in the X direction is negative. When the stage moves right of the reference point (from the point of view of the patient), the movement is positive.
  • Page 189 Affirm Prone Biopsy System User Guide Index Index Cautions, Warnings, and Notes - definition of each circuit breaker of Generator - location illustrated - cleaning - 115 about screen - 123 general cleaning - 115 access preventing possible injury or equipment...
  • Page 190 Affirm Prone Biopsy System User Guide Index Image Display Monitor of Acquisition download, images - 125 Workstation (AWS) DVD/CD drive of Acquisition Workstation - location illustrated - 26 location illustrated - 26 images creating - 125 image, downloading - 125...
  • Page 191 Affirm Prone Biopsy System User Guide Index procedures close a procedure - 47 needle guide - 90 open a procedure - 37 network interface environment specifications for product dimensions/measurements - 131 Acquisition Workstation (AWS) - 136 Notes, Warnings, and Cautions - definition of each...
  • Page 192 Affirm Prone Biopsy System User Guide Index start the system - 27 storage environment - 133 Uninterruptible Power Supply symbols - 5 Uninterruptible Power Supply (UPS) system - 137, 138, 140 Power/Reset Button of AWS - location log in - 28...
  • Page 194 Affirm Prone Biopsy System User Guide Index Refer to the corporate website for more facilities worldwide. www.hologic.com Page 178 MAN-10818-004 Revision 001...

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