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General| Type | Breast Biopsy Guidance System |
|---|---|
| Detector Type | Digital Detector |
| Imaging Modality | X-ray |
| Category | Medical Equipment |
| Manufacturer | Hologic |
| Software | Affirm Prone Biopsy Software |
| Targeting Method | 3D Stereotactic |
| Needle Guidance | Stereotactic |
| Patient Positioning | Upright or Prone |
| Technology | Stereotactic |
| Biopsy Needle Size | Various sizes supported |
| Imaging Capabilities | 2D and 3D Imaging |
Defines the Affirm system's purpose and intended application for breast biopsy procedures.
Details user roles (Mammography Technologist, Radiologist, Physicist) and required training.
Covers warranty, support, complaints, cybersecurity, symbols, and warning definitions.
Describes the Affirm biopsy system's main components and its attachment to the C-arm.
Provides instructions on how to lift, move, and store the Biopsy Guidance Module safely.
Covers general safety, warnings, precautions, and system compliance requirements.
Illustrates the locations of important labels on the Biopsy Guidance Module and Lateral Arm.
Details the components of the Biopsy Guidance Module and their functions.
Details the components of the Biopsy Control Module and their functions.
Step-by-step guide for attaching the Biopsy Guidance Module and Biopsy Control Module.
Procedures for installing and removing accessories like Biopsy Paddles, Needle Guides, and Lateral Arm.
Procedures to verify system installation, including host connection.
Instructions for safely removing the Biopsy Control Module and Biopsy Guidance Module.
Information on using the tabletop stand and storing the Lateral Arm and components.
Displays user ID, error messages, and the Go button to navigate to Target Guidance.
Shows current biopsy device position, target coordinates, and difference between them.
Allows manual overwriting of targeting coordinates using arrow buttons.
Enables selection of different targets or movement to Home positions.
Explains stereo views for 2D biopsy and tomosynthesis for 3D biopsy.
Procedures for adding new views and assigning/modifying views in a biopsy procedure.
Details Auto and Manual C-arm Stereo Modes for acquiring stereo images.
Describes the Biopsy Tab interface and available target management options.
Covers stereotactic 2D, tomosynthesis, and multi-pass lesion targeting procedures.
Steps for post-biopsy procedures and printing stereo pair images.
Lists essential procedures for correct system operation and accuracy.
Daily tests to confirm system accuracy, including standard and lateral needle approaches.
Procedure for semiannual geometry calibration to ensure system accuracy.
General guidelines for cleaning and disinfecting system components that contact patients.
Schedule of maintenance tasks for Radiologic Technologists and Service Engineers.
Detailed steps for cleaning the system and its components to prevent damage and ensure safety.
Provides physical dimensions and weight specifications for the Affirm Biopsy Guidance Module.
Provides physical dimensions and weight specifications for the Lateral Arm accessory.
Details accuracy, movement range, and power specs for Guidance, Lateral Arm, and Control Modules.
Lists system audible alerts, their frequency, duration, and repeat behavior.
Details common error messages and provides instructions on how to correct them.
Lists messages displayed on the Acquisition Workstation and user actions to clear them.
Provides CNR correction factors for stereotactic 2D biopsy imaging based on compression thickness.
Provides CNR correction factors for tomosynthesis biopsy imaging based on compression thickness.
Template for recording results of daily QAS tests for system accuracy.
Template for recording QAS test results specific to the Lateral Arm.
Lists Hologic-verified biopsy devices with their manufacturer, description, and model numbers.
Provides part numbers, descriptions, and usage for wire localization needle guides.
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