Affirm Breast Biopsy Guidance System User Guide
Table of Contents
vi MAN-06411-002 Revision 003
3.5
System Verifications ............................................................................................................................................. 36
3.5.1 Confirm the Host Connection ............................................................................................................... 36
3.6 Removal of the Main Components ..................................................................................................................... 37
3.6.1 Biopsy Control Module .......................................................................................................................... 37
3.6.2 Biopsy Guidance Module ...................................................................................................................... 37
3.7 Tabletop Stand for the Affirm System ............................................................................................................... 38
3.8 Storage Case for the Lateral Arm ........................................................................................................................ 39
4: User Interface - Biopsy Control Module ________________________________________41
4.1 Biopsy Control Module Screens .......................................................................................................................... 41
4.1.1 Home Screen ............................................................................................................................................ 41
4.1.2 Target Guidance Screen ......................................................................................................................... 42
4.1.3 Jog Mode Screen...................................................................................................................................... 46
4.1.4 Select Target Screen ................................................................................................................................ 48
5: Biopsy ______________________________________________________________________51
5.1 Biopsy Views ......................................................................................................................................................... 51
5.1.1 Add a Biopsy View ................................................................................................................................. 52
5.1.2 Edit a Biopsy View ................................................................................................................................. 54
5.2 C-Arm Stereo Modes ............................................................................................................................................ 55
5.2.1 C-Arm Rotation in the C-Arm Stereo Modes ...................................................................................... 55
5.2.2 How to Select the C-Arm Stereo Mode for Image Acquisition ........................................................ 57
5.3 Biopsy Tab .............................................................................................................................................................. 58
5.3.1 Biopsy Options ........................................................................................................................................ 59
5.4 Stereotactic 2D Lesion Targeting ........................................................................................................................ 62
5.4.1 Verify the Position of the Biopsy Device ............................................................................................. 63
5.5 Lesion Targeting with Tomosynthesis Guidance ............................................................................................. 64
5.5.1 Verify the Position of the Biopsy Device ............................................................................................. 65
5.5.2 Project Targets on Post-Fire Scout Image ............................................................................................ 65
5.6 Lesion Targeting Using Multi-Pass .................................................................................................................... 66
5.7 Post Biopsy ............................................................................................................................................................. 70
5.8 Printing Stereo Pair Images ................................................................................................................................. 70
6: Quality Control ______________________________________________________________71
6.1 Required Quality Control Procedures ............................................................................................................... 71
6.2 QAS Test ................................................................................................................................................................. 71
6.2.1 QAS Test for Standard Needle Approach ........................................................................................... 72
6.2.2 QAS Test for Lateral Needle Approach ............................................................................................... 75
6.3 Geometry Calibration ........................................................................................................................................... 78
6.3.1 Geometry Calibration Procedure.......................................................................................................... 78
7: Care and Cleaning____________________________________________________________79
7.1 General Information ............................................................................................................................................. 79
7.2 Preventive Maintenance Schedule ...................................................................................................................... 79
7.3 Service Preventive Maintenance Schedule ........................................................................................................ 81