Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
MAN-05754 Revision 002 Page 87
Validate Needle
1. Open the same procedure used earlier with the QAS needle and select the previously
acquired stereo pair.
2. Select the Device from the list.
3. Select Resend Target.
4. If necessary, remove the device and reinstall with the aperture opened.
5. On the Biopsy Control Module, press and hold Motor Enable until the X and Y
motion stops.
6. Jog in 0.5 steps 2 mm away from the chest wall (four steps).
7. Move the Z knob until the tip of phantom pin is aligned with the center of the biopsy
needle aperture.
8. Jog back towards the chest wall the same amount you moved away from the chest
wall in the earlier step.
9. Confirm that the X Diff, Y Diff, and Z Diff value reads ±2.0 mm maximum (The
system and the new needle each contribute 1.0 mm.)
• If the ‘X’ target value is not correct, recheck the Needle Guide alignment.
• If the ‘Y’ target value is not correct, recheck the Offset measurement.
• If the ‘Z’ target value is not correct, recheck needle length, Aperture, and Dead
Space values. Note: Some Needle Core Biopsy devices retract the biopsy needle tip in the
pre-fire (open aperture) position. For these devices, the Z diff value may exceed ±2 mm.
This value is acceptable provided the phantom pin tip lies within the middle one-third of
the aperture.
10. Jog the needle away from the chest wall before removing the needle.
Note
Loaner biopsy devices require revalidation. Use professional judgment to
determine needle validation. Be aware of any changes in devices by
vendors.
Note
If you are validating a Wire Localization Needle, also perform the steps in
Validate the Wire Localization Needle on page 90.
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