Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
MAN-05754 Revision 002 Page 83
5. Install the QAS needle in the extended position.
6. At the Biopsy Control Module, select a Home position and press and hold the front
and back Motor Enable buttons.
7. At the Acquisition Workstation, create a Biopsy test patient. Select a name that is
easy to remember as you are exiting and entering this patient throughout this
procedure.
8. Select Stereo Pair.
9. Acquire and accept a stereo image pair of the validation phantom using 25 kVp at
12 mAs.
10. Select the QAS needle at the Acquisition Workstation.
QAS Needle Verification Procedure
1. Target on the tip of the needle (not the center of the ball) in each of the two stereo
images, and then select Accept (Create) Target.
2. At the Biopsy Control Module, press and hold the Motor Enable buttons to move to
the target.
3. Select the Jog button, then the Jog away from the chest wall once. Press and hold the
Motor Enable buttons. This sequence essentially moves the "target" 0.5 mm away
from the phantom tip to allow easier positioning of the QAS needle tip. It also avoids
a collision between the QAS tip with the phantom tip.
4. Move the Z down to so that the tip of the QAS needle is at the same level as the tip of
the phantom.
5. Visually verify the alignment of X and Y. If X or Y appears to be off, press Motor
Enable to be sure that the motorized movement was completed. Do not make any
other adjustments. Do not move the phantom.
6. Inspect the Diff line for ± 1 mm (maximum) X, Y, and Z values on the Biopsy Control
Module.
7. Raise the Z and carefully remove the QAS Needle. Do not move the compression or
the phantom.
8. Close the procedure "In Progress".
• To configure a "new" or an existing needle, proceed to Obtain Needle Specifications
on page 84.
• To validate an existing needle, proceed to Validate Needle on page 87.
• To configure a new Wire Localization needle, proceed to Validate Needle on page
92.
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