Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
Page 92 MAN-05754 Revision 002
7. Read the Z Diff from the Biopsy Control Module. This number is added to the
previously entered Length in the Acquisition Workstation Biopsy menu in the next
procedure.
Length = Manufacturer Length + Z Diff
Manufacturer Length was recorded earlier in Obtain Needle Specifications on page
84.
Z Diff was noted earlier in Calculate New Needle Parameters on page 86.
8. At the Acquisition Workstation, close the patient "In Progress".
D.3.5 Adjust the Needle Length on the Acquisition Workstation
1. Select Admin; then in the System section, select Biopsy Devices.
a. Select the Wire Loc needle in the list.
b. Select Edit.
c. Enter the new calculate Length in the length field.
2. Select Save.
D.3.6 Validate Needle
1. Open the procedure used earlier with the QAS needle, and select the previously
acquired stereo pair.
2. Select the needle from the list.
3. Select Resend Target.
4. At the Biopsy Control Module, press and hold the Motor Enable buttons to move to
the target.
5. Move the Z down to align the tip of the needle with the tip of the Phantom Pin.
6. On the Biopsy Control Module, confirm that the X Diff, Y Diff, and Z Diff value reads
±2.0 mm. (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 (refer to Calculate and
Confirm the New Wire Localization Needle Parameters on page 91).
Note
Loaner biopsy devices require revalidation. Use professional judgment to determine
needle validation. Be aware of any changes in devices by vendors.
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