Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
Page 90 MAN-05754 Revision 002
D.3.3 Validate the Wire Localization Needle
1. Record the following information from the wire localization needle manufacturer.
For needle diameter, convert the needle gauge listed by the manufacturer into
millimeters.
• Needle Name ___________________________
• Diameter ___________________________mm
• Length _____________________________mm
2. Record the needle offset measurement. Unless otherwise specified by the
manufacturer, use 37.5 mm.
Needle Offset (NO) =_____________mm.
The needle offset is the vertical distance between the center of the needle and the top
of the wire localization (loc) needle adapter. The following figure shows the wire loc
needle adapter upside down against a flat surface for easier measurement.
Figure 58: Needle Offset with Wire Loc Needle Adapter Installed
3. Record the front edge measurement. Unless otherwise specified by the manufacturer,
use 100.0 mm.
Front Edge (FE) =_____________mm
The front edge measurement is the horizontal distance between the alignment pin on
the wire loc needle adapter and the end of the wire needle guide. See the following
figure.
Figure 59: Front Edge Distance with Wire Loc Needle Adapter Installed (Left Approach)
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