Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
MAN-05754 Revision 002 Page 85
3. Measure the Front Edge (FE) parameter with the device in the extended (or post-fire)
position.
a. Install the fired device in the holder, and place the holder upside down on a flat
surface.
b. Measure the distance from the center of the alignment pin to the front-most point
of the needle holder on the device. See the following figure. Add another 8 mm
to your measurement to account for the width of the Lateral Arm needle holder
when the biopsy device is installed on the Lateral Arm. FE =_____________ mm
(including the 8 mm addition).
Figure 54: Front Edge (FE) Measurement with Biopsy Device in Extended (post-fired) Position
4. Measure the Body Size (BS) parameter with the device in the extended (or post-fire)
position.
a. Install the fired device in the holder and place the holder upside down on a flat
surface.
b. Measure the vertical distance between the middle of the needle and the top of the
device holder. See the following figure. BS =_____________mm.
Figure 55: Body Size (BS) Measurement with Biopsy Device in Extended (post-fired) Position
5. Add (or edit) the biopsy device on the Acquisition Workstation.
a. Select Admin; then in the System section, select Biopsy Devices.
b. Select New (if adding a new device) or Edit (if editing an existing device).
c. Enter 0 for Aperture and Dead Space. This setting allows the reference to be the
needle tip (instead of the center of the aperture) for determining accurate needle
length (NL).
d. Enter the remaining biopsy device parameter information from the values
measured in steps 2 to 4. Refer to Biopsy Device Parameters on page 78 for valid
parameter ranges.
e. Select Add (if adding a new device) or Save (if editing an existing device). The
measurements are now available on the Acquisition Workstation.