Hologic Affirm - Care and Cleaning; General Information; Preventive Maintenance Schedule

Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
MAN-05754 Revision 002 Page 79
Table 12: Biopsy Device Parameters (see also following four figures)
Measurement
Description
Valid Range
(in mm)
Aperture (AP) Opening of the biopsy device 0 to 50.0
Dead Space (DS) Distance from needle tip to opening-edge 0 to 20.0
Needle Diameter
(ND)
Outside-to-outside distance of biopsy device,
assuming biopsy device is cylindrical
0 to 25.00
Front Edge (FE) The length on the biopsy needle device from the
alignment pin to the front-most point of the needle
guide holder
0 to 105.0
Needle Length
(NL)
Length of needle, measured from Biopsy Guidance
Module Locality pin to needle tip in post-fire position
20.0 to 300.0
Needle Offset
(NO)
Distance from the Biopsy Guidance Module surface
to center of needle cylinder
0.01 to 100.0
Body Size (BS) Vertical distance between the middle of the needle
and the bottom of the biopsy needle device
0 to 40.0
Pre-Fire Pullback
(PB)
Distance between target and pre-fire position of
aperture center
-30.0 to 30.0
Stroke (ST) Distance between needle tip position before and after
firing biopsy device, measured along firing-axis
0 to 30.0
Items to Remember:
• Data entry accepts any information. Make sure entries stay within the valid range for
each parameter.
• A validity check (range limit met) is performed immediately upon entry. If a
parameter is outside the proper range, a BGM(34:64) Invalid Needle Parameter
Fault is displayed in the Biopsy Guidance Module reports.
• The stereo pair using the QAS needle acquired in the first steps of this procedure is
used throughout the procedure. You are closing the patient and returning to the
patient throughout. Always close "In Progress".
• It is critically important that the phantom not move during this procedure. Do not
release compression on the phantom, as that may cause the phantom to move. If the
phantom moves, the procedure must be restarted.
• It is important to know how your device operates. When the procedure states that
the device should be in the extended (post-fire) position, it is assumed the devices are
in their maximum extended position. However, some devices in the post-fire position
retract slightly when the aperture is opened. In this case, the aperture should be
closed for the device to be in their maximum extended position.