Hologic Affirm - Appendix D Biopsy Device Evaluation Procedure; Introduction; Please Read Prior to Performing Calibration

Affirm Breast Biopsy Guidance System Service Manual
Appendix D: Biopsy Device Evaluation Procedure
MAN-05754 Revision 002 Page 77
Appendix D Biopsy Device Evaluation Procedure
D.1 Introduction
These instructions are supplied for validating biopsy devices from manufacturers other
than Hologic Factory-Verified Devices listed in the table on page 88. This procedure is
written for use with the Hologic ASY-08307 Targeting Phantom.
Figure 48: Hologic ASY-08307 Targeting Phantom
D.1.1 Please Read Prior to Performing Calibration
These procedures are designed to be used in conjunction with (not to replace) the
procedures in the Affirm system Service Manual and User Guide, as well as the procedures
in the User Guide of any biopsy device that is used with the Affirm system. These
procedures provide step-by-step instructions for validating biopsy devices for use with
the Affirm system.
The validation procedures shall only be performed by those who have received training
on the Affirm system and the Selenia Dimensions or 3Dimensions digital mammography
system before use on patients. Hologic training programs address the MQSA training
requirements for any Technologist or Physician. Hologic will bear no risk for the use of
the Affirm system with biopsy devices that have not been validated using the procedures
outlined herein, and does not accept responsibility for injury or damage from incorrect
system operation.
Appendix D