Affirm Breast Biopsy Guidance System User Guide
Chapter 6: Quality Control
MAN-06411-002 Revision 003 Page 71
6: Quality Control
MQSA has no requirements for interventional procedures (such as breast biopsy). If your
facility is ACR accredited for breast biopsy, refer to the 1999 ACR Stereotactic Breast
Biopsy Quality Control Manual on how to do quality control. If your facility is seeking
ACR accreditation, refer to the 1999 ACR Stereotactic Breast Biopsy Quality Control
Manual to start a quality control program.
Outside of the United States, follow local requirements (such as EUREF guidelines) to
create a quality control program for breast biopsy systems).
Note
Refer to CNR Correction for Biopsy on page 93 for CNR correction factors.
6.1 Required Quality Control Procedures
The following procedures are necessary for correct system operation.
Table 7: Required Procedures
Test Frequency
QAS Test for Standard Needle Approach Daily - before clinical use
QAS Test for Lateral Needle Approach Daily - before clinical use
Geometry Calibration Semi-annually
6.2 QAS Test
Each day that you plan to use the system, do this test one time to confirm the system
accuracy. Record your results in the QAS Test Checklist on page 95.
Note
You can use Auto C-arm Stereo Mode or Manual C-arm Stereo Mode for the QAS Test.
For more information about these modes, refer to C-Arm Stereo Modes on page 55.
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