Hologic Affirm - Alignment for Standard Approach; Alignment for Lateral Approach

Affirm Breast Biopsy Guidance System Service Manual
Chapter 4: Calibration Procedures
MAN-05754 Revision 002 Page 47
4.2.1 Alignment for Standard Approach
Required Tools/Equipment
• X-ray and Light Field Size Adjust Fixture (TLS-01063)
• Biopsy Device with Holder
• Needle Guide (14-gauge)
• Needle (14-gauge)
Procedure
1. Install the Needle Guide on the front Needle Guide mount.
2. Install the Biopsy Device with 14-gauge biopsy needle (inspect for bent or damaged
needle) on the Biopsy Guidance Module so that the needle passes through the front
Needle Guide. Tighten the Biopsy Guidance Module knob to secure the Biopsy
Device in place.
3. Turn the Z-axis adjustment to position the Biopsy Guidance Module mount to the
top of its travel.
4. Place the X-ray and Light Field Size Adjust Fixture (TLS-01063) on the breast tray,
ensuring the front locating pins are flush against the tray.
5. Slide the front Needle Guide fully toward the breast tray.
6. Using the Biopsy Control Module XY jog functions, (refer to Confirm the Host
Connection on page 24) move the X- and Y-axes until the needle tip is positioned over
the QAS Needle Zero Reference point on the fixture. Use the Z-axis adjustment to
position the needle tip just over the Reference point line intersection; it may be
necessary to jog Y while adjusting Z.
7. Slowly slide the front Needle Guide upward until just short of full travel.
8. Observe the needle tip; if the position of the tip relative to the fixture Reference point
line intersection has deviated in X, Y, or both axes:
a. Loosen the screws securing the front Needle Guide.
b. Move the Needle Guide to return the needle tip to the Reference point.
c. Tighten the screws and recheck the needle movement.
9. Repeat as necessary until the needle tip does not deviate between the top and bottom
front Needle Guide positions.
4.2.2 Alignment for Lateral Approach
Required Tools/Equipment
• Biopsy device with holder
• Removable device mount
• Left (blue) and right (gold) needle guide mounts
• Needle guide, plastic (sized to biopsy device used)