Hologic ATEC Bedienungsanleitung Seite 4

Instructions for Use
1. Standard aseptic patient preparation should be employed prior to use of the ATEC
ILS.
2. Prior to use of the ILS, inspect the protective packaging and device to verify that
neither has been damaged during shipment. If it appears the packaging has been
compromised, do not use the device.
3. Insert the introducer stylet into the introducer sheath. Position the depth stop on the
introducer sheath at the appropriate location according to the pre-determined "Z" value.
4. A standard protocol should be employed to anesthetize the patient and the biopsy
site.
5. Insert the sterile needle guide into the compression grid at the identified target area.
6. Insert the introducer sheath/introducer stylet assembly into and through the needle
guide to the depth stop. Rotate the sheath/stylet assembly while advancing. This will
create access to the target area.
7. Remove the introducer stylet from the introducer sheath while leaving the introducer
sheath in place. Insert the localizing obturator into the introducer sheath. Move the
patient into the imaging field and image to confirm target accuracy.
Note 1: The usable length of the localizing obturator is equal to the distance from the
hub of the ATEC handpiece to the middle of the sampling aperture.
Note 2: The localizing obturator shows up as a "black dot" on the image screen in
the sagittal view and as a "black line" in the axial view and provides identification,
localization and confirmation of the target area.
8. Move the patient out of the imaging field and remove the localizing obturator. Insert
the ATEC handpiece through the introducer sheath to the biopsy site in preparation for
the biopsy to be performed.
9. Ensure the ATEC handpiece is advanced until handpiece hub is contacting the hub
of the introducer sheath. Then, follow the instructions for handpiece use in the ATEC
console Operator's Manual to perform the biopsy.
10. Once the biopsy is completed, remove the ATEC handpiece while leaving the
introducer sheath in place. Re-image the patient to confirm acquisition of the suspect
target area.
11. If desired, place a biopsy site marker. Follow the instructions for use.
12. Take a final image of the target area to confirm marker location. Remove Introducer
Sheath and Needle Guide and dispose per standard procedures.
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