Hologic eviva Mode D'emploi page 5

6. Power console on (console will default to "Biopsy" mode).
7. Ensure device is in post-fire position by confirming the green button on the
remote valve is fully depressed (firing device only).
8. Select "Setup" to prime device (saline visible in aperture) and confirm adequate
vacuum is achieved ("Vacuum Ready" light should be illuminated green). If
ample vacuum is not achieved, the "Vacuum Ready" light will flash. If the light
flashes, refer to the Troubleshooting section of this IFU and/or the Troubleshooting
section of the "ATEC Breast Biopsy and Excision System Operator's Manual."
9. Select "Test" and ensure one diagnostic biopsy cycle is completed (console
automatically switches to "Biopsy" after passing the "Test" cycle). If the
"Return to Setup" or "Retest Handpiece" lights illuminate, then refer to the
Troubleshooting section of this IFU and/or the "ATEC Breast Biopsy and Excision
System Operator's Manual."
10. Depress the white button on the remote valve to place the device in the pre-fire
position. Refer to Figure C. Then, depress the green button on the remote valve
to ensure that the outer cannula travels to the post-fire position.
11. Attach adapter and needle guide to the stage of the imaging system. Some
imaging systems require input dimensions for the Eviva device. In these cases,
refer to the documentation included with the adapter for your system.
Performing a Biopsy (all steps to be performed
per standard intervential technique)
1. Identify targeted area.
2. Prepare the site as required.
Firing Device (20mm or 12mm aperture)
a. Carefully remove the device from tray.
b. Remove protective sheath from the device.
c. Remove introducer from tray and carefully assemble introducer onto device,
(refer to Figure A).
d. Confirm the console is in "Biopsy" mode, prior to manipulation of the remote
valve.
Note: If console is not in the "Biopsy" mode, then the device may not function
appropriately when attempting to place it in the "pre-fired" position.
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