14
ATEC Breast Biopsy and Excision System:
Sapphire Unit Check Out
1. Power up the system by switching the
green
“Power” switch on the console to
the “
I
” position. This switch will illuminate
green
when “on”.
2. The power up or default mode is “Biopsy”.
3. Select the Setup mode. “Setup” mode will prime the system and generate
vacuum.
When the console is in “Setup” Mode, the “Vacuum Ready” light will illuminate
solid
green
when ample vacuum is achieved (see
Figure 4
). If ample vacuum
is not achieved, the “Vacuum Ready” light will flash
green
to alert the user to a
possible problem. If the “Vacuum Ready” light flashes, refer to the
Troubleshooting
section of this manual for suggested steps to diagnose
and correct a potential problem.
4. Verify the silicone section of the saline tubing line into the pinch valve labeled
“Saline PV” as shown in
Figure 5.
5. Visually verify the flow of saline into the aperture (mouth) and tissue filter
canister of the ATEC handpiece.
CAUTION:
Do not remove the protective sheath from the handpiece tip.
6. The “Vacuum Ready” indicator will illuminate solid
green
to verify that
vacuum has been attained.
7. Select the “Test” mode.
8. The ATEC handpiece will complete one test cycle. If the “Retest
HP” or “Return to Set up” indicator begins to flash
red
refer to the
Troubleshooting
section of this manual for suggested steps to diagnose
and correct a potential problem.
9. Upon completion of a successful test cycle, the ATEC handpiece will return to
“Biopsy” and is ready for tissue acquisition.
ATEC Breast Biopsy and Excision System:
Sapphire Unit Operating Instructions
Using the System in MRI, Stereotactic or Ultrasound Guidance
1. When the console is in “Biopsy” mode, depressing the footswitch will activate the vacuum and operation of the ATEC
handpiece. Removing your foot from the footswitch will inactivate or stop the device after completing the current cycle.
2. When the console is in “Lavage” mode, the vacuum system is activated and will pull saline through the system.
Depressing the footswitch does not control the flow of saline in this mode.
3. When the console is in “Manual Aspiration” mode, depressing the footswitch allows the user to independently control
aspiration without taking a tissue sample. This function may be used to vacuum or irrigate the biopsy cavity. Saline does
not flow on this mode.
Performing a Biopsy Using MRI Guidance
When performing a biopsy under MRI guidance, an ATEC ILS kit is required in addition to the ATEC handpiece, as stated in
table 4. Please refer to the ATEC ILS (MRI) IFU for operating instructions.
Performing a Biopsy Using Stereotactic Guidance
When performing a biopsy under stereotactic guidance, a stereotactic adapter is required to hold the ATEC handpiece or
Eviva biopsy device in place on a stereotactic system.
Hologic offers multiple stereotactic adapter models for the ATEC handpiece. For additional instructions, please refer to the
ATEC stereotactic adapter instructions (IFU) and Appendix A.
Additional stereotactic adapter models are offered for the Eviva biopsy device. For additional instructions on using the Eviva
devices, please refer to the Eviva Instructions for Use (IFU).
FIGURE 4: ATEC BREAST BIOPSY
AND EXCISION SYSTEM: SAPPHIRE
UNIT CHECK OUT
FIGURE 5: SALINE PINCH VALVE
CONNECTION
3
7
2
1
8
6
