4
NOTE: The driver does not contain an on-off switch. The driver automatically recognizes the
probe type, senses when the probe has been properly inserted and performs an initialization to
synchronize the driver and probe. The driver sounds one beep and the “PRIME/PIERCE” and
“SAMPLE” indicator lights display green indicating the probe is properly inserted. During the
initialization the motor is audible.
6. After initialization is complete, remove the protective sleeve from the probe.
NOTE: If the driver is left undisturbed for 120 seconds after loading a probe, the driver will
enter a sleep mode to conserve battery charge. During sleep mode, the “PRIME/PIERCE” and
“SAMPLE” indicator lights will turn off and the buttons will be deactivated. Once the driver is
moved, a motion sensor is activated and the driver automatically turns on. The driver will not
enter sleep mode if the probe is primed.
Performing a Biopsy
1. Prepare the biopsy site using appropriate aseptic techniques and adequate local anesthesia.
Appropriate precautions should be followed for any percutaneous procedure (personal protective
gear such as gloves and glasses/shields, etc. should be worn).
2. Make a small incision or puncture the skin with a scalpel.
3. Using imaging guidance, insert the probe through the incision and position the tip to the
appropriate depth:
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lesion.
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target region. (The center of the sampling chamber is approximately 17mm from the tip of the
probe.)
4. If piercing is desired, prior to inserting the probe into the breast press the
“PRIME/PIERCE”
button to retract the probe 20-22mm. After inserting the probe press the
“PRIME/PIERCE”
button to advance the probe 20-22mm into the region of interest prior to taking
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be sampled.
NOTE: Do not leave the system unattended with the probe in the primed state.
NOTE: During the initial positioning of the probe, it is recommended to advance the probe into
the tissue using the optional piercing mode. During subsequent samplings, the physician may
wish to forego this step.
NOTE: The probe may be primed for piercing while inside the patient if additional piercing shots
are desired to access dense tissue or lesions.
5. Begin tissue sampling by pressing the
“SAMPLE”
button. The sampling process proceeds
automatically: A vacuum is created, the outer cannula of the probe is automatically retracted,
tissue is drawn by vacuum into the sampling chamber and the outer cannula is released cutting
the tissue. The tissue sample is then transported to the sample container. During this process
the
“SAMPLE”
indicator light continuously illuminates orange and the motor will be audible. The
sample container illuminates to aid in visualizing the tissue sample. After the tissue sample is
deposited into the sample container the system resets to acquire another sample if desired.
NOTE: Do not press on the sample container or remove the sample container while acquiring
tissue samples. If the system detects an error related to the sample container it will illuminate
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the probe, clear any tissue underneath the container or from the probe where the container is
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that the sample container is properly inserted. Press the SAMPLE button to resume. The system
will show the SAMPLE light continuous green. If error is not resolved see Troubleshooting.
6. To acquire multiple samples, repeat Step 5 above.
NOTE: Collecting multiple tissue samples may help minimize the risk of a false negative biopsy.
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site as appropriate.
NOTE: Prior to removing the probe from the breast, the integrated coaxial cannula may be
detached and remain in the breast to retain a track to the biopsy site while placing a tissue
marker (Figure 7).
ENGLISH
