BD EleVation Instructions For Use Manual page 5

the sample sequence is in operation. During this time, the PRIME/PIERCE button will be off
and deactivated. During the automatic sampling process, the vacuum is turned on. The BD
Elevation Probe's cutting cannula is pulled back exposing the sample notch. The tissue is
drawn into the sample notch. The cutting cannula moves rotationally forward over the sample
notch to cut the sample. The tissue sample is transported to the sample container. The
BD EleVation™ Breast Biopsy System will automatically reset for the next sampling or piercing
sequence, at which point the buttons will illuminate green.
• Also located on the BD EleVation™ Driver are three indicators: ERROR, BATTERY, and SMART
MODE. The ERROR indicator visually and audibly informs the user that action is required for
the BD EleVation™ Breast Biopsy System to become operable. The BATTERY indicator visually
informs the user of the BD EleVation™ Driver's charge state. The BD EleVationn™ Breast
Biopsy System features SMART MODE, which automatically engages when the BD EleVation
Driver motors need additional time to ensure the sample is cut and transported to the sample
container, and therefore sampling time may be extended.
Loading the BD EleVation™ Probe into the BD EleVation™ Driver
1. Ensure the BD EleVation™ Driver has been fully charged prior to inserting the BD EleVation™
Probe. The BATTERY indicator will illuminate green when there is sufficient charge to perform
a biopsy procedure. The BD EleVation™ Driver should be charged overnight after daily use.
2. The BD EleVation™ Probe may be inserted into the driver in either of the following ways:
• Remove the BD EleVation™ Probe from the package using aseptic technique by grasping the
BD EleVation™ Probe from below and carefully aligning BD EleVation™ Probe tabs and sample
container with corresponding BD EleVation™ Driver slots and slide the BD EleVation™ Probe
back to lock into place.
• While the BD EleVation™ Probe remains in the tray packaging, align the BD EleVation™ Driver
to the corresponding BD EleVation™ Probe tabs and sample container opening, and slide the
BD EleVation™ Driver forward to lock into place.
Ensure the BD EleVation™ Probe remains sterile throughout insertion into the BD EleVation™ Driver.
Confirm the BD EleVation™ Probe tab is locked into the BD EleVation™ Driver after loading.
NOTE: Check BD EleVation™ Probe and sterile BD EleVation™ Accessories packaging for broken
seals or any foreign material present during unpacking or set-up prior to use. Do not use if there is
a broken seal, damage to the sterile barrier, or foreign material.
NOTE: The BD EleVation™ Driver automatically recognizes when a BD EleVation™ Probe has been
properly inserted, and the BD EleVation™ Driver will perform a calibration to synchronize with the
BD EleVation™ Probe. All buttons will be disabled during the calibration process. Upon completion
of the calibration, the BD EleVation™ Driver's PRIME/PIERCE and SAMPLE buttons illuminate green
to indicate the BD EleVation™ Probe is properly inserted. During the calibration process, the motors
may be audible. Calibration of the BD EleVation™ Breast Biopsy System takes up to approximately
10 seconds.
NOTE: Prior to the biopsy, remove the needle protector from the BD EleVation™ Probe.
NOTE: Corresponding sized BD EleVation™ Introducer Stylet to BD EleVation™ Probe may be used
to target the biopsy site under ultrasound-guided imaging. After creating a track to the biopsy site
and detaching the support cannula, the BD EleVation™ Probe may be inserted and attached to the
support cannula to obtain tissue samples.
NOTE: If the BD EleVation™ Driver is left undisturbed for 120 seconds after loading the BD
EleVation™ Probe, the BD EleVation™ 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. When the BD EleVation™ Driver is moved, a motion sensor is activated and the BD
EleVation™ Driver automatically turns on. The BD EleVation™ Driver will not enter sleep mode when
the BD EleVation™ 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 (e.g. personal
protective gear such as gloves should be worn).
NOTE: The BD EleVation™ Breast Biopsy System has an integrated LED to facilitate visualization of
the biopsy site in procedure room.
2. Make a small incision or puncture the skin with a scalpel.
Optional: Prior to inserting the BD EleVation™ Probe into the breast, press the PRIME/PIERCE button
to retract the inner needle and cutting cannula 2cm. After inserting the BD EleVation™ Probe into
the breast, press the PRIME/PIERCE button a second time to advance the inner needle and cutting
cannula 2cm into the region of interest prior to taking the first tissue sample. (See Figure 3 for
dimensions.)
3. Using ultrasound imaging guidance, insert the BD EleVation™ Probe through the incision and
position the tip at the appropriate location:
a. If the lesion is going to be pierced: Position the tip of the BD EleVation™ Probe proximal at
the edge of the lesion.
b. If the lesion is not going to be pierced: Position the sample notch at the target region. See
Figure 3 for dimensions.
Figure 4
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Figure 6
Figure 7
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