Device description
The BD EleVation™ Breast Biopsy System is a handheld, self-
contained, single insertion, multiple sample biopsy device and is
intended to be used with ultrasound guidance.
Loading and locking the BD EleVation™
Probe into the BD EleVation™ Driver
Step 1: Insert probe
The BD EleVation™ Probe may be inserted into the driver in either of
the following ways:
OPTION 1: Remove the BD EleVation™ probe from the package
using aseptic technique by grasping the BD EleVation™ probe from
below. Carefully align BD EleVation™ probe tabs and sample
container with corresponding BD EleVation™ Driver slots. Slide the
BD EleVation™ probe back to lock into place.
OPTION 2: 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. Slide the
BD EleVation™ Driver forward to lock into place.
Step 2: Locking the probe
After loading the probe in one of the following ways shown above,
confirm the BD EleVation™ Probe tab is locked into the BD EleVation™
Driver after loading.
Removing the sample
Turn the sample container counterclockwise to remove from the
driver.
Remove the tissue samples from the sample container by hinging
it open. If additional samples are required, replace the sample
container into the device by turning clockwise to lock into place.
Ensure the sample container is secure before acquiring additional
samples.
Removing the cannula
The support cannula may be detached and remain in the breast to
retain a track to the biopsy site to place a breast tissue marker. To
remove the support cannula from the BD EleVation™ probe, depress
the coaxial arm and then twist the coaxial hub.
Sample container
closed
Sample container
hinges open
Removing the probe
Remove the BD EleVation™ Probe from the BD EleVation™ Driver
by pressing down on the locking tab, sliding the BD EleVation™
Probe cover completely forward and then pulling the BD EleVation™
Probe straight up from the BD EleVation™ Driver.
Cleaning and maintenance
• After each use, wipe the BD EleVation™ Driver with a Super
Sani-Cloth or a cloth dampened with water to remove any excess
blood or fluids present on the device.
Following the initial wipe, throughly clean the BD EleVation™
Driver with Super Sani-Cloths, paying particular attention to the
buttons and indicators, locking tab, LED lights, internals gears,
and the sides of the driver. Allow the driver to remain wet for a
minimum of 3 minutes.
Allow the BD EleVation™ Driver to air dry throughly before
placing in the wireless charging stand.
• Other than routine cleaning, no other preventative maintenance
is required. However, it is recommended to return the device
to an authorized Service and Repair Facility once per year for
inspection and servicing.
• Do not spray the BD EleVation™ Driver with any fluids.
Submerging the BD EleVation™ Driver in fluids may cause it to
malfunction and will void the standard warranty.
• Sterilization and exposure to fluids may damage the electrical
components of the device. If the BD EleVation™ Driver is
inappropriately cleaned, it may cause the BD EleVation™ Driver
to malfunction and will void the standard warranty.
• Do not autoclave. Do not heat over 54 (129 F).
• The wireless charging stand may be cleaned with the same
methods as the BD EleVation™ Driver.
Quick Reference Guide
s
Inner needle with
sample notch
Echogenic marking
Cutting cannula
Support cannula
Battery LED
Error LED
Smart Mode LED
Prime/Pierce
Sample
Sample container
10cm
TriConcave™ Tip
BD EleVation
TM
Breast Biopsy System
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