Directions For Use - BD EleVation Instructions For Use Manual

7. The BD EleVation™ Breast Biopsy System is not suitable for use in the presence of
flammable anesthetic.
8. The BD EleVation™ Breast Biopsy System is not suitable for use in an oxygen rich
environment.
9. The BD EleVation™ Driver must only be used with BD EleVation™ Probes and BD
EleVation™ Accessories.
10. All breast biopsies should be performed under ultrasound guidance to confirm the BD
EleVation™ Probe's position relative to the target region to be sampled and to help
mitigate the occurrence of a false negative biopsy. The BD EleVation™ Breast Biopsy
System is intended for use with ultrasound imaging only.
11. The battery may only be replaced or disposed of by an authorized Service and Repair facility.
12. Use only with supplied AC power BD EleVation™ Accessories. Removing the AC adapter
plug from wall power shall serve as isolation mains. Do not position the AC adapter plug
and wireless charging stand such that it is difficult to remove the AC adapter plug from
the wall outlet if needed to remove mains power.
13. Do not reuse BD EleVation™ Probe. Reusing the BD EleVation™ Probe bears the risk of
cross-patient contamination as biopsy probes, particularly those with long and small
lumina, joints, and/or crevices between components, are difficult or impossible to clean
once body fluids or tissues with potential pyrogenic or microbial contamination have had
contact with the BD EleVation™ Probe for an indeterminable period of time. The residue
of biological material can promote the contamination of the BD EleVation™ Probe with
pyrogens or microorganisms which may lead to infectious complications.
14. Do not resterilize BD EleVation™ Probe. After resterilization, the sterility of the BD
EleVation™ Probe is not guaranteed because of an indeterminable degree of potential
pyrogenic or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing and/or resterilizing the BD EleVation™ Probe increases the
probability that it will malfunction due to potential adverse effects on components that
are influenced by thermal and/or mechanical changes.
Precautions
1. The BD EleVation™ Breast Biopsy System should only be used by a physician trained in its
indicated use, limitations, and possible complications of percutaneous needle techniques.
2. Do not attempt to remove the cover or modify the device in any way.
Potential Complications
1. Potential complications are those associated with any percutaneous removal/biopsy
technique for tissue collection. Potential complications are limited to the region surrounding
the biopsy site and include hematoma, lymphedema, hemorrhage, infection, non-healing
wound, pain, nerve injury, and tissue adherence to the BD EleVation™ Probe while removing it
from the breast.
2. As per routine biopsy procedures, it may be necessary to cut tissue adhering to the BD
EleVation™ Probe while removing it from the breast.
Equipment Required
The following equipment is required for a biopsy procedure:
• Appropriate ultrasound imaging system and accessories
• BD EleVation™ Driver
• BD EleVation™ Probe
• Surgical gloves and drapes
• Local anesthetic
• Scalpel
• Other equipment as necessary
• Optional BD EleVation™ Accessories

Directions for Use

BD EleVation™ Driver Button and Indicator Operations
•
The PRIME/PIERCE button initiates the optional prime/pierce sequence. Before being pressed,
the PRIME/PIERCE button will illuminate green. Once engaged, the PRIME/PIERCE button
will turn red until the priming position has been reached. The PRIME/PIERCE button will
illuminate green when the cutting cannula and inner needle have retracted 2cm. The user
can advance the inner needle approximately 2cm by pressing the PRIME/PIERCE button a
second time. Using ultrasound guidance, the BD EleVation™ Probe's post-pierce position can
be verified. While the BD EleVation™ Breast Biopsy System is primed, the SAMPLE button is
deactivated until the device completes the PRIME/PIERCE sequence. Once this sequence has
been completed, both the PRIME/PIERCE and SAMPLE buttons will illuminate green.
• The SAMPLE button will acquire tissue samples while in the breast. The SAMPLE button will
illuminate green when ready and initiate the sampling sequence when pressed. After the
sampling sequence has been initiated, the SAMPLE button will illuminate red indicating
Primed:
Pierced / Closed:
Echogenic Markings
2cm
Open:
Dead Space: 10G - 0.7cm
12G - 0.5cm
14G - 0.4cm
BATTERY
LED
ERROR
LED
SMART
MODE
LED
PRIME
PIERCE
SAMPLE
Figure 2
Figure 3
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