Bard FINESSE Ultra Mode D'emploi page 3

6. Not suitable for use in an oxygen rich environment.
The driver must only be used with F
7.
Do not reuse F
8.
INESSE
contamination as biopsy probes – particularly those with long and small lumina, joints, and/or
with potential pyrogenic or microbial contamination have had contact with the probe for an
indeterminable period of time. The residue of biological material can promote the contamination
of the probe with pyrogens or microorganisms which may lead to infectious complications.
Do not resterilize F
9.
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 probe increases the probability that it will malfunction due to potential
position relative to the target region to be sampled and to help mitigate the occurrence of a
false negative biopsy.
11. The battery may only be replaced or disposed of by an authorized Bard Service and Repair
facility.
12. Use only with supplied AC power accessories. Removing the AC adapter from wall power
shall serve as isolation means. Do not position the AC adapter and charging stand such that
E. Precautions
Do not use the F
1.
INESSE
coaxial cannula may be removed after the biopsy to retain a track to the biopsy site when placing
a tissue marker.
The F U
®
2.
INESSE LTRA
indicated use, limitations, and possible complications of percutaneous needle techniques.
3. Do not demonstrate sample acquisition sequence in air prior to performing a biopsy procedure.
Damage may occur to the needle or cannula tip.
4. Do not attempt to remove the cover or modify the device in any way.
F. 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, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the
biopsy probe while removing it from the breast.
2. As per routine biopsy procedures, it may be necessary to cut tissue adhering to the biopsy probe
while removing it from the breast.
G. Equipment Required
The following equipment is required for a biopsy procedure:
F U
®
Biopsy Driver
INESSE LTRA
F U
®
Biopsy Probe
INESSE LTRA
H. Directions for Use
Driver Button Operations (Figure 3):
Two buttons operate the driver (PRIME/PIERCE and SAMPLE)
forward 20-22mm to assist in penetrating dense breast tissue.
INESSE
® U
Biopsy Probes. Reusing the probe bears the risk of cross-patient
LTRA
® U
Biopsy Probes. After resterilization, the sterility of the probe
INESSE LTRA
U
®
Biopsy Probe without the integrated coaxial cannula. The integrated
LTRA
Breast Biopsy System should only be used by a physician trained in its
® U
Biopsy Probes.
LTRA
2