Bard SenoMark Ultra Gebrauchsanweisung

S M ® U
S M U Breast Tissue Marker for Use with
®
ENO ARK LTRA
9 or 12 Gauge ATEC ™ Biopsy Probe
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) law restricts this device to sale by
or on the order of a physician.
DESCRIPTION
The S M U Breast Tissue Marker consists of a
®
ENO ARK LTRA
disposable applicator containing:
resorbable polyglycolic acid PGA pads that are essentially
resorbed in approximately 12 weeks. The center pad contains a
Titanium or BioDur 108 wireform with an interwoven polyvinyl
™
alcohol P A polymer for permanent ultrasound enhancement.
Please note the P A polymer is not resorbed.
1 polyethylene glycol PEG push pellet.
The wireform is intended for long-term radiographic marking of the
biopsy site. The P A polymer is intended for long-term sonographic
marking of the biopsy site.
The syringe-like applicator ts within the 9 or 12 gauge ATEC
Biopsy Probe to access the biopsy cavity. Pads are deployed from
the applicator through the biopsy probe and into the biopsy cavity.
Product Wireform
Code Material
SMAT9 Titanium with P A
SMAT9C
™
BioDur 108 with P A
SMAT12 Titanium with P A
SMAT12C
™
BioDur 108 with P A
INDICATIONS FOR USE
The S M U Breast Tissue Marker is intended to
®
ENO ARK LTRA
radiographically and sonographically mark breast tissue during a
percutaneous breast biopsy procedure.
CONTRAINDICATIONS
Patients with a known hypersensitivity to the materials listed in the
device description may suffer an allergic reaction to this implant.
WARNINGS
1. Use caution when placing near a breast implant to avoid
puncture of the implant capsule.
2. Avoid the use of excessive force during removal of the
applicator to prevent breakage of the applicator tip.
3. Do not use in the presence of infection.
4. This device has been designed for single use only.
Reusing this medical device bears the risk of cross-patient
contamination as medical devices – particularly those with
long and small lumina, joints, and/or crevices between
components – are dif cult or impossible to clean once
body uids or tissues with potential pyrogenic or microbial
contamination have had contact with the medical device for
an indeterminable period of time. The residue of biological
material can promote the contamination of the device with
pyrogens or microorganisms which may lead to infectious
complications.
5. Do not resterilize. After resterilization, the sterility of the
product is not guaranteed because of an indeterminable
degree of potential pyrogenic or microbial contamination
which may lead to infectious complications. Cleaning,
reprocessing and/or resterilization of the present medical
device increases the probability that the device will
malfunction due to potential adverse effects on components
that are in uenced by thermal and/or mechanical changes.
™
Wireform Probe
Shape Compatibility
ibbon 9G
Coil 9G
ibbon 12G
Coil 12G
PRECAUTIONS
1. This product should only be used by a physician who is
completely familiar with the indications, contraindications,
limitations, typical ndings and possible side effects of breast
tissue marker placement.
2. Store in a cool, dry place.
. Do not use if the temperature indicator is black.
4. Use caution when handling the device to prevent premature
deployment of the breast tissue marker.
. Do not kink the exible tube.
. Maintain correct alignment of the alignment indicator D in
igure 1 with the sample notch when dispensing pads.
7. Ensure that all pads are dispensed.
8. After use, this product may be a potential biohazard. Handle
and dispose of in accordance with acceptable medical practice
and applicable local, state, and federal laws and regulations.
POTENTIAL COMPLICATIONS
Complications may occur at any time during or after the procedure.
Potential complications of breast tissue marker placement may
include, but are not limited to: hematoma, hemorrhage, infection,
adjacent tissue injury and pain.
EQUIPMENT REQUIRED
The following equipment is required to place the breast tissue
marker:
Appropriate imaging modality and accessories
Appropriate biopsy probe
Surgical gloves and drapes
ocal anesthetic
ther equipment as necessary
HOW SUPPLIED
The S M U Breast Tissue Marker is provided sterile and
®
ENO ARK LTRA
non-pyrogenic unless the package has been opened or damaged.
Sterilized by using irradiation. For single use only. Do not
reuse. Do not resterilize.
DIRECTIONS FOR USE (Refer to Figure 1)
Alignment Indicator D
1. Make certain that the collection of biopsy specimens has
been completed. Ensure that the sample notch of the
biopsy probe has been cleared of all tissue.
2. Inspect the package to ensure that the package integrity
has not been compromised. The product is sterile unless
the seal is broken.
. emove the sample collection chamber from the back of
the ATEC ™ Biopsy Probe. Use the provided cap B to
seal the collection chamber after removing the chamber
from the biopsy probe.
4. emove the guide seal C from the package and lock into
the back of the biopsy probe.
5. Using standard aseptic technique, remove the S
U Breast Tissue Marker from the package and inspect
LTRA
for damage. EM
1
Figure 1
Plunger
Applicator Handle E
Guide Seal C
Cap B
Tip Protector A
ENO
E TIP P TECT A .
M
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