BD SenoMark Instrucciones De Uso

S M
®
S M Biopsy Site Marker
®
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For use with 9 Gauge ATEC
™
ENGLISH
SMTSU9G
Instructions For Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
DESCRIPTION
The Bard Inc. S M Biopsy Site Marker consists of a disposable applicator containing:
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3 resorbable polyglycolic acid (PGA) pads. The center pad
contains a titanium wireform.
1 polyethylene glycol (PEG) plug at the proximal end.
Product Code Wireform Material
SMTSU9G Titanium
The wireform is intended for long-term radiographic marking of the biopsy site. The pads
are visible via ultrasound for approximately 3 weeks and are essentially resorbed in
approximately 12 weeks.
The syringe-like applicator ts within the 9 gauge ATEC
are deployed from the applicator through the biopsy device and into the biopsy cavity.
INTENDED USE
The S M ® is intended to radiographically and sonographically mark breast tissue
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during a percutaneous breast biopsy procedure.
CONTRAINDICATIONS
This device is not intended for use except as indicated.
WARNINGS
Patients with a known hypersensiti ity to the materials listed in the de ice
description may suffer an allergic reaction to this implant.
The S M is not recommended for use in patients with breast implants.
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Do not use in the presence of infection.
A oid the use of e cessi e force during remo al of the applicator to pre ent
breakage of the applicator tip.
This de ice has been designed for single use only. Reusing this medical de ice
bears the risk of cross patient contamination as medical de ices particularly
those with long and small lumina oints and or cre ices between components
are dif cult or impossible to clean once body uids or tissues with potential
pyrogenic or microbial contamination ha e had contact with the medical de ice for
an indeterminable period of time. The residue of biological material can promote
the contamination of the de ice with pyrogens or microorganisms which may lead
to infectious complications.
Do not resterili e. After resterili ation 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 resterili ation of the present medical de ice increases the probability that
the de ice will malfunction due to potential ad erse effects on components that
are in uenced by thermal and or mechanical changes.
PRECAUTIONS
The device should only be used by physicians trained in percutaneous biopsy
procedures.
o not use this product if the sterile barrier has been previously opened or if the package
is damaged.
This product is provided sterile and is intended for single use only.
DO NOT RESTERILIZE.
o not kink the exible tube.
Maintain correct alignment of the indicators (C
when dispensing pads.
Ensure that all pads are dispensed.
Store at temperatures below 2
Published studied with comparably si ed 31
shown no marker movement and insigni cant marker heating when tested in an M I
System with a 1. T eld strength.
COMPLICATIONS
Potential complications (e.g. infection) that may be associated with the use of the S
are the same as those associated with the use of other biopsy marking devices.
Wireform Shape Probe Compatability
to access the biopsy cavity.
™
in Figure 1) with the sample notch
C ( F).
stainless steel biopsy markers have
HOW SUPPLIED
The S M
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DIRECTIONS FOR USE (Refer to Figure 1)
Secondary Alignment Indicator (C)
Handle (B)
Plunger (A)
1. Make certain that the collection of biopsy specimens has been completed. Ensure that
the sample notch 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.
3. Using standard aseptic techni ue remove the S
9G ATEC ™
and check for damage. EM
. emove Adaptor (E) if using ATEC
Biopsy evice. For the ATEC
evice slide the Adaptor (E) in the direction of the handle until it engages with the stop
( ) on the applicator shaft.
. Following ATEC
Pads
1
cannula leaving the cannula in the breast.
. Place the S
until the ATEC
. Align the S
cannula.
8. Immediately deploy the S
maintaining forward pressure on the handle (B) and correct alignment of the applicator
with the sample notch. The pads will be fully dispensed when the plunger contacts the
handle.
9. otate the biopsy device cannula 18 degrees to position the sample notch away from
the dispensed pads.
1 . emove the S
force. (See Caution below.)
11. Close the sample notch and remove the biopsy device per manufacturer s instructions.
12. ispose of the applicator properly.
13. Con rm nal marker position with imaging.
Caution: If any resistance is encountered while removing the applicator leave the
S M applicator within the probe and remove the entire probe/applicator assembly.
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Failure to do so may result in breakage of the applicator tip.
WARRANTY
Bard Peripheral ascular warrants to the rst purchaser of this product that this product
will be free from defects in materials and workmanship for a period of one year from the
date of rst purchase and liability under this limited product warranty will be limited to repair
or replacement of the defective product in Bard Peripheral ascular s sole discretion or
refunding your net price paid. Wear and tear from normal use or defects resulting from
misuse of this product are not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT
WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT
WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING
OR USE OF THIS PRODUCT.
Some states/countries do not allow an exclusion of implied warranties incidental or
consequential damages. You may be entitled to additional remedies under the laws of your
state/country.
An issue or revision date and a revision number for these instructions are included for the
user s information on the last page of this booklet. In the event 3 months have elapsed
between this date and product use the user should contact Bard Peripheral ascular Inc. to
see if additional product information is available.
Assembled in Thailand.
M ®
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1
® is provided sterile and is intended for single use only.
Tip Protector (G)
™
ATEC Stop with
Alignment Indicator (D)
Figure 1
E TIP P TECT
™ 912-2 (12cm ) or 912-12 (12cm Petite)
™ 9 9-2 (9cm ) or 9 9-12 (9cm Petite) Biopsy
instructions remove the driver mechanism from the biopsy device
™
M ® applicator into the ATEC
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™ stop ( ) or the Adaptor (E) is seated in the cannula.
M indicators (C ) with the sample notch in the biopsy device
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M ® pads by advancing the plunger (A) while
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M ® applicator from the biopsy device cannula. Avoid the use of
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Pellet Deployment
Aperture (F)
Adaptor (E)
(slide back for 9 cm cannula
or remove for 12 cm cannula)
M device from the package
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(G).
™ biopsy device cannula and advance