Product Description; Contraindications - Bard CapSure Gebrauchsanweisung

PRODUCT DESCRIPTION

The C S ™ Permanent Fixation System is a sterile single use device that delivers either 15 or
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30 permanent polyetheretherketone (PEEK) and 316L stainless steel fasteners. The shaft on the
C S ™ Fixation System is 37 cm in length. The fastener, including the PEEK cap and 316L stainless
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steel coil, is 4.2 mm in length. The fi xation instrument shafts have an outer diameter of 5 mm, and may
be used in open procedures or with most 5 mm trocars in laparoscopic procedures. The device includes
a fastener gauge located on the top of the hand piece. The gauge will move right to left as the fasteners
are deployed that indicates the approximate level of fasteners remaining in the device.
15
15 count fastener level indicator
starts at midpoint and moves
towards left as fasteners deplete.
• REF 0113215 C S
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• REF 0113230 C S
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INDICATIONS
The C S ™ Permanent Fixation System is indicated for the approximation of soft tissue and fixa-
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tion of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

CONTRAINDICATIONS

1. This device is not intended for use except as indicated.
2. Do not use this device where hemostasis cannot be verifi ed visually after application.
3. Contraindications associated with laparoscopic and open surgical procedures relative to mesh fix-
ation apply, including but not limited to: fi xation of vascular or neural structures and in ischemic or
necrotic tissue.
4. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetra-
tion of underlying structures such as bone, nerves, vessels, and viscera. Use of the C
Permanent Fixation System in the close vicinity of such underlying structures is contraindicated.
For reference, the length of the fastener below the fastener head is 3.2 mm, the fastener head is
another 1 mm (total 4.2 mm).
5. This device should not be used in tissues that have a direct anatomic relationship to major vascular
or nerve structures. This includes the deployment of tacks in the diaphragm in the vicinity of the
pericardium, aorta, or inferior vena cava during diaphragmatic hernia repair.
WARNINGS
1. The C S ™ Permanent Fixation System is intended for Single Use Only - DO NOT
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RESTERILIZE. Reuse, reprocessing, resterilization or repackaging may compromise the
structural integrity and/or essential material and design characteristics that are critical to the
overall performance of the device and may lead to device failure which may result in injury
to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of
contamination of the device and/or cause patient infection or cross infection, including, but not
limited to, the transmission of infectious diseases from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient or end user.
2. Do not use beyond the expiration date on the package.
3. Prior to use, carefully examine package and product to verify neither is damaged and that all
seals are intact. Do not use if the package is damaged or open.
4. Verify mechanical and electrical compatibility of devices from different manufacturers prior
to using them together in a procedure.
5. Prosthetic should be evaluated for compatibility prior to use.
6. Users should be familiar with surgical procedures and techniques involving permanent ma-
terials before employing C
as the risk of wound dehiscence may vary with the site of application and the material used.
7. As with any implant material, the presence of bacterial contamination may enhance bacterial
infectivity. Accepted surgical practice must be followed with respect to drainage and closure
of infected or contaminated wounds.
C S
Permanent Fixation System
™ Permanent Fixation System, Straight 37 cm length, 15 Fasteners
™ Permanent Fixation System, Straight 37 cm length, 30 Fasteners
S ™ Permanent Fixation System fasteners for wound closure,
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™
30
30 count fastener level indicator
starts on the right and moves
towards left as fasteners deplete.
S ™
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