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ADVERSE REACTIONS
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Punctures or lacerations of vessels, nerves, bladder or bowel may occur during needle passage and may require
surgical repair.
•
Transitory local irritation at the wound site and a transitory foreign body response may occur. This response
could result in extrusion, erosion, fi stula formation and infl ammation.
•
As with all foreign bodies, PROLENE Mesh may potentiate an existing infection. The plastic sheath initially
covering the PROLENE Mesh is designed to minimize the risk of contamination.
•
Over correction, i.e., too much tension applied to the Implant may cause temporary or permanent lower urinary
tract obstruction.
ACTIONS
Animal studies show that implantation of PROLENE Mesh elicits a minimal infl ammatory reaction in tissues and
stimulates the deposition of a thin fi brous layer of tissue that can grow through the interstices of the mesh, thus
incorporating the mesh into adjacent tissue. The material is not absorbed, nor is it subject to degradation or
weakening by the action of tissue enzymes.
STERILITY
The GYNECARE TVT EXACT™ Continence System is sterile if kept in original, unopened packaging. DO NOT
RESTERILIZE. DO NOT REUSE. Do not use if package is opened or damaged. Discard all opened, unused devices.
The reusable GYNECARE TVT Rigid Catheter Guide is supplied separately and is non-sterile. It is to be cleaned and
sterilized prior to each use as described below.
INSTRUCTIONS FOR CLEANING GYNECARE TVT Rigid Catheter Guide (available separately)
To ensure the reliability and functionality of the GYNECARE TVT Rigid Catheter Guide, clean the instrument before
initial use and after each procedure. The following are suggested manual and automated methods for cleaning
the instruments.
Manual Method:
1. Soak the instrument in an enzyme cleaner suitable for stainless steel instruments.
2. Wash in a surgical detergent and disinfecting solution at a temperature of 86°F to 95°F (30°C to 35°C). Remove
any contamination from body fl uids or tissues using a soft brush.
3. Place the instrument in an ultrasonic bath with fresh detergent solution for approximately 10 minutes or follow
the instructions below if using an automatic washing cycle.
4. Rinse thoroughly in a stream of fresh tap water followed by towel drying. The instrument may be treated with
instrument lubricant.
Automated Method:
Automatic washing cycles are suitable for stainless steel instruments. One recommended cycle is described below:
•
Rinse/Wet Cycle Cold Water – 1 minute
•
Wash 176°F (80°C) – 12 minutes
•
Rinse Cycle – 1 minute
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Rinse Cycle – 12 minutes
•
Final Rinse – 2 minutes
•
Rinse with Demineralized water 176°F (80°C) – 2 minutes
•
Dry 199.4°F (93°C) – 10 minutes
STERILIZATION RECOMMENDATIONS FOR GYNECARE TVT Rigid Catheter Guide (available separately)
The GYNECARE TVT Rigid Catheter Guide is supplied non-sterile. To sterilize, steam autoclave prior to each use. Steam
autoclave at a temperature of 270°F to 284°F (132°C to 140°C) for a minimum of 4 minutes (pre-vacuum). It is the
responsibility of the end user to assure sterility of the product when using sterilization process recommended, since
bioburden and sterilization equipment will vary.
GYNECARE TVT Rigid Catheter Guide MAINTENANCE
Before each use, inspect the instrument. Check to ensure that the long end which traverses the catheter channel has
no sharp edges or burrs.
DISPOSAL
Dispose of the devices and packaging according to your facility's policies and procedures concerning biohazardous
materials and waste. Please visit http://www.ethicon.com/recycling for more information.
STORAGE
Recommended storage conditions: controlled room temperature and relative humidity (approximately 25°C,
60% RH), keep away from high moisture and direct heat. Do not use after expiration date.
SYMBOLS
Do not reuse/resterilize
See instructions for use
Catalogue number
Use by — year and month
Method of Sterilization –
Ethylene Oxide
LOT
Batch number
7
0086
CE mark and identification number
of Notified Body. Product conforms
to the essential requirements of the
Medical Device Directive 93/42/EEC
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