Teleflex Medical

Applier and Ligating Clips

Applier Care and Maintenance Guide

1 Page

WECK® CARE AND MAINTENANCE Clip Applier Care and Maintenance  INSPECTION  Please examine endoscopic and open appliers for potential damage before use in surgery. Pay particular attention to the jaws. Damaged or misaligned jaws may not allow clips to close acceptably for occlusion of intended structure.  OPEN AND ENDOSCOPIC APPLIERS  OPEN APPLIERS  Alignment Always check the alignment of the applier jaws before use. When closed, jaw tips should be directly aligned and not offset.  Check the following components of your open clip appliers: • Spring Examine to ensure spring is not loose, bent, or rusted. • F lag Condition Examine to ensure flag is not missing or damaged.  CLEANING THE PORT  Endoscopic appliers are provided with a cleaning port that permits access to the interior channels and cavities. Uncap the cleaning port and flush the applier with warm distilled or filtered water for approximately two minutes or until the visible gross debris is removed from the device.  OPENING THE BOX LOCK  • Lightly squeeze shanks together with one hand • Lift the spring off the flag • Open the applier  WECK OPEN LIGATING CLIP APPLIERS  WECK ENDOSCOPIC LIGATING CLIP APPLIERS  Weck Ligating Clip Appliers should be cleaned independently according to the instructions listed below. The instruments are approved to be cleaned according to each of the following options:  Weck Ligating Clip Appliers should be cleaned independently according to the instructions listed below. The instruments are approved to be cleaned according to each of the following options:  Note: It is the responsibility of the health care facility to ensure adequate cleaning of the brushes between each use.  Note: It is the responsibility of the health care facility to ensure adequate cleaning of the brushes between each use.  AUTOMATIC PROCESSING INSTRUCTIONS FOR USE WITH ALKALINE OR ENZYMATIC DETERGENTS  AUTOMATIC PROCESSING INSTRUCTIONS FOR USE WITH ALKALINE OR ENZYMATIC DETERGENTS  Pre-Cleaning • Soak the instrument in tap water for a minimum time of 5 minutes and clean with a soft brush • Disassemble the instrument (if applicable) • Brush under tap water with a soft brush until all visible residues are removed Cleaning • Place the opened instrument in a wire basket on the slidein tray and start the cleaning process • Pre-rinse for 1 minute with cold water • Empty • Pre-rinse for 3 minutes with cold water • Empty • Wash for 5 minutes at 131°F (55°C) with a 0.5% alkaline detergent or at 113°F (45°C) with a 0.5% enzymatic detergent • Empty • Neutralize for 3 minutes with warm water (>104°F [>40°C]) • Empty • Rinse for 2 minutes with warm water (>104°F [>40°C]) • Empty Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the Instructions for Use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments  MANUAL PROCESSING INSTRUCTIONS FOR USE WITH ENZYMATIC DETERGENTS Pre-Cleaning • Soak the instrument in tap water for a minimum time of 5 minutes and clean with a soft brush • Disassemble the instrument (if applicable) • Brush under tap water with a soft-bristled brush until all visible residues are removed Cleaning • Place the instrument in an ultrasonic bath at 104°F (40°C) with a 0.5 % enzymatic detergent • Sonicate for 15 minutes (minimum) • Remove the instrument and flush with de-ionized water for approximately 15 seconds while simultaneously brushing using a soft-bristled brush until all detergent residue has been removed Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the Instructions for Use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments. Drying Dry instruments with a sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens. Disinfection Teleflex does not provide disinfection instructions due to the sterility instructions provided  Pre-Cleaning • Soak the instrument in tap water for a minimum time of 5 minutes • Brush under tap water until all residues are removed • Flush the distal pivot joint and proximal handle joint with a syringe until the rinse water is clear Cleaning • Place the opened instrument in a wire basket on the slide-in tray and start the cleaning process • Pre-rinse for 2 minutes with cold water • Empty • Wash for 5 minutes at 131°F (55°C) with a 0.5% alkaline detergent or at 131°F (55°C) with a 0.8% enzymatic detergent • Empty • Neutralize for 3 minutes with cold water • Empty • Rinse for 2 minutes with cold water • Empty Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the Instructions for Use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments.  MANUAL PROCESSING INSTRUCTIONS FOR USE WITH ENZYMATIC DETERGENTS Pre-Cleaning • Soak the instrument in tap water for a minimum time of 5 minutes • Brush under tap water for approximately 40 seconds until no residues are visible • Flush the distal pivot joint and proximal handle joint with a syringe until the rinse water is clear Cleaning • Place the instrument in an ultrasonic bath at 104°F (40°C) with a 0.8 % enzymatic detergent • Sonicate for 10 minutes • Remove the instrument and flush with de-ionized water for approximately 15 seconds Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the Instructions for Use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments. Drying Dry instruments with a sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens. Disinfection Teleflex does not provide disinfection instructions due to the sterility instructions provided.  Drying Dry the outside of the instruments using the drying cycle of the cleaning equipment. If necessary, instruments can be dried by hand with a sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens.  Drying Dry the outside of the instruments using the drying cycle of the cleaning equipment. If necessary, instruments can be dried by hand with a sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens.  Disinfection Teleflex does not provide disinfection instructions due to the sterility instructions provided.  Disinfection Teleflex does not provide disinfection instructions due to the sterility instructions provided.  CARE, CLEANING, AND STERILIZATION  Manual-load applier jaws are delicate and can easily become damaged, as can some other applier components. Mishandling of appliers may result in improper load and/or closure of the ligating clips. Appropriate care, cleaning, lubrication, and maintenance are important to ensure proper function. Please examine the applier before each surgery for potential damage. Pay particular attention to the jaws. Damaged or misaligned jaws may not allow clips to close acceptable for occlusion of intended structure.  PREPARATION AT POINT OF USE  Directly after use, remove coarse contamination from the instruments and keep the instrument moist for transit to the processing site. Prior to cleaning and sterilization do not use any fixing agents or hot water (>104°F (>40°C)) since this may lead to the fixation of residue and can interfere with the cleaning process.  STERILIZATION  Instruments should be sterilized in the disassembled/open position, where applicable. Engaged ratchets can result in damage to the instrument. To avoid electrochemical reactions, separate instruments fabricated from different materials. The instruments are approved to be sterilized according to the following parameters: STERILIZATION METHOD (OPEN & ENDO)  FUNCTIONAL CHECK  Inspect instruments after each sterilization cycle and prior to each use as they may be damaged during transit to the customer, during receiving at the customer’s site, during use in a previous procedure or during the cleaning or sterilization processes. All moving parts must be inspected for wear and confirmed to be functional. Confirm smooth operation during opening and closing of instrument handle and reinforcing screw. Inspect instruments for rust, pitting, cracking or burrs, staining or discoloration, and worn or broken parts. Repair or replace any instrument found not to be acceptable.  The assembly and disassembly of the instrument must only be performed by personnel trained to the institution’s training requirements. The instrument must be cleaned, lubricated, functionally checked, and sterilized prior to each use. Use a non-silicone, waterbased lubricant prior to sterilization. Do not use mineral oil, petroleum or silicon-based lubrication products. Do not use an instrument with broken, cracked or worn parts. Only use the instrument for its intended use. Misuse or improper handling may result in damage, potentially resulting in user or patient injury. If repair is required, return clean and sterile instruments to Teleflex.  TEMPERATURE  EXPOSURE TIME (MINIMUM)  DRYING TIME (MINIMUM)  Wrapped  270°F (132°C)  4 min.  10 min.  Wrapped  275°F (135°C)  3 min.  10 min.  Wrapped  273°F - 279°F (134°C - 137°C)  3 min.  10 min.  After cleaning and inspection, place the instrument in a sterilization container or packaging which will protect the instrument from the environment as well as permit sterilization. After sterilization the instrument should remain in the sterilization container or packaging for protection from the environment and to maintain sterility.  PreVac (Endo only)  Wrapped  250°F (121°C)  30 min.  10 min.  STORAGE  Gravity  Wrapped  270°F - 275°F (132°C - 135°C)  10 min.  10 min.  Gravity (Open only)  Wrapped  250°F - 253°F (121°C - 123°C)  30 min.  10 min.  PreVac  TRANSPORTATION  During the transportation of the instrument to the processing site, store contaminated instrument securely in a closed container to avoid damage to the instrument and/or contamination of the environment.  MAINTENANCE, HANDLING AND OPERATION OF SURGICAL INSTRUMENTS  INSTRUMENT CONFIGURATION  Note: Flash sterilization is not recommended for use with these instruments. Note: The following methods of sterilization are not recommended as they could damage the instrument: ethylene oxide sterilization, dry heat sterilization, liquid chemical sterilants, chemical sterilant gases.  Note: These instructions do not apply to the Weck Take Apart Appliers and Removers.  Teleflex and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-000131  TELEFLEX PO Box 12600 Research Triangle Park, NC 27709 Toll Free: 866.246.6990 Phone: +1.919.544.8000 TELEFLEX.COM  PACKAGING  Instrument must be stored in a dry, clean, chemical free and dust free environment. Instrument must remain wrapped or within the sterilization container to maintain sterility.  ADDITIONAL INSTRUCTIONS  Use of cleaning and sterilization methods other than those provided by Teleflex must be validated by the healthcare facility using appropriate validated laboratory methods.
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