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INSTRUMENT DESCRIPTION The following instructions are for metal reusable general surgical instruments that are characterized by the following design features (examples): •
Tubular construction instruments that have a central lumen
For additional information or guidance on Cleaning and Sterilization instructions, contact your Teleflex Sales Representative or Teleflex Customer Service. INDICATIONS FOR USE Teleflex instruments are designed to perform a specific function, such as cutting, grasping, clamping, dissecting, probing, retracting, draining, aspirating and suturing. Instruments are for use by, or as directed by, a trained medical professional. Instruments should be used only for the purpose for which they are designed. The proper technique for the use of the instrument is the responsibility of the medical professional. PREPARATION AT POINT OF USE Directly after use, remove coarse contamination from the instrument 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. 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. PREPARATION FOR REPROCESSING Where applicable, instruments must be disassembled and/or opened for cleaning and sterilization. Open ring handled instruments so that ratchets are not engaged. Failure to properly clean and sterilize the instrument could lead to contaminated instruments being placed back into circulation. If appropriate, remove stylets prior to cleaning.
CLEANING, DISINFECTION AND DRYING INSTRUCTIONS Automatic Processing Instructions For Use with Alkaline or Enzymatic Detergents
Manual Processing Instructions For Use with Enzymatic Detergents
PRE-CLEANING PRE-CLEANING • Using a syringe, flush and fill the • Using a syringe, flush and fill the lumen with lukewarm tap water. lumen with lukewarm tap water. • Soak the instrument in lukewarm tap • Soak the instrument in lukewarm tap water for a minimum time of 5 minutes. water for a minimum time of 5 minutes. • Flush the inside of the instrument with • Flush the inside of the instrument with lukewarm tap water using a syringe. lukewarm tap water using a syringe. • Brush under lukewarm tap water with a • Remove the instrument and flush with soft brush until all visible residues are lukewarm tap water for approximately removed. 15 seconds while simultaneously brushing with a soft-bristled brush. • Flush the inside of the instrument with lukewarm tap water using a syringe. ENZYMATIC CLEANING • Place the opened instrument in a perforated 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 0.8% 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 of the manufacturer. Examples of detergents used in validations: Enzymatic Detergent: Cidezyme/Enzol.
CLEANING • Place the instrument in an ultrasonic bath at 104°F (40°C) with a 0.8% enzymatic detergent. • Sonicate for 10 minutes (minimum). • Remove the instrument and flush with lukewarm tap water for approximately 15 seconds while simultaneously brushing with a soft-bristled brush. • Dry with a lint-free cloth. Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the instructions for use of the manufacturer. Examples of detergents used in validations: Enzymatic Detergent: Cidezyme/Enzol.
ALKALINE CLEANING • Place the opened instrument in a perforated basket on the slide-in 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. • 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 of the manufacturer. Examples of detergents used in validations: Alkaline Detergent: Neodisher Mediclean. DRYING DRYING Dry the outside of the instruments Dry instruments with a lint-free cloth. using the drying cycle of the cleaning Compressed, filtered air can be used for equipment. If necessary, the instruments instruments with lumens. can be dried by hand with a lint-free cloth. Compressed, filtered air can be used for instruments with lumens. DISINFECTION DISINFECTION Teleflex does not provide disinfection Teleflex does not provide disinfection instructions due to the sterility instructions instructions due to the sterility instructions provided. provided.
INSPECTION AND FUNCTIONAL CHECK Inspect the instrument after each sterilization cycle and prior to each use as it may be damaged during transit to the customer, during receiving at the customer site, during use in a previous procedure or during the cleaning or sterilization processes. All moving parts, tips, box locks, ratchets, serrations and cutting edges, if applicable, must be inspected for wear and confirmed to be functional. Confirm smooth operation during opening and closing of a hinged instrument and that tips/blades align properly. Screws may become loose during normal operation of an instrument. Inspect before sterilization and prior to use in order to ensure proper function. Inspect instrument for rust, pitting, cracking or burrs, staining or discoloration, readability of device markings as applicable and worn or broken parts. Repair or replace any instrument found not to be acceptable. MAINTENANCE, HANDLING AND OPERATION OF SURGICAL INSTRUMENTS 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, water-based 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.
WARNING Instruments which are used consciously on patients with a prion based disease (transmissible spongiform encephalopathy disease, CJD, BSE, etc.) or on patients suspected of having one of these diseases are not safe to be reused and must be disposed of as per approved hospital procedures. Do not clean and/or sterilize instruments suspected of prion-contamination prior to disposal, as introducing these instruments to the reprocessing facility may lead to contamination of other instruments and/or the reprocessing facility equipment. PRODUCT INFORMATION DISCLOSURE Teleflex excludes all warranties, except Teleflex’s applicable Standard Warranty whether expressed or implied, including but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Teleflex shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from use of this product except for the intended use specified. Teleflex does not assume nor authorize any person to assume for them any other or additional liability or responsibility in connection with these products. For additional information, go to: www.teleflex.com/ifu
PACKAGING After cleaning and inspection, place the instrument in terminally sterilized packaging (as per ISO 11607) or a sterilization container which will protect the instrument from the environment as well as permit sterilization. After sterilization the instrument should remain in the packaging or sterilization container for protection from the environment and to maintain sterility. STERILIZATION Instrument should be arranged in a 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 following steam sterilization cycles may be used for instruments: Sterilization Instrument Method Configuration Pre-vacuum
Wrapped
Pre-vacuum
Wrapped
Pre-vacuum Gravity Displacement
Wrapped Wrapped
Temperature 270°F (132°C) 273°F (134°C) to 279°F (137°C) 275°F (135°C) 270°F (132°C) to 275°F (135°C)
Exposure Time (minimum) 4 minutes
Drying Time (minimum) 10 minutes
3 minutes
10 minutes
3 minutes
10 minutes
10 minutes
10 minutes
Note: Flash sterilization is not recommended for use with these instruments. STORAGE 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 health care facility using appropriate validated laboratory methods.
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