Teleflex Medical

ALBERT-SANDERS VENTURI

Pilling General Instruments Sterility Reprocessing IFU

14 Pages

en  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.
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File Name: Teleflex Medical - L000603 R00 - Pilling General Instruments Sterility Reprocessing IFU - 2022-08 - R00.pdf

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