TIMESCO Reusable Surgical Instruments , Laryngoscopes and Podiatry Instruments

2 Pages

INSTRUCTIONS FOR RE-PROCESSING TIMESCO REUSABLE SURGICAL INSTRUMENTS, LARYNGOSCOPES & PODIATRY INSTRUMENTS Manufacturer: TIMESCO HEALTHCARE LTD.  Reference I.C.001/9  Date: October 2020  The following instructions are for all Timesco reusable surgical instruments, laryngoscopes and podiatry instruments manufactured by Timesco Healthcare, unless stated otherwise with the packaging of the product. Additional instructions applicable to specific devices may be necessary and these are documented overleaf. All reusable devices are supplied non sterile and should be cleaned and sterilised before first use and after each subsequent use. These instructions are intended for use only by persons with the required specialist knowledge and training. • WARNINGS • • • • • •  LIMITATIONS ON REPROCESSING  • •  Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants and cleaning agents used. Wherever possible avoid use of mineral acids and harsh, abrasive agents. Do not use chemical sterilants with caustic ingredients such as: surgical scrub solutions, povidone-iodine solutions, bleach, peroxide solutions, Virox 3, Sporox and Cidex PA. Do not use garment or surface disinfectants. Do not autoclave with sub standard stainless steel surgical instruments as this may cause a reaction and lead to rust or discolourisation. No part of the process shall exceed 140º C. Ultrasonic cleaning is not permitted, as this will cause damage to the glass fibre optic bundle. Do not flash autoclave, this will invalidate our guarantee. When reprocessing medical devices, handle with care, wearing protective clothing and face visors or goggles where appropriate. Batteries must be removed from any battery operated devices before reprocessing. These reprocessing instructions will have a minimal effect on all devices, but repeated autoclaving, especially for extended periods can affect certain devices, please see overleaf for specific guidance.  INSTRUCTIONS •  INSPECTION AND FUNCTION TESTING  • •  If possible, soiled devices should be placed in a holding solution (combined disinfectant/enzyme solution) immediately after use and prior to cleaning. Reprocess all devices as soon as it is reasonably practical to do so. Where necessary disassemble devices that require disassembly for adequate cleaning and reprocessing. Some devices cannot be effectively cleaned by a washer-disinfector, those items should be manually cleaned as follows and then cleaned in a washer-disinfector as below: Using a sink dedicated for instrument cleaning (not used for hand washing), rinse excess soil from the device (water temp <35º C). Keeping the device submerged, with a brush, apply CE marked cleaning solution to all surfaces. Pay particular attention to underside and any jointed part of the device. Always brushing away from the body. Do not use a wire brush. Rinse the device thoroughly with clean water, so that the water reaches all parts of the device, then carefully hand dry or use a drying cabinet. Use only either CE marked or validated washer-disinfector machines and cleaning agents, following the manufacturers’ instructions for use, warnings and recommended cycles. Load devices carefully, ensure any delicate parts of the device are not liable to damage during the loading procedure. Timesco devices have been validated to the following automatic washer-disinfector cycle: Pre wash 28 ºC for 4 minutes, Wash at 50 ºC for 8 minutes, Rinse at 50ºC for 4 minutes, Thermal Disinfection at 90ºC – 95ºC for 1 minute, Drying for 25 minutes. Validated detergents, Instro-Klenz, Enzycare, Olympic Spraydry 1000 and Sprayclean 2000. After cleaning, check all surfaces for complete removal of soil. If any soil is still visible, return the device for repeat decontamination. If any devices have been disassembled, reassemble in accordance with any product specific instructions for use and test. Visually inspect and check all devices for damage and wear. Remove for repair or replacement any damaged product.  PACKAGING  •  All devices should to be packed following local protocol in accordance with BS standards.  •  Either CE marked or validated vacuum autoclave operating at 134-137ºC 2.25 bar for a minimum holding time of 3 minutes - always following the instructions of the machine manufacturer. When sterilising multiple instruments in one autoclave cycle, ensure that the steriliser manufacturer’s stated maximum load is not exceeded. Ensure all devices are dry before sterilisation. If the devices cannot be dried prior to sterilisation, then use distilled/de-ionised water in the final-rinse stage of cleaning. Timesco devices have been validated to the following steriliser cycle: Sterilising temperature 134 – 137ºC, Sterilizing time 3 minutes, Normal drying time 5 minutes, Extended Drying time 15 minutes. Timesco reusable laryngoscopes have successfully passed all of the test criteria and are validated for reprocessing in the V-PRO® Low Temperature Sterilisers. Timesco recommend that you consult and follow all product labelling and instructions for use for the V-PRO® Steriliser using the operator manual for packaging and weight limitations.  FROM POINT OF USE PREPARATION FOR DECONTAMINATION  • • •  CLEANING: • MANUAL • • • CLEANING: AUTOMATED  CLEANING: INSPECTION  •  • • •  REASSEMBLY  STERILISATION • •  •  STORAGE  •  Ensure all devices are dry before storage, and stored in dry, clean conditions at an ambient room temperature.  •  Other forms of cleaning (alkaline and neutral) and sterilisation (Cidex OPA, Ethylene oxide up to 65ºC for anaesthetic devices) are permitted. However, always follow the instructions for use as issued by Timesco and always consult with us if in any doubt over the suitability of any process used. Follow cleaning and sterilising guidelines as per HTM 01-01.  ADDITIONAL INFORMATION • MANUFACTURER  Page 1 of 2  Timesco Healthcare Ltd, Timesco House, 3 Carnival Park, Carnival Close, Basildon, Essex, SS14 3WN, England. E-mail info@timesco.com, Website www.timesco.com
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