Blue Ortho

Reamers

AcuDriver Reusable Surgical Instruments Reprocessing Instructions

4 Pages

Reprocessing Instructions for AcuDriver Reusable Surgical Instruments Manufacturer: Exactech, Inc ®  Devices: These instructions apply to the reprocessing of the AcuDriver pneumatic-powered handpiece and accessories. Reprocessing for surgical instruments distributed by Exactech are not covered by these instructions and must be provided by the manufacturer. Cleaning and sterilization equipment varies in performance characteristics and must be validated accordingly. The reprocessing facility is responsible for the routine validation and monitoring of all equipment, materials and personnel used in their facility to ensure the desired results are achieved. These instructions have been validated as being capable of preparing Exactech reusable surgical instruments for reuse. Any deviations from these procedures must be evaluated for efficacy by the reprocessing facility. WARNINGS  These instructions have not been proven effective for sterilizing instruments contaminated with unconventional transmissible agents (prions) such as the causative agents of Creutzfeldt-Jakob Disease (CJD) and Bovine Spongiform Encephalopathy (BSE). It should not be assumed that the methods described are effective against such agents. Cleaning is an essential pre-requisite to ensure effective sterilization. Lumens, blind holes, cavities, serrations and joints require particular attention during cleaning. Failure to completely remove organic debris and/or cleaning residues may lead to inadequate sterilization and result in an increased probability of infection. Failure to thoroughly remove cleaning agents may lead to sensitivity and/or allergic reactions. Wear appropriate protective equipment and follow local infection control policies while handling contaminated instruments. This includes but is not limited to waterproof clothing, robust gloves and eye protection. Avoid splashing and creation of aerosols. Handle sharp instruments with care to avoid injury. Caustic substances and those containing a chemical make-up of highly acidic or alkaline-based solutions may cause corrosion and shorten instrument life. Instruments with anodized coatings are particularly sensitive to highly alkaline (pH>9) solutions. Exposure to temperatures above 137 ºC (279 ºF) may accelerate instrument degradation. Water impurities, such as alkali metal, metal and chloride ions may discolor or corrode instruments. Use potable tap water for final rinsing. Saline may cause deterioration of instrument surfaces. Corrosion, rusting and pitting may occur when blood and debris are allowed to dry on surgical instruments. Only legally marketed medical equipment, solutions and accessories should be used for reprocessing surgical instruments. Do not use non-absorbent tray accessories as these may cause condensation to pool and extend drying times. All non-sterile instruments must be thoroughly cleaned and sterilized prior to use. Exactech products labeled for “single use only” must not be reprocessed. Always clean and sterilize surgical instruments before returning them to Exactech. Never re-use osteotomes. They are provided sterile and are designed to be single-use instruments only. Do not lubricate. The handpiece is pre-lubricated. Lubrication of the AcuDriver handpiece may result in damage to the internal parts. Never immerse the AcuDriver handpiece or accessories completely. Immersion into any solution  0314  700-096-035 rev C page 1 of 4
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File Name: Exactech - 700-096-035 - AcuDriver Reusable Surgical Instruments Reprocessing Instructions - 2014-03 - Rev C.pdf

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