Actuality: KARL STORZ Products that can be sterilized
Contents
1. STORZ Indications for use of Actuality STERRAD Sterilization Systems KARL STORZ ENDOSKOPE 20 08 2008 Indications for use of STERRAD Sterilization Systems KARL STORZ Products that can be sterilized with STERRAD Sterilization Systems KARL STORZ Products which can not be sterilized with STERRAD Sterilization Systems KARL STORZ has conducted material compatibility and sterilization efficacy studies of KARL STORZ products with the STERRAD Sterilization system These studies have been conducted in conjunction with Advanced Sterilization Products ASP in accordance with the AAMI guidelines Devices in these studies have been validated through at least one hundred consecutive STERRAD cycles with the exception of video cameras which have been validated for two hundred consecutive cycles and telescopes which have been validated for three hundred cycles Twelve product categories were tested representing the various materials devices and device configurations i e lumens hinges etc of the extensive KARL STORZ product line These devices were sterilized in accordance with the STERRAD Sterilization System Operators Manual Only STERRAD instrument trays and wraps recommended for use with the STERRAD Sterilization System were used for the studies Material compatibility testing determines whether a device will withstand sterilization with STERRAD without significant impact on the materials or functi2. the sterility of the device KARL STORZ Products which can not be sterilized with STERRAD Sterilization System e HAMOU telescopes with eyepiece drive mechanism 26156 B BU 26157 BU 27156 BU 28720 BH 7200 BH BH e Video Camera ENDOVISION XL reusable tubing sets e g for ENDOFLATOR ENDOMAT HYDROMAT Resectoscope Please note that special materials and containers for packaging and storage are necessary to ensure sterility Validations have been performed using the packaging recommended by Johnson amp Johnson KARL STORZ 39501 series baskets are also suitable for use Please keep in mind that any deviations from the recommended STERRAD sterilization parameters must be validated by the user KARL STORZ recommends contacting Johnson amp Johnson or ASP when there are any questions regarding the safety of sterilization with the STERRAD System If you have any other questions concerning cleaning sterilization or care of our products please contact our Quality Assurance department Association for the Advancement of Medical Instrumentation Designing Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities A Guide for Medical Device Manufacturers AAMI RDA TIR12 8 94 Arlington VA AAMI 1994 AAMI Technical Information Report The fiberscopes were validated in co operation with Johnson amp Johnson and may only be valid outside of the USA 3The recommendations given on this w
3. ebpage may not be valid in the US contact KSEA or ASP for additional information
4. onality of the device Sterilization efficacy testing determines whether a device is actually sterile after exposure to the STERRAD sterilization cycle Sterility testing was done using the AAMI overkill method to a sterility assurance level SAL of 10 The results of these studies are presented below KARL STORZ Products which can be sterilized with STERRAD Sterilization Systems e Rigid Telescopes except HAMOU with eyepiece drive mechanism Flexible Fiberscopes Semi rigid Fiberscopes and Microendoscopes Video Cameras except ENDOVISION XL e Fibre Light Cables Clickline Instruments Insulated Clickline Instruments Non insulated Surgical Instruments Insulated forceps scissors etc Surgical Instruments Non insulated forceps scissors etc e Trocars Shafts Cannulas Obturators e Working Elements Ureter Light Probe e High frequency Cords EHL Probe Cable part no 27080 KA Devices in the compatible list may exhibit cosmetic changes caused by STERRAD sterilization that do not affect the functionality of the device STORZ Indications for use of Actuality STERRAD Sterilization Systems KARL STORZ ENDOSKOPE 20 08 2008 Please note that there are restrictions as to what may be sterilized in the STERRAD Sterilization Systems based on lumen size and materials Please follow the instructions in the STERRAD User s manual or contact ASP directly to ensure
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