Austofix

SCREW HOLDER

Instructions for Cleaning, Sterilisation, Inspection and Maintenance of Austofix Devices

13 Pages

Instructions for Cleaning, Sterilisation, Inspection and Maintenance of Austofix Devices Contents  Warnings ... 1 Important Notes: ... 1 Limitations on Reprocessing ... 2 Manufacturer Contact Details: ... 2 Cleaning and Sterilisation Instructions ... 3 Additional Information... 6 Cleaning machine recommendations ... 6 Reprocessing staff training ... 6 Disassembly Instructions ... 7 Inspection Guidelines... 9 Background information on the Cleaning and Sterilisation Validation for Austofix Reusable Instruments ... 13  Warnings The sterilisation processing parameters recommended in this document, and validated for all Austofix reusable instruments or single use implants that are intended to be sterilised by hospitals prior to use. The instructions are not intended for, and not suitable for, inactivation of prions including transmissible spongiform encephalopathies (TSEs) e.g. Creutzfeldt-Jakob Disease (CJD). All used surgical instruments and implants intended to be sterilised by the end user should be regarded as contaminated. Their handling, collection and transportation should be strictly controlled to minimise any possible risks to patients, personnel and any area of the healthcare facility. Instruments and single use (non-sterile devices) must be inspected and checked off per the instructions below to prevent incomplete instrument sets causing delays or poor outcomes. Single use gamma sterilised items cannot be reprocessed using these instructions for use. Flash sterilisation has not been validated and is not suitable for reprocessing Austofix Reusable or Single Use devices intended to be autoclaved. Full Cleaning and Sterilisation procedures in this document are required before use.  Important Notes: Austofix devices must only be used by qualified surgeons familiar with the surgical technique(s) used for the kind of device.  Page 1 of 13  F40-LG-07 General Requirements for Reprocessing Rev 3
File Type: PDF
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File Name: Australian Orthopaedic Fixations Pty Ltd - Austofix - F40-LG-07 - Instructions for Cleaning, Sterilisation, Inspection and Maintenance of Austofix Devices - Rev 3.pdf

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