WRIGHT Medical

WRIGHT Instruments Cleaning and Handling Instructions

5 Pages

INSTRUCTIONS FOR USE - EN CLEANING AND HANDLING OF WRIGHT  The Symbol Key can be found online at ifu.stryker.com  I. GENERAL PRODUCT INFORMATION Surgical instruments that are supplied non-sterile must be cleaned and sterilized before use. After use,  INSTRUMENTS  these instruments must be, at a minimum, properly decontaminated, cleaned, and stored. The following  150824 EU EN Rev 6  information outlines the proper steps for reprocessing Wright Medical surgical instruments (under various tradenames) to ensure fit for use and to help assure their long life. Wright Medical instruments are intended to facilitate the implantation and explantation of Wright Medical Implant systems. Please refer to the associated implant package insert for specific indications, contraindications, and warnings associated with those devices.  *CE-Marking is only valid if it is also mentioned  2797*  Warning: All instructions for use and labelling must be read carefully prior to clinical use.  on the external package labeling.  The licensed healthcare professional should be qualified by appropriate training methods (for example, relevant surgical residency programs).  Wright Medical Technology, Inc.  A. INTRA-OPERATIVE PRECAUTIONS  1023 Cherry Road Memphis, TN 38117  Warning: The licensed healthcare professional and operating room team must be thoroughly familiar with  U.S.A.  the operating technique, the instruments, as well as the range of implants to be applied. Complete information and labeling on these subjects must be readily available at the workplace. EC  Warning: While rare, intra-operative breakage of instruments can occur. Instruments which have  REP  experienced excessive use or excessive force are susceptible to breakage. Instruments should be  Tornier SAS  examined for wear and damage prior to surgery.  161 Rue Lavoisier  Warning: Single use devices cannot be reused, as they are not designed to perform as intended after the  38330 Montbonnot Saint Martin  first usage. Mechanical, physical, and/or chemical properties of single use devices may be compromised  France  after the first usage. In this case, the safety and performance of the devices are not supported by the manufacturer and compliance to relevant specifications cannot be ensured. Warning: Ensure that all components needed for the operation are available in the operation theatre. Warning: During the course of the operation, repeatedly check to ensure that the connection between  ™ and ® denote Trademarks and Registered Trademarks of Stryker Corporation, or its affiliates.  the implant and the instrument, or between instruments, required for precise positioning and fixing is secure.  ©2021 Stryker Corporation, or its affiliates. All Rights Reserved.  Warning: The surgeon must advise patients of surgical risks and make them aware of adverse effects and alternative treatments.  For additional information and translations please  Advise the patient of the nature and safety of unretrieved device fragments including the following  contact the manufacturer or local distributor.  information:  GLOBAL-FORM-0153 Rev. A  a.  The material composition of the fragment (if known);  b.  The size of the fragment (if known);  c.  The location of the fragment;  Published 20-Apr-22  1 of 5
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File Name: WRIGHT Medical - KARL STORZ - 150824 - WRIGHT Instruments Cleaning and Handling Instructions - 2022-04 - Rev 6.pdf

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