medtronic

REUSABLE TRANSPORTATION/STERILIZATION CASSETTES and INSTRUMENTS Instructions for Use

11 Pages

NOT FOR DISTRIBUTION IN THE U.S.A. OR ITS TERRITORIES  M708348B571E Rev. C  Medtronic Reusable Instruments 2016-08-01  IMPORTANT INFORMATION FOR MEDTRONIC REUSABLE INSTRUMENTS AND REUSABLE TRANSPORTATION/STERILIZATION CASSETTES DESCRIPTION Reusable instruments are manufactured from a variety of materials commonly used in orthopedic procedures, which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a legally marketed and/or appropriate sterilization wrap, to allow steam sterilization of non-sterile devices. Medtronic aluminum Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices.  INTENDED USE Orthopedic surgical instruments are intended for use in surgical procedures to manipulate tissue, bone, or for use with other devices in orthopedic surgery. An instrument may incorporate a measuring function, which has uses as described on the label and the instrument. Note: do not implant the instruments. The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed and/or appropriate sterilization wrap. Medtronic does not warrant the use of the instruments, Medtronic Transportation/Sterilization Cassettes, or any of the component parts upon which repairs have been made or attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Caution: these instructions do not apply to single use devices. For non-sterile, single use instruments refer to the Medtronic nonreusable and non-sterile instruments IFU, M708348B359.  WARNINGS ▪ Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient, or surgical or reprocessing personnel.  ▪ Improper maintenance, handling, or inadequate cleaning procedures can render the instrument unsuitable for its intended purpose and may present a danger to the patient, or surgical or reprocessing personnel.  ▪ There are additional risks associated with instruments used for bending and cutting rods. Use of these types of instruments can cause injury to the patient by virtue of the extremely high forces required. Do not cut rods in situ. Any breakage of an instrument or the implant in this situation could be extremely hazardous. The physical characteristics required for many instruments do not permit them to be manufactured from implantable materials, and if any broken fragments of instruments remain in the body of a patient, there could be allergic or infectious consequences. ▪ The surgeon should use extreme caution when working in close proximity to vital organs, nerves or vessels. In addition, excessive force should not be used when positioning instruments or implants, since it could cause injury to the patient. ▪ Breakage, slippage, misuse, or mishandling of Medtronic Transportation/Sterilization Cassettes, such as on sharp edges, may cause injury to the patient or operative and reprocessing personnel. ▪ Improper maintenance, handling, or poor cleaning procedures can render Medtronic Transportation/Sterilization Cassettes unsuitable for their intended purpose, or can even be dangerous to the patient or surgical staff.
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