medtronic

07.0 MM TAP WITH BALL HANDLE

Medtronic Reusable Instruments and Accessories Manual

234 Pages

FOR INTERNATIONAL AUDIENCES ONLY US audiences refer to www.medtronic.com/manuals  M333023W134EU Rev. A  Medtronic Reusable Instruments and Accessories US Audiences STOP - refer to www.medtronic.com/manuals 2021-01-05  ENGLISH  IMPORTANT INFORMATION FOR MEDTRONIC REUSABLE INSTRUMENTS AND ACCESSORIES  DESCRIPTION Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in accessories. Accessories include cases, trays, lids, caddies, and modules fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic and neurological reusable instruments.  INTENDED USE Reusable instruments are intended for use in orthopedic and neurological surgical procedures to manipulate tissue, bone, or for use with other devices in surgery. An instrument may incorporate a measuring function, which has uses as described on the label and the instrument. Note: do not implant instruments. Accessories 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. Accessories 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 use of instruments, accessories, or any 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.  WARNINGS ▪ Breakage, slippage, misuse, or mishandling of instruments or accessories, such as on sharp edges, may cause injury to the patient, surgical personnel, or processing personnel.  ▪ Improper maintenance, handling, or inadequate cleaning procedures can render instruments or accessories  unsuitable for the intended purpose and may present a danger to the patient, surgical personnel, or processing 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. Breakage of an instrument or implant in this situation could be extremely hazardous. Physical characteristics required for many instruments do not permit them to be manufactured from implantable materials. If 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, as it could cause injury to the patient. ▪ Correct handling of accessories is extremely important. Do not modify accessories. Do not notch or bend accessories. Notches, scratches, wear, or other damage in accessories occurring during surgery may contribute to breakage.
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File Name: medtronic - M333023W134EU - Medtronic Reusable Instruments and Accessories Manual - 2021-01 - Rev A.pdf

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