acumed Anatomic Radial Head System Gebrauchsanweisung Seite 45

EN Instructions for use
LIFETIME
• The prosthesis has been tested at standardized conditions to establish a minimum service life of 1 million
cycles, which may be shorter than the life of the patient. Actual use conditions may affect the service life of
the prosthesis.
• Multiple-use instruments have a lifetime that is affected by usage, handling, and processing. Assess
multiple-use instruments for fitness during the pre-sterilization inspection.
• Sterile parts may be implanted up to the date of expiration indicated on the label.
STERILITY
• Implants and instruments may be provided either sterile or non-sterile as indicated on the label.
• Non-sterile devices are intended to be sterilized before use.
• Devices purchased and received sterile were exposed to a minimum dose of 25.0 kGy gamma radiation to
obtain a minimum sterility assurance level of 10
IMPLANTS
MATERIALS
• The radial head implant is manufactured from wrought cobalt-28chromium-6molybdenum alloy (UNS
R31537) per ASTM F1537.
• The stem implant is manufactured from wrought annealed titanium-6aluminum-4vanadium ELI (extra low
interstitial) alloy (UNS R56401) per ASTM F136.
• Consult our document "Metal Sensitivity Statement" at
Acumed metal implants.
SINGLE USE
• Implants are intended for single use only, as indicated on the label.
• Do not reuse single use implants as this may increase the risks of failure and cross-contamination.
• Dispose of any unused implant that is contaminated with human blood or tissue. Do not process a
contaminated implant.
IMPORTANT
• For safe and effective use, the surgeon must be thoroughly familiar with the implant, the methods of
application, instruments, and the recommended surgical technique.
• Physiological dimensions limit implant sizes. Select the type and size of implant that best meets the
patient's requirements for close adaptation and firm seating with adequate support.
• Implants are not designed to withstand the stresses of full weight or load bearing, or excessive activity.
• Improper selection or improper implantation of the device may increase the possibility of loosening or
migration.
• Only combine implants when they are intended for that purpose.
• Protect implants against scratching and nicking to prevent stress concentrations, which can result in failure.
• Prevent unused implants from becoming soiled.
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English (non-U.S.) – EN / PAGE 45
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