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Instructions for use
MRI SAFETY INFORMATION
Many Acumed implants have been evaluated for safety in the MR environment. Consult our publication
"Acumed Implants in the MR Environment" at
LIFETIME
• 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 nail, end cap, hexalobe screw, and optional Tip-Loc™ bushing implants are manufactured from
Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
• The optional Tip-Loc™ set screw implant is manufactured from cobalt-chrome alloy (Co-Cr) per ASTM
F1537.
• Consult our document "Metal Sensitivity Statement" at
composition of 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.
www.acumed.net/ifu
for more information.
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.
www.acumed.net/ifu
U.S. English – US / PAGE 4
for the chemical
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