acumed Polarus Instrucciones De Uso página 4

US Instructions for use
Important: The instruments and implants in this system are intended to be used by suitably trained
and qualified surgeons in a hospital operating room setting. Before treatment, the surgeon is
advised to read and fully understand all instructions and communicate to the patient any relevant
medical information provided therein, including the use, limitations, risks (safety communications),
and possible adverse effects of the proposed treatment.
Consult the most recent versions of the Instructions for Use and Surgical Techniques as they are
subject to change. Contact Acumed or an authorized agent to request any additional information.
MRI SAFETY INFORMATION
The implants have not undergone testing 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 implants are made of PEEK, or titanium alloy per ASTM F136.
• 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.
www.acumed.net/ifu for more information.
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www.acumed.net/ifu
U.S. English – US / PAGE 4
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