acumed Anatomic Radial Head System Gebrauchsanweisung Seite 5

US Instructions for use
• The color of anodized implants may change over time due to processing. This color change does not
affect the mechanical properties of the implants.
INSTRUMENTS
MATERIALS
The instruments are manufactured from various grades of titanium, stainless steel, aluminum, silicone, Radel,
and Ultem.
MULTIPLE USE and SINGLE USE
• Instruments are intended for multiple use unless identified on the label for single use only.
• Single use instruments are intended to be disposed after use on a single patient during a single procedure.
• Do not reuse single use instruments as this may increase the risks of failure and cross-contamination.
• Multiple use instruments are only intended for use on a single patient and a single procedure before
requiring processing.
• Multiple (limited) use instruments, such as drills and reamers, have a limited lifespan. Immediately replace
any multiple use instrument if performance becomes inadequate.
• Multiple use instruments potentially contaminated with transmissible spongiform encephalopathy (TSE)
agents shall not be processed for reuse.
IMPORTANT
• Protect instruments against scratching and nicking to prevent stress concentrations, which can lead to
instrument failure.
• Near the point of use: Wipe excess contamination from instruments and prevent any soil from drying.
Instruments with substantial or dried soil are particularly difficult to reliably process. Transport contaminated
instruments for processing as soon as possible after use.
• Avoid prolonged instrument contact with iodine and saline.
• Handle and transport soiled instruments in a manner that avoids contamination of any unused implants.
PROCESSING
Important: Processing personnel must be qualified with suitable training and experience. Use proper
personal protective equipment (PPE) when working with contaminated devices.
IMPORTANT
• Promptly perform the processing steps to limit microbial growth and maximize the effectiveness of
sterilization.
• Inspect implants for contamination by blood or tissue and dispose of them when found. Do not process
contaminated implants.
U.S. English – US / PAGE 5