Össur ICELOCK 214, Instructions For Use Manual

Page: 8 / 115

8
REPORT OF SERIOUS INCIDENT
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
DISPOSAL
The device and packaging must be disposed of in accordance with
respective local or national environmental regulations.
LIABILITY
Össur does not assume liability for the following:
• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or
environment.
Compliance
This device has been tested according to ISO 10328 standard to three
million load cycles.
Depending on patient activity, this may correspond to 3-5 years of use.
ISO 10328 - P5 - 120 kg *)
*) Body mass limit not to be exceeded!
For specific conditions and limitations of use
see manufacturer’s written instructions on
intended use!