Environmental Conditions - Ossur Flex-Foot Cheetah Gebrauchsanweisung

If the duration of loading the prosthesis is shorter compared to the
contralateral side:
• The foot module is too stiff
• The prosthesis is too long
• The foot is aligned too far posteriorly
NOTE: If you move the A-P position of the foot, there will be an effect on
hip flexion, stride length and trunk motion.
Maintenance
The device must be examined for splinters and/or delamination regularly
by a medical professional. Interval should be determined based on
patient activity.
Additionally, the Cheetah Xpanse must be examined for splinters and/or
delamination every three months by a medical professional if used for
long jump.
Cleaning and care
Clean with a soft cloth and a mild soap.

ENVIRONMENTAL CONDITIONS

The device can be used in temperatures between -15 °C to 50 °C.
The device is waterproof.
A waterproof device can be used in a wet or humid environment and
temporarily submerged in shallow fresh water.
Dry thoroughly after contact with fresh water.
No salt water or chlorinated water allowed.
Clean with fresh water in case of accidental exposure to salt water or
chlorinated water.
REPORT A SERIOUS INCIDENT
Important notice to users and/or patients established in Europe:
The user and/or patient must report any serious incident that has
occurred in relation to the device to the manufacturer and the competent
authority of the Member State in which the user and/or patient is
established.
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 two
million load cycles.
The load level specification is shown in the tables below.
The device service life cannot be determined since load varies depending
on the sport and patient activity level.
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