Environmental Conditions - Ossur Flex-Run Junior Gebrauchsanweisung

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.
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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