Ossur Vari-Flex Gebrauchsanweisung Seite 7

Inhaltsverzeichnis

Verfügbare Sprachen

It can also tolerate occasional exposure to sand, dust, and dirt. Continuous exposure is not

allowed.

A Weatherproof device can be used in a wet or humid environment and can tolerate being

splashed by fresh water (e.g., rain), no submersion is allowed.

No contact with salt water or chlorinated water is allowed.

Dry with a cloth after contact with fresh water or humidity.

Clean with fresh water after exposure to other liquids, chemicals, sand, dust, or dirt and dry with

a cloth.

MAINTENANCE

The device and the overall prosthesis should be examined by a healthcare professional. Interval

should be determined based on patient activity.

Noise from Foot

Noise may occur if sand or debris is present in device. In that case, the healthcare professional

should doff the foot, clean it with the help of compressed air and replace the Spectra sock if it is

damaged.

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 prosthetic devices are designed and verified to be safe and compatible in combination with

each other and custom-made prosthetic sockets with Össur adapters, and when used in

accordance with their intended use.

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.

Depending on patient activity this may correspond to 2-3 years of use.