Össur VARI-FLEX XC Instrucciones De Uso página 7

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FLEX-FOOT SOCK

The toe end of the sock is divided by a thread and fits within the toe split.

Upon fitting the sock, hold the top of the toe thread and slide the sock

into the toe split. The thread of the sock should rest on top of foot

module and not underneath the toe split. The sock should be loose from

the heel area and secured proximally with the cable tie provided.

SHOE HORN (Figure 5 & 6)

When removing and installing the cover use shoehorn to avoid damage

to foot or cover.

LIABILITY

The manufacturer recommends using the device only under the specified

conditions and for the intended purposes. The device must be

maintained according to the instructions for use. The manufacturer is

not liable for damage caused by component combinations that were not

authorized by the manufacturer.

CE CONFORMITY

This device meets the requirements of the 93/42/EEC guidelines for

medical devices. This device has been classified as a class I device

according to the classification criteria outlined in appendix IX of the

guideline.

COMPLIANCE

This component has been tested according to ISO 10328 standard to two

million load cycles. Depending on the amputee's activity this

corresponds to a duration of use of two to three years. We recommend

carrying out regular yearly safety checks

ISO

- "P" - "m"kg *)

Body mass limit not to be exceed!

For speci c conditions and limitations of use see

manufacturer's written instructions on intended use!

have been adapted adequately on the basis of the specified load level.

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