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3 – LIMITATIONS AND CONTRAINDICATIONS
Weight limit, activity level, carrying loads
Do not exceed the weight limits reported in the above chart. Risk of device failure.
Intended Life
This device has been tested according to ISO 10328 standard to two million load cycles.
Depending on the amputee’s activity this corresponds to two to three years of use.
For an extended use beyond this time frame, periodic safety checks are
recommended, taking into consideration the level and the type of activities performed
with the prosthetic leg, the user weight, the effective operating time of the product.
Inspect the device and discontinue the use in case of signs of wear or deterioration.
Environment
The device can be used in temperatures between -23° C (–10° F) and 93°C (200° F).
The device is weather proof: it is not intended for patient activities that will routinely
and repeatedly cause the foot to be submerged in salt or chlorinated water or to be
exposed to corrosive environments (such as sand, mud or salt water).
If occasional submersion/contact occurs, the following protocol must be followed by
a certified professional:
Remove foot shell and spectra sock
Rinse the foot shell, spectra sock, and the foot with tap water
Thoroughly dry the foot shell, spectra sock, ankle shank, foot keel, and
proximal pyramid components with a clean towel
A household hair dryer on a low to medium heat setting can be utilized to
facilitate the drying process