6
No modification of the device.
The device should not be modified by cutting
or grinding the calf shank or foot keel; fasteners, set to the proper tension
and sealed with Loctite, should not be loosened. Any structural alterations or
adjustments made by the certified professional or by the patient may create
liability and will void the product warranty.
Warnings for the patient
Please explain this section to the patient before delivering the device.
Change in performance, weight, activity
o
Patient must immediately contact a certified professional and
discontinue the use of the device until an accurate inspection is
performed by the certified professional in the following cases:
o
there is a change or loss in device performance or functionality
o
unusual noise
o
the device shows signs of damage or wear
o
the patient has increased levels of physical activity with his prosthetic
leg
o
If the patient experiences a weight gain equal to or greater than 20 lbs
(9.1 kg)
•
Correct use and maintenance of the device
The patient should be further informed that:
o
wearing a shoe with an extreme heel height or walking barefoot may
result in a misalignment of the prosthetic leg and increase the risk of
falls
o
a regular visual check of the foot is recommended. Signs of wear that
may affect function should be reported to a certified professional
o
dry with a cloth after any contact with water or humidity
o
the device 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, a certified professional
should be contacted immediately
