Spectra sock
A Spectra sock is included to protect the foot shell and fiberglass components and minimize noise. It must be placed over the keel
and sole plates before mounting the foot shell.
NOTE: The H2O models are not intended to be worn with a foot shell. Therefore, they do not include a Spectra sock.
Foot shell
To install and remove the foot shell, use a shoehorn to prevent damage to the foot module.
Never remove the foot from the foot shell by pulling manually. Never use a screwdriver or any other inappropriate
instrument to remove it. This could damage the foot.
The H2O models are not intended to be worn with a foot shell. Doing so may damage the foot module.
10.
ADJUSTMENTS
If the patient still requests additional heel stiffness, use the heel wedges provided. These heel wedges use a double-sided sticker
so the lower face of the sole plate should be degreased before using. See figures below for correct wedge placement.
NOTE: The H2O models do not include heel wedges.
CORRECT HEEL WEDGE PLACEMENT
Install Heel Wedge on plantar surface of the sole plate
approximately 3.2 mm (1/8") forward from posterior end.
11.
TROUBLESHOOTING
If the patient notices any abnormal behavior or feel any changes in the characteristics of the device (noise, play, excessive
wear...), or if the device has received a severe impact, they should stop using the device and consult their prosthetist.
12.
WARNINGS
In case of damaged packaging, check the integrity of the device.
Never use the foot without a foot shell and a Spectra sock (except for H2O models).
Never loosen the pyramid fastening screws.
The patient must inform their prosthetist if they gain or lose significant weight.
Make sure that the foot and inside of the foot shell are free of impurities (e.g., sand). The presence of impurities causes
the fiberglass parts and the foot shell to wear out. Clean the foot according to the instructions (see §17).
After swimming or using in water, the foot including its foot shell must be cleaned (see §17).
Failure to follow the instructions for use is dangerous and will void the warranty.
13.
CONTRAINDICATIONS
Do not use for a patient whose maximum weight (load carrying included) may exceed 166 kg / 365 lbs.
Do not use for a patient who does not meet the requirements of an activity level of K3 or higher.
Do not use for activities associated with a risk of significant impact or excessive overloading.
14.
SIDE EFFECTS
There are no known side effects directly associated with the devices.
Any serious incident that has occurred in relation to the devices should be reported to the manufacturer and to the competent
authority of the Member State in which the user is established.
INSTRUCTIONS FOR USE
INCORRECT HEEL WEDGE PLACEMENT
Placement between components will adversely affect foot
performance.
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IFU-02-012