9.
ASSEMBLY
After dynamic alignment, tighten the pyramid adjustment screws according to the specifications of the connector manufacturer.
Secure pyramid adjustment screws with a thread locking adhesive (e.g., Loctite 242).
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.
Foot shell
To install and remove the foot shell, use a shoehorn to prevent damage of 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.
10.
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.
11.
WARNINGS
In case of damaged packaging, check the integrity of the device.
Never use the foot without a foot shell and a Spectra sock.
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 §15).
After swimming or using in water, the foot including its foot shell must be cleaned (see §15).
Failure to follow the instructions for use is dangerous and will void the warranty.
12.
CONTRAINDICATIONS
Do not use for a patient whose maximum weight (load carrying included) may exceed 166 kg / 365 lbs (RUSH ROVER) or
61 kg / 135 lbs (RUSH Kid).
Do not use for a patient who do 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.
13.
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.
14.
MAINTENANCE AND CONTROL
No maintenance operation such as lubrication, work on the screws or other parts is required.
The foot module must be inspected by the prosthetist at least every six months. Inspections at shorter intervals are required if the
user is more active.
The Spectra sock and the foot shell must be replaced by the prosthetist at regular intervals, depending on the patient's level of
activity. If these parts are damaged, it can lead to premature foot wear.
15.
CLEANING
Remove the foot shell and the Spectra sock, rinse the foot in clear water, clean it with neutral soap and dry carefully.
INSTRUCTIONS FOR USE
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IFU-02-013