PROTEOR DYNADAPT F10 Notice D'utilisation page 5

12. WARNINGS
In case of damaged packaging, check the integrity of the device.
Never use the foot without a foot shell.
Never loosen the pyramid fastening screws.
The patient must inform their prosthetist if they gain or lose significant weight.
Always use the foot with a sock and shoe. Failure to adhere to this advice may cause product failure, as well as serious
injury.
Make sure that the foot and inside of the foot shell are free of impurities (e.g., sand). The presence of impurities causes
the graphite parts to wear out. Clean the foot according to the instructions (see §16).
After swimming, using in water or if splashed by a liquid, the foot must be cleaned (see §16).
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.
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 activities associated with a risk of excessive overloading
14. SIDE EFFECTS
There are no known side effects directly associated with the device.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent
authority of the Member State in which the user is established.
15. MAINTENANCE AND CONTROL
No maintenance operation such as lubrication, work on the screws or other parts is required.
It is recommended that the foot be inspected by the prosthetist at least every six months to check for damage to any components
that may compromise the performance. Inspections at shorter intervals are recommended if the user is more active.
The Spectra sock and the foot shell should also be evaluated 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.
The lifetime of the foot depends upon the patient's level of activity.
The EVAQ8 models' components (tubing, inline filter, one-way valves housed inside the Valve Body Assembly, etc) may need
periodic cleaning or replacement during the life cycle of the system and are not replaceable under the warranty as it is considered
normal wear.
16. PERIODIC INSPECTION OF THE EVAQ8 SYSTEM
Visually inspect the tubing for kinks, cracks, or wear that may leak air into the system. Replace tubing if any of these
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conditions exist.
Remove the inline filter from tubing and look through it. If light can be seen, the filter is clean. If light is blocked, push air
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from a syringe through the inline filter from distal to proximal end (reverse of normal flow) to attempt to clear the
blockage. If blockage persists, the filter needs to be replaced.
The one-way valves contained in the vacuum heel may need to be cleaned and flushed with distilled water or isopropyl
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alcohol to ensure proper function. This procedure should only be done by a qualified professional.
INSTRUCTIONS FOR USE Page 4 of 6
IFU-01-036