PROTEOR KINTERRA RM3 Notice D'utilisation page 10

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Rapid knee flexion moment, instability at heel
Heel too hard strike.
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Lack of energy return sensation at heel strike.
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Foot module Flat spot in rollover motion.
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too stiff
Difficult to progress over toe.
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Foot module Clicking noise at initial contact.
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too soft
Excessive toe deflection.
12. WARNINGS
In case of damaged packaging, check the integrity of the device.
Failure to follow the instructions for use is dangerous and will void the warranty.
Advise users to practice driving, sitting, and standing with the Kinterra in a safe place to ensure they adjust to the plantar
and dorsiflexion movement provided by the ankle.
Never use the foot module without a foot shell and a spectra sock. Failure to comply may cause premature wear, loss of
function, and/or product failure.
Always use the foot module with a shoe. Failure to comply may cause premature wear, loss of function, and/or product
failure.
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 and the foot shell to wear out. Clean the foot according to the instructions (see §16).
Never attempt to loosen the bolts affixing the ankle to foot.
If the patient notices any abnormal behavior or feels 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.
The patient must inform their prosthetist if they lose or gain weight.
Avoid prolonged use in water. Extended exposure to moisture may have a negative impact on the life of the product.
After use in water, completely dry the foot, including its foot shell.
Avoid prolonged use in salt or chlorinated water. Extended exposure to these environments may have a negative impact
on the life of the product. After use in these environments, the foot including its foot shell must be cleaned and dried
(see §16).
13. CONTRAINDICATIONS
Use for a patient whose maximum weight (load carrying included) may exceed 150 kg / 330 lb.
Use for K4 patient or activities associated with a risk of significant impact or 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
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 wear of the foot module.
The lifetime of the foot depends upon the patient's level of activity.
16. CLEANING
Remove the foot shell and the spectra sock, clean the foot with soap and clear water and dry carefully.
The foot shell can be cleaned with a damp cloth or sponge. It must be dried before reuse.
The device is not resistant to solvents. Exposure to solvents may cause damage.
INSTRUCTIONS FOR USE
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Check anteroposterior alignment, ensure foot is
not positioned too far posterior.
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Reduce plantarflexion resistance.
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Assess true impact level (low or moderate).
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Consider a lower category foot module.
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Assess true impact level (low or moderate).
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Consider a higher category foot module.
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IFU-02-005