PROTEOR HYDEAL II Instrucciones De Uso página 12

8. WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS
A. Warnings
Caution, the patient may need to take time to get used to a new knee.
To reduce the risk of falling when going down stairs, it is advisable to hold on to handrail.
So as not to damage the knee, do not apply talcum powder to eliminate rubbing noises - use silicon spray instead. Talc degrades
the mechanical components, which might cause a malfunction and possibly a fall.
PROTEOR disclaims all liability if talcum powder is used.
It is possible to trap a finger or pinch clothing in the knee joint. To avoid the any injury caused by the movement of the joint, make
sure that no-one's hand or fingers is near the mechanism.
The knee is resistant to bad weather, but needs to be dried if it does get wet.
B. Contraindications
The following are strictly prohibited: removing the covers, screwing in or unscrewing any screws on the knee with the exception of
the two adjustment screws (E and F) and the two tightening screws (V1 and V2) on the Ø34 tube clamp adapter.
It must be possible to rotate the extension assist cylinder R. Never tighten it fully so that it can be loosened if necessary.
Never lubricate the knee pins; this can cause them to degrade rapidly.
The knee has been designed for patients with a maximum weight of 125 kg (including carried load). If overloaded, a safety feature
releases the hydraulic system which can lead to rapid flexion of the knee.
If a load is being carried, the operation of the knee may be disrupted. Particularly, the resistance when going down stairs may be
insufficient, or the knee may lock up suddenly.
If the patient's weight increases significantly, he or she should arrange for the prosthetist/orthotist to readjust the knee's safety
settings.
The warranty does not cover damage or degradation caused by misuse, unsuitable alignment, use without suitable protection in
a very dusty environment or any other inappropriate use.
The knee should not be exposed to environments which might induce corrosion of the metal components (fresh water, sea water,
chlorinated water, acids, etc.).
Showering or taking a bath while wearing the prosthesis is prohibited; this might impair its properties and its correct operation.
Intensive use of the knee brake (e.g. due to a prolonged period of walking down a slope or stairs) may cause the hydraulic system
to overheat and the braking effect to diminish. Do not touch the knee and reduce the activity level to give the components time to
cool down.
Never leave this device near a source of heat since it might burn or release toxic fumes.
If used in very cold (<10°C) or very hot (>40°C) conditions the behaviour of the knee may change significantly. In this case, take
precautions when walking and going down slopes or stairs.
The use of solvents is prohibited.
C. Side effects
There are no side effects directly associated with the device.
Any serious incident that occurs which relates to the device must be reported to the manufacturer and to the competent authority of
the member state in which the incident occurred.
9. MAINTENANCE, STORAGE, DISPOSAL AND SERVICE LIFE
A. Maintenance/cleaning
You can clean the knee using a damp sponge
Do not immerse the knee or hold it under running water
Dry you knee if it is exposed to bad weather (rain) or accidental splashing.
The following components may need to be replaced:
•
Spare extension stop: EE015 (x1) to be bonded using PROTEOR XC051 glue
•
Spare maximum flexion stop: EY001 (x1), self-adhesive
B. Storage
Service and storage temperature: -10°C to +40°C
INSTRUCTIONS FOR USE Page 5 of 6