Description Of The Symbols; Regulatory Information - PROTEOR HYTREK Instrucciones De Uso

If your weight increases significantly, arrange for your 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.
8. 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.
B. Storage
Service and storage temperature: -10°C to +40°C
Relative humidity of the air: no restrictions
C. Disposal
The various components of this device are considered as special waste: elastomer, plastic, aluminium, titanium, steel, brass and oil.
They must be treated in accordance with current, applicable legislation.
D. Service life
It is advisable to arrange for a prosthetist/orthotist to check the product once a year.

9. DESCRIPTION OF THE SYMBOLS

Manufacturer

10. REGULATORY INFORMATION

This product is a CE-marked medical device that is certified as conforming with regulation (EU) 2017/745
11. NAME AND ADDRESS OF MANUFACTURER
PROTEOR SAS
6 rue de la Redoute – 21850 Saint-Apollinaire – France
Tel.: +33 3 80 78 42 42 – Fax: +33 3 80 78 42 15
cs@proteor.com – www.proteor.com
INSTRUCTIONS FOR USE
Identified risk
CE marking and year of first declaration of
conformity
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