Description Of The Symbols; Regulatory Information - PROTEOR 1M115 Instrucciones De Uso

The warranty excludes deterioration caused by misuse, unsuitable alignment, use in a very dusty environment and without
suitable protection, or any inappropriate use.
Avoid exposing the knee to environments that could cause corrosion of the metal parts (soft water, seawater, chlorinated water,
acids, etc.).
It is prohibited to shower or bathe with the prothesis, as this could degrade its resistance and performance.
Never use this device near a heat source: risk of burns.
Use of solvents is prohibited.
C. Side effects
There are no side effects directly linked to the device.
Any serious incident arising in relation to the device must be reported to the manufacturer and to the competent authority of the
Member State.
9. CARE, STORAGE, DISPOSAL AND SERVICE LIFE
A. Care/ cleaning
You can clean the knee using a wet sponge
Do not immerse it or expose it to water
After a storm (rain) or inadvertent splashing, the knee must be dried.
The extension return may require replacement, and can be ordered separately.
B. Storage
Usage and storage temperature: -10°C to +40°C
Relative air humidity: no restrictions
C. Disposal
The various components of this device are special waste: elastomer, titanium, steel and brass. They must be treated in accordance
with the locally applicable legislation.
D. Service life
It is advisable to arrange for an orthopaedic prosthetist to perform an annual check.

10. DESCRIPTION OF THE SYMBOLS

Manufacturer

11. REGULATORY INFORMATION

This product is a CE marked medical device, and certified compliant with Regulation (EU) 2017/745
12. 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
[email protected] – www.proteor.com
USER MANUAL
Risk identified CE marking and year of 1st declaration
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