Environmental Conditions; Description Of The Symbols; Regulatory Information - Proteor Kinterra Rm3 Notice D'utilisation

17.

ENVIRONMENTAL CONDITIONS

Temperature range for use and storage: -29°C to +49°C [-20°F to 120°F]
Relative air humidity: no restrictions
Water-resistance: Occasional submersion in fresh water for maximum 30 minutes in 1 m of water. Not recommended for a
shower prosthesis.
18. DISPOSAL
The device is made of carbon fiber and other composite fibers, aluminum, titanium, stainless steel, hydraulic fluid, rubber, and
epoxy. The foot shell is made of thermosetting polymer material. The device and its packaging must be disposed of in accordance
with local or national environmental regulations.
19.

DESCRIPTION OF THE SYMBOLS

Manufacturer
Authorized representative
in the European Union
20.

REGULATORY INFORMATION

This product is a CE-marked medical device and is certified as conforming with Regulation (EU) 2017/745.
INSTRUCTIONS FOR USE
Identified risk
Single patient,
multiple use
Page 5 of 5
CE marking and year of
st
1 declaration
IFU-02-005