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).
19.
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.
20.
DESCRIPTION OF THE SYMBOLS
Manufacturer
Authorized representative
in the European Union
21.
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 7 of 7
CE marking and year of
st
1
declaration
IFU-02-005