Legal Information - Otto Bock 17BK2 Series Instructions For Use Manual

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  • ENGLISH, page 12
2) Slightly flex the orthosis against the tension until the lock disengages
with audible feedback.
The orthosis moves freely and the preconfigured corrective spring force
is in effect.
If the orthosis is not used for extended periods of time, disengage the lock
in order to prevent premature fatigue of the spring.
5 Further usage restrictions
The product is designed for use on one patient only. Re-use of the product
is not permitted.
The duration of use and the period of therapy depend on the medical indi-
cation and the treating technician.

6 Legal information

All legal conditions are subject to the respective national laws of the country
of use and may vary accordingly.
6.1 Liability
The manufacturer will only assume liability if the product is used in accord-
ance with the descriptions and instructions provided in this document. The
manufacturer will not assume liability for damage caused by disregard of
this document, particularly due to improper use or unauthorised modifica-
tion of the product.
6.2 CE conformity
This product meets the requirements of the European Directive 93 / 42 / EEC
for medical devices. This product has been classified as a class I device
according to the classification criteria outlined in Annex IX of the directive.
The declaration of conformity was therefore created by the manufacturer
with sole responsibility according to Annex VII of the directive.
Ottobock | 19

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