Legal Information - Otto Bock 12K19 Instructions For Use Manual

Assembly
Refer to Assembly of 12K5=* / 12K20=* (Section 4.2.1).

5 Legal information

All legal conditions are subject to the respective national laws of the country
of use and may vary accordingly.
5.1 Liability
The manufacturer will only assume liability if the product is used in accor-
dance 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 modi-
fication of the product.
5.2 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.
16 | Ottobock