Liability
Genium - Bionic Prosthetic System
68 | Ottobock
Liability
Genium - Bionic Prosthetic System
68 | Ottobock
11 Liability
The product may only be used under the specified conditions and for the intended purpose, and in conjunction with
the modular component combinations tested for the prosthesis in accordance with MOBIS, the Ottobock MOBIS
mobility system, and must be maintained in accordance with the instructions for use. The manufacturer is not liable
for damage caused by component combinations that were not authorised by the manufacturer.
12 Trademarks
All product names mentioned in this accompanying document are subject without restriction to the respective appli-
cable trademark laws and are the property of the respective owners. All brands, trade names or company names may
be registered trademarks and are the property of the respective owners.
Should trademarks used in this accompanying document fail to be explicitly identified as such, this does not justify the
conclusion that the respective designation is free of third-party rights.
13 CE conformity
The 3B1/ 3B1=ST Knee Joint meets the requirements of the 93/42/EEC guidelines for medical devices. This device
has been classified as a class I device according to the classification criteria outlined in appendix IX of the guidelines.
The declaration of conformity was therefore created by Ottobock with sole responsibility according to appendix VII
of the guidelines.
The 3B1/ 3B1=ST Knee Joint also meets the requirements of Directive 1999/5/EC for radio equipment and telecom-
munications terminal equipment. The declaration of conformity was created by Ottobock according to appendix IV of
the guidelines. A copy of the declaration of conformity can be requested from the manufacturer (see reverse).
