Otto Bock Genium X3 Series Patient Information page 28

Bionic prosthetic system
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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
the Ottobock MOBIS mobility system, and in accordance with the instructions� The manufacturer is not
liable for damage caused by component combinations that were not authorised by the manufacturer�
Trademarks
All product names mentioned in this accompanying document are subject without restriction to the
respective applicable 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�
CE Conformity
The Genium X3 3B5-X3/3B5-X3=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 Genium X3 3B5-X3/3B5-X3=ST knee joint also meets the requirements of Directive 1999/5/
EC for radio equipment and telecommunications terminal equipment� The conformity assessment
was carried out by Ottobock according to Appendix I of the directive� A copy of the declaration of
conformity can be requested from the manufacturer (see reverse)�
28 | Ottobock
Genium X3 - Bionic Prosthetic System

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