Liability; Ce Conformity - Otto Bock C‑Leg 3C98-1 Manual De Instrucciones

3.6 Liability

The device is only to be used under the specified conditions and for the intended purposes. The device must be
maintained according to the Instructions for Use. The device must only be operated with tested modular compo-
nents in accordance with the Otto Bock Mobility System. The manufacturer is not liable for damage caused by
component combinations that were not authorized by the manufacturer.

3.7 CE Conformity

The electronic 3C88-1/3C98-1 C-Leg® Prosthesis System meets the requirements of the 93/42/EEC guidelines for
medical devices. This product 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 Otto Bock with sole respon-
sibility according to appendix VII of the guidelines.
The electronic 3C88-1/3C98-1 C-Leg® Prosthesis System also meets the requirements of the 1999/5/EC guidelines
for radio equipment and telecommunications terminal equipment. Conformity assessment was carried out by Otto
Bock according to appendix II and appendix III of the guidelines. A copy of the declaration of conformity can be
requested from the manufacturer (see back side).
C-Leg® Service
USA: 800-328-4058
Canada: 800-665-3327
Great Britain: 1784 744 900
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