Transportation; Guaranty; Liability; Ce Conformity - Ottobock C-Leg Prosthetic System Instrucciones De Uso

3.4 Transportation

Always use the X-3C100 Shipping Case when transporting your electronic joint system and the Service Joint.

3.5 Guaranty

Ottobock offers an extensive guaranty service on the basis of the current C-Leg guaranty concept (see 646D241=*
C-Leg Service Card). Please comply with the prescribed service intervals (see Section 3.1 "Service Intervals"). For
your own interest, we also recommend obtaining a confirmation from your patients for the provision of instructions
and the handing over of the device.

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 Ottobock 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 3C88-2/3C98-2 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 Ottobock with sole respon-
sibility according to appendix VII of the guidelines.
The electronic 3C88-2/3C98-2 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 Ot-
tobock according to appendix IV of the guidelines. A copy of the declaration of conformity can be requested from
the manufacturer (see back side).
C-Leg Prosthetic System
C-Leg Service
USA: 800-328-4058
Canada: 800-665-3327
Great Britain: 1784 744 900
Ottobock 53