Legal Information - Ottobock 3R20 Gebrauchsanweisung

Attention! Please inform your patients.
Due to different environmental conditions and conditions of application, the function of
the knee joint can be impaired. To avoid the risk of accident and possible injury to the
patient, the knee joint must no longer be used after a noticeable change of function has
occurred. This noticeable change of function can be for example stiffness, non-attain-
ment of the extension stop, decreasing swing phase control or stance phase stability,
abnormal noises, etc.
Measure
Have the knee joint examined by a specialist workshop.
Ottobock recommends the readjustment of the knee joint's settings after the patient has spent a
period of time getting used to the prosthesis. This period of time varies depending on individual
patient characteristics.
Please check the wear and functionality of the knee joint at least once a year and make readjust-
ments if need be. Pay special attention to resistance to movement and the development of unusual
noises. Complete flexion and extension must be guaranteed.

8 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
8.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip-
tions 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
modification of the product.
8.2 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 manufac-
turer with sole responsibility according to Annex VII of the directive.
16 | Ottobock 3R20, 3R36