Legal Information - Ottobock 3R55 Gebrauchsanweisung

Attention!
To eliminate noise in the cosmetic foam cover, use 519L5 Silicone Spray. Do not use
talcum powder! Talcum powder reduces the lubrication of the mechanical parts, which
may lead to a malfunction and thus increase the risk of failure. Using this medical
product after application of talcum powder will render all claims against Otto Bock
HealthCare null and void.
Useful information
To optimise sliding and for eliminating noises, please apply 519L5 Silicone Spray directly
on the friction surfaces of the cosmetic foam covers.
4.5 Maintenance information
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 follow-up
adjustments if need be. Pay special attention to resistance to movement and the development of
unusual sounds. Complete flexion and extension must be guaranteed.
We recommend carrying out regular safety checks once a year.
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 loss of function has occurred. This
noticeable loss of function can be for example stiffness, non-attainment of the extension
stop, decreasing swing phase control or stance phase stability, abnormal noises, etc.
Measure
Have the knee joint examined at a specialist workshop.

5 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
5.1 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.
5.2 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.
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