Legal Information - Otto Bock 3R93 Instructions For Use Manual

INFORMATION
This component has been tested according to the ISO 10328 standard for three million load cy-
cles. Depending on the amputee's activity this corresponds to a service life of three to five years.
We recommend carrying out regular safety checks once a year.
INFORMATION
When using exoprosthetic knee joints, servomotor, hydraulic, pneumatic or brake load depend-
ent control functions can cause movement noise. This kind of noise is normal and unavoidable.
Usually, it does not cause any problems.
If movement noise increases noticeably during the life cycle of the the knee joint, the joint should
be inspected by a prosthetist immediately.
Ottobock recommends readjusting the knee joint settings once the patient has gotten used to the
prosthesis. This period of time varies depending on individual patient characteristics.
Please check the knee joint for wear and proper function once a year and make adjustments, if
necessary. Special attention should be paid to movement resistance, changed brake tolerance
and abnormal noises. Full flexion and extension must be guaranteed.
Do not disassemble the joint. If you have a problem, please send the complete joint to Ottobock
for repair.

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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