Legal Information - Otto Bock 3R46 Instructions For Use Manual

Attention - Please inform your patients !
The knee joint function can be altered by environmental conditions and type of use. To
avoid risk to the patient, the knee joint should not be used after noticeable functional
changes have taken place. Noticeable functional changes may include, among others,
poor response, incomplete extension, diminished swing phase control or stance phase
stability and abnormal noises.
Action to be taken
Have the prosthesis examined at a specialist workshop.
4.5 Maintenance instructions
Ottobock recommends readjusting the knee joint settings once the patient has gotten used to the
prosthesis. The duration of this breaking-in period may differ from patient to patient. Check the
knee joint for wear and proper function at least once a year and make adjustments if necessary.
When doing so, pay special attention to the resistance to movement and to the development of
unusual noise. A complete flexion and extension must be ensured.
We recommend carrying out regular safety checks once a year.
Attention!
Proceed with caution and in small increments when adjusting the resistances, since
there is the risk of falling!
When making extension damping adjustments, make sure that the leg still comple-
tely extends with each step. When adjusting the swing phase control, the influence of
a cosmetic foam cover must be compensated for.

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 out-
lined in Annex IX of the directive. The declaration of conformity was therefore created by the
manufacturer with sole responsibility according to Annex VII of the directive.
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