Legal Information - Otto Bock 3R106 Instructions For Use Manual

Attention!
Do not use talcum powder to eliminate noise in the cosmetic foam cover. 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 null and void.
Note:
To eliminate noise, please apply Silicone Spray (519L5) directly on the contact surfaces
of the cosmetic foam cover.
4.6 Maintenance instructions
Attention!
The knee joint must not be lubricated or greased, since this would result in a risk of
bearing damage and loss of functionality.
Do not use any aggressive cleaning agents since they could cause damage to bear-
ings, seals and plastic parts.
Do not disassemble the knee joint! If you have a problem, please send the knee joint
in for service.
As a basic principle, all Ottobock knee joints are subjected to tests involving three mil-
lion load cycles. 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
Ottobock recommends readjusting the knee joint's 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 at least once a year and make adjust-
ments if necessary. Special attention should be paid to the flexion and extension resistances,
bearings, and abnormal noises. Full flexion and extension must be guaranteed.
5 Disposal
In some jurisdictions it is not permissible to dispose of the product with unsorted household waste.
Improper disposal can be harmful to health and the environment. Observe the information provided
by the responsible authorities in your country regarding return, collection and disposal procedures.

6 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
6.1 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.
6.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745on medical devices. The CE
declaration of conformity can be downloaded from the manufacturer's website.
20 | Ottobock 3R106, 3R106=KD, 3R106=ST, 3R106=HD