Legal Information - Otto Bock 3R60-PRO ST Instructions For Use Manual

Attention!
The knee joint must not be lubricated or greased, since this would result in a risk of
bearing damage and loss of function.
Attention! - Please inform your patients!
The knee joint function may be affected by both environmental and service conditions.
To reduce risk for the patient, the knee joint should not be used when noticeable func-
tional changes occur.
Noticeable functional changes may include poor response, incomplete extension, dimin-
ished swing phase control or stance phase stability, abnormal noises, etc. In extreme
cases of dynamic permanent loading, the hydraulic damping systems can heat up.
When using the knee joint do not reach into the joint mechanism since there is the risk
of injury.
Measure after noticeable functional changes have occurred:
Have the prosthesis examined at a specialist workshop.
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 adjustments
if necessary. Special attention should be paid to the flexion and extension resistances, bearings, and
abnormal noises. Full flexion and extension must be guaranteed.
This component has been tested according to ISO 10328 standard for three million
load cycles. Depending on the amputee's activity this corresponds to a duration of
use of three to five years.
We recommend carrying out regular yearly safety checks.

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.
3R60-PRO, 3R60-PRO=ST, 3R60-PRO=KD, 3R60-PRO=HD Ottobock | 23