Legal Information - Ottobock 3R30 Gebrauchsanweisung

the gait of patients with higher activity and mobility levels, we recommend the 3R46 Ottobock
Modular Knee Joint with Hydraulic Regulator.
4.4 Cosmetic foam cover
Use Foam Cover 6R6 (3R6, 3S106) for joints 3R30/3R21.
Attention
Do not use talcum powder to eliminate noise in the cosmetic foam cover. Talcum draws
out grease from the mechanical components. This causes considerable mechanical
malfunctions and can result in blockage of the knee joint, in turn leading to the fall of
the patient. Therefore, using talcum with this medical device will render any warranty
claims against the manufacturer null and void.
Note
To reduce friction and to eliminate noise, apply 519L5 Silicone Spray directly onto the
contact surfaces of the cosmetic foam cover.
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.
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.
Note:
As a basic principle, all Ottobock knee joints are subjected to tests involving three million 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.

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.
12 | Ottobock 3R30/3R21