Legal Information - Otto Bock 2R2 Instructions For Use Manual

Adjustment
The 4 set screws can be used to make static adjustments at any time during
alignment, trial fittings, and even after the prosthesis is finished.
Replacement and Disassembly
When replacing or disassembling the prosthesis component, the previously
adjusted position can be maintained if the two deepest screwed-in set
screws, which are NOT located opposite to each other, are removed.
6 Maintenance
• The prosthesis components should be inspected after the first 30 days of
use.
• Inspect the entire prosthesis for wear during normal consultations.
• Conduct annual safety inspections.
7 Disposal
This product may not be disposed of with regular domestic waste in all juris­
dictions. Disposal that is not in accordance with the regulations of the coun­
try where the product is used may have a detrimental impact on health and
the environment. Please observe the information provided by the responsible
authorities in the country of use regarding return and collection processes.

8 Legal Information

All legal conditions are subject to the respective national laws of the country
of use and may vary accordingly.
8.1 Liability
The manufacturer will only assume liability if the product is used in accord­
ance with the descriptions 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.
8.2 CE Conformity
This product meets the requirements of the European Directive 93 / 42 / E EC
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 manufacturer
with sole responsibility according to Annex VII of the directive.
18 | Ottobock