Maintenance Instructions; Legal Information - Ottobock 4R91 Instrucciones De Uso

Attention!
(Applies to the application of the Tube Adapters 2R57; 2R58;
2R76; 2R77 and Tube Clamp Adapters 4R82; 4R91)
For testing: with the torque wrench 710D4, screw in the set
screws 506G3 of the Adapter clockwise at 10 Nm (7.4 lbf. ft /
88.5 lbf. in).
For finalizing the prosthesis: secure the set screws 506G3
with Loctite 636K13, tighten the set screws clockwise at 10 Nm
(7.4 lbf. ft / 88.5 lbf. in) first and then tighten completely at 15 Nm
(11.1 lbf. ft / 133 lbf. in).

4.3 Maintenance instructions

Note:
As a basic principle, all Ottobock modular adapters 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 coun-
try of use and may vary accordingly.
5.1 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 modifica-
tion 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 manufacturer
with sole responsibility according to Annex VII of the directive.
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