Legal Information - Ottobock 4R88 Gebrauchsanweisung

The sliding adjustment is limited by the 506G3=M5×8 Stop Screw (Fig. 3
and 4). For adjustments in the opposite sliding direction, it must be moved.
Attention!
It is not permissible to use the sliding adapter without the 506G3=M5×8
Stop Screw, since this could make the adapter come loose and as
a result cause the patient to fall!
Tighten the stop screw using the 710D122 Torque Wrench.
Torque moment: 5 Nm (3.7 lbf.ft., 44 lbf.in).
4.1 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 country
of use and may vary accordingly.
5.1 Liability
The manufacturer will only assume liability if the product is used in accor-
dance 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 modi-
fication 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.
10 | Ottobock