8 Legal Instructions
8.1 Liability
The manufacturer recommends using the device only under the specified conditions and for the
intended purposes. The device must be maintained according to the Instructions for Use. The
device must only be operated with tested modular components in accordance with the Otto Bock
MOBIS® Mobility System. The manufacturer is not liable for damage caused by component com-
binations that were not authorized by the manufacturer.
8.2 CE Conformity
This device meets the requirements of the 93/42/EEC guidelines for medical devices. This device
has been classified as a Class I device according to the classification criteria outlined in appendix
IX of the guidelines. The declaration of conformity was therefore created by Otto Bock with sole
responsibility according to appendix VII of the guidelines.
INFORMATION
Explanation of the warning symbol :
ISO 22675 – “P” – “m” kg*
)
*
)
Body mass limit not be exceeded!
For specific conditions and limitations of use see
manufacturer’s written instructions on intended use!
In the standard mentioned on the left, test levels
(P) are assigned to certain maximal body masses
(m in kg). In some cases, which are marked with
, no test level is assigned to the product-related
maximal body mass.
In these cases, the test loads have been adapted
adequately on the basis of the specified test level.
INFORMATION
This component has been tested according to ISO 22675 standard for two million load cycles.
Depending on the amputee’s activity this corresponds to a duration of use of two to three years.
We recommend carrying out regular yearly safety checks.
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