Liability; Trademarks; Ce Conformity - Otto Bock Genium X3 Instructions For Use Manual

Liability

INFORMATION
Since the trochanter is often difficult to recognise as a reference point or because of changes in the hip and
pelvic region due to the amputation, this process to determine the socket reference point as the assumed hip
rotation point is intended to facilitate prosthesis alignment
INFORMATION
If the LASAR/PROSA Assembly is used, the socket reference point must be marked when the prosthesis
is already secured in the alignment unit
This is due to the 5° outward rotation of the prosthesis in the alignment unit
9 Liability
The product may only be used under the specified conditions and for the intended purpose, and in conjunction
with the modular component combinations tested for the prosthesis, in accordance with the Ottobock MOBIS
mobility system, and in accordance with the instructions for use The manufacturer is not liable for damage
caused by component combinations that were not authorised by the manufacturer

10 Trademarks

All product names mentioned in this accompanying document are subject without restriction to the respective
applicable trademark laws and are the property of the respective owners All brands, trade names or company
names may be registered trademarks and are the property of the respective owners
Should trademarks used in this accompanying document fail to be explicitly identified as such, this does not justify
the conclusion that the respective designation is free of third-party rights

11 CE Conformity

The knee joint 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 Ottobock with sole responsibility according to Appendix VII of
the guidelines
The knee joint also meets the requirements of the 1999/5/EC Directive for radio equipment and telecommu-
nications terminal equipment Conformity assessment was carried out by Ottobock according to Appendix IV
of the directive A copy of the declaration of conformity can be requested from the manufacturer (see back page)
34 | Ottobock
Service Numbers
USA:
Germany:
Austria:
Canada:
Great Britain:
+1 800-328-4058
(+49) 55 27 848-3333
(+43) 1-523 37 86 430
+1 800-665-3327
(+44) 1784 744 900
Genium X3 - Bionic Prosthetic System