Otto Bock Genium Patient Information page 22

Bionic prosthetic system
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AXON Tube Adapter
Description
Weight
Material
Body weight max.
Water-resistance of the AXON tube
adapter
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. The manufacturer is not
liable for damage caused by component combinations that were not authorised by the manufacturer.
CE Conformity
The 3B1/ 3B1=ST 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 3B1/ 3B1=ST knee joint also meets the requirements of Directive 1999/5/EC for radio equipment
and telecommunications terminal equipment. The conformity assessment was carried out by Ottobock
according to Appendix I of the directive. A copy of the declaration of conformity can be requested from
the manufacturer (see reverse).
46 | Ottobock
2R20
190-300 g / 0.42-0.66 lbs
150 kg (330 lbs.)
IPX4, protected against splashed water from any direction,
but not against submersion, jets of water or steam.
2R21 (torsion unit)
435-545 g / 0.96-1.20 lbs
Aluminium
125 kg (275 lbs.)
Genium - Bionic Prosthetic System

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