Application; Indications For Use; Conditions Of Use; Indications - Otto Bock Genium X3 3B5-3 Instructions For Use Manual

3 Application

3.1 Indications for use

The product is to be used solely for lower limb exoprosthetic fittings.

3.2 Conditions of use

The product was developed for everyday use and must not be used for unusual activities. These unusual activities
include, for example, extreme sports (free climbing, parachuting, paragliding, etc.).
Permissible ambient conditions are described in the technical data (see page 102).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
Our components perform optimally when paired with appropriate components based upon weight and mobility
grades identifiable by our MOBIS classification information and which have appropriate modular connectors.
The product is recommended for mobility grade 3 (unrestricted outdoor walker) and mobility
grade 4 (unrestricted outdoor walker with particularly high demands). Approved for a max. body
m°
weight of 150 kg (330 lbs).
kg

3.3 Indications

• For patients with knee disarticulation, transfemoral amputation or hip disarticulation
• For unilateral or bilateral amputation
• Dysmelia patients with residual limb characteristics corresponding to knee disarticulation, transfemoral ampu­
tation or hip disarticulation
• The patient must fulfil the physical and mental requirements for perceiving visual/acoustic signals and/or mech­
anical vibrations.

3.4 Contraindications

3.4.1 Absolute Contraindications

• Body weight over 150 kg

3.5 Qualification

The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding
training.
If the product is to be connected to an osseointegrated implant system, the qualified personnel must also be autho­
rised for the connection to the osseointegrated implant system.
Genium X3 3B5-3/3B5-3=ST
Application
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