Application; Indications For Use; Conditions Of Use; Qualification - Ottobock Genium-Bionic Prosthetic System 3B1 Gebrauchsanweisung

Thanks to the microprocessor-controlled stance and swing phase, the product can be individually
adapted to your needs.
For this purpose, the product is adjusted by qualified personnel using adjustment software.
The product features MyModes for special motion types (e.g. cross-country skiing, ...). These are
pre-configured by the prosthetist using the adjustment software and can be activated with special
motion patterns, the cockpit app and the remote control (optional accessory) (see Page 89).
In case of a product malfunction, safety mode makes restricted operation possible. Resistance
parameters that are predefined by the product are configured for this purpose (see Page 92).
Empty battery mode permits safe walking when the battery is drained. Resistance parameters that
are predefined by the product are configured for this purpose (see Page 92).
The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
• Stability while standing and walking
• Adaptation of product characteristics to various surfaces, inclines, gait situations and walking
speeds

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 95).
The product is intended exclusively for use on one user. 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 appro­
priate modular connectors.
Knee joint with attached 2R20 AXON tube adapter
The product is recommended for mobility grade 2 (restricted outdoor walker),
mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted
m°
outdoor walker with particularly high demands). Approved for a body weight of up
kg
to 150 kg (330 lbs).
Knee joint with attached 2R21 AXON tube adapter with torsion
The product is recommended for mobility grade 2 (restricted outdoor walker),
mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted
m°
outdoor walker with particularly high demands). Approved for a body weight of up
kg
to 125 kg (275 lbs).

3.3 Qualification

The product may be fitted only by qualified personnel authorised by Ottobock after completing the
corresponding training.
Only valid for the products 3B1-2/3B1-2=ST
If the product is to be connected to an osseointegrated implant system, the qualified personnel
must also be authorised for the connection to the osseointegrated implant system.
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