Application; Indications For Use; Conditions Of Use; Indications - Otto Bock Genium 3B1-3 Instructions For Use Manual

Application

plied with for the implant system, corresponding exoprosthetic components, corresponding adapters and for the
knee joint.
Among other things, this relates to the body weight, mobility grade, type of activity, load capacity of the implant and
bone anchoring, freedom from pain under functional load and compliance with the permissible ambient conditions
(see Page 49).
Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but
also for the connection to the osseointegrated implant system.
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 49).
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.
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 outdoor walker with particularly
m°
high demands). Approved for a body weight of up to 150 kg (330 lbs).
kg
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 outdoor walker with particularly
m°
high demands). Approved for a body weight of up to 125 kg (275 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

3.4.2 Relative Contraindications

None.

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
authorised for the connection to the osseointegrated implant system.
14 Genium 3B1-3/3B1-3=ST