Indications; Contraindications; Absolute Contraindications; Relative Contraindications - Otto Bock Genium 3B1-3 Instructions For Use Manual

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3.3 Indications

For users with knee disarticulation, transfemoral amputation or hip disarticulation.
For unilateral or bilateral amputation
Dysmelia patients with residual limb characteristics corresponding to knee disarticulation,
transfemoral amputation or hip disarticulation
The user must fulfil the physical and mental requirements for perceiving optical/acoustic sig­
nals and/or mechanical 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.

4 Safety

4.1 Explanation of warning symbols

Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
Warning regarding possible technical damage.
NOTICE

4.2 Structure of the safety instructions

WARNING
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instruc­
tions. Consequences are presented as follows if more than one consequence is possible:
>
E.g.: Consequence 1 in the event of failure to observe the hazard
>
E.g.: Consequence 2 in the event of failure to observe the hazard
This symbol identifies activities/actions that must be observed/carried out in order to avert
the hazard.

4.3 General safety instructions

WARNING
Non-observance of safety notices
Personal injury/damage to the product due to using the product in certain situations.
Observe the safety notices and the stated precautions in this accompanying document.
WARNING
Using the prosthesis while operating a vehicle
Accident due to unexpected behaviour of the prosthesis because of changed damping beha­
viour.
10

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