Intended Use - Otto Bock Michelangelo Hand 8E500 Instructions For Use Manual

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2.2 Combination possibilities
This product is to be combined exclusively with components in the Axon-Bus prosthetic system.
Components of the Ottobock MyoBock system or components from other manufacturers cannot
be used with this product.

3 Intended use

3.1 Indications for Use
The Michelangelo Hand 8E500 is to be used exclusively for exoprosthetic fittings of the upper
limbs.
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, sports which involve excessive strain and/or shocks to the
wrist joint (pushups, downhill racing, mountain biking, ...) or extreme sports (free climbing,
paragliding, etc.). Furthermore, the product should not be used to operate motor vehicles, heavy
equipment (e.g. construction machines), industrial machines or motor-driven equipment.
The product is intended exclusively for use on one patient. Use of the product by another person
is not approved by the manufacturer.
Permissible ambient conditions are described in the technical data (see page 14).
3.3 Indications
Amputation level transradial and transhumeral
For unilateral or bilateral amputation
Dysmelia of the forearm or upper arm
The user must be able to understand usage instructions and safety notices and put them into
practice.
The patient must fulfil the physical and mental requirements for perceiving visual/acoustic sig­
nals and/or mechanical vibrations.
3.4 Contraindications
All conditions which contradict or go beyond the specifications listed in the section on
"Safety" and "Indications for use".
3.5 Qualification
The fitting of a patient with the product may only be carried out by O&P professionals who have
been authorised with the corresponding Ottobock training.
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
5

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