Intended Use - Otto Bock Michelangelo Hand Transcarpal 8E550 Instructions For Use Manual

3 Intended use

3.1 Indications for use
The 8E550 Michelangelo Hand Transcarpal is to be used exclusively for upper limb exoprosthet­
ic fittings.
3.2 Conditions of use
The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusu­
al activities. These unusual activities include, for example, sports with excessive strain and/or
shocks to the socket connection (pushups, downhill racing, mountain biking, ...) or extreme
sports (free climbing, paragliding, etc.). Furthermore, the Axon-Bus prosthetic system should not
be used for the operation of 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 13).
3.3 Indications
The 8E550 Michelangelo Hand Transcarpal can be used for unilateral or bilateral amputees from
a transradial to transcarpal amputation level or in the case of dysmelia of the forearm.
• 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
> 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.
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