Otto Bock Michelangelo Hand Transcarpal 8E550 Instructions For Use Manual page 16

3 Application
3.1 Indications for use
The 8E550 Michelangelo Hand Transcarpal is to be used exclusively for upper limb exoprosthet­
ic fittings.
3.2 Use/Field of Application
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.
3.3 Environmental conditions
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 prosthetic system is intended exclusively for use on one user. Use of the prosthetic system
by another person is not approved by the manufacturer.
Permissible ambient conditions are described in the technical data (see Page 24).
3.4 Service Life
The product is a wear part, which means it is subject to natural wear and tear. The service life
diminishes or increases depending on the individual level of use. Only when the instructions for
use are observed it is possible to achieve the maximal service life, in dependence of the level of
use.
This product has been tested by the manufacturer with 500,000 gripping cycles according to
internal testing procedures. Depending on the patient's activity level, this corresponds to a ser­
vice life of 5 years.
3.5 Qualification
Fitting a patient with the product may only be carried out by orthopaedic technicians who have
been authorised by Ottobock after completion of a corresponding training course.
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