Intended Use - Otto Bock 8E70 Series Instructions For Use Manual

Note the instructions for use
This document contains the sections "Intended use" and "Safety", and does not
replace the instructions for use. The instructions for use are available in digital
form (PDF format) (see page 2 of this document). To view PDF files, you need an
Internet browser or other program capable of opening this file format.
You may request a printed copy of the instructions for use under the link on page
2. This will be delivered to the specified address within 7 days after the order is
received.
The products "8E70=* bebionic hand EQD, 8E71=* bebionic hand Short Wrist and 8E72=*
bebionic hand Flex" are referred to as the product/terminal device/hand in the following.
8E70=* Basic UDI-DI: 40644110000000008E550LE
8E71=* Basic UDI-DI: 406441100000000008E71HM
8E72=* Basic UDI-DI: 406441100000000008E72HP

2 Intended use

2.1 Indications for use
The product is intended exclusively for upper limb exoprosthetic fittings.
2.2 Conditions of use
The product is intended exclusively for use on one user. Use of the product by another person is
not approved by the manufacturer.
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.
Permissible ambient conditions are described in the technical data (Technical data).
2.3 Indications
• Amputation level below-elbow, above-elbow and shoulder disarticulation
• For unilateral or bilateral amputation
• Dysmelia of the forearm or upper arm
• The patient must be able to understand usage and safety messages and put them into prac­
tice.
• The patient must fulfil the physical and mental requirements for perceiving visual/acoustic sig­
nals and/or mechanical vibrations.
2.4 Contraindications
• All conditions which contradict or go beyond the specifications listed in the section on
"Safety" and "Indications for use".
2.5 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.
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
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