1 Foreword
English
INFORMATION
Date of last update: 2022-02-09
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Please read this document carefully before using the product and observe the safety
notices.
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Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the product or in case of prob
lems.
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Report each serious incident related to the product to the manufacturer and to the relevant
authority in your country. This is particularly important when there is a decline in the health
state.
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Please keep this document for your records.
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.
These instructions for use provide you with important information on the use, adaptation and
handling of the product.
Only put the product into use in accordance with the information contained in the accompanying
documents supplied.
According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operat
or of the product according to the IEC 60601-1:2005/A1:2012 standard.
2 Product description
2.1 Design
The product consists of the following components:
1. Distal phalanx
2. Middle finger joint
3. Finger chain
4. Program switch (see page 7)
5. Back of the hand
6. Wrist joint
7. CMC joint of the thumb
8. Gaiter
9. Distal thumb joint
2.2 Function
The product is a myoelectrically controlled and multiarticulating hand prosthesis.
The product enables objects to be gripped, pushed, pulled and carried with multiarticulating
functionality. The product is designed to resemble the anatomical structure and weight of a
human hand.
The thumb can be set to two different positions (opposition and lateral), allowing for 14 different
grips (see page 3). Eight grips can be preconfigured using the adjustment software.
A finger chain that protects the drive serves as overload protection for the 4 actively powered fin
gers. In case of overloading, the corresponding finger cannot be flexed anymore since the con
nection to the drive was severed. The finger chain can be replaced without disassembling the ter
minal device (see page 22).
Essential performance of the product
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No essential performance according to IEC 60601-1
3
