03/2010
B500 | B500-S
Page 87
Safety
2
Safety
2.1 Standards and Directives
All information on safety contained in these instructions
for use refers to the currently valid national laws and reg-
ulations of the European Union. In other countries com-
pliance with the applicable laws and national regulations
is required.
Besides the safety instructions contained in these instruc-
tions for use, the user is required to observe and comply
with the generally valid professional association regula-
tions, the accident prevention regulations and environ-
ment protection regulations. All information contained in
these instructions for use must be complied with at all
times without restrictions.
The B500 power wheelchair has been constructed in
accordance with the currently valid technical rules and
is safe to operate. The safety of the B500 power wheel-
chair has been confirmed by CE certification and the
declaration of conformity.
2.2 cE conformity
This device meets the requirements of the 93 / 42 / EEC
guidelines for medical devices. This device has been
classified as a class I device according to the classifica-
tion criteria outlined in appendix IX of the guidelines. The
declaration of conformity was therefore created by Otto
Bock with sole responsibility according to appendix VII
of the guidelines.
2.3 General Safety Instructions
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The B500 may only be used properly.
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The B500 may only be used by persons trained in its
use and must not be used by unauthorised persons.
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The B500 may be used for transporting only one
person.
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For safety reasons, it is strictly recommended that the
user always apply and fasten the lap belt, which is
available from Otto Bock as an accessory.
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All safety instructions contained in these instructions
for use and in all further applicable documents are to
be observed and complied with. The instructions for
use must be available to the user at all times.
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The back upholstery and seat cushion of the power
wheelchair are not highly flammable, but can however
catch fire. For this reason, use utmost caution near
flammable objects or fire, especially lit cigarettes.
