Safety; Standards And Directives; Ce Conformity - Otto Bock C1000 Instructions For Use Manual

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 C1000 power wheelchair has been constructed in
accordance with the currently valid technical rules and
is safe to operate. The safety of the C1000 power wheel-
chair has been confirmed by CE certification and the
declaration of conformity.
C1000
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 appen-
dix VII of the guidelines.
12/2009
Safety
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