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• • • User Manual ref1109
11 EG - Statement of Conformity
We:
OpeMed (Europe) Ltd
Dogflud Way
Farnham, Surrey
GU9 7UD
Hereby declare under our own responsibility that the:
The OT200/ OT400 ceiling hoist system and all attached parts
to which this declaration relates and which fall within Class I of the European Medical Devices Directive, in
accordance with the provisions of the following directive:
11.1.1.1.1.1.1
Guideline 93/42/EEG
and also complies with the following standards or normative documents:
ISO/DIS 14971
EN 10535
NEN-EN-60601-1
NEN-EN-60601-1-2 (EMC)
pr EN 980
BS 12182
On behalf of OpeMed Ltd,
Place and date : Farnham, Surrey, June 31
st
2014
Name and function : N. Kent, director
Signature :
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