User Guide
Wheelchair ‘Kontiki’
Page 32 of 54
EC
D
ECLARATION OF
C
ONFORMITY
Concerning the Medical Devices Directive.
We
declare entirely under our own responsibility:
1-
We are the manufacturers of the medical device:
Wheelchair
Mark:
Wheelbase
Type:
Kontiki
Serial no.:
all serial numbers of this type
to which this declaration refers.
2-
The wheelchair has been designed and built conforming to the requirements of
the Medical Devices Directive 93/42/EC.
3-
The wheelchair has been designed and built in accordance with the (European)
Standards or standard documents:
2nd Dev. NEN-EN 12182:1997
Technical aids for the disabled
NEN-EN 12183: 1999
Hand-propelled wheelchairs
NEN-EN 1441:1997
Medical aids – Risk Analysis
NEN-EN 1041:1998
Information supplied by the manufacturer
together
with
the
medical
aids
Signed at
Helmond
Date:
...
Signed by:
D. G. J. van de Beek
Position: Director
Wheelbase Products BV
Vossenbeemd 104
5705 CLHelmond
Nederland
Tel: +31 (0)492 593888
+31 (0)492 537931
