User Guide
Wheelchair ‘Kontiki’
Page 51 of 54
EC
D
ECLARATION OF
C
ONFORMITY
Concerning the Medical Devices Directive
We
certify, entirely under our own responsibility:
1-
We are the manufacturers of the medical device:
Wheelchair
Brand name: Wheelbase
Model: Kontiki,
motor-assisted
Serial no.:
all serial numbers for this model
to which this declaration refers.
2-
The wheelchair has been designed and manufactured in accordance with the
requirements of the Medical Devices Directive 93/42/EEG
3-
The wheelchair has been designed and built in accordance with (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
Wheelbase Products BV
Vossenbeemd 104
5705 CLHelmond
Nederland
Tel: +31 (0)492 593888
+31 (0)492 537931