Page 22 of 23
USER MANUAL
ADS intelligent
Softwareversion:
0.95
14
Declaration of conformity
EC-Certificate of conformity
The manufacturer:
AirMed PLUS GmbH,
Harpener Feld 34
44805 Bochum
Germany
Declares herewith, that the following medical device:
Product name:
ADS
intelligent
Meets the requirements of the European directive for medical products 93/42/EWG and
2007/47/EC. The ADS
clinic
is consistent with risk class 1 based on annex IX rule 1 of the
directives 93/42/EWG and 2007/47/EC.
Applied standaards:
DIN EN 980
DIN EN 1041
DIN EN ISO 14971
DIN EN 60601-1
DIN EN 60601-1 -1, -2, -4, -6,
Bochum,
31.12.2015
Datum Geschäftsführer AirMed PLUS GmbH