Daum electronic ergo_bike medical8, Руководство по эксплуатации

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EC manufacturer's declaration of conformity
EC manufacturer's declaration of conformity
For the following designated product
Product: ergo_bike
Model: ergo_bike medical8
We hereby declare that the aforementioned product complies with the following prescriptions:
EC-directive 93/42EEC of the council of June 14, 1993 about medical products
The following standards and prescriptive provisions were used to evaluate the product :
Standard description Issue
EN 1041 Informationen supplied by the manufacturer 1998
with medical devices
EN 60601-1 + A1 + A2 Medical electrical equipment Part 1 – General 1996
requirements for safety
EN 60601-1-2 Medical electrical equipment Part 1 – General 2001
requirements for safety
2. additional form : electromagnetic compatibility -
requirements and tests
The quality assurance system of daum electronic gmbh is certified by the DQS GmbH according to the
representation models ISO 13485:2003 and according to 93/42EEC annexe II item 3, (CE 0297)
daum electronic gmbh
Flugplatzst. 100
D-90768 Fürth
Tel.: ++49 (0)911 / 9 75 36-0
Fax: ++49 (0)911 / 9 75 36-96
Fürth, November 30, 2006
0297