G.Comm POLARIS Manual De Instrucciones página 11

DENTAL LED OPERATING LIGHT POLARIS
ENGLISH
DECLARATION OF CONFORMITY
The manufacturer G.COMM
Via Donizetti, 22
20872 Cornate D'Adda (MB)
Italy
DECLARES
under its sole responsibility that the equipment of
Model: POLARIS
complies with the requirements of the Italian Law D.Lgs. 46 dated 24/02/97 which enacts the Eu-
ropean Directive 93/42/EEC, amended with the Italian Law D.Lgs. 37 dated 25/01/10 which enacts
the European Directive 2007/47/EC on medical devices of Class I.
This product complies with the following norms:
- EN 60601-1 :1990 "Medical electrical equipment – Part 1 : General requirements for safety " +
A1:1993 + A2:1995
- EN 60601-1-2:2001 "Medical electrical equipment - Part 1: General norms on safety - 2:
Collateral standard: Electromagnetic Compatibility - requirements and tests" + A1:2006
- EN ISO 14971:2007 "Application of risk management to medical devices"
- UNI EN ISO 9680:1996 "Dental operating light"
G.COMM also states that this declaration of conformity is valid provided that:
1. periodical servicing is performed only by G.COMM's instructions and by G.COMM's authorised
personnel;
2. no part of these products is replaced with spares which are not approved by G.COMM;
3. no appliance is connected to these products after their first delivery without prior G.COMM's
authorisation.
As stated in DPR 224/1988 and Dir. 85/374/EEC, any responsibility for damages resulting from
defective products stops 10 years after the date of the first delivery of this product by manufacturer;
successively, the user undertakes this responsibility.
Giaffreda Nicola
Managing Director
This certificate is a reproduction of the original on file at the manufacturer's premises.
USER'S GUIDE
11