Konformitätserklärung - DENTSPLY Eclipse Junior Unit 9495151 Bedienungshandbuch

Konformitätserklärung
Dentsply Ceramco certifies that the following product:
Names: Eclipse Junior Unit
Light Curing Unit
Serial Numbers: JGExxxx-xxx (Where x is a number from 0-9)
Conforms with the basic requirements of the following EC guidelines:
- Low Voltage Directive 73/23/EEC Electrical system safety
with 1. Modification 93/68/EEC
- Machinery Directive 98/37/EC Mechanical system safety
- EMC Directive - 89/336/EEC Electromagnetic Compatibility
with 1. Modification 92/31/EEC
- RoHS Directive 2002/95/EC Regulation of Hazardous Substances (Lead, Mercury, Cadmium, Hexavalent
Chromium. Polybrominated Biphenyls ((PPBs), or Polybrominated Diphenyl Ethers (PBDEs),
The regulated hazardous substances have been eliminated or controlled to the specified
concentrations of 0.1% for materials listed above except for Cadmium which is specified at 0.01%.
- WEEE Directive 2002/96/EC Waste from Electrical and Electronic Equipment reuse, recycling, recovery
and disposal.
The WEEE Directive on electrical and electronic waste disposal and recycling is implemented through
our EU representative listed below
The following Harmonized Standards were applied:
- EN61326:1997 Electrical equipment for measurement, control and laboratory use
- EN 12100 – 1:2003, - 2:2003
- EMC requirements (includes amendment A1: 1998 and A2: 2001) (IEC61326: 1997 +A1: 1998
+A2:2001)
Dentsply Ceramco's quality system meets these requirements:
- ISO 13485:2003 (Quality)
Our European Representative is:
Hartmut Brinkmann
Bios Dental GmbH – Degussa
Burgerm. – Otto-Knapp Strasse 45
D-49163 Bohmte, Germany
_______________________
Erich G. Melzer
Elektronik-Projektingenieur
_______________________
John H. Holbeck
Mechanik-Projektingenieur
2. Modification 93/68/EEC
13553 Calimesa Blvd.
Yucaipa, CA 92399
USA
_______________________
Richard D. Roy
Werksleiter
Date: 2006.07.11
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