Protec optimax 2010, Operation Manual, Page: 2 / 52

6 OPTIMAX
®
2010
EU-Declaration of Conformity
EU-Declaration of Conformity
PROTEC
®
declares, that the product
Description:
OPTIMAX
®
2010
Machine type:
X-Ray-Film Processor
Model no.
116x-y-0000
x is a number between ›0‹ and 9, y is a number between 1 and 9
conforms to the following harmonized standards:
Safety:
IEC 61010-1:2001 + A1:92 + A2:95; DIN 1988 T4:12/1988; UL 3101-1; CSA 22.2-1010-1
EMC:
EN 50081 Part 1, 03/1993; EN 50082 Part 1, 03/1993
according to the regulations of:
• the Medical Device Directive 93/42/EEC “Class 1”,
• the Low Voltage Directive 73/23/EEC and the
• EMC Directive 89/336/EG
PROTEC GmbH & Co. KG, Lichtenberger Strasse 35, D-71720 Oberstenfeld, Germany
Supplementary guide-
lines:
• DIMDI: DE / 0000042967
• WEEE: DE 55471807
Location and date of issue
Oberstenfeld, 2. July 2007, Jochen Krupp (Technical Manager Analogue Systems)