2compact 2, Eu-declaration of conformity – Protec Protech Compact2 Film Processor SX 2 User Manual
Page 2
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COMPACT 2
TM
EU-Declaration of Conformity
®
EU-Declaration of Conformity
PROTEC
®
Medizintechnik
declares, that the product
Description:
COMPACT 2
TM
Machine type:
X-Ray-Film Processor
Model no.
117x-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
®
Medizintechnik GmbH & Co. KG
,
Lichtenberger Straße 35, D-71720 Oberstenfeld, Germany
Supplementary
Guidelines:
•
DIMDI: DE / 0000042967
•
WEEE: DE 55471807
Place and date of issue:
Oberstenfeld,
23. May 2006
, Jochen Krupp (Technical Manager Analogue Systems)