Protec OPTIMAX - EU-Declaration of Conformity; Supplementary Guidelines

2 OPTIMAX
®
EU-Declaration of Conformity
®
EU-Declaration of Conformity
PROTEC
®
Medizintechnik declares, that the product
Description:
OPTIMAX
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. Mai 2006, Jochen Krupp (Technical Manager Analogue Systems)