Ormed ARTROMOT-K4, Руководство по эксплуатации

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Declaration of Conformity
According to the EC-Regulation for medical devices the
EC Medical Devices Directive (MDD) 93/42/EEC dated 14
th June 1993,
appendix 2
The Manufacturer
ORMED GmbH & Co. KG
Merzhauser Straße 112
D-79100 Freiburg
herewith declares that the following units
Type Knee & Hip
Name ARTROMOT ® -K4
meets all requirements of following EC-directives:
EN 60 601-1 1990 Electrical Medical Devices, Part 1, Basic Rules
for Safety
EN 60 601-2 1993 Electrical Medical Devices, Part 1 and 2,
additional norm: electromagnetic compatibility –
requirements and testing
The adherence to the standard specifications
entitles to marking of these devices with CE 0297.
0297
Freiburg, January 20, 2002
Quality Control Manager
D
ECLARA
TION
OF
CONFORMITY
DIN EN 46 001 ORMED Nr. 018 829-01
© ORMED 4/
03
Ormed GmbH & Co. KG • Merzhauser Straße 112 • D-79100 Freiburg • Phone ++49(0)761/45 66-281
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St. Paul/USA, Phone 001-800-4402784, Fax 001-651- 4157405 • Prague/CR, Phone 02-84094650,
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