
06/2009 SM731_K2200_01_en
6-1
6. Technical Specifications
Compliance with International Standards
Manufactured by:
Trophy
A subsidiary of Carestream Health, Inc.
4, rue F. Pelloutier - Croissy-Beaubourg
77435 Marne-la Vallée Cedex 2
France
For :
Carestrem Health, Inc.
150 Veronal Street
Rochester,
New York – USA 14608
Models
KODAK 2200
Compliance with International Regulations
•
Medical Device directives 93/42/European Economic Community (EEC),
Class II b
•
ElectroMagnetic Compatibility (EMC) directive 89/336/EEC
•
FDA Center for Devices & Radiological Health (CDRH-21-CFr title 21 sub-
chapter J) (USA)
•
Radiation Emitting Devices Act – C34 (Canada)
•
Medical Devices Regulations (Canada)
Compliance with European and International Standards
•
EN 60601-1 / IEC 60601-1
•
EN 60601-1-3 / IEC 60601-1-3
•
EN 60601-2-7 / IEC 60601-2-7
•
EN 60601-2-28 / IEC 60601-2-28
•
EN 60601-1-4 / IEC 60601-1-4
•
CSA 601.1
•
UL60601.1
•
EN ISO 14971
Electric power supply
(during exposure)
•
230–240 V AC (± 10%), 50/60 Hz, 5 A, apparent resistance 0.5
Ω
•
100–110–130 V AC (± 10%), 50/60 Hz, 12 A, apparent resistance 0.2
Ω
Electric power supply
(no exposure)
•
230–240 V AC (± 10%), 50/60 Hz, 220 mA
•
100–110–130 V AC (± 10%), 50/60 Hz, 220 mA
Summary of Contents for 2200
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