Technical Specifications; Compliance With International Standards - Kodak 2200 User Manual

6. Technical Specifications

Compliance with International Standards

06/2009
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
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