Medical Device Directive
Definium 5000 X-Ray System 5197809-1EN Rev. 4 (13 February 2008) i
Operator Manual © 2008 General Electric Company. All rights reserved.
Medical Device Directive
This product complies with the following requirements:
Council directive 93/42/EEC concerning medical devices when it bears the following CE marking of
conformity:
The location of the CE mark label on the equipment is in the service system manual.
European registered place of business:
GE Healthcare Europe
Quality Assurance Manager
BP 34
F 78533 BUC CEDEX
Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK).
Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration,
Department of Health, USA).
Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
Canadian Standards Association (CSA).
International Electrotechnical Commission (IEC), international standards organization, when applicable.
Documentation, trademark and the software are copyright reserved. Under the copyright laws, the
documentation may not be photocopied, reproduced, translated, or reduced by any electronic machine
to a readable form, in whole or part, without the prior written permission of General Electric Company.
The General Electric Company reserves the right to revise this manual and to make changes in the
content of it without notify any person of such revision or changes.
The original language of this manual is English.
GE Medical Systems reserves the right to make changes in specifications and features shown herein, or
discontinue the product described at any time without notice or obligation.
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
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