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Certifications
The X-ray Unit covered by this Operation Manual is authorized to be marked with CE MARKING in
accordance with the provisions of the Council Directive 93 / 42 / EEC concerning Medical Devices.
Classification
The X-ray Unit covered by this Operation Manual is classified as:
•
Protection against Electric Shock: Class I – Type B applied parts.
•
Protection against Harmful Ingress of Water: Ordinary.
•
Degree of Safety in the presence of Flammable Anesthetics Mixture with air or with oxygen or with
nitrous oxide: Not suitable for use in the presence of Flammable Anesthetics Mixture with air or with
oxygen or with nitrous oxide.
•
Mode of Operation: Continuous.
•
Permanently Installed Equipment.
Environmental Statement on the Life Cycle of the Equipment or
System
This equipment or system contains environmentally dangerous components and materials (such as
PCB's, electronic components, used dielectric oil, lead, batteries etc.) which, once the life-cycle of the
equipment or system comes to an end, becomes dangerous and need to be considered as harmful
waste according to the international, domestic and local regulations.
The manufacturer recommends to contact an authorized representative of the manufacturer or an
authorized waste management company once the life-cycle of the equipment or system comes to an
end to remove this equipment or system.
Disposal of Waste
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as
unsorted municipal waste and must be collected separately. Please contact an authorized
representative of the manufacturer or an authorized waste management company for information
concerning the decommissioning of your equipment.
This product consists of devices that may contain mercury, which must be recycled or disposed of in
accordance with local, state, or federal laws. (Within this system, the backlight lamps in the monitor
display contain mercury.)
Definium 5000 X-Ray System
Operator Manual
5197809-1EN
Rev. 4 (13 February 2008)
© 2008 General Electric Company. All rights reserved.
Chapter 2: Safety and Regulatory
2-11
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