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Sedecal SHF-415 - Certifications; Classification

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HF Series Generators -- RAD Console
Operation
OM- 0279R1
4
1.4 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.
1.5 CLASSIFICATION
The X-ray Generator 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 operation with intermittent loading.
Permanently Installed Equipment.

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