TXR 425 - Certifications; Classifications

Standard Frequency Series Generators
Operation
3
M-2008-7-14
1.4. CERTIFICATIONS
This equipment meets the following Safety Standards: IEC 60601-1, IEC 60601-2-7.
This Product conforms to DHHS Radiation Standards of 21 CFR Subchapter J as of the date of manufacture.
Class 1 Device.
This equipment meets requirements of EMC/EMI and all Part 2 Standards that apply.
1.5. CLASSIFICATIONS
TheX-rayGeneratorcoveredbythisOperationManualisclassiedas:
• ProtectionagainstElectricShock:Class1–TypeB(
) applied parts.
• ProtectionagainstHarmfulIngressofWater:Ordinary.
• DegreeofSafetyinthepresenceofFlammableAnestheticsMixturewithairor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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