Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, this device is classified as following:
Table 1: Equipment classification
Class I equipment
Equipment in which protection against electric
shock does not relay on basic insulation only, but
includes a power supply cord with protective earth
conductor. For earth reliability always plug the
main power cord into an earthed mains power
outlet.
Type B equipment A Type B piece of equipment is one that provides a
particular degree of protection against electric
shock particularly regarding allowable leakage
current and reliability of the protective earth
protection.
Water ingress This device does not have protection against
ingress of water.
Cleaning See section on cleaning and disinfecting.
Disinfection See section on cleaning and disinfecting.
Flammable anesthetics This device is not suitable for use in the presence of
a flammable anesthetic mixture with air, or in
presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.
Operation Continuous operation.
Non-medical equipment
Following components are classified as non-medical equipment:
• Workstation
• DR detector control unit
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
14 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
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