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EDAN SE-3 - Safety Information

EDAN SE-3
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SE-3 Electrocardiograph Service Manual Safety Guidance
- 6 -
Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community
The symbol indicates that the device complies with the
European Council Directive 93/42/EEC concerning medical
devices.
The symbol indicates that the device should be sent to the
special agencies according to local regulations for separate
collection after its useful life.
Rx only (U.S.)
Federal (U.S.) law restricts this device to sale by or on the
order of a physician
2.2 Safety Information
Safety Standard:
IEC/EN 60601-1+A1+A2, IEC/EN 60601-1-2+A1, IEC/EN60601-2-25,
ANSI/AAMI EC-11
Classification:
Anti-electric-shock type: Class І with internal power supply
Anti-electric-shock degree: Type CF
Degree of protection against harmful
ingress of water:
Ordinary equipment (Sealed equipment without
liquid proof)
Disinfection/sterilization method: Refer to the user manual for details
Degree of safety of application in the Equipment not suitable for use in the presence

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