Comen CM300 - 1.1.3 Cautions

Shenzhen Comen Medical Instruments co., ltd.
1
Chapter 1 Safety Guidance
1.1 Safety Information
The design of the 3-channel electrocardiograph complies with international standard IEC 60601-1
Medical Electrical Equipment: General Requirements for Safety and IEC 60601-2-25 Particular
Requirements for the Safety of Electrocardiographs etc. The classification of this equipment is
Class І, type CF, which means a higher degree of protection against electric shock and the patient
connection is fully isolated and defibrillation protected.
This equipment is not explosion-proof. Do not use it in the presence of flammable
anesthetics.
This equipment is designed for continuous operation and is ‘ordinary’ (i.e. not drip or
splash-proof).
Classification:
Anti-electric-shock type:
Class І with internal power supply
Anti-electric-shock degree:
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
presence of flammable gas:
Equipment not suitable for use in the presence
of flammable gas
Working Mode:
Continuous operation
EMC:
Group І, Class A
1.1.1 Danger
There are no dangers that refer to the product in general. Specific “Danger” statements may be
given in the respective sections of this manual.