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Chapter 1 Safety Guidance
1.1 Safety Information
The design of this electrocardiograph complies with the international standard IEC 60601-1 Medical
Electrical Equipment: General Requirements for Safety and IEC 60601-2-27 General Requirements of the
Electrocardiograph. The classification of this equipment is class I and type CF which complies with IEC
60601-1Regulations of the Protection against Electric Shock and it has the function of defibrillation
protected.
This electrocardiograph is continuous operation equipment which is ordinary and it should be protected from
water; this equipment is not explosion-proof and it cannot be used in the presence of flammable anesthetics.
CM1200B Electrocardiographs narrow screen (5.6 inch screen).
Before using of the equipment, check the equipment, ECG cable and electrode to find whether there is
damage which may affects the patient safety, if obvious damage or aging is found, this part should be
replaced before using. The replaced part should be the same as the original one.
This equipment should be maintained by the authorized and qualified engineers. If the modification and
maintenance are not conducted by the personnel authorized by Comen Company, Comen Company will be
not responsible for the safety, reliability and performance of the equipment.
1.1.1 Guide to Labels in the Manual
To warn you of the conditions where serious consequence, disadvantageous matters or danger may
occur. Failure to comply with the warning will result in severe personal injury or death of the user
or the patient.
To indicate potential danger or unsafe operation. If not avoided, it may lead to mild personal
injury, product malfunction, damages or property loss. It may also give rise to more severe harm.
It emphasizes primary warnings or provides descriptions or explanations so that this product can
be used in a better way.
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