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Earth leakage current, Limit Value: NC 500uA, SFC 1000uA.
Patient current leakage, Limit Value: 10uA. (Type CF equipment)
When AC power is applied, limit value patient current leakage is 50 uA (Type CF equipment)
in single trouble status. The test results have to be recorded and performed by the authorized
staff. If the equipment failed in any of the tests, it has to be repaired.
The equipment and reusable accessories can be sent back to the manufacturer for recycling
or proper disposal after their useful lives.
If any accident happens during use, please turn off the ECG immediately.
2.4 Cleaning, Disinfection and Maintenance
Turn off the main unit and remove power supply cable and patient cable before cleaning
and disinfection.
Prevent the detergent from seeping into the main unit while cleaning. Do not immerse the
main unit or patient cables into liquid under any circumstances.
Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
Be sure no cleanser remains on the unit, patient cable or electrodes.
Disinfection, if required, can not be done with high temperature, autoclaving or radiation.
Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
Maintenance and repair should be applied on the main units and accessories regularly (at
least once every half year)
ECG machines are classified into Measuring Instrument, so users should send it to Official
Measurement Administrative to test and certify according to national metrological calibration
regulation of electro-cardiograph and electroencephalogram machine every year.
The instrument signal input/output connector (when needed) must be connected with Class
I equipment which is IEC-60601-1 compliant, and the total leakage current should be tested to be
available by users themselves.
Electrical schematic diagram and parts lists are only available to qualified repair stations or
staff of ECGMAC authorized.
2.5 Intended Use
The intended use is to acquire the ECG waveforms from adults and children patients through
electrodes. It should be used by doctors or trained nurses in medical institutions. The ECG signals
recorded by the instrument can help users to analyze and diagnose heart diseases. The multi-channel
Summary of Contents for EM-1201
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