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Appendix II EMC Guidance and Manufacturer Declaration
Warning
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The use of ACCESSORIES, transducers and cables other than those specified, with
the exception of transducers and cables sold by the MANUFACTURER of the the
device as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
The following cable types must be used to ensure that they comply with interference
radiation and immunity standards:
No.
Name
Cable length (m)
1
Power cord
1.7
2
ECG lead cable
3.4
3
Potential equalization conductor
3.0
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Active medical devices are subject to special EMC precautions and they must be
installed and used in accordance with these guidelines.
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Portable and mobile communication radiation equipment may affect the normal use
the medical device.
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The device should not be used when they are close to or stacked with other
equipment, if necessary, please observe and verify that they can operate normally in
the configurations.
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Basic performance: Stability of working state: Waveform noise and measurement
error appeared during measuring are automatically eliminated 10s after removing
the interference, the working state of device are not changed, it could collect and
record data continuously, and the waveform does not show obvious changes before
and after the test.
Electromagnetic emission
Guidance and manufacture’s declaration-electromagnetic emission
The device is tended for use in the electromagnetic environment specified below. The
purchaser or the user of the device should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The device uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The device is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public low
Harmonic emissions
Class A
Summary of Contents for 1200G ECG
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