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12.3. Electromagnetic emissions
12.4. Electromagnetic immunity
GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC EMISSIONS
DA-20 is designed for use in the electromagnetic environment described in the table below. The user or purchaser must ensure that the
medical device is used in the environment described below.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions GB 4824
Group 1
DA-20 uses radiofrequency energy for its internal operation. Consequently, its
radiofrequency emissions are very low and are not likely to create any interference with
other nearby equipment.
RF emissions GB 4824
Class B
DA-20 is suitable for use in all establishments, including domestic and those directly
connected to the low voltage energy supply public network supplying buildings used for
domestic purposes.
Harmonic emissions
GB 17625.1
N/A
Voltage fluctuation and
flickers GB 17625.2
Conforming
GUIDANCE AND MANUFACTURER’S DECLARATION- ELECTROMAGNETIC IMMUNITY
DA-20 is designed for use in the electromagnetic environment described in the table below. The user or purchaser must ensure that the
medical device is used in the environment described below.
Immunity test
IEC 60601
test level
Conformity level
Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
GB/T 17626.2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, relative humidity should be at
least 30%.
Electrical fast
transient/burst
GB/T 17626.4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power
supply lines
±1 kV for link cable
Main power quality should be
that of a typical commercial or
hospital environment.
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