EMC INFORMATION
EN-18
The device complies with the EMC (Electromagnetic Compatibility) standard (IEC 60601-1-2: 2014/ EN IEC
60601-1-2: 2015).
The device may cause malfunctions such as LCD error (MTP, PTP, other indications), freeze, reset, power
off etc. if it is not used under specified environmental conditions and exposed to strong Electromagnetic
disturbances.
Check the following compatibility carefully before installation and use.
Intended environment: Home medical environment (residential area_residential/home/nursing facility)
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Emission test
Emission test
Standard / Test level
Compliance
Conducted emissions
CISPR 11 Group 1, Class B
Not applicable
Radiated emissions
Group 1, Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Not applicable
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Immunity test
Immunity test
Standard / test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2, 4, 8, 15 kV air
±8 kV contact
±2, 4 ,8, 15 kV air
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1kV for input/output lines
USB cable
±1kV for input/output lines
Surge
IEC 61000-4-5
±1 kV for line(s) to line(s)
±2 kV for line(s) to earth
Not applicable
Voltage dips, short
interruptions and voltage
variations on power supply input
lines
IEC 61000-4-11
Voltage dips
0 %
U
T
0.5 cycle
Phase angle
0°, 45°, 90°, 135°,180°, 225°, 270°and 315°
0 %
U
T
1 cycle and 70 % UT 25/30 cycle
Single layer phase angle 0°
Short interruption
0 %
U
T
250/300 cycle
Not applicable
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m (50/60 Hz)
Conducted RF
IEC 61000-4-6
3 Vrms in between 0.15 MHz and 80 MHz
6 Vrms in ISM and amateur radio bands between 0.15 MHz
and 80 MHz
80% Amplitude modulation (1 kHz)
USB cable
3 Vrms in between 0.15 MHz and 80 MHz
6 Vrms in ISM and amateur radio bands
between 0.15 MHz and 80 MHz
80% Amplitude modulation (1 kHz)
Radiated RF
IEC 61000-4-3
10 V/m
80MHz ~ 2.7GHz
80%
Amplitude modulation (1 kHz)
10 V/m
Immunity to near
electromagnetic fields from RF
wireless communication
equipment
IEC 61000-4-3
According to Table-1
According to Table-1
