Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic enviroment specified below.
The customer of the user of the device should ensure that it is used in such an environment.
Immunity testIEC 60601 test levelCompliance levelElectromagnetic environment - guidance
Conducted RF EN 61000-4-6
3 Vrms
150kHz to 80 MHz
3 V RMS outside the ISM
band and amateur bands
80 % AM at 1 kHZ
Not applicable
Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 0.35 √ p
d = 1.2 √ p
Radiated RF EN 61000-4-3
10 V/m
80 MHz to 2.7 GHz
80 % AM 1 kHZ
10 V/m
80 MHz to 2.7 GHz
80 % AM 1 kHZ
80 MHz to 800 MHz: d = 1.2 √ p
800 MHz to 2.7 GHz: d = 2.3 √ p
Where, P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance.
Field strengths from fixed RF transmiters, as determined by an
electromagnetic site survey, should be less than the compliance
level in each frequency range. Interference may occur in the
vicinity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
A.) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the device.
B.) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic enviroment specified below.
The customer of the user of the device should ensure that it is used in such an environment.
Immunity testIEC 60601 test levelCompliance levelElectromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
Floors should be wood, concrete or ceramic tile. If floor are
covered with synthetic material, the relative humidity should
be at least 30 %.
Electrical fast transient/
burst IEC61000-4-4
±2 kV for power supply lines
±1 kV for input/output linesNot applicableMains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earthNot applicable
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
0 % UT; 0.5 cycle at 0 °,
45 °, 90 °, 135 °, 180 °, 225 °,
270 °, 315 °
0 % UT; 1 cycle
70 % UT; 25/30 cycle
0 % UT; 250/300 cycle
Not applicable
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the device requires continued
operation during power mains interruptions, it is recommended
that the device be powered from an uninterruptible power supply
or a battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4- 8
3 A/m
50/60 Hz
3 A/m
50/60 Hz
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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