77
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
IMMUNITY test
IEC 60601- test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 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,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
Not applicable
Mains 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 earth
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short interruptions
and voltage
variations
on power supply
input lines
IEC 61000-4-11
<5 %
(>95 % dip in
)
for 0,5 cycle
40 %
(60 % dip in
)
for 5 cycles
70 %
(30 % dip in
)
for 25 cycles
<5 %
(>95 % dip in
)
for 5 s
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
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE
is the a.c. mains voltage prior to application of the test level.
Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT
and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment
Emissions 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
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME
EQUIPMENT and ME SYSTEMS
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