36
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 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
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 UT 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
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