B-2
WARNING
This equipment/system is intended for use by healthcare professionals only. This equipment/ system may
cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM] or shielding the
location.
Guidance and 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
IEC60601 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
±2 kV for power supply lines
±1 kV for input/output lines
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
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
<5 % U
T
(>95 % dip in U
T
) for
0.5 cycle
40 % U
T
(60 % dip in U
T
) for 5
cycles
70 % U
T
(30 % dip in U
T
) for
25 cycles
<5 % U
T
(>95 % dip in U
T
) for
5 s
<5 % U
T
(>95 % dip in U
T
) for
0.5 cycle
40 % U
T
(60 % dip in U
T
) for 5
cycles
70 % U
T
(30 % dip in U
T
) for
25 cycles
<5 % U
T
(>95 % dip in U
T
) for
5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of our
product requires continued
operation during power mains
interruptions, it is recommended
that our product 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: U
T
is the AC mains voltage prior to application of the test level.
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