46
Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity for all EQUIPMENT AND SYSTEMS
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
Vital Signs Monitor is intended for use in the electromagnetic environment specified below. The customer or
the user of the equipment or system should assure that it is used in such an environment.
Immunity test
IEC60601 test
level
Compliance
level
Electromagnetic environment
-guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±6 kV contact
±8kV air
±6 kV contact
±8kV air
Floors should be wood, concrete or cera-
mic tile. if floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC61000-4-4
±2kV for power
Supply lines
±1 kV for
input/output lines
±2kV for power
Supply lines
±1 kV for
input/output lines
Mains power quality should be that of
a typical commercial or hospital envi-
ronment.
Surge
IEC 61000-4-5
±1kV line (s)
to line(s)
±2kV line(s)
to earth
±1kV differential
mode
±2kV common
mode
Mains power quality should be that of
a typical commercial or hospital envi-
ronment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC61000-4-11
<5%
U
T
(>95%
dip in
U
T
) for 0.5
cycle
40%
U
T
(60% dip
in
U
T
) for 5 cycle
70%
U
T
(30% dip
in
U
T
) for 25 cycle
<5%
U
T
(>95%
dip in
U
T
) for 5
sec
<5%
U
T
(>95%
dip in
U
T
) for 0.5
cycle
40%
U
T
(60%dip
in
U
T
) for 5 cycle
70%
U
T
(30% dip
in
U
T
) for 25 cycle
<5%
U
T
(>95%
dip in
U
T
) for 5 sec
Mains power quality should be that of
a typical commercial or hospital envi-
ronment. If the user of the equipment or
system requires continued operation du-
ring power mains interruptions, it is recom-
mended that the equipment or system be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50Hz/60Hz) magnetic
field IEC61000-4-8
3A/m
3A/m
Power frequency magnetic fields should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
