Patient monitor User’s manual
41
Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The customer or the user of
monitor 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 floor are covered
with synthetic material, the relative
humidity should be at least 30%.
Users must eliminate static in their
hands before use it.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV 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
environment.
Make sure there is not impulse
interference >1kV in use
environment.
Surge
IEC 61000-4-5
1 kV differential mode
2 kV common mode
1 kV differential mode
2 kV common mode
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% 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 sec
<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 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
monitor requires continued
operation during power mains
interruptions, it is recommended
that the monitor be powered from
an uninterruptible power supply or
a battery.
Power frequency
(50Hz) magnetic field
IEC 61000-4-8
3A/m 3A/m If image distortion occurs, it may
be necessary to position the
monitor further from sources of
power frequency magnetic fields
or to install magnetic shielding.
The power frequency magnetic
field should be measured in the
intended installation location to
assure that it is sufficiently low.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.