44
Guidance and manufacturer´s declaration – electromagnetic immunity
The Palm Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of the Palm Pulse Oximeter should assure that it is used in such an environment.
Immunity test
EN 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 %.
Electrostatic
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
±1 kV for input/output
lines
N/A
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
N/A
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
N/A
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Palm Pulse Oximeter requires
continued operation during power
mains
interruptions,
it
is
recommended that the Palm Pulse
Oximeter 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 a. c. mains voltage prior to application of the test level.