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Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity
The Pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the Pulse oximeter 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
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 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
0 % UT; 0,5 cycle g)
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle
N/A
Mains power quality should be that of
a
typical commercial or hospital
environment. If the user of the Pulse
oximeter requires continued operation
during power mains interruptions, it is
recommended that the Pulse oximeter
be powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.