TruSat Technical Reference Manual
1–10
Guidance and manufacturer’s declaration - electromagnetic immunity
The TruSat pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or
the user of the monitor should assure that it is used in such an environment.
Immunity test EN 60601-1-2 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 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 requires continued
operation during power mains
interruptions, it is
recommended that the TruSat
be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
10 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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