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Guidance and manufacturer’s declaration – Electromagnetic immunity
The HemoCue systems are intended for use in the electromagnetic environment specified below. The customer or user of the
HemoCue systems 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 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 ±1 kV differential
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short interrup-
tions and
voltage variations on power
supply lines
IEC 61000-4-11
<5%U (>95% dip in U) for
a 0.5 cycle
40%U (60% dip in U) for
5 cycles
70%U (30% dip in U) for
25 cycles
<5%U (>95% dip in U) for
5 seconds
For explanation of U see
NOTE 1
<5%U (>95% dip
in U) for a 0.5 cycle
40%U (60% dip in
U) for 5 cycles
70%U (30% dip in
U) for 25 cycles
<5%U (>95% dip
in U) for 5 seconds
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the HemoCue systems image
intensifier requires continued operation during
power mains interruptions, it is recommended
that the HemoCue systems image intensifier be
powered from an uninterruptible power supply
or a battery.