Guidance And Manufacturer’s Declaration – Electromagnetic Immunity - HemoCue WBC DIFF Operating Manual

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
Electrostatic discharge ±6 kV contact
(ESD)
IEC 61000-4-2 ±8 kV air
Electrical fast transient/ ±2 kV for power supply
burst lines
IEC 61000-4-4 ±1 kV for input/output lines
Surge ±1 kV differential mode
IEC 61000-4-5
Voltage dips, short interrup- <5%U (>95% dip in U) for
tions and a 0.5 cycle
voltage variations on power
supply lines 40%U (60% dip in U) for
5 cycles
IEC 61000-4-11
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
Compliance level Electromagnetic environment – guidance
±6 kV contact Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
±8 kV air relative humidity should be at least 30 %.
2 kV for power Mains power quality should be that of a typical
supply lines commercial or hospital environment.
±1 kV for input/
output lines
±1 kV differential Mains power quality should be that of a typical
mode commercial or hospital environment.
<5%U (>95% dip Mains power quality should be that of a typical
in U) for a 0.5 cycle commercial or hospital environment.
40%U (60% dip in If the user of the HemoCue systems image
U) for 5 cycles intensifier requires continued operation during
power mains interruptions, it is recommended
70%U (30% dip in that the HemoCue systems image intensifier be
U) for 25 cycles powered from an uninterruptible power supply
or a battery.
<5%U (>95% dip
in U) for 5 seconds
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