50
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 Hemo-
Cue 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 requires
continued operation during power mains inter-
ruptions, it is recommended that the HemoCue
systems be powered from an uninterruptible
power supply or a battery.