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 (ESD)
±6 kV contact
IEC 61000-4-2
±8 kV air
Electrical fast transient/burst
±2 kV for power supply lines
IEC 61000-4-4
±1 kV for input/output lines
Surge
±1 kV differential mode
IEC 61000-4-5
Voltage dips, short
<5 %U (>95 % dip in U) for a
interruptions and voltage
0.5 cycle
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 relative
±8 kV air
humidity should be at least 30 %.
2 kV for power supply
Mains power quality should be that of a typical
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 in U)
Mains power quality should be that of a typical
for a 0.5 cycle
commercial or hospital environment.
40 %U (60 % dip in U)
If the user of the HemoCue systems requires continued
for 5 cycles
operation during power mains interruptions, it is
recommended that the HemoCue systems be powered
70 %U (30 % dip in U)
from an uninterruptible power supply or a battery.
for 25 cycles
<5 %U (>95 % dip in U)
for 5 seconds
40