HemoCue Albumin 201 Manuel D'utilisation page 54

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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
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 in-
<5 %U (>95 % dip in U)
terruptions and voltage
for a 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
±8 kV air
synthetic material, the relative humidity
should be at least 30 %.
2 kV for power
Mains power quality should be that of a
supply lines
typical commercial or hospital environ-
ment.
±1 kV for input/
output lines
±1 kV differenti-
Mains power quality should be that of a
al mode
typical commercial or hospital environ-
ment.
<5 %U (>95 %
Mains power quality should be that of a
dip in U) for a
typical commercial or hospital environ-
0.5 cycle
ment.
40 %U (60 % dip
If the user of the HemoCue systems re-
in U) for 5 cycles
quires continued operation during power
mains interruptions, it is recommended
70 %U (30 %
that the HemoCue systems be powered
dip in U) for
from an uninterruptible power supply or
25 cycles
a battery.
<5 %U (>95 %
dip in U) for
5 seconds
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