HemoCue Albumin 201, Operating Manual

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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 environ-
ment.
Surge
IEC 61000-4-5
±1 kV differential mode ±1 kV differenti-
al mode Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Voltage dips, short in-
terruptions 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 environ-
ment.
If the user of the HemoCue systems re-
quires continued operation during power
mains interruptions, it is recommended
that the HemoCue systems be powered
from an uninterruptible power supply or
a battery.