Edwards HemoSphere

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HemoSphere Advanced Monitor G Guidance and Manufacturer’s Declaration
Table G-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)
Immunity Test IEC 60601-1-2 Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified
below. The customer or user of the HemoSphere advanced monitor should assure that it is used in such
an environment.
Electrostatic discharge
(ESD) IEC 61000-4-2
±8 kV contact ±8 kV Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
±15 kV air ±15 kV
Electrical fast transient/
burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for 1 kV for input/output
lines > 3 meters
±2 kV for power
supply lines
±1 kV for 1 kV for
input/output lines
> 3 meters
Mains power quality should be that of a
typical commercial and/or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s) ±1 kV line(s) to
line(s)
±2 kV line(s) to earth ±2 kV line(s) to
earth
Voltage dips, short
interruptions and
voltage variations on
power supply AC input
lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for 0.5
cycle
<5% U
T
Mains power quality should be that of a
typical commercial or hospital
environment. If the HemoSphere
advanced monitor user requires
continued operation during power
mains interruptions, it is recommended
that the HemoSphere advanced
monitor be powered by an
uninterruptible power supply or battery.
40%U
T
(60% dip in U
T
) for 5
cycles
40% U
T
70% U
T
(30% dip in U
T
) for 25
cycles
70% U
T
<5% U
T
(>95% dip in U
T
) for 5 sec <5% U
T
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A(rms)/m 30 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14