Edwards EV1000

Guidance and Manufacturer's Declaration
F-3
Table F-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment -Guidance
The EV1000 Clinical Platform NI is intended for use in the electromagnetic environment specified below. The customer or user of
the EV1000 Clinical Platform NI should assure that it is used in such an environment.
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact ±6 kV Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
±8 kV air ±8 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 EV1000 Clinical Platform NI user
requires continued operation during power
mains interruptions, it is recommended that
the EV1000 Clinical Platform NI 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
3 A/m 3 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.