Immunity Test
Electrostatic
Discharge (ESD) IEC
61000-4-2
Electrical Fast
Transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power Frequency
50/60 Hz Magnetic
Field
IEC 61000-4-8
IEC 60601
Test Level
±6 kV contact
±8 kV air
±2 kV Mains
±1 kV for input/
output lines
±1 kV Differential
±2 kV Common
> 95% dip for 0.5
cycle
60% dip for 5 cycles
30% dip for 25
cycles
> 95% dip for 5
seconds
3 A/m
Compliance
Level
±8 kV contact
±15 kV air
±2 kV Mains
±1 kV for input/
output lines
±1 kV Differential
±2 kV Common
> 95% dip for 0.5
cycle
60% dip for 5 cycles
30% dip for 25
cycles
> 95% dip for 5
seconds
3 A/m
Electromagnetic
Environment –
Guidance
Floors should be wood,
concrete, or ceramic tile. If
floors are synthetic, the relative
humidity should be at least
30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the Automated
Impella® Controller requires
continued operation during
power mains interruptions,
it is recommended that
the Automated Impella®
Controller be powered from an
uninterruptible power supply or
battery.
Power frequency magnetic
fields should be that of a
typical location in a typical
commercial or hospital
environment.
8.7
TABLE 202
Guidance and Manufacturer’s Declaration – Immunity
The Automated Impella® Controller is intended for use in the electromagnetic environment specified
below. The customer or user of the Automated Impella® Controller should ensure that it is used in
such an environment.
Impella
®
RP with the Automated Impella
®
Controller
