Berlin Heart EXCOR Pediatric VAD, Manual, Page: 242 / 250

Chapter 17 EMC tables
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment -guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood,
discharge
(ESD)
± 8 kV air ± 8 kV air
concrete or ceramic tile.
If floors are covered with
IEC 61000-4-2
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 environment.
Surge
IEC 61000-4-5 ± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth ± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips, < 5 % UT < 5 % UT Mains power quality
short (>95 % dip in UT) (>95 % dip in UT) should be that of a
interruptions for 0.5 cycle for 0.5 cycle typical commercial or
and voltage
variations on
power supply
input lines
40 % UT
(60 % dip in UT)
for 5 cycles 40 % UT
(60 % dip in UT)
for 5 cycles
hospital environment. If
the user of the Ikus
requires continued
operation during power
IEC 61000-4-11
70 % UT
(30 % dip in UT) 70 % UT
(30 % dip in UT)
mains interruptions, it is
recommended that the
for 25 cycles for 25 cycles
Ikus be powered from an
< 5 % UT < 5 % UT
uninterruptible power
(>95 % dip in UT) (>95 % dip in UT) supply or a battery.
for 5 sec
for 5 sec
Power 3 A/m 100 A/m The Ikus can be used up
frequency (50/ to 1 m from power
60 Hz) cables carrying up to
magnetic field 100 A.
IEC 61000-4-8
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Tab. 17-2 Electromagnetic immunity - part 1
17.4 Electromagnetic immunity - part 2
The Ikus is intended for use in the electromagnetic environment specified below. The
customer or the user of the Ikus should ensure that it is used in such an environment
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