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12.4 Appendix IV – Electromagnetic Immunity
Guidance and manufacturer's declaration – electromagnetic immunity
The CentriMag Circulatory Support System with 2
use in the electromagnetic environment specified below. The customer or the user of the System should assure that it
is used in such an environment.
Immunity Test
IEC 60601 test level
Electrostatic
± 6 kV contact
Discharge (ESD)
± 8 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power supply
transient/burst
lines
IEC 61000-4-4
± 1 kV for input/output
lines
Surge
± 1 kV line(s) to line(s)
IEC 61000-4-5
± 2 kV line(s) to earth
Voltage dips, short
<5 % U
interruptions and
U
) for 0,5 cycle
T
voltage variations
40 % U
on power supply
for 5 cycles
input lines
70 % U
IEC 61000-4-11
for 25 cycles
<5 % U
U
) for 5 s
T
NOTE: U
is the AC mains voltage prior to application of the test level.
T
Power frequency
(50/60 Hz) magnetic
3 A/m
field
IEC 61000-4-8
TM
CentriMag
Circulatory Support System Operation Manual (US)
© 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
Generation CentriMag Console and Mag Monitor is intended for
nd
Compliance Level
± 6 kV contact
± 8 kV air
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
(>95 % dip in
<5 % U
T
U
) for 0.5 cycle
T
(60 % dip in U
)
40 % U
T
T
U
) for 5 cycles
T
(30 % dip in U
)
70 % U
T
T
U
) for 25 cycles
T
(>95 % dip in
<5 % U
T
U
) for 5 s
T
3 A/m
Electromagnetic environment-guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, 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.
(>95% dip in
Mains power quality should be that of a
T
typical commercial or hospital
environment. If the user of the System
(60% dip in
T
requires continued operation during
power mains interruptions, it is
recommended that the System be
(30 % dip in
T
powered from an uninterruptible power
supply or a battery.
(>95 % dip in
T
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
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