Abbott CentriMag - Appendix IV - Electromagnetic Immunity

CentriMag
TM
Circulatory Support System Operation Manual (US) Page 123 of 126
© 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
12.4 Appendix IV – Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The CentriMag Circulatory Support System with 2
nd
Generation CentriMag Console and Mag Monitor is intended for
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 Compliance Level Electromagnetic environment-guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
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 differential
mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in
U
T
) for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in
U
T
) for 5 s
<5 % U
T
(>95% dip in
U
T
) for 0.5 cycle
40 % U
T
(60% dip in
U
T
) for 5 cycles
70 % U
T
(30 % dip in
U
T
) for 25 cycles
<5 % U
T
(>95 % dip in
U
T
) for 5 s
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the System
requires continued operation during
power mains interruptions, it is
recommended that the System be
powered from an uninterruptible power
supply or a battery.
NOTE: U
T
is the AC mains voltage prior to application of the test level.
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.