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Operations & Maintenance Manual: Product Specifications
ELECTROMAGNETIC IMMUNITY
Table 27. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity
The AortaScan AMI 9700 system is intended for use in the electromagnetic environment specified below.
The customer or the user of the AortaScan AMI 9700 system should assure that it is used in such an
environment.
IMMUNITY TESTS
IEC 60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT –
GUIDANCE
Electrostatic discharge
(ESD)
IEC 61000‑4‑2
± 6 kV contact
± 8 kV air
In compliance
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
In compliance
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
In compliance
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
In compliance
Mains power quality should be
that of a typical commercial or
hospital environment. If the user of
the AortaScan AMI 9700 system
requires continued operation during
power mains interruptions, it is
recommended that the AortaScan
AMI 9700 system be powered from
an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000‑4‑8
3 A/m
In compliance
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
Conducted RF
IEC 61000‑4‑6
3 Vrms
150 kHz to 80 MHz
3 V
Portable and mobile RF
communications equipment
should be used no closer to any
part of the AortaScan AMI 9700
system, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance d (m)
d
=1.2 √
P
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