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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
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
Conducted RF
IEC 61000‑4‑6
Operations & Maintenance Manual: Product Specifications
IEC 60601 TEST LEVEL
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<5% U
(>95% dip in U
t
for 0.5 cycle
40% U
(60% dip in U
)
t
t
for 5 cycles
70% U
(30% dip in U
)
t
t
for 25 cycles
<5% U
(>95% dip in U
t
for 5 s
3 A/m
3 Vrms
150 kHz to 80 MHz
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT –
LEVEL
Floors should be wood, concrete,
or ceramic tile. If floors are covered
In compliance
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
In compliance
of a typical commercial or hospital
environment.
Mains power quality should be that
In compliance
of a typical commercial or hospital
environment.
Mains power quality should be
)
t
that of a typical commercial or
hospital environment. If the user of
the AortaScan AMI 9700 system
requires continued operation during
In compliance
power mains interruptions, it is
recommended that the AortaScan
AMI 9700 system be powered from
)
t
an uninterruptible power supply or a
battery.
Power frequency magnetic fields
should be at levels characteristic
In compliance
of a typical location in a typical
commercial or hospital environment.
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
3 V
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance d (m)
d=1.2 √P
GUIDANCE
73
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