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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
Radiated RF
IEC 61000‑4‑3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d
=1.2 √
P
80 MHz to 800 MHz
d
=2.3 √
P
800 MHz to 2.5 GHz
where
P
is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and
d
is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should
be less than the compliance level in
each frequency range.
b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note: U
t
is the AC mains voltage prior to application of the test level.
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which
the AortaScan AMI 9700 system is used exceeds the applicable RF compliance level above, the AortaScan AMI 9700 system should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re‑orienting or
relocating the AortaScan AMI 9700 system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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