Electromagnetic Immunity, Handheld Radiofrequency Equipment
The device is designed for use in the magnetic and electromagnetic environment described in
the table below. The user must ensure conformity of the electromagnetic environment.
Immunity test
Portable and mobile radiofrequency communication devices must not be used near the
medical device (including cables) at a distance below that recommended and calculated
according to the frequency and power of the transmitter.
Radiated
radio
frequency
electromagnetic field
(IEC61000-4-3)
Radio
frequency
conducted
disturbance
(IEC61000-4-6)
The electromagnetic field intensity of fixed radiofrequency
transmitters, as determined by an electromagnetic environment
measurement (a), must be less than the conformity level for each
frequency range (b). Interference may occur near equipment marked
with the following symbol:
Note 1: At 80 MHz and 800 MHz, the highest frequency range applies.
Note 2: These specifications may not be applicable in all situations. The electromagnetic propagation is affected
by the absorption and reflection of structures, objects and people.
(a) The electromagnetic field strengths of fixed radiofrequency emitters, such as base stations for mobile
telephones (cellular / cordless), mobile radios, amateur radio, AM/FM radio broadcasts and TV broadcasts
cannot be determined exactly by theory. To assess the electromagnetic environment due to fixed radiofrequency
emitters, an electromagnetic environment measurement must be made. If the measured radiofrequency field
strength in the immediate environment where the product is used exceeds the compliance level specified above,
the performance of the product must be tested to verify whether it conforms to the specification. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the product.
(b) In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3 V/m.
Test level
3 V/m
80 MHz to 2.7 GHz
3 V/m
150KHz to 80MHz
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Compliance Level
3 V/m
3 V/m
Electromagnetic
Environment
Guidance
d = 2.3 √P 800 MHz
to 2.5 GHz
Where
(P)
is
the
maximum
nominal
power
of
the
transmitter in Watts
(W) according to the
manufacturer
specifications and (d)
is
the
minimum
recommended
separation distance in
meters (m).
d = 1.2 √P 80 MHz to
800 MHz
Recommended
separation distance:
d = 1.2 √P
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