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Aerogen®
42
Table 11. Guidance and manufacturer’s declaration – electromagnetic immunity for
the Aerogen Solo nebuliser system that is not life supporting (Continued)
Immunity Test IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment – Guidance
9 V/m, 217 Hz PM
5500 MHz
9 V/m, 217 Hz PM
5785 MHz
9 V/m, 217 Hz PM
5500 MHz
9 V/m, 217 Hz PM
5785 MHz
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: 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 Aerogen Solo nebuliser system is used exceeds the applicable
RF compliance level above, the Aerogen Solo nebuliser system should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orientating or relocating the Aerogen Solo nebuliser system.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m.
44


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