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COMPLIANCE AND IEC CLASSIFICATION
12
GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY
The Breathe Technologies® Life2000® Ventilation System is intended for use in the electromagnetic
environment specified below. The customer or user of the ventilation system should ensure that it is used in
such an environment.
BREATHE TECHNOLOGIES® LIFE2000® VENTILATION SYSTEM
Immunity Test
IEC 60601
Requirement
Compliance Level
Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz,
6 Vrms in ISM and
amateur radio band
between 0.15 MHz
and 80 MHz, 80%
modulation at 1 KHz
3 Vrms
150 kHz to 80 MHz,
6 Vrms in ISM and
amateur radio band
between 0.15 MHz
and 80 MHz, 80%
modulation at 1 KHz
Portable and mobile RF communications equipment
should be used no closer to any part of the Breathe
Technologies® Life2000® Ventilation System, including
cables, than the recommended separations distance
calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance:
d = 1.17 √P 150 kHz to 80MHz
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 800 MHz to 2.5GHz
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* should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Radiated RF
IEC 61000-4-3
Shall withstand
test frequencies,
amplitudes, and
conditions specified
in Table 9 of IEC
60601-1-2 (4th ed.)
Tested to
frequencies,
amplitudes, and
conditions specified
in Table 9 of IEC
60601-1-2 (4th ed.)
NOTE 1:
U
T
is the AC mains voltage prior to application of the test level.
NOTE 2:
At 80 MHz, the higher frequency range applies.
NOTE 3:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
* 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 TB broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be
considered. If the measured field strength in the location in which the ventilation system is used exceeds the applicable RF
compliance level above, the ventilation system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the ventilation system.
