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BF Applied Part – whole device
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EMC Table/Environment
The iCOquit® Smokerlyzer® complies with the Medical Device Directive 93/42/EEC as amended by
2007/47/EC and the Medical Device Electromagnetic Compatibility standard IEC 60601-1-2 and EN
60601-1-2.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the iCOquit®
Smokerlyzer® including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result. This equipment should be moved if necessary, to avoid
interference.
Guidance and manufacturer's declaration: Electromagnetic Immunity (IEC 60601-1-2)
The iCOquit® Smokerlyzer® is intended for the use in the electromagnetic environment specified below. The
customer or the user of the iCOquit® Smokerlyzer® should assure that it is used in such an environment.
Immunity test
IEC 60601 Test level
Radiated
10V/m (1kHz 80%)
Immunity
80MHz – 2.7GHz
EN61000-4-
3V/m (80% 1kHz)
3:2006 +
2.7Hz – 6.0GHz
A1:2008 +
385 MHz 27 V/m
A2:2010
PM 18 Hz
450 MHz 28 V/m
IEC61000-4-
FM 1 kHz sine
3:2006
710 MHz 9 V/m PM
+A1:2007 +
217 Hz
A2:2010
745 MHz 9 V/m PM
217 Hz
780 MHz 9 V/m PM
217 Hz
810 MHz 28 V/m
PM 18 Hz
870 MHz 28 V/m
PM 18 Hz
930 MHz 28 V/m
PM 18 Hz
1720MHz 28 V/m
PM 217 Hz
1845 MHz 28 V/m
PM 217 Hz
Compliance
Electromagnetic environment – guidance
level
Criterion A
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.
Interference may occur in the vicinity of
equipment marked with the following symbol:
28
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