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Appendix IV – EMC
Guidance and manufacturer's declaration – electromagnetic immunity
The Dena350 Electrocardiograph is intended for use in the electromagnetic environment
specified below. The customer or the user of the Dena350 should assure that it is used in such an
environment.
Immunity test
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, 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 radio
and FM radio broadcast and TV broadcast cannot be predicted the oretically 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 Dena350is
used exceeds the applicable RF compliance level above, the Dena350 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may necessary, such as reorienting or relocating the Electrocardiograph.
b
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m
IEC 60601
Compliance
test level
3 V
3 V/m
Electromagnetic environment –
level
Portable and mobile RF communications
equipment should be used no closer to any
part of the Dena350 Electrocardiograph,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
P
d
= 1.17
P
d
= 1.17
P
d
= 2.33
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
a
survey,
should be less than the
compliance level i
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
.
64
guidance
80
MHz to 800 MHz
800
MHz to 2.5 GHz
n each frequency range.
s, amateur radio, AM
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