E30 Digital Electrocardiograph User’s Manual
25
Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The E30 Digital Electrocardiograph is intended for use in the electromagnetic environment specified below. The
customer or the user of E30 Digital Electrocardiograph should assure that it is used in such an environment.
Immunity test EN 60601 test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the E30 Digital Electrocardiograph,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
P
V
d
⎥
⎦
⎤
⎢
⎣
⎡
=
1
5.3
P
E
d
⎥
⎦
⎤
⎢
⎣
⎡
=
1
5.3
80 MHz to 800 MHz
P
E
d
⎥
⎦
⎤
⎢
⎣
⎡
=
1
7
800 MHz to 2.5 GHz
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 metres
(m).
b
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.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic 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 E30 Digital Electrocardiograph is
used exceeds the applicable RF compliance level above, the E30 Digital Electrocardiograph should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the E30 Digital Electrocardiograph.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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