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EDAN SE-601 Series - Page 122

EDAN SE-601 Series
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SE-601 Series Electrocardiograph User Manual
- 115 -
Guidance and manufacture’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The SE-601 Electrocardiograph is intended for use in the electromagnetic environment
specified below. The customer or the user of SE-601 Electrocardiograph should assure that it is
used in such an environment.
Immunity
test
IEC 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
3V
rms
3 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
SE-601 Electrocardiograph, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Pd 2.1=
Pd 2.1=
80 MHz to 800 MHz
Pd 3.2= 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).
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 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 SE-601
Electrocardiograph is used exceeds the applicable RF compliance level above, the
SE-601 Electrocardiograph should be observed to verify normal operation. If abnormal

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