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Guidance and manufacture’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The cus-
tomer or the user of Pulse Oximeter 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
3V (0.15MHz–
80MHz), 6V
(in ISM bands
between
0.15MHz
and 80MHz)
10 V/m
80 MHz to
2.7GH
3V (0.15MHz–
80MHz), 6V
(in ISM bands
between
0.15MHz
and 80MHz)
10 V/m
Portable and mobile RF communications equip-
ment should be used no closer to any part of
the Pulse Oximeter, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,7 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in metres (m).
Field strengths from xed 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 vicin-
ity of equipment marked with the
following symbol:
NOTA 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
reection from structures, objects and people.
a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld strength in the location in which the Pulse Oximeter is used exceeds
the applicable RF compliance level above, the Pulse Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Pulse Oximeter.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
3.5
V 1
P
d=
3.5
E 1
P
d=
7
E 1
P
d=
Guidance and manufacture’s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS
that are not LIFE-SUPPORTING
ENGLISH
17


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