Guidance and manufacture's declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS
that are not LIFE-SUPPORTING
Guidance and manufacture's declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of Pulse Oximeter should assure that it is used in such an environment.
Immunity
IEC 60601
test
test level
Conducted
3V (0.15MHz–
RF
80MHz), 6V
IEC
(in ISM bands
61000-4-6
between
0.15MHz
and 80MHz)
Radiated RF
10 V/m
IEC 61000-
80 MHz to
4-3
2.7GH
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
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 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, field strengths should be less than 3 V/m.
ENGLISH
Compliance
level
3V (0.15MHz–
80MHz), 6V
(in ISM bands
between
0.15MHz
and 80MHz)
10 V/m
Electromagnetic environment - guidance
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
3.5
√P
d=
V
1
3.5
√P
d=
80 MHz to 800 MHz
E
1
7
√P
d=
800 MHz to 2,7 GHz
E
1
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 fixed RF transmitters, as
determined by an electromagnetic site survey,
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:
34
a