Technical Information
181
APPENDIX
Guidance and manufacturer’s declaration – electromagnetic immunity
The Incu i is intended for use in the electromagnetic environment specified below. The customer or the user
of the Incu i should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
(ISO 9919)
Radiated RF
IEC 61000-4-3
(
IEC60601-2-19
)
Electromagnetic environment guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Incu i,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
d = 1.2 P
80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts(W) according to the trans-
mitter manufacturer and d is the recommended
separation distance in meters(m).*
b
Field strength from fixed RF transmitters, as deter-
mined by an electromagnetic site survey, *
c
should
be less than the compliance level in each frequency
range. *
d
Interference may occur in the vicinity of equipment
marked the following symbol:
IEC 60601
test level
3Vrms
150kHz to 80MHz
outside ISM bands
10Vrms
150kHz to 80MHz
in ISM bands
SpO2 : 3Vrms
3V/m
80MHz to 2.5GHz
The equipment
continues to
perform its in-
tended function.
10V/m (80MHz to
2.5GHz)
The equipment
continues to
perform its in-
tended function or
stops without
causing any harm.
Compliance
level
3V
10V
10V/m
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.
*b The ISM compliance level in the ISM frequency band between 150kHz and 80MHz and in the frequency range 80MHz
to 2.5GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause inter-
ference if it is inadvertently brought into patient areas. For this reason an additional factor of 10/3 is used in calculating
the recommended separation distance for transmitters in these frequency ranges.
*c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radio, 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 consid-
ered. If the measured field strength in the location in which the Inuc i is used exceeds the applicable RF compliance level
above, the Inuc i should be observed to verify normal operation. If abnormal performance is observed, additional mea-
sures may be necessary, such as reorienting or relocating the Inuc i.
*d Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
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