Monitored Therapeutics, Inc. © Copyright 2020 20 P/N 45-50035 Rev. K, 2020-10-21
Guidance and manufacturer’s declaration – electromagnetic immunity
The GoSpiro Spirometer is intended for use in the electromagnetic environment specified below. The customer or user of the
GoSpiro should assure that it is used in such an environment.
IEC 60601-1-2:2014
(4
th
Edition) test
level
Electromagnetic environment - guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 V rms
150 kHz to 80 MHz
6 V rms
in ISM and amateur
radio bands 150
kHz to 80 MHz
10 V/m
80 to 2700 MHz
80% AM at 1 kHz
3 V rms
150 kHz to 80 MHz
6 V rms
in ISM and amateur
radio bands 150
kHz to 80 MHz
10 V/m
80 to 2700 MHz
80% AM at 1 kHz
Portable and mobile RF communications equipment must be used no
closer to any part of the GoSpiro Spirometer, 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=0.58 √P
d = 0.35√P 80 MHz to 800 MHz
d = 0.7√P 800 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacture and d is the
recommended separation distance in meters (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 GoSpiro Spirometer is used exceeds the applicable RF compliance level above, the GoSpiro Spirometer should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the GoSpiro Spirometer.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the
GoSpiro Spirometer
The GoSpiro Spirometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the GoSpiro Spirometer can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and GoSpiro Spirometer as recommended below, according to
the maximum output power of the communications equipment.
R
a
te
d
maximum
ou
t
p
u
t
power of
tr
a
n
s
m
itte
r
S
e
p
a
r
a
tio
n
distance
according to frequency of
tr
a
n
s
m
i
tt
e
r
In meters
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