Instructions for Use for KardiaMobile® (Model AC-019)
Page 20 of 23
Guidance and manufacturer’s declaration—electromagnetic immunity
KardiaMobile® (Model AC-019) is intended for use in the electromagnetic environment specified
below. The customer or the user of KardiaMobile® (Model AC-019) should assure that it is used in
such an environment.
Immunity
test
IEC 60601
test level
Complian
ce level
Electromagnetic environment - guidance
Radiated RF
IEC 61000-4-
3
10 V/m
80 MHz to
2.7 GHz
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of KardiaMobile® (Model AC-019), including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
< 80MHz
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
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 strength 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 KardiaMobile® (Model AC-019) is used exceeds the applicable RF
compliance level above, KardiaMobile® (Model AC-019) should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating KardiaMobile® (Model AC-019).
P
V
d
]
5
.
3
[
1
P
E
d
]
5
.
3
[
1
P
E
d
]
7
[
1