page 18
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The MoMe
®
Kardia is intended for use in the electromagnetic environment
specified below. The customer or the user of MoMe
®
Kardia should assure
that it is used in such an environment
Immunity
Test
IEC 60601
Test Level
Level
Electromagnetic
Environment - Guidance
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz
to 80 MHz
Not
applicable
Portable and mobile RF
equipment should be used no closer to
any part of the
unit, 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 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 transmitter
and d is the recommended separation
distance in meters (m). Field strengths
from fixed RF transmitters, as
by an electromagnetic site survey, s
be less than the compliance level in
frequency range. Interference may
in the vicinity of equipment marked with
the following symbol:
Radiated
RF IEC
61000-4-3
3 V/m
80 MHz
to 2.5 GHz
Not
applicable
3 V/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.
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 broad-
cast 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
unit is used exceeds the applicable RF compliance level above, then the unit should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the unit.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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