AliveCor KardiaMobile Card Instructions For Use Manual - Page 15
Browse online or download pdf Instructions For Use Manual for Medical Equipment AliveCor KardiaMobile Card. AliveCor KardiaMobile Card 17 pages.
Print Page
Instructions for Use for KardiaMobile Card (AC-021)
Guidance and manufacturer's declaration—electromagnetic immunity
KardiaMobile is intended for use in the electromagnetic environment specified below. The customer or the user
of KardiaMobile Card should assure that it is used in such an environment.
Immunity
IEC 60601
test
test level
10 V/m
Radiated RF
80 MHz to
IEC 61000-4-3
2.7 GHz
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 Card is used exceeds the applicable RF compliance level above, KardiaMobile Card should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating KardiaMobile Card.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Compliance
Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of KardiaMobile
Card, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
10 V/m
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,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
< 80MHz
80 MHz to 800 MHz
800 MHz to 2.7 GHz
b
a
Page 15 of 17