Instructions for Use for KardiaMobile Card (AC-021)
Page 14 of 17
Electrical Safety
Guidance and manufacturer's declaration - electromagnetic emissions
KardiaMobile Card 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.
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
KardiaMobile Card uses RF energy only for its internal
function. RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
KardiaMobile Card is intended for use in domestic
surroundings.
Harmonic emissions
IEC 61000-3-2
N/A
KardiaMobile Card is powered from a lithium manganese
dioxide battery and does not require AC mains power
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
N/A
Guidance and manufacturer’s declaration—electromagnetic immunity
KardiaMobile Card 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 test
IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±2 kV contact
±4 kV contact
±6 kV contact
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
±2 kV contact
±4 kV contact
±6 kV contact
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
N/A
N/A
KardiaMobile Card is powered
from a lithium manganese dioxide
battery and does not require AC
mains power.
Surge
IEC 61000-4-5
N/A
N/A
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
N/A
N/A
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
