Instructions for Use for KardiaMobile® (Model AC-019)
Page 19 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
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® (Model AC-
019) is powered from a
lithium coin cell 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.
