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Instructions for Use for KardiaMobile 6L
Page 15 of 18
Guidance and manufacturer’s declaration—electromagnetic immunity
KardiaMobile 6L is intended for use in the electromagnetic environment specified below. The customer or
the user of KardiaMobile 6L 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 6L 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.
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