AliveCor KardiaMobile Card Gebruiksaanwijzing - Pagina 14

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AliveCor KardiaMobile Card Gebruiksaanwijzing
Instructions for Use for KardiaMobile Card (AC-021)

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