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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The MoMe
®
Kardia is intended for use in the electromagnetic environment
specified below. The customer or the user of MoMe
®
Kardia 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
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
+/- 2 kV for
power
supply lines
+/- 1 kV
for input/
output lines
Not
applicable
Surge IEC
61000-4-5
+/- 1 kV line(s)
to line(s)
+/- 2 kV
to earth
Not
applicable
Voltage
dips, short
interruptions
and voltage
variations
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5s
Not
applicable
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commer-
cial or hospital environment.