Icare HOME2 - Page 44

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Guidance and Manufacturer’s Declaration IEC 60601-1-2:2014; Edition 4.0
Electromagnetic Immunity
iCare HOME2 tonometer (TA023) is intended for use in a home healthcare environment with
electromagnetic characteristics specified below. The user of the iCare HOME2 tonometer (TA023)
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
± 8 kV contact
± 15 kV air
± 8 kV contact
± 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
Transients / burst
IEC 61000-4-4
± 2 kV
100 kHz repetition
frequency
NOT APPLICABLE NOT APPLICABLE
Surge
IEC 61000-4-5
±1 kV for line(s) to
line(s)
±2 kV for line(s) to
earth
NOT APPLICABLE NOT APPLICABLE
Voltage dips, short
interruption and
voltage variations on
power supply lines
IEC 61000-4-11
0 % UT for 0.5 cycle
(1 phase)
0 % UT for 1 cycle
70 % UT for 25/30
cycles (50/60 Hz)
0 % UT for 250/300
cycles
(50/60 Hz)
NOT APPLICABLE NOT APPLICABLE
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.
WARNING!
Sources of
power
frequency magnetic
field should be used no
closer than 15 cm (6
inches) to any part of
iCare HOME2 (TA023),
including cables
specified by the
manufacturer, to avoid
the degradation of
performance.