Icare HOME2 Instruction Manual page 44

Guidance and Manufacturer's Declaration IEC 60601-1-2:2014; Edition 4.0
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
Transients / burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruption and
voltage variations on
power supply lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
44
Electromagnetic Immunity
IEC 60601 Test level
± 8 kV contact
± 15 kV air
± 2 kV
100 kHz repetition
frequency
±1 kV for line(s) to
line(s)
±2 kV for line(s) to
earth
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)
30 A/m
Compliance level
± 8 kV contact
± 15 kV air
NOT APPLICABLE
NOT APPLICABLE
NOT APPLICABLE
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%
NOT APPLICABLE
NOT APPLICABLE
NOT APPLICABLE
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.