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WARNING!
Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
WARNING!
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
Icare HOME is class B equipment and needs special precautions regarding EMC and
needs to be installed and put into service according to EMC information provided
below.
English
Icare HOME tonometer Instruction manual for health care professionals
20.
ELECTROMAGNETIC DECLARATION
Guidance and manufacturer’s declaration IEC 60601-1-2: Edition 4.0; 2014-02 - Electromagnetic emissions
Icare HOME (TA022) is intended for use in
a home
healthcare
environment with
electromagnetic
characteristics
specified below. The user of the Icare HOME (TA022) should assure that it is used
in such an environment.
RF emissions CISPR 11
Group 1
Icare HOME (TA022) is battery operated and uses RF
energy only for its internal function. Therefore, its RF
emissions are low and are not likely to cause any
interference in nearby equipment.
RF emissions CISPR 11
Class B
Icare HOME (TA022) is suitable for use in all
establishments, including domestic establishments and
those directly connected to public low-voltage power
supply network that supplies buildings used for
domestic purposes
Harmonic emissions
IEC 61000-3-2
Not applicable
Power level of Icare HOME (TA022) is below standard
requirement, batteries are not rechargeable
Voltage fluctuations
flickering emissions
IEC 61000-3-3
Not applicable
Icare HOME (TA022) batteries are not rechargeable
Icare HOME
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Icare HOME
Guidance and manufacturer’s declaration IEC 60601-1-2: Edition 4.0; 2014-02 - Electromagnetic immunity
Icare HOME (TA022) is intended for use in a home healthcare environment with electromagnetic
characteristics specified below. The customers or users of Icare HOME (TA022) should assurre that it is
used in such enviroment
Immunity test
IEC 60601 Test level
Compliance level
Electromagnetic
environment-Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2kV, ±4kV, ±8kV, ±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
Icare HOME (TA022) tonometer
is not operational when
connected to an external
computer, Icare HOME (TA022)
batteries are not rechargeable
Surge
IEC 61000-4-5
±1 kV for line(s) to line(s)
±2 kV for line(s) to earth
Not applicable
Icare HOME (TA022) tonometer
is not operational when
connected to an external
computer, Icare HOME (TA022)
batteries are not rechargeable
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
Icare HOME (TA022) tonometer
is not operational when
connected to an external
computer, Icare HOME (TA022)
batteries are not rechargeable
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
HOME (TA022), including cables
specified by the manufacturer.
Otherwise, degradation of the
performance could result.
English
Icare HOME tonometer Instruction manual for health care professionals
Icare HOME tonometer Instruction manual for health care professionals
ENGLISH
30
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