Electromagnetic Declaration - Icare HOME2 Instruction Manual

the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
This Product operates in the unlicensed ISM band at 2.4GHz. In case this
Product is used around the other wireless devices including microwave and
wireless LAN, which operate same frequency band of this Product, there is
a possibility that interference occurs between this Product and such other
devices. If such interference occurs, please stop the operation of other
devices or relocate this Product before using this Product or do not use
this product around the other wireless devices

17.12 Electromagnetic declaration

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.
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! Interference may occur in the vicinity of equipment marked with the
non-ionizing radiation symbol.
PRECAUTION! Non-ME equipment (computer or mobile device) used in the system
for transferring data must comply with the electromagnetic emission and immunity
requirements for multimedia equipment: CISPR 32 and CISPR 35.
PRECAUTION! The measurement method of the tonometer is based on a magnetically
induced motion of a probe and therefore an external magnetic or radiated RF
electromagnetic field disturbing the probe may prevent the measurement. In such a
case the tonometer continuously displays error messages during measurement and asks
you to repeat the measurement. Situation can be solved either by removing the source
of interference from the vicinity of the device or by performing the measurement in
different location with no such interference.
PRECAUTION! The measurement data transfer may be interrupted during
electromagnetic disturbance. In such case, reconnect the tonometer to the computer
or mobile device. If this does not solve the issue, perform the data transfer in other
location with no such interference. The measurement data will not be deleted from
the device before the data is transferred successfully.
PRECAUTION! Portable and mobile RF communications equipment can affect the
tonometer.
PRECAUTION! Although the tonometer's own electromagnetic emissions are well below
the levels permitted by the relevant standards, they may cause interference in other,
nearby devices, for example sensitive sensors.
The iCare HOME2 tonometer is a class B equipment and needs special
precautions regarding EMC and needs to be installed and put into service
according to EMC information provided in following tables.
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Guidance and Manufacturer's Declaration IEC 60601-1-2:2014; Edition 4.0
Electromagnetic Emissions
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.
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions NOT APPLICABLE
IEC 61000-3-2
Voltage fluctuations flickering NOT APPLICABLE
emissions
IEC 61000-3-3
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
Electrostatic ± 8 kV contact
discharge (ESD) ± 15 kV air
IEC 61000-4-2
Electrical fast ± 2 kV
Transients / burst 100 kHz repetition
IEC 61000-4-4 frequency
Surge ±1 kV for line(s) to
IEC 61000-4-5 line(s)
±2 kV for line(s) to
earth
Voltage dips, short 0 % UT for 0.5 cycle
interruption and (1 phase)
voltage variations on 0 % UT for 1 cycle
power supply lines 70 % UT for 25/30
IEC 61000-4-11 cycles (50/60 Hz)
0 % UT for 250/300
cycles (50/60 Hz)
Power frequency 30 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
iCare HOME2 (TA023) 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.
iCare HOME2 (TA023) 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
NOT APPLICABLE
NOT APPLICABLE
Compliance level Electromagnetic
environment-Guidance
± 8 kV contact Floors should be wood,
± 15 kV air 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 NOT APPLICABLE
NOT APPLICABLE NOT APPLICABLE
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.
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