Icare HOME2, Instruction Manual

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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.
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 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.
RF emissions CISPR 11 Class B 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
Harmonic emissions
IEC 61000-3-2
NOT APPLICABLE NOT APPLICABLE
Voltage fluctuations flickering
emissions
IEC 61000-3-3
NOT APPLICABLE NOT APPLICABLE