32
GUIDANCE AND MANUFACTURER’S DECLARATION
(Table 1)
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC61000-3-3
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile
(cellular) telephones, medical devices in use may be susceptible to
electromagnetic interference from other devices. Electromagnetic interference
may result in incorrect operation of the medical device and create a potentially
unsafe situation. Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibil-
ity) with the aim to prevent unsafe product situations, the IEC60601-1-2
standard has been implemented. This standard defines the levels of immunity
to electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
Medical devices manufactured by OMRON Healthcare conform to this
IEC60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specified by OMRON,
with the exception of cables sold by OMRON as replacement parts for
internal components, may result in increased emission or decreased
immunity of the device.
• The medical devices should not be used adjacent to or stacked with other
equipment.
In case adjacent or stacked use is necessary, the medical device should be
observed to verify normal operation in the configuration in which it will be
used.
• Refer to further guidance below regarding the EMC environment in which
the device should be used.
• The MEDICAL ELECTRICAL EQUIPMENT BPM needs special
precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this documentations.
OMRON BPM is intended for use in the electromagnetic environment
specified below. The customer or the user of this OMRON BPM should
assure that it is used in such environment.
Electromagnetic environment
– guidance
Group 1
Class B
RF emissions CISPR 11
RF emissions CISPR 11
The OMRON BPM uses
RF energy only for its internal
function. Therefore, its RF emissions
are very low and are not likely to
cause any interference in nearby
electronic equipment.
The OMRON BPM
is suitable for use in all establishments,
including domestic establishments and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Compliance
Not
Applicable.
Not
Applicable.
• The Essential Performance of the BPM is to measure a blood
pressure and a pulse rate and using the memory function.
The BPM may be interfered with by other equipment, even if that other
equipment complies with CISPR EMISSION requirements.
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