User Manual

45
FCC STATEMENT
FCC CAUTION
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equipment.
Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with 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:
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46
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
Compatibility) with the aim to prevent unsafe product situations,
the IEC60601-1-2 standard has been implemented. This standard
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as well as maximum levels of electromagnetic emissions for
medical devices.
Medical devices manufactured for OMRON Healthcare conform to
this IEC60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
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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.
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with other equipment. In case adjacent or stacked use is
necessary, the medical device should be observed to verify
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the medical device. This may result in incorrect operation of the
unit and create a potentially unsafe situation. Recommendation
is to keep a minimum distance of 7 m. Verify correct operation
of the device in case the distance is shorter.
During the immunity tests described below the device operated
normally.
47
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
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that it is used in such environment.
Electromagnetic emissions IEC60601-1-2
Emissions test Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The PM311 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.
RF emissions
CISPR 11
Class B
The PM311 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
Harmonic emissions
IEC 61000-3-2
not applicable
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IEC 61000-3-3
not applicable
48
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
Electromagnetic immunity IEC60601-1-2
Immunity test IEC 60601 Test level Compliance level
Electromagnetic environment –guidance
Electrostatic
discharge, ESD
(IEC 61000-4-2)
Contact discharge:
±6 kV
Air discharge:
±8 kV
Contact discharge:
±8 kV
Air discharge:
±15 kV
The relative humidity should be at least 5 %.
Electrical fast
transients / bursts
(IEC 61000-4-4)
Power supply lines:
±2 kV
Longer input / output
lines: ±1 kV
Power supply lines:
±2 kV
Longer input / output
lines: N/A
Mains power quality should be that of a typical home,
commercial or hospital environment.
Surges on AC mains
lines
(IEC 61000-4-5)
Common mode:
±2 kV
Differential mode:
±1 kV
Common mode:
±2 kV
Differential mode:
N/A
Mains power quality should be that of a typical home,
commercial or hospital environment.