Electromagnetic Compatibility Information - Sanitas SBM 52 Instructions For Use Manual

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Electromagnetic Compatibility Information

Guidance and manufacture's declaration – electromagnetic emissions – for all EQUIPMENT and SYSTEMS
Guidance and manufacture's declaration – electromagnetic emission
The SBM52 blood pressure monitor is intended for use in the electromagnetic environment specifi ed below. The custo-
mer of the user of the SBM52 blood pressure monitor should assure that it is used in such and environment.
Emission test
RF emissions CISPR 11 Group 1
RF emission CISPR 11
Guidance and manufacture's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS
Guidance and manufacture's declaration – electromagnetic immunity
The SBM52 blood pressure monitor is intended for use in the electromagnetic environment specifi ed below. The custo-
mer or the user of the SBM52 blood pressure monitor should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Power frequency (50Hz)
magnetic fi eld
IEC 61000-4-8
Guidance and manufacture's declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacture's declaration – electromagnetic immunity
The SBM52 blood pressure monitor is intended for use in the electromagnetic environment specifi ed below. The custo-
mer or the user of the SBM52 blood pressure monitor should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Conducted RF
3 V
rms
IEC 61000-4-6
150 kHz to
80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to
2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aff ected by absorption and
refl ection from structures, objects and people.
Compliance Electromagnetic environment – guidance
The SBM52 blood pressure monitor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interfe-
rence in nearby electronic equipment.
Class B
The SBM52 blood pressure monitor is suitable for use in all establishments, inclu-
ding domestic establishments and those directly connected to the public low-vol-
tage power supply network that supplies buildings used for domestic purposes.
IEC 60601
Compliance
test level
level
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
3 A/m
3 A/m
Compliance
Electromagnetic environment – guidance
level
Portable and mobile RF communications equipment should be used no clo-
ser to any part of the SBM52 blood pressure monitor, including cables, than
the recommended separation distance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance:
d =
3 V
rms
d =
d =
3 V/m
Where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended sepa-
ration distance in metres (m).
Field strengths from fi xed RF transmitters, as determined by an electroma-
gnetic site survey,
quency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If fl oor
are covered with synthetic material, the relative humi-
dity should be at least 30%.
Power frequency magnetic fi elds should be at levels
characteristic of a typical location in a typical commer-
cial or hospital environment.
80 MHz to 800 MHz
800 MHz to 2.5 GHz
a
should be less than the compliance level in each fre-
b
31

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