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APPENDIX 1
Guidance and manufacturer's declaration electromagnetic emission for all EQUIPMENT and
SYSTEMS
The pulse oximeter (CMS60F) is intended for use in the electromagnetic environment specified below. The customer
of the user of the Pulse Oximeter should assure that it is used in such environment.
Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emission
IEC 6100-3-3
Guidance and manufacturer's declaration electromagnetic immunity for all EQUIPMENT and
SYSTEMS
The pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the pulse oximeter should assure that it is used in such an environment
Immunity test
Electrostatic dischrge
(ESD) IEC 61000-4-2
Power frequency (50Hz)
magnetic field IEC 61000-
4-8
Guidance and manufacturer's declaration electromagnetic immunity for EQUIPMENT and
SYSTEMS that are not LIFE-SUPPORTING
The pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the pulse oximeter should assure that it is used in such an environment
Immunity test
IEC60601 test level
Conducted RF
3V rms
IEC 61000-4-6
150kHz to 80 MHZ
DE
PT NL
SWE
Guidance and manufacturer's declaration -- Electromagnetic emission
Compliance
Group 1
Class B
Not applicable
Not applicable
Guidance and manufacturer's declaration-elecrtomagnetic immunity
IEC60601 test level
±6 KV contact
±9 KV air
3 A/m
Guidance and manufacturer's declaration-elecrtomagnetic immunity
Compliance level
3Vnms
PL
DK
Electromagnetic environment-guidance
The pulse oximter 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 pulse oximeter is suitable for use in all establishments,
including domestic establishments and those directly
connected t the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Compliance level
Electromagnetic environment.guidance
±6 KV contact
Floors should be wood, concrete or
±9 KV air
ceramic tile If floor are covered with
synthetic material, the relative humidity
should be at least 30%
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hos-
pital environment.
Electromagnetic environment-guidance
Portable and mobile RF communication equipment
should be used no closer to any part of the pulse
oximeter including cables, than the recommended
separation distance calculated from the equiation
applicable to the frequency of the transmitter.
Pulse oximeter
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