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Appendix
Appendix 1
State
Low voltage alarm
SpO2 alarm
Pulse rate alarm
Probe error alarm
Appendix 2
Guidance and manufacture's declaration – electromagnetic emissions-
Guidance and manufacture's declaration – electromagnetic emission
The Pulse Oximeter 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 and environment.
Emission test
Compliance
RF emissions
CISPR 11
RF emission
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuationsflicker
emissions
IEC 61000-3-3
Guidance and manufacture's declaration – electromagnetic immunity –
Guidance and manufacture's declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of Pulse Oximeter should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Alarm condition delay
0.6s
400ms
400ms
400ms
Guidance and manufacture's declaration
for all EQUIPMENT and SYSTEMS
Electromagnetic environment – guidance
The Pulse Oximeter uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
Group 1
not likely to cause any interference in nearby electronic
equipment.
Class B
The Pulse Oximeter is suitable for use in all establishments,
Not applicable
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Not applicable
for all EQUIPMENT and SYSTEMS
IEC 60601 test
level
6 kV contact
8 kV air
Alarm signal generation delay
20ms
20ms
20ms
20ms
Compliance
Electromagnetic environment - guidance
level
6 kV contact
Floors should be wood, concrete or
6 kV air
ceramic tile. If floor are covered with
synthetic material, the relative humidity
should be at least 30%. The
manufacturer may recommend the ESD
precautionary procedures to user.
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