ResMed Stellar 100 用户手册
29
Technical specifications
En
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Guidance and manufacturer’s declaration – electromagnetic
emissions and immunity
emissions and immunity
Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to EMC information provided in this document.
installed and put into service according to EMC information provided in this document.
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
device should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR11
Group 1
The device 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.
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 device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage network that
supplies buildings used for domestic purposes.
including domestic establishments and those directly
connected to the public low-voltage network that
supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
IEC 61000-3-2
Class A
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Emissions IEC 61000-3-3
Complies
Warnings: The device should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may
result in increased emissions or decreased immunity of the device.
If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may
result in increased emissions or decreased immunity of the device.
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
device should assure that it is used in such an environment.
Immunity test
IEC60601-1-2 test
level
level
Compliance level
Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
IEC 61000-4-4
±2 kV for power
supply lines
supply lines
±1 kV for input/output
lines
lines
±2 kV
±1 kV
Mains power quality should be that of a typical
commercial or hospital environment.
commercial or hospital environment.
Surge IEC
61000-4-5
61000-4-5
±1 kV differential
mode
mode
±2 kV common mode
±1 kV differential
mode
mode
±2 kV common
mode
mode
Mains power quality should be that of a typical
commercial or hospital environment.
commercial or hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% Ut (>95% dip in
Ut) for 0.5 cycle
Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
Ut) for 25 cycles
<5% Ut (>95% dip in
Ut) for 5 sec
Ut) for 5 sec
< 12 V (>95% dip in
240V) for 0.5 cycle
240V) for 0.5 cycle
96 V (60% dip in
240 V) for 5 cycles
240 V) for 5 cycles
168 V (30% dip in
240 V) for 25 cycles
240 V) for 25 cycles
<12 V (>95% dip in
240 V) for 5 sec
240 V) for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the device requires continued
operation during power mains interruptions, it is
recommended that the device be powered from
an uninterruptible power source.
commercial or hospital environment.
If the user of the device requires continued
operation during power mains interruptions, it is
recommended that the device be powered from
an uninterruptible power source.
Power
frequency
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
levels characteristic of a typical location in a
typical commercial or hospital environment.