ResMed AirSense 10, AirCurve 10, S9, VPAP Tx, Series III, S8, S8 Series II CPAP device, Stellar Home medical equipment, ApneaLink Plus, Air Sleep monitoring device Guidance and Manufacturer’s Declaration
Below you will find brief information for AirSense 10, AirCurve 10, S9 Series, Stellar, VPAP Tx. These devices are intended for use in the electromagnetic environment specified. This information is intended for use by customers and users of these devices.
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Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
AirSense
™
10 | AirCurve
™
10
S9
™
Series
Stellar
™
VPAP
™
Tx
ApneaLink
™
| ApneaLink
™
Plus | ApneaLink
™
Air
S8
™
& S8 Series II | VPAP
™
Series III
English
Page
1 - 3
4 - 6
7 - 9
10 - 12
13 - 15
16 - 18
AirSense
™
10 | AirCurve
™
10
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
English
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.
This declaration currently applies for the following ResMed devices:
• AirSense
™
10
• AirCurve
™
10
Guidance and manufacturer’s declaration—electromagnetic emissions
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Compliance
Group 1
Class B
Electromagnetic environment—guidance
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.
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.
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions IEC
61000-3-3
Class A
Complies
WARNING
• 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 other than those specified for the device is not recommended. They may result in increased emissions or decreased immunity of the device.
AirSense™ 10 | AirCurve™ 10 2
Guidance and manufacturer’s declaration – electromagnetic immunity
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
IEC60601-1-2 test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Electromagnetic environment—guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/ burst IEC 61000-4-4
Surge
IEC 61000-4-5
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% Ut (>95% dip in Ut) for 0.5 cycle
40% Ut (60% dip in Ut) for 5 cycles
70% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip in Ut) for 5 sec
3 A/m Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
±2 kV
Not Applicable
±1 kV differential mode
±2 kV common mode
100V
240V
3 A/m
10 Vrms
150 kHz to 80 MHz
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 0.35 √P d = 0.35 √P 80 MHz to 800 MHz d = 0.70 √P 800 MHz to 2.5 GHz
Where (P) is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an a should be less than the compliance level in electromagnetic site survey, each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Notes:
• Ut is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
AirSense™ 10 | AirCurve™ 10 3
Recommended separation distances between portable and mobile RF communications equipment and the device
These devices are intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
0.01
0.1
1
10
100
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 0.35 √P
80 MHz to 800 MHz d = 0.35 √P
800MHz to 2.5 GHz d = 0.7 √P
0.35
0.035
0.070
0.11
0.35
0.11
0.35
0.22
0.70
1.1
3.5
1.1
3.5
2.2
7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
AirSense™ 10 | AirCurve™ 10 4
S9
™
Series
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
English
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.
This declaration currently applies for the following ResMed devices:
• S9
™
Series (with or without H5i and ClimateLine
™
).
Guidance and manufacturer’s declaration—electromagnetic emissions
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
Compliance
Group 1
RF emissions CISPR 11 with or without USB adapter with or without Oximeter adapter
Harmonic Emissions
IEC 61000-3-2 with or without USB adapter with or without Oximeter adapter
Voltage Fluctuations/Flicker Emissions IEC
61000-3-3 with or without USB adapter with or without Oximeter adapter
Class B
Class A
Complies
Electromagnetic environment—guidance
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.
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.
WARNING
• 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 other than those specified for the device is not recommended. They may result in increased emissions or decreased immunity of the device.
S9™ Series 5
Guidance and manufacturer’s declaration – electromagnetic immunity
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
IEC60601-1-2 test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Electromagnetic environment—guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/ burst IEC 61000-4-4
Surge
IEC 61000-4-5
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% Ut (>95% dip in Ut) for 0.5 cycle
40% Ut (60% dip in Ut) for 5 cycles
70% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip in Ut) for 5 sec
3 A/m Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
±2 kV
Not Applicable
±1 kV differential mode
±2 kV common mode
< 12V (>95% dip in 240V) for 0.5 cycle
96V (60% dip in 240V) for 5 cycles
168V (30% dip in 240V) for 25 cycles
<12V (>95% dip in 240V) for 5 sec
3 A/m
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1.17 √P d = 0.35 √P 80 MHz to 800 MHz d = 0.70 √P 800 MHz to 2.5 GHz
Where (P) is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an a should be less than the compliance level in electromagnetic site survey, each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Notes:
• Ut is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
S9™ Series 6
Recommended separation distances between portable and mobile RF communications equipment and the device
These devices are intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
0.01
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 1.17 √P
0.12
80 MHz to 800 MHz d = 0.35 √P
0.04
800MHz to 2.5 GHz d = 0.7 √P
0.070
0.1
1
10
100
0.37
1.2
3.7
12
0.11
0.35
1.1
3.5
0.22
0.70
2.2
7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
S9™ Series 7
Stellar
™
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
English
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.
This declaration currently applies for the following ResMed device:
• Stellar TM
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.
Emissions test
RF emissions CISPR11
Compliance
Group 1
Electromagnetic environment - guidance
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.
RF emissions CISPR 11
Harmonic Emissions
IEC 61000-3-2
Class B
Class A
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.
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Complies
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.
WARNING:
• 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 (e.g. humidifiers) other than those specified in this manual is not recommended. They may result in increased emissions or decreased immunity of the device.
Stellar™ 8
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.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
IEC60601-1-2 test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Electromagnetic environment –guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Electrical fast transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5
±2 kV for power supply lines
±1 kV for input/output lines
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
±1 kV differential mode
±2 kV common mode
<5% Ut (>95% dip in Ut) for 0.5 cycle
40% Ut (60% dip in Ut) for 5 cycles
70% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip in Ut) for 5 sec
Power frequency
(50/60 Hz) magnetic field IEC
61000-4-8
Conducted RF
IEC 61000-4-6
3 A/m
3 Vrms
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
±2 kV
±1 kV
±1 kV differential mode
±2 kV common mode
< 12 V (>95% dip in 240V) for 0.5 cycle
96 V (60% dip in 240 V) for 5 cycles
168 V (30% dip in 240 V) for 25 cycles
<12 V (>95% dip in 240 V) for 5 sec
3 A/m
3 Vrms
3 V/m
Mains power quality should be that of a typical commercial or hospital environment.
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.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance: d = 1.17 √P d = 1.17 √P 80 MHz to 800 MHz d = 2.33 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
Note:
• Ut is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Stellar™ 9
Recommended separation distances between portable and mobile RF communications equipment and the device
The device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
0.01
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 1.17 √P
0.12
80 MHz to 800 MHz d = 1.17 P
0.12
800MHz to 2.5 GHz d = 2.33 √P
0.23
0.1
1
10
100
0.37
1.17
3.70
11.70
0.37
1.17
3.70
11.70
0.74
2.33
7.37
23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Stellar™ 10
VPAP
™
Tx
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
English
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.
This declaration currently applies for the following ResMed device:
• VPAP TM Tx.
Guidance and manufacturer’s declaration—electromagnetic emissions
This device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11 with Txlink
Compliance
Group 1
Class A
Electromagnetic environment—guidance
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.
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.
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions IEC
61000-3-3
Class A
Complies
* Class A for all system configurations.
Class A is suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.
WARNING
• 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 other than those specified for the device is not recommended. They may result in increased emissions or decreased immunity of the device.
VPAP™ Tx 11
Guidance and manufacturer’s declaration – electromagnetic immunity
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
IEC60601-1-2 test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Electromagnetic environment—guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/ burst IEC 61000-4-4
Surge
IEC 61000-4-5
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
40% Ut (60% dip in Ut) for 5 cycles
70% Ut (30% dip in Ut) for 25 cycles
3 A/m Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
±2 kV
Not Applicable
±1 kV differential mode
±2 kV common mode
No effect
No effect
3 A/m
3 Vrms
150 kHz to 80 MHz
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
30 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1.17 √P d = 0.12 √P 80 MHz to 800 MHz d = 0.23 √P 800 MHz to 2.5 GHz
Where (P) is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Notes:
• Ut is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
VPAP™ Tx 12
Recommended separation distances between portable and mobile RF communications equipment and the device
These devices are intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
0.01
0.1
1
10
100
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 1.17 √P
80 MHz to 800
MHz d = 0.12 √P
800MHz to 2.5 GHz d = 0.23 √P
0.12
0.37
1.2
3.7
12
0.012
0.037
0.12
0.37
1.2
0.023
0.074
0.23
0.74
2.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
VPAP™ Tx 13
ApneaLink
™
| ApneaLink
™
Plus | ApneaLink
™
Air
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
English
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.
This declaration currently applies for the following ResMed devices:
• ApneaLink TM
• ApneaLink TM Plus
• ApneaLink TM Air
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.
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.
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.
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.
WARNING:
• 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 other than those specified in the clinical guide is not recommended. They may result in increased emissions or decreased immunity of the device.
ApneaLink™ | ApneaLink™ Plus | ApneaLink™ Air 14
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.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
IEC60601 test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Electromagnetic environment –guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency
(50/60 Hz) magnetic field IEC
61000-4-8
Conducted RF
IEC 61000-4-6
3 A/m
3 Vrms
150 kHz to 80 MHz
3 A/m
3 Vrms
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance: d = 1.2 √P d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
Notes:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
ApneaLink™ | ApneaLink™ Plus | ApneaLink™ Air 15
Recommended separation distances between portable and mobile RF communications equipment and the device
The device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
0.01
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 1.17 √P
0.12
80 MHz to 800 MHz d = 1.17 P
0.12
800MHz to 2.5 GHz d = 2.33 √P
0.23
0.1
1
10
100
0.38
1.2
3.8
12
0.38
1.2
3.8
12
0.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
• As ApneaLink
TM
Air does not have essential performance all ApneaLink
TM
Air immunity tests have been performed during
Recording Mode and during USB Communication Mode.
ApneaLink™ | ApneaLink™ Plus | ApneaLink™ Air 16
S8
™
& S8 Series II | VPAP
™
Series III
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
English
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.
This declaration currently applies for the following ResMed devices:
• S8
™
& S8 Series II
• VPAP
™
Series III.
Guidance and manufacturer’s declaration—electromagnetic emissions
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
Compliance
Group 1
Electromagnetic environment—guidance
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.
RF emissions CISPR 11 with serial adapter with USB adapter
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions IEC
61000-3-3
Class B
Class B*
Class B
Class A
Complies
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.
* Class B for all system configurations except when a PC is attached to the device via a serial adapter, in which case the system is Class A compliant.
(S8 Series II only) Class B for all system configurations except when a ResLink with oximeter is attached to an S8 Series II device powered from a DC-12 adapter, in which case the system is Class A compliant.
Class A is suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network which supplies buildings used for domestic purposes.
WARNING
• 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 for the device is not recommended. They may result in increased emissions or decreased immunity of the device.
S8™ & S8 Series II | VPAP™ Series III 17
Guidance and manufacturer’s declaration – electromagnetic immunity
These devices are intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
IEC60601-1-2 test level
±6 kV contact
±8 kV air
Compliance level
±6 kV contact
±8 kV air
Electromagnetic environment—guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/ burst IEC 61000-4-4
Surge
IEC 61000-4-5
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% Ut (>95% dip in Ut) for 0.5 cycle
40% Ut (60% dip in Ut) for 5 cycles
70% Ut (30% dip in Ut) for 25 cycles
<5% Ut (>95% dip in Ut) for 5 sec
3 A/m Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
±2 kV
Not Applicable
±1 kV differential mode
±2 kV common mode
< 12V (>95% dip in 240V) for 0.5 cycle
96V (60% dip in 240V) for 5 cycles
168V (30% dip in 240V) for 25 cycles
<12V (>95% dip in 240V) for 5 sec
3 A/m
10 Vrms
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
Recommended separation distance d = 1.17 √P d = 0.35 √P 80 MHz to 800 MHz d = 0.70 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
should be less than the compliance level in electromagnetic site survey, a each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Notes:
• Ut is the AC mains voltage prior to application of the test level.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
S8™ & S8 Series II | VPAP™ Series III 18
Recommended separation distances between portable and mobile RF communications equipment and the device
These devices are intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)
0.01
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz d = 1.17 √P
0.17
80 MHz to 800 MHz d = 0.35 √P
0.04
800MHz to 2.5 GHz d = 0.7 √P
0.07
0.1
1
10
100
0.37
1.17
3.69
11.70
0.11
0.35
1.11
3.50
0.22
0.7
2.21
7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
PRODUCT
ApneaLink /Stellar
All others
ResMed Germany Inc. Fraunhoferstr.
16 82152 Martinsried Germany
ResMed Ltd 1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia
DISTRIBUTED BY
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA,
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA,
ResMed (UK) (for Ltd) 96 Jubilee Avenue Milton Park Abingdon Oxfordshire OX14 4RW UK
See www.resmed.com for other ResMed locations worldwide. AirSense, AirCurve, ClimateLine, H5i, S9, S8, Stellar and VPAP are trademarks of ResMed Ltd. ClimateLine S9, Stellar, VPAP and
ApneaLink are registered in U.S. Patent and Trademark Office. ApneaLink is a trademark of ResMed R&D Germany GmbH. © 2014 ResMed Ltd. © 2014 ResMed Ltd. 1017993/1 2014-08
ResMed.com
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Key Features
- Electromagnetic Emissions & Immunity
- Intended for use in specific electromagnetic environment
- Emissions and immunity test results
- Recommended separation distances between portable and mobile RF communication equipment
Frequently Answers and Questions
What is electromagnetic emissions & immunity?
What is electromagnetic environment?
What is the recommended separation distances between portable and mobile RF communication equipment?
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