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Appendix A: EMC Information
Guidance and Manufacturer’s Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment specified below. The user of this device should
make sure it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment-Guidance
RF emissions
CISPR 11
Group1 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
Harmonic
emissions
IEC61000-3-2
Class A
Voltage
fluctuations /
Flicker emissions
IEC61000-3-3
Complies
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network.
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The
user of this device should make sure it is used in such an environment.
Immunity Test IEC60601 test
level
Compliance Electromagnetic Environment-Guidance
Electrostatic
Discharge(ESD)
IEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
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
IEC61000-4-4
±2kV for power
supply line
±1kV for input/out
line
±2kV for power
supply line
±1kV for input/out
line
Mains power quality should be that of a typical
commercial or hospital environment
Surge
IEC61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC61000-4-11
<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
<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
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
this device requires continued operation during
power mains interruptions, it is recommended that
the device be powered from an uninterruptible power
supply or a battery.
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EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the
IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment to an outlet on a circuit different from that to which the other device(s) are
connected.
- Consult the manufacturer or field service technician for help.
1.2 Intended Use
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of
adult Obstructive Sleep Apnea (OSA). The integrated heated humidifier is designed to increase
the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that
some people may experience.
Cautions: Some patients might have pre-existing contraindications for CPAP therapy,
or might experience some potential side effects of using a CPAP device.
Please consult your doctor if you have any questions concerning your
therapy.
NOTE: Equipment not suitable for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
1.3 Contraindications
Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP
therapy for some patients. Should you have any of these conditions, your physician will determine
if CPAP therapy is appropriate for you.
zBullous lung disease
zPneumothorax
zPathologically low blood pressure due to or associated with intravascular volume depletion
zSevere cardiac arrhythmias or coronary artery disease
zStroke
zSeizures
zPenumocephalus has been reported in a patient using nasal Continuous Airway pressure
