•
The following surface temperatures may exceed 41 ˚C under certain conditions:
•
External surface of CPAP ........................................ 43˚C
•
Patient tubing connector .......................................... 45˚C
•
Encoder shaft (with control knob removed) ............. 42˚C
•
Humidifier heater plate ............................................ 65˚C
•
External power supply ............................................. 42˚C
•
Equipment not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.
•
Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the Electromagnetic Compatibility [EMC]
information provided in the accompanying documents.
•
Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment.
•
The equipment or system should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the equipment or system
should be observed to verify normal operation in the configuration in which it will be
used.
•
If you are using a full face mask (a mask covering both your mouth and your nose),
the mask must be equipped with a safety (entrainment) valve.
•
Do not connect the device to an unregulated or high pressure oxygen source.
•
Do not use the device near a source of toxic or harmful vapors.
•
Do not use this device if the room temperature is warmer than 40° C (104° F). If the
device is used at room temperatures warmer than 40° C (104° F), the temperature of
the airflow may exceed 43° C (109° F). This could cause irritation or injury to your
airway.
•
Do not operate the device in direct sunlight or near a heating appliance because
these conditions can increase the temperature of the air coming out of the device.
•
Contact your health care professional if symptoms of sleep apnea recur.
•
If you notice any unexplained changes in the performance of this device, if it is
making unusual or harsh sounds, if it has been dropped or mishandled, if water is
spilled into the enclosure, or if the enclosure is broken, disconnect the power cord
and discontinue use. Contact your home care provider.
•
Periodically inspect electrical cords and cables for damage or signs of wear.
Discontinue use and replace if damaged.
A-DV64
CAUTION
A Caution indicates the possibility of damage to the device.
•
For proper operation, place system on a flat, sturdy, level surface. Do not place the
device where it can be knocked onto the floor or where the power cord may create a
trip hazard.
•
Never block air openings of the device. Do not insert objects into any openings or
tubes.
•
Use only accessories recommended by DeVilbiss.
•
The USB port located on the back of the device is for provider use only. The port
must only be used with accessories approved for use by DeVilbiss. Do not attempt to
attach any other device to this port as it may damage the CPAP or the accessory
device.
•
Only the DeVilbiss DV6 series Heated Humidifier system is recommended for use
with this device. Other humidifier systems may prevent the device from detecting
respiratory events and may cause inappropriate pressure levels in the mask.
•
The height of the device must be lower than the mask when using a humidifier to
prevent water from getting into the mask
•
Never rinse or place the device in water. Never allow liquids to get into or around any
of the ports, switches or air filter; doing so will result in product damage. If this
occurs, do not use the device. Disconnect the power cord and contact your
equipment provider for service.
•
Condensation may damage the device. If this device has been exposed to either very
hot or very cold temperatures, allow it to adjust to room temperature (operating
temperature) before starting therapy. Do not operate the device outside of the
operating temperature range shown in the Specifications.
•
Do not place the device directly onto carpet, fabric, or other flammable materials.
•
Tobacco smoke may cause tar build-up within the device, which may result in the
device malfunctioning.
•
Dirty inlet filters may cause high operating temperatures that may affect device
performance. Regularly examine the inlet filters as needed for integrity and
cleanliness.
•
Never install a wet filter into the device. You must ensure sufficient drying time for the
cleaned filter.
•
Only use a DeVilbiss DC Power Cord and Battery Adapter Cable. Use of any other
system may cause damage to the device.
•
Oxygen is a prescribed gas and should only be administered under the supervision of
a physician.
EN - 5