1. Introduction
This manual should be used for initial set up of the system and saved for reference purpose.
1.1
General Information
Obstructive Sleep Apnea (OSA) is a condition that an intermitted and repetitive obstruction of the
upper respiratory tract causes a complete (apnea) or partial (hypopnea) block of breathing airflow
during sleep. The syndrome varies depending on the degree of relaxation of the tongue and soft
palate muscle.
The most common treatment for OSA is Continuous Positive Airway Pressure (CPAP). CPAP devices
can deliver a constant air pressure into your upper airway via a nasal mask. This constant air pressure
can keep your airway open during sleep, therefore prevents the OSA.
This device is a micro-processor controlled continuous positive airway pressure device. It features
the illuminated, menu-driven LCD display, universal power supply, and ramp time adjustment. The
ramp time adjustment and ultra quiet operation ensure you to fall asleep comfortably while air
pressure slowly build up to treatment level. The user compliance meter records the total system’s
operating time for physician’s reference.
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the
IEC 60601-1-2:2004. 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 into 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.
This system has been tested and compliance to the following volunteer standards:
FDA
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.
NOTE: Equipment not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.
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