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The BreathePal Bilevel is intended to provide non-invasive ventilator (NIV) support for adult patients weighing over 30 kg (66lbs) who suffer from Obstructive Sleep Apnea (OSA) and Respiratory Impairment. It is intended for use in both home and clinical environment, including hospitals, sleep laboratories, and sub-acute care institutions.

BreathePal Bilevel devices are blower-based positive airway pressure systems designed to provide non-invasive ventilation only. These devices deliver two distinct pressure levels: a higher pressure during inhalation (IPAP) and a lower pressure during exhalation (EPAP). This pressure differential facilitates the flow of air into and out of the lungs. The system can also be configured to provide a single, constant pressure level, known as Continuous Positive Airway Pressure (CPAP).

The BreathePal Bilevel utilizes a microprocessor-controlled blower along with integrated pressure and flow sensors to detect patient breathing patterns and deliver precise therapeutic pressure. The device includes a comprehensive alarm system, featuring both therapeutic alerts (e.g., large leak) and technical alarms (e.g., system fault). A user interface allows for the adjustment of clinical parameters and the display of monitored therapy data. Additionally, the device features comfort settings, such as iBreath (FLEX), which provides adaptive pressure relief during the initial phase of exhalation to enhance patient comfort.

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