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  • Devices designed to apply positive airway pressure at two different separately adjustable levels (i.e., bi-level PAP) during each breathing cycle, providing independent pressures during inhalation and exhalation while the patient is performing spontaneous breathing. These units are used to assist spontaneous respiratory efforts and supplement the volume of air a patient inspires into the lungs. Some bi-level units additionally include a time back-up feature (known as spontaneous timing or S/T) to ensure that the appropriate amount of air is provided when it detects that a patient has stopped or delayed breathing. Bi-level PAP units are intended to provide noninvasive (i.e., through a nasal or oronasal mask, mouthpiece, or lipseal) positive pressure breathing assistance therapy; they are frequently used in patients suffering from restrictive thoracic disorders (e.g., muscular dystrophy, amyotrophic lateral sclerosis), severe chronic obstructive pulmonary disease (COPD), central sleep apnea, or obstructive sleep apnea (OSA). They are not intended for continuous breathing support.
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