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Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device. - The use of Pulsehaler™ improves clearance of secretions . - The use of Pulsehaler™ may reduce the need for postural drainage ● - Pulsehaler™ facilitates opening of airways in patients ● - Pulsehaler™ may be used to prevent or reverse atelectasis ● - Pulsehaler™ mav also be useful in the removal of mucus from the lungs ● Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.

Pulsehaler™ is a non-invasive handheld treatment device used daily by the patient to promote airway opening and secretion clearance by vibrating the airways at a variety of different frequencies. It consists of Base Unit with an LCD touch screen that provides a pressure source, and a Hand Unit with a rotating disc that periodically interrupts the pressure source to deliver pressure pulsations to the patient. These components are connected by an air hose and an electrical power and data cable. While sitting in a relaxed position, the patient holds the Hand Unit and breathes normally through its mouthpiece. A steady flow of pressurized air is delivered to the Hand Unit component by the Base Unit and enters the air inlet of the Hand Unit. The pressurized air passes along the internal airflow duct of the Hand Unit through an air filter until it reaches the rotating disc. When it rotates the disc interrupts the continuous flow of air from the Base Unit and then releases the flow in pulses at a rate corresponding to the rotation speed. The rotation speed of the disc is determined by the software using a pre-set protocol. The exhalation port is restricted in size, which together with the positive pressure generated by the Base Unit, induces PEP. The patient is treated with the device for 20 minutes at a time, up to three times a day according to the prescribing physician's instructions. During each 20-minute treatment, Pulsehaler™ delivers pulses varying from 5 to 50 pulses per second. The patient may use the User Interface to pause the treatment at any time or resume after a pause. Pulsehaler™ is intended for single adult patient, multiple reuse, at home or in a healthcare facility and is non-sterile. The instructions for use contain cleaning and high-level disinfection instructions that involve the use of Cidex. Expected Use Life of the device is 5 years and Shelf Life is 6 Months.