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The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough. SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.

The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.

The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable. The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece. In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery. There are two different Y-adapters available that act as "waveguides" to direct sound waves from the audio speaker in the HHT to the mouthpiece that is held in the patient's mouth in the same manner as with other breathing treatment mouthpieces. The purpose of the Y-adapters is two-fold: - · To direct the sound waves into the airway opening, and - · To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.

The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing. The Philips Respironics SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough. The SimplyClear device is for use in a hospital, institutional environment or in the home.

The Philips Respironics SimplyClear device promotes airway clearance by loosening, mobilizing and clearing secretions. The loosening and mobilization occurs by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The positive to negative shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing. The SimplyClear device combines the loosening and mobilization functionality of the Vest Airway Clearance System (K024309) with the secretion clearance functionality of the CoughAssist device (K002598), Dima Italia Negavent DA-3 Plus Pegaso (K072292) and the CoughAssist T70 device (K121955).