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The Maximus™ System provides features of both the Synclara™ System and the Volara™ System. The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness. The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.

The Maximus™ System is a 2 in 1 device which combines 2 main types of therapies referred to as: - MIE (Mechanical Insufflation-Exsufflation) Synclara® - OLE (Oscillation and Lung Expansion) - Volara™ The modification is to add the ability to provide aerosol from the nebulizer via the Ventilator Tee adaptor during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator. All components were cleared under K192143.

The Maximus™ System provides features of both the Synclara™ System and the Volara™ System. The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness. The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.

The Maximus™ System is a 2 in 1 device which is a combination of two (2) already cleared devices. The Maximus™ System provides the individual therapies of the predicates: Vital Cough and MetaNeb®. The Maximus™ can be programmed to allow the user to provide both therapies or one only. The 2 main types of therapies are referred to as: - . MIE (Mechanical Insufflation-Exsufflation) - OLE (Oscillation and Lung Expansion) ●

The Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.

The Monarch™ Airway Clearance System consists of a garment which contains actuators together with the Main Control Box and pendant controller. The Main control box contains the electronics used to control the actuators which are organized into 8 discrete zones. The pendant controller is tethered to the garment and consists of a LCD display and selection controls to facilitate visual feedback of the therapy and system information while allowing the user to adjust the therapy settings to adhere to the prescribed therapy ordered by the physician. It has adjustment mechanisms over each shoulder and on each side of the mid chest area to provide the wearer with a personal and evenly distributed snug fit. The buckles on each side of the device together with the front zipper help provide a repeatable fitting by allowing the wearer to wear and remove the garment without making changes to the adjustment mechanisms. The product also includes an external charger for the battery and can run on either power source as per desired by the user. The major components to the Monarch™ Airway Clearance System are: - Garment which contains the "pods" . - . Garment shell - covers the underlying the garment - . Pendant – controls the device function - . Battery - installed in the backpack cover - Garment adjustment mechanisms means to secure and adjust the fit of the Garment to the . user

The MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

The MetaNeb® 4 System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: Aerosol, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.

The MetaNeb® System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

The MetaNeb® System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: Aerosol, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.