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The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.

The New Aera Tidal Assist Ventilation (TAV) system comprises a small, lightweight, wearable, battery-powered ventilator, TAV-C100, and a nasal pillow interface, TAV-NP10. The system is intended to connect to an air or oxygen source and supports three modes of delivery: - Tidal Assist mode, a breath-activated ventilation assist mode in which the delivered gas from the source entrains additional room air at the nasal pillows interface, delivering it under positive pressure during the patient's inhalation to assist breathing; - Conserve mode, a breath-activated delivery mode used to conserve oxygen consumption when using a cylinder with regulator; and - Constant mode, presenting a continuous 1 – 5 LPM flow of oxygen to the patient. For the Tidal Assist mode, the user may select one of five flow delivery settings, corresponding to a delivered minute volume of approximately 1 - 5 LPM. For the Conserve mode, the user may select one of five pulse delivery settings, corresponding to an equivalent gas flow rate of approximately 1 - 5 LPM. For the Constant mode, the user may select one of five flow delivery settings, corresponding to a delivered gas flow rate of approximately 1 - 5 LPM. The TAV system is battery operated, running from a single AA alkaline battery. Under typical usage, battery life is ~ 14 days; a low battery alert activates when battery life is less than 2 days under typical usage. The system has a simple user interface, comprising: - a mode selection button; - buttons to increase or decrease the delivered flow rate; - a button to turn the device on and off, and to temporarily silence any alarms; - LED indicators for the current delivery mode, flow setting, and low battery and alarm conditions; and - an audible buzzer used to alert the user to an alarm condition. The device has two pneumatic ports: - an inlet port, used to connect the regulated gas source to the device, and - an outlet port, used to connect the device to the patient interface. Lastly, the device has a bypass valve, used to deliver a constant 2 LPM gas flow rate to the patient in the event of a system failure.