AIRone: type of ventilator

The AIRone operates and functions as a regular, pressure-regulated ventilator, but with essential functionalities only. In short, it uses a pressurised gas source, reduces the pressure accordingly and delivers gas to the patient by a set of proportional valves (see below for more details). Oxygen concentration is regulated using two Mass Flow Controllers on the gas inlets.

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Intended use

TheĀ  AIRone provides positive-pressure ventilation (PPV) for emergency automatic ventilation, created for the use on adult (suspected) COVID-19 patients who need non-weaned respiratory support to bridge a longer period of time until conventional ventilation becomes available.

Adjustable settings

* Inspiratory pressure (Pinsp)
* Positive end-expiratory pressure (PEEP)
* Respiratory rate (RR)
* I:E ratio
* Oxygen concentration(%) (FiO2)

Project status

The design of the AIRone is final. As national ICU admissions are dropping large scale production is not necessary. The AIRone is currently being produced in a small batch to complete the design cycle and to share this expertise with the international community. Software engineers will continue to work on an additional module to enable patient respiration triggers for weaning.

The AIRone was recommended by clinicians to be used at times of national shortage of certified ventilators. Official approval has not been obtained, due to the disappeared urgency of emergency ventilators. Therefore, the safety or efficacy of the AIRone for use in humans has not been proven. However, thorough design verification was performed using an advanced artificial test lung. Additionally, design documentation is under review by a notified body. Also, multiple usability tests by doctors and nurses lead to the current user-friendly design.

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