CAUTION: The technical solution contained in this document was developed in response to the emergency of SARS-Cov-2 virus pandemic and did not go through all tests and controls normally required for the development of medical-surgical devices. All the necessary procedures to comply with European safety rules have been followed (electromagnetic compatibility and electrical safety testing, ethical approval, clinical study, Italian Ministry of Health notification).
DIEGO (Device for Inspiration and Expiration, Gravity Operated) is a non-profit, open-access project with the goal to design an emergency device to be used as an accessory of an Ambu®-like self-inflating resuscitators designed for manual ventilation. DIEGO can be used whenever manual operation cannot be sustained because of the lack of experienced operators or because of a high number of patients needing ventilator support, such as in case of a COVID-19 pandemic crisis.
DIEGO’s principle of operation can be adopted to automatically squeeze and release the Ambu®-like bag. The switch from automatic to manual ventilation is immediate. The operator can control all the relevant ventilation parameters, such as tidal volume, respiratory phases duration (inspiration/expiration ratio), respiratory frequency and end-expiratory pressure (PEEP).
DIEGO’s principle of operation can be applied to different mechanical solutions with the advantage that the necessary mechanical components are easily reproducible anywhere with commonly available materials and basic mechanical workshop tools. The principle of mechanical actuation and the simplicity of the all-analog electronics, it makes the solution intrinsically safe for the patient as well as the operator.
The first experimental prototype has been realized to verify its compliance with international safety rules and tune the proper ventilation parameters. Permission for the clinical test was granted by the “Regione Emilia Romagna” Ethical Committee and was successfully completed in May 2020. The prototype was tested as a ventilator during surgery requiring deep-anaesthesia.
Starting from the experimental prototype realized to allow adequate control of the parameters during the initial clinical testing, industrialization of the project and the manufacture of the first series of devices has been completed by SCM Group, an Italian multinational company leader in the production of numerically controlled machining machines that has offered to provide the necessary components for free.
Emergency Ventilator DIEGO should be used under close medical supervision and, if any malfunctioning occurs, can be immediately switched to manual operating mode.
Diego is an entirely open source project released under Creative Commons License (CC-BY-NC-SA)
All documentation is accessible through Zenodo.