Other Open Access
Luciano Fadiga; Giulio Sandini; Diego Torazza
THIS WORK IS SHARED UNDER THE FOLLOWING LICENSE
CREATIVE COMMONS ATTRIBUTION-NONCOMMERCIAL-SHAREALIKE 4.0 INTERNATIONAL (CC BY-NC-SA 4.0) https://creativecommons.org/licenses/by-nc-sa/4.0/
Diego is a non-profit, open access project with the goal to design an emergency device to be used as an accessory of Ambu®-like self-inflating resuscitators designed for manual ventilation. DIEGO can be used whenever manual operation cannot be sustained because of 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 and switching 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 makes the solution intrinsically safe for the patient as well as the operator.
This release describes in details the principles of operation and the first experimental prototype that has been realized to verify its compliance to international safety rules and to tune the proper ventilation parameters to use for clinical test. Permission for clinical test was granted by the “Regione Emilia Romagna” Ethical Committee and was successfully completed in May 2020 as a ventilator used during surgery requiring deep-anesthesia .
A simpler industrial prototype is being designed for industrial production to be distributed at no charge.
DIEGO’s design is fully open source and the documentation includes all details of mechanical and electrical design as well a user manual. Links to YouTube video tutorial explaining how to use and calibrate the system are also included.