What's new after the approval
From the first prototype we built based on Arduino, we incorporated advanced devices to control pressure, PEEP, volume control... All the experience we have gained during the last weeks has allowed us to get the homologation of our respirator and has helped us to improve the safety and effectiveness of the device.
This design, which was the one approved on April 4, and no other, is the only one approved for use in clinical trials. After obtaining a homologation, the device must not be modified, since any future change must be notified for its new homologation.
Due to the lessons learned from the project, we have had to define that this project operates under an open on-demand system. Our priority from the beginning has been to get our respirator to those who need it most as soon as possible.