CRT Announces Second Functional Prototype Completed
The COVID Response Team (CRT) is building a Volume Controlled Mandatory Mechanical Ventilator for deployment during the Covid 19 Pandemic. The project is being run on a not-for-profit basis and the CRT will share the detailed designs with competent manufacturers anywhere in the world. The CRT concept is a robust, easy to manufacture mandatory ventilator that can support a patient for up to a number of weeks.
The CRT team, with great support from our many collaborators, has completed the build of its second functional prototype. While the first iteration was a proof of concept device which allowed the team to confirm the design in principle, this second prototype is a fully engineered machine. The 3D graphic above provides an overview of the current prototype. The project team has prepared detailed manufacturing drawings and has produced all the parts to assemble this system which is now on test.
The second-generation prototype is designed to deliver a range of functionality including:
Tidal volume in the range of 200 ml to 800 ml.
Breaths per minute rate between 10 and 30.
Inhale to Exhale ratios in range of 1:1 to 1:3.
PEEP Pressure in the range of 5 to 25 cm H2O
A peak pressure range of 25 to 70 cm H2O.
There are several safety features including emergency blow-off pressure relief valves, battery backup and alerts.
The team has begun the process of seeking regulatory approval in Ireland and abroad. Rigorous testing of the device, as per UK MHRA and WHO guidelines, is currently being undertaken and a full protocol is being prepared. To ensure patient safety, we are continuing to work as much as possible to satisfy the requirements of the many standards that ordinarily apply to the design of ventilator devices.
While we are making great progress, we are still experiencing challenges. The most significant at this time is sourcing the low-pressure pneumatic components required for a production run of the system. We are, however, making progress in this regard on several fronts.
We are entering a “design for manufacture” phase. This involves a thorough design review and further modifications to build the third and final prototype before the first production run. This design review is intended to simplify the design with three key objectives while still delivering a machine that works to its intended specification. Our objectives are about reducing the cost per unit, reducing the size per unit and reduce the weight per unit.
At all stages, we have been working with a team of medical experts, medical device experts and highly experienced engineers, the work of whom has been invaluable in progressing this far. We currently have further teams working on regulatory affairs, training material, packaging and documentation and more.
As we look forward towards production, our plan is to begin this process locally in Ireland. The number of units to be produced is currently in discussion and will depend on how the design review and regulatory process proceeds. Our aim is that this first production run will allow us to produce the build and assembly instructions and refine the testing protocols that will allow us to work with other potential competent manufacturers around the world who may produce CRT ventilators.
We will provide further updates as we progress and many thanks for the support received by so many.