DESIGN NAME: Breath
PRIMARY FUNCTION: Medical Ventilator
INSPIRATION: Once we started working on the device, hospitals didn't have enough ventilators and it is difficult to buy new equipment due to its high cost and limited availability. As a team of engineers with experience in the manufacture of medical devices we couldn't sleep well, knowing that in our neighbouring countries people are dying due to a lack of appropriate respiratory support equipment. We wanted to do everything we can to avoid such a situation in Poland and in other parts of the world.
UNIQUE PROPERTIES / PROJECT DESCRIPTION: Breath is a simple, accessible, and inexpensive Emergency Use Resuscitator System, designed to help hospitals that do not have enough high-end respirators available. We constructed a mechanism that presses on the AMBU bag and helps to deliver oxygen to the lungs. Parameters, such as the air capacity and pressing frequency can be set. Pressure sensors that monitor the whole mechanism and can report a potential fault are also included. It was designed according to the AAMI and FDA recommendations.
OPERATION / FLOW / INTERACTION: Device is operated in four easy steps: turn on, adjust respiratory rate (from 10 to 20), adjust volume (200 to 600ml), start/stop operation. This makes it very easy for people even without medical knowledge. Device also has a battery to operate without mains supply. The device can work with external monitoring devices to monitor patient vital functions.
PROJECT DURATION AND LOCATION: The project started in March 2020 in Warsaw, Poland. Based on the project developed in cooperation with the doctors, we created the first prototype. After 10 days we had the second, fully functional version of the device, which was then tested in a hospital and using an artificial lung. The first half of May 2020 there is a final prototype and we are ready to certify the product and organise clinical tests. Device is calibrated but clinical tests can trigger some small adjustments.
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PRODUCTION / REALIZATION TECHNOLOGY: It’s mechanism that presses on the AMBU bag and helps to deliver oxygen to the lungs.It consists of a resuscitator and an external system for automatically controlling it.It has a control unit associated with the pneumatic system.You can adjust the number of breath cycles per min and the tidal volume.It is designed to work with the AU60347 Adult resuscitator, by AUG Medical.Housing sheet metal powder painted aluminum.Front panel-milled, brushed aluminum.Cover for the AMBU bag-milled polycarbonate
SPECIFICATIONS / TECHNICAL PROPERTIES: Type of the device: Emergency Use Resuscitator System according to AAMI CR503:2020; Dimensions: 380 mm by 293 mm by 253 mm, weight: 7,2 kg; isolation class I, applied part type BF, IP 21; Power input: 100 - 240 V AC, 50Hz/60Hz, power 60 W; backup battery: 12 VDC, 5 Ah; battery operation time: 2 hours; respiratory rate: 10 – 20 cycles per minute; I:E ratio: 1:2.0; tidal volume: 200 to 600 ml; alarm sound level: 90 dB
TAGS: Mudita Breath, Breath, Respirator, Ventilator, Medical Ventilator, AMBU bag
RESEARCH ABSTRACT: It started from brainstorming between engineers and physicians.The concept is currently developed by teams all over the world. From the beginning,we are following guidelines issued by the AAMI.We are validating each prototype on the professional test lung from Michigan Instruments.Such equipment is widely used to certify ventilators.Use of the test lung allows us to simulate a variety of dysfunctions of patients.Testing scenarios and results are consulted with the physicians.
CHALLENGE: The essential part of our research is to confirm the clinical function, which is safe mechanical ventilation of patients. Our device needs to be easily manufactured and reliable. So, we decided to base the clinical functionality on the analogue electronic components. The hardest part of the research is to test several combinations of key components that also need to be reasonably priced and available.
ADDED DATE: 2020-05-26 09:55:22
TEAM MEMBERS (22) : Adrian Krupowicz, Łukasz Anwajler, Tomasz Nosal, Małgorzata Szostak, Magda Katana, Katarzyna Bocheńska, Artur Sawka, Jakub Siemion, Joanna Mazur-Kobylecka, Łukasz Meyer, Mateusz Baczewski, Urszula Bieniecka, Wojciech Wasiluk , Magdalena Płaza, Agnieszka Romowicz, Ernest Miller, Karolina Rudzka, Krzysztof Kryczka, Marcin Gąska, Michał Główczyk , Michał Kowalczyk and Aleksandra Świerszczyńska
IMAGE CREDITS: Image #1: Creator, Mudita, Breath Front, 2020
Image #2: Creator, Mudita, Breath Rear, 2020
Image #3: Photographer, Agata Falkowska, Breath, 2020
Image #4: Photographer, Agata Falkowska, Breath, 2020
PATENTS/COPYRIGHTS: Patent-pending: Self-expanding bag control system P.433528 [WIPO ST 10/C PL433528]
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