June 15th, 2020 New webinar organized by Mr. Raza Jafar and "The Health Bank" with the latest updates, feedback, and guidelines for helmet based noninvasive ventilation. When we are talking about the importance of ventilators for COVID 19 patients, we have to remember that underdeveloped countries don't have enough of them. The helmet based NIV system is an option for those countries that will improve the outcomes for patients and save more lives. The Health Bank is a global health management company that specializes in providing individuals, families, and corporates personalized health and wellness services. Speakers: Dr. Bhakti Patel, Dr. Naeem Lughmani, Michael Lombardi (Subsalve), Emma Macbeath, and Aurika Savickaite. Video

We have other formats available to quickly educate yourself on Helmet Ventilation (NIV). You can use (1) The Interactive Smart Procedures and/or (2) Training Videos from UChicago Medicine and Penn Medicine. Sharable PC to Mobile QR code to access this page. 1. Mobile Smart Procedures for Helmet Ventilation (NIV) This is a free tool courtesy of AmbiFi, translation into more languages is in the process. There are a number of advantages to the Smart Procedure: Narrated Step-by-Step Instructions and Critical Checklists: Patient Triage, Helmet Setup, Help Placement, Monitoring, Weaning Navigation based on your situation and equipment Do's & Don'ts and Resources Replay any section Mobile apps iOS and Android Mobile App for phones and tablets: Download 'AmbiFi' from Apple App Store or Google Play Store Login with credentials: Username: covid19 / Password: Covid19! Mobile Smart Procedure Based on The University of Chicago Medicine Guidelines, Dr. Bhakti Patel 4/11/2020 Smart Procedure Access using a Web Browser Link: English Link: Spanish (video how to enable Spanish dialect from the menu) Many thanks to the "Helmets for Humanity" team for translating the smart procedure into Spanish. Mobile App for smartphones and tablets Download 'AmbiFi' from Apple App Store or Google Play Store Login with credentials: Username: covid19 / Password: Covid19! Available in Englis and Spanish All content in the “Helmet Ventilation NIV UChicago Medicine” Smart Procedure is directly from the Protocols and Guidelines from the University of Chicago Medicine. We completed the Helmet Ventilation (NIV) Smart Procedure with a final review by Dr. John P. Kress on 4/10/2020. Mobile Smart Procedure Based on The University of Pennsylvania Medicine Guidelines, Dr. Maurizio F. Cereda 05/25/2020 Smart Procedure Access using a Web Browser Link: English Link: Spanish Link: Portuguese Many thanks to Fernando Herreras and his team in Paraguay for translating the smart procedure into Spanish and Dr. Cedar Vardas and his team in Bolivia for the Portuguese version. Mobile App for smartphones and tablets Download 'AmbiFi' from Apple App Store or Google Play Store Login with credentials: Username: covid19 / Password: Covid19! Available in English, Spanish and Portuguese All content in “Non-Invasive CPAP by Helmet - Penn Medicine” Smart Procedure was developed and reviewed by Maurizio F. Cereda, MD, a University of Pennsylvania Intensive -Care doctor who trained in Italy where helmet use is common. Updated 05/22/2020 Mobile Smart Procedure "Helmet Positive Airway Pressure (HPAP) with Subsalve Oxygen Treatment Hood" 08/10/2020 Currently unavailable The following procedures can be used for COVID-19 patients in ICU settings. "Subsalve" helmet is FDA EUA approved - more info here Smart Procedure Access using a Web Browser Link: English Link: Spanish Link: Portuguese Link: French Link: Chinese Many thanks to Dr. Cedar Vardas and his team in Bolivia for the Spanish and Portuguese versions. 2. Training Videos Training video from UChicago Medicine The most reliable and comprehensive training material about the use of an NIV Helmet "Oxygen Hood" connected to wall gases or to BiPAP V60 and detailed assembly instructions for a helmet from Dr. Bhakti Patel, The University of Chicago Medical Center (UChicago Medicine). Updated 04/28/2020 Objectives Review our experience with helmet ventilation Detailed assembly instructions for the helmet Demonstrate the use of a helmet with Oxygen and Medical Air. Demonstrate the use of a helmet with a BiPAP V60 Applications for helmet NIV in the COVID pandemic Helmet FAQs Link: https://uchicago.hosted.panopto.com/Panopto/Pages/Viewer.aspx?id=a8a10af6-4d6f-4da2-b1e2-ab8b0040b9ad The newest training video with the newest updates, feedback, and guidelines for helmet based noninvasive ventilation from Dr. Bhakti Patel, University of Chicago Medicine, and the Helmets for Humanity Project supported by Apple. Updated on 5/2/2020 Link: https://www.helmetbasedventilation.com/post/niv-helmet-oxygen-hood-training-video-guidelines-faq-bhakti-patel-helmets-for-humanity-project-apple Training video from Penn Medicine The newest training video with the newest updates from Maurizio F. Cereda, MD, a University of Pennsylvania Medicine. Date 08/21/2020 COVID-19: Can Helmet CPAP Be More Effective Compared to Other Non-Invasive Respiratory Support? Non-Invasive CPAP by Helmet system developed by Maurizio F. Cereda, MD, a University of Pennsylvania Medicine. Date 4/12/2020 NOTE: This video is Outdated and New Guidelines from Penn Medicine are available on the AmbiFi Smart Procedure app (See above). Great video from Italian Helmet Manufacturer "DIMAR". You can learn from it how to connect the helmet and more, including instructions on how to use different types of circuits - 2 Limb Y Piece, Co-axial circuit, 2 way expiratory valve, 1 Limb with Whisper, 3 ways expiratory valve. PDF Guidelines UChicago Medicine Penn Medicine: "Life Link III" Helmet NIV Procedure for Patient Transport: Video Robert Beckl , Use of Helmet Based Noninvasive Ventilation in Air Medical Transport of COVID-19 Patients, Air Medical Journal (2020), doi: https://doi.org/10.1016/j.amj.2020.11.009 "Hamilton Medical" Helmet Ventilator Set-up: Page Updated 11/26/2020

5/15/2020 Chicago Marek Macner did some sports, including scuba diving, during his free time before he was diagnosed with Lymphoma. When Covid-19 swept over the world, continent by continent, he knew he had to step up to the plate. He had been in the medical field and knew of easy solutions like a helmet based ventilator that can turn things around at a much faster pace. His passion and vision convinced his friends, family, and acquaintances to help out. Marek Macner’s daughter, Karolina, is working in a bank in New York City, the hardest-hit city in the United States, and she knew her father was deep-diving into Covid-19 solutions back home in Poland. Physically separated only by geographical distance, she found ways to help her father spread his message thanks to her exposure and knowledge in online strategies. And that’s when they found a group of enthusiasts who were geared for the same mission - to help people all around the world with their skills, experiences, and knowledge. All for pennies for the dollar. Marek Macner is actively helping to curb the Covid-19 death rate from his home in a suburb of Poland. Through the Facebook group "NIV Helmet Manufacturing Project to Combat COVID-19" and other online means, connections were made with people of like-mind from all around the world. It was fuel to his fire. The condition of his health was no deterrent, that’s how urgently he saw the mission. The Beginnings of the Mission Many have shared before him about the feasibility of using basic scuba diving gear to efficiently deliver oxygen to patients with respiratory ailments. When the world was first confronted with a worldwide pandemic that involved robbing a patient of his or her lifeline - oxygen - he wanted to tip the scales. This is not the first time the use of scuba diving gear for purposes other than diving has come in handy. Some have combined the practical use of diving gear with 3D printed plumbing supplies to deliver cost-effective masks for Covid-19 and respiratory patients. After all, the idea is to control the oxygen supply and contamination level around the Coronavirus patient as quickly and efficiently as possible. His staid support for communities, groups, and individuals who are also actively helping others saw him connecting with global citizens who have invested time and money into coming up with their own affordable versions of helmet ventilation systems. He shares much of his discoveries, data, and designs on Facebook. Heartened by the commitment and sacrifices of those around him and around the world, he has designed prototypes, samples, and complete helmet ventilators right from his home studio. Those designs free to download on his website. The Red Tape Problems of the ‘Unconventional’ The helmet based ventilators are proven, workable solutions for respiratory patients in many parts of Europe and the United States. They have even received positive feedback from government bodies in Europe for treating Covid-19 patients. As noted by Marek in his interview, getting the documentation and certification done takes time. Working closely with government officials and local administration is dragging things out. In some parts of the world, however, ‘improvised PPE’ has made it past the red tapes with FDA. They're leaving behind a path of breadcrumbs to something awesome. Like many others, Marek is also planning, designing, and producing his own armory of helmet based ventilators to scale up the production due to the urgency of the situation. Zeroing In On Helping Those In Need Marek, however, is undeterred by the obstacles and delays standing in his way. A one-man-show, he designs helmet based ventilators in his home studio with the help of a 3D printer. His helmets have, so far, been delivered to hospitals although the supply could have been upped. Beyond that, Marek, with the help of his daughter, freely shares his designs and ideas online with others, in hope of helping those who are in desperate need. Marek is, as far as he can tell, the only person in Poland to be making helmet based ventilators despite the continued shortages of ventilators in his home country. “Doctors have to make very difficult decisions every day - who gets to live, who does not. The doctors and physicians in Italy and everywhere around the world, are forced to play God because of the shortage of ventilators,” he shares thoughtfully. And he’s right. Being in such an unenviable position can leave a deep, long-lasting psychological effect on those who make those decisions. Passionate About Spreading the Word Like many others in his network, Marek is passionate and all-in when it comes to helping those in need. He knows that with the use of the helmet based ventilators, people will be safer. It is very possible to increase the chances of survival and efficiency of the treatment of Covid-19 patients all around the world. The helmet can be used as a medical device, not at home but in hospitals under the watchful eyes of trained doctors and nurses. Producing the helmets is not the problem because it can be assembled and tested very quickly. Within a more respectable time frame, the helmets can be ready for dispatch to hospitals, beating the clock, getting them to those in need faster than the virus. Marek has met a lot of like-minded people who knew the inner workings of a helmet based ventilators and they’ve remained in contact. They’ve, however, been reduced to doing their own things in their homes (or wherever possible). Their main motivation is to try to help as many people in need as possible. Part of the bid is to get the backings from world organizations and local governments and hospitals. Beating the Virus at its Own Game When the virus took hold of the world of medical science, the focus was on intubation. Some in the industry believe that intubation may not be the best choice. QUOTE: “This is not to say that the pathophysiology underlying it is similar, but clinically they look a lot more like high-altitude sickness than they do pneumonia,” Kyle-Sidell said in a Medscape interview. Frontliners have been saying, time and time again, that non-invasive intubation for Covid-19 and other similar patients should be made more easily available to save more lives. The main goal should be to avoid intubation as much as possible. The message seems to be coming through stronger and stronger by the day as data streams out from severely affected countries. In Italy, a country with 213,000 confirmed Covid-19 cases and nearly 30,000 deaths (accurate at the point of writing), revealed that 20% to 30% of their patients had benefited from using helmet based ventilators. These figures should not be sidelined or ignored. More data will be coming out as we continue this fight against the virus. Not only are helmet based ventilators better at decreasing the need for ventilators (and reduce the number of critical patients), if released and made available on time, these non-invasive ventilators will reduce the number of unnecessary deaths. The efficiency of a Helmet Based Ventilator There are many benefits to using a helmet based ventilator but the biggest one is that they’re easy to assemble and are affordable. The downside? The resistance. The helmet based ventilation system is an approach and method that is unfamiliar and not widely accepted (yet) in the medical field. If these inventors can produce working ventilation systems from their homes, with simple 3D printers and available designs and documentation, we know we can do more in drastically-affected countries. Innovators like Marek are producing these solutions on their own because of their commitment to helping those in need. If Marek can produce thousands of helmets in weeks, with the help of his family members and friends, big manufacturers like high capacity equipment can during the twilight hour! These helmets are already well-known in many parts of the world in the medical field. We have doctors who worked abroad on Covid-19 cases who are already trained on the usage of these helmet based ventilators. The problem arises when they come back to their home countries, such as in the case in Poland, there are no helmets available. In fact, helmets are made in the United States are sometimes shipped out to countries like Spain, Ukraine, and South Africa, just to name a few. Getting the Word Out Considering this, that word needs to go out. More people need to know about the usefulness, efficiency, and high-performance level of helmet based ventilators for Covid-19 and respiratory illness patients like pneumonia. After all, helmet ventilators have been in use for more than 30 years in some parts of Europe. Technology played a big part in connecting these passionate, innovative individuals and groups together. Now, it is all about maneuvering their way around the red tapes and full-stops in the industry. Selfless Sacrifices Marek’s endeavors should be a shining example to people all around the world. By making his designs available on his website free of charge, he is showing the world that we need more people who care. Even as we speak, news of 15 children in New York who were hospitalized, possibly linked Covid-19-linked, has been making its rounds. QUOTE: “Since being hospitalized, five of them have needed a mechanical ventilator to help them breathe, and most of the 15 “required blood pressure support.” In times like these, even individual states within the United States are fighting amongst themselves to attain the much-needed ventilators. We have to put in the paces and step up against this phantom virus to reach as many people in need as possible. A Possible Reprieve, Not Yet The End As we approach the summer months, some countries may go through a short respite from the Covid-19 onslaught. However, in smaller countries, in sidelined villages and locked-down countries, they face an even more dire need for help and outside aid. The saving grace may come from these small groups of groups and good samaritans who are already working on helmet based ventilators to keep the pendulum swinging. The helmets can be used to facilitate healthcare workers or even on a repairman assigned to a closed-off hospital or quarantine area to provide medical assistance or carry out simple repair works. When someone enters these quarantined areas, they are automatically placed under a two-week quarantine. They can only leave with a clean bill of health. It’s not uncommon for hospitals to strike out when they need to get someone into the quarantined area. The helmet based ventilators will help these service people get in and out of the hospital or quarantined area seamlessly. They are protected by the helmet which filters the atmospheric quality around them and they can enter and leave the hospital contamination-free. Conclusion People like Marek are everywhere. These are the people who have the skills, knowledge, and experience to design and produce these noninvasive ventilation helmets and they’re online, communicating and sharing freely with each other, hot on the heels of medical revelations. It is now up to authorities and governments to recognize their effort and give these innovative inventions a chance, just like how other countries have, to treat Covid-19 and other respiratory patients faster. We are sure we will see grander medical innovations from people like Marek in the future. Video interview

5/18/2020 Chicago This is a video review of the Non-invasive Ventilator Helmet made by Amron International from California. More An interview with the designer of this helmet Scott Ritchie. You can order this helmet directly from the manufacturer here. More about Amron International Video review of all 5 NIV helmets that are made in the USA (as of 5/19/2020)

5/14/2020 Chicago Over the last 42 years, California-based Amron International has focused its attention on commercial diving, hyperbaric and military equipment. They had no way of knowing that one of their products would be used to help fight a worldwide pandemic. Fast forward to March 2020 and that is right where the medical division at Amron has found themselves. In a recent interview with Aurika Savickaite, co-founder of www.HelmetBasedVentilation.com, Amron’s Vice President of Engineering and Manufacturing, Scott Ritchie, shared the company’s history with helmet ventilation and how it has adapted the design of its oxygen treatment hood to meet the increased demand from hospitals caused by the COVID crisis. A 34-year veteran with Amron International, Ritchie has focused much of his career on product design and development. He also oversees the manufacturing division, quality, and safety at the company. In the late nineties, the company had developed a hood to be used in clinical decompression chambers, which provides treatment for diseases such as multiple sclerosis, cerebral palsy, serious infections, and wounds that will not heal due to gangrene, diabetes and radiation injuries. “It was actually a fun product to design and it became a very successful product for Amron, Ritchie said”. In the beginning, getting customer input was important, so the company sent out a survey to its clients, including medical personnel, to see what features they would like to see incorporated into the design. “I gathered all the information and then came up with the design,” Ritchie said. “There were many requirements that doctors wanted to see incorporated into the product.” That included the ability to allow the patient to lay down – which required the design to feature an offset neck opening, back towards the rear of the helmet, and not have the hood lift over their head. A two-part design provides a means of securing the neck ring with a neck seal on the patient, allowing full access to the patient to make adjustments as needed, including control of the gas supply. It also allows for the temporary removal of the hood without disturbing the patient, connections, or gas supply. Entering 2020 and with COVID-19, the helmets found a new application. “We went into (what) I would call “hyper-speed mode” considering the new requirements and redesigning certain aspects of the hood to make it more compatible for CPAP, NIVA and other types of treatments hospitals need,” Ritchie said. Because helmet ventilators require higher internal pressures, Amron incorporated a unique locking system that eliminates the need for locking clips. This locking system also acts as a built-in pressure release feature at 40-plus cm of water. Straps and strap retainers were added to help secure the hood system to the patient due to elevated pressures. Ritchie had ideas for the current design back in the late nineties, but at that time, the design was cost-prohibitive and certain FDA-approved materials available today, were not available at that time. Another feature of the Amron hood is the solid one-piece neck ring design, which Ritchie refers to as the “heart of the design.” The neck seal is removable and easily attaches to the neck ring. The neck ring is made from an autoclavable medical-grade plastic, which can meet the various cleaning processes at different hospitals. The one-piece design helps eliminate contamination and can be soaked in a germicidal disinfectant, and unlike two- or three-piece designs, it can dry quickly. The ring itself is the main base, which includes a patented front placement of the couplers. The supply of oxygen comes over the patient’s face providing a fresh breath, eliminating fogging and helps to keep the viewing window clear. The rounded shape helps scrub out the CO2. Much study went into the coupler placement design to make sure the lower flow rates – especially for younger patients – were perfect. Attention also was given to address the various flow-rate noise levels, to avoid the ear area and to aid oxygen circulation. “We found that many patients using other products would overheat, where they just never felt like they were receiving fresh oxygen,” he said. “That’s why we felt the circulation going from front to back, up and over and back is a better concept because it does cool, it gives them fresh oxygen and you’re getting that fresh breath”. “And it reduces the CO2 levels, as well,” Ritchie said. “So that was a key part of that ring design.” Ritchie believes that physicians should monitor and measure the CO2 flows for the unique, individual needs of the patient, he said. Monitoring CO2 levels can be the best tool to determine success, along with proper flow rates. The hood is easy for the attendant to place over the patient’s head. The hood’s viewing window is made of optical quality vinyl and not only provides comfort for the patient, allowing them to watch TV or read but is also a safety aspect. Due to the inherent thickness of the hood window material, the patient is able to breathe, even if the hood is pushed against the user’s face. A multi-access port allows for multiple uses for both the patient and the physician, from testing CO2 levels to providing liquids, to suctioning the patient, if needed. “That’s one of the features that everybody is looking for in the medical field,” Savickaite said. “It’s patient comfort and definitely it helps the staff to take care of the patient.” The silicone neck seal is unique as the base is thicker for increased durability and provides a good seal, yet is thinner around the neck, allowing for improved patient comfort. The silicone neck seal is a patented product and the overall hood was patented in 1998. The hood has been FDA approved since 2001, and has had to undergo testing at Amron, in hospitals, and at the US government. A variety of toxicology tests also had to be passed to achieve marketing approval. Amron has also implemented a robust ISO 9001:2015 quality management system that actively promotes customer feedback into its processes in order to continually improve its products as well as customer satisfaction. “That’s what we’re all about; we’re constantly improving all of our products. It’s been a great journey for the product,” said Ritchie. The medical manufacturing division is one of the three market-segment divisions at Amron International, in addition to the military and commercial diving divisions. While the commercial diving industry is slow right now, due primarily to plummeting oil prices and the economic impacts of COVID-19, the last several weeks have been extremely busy for the medical division. “We were in the hyper-speed mode to develop our new hood for COVID-19, but we continue to sell the hyperbaric hood,” he said. COVID-19 has not only garnered international interest in the hoods but also in the United States. “Even in the US, I can see where hospitals are starting to slowly incorporate this product and our hope is to try and get the hood introduced into clinical studies for use in hospitals, and to also promote education because I do feel the hood is very beneficial versus intubating a patient and putting them on ventilators, which they’ve found isn’t always the best solution. “With hoods, we’re using PEEP valves with elevated pressures, which is found to be a significant help for some COVID patients,” he said. Savickaite was pleased to hear of the US interest. “We still have a big learning curve,” she said. “I’m so glad that you are also listening to your customers so well and making all these changes to the design, which are beneficial for patient treatment.” Ritchie is excited and passionate about Amron’s participation in the fight against COVID-19. “At Amron, we would like to see this type of therapy become more widely utilized by hospitals in order to accommodate differing levels of pulmonary and respiratory treatments as well as COVID-19 – we find it extremely fulfilling to help doctors save lives, and because of that, I would like to help spread the word.” Ritchie would like to see all unite to get through the COVID-19 era. “I hope that doctors, clinicians, and related communities will try and create a unified group,” he said, acknowledging that it’s been a challenge. “As a whole, I think everyone can all agree these types of therapies are beneficial for patients”. “The goal is to save lives and help people,” he said. “We have to keep the common goal in mind, in moving forward, always.” Savickaite agreed. “When the physicians and the patients see the benefits of the helmet-based ventilation, this is when it’s going to be more widely accepted,” she said. “I truly believe we both have the ultimate goal of patient safety in mind – to make sure the patient is safe, that the patient gets better, and that clinicians learn and study more about non-invasive ventilation via the helmet.” Savickaite acknowledged Ritchie and Amron’s dedication to the helmet-based ventilation effort. “It’s a good goal to have, and I believe we are all are on the same page here,’ she said. Now we just need more helmet champions – and one of them is you and your company.” Video A video review of this helmet.

5/14/2020 Chicago NASA’s Armstrong Flight Research Center in California partnered with Antelope Valley Hospital, the City of Lancaster, Virgin Galactic, The Spaceship Company (TSC), Antelope Valley College and members of the Antelope Valley Task Force to design and manufacturer a positive pressure helmet for noninvasive ventilation to treat COVID-19 patients. Last week a team of engineers and scientists sent us the prototype of NIV positive pressure helmet for a review. A few days later Aurika Savickaite had a Zoom video meeting call with the helmet designer, Mike Buttigieg, David Voracek at NASA Armstrong Flight Research Center, Dr. Daniel B. Khodabakhsh an emergency medicine physician at the Antelope Valley Hospital and others. During the Zoom meeting, Aurika Savickaite gave her and Dr. JP Kress's feedback about this helmet prototype and what further improvements can be made. According to Mr. David Voracek: our current status is working the FDA EUA filing. We know that there is a need for these types of helmet designs, we feel that if EUA comes through and if tasked we could get 50,000 of them made easily. Just to make sure you know, this was created as an Emergency Use device, not a production unit. We are looking for emergency use authorization from the FDA. (5/5/2020) Here is a video review this helmet Video review of all 5 NIV helmets that are made in the USA (as of 5/19/2020)

5/9/2020 Chicago COVID-19 is a worldwide pandemic, not choosing who it takes down. And the efforts to combat the virus also is taking worldwide efforts, as physicians, researchers, and manufacturers work together to find remedies. A Canadian physician is excited to be able to share not only his experiences with helmet-based ventilation systems – but also to be able to share the design with others during the COVID-19 pandemic. Scott Loree hopes to soon be able to have helmet-based ventilation hoods available for COVID-19 patients in Canada. Loree recently spoke with Aurika Savickaite about the efforts and achievements to manufacture helmets for patients. Video Loree is working to tweak designs to get the helmets out as soon as possible. It has been a whirlwind effort, with more successes as non-invasive ventilation is gaining recognition. “The thrust of my deployment, the thrust of my interest for this, is going to be mostly rural, because we have places that are two, three, four, six hours drive from an ICU,” he said. “You can imagine what would happen with an intubated patient out there.” Loree has a substantial interest in rural medicines and vast experience in small rural hospitals in Alberta where there often is only one physician in town. “When COVID started ramping up and we started seeing more and more people needing ICU care, I started to worry about what was going to happen in a lot of these smaller places,” Loree said. Many of those hospitals lack negative-pressure rooms available, or staff with little experience with intubation. That inspired Loree to look for a solution – and he found a video from Italy where the helmets were being used. “That inspired me to go looking as to whether that would be a good solution – why were they using these in the Italian ICUs – maybe they know something we don’t.” An Internet search led him to manufacturers including Sea-Long, Amron, and Intersurgical (Italy). He quickly realized the companies would be tapped out of their supplies due to universal demand. “I concluded if we were going to have these things here for us, we would have to build them locally,” he said. His continued research led him to the HelmetBasedVentilation.com website, which validated the success of the helmets. Loree started searching for plastic manufacturers in Alberta who might be interested in collaborating to develop helmets. He found Tom Vermeeren of Gemma Plastic Products, Inc., in Edmonton which builds a variety of custom pieces for oil fields to plastic bags and lots in-between. “Tom was quite enthusiastic about it, in fact, he had already ordered 20,000 liters of ethanol to make hand sanitizer and build the bottles for our local health authority,” Loree said. “So, he was already in it up to his waist, so I dragged him in and put him up to his eyeballs.” The men exchanged ideas, designs, redesigns, and more, settling on a cast polyurethane process for the neck ring. Vermeeren designed a plastic master for the neck ring, thinking they would use a 3-D printer – but that did not work as they hoped, Loree said. The part shrunk 0.5% coming off the printer, causing fitment problems. “It was frustrating,” Loree said. For the soft, flexible neck seal, Vermeeren first tried a type of special effects silicone used to build make-up prosthetics – a soft material which sealed very well – but more durability was needed. Vermeeren brainstormed with one of his machinists, and the two came up with an injection-molding approach, and, using a CNC machine made a mold out of steel – a process that took about 30 hours. The search is now on to find the best material to injection mold the neck seal -- not too stiff, but durable enough to stretch more than 500% and pull over a patient’s head without discomfort. It is an ongoing process, Loree said, and he and Vermeeren are hard-set on wanting the product to be successful, Loree said. Manufacturing is challenging, Loree said. “It’s a matter of making sure this is right,” Loree said regarding the urgency to help patients. “Tere is a sort of a spectrum between it works, and it works good enough and it’s perfect. Not good enough or it barely works is sure to sink the project,” he said. The goal is to make 200 helmets, Loree said, adding that is a lot “to make on your kitchen table.” “And then there’s the issue that healthcare workers are not ‘makers’ – they’re not interested in fiddling with it to make it work – if it doesn’t just work and go on and do what it is supposed to, they’re not going to want to use it,” Loree said. The health authorities are not interested in something that is manufactured on the kitchen table, he added. Canadian hospitals are working cooperatively together to combat COVID-19, determining which hospitals will offer what services – and are not in competition, Loree said. Loree talked to the Zone Emergency Operations Center in Calgary, where the Head of Procurement expressed interest in the helmet, and suggested they pursue Health Canada approval – which Loree found had a special approval process for emergency COVID-related medical devices. Loree compiled information he and Vermeeren had, University of Chicago information from the HelmetBasedVentilation.com website, cited the rationale for the helmet use, along with analysis of failure scenarios and how to deal with those and submitted it. Health Canada responded with questions and requests, including generating a unique code to identify the product. Loree complied and within 10 days, was issued a Health Canada approval. A letter of approval must go out with each hood, Loree said, and they are required to track adverse events. “My plan is that everyone that uses it should be emailing us back with results – the status of why they used it, and what vitals looked like – a brief case report kind of thing,” he said. Loree found the information, including studies and videos, on HelmetBasedVentilation.com website very helpful in gaining approval, he said. “Health Canada employees were all very supportive -- they quickly came to the conclusion it wasn’t dangerous, and our manufacturing plan was responsible and usable,” Loree said. Savickaite pointed out there is a learning curve and emphasized how important it is to follow guidelines. “Look at the physiology, look at the patient and see what’s happening and then make a decision based on that,” she said. “I hope very soon we’re going to have a protocol we can publish,” Savickaite said. Loree commended Savickaite for the website HelmetBasedVentilation.com she and her husband David Lukauskas developed. “The tutorials, and protocols, and information you’ve put on online with the website are extremely helpful,” he said. “Those are basically most of my plans for the instruction manual for this helmet. “It needs to be written, as well, but to connect them with the information out of the website, it’s important to be able to educate them as an in-service type process, because there is no way we are going to be able to give everyone experience with this before they use it,” Loree said. Savickaite shared that Loree started a GoFundMe page to help support helmet production for Canada. The helmets will be sent as a kit, with all the parts needed, so no medical facility must seek out parts. “Keep sharing ideas,” Loree said. “It’s a cooperative effort; it’s not a competition.” About Scott Loree Scott Loree is a Family-trained Emergency Physician in Calgary, whose extensive experience in rural hospitals and care inspired him to seek a way to efficiently and successfully manufacture non-invasive helmet-based systems to help patients dealing with COVID-19. He is quite familiar with the use of ventilators from his time as a critical care transport paramedic before medical school, and through his daughter, who has been dependent on a ventilator for much of her life. He holds degrees in Physiology, Psychology and Philosophy, and a Wilderness Medicine Fellowship with experience in Disaster, Diving, and High-Altitude Medicine. He also enjoys making things to help solve problems. Click here to go to Loree’s GoFundMe page. About Tom Vermeeren Tom has a background in structural design and plastics manufacturing. This has been very beneficial when designing new products and converting metal parts to plastic products over the last 27 years. Tom has worked in the rubber industry compounding and molding rubber. On the plastic side, he has worked in pultrusion, extrusion, injection molding, and casting of materials. Tom is a graduate of Fanshawe College Civil Engineering Technology program with a major in structural design, and a graduate of the NAIT Plastic Engineering Technology program. About Aurika Savickaite and David Lukauskas Aurika Savickaite NP, RN and her husband, David Lukauskas, an entrepreneur, and biohacker, founded and developed the website HelmetBasedVentilation.com to compile and share information about NIV helmet based ventilation during the COVID-19 pandemic. Aurika Savickaite, NP, RN, MSN, was involved in the successful testing of the helmet ventilator in the ICU at the University of Chicago during a three-year trial study. While in pursuit of a Master of Science in Nursing – Acute Care Nurse Practitioner degree at Rush University College of Nursing (2014), she wrote her capstone paper, Noninvasive Positive Pressure Ventilation (NIPPV) for Treatment of Acute Respiratory Failure in Immunocompromised Patient, based on her experience with ventilation via the helmet. Savickaite has worked as a registered nurse and patient care manager at the University of Chicago Medical Center, Medical Intensive Care Unit, and as a staff nurse at Vilnius University Hospital, Santariskiu Clinic, in the intensive care unit. She earned a Bachelor of Rehabilitation and Nursing at Vilnius University Faculty of Medicine in 2001.

5/2/2020 Chicago New training video with the newest updates, feedback, and guidelines for helmet based noninvasive ventilation from Dr. Bhakti Patel, Dr. JP Kress, University of Chicago Medicine, and the Helmets for Humanity Project. Video Table of Content 1. Welcome - Deeana ljaz Ahmed, MS MPH (5 min) Introductions Logistics and points of contact Tech support plan 2. NIV Helmet training - Bhakti Patel, MD (20 min) Why Helmet Ventilation and basic setup UChicago Medicine patient experiences Overview of types of oxygen delivery 3. Q&A - Bhakti Patel, MD and John Kress, MD (20 min) Experiences with implementation Patient successes and failures Device awareness 4. “Helmets for Humanity” - Kaleem Malik, MD (5 min) About Humanity First pilot Initial shipments Scaling plan 5. Training Survey - Dr. Martinez (10 min) Survey purpose Link and feedback timing Future survey plan In this video, an NIV Oxygen Treatment Hood made in the USA by SUBSALVE was used

4/25/2020 Chicago This is a video review of the Non-invasive Ventilator Helmet made by EXTOL Inc from Michigan. This manufacturer just started making helmets in March of 2020 to help hospitals in the fight with the COVID-19 pandemic. Video More You can order this helmet directly from the manufacturer here. Video review of all 5 NIV helmets that are made in the USA (as of 5/19/2020)

4/25/2020 Chicago This is a video review of the NIV COVID Helmet" (PN 5401, PN 5404) made by the Sea-Long Medical Systems LLC from Texas. This helmet is FDA approved, it was used in the study at the University of Chicago Hospitals in 2016. More An interview with the owner of Sea-Long Medical Systems LLC Chris Austin. You can order this helmet directly from the manufacturer here. More about Sea-Long Medical Systems. Video review of all 5 NIV helmets that are made in the USA (as of 5/19/2020)

4/25/2020 Chicago We can't afford to play a Cat and Mouse game with a deadly virus. As of Apr 20, 2020, the total number of confirmed COVID-19 cases in the United States stands at 770,564 with over 41,000 deaths. That’s approximately 5.3% risk of death for new patients in the world’s most developed country. On the same date, Singapore recorded a dramatic spike in new cases, confirming 1,426 new COVID-19 infections within the island state in a single day. Foreign workers living in cramped dormitories account for a large number of new cases. What it shows us is that even in a developed country that has firmly held its ground as one of the best-equipped countries in the world, it can be left unprepared for sudden spikes. Within the United States, some communities are still more socially and economically challenged than others. In these communities, social isolation may not be the ideal solution. The Coronavirus recognizes no race, religion, ethnicity, culture, financial status, nationality, and knows no boundaries. Without discrimination, the virus makes the call until we find a cure to protect ourselves against it. The truth is, the more developed a country is, the better the position the government will be in to provide countermeasures against an outbreak. This leaves under-developed nations in a desperately vulnerable position. While the rest of the world locks down on people's movement, bringing economies down to a grinding halt, in an effort to 'flatten the curve', the social isolation solution is simply not an option in some cases. For people living in countries that are essentially cut off from the rest of the world, social isolation could be a deadly game of Russian Roulette. Even humanitarian organizations and workers have had to leap through obstacle courses of red tapes and clearance checks to get past stringent borders. As authorities and medical professionals wrestle their way around the clock to bring order to the disease, they are still ill-equipped for a potential medical emergency. The United Nations Development Programme (UNDP) are on the ground, deploying as many resources to developing nations like Bosnia and Herzegovina, Djibouti, El Salvador, Eritrea, Kyrgyzstan, Madagascar, Nigeria, Paraguay, Serbia, Ukraine, and Vietnam as the countries strap themselves in for a rough ride against health risks and potential deaths. These countries are severely under-resourced and their fragile healthcare system may collapse if left without international intervention. It is inherently driven into us that we need to extend a helping hand out to those who are less privileged and are hunkered down without aid. We're, after all, dealing with a respiratory illness that may rob its victims from its lifeline - oxygen. It was reported by Al Jazeera that there are only 20 available ventilation devices for the 2 million people in the Gaza Strip. There is also an inadequate number of beds for the 20 million people that call Burkina Faso home. In these countries and vulnerable communities, getting fast, efficient, and cost-effective solutions to them should be the game plan. According to data provided by the World's Bank for 2017, many healthcare systems are under-funded by up to 70%, especially in under-developed countries. What these under-developed nations need are resources to help stop the spread of the virus, provide adequate support during an outbreak, and funding to bolster a potential economic breakdown. We don't want to wait and be caught off-guard when infections start spreading unbeknownst to authorities where there is not enough medical equipment and quarantine facilities to cope with an outbreak. Such is the case in Palestine. It is time for us to look for alternative solutions that work. One good example would be a helmet-based oxygen supply system which is cost-effective and easy to develop. The helmet-based respiratory NIV Hood, also known as a non-invasive helmet-based ventilation system, has proven itself as a plausible solution for COVID-19 patients. Without the need for a ventilator or any other machines to hook up to, the helmet-based ventilator uses a mix of oxygen and the correct airflow to provide relief and quickly soften the blow for a COVID-19 patient’s symptoms. In 20%-30% of the cases, the helmet eliminated the need for intubation in patients with COVID-19. As seen in most underdeveloped countries, there is a severe shortage of facilities, especially ventilators. Using the helmet-based ventilators brings us to the winning side of the equation in underdeveloped countries. This alternative use of non-invasive ventilation via helmet is another way medical staff can help patients with COVID-19 while trying to keep ICU beds ready for those in critical condition. The helmet also provides both the patients and medical staff with an ease of mind because patients using the helmet-based system are awake and do not require sedation. This way, they maintain their ability to convey their immediate or urgent needs to attending medical staff. During an outbreak where every second count, putting patients needing urgent attention on the helmet could buy them 6 to 7 hours of extra time before intubation, if necessary. The helmets also put the most vulnerable people, health workers in these medical facilities, in a better state of mind to perform their duties. Facing the highest risk for infection are respiratory therapists, emergency room staff, and doctors. In an ideal, proactive, and calibrated approach to helping these communities deal with a potential outbreak, countries should be bringing in these solutions to bolster the blow. QUOTE: "During its recent COVID-19 outbreak, the Monza hospital Cereda was affiliated with experienced notable success with the helmets. About 200 patients were simultaneously treated via helmet-based ventilation, compared to 50 to 60 intubated patients." - Dr. Maurizio Franco Cereda of the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center This is where regional and international collaboration comes into play; to level the playing field for the healthcare systems between well-off and underdeveloped countries. What we need is a more uniform and affordable approach to bring the COVID-19 pandemic to its knees. And until we have a cure for it, the winner is still the virus. Let's look at the big picture because the helmets could change the entire ballgame and it's the wrong time to play the waiting game. Sources: The oxygen divide: Ventilators for Europeans, soap for Africans? Singapore confirms record jump of 1,426 COVID-19 cases Commentary: Obviously, we want ASEAN to collaborate better on COVID-19 The oxygen divide: Ventilators for Europeans, soap for Africans? COVID-19: Looming crisis in developing countries threatens to devastate economies and ramp up inequality African Americans struggle with disproportionate COVID death toll

5/18/2020 Chicago As of 5/19/2020, there are five NIV helmet manufacturers in the USA. In this video, you will see all 5 noninvasive ventilation helmets "oxygen hoods" made by: Amron International from California helmet (FDA approved). SUBSALVE from Rhode Island (FDA approval is in the process). Sea-Long from Texas (FDA approved). Extol from Michigan (FDA approval is in the process). NASA - Virgin Galactics from California (FDA approval is in the process). A previous video review of 3 helmets by Sea-Long, Extol & SUBSALVE recorded on 4/24/2020. We didn't have the two helmets from Amron and NASA at that time. Video reviews of these helmets individually Amron - a video review about this helmet. SUBSALVE - a video review about this helmet. Sea-Long - a video review about this helmet. Extol - a video review about this helmet. NASA, Virgin Galactic & The Spaceship Company - a video review about this helmet. Order online Find how to purchase the helmets here