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08/18/2020 Chicago NEW YORK -- As a child, Susan Houde-Walter was groomed to become an artist – until she found she would need to learn physics to make holograms. She fell in love with lasers and optical engineering – and ultimately became the CEO of LMD Power of Light Corp. (“LMD”), a laser manufacturer in Rochester, NY. LMD has become part of the growing community working together to fight COVID-19. Susan shared the story with the co-founder of the website www.HelmetBasedVentilation.com, Aurika Savickaite. With LMD based in New York, Susan could attest to the impact COVID-19 had in the state. “New York was in tough shape. Governor Cuomo got on the news and basically said, ‘any manufacturers, if you know how to help New York State, contact our office,’” Susan explained. “So we did, and that’s how we got involved.” The company did their research – starting with information, webinars and videos on www.HelmetBasedVentilation.com. Inspired by the community of clinicians and industry coming together, the company focused its deep engineering bench and manufacturing know-how on a patientcentric solution. The result is the “Vyatil,” (pronounced vital), a nonpowered oxygen tent. The process was educational, she said. Perusing the medical literature, they learned about characteristics that affected COVID-19 patients : COVID-19 patients fared particularly poorly on mechanical ventilators; Supplemental oxygen with gentler interventions (nonmechanical) may be more effective at returning people to health; Proning the patient during treatment -- taking the weight of the heart off the lungs -- seems to be beneficial in quicker recovery; Hospitalization can be weeks long before a patient is considered recovered; and If the viral load is reduced, thus reducing the chance of infection, the medical staff can be better protected amid constant exposure. “All of these points suggested that a nonpowered oxygen tent may help the patient recover and also help protect the medical staff from the pathogen,” Susan said. Savickaite said another point was that noninvasive ventilation and proning can be used early in the treatment, can provide better outcomes for the patients. The takeaway – and motivation – was if patients can be kept off mechanical ventilation, it was best for the patient and the medical staff. A lot of resources – i.e. hospital beds and mechanical ventilators -- also are saved by using noninvasive ventilation, the two women agreed. The effort was a departure from making lasers. “LMD is a laser company,” Susan said, “we had to start with a clean sheet of paper and build our design from the point of view of patient needs.” Since the patient might be in the Vyatil for an extended period of time, the company emphasized patient comfort and safety. The Vyatil features a soft tent and a zipper across the top. The zipper allows immediate access for suctioning or other medical interventions, and also allows the patient to open the tent if they get claustrophobic. It was also important that the patient could be comfortably proned for a long period of time. “We’re using materials that are considered by the FDA to be some of the safest available for medical use, because the patient might be in it for a long time,” Susan said. LMD does not use latex or even PVCs because they can contain phthalates and dioxins. “We took all these things to heart when we designed our version,” she said. The helmet is registered with the FDA as a Class 1 nonpowered oxygen tent, which means it can be used with hospital wall gas or an oxygen tank, she said. The tent features soft inflatable tent, the zipper, inlet port, outlet port, a hydration port to allow the seal to be held, but lets the patient drink, soft silicone neck seal, and adjustable arm straps. The port positions maximize the mixing of gas inside the tent and minimizing CO2 rebreathing. Also by keeping the ports away from the ears, the noise also is reduced for the patient. The tent also provides lots of room for the patient, along with great visibility for the patient and the medical staff. “You are the first ones in the US to develop a tent with a zipper,” Savickaite pointed out. The tent is put on the patient with the zipper open, fitted with a viral filter and PEEP valve, hooked up to the oxygen, and the air is turned on. Once zipped up, the tent is inflated in seconds. The patient, if able, can walk around while wearing the tent. Savickaite noted the tent is very lightweight, adding to the comfort for the patient. They also collapse flat for easy shipping and storage. Clinicians have commented favorably on the zipper and the quality of the neck seal. “We are delighted to get clinicians’ feedback,” Houde-Walter said. “We’re planning on a series of these, so any kind of feedback will be very valuable, especially if it is patient focused – that’s our primary interest.” LMD is selling the Vyatils – and have set up a special website with videos and downloadable materials, https://www.vyatil.com. Video Hands-On Review - VYATIL Oxygen Tent video

08/13/2020 Chicago People diagnosed with COVID-19 -- and the physicians treated them -- have just received another piece of arsenal to fight the virus – the FDA issued Emergency Use Authorization (EUA) for the "Subsalve" noninvasive ventilation helmet. “This is a huge achievement for Michael Lombardy, his team, and the whole helmet industry,” said Aurika Savickaite, cofounder of www.HelmetBasedVentilation.com. “The FDA gave a green light for all the physicians to use the helmet for the COVID patients for noninvasive ventilation in the ICU settings, which is great.” The helmets gained momentum with the onset of COVID-19 early this year, with countries like Italy leading the way and introducing the concept to hospitals, physicians, and manufacturers in the United States. With many advantages over invasive-type ventilation, the helmet gained great interest when able to be used in the right situations for patients fighting COVID-19. Savickaite and her husband, David Lukauskas, started the website with the intention to share information about the noninvasive helmets when the COVID-19 pandemic struck, sharing the stories of physicians throughout the world, helmet manufacturers, and studies regarding helmet use. Savickaite, MSN, RN, was involved in the successful trial of the helmet ventilator in the ICU at the University of Chicago during a three-year study. Advantages of the helmet include faster recovery time, shortening an ICU stay, less need to intubate, lower ICU mortality, minimal or no sedation, and less cost, due to faster recovery, less-invasive treatment, and lower-cost device. However, these advantages were not being optimized, because some were hesitant to use "off-label" the FDA approved helmet, Savickaite said. It was more difficult to gain administrative approval for helmets – and there were some facilities that would not use the devices." Now, with FDA EUA approval, the doors will open more easily, gaining faster approval from administrators, less paperwork, and a safer legal process for the treatment. With faster administrative approval, more clinicians will be able to access the helmets, and more patients can be treated. “Hospitals should feel comfortable using this device and save more lives,” Savickaite said. “I truly believe, this will help more COVID patients, and at the same time, physicians will notice how well (the helmet) works for respiratory distress. In the future helmet can be used for patients who don’t have COVID, but who require non-invasive ventilation,” Savickaite said. For more information on the FDA approval for each helmet, got to the "Buy" page.

08/07/2020 Chicago This is a video review of the VYATIL Nonpowered Oxygen Tent made by the LMD-Power of Light, NY. VYATIL Neck Size Guide: The VYATIL is FDA approved. You can order this helmet directly from the manufacturer here.

08/06/2020 WORCESTER, MASS -- Aurika Savickaite, co-founder of HelmetBasedVentilation.com refers to Rachel Carragher as a helmet “champion” and “pioneer.” Early in the battle to fight COVID-19, Carragher, a respiratory therapist at UMass Memorial Health Care, Worcester, Mass. started researching the use of the noninvasive helmet. The physicians began looking at helmets in March, and after talking with doctors in Italy about their use, one of the anesthesiologists who works in critical care medicine, Dr. Rebecca Bauer, ordered and purchased the helmets on her own. The helmets were delivered to Bauer in April, and she brought them to Carragher’s office. “And that’s how I ended up with the helmets,” Rachel said. “We all came together as a group to try to figure out the best way to utilize these helmets for the patients,” she said. At that time, there was not a lot of information about the helmets, so the medical staff worked together to develop the best practices. The BiPAP machine proved to be too loud, so they switched to the high-flow set-up for the nine patients they used the helmets on; the average age of the COVID-19 patients the helmets were used on was the mid-50s, Carragher said. The patients came up to the ICU from the emergency room. They were usually on high-flow and were switched to the helmet in the ICU. They kept the flow to 80-85 L/min, Carragher said, which proved to be the most effective and most comfortable for the patients. Higher flows would prevent any fogginess, she added. The team started to network with other physicians in Chicago and at UMass hospital. Carragher’s medical director, Christine L. Bielick Kotkowski, who specializes in pulmonary disease, and Dr. Bauer were among those who were rallying for helmet use. “They were true supporters of the helmet with me and helped me on a physician level to get buy-in from the physicians,” Carragher said. One of the trial patients was a 56-year-old male in severe distress – and it was his initial success that impressed many of the doctors and nurses. “When we put (the helmet) on … he turned the corner so quickly, he was actually sitting in a chair, facetiming his family, he was doing extremely well with the helmet,” Carragher said. “We got a lot of buy-in from the nurses because they actually saw how well he improved, so that was great that the nurses in the ICU, actually witnessed how well this individual turned around,” she said. Not all patients are candidates for the helmet, as some can’t tolerate the hood. The patients in the trial averaged about three to four days, and some did need to be intubated, as well, Carragher said. The trial patients were not prone, Carragher said. “We wanted to, we just weren’t at that time, doing that,” she said. Some patients received low sedation to help their comfort level, she added. Letting patients get their nutrients also helps with comfort. The helmet requires work and is time-consuming in the beginning, and education is essential. Some of the early challenges including feeding patients and making sure the helmet was fit correctly. “You have to learn you have to go over those bumps before you start to feel very comfortable using the helmet,” Savickaite said, referring to the protocols shared on the HelmetBasedVentialation.com website. Medical personnel should also watch for pressure injuries around the arms and other areas, Carragher said. “And then just really be careful around the patient’s neck,” she said, adding they used a DuoDERM® dressing for a patient who used a helmet for a whole week. The dressing helps seal the helmet as well, and can be more comfortable, Savickaite added. With COVID cases currently down in her area, Carragher said they will be able to regroup and learn more about the helmet, and different ways the helmet can be used with patients who have respiratory needs. Carragher shared an important feature of the "Sea-Long" helmet. “There is an inspiratory side (with a one-way valve) and an expiratory side,” she said. “That’s really important to know.” Patient education is important, and is an ongoing process, Savickaite said. In conclusion, Carragher said that it is important to have a helmet “champion” on the team. “You need a ‘superuser’; you need someone who is passionate and is willing to try new things,” Carragher said, suggesting someone in the anesthesiology department. “You need someone very clinically strong and who is willing to devote time to put something in place and then be able to educate your nursing staff, your physician staff, your respiratory therapists." “It’s lots of work, but hopefully the outcome is that these patients aren’t getting intubated,” Carragher said. Video -

07/14/2020 A “mom and pop” medical systems manufacturer – once manufacturing 60 to 100 helmet ventilators a week, now is seeing orders go off the charts since the onset of the COVID-19 pandemic. The owners estimate the company now manufactures 1,000 per day, all of which go through quality checks. Chris Austin, who leads the family-owned Sea-Long Medical Systems, Inc. in Texas, describes the journey as a “Cinderella” story. Once the shoe fit, so to speak, life as Sea-Long knew it entered a whole new realm. He and some of his leadership team shared the story with Aurika Savickaite, co-founder of the helmet-based ventilation website, www.HelmetBasedVentilation.com. It all began a few months ago, when Wall Street Journal reporter called and asked to do a story on the company’s efforts to manufacture the noninvasive helmet ventilators. “Within 24 hours or less – we had calls from NBC, CBS, overseas newspapers, TV stations, New York Times … I mean I could just go on and on,” Chris Austin said. “It was just so overwhelming to see that kind of response.” Within two days, Sea-Long’s phones were ringing off the hook in the shop behind their home in Waxahachie, Texas. “Every time you went to go take a phone call, you couldn’t even pick the phone call up without it ringing,” Austin said. That pace continued for weeks – and it was both exciting and frustrating. It was troubling, Austin said, because the company felt they were missing many calls and email inquiries – and it was frustrating some customers. That said, they were working at the shop for 18 to 20 hours a day, filling the thousands of orders they did get. “It was an interesting time, but it was critical to allow us to expand and grow the way we did so fast and partially due to the caliber of people who believed in the product – but more importantly maybe, believed in the technology to save lives, and that’s what we’re all about,” Austin said. “There was no way we could turn away anybody, “he said. “We always tried to put ourselves in their shoes – or their shoes in watching their grandmother or grandfather or son or daughter for that matter in that hospital bed.” As word continued to spread, so did the offers to help with the cause. Several companies – including Virgin Galactic -- contacted Sea-Long to expand to the manufacturing facility with state-of-the-art equipment to keep up with the current demand – something that would normally take years instead of a few months. The demand brought out a vast variety of workers from miles away – including volunteers who would sleep in their vehicles to help put out the orders. Chris Austin talked about tweaks to the Sea-Long helmet to enhance the seal design, and also improvements in the training materials. The company also developed kits which contain all materials needed for hospitals to implement the helmets. “Any great medical growth comes from situations like this,” said Dr. Laura Austin of Sea-Long, referring to the pandemic “We knew there was a benefit and an opportunity to be using this hood for noninvasive ventilation,” Laura Austin said. “Anybody who has had any work in the medical realm could say what a benefit that is if you don’t have to intubate a patient, or trach a patient, and how much quicker they’re going to better, the amount of comorbidity is not going to be there afterwards – all (those) negative side effects. “But you have to get doctors and hospitals on board to do the research, we can’t physically do the research, we have to have those partnerships to help take this product and then say ‘Hey, this is what is really can do,’” she said. Research needs to continue, Dr. Laura added. “We need multiple studies to continue to further this in order to really show this is a huge benefit, and at very low cost, very low, negative side effects afterward, and overall a much quicker healing time.” That helps decrease the cost of care, another benefit, Dr. Laura said. “Best evidence, best care for the patients, as low cost as possible,” she said. The feedback from clinicians was crucial to the company’s focus – knowing they were working the greater good. The Sea-Long team knew they were contributing to saving lives – even while fighting the red-tape bureaucracy of the hospitals to hasten implementing the technology. “We had quite a few doctors buying (the helmets) themselves out of their own money to get the products shipped to them right away to their homes, because they couldn’t go through channels because they knew it would take weeks and weeks … and they would tell us .. if I don’t get this to them by day after tomorrow, they will be dead, I know they will be dead,” Chris Austin said. Sea-Long decided then and there to incorporate overnight shipping to accommodate the need – even at some financial loss. Austin shared a story how they rushed a helmet out to a doctor who was in tears because she was afraid she would lose a patient. Sea-Long rushed out a helmet – and within 24 hours the doctor called, again in tears, but this time to say the patient’s condition immensely improved in just a few hours. “At the end of the day, we can really feel good about what we were doing, because people’s lives were saved,” Dr. Laura said. Currently, the helmets are being sold within the United States, and also outside of the US, including South America, South Africa, and Indonesia. Sea -Long has discussed ways to help manufacture helmets in other countries, as well. The simplicity and low-cost of the helmets make it an excellent option for many, Aurika added. The benefits of noninvasive ventilation are evident in not only the benefits patients receive – but in the high risks they avoid, said Dr. Duke Eason, including pneumonia, vocal cord damage, tracheostomies -- even death from the efforts to save their life. “(This helmet) is simple, it’s direct, it’s easy to understand the physics and physiology, and it really has made a big difference,” Eason said. “I can’t say that I’m aware of any specific bias against European-based research.” The numbers are there to back up those challenges, he said. Despite the fact the helmet was widely used in European countries, until the media – and the pandemic – brought attention to the helmet, its benefits were almost a secret, he said. The simple, noninvasive helmet continues to be another step in fighting COVID-19, and a real chance to avoid intubation, Savickaite said. As areas are starting to experience another wave of COVID-19, this is not the time to stand by. “Now we know that some states are experiencing a huge rise in COVID cases – some are taking a ‘break’ – but still, all clinicians who are not having COVID patients, I think it’s a good time to learn the system,” Savickaite said. “We know, COVID patients will not disappear this year, we know there will be another flu season. “Now it good timing, actually, to prepare for that next peak that is going to hit your country, your state, or your hospital,” Savickaite said, encouraging medical clinicians, and respiratory therapists to read all the research, and test the product while learning. It’s the time to be proactive, all agreed, to improve the quality of the hood, and also consider the respiratory uses of the helmet post-COVID-19. Video Instruction video for Sea-Lond Helmet setup

July 2, 2020, | Chicago | Infographics #5 by HelmetBasedVentilation.com Source: Patel, B. K., Wolfe, K. S., Pohlman, A. S., Hall, J. B., & Kress, J. P. (2016). Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA, 315(22), 2435–2441. https://doi.org/10.1001/jama.2016.6338 Kyeremanteng, K., Gagnon, L. P., Robidoux, R., Thavorn, K., Chaudhuri, D., Kobewka, D., & Kress, J. P. (2018). Cost Analysis of Noninvasive Helmet Ventilation Compared with Use of Noninvasive Face Mask in ARDS. Canadian respiratory journal, 2018, 6518572. https://doi.org/10.1155/2018/6518572 Norris, C., Jacobs, P., Rapoport, J., & Hamilton, S. (1995). ICU and non-ICU cost per day. Canadian journal of anaesthesia = Journal canadien d'anesthesie, 42(3), 192–196. https://doi.org/10.1007/BF03010674

Dr. Yasser Khan recently shared his experience in developing a portable CPAP/BiPAP machine to be used with COVID patients with HelmetBasedVentilaton.com co-founder Aurika Savickaite. Khan, born in Bangladesh, came to the United States for his undergrad and went to Saudi Arabi for his masters. The project began when he saw the dire need for ventilation for patients in poorer countries like Bangladesh. “It’s actually quite challenging in Bangladesh,” he said. “We didn’t expect the cases to surge as much – and now it’s surging really fast.” The lack of accessibility to treatment is even more challenging for COVID patients. Doctors are overworked, as well. He reached out to many friends to help with the project – from financials, logistics, or technical needs. “Every email I sent, I got a ‘yes’ response back,” he said. “This is a community effort … it’s not just me, … it’s everyone, whenever we asked for help.” In the beginning, the men found that intubation with patients in these countries would be difficult because there were not enough ICUs combined with a lack of trained medical personnel. “That’s why we started focusing on non-invasive ventilation,” Khan said. It was essentially a volunteer project, Khan said, utilizing the help of students, and researchers in the Bay area. Engineers from Bangladesh and working at Stanford and Berkeley soon joined the project, Khan said. “We started looking into how can we create a low-cost solution that can be deployed in a country where we don’t have enough medical resources,” Khan said. That led to work on the CPAP/BiPAP machine, which does not need a compressed air source. With an invasive ventilator, an air source which is high pressure/high flow is needed from the wall -- available from developed countries – but much less available in underdeveloped countries. “With CPAP/BiPAP, you use a blower, so essentially you have the source within the unit, so that is one of the biggest benefits of having this solution,” Khan said. “Another thing is we needed to make something which is low-cost, portable, and easy-to-use,” Khan said. “These are extremely important factors because if it’s expensive, we cannot afford it. If it’s hard to use, we cannot give it to doctors to train.” Portability was important in order to get the unit in as many hospitals as possible. Working around the clock for several weeks, the team worked to meet those criteria, testing out different blowers and motors, and within six weeks, developed a small unit which met all the needs. The self-contained unit – easily held in one hand, includes a blower and compressor and has a touch screen display to provide easy set-up and use. The challenge was making the unit useful for COVID patients without contaminating the unit. “At that time, on your website, we found that helmet-based ventilation is a good option,” Khan said, explaining the aerosolization of the virus is contained. Once this option was explained to leery physicians, the doctors changed their mind. “Then they became super excited -- they started telling us ‘we need this immediately’,” Khan said. Khan described the progress as the end of phase one, with test units now in Bangladesh. “We have a medical team over there (and) they are going to test the units,” he said. “Once we have feedback from them, then we will plan the next step.” Khan said communication with the patient is important, to keep them calm and informed. He also found the ease of getting the helmet on and off, and the access ports make it easy to keep the treatment interrupted, as well. Aurika described the compact machine as life-saving – stating how the unit can deliver the flow at a max rate of 180 liters per minute – something usually only seen in large facilities. The units are now in a 2,600-bed teaching/research hospital in Bangladesh. COVID patients follow a protocol and that research will be used to fine-tune the design. Currently, the unit costs about $200 per unit made in the small research lab – but Khan hopes with high-volume production will lower that cost, in addition to more cost-reducing strategies. Alarms also alert medical staff to disconnects, a plus for the staff working with the patients. “Hopefully, once the design is validated by the doctors, one of the manufacturers can take the design and start making this in bulk,” Khan said. “That will actually reduce the cost. That’s our plan.” Kahn also is looking for feedback from patients and physicians to help improve the machine. Once the unit is validated and specs are confirmed, the design will be open to be shared with others, Khan said. There also are plans to have the unit FDA-approved, he said. FDA-approved devices can often get faster approval in other countries. “This is an all hands-on-deck project,” Khan said. “Everyone is chipping in on this. It’s not just Bangladesh. Once we go through the whole thing, we can share our story, share our design. The other countries can also pick that up.” “That will help all the countries, not just Bangladesh.” The challenges are felt around the world, Khan said. “It’s quite daunting for the whole country (Bangladesh),’ he said. “The government is trying,” Khan said. “The problem is the whole world is suffering. “Since the whole world is suffering, it’s hard to mobilize help from other countries to help countries in need. It’s a huge challenge, I think it’s the biggest challenge of our lifetime.” Video More videos from Dr. Yasser Khan

6/25/2020 Chicago Michael Lombardi of Lombardi Undersea LLC shares his expertise on Subsalve helmet - oxygen-hood NIV respiratory circuits and how to access some safety features through off-the-shelf components. The Respironics piece is a spring-loaded, one-way directional valve. When the flow fails, it leaves three ports on the side open (~2cmH2O). This still needs to be tested to determine how much fresh gas can be drawn through that port. This setup can be an effective and easy way for any helmet to allow the hood to open instead of close in case of an emergency. Pressure relief setup: To reduce COVID19 virus aerosolization, you must use viral filters with the helmet. Unfortunately, filters can clog easily with condensate. This following setup will provide a pressure relief feature and prevent the filter from clogging. First, the standard respiratory limp should point up; this will keep fluids from running down into the filter. You still have your PEEP valve to control pressure; you will need to add a second PEEP valve and point it down low. Set the second PEEP valve on higher pressure than the primary PEEP. If the filter connected to the primary PEEP valve gets clogged, then the secondary PEEP valve will kick in and act as an overpressure valve. As an example: The primary PEEP is set at 10 centimeters and the secondary PEEP is set at 12 or 15 centimeters. The secondary PEEP acts as the overpressure valve while also reducing any significant pressure increase. Thanks to multiple teams, including Subsalve, helmet developers are continuing work to fight the pandemic, including delivering kits to underdeveloped countries. Countries like Nigeria, the Philippines, and a few places in Central America have approved helmet-based ventilation and will use it for patients in respiratory distress. Video Click here to learn more about Michael Lombardi

6/3/2020 Like many people and businesses worldwide, Fernando Herreros' event planning business was closed due to COVID-19. “So, we had to find a new way to make money,” said Fernando, who lives in Asunción, Paraguay. Fernando shared the story of how his quest to make up lost income led him to support the effort to help patients with COVID-19 with Aurika Savickaite, co-founder of the www.HelmetBasedVentilation.com website. The businessman – who had no connection with the medical field -- started to look around for inspiration as the world around him closed down and found isolation pods were being used to transport patients with COVID-19. They went back to their factory and manufactured a pod. Medical personnel started asking if they could make products – and eventually were contacted by a physician who asked if they could make a helmet. Fernando’s team got to work – and, working with physicians, came up with a helmet. Once the prototype was complete, Fernando’s team started reaching out to physicians to have them try the design. Utilizing information found on the www.HelmetBasedVentilation.com, the team was able to demonstrate for physicians the different ways the helmets could be used – from wall oxygen to high-flow machines. “It worked perfectly every time,” Fernando said. With little to no helmet awareness in Paraguay, the concept was welcomed with open arms to fight COVID. “We’re like the pioneers in this [the Helmet NIV],” Fernando said. “The doctors are very happy with this and need it for COVID right now, to protect them more than the patients.” The one-piece helmet is made entirely out of PVC, with all SDS certifications, with ports for patient access, expiration, inhalation ports, and the neck seal and arm straps are silicone-based. The helmets also can be cleaned for use with another patient, and the neck seals can be replaced if needed. The flexible neck seal can be somewhat adjusted to adapt to different sizes. In demonstrating the helmet, Fernando was able to put the helmet on within seconds. The positive pressure inside the helmet, the negative pressure outside, and the silicone neck seal combine to make a good, leak-free seal. The flexible PVC allows patients to lie down, as well. “[Nurses] told us one of the major benefits was getting the seal right,” Fernando said. “When you put the helmet on, the seal in the neck just sticks to your neck.” Fernando’s team found having the straps adjusted correctly also is very important, as there are no leaks when they are pulled tight. One “inconvenience” is it is difficult to hear when wearing the helmet, and medical personnel might have to speak a bit louder when talking to the patient. “That’s it, that’s the only thing we found negative,” Fernando said. Unlike the helmets, many more adjustments are needed with a face mask to find the perfect fit and seal to avoid leaks – and those adjustments can sometimes take 20 minutes – crucial minutes. In one clinical trial, a patient had a low saturation of oxygen, Fernando said. “After 10 to 20 minutes of using a helmet, the saturation got a lot better – in 20 minutes' time,” he said. “And that was how long it took to put the mask on before.” Patients often relax more when using the helmet, allowing them to rest easier and help in recovery. There are not many doctors in the small country of Paraguay, so the impact of COVID can be even more devastating. “If we get to the time where our doctors start to get ill, it’s going to be very bad for us,” he said. “So, we started working on this and we’re hoping to help the most people we can.” So far, 10 helmets have been made and given away to hospitals to try. (Country) is poor, medical care scare, and there are very few ventilators available. A pediatric helmet is in the works – in an infant/toddler and older child model. Intubation is extremely hard on adults – even more so on children, with long-lasting effects. Dubbing the helmet as an “astronaut” helmet, youngers are more receptive, and the process is much easier on them than adjusting a mask. Avoiding unnecessary intubation is a major plus. “I think that’s going to be the first thing we are going to deliver because they really need it there,” Fernando said. Savickaite agreed the need is there.“It’s so sad when you see those little kids being on a ventilator,” Savickaite said. Overall, the availability of helmets in Paraguay and other countries will be a great benefit to medical personnel and patients. “We know that the helmet is going to very helpful there,” Fernando said, adding that a helmet was used in an ambulance and it worked. “Everybody is afraid of COVID right now,” he said. “So, it [the helmet] would be great protection for everybody. And imagine just like taking the patient with the helmet on from the ambulance to the hospital; everything is quicker.” And being able to avoid intubation, if possible, is a great benefit, Savickaite added. Now is a good time to introduce the helmets, Savickaite said, adding cases are low right now. “Right now, we have just 10 people in hospitals, and 1,000 cases,” Fernando said. But they are preparing. “Brazil has a lot of cases; it’s just a matter of time,” Fernando said. Flu season is on its way, so it could be even more of a struggle. The physicians are receptive to using the helmets and are trying different types of configurations to see how it works. “We’re getting a lot of help from the physicians here, we’re very happy about that they want to use the helmet,” Fernando said. “We just need to get the final certification to be able to get it out there, but we have everything perfect.” Savickaite agreed, saying FDA approvals tend to take a while. Fernando estimates production at about 100 per week, with the potential to upscale those numbers. The website, www.HelmetBasedVentilation.com was very helpful in the development of their helmet, Fernando said. “We got a lot of information from your website, and watching the videos and reading the studies,” Fernando said. The global effort to develop helmets to combat COVId-19 is appreciated by all involved. “It’s a huge thing to get help from people who don’t even know you,” Fernando said. “We just want to help – we know it’s going to help a lot of people,” Fernando said. “Especially the doctors, the nurses – and everybody that works in health care.” It’s a win-win for all, according to Fernando and Savickaite. “They’re scared to go to work, so we think if we put a helmet on the patient, it’s going to be a little bit less scary and the therapy is going to work on the patient,” Fernando said.

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