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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

4/22/2020 Chicago This is the story that led to a remarkable digital solution for physicians and clinicians trying to adopt Helmet Ventilation (NIV) to treat COVID-19 patients globally - a Mobile Digital Smart Procedure for Helmet Ventilation (NIV). When James Sharpe saw a segment on the Today Show about helmet-based ventilation systems, his first thought was it was going to be a hard sell to physicians. “Physicians aren’t going to use it because it’s new and they’re not comfortable or even familiar with using a helmet. We’re in the middle of a pandemic, some will be risk-averse – they are going to go with what they know.” Sharpe recalled telling his wife. “You know what, we could create, an AmbiFi, a smart procedure, that could get them comfortable, confident – and then competent in actually using the helmet,” he told her. Once the wheels started turning, not only did they not stop, they went into high gear. AmbiFi is an advanced software as a service (SaaS) solutions company founded by Jeff Bonasso, who has worked with Sharpe for more than 25 years, first at IBM (15+ years), then together at a silicon valley startup, all the time focused on a mission to transform the way people learn and perform. For example, the first client that ignited their mission was Caterpillar. They pioneered the technology for developing learning and empowering subject matter experts. As union craftsmen retired – or passed away, their skills and knowledge would fade away as well. So, they taught these craftsmen how to create interactive programs to teach the next generation. That became a model they called “The Knowledge Factory,” interactive eLearning studios shared throughout the world and the United States. “And then we sold that same capability to customers, so we created Knowledge Factories in some of the largest corporations in the world where they could create their own content,” Sharpe said. “It was an insatiable appetite for content, and we’ve been doing that model over and over and over.” “What you see today, fast forwarding through all the brilliant technology that Jeff has created to tackle this one mission is absolutely incredible” Sharpe said. AmbiFi allows users to build procedures as you go, “take pictures and record videos to enhance the experience, making knowledge transfers and many hours dedicated to training a thing of the past,” according to the company’s website. The name of the company is derived from the philosophy of ambient intelligence – putting the computer in the background – wherever the user is at, the computer is at, providing real-time input and support. “In the last 10 years, I would say, as mobile technology became more prominent and the Internet was really everywhere, now the focus was how do we get this so that people can do this right on their phones, right on their tablets, and also get all the content that we create working on every one of these devices, so the content is as accessible as possible, at the instant of need, right in the user's workflow” Bonasso said. As a trained pilot, Bonasso said checklists were ingrained into his methodology since day one. Bonasso and Sharpe take much inspiration from the book, “The Checklist Manifesto” by Atul Gawande. “With that book, (The Checklist Manifesto by Atul Gawande) and all the experience we had building these types of platforms, the vision was to build what AmbiFi’s has become -- and that is this platform to be able to have subject matter experts – or anyone with knowledge to share -- to create the content and deliver it to anyone, anywhere, as well and follow it with this checklist manifesto methodology behind it,” Bonasso said. After seeing the helmet-based ventilation segment on the Today show, Sharpe knew AmbiFi could help medical personnel. They have already been working on many use cases in the hospital setting which Bonasso covers in one of the cases about sterile processing in an article - Workflow Learning & Performance Support: Get Things Right. Sharpe started researching and found the www.HelmetBasedVentilation.com website. “That’s when – before we contacted (Aurika Savickaite of www.HelmetBasedVentilation.com) we met as a leadership team and decided to invest in taking the University of Chicago’s content in creating the prototype,” he said. Sharpe knew they would need to be able to show what the power of AmbiFi could do in the capacity of understanding the procedures of the helmet-based ventilation systems – and how that could benefit those needing to use the systems – physicians and clinicians -- in the high-risk, high-consequence situations of COVID-19. “That’s where we felt pretty passionate, we saw a need, and we created a functional prototype,” Sharpe said. Together, after many hours of meticulous work and with help from Aurika Savickaite and physicians from the University of Chicago Medicine the app was developed and is now being used by physicians from around the world. Savickaite shared their enthusiasm. “I personally feel much better now suggesting to the clinicians to use the helmet,” she said. “AmbiFi is like software for the helmet; this is what is going to bring more success in its application.” Bonasso agreed, again returning to his pilot experience. “AmbiFi is a co-pilot for your clinicians. There is even a hands-free component where all procedures can be navigated with your voice, and each step is read back verbally,” he said. The technology is like having COVID-19 physicians from around the country or even the world, sitting next to you, they said. More about the Mobile Digital Smart Procedure for Helmet Ventilation (NIV) “Depending on the procedure – their knowledge is being passed to you in a way that works at a really, really interesting level,” he said. The men said clinicians seeing the technology have been enthusiastic – using the term “giddy.” “This was built with clinicians for clinicians,” Sharpe said. “They love it, they’re excited about it and they’re engaged as they’ve never been before. “We really think this is a great way to help them be productive without making mistakes,” he said. Another great capability of AmbiFi is that at any point in a procedure, the user can provide feedback and questions – exactly at the instant they need it – and those notes, whether typed, recorded – are instantly transmitted. Those notes get sent to the expert who wrote the procedure, and they can get their questions or concerns clarified – in real-time. Sharpe and Bonasso believe their vision for technology can change the future for the medical field throughout the world. The technology used in other industries needs to transcend into the health field. “We know how to do it and we want to help the physicians and clinicians,” Sharpe said. “This pandemic is going to teach us all that we need to figure out a way to work better together.” “What we’d like to do is create global standards for medical procedures, for protocols; go to World Health Organization and have an interoperability standard, that hospitals can share procedures like these, globally, so that as you build and really become good at one of these procedures, you’re able to publish those, translate those, into any number of languages, so physicians and clinicians all over the world can share these next best practices,” he said. “With all of the technology that is available to other industries, for some reason, the health industry is still stuck in paper and just very, very slow at adopting ways of creating better performance, in the most stressful, high consequence industry there is, which is life.” To learn more about AmbiFi, check out www.AmbiFi.com.

4/20/2020 Chicago “How can you help us, and what can we do to make it happen?” This is how Aurika Savickaite began her interview with Dr. Yuri Gelland, from Sharp Grossmont Hospital based in San Diego, California. They were discussing helmet based ventilation equipment, and how it could be used against the COVID-19 pandemic. Dr. Gelland has experience using helmet based ventilation for pediatric patients with pneumonia, stretching back to his practice in Russia during the 1980’s. Similar ad-hoc helmet devices were used in rural hospitals when pediatric ventilators were not available. These helmets provide continuous positive airway pressure (CPAP) with an up to a 100% oxygen environment. Dr. Gelland is working to use that experience to help medical teams around the world create similar simple, inexpensive, and effective devices for non-invasive ventilation. In developing countries, there is not always access to traditional ventilators for COVID-19 patients in critical condition, so this simple method of creating a CPAP helmet for non-invasive ventilation is imperative. It is intended for non-intubated patients who may or may not be conscious. It can be applied and used in a supine or prone position. For some patients, it will delay or avoid endotracheal intubation and mechanical ventilation. Applying CPAP early in a prone position helps the lungs of COVID-19 patients suffering pneumonia to recruit alveoli and improve ventilation-perfusion matching. There are a few commercial models on the market, but for the most part, they are unavailable internationally. Currently, the Sea-long brand helmet is approved by the Food and Drug Administration (FDA) for use in the United States and is readily available at a low cost. But what about other countries? Dr. Gelland believes that by designing a helmet that is effective, comfortable, and can be assembled locally with simple materials, many people abroad that otherwise wouldn’t receive effective treatment can be saved. He currently shares his ideas for improvement on Twitter. Many of the current helmet-based ventilation systems that are appearing on the market today can be too heavy for the patient and limit their neck movement, and make eating and drinking difficult. Neck openings need to be sufficiently sealed while allowing the patient to move comfortably. Some European companies have solved this problem by making each helmet completely personalized for the user by cutting an almost wet-suit-like fabric to fit. So, how can Dr. Gelland help? He will work to improve existing designs and create something simple that can be distributed as quickly to areas that may not have access to helmet based ventilation equipment. The real challenge will be distribution. As Dr. Gelland said, we all need to work as quickly as possible to create a simple design and distribute it to manufacturing companies all over the world. We will be working to facilitate distribution channels. If you are a manufacturer or distributor, please get in touch.

April 19 2020 | Chicago | Infographics #5 by HelmetBasedVentilation.com High-resolution image