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                                          FREQUENTLY ASKED QUESTIONS

How are we different from other PAPR’s in the market?
Our product is the first with an outlet filter in the hood. This helps prevent transmission of infection from asymptomatic individuals wearing the hood, just how a non-valved mask is advised over a valved mask.

Why does UPPER cost much less than other PAPR’s in the market?
Since UPPER is a direct-to-consumer product, we spend no money on advertising. We only sell online so as to cut out any middlemen (like distributors and retailers) and transfer the price advantage directly to the buyer. When you buy from a big brand, you aren’t only paying for the product, you are paying or all the enormous costs they have as a company.

Can I return the product if I am not satisfied with it?
Yes, you have an option to return the main unit (except the hood) within 15 days of delivery. Refunds (except the hood) will be processed and paid within 2 weeks of receipt of product.

How do we know that the air entering the hood is filtered?
Though we were unable to test the device for viral filtration per se, we believe the claims made by Drager company which has tested the same for viral filtration efficacy at Nelson Labs, USA. Particle filtration efficacy upto 0.3 microns were tested informally at I.I.Sc, Bangalore and found to the satisfactory even after 2 weeks of usage.

 

Can I use a 3M P100 filter with this device?

Yes. You can buy an additional P100 filter attachment which can hold two 3M P100 filters and fix at the inlet instead of the given filter and filter cap. To know more about this feature, please mail us at support@innodeev.com..

Whom do I contact if I need more information about the product?
You can e-mail support@innodeev.com for any queries and suggestions.

Is it approved by CDSCO or FDA?
No. Since PAPR falls under newly notified medical devices, it falls under voluntary registration and hence not mandatory until October 2021. We are in the process to get it registered.

   The SARS-CoV-2 virus infection is a rapidly spreading global pandemic. Recent media coverage has highlighted the importance of protecting health-care workers together with issues surrounding availability and suitability of Personal Protective Equipment (PPE). As of August 26, 2020,over 87,000 healthcare workers in India were infected by COVID-19 with a reported death of 573. This leads to staff absence at a critical point during the pandemic, and unfortunately in some cases mortality.

   The spread of asymptomatic cases of coronavirus has always been a point of concern for India. On April 20, the health ministry warned that 80 per cent of all coronavirus patients were asymptomatic or showed mild symptoms. This adds an additional concern as we do not know how many of the doctors and surgeons are actually COVID positive and are still asymptomatic. As they come in close contact with a number of patients during surgical procedures, there is a high probability of transmitting the same to normal patients. Hence, prevention of doctor to patient transmission is of utmost importance.

   PPE plays a major role in control programs. Standard PPE such as N95/FFP3 facemasks have limitations such as an ineffective seal during talking or after prolonged use, face shapes which cannot be adequately fitted, and logistical issues ensuring availability of the correct mask for each person. Moreover, these devices cannot be worn continuously for a very long duration and cannot be used along with magnifying loupes used by plastic surgeons. Studies have shown a fall in blood oxygen levels of the wearer on prolonged use which may affect the surgeon’s concentration during a long surgical procedure.

   PAPRs are special filtered masks that completely cover the head. PAPR is superior in every aspect, including vision, protection and comfort. PAPR can be disinfected repeatedly, so each team will only need several PAPRs. Most of the PAPR’s currently available in the market are actually designed for industrial use where only the person wearing them needs protection and are expensive too. Keeping this in mind, we developed a PAPR hood with an outlet filter to filter out the expired air. This would be the world’s first PAPR hood with an outlet filter to protect patients even if the surgeon is COVID positive.

   Our device includes a hood which covers the face and gets an inlet of purified air. The source of air depends on the setup. For operation theatres where there is an existing medical air outlet, we utilise the same and filter the air through a standard HME/BVF filter. For other setup where air outlet is not an option, we have developed a simple pressurised air purified respirator unit, incorporating a combination of inexpensive and widely available components. The prototype was developed to minimise the number and complexity of manufacturing steps. This device delivers filtered air from a battery powered blower fan-filter assembly through a lightweight hood/face mask that can be comfortably worn for several hours.

PROJECT UPPER

The Problem

 

Frontline workers need to wear effective and comfortable PPE’s during COVID-19 pandemic

 

Current N95 masks

  • Doesn’t provide a perfect seal

  • Creates bruises on the face if worn tightly

  • Feels uncomfortable to breathe after prolonged use

  • Requires extra goggles for eye protection

  • Requires head/hair covering disposable caps

  • Higher chance of self contamination during doffing

 

Half or full face-piece respirators

  • Do not filter exhaled air

  • Difficult to wear along with spectacles and surgical loupes

 

Powered Air Purifying Respirators (PAPR)

  • Expensive and short supply

  • Do not filter exhaled air

What is a PAPR?

 

It is a type of PPE used to safeguard health workers against contaminated air and are used during the most high-risk procedures. PAPR is an enclosed air chamber around the entire head that provides clean breathing air via a fan-powered filtering unit or through filtered compressed air. PAPR's are much more comfortable than a face mask and function properly without requiring a continuously perfect face seal.

 

Why a PAPR?

The currently available conventional PPEs like N95 masks have some difficulties whilst using. They are not suitable for all face types so they are not providing a perfect seal and not covering the full face. Moreover, they cause bruises on face for long time usage. Fully enclosed PAPR's protect against aerosols and splash from all directions. These respirators can also be used for health workers who have failed mask “fit” testing, i.e. where due to a poor fit, conventional face masks do not offer protection.

In addition, a PAPR has an APF (Assigned Purifying Factor) of 25 compared to an N-95 mask which has an APF of 10, meaning that a PAPR provides 150 percent more protection than an N-95 mask.

 

But the currently available PAPR’s in the market are expensive (more than 1 lakh INR), mostly imported, not designed for medical use and does not filter exhaled air.

 

 

 

 

 

 

 

 

 

 

 

 

 

Our Solution

 

We have developed a PAPR unit with a unique hood design. The main unit consists of a series of laser cut acrylic plates placed in front of a centrifugal blower fan which then pushes the filtered air into a hood through a conduit pipe. The flow rate is 12 CFM at the maximum speed and the battery lasts for 12hrs on a single charge.

 

We have also incorporated a filter at the region of outlet to make sure that the exhaled air is also filtered (in case the wearer is a asymptomatic COVID carrier). The fabric is certified by SITRA with respect to synthetic blood penetration test.

 

We are currently using the filter harvested from a Drager CareStar Bacterial/Viral filter used in anaesthesia circuit. This filter is certified by Nelson Labs (USA) for its viral filtration efficacy. Though the company advises its use for 24hrs, we are yet to determine its maximum duration of use.

How are we different from others?

 

  1. Our hood design is the first in the world to incorporate an outlet filter in order to purify the exhaled air.

  2. It has a separate access port for using stethoscopes and cellphones without breaching the air seal.

  3. By offering 2 different concepts, we cater to a wider population who can select what they want based on their willingness to pay.

  4. We have designed an additional hood model which can be used over surgical loupes.

  5. We can also use it with surgical microscopes as the visor collapses over the eyepiece.

Recognition

 

Our device won the first place in the R.G.U.H.S Covid Innovation Challenge among 1200 entries. The product is supported by NSRCEL (IIMB) and BBC.

How will it protect healthcare workers ?

 

With a rapid increase in corona virus cases, healthcare workers are resorting to various industrial respirators to protect themselves. They do so as most of the N95 respirators do not fit well or are uncomfortable to wear for long periods.

 

But these respirators are designed to filter only the inlet air. The exhaled air passes freely unfiltered across a expiratory valve, similar to a valved mask which the India Govt warned against recently.

 

We believe our device will not only provide complete protection to the wearer, but also filter out the exhaled air and protect other healthcare workers and patients. The basic concept is to maintain continuous positive pressure within the hood which prevents entry of virus against the flow of air.

OUR STORY

In the first week of May 2020, when the pandemic had resulted in quite a bit of chaos in India, my wife one day came to me and explained how difficult it is to wear the PPE for long hours in the operation theatre. A brief search on google showed multiple products (PAPR's) to overcome this issue, but there were 2 things going against them and those were - cost of the device and unfiltered exhaled air.

So our journey to develop a PAPR to solve these two issues began. A couple of days later I got a call from my former professor Dr. Vijay Joseph expressing similar concerns with existing face masks and PPE's. Now I had someone with me who would make sure that whatever comes out would be perfect. His contacts with Gokaldas exports helped us design the first few hood models which underwent almost 7 iterations to reach the current form.

 

Simultaneously I began work on the powered unit which would blow filtered air into the hood. I began testing multiple blower fans until I zeroed it on to one particular model which was strong enough to pull sufficient air across a Drager filter. With SP road being locked down and shipping disrupted, it was a difficult and time consuming to acquire the components and test them one after the other. And with COVID cases spreading rapidly, I had to refrain from recruiting people and had to manage everything from designing to electronics, all alone.

There was one thing which me and my professor wanted in common - to source all components from within India, or atleast not from China. I knew this was difficult but not impossible. Unfortunately we weren't able to achieve it so far but hope our future models will have 100% Indian components.

One of our main concerns was to have a good filter in our device which would even filter the virus. We tried a couple of HME/BVF filters, both Indian and imported, but weren't as satisfied as the Drager filter. This filter was certified by Nelsonlabs (USA) for its viral filteration efficacy. Our challenge was to harvest the filter per se from the HMEF unit for which we ultimately developed a device which would do so without damaging the filter.

With all the work happening, we also registered for a COVID innovation challenge organised by RGUHS which went through multiple rounds until we won the first place among 1200 entries. This was a big boost for our project.

 

By the mid-july, started churning out version1 of our device and began pilot testing at St.Johns hospital to get user feedback. Our v1 was designed to draw power from a regular powerbank to run the motor. For this, I tried to develop a circuit to trick the powerbank to pump out 12v instead of 5v. I was happy with the initial results but unfortunately it ran into troubled waters when few users struggled to get the unit starting. This was unacceptable, and hence we decided to abandon v1. The protocol to draw 12v from a QC 3.0 powerbank is still a tightly kept secret by Qualcomm and we weren't able to fool the powerbank everytime.

The v2 version had a in-built lithium ion battery sourced from a battery assembly company based in Bangalore, so all we had to do is regulate the speed of the blower unit. But we still lacked the battery capacity indicator which is vital to know how long we can use the unit before it runs out of power. So it was a quick jump to include a battery capacity indicator and this was v3 (current version). We are also developing further versions with a HEPA filter and complete non-chinese components but this would take few more months to hit the market.

The initial non-formal filteration efficacy test was done by Dr Akshay Naik (and CENSUS team) for which I am greatly indebted. Unfortunately, IISc being a central institute, cannot certify a third party device. These test confirmed the particle filtration of the Drager filter and also its integrity after prolonged usage at high airflow across them.

Efficient

With electrostatic filters sourced from Drager BVF, you are rest assured that the air you breathe is free from bacteria and virus

Comfort

Well designed hood keeps you comfortable even for prolonged periods of use

Powerful

With air flow above 7 CFM, the device meets the standards of NIOSH for PAPR's

Long battery

Single full charge can last you for 12 hours of continous usage

INNODEEV

SOLUTIONS

PVT LTD

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Mail: info@innodeev.com

Tel: 080-23420533