bunnyPAPR, $10-$30 public use Viral Helmet. (presenting Aug4)

This is a stub issue to "pre-discuss" and "post-discuss" bunnyPAPR.

I'll be presenting on Aug4 for bunnyPAPR. Feel free to look at our tech.

It is a doctor-designed, in-use in hospitals, new PAPR design that uses about 30-60L/min (instead of standard 115L/min+) by using a flexible hood. (Bag collapses in deep exhale, no negative pressurization, tested.) We have about 30 users in 3 countries. Please take a look and let me know if you have any questions.

LINKS

• https://devpost.com/software/bunny-papr (5 min video)
• https://bunnypapr.org (public facing site)
• https://tinyurl.com/bunnyPAPRdisclosuresv1 (extra videos)

(updated 07/28, 2pm PDT)

ASKS

We already have an inventory of about 400 of these and we know they work (see video).

• USERS/ LEVEL 2 TEST. Our biggest needs right now are getting the word out and finding users who want to use these for a Level 2 test. We have plenty of Level 1 tests: individual users. A Level 2 test is larger scale, like 10+ users in the same setting.
• A partner like a Gates Foundation or Clinton Global Foundation could go a long way in credibility and finding testing partners. We are working ur networks and hae a link with a UCSF HIV/AIDS researcher who has partners in Uganda.
• Ideal Level 2 testers: a private/small school. An Amazon.com warehouse. A meatpacking plant. A sports stadium (NBA). An airline. Having somewhere where aerosol risk is high because of confined spaces.

Brilliant Question: Communications assessment?

1. How loud is the fan (dB if measured and where measured-how far from fan)? (There are other factors that contribute to "noise" extent of voice interference beyond pure dB)
2. Have you a rough sense of how well the user is heard and can hear others?
3. Have you measured flow rates and diminution over life of battery charge and it's effect on CO2 retention?

Some user safety issues to consider if you haven't already

1. Low voltage alarm
2. Low flow alarm (better, but more complicated/expensive)
3. Neck securing strap/device should be either elastic or break-away

@wbaker Thank you for the great questions. I was just watching you in the June2020 video recap, so I feel like I already know you a little!

LOUDNESS

It's always the number 1 question!

1. LOUDNESS: I will wear mine on Aug4 during the presentation. dBA of our standard fan is about 42dbA (spec). We have some fans in the 35dbA range. It's doesn't get in the way of communication in surgical room. (invented and 35dBa used daily by a Seattle Anesthesiologist).

You can see a video with talking here: https://youtu.be/NXW0xUPl0_c?t=578. (queued to fan on and talking)

2. the 42dBa ($4) fan is rejected as "too loud for long term wear" by about 50% of people. 100% can still have a conversation. But some people are noise sensitive. The 35dBa ($12) is good for all.

3. Yes. EtCO2 and FiCO2 have been measured. I can't post the full testing report publicly (see note at end), but here is a screenshot. FiCO2 stays below 8 at worst, nominally around 3-5.

For flow rates and battery, the flow rate is dependent on voltage. In the voltage range of the battery (11hour wear test), flow rate was fine. Our current distributed design uses a step up voltage converter hooked up to a 5V USB battery pack. The way that works is that it outputs 12V consistently and then it falls off a cliff, goes to nearly 0V.

In this case, the bailout time is at least 4 minutes of self-rescue. We recommend a spare battery, and just unplug dead one and plug in charged one. Alternatively, if no battery, leave the contaminated room and unseal the bunnyPAPR. Put on a backup mask.

(We've got about 1000-1500 engineering hour in on this. So, we've checked a LOT of stuff. Still happy to answer these good questions.)

USER SAFETY:

Audible beeping alarm is doable, but it's just a cost issue. We have two low-tech alarms.

1. Audible... the fan noise stops.
2. Visual: The bag fullness collapses.

100% of conscious people notice these. If you are sleeping or unconscious... bunnyPAPR is not appropriate.

(because we use a standard 5V USB, we can stick a turnkey commercial USB low voltage alarm in series.)

And, yes, the neck strap should be easy to remove. In a WHO/field medicine situation, we don't want to specify specific parts. For NBA or School users, we will supply a specific. FDA and 510k will always want a specific solution.

Weight

You didn't ask, but the weight is about 200 grams. About the weight of a heavy hat. Dr Kuo wears it daily for long surgeries.

NOTE: *I can share the full testing report to partners who sign an NDA because it includes some confidential info and trade secrets on the design. For the general public, we just say, "Anesthesiologist tested for O2 and CO2. Worn for 11hours+ continuously in hospital"

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Thanks for the detailed response including ET and FiCO2 info. Looks like you guys are considering all angles.

Do PAPRs require require active warning indicators for battery life or airflow (I'm no NIOSh expert)? Even for deployment in more austere "non-regulated" markets, I would recommend similar safety features as required by regulatory groups. Awake, competent users would of course notice the lack of airflow and absence of fan noise, but the tired, focused user or one that falls asleep might not. Also, the active alarm would alert nearby staff. The consequences of failure of the fan/flow and failure to notice (by the user) are high. Of course it would add to the cost.

You are right. NIOSH requires low battery alarm. (I don't think there is an airflow alarm. Some 3M PAPRs ship without one.) But, we don't fit the PAPR standards for NIOSH, because of the low flow and flexible shell design.

If we are supplying it widely, we will probably include an audible alarm. Audible alarm will be required for school use (my guess) in our instructions.

We don't want to say it's "mandatory" because teams in Malaysia, Brazil, and India are already having problems sourcing fans.

Agree.... consequences of falling asleep in a PAPR (bunnyPAPR or a 3M PAPR) are very bad. We have a warning against use if a person is prone to seizures or sudden unconsciousness.

The slides from the Aug 4 presentation: https://docs.google.com/presentation/d/1JMrqnXDJh-5bfmOT5FO8JXLEg7XMjJESv19STZTkeFs/edit?usp=sharing

Thanks for listening!

Rate Limiting Steps

ASKS:

• Connect with a large foundations (Gates Foundation, Clinton Global Foundation, etc)
• Connect with groups of users (20+ people). Churches, Factories, Meatpacking plants, K12 schools, University labs

We have already linked to a couple of schools and one Ivy league university (can't name it) and are exploring a bulk/group test there for a semester.

How to reach me: hocho@bunnypapr.org

I can't locate Michael Bernstein in the user list. He said "I'll help with understanding injection molding costs" (paraphrased). Does someone have a contact?

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I didn't mention this in the 5 minutes, but...

Why aren't you marketing to hospitals?

Answer: we tried early on. The US hospital approval process, even for donated PPE, is very complex. After asking a lot (think 30-100) of US hospital people (nurses, doctors, etc), they mostly said that they could not approve or allow use of the device. Liability reasons. Some essentially, "we like it, but can't go first especially without FDA approval".

Maskson.org is leading in the medical donation space for respirators for larger entities/hospitals (a guess based on their website, their contact email is non-responsive.) With a $2M+ budget, they still don't have an EUA after 3 months of trying.

Smaller hospitals and DIY seem to have centered on the Montana Mask as a good design. (also a guess, no central info on hospital use of DIY gear... they don't advertise it... it makes hospitals look bad to not have enough N95s).

We ARE working on non-US hospitals, where there are different politics and stakeholders at work.