Resvent iBreeze APAP and BiPAP info

[TechieHippie]

TLDR: Given the Philips situation, Resvent iBreeze APAP is an affordable low-end, feature-rich APAP made in China, integrated with OSCAR. Earlier firmware problems have been resolved but the APAP doesn't integrate with oxygen monitors as they imply, and not all have wireless connectivity.  Resvent also makes a Auto Bi-level ST/30 device. If anyone has this Resvent BiPAP we would love a copy of some data to test with OSCAR. 

For those not familiar, the Resvent iBreeze APAP is an affordable and feature-rich APAP made in China.  OSCAR integration works well with my APAP.  I have been talking with Resvent USA Clinical Director about the BPAP/ST machine as well and getting it into OSCAR, since I believe with Philips not selling in the US, we need competition to keep prices affordable.

NOTE: I'm a newbie PAP user and I have no affiliation with Resvent or any other PAP company. My experience with the AutoPAP has been great so far. I got it new w/o a script for $355, less than my home-sleep test copay.  It has EPR 1-3 (they call it iPR, see graph below), Auto ramp, auto on/off, EPR, leak compensation, Mask fit, tube drying, SD card storage and an integrated humidifier with water level detection, which I love (I can't fathom why Resmed hasn't added this!) The SD card doesn't have to be in place when the data is recorded; if the SD card is forgotten in my computer, I can insert it in the iBreeze and it will write the data from that night. Early reports had strange behavior, a "bump" in the flow, which was fixed through a firmware update - my machine had more recent software than the firmware updates and doesn't have this issue out of the box.

The iBreeze 20A APAP sold in the US has only SD card, not the Bluetooth / wireless connectivity advertised; the 20A+ which is sold in the UK and overseas does have optional WiFi/GPRS/Bluetooth but is *either* only integrated with an in-house product, which I cannot find information about anywhere and I suspect is nonexistent, or it only has a Bluetooth protocol that could be used in the future but hasn't been (I suspect this is the case because they show a generic o2 monitor similar to the Checkme but they don't name it). There are unused data channels for pulse and oxygen in the data files. Since OSCAR can import oxygen data and is open-source, I trust it more anyway.

They claim: "Algorithm innovated by resvent can continuously determine and monitor respiratory events (AHI, OAI, CAI, HI, SNI, FL, RERA, PB, etc)...." 

I asked about whether a BiPap might be available for testing the integration with OSCAR, given the situation with Philips and the likelihood of ResMed bumping prices, but she didn't have one. I'll be reaching out again to request they generate data for us, but if anyone uses the Bi-level iBreeze I would like to see if we can get some data as this device is not tested with OSCAR.  

She said that the bi-level devices are not just bi-level but a powerful auto ST ventilation device going to 30cmH2O and that gets into gas exchanges and one has to be very careful/under medical supervision. It includes ST (Spontaneous/Timed) with Backup Rate and EVAPS (Essential Volume Assured Pressure Support); "when enabled, system will adjust optimal supporting pressure automatically and ensure the delivery of pre-setting target tidal volume."  The Bi-Pap has both PS and iPR; see below.

I'll keep you updated as I learn more.

- Lisa

[Sleeprider]

How comfortable are you with this device being sold under an FDA Emergency Use Authorization, rather than the standard review and approval process? Does this shortcut that enables the sale of low-cost Chinese ventilators and CPAPs disadvantage the companies that had to follow the full approval process? https://www.fda.gov/medical-devices/covi...ories-euas

[TechieHippie]

Good question. I verified that they still are under EUA; she did say they are in trials now for full approval. I will try to find out the official status and timeline and get back to you.

As to how I feel about it, I have mixed feelings. I think consumers should be protected, but I feel a monopoly in league with the insurance companies wouldn't be the best for users either. I think people should be able to manage their own treatment and was very glad to be able to get this machine instead of "following the proper process."

Admittedly, my feelings are influenced by caretaking my dad and using a SleepU oxygen monitor when he went to rehab after a brain bleed. The medical personnel first acted like we were overreacting and he wouldn't need oxygen monitoring even though it was still fluctuating wildly (he used high flow oxygen to his BiPAP), then they hemmed and hawed that it wasn't an approved medical device.... But it helped save his life a couple times for less than $200. They were hard to find for a while because they company wasn't allowed to sell them....

I know that auto CPAPs are different and could cause harm, but I still feel one shouldn't have to jump through so many hoops and this seems to be a good machine.