Why are pulse oximeters restricted from sale for patient use

Paul B · Post by **Paul B** » Thu Feb 16, 2006 4:18 pm

To me, the ideal APAP would include a pulse ox. integrated within the unit. What we really want to know is how well the heart and lungs are providing oxygen into the blood stream for the health of our major organs. I'd like to know when, during sleep, the rate dips below 90. I can't understand the reluctance of the medical community to have us help them in their treatment of our sleep apnea condition.

dsm · Post by **dsm** » Thu Feb 16, 2006 4:21 pm

I don't know that you can't buy a PO. There are tons on ebay. No mention of FDA medical requirement.

But I do know that Respironics & Resmed say on their web sites they only sell their oximetry add-ons to clinicians.

Cheers

DSM

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NightHawkeye · Post by **NightHawkeye** » Thu Feb 16, 2006 4:36 pm

Paul, pulse oximeters are not restricted. E-bay apparently requires the sellers of all medical equipment to post a notice to the effect that if the item is restricted, then the buyer must furnish some proof . . .

You can buy a pulse oximeter without any restriction on e-bay. It's probable that some medical supply companies may not sell to individuals, but that is only a policy decision on their part. So far as I know, all the vendors on e-bay are glad to sell to anyone who has the cash.

Oh, I know from direct experience. I bought one on e-bay and didn't furnish any proof of whatever.

Regards,
Bill

sleeps like a baby · Post by **sleeps like a baby** » Thu Feb 16, 2006 5:44 pm

here is a website that has a few different oximeters
mvapmed.com

sleeps like a baby · Post by **sleeps like a baby** » Thu Feb 16, 2006 5:47 pm

sorry about above post I didnt realize they do not sell to general public. found it by surfing for medical supplies. should of looked closer

Bonnie · Post by **Bonnie** » Thu Feb 16, 2006 8:35 pm

Bill,
Can you explain how you use it? What data does it provide to you? Is it something you wear all night or is it more of a "put it on and read it". Please enlighten those of us who would like to learn more from an actual user.

dsm · Post by **dsm** » Thu Feb 16, 2006 8:56 pm

Bonnie,

The unit is a bedside model Bill has a Nellcor N595. It has an extension cable and into that is usually plugged a Nellcor DS100A finger probe.

The FP is a 'crocodile' like hinged unit that is clamped onto a finger. It is usually then taped in place.

As alternates to the finger probes, some folk may use stick on DS-25A disposable probes while other may opt for reusable ear-clip probes.

IIRC The probe has two emitter diodes - one for red light & the other infrared. There are also two receptor chips in the probe for the red & infrared. The machine takes the returned data from the 2 receptor chips and by calculating the difference between the absorbed red light/infrared light can work out one's haemoglobin oxygen absorbtion SpO2.

This data can be streamed from the Nellcor unit to a PC or can be stored & downloaded later.

DSM

NightHawkeye · Post by **NightHawkeye** » Thu Feb 16, 2006 9:02 pm

Bonnie, here's a chart from the oximeter software which shows pulse rate and oxygen saturation for an eight hour period. The sharp drops in the green line are desaturations caused by apneas. The red line is pulse rate.

Thanks for the explanation, DSM.

Regards,
Bill

Bonnie · Post by **Bonnie** » Fri Feb 17, 2006 7:40 am

With the explanation and the visual it is now easier to understand...
Thanks, Guys!!...........

Roger... · Post by **Roger...** » Fri Feb 17, 2006 9:20 am

This thread is interesting because it takes us closer to completing the PAP treatment picture, and because I've wondered about how effective are my titration settings.

Bill,
Can you talk a little about the PO result changes you've seen from before you began or didn't use PAP treatment to what you see in the PO readings while using the PAP treatment?

Can you also mention whether you've used any information from the PO results to help you make a titration setting decision?

Thanks for sharing your chart above.
Roger...

NeurosurgeryNP · Post by **NeurosurgeryNP** » Fri Feb 17, 2006 9:47 am

Unless you have an integrated pulse ox that integrates witrh your machine, it is useless unless you have someone to monitor it throughout the night . Pulse ox's don't have memory and can't be downoladed for info - unless there is one that exists out there that does, and if it does, I am sure it is very pricey. I work in a hospital, and unless you are attatched to a puse ox hooked to a central monitoring station, you can not get info from past use. Only real time info - and if you are sleeping, how can u do that?

Paul B · Post by **Paul B** » Fri Feb 17, 2006 10:10 am

Many hand held pulse oximeters do have at least an 8 hour memory capability, but without their software, which is usually a $300-500. extra, you can't get at the data. The other alternative is to borrow one overnight from your sleep center, if you have one, and bring back the unit to them for analysis, which is a one time event and somewhat tedious.

What I would like to see is Resmed and Respironics integrate one into their APAP's as inexpensively as possible as well as have it integrated into the Autoscan software with a nice intuitive user interface.

NightHawkeye · Post by **NightHawkeye** » Fri Feb 17, 2006 10:41 am

Roger... wrote:Can you talk a little about the PO result changes you've seen from before you began or didn't use PAP treatment to what you see in the PO readings while using the PAP treatment?

Gladly Roger,

First, desaturation events are automatically scored by the software. I don't know the entire formula but part of it is a rapid 4% decrease in oxygen saturation.

The most recent indicator I have from the pulse oximeter is that I had only 1 desaturation event last night while having a pretty decent full night's worth of sleep. This compares to a low of 7 desaturations for the best single night before I started xPAP, with an average of around 15 desaturations per night and a high somewhere around 30. Unfortunately, I can't give an AHI number for the entire night last night because the Smart Card didn't record data for the second half of the night. (I've been having problems with getting the APAP to recognize the card and last night it failed completely. Will probably return the machine, but that's another story.)

For the past few nights after increasing pressure, the number of desaturations has been in the 1 to 3 range I believe. This doesn't correlate directly with apnea events because apnea events of 30 seconds (my average) don't have much effect on desaturation by themselves. The desaturations seem to occur on single long apnea events and with heavy clusters of apnea events. I also can't tell that my hypopneas have much effect on desaturations either.

Roger... wrote:Can you also mention whether you've used any information from the PO results to help you make a titration setting decision?

I'm just now at the point of being able to raise my pressure (another long story), and besides feeling better physically, I'm tickled to see the tremendous improvement in oximeter results. I didn't get the oximeter to help with titration, per se, but it is an independent measure that clearly shows the effectiveness of the treatment. Exactly how, or if, it becomes a factor in titration remains to be seen.

I'm pretty sure that the top end of my pressure needs to go higher than 10 cm, but it seems that I'm getting pretty close.

One other thing worthy of note that I haven't explored in great detail yet is that my desaturations increase greatly when I sleep on my back. I have avoided that like the plague for years, but sometimes it just happens anyway. Sleeping on my back for a little while doesn't seem to greatly affect my AHI but it sure does affect the number and severity of the desaturations. I'm pretty sure that this is an indicator of much longer apnea events when I sleep on my back. After I get the titration range settled for side sleeping then I will take a look at that. Obviously, without an oximeter I wouldn't necessarily know this.

For me, getting the oximeter was a life saver. It allowed me to challenge the sleep lab diagnoses and get started on xPAP. Don't know if everyone would find it useful, but I suspect that many here on this forum would find the data very informative and having one would benefit some in their treatment. Oh, and using an oximeter is a lot less intrusive than xPAP, (although at about the same cost as CPAP). All you have to do to use an oximeter though is attach an inocuous little device to your finger and sleep with that on. .

Regrds,
Bill

NightHawkeye · Post by **NightHawkeye** » Fri Feb 17, 2006 11:02 am

NeurosurgeryNP wrote:Unless you have an integrated pulse ox that integrates witrh your machine, it is useless unless you have someone to monitor it throughout the night . Pulse ox's don't have memory and can't be downoladed for info - unless there is one that exists out there that does, and if it does, I am sure it is very pricey. I work in a hospital, and unless you are attatched to a puse ox hooked to a central monitoring station, you can not get info from past use. Only real time info - and if you are sleeping, how can u do that?

NeurosurgeryNP, those statements are simply not accurate.

My Nellcor N-395 has over 48 hours of memory, along with an internal battery. I simply download it to my computer at the same time I look at the smart card data. My N-395 cost me $395, I believe. You can buy them all day long for about that price on e-bay. I'm sure some folks could find one for much less.

With the N-395, the entire night's data is viewable from the front screen. You can simply scroll through the entire night's data. That's not really very hard to do. I happen to use the software but it's not at all necessary with the N-395.

The N-290, however, which doesn't have the front panel LCD, but otherwise does everything the N-395 does, would benefit from the use of some software. Worst case is you'd have to buy a new version of the software for about $300 directly from the manufacturer for a total cost of about $500. Not too bad, really.

Some here wouldn't need the software though. The data can also be accessed directly with a companion printer or at least a half dozen other peripherals. Since the data is available in ASCII format directly from the serial port, many of the technically inclined here could easily download it and evaluate the results, or import it into Excel, without needing the manufacturers software.

Hope this clarifies.

Regards,
Bill

rested gal · Post by **rested gal** » Fri Feb 17, 2006 11:17 am

If what a person wants to know is basic info about their overnight O2 levels with/without CPAP, it's possible to obtain very useful data without spending a fortune for the device and without buying software.

The recording pulse oximeter I borrowed could print out the overnight results on a little roll of paper that was in the oximeter itself.

My experience with a recording pulse oximeter at home

Machine

Machine