Pandaboard premiums

I’ve had serious thoughts about running RiscOS on a Panda – but there’s a 10x markup on many of the Ebay offerings. At first I thought it was simple gouging, but then read the disclaimer about US residents needing an FDA license, on one of the seller pages.

Now, since some of the pandas are known to have stability issues, one wouldn’t think they’d be prime candidates for medical devices, which is exactly what the disclaimer is all about.

So, Pandas either are missing something, or have something, that somebody doesn’t like. Which is it? Or am I reading too much between the lines?

I obviously can’t get an FDA license. So, if I visit GB maybe I can play with my Panda? (Using RiscOS, of course).

I wouldn’t have imagined a normal US resident would have needed to worry about an FDA licence. If you’re running RISC OS on it, it is hardly a critical medical application.
If you are resident in the US (and I’m guessing you are), why not call the FDA to clarify this instead of believing something on eBay (or a forum for that matter ;-) ).

@RickMurray: I don’t know how “normal” I’m considered to be. That’s classified.

But – you have a good point to make. The warning is a little ambiguous. Perhaps I should contact the vendor directly, for more info. Googling the subject, I find only FDA proposals, and not any specific rule-making codes. So, it may be a case of CYA on the part of the seller. Really, there may be no merit to it at all. I guess I’ll try using a direct query sent to the Ebay Panda seller.

I know it’s probably FUD, but it’s keeping me out of the Panda market til I sort it out. I’d rather see a brown uniform at my door than a blue one.

I find only FDA proposals, and not any specific rule-making codes.

F-bleeding’-DA
Used by various medical companies as the reason why they have to do their network connectivity a particular way, which changes according to which part of the company the engineer works for and which engineer turns up.
I quote SGP rules¹ and tell them no rules compliance no connection. I’m ahead on points.²

Quite why they think FDA regulations apply in the UK I don’t know.

¹ “My network, my rules” :)
² I’ve been told (penetration testers) that the hospital network is the widest hospital deployment of RADIUS they’ve seen. I still want to complete the job and lock everything down. Makes for a quiet life when you lock onan**** out of your network.

F-bleeding’-DA

(Used by various medical companies as the reason why they have to do their network connectivity a particular way, which changes according to which part of the company the engineer works for and which engineer turns up.

I quote SGP rules1 and tell them no rules compliance no connection. I’m ahead on points.)

@StevePampling: If that’s all it is, then I’m happy. Maybe the warnings are superfluous FUD-CYA for normal people. It’s only a minority of the sellers who post the warnings anyway. Here’s an example:

This FDA DISCLAIMER is for MEDICAL DEVICES only and not for all our products:
“The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, DO NOT bid on this item unless you are an authorized purchaser.

The wording maybe implies that it’s a problem only if the item is used for medical devices.

That particular example reads like a generic disclaimer that that seller adds to everything (presumably they sell a lot of medical devices).

Quite why they think FDA regulations apply in the UK I don’t know.

Don’t you know? US rules apply everywhere. The person that mentions some other set of rules is merely an inconvenience. ;-)

I encountered this when I contacted the European support centre for Texas Instruments to ask about a TMS320DM320 datasheet. This is a European talking to a European centre, right? Thank you for contacting the European Customer Support Center. In compliance with U.S Export Laws and Regulations, Texas Instruments is required to know to whom they are providing information or services.

I really wanted to tell them where they could stick their US Export Laws. Instead I found the documents on a Chinese server…

Texas is better now, the OMAP datasheets are very detailed, but I just get annoyed when companies trot out American laws as if they have any relevance over this side of the world. Like those file share sites that uphold the principles of the DMCA when they’re based in Holland and block US IP addresses!

Tell you what, Obama – I’ll give a damn about your DMCA when you properly respect the Berne Convention. Wiki says: Copyright under the Berne Convention must be automatic; it is prohibited to require formal registration (note however that when the United States joined the Convention March 1, 1989, it continued to make statutory damages and attorney’s fees only available for registered works). and the practice of declaring something as being “American” by virtue of being published on the Internet is surely only there to prevent foreigners from claiming damages and fees (as their properly compliant copyright system does not require any formal registration of works). In essence, a copyright law that does not provide damages/fees for infringement because of the necessity of a registration that should not be required is… what’s the word… useless? Stupid? Pointless?

And, yet, American law applies. Microsoft (in Ireland) vs the US being a good example. With a legal system like that, there is surely no possible way that any cloud-based operator with any sort of presence in the US can lawfully offer their services to Europeans. They cannot hope to respect European laws on data privacy.

I quote SGP rules and tell them no rules compliance no connection.

Damn right. Unless they are willing to accept sole and total liability for any issue (including indirect issues) and provide compensation where necessary, they either follow the SGP rules, or get out of the room.

SGP rules… I’m guessing your middle initial is ‘G’? ;-)

The wording maybe implies that it’s a problem only if the item is used for medical devices.

Things change greatly when it is a medical device. You wouldn’t want a situation where some software running on a board of this nature is performing a chest X-ray and the CPU freezes (overheating or whatever) whilst the radio source is active. When I had my chest insides photographed, it was done in an instant to a 5mpix sensor. How long would you imagine it would take for the operator to realise the machine has stiffed, reboot it, and for it to then turn off the radiation source. Logic would say there would be a panic button to cut the power directly, but I’ve seen a lot of really shoddy things.
For example, at work we have big bright red panic buttons on equipment. They stick out, so they tend to get hit with things and this breaks the red button off. And d’you know what? They fail unsafe. A panic button with no button part is open circuit so not only is the machine operational, the panic button is now non-functional. Lovely.
So with that in mind, I will ask Steve if he can ask a radiologist on a breaktime some day, if a person’s X-ray takes mere milliseconds, what would be the anticipated effect of being exposed for, oh, let’s say 40 seconds… It’ll be more than just a nasty case of sunburn.

This doesn’t say how or for how long: http://www.ncbi.nlm.nih.gov/pubmed/8844051

This is interesting: http://www.all-science-fair-projects.com/print_project_1429_50 (I like how it says the project cost is $30; needed for the project – an X-ray machine). ;-)

Now this is just one example. There are many others. Insulin pumps that don’t deliver the correct dose, oxygen monitors that misread, AEDs that zap a person with a normally functioning heart… One doesn’t build medical devices without going through huge amounts of red tape and approvals. Why do you think you won’t find much info regarding using oscilloscopes as EKG machines on line, and why I have not attempted to do it? It might be fun to hold a probe in each hand to see what the human body picks up, but when you are attaching gelled pads across your heart or brain, you want to be absolutely damn certain that not a single stray milliamp of current is going to be going the wrong way. Expensive machines are designed not just to carefully read the minute signals the body creates, but also to not injure the patient in the process. I do not feel that a generic school oscilloscope is going to have the same level of assurance. Okay, it shouldn’t put mains on the probes unless it is very broken, but it would take a lot less than that to kill a person. That’s the general opinion here: http://www.dutchforce.com/~eforum/index.php?s=d1f1d4eceb653e93ab9f678706fbdf40&showtopic=40642
Here (http://www.ni.com/tutorial/14246/en/) they cheat and use a photoresistor so it would measure without electrical contact in much the same way that my phone can take my pulse. 69bpm, in case anybody is interested.
You can buy things that might work as well as the DIY (http://www.ebay.fr/itm/CooSpo-clip-oreille-Infared-capteur-Heart-Rate-Monitor-Telephone-F13689-/261832997787) perhaps that with a bandpass filter hooked to an ADC would do a lot better than risking electrical contact to a ’scope! It costs a fiver (€). Three times that gets you a ready made device to save the hassle of building something (http://www.ebay.fr/itm/OXYMETRE-SATUROMETRE-POULS-METRE-ECG-OXYMETER-OM-CMS50C-/221484539704). And, still, no direct electrical connection.

I’m guessing your middle initial is ‘G’?

:)

So with that in mind, I will ask Steve if he can ask a radiologist on a breaktime some day, if a person’s X-ray takes mere milliseconds, what would be the anticipated effect of being exposed for, oh, let’s say 40 seconds… It’ll be more than just a nasty case of sunburn.

Oh, from conversations I already know the current levels of exposure on the high detail CT units are close to being treatment exposure.

Treatment machines tend to have modifiable shutter systems (simplistic description) and fail safe in that a lack of communication between the control unit and the actual in room system will shut down the treatment session.

One doesn’t build medical devices without going through huge amounts of red tape and approvals.

Back in the mid 80’s¹ I built a set of fibrillators (yep, they do the opposite of a de-fibrillator) for use in the cardiac theatres. :)

but also to not injure the patient in the process.

Isolation transformers, opto-isolators etc. That’s old stuff, not looked at a modern circuit (or any in 25 years)

Okay, it shouldn’t put mains on the probes unless it is very broken, but it would take a lot less than that to kill a person.

Internally, micro-volts. Externally milli-volts in the right place at the right time. It’s more about current than voltage as you’ve picked up.

¹ Pre-computer commonness.

@RickMurray: I suppose with medical devices you want a lot of redundancy. I’m sure there is plenty of red tape to ensure that the things you mention do or don’t happen. Sorry for the US/FDA specific conversation – although there are likely a few (or very few) others in the US with my ideas about using Panda with RiscOS.

As far as the Panda ads go, I think it’s a non-issue. I think I wasted some of the eyeball time of forum members on this one. Now I can’t even find the FDA proposal links that I thought I saw earlier.

I did find that people have thought about the Panda for medical applications:

http://www.medicalelectronicsdesign.com/blog/medblog/developing-pandaboard-kozio-tools

But that;s probably not happening anymore since Panda is EOL.