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**James @ Intus** · 5 October 2009, 16:29

Hi and welcome to the forums!

Yes, there still is a price difference but bear the following in mind (I know from direct experience with patients I spoke with on e-mail and the phone).

1. If it breaks, you're stuffed. Serial numbers are recorded country by country and you won't get service here for a product intended for the US market.

2. It's illegal for them to sell non-CE marked products. If it's caught at the border, you won't be getting it and will have to fight to get your money back.

3. The electrical circuits may work differently. We get many Americans who blow up their machines the moment they plug it in to their London hotel when they're over. (Depends on make and model.)

Also, you may get charged import duties / handling fees when it enters the UK. These hidden charges can add up as some here can confirm.

So all in all, some have been successful in this importing, others have had disaster struck and ultimately paid the price. It's a gamble and whether it's worth the risk is up to you.

If for example you were to buy a SleepCube Auto from us, as many here have, you also get free SmartCode reports and support to assist in your progress. We'd charge if they weren't machines that came from us.

So take all that in to account and go from there.

**tomtom** · 5 October 2009, 19:28

James

Thanks for your quick reply and may I express my appreciation to your company for hosting the site and forum. I can also see that your contributions are solid.

I am in the process of finding out the VAT and duty on the importation of medical equipment supplied against a prescription and agree that if I cannot get an exemption then it becomes less attractive.

I am an electrical engineer by training but have been in software design for quite some time now and whilst I do not profess to be an expert I believe the actual APAP/CPAP machine is exempt from CE because it is a low voltage device �..

�1. Background
The Low Voltage Directive (LVD) was introduced at a time when directives contained detailed technical annexes which were intended to supersede national laws. The LVD set out the essential protection requirements, with the relevant technical details being defined by standards-making organizations. This subsequently paved the way for what were to be known as the New Approach Directives.

2. Scope
2.1 The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, this Directive is called often "Low Voltage Directive" which applies to the vast majority of electrical equipment in everyday use. The Electrical Equipment may be placed on the market only if it does not endanger the safety of persons, domestic animals or property. There are 11 principal elements of the safety objectives listed in Annex I.�

� Now this equipment is sold as dual voltage 110/220v. For any reputable company this means that the 220v must be certified for use in Europe. Check out your notebook, no CE sticker on the notebook (20v) but the switch mode power supply will have CE and (at least) US compliance stickers on it.

There is the matter of the actual machine being suitable for use in Europe. I have an interest in a Respironics M series and I have been given a brochure by the Philips rep, guess what it�s an American pamphlet and the choices, five different power cords for the various world markets.

Hopefully, as with reputable notebook manufacturers there should be a worldwide warranty for those of us that spend a considerable amount of time overseas in the course of a year.

Please don�t think I am �having a go�, I know all about unfair trading practices and that the majority of people would never consider buying outside of their own country but unless we show these organisations up for what they are then nothing will improve. You can�t make a fuss because it could jeopardise your supply line - but I can.

I am all in favour of value add and do take that into consideration when making a purchase but (unfortunately) you do not supply the kit I am interested in, if you did and the price differential was �50/80 then it wouldn�t be worth the hassle. However paying a company�s direct sales team �540 for the identical model sold in the USA for $460 does stick in the craw a bit!

Cheers, tomtom

**James @ Intus** · 6 October 2009, 08:27

They should be 0% VAT if they mark it with the right codes but there's often duty/handling on top.

They most definitely have to be CE marked. It's not to do with voltage. Even masks, which have nothing to do with electricity, need to have a CE mark. We know how much that process costs and wouldn't do it if it wasn't absolutely necessary.

Because CPAP machines are medical devices, they are Class IIa medical devices as far as CE goes. If they're not marked to that effect, they're illegal.

A notebook is no medical device, it's apples and pears in that sense. If I walk to the warehouse here, every single machine and mask will have a CE mark on it and a number from a notified body (not self-certified). So I'm 100% sure you are wrong on the CE part of it.

But of course, we all want the best deal possible and all I can do is point you at the advantages of buying locally and the disadvantages of going abroad. It's indeed often the case that it seems the UK marks things up because companies can, but in CPAP it's different. In Ireland they pay 3K Euro for that same machine. In Germany about 1-2K and the same or more in Greece. Apart from the US, the UK is the most affordable in terms of private CPAP therapy purchases. So actually, for once the Brits aren't in too bad a position.

But of course, it's up to you. Some people prefer a close working relationship with a local provider like some here who I have regular contact with to try and improve their therapy numbers, for free! That kind of service has to be paid for somewhere so we can only extend it to those who buy from us. But if you don't need that, are happy to ship it back and be without for 2 weeks if it breaks etc. then yeah, hunt the best deal, by all means.

**Tigers Fan** · 6 October 2009, 17:17

Research, research, research!

The information you want exists right here on the forum.

TF

**gvader** · 6 October 2009, 17:23

Buying APAP overseas - a Word of Caution

Having just returned from holiday in America I'm catching up on the forum and read this one with interest, I can add a bit from the reverse side!

At the start of June I bought a Sandman Auto APAP from Intus which joined me on my American holiday. I spent the first week in Arizona where the machine worked perfectly and then I drove to Las Vegas. The first night there I put on my mask, turned the machine on and hit the pillow. A few seconds later I thought "something's not right" and waved my hand over the exhaust holes where I found nothing. Turned the machine off and on again and I still got no air, all I got was a display that showed 0.0cm for a few seconds and then a big flashing triangle that read "SERVICE". Oops.

Being a long way from home and 8 hours behind I sent an email to James to see if he had any ideas and he was able to give me a US phone number for the manufacturer. After being bounced around from division to division I eventually got a number for their helpline and duly called them. Getting a "customer service technician" on the line my conversation went like this:

Me:Hi, I'm on holiday in the US, my Sandman Auto has broken down and I'm looking for some help.
Them:Where did you buy your machine?
Me:In the UK, I'm over here on holiday.
Them:Well you need to call your supplier or primary healthcare provider for help.
Me:They are in the UK, I'm here in the US.
Them:Sir, the warranty on your device is only good for the area that the device was purchased in so you need to call your supplier.
Me:I contacted then but as I am 5,000 miles away they suggested that I call you.
Them:I'd like to help you sir but as your device was purchased in the UK then there's nothing I can do.
Me:So I'm stuck with no working APAP until I get home then?
Them:You could try and hire one for the rest of your stay, have a nice day.

Customer service at it's finest

So,yes, devices are cheaper in the US but be wary, you might save a couple of hundred bucks (if you can find somewhere that will accept a prescription from a UK doctor, all of the sites I've looked at in the US still require a prescription for the sale of CPAP/APAP devices) but that's not a lot of good when you get a fault and can't get the problem resloved without sending the machine back to the country where it was sold.

**tomtom** · 6 October 2009, 19:07

James

I am well aware that they require medical compliance but if you read my post carefully I am referring to the electrical CE because that is one reason that is being put forward as a block to importation. I have approached manufacturers of equipment that offer the same model into Europe as the US in an effort to ascertain what the differences are between say the Breas iSleep, by example, offered on both sides of the pond, if any.

I spend a fair bit of time in the USA and the notebook (not a piece of medical equipment just in case there is any doubt) that I take has a global warranty. I would expect the same level of service (at a minimum) from a CPAP manufacturer that sells the same model in the countries that I visit during my working life. I don�t think that is unreasonable and nor do the vendors whose equipment I use (of a non medical nature).

You seem to be taking my observations as some form of personal attack; nothing could be further from the truth. What I am after is a fair deal, how can a company (manufacturer not retailer) justify a price differential of �214? Funny how the US price is $575 and the UK price �575, what a coincidence. In your role as retailer I am not suggesting that is an extra margin for yourself.

Incidentally my current mask, issued by the NHS last month does not have a CE mark, just the manufacturers name. If anyone is paying 3000 Euro in Ireland for a CPAP then they have more of a problem than us but that in no way makes our prices �OK�.

I do understand what you are saying about providing an extra level of service and you are to be commended for it but you can�t help me when I�m in Vermont and have a problem with my kit, which to date, I have not. Even so, I doubt any global warranty/service contract will be of much use to me in the highlands of Kenya but you can�t have everything.

**James @ Intus** · 6 October 2009, 22:36

I wasn't personally affected, just writing out the facts, or at least, as I understand them. Perhaps you're not yet used ot my style of writing. Apologies if it came across the wrong way!

I'm not aware of "electrical CE". As far as I know, CE marking has little to do with electricity. Even boats need CE marking. As to the mask, if a CE mark cannot be placed on the product itself, it has to be on its packaging. Most likely, the hospital ripped it out of its packaging.

With regards to what the difference may be between products either side of the pond, in a lot of cases there won't be a difference other than the lack of the magic CE mark.

@GVader, I wondered how that was solved, sorry to hear it wasn't. Let me know if you need further assistance. Your story does illustrate what I meant above, with regards to geographical boundaries. Having said that, I had expected more from Covidien than that treatment! Perhaps their imminent take-over is causing brain-freeze.

Time for bed now guys!

**Tigers Fan** · 7 October 2009, 08:57

Americans don't recognise CE

I've tried to resist but can't ........

I think it's fair to say that all/most developed countries have their very own safety standards and marks - and that they don't recognise each others. CE is just the British mark, isn't it, and meaningless in the US. That doesn't mean our gear is not safe in the US any more than US gear is not safe in UK - given you get voltages and TV systems right, of course.

It's a lot like I can give blood in UK, fly to US and can't give because I've travelled. Fly straight back to UK and can't give because I've travelled. Same blood, no contaminants - but it's not from here!

Try re-flagging a ship a few years ago - before SOLAS member states got their act together and accepted compatibility and equivalence. For instance, perfectly good lifeboats and their davits approved by one nation would have to be junked and replaced by boats and davits approved by the new member state to which the ship was being registered.

My Remstar APAP was bought in the US and Respironics UK took over warranty without blinking. Half the stuff in my home was bought abroad on my travels. It's all perfectly safe - just not approved by British authorities.

A lot of waffle to get to my point - that we really must resist confusing market protection tactics with safety. The market always has been global but only open to travellers - now, the internet makes it available to us all (provided we understand national differences in voltages, AV sytems and the like).

Specific to CPAP - notice how manufacturers do not make input voltage suitable only for their own country (110VAC in US) but make gear to accept voltages over a range (some don't, and look at their problems!) so that the same product can be sold around the world - once it's gone through national safety checks, of course - and the price been inflated!

gvader - may I suggest that if you don't get the answer you want from one person in Customer Services - or anywhere else - you keep calling back till you get someone you feel is fully competent to answer your question. Not all operatives are equal - or equally knowledgable! Global companies have global warranties, just some need reminding.

TF

**Tigers Fan** · 7 October 2009, 11:01

An afterthought

I think a lot of what James says is absolutely valid. Buying overseas is not for the faint-hearted because it carries some risk - probably a little higher than buying in the High Street (see Ester Rantzen) but in my experience, not hugely so. The main difference in my view is the comfort factor - your relationship with the vendor, through after sales, but mainly in not feeling alone in your purchase.

You buy abroad and import, you do so alone and have to deal with all the agencies by yourself. Buy on the High Street - well, time for tea!

And when you meet a vendor like James, well, I don't think you could be less alone or more backed-up. He can't help the huge mark-up manufacturers put on goods sold in UK - but nowadays he is in competition not only with foreign vendors but with the NHS that is at last taking OSA seriously enough to fund its treatment.

A final (some hope!) thought - if you buy abroad using an internationally recognised (but British registered) credit card, you are protected under British consumer law.

TF

ps (I told you) tomtom, I can tell you haven't bothered to dig out the old thread on this topic. Be worth your while.

**tomtom** · 7 October 2009, 11:41

TG - Could you please post a URL to the thread, I have searched but not found anything specific to my questions?

CE covers boats (over 2.5mtrs), high voltage (lethal), medical etc, etc � it is European legislation, not British. Breas had CE approval for their APAP machine, the power supply has CE approval also (above 50v AC) , the same machine then received the appropriate certification for the USA to allow them to sell the SAME* machine in the USA and Europe.

*When you ask manufacturers if the machines have different internals (pump/software) they do not answer. I assume that they are the same, a point that is yet to be denied.

�A lot of waffle to get to my point - that we really must resist confusing market protection tactics with safety. The market always has been global but only open to travellers - now, the internet makes it available to us all (provided we understand national differences in voltages, AV sytems and the like).� Exactly!!

James made the point that masks are CE marked, that has now been confirmed as that is just the packaging (ResMed at least). So much for the statement that the equipment must be CE marked. Does this mean that if we take the mask out of the bag it is no longer compliant and I can't bring it back into the UK - beaurocracy at its finest

**gvader** · 7 October 2009, 16:30

Tigers,

Thank you for your patronising comment. I have been on this planet long enough to know that most customer service desks are staffed by chimps, I spent 3 hours on the phone to many different departments within Covidien only to get the same message. At that point I just gave up and fixed the thing myself.

The attitude of the manufacturer is abysmal and the point I was trying to get across is simply that you will be fighting against that every time you have a problem.

If Respironics in the UK are happy to deal with your US sourced machine then lucky you but don't then assume that all manufacturers will act the same.

**GrumpyBiker** · 7 October 2009, 17:21

Originally posted by tomtom View Post

James

Thanks for your quick reply and may I express my appreciation to your company for hosting the site and forum. I can also see that your contributions are solid.

I am in the process of finding out the VAT and duty on the importation of medical equipment supplied against a prescription and agree that if I cannot get an exemption then it becomes less attractive.

I am an electrical engineer by training but have been in software design for quite some time now and whilst I do not profess to be an expert I believe the actual APAP/CPAP machine is exempt from CE because it is a low voltage device …..

“1. Background
The Low Voltage Directive (LVD) was introduced at a time when directives contained detailed technical annexes which were intended to supersede national laws. The LVD set out the essential protection requirements, with the relevant technical details being defined by standards-making organizations. This subsequently paved the way for what were to be known as the New Approach Directives.

2. Scope
2.1 The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, this Directive is called often "Low Voltage Directive" which applies to the vast majority of electrical equipment in everyday use. The Electrical Equipment may be placed on the market only if it does not endanger the safety of persons, domestic animals or property. There are 11 principal elements of the safety objectives listed in Annex I.”

… Now this equipment is sold as dual voltage 110/220v. For any reputable company this means that the 220v must be certified for use in Europe. Check out your notebook, no CE sticker on the notebook (20v) but the switch mode power supply will have CE and (at least) US compliance stickers on it.

The CE marking directive covers so many things and yes the APAP falls outside of the 'low-voltage' equipment directive but is smack-bang in the middle of the 'Medical Equipment' directive:
Medical Devices
A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
investigation, replacement or modification of the anatomy or of a physiological process.
control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.

See here for more information.

Andy (who has to struggle with this d@mn list most weeks at work)

**Tigers Fan** · 7 October 2009, 21:17

Off topic

Hi gvader

You wish to feel patronised, I'll leave you alone to get on with it. I thought my "may I suggest" indicated courtesy but clearly you read into it something that was not intended.

I find your "most customer service desks are staffed by chimps" objectionable - just because you failed to be persuasive and assertive enough to get a global company to recognise its global responsibilities does not make its staff less than you - they all had a nice day, after all.

TF

**Tigers Fan** · 7 October 2009, 21:27

Thanks for the info

Hi GrumpyBiker

Thanks for the info and the link to more. I have learned that CE is a European standard, not just British, as I had thought.

At the bottom of the linked page is a papragraph that I think is very relevant to this thread -
quote
........ and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel
unquote

I've not looked at those Agreements on Mutual Recognition but am pleased to see that there is at least movement toward accepting that a CPAP that is safe for an American is safe for us, too - always provided that voltage de dah.

TF

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