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CME T34 Internal Battery

Posted By: Andrew Stallard

CME T34 Internal Battery - 14/02/19 2:00 PM

Has anyone found a UK source for the internal CR1220 PCB battery with the correct pin configuration?
They're also used in the CME BodyGuard.
We're paying nearly £12 each for the "official" ones, but the only ones I can seem to find by a third-party (eg: RS @ £1.08) requires a little tweaking and risks shorting the pins!

Any help to save a little would be much appreciated.
Regards,
Andrew.
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 14/02/19 5:17 PM


Do you have any picture(s) for us, Andrew? think

Which one? ... eBay? Amazon?

Otherwise ... at those rates surely you can risk a little "tweaking"? smile
Posted By: Mithrandir

Re: CME T34 Internal Battery - 01/03/19 3:53 PM

Hi, had the same issues here. The part you are looking for is the CR-1220/FCN, the leg configuration on the Farnell one is VCN and needs bending but some consider it a "modification" so will not approve it.

I have found some in Europe but I am currently trying to get a friendly battery supplier in the UK to give me details and prices, If they can do it I have asked them to post on here, if they are not allowed as it is "advertising" then I will.

The price mark up on these batteries is obscene, I have sourced them in the US at just over a dollar but they will not air freight. Alibaba do them for 7 cents US with 50 as a min order, but not sure about shipping from China.

I will keep you posted on my efforts.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 04/03/19 2:42 PM

An update, try euro energy part number 50327
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 04/03/19 6:21 PM


Nice one, Mithrandir. Well done! smile
Posted By: MikeX

Re: CME T34 Internal Battery - 10/03/19 10:15 AM

Everyone should remember that all medical devices need to meet the strict requirements of the medical device directive (now medical device regulations). If you fit a part that is not sourced from the OEM or failed to fit an OEM part in accordance with their instructions, you have effectively made a modification to the device and invalidated the CE marking. All liability for the device has now passed to you!

If your cheap Chinese import battery burst into flames or causes the pump to malfunction I hope you have good legal cover!
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 10/03/19 5:55 PM


I wonder where the OEM gets them from? think
Posted By: MikeX

Re: CME T34 Internal Battery - 10/03/19 8:07 PM

The OEM will obtain them from either the manufacturer or their approved supplier, who will be ISO certified with full traceability. The OEM may also do their own quality control tests and checks before use. If there was a recal or other fault found the OEM would issue a field safety notice to be able to rectify the issue.

This is what is required by the medical device directive and is one of the reasons medical spare parts cost more than off the shelf parts. Most OEM follow ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes. How many of those repairing medical devices follow this?
Posted By: Mithrandir

Re: CME T34 Internal Battery - 11/03/19 12:45 PM

MikeX, you are saying that all the batteries sold by Medgraphics and Euroenergy, and fitted by lots of us, are a modification when they are identical in form, fit and function? The lamps I get from hospital lamps supplies are non OEM, is that a modification too?
Some bits I can understand the reasoning, but these batteries are all made in the same factories, the OEM sources them from the same sources as the battery suppliers we use, they all have ISO certification and the requisite traceability, it is not as if they are buying off the "grey" market.
The argument you use sounds like a manufacturer trying to justify monopoly pricing at gouge levels.
Posted By: Andrew Stallard

Re: CME T34 Internal Battery - 11/03/19 1:15 PM

Mithrandir - Thanks for the EuroEnergy info. I can't find any reference to that part number on their website, or in any lists that we have though!
Is it a new part that you have managed to get them to source for you? Do you have a price?
Regards.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 11/03/19 2:31 PM

give them a call, not in the catalogue as not many people have sourced it from them before, not sure of exact price, but it was under a fiver
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 11/03/19 5:40 PM


The Medical Device Directive is an EU document (or set of documents). I believe that the idea behind it is to facilitate the free movement of new medical devices within the member states of the European Union; in other words, the EU market. I could be wrong, but I don't think it mentions maintenance very much.

Now I'm wondering - how come kit made outside of the EU - USA, China, Israel et al - gets a free ride (CE marked, and all the rest)? think

Do we suppose that all medical kit has to undergo Type Testing before being released into the EU market? Or is it just a question of paperwork, and (or) the payment of extra tariffs? After all, the FDA are already pretty tough on new kit coming into the US market - "equal to, or better than" (probably the latter) the EU, I would have thought.
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 11/03/19 5:52 PM


Originally Posted by Mithrandir

The argument you use sounds like a manufacturer trying to justify monopoly pricing at gouge levels.


Yes. frown

Am I right in assuming that these batteries are simply for data (config) retention purposes? I wonder where the factory in Israel sources them from, and how much they (and the factory) would charge. They are the OEM, after all.
Posted By: MikeX

Re: CME T34 Internal Battery - 11/03/19 6:44 PM

Originally Posted by Mithrandir
MikeX, you are saying that all the batteries sold by Medgraphics and Euroenergy, and fitted by lots of us, are a modification when they are identical in form, fit and function?
These parts are a copy and therefore not approved by the OEM. Just because Medgraphics are ISO 9001 registered does not mean they conform to MDR and ISO 13485.

Originally Posted by Mithrandir
The lamps I get from hospital lamps supplies are non OEM, is that a modification too?
Yes, most likely! If you report to the supplier a batch of lamps explode after 20 hours use and have required patients examinations to be repeated how will they report this to all other customers? An OEM would issue a field safety notice for all users.

Originally Posted by Mithrandir
Some bits I can understand the reasoning, but these batteries are all made in the same factories, the OEM sources them from the same sources as the battery suppliers we use, they all have ISO certification and the requisite traceability, it is not as if they are buying off the "grey" market.
They will only have 9001 certificates and not the higher level for medical devices, such as 13485. How do you know they are made in the same factory and to the same specifications? Did the OEM provide you with this information? Again if a fault occurs how will the supplier inform all others of the issue? I doubt they even know who they sold them to!

Originally Posted by Mithrandir
The argument you use sounds like a manufacturer trying to justify monopoly pricing at gouge levels.
It may sound like that but the cost is justified when you understand the legal obligations medical device manufacturers are under. As always, until something happens and it results in a court case will you find out if the cost savings you think you are making are real savings or just “chancing your luck”.
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 11/03/19 7:18 PM


I can't argue with any of that, Mike ... from the legal point of view, that is.

However ... I would point out that over the years we have heard a lot here on the forum about "court cases" and so forth - but I don't recall any examples of such cases actually being cited. frown

Meanwhile - any one else remember (the concept of) "Risk Assessment"? think
Posted By: MikeX

Re: CME T34 Internal Battery - 11/03/19 7:35 PM

Geoff, you don’t hear about many court cases as they are often settled out of court to avoid publicly!

I do know of some coroners court rulings that have required some changes to safety standards, such as the need for metal clad consumer units, and changes to guidance regarding socket-outlets in medical locations (see HTM 06-01). However, the information is not easy to come by unless you get directly involved with the incidents, consequences or changes to standards, etc.
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 11/03/19 7:48 PM


Fair enough ... but neither have I heard of such incidents resulting in anyone being struck off the infamous "Register"!*

"Paper Tiger(s)" is the phrase that comes to mind. whistle

* No doubt my contacts into the grapevine are not as strong as they once were.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 12/03/19 1:25 PM

Originally Posted by Geoff Hannis

The Medical Device Directive is an EU document (or set of documents). I believe that the idea behind it is to facilitate the free movement of new medical devices within the member states of the European Union; in other words, the EU market. I could be wrong, but I don't think it mentions maintenance very much.

Now I'm wondering - how come kit made outside of the EU - USA, China, Israel et al - gets a free ride (CE marked, and all the rest)? think

Do we suppose that all medical kit has to undergo Type Testing before being released into the EU market? Or is it just a question of paperwork, and (or) the payment of extra tariffs? After all, the FDA are already pretty tough on new kit coming into the US market - "equal to, or better than" (probably the latter) the EU, I would have thought.



The T34 states "made in Germany" on the label. I guess they make all the component parts in Israel, then ship them into Germany at low value to reduce EU tariff charges, assemble in Germany, where "the value is added" so that it then meets EU rules and CE marking rules.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 12/03/19 1:33 PM

from the CME website

"CME Medical operates a quality management system which is certified to ISO 9001. In addition, our technical service department has achieved ISO 13485 certification. To find out more, visit Quality and regulatory."

So looks like manufacture is ISO9001, but service is 13845, so the original fitted batteries will only be supplied to 9001...
Posted By: MikeX

Re: CME T34 Internal Battery - 12/03/19 2:08 PM

Originally Posted by Mithrandir
So looks like manufacture is ISO9001, but service is 13845, so the original fitted batteries will only be supplied to 9001...
The T34 specifications states:
Quote
Manufactured in accordance with ISO 9001;2008 and ISO 13485;2003. CE marked (in accordance with the Medical Devices Directive 93/42/EEC).

So to maintain the CE marking you have to fit parts supplied by the OEM. You can't just use parts supplied by a company following ISO 9001 and assume you have not affected the CE marking or safety of the device.
Posted By: MikeX

Re: CME T34 Internal Battery - 12/03/19 2:12 PM

Originally Posted by Mithrandir
The T34 states "made in Germany" on the label. I guess they make all the component parts in Israel, then ship them into Germany at low value to reduce EU tariff charges, assemble in Germany, where "the value is added" so that it then meets EU rules and CE marking rules.
A device can be made in any country but must be CE marked if sold in Europe. It does not have to be made (assembled) in Europe! Some devices need to be assessed by a "notified body" before they can be placed onto the market, but again these are available throughout the world.
Posted By: Rob1234

Re: CME T34 Internal Battery - 12/03/19 9:39 PM

Originally Posted by MikeX

An OEM would issue a field safety notice for all users.

Please! You report consistent/repeatable faults to manufacturers and the standard response is 'You're the only ones to experience this'.
I can get a well known manufacturers defib to completely lockup and be unusable while displaying a ready for use indicator (you have to remove the AC power and batteries to get it to respond!) by doing something that a member of staff could do easily - I reported it to the manufacturer and after several months the response was 'You're not using it according to the instructions'! - Sorry, but you give me a piece of equipment and a nurse and I give you Murphy's Law...

Manufacturers don't give a monkeys once they've had your money and the MHRA are (tooth/use)less - but this is not a debate for this particular thread.
Posted By: MikeX

Re: CME T34 Internal Battery - 12/03/19 9:54 PM

Originally Posted by Rob1234
Originally Posted by MikeX

An OEM would issue a field safety notice for all users.

Please! You report consistent/repeatable faults to manufacturers and the standard response is 'You're the only ones to experience this'....

Manufacturers don't give a monkeys once they've had your money and the MHRA are (tooth/use)less - but this is not a debate for this particular thread.

And your point is?
Are you suggesting it is OK to ignor the rules and regulations because of your experience with one bad company? Can we all do as we wish because the regulator is ineffective? We all know the police are ineffective so do we all decide it is OK to steal?

As professionals with a consciece we should uphold standards and regulations.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 13/03/19 10:05 AM

moot point now, euro energy say they got it wrong and cannot supply this part, they say they have the VCN version that needs bending, which is a modification, but earlier said that this was not the case.. Makes me wonder if pressure has been brought to bear.. but enough conspiracy theory, back to looking for a traceable European source. I will keep those who are interested updated if I do find a suitable source and not some dodgey ebay seller
Posted By: MikeX

Re: CME T34 Internal Battery - 13/03/19 10:23 AM

No matter where you find them unless they are the ones supplied by the original medical device manufacturer, fitting them would constitute a modification!
Posted By: Mithrandir

Re: CME T34 Internal Battery - 13/03/19 11:17 AM

Originally Posted by MikeX
No matter where you find them unless they are the ones supplied by the original medical device manufacturer, fitting them would constitute a modification!


Unfortunately then I suppose the biomed is dead, anything we fit must be OEM, might as well send all repairs back to OEM, just to be safe. Fitting a new fuse, if not brought from the oem, with associated traceability, would constitute a modification, CME don't want the pumps used with any but their "recommended" PP3 batteries, so a district nurse fitting a battery she bought from the local shop is modifying the device.

Maybe we should just stop doing anything and let the OEM control the whole process.

Sorry MikeX but the level of defeatism is not how change has been brought about in industries that monopolise and control publicly funded bodies, where they see us as a cash cow.
Posted By: MikeX

Re: CME T34 Internal Battery - 13/03/19 11:35 AM

EBME dead? No, just evolving!

Providing you use original OEM sourced parts and fit them in accordance with the manufacturers instructions then nothing is stopping you making repairs.

The role of the EBME departments is evolving due to changes in technology. Whereas in the past it was simple to repair down to component level now it is becoming impossible. Embrace the change to the new environment! The new role is to be the technology gateway and manage the service rather than actually making repairs. As automation and robots rise we will all need to adapt.

Remember, you are also extracting money from public bodies, so should not blame others for what you are also doing! Working in partnership with manufacturers can actually bring about savings, and not be just about gouging public bodies for more money. Embrace the change.
Posted By: Andrew Stallard

Re: CME T34 Internal Battery - 13/03/19 12:09 PM

You beat me to it Mithrandir.....
I contacted EuroEnergy with the part number you gave and they quoted me £4.25 each. I asked for a datasheet to be emailed to me for confirmation which ended up showing the CR1220/VCN rather than the CR1220/FCN that we need.
I went back to them to double-confirm when they admitted it needed the pins bending to fit!
They also said they couldn't supply the /FCN as:
Quote
Panasonic only supply it in large volumes on an 18 week lead time

As you stated.... it's back to the drawing board!
Posted By: Mithrandir

Re: CME T34 Internal Battery - 13/03/19 2:01 PM

Maybe we could convince supply chain to buy the batteries from Panasonic ( from what I can find out 1000 seems to be the minimum order quantity), and then with it's collective buying power it could obtain the best prices for the NHS ( i think that is what the intention was originally).

Early research shows buying from recognised electronic wholesalers will bring these in at around a euro each when buying a thousand. I am almost considering it as it is cheaper than buying 100 from the OEM, but maybe if a few hospitals pooled their buyer needs it could work, but maybe we would all be modifying the pumps....
Posted By: MikeX

Re: CME T34 Internal Battery - 13/03/19 2:13 PM

Nice to see many just ignoring the previous comments and carrying on using non-OEM parts regardless.

I just hope if something does go wrong it was not your decision to save money and use the incorrect parts.
Posted By: billy11

Re: CME T34 Internal Battery - 13/03/19 5:56 PM

If we go one step further would you state using a flowmeter nipple for Ohmeda on a Therapy equipment flowmeter would be a modification if so the world has gone mad considering they are the same size/threads.
Posted By: Geoff Hannis

Re: CME T34 Internal Battery - 13/03/19 7:26 PM


I'm sure we could all come up with a hundred such examples, Billy. smile

If the NHS supplies organisation (whatever it's called these days) was properly organised, biomeds would be able to request parts from the Hospital Stores and they would be left to source the parts (carry the can, take the blame, procure the parts quickly and cheaply ... whatever).

Perhaps one day some Genius will amaze everybody by coming up with an idea called "economies of scale" - and start off by buying the batteries in question as a job lot from Panasonic and holding them against a stock number in Central Stores!

Meanwhile, those of us outside of the NHS shall no doubt carry on following Good Engineering Practices (aka Common Sense) aimed at meeting customers' expectations in a timely, cost effective and efficient manner! whistle
Posted By: Mithrandir

Re: CME T34 Internal Battery - 14/03/19 9:27 AM

For those worried about using non OEM parts, here is a link to "Managing Medical Devices" from the MHRA on the Gov.UK website

https://www.gov.uk/government/publications/managing-medical-devices

relevant quote

"To ensure that replacement parts are of the correct specification, purchase them
either directly from the manufacturer or to the same specification.
When obtaining replacement spare parts from sources other than the manufacturer,
you must take care to ensure that all aspects of the technical specification are met,
including, for example: physical dimensions, material strength, mechanical properties
and compatibility.
Any agreements to supply parts from sources other than those recommended by the
manufacturer should be properly risk assessed, costed and documented, before a
decision is made to buy them."
Posted By: MikeX

Re: CME T34 Internal Battery - 14/03/19 9:36 AM

The key point here is ""ensure all aspects of the technical specification are met". So unless the manufacturer has provided you with the full specification and any testing they perform then you do not meet the requirements.

Also did you cost in all your time into the equation? This is not just the time you spend finding the part but all the documentation and testing to ensure you fulfil all the requirements. In the end it is just cheaper to buy from the manufacturer! Better to spend the time negotiating a good price! As I said the role of EBME is evolving so embrace the change!
Posted By: MikeX

Re: CME T34 Internal Battery - 14/03/19 9:58 AM

An interesting point further down in the MHRA document is:
Quote
An organisation could be held responsible under health and safety law and civil liability in the event that a patient or member of personnel died or suffered personal injury or damage as a result of inappropriate replacement of batteries.
I know of a fire started in a hospital due to a battery fault in a laptop on test after repair. It resulted in damage to equipment costing them over £600,000! Should make you think about the savings you thought you made!
Posted By: Mithrandir

Re: CME T34 Internal Battery - 14/03/19 10:13 AM

MikeX, do you have a role within an OEM by any chance? Or is it that you are so risk adverse that you do not think that a Bio med should do anything?

The risk of a battery fire ( note, on a laptop, not a medical device) is always there, a cmos support battery carrying 35mAhr is not a major risk of fire in my experience ( I used to design and develop batteries for the Navy).

Risk assessment has replaced common sense, they should be the same, but one comes with a form to back up your thinking.
Posted By: Andrew Stallard

Re: CME T34 Internal Battery - 14/03/19 10:29 AM

With regards to non-OEM....

In this particular case, the battery is third-party in the first place. It's a Panasonic CR1220/FCN.
As long as that is the part being sourced from another supplier (as is the purpose of this thread), then there is no modification involved.

Slightly different, I guess, for parts made exclusively for a device.
Posted By: MikeX

Re: CME T34 Internal Battery - 14/03/19 10:39 AM

Originally Posted by Andrew Stallard
In this particular case, the battery is third-party in the first place. It's a Panasonic CR1220/FCN.
As long as that is the part being sourced from another supplier (as is the purpose of this thread), then there is no modification involved.
This may not be true, as the medical device manufacturer may perform their own testing of the part to ensure it meets the required specification.

I know of a case where a potentiometer was replaced with one of exactly the same model as the original part (same make and part number) but this caused subsequent errors. It turned out the part supplied by the manufacturer had been selected by testing to meet stricter linearity requirements than the pot manufacturer specifications. In other words, from a batch of 100 pots only half were deemed to meet the required specification. This is a common industry practice.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 14/03/19 11:06 AM

How would you select on test a primary cell, to test it would deplete a battery, rendering it useless.
Posted By: MikeX

Re: CME T34 Internal Battery - 14/03/19 11:17 AM

Originally Posted by Mithrandir
How would you select on test a primary cell, to test it would deplete a battery, rendering it useless.
Clutching at straws now? Well, you could measure the internal impedance (by applying short current discharge pules).
However, if a manufacturer specified you could only use primary cells supplied by them, I would have never considered purchasing such devices, unless the total cost of ownership matched or beat other equivalent devices.
Posted By: Mithrandir

Re: CME T34 Internal Battery - 14/03/19 3:25 PM

I despair, a cmos support battery that you can buy for a pound everywhere else. Common sense tells you it is nothing special, the OEM supply them without even a date code, let alone any form of lot code . Some things are so obvious, but still there are those who bind themselves slavishly to the "rules", or should I say their interpretation of the rules.
I will continue to be a rebel, because free thought and a desire to see through the facade that some regulations appear to give.

Embracing the change in BioMed engineering and becoming an extension of the OEM into the NHS is not for me. I will be there to challenge the line" the manufacturer knows best" and " you are the only one seeing this problem" if we do not question their monopoly on these devices then we leave ourselves at their mercy. Unlike MikeX I do not have the luxury of deciding what is purchased, I just have to keep on fixing it, keep on applying the field safety notices, react to the device alerts and try and make the budget work at the end of the year, and keep the patient safe in the process.
Posted By: Andrew Stallard

Re: CME T34 Internal Battery - 14/03/19 3:56 PM

What about third-party BP cuffs?
Does ANYONE buy OEM?
Posted By: billy11

Re: CME T34 Internal Battery - 14/03/19 6:26 PM

Third party BP cuff are widely used within the NHS to no detriment to the patient resulting in cost savings and also forcing the OEM to compete at a more acceptable cost. Here we have people seeking to hide behind the rule book and default to OEM parts. Why not risk assess and try the parts in a controlled way?
Posted By: Nguyễn

Re: CME T34 Internal Battery - 31/03/19 3:21 PM

Does ANYONE buy OEM?
Posted By: MikeX

Re: CME T34 Internal Battery - 01/04/19 7:29 AM

The "rule book" (standards and regulations) is there to protect everyone, including the patients and those supplying and maintaining medical devices. If someone decides they don't want to buy OEM parts, then they are accepting responsibility to meet the required standards and regulations. The OEM would no longer be responsible for failures of the device, as that has would have fallen to the person (or organisation) making the modification.

So feel free to fit non-OEM parts but understand your liabilities!
Posted By: billy11

Re: CME T34 Internal Battery - 03/04/19 4:58 AM

Fitting non OEM parts as long as risk assessed is fine, I have fitted many 3rd party batteries to ECG recorders as we assessed the risk as minimal however that is not the case with transport ventilators where the OEM is used.
Posted By: Neil Porter

Re: CME T34 Internal Battery - 03/04/19 5:29 PM

Wouldn't it be nice if all batteries were of a standard size/shape for medical equipment along the lines of AA & AAA irrelevant of which manufacturer or equipment the batteries were being used with.Image the storage space you would save in the workshops if you did not have to store all the different batteries that are available today.
Posted By: Neil Porter

Re: CME T34 Internal Battery - 03/04/19 5:31 PM

Best cuffs to buy are Welch Allyn (Flexi Port), adaptable to all medical equipment.
Posted By: DaveC in Oz

Re: CME T34 Internal Battery - 03/04/19 9:25 PM

I'm with Billy on this, non OEM is fine in non life support devices but OEM only on things like defibs, vents and IABPs
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