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Philosopher
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Philosopher
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So I take it you'd never use EuroEnergy or Medgraphics even if as often in the case of Smart Batteries the original battery manufactures lable with part number was printed on it, since you couldn't guarantee country of origin?

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Mr R J Ling
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So I take it you'd never use EuroEnergy or Medgraphics even if as often in the case of Smart Batteries the original battery manufactures lable with part number was printed on it, since you couldn't guarantee country of origin?

As I've stated, based on experience, the country of origin might actually make a difference in some cases. Also the OEM pack smart functions may actually be reprogrammed. Some more expensive packs may consist of matched cells, etc.

The fact that battery manufacturers actually work with OEM medical device manufcturers and get involved with "customising" the SoC, SoH indicators and charging algorithms in "standard" packs is a reason why we should be cautious.

I don't have to guarantee anything - the supplier does, to my satisfaction, if I'm the purchaser and I'm going to take on any liability by fitting a non-recommended battery pack in a medical device.

Personally speaking I'd be prepared to use any 3rd party company that supplies batteries, including the two you name, but only if it supplies batteries that are proven to have the same specification/performance and be fully compatible as the OEM supplied battery.

The application would not be safety-critical medical either, i.e. not ambulatory therapy, portable monitoring, portable suction, ventilation, etc, etc, because the use of 3rd parties batteries has to be considered carefully in these sort of applications and there is some additional risk when considering a non-recommended battery/supplier.

Cost comes into it but it's not the main consideration if there are no guarantees and the battery supplier is not liable for any outcome involving the medical device the battery is fitted to. The individual deciding to fit non-OEM recommended batteries might become liable if there were issues.

This means that I'd be looking for evidence that the battery is produced by the same manufacturer to the same specifications but I'd need some proof of this from the supplier. Looking at other threads this has not always worked out successfully despite efforts to gain these assurances. As you said yourself, earlier:

Quote:
Sounds more like they didn't if you read it fully, first they claimed they were EXACT equivalent then had to put out an an URGENT recall when they found they weren't. Are they fully equivalent or is there something else they don't know? Probably best to go with the MHRA guidance.

For safety-critical applications my preference would be to buy direct from the OEM device manufacturer, from another supplier only if it was recommended by the OEM device manufacturer, or, as a last resort, from a 3rd party if they could guarantee that the battery was identical. This shouldn't be a problem for the supplier if they are, in fact, identical.

The inability to source the battery from elsewhere, not necessarily cost, would be a "last resort" for example.

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Philosopher
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Originally Posted By: Mr R J Ling
The fact that battery manufacturers actually work with OEM medical device manufcturers and get involved with "customising" the SoC, SoH indicators and charging algorithms in "standard" packs is a reason why we should be cautious.

That's the whole point of smart batteries, the manufactures no longer have to work with OEM medical device manufactures. They can mass produce a standard off the shelf battery with a spec sheet something like this and freely provide the technology to program it. Thus as long as the same manufactures spec is ordered it should be compatable with the battery management unit. Actually a smart battery has so much leeway in the way that it's charged that the performance of a smart battery to a particular spec will change per the battery management unit charging it!

Quote:
Cost comes into it but it's not the main consideration if there are no guarantees and the battery supplier is not liable for any outcome involving the medical device the battery is fitted to. The individual deciding to fit non-OEM recommended batteries might become liable if there were issues.

Richard I think here what you are actually purchasing is a warranty on the battery provided by the medical equipment manufacturer. You said that you would need to look for evidence that the battery is produced by the same manufacturer to the same specifications but then you said that batteries produced in different countries to the same spec are different. Therefore I get the feeling you want 100% guarantee that a battery made by a certain manufacturer, to a certain spec, on a certain day with a R in the month will be OK.

Quote:
This means that I'd be looking for evidence that the battery is produced by the same manufacturer to the same specifications but I'd need some proof of this from the supplier. Looking at other threads this has not always worked out successfully despite efforts to gain these assurances. As you said yourself, earlier:

Quote:
Sounds more like they didn't if you read it fully, first they claimed they were EXACT equivalent then had to put out an an URGENT recall when they found they weren't. Are they fully equivalent or is there something else they don't know? Probably best to go with the MHRA guidance.
The difference between a Smart Battery and the battery used on the XL is that EuroEnergy had to get the details from Philips where as the spec for a Smart Battery is freely available. If choosing to purchase either battery from them I as long as they correctly identified which battery had been selected by the device manufacturer, purchased direct from this manufacturer and cloned the battery using freely available tools on the internet (yes I'm sure Geoff will be looking for them) it shouldn't have the same problems as the XL battery did.

Although! I would still go back to the device manufacturer and check that these were OK and if informed they weren't I'd still ask why an off the shelf product they purchase for a few pounds was sold for a hundred and a bit!

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Therefore I get the feeling you want 100% guarantee that a battery made by a certain manufacturer, to a certain spec, on a certain day with a R in the month will be OK.

No, a limited warranty, e.g. replacement if it fails within a defined period, etc, I'm actually entitled to with any purchase of a battery - 3 months duration, whatever. Because batteries are a relatively "unknown quantity" if they're not OEM supplied then I expect very little from cheaper 3rd party product. As I said I'd rather not find out the hard way.

What I'm after is for the supplier to commit themselves on paper to supplying a fully compatible battery so that I have evidence that I did everything in my power to select an equivalent if some battery-related incident should occur with the medical device.

Remember the manufacturer typically recommends their own spares and accessories and we accept liabilty to some extent if we do not purchase recommended spares and accessories. The 3rd party battery supplier takes no responsibility if you read the small print - the purchaser decides suitability at the end of the day.

Quote:
The difference between a Smart Battery and the battery used on the XL is that EuroEnergy had to get the details from Philips where as the spec for a Smart Battery is freely available. If choosing to purchase either battery from them I as long as they correctly identified which battery had been selected by the device manufacturer, purchased direct from this manufacturer and cloned the battery using freely available tools on the internet (yes I'm sure Geoff will be looking for them) it shouldn't have the same problems as the XL battery did.

Perhaps it's all in the "difference", eh? Maybe the cloning is where the cost comes into it? Have you ever wondered why the battery suppliers don't do the cloning? Perhaps you have plenty of free time to reprogram smart batteries in your department? You're seriously considering adapting a non-recommended battery off the shelf for use on your defibrillators (I doubt it). I can just see Chris Grieves face now!

In this case, if you're being serious, I guess you'll risk invalidating the battery supplier's limited warranty and then you'll pobably be at risk, yourself, for fitting a medical device with a battery that you've tampered with; if there's a battery related incident and it comes to light. What you're suggesting is tampering or re-manufacturing; not selecting an equivalent product. You're authorised to do this then? You run a BSI Quality System at UHBT?

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Super Hero
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Originally Posted By: Chris Watts
... yes I'm sure Geoff will be looking for them

Bit short of time at the moment, Chris. But feel free to have a go yourself, Mate. smile


If you don't inspect ... don't expect.
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Philosopher
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Originally Posted By: Mr R J Ling
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Perhaps it's all in the "difference", eh? Maybe the cloning is where the cost comes into it? Have you ever wondered why the battery suppliers don't do the cloning?
Probably haven't got around to it yet, that you'll have to find out from someone like EuroEnergy.

[quote]Perhaps you have plenty of free time to reprogram smart batteries in your department? You're seriously considering adapting a non-recommended battery off the shelf for use on your defibrillators
We don't we checked what battery goes into the units and confirmed that they were used exactly how the device manufacture receives them from the battery manufacture. Presented with this evidence the device supply informed us, well perhaps we can do a deal if purchased direct from us!

Personannly I doubt that a smart battery would ever be used in a defibrillator anyway, from what I've experienced they have problems just coping with interference from switch mode power supplies let alone a defib firing!

Quote:
In this case, if you're being serious, I guess you'll risk invalidating the battery supplier's limited warranty and then you'll pobably be at risk, yourself, for fitting a medical device with a battery that you've tampered with; if there's a battery related incident and it comes to light. What you're suggesting is tampering or re-manufacturing; not selecting an equivalent product. You're authorised to do this then? You run a BSI Quality System at UHBT?
No we check what battery is being used and use the same manufactures recommended battery, often purchasing from either someone like euroenergy or Medgraphics or someone else if it's an industrial standard and it can be confirmed.

Taking your point that standard batteries like Yaesu can still be different if the same product spec, where do you keep all these batteries? I take it you can't keep a standard battery draw and that a Welch Aylln Yaesu of the same spec can't be used in a GE machine, that's going to be a lot of batteries! Or do you either keep a lot of spare equipment, or leave them broken while waiting from a replacement battery from each supplier?

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Mr R J Ling
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Taking your point that standard batteries like Yaesu can still be different if the same product spec, where do you keep all these batteries? I take it you can't keep a standard battery draw and that a Welch Aylln Yaesu of the same spec can't be used in a GE machine, that's going to be a lot of batteries! Or do you either keep a lot of spare equipment, or leave them broken while waiting from a replacement battery from each supplier?

To be quite truthful we don't have masses of battery failures of "standard" packs. Perhaps this is because we stick to OEM packs generally speaking? Only GE Healthcare Dinamap LA batteries cause us any real concerns at the moment, with relatively high rates of failure (possibly abuse).

We have 4 spare defibrillators with Li-Ion rechargeable smart batteries and MnO2 non-rechargeable batteries, that we maintain, to cover the 100+ defibrillators on our site. As I said we've arranged something with the supplier for both rechargeables and non-rechargeables.

For our Philips transfer-monitoring systems in the critical care areas we have arranged for critical care areas to keep spare Li-ion smart batteries cycling in the reconditioning units that we recommended they buy and these are located around the hospital.

We have used call-off ordering systems where the turnaround from companies like Philips is next day or even the same day. We also store technologies like NiCd where they are tolerant to being stored over relatively long periods.

More recently we have had to rely upon the speed of the purchasing system, rather than call-off orders, so that we can turn around repairs quickly. We are tending to buy relatively few batteries from 3rd parties.

At the last place I worked it took 3 weeks sometimes to process an order and the manager was severely limited on spending authorisation - where I work now it takes a couple of days.

Our AED/Manual defibrillators do use Li-Ion packs and these are OEM packs with SoC and SOH that don't need maintenance per-se but do need the SoC calibrating periodically.

We keep NiCd for infusion devices (Alaris PK, GH, SE Gold) since they can be stored over relatively long periods at any state of charge. My objective is to battery cycle the SE pumps 3 times at every 12 months service, as recommended and the Alaris syringe drivers once, to indentify problems.

For transport incubators we get the manufacturer in to replace batteries on the major service - it makes sense given that the batteries represent a small proportion of the cost of the work carried out.

If I had my way we'd automatically replace batteries at predefined intervals on ALL mission/safety-critical equipment (that includes stuff like portable suction and anaesthesia pumps). Saying that I'm not the manager so I don't have to justify the spend.

To be fair I must add that our infusion systems, defibrillators and monitoring systems are relatively new (all purchased within the last 3-4 years) so we shall see how it goes.

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Philosopher
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I see you don't do predefined changes, here we do probably explains why don't see the same problems with batteries you do.
Actually thinking about it isn't not having a battery change policy on mission/safety-critical equipment just as bad as not buying batteries direct from the manufacturer?

You do keep emergency batteries just incase one packs up?

Here we keep stores, we even have some spare Philips parts and a whole set of OEM and branded batteries since in some cases next day is just too late.

Just to make things clear the batteries we would order from someone like EuroEnergy would be what they call generic batteries as compared to what they describe as OEM packs which in the cases you describe would certainly in most cases need obtaining from the device manufacturer.

Although if you order what you think is going to be an OEM and receive a 3rd party branded cell then as long as this branded cell hasn't been modified by the manufactures (if it has they should really put their own lables on!) I can't see any problem cutting out the middle man.

Ps. I notice that Euroenergy already sell smart batteries for various equipment so they must have goten over compatability problems. (otherwise the equipment would not recognise the battery)

Last edited by Chris Watts; 14/10/07 4:24 PM.
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Mr R J Ling
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Serious industrial battery users operating biomedical instruments, data collection devices and survey equipment use Level 3 chargers with full-fledged charge protocol. No shortcuts are applied. To assure compatibility, the charger and battery are matched and only approved packs are used. The need to test and approve the marriage between specific battery and charger types is unfortunate given that the ‘smart’ battery is intended to be universal.


Quote:
The level of non-compliance is another problem with the SMBus. Unlike other tightly regulated standards, such as the long play record introduced in the late 1950s, the audiocassette in the 1960s, the VCR in the 1970s, ISDN and GSM in the 1980s and the USB in the 1990s, some variations are permitted in the SMBus protocol. These are: adding a check bid to halt the service if the circuit crashes, counting the number of ischarges to advise on calibration anddisallowing a charge if a certain fault condition has occurred. Unfortunately, these variations cause problems with some existing chargers. As a result, a given SMBus battery should be checked for compatibility with the designated charger before use to assure reliable service. Ironically, the more features that are added to the SMBus charger and battery, the higher the likelihood of incompatibilities.

Isidor Buchmann from "Batteries in a Portable World".

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Philosopher
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Yes, but Richard if four companies sell you the same model of battery from the same battery manufacturer as long as they haven't been modified after dispatch from the supplier surely they should be the same?

If not I think there's a serious problem since staff have responsibility for the conditioning these, they are probably going to get mixed up and since they will have identical part numbers there will be no way of telling them apart!

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