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Super Hero
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@Malcolm:- Indeed; but what does Mr.Lightman say?

@Dave:- Bravo! (Lipton Yellow Label preferred)

ISO 80601-2-61 has an Annex entitled "Simulators, calibrators and functional testers for pulse oximeter equipment". And Section 201.12 talks about "accuracy" under various conditions. Does anyone have a copy of the latest edition?

I have found the 1st. (2011) edition of 80601-2-61 on line. The following quote has been lifted from that:-
Quote
- Unlike many other types of ME EQUIPMENT, PULSE OXIMETER EQUIPMENT is not designed to be calibrated after it leaves the factory.

- There is today no accepted method of VERIFYING the correct calibration of a PULSE OXIMETER PROBE and PULSE OXIMETER MONITOR combination other than testing on human beings.

All available tools for testing PULSE OXIMETER EQUIPMENT, at the time of writing, are properly called FUNCTIONAL TESTERS. 201.7.9.3.1.101 aa) requires the instruction manuals of PULSE OXIMETER EQUIPMENT to state that FUNCTIONAL TESTERS cannot in general be used to measure the SpO2 ACCURACY OF PULSE OXIMETER PROBES and PULSE OXIMETER MONITORS.
So it seems that we all need an index* finger of Malcolm's quality.

* Middle finger may also be used.


If you don't inspect ... don't expect.
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Dreamer
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Hi All

I totally understand the points being made regarding pulse oximeter testing (I'm using a Fluke Spot Light as I read this).

I would like to add that if you compare a units results year on year using a specific tester, then at least you will know that the unit under test is behaving the same as it did when you commissioned it. And, if the unit under test results are the same or similar to its make/models cohort, again, it gives a degree of certainty that the unit is behaving properly.

Phil

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Generally in China, important diagnostic departments cannot use Mindray monitors.For example: operating room, ICU care unit, etc.
Because we don't think he's accurate。You can use the same ECG simulator to compare ECG parameters from different monitors. Of course, Mindray also compares within the queue.You will find that Mindray's waveform is different from other monitor waveforms。Personally think that Mindray has filtered a lot of useful information.
The same principle applies to blood oxygen parameters.
As a test instrument, whether to restore the real data 100% or to display the data artificially is a question worthy of discussion.


daisizhou@sina.com
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GlynEd Offline OP
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Originally Posted by daisizhou
Generally in China, important diagnostic departments cannot use Mindray monitors.For example: operating room, ICU care unit, etc.
Because we don't think he's accurate。You can use the same ECG simulator to compare ECG parameters from different monitors. Of course, Mindray also compares within the queue.You will find that Mindray's waveform is different from other monitor waveforms。Personally think that Mindray has filtered a lot of useful information.
The same principle applies to blood oxygen parameters.
As a test instrument, whether to restore the real data 100% or to display the data artificially is a question worthy of discussion.

That's interesting daisizhou. I presume Mindray meet the required standards to be sold on the Chinese market yet you say they are not used in the likes of ICU. Obviously they meet the CE mark standard to be sold in Europe.
Do you have any particular evidence you can refer to expand on this?

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Visionary
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Hi Glyn

We have had similar issues to yourself on adult Critical care with Mindray over reading Spo2 sometimes by up to 10%.
Would you like to have a conversation off line to discuss what we and yourselves have done to address this?

Richard Aldridge
Lead technologist ACCU Royal London Hospital
tel 0203 59 40302


Richard Aldridge
Lead Technologist
Adult Critical care unit
Royal London Hospital
Whitechapel Road
London E1 1BB
Tel 0203 59 40302
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Visionary
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Hi Glyn

Id still like to have a conversation with you about the issues youve seen.

Regards

Richard
Royal London ACCU


Richard Aldridge
Lead Technologist
Adult Critical care unit
Royal London Hospital
Whitechapel Road
London E1 1BB
Tel 0203 59 40302
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Master
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What sort of results do you get using the "trusted" two fingers on the same hand method ??

I note that the spec sheet for these monitors quote a 2% accuracy, so 10% is a large error.

Last edited by Malcolm; 11/04/22 10:25 AM.
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GlynEd Offline OP
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Originally Posted by brompton
Hi Glyn

Id still like to have a conversation with you about the issues youve seen.

Regards

Richard
Royal London ACCU

Hi Richard,

I have tried ringing you on the number you posted, I have left an answer phone message. You can contact me on 01283 566333 ext 5407

Thanks
Glyn

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Master
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Just a thought....

are these errors technology dependent?
It seems hard to believe Mr Masimo would accept these discrepancies on monitors using his tech or are your monitors using Mindray SpO2 modules.

After reading the initial post I carried out a brief control of our 20 monitors in the A&E dept. which were supplied with Nellcor technology and whilst the sensor position can sometimes cause problems the actual reading is within spec.

I wonder, is it possible to connect a sensor that is not the same technology as the internal module but rather than not providing a "sensor not connected" alarm it gives an erroneous value....

Again just a thought...

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I mean the SPO2 value displayed on the monitor is only for the monitoring of the nursing staff, not for the diagnostic purpose of the doctor.Especially Mindray's monitor.
For example, in my country people used to use mercury thermometers and it was very accurate (oral measurement). But mercury is a harmful metal, so it's now being discontinued, replaced by in-ear thermometers. In the same way, due to the different measurement methods, the in-ear ear thermometer measurement is very inaccurate, so it can only be used for large-scale screening, and cannot be used for accurate measurement.


daisizhou@sina.com
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