Is Defib Protection mandatory for wearable ECG?

K

krystle

#1
Hi everyone :bigwave:,

we're having some trouble identifying the right wording to explain to our lab that the defib protection for our device is not necessary. the lab is doing testing for us for IEC 60601-1, -1-2, -1-11, -2-25 and -2-47. The lab asked us to comment on how the essential requirement 201.8.5.5.1 of the 60601-2-25 was guaranteed or to provide rationale for it being not applicable.

We have a product with a disposable sensor and a small wearable ECG monitor that clips onto the sensor (no lead wires). Our NB auditor did not comment on whether defib protection is necessary or not when he saw the symbols we used and the lab's report. We've come up with a few arguments to give back to the lab but i wanted to see if anyone here has any experience and can help us out.

Thanks a lot!
Krystle
 
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subbash

Involved In Discussions
#2
We are also working on a wearable ECG product. We have included the Defibrillator circuit.

I am not an expert but, I believe the requirement of the circuit depends the type of applications that the Wearable device is intended for.

I am also eager to hear the expert opinions of others in this group.
 
G

gyiszu

#3
Hello,

Which one of the scopes of the particular standards are applicable to your device? (I have not seen an ECG to which both 2-25 and 2-47 is applicable as they have totally different intended use.)

If one particular standard applies than you have to fulfill all the essential performance requirements defined, if you cannot than your device is not an ECG (in terms of 60601-2-25, 60601-2-27, 60601-2-47) just a device capable of collecting data about electrical activity of the heart.

How many leads do you have in the sensor? If you cannot fulfill 201.12.4.102.2 Minumum required configuration of 60601-2-25 it is definetly not applicable.

You can still use an approach that you define requirements by sub-clause 4.5 60601-1 so you accuracy can be measured at least...

Sorry I hope I did not confused you.

BR,

gyiszu
 

subbash

Involved In Discussions
#4
Dear gyiszu,


We are still in the schematic phase. We still need to go through the applicable standards for our wearable ECG product. The current configuration is for a single lead ECG.


Please do let me know if you have any update regarding the standard applicable.



Thanks and Regards,
Subbash
 
#5
As has been mentioned earlier the 3 possibly applicable standards are for quite different applications. It would probably help you if you identified which (if any) of the 'Particular' standards to apply early in your project.

You can view previews of the standards from the IEC web-store. This shows you the first few pages; usually enough to decide on applicability without having to buy the standard, for considerable sums.

From the 60601-2-47 preview:
Within the scope of this standard are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously.

The type of storage media used is irrelevant with regard to this standard;

b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

The safety aspects of this standard apply to all types of systems falling in one of the above mentioned categories.

If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply.
MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard.
So that is quite prescriptive. Elsewhere they refer to this sort of device as a 'Holter recorder' if that helps to recognise what type of device it is meant for.

From what I can see from the Contents page of the preview -2-47 does not require defibrillator proof parts.
 
K

krystle

#6
Hi all, thank you for your comments.
Our device is both a monitor for the generation of a diagnostic ECG file and a holter device. We confirmed months ago with our NB and testing lab that both 60601-2-25 and -2-47 are applicable.
in the meantime we heard back from our auditor who told us that we can claim defibrillation protection is not applicable because our device is not diagnostic in real-time so it cannot be used in emergency cases or in ambulances where a defibrillator would be applied. We're adding in the user manual that device needs to be taken off when a defib is to be used and that it cannot be used during emergency but only for day-to day monitoring.
Hope this helps someone else out there!
thanks to all once again :)
Kry
 
G

gyiszu

#7
Dear subbash,

If -2-25 is applicable than defibrillation proof requirements also apply, because you use the information of the ECG to determine that another definitely charge is needed.

But as I said with one lead you will fail on-2-25 because you will not meet with minimum lead requirements. And I suppose that with one lead you will have severe difficulties to pass the DC offset test....

BR,

Gyiszu
 

Peter Selvey

Staff member
Super Moderator
#8
Forgetting the standards, careful consideration about defibrillation seems to make sense if the ECG is intended for use on a patient with suspected heart problems, since it is more likely that they will need to be defibrillated.

However, it is unlikely the device itself is is useful for detecting if the defib was successful - it may not have an actual real time display or if provided might be on a smart phone which is not exactly useful in an emergency situation. Rather, the person performing the defibrillation is most likely to use the defib's own ECG monitor to tell if the defibrillation was successful. These days AED devices do this automatically.

What is important is to make sure the wearable device does not get in the way of the defibrillation or cause any trouble. This could be:
- due to position of the electrodes (gets in the way of good defib pad placement),
- shunting of energy which decreases the success rate of normal defibrillation
- burns at the electrodes
- exploding device
- damage create noise that stops the defib monitor from picking up a clean ECG trace

Given the possible issues, it may be that a prominent label "remove before defibrillation" is needed if the device is not designed to handle defib pulses.
 
C

cdewitt

#9
Also, putting a statement in the user manual is not useful since someone needing defib probably will not have the manual on them at the time and whoever is administering the defib probably would not take time to read it anyway.
 
#10
Hello Kry,

I was wondering about your ability to avoid the defib tests for 2-25 and 2-47. The two main issues are whether the device continues to function after the defib pulse is applied, which I firmly believe in your product's case is irrelevant. But the other issue is related to interference of the device during defib, as Peter puts it, making sure it does not get in the way or cause a problem. We found that we could justify one of our products being 'disabled' by the defib, but we could not justify it absorbing too many Joules from the defib pulse.

Secondly, I'm wondering who your auditor is as we have a tie-up in Malta and may want to use them.

Thanks,

Kevin
 
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