IEC EN 60601-1-8: Battery monitor considered an alarm?

M

mr.mike

#1
Hi There,

My company has not yet purchased 60601-1-8, as we're not sure yet if it applies. (...so forgive me here, I'm going off what I know of the standard through related articles, and other posts on this forum..).

My question is this: Does a battery-meter constitute an alarm?

I realize that both the definition & implementation of an alarm (either visual or auditory), are tied to the Risk Management assessment results done by the manufacturer.

So, the relevant question in this case would be : "Does the battery depletion represent a potential hazardous situation to the User?", correct?
...however, even this is open to interpretation....

For example, consider a hearing-aid that is battery powered.
- If the battery fails, there is no immediate danger to the user. (low risk)
- However, the fact that their hearing-aid has stopped working might mean they fail to hear, for example, an on-coming car. (high risk)
- BUT, the failing of the battery should be highly detectable by the user (they'd notice if they suddenly can't hear as well), which would mitigate the risk above. (medium risk?)

So, in the end, would the device require a "low-battery" alarm as per 60601-1-8?

Any thoughts/advice much appreciated!
MM.
 
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Roland chung

Trusted Information Resource
#2
I do not think low battery alarm is necessary in your case. We do not manufacture the hearing aid, but my grandpa use it. I do not find the hearing aid has mentioned alarm function. BTW, the hearing aid is CE approval.

I would think that the risk of such device is really low. Actually, the analysis in your post is fine but divorced from the reality a little bit. There is no difference even the device with low battery alarm if you are crossing the street and the battery depleting. Note that besides the hearing, we also have eyes and the driver MUST obey the rules of traffic.

Of course, this is just my thinking.
 
M

mr.mike

#3
Ok, another example then:

The battery in the hearing-aid depletes (without the user knowing), and they then fail to hear the fire-alarm in the hallway of their appartment. Hazardous situation to be sure.

BUT, if there were a low-battery alarm in the hearing-aid that had drawn the user's attention to the fact that the batteries are about to run out, the hazardous situation might have been avoided.

We're tempted just to incorporate a battery alarm into the device specs, but if IEC EN 60601-1-8 is indeed applicable, then it might be more complicated...

Furthermore, due to the small size of the device we are developing, we want to avoid any unecessary extra electronics. We also, however, want to make sure that we've got all our bases covered in terms of regulatory requirements.

So, not sure what to do... Anyone else have any experience as to whether low-battery notifications constitute an MD alarm as per 60601-1-8?

Thanks,
MM.
 

Peter Selvey

Staff member
Super Moderator
#4
From a logistical point of view, the need for an "alarm" per IEC 60601-1-8 is determined by risk management.

Unfortunately, IEC 60601-1-8 nowhere really states clearly exactly what the objective of the standard is, from which you could then use risk management to decide if the standard is appropriate.

The term "ALARM" is not actually defined. In the real world we use the word "alarm" to mean anything from wake up call (alarm clock) to serious danger (fire alarm). So when we use the word "alarm" (e.g. low battery alarm) it does not automatically mean IEC 60601-1-8 is applicable.

Looking at the alarm characteristics in IEC 60601-1-8, it seems clear the objective of the standard is for alarms that are intended to get the user's attention to the medical device when the the user may be in the same room, but their attention is focused on other things. Most significant is the need for a visible alarm indicator that can be seen from 4m away.

Looking at these these characteristics, we can see that IEC 60601-1-8 would not be appropriate for a hearing aid low battery alarm and many other "alarms" in medical devices. In other words, these characteristics would not reduce the risk (and could even increase the risk). Hence the standard would not be applicable in such cases.
 

Roland chung

Trusted Information Resource
#5
Looking at these these characteristics, we can see that IEC 60601-1-8 would not be appropriate for a hearing aid low battery alarm and many other "alarms" in medical devices. In other words, these characteristics would not reduce the risk (and could even increase the risk). Hence the standard would not be applicable in such cases.
Why low battery alarm in this case can increase the risk? If I misunderstood what you meant?
 

Peter Selvey

Staff member
Super Moderator
#6
Sorry for my confusing explanation.

Having a "low battery alarm" is good and reduces the risk.

However, applying IEC 60601-1-8 to that alarm in many cases makes no sense and would add unnecessary complications and costs. For example, adding an indicator light to a hearing aid that can be seen from 4m away.
 

Roland chung

Trusted Information Resource
#7
However, applying IEC 60601-1-8 to that alarm in many cases makes no sense and would add unnecessary complications and costs. For example, adding an indicator light to a hearing aid that can be seen from 4m away.
I absolutely agree with your point. Not all indication shall be regarded as alarm which required to comply with 60601-1-8. It does make no sense.
 
M

mr.mike

#8
Thank you very much for your input.

What we will likely do is implement a simple low-battery alarm, but not worry about all the strict audio/visual requirements of 60601-1-8. It will certainly make prototyping simpler!
 

Eamon

Involved In Discussions
#9
If you don't want trouble when you send it for evaluation, a little semantic forethought can help. Try changing the feature name from "low battery alarm" to "low battery alert".

- Eamon
 
M

mr.mike

#10
Interesting suggestion. Will definitely take note!

Other possibilities I suppose would be "notification", "signal" or "indicator" (I was going to say "warning", but I guess that would be carry the same hazard implication as "alarm").

...but I like "alert", think I'll go with it. ;)
 
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