Light indication

[evan_kim90]

Hi, everyone.

I have one question regarding for warning light for EN 60601-1
So, standard want red light as a warning, when hazardous situation like death or serious injury.

But I checked our device red light is for when device has stopped or battery is died.
I know both situation is not related death or serious injury but customer cannot use device.

Is there any explanation we can use red light for this situation or should we change color?

 

[Tidge]

You should be able to differentiate between technical and physiological alarm conditions in the labeling (and risk management file). You ought to plan for user validation to demonstrate that users can understand the alarm schema as implemented.

I don't expect a NRTL testing grognard to put up much of fight about this sort of thing, unless they themselves get confused, or you go out of your way to confuse them. I went through this sort of things many times (common sense indicators for technical alarm signals) in several different submissions, as far as I know it barely registered with NRTLs or regulators.... and I doubt it was because of my own thoroughness.

 

[Bryan Ye]

IEC 60601-1, required that a Red indicator, not flashing is a warning signal. Warning lights do not require OPERATOR action.
I think this may not be for your case. The battery is empty, so action is required by the operator.
IEC 60601-1-8 gives an example, "EXAMPLE 2 A battery status notification that replacement will be needed in a day. " this could be ADVISORY SIGNAL, which is a kind of which is an INFORMATION SIGNAL.
The device stops or the battery dies. this will cause delay, which will cause Discomfort or reversible minor injury.

you may check IEC 60601-1-8 requirement.

Suggestion:
you may use the red flashing indicator but the flashing does not meet the flashing requirement/definition in IEC 60601-1-8. for example, frequency is not 1,4 Hz to 2,8 Hz

 

[Avidan B]

if it's not a big hassle, I would have suggested to replace the red lamp to Yellow.
If this lamp is not necessarily needed, you can try to cover it.
and if you leave the red lamp, you can add a caption on the panel explaining what is that lamp...

 

[Tidge]

I don't think it is appropriate for us on the outside to try to quarterback the harms for this device.

 

[Avidan B]

I don't think it is appropriate for us on the outside to try to quarterback the harms for this device.

Right, but if the mnf. do a risk analysis and able to show that no unacceptable risk exists in such case (battery has died) , then, I think, he can cover that lamp and refer to the dead battery in the IFU...

 

[Bryan Ye]

Right, but if the mnf. do a risk analysis and able to show that no unacceptable risk exists in such case (battery has died) , then, I think, he can cover that lamp and refer to the dead battery in the IFU...

I don't think it's a good idea to cover the indicator light.
You can't indicate in the manual when you need to deal with the battery problem, which will cause many customers to contact the service staff.
In addition, you need to pay attention to IEC 60601-1 standard requirement below：

In ME EQUIPMENT incorporating a means for charging an INTERNAL ELECTRICAL POWER SOURCE,
the charging mode shall be visibly indicated to the OPERATOR.

 

[Avidan B]

I don't think it's a good idea to cover the indicator light.
You can't indicate in the manual when you need to deal with the battery problem, which will cause many customers to contact the service staff.
In addition, you need to pay attention to IEC 60601-1 standard requirement below：

In ME EQUIPMENT incorporating a means for charging an INTERNAL ELECTRICAL POWER SOURCE,
the charging mode shall be visibly indicated to the OPERATOR.

The intention was to solve the existed red-light problem.
what is worse (higher risk): to have a Red light (which shouldn't be red) or not having visual indication for charging ?!

 

[Bryan Ye]

"the charging mode shall be visibly indicated to the OPERATOR." this is a standard requirement that is a must if applicable.
For the red-light problem, I provided suggestions in my previous post.

 

[Tidge]

I don't think it is appropriate for us on the outside to try to quarterback the harms for this device.

Right, but if the mnf. do a risk analysis and able to show that no unacceptable risk exists in such case (battery has died) , then, I think, he can cover that lamp and refer to the dead battery in the IFU...

So rather than taking my advice, you decide to double-down. Leveraging risk management for a medical electrical device covered by consensus standards isn't an area when anonymous forum should come back with the "I think you don't need to do _____."

Going back to the OP:

But I checked our device red light is for when device has stopped or battery is died.
I know both situation is not related death or serious injury but customer cannot use device.

I've worked with multiple ME devices which has some sort of similar wording in the risk management file, some of them even ended up undergoing design changes based on recalls because the customers couldn't use the device because a battery was discharged. Those devices went back on the market using common-sense battery status indicators that happened to be red.