Medical Device Disassembly Instructions to Remove the Battery

K

KamakshiKariya

Friends,

I understand that we have to provide device disassembly instructions appropriately in the instructions for use to remove the Battery per EU regulations. However I have been instructed to provide the instructions for removal on the device (with a screw driver marking near the screws) by our consultant, but I am not sure whether this is really required or not and also I am hesitating to do this due to the device size (Device size: LXBXH - 165X38X41 mm) as I already have hand full of markings to be provided on device. Hence please advise. As well it would be great if any of you could let me know where to find that symbol in case if the disassembly instructions on the device is mandatory (I searched ISO 7000 but didnt find any screw driver symbol).

Thanks & Regards
KK
 

Stijloor

Leader
Super Moderator
Friends,

I understand that we have to provide device disassembly instructions appropriately in the instructions for use to remove the Battery per EU regulations. However I have been instructed to provide the instructions for removal on the device (with a screw driver marking near the screws) by our consultant, but I am not sure whether this is really required or not and also I am hesitating to do this due to the device size (Device size: LXBXH - 165X38X41 mm) as I already have hand full of markings to be provided on device. Hence please advise. As well it would be great if any of you could let me know where to find that symbol in case if the disassembly instructions on the device is mandatory (I searched ISO 7000 but didn't find any screw driver symbol).

Thanks & Regards
KK

Can someone help?

Thank you!!

Stijloor.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Friends,

I understand that we have to provide device disassembly instructions appropriately in the instructions for use to remove the Battery per EU regulations. However I have been instructed to provide the instructions for removal on the device (with a screw driver marking near the screws) by our consultant, but I am not sure whether this is really required or not and also I am hesitating to do this due to the device size (Device size: LXBXH - 165X38X41 mm) as I already have hand full of markings to be provided on device. Hence please advise. As well it would be great if any of you could let me know where to find that symbol in case if the disassembly instructions on the device is mandatory (I searched ISO 7000 but didnt find any screw driver symbol).

Thanks & Regards
KK

In my opinion, instructions should be written so that anyone can understand and use them. I also feel that the more specific the instructions are, the better, as long as they are written so that the "normal" less experienced person can follow them. They should not be written so that a Scientist is the only person capable of using them.

But, that is my opinion, and the medical field is not my specialty, nor are the regulations passed down in regards to medical devices.
 

somashekar

Leader
Admin
I guess you are talking about instructions to remove the battery cover off the case in order to remove and replace the battery.
1. Perhaps your design could have thought of a snap in and lock type cover that can be snapped out for battery replacement and closed again.
2. The design could have the caution symbol moulded near the screw head place directing you to the IFU
3. You can place a caution label near the screw head place directing the user to the IFU, where the details can be with pictures and description (taking care of language requirement) in a seperate section in the IFU "How to replace battery"
 
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J0anne

Joanne
There is no requirement in Europe for a screw driver symbol on medical devices.
Insist that your consultant shows you where he got that information from.
Why are you referencing ISO 7000?
BS EN 980 is more appropriate and it comes with a symbol library on CD.
 
K

KamakshiKariya

Thanks everyone.
I realized that I missed to mention complete information. This is for the Battery Disposal per EN Regulations and no replacement of the batteries in our device, User will dispose the compelte device once the life expectancy is reached.
The argument by the reviewers based on the other medical device compliance is... User would be able to read the instructions for use document but when he disposes the entire device, the device goes to the appropriate disposal party and they will have no idea how to open the device unless something is specified on the device and they are proposing to have instructions on device (symbol near screw) so that the disposal party can remove the battery safely. please shed some light on this.
 

J0anne

Joanne
There is no requirement for a screwdriver symbol on your labelling.

You can tell the user how to dismantle and dispose of the product in accordance with local laws and EU directives. You can write this in your instructions for use.

Read the battery directives (EU law) for the correct symbol.
 

Pads38

Moderator
As it is for 'final' dis-assambly you might try identifying the required screws with an arrowhead - well it is an arrowhead with a length ways split. Look on the back of monitors or PCs. It seems to be a well used symbol recognised in the disposal industry.
 
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