Symbols - Consult Instructions for Use

Q

QA-RA-Newbie

#1
Hi there!
I've used Elsmar Cove a lot over the past few years but this is my first post! Yay!

I have a question regarding symbols that tell the user to "consult accompanying documents" in one way or another for a Medical Electrical device. There are several symbols which appear to mean the same thing. How do you determine which should be included on labels, in manuals, or in software? Or do they all need to be used?

IEC 60601-1 3rd ed. - Table D.1 Symbol 11 is a book with an 'i' and means "operating instructions"

IEC 60601-1 3rd ed. - Table D.2 Symbol 10 is a blue circular safety sign with a person reading an instruction manual and means "Refer to instruction manual/booklet. Note: On ME Equipment "Follow instructions for use.""

ISO 15223-1:2007 - Section 5 Table 1 Symbol 5.3 is a book with an 'i' and means "consult instructions for use"

ISO 15223-1:2007 - Section 5 Table 1 Symbol 5.4 is a white triangle with an '!' and means "caution, consult accompanying documents."

When is it appropriate to use each of those symbols?

Thanks in advance and I hope I've included enough information!
 
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sreenu927

Quite Involved in Discussions
#2
Hi QA-RA-Newbie,

Usually for product primary labels,

- open book with i" symbol is used to indicate the to consult the IFU or User guide to look for more details such as ECREP contact name and address. (On the label, ECREP symbol will be placed..to look for the name and address, this open book with i symbol will be placed jsut beside this eCREP symbol).

- if your product has any safety warnings to be informed to the customer, then place the triangle with exclamation mark" symbol on the product primary label.

The information of ECREP name & contact address and safety precauations or warnings will be mentioned in the User Guide or IFU.

Hope this helps!

Regards,
Sreenu
 
Q

QA-RA-Newbie

#3
Hi Sreenu,
That does help somewhat, thank you!

What about the blue IEC 60601-1 symbol? When would that be used over the other "refer to instructions" symbols?

IEC 60601-1 3rd ed. - Table D.2 Symbol 10 is a blue circular safety sign with a person reading an instruction manual and means "Refer to instruction manual/booklet. Note: On ME Equipment "Follow instructions for use."

Thanks!
Julie
 
#4
The old symbol (open book with i) is identified as just meaning "Operating Instructions". Perhaps could be used to identify some instructions printed near a user replaceable part.

The other symbol (blue circle) is a "Mandatory Action" symbol. I would suggest that if, by Risk Assessment, you have identified that part of your device or process needs proper instruction then that symbol should be used.
 
M

MariuszPoland

#5
Are there any requirements that say that the CE mark should be placed in the "About Software" ? Its class I device with biofeedback software
 
#6
Software is considered to be "a device" so the same labeling requirements apply to the software as to hardware. If you are claiming compliance with the directive then any device needs to be labelled with the CE mark.

I have found that the easiest thing to do is to include the CE mark on the "About" page and, also, to supply the software on CD with all of the necessary information printed on.
 
M

MariuszPoland

#7
Where I can find this regulation? Could you show me an example of "about" in software?

It doesnt matter that software is an inherent part of the device and can not be sold seperately? And its possible to get device without software
 
#8
Where I can find this regulation?
It is a key part of the Medical Device Directive. In fact all of the European 'New Approach' directives share the requirements for labeling.

The idea is that any device (or part) can be readily identified and the manufacturer (or EU representative) can be contacted by any authority in the EU. This is to ease any required investigations wherever they take place.
 
#10
The purpose of the information is to ensure traceability. The CD will become a drinks coaster and get lost. Therefore, the information needs to be 'in' the software itself.
 
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