Instructions for Use - Class II Rx Device which is used in Hospitals

Java23

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Hi - I don't know if I am in the correct forum - :eek:
I began the review of an Instruction Manual for a Class II Rx device which is used in hospitals.

The current manual is written in paragraph form - lots of sentences no bulleting of warnings/cautions / set up / maintentance /cleaning etc.

The manual is used globally. I went out on the web to look at some competitor manuals to get an idea of the types of topics included.

Does anyone know where I can find some regulatory requirements for what must be included in instruction manuals?

I believe we should have a statement that says to "read all instruction before using the device" .

Also, I feel INTENDED USE of the device should be in the manual.

How about a statement instructing that when the package is received it should be inspected for damage and DO NOTUSE if damage is present.

What about patient population?? Adult, pediatric, infant use?

Should the manual contain any verbiage regarding disposal of the device?

If anyone can point me to some guidance documents or suggestions, I would be forever grateful.

Thank you!:thanks:
 
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