S
Hi Doug/Pads,
Thanks again for the feedback and intended assistance.
Literally just got a copy of IEC 60601-1-11 - and am now going through it. For one thing the age bit (max. 8 years education) can be looked at few different ways. As I indicated the FDA presentation infers 8th grade education. In the UK you have to do 'education' reports for 2.5 year olds under OFSTED (my other half was a nursery teacher) - so does that mean the education level of a 10.5 year old?
From my experience as a teacher and adult trainer (previous life) I have come across many an adult/teenager with a reading age of a 6 year old. Looks like my IFU will actually have to be as per "Janet & John" books with nice pictures of duckies and moo cows! The operating parts will no doubt need to end up looking like a Fisher Price toddler trainer toy - with all nice bright colours and big buttons to press to meet 'Lay Operator' requirements.
Sorry about the rant - 60601 standards - grrrrh!
Steve
Thanks again for the feedback and intended assistance.
Literally just got a copy of IEC 60601-1-11 - and am now going through it. For one thing the age bit (max. 8 years education) can be looked at few different ways. As I indicated the FDA presentation infers 8th grade education. In the UK you have to do 'education' reports for 2.5 year olds under OFSTED (my other half was a nursery teacher) - so does that mean the education level of a 10.5 year old?
From my experience as a teacher and adult trainer (previous life) I have come across many an adult/teenager with a reading age of a 6 year old. Looks like my IFU will actually have to be as per "Janet & John" books with nice pictures of duckies and moo cows! The operating parts will no doubt need to end up looking like a Fisher Price toddler trainer toy - with all nice bright colours and big buttons to press to meet 'Lay Operator' requirements.
Sorry about the rant - 60601 standards - grrrrh!
Steve