Force for propulsion: IFU Wording

[Alisa542]

Hi,

We recently completed IEC 60601-1 testing and narrowly exceeded the 200 N propulsion force limit defined in Clause 9.4.2.2 (Force for propulsion), with a measured force of 217 N. The clause states that the force required to move the device shall not exceed 200 N unless the instructions for use specify that more than one person is needed.

Our device is on castors and is easy for one person to push in normal use. While our handles can accommodate two people, we do not believe two operators are actually necessary. We were considering adding language to the IFU stating that “more than one person may be required” to move the equipment. Is this acceptable? We would prefer not to imply that two operators are routinely required.

Thanks!

 

[yodon]

Hard for anyone to say what's going to be acceptable. Seems like this is a case for the 'blue circle with a guy reading a book' label (not the book with the 'i' in it) with a note in the IFU. I would probably suggest that you "recommend" a 2-person push (rather than "may be required"). May not make any difference but maybe a bit more assertive. And you could even add why you recommend it.

 

[Al_Z1]

Clause 9.4.2.4.2 (Force for propulsion) requires strict compliance:
"The force required for moving MOBILE ME EQUIPMENT along a hard and flat horizontal surface shall not exceed 200 N unless the instructions for use state that more than one person is needed ."
Theoretically speaking, it is possible to adjust it via risk management, according to clause 9.4.2.4.1:
"The means used for transportation of MOBILE ME EQUIPMENT, e.g. castors or wheels, shall not result in an unacceptable RISK when the MOBILE ME EQUIPMENT is moved or parked in NORMAL USE."
But you need to support the claim that there are no risks with objective data, and just test reports or IFU won't suffice, in my opinion, cause you want to justify non-compliance with the standard, which could be "red flag" for many NB reviewers.