User Manual Content Requirements and EMC information

[Nissim Shaked]

According to the essential requirements document (section 11.4.1)- devices that emit radiation should add information in their user manual stating
"detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risk inherent in installation".
Which part of my EMC test report (IEC60601-1-2) should I present in such a case in the user manual, I can not present all of it....?

 

[Pads38]

Re: User manual and EMC information

The required information is the 4 Tables described in 60601-1-2 clause 5.2.2. For the non-life supporting equipment we make that means tables 1, 2, 4 and 6.

Examples of how to fill in those tables is given in Annex C of 60601-1-2:2007.

If your risk management process identifies a particular EMC risk you may, additionally, need more prominent / simpler cautions or warnings, dependent upon your likely end-user.