A system, including a modified one, is accompanied by documents with all the data for its intended use and an address for the responsible organisation, regarded as part of the system: the accompanying documents of each ME and non-ME item the manufacturer provides; the system specification with intended use and a list of all items; installation, assembly and modification instructions for continued compliance; cleaning, disinfection and sterilisation instructions per item; additional safety measures during installation; which parts suit the patient environment; additional preventive maintenance measures; warnings that a separate multiple socket-outlet must not be placed on the floor, that no further extension cord or multiple socket-outlet may be connected, and that only specified or compatible items may be connected; the maximum permitted load of any multiple socket-outlet and the instruction to use it only for items of the system; explanations of the risks of connecting supplied non-ME equipment directly to the wall outlet when it is meant to be fed through a separating transformer and of connecting non-supplied equipment to the multiple socket-outlet; environmental conditions including transport and storage; the instruction not to touch the 16.4 parts and the patient at once; and advice to carry out the specified adjustment, cleaning, sterilisation and disinfection and that assembly and later modification of systems require evaluation to this standard.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.