Equipment comes with accompanying documents that include, at a minimum, a technical description and the instructions for use, regarded as part of the equipment, identifying it by the manufacturer's name and contact information and the model or type reference, stating any particular skills, knowledge and training the operator or responsible organisation needs and any limits on where, or in what environment, it may be used, written at the level of their intended readers, and, where provided electronically, the usability engineering process decides what must also be in hard copy or marked on the equipment such as emergency operation. The instructions for use document the intended use, the frequently used functions, known contraindications and which parts must not be serviced while a patient is connected; if the patient is meant to operate the equipment they state this, warn against servicing during use and say which functions and maintenance the patient may perform; they give the manufacturer's name and address, the model reference, the clause 6 classifications, the 7.2 markings and what the safety signs and symbols mean, in a language acceptable to the operator; they include all warning and safety notices, the class I protective-earth warning, warnings about reciprocal interference during specific investigations or treatments and about electromagnetic or other interference with advice to avoid it, and for an integral multiple socket-outlet a warning that connecting equipment creates an ME system with possibly reduced safety; they state the separate power supply specification or ME system, warnings on additional power sources needing periodic checking, battery removal during storage, replaceable internal source specification and connection to an appropriate source where loss would be unacceptable; a brief description, how the equipment functions, its significant characteristics, where the operator, patient and other people are expected to be, materials to which the operator or patient is exposed where that poses a risk, restrictions on signal input and output connections, and the applied parts; installation references, the instruction not to position equipment so the mains disconnection device is hard to operate, the start-up procedure and pre-use handling, operating instructions with controls, displays, signals, sequence, detachable parts and consumables and all system, error and fault messages with causes and operator actions, the shutdown procedure, cleaning, disinfection and sterilisation methods and the parameters parts tolerate, preventive inspection, maintenance and calibration by the operator with frequency and the parts service personnel maintain, rechargeable battery maintenance, a list of the detachable parts, accessories and materials and specification of other equipment supplying power, disposal risks and advice, the technical description or where it is found, for radiation used medically, its nature, type, intensity and distribution, sterile supply and re-sterilisation, and a unique version identifier. The technical description gives all data essential for safe operation, transport, storage and installation: the 7.2 information, environmental conditions of use, transport and storage, all characteristics with ranges, accuracy and precision, special installation requirements such as maximum supply impedance, cooling liquid parameters, the means of mains isolation where not incorporated, oil level checking, a warning against unauthorised modification, essential performance and any recurrent basic safety and essential performance testing with means, methods and frequency, the qualifications of service personnel where designated, fuse types and ratings, whether a non-detachable cord is replaceable and how, replacement of service-replaceable parts with warnings where replacement could be hazardous, a statement that circuit diagrams, parts lists and calibration instructions will be made available for repairable parts, and the means used for mains isolation; a separable technical description repeats the markings, classifications, notices, description and version identifier. Compliance is checked by inspecting the documents in the operator's language and, for electronic documents, per IEC 60601-1-6.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.