information constituting the instructions for use allowing the physician and, where appropriate, the patient to use the device, its accessories and software correctly, as well as information on the nature, scope and times for operating controls and trials and, where appropriate, maintenance measures,
podatki, ki sestavljajo navodila za uporabo in omogočajo zdravniku ter, kadar to pride v poštev, pacientu, da pravilno uporablja pripomoček, njegove dodatke in programsko opremo, kakor tudi podatki o naravi, področju in rokih za nadzore in preskuse delovanja ter, kadar to pride v poštev, ukrepih vzdrževanja,