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"a manual usually accompanying a technical device and explaining how to install or operate it" Essential Requirements - Medical Device Directive 93/42/EEC - Annex I, 13.1: Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential user. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging of each unit. If not practicable, the information must be set out in the leaflet supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, no such instruction leaflet is needed for devices in Class I or Class IIa if they can be used completely safely without any such instructions.
"un manual normalment acompanyant un dispositiu tècnic i explicant com instal·lar o operar-lo" requisits imprescindibles - mèdic dispositiu directiva 93/42/EEC - Annex I, 13.1: cada dispositiu ha d'anar acompanyada de la informació necessària per utilitzar-lo de manera segura i identificar el fabricant, prendre compte de la formació i el coneixement de l'usuari potencial. Aquesta informació està formada pels detalls sobre l'etiqueta i les dades de les instruccions per utilitzar. Pel que fa a practicables i apropiat, la informació necessària per utilitzar el dispositiu amb seguretat cal definir en el propi dispositiu i/o en l'envasament de cada unitat. Si no practicables, la informació ha d'establir en el prospecte subministrat amb un o més mecanismes. Instruccions d'ús han de figurar en l'envasament per cada dispositiu. Manera excepcional, no tan prospecte instrucció és necessària per a dispositius a l'aula o classe IIa si es poden utilitzar completament segura sense cap d'aquestes instruccions.
