FUNCTIONAL VERIFICATION WITH REPLACEMENT DEFIBRILLATOR

Functional Verification CEI 62-13 EN 60601-2-4 + Replacement Defibrillator with defibrillators erogated energy analyzer on the discharge load according to the standard requirements CEI 62.5 with the release of the certification (trasport excluded)

Gazzetta Ufficiale Della Repubblica Italiana del 20/07/2013 conversione in Legge Allegato (E) Punto 4.3 Manutenzione e segnaletica (Pag. 13/24):

Punto 4.3 Manutenzione e segnaletica: DAE shall be subject to functional verification, to controls and to periodic maintenance according to the deadlines in the user manual and in compliance with the current regulations on electromedical equipment.

The DAEs must be maintained in working conditions; the battery shall have enough power to ensure its operation; the adhesive pads must be replaced on expiry date. The DAEs owners can take agreements with the Health Care Companies or with private parties in order to provide for the maintenance of the device, placing the costs on the owner.