Device Dossier

Smarty Saver Electrode Pads SMT C2002 - Multifunction cardiac electrode, adult

Device Dossier for Smarty Saver Electrode Pads SMT C2002 - Multifunction cardiac electrode, adult (Multifunction cardiac electrode, adult, Class III,…

Intended purpose

The defibrillator pads are intended to be used in a non-sterile environment (therefore outside the operating room), in combination with an AMI automatic external defibrillator (AED), for the treatment of heart rhythm disturbances in emergency situations or for specific clinical uses, in the following clinical applications: • External defibrillation • Temporary transthoracic (non-invasive) cardiac electrical stimulation • Transthoracic synchronized cardioversion • EKG monitoring It is specified that depending on the unit used or the interface system, it is possible that not all of the indicated clinical applications are feasible

Functional description

The Device is made up of two active electrodes, one intended to be positioned on the patient's sternum, the other intended to be positioned on the chest at the apex of the heart; each electrode is connected via an insulated monopolar electric cable (multistranded conductor, PVC/PE insulation) to the defibrillator connection connector

TGA Public Summary