X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Approval order statement

Approval for the X Series Defibrillator Function. The X Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulseThe X Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The X Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.The X Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients. R Series Defibrillator FunctionThe R Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse.The R Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The R Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.The R Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients. AED ProThe AED Pro system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse and other signs of circulation.The device is also indicated for use when ECG monitoring is indicated to evaluate the patient’s heart rate or ECG morphology. The AED Pro system is indicated for adult and pediatric patients.AED 3 BLSThe ZOLL AED 3 system is indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse and other signs of circulation.The AED 3 system is indicated for adult and pediatric patients. ...