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The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse. The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semiautomatic mode, AccessALS functions identically to the AccessAED. The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.

The AccessAED™ Automatic External Defibrillator has been designed specifically for the treatment of ventricular tachyarrhythmias in cardiac arrest. The AccessAED delivers a high-energy 200 or 360J biphasic waveform to patients in cardiac arrest resulting from ventricular fibrillation or high rate ventricular tachycardia. The AccessAEDTM features include: - LED ready indicator . - power button . - shock delivery button . - LCD display with text messaging and ECG display option . - defibrillation pads housed in a tray for rapid application to patient . - . disposable Lithium battery system - rhythm analysis software . - energy selection button (manual mode only) ● - synchronization button (manual mode only) . - . analysis button (manual mode only) - charge button (manual mode only) . When the AccessAED™ algorithm software identifies a rhythm that requires defibrillation, the device charges to the required energy level algorithm (200 J or 360 J) as dictated by the internal algorithm. When the device indicates a full charge and instructs the operator to push the shock button, the operator delivers the shock by pressing the shock delivery button.