EMBLEM™ S-ICD Programmer Model 3200 - Cardiac pulse generator programmer

Intended purpose

The EMBLEM™ S-ICD programmer is a component the S-ICD System which is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. The programmer is intended to communicate with the implanted pulse generator using wireless telemetry. The programmer software controls all such telemetry functions

Functional description

The programmer is a non–sterile, non–implantable, tablet computer controlled by a graphic user interface (GUI) displayed on a touchscreen.The programmer uses a connected RF telemetry wand to communicate wirelessly with the EMBLEM S-ICD pulse generator in order to adjust programmable settings and to collect patient data. Programmer components include Model 3200 Programmer with pre-loaded software, Model 3203 Telemetry Wand and Model 3204 External power supply and AC power cord