AAMI DF2-96 PDF download

Cardiac Defibrillator Devices

AAMI DF2-96 – Cardiac Defibrillator Devices

This standard provides minimum labeling, performance, and safety requirements for cardiac defibrillator devices, and includes referee test methods by which compliance can be verified. Specifically, this standard addresses: a) conventional defibrillators for use in hospitals, clinics, physicians’ offices, and emergency medical services; b) defibrillators with an integrated cardiac monitor or attached to an external cardiac monitor-defibrillator; c) defibrillators that are line-powered or battery-powered; d) defibrillators with special controls and circuitry intended for synchronized cardioversion, i.e., the treatment of ventricular tachycardia or atrial fibrillation by means of an electric shock synchronized with ventricular contractions; e) external transcutaneous pacers that are a part of a defibrillator-pacer instrument; f) self-adhesive single- or multiple-function (defibrillation/monitoring/pacing) electrodes.