ANSI AAMI DF2:1996 (2000) pdf download.Cardiac defibrillator devices.
1.1 General
A cardioverter-defibrillator is an electronic apparatus used to terminate cardiac tachyarrhythmias, including ventricular fibrillation, by the application of electrodes to deliver a brief electric shock to the heart. This standard establishes minimum performance and safety requirements for all conventional hospital or mobile rescue cardiac defibrillators.
Special features, such as the capability for synchronized discharge for the reversion of atrial fibrillation or ventricular tachycardia (synchronized cardioversion), are addressed but are optional in nature and are not to be construed as required for all defibrillators. Where such features are provided, however, they shall comply with the applicable requirements of this standard.
A section containing referee test methods is included in this standard to define the methodology by which compliance with the requirements can be verified. These test methods are not intended for use by end users of the device.
This 1996 standard replaces the 1989 edition (ANSI/AAMI DF2-1989). Some requirements have been modified, and new ones have been added. The requirements in this document, as well as any subsequent revisions, are not retroactive.
1.2 Inclusions
This standard specifically addresses
a) conventional defibrillators for use in hospitals, clinics, physicians’ offices, and emergency medical services;
b) delibrillators 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;
0 self-adhesive single- or multiple-function (defibrillation/monitoring/pacing) electrodes.
1.3 Exclusions
This standard does not cover:
a) automatic or advisory external defibrillators that contain rhythm detectors and shock-decision algorithms. These devices are covered more completely by a separate standard, ANSI/AAMI DF39—l 993:
b) stand-alone pacemakers, implantable or external transcutaneous:
c) automatic implantable cardioverter-defibrillators, with or without pacing (ICDs).
1.4 Abbreviations and acronyms
A, mA, Ampere, milliampere, microampere,
uA, nA nanoampere (units of electrical current)
uA p-p microampere peak-to-peak
ANSI American National Standards Institute
CISPR International Special Committee on Radio Interference
ECG Electrocardiogram
EMAX Maximum delivered energy
EMC Electromagnetic compatibility
2 Normative references
The following documents contain provisions that, through reference in this text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to use the most recent editions of the documents indicated below.ANSI AAMI DF2 pdf download.