ANSI/AAMI DF39-1993 pdf download.Automatic external defibrillators and remote-control defibrillators.
1 Scope
1.1 General
This standard covers minimum labeling, performance, and safety requirements for automatic or semi-automatic (advisory) external defibrillators (AED), remote-control defibrillators (RCD), and self-adhesive combination electrodes. An AED is an electronic apparatus that includes sensors and analysis algorithms capable of identifying ventricular fibrillation (VF) and other electrocardiographic (ECG) rhythms. The AED is connected to a patient and delivers a brief electrical shock to the heart if the device indicates VF or other arrhythmias for which a shock is appropriate. The defibrillator shock is delivered automatically by the device in the case of an automatic defibrillator, or is delivered by the operator (upon recommendation from the device) in the case of a semiautomatic or advisory defibrillator.
An RCD transmits an ECG by telephone to a medical response center and is remotely operated from that center.
Self-adhesive electrodes for monitoring and defibrillation, which are a necessary and important component of AEDs and RCDs, are also covered by this standard.
Algorithms for prompt and accurate identification of cardiac rhythms, particularly VF, are an essential requirement for the performance and safety of AEDs. Though it is difficult to develop a traditional standard for a VF detection algorithm, this standard defines minimum testing and reporting procedures for describing and verifying the performance of the arrhythmia detection component of the AED. Only ECG rhythm detectors are considered, as it is premature to specify and standardize requirements for other non-ECG rhythm detectors which may be developed and used in the future.
AEDs may be designed specifically for hospital use, for prehospital use by emergency response teams, or for use in homes or various locations (factories, airplanes, etc.). This standard recognizes and covers the differentiation of requirements for these various applications.
AEDs may also have additional optional functional capabilities. This standard covers the most important of these optional functions, i.e., external transcutaneous pacing.
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 designed and intended for use primarily by manufacturers, though end users of the device may also find them useful.
1.2 Inclusions
This standard specifically addresses
a) AEDs, including algorithms for recognition of cardiac rhythms and particularly detection of VF;
b) RCDs, which communicate with and are controlled from a medical response center;
c) external transcutaneous pacers, when a part of a defibrillator-pacer instrument;
d) self-adhesive combination (defibrillation/monitoring) or universal function (defibrillation/monitoring/pacing) electrodes.ANSI/AAMI DF39 pdf download.