Especificações mínimas aceitáveis de um analisador de desfibriladores e cardioversores

Abstract

This study aims to recommend specifications for defibrillator and cardioverter analyzers, such as maximum permissible measurement error, resolution, operating conditions and desirable features. The recommendations are based on the test requirements from the ABNT NBR IEC 60601-2-4:2005 and ANSI/AAMI DF80:2003 standards. An evaluation of the specifications provided by four imported analyzers (Fluke QED 6, Fluke Impulse 7000, MTK-Biomed Delta 3000 MKII and NETECH Delta 3000) and two Brazilian analyzers (Transmai JM-01 and Ourox JAU-110) has also been performed, and several problems were found with specifications of those analyzers. These problems range from unsupplied data to less than desirable conditions for a defibrillator and cardioverter analyzer. The most serious problems encountered are related to the lack of specifications such as precision, accuracy, maximum permissible measurement error or other specifications that would help determine the coverage interval of the measure, an unacceptable mistake for a measurement instrument. Other problems were related to measurement error and operating conditions not complying with the requirements of the ABNT NBR IEC 60601-2-4:2005 and the ANSI/AAMI DF80:2003 standards.