This paper describes a research involving the development of a defibrillator and cardioversor analyzer and its metrological evaluation. The evaluation results are presented. The evaluation of measurement uncertainties was performed according to the directives of the Brazilian version of the EA-4/02 - Expressing Uncertainty in Calibration Measurements - published by INMETRO. The results conformed to the accuracy prescriptions defined in the ANSI/AAMI DF2 (American..., 1996) and ANSI/AAMI DF80 (American..., 2003) standards, presenting an expanded relative uncertainty of energy measurements of 1.0% in worst cases. An uncertainty analysis was performed for the calibration process employed in the research and the process capacity was evaluated. A maximum error of 5% or 1.0 J, whichever is greater, was determined for the energy measurements taken to calculate process capacity. The maximum error is 1/3 of the maximum error acceptable for the energy delivered by the defibrillators, i.e., it is the maximum error acceptable for a measurement device according to the ANSI/AAMI DF2 (American..., 1996) standard. The results for the capacity of the calibration procedure were shown to be appropriate for the specifications of a defibrillator and cardioversor analyzer. At worst case the capacity index Cm was 2.87, well above the threshold of 1.0, which is the minimum value needed to consider the procedure as capable of calibrating energy measurements without incurring in a large definition uncertainty.
Evaluation; Metrology; Analyzer; Defibrillators; Cardioverters
