除颤分析仪检定结果的不确定度分析评定

目的：通过分析DA-1型除颤分析仪在检定中的不确定度来源,评定和验证除颤能量的不确定度、重复性和稳定性,确保分析仪的质量安全。方法：着重对最大允许误差、能量显示分辨力及释放能量测量重复性3个方面的不确定度来源进行了分析和评定。结果：依据WSB64-2003《心脏除颤器和除颤分析仪检定规程》的各项要求,得出了相应的相对扩展不确定度。结论：经过分析和评定,除颤分析仪的各项不确定度来源的结果符合规程要求,可以检测临床使用的除颤器,确保其质量安全。

Analysis and evaluation of uncertainty of the verification results about the defibrillator analyzer

Objective：Through analyze the uncertainty sources in verification about defibrillation analyzer of DA-1 type, assess and verify of defibrillation energy uncertainty, repeatability and stability to ensure the quality of the analyzer. Methods：The maximum permissible error, energy display resolution, releasing energy measurement repeatability three aspects：source of uncertainty was analyzed and evaluated. Results：On the basis of WSB64-2003“verification regulation for cardiac defibrillators ＆amp; cardiac defibrillator-monitors”, the relative expanded uncertainty can be obtained. Conclusion：Through analysis and evaluation, the source of the uncertainty of the results of defibrillation analyzer are conform to rules of the regulation, the defibrillation analyzer can detect the defibrillator of clinical to ensure the quality and safety.