Validation of the Nihon Kohden PVM-2701/Impulse-1 automated device by both AAMI (2002) and ISO standards testing

Abstract

We evaluated a new algorithm, the Nihon Kohden PVM-2701/Impulse-1, in an automated sphygmomanometer against the requirements of both the Association for the Advancement of Medical Instrumentation (AAMI) SP10 and International Standards Organization (ISO) standards. The Impulse-1 algorithm primarily utilizes a 1 pulse/step deflation. The advantage of the system is to reduce the time of deflation and improve patient comfort. We tested 110 participants (41 children) to fulfill the Standards requirements. We used the more up-to-date statistical analyses in the ISO standard. The mean ± SD for method 1 analyses for systolic blood pressure was 0.3 ± 6.5 mmHg. For diastolic blood pressure the value was -0.3 ± 7.7 mmHg. Method 2 analyses gave values of 0.3 ± 5.2 mmHg for systolic blood pressure and -0.3 ± 6.7 mmHg for diastolic blood pressure. All of the data were within the Standards requirements to pass testing. There was no trend for overestimation or underestimation of BP at either low or high BP levels. The Impulse-1 algorithm passed both the AAMI and ISO standards testing in children and adults. The novelties of the 1 pulse/step deflation algorithm are the significant reduction in deflation time and the manufacturer's claim concerning artifact rejection for both dysrhythmia and motion.