Validation of the Welch Allyn Pro BP 2000, a professional-grade inflation-based automated sphygmomanometer with arrhythmia detection in a combined pediatric and adult population by ANSI/AAMI/ISO standard testing

通过ANSI/AAMI/ISO标准测试,对Welch Allyn Pro BP 2000(一款专业级充气式自动血压计,具备心律失常检测功能)在儿童和成人混合人群中的有效性进行了验证。

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Abstract

OBJECTIVE: The Welch Allyn Pro BP 2000, an automated sphygmomanometer, was subjected to ANSI/AAMI/ISO testing. PATIENTS AND METHODS: The protocol used was the same-arm sequential procedure described in the ANSI/AAMI/ISO 2013 Standard. Eight-eight (53 adults and 35 children aged 3-12 years old) patients completed testing successfully. Arm circumferences ranged from 15 to 49.5 cm. Seven different cuff sizes were used, including two long cuffs. RESULTS: All requirements for age, sex, blood pressure (BP), and cuff sizes were fulfilled. The mean±SD was -2.8±6.37 mmHg for systolic BP for criterion 1 and -3.6±6.14 mmHg for diastolic BP. The SD for criterion 2 were 5.29 for systolic BP and 5.75 for diastolic BP. All data passed the Standard's requirements. CONCLUSION: The Pro BP 2000 uses an accurate inflationary algorithm. The time for each inflation/deflation cycle is short, thus improving patient comfort. There is also arrhythmia detection to caution the use of BP values obtained during irregular heart rhythms. The algorithm for the professional-grade Pro BP 2000 is also contained in the Home BP 1700, targeted for home use. This encourages out-of-office self-measurement. The healthcare professional can be confident that the values obtained at different sites are comparable.

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