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

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.