Validation of the BIOS BD240 home blood pressure monitor in a multi-racial, multi-morbid Canadian population according to the International Standards Organization 2018 Protocol. Issue 3 (June 2020)

• Record Type: Journal Article
• Authors: Ringrose, Jennifer S.; Wood, Peter W.; Diaz-Carvallo, Fabiola; Wirzba, Mira; Padwal, Raj
• Is Part Of: Blood pressure monitoring. Volume 25:Issue 3(2020)
• Publication Date: 2020-06
• Subjects: auscultatory -- blood pressure measurement -- oscillometric -- validation; Blood pressure -- Measurement -- Periodicals; Blood Pressure Determination -- Periodicals; Blood Pressure Monitoring, Ambulatory -- Periodicals; Blood Pressure Monitors -- Periodicals; Hypertension -- Periodicals; 612.140287
• DOI: 10.1097/MBP.0000000000000444
• Languages: English
• ISSNs: 1359-5237

Abstract

Abstract : Objective: Assess the accuracy of the BIOS BD240 home blood pressure (BP) monitor and wide-range cuff according to the International Organization for Standardization (ISO) 2018 standard. Methods: Eighty-five subjects (aged ≥18 y) with arm circumferences between 24 and 43 cm were studied. Blinded, two-observer, mercury-based auscultation performed using a two-piece cuff chosen for upper arm size was used for reference measurements. Accuracy criteria 1 and 2 of the ISO standard were determined and Bland–Altman plots generated. Results: Sixty percent of the study sample was female and 42% had hypertension. Mean device-to-reference standard differences in SBP/DBP were 0.0 ± 6.2/−0.2 ± 6.3 for criterion 1 and 0.0 ± 4.8/−0.2 ± 5.8 for criterion 2. Conclusion: The BIOS BD240 passed the requirements of the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ISO standard for both SBP and DBP and can be recommended for use.