Validation of the LD-526 brachial blood pressure monitor according to the International Organization for Standardization protocol (ISO 81060-2:2018/AMD 1:2020/AMD 2:2024).

Abstract

OBJECTIVE: The LD-526 oscillometric upper-arm blood pressure (BP) monitor is intended for self-measurement of BP in adults. The aim of this study was to evaluate the accuracy of LD-526 oscillometric upper-arm BP monitor in the general population according to the International Organization for Standardization (ISO) universal standard (ISO 81060-2 : 2018/AMD 1 : 2020/AMD 2 : 2024). METHOD: Subjects were recruited to fulfill the age, gender, BP, and cuff distributions of the ISO universal standard in the general population using the same-arm sequential BP measurement method. The test device was used with one universal cuff for arm circumferences of 22-42 cm. Reference BP measurements were obtained using a calibrated mercury sphygmomanometer, with two cuffs (inflatable bladder sizes of 12 × 24 and 16 × 32 cm, respectively). RESULTS: Of the 98 recruited subjects, 85 [women/men: 46/39; mean (±SD) age: 52.2 ± 17.4 years] were analyzed, and 13 were excluded from the final analysis: 10 because of reference BP variability and three because of cardiac arrhythmias. For validation of criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.34 ± 5.56/-0.31 ± 4.36 mmHg (systolic/diastolic). For criterion 2, the SD of the average BP differences between the test device and reference BP per subject was 4.51/3.77 mmHg (systolic/diastolic). CONCLUSION: The LD-526 BP monitor fulfilled all the requirements of the ISO universal standard (ISO 81060-2 : 2018/AMD 1 : 2020/AMD 2 : 2024) in the general population and can be recommended for self-measurement.