Validation of the QMon-20 oscillometric blood pressure monitor for professional office use in the general population according to the ANSI/ESH/ISO 81060-2:2018 protocol

Abstract

Objective: we assessed the accuracy of the QMon-20 oscillometric upper-arm cuff device professional for office blood pressure (BP) in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Methods: Subjects were recruited according to AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-31 (medium) and 32-42 cm (large).

Results: One-hundred and fourteen subjects were recruited and 106 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.8 ± 5.4/-0.5 ± 4.2 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 4.34/3.48 mmHg (systolic/diastolic).

Conclusion: The QMon-20 oscillometric device for office BPs measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.