Validation of the EDAN SA-10 ambulatory blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard

Abstract

Objective 

To evaluate the accuracy of the EDAN SA-10 oscillometric upper-arm professional office ambulatory blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) Universal Standard (ISO 81060-2:2018).

Methods 

Subjects were recruited according to the AAMI/ESH/ISO Universal Standard using the same arm sequential BP measurement method. Four cuffs of the test device were used for arm circumference 16–21.5 cm (extra small), 20.5–28 cm (small), 27–35 cm (medium), and 34–43 cm (large).

Results 

A total of 105 subjects were recruited, and 97 subjects were included in the final analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was −0.59 ± 4.04/−1.79 ± 4.39 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 3.10/3.80 mmHg (systolic/diastolic).

Conclusion 

The EDAN SA-10 upper-arm ambulatory BP monitor has passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.