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.

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.