Validation of the iHealth ambulatory blood pressure monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization standard

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Abstract

Objective

To assess the accuracy of the iHealth oscillometric ambulatory blood pressure (BP) monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard.

Methods

Adults were recruited to fulfil the age, sex, BP and cuff distribution criteria of the ANSI/AAMI/ISO standard using the same-arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22–34 and 30–42 cm.

Results

A total of 100 individuals were recruited and 85 were included in the analysis. For validation criterion 1, the mean±SD of the differences between the test device and reference BP was −0.7±6.0/0.7±4.8 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference per participant was 4.72/3.97 mmHg (systolic/diastolic).

Conclusion

The iHealth ambulatory BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard in adults and can be recommended for clinical use.

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