Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z)

Abstract

Background

Allowing patients to measure their blood pressure (BP) at home will be the standard for evaluating the disease state as the process of clinical diagnosis, and it is recognized as having great clinical utility. To measure BP as accurately as possible, innovative techniques have been incorporated into home BP measurement devices.

Objective

The present study aimed to evaluate the performance of the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z), which are equipped with functions to detect irregular pulses and arm movement that lead to inaccurate BP readings.

Methods

A team of three trained medical doctors validated the performance of these devices by comparing the data alternatively obtained from both devices with those from a standard mercury sphygmomanometer.

Results

The magnitude of the difference in BP readings between the tested device and the standard mercury sphygmomanometer in the Omron BP765 and BP760N was within the range of ±3 mmHg (mean) allowed by the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2009 guidelines.

Conclusion

The Omron BP765 and BP760N were found useful for the self-measurement of BP at home, and their performance fulfilled the requirement of the ANSI/AAMI/ISO 81060-2:2009 guidelines.

Keywords:

• blood pressure
• self-measurement
• device
• validation
• ANSI/AAMI/ISO 81060-2:2009

Acknowledgments

We are grateful to the volunteers who agreed to have their blood pressure measured for the purpose of validating the Omron BP760N and BP765 and to Omron Healthcare Co, Ltd, for supplying these standard devices used in the present study. This research received no special grant from any funding agency by public, commercial, or not-for-profit organizations but was supported by the Kansai Medical University.

Disclosure

The Omron Healthcare Co, Ltd provided the standard devices, BP760N and BP765, used in the present study. The authors have no other conflicts of interest in the work.