Journal of Clinical Physiology
Online ISSN : 2435-1695
Print ISSN : 0286-7052
Original Article
Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010
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2019 Volume 49 Issue 1 Pages 37-46


Objective: Enabling patients to measure their blood pressure (BP) at home is recognized as being of great clinical utility. Moreover, the monitoring devices that make this possible can be equipped with accessary functions useful to the promotion of health management. These include elimination of noise due to arm movement; guidance in arm wrapping; detection of irregular pulses; and various types of information-communication technology. The most important function of the device, however, is to accurately measure BP. Therefore, protocols for validation of BP monitoring devices have been proposed. Such a device can only be considered suitable for home use if it meets the criteria of these protocols. The aim of the present study was to evaluate the performance of 3 such devices according to the ESH-IP revision 2010.

Methods: Three trained medical technologists evaluated the performance of the Omron HEM-7600T-E, HEM-9210T, and HEM-7134-E in comparison with data obtained with a standard mercury sphygmomanometer. A total of 33 participants were enrolled in the experiments.

Results: The mean differences between each device and the mercury readings for systolic and diastolic BP were as follows: HEM-7600T-E, -0.1±5.0 mmHg and 0.2±4.1 mmHg, respectively; HEM-9210T, -2.1±4.7 mmHg and -1.2±4.1 mmHg, respectively; and HEM-7134-E, -0.9±5.4 mmHg and 0.6±4.7 mmHg, respectively. These findings indicate that the readings obtained with each device were similar to those of the mercury sphygmomanometer. The number of absolute differences between the devices and observers was found to meet the requirements of ESH-IP revision 2010.

Conclusion: The Omron HEM-7600T-E, HEM-9210T, and HEM-7134-E passed all the requirements of the ESH-IP 2010 revision.

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© 2019 Japanese Society of Clinical Physiology
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