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)

• Published in: Vascular health and risk management 2015-01, Vol.11 (default), p.49-53
• Main Authors: Takahashi, Hakuo, Yoshika, Masamichi, Yokoi, Toyohiko
• Format: Article
• Language: English
• Subjects: Adult; Aged; ANSI/AAMI/ISO 81060-2:2009; Automation; Blood Pressure; Blood Pressure Determination - instrumentation; Blood Pressure Determination - standards; Cardiac arrhythmia; Clinical medicine; device; Equipment Design; Experiments; Female; Heart beat; Heart rate; Humans; Hypertension; Male; Measurement; Middle Aged; Original Research; Oscillometry; Practice Guidelines as Topic; Predictive Value of Tests; Reproducibility of Results; self-measurement; Social impact; Society; Sphygmomanometer; Sphygmomanometers; Systematic review; Testing; Upper Extremity - blood supply; validation; Working groups; Young Adult
• ISSN: 1178-2048; 1176-6344; 1178-2048
• DOI: 10.2147/vhrm.s72438

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. 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. 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. 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. 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.