Accuracy of the OMRON M4 automatic blood pressure measuring device

Abstract

Despite widespread use of the automatic blood pressure (BP) measuring device OMRON M4, there is little formal validation on its accuracy. A study was conducted to assess the accuracy of the OMRON M4 compared with the true indirect BP measured by mercury sphygmomanometer (MS). A rapid method for the evaluation of automatic blood pressure measurement devices (READ) was applied for this study. The READ is based on numerous BP measurements at rest and during a standardised postural challenge in a small number of subjects who exhibit a wide range of BPs. Blood pressure measurements were done in supine position for 10 min followed by head-up tilt for 30 min and again supine for 10 min. The automatic device (AU) and the MS were connected to one arm-cuff by means of a T connector. A stethoscope with dual sets of ear-pieces was used for duplicate MS measurements (MS1 and MS2). The MS1, MS2 and AU measurements were taken simultaneously in a blinded manner. Three units of the automatic instrument were evaluated. An average of 111 measurements per unit were performed, every BP category being present in у15 MS measurements. The differences between MS1 and MS2 measurements (⌬BP: MS1-MS2)

Assessment of target-organ damage in adolescent white-coat and sustained hypertensives

“…Blood pressure measurement procedure After 10 min of rest, systolic and diastolic blood pressures were measured in the sitting position on the right arm using validated OMRON M4 digital oscillometry manometer (OMRON Healthcare GmbH, Hamburg, Germany) [15,16]. If the forearm circumference was 34 cm or over, an obesity-cuff was used.…”

“…Because of the potential genetic, geographic and environmental differences, we calculated our 'Central-European' reference data, and compared our results with those of the guidelines. We grouped our adolescents by sex (males, females), and age (15 years [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19], and all of these eight groups also by height (<25 pc; 25-49 pc; 50-74 pc; !75 pc). Altogether we had 2 Â 4 Â 4 ¼ 32 subgroups.…”

Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT)

“…Ideally, recommended devices should have been submitted to independent clinical validation procedures. During recent years, various automated devices for selfmeasurement of BP have been fabricated; only some of them have been validated [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] according to recognized protocols specifically designed for this purpose, such as the British Hypertension Society (BHS) protocol [24,25], the Association for the Advancement of Medical Instrumentation (AAMI) protocol [26,27] and the most recent International Protocol [22,28] published by the European Society of Hypertension (ESH). In this study, accuracy of two devices for self-measurement of BP was assessed according to the ESH protocol in two separate studies [28].…”

Automated non-invasive blood pressure devices: are they suitable for use?

“…[27]. We found a published study which concluded that the device did not meet the requirements of the BHS protocol [28]. Omron M5-I Claimed to be validated owing to similarity with Omron HEM-757 which meets AAMI criteria according to an unpublished report [29].…”