THE ACCURACY AND CLINICAL-PERFORMANCE OF A NEW COMPACT AMBULATORY BLOOD-PRESSURE MONITORING DEVICE, THE ES-H531

The validity and clinical performance of the ES-H531, a newly develope d ambulatory blood pressure (BF) monitoring device, were evaluated. Th e validity was assessed by simultaneous comparisons (total of 223 meas urements) with the measurements made by two experienced observers usin g standard mercury column sphygmomanometers in 121 subjects. The clini cal performance was evaluated through the number of measurement failur es by observation of the cuff equipped site, and tolerability was asse ssed by administering a questionnaire to 30 of the subjects following completion of 24-h BF monitoring. The differences in systolic and in d iastolic BP measured by the standard auscultation method and that meas ured with the ES-H531 by the Korotkoff method (K method) was 0.9 +/- 3 .7 mm Hg (mean +/- standard deviation) and 0.1 +/- 3.2 mm Hg, respecti vely. These values satisfy the accuracy criteria of the American Assoc iation of Medical instruments (AAMI) and accord with the grade of A in the accuracy criteria of the British Hypertension Society (BHS). The mean difference in systolic and in diastolic BP as assessed by the sta ndard auscultation method and with the ES-H531 by the oscillometric me thod (O method) wars 1.1 +/- 4.6 mm Hg and 2.7 +/- 5.4 mm Hg, respecti vely. This accords with grade B in the BNS accuracy criteria. Failures or errors in measurement occurred in 4.4% of the readings. A few subj ects experienced discomfort because of noise or pain during measuremen ts. The ES-H 531, a new compact and light weight ambulatory BP monitor ing device, offers acceptable validity and sufficient comfort: for cli nical use. (C) 1998 American Journal of Hypertension, Ltd.