Validation of the Parama-Tech PS-501 Device for Office Blood Pressure Measurement According to the International Protocol

Abstract

The PS-501 device (Parama-Tech, Fukuoka, Japan), an automated device for office blood pressure measurement based on the Korotkoff method and designed for professional use in clinical settings, was validated. Consecutive outpatients with hypertension and ≥30 years old at an outpatient hypertension clinic were recruited. According to the European Society of Hypertension protocol, 33 participants were included in the validation study (phase 1, n = 15; phase 2, n = 18). The cuff deflation rate can be selected manually from 2, 3, and 4 mm Hg/beat. The validation was performed with the device deflating at a rate of 2 mm Hg/beat. All blood pressure readings were measured on the left arm. The tested device passed all criteria for both systolic and diastolic blood pressure measurements. The mean (± standard deviation) differences in systolic and diastolic blood pressure between the tested device and the mean of observer readings were −1.9 ± 4.6 and −2.5 ± 2.9 mm Hg, respectively. The PS-501 device for office blood pressure measurement passed all the validation criteria of the European Society of Hypertension and can therefore be recommended for clinical use in an adult population.

• Korotkoff
• validation
• accuracy
• International Protocol
• Parama-Tech
• office blood pressure

ACKNOWLEDGMENTS

This work was mainly funded by a grant from Fukuda Denshi Co., Ltd., Tokyo, Japan. This work was also supported in part by Grants for Scientific Research (18390192, 18590587, 19590929, 19790423, 20590629, 21390201, 21591016, 22590767, 22790556, and 22890017) from the Ministry of Education, Culture, Sports, Science, and Technology, Japan; Grant-in-Aid (H18-Junkankitou[Seishuu]-Ippan-012, and H20-Junkankitou[Seishuu]-Ippan-009, 013) from the Ministry of Health, Labor and Welfare, Health and Labor Sciences Research Grants, Japan; Grant-in-Aid for Japan Society for the Promotion of Science (JSPS) fellows (18.54042, 19.7152, 20.7198, 20.7477, and 20.54043); Health Science Research Grants and Medical Technology Evaluation Research Grants from the Ministry of Health, Labor and Welfare, Japan; Japan Arteriosclerosis Prevention Fund; Biomedical Innovation Grants; and Miso Central Institute, Tokyo, Japan.

Declaration of interest: The authors report no conflicts of interest. The authors are responsible for the content and writing of the paper.