title: 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.
authors.affiliation: Department of Planning for Drug Development and Clinical Evaluation, Graduate School of Medicine and Pharmaceutical Sciences, Tohoku University, Sendai, Japan. kikuyam@m.tains.tohoku.ac.jp
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kikuya
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Ohkubo
authors.forename: Michihiro
authors.initials: M
authors.lastname: Satoh
authors.forename: Takanao
authors.initials: T
authors.lastname: Hashimoto
authors.forename: Takuo
authors.initials: T
authors.lastname: Hirose
authors.forename: Hirohito
authors.initials: H
authors.lastname: Metoki
authors.forename: Taku
authors.initials: T
authors.lastname: Obara
authors.forename: Ryusuke
authors.initials: R
authors.lastname: Inoue
authors.forename: Kei
authors.initials: K
authors.lastname: Asayama
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Totsune
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Imai
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure; D001795:Blood Pressure Determination / Q000295:instrumentation* / Q000592:standards* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis*; D038622:Internationality; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D010824:Physicians' Offices; D015203:Reproducibility of Results