title: Validation of the FM-800 ambulatory blood pressure monitor according to the Association for the Advancement of Medical Instrumentation criteria and the International Protocol.
abstract: To validate the FM-800 device (Fukuda Denshi Co., Ltd., Tokyo, Japan) for ambulatory blood pressure monitoring (ABPM), this validation study was performed based on the European Society of Hypertension (ESH) protocol and the Association for the Advancement of Medical Instrumentation (AAMI) criteria. Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2) in the ESH protocol. The device was tested on 85 participants according to the AAMI criteria, which require a mean device-observers discrepancy within 5 ± 8 mmHg. The tested device passed all the criteria for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), and for the Korotkoff and oscillometric methods according to the ESH protocol. The test device also fulfilled the AAMI accuracy criteria for the 85 participants; the mean ± SD of the SBP/DBP differences between the tested device and the mean of the observer readings were -1.1 ± 4.2/-0.8 ± 4.2 mmHg for the Korotkoff method and 2.3 ± 3.9/-2.3 ± 3.9 mmHg for the oscillometric method. The FM-800 device for ABPM passed all the validation criteria of the ESH and AAMI and can, therefore, be recommended for clinical use in an adult population.
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Sciences and Medicine, Sendai, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Nakamura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kikuya
authors.forename: Azusa
authors.initials: A
authors.lastname: Hara
authors.forename: Takuo
authors.initials: T
authors.lastname: Hirose
authors.forename: Taku
authors.initials: T
authors.lastname: Obara
authors.forename: Hirohito
authors.initials: H
authors.lastname: Metoki
authors.forename: Kei
authors.initials: K
authors.lastname: Asayama
authors.forename: Ryusuke
authors.initials: R
authors.lastname: Inoue
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Ohkubo
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Totsune
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Imai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation* / Q000592:standards*; D015924:Blood Pressure Monitors / Q000592:standards*; D002985:Clinical Protocols / Q000592:standards; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D012958:Societies, Scientific