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.
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