TY - JOUR
T1 - Validation of the FM-800 ambulatory blood pressure monitor according to the association for the advancement of medical instrumentation criteria and the international protocol
AU - Nakamura, Kaori
AU - Kikuya, Masahiro
AU - Hara, Azusa
AU - Hirose, Takuo
AU - Obara, Taku
AU - Metoki, Hirohito
AU - Asayama, Kei
AU - Inoue, Ryusuke
AU - Ohkubo, Takayoshi
AU - Totsune, Kazuhito
AU - Imai, Yutaka
N1 - Funding Information:
Scientific Research (15790293, 16590433, 17790381, 18390192, 18590587, 19590929, and 19790423) from the Ministry of Education, Culture, Sports, Science, and Technology, Japan; Grant-in-Aid (H17-Kenkou-007, 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 (16.54041, 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 Atherosclerosis Prevention Fund; Uehara Memorial Foundation; Takeda Medical
Funding Information:
This work was funded by a grant from Fukuda Denshi Co., Ltd., Tokyo, Japan. The authors gratefully acknowledge the technical assistance of Koji Imai, Shinichi Kawamura (Fukuda Denshi Co., Ltd., Tokyo, Japan). This study was also supported in part by Grants for
PY - 2010
Y1 - 2010
N2 - 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.
AB - 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.
KW - accuracy
KW - ambulatory blood pressure monitoring (ABPM)
KW - validation
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U2 - 10.3109/10641963.2010.496513
DO - 10.3109/10641963.2010.496513
M3 - Article
C2 - 21091358
AN - SCOPUS:79251514692
VL - 32
SP - 523
EP - 527
JO - Clinical and Experimental Hypertension
JF - Clinical and Experimental Hypertension
SN - 1064-1963
IS - 8
ER -