Department of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Sciences and Medicine, Sendai, Japan.
Clin Exp Hypertens. 2010;32(8):523-7. doi: 10.3109/10641963.2010.496513.
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.
为了验证 FM-800 设备（日本福岛电子有限公司）用于动态血压监测（ABPM）的准确性，本验证研究基于欧洲高血压学会（ESH）方案和美国医疗器械促进协会（AAMI）标准进行。该 ESH 方案纳入了 33 名参与者（第 1 阶段 15 名，第 2 阶段另外 18 名）。根据 AAMI 标准，该设备在 85 名参与者中进行了测试，该标准要求设备与观察者之间的平均差异在 5 ± 8 mmHg 以内。根据 ESH 方案，所测试的设备通过了所有收缩压（SBP）和舒张压（DBP）的标准，以及柯氏音法和示波法的标准。根据 AAMI 标准，该测试设备也满足 85 名参与者的准确性标准；测试设备与观察者读数平均值之间的 SBP/DBP 差值的平均值 ± SD 为柯氏音法为-1.1 ± 4.2/-0.8 ± 4.2 mmHg，示波法为 2.3 ± 3.9/-2.3 ± 3.9 mmHg。FM-800 用于 ABPM 的设备通过了 ESH 和 AAMI 的所有验证标准，因此可以推荐在成年人群中用于临床使用。
