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.
| Original language | English |
|---|---|
| Pages (from-to) | 523-527 |
| Number of pages | 5 |
| Journal | Clinical and Experimental Hypertension |
| Volume | 32 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 2010 Dec 1 |
| Externally published | Yes |
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Keywords
- accuracy
- ambulatory blood pressure monitoring (ABPM)
- validation
ASJC Scopus subject areas
- Internal Medicine
- Physiology
Cite this
Validation of the FM-800 ambulatory blood pressure monitor according to the association for the advancement of medical instrumentation criteria and the international protocol. / Nakamura, Kaori; Kikuya, Masahiro; Hara, Azusa; Hirose, Takuo; Obara, Taku; Metoki, Hirohito; Asayama, Kei; Inoue, Ryusuke; Ohkubo, Takayoshi; Totsune, Kazuhito; Imai, Yutaka.
In: Clinical and Experimental Hypertension, Vol. 32, No. 8, 01.12.2010, p. 523-527.Research output: Contribution to journal › Article
}
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
PY - 2010/12/1
Y1 - 2010/12/1
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
UR - http://www.scopus.com/inward/record.url?scp=79251514692&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79251514692&partnerID=8YFLogxK
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 -