Τίτλος:
Validation of the InBody BPBIO210 manual auscultatory hybrid device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
OBJECTIVE: To evaluate the accuracy of the InBody BPBIO210 manual auscultatory mercury-free hybrid blood pressure (BP) measuring device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS: Subjects were recruited to fulfil the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). RESULTS: A total of 94 subjects were recruited and 86 were analysed (mean age 53.7 ± 18.4 [SD] years, 50 men, arm circumference 32.5 ± 4.8 cm, range 22-42 cm). For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.0 ± 4.1/-0.7 ± 2.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 2.65/1.59 mmHg (systolic/diastolic). CONCLUSIONS: The InBody BPBIO210 manual auscultatory hybrid device for professional office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Συγγραφείς:
Ntineri, A.
Menti, A.
Kyriakoulis, K.G.
Bountzona, I.
Prapa, S.
Kollias, A.
Stergiou, G.S.
Περιοδικό:
Blood Pressure Monitoring
Λέξεις-κλειδιά:
adult; aged; blood pressure; blood pressure measurement; blood pressure monitor; human; hypertension; male; middle aged; standard, Adult; Aged; Blood Pressure; Blood Pressure Determination; Blood Pressure Monitors; Humans; Hypertension; Male; Middle Aged; Reference Standards
DOI:
10.1097/MBP.0000000000000571
