TY - JOUR
TI - 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
AU - Ntineri, A.
AU - Menti, A.
AU - Kyriakoulis, K.G.
AU - Bountzona, I.
AU - Prapa, S.
AU - Kollias, A.
AU - Stergiou, G.S.
JO - Blood Pressure Monitoring
PY - 2022
VL - 27
TODO - 2
SP - 135-138
PB - NLM (Medline)
SN - 1359-5237, 1473-5725
TODO - 10.1097/MBP.0000000000000571
TODO - 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
TODO - 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.
ER -