Blood pressure monitoring · 2020
Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Kollias Anastasios, Anagnostopoulos Ioannis, Gravvani Areti, Stambolliu Emelina, Bountzona Ioanna, Menti Ariadni, Stergiou George S
Аннотация
OBJECTIVE: To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home blood pressure (BP) monitor in 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 fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in 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: One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.9 ± 6.9/0.5 ± 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic).
CONCLUSION: The InBody BP170 oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.
METHODS: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in 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: One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.9 ± 6.9/0.5 ± 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic).
CONCLUSION: The InBody BP170 oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.