Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Microlife BP3KT1-4X (BP B3 Comfort PC) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypert
Dimitrios Mariglis, Ariadni Menti, Vasileios Ntousopoulos, Petroula Lempidaki, Konstantina-Rozalia Bakalakou, Aikaterini Komnianou, Konstantinos G. Kyriakoulis, Anastasios Kollias, George S. StergiouObjective
This study evaluated the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) device Microlife BP3KT1-4X (BP B3 Comfort PC) for home 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) and its amendments (1:2020 and 2:2024).
Methods
Participants were recruited to fulfill the age, sex, BP, and arm distribution criteria of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) in a general population using the same arm sequential measurement method. A single wide-range cuff of the test device was used for arm circumference 22–42 cm.
Results
A total of 122 individuals were recruited, and 85 were analyzed [mean age 54.5 ± 15.7 (SD) years, 34 men (40%), arm circumference 31.6 ± 5.4 cm, range 22.8–41.8 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings (
Conclusion
The automated oscillometric home BP monitor Microlife BP3KT1-4X (BP B3 Comfort PC) fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its amendments (1:2020 and 2:2024) in a general population and therefore can be recommended for self-monitoring of BP at home.