Abstract
To evaluate the overall effectiveness and safety of the ARM-30F-XL arm blood pressure (BP) monitor in individuals with an arm circumference of 22–52 cm. Subjects were recruited from patients, patient companions, and individuals attending routine health examinations at the hospital. The test device was the ARM-30F-XL, and the reference device was a mercury sphygmomanometer. Using BP readings obtained from the mercury sphygmomanometer as the reference standard, the accuracy of the noninvasive BP module of the test device was evaluated to determine whether it met the specified requirements. This study analyzed valid BP data from 97 subjects. According to criterion 1, the mean difference in SBP between the test device and the reference device was 1.69 mmHg, and the SD was 5.00 mmHg. The mean difference in DBP was −2.16 mmHg, and the SD was 4.45 mmHg. The mean difference of both SBP and DBP was less than ±5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to criterion 2, the SD of SBP was 4.00 mmHg, which was less than 6.73 mmHg and met the requirements. The SD of DBP was 3.73 mmHg, which was less than 6.58 mmHg and met the requirements. The ARM-30F-XL complies completely with International Standard ISO 81060-2:2018+Amd 2:2024 and is recommended for BP measurement in individuals with an arm circumference of 22–52 cm for home and clinical use.