Validation of the JOYTECH DBP-6279B blood pressure monitor in adults and adolescents according to the AAMI/ESH/ISO universal standard(ISO 81060-2:2018†+†Amd.1:2020).

This study aimed to validate the accuracy of DBP-6279B, an automated inflationary oscillometric upper-arm blood pressure (BP) monitor, in the sitting position according to the AAMI/ESH/ISO (81060-2 : 2018 + Amd.1 : 2020) universal standard protocol. SBPs and DBPs were measured simultaneously on the same arm in 88 adults (female : male = 47 : 41) with a mean age of 56.85 years using a mercury sphygmomanometer (two observers) and a DBP-6279B device (one supervisor). The AAMI/ESH/ISO 81060-2 : 2018 and Amd.1 : 2020 universal standards for the validation of BP-measuring devices in adults and adolescents were followed. A total of 259 valid pairs of data were used in the analysis. According to Criterion 1, the mean difference of SBP between the test device (DBP-6279B) and the reference device (the mercury sphygmomanometer) was 0.75 mmHg, with a SD of 7.66 mmHg. The mean difference in DBP was 1.13 mmHg, with a SD of 6.14 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 mean difference of SBP between the test device and the reference device was 0.85 mmHg, and the SD was 6.56 mmHg, which was less than 6.88 mmHg and met the requirements. The mean difference in DBP was 1.27 mmHg, and the SD was 5.42 mmHg, which was less than 6.82 mmHg and met the requirements. DBP-6279B fulfilled the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018 + Amd.1 : 2020); hence, it can be recommended for both clinical and self/home BP measurement in adults and adolescents.

Validation of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the ISO 81060-2:2018/AMD 1:2020 Protocol.

OBJECTIVE: To evaluate the accuracy of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the Universal Standard (ISO 81060-2:2018/AMD 1:2020). METHODS: Subjects were recruited to fulfill the age, gender, blood pressure (BP) and cuff distribution criteria of the Universal Standard in a general population using the same arm sequential BP measurement method. A single cuff for wrist sizes 13.5-21.5 cm was used on this test device. RESULTS: According to Criterion 1, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, with an SD of 6.48 mmHg. The mean difference of DBP was -0.44 mmHg, with an SD of 5.98 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 mean difference of SBP between the test device and the reference device was 1.51 mmHg, and the SD was 5.88 mmHg, which was less than 6.78 mmHg and met the requirements. The mean difference of DBP was -0.44 mmHg, and the SD was 5.22 mmHg, which was less than 6.93 mmHg and met the requirements. CONCLUSION: All results passed the Standard (ISO 81060-2:2018/AMD 1:2020) requirements. The U60EH Wrist Electronic Blood Pressure Monitor can be recommended for home and clinical use.