Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

OBJECTIVE

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010.

METHODS

Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants.

RESULTS

The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3).

CONCLUSION

The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults.