Validation of the G.LAB MD6300 upper arm blood pressure monitor in different positions according to the AAMI/ESH/ISO Universal Standard (ISO81060-2:2018+AMD1:2020).

Abstract

Objective: To validate the accuracy of the G.LAB MD6300 oscillometric upper arm blood pressure monitor in the sitting, supine, and right lateral decubitus position in the 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+AMD1 : 2020).

Methods: The qualified participants were recruited in the study and the same left-arm sequential method was used for blood pressure measurement according to the Universal Standard. The validation results were assessed for the three positions and the Bland-Altman scatter plot was used to show the difference between the test device and reference results.

Results: A total of 85 participants were included in the analysis. The mean differences between the test device and reference readings were 0.95 ± 6.76/0.47 ± 6.71 mmHg, 0.55 ± 6.73/-0.20 ± 6.72 mmHg, and -0.71 ± 7.11/-0.86 ± 7.06 mmHg for SBP and DBP for the validation criterion 1 in the sitting position, supine with upward palm position, and right lateral decubitus position with downward left palm flat on left side position, respectively. Furthermore, the mean differences and their standard deviations for SBP and DBP calculated according to criterion 2 in the ISO81060-2 : 2018+AMD1 : 2020 were acceptable in all three positions.

Conclusion: The G.LAB MD6300 upper arm blood pressure monitor fulfilled the validation criteria of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018+AMD1 : 2020) in the sitting position, and its accuracy in the supine and right lateral decubitus position was acceptable and roughly equivalent to that in the sitting position. Therefore, it can be recommended for clinical use and self-measurement in the general population.