Validation of the complex for daily monitoring of ECG and blood pressure "Medicom-Combi" for blood pressure measurement in medical institutions in the general population (according to the Universal standard AAMi / ESH / ISO UNIVERSAL)

Purpose. To assess the accuracy of blood pressure measurement by oscillometric and auscultatory methods using the complex for daily monitoring of ECG and blood pressure «Medicom-Combi» in accordance with the criteria outlined in the Universal Standard AAMI/SH/ISO (ISO 81060-2:
2018) for children and adults.
Materials and methods. The study involved 90 patients (average age -33.8 ± 26.7 years) of the cardiological profile of the City Clinical Hospital No. 13 DZM, Children’s City Clinical Hospital No. 9 named after G. N. Speransky, as well as medical personnel, of which 85 were included in the analysis. For each participant, 3 pairs of valid measurements were obtained (reference-test, 255 pairs of measurements in total). Reference measurements were carried out by two experts, independently of each other, using the auscultatory method. Test measurements were read from the complex by a third expert.
Results. According to validation criterion 1, the mean ± standard deviation of differences between test and reference measurements was 0.1 ± 6.0/1.7 ± 5.8 mm Hg for SBP/DBP by the oscillometric method and 0.0 ± 6.5/1.3 ± 6.6 mm Hg for SBP/DBP by the auscultatory method. According to validation criterion 2, the standard deviation of the average difference between the BP values of the same patient according to the results of test and reference measurements did not exceed 6.95/6.73 for SBP/DBP by the oscillometric method and 6.95/6.82 mm Hg for SBP/DBP by the auscultatory method.
Conclusion. The complex for daily monitoring of ECG and blood pressure «Medicom-Combi» meets the requirements of the Universal Standard AAMI/ESH/ISO in terms of measurement accuracy for devices intended for use among children and adults when assessing blood pressure by oscillometric and auscultatory methods. 

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