VALIDATION OF THE MECG-DP-NS-01 MONITOR IN OSCILLOMETRY AND AUSCULTATION MODES, ACCORDING TO ESH, BHS AND AAMI PROTOCOLS

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Abstract

Background: Ambulatory blood pressure monitoring is one of the main methods for hypertension diagnosis. According to the recommendations of the Russian Medical Society of Hypertension and the All-Russian Society of Cardiology, only devices that passed all of the international protocols requirements can be recommended for ambulatory blood pressure monitoring. Aim: Validation of the MECG-DP-NS-01 upper arm blood pressure monitor produced by the DMS Advanced Technologies Ltd., in oscillometry and auscultation modes, for ambulatory blood pressure monitoring, in an adult population at rest according to the ESH International Protocol revision 2010 (ESH-IP2), the BHS protocol revision 1993 and the AAMI standard. Materials and methods: A group of 85 people (50 men and 35 female) aged 19 to 86 years (mean age 47.7±18.0 years) was recruited for the validation study. Expert and device blood pressure measurements were taken for each patient according to the international protocols. Results: The MECG-DP-NS-01 upper arm blood pressure monitor produced by the DMS Advanced Technologies Ltd. for ambulatory blood pressure monitoring, was validated in oscillometry and auscultation modes in an adult population at rest according to the BHS protocol revision 1993, the ESH-IP2, and the AAMI standard. The device achieved an A/A grading for the BHS protocol revision 1993 both in the oscillometry and auscultation modes. The device maintained its A/A grading throughout the low-pressure, medium-pressure, and high-pressure ranges. Conclusion: The MECG-DP-NS-01 passed all of the requirements and, fulfilling the standards of the protocols, is recommended for ambulatory blood pressure monitoring according to BHS protocol revision 1993, ESH-IP2, and AAMI standard. According to the Declaration of Blood Pressure Measuring Device Equivalence signed by the manufacturer there are no differences that will affect blood pressure measuring accuracy between the MDP-NS-02s (Voshod) upper arm blood pressure monitor produced by the DMS Advanced Technologies Ltd. and the MECG-DP-NS-01, which passed the ESH-IP2, BHS and AAMI protocols.

About the authors

S. I. Fedorova

Moscow Regional Research аnd Clinical Institute (MONIKI); 61/2 Shchepkina ul., 129110 Moscow, Russian Federation

Author for correspondence.
Email: fsi120@yandex.ru
PhD, Head of the Department of Functional Diagnostics, MONIKI Russian Federation

N. V. Kulakov

Moscow Regional Research аnd Clinical Institute (MONIKI); 61/2 Shchepkina ul., 129110 Moscow, Russian Federation

Email: fake@neicon.ru
MD, physician of the Department of Functional Diagnostics, MONIKI Russian Federation

E. V. Kulakova

Moscow Regional Research аnd Clinical Institute (MONIKI); 61/2 Shchepkina ul., 129110 Moscow, Russian Federation

Email: fake@neicon.ru
a nurse of the Department of Functional Diagnostics, MONIKI Russian Federation

References

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Copyright (c) 2016 Fedorova S.I., Kulakov N.V., Kulakova E.V.

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