VALIDATION OF THE MECG-DP-NS-01 MONITOR IN OSCILLOMETRY AND AUSCULTATION MODES IN PREGNANCY, ACCORDING TO ESH IP-2, BHS AND AAMI PROTOCOLS

Cover Page


Cite item

Abstract

Background: Arterial hypertension in pregnancy is a major cause of maternal death and perinatal mortality. According to the Russian recommendations, only devices that have been evaluated according to international protocols may be used for ambulatory blood pressure monitoring in pregnancy.

Aim: Validation of the MECG-DP-NS-01 upper arm blood pressure monitor manufactured by the DMS Advanced Technologies Ltd., in oscillometry and auscultation modes for ambulatory blood pressure monitoring in pregnancy, 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 39 pregnant women at various gestation time (from 9 to 40 weeks, 29.2 ± 9.9 weeks) aged 25 to 43 years (31.9 ± 4.3 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 pregnancy, according to the BHS protocol revision 1993, the ESH-IP2 and the AAMI standard. The device met 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 met all the requirements and, fulfilling the standards of the protocols, is recommended for ambulatory blood pressure monitoring in pregnancy 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 and Clinical Institute (MONIKI)

Author for correspondence.
Email: fsi120@yandex.ru

PhD, Head of the Department of Functional Diagnostics

Russian Federation

N. V. Kulakov

Moscow Regional Research and Clinical Institute (MONIKI)

Email: fake@neicon.ru

Physician, Department of Functional Diagnostics

Russian Federation

V. P. Pronina

Moscow Regional Research and Clinical Institute (MONIKI)

Email: fake@neicon.ru

PhD, Senior Research Fellow, Department of Functional Diagnostics

Russian Federation

S. R. Mravyan

Moscow Regional Scientific Research Institute for Obstetrics and Gynecology

Email: fake@neicon.ru

MD, PhD, Professor, Head of the Therapeutic Group

Russian Federation

References

  1. Диагностика и лечение сердечно-сосудистых заболеваний при беременности. Российские рекомендации. Российский кардиологический журнал. 2013(4 Прилож. 1):1–40. (Diagnosing and Treating of Cardiovascular Diseases in Pregnancy. Russian Recommendations. Rossiyskiy kardiologicheskiy zhurnal. 2013(4 Suppl 1):1–40. Russian).
  2. O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010;15(1):23–38.
  3. O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG, Bland M, Coats A, Atkins N. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993;11(6):677–9.
  4. Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002/A1. USA:AAMI; 2003.
  5. Федорова СИ, Кулаков НВ, Кулакова ЕВ. Тестирование осциллометрического и аускультативного режимов работы монитора МЭКГ-ДП-НС-01 по протоколам ESH, BHS и AAMI. Альманах клинической медицины. 2014;31:34–9. (Fedorova SI, Kulakov NV, Kulakova EV. [Validation of the MECG-DP-NS-01 monitor in oscillometry and auscultation modes, according to ESH, BHS and AAMI protocols]. Al'manakh klinicheskoy meditsiny. 2014;31:34–9. Russian).
  6. O'Brien E, Mee F, Tan KS, Atkins N, O'Malley K. Training and assessment of observers for blood pressure measurement in hypertension research. J Hum Hypertens. 1991;5(1):7–10.
  7. Atkins N, O'Brien E. The dabl Educational Trust device equivalence procedure. Blood Press Monit. 2007;12(4):246–9.

Copyright (c) 2015 Fedorova S.I., Kulakov N.V., Pronina V.P., Mravyan S.R.

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies