Email this article VALIDATION OF THE MECG-DP-NS-01 MONITOR IN OSCILLOMETRY AND AUSCULTATION MODES, ACCORDING TO ESH, BHS AND AAMI PROTOCOLS
- Authors: Fedorova S.I.1,2, Kulakov N.V.1,2, Kulakova E.V.1,2
-
Affiliations:
- Moscow Regional Research аnd Clinical Institute (MONIKI)
- 61/2 Shchepkina ul., 129110 Moscow, Russian Federation
- Issue: No 31 (2014)
- Pages: 34-39
- Section: ARTICLES
- URL: https://almclinmed.ru/jour/article/view/56
- DOI: https://doi.org/10.18786/2072-0505-2014-1-31-9-16
- ID: 56
Cite item
Full Text
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 Россия
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 Россия
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 Россия
References
- Диагностика и лечение артериальной гипертензии. Рекомендации Российского медицинского общества по артериальной гипертонии и Всероссийского научного общества кардиологов. Системные гипертензии 2010;(3):5-26. [Arterial hypertension diagnosis and therapy. Recommendations of the Russian Medical Society of Hypertension and the All-Russian Society of Cardiology. Sistemnye gipertenzii 2010;(3):5-26 (in Russian)].
- Mancia G., Fagard R., Narkiewicz K., Redón J., Zanchetti A., Böhm M., Christiaens T., Cifkova R., De Backer G., Dominiczak A., Galderisi M., Grobbee D.E., Jaarsma T., Kirchhof P., Kjeldsen S.E., Laurent S., Manolis A.J., Nilsson P.M., Ruilope L.M., Schmieder R.E., Sirnes P.A., Sleight P., Viigimaa M., Waeber B., Zannad F. Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertension 2013;31(7):1281-357.
- O’Brien E., Atkins N., Stergiou G., Karpettas N., Parati G., Asmar R., Imai Y., Wang J., Mengden T., Shennan A.; On behalf of the 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.
- O’Brien E., Petrie J., Littler W., de Swiet M., Padfield P.L., Altman D.G., 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.
- Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002/A1. USA: AAMI; 2003.
- O’Brien E., Mee F., Tan K.S., 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.
- Atkins N., O’Brien E. The dabl Educational Trust device equivalence procedure. Blood Press Monit 2007;12(4):245-9.
Supplementary files
