A.I. BURNASYAN FMBC CLINICAL BULLETIN

ISSN 2782-6430 (print)

State Research Center −Burnasyan Federal Medical Biophysical
Center of Federal Medical Biological Agency

The journal is published in Russian.
Format – A4.
The periodicity of the journal is 4 times a year.

Issue №2 2025 год

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A.I. Burnasyan  FMBC clinical bulletin. 2024 № 2

I.N. Posokhov1, O.S. Orlova1,2, E.А. Sukhodolova2, A.V. Lystseva2

Validation of an Automatic Sphygmomanometer with Cuff Range of “17-22”
for Measurements in Adults with Upper Arm Circumference of 22 Centimeters or Less

1International Office, State Research Center – Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency, Moscow, Russiа

2Pirogov Russian National Research Medical University, Moscow, Russia

Contact person: Lystseva Aleksandra Vasilevna: aleksandra.lyst@gmail.com

 

Abstract
To validate a blood pressure (BP) monitor 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) in a special population of adults with an upper arm circumference of 22 cm or less 37 subjects were recruited. The previously validated in general population OMRON M2 Basic (HEM-7121) was used with a HEM CS24 cuff designed for an upper arm circumference of 17–22 cm.  Sequential measurements of BP were obtained using the test device and the standard mercury sphygmomanometer. A total of 108 sets of comparison data were obtained and analyzed. According to the validation criterion 1, the mean ± SD of the differences was -7.81 ± 5.20 / -10.66 ± 5.48 mmHg. In this special group HEM-7121 and HEM CS24 do not meet the requirements of ISO 81060-2:2018.

Keywords: AAMI/ESH/ISO 81060-2:2018, blood pressure monitor, blood pressure measurement, hypertension, validation

For citation: Posokhov IN, Orlova OS, Sukhodolova EА, Lystseva AV. Validation of an Automatic Sphygmomanometer with Cuff Range of “17-22” for Measurements in Adults with Upper Arm Circumference of 22 Centimeters or Less A.I. Burnasyan Federal Medical Biophysical Center Clinical Bulletin. 2024.2:53-56. (In Russian) DOI: 10.33266/2782-6430-2024-2-53-56

 

REFERENCES

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Conflict of interest. The authors declare no conflict of interest.
Financing. The study had no sponsorship. 
Contribution. Article was prepared with equal participation of the authors.
Article received: 20.04.2024. Accepted for publication: 13.05.2024

© 2025 Scientific journal - "Clinical Bulletin of the FMBС im. A.I. Burnasyan"
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