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,  A.V. Lystseva2, E.А. Sukhodolova2

Validation of an Automatic Sphygmomanometer with “360°” Cuff 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: Sukhodolova Ekaterina Arsenyevna: prosto0600788@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. Sphygmomanometer “Armed” identical to previously validated in the general population group YuWell YE660E was used with a “360°” cuff designed for an upper arm circumference of 18 – 36 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 8.00 ± 6.30 / -16.11 ± 5.15 mmHg. In this special group “Armed” YE660E with “360°” cuff 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 I.N., Orlova O.S., Lystseva A.V., Sukhodolova E.А. Validation of an Automatic Sphygmomanometer with “360°” Cuff for Measurements in Adults with Upper Arm Circumference of 22 Centimeters or Less. A.I. Burnasyan Federal Medical Biophysical Center Clinical Bulletin. 2024.2:57-60. (In Russian) DOI: 10.33266/2782-6430-2024-2-57-60

 

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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