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Validation of two automatic sphygmomanometers according to the modified International Standardization Organization
Igor N Posokhov1, Evgeny A Praskurnichiy1,2, Olga S Orlova1,2
1Department of Therapy, State Scientific Center of the Russian Federation - Federal Medical Biophysical Center named after A.I. Burnazyan.
Objective:
A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm.
Methods:
Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17-22 cm. Test device B was the YuWell YE660Е with the YuWell '360°' cuff (18-36 cm). Data from 37 participants aged 20.14 ± 2.23 (18-28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018.
Results:
According to criterion 1, the mean ± SD of the BP differences for the device A was -7.81 ± 5.20/-10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was -8.00 ± 6.30/-16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements.
Conclusion:
Since devices A and B, which had passed in a general population study, failed in adults aged 18-28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.
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Pre-Procedural Guidelines for Assessing Blood Pressure
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Prepare for the Procedure:
Special considerations while measuring blood pressure
Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.
Equipments Used To Measure Blood Pressure
This invasive approach involves cannulating a peripheral artery. During each cardiac contraction, pressure generates mechanical motion within the catheter, transmitted through rigid, fluid-filled tubing to a transducer. This transducer converts mechanical motion into electrical signals displayed as waveforms on a monitor. An automatic flushing system prevents blood backflow. Due to the potential risk of unexpected arterial blood loss, this method is primarily used in intensive...
Sites for measruring blood pressure
The Brachial Artery: Primary Site for Blood Pressure Measurement