Validation of the Raycome RBP-1200 upper-arm pulse wave device in children aged 3–12 years according to the Association for the Advancement of Medical Instrumentation protocol

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Abstract

Objective

To validate the accuracy of Raycome RBP-1200 used for blood pressure (BP) measurements in Chinese children aged 3–12 years according to the Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization 81060-2:2013(E) protocol.

Methods

A prospective observational study was carried out using ‘the same arm sequential method’ as described in the AAMI protocol. Eighty-seven children participated in this examination and 255 paired-determinations were analyzed.

Results

The BP difference between the RBP-1200 and the mercury sphygmomanometer device was −0.9±5.3 mmHg for systolic BP and −1.1±5.0 mmHg for diastolic BP, which were within the range of ±5±8 mmHg as required by criterion 1 of the AAMI protocol. The SD of the averaged difference for each participant was 4.1 mmHg for systolic BP and 3.9 mmHg for diastolic BP, which were also within the requirement of criterion 2 of the AAMI protocol.

Conclusion

The Raycome RBP-1200 device fulfills the requirements of the AAMI protocol and it can be recommended for BP measurements in Chinese children aged 3–12 years with low or normal BP values.

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