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Validation of the GE Carescape V100 and Omron HEM-9210T by the AAMI/ESH/ISO 81060-2:2018 in multi-ethnic South-East Asian adult population

Chan, J.; Cai, S.; Ng, J. Y. Q.; Mohammed Noor, S.; Wong, S. C. Y.; Chan, G.; Chong, C. S.; Ng, W. J. W.; Chambers, J. C.; Loh, M. C. S.; Mina, T. H.

2022-11-28 cardiovascular medicine
10.1101/2022.11.23.22282694 medRxiv
Show abstract

ObjectiveTo ascertain the accuracy of 2 upper-arm blood pressure monitors, GE Carescape V100 Vital Signs and Omron HEM-9210T, used in a large, South-East Asian epidemiological cohort by the AAMI/ESH/ISO 81060-2:2018. Methods149 participants were recruited from the ongoing Health for Life in Singapore (HELIOS) Study in multi-ethnic Singapore. Results110 datasets were analysed. For criterion 1, the mean {+/-} SD of differences for GE Carescape V100 was -3.5 {+/-} 7.4/ -3.5 {+/-} 7.4 mmHg (systolic/diastolic), and -4.2 {+/-} 6.9/ -4.2 {+/-} 6.9 mmHg (systolic/diastolic) for Omron HEM-9210T. For criterion 2, GE Carescape V100was -3.5 {+/-} 5.6 / -3.5 {+/-} 5.6 mmHg (systolic/diastolic), and -4.2 {+/-} 4.5 / - 4.2 {+/-} 4.6 mmHg (systolic/diastolic) for Omron HEM-9210T. ConclusionBoth GE Carescape V100 Vital Signs and Omron HEM-9210T monitor passed the AAMI/ESH/ISO 81060-2:2018 validation standard.

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