Omron HBP-1300 (HBP-1300-E)
The technology used in the Omron HBP-1300 (HBP-1300-E), to measure blood pressure, has passed in a clinical validation study, in a general population including children, according to a recognised standard protocol, as published in a peer-reviewed publication.
|Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|BIHS (UK and IRL)||Professional use for pregnancy||Published evidence|
|ESH (Europe)||Professional use for adults and children||Published evidence|
|Japanese Society of Hypertension||Professional use (2016-2018)||Published evidence|
|Stride BP||Professional use for adults and children (Preferred)||Published evidence|
|MDR Criteria||Professional use||Published evidence|
Cao X, Song C, Guo L, Yang J, Deng S, Xu Y, Chen X, Sapa WB, Wang K. Quality Control and Validation of Oscillometric Blood Pressure Measurements Taken During an Epidemiological Investigation. Medicine (Baltimore). 2015 Sep;94(37):e1475. doi: 10.1097/MD.0000000000001475. PMID: 26376388.
Ad Hoc protocol General population (Note: Modified protocols)
Meng L, Zhao D, Pan Y, Ding W, Wei Q, Li H, Gao P. Validation of Omron HBP-1300 professional blood pressure monitor based on auscultation in children and adults. BMC Cardiovasc Disord. 2016 Jan 13;16(9):5. Epub: 2016 Jan 13. doi: 10.1186/s12872-015-0177-z. PMID: 26758197. Available from: bmccardiovascdisord.biomedcentral.com.
81060-2:2013 - Pass Adults and chlidren
Abbud L, Nzelu D, Salaria M, Kay P, Kametas NA. Validation of the Omron HBP-1300 in pregnancy for medium-arm and large-arm circumferences according to the British Hypertension Society protocol. Blood Press Monit. 2018 Oct;23(5):277-80. Epub: 2018 Jul 9. doi: 10.1097/MBP.0000000000000341. PMID: 29994925.
BHS:1993 Pregnancy; Arm circumference 24 cm to 32 cm (n=36) (Note: Confusingly, the results would suggest that the device should have an A/A grade but this is not stated in the paper and no reason is provided for the omission.)
BHS:1993 Pregnancy; Arm circumference 33 cm to 43 cm (n=36) (Note: Confusingly, the device appears to pass with an A/A grade but this is not stated in the paper and no reason is provided for the omission.)
Even though the study is stated to have been carried out according to the BHS protocol, the BHS grades are omitted. Means and standard deviations are provided and the device is recommended but there is no reference as to the basis for this recommendation. These are serious anomalies that should have been resolved during the review process. Without this resolution, the hypothesis that the results are invalid cannot be rejected.