Background: Non-invasive self blood pressure monitoring has become increasingly popular. To assure the accuracy of devices used for this purpose, all need to be validated independently prior to marketing. The objective of this study was to assess the accuracy of the HEM-907, a new semi-automatic, non-invasive, oscillometric blood pressure monitoring device specifically designed to be used in the clinic or physician's office setting.
Methods: Blood pressure measurements taken employing this device were compared with the results obtained by two experienced observers using a mercury sphygmomanometer on 100 subjects and patients (384 measurements). The limits of agreement were calculated for the device compared with the results of the two observers according to the standards of the Association for the Advancement of Medical Instrumentation (AAMI).
Results: The agreement between the two observers was -0.36+/-2.32mmHg for systolic blood pressure and 0.02+/-2.42mmHg for diastolic blood pressure. The agreement between the device and the observers was 1.56+/-4.42mmHg and 3.49+/-4.61mmHg for systolic and diastolic blood pressure respectively.
Conclusions: The Omron HEM-907 satisfied the AAMI criteria for accuracy for a non-invasive blood pressure monitoring device.