Validation of the Omron F3 blood pressure measuring device for use in the finger through simultaneous invasive comparative measurements according to the German Institute for Validation (DIN) 58130 protocol.

ABSTRACT

OBJECTIVES AND DESIGN: Simultaneous invasive comparative measurements in order to validate the blood pressure measuring device Omron F3 for use in the finger, in accordance with the German Institute for Validation (DIN) 58130 protocol. METHODS: A total of five consecutive simultaneous blood pressure comparative measurements were carried out in each of 15 patients (n = 75). Blood pressure was measured in the left index finger using the blood pressure measuring device Omron F3, and at the same time invasively using a pigtail catheter situated in the aortic arch. The measuring arrangements, validation of the unit of invasive measurement and evaluation were all carried out in accordance with the DIN 58130 protocol. RESULTS: The blood pressure measuring device Omron F3 for use in the finger fulfils the criteria of the European Standard prEn 1060-3. Systolic blood pressure decreased by 2.9+/- 6.6 mmHg and diastolic blood pressure decreased by 2.6+/- 5.9 mmHg. CONCLUSION: The blood pressure measuring device Omron F3 measures blood pressure reliably and accurately if used correctly in appropriate patients. Before using the device for the first time, comparative blood pressure measurements in the upper arm, using the standard auscultatory blood pressure measurement technique according to Riva-Rocci and Korotkoff, should be carried out, in order to check the accuracy of measurement.