Validation of the TM-2441 ambulatory blood pressure measurement device according to the ISO 81060-2: 2013 standard.

OBJECTIVE

The aim of this study was to validate the TM-2441 ambulatory blood pressure monitoring (ABPM) device using the ISO 81060-2:2013 standard.

PARTICIPANTS AND METHODS

Participants were healthy individuals aged more than 12 years who were recruited from among the outpatients and volunteers of Jichi Medical University (Tochigi, Japan). The same-arm sequence protocol (clinical validation) and the opposite-limb simultaneous method (ambulatory validation) from the ISO 81060-2:2013 standard were used.

RESULTS

One hundred and seven participants were enrolled; 85 participated in the clinical validation and 35 participated in the ambulatory validation (13 participants were included in both validation protocols). The TM-2441 device performed well against the standard in both the clinical and ambulatory validations; the mean and SD values for the differences between device and observed systolic and diastolic blood pressure values in both tests fulfilled criterion 1 and criterion 2 of the standard. The Bland-Altman plots did not show any systematic variation in the error.

CONCLUSION

The TM-2441 ABPM device was accurate and fulfilled all ISO 81060-2:2013 standard requirements for ABPM determination in adults. It is therefore suitable for use for ABPM in adults with hypertension.