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.
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.