Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol

Abstract

We evaluated the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor accuracy by both the International Standards Organization (ISO) Standard and the British Hypertension Society (BHS) protocol. We tested children, adolescents, and adults. The requirements for both ISO and BHS were completed for 85 individuals each. The Ambulo 2400 passed both ISO and BHS criteria. For ISO method 1, the mean±SD for the difference between device and manual systolic blood pressure (SBP) was -1.8±6.5 mmHg; for diastolic blood pressure (DBP) the values were 0.7±7.3 mmHg. For the method 2 analyses, the differences were -1.8±4.7 and 0.7±6.3 mmHg for SBP and DBP, respectively. The percentage of differences within 5, 10, and 15 mmHg were 60, 86, and 98% for SBP, and 60, 85, and 96% for DBP. The Ambulo 2400 passed all phases of the ISO testing and achieved an A grade for both SBP and DBP per BHS analyses. There was no decrease in accuracy in either high or low BP ranges. The Ambulo 2400 integrates activity monitoring for assigning actual awake and asleep times. There are software features that are particularly beneficial to monitor children and adolescents.