Objective: The devices to be used in clinical practice should be tested for accuracy and should be validated through the validation protocol. The aim of this study was to determine the accuracy of the Meditech-ABPM-06 ambulatory blood pressure monitor.
Materials and methods: The test was carried out in accordance with the protocol established by the European Society of Hypertension (ESH-IP), the British Hypertension Society, and the ANSI/AAMI/ISO 81060-2-2013 protocols.
Results: In the European Society of Hypertension validation procedure the subjects with two or three of the absolute differences between observer and device SBP/DBP measurements within 5 mmHg were 31/31. The average device-observer difference was -0.4 ± 3.9 mmHg for SBP and -0.4 ± 2.8 mmHg for DBP. In the British Hypertension Society validation procedure the mean differences of the test device and observer readings were -1.0 ± 4.6 (systolic) and -1.1 ± 4.5 (diastolic). In the ANSI/AAMI/ISO 81060-2-2013 validation procedure (criterion 1) the mean ± SD of the differences between the test device and reference BP was -0.5 ± 4.0/-0.3 ± 4.5 mmHg (systolic/diastolic). The two criteria of the ANSI/AAMI/ISO were fulfilled.
Conclusion: The Meditech ABPM-06 blood pressure measure device met the requirements specified by the British Hypertension Society, the European Society of Hypertension International Protocol and the AAMI, and therefore was considered acceptable to clinical use with a Grade of A/A.