Validation of the TRANSTEK blood pressure monitor TMB-986 for home blood pressure monitoring according to the International Protocol

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Abstract

Objective

To test the accuracy of the TRANSTEK home blood pressure monitor TMB-986 using the International Protocol of the European Society of Hypertension.

Method

Device evaluation was performed on 33 participants (15 men and 18 women) with a mean±standard deviation age of 56.2±12.8 years (range: 35–80 years). Blood pressures (systolic blood pressure; SBP and diastolic blood pressure; DBP) were sequentially measured using mercury sphygmomanometer (two trained observers) and alternately measured by the test device (one supervisor).

Results

In phase 1, 35, 44, 45 of SBP measurements and 41, 45, 45 of DBP measurements were within 5, 10, 15 mmHg. In phase 2.1, 70, 94, 99 of SBP measurements and 78, 93, 99 of DBP measurements were within 5, 10, 15 mmHg. In addition, the difference between the device and the mean of two observers was 2.2±5.0 and 1.7±4.8 mmHg for SBP and DBP, respectively. In phase 2.2, for SBP and DBP, respectively, 25 and 26 of 33 participants had at least two of their three differences with 5 mmHg and there were two and one participants who did not have any difference within 5 mmHg.

Conclusion

The TRANSTEK blood pressure monitor TMB-986 passed all the phases of the International Protocol both for SBP and DBP and is recommended for home use.

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