Validation of the TRANSTEK TMB-988 wrist blood pressure monitor for home blood pressure monitoring according to the International Protocol

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Abstract

Objective

To evaluate the accuracy of the TRANSTEK TMB-988 for home blood pressure monitoring according to the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension.

Method

Device evaluation was done in 33 participants (16 men and 17 women) with a mean±SD age of 58.2±11.8 years (range 32–80 years). Blood pressures [systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were sequentially measured using mercury sphygmomanometer (by two trained observers) and alternately measured by the test device (by one supervisor).

Results

In phase 1, a total of 33, 42, and 44 of SBP differences and 40, 43 and 45 of DBP differences were within 5, 10 and 15 mmHg, respectively. In phase 2.1, 68, 93, and 97 of SBP differences and 75, 92 and 98 of DBP differences were within 5, 10 and 15 mmHg. The difference between the device and the mean of two observers was −0.6±5.0 mmHg for SBP and 0.2±5.8 mmHg for DBP, respectively. In phase 2.2, for SBP and DBP, respectively, 27 and 26 participants had at least two of their three differences with 5 mmHg, and there were two participants who did not have any difference within 5 mmHg for both SBP and DBP.

Conclusion

The TRANSTEK TMB-988 successfully passed all the phases and is recommended for home use in adults.

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