Validation of the TRANSTEK blood pressure monitor TMB-986 for home blood pressure monitoring according to the International Protocol.
OBJECTIVE
To test the accuracy of the TRANSTEK home blood pressure monitor TMB-986 using the International Protocol of the European Society of Hypertension.


METHODS
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.


CONCLUSIONS
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.
Liu
Wen Jun
WJ
Biomedical Engineering Lab, School of Biomedical Engineering, Southern Medical University, Baiyun District, Guang Zhou City, GuangDong, China. sugang.li@gmail.com
Li
Su Gang
SG
Song
Zhe
Z
Gong
Wei
W
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged