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PP.03.09: VALIDATION OF THREE AUTOMATIC BLOOD PRESSURE MONITORS FOR SELF-MEASUREMENT ACCORDING TO EUROPEAN SOCIETY OF HYPERTENSION INTERNATIONAL PROTOCOL REVERSION 2010

Objective: This validation aimed to evaluate the accuracy of three automatic blood pressure monitors for home use, namely Transtek TMB-1490, LS808-B and LS810-B according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2010) in three separate studies. The three Transtek devices use the oscillometric method and TMB-1940 and LS808-B are arm devices, while LS810-B is wrist devices. Design and method: The International Protocol requirements were followed precisely in three studies. In each study, 33 adult individuals were finally recruited and sequentially measured systolic blood pressure (SBP) and diastolic blood pressure (DBP) using the mercury sphygmomanometer and each of the tested devices. According to the validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained in each study (three pairs for each participant). Results: All three tested devices passed the validation process. Transtek TMB-1490 produced 83, 98, 99 measurements within 5, 10, and 15mmHg for SBP and 87, 98, 99 for DBP, respectively, 74, 95, 98 measurements for SBP and 80, 94, 99 for DBP, using LS808-B, 74, 95, 99 measurements for SBP and 83, 95, 99 for DBP using LS810-B. The mean(±SD) device-observer difference were 1.0 ± 3.3 and -1.3 ± 3.0 mmHg (TMB-1490) for systolic and diastolic, -0.1 ± 4.3 and -0.9 ± 3.6 mmHg (LS808-B), and -0.6 ± 4.9 and 0.5 ± 3.9 mmHg (LS810-B). The number of participants with two or three device-observer differences within 5mmHg was 28 for SBP and 31 for DBP(TMB-1491), 24 for SBP and 28 for DBP (LS808-B), and 25 for SBP and 26 for DBP (LS810-B). None of the participant had no device-observer difference within 5mmHg for SBP and three participants had the same for DBP using TMB-1491. For LS808-B and LS810-B, the number of participants had no device-observer difference within 5mmHg is 0 for SBP and 3 for DBP, 2 for SBP and 3 for DBP,respectively. Conclusions: According to the validation results on basis of the ESP-IP 2010, Transtek blood pressure monitors TMB-1490, LS808-B and LS810-B can be recommended for self-measurement use in general adult population.