LB.01.08] VALIDATION OF THE SUNTECH® CT40™ BLOOD PRESSURE MEASUREMENT DEVICE BY THE BHS PROTOCOL AND THE AAMI/ISO 8160-2

Abstract

Objective: To perform a simultaneous, independent validation of the oscillometric CT40 device for BP measurement, produced by SunTech®, according to the 1993 protocol of the British Hypertension Society (BHS) and the standard of the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) 8160-2:2013.Design and method: Study participants were aged > 18 years old and written informed consent was obtained from each subject. The study was approved by the institutional review board. Subjects recruitment conditions (sex, arm circumference, BP readings) as long as procedures and data analysis fulfilled the requirements stated by BHS protocol and AAMI/ISO8160-2:2013 standard. Results: A total of 94 participants were included, 52 females (55.3%), mean age (years ± SD) 63.1 ± 18.0, mean arm circumference (cm ± SD) 35.0 ± 9.0. The average of observers entry BPs were 146.9 ± 37.2 mmHg for systolic (SBP) and 82.2 ± 22.1 mmHg for diastolic BP (DBP), Table 1. As for the BHS protocol, differences between standard measurement and test device within 5, 10, and 15 mmHg, for the better observer (A), were 79.4, 95.4 and 100.0%, respectively for SBP, and 82.6, 97.2 and 100.0% for DBP, Table 2. Figures in the low, medium and high pressure ranges are shown in Table 3. Scatter plots of differences between the test device and the better observer (A) against the average of the device and observer pressure values are shown for SBP (Figure 1) and DBP (Figure 2). The mean difference between the readings obtained by using the test device and those obtained by the observers (AAMI/ISO8160-2:2013 standard criteria 1) were 0.3 ± 5.0 mmHg (SBP) and −0.8 ± 4.3 mmHg (DBP), and the mean differences between the average of three readings of the test device and the average of the observers, for each participant (criteria 2), were 0.3 ± 3.9 and −0.8 ± 3.5 mmHg for SBP and DBP, respectively. Conclusions: The CT 40 blood pressure device achieved A/A grade of the BHS protocol and fulfilled the requirements (criteria 1 and 2) of the AAMI/ISO standard. CT 40 can be recommended for BP measurement in adults.