Comparison of wrist watch type device (GT-103) and oscillometric device for blood pressure measurement following the AAMI/ESH/ISO standards

ABSTRACT

Background@#Cuffless devices have been studied and developed in the past and in recent years products that employ photoplethysmography became available in the market. However, the vast majority of available product’s accuracy have not yet been studied.@*Objective@#The main objective of this study was to compare a wristwatch device GT 103 to an oscillometric blood pressure device Omron HEM 7120 using the standards set by Association for the Advancement of Medical Instrumentation (AAMI) / The European Society of Hypertension (ESH) Working Group on Blood Pressure / International Organization for Standardization (ISO).@*Methods@#This is a cross sectional study involving blood pressure measurements of 85 individuals using the test device (GT 103) and the reference device (Omron HEM 7120). Demographic characteristics such as age, arm circumference, diagnosis of hypertension, and treatment status were also reported. Sequential blood pressure measurements followed the prescribed steps of AAMI/ESH/ ISO. Paired measurements were statistically treated using the Paired T test. Mean differences of the paired measurements are reported in mean±SD, and proportions of blood pressure differences at ±5mmHg, ±10mmHg, and ±15mmHg are also reported.@*Results@#The mean SBP difference of GT 103 and Omron 7120 was 1.5±20.5mmHg which is not significant (p=0.25) and mean DBP difference of 3±12.6 which is significant (p=0.00017). The result is in accordance with the criterion 1 of ANSI/AAMI/ISO 81060–22013 standard requirements (≤5±8 mmHg), but did not fulfil the criterion 2 which requires an SD of less than or equal to 6.47 for SBP and less than or equal to 6.90 mmHg for DBP. The proportion of paired blood pressure readings within ±5mmHg, ±10mmHg, and ±15mmHg were 19.61%, 36.08%, 45.1% for SBP and 30.98%, 56.07%, 69.8% for DBP. This shows that SBP and DBP measurements did not meet the requirement of AAMI/ESH/ISO.@*Conclusions and Recommendations@#This study showed that GT 103 did not fulfill the requirements for acceptable device accuracy. The use of the device for blood pressure measurement is still not recommended by the researcher. Future studies of other similar devices can be done to ensure accuracy of blood pressure measurement.