Abstract

Background: This in-house study aims to evaluate the accuracy and precision of MD Mouse. The blood pressure(BP) readings taken by MD Mouse were compared with the results obtained using Mercury sphygmomanometer method in 210 subjects (603 valid MD Mouse measurements) with systolic blood pressure ranging from 90 – 183 mmHg and diastolic blood pressure ranging from 52 – 130 mmHg.

Methods: The British Hypertension Society (BHS) protocols and the Association for the Advancement of Medical Instrumentation (AAMI) standards (SP10) were used as validation quality assessment.

Results & Analysis: Both Systolic BP and Diastolic BP readings from MD Mouse passed the validation process. The cumulative percentage falling within 5, 10 and 15 mmHg from mercury method of SBP and DBP are 54.39%, 82.26%, 95.36% and 61.36%, 91.87%, 98.84%, respectively. The mean differences between the device and mercury readings were -0.29± 7.79 and +0.01± 6.08 mmHg for systolic and diastolic BP, respectively.

Conclusion: MD Mouse achieved Grade ‘B’ for systolic BP and Grade ‘A’ for diastolic BP according to the BHS criteria. The device also satisfied the AAMI SP10 standard, that requires differences of less than ±5 (mean difference) and 8 (standard deviation) mmHg*.

Full Report download: mdmouse_in_house_study_11_28_2016