Analysis Of Bland-Altman On Wrist-Cuff Blood Pressure Monitor Measurements Based On Oiml R16-2

Abstract

Accuracy of wrist-cuff blood pressure monitors is essential for self-monitoring. This study analyzes the accuracy, precision, and agreement of Omron HEM-6161 and HEM-6232T based on OIML R16-2 standards using the Bland-Altman method. Testing involved ten units (five per model) using an at 80/55, 120/80, and 160/100 mmHg. Results showed all units met systolic accuracy with a 100% agreement rate. However, for diastolic parameters, agreement at 80 mmHg decreased to 80% (HEM-6161) and 60% (HEM-6232T), reaching 0% at high pressure (100 mmHg). Precision evaluation showed 100% compliance for all units across all parameters. Bland-Altman analysis revealed HEM-6232T had a higher agreement level, with 98% of data within the (LoA), compared to 92% for HEM-6161. It is concluded that HEM-6232T offers more consistent measurement performance, although both models show accuracy limitations at high diastolic pressure.