Validation of the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol

OBJECTIVE: Assessment of the accuracy of the A&D UM-101 mercury-free professional device for auscultatory blood pressure (BP) measurement according to the European Society of Hypertension International Protocol. Further to auscultation, the device has a button to mark readings during deflation. METHODS: Fifteen adults were included in phase 1 and another 18 in phase 2. Simultaneous BP measurements were taken by two observers (connected mercury sphygmomanometers) four times, sequentially with three measurements using the tested device (two connected tested devices, one used with and the other without the mark button). RESULTS: In phase 1, the device produced 44/45/45 measurements within 5/10/15 mmHg, respectively, for systolic BP (SBP) and 39/43/45 for diastolic (DBP). In phase 2.1, 87/97/99 measurements within 5/10/15 mmHg, respectively, for SBP, and 91/97/99 for DBP (using the mark button 65/93/98 for SBP and 76/96/99 for DBP). In phase 2.2, 29 participants had at least two of their SBP differences within 5 mmHg and none had any differences within 5 mmHg, whereas 32 and none, respectively, for DBP (with mark 24/4 participants for SBP; 29/1 for DBP). Mean SBP differences were -1.5+/-3.5 mmHg and DBP -1.3+/-3.0 (with mark -3.6+/-4.2 and -2.8+/-3.7). The difference in SBP measured by the tested device with versus without using the mark button was 3.0+/-3.3 mmHg (P<0.001) and DBP 1.9+/-2.5 mmHg (P<0.001). CONCLUSION: The device comfortably passed the validation protocol requirements. Using the mark button, the device, however, failed to meet the validation criteria. Therefore, it is recommended for clinical use without using the mark button.