VALIDATION OF A NONINVASIVE REGISTRY MONITOR OF OUT PATIENT BLOOD-PRESSURE - THE NOVACOR DIASYS-200

BACKGROUND: The aim of this study was to validate the measurement precision of the portable automatic non invasive monitor of blood pressure-Novacor DIASYS 200. METHODS: A mercury sphigmomanometer was used as the reference measurer. To validate the DIASYS 87 persons (45 males, 42 females-age range 17-76 years) with a systolic blood pressure between 90.225 mmHg and diastolic blood pressure of between 64-149 mmHg were selected. RESULTS: The differences between the two apparatus were: systolic blood pressure 6.1 +/- 12.2 mmHg (r=0.909); diastolic blood pressure -1.9 +/- 6.8 mmHg (r=0.929) and cardiac frequency -2.0 +/- 6.3 ppm (r=0.942). In healthy subjects of under 31 years of age (n=20) the differences for systolic and diastolic blood pressure and cardiac frequency were 0.2 +/- 8.0 mmHg; -1.3 +/- 5.8 mmHg and -0.1 +/- 8.0 ppm, respectively. For subjects over the age of 59 years (n=29) the measurements were 9.2 +/- 12.0 mmHg, 2.5 +/- 6.0 mmHg, -1.5 +/- 4.4 ppm, respectively. With the sample subdivided according to blood pressure the differences found in the normotense subgroup (n=23) were: -1.7 +/- 7.8 mmHg, -2.4 +/- 4.9 mmHg, and -2.4 +/- 7.9 ppm, respectively; in the subgroup with slightly high blood pressure (n=40) 6.4 +/- 14.0 mmHg, -2.8 +/- 6.0 mmHg and -2.3 +/- 5.1 ppm, and in the subgroup with moderate-severe high blood pressure (n=24) 10.4 +/- 10.9 mmHg, 0.2 +/- 9.1 mmHg and -0.9 +/- 6.5 ppm, respectively. CONCLUSIONS: The DIASYS fulfills the criteria of validation and precision for the measurement of diastolic blood pressure and cardiac frequency in all the cases. However criteria for systolic blood pressure are only fulfilled in normotensive and young subjects (less than 31 years of age).