Table 1.
INITIAL BP MEASUREMENTS* | ||
---|---|---|
1. | Take reference BP measurement by the 2 observers | R0 |
2. | Take test device BP measurement | T0 |
VALIDATION BP MEASUREMENTS FOR ACCURACY EVALUATION | ||
3. | Take 1st reference BP measurement by the 2 observers | R1 |
4. | Take 1st test device BP measurement | T1 |
5. | Take 2nd reference BP measurement by the 2 observers | R2 |
6. | Take 2nd test device BP measurement | T2 |
7. | Take 3rd reference BP measurement by the 2 observers | R3 |
8. | Take 3rd test device BP measurement | T3 |
9. | Take 4th reference BP measurement by the 2 observers | R4 |
Measurement R0 shall not be used in the evaluation of reference BP distribution and variability criteria. Measurements R0 and T0 shall not be used in the evaluation of the test device accuracy.