Terumo CDI OneView - System Accuracy

B-4
System Specifications
System Accuracy
The CDI OneView System has been subjected to rigorous bench tests to simulate clinical
use of the device and assess its accuracy and precision over the system operating ranges
of measured parameters. Blood samples taken from the test circuit were analyzed in
conventional analyzers, and these results were compared on a sample-by-sample basis
to values displayed by the CDI OneView System. The absolute values of the differences
were then used to calculate error for each measurement.
Error = | CDI – Analyzer |
The population of errors for each sensor is summarized statistically using a Weibull
Distribution.
Note: This analysis method using absolute value utilizes a different statistical approach
from legacy CDI products that is more suitable for the distribution of data across all
operating conditions. Therefore the statistical summary should not be used for direct
comparison to legacy CDI product performance specications.
Sensor Median Error Standard Deviation
pH (pH units)
0.01 0.02
pCO
2
(mmHg)
1.35 0.96
pO
2
Arterial (>80 mmHg)
7.24 1.48
pO
2
Venous (<80 mmHg)
1.22 0.85
SO
2
(%)
0.69 0.85
Total HGB (g/dL)
0.44 0.40
K
+
(mmol/L)
0.15 0.09
HCT (%)
1.35 1.19
Flow Sensor Q

1/4” x 1/16” (% of reading) 3.77 7.54
1/4” x 3/32” (% of reading) 4.26 6.76
3/8” x 3/32” (% of reading) 4.82 2.13