Terumo CDI 550, Operator'S Manual

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system specifications appendix b B-4
System accuracy limits
The CDI System 550 has been subjected to rigorous bench tests to simulate the
clinical use of the device and assessed its accuracy and precision over the system
operating ranges of the 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 analyses provided by the CDI System 550. Accuracy
values were generated by using the results from the CDI System 550 minus conven-
tional analyzer results The following table shows the mean difference between the
two measurement techniques, and the standard deviation of the distribution differ-
ences found.
pH Sensor (pH units): Total Hemoglobin Value (g/dl):
Mean: 0.007 Mean: -0.17
Standard Deviation: 0.014 Standard Deviation 0.54
PCO
2
Sensor (mmHg): Potassium Sensor (mmol/L):
Mean: 0.0 Mean: 0.05
Standard Deviation: 2.9 Standard Deviation: 0.18
PO
2
Sensor − Arterial (>80 mmHg): Hematocrit Value (%):
Mean: -0.5 Mean: -0.5
Standard Deviation: 5.5 Standard Deviation: 1.7
PO
2
Sensor - Venous (<80 mmHg):
Mean: -0.4
Standard Deviation: 0.8
Oxygen Saturation Value (%):
Mean: -0.5
Standard Deviation: 1.6