DRAFT 20 June 2005
Jaundice Meter Instructions for Use (MU01380) Page A - 17
Conclusion
The data shows that the estimated bilirubin concentration measurement
from the Jaundice Meter correlates to the serum bilirubin measurements.
This data supports the use of this non-invasive device along with other
clinical indicators as an aid in the management of jaundice in the
neonatal patient population.
Table 2: Reproducibility Data
Body Site
Deviation
Range
Deviation
Mean
Deviation
Median
Mean
Estimated
Bilirubin
Measure
ment
Range
(mg/dL)
Sternum 0.0 - 2.2 0.3 0.3 0.8 - 18.5
Forehead 0.0 - 2.6 0.3 0.2 0.1 - 19.5
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