Konica Minolta JM-103 User Manual page 13

Averaging of Measurements
There was no significant difference between the averaged measurements
and the single measurement approaches in the largest study for sternum
measurements. The mean of three measurements showed the highest
degree of correlation (r=0.965), however, the difference was minimal
with a single measurement (r=0.963).
The advantages of using average measurements should be assessed at
each facility.
Action Levels
Each facility should determine their own action levels based on studies
of performance of the device on their population. Appropriate action
levels may vary depending on performance of the device, such as
precision or correlation with serum bilirubin, in the hands of the user.
Some factors that could affect performance of the device or appropriate
action levels include skin color, age, or measurement site. Careful
selection of action levels should be made so that false negatives do not
prevent appropriate follow up measures.
Calibration
There is no user calibration of this device. The system does include a
checker that measures the intensity of light from the device to ensure the
light output is within range.
Processing of Measured Values
The Jaundice Meter (JM-103) determines the yellowness of the
subcutaneous tissue by measuring the difference in the optical densities
for light in the blue and green wavelength regions. The optical density
difference has been shown to have a linear correlation with serum
bilirubin concentration. The device computes an estimated bilirubin
concentration based on this linear correlation and provides the value on
the display. The correlation coefficient used in this computation was
derived from clinical data.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 2 - 5