Konica Minolta JM-103 User Manual page 59

Graph 24 – Clinical Study Site A Birthweight Error Plot, Sternum
Reproducibility
Reproducibility of the light output of the device was tested daily using
the checker. The checker determines the intensity of the light output of
the device. The accuracy of the device is determined by how well the
detectors in the unit measure the returning light. The results of the
device testing using the checker show that the device produced output
within the required range over the course of both clinical studies.
Reproducibility testing in the patient population can be derived from the
data taken in Clinical study site A. The reproducibility data is based on
467 babies. Three independent measurements were taken at each site,
forehead and sternum. Each measurement was recorded, the mean and
standard deviation computed and recorded. The average standard
deviation for forehead and sternum measurements was 0.3 for both.
Jaundice Meter (JM-103) User Manual (usr070rb) Page A - 15