Dräger JM-103 Instructions Manual page 72

DRAFT 20 June 2005
Graph 23 – Hospital 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 hospital studies.
Reproducibility testing in the patient population can be derived from the
data taken in Hospital study site A. The reproducibility data is based on
467 infants. Three independent measurements were taken at each site—
forehead and sternum. Each measurement was recorded, and the mean
and standard deviation were computed and recorded. The average
standard deviation for forehead and sternum measurements was 0.3 for
both.
Page A - 16 Jaundice Meter Instructions for Use (MU01380)