Dräger Medical JM-103, Руководство по эксплуатации

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DRAFT 20 June 2005
Jaundice Meter (JM-103) User Manual (usr070) Page A - 1
Appendix A
Clinical Performance Summary
Introduction
The Jaundice Meter (JM-103) has been the subject of clinical studies in
Japan and the United States. The following is a summary review of two
clinical studies in the US and a later study in the doctor’s office setting.
Because this device performs measurement through the use of light it is
non-invasive and painless for the infant. The objective of the clinical
studies was to confirm that the device measurement, displayed in units
of estimated bilirubin concentration, does correlate with the serum
bilirubin concentration sufficiently well to warrant its use as a screening
tool.
The data in the following sections is provided to demonstrate results of
the JM-103 clinical studies, in comparison to total serum bilirubin. The
JM-103 reports values over a range of 0-20 mg/dL estimated bilirubin.
Appendix A pages A2 - A18 illustrate results of hospital site studies.
Appendix B pages B3 - B8 illustrate results of physicians’ office site
studies.
The following is a summary of the study protocols:
Study Design
Selection Criteria
The patient selection criteria used for the studies included infants less
than 30 days old and weighing greater than 1000 grams. Although the
selection criteria was established to be “less then 30 days of age,” the
infants in the hospital studies would be expected to be primarily NICU
and newborn infants unless their medical condition required a longer
duration of care. The test was performed on infants who were
determined by their physician to require a serum bilirubin test. A
tabulation of weight distribution is provided in graph 22
Infant Weight
Distribution . Error plots by weight are provided in graphs 23 Clinical
Study Site A Birthweight Error Plot, Forehead and 24 Clinical Study
Site A Birthweight Error Plot, Sternum .