Dräger JM-103 Instructions Manual page 58

DRAFT 20 June 2005
Demographics of Patient Population
All patients meeting the above criteria were included in the study. There
was significant effort to ensure sufficient representation of all skin
pigmentation to verify that the JM-103 could be used across all
populations with consistent results. The demographics of the patient
population included Caucasian, African-American, East-Asian, Indian-
Pakistani, and Hispanic infants.
Sample Size
The total number of infants in the sample populations are shown on the
graphs of the trials presented on pages A-3 through A-15. The hospital
trials studied 613 patients. The data for the doctors' office study is in
Appendix B and encompassed 201 infants.
Measurement Selection
At the Beaumont and Hutzel study sites, triplicate measurements were
taken, each measurement was recorded, and the three measurements
were averaged. At the Jefferson study site, only single measurements
were taken. Estimated bilirubin measurements taken during the studies
ranged from 1.1 to 20 mg/dL.
Body Sites Tested
In the hospital setting, the measurements were taken on the forehead
and sternum each time the measurements were taken for a particular
patient. In the doctors' office setting all measurements were taken at the
sternum.
Number of Hospital Sites
Two hospital sites participated in the hospital study: hospital study site
A with 513 patients studied and clinical study site B with 100 patients
studied.
Page A - 2 Jaundice Meter Instructions for Use (MU01380)