Dräger Medical JM-103, Руководство по эксплуатации

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DRAFT 20 June 2005
Jaundice Meter (JM-103) User Manual (usr070) Page A - 3
20.0 mg/dL (0 – 340
µ
mol/L). The data include graphs in the form of x-
y plots where x is the total serum bilirubin concentration measured and
y is the JM 103 estimated bilirubin measurement. Refer to the graphics
results provided in this appendix for the results of studies at hospital
sites. To address device performance in doctors’ office setting, a study
of 201 infants was performed. Results showed similar performance at
doctors’ offices as shown in Appendix B. The data for the doctor’s
office setting contained no forehead measurements as all measurements
were taken at the sternum. This data correlated well with prior sternum
data (refer to page A-12). The serum bilirubin measurements were taken
using direct spectrophotometry in Clinical Study A and specifically with
the Beakman-Colter Synchron LX-20by in Hospital Study B. Both
systems were used int he doctors’ office study as well.
Graph 1 – Hospital Study Site A All Patients, Forehead