Dräger Medical JM-103, Руководство по эксплуатации

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DRAFT 20 June 2005
Page A - 2 Jaundice Meter (JM-103) User Manual (usr070)
Demographics of Patient Population
All patients meeting the above criteria were included in the study. There
was significant effort to ensure that there was 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, and other.
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 studies 613 patients. The data for the doctors’ office study is in
Appendix B and encompassed 201 infants.
Measurement Selection
One study followed a protocol where three measurements were taken,
each measurement was recorded and then the three measurements were
averaged. The second study took one measurement only. Estimated
bilirubin measurements taken during the studies ranged from 1.1 to 20.8
mg/dL. In the doctor’s office setting no measurement averaging was
performed.
Body Sites Tested
In the hospital setting the measurements were taken on the forehead and
sternum each time the measurements were taken for a given patient. In
the doctor’s office setting all measurements were taken at the sternum.
Number of Hospital Sites
There were two hospital sites that participated in the hospital study.
Hospital study site A with 513 patients studied. Clinical study site B
with 100 patients studied.
Performance Data
The data in the following sections, as well as Appendix B, is provided to
demonstrate the performance of the JM 103. This series of graphs show
the correlation of the estimated bilirubin concentration taken non-
invasively with the JM 103 to the actual serum bilirubin concentration
measured from a blood sample taken from the patient (TSB) as
explained in Sections 4 and 5. The device operates over a range of 0.0 –