Dräger JM-103 Instructions Manual page 76

The doctor's office study was composed of the following ethnic groups:
Caucasian
African-
American
Mid-Eastern
Indian
Hispanic
Asian
NOTE:
Doctor's Office #1: 83.5% Caucasian and 16.5% darker skin tone
Doctor's Office #2: 75% Caucasian and 25% darker skin tone
Exclusion Criteria
Infants requiring Exchange Transfusion or Phototherapy Initiated were
not allowed in the study.
Sample Size
The doctors' office use trial studied 201 patients.
Measurement Selection
Estimated bilirubin measurements taken during the studies ranged from
2.3 to 19.5 mg/dL. No "Averaging of Readings" was used with the JM-
103.
Body Sites Tested
All infants were measured at the sternum location ONLY.
Number of Doctors' Office Sites
For the doctors' office study, two sites were chosen for application of
the device. Sample size was 201 patients.
Page B - 2
DRAFT 20 June 2005
TcB Range
2.3-19.5
4.9-17.3
8.8 - 16.0
6.6- 17
7.6
4.8-12.6
Jaundice Meter Instructions for Use (MU01380)
Qty Age
≤
167
97 72 hrs & 70
≤
13
6 72 hrs & 7
≤
5
4 72 hrs & 1
≤
5
4 72 hrs & 1
1
≤
10
3 72 hrs & 7
≥
72hrs
≥
72hrs
≥
72hrs
≥
72hrs
≥
72hrs