Dräger JM-103 Instructions Manual page 14

DRAFT 20 June 2005
Use of the Device
Patient Population
The Jaundice Meter is indicated for use in neonatal patients born >35
weeks gestation who have not undergone transfusion or phototherapy
treatment.
Averaging of Measurements
Averaging measurements may allow for more precise results. Averaging
three or more readings, computed automatically by the Jaundice Meter
when the desired number of measurements is set (see "Setting the
Number of Average Measurements" on page 5-5), provides more
precise transcutaneous bilirubin measurements than using a single
measurement. Assess the advantages of using average measurements at
your facility. The mean of three measurements showed the highest
degree of correlation (r=0.965); however, the difference compared to a
single measurement was minimal with a single measurement (r=0.963).
Each facility should consider the advantages of averaging multiple
measurements versus using single measurements.
Averaging was not evaluated in the doctors' office study.
Action Levels
Action levels are Jaundice Meter readings when the nurse must take
some type of action, as determined by individual facility policy, for
example: reporting results immediately to the physician, or obtaining a
serum total serum bilirubin. A facility's action level may be determined
by the performance of the device in their unique population, which
depends on factors such as skin color, skin thickness, infant age, and
measuring site. The bias relative to serum bilirubin differs between
hospital versus physicians' office sites (see Appendices A and B).
Different action levels may be appropriate for hospital versus
physicians' offices.
NOTE:
Using proper action levels avoids false negatives - where an infant is
believed not to have significant jaundice but does, in fact, have
significant jaundice that might require treatment.
Calibration
The JM-103 does not require user calibration. The system includes a
checker that measures the intensity of light from the device to ensure the
light output is acceptable for proper use. Light intensity must be
checked daily.
Page 2 - 4 Jaundice Meter Instructions for Use (MU01380)