Dräger Medical JM-103, Operating Instructions Manual

Page: 9 / 92

DRAFT 20 June 2005
Jaundice Meter (Model JM-103) User Manual (usr070) Page 2 - 1
SP
ECI
FIC
AT
IO
NS
Section 2
Introduction, Features,
and Specifications
Introduction
To prevent kernicterus in newborn infants, it is very important to detect
jaundice in its early stages. The Jaundice Meter (JM-103) is a non-
invasive transcutaneous bilirubinometer. This hand-held device allows a
quick, non-invasive estimate of bilirubin concentration, to be used as an
aid for the management of jaundice in newborn infants. The
measurements are taken automatically when you place the instrument’s
measuring probe against the measuring site of the infant and press it
gently; the measured value is then displayed.
Measuring Point
Measurements must be taken only on the infant’s forehead (at hospital
sites only) or sternum (at hospital sites or physicians’ offices) where a
sufficient amount of blood is circulated. A possibility exists that the
bilirubin in the subcutaneous tissue may measure low for areas with
minimal blood flow or areas in which the subcutaneous tissue is subject
to keratinization.
Although correlation with serum bilirubin was observed for both
forehead and sternum measurements, the clinical studies performed with
the Jaundice Meter (JM-103) show consistently better results with
measurements taken at the sternum versus the forehead. There is a
possibility that this difference may be more pronounced for infants that
have been exposed to sunlight, such as infants seen at doctors’ offices.
Only sternum measurements were evaluated during the studies
conducted at doctors’ offices; correlation of forehead measurements
with serum bilirubin has not been evaluated, and the device is not
intended for forehead measurements at doctors’ offices.
Therefore, use
the sternum location when taking measurements at doctors’ offices.
Phototherapy
WARNING:
Do not use the Jaundice Meter after initiation of phototherapy or
after an exchange transfusion as results may be inaccurate under
these conditions. Patient injury could occur.