Intended Use - Dräger JM-103 Instructions Manual

Intended Use

WARNING:
Magnetic Resonance Imaging (MRI) procedures interfere with
Jaundice Meter operation. Inaccurate readings could occur.
WARNING:
Do not use a mobile telephone when using the Jaundice Meter. A
measurement error could occur.
Intended Use of the Jaundice Meter
The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It
measures yellowness of subcutaneous tissue in newborn infants. The
unit provides a visual digital measurement that has been shown to
correlate with serum bilirubin in newborn infants.
The device is intended for use in hospitals or doctors' offices under a
physician's supervision or at their direction to assist clinicians in
monitoring of newborn infants. The device is not intended as a stand-
alone screening device for diagnosis of hyperbilirubinemia. It is to be
used as a screening device in conjunction with other clinical signs and
laboratory measurements.
Newborn infants whose Jaundice Meter test results are indicative of
hyperbilirubinemia should be evaluated by their physician(s) for
appropriate patient management. Specific neonatal patient bilirubin
levels should be confirmed by other methods, such as serum bilirubin,
prior to treatment determinations.
The Jaundice Meter is not intended for home use.
Limitations (Doctors' Office Use)
Use only on infants up to 14 days of age.
For doctors' office application, use only the sternum location when
taking measurements.
Please be aware, performance in doctors' offices may vary from
performance in hospitals.
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DRAFT 18 May 2005
Jaundice Meter Instructions for Use (MU01380)