Dräger Medical JM-103, Operating Instructions Manual

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DRAFT 18 May 2005
Jaundice Meter (Model JM-103) User Manual (usr070) Page 1 - 3
Intended Use
CAUTION:
Magnetic Resonance Imaging (MRI) procedures interfere with
Jaundice Meter operation. Inaccurate readings could occur.
CAUTION:
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 (JM-103) is a non-invasive transcutaneous
bilirubinometer. It measures yellowness of subcutaneous tissue 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
standalone for diagnosis of hyperbilirubinemia. It is to be used in
conjunction with other clinical signs and laboratory measurements.
Newborn infants whose Jaundice Meter (JM-103) 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 (JM-103) 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.
Precocious Jaundice
Do not use this device on infants with precocious jaundice. If there is a
possibility that the infant is suffering from precocious jaundice, as a
result of an incompatible blood type or hemolytic jaundice, it is
recommended that the total serum bilirubin be measured.