Intended Use - Konica Minolta JM-103 User Manual

Intended Use

Indications for the Use of the Jaundice Meter (JM-103)
The Jaundice Meter (JM-103) is a non-invasive transcutaneous
bilirubinometer. It measures yellowness of subcutaneous tissue in
newborn infants and displays a measured value which has been shown
to correlate with serum bilirubin. The device is for use in the hospital to
assist clinicians in monitoring the status of newborn infants for the
development of hyperbilirubinemia. 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 are evaluated by their doctor(s) for
appropriate patient management. Bilirubin levels should be confirmed
by other methods, such as serum bilirubin, prior to treatment
determinations.
Intended Use of the User Manual
This manual provides instructions for installation, use, operator
maintenance, and troubleshooting of the Jaundice Meter (JM-103) from
Konica Minolta and Hill-Rom Air-Shields. Konica Minolta/Hill-Rom
Air-Shields cannot be responsible for the performance of the Jaundice
Meter if the user does not operate the unit in accordance with the
instructions, fails to follow maintenance recommendations, or makes
any repairs with unauthorized components. Only qualified service
personnel should perform repair. Service information is available
through your local distributor or Konica Minolta/Hill-Rom Air-Shields.
Jaundice Meter (Model JM-103) User Manual (usr070rb) Page 1 - 3