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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. This device is not intended for home use. This is a prescription device.

The JM 103 Jaundice Meter is designed to provide a non-invasive measurement of the yellowness of subcutaneous tissue. This measurement is converted to an estimated bilirubin concentration and displayed in units of mg/dL or umole/L. This measurement is taken using a dual path optical system. The measurements from each path are then subtracted to minimize the impact of skin pigmentation. The software in the device then computes the estimated bilirubin concentration based on an established correlation coefficient.

The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including humidification. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The Versalet™ 7700 Care Center offers access to the infant by allowing the caregiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two Calrod (Magnesium oxide encased in Incoloy sheath) heaters that provide heat when the canopies are opened or the over head arm is raised. In addition to providing thermal support, the Versalet™ 7700 Care Center is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. A humidification accessory is designed to operate with the Versalet™ 7700 Care Center.