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The intended use of the SimpleChoice reservoir Pro is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

The SimpleChoice reservoir Pro (3.0mL), Reference Number RP-30, is a single use reservoir system used to deliver medications subcutaneously. The user fills the reservoir via a standard hypodernic needle provided with the device. The 3.0 ml reservoir Pro then attaches to an SimpleChoice infusion set having a female luer lock with a retainer feature, and is placed in an external infusion pump. If the reservoir will be used with a Paradigm pump the plunger rod is detached and the reservoir is secured with the retainer feature.

The BiliChek Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Pressure Liquid Chromatography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

The Bilichek consists of the BiliChek hand-held unit, the BiliCal Individual calibration tips, a charger base, and rechargeable battery packs. The BiliChek hand-held unit contains a light source, a fiberoptic probe, a microspectrometer, and a microprocessor control circuit within an 8.5 x 2x 4 inch assembly. The hand-held unit is battery powered and is controlled by an internal microprocessor. Operator interface with the microprocessor is achieved through three buttons and a liquid crystal display (LCD). The buttons are used to select different set-up options. The measurement is initiated when the operator presses the Trigger button on the bottom of the unit. The LCD window on the device displays the calculated bilirubin value, date and time, battery status, and permits the unit set-up parameters to be programmed. The BiliCal disposable tips protect the fiber-optic probe, ensure a hygienic contact with the patient, provide a means for calibration of the BiliChek, and serve as a positioning aid. The disposable tip includes a removable target with calibration material which is used in the initial calibration of the device prior to use on each patient. Before a measurement is taken, the BiliChek runs a baseline reference calibration scan which measures the removable target on the tip. After calibration, the target is removed from the tip to expose an optically clear window through which measurements are made. Sensors in the BiliChek detect when the tip is correctly installed and the depression of the tip under pressure when it is applied to the patient. Two rechargeable nickel-cadmium battery packs are supplied with the system. The battery pack is inserted in the bottom of the BiliChek Hand-held Unit. The BiliChek Hand-Held Unit includes status indicators which indicate if the battery is low or dead. When fully charged, each battery pack provides sufficient power to conduct 100 measurements. The Bilichek battery charger includes two charging wells, one for the Bilichek and the other for the spare battery pack. The charger is provided power from a 110 volt power supply.