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The Neonatal Phototherapy System, Model: KANGALITE is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates: gestational age ≥38 weeks and weight within 2500-4500 grams. It can be used in the clinical setting or in the home environment. It should be used for neonates whom phototherapy has been prescribed.

The Neonatal Phototherapy System, Model: KANGALITE is a wearable phototherapy system that consists of six components: Light Source with AC Power Cord, Dual Fiber Optic Panels (Standard accessory) /Single Fiber Optic Panel (optional accessory), Swaddle, Strap, Disposable Covers and Table Mounting Clip (optional accessory). The Neonatal Phototherapy System, Model: KANGALITE delivers a narrow band of high-intensity blue light emitting diode (LED), in order to provide phototherapy treatment for neonatal hyperbilirubinemia. The Neonatal Phototherapy System, Model: KANGALITE Light Source contains a blue LED which emits light in the range 400-500 nm (peak wavelength 455±10 nm). The system gives only one blue light irradiance output level which is not adjustable. This blue light is directed through the optical fiber bundle to the illuminating area of the Fiber Optic Panel where the newborn receives blue light therapy. The Fiber Optic Panel is inserted into the Disposable Cover and is placed in a soft and comfortable Swaddle, while the baby is wrapped inside to receive phototherapy. Baby is allowed to receive kangaroo care. Besides, compare to conventional phototherapy, no eye protection for the baby is required as blue light will not leak out when properly set up. The light output (>30 µW/cm²/nm) is sufficient to provide intensive phototherapy which is defined as in the American Academy of Pediatrics (AAP) standard. Average irradiance for: Dual Fiber Optic Panels: 50 µW/cm2/nm (±25%); Single Fiber Optic Panel: 60 uW/cm2/nm (±25%). The spectrum range of the blue LED light matches with the spectral absorption of bilirubin. Under blue light irradiation, subcutaneous bilirubin absorbs strongly in the blue region of the light spectrum and converts into less lipophilic waste products which can be excreted through the bile or urine without the need for conjugation. The Neonatal Phototherapy System, Model: KANGALITE can be directly connected to nominal voltages readily available throughout the world as the Light Source is affixed with a wide-range medical adaptor, rated from 100-240 VAC and 50/60 Hz. It converts the power to 15 VDC to power up the Light Source.