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The Giraffe Blue Spot PT Lite phototherapy system provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital.

The Giraffe Blue Spot PT consists of two main sub-assemblies the same as the predicate devices; a sub-assembly that generates the phototherapy light and a sub-assembly that transfers the light to the patient. For the Giraffe Blue Spot PT Lite the two halves are generically known as the Light Pipe and the Light Box. The Light Pipe is a flexible arm that consists of a single optical fiber passing through a set of springs to a shade assembly that will focus the output light to the desired spot size from a given distance. The spring portion of the assembly provides the ability to quickly position the light pipe without the need for tools, while also providing sufficient rigidity to keep light pipe from drooping or rising out of position. The phototherapy light provided to the patient is controlled by the operator by adjusting the positioning of the output shade above the patient. The therapy delivered to the patient varies directly with the distance of the light shade from the patient being treated. The operator changes the intensity and spot size by manually adjusting this distance. The Light Box contains a single blue light LED providing the phototherapy light source that is then transmitted utilizing the Light Pipe. The Light Pipe is used to position and direct the therapy light onto the patient from above. There is no direct contact with the patient. The light source operates at a single light intensity and is not adjustable by the operator or patient. The phototherapy LED emits light in a narrow bandwidth; 400nm - 500nm with a 450nm -475nm peak. As such, and confirmed by physical testing to IEC60601-2-50, there are very low levels of energy in the ultraviolet (UV) or infrared (IR) regions of the light spectrum. The Light Box also contains an internal cooling fan to cool the internal circuitry and the phototherapy LED in order to extend product lifetime. The device is ready for use once connected to an AC power source. The device is equipped with an internal switching power supply that accepts 100-240VAC 50/60Hz power. Power connection is made through supplied power cord connected to an IEC appliance inlet with built-in fuses protection. The front cover of the unit provides numerous operating features including an ON/OFF pushbutton to turn the phototherapy LED on and off, LED indicators for Standby/Ready, phototherapy ON and over/under temperature; and an hour meter that tracks accumulated phototherapy hours on the device. The over/under temperature indicator provides feedback to the operator that the phototherapy LED is currently too hot, or too cold, to allow it to be turned on and that the fan is actively cooling, or warming, the unit until appropriate temperatures are reached. Once the unit is at the appropriate temperature range, the Standby/Ready indicator illuminates. On the bottom of the unit are the IEC power inlet and associated fuses, a potential equalization ground stud and the air intake filter. A mounting bracket on the back of the unit allows the unit to be positioned and secured in the dovetail slot of an accessory rail. Tightening three socket head mounting screws holds the unit in position.

The BiliSoft Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly know as neonatal jaundice, during the newborn period in the hospital or home setting. The BiliSoft Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

The Bili-Soft Phototherapy System is a mobile phototherapy device that delivers high intensity blue light using blue light emitting diodes (LEDs) that transmit light to a fiber optic pad. The device consists of a light source box and one of two different size fiber optic pads. The light source operates in a single light intensity mode and includes features such as an over temperature indicator with automatic LED shutoff and an hour meter to indicate life. The light source has an automatic universal voltage selection of 90-264 VAC at 47-63 Hz. Fiber optic pad covers are made of a clear, medical grade, hypoallergenic and latex-free material. The smaller fiber optic pad emits an average output of 35 µW/cm-/nm through a typical snuggly/pad cover, and the larger fiber optic pad emits an average output of 50 µW/cm /nm through a typical snuggly/pad cover. Disposable fiber optic pad covers are available to help comfortably position the baby on the fiber optic pad and to prevent cross contamination of bodily fluids between infants. LED's have very little light degradation over their lifetime with proper use and care. During normal operating conditions the device is expected to last for approximately 10,000 hours. Once the LED's have reached the end of their life a replaceable LED module is available for purchase. LED's emit no appreciable energy in the ultraviolet (UV) region of the spectrum, so there is no concern for UV exposure to the infant. In addition, LED's emit no significant energy in the infrared (IR) region of the spectrum; therefore there is no concern for excessive warming of the infant due to IR energy.