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78 The Biolux LED device is meant to be operated under the dentist prescription and to be used by the eligible patients in a home setting according to preset frequency and intensity. The Biolux LED device consists of three main components: 1. A stationary LightPodTM Controller (see Figure 1), which houses the microprocessor, the menu driven software and the LCD screen. The Controller plugs into the power mains via a medically approved, UL certified (to CSA 60601-1) isolation transformer, which reduces the operating voltage to 24V and the leakage current to less than 10 μA. 2. An Extra-Oral Mini-Array connected to the Controller and mounted on the Face Frame (see Figure 2). 3. A Face Frame, similar to an eyeglass support structure, to be worn by the patient and hosting the Mini-Array (see figure 2) Figure 1 – LightPodTM Controller Figure 2– Biolux LED device in Situ on Patient The Biolux LED device does not contain animal tissue or derivatives, is non-sterile, does not emit ionizing radiation, does not contain pharmaceuticals, and does not store or channel blood or body liquids. The device is an active stationary equipment, powered by the supply mains via a medically approved detachable power transformer, suitable for short-time operation (transient use for 20 minutes daily, transient use for 30 minutes daily, or in clinic use for 60 minutesPDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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