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A5. Biolux Light Emitting Diode Device User Guide Biolux LED Device User Guide for Patients Manufacturer: Biolux Research Ltd. INVESTIGATIONAL DEVICE – TO BE USED UNDER THE SUPERVISION OF QUALIFIED INVESTIGATORS ONLY – USE ONLY AS DIRECTED Please read this manual in its entirety, before beginning treatment with the BIOLUX LED Device. Before using the Biolux LED Investigational Device, ensure you have signed the Informed Consent document and have been thoroughly trained by your Orthodontist/Dentist on use of the Biolux LED Investigational Device. The LED device emits an intense beam of invisible near-infrared light. DO NOT STARE DIRECTLY AT THE LIGHT SOURCE. Laser Radiation Do Not View Directly with Optical Instruments Class 1M Laser Product Safe under reasonably foreseeable conditions Classified per IEC 60825-1, Ed.2, 2007 WARNINGS: • As with any electrical device, DO NOT use the Biolux LED device in or near water or heat producing appliances as they may damage the device and may pose possible fire hazards. Keep the Biolux LED device away from the reach of children. • This device has not been tested in conjunction with High Frequency (HF) surgical 81PDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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