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79 weekly), and not designed for use in the presence of flammable anaesthetic mixtures. The device contains no heating systems and the only intentionally emitted energy is near-infrared light. Medical Electrical and Product System Safety The Biolux LED device medical device has been designed to comply with the following harmonized standards: 1. CAN/CSA-C22.2 No 601.1-M90 (R2001): Safety of Medical Electrical Equipment – Part 1: General Requirements for Safety 2. CAN/CSA-C22.2 No 60601-1-2 (2003): Safety of Medical Electrical Equipment – Part 1-2: Electromagnetic Compatibility Requirements 3. IEC 60825-1 (2001): Safety – Part 1: Equipment Classification, Requirements and User’s Guide The LED Array currently selected for the Biolux LED device has been classified by the manufacturer (according to IEC 60825-1) as a Class 1M device “Safe under reasonably foreseeable conditions”. To assure patient safety against any possible thermal effects of the LED, an integral temperature sensor has been built into the Investigational Device headset. The system software will automatically shut down the Biolux LED device if the temperature sensor indicates 41°C or greater. In order to minimize as much as possible any risks to the patient associated with the electrical system, the Controller unit and the LED Array have been powered at 24V DC using a medically approved power supply, which limits leakage currents to less than 10μA. Preliminary Risk Assessment A preliminary risk analysis has been carried out on the Biolux LED device investigational device in accordance with ISO 14971:2007 “Medical devices – Application of risk management to medical devices.” After review of the risks associated with the use of the Biolux LED device prototype in the feasibility study, the residual risk is considered acceptable as none of the recognized hazards leads to a risk within the intolerable range. The ranking of each potential risk, after allPDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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