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equipment (e.g., electrocautery) and should not be used with such equipment. • Care should be exercise when handling the unit, to avoid damaging the Biolux LED device components. Extreme force should never be applied when setting up or storing the device. • The device controller should be placed on a stable flat surface. • The investigational unit should be used while sitting. • Cables should be routed away from where people can trip on them, and kept away from pets and children. • The device should be kept out of the reach of children. • Do not cover the Array heat-sink vents. • Do not use the investigational device if excessive heat is present. • Use the appropriate laser safety glassed provided with the investigational device. • The device is to be used when resting or performing passive activity such as listening to music or reading. • The device should not be used by a photosensitive patient. A medical professional should be consulted if this skin irritation or burns occur or are suspected. • Use should be discontinued if adverse reactions are noticed, in which case please inform your study dentist immediately. • The device should not be used by a patient with epilepsy. A medical professional should be consulted if epilepsy is suspected. • Do not use on patient with known acute infection. • Use the investigational device as directed, treat gently, avoid mechanical mistreatment and do not use the device if damage is suspected. • Do not open or tamper with the case. Servicing should be performed only by the manufacturer. CAUTION: Any changes or modifications to this equipment not expressly approved by the manufacturer will void the Qualified Investigator’s authority to operate and/or prescribe this equipment for use. Safety Information: CAUTIONS • To ensure that the Treatment Array remains in the correct position, the patient should always keep their mouth closed and their teeth together during treatment. 82PDF Image | Effect of LED Phototherapy on the Rate of Orthodontic Tooth Movement
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