KaVo EXPERTsurg LUX 1.008.3500 Instructions For Use Manual

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KaVo EXPERTsurg LUX 1.008.3500 Instructions For Use Manual Manual pdf 13 page image

Instructions for use EXPERTsurg LUX REF 1.008.35003 Product description | 3.1 Intended use3 Product descriptionThe EXPERTsurg LUX is a surgical controller according to 21 CFR § 872.4200 (dentalhandpiece and accessories). The device consists of a surgical control unit, a foot con-troller, a surgical motor (separate IFU) + motor cable, an instruments tray, a holderand a tube set. As a functional principle the software-based surgical control unit con-trols the speed and torque of a dental micro motor. The unit is equipped with a pumpfor the use with external irrigation tubing allowing irrigation of the working area. Thesurgical control unit is operated through the buttons on the tabletop console or via footcontrol. The device is intended to be used with the INTRA LUX S600 LED (separateIFU) motor. Straight or contra-angle handpieces with a handpiece connection accord-ing to ISO 3964 can be equipped. The instrument tray allows the dentist to deposit thehandpieces in a safe position. The holder is intended to be used for general storage ofthe bottle. The tube set is needed to deliver the external irrigation from the bottle to thedifferent handpieces. A power cord provides electric power to the unit. The EX-PERTsurg LUX will be delivered with software on the surgical control unit.3.1 Intended useIndications for useThis KaVo product is intended for surgery to expose and dissect oral tissue structuresor endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and im-plantations).CAUTIONUS Federal law restricts this device to sale by or on the order of a health care profes-sional / dentist.For dental use only.Proper UseNoteThe EXPERTsurg LUX is approved for use in surgical theatres.The overarching guidelines and/or national laws, national regulations and the rules oftechnology applicable to medical devices for start-up and use of the KaVo product forthe intended purpose must be applied and followed.The user must ensure that the unit works properly and is in satisfactory condition be-fore each use.The applicable national legal regulations must be observed during the use of thedevice, in particular the following:▪ Applicable regulations governing the connection and start-up of medical devices.▪ Current occupational safety regulations.▪ Current accident prevention regulations.It is a responsibility of the user:▪ to only use equipment that is operating correctly,▪ to protect him or herself, the patient and third parties from hazards, and13 / 72