NSK NAKANISHI

High Speed Drill System

Variosurg Operation Manual

Operation Manual

15 Pages

English  Ultrasonic Bone Surgery System  OPERATION MANUAL  0197  Please read this Operation Manual carefully before use, and file for future reference...  Classification of Devices • Classification by type of protection against electric shock: — Class I devices • Classification by degree of protection against electric shock: — Applied part type BF • Classification by sterilization or disinfection method allowed by the manufacturer: — Refer to Sterilization...  Classification by degree of protection against harmful intrusion of liquid based on IEC60529: — Foot Control ··· IPX8 (protected against immersion) • Classification by safety level of use in air, flammable anesthetic gas or dinitrogen monoxide (laughing gas), flammable anesthetic gas — Not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous dioxide • Classification by mode of operation: — Continuously operating device  Safety Precautions and Indications of Dangerous Items We recommend that prior to using the device; you read carefully the safety precautions in order to operate it correctly... ndications of Dangerous Items is designed so that you can use the product safely, thus obviating any safety hazard or damage to you or others... hey are classified according to their magnitude and emergency degree of safety hazard or damages... s each and every item concerns safety, observe them... lassification  Degree of Danger or Danger and Seriousness  WARNING  Explains an instruction where personal injury or physical damage may occur... CAUTION  Explains an instruction where minor to medium injury or physical damage may occur... NOTICE  Explains an instruction that should be observed for safety reasons... 1... afety precautions prior to use Warning • Do not plug or unplug the power cord with a wet hand... ou may get an electric shock...  Do not use the unit in any room where there is the risk of explosion or in the vicinity of combustible material... n particular, you must not use the unit for a patient who has been anesthetized with flammable anesthetic gas (laughing gas)...  In use, be careful so that no water or antiseptic solution spills onto the control unit, which might cause fire or have you get an electric shock... f any water or antiseptic solution spills, immediately wipe it off with a dry cloth, etc...  Be careful not to give strong shock (dropping, in particular) to a handpiece... his might break the optics (Optic Handpiece only) or give you an electric shock...  You must not touch the connections (electric pins) of the handpiece or of the handpiece cord...  You must neither disassemble nor make alterations to the handpiece/control unit...  Do not use the unit on any patient who has a cardiac pacemaker (the unit may affect operation of a cardiac pacemaker)...  Make sure to use the specified fuse...   Warning • Do not turn the power ON/OFF switch without reason, It might blow out a fuse...  If you feel any abnormality such as vibration, heat generation, abnormal noise, etc... prior or during the use of the unit, immediately stop using it...  This product is Medical Electrical equipment... MC (Electromagnetic compatibility) is described in the accompanying documentation...  Portable and mobile RF communications equipment can affect Medical Electrical equipment... o not use RF equipment outskirts for the product...  Do not place anything within 10 centimeters around the unit... autions • Only qualified personal is allowed to use the device in dentistry or oral surgery : Qualified doctors in medicine and surgeons... ssistants and paramedical personal, under the responsibility of qualified doctors in medicine or surgeons...  When using the unit in surgery, make sure to take action for contingency, such as preparing 2 sets of the unit in case of failure...  Give the priority to patient’s safety, and pay adequate attention so that there will be no accident...  This product does not consider patient’s age (except infants), gender, weight or nationality...  This product does not consider operater’s age (mature person), hight, weight, gender, or nationality...  Do not use this product if the patient has the any of the following conditions: · Patient complications · Patient allergic reactions · Patient has preexisting condition e...  (heart, lung, renal, high-blood pressure) · Patient is Pregnant, patient of child-bearing potential or lactating patient · Patient is an infant (Age) · Patient has a heart pace maker fitted •The end user shall be responsible for any judgment that applies this product to a patient...  Place the unit on a flat and horizontal area... e careful not to give any strong shock (such as dropping) to the control unit...  Before using the unit, make sure to operate it outside the oral cavity for checking... hen, if you find any abnormality, immediately stop using it and contact the dealer...  Turn the power switch OFF prior to disconnecting the power cord or handpiece cord by holding their plugs... o not unplug by pulling on cords: they may be broken...  Do not unplug the power cord or handpiece cord while pressing on the foot control...  When the pump gets wet, wipe well and dry it... f the pump remains wet, it may not work normally as the roller inside the pump may slip...  If you bend or fold the irrigation tube while the pump is in operation, the irrigation tube may be broken or disconnected...  If you feel any abnormality in the irrigation flow, there is the possibility that the irrigation tube is worn and saline solution leaks out... hus, replace the irrigation tube...  The irrigation tube is disposable... fter using it once, dispose of it as medical waste...  Do not separate the handpiece from its cord, except when you replace the lamp (Optic Handpiece only)...  Neither turn the power switch ON with the handpiece cord unconnected, nor turns it ON while pressing on the foot control...  Always remove the tip prior to disconnecting the handpiece cord, install or remove the irrigation tube... therwise, you might get your hand, etc... njured by the tip...  Saline solution is used for irrigating and cooling down... f the irrigation flow is not adequate, bone cells might necrotize or tooth surface might be damaged...  In use, never allow the vibrating tip to touch any prosthesis such as ceramics... ouching might cause break or chipping...  In use, never allow the vibrating tip to touch a metal crown, porcelain crown, etc... which may cause loosening or breakage, etc...  You must use the tip within the power range described on the tip case... f you use it out of the power range, the tip might break or damage an operative site...  Do not use a tip that is scratched, twisted or rusted, etc... n use, the tip may break...   English  Thank you for purchasing our VarioSurg... his device is intended for use in dentistry and oral surgery... mplant site preparation, Bone harvesting, Sinus surgery, Osteoplasty, Osteotomy, General oral surgery, Tooth extraction, Syndesmotomy, Tooth avulsion, Periodontal surgery, Cyst surgery... e recommend that prior to use, you carefully read this document regarding instructions for use, handling method, or maintenance check so that you can carry on using the unit in the future... n addition, please keep this operation manual in a place where a user can refer to it at any given time...
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File Name: variosurg_operation_manual.pdf

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