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Operating instructions

1. J MLO nano ed oe E GEAF ra 1 5 Fig Normal display when using micromoior While the display shows the fig 1 you can control a motor by pressing the foot control pedal e Rotation display fig 1 When the motor is stopping the display shows the maximum rotation speed When the Motor is rotating the display shows the actual rotation speed When the motor stops the display shows 0 on the display then turn to the maximum rotation speed originally selected Forward Mode Motor turns clockwise Reverse Mode Motor turns counter clockwise e Rotation speed display fig 1 The display shows rotation speed you selected While the motor is rotating the actual rotation speed will show on the display Page 36 of 54 SET VALUE display The pre programmed maximum rotation speed is indicated on the display The icon will go off while the motor is rotating While the motor is rotating the speed icon appears for 1 second e Program number display fig 1 The program number you selected will be displayed For detailed program setting refer to section A Useful functions e Gear ratio display fig 1 The preset gear ratio is displayed A total of 10 different gear ratios can be selected 8 gear ratios are default and cannot be changed 2 gear ratios are for customized setting by users For detailed gear ratio setting refer to section A6 Settings A5 2 SCALER TC MODE NS Endo O POWER Fig 2 No
2. Disconnection in the Handpiece Cord or failure in Module Contact your NSK dealer NSK u B o Autoclavable at 135 C max B11 Spare parts Z217851 Page 51 of 54 NSK Annex C Operation manual Micromotor NLXnano Please read this Operation Manual carefully before use C1 General information A Precautions for the handling and operation e Read these safety cautions thoroughly before use and operate for their intended purpose according to this manual e These indicators will show you how to operate the product safely and prevent danger to you or others They are classified by degree and or severity of danger All contents relating to safety should be observed Classification Degree and severity of danger or damage Provides an instruction where death or the instructions may occur Danger Provides an instruction where personal injury or physical damage may Warning occur A l Provides an instruction where minor to medium injury or physical damage Caution may occur A Notice Provides an instruction that should be observed for safety reasons A Caution When operating this system always consider the safety of the patient and operator The motor is designed only for dental use by qualified personnel This product can t be operated without the exclusive Dentalone control panel Do not allow any impact on the motor and do not drop it as this may cause a malfunction Check for vibration noise an
3. gt LCD XXXX gt NLX XXXX gt VA170 XXXX Scaler In the case of connected to the Varios 170 this menu is displayed at the setup gt LCD XXXX VA170 XXXX NLX XXXX A2 Features e Integrated System of Electric Micromotor NLX BF and Multi Function Ultrasonic Scaler Varios 170 can be controlled with the multi control panel e User settings are achieved via the LCD graphical user interface e Visual identification of graphics on the multi control display is possible even during operation of the handpiece e The multi control panel allows up to 8 custom programs for your exacting needs motor only The multi control panel supports 5 languages English Espanol Italiano Francais and Deutsch Page 35 of 54 NSK A3 Description of the user interface Display gs Dentalone MODE key SELECT key FWD REV key UP key n ENT SAVE key Fass y SET UP key ESC key DOWN key A4 Start up When turning the power ON the name of connected instruments will be displayed for about 3 seconds along with a beep tone Then the LCD display will switch to operating screen automatically When turning the power on and simultaneously push the foot control the display of the multi control display will show the error message with Release Foot Pedal until a beep is heard The error message will disappear when foot controls is released A5 Description of the display A5 1 MOTOR lt 2 2Poooo00
4. from the handpiece cord Water does not comes out or weak from handpiece cord No Weak water No weak water from the handpiece Water leakage Water is leaking from the joint between the handpiece and the cord Tip oscillate but Handpiece LED doesn t turn on and off Handpiece LED does not illuminate Varios 170Lux Tip oscillate but Handpiece LED turns on and off Page 50 of 54 Power has not been properly adjusted for the case label Do not tip exceed firmly tip wrench clicks handpiece or the module Power has not been Adjust the power level correctly adjusted for the the power guide or tip case label Do not exceed firmly tip wrench clicks A your NSK dealer handpiece or the module hinian the water circuitry and supply to the unit Turn the water adjustment dial and set it to an appropriate water volume The water filter is Contact your NSK dealer clogged There may be exogenous Blow out with the material in the internal appliance such as water line syringes from the rear of the handpiece If it is still unsolved contact dealer O r at the handpiece cord Replace with new is worn or damaged O Ring Refer to section A6 6 2 Changing O Ring Firmly insert the handpiece into the handpiece cord Adjust the power level the power guide or tip tip The water adjustment dial is closed The handpiece is not connected into the handpiece cord correctly
5. recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey C should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 2 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed FR transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the DENTALONE is used exceeds the applicable RF compliance level above the DENTALONE should be checked to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the DENTALONE gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 10 of 54 4 3 Electromagnetic Environmental Recommendations Separation distances between portable and mobile RF communications equipment and DENTALON
6. Page 30 of 54 13 Technical data Mechanical data Dimensions including cover Heightxwidthxdept 580 x 415 x 365 mm Dimension without cover in operating position 770 x 405 x 350 Heightxwidthxdept Weight including cover 19 5 Kg Protection type covered IP32 nach EN 60529 Protection type without cover IP30 nach EN 60529 a E Electrical data o o oo d Protection in the installation 16 A idle e g circuit breaker with B cnaracter Protection class according DIN EN 61140 Classification according to MDD 93 42 EWG annex IX e TI ee aaa ae SS Operating data _ __ _ _ o Compressor air pressure max Max 34Ncm S Motor torque Max 3 4 N cm Operating temperature 15 40 C Life time 5 years Storage and transport conditions Temperature area 10 60 C Relative air humidity non condensing no tropical 10 85 protection u 500 1060 mbar Page 31 of 54 NSK KONFORMIT TSERKL RUNG DECLARATIONOF CONFORMITY Wir We Hersteller Manufacturer NSK WT GmbH Portitzer Stra e 69 d D 04425 Taucha Germany erklaren in eigener Verantwortung dass das Medizinprodukt declare on our own responsibility that the medical device Nentalone Artikel Nr Article number 9070 allen relevanten Anforderungen der Richtlinie 93 42 EWG und der Richtlinie 2006 42 EG entspricht meets all the provisions of the Directive 93 42 EEC and Directive 2006 42 EC which apply to him Angewendete Normen App
7. RF communications equipment can affect the DENTALONE The following cables components are part of the DENTALONE and can be used exclusively on the DENTALONE except power cord Page 7 of 54 NSK Ident number Cable type length 31338 1 HO5VV F 3x0 75mm unshielded Scaler cord VALux SC 37075 2x0 25mm unshielded 2x0 16mm 1 2m unshielded Motor cord NLX CD 37074 3x0 25mm unshielded 2x0 16mm 1 2m unshielded Multifunction syringe 57066 2x0 25mm unshielded Foot switch 37100 4x0 16mm unshielded Use of other cables may result in increased emissions or decreased immunity 4 1 Guidance and manufacturer s declaration electromagnetic emissions The DENTALONE is intended for use in the electromagnetic environment specified below The customer or the user of the DENTALONE should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The DENTALONE uses RF energy only for its CISPR 11 internal function Therefore RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The DENTALONE is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to the public low IEC 61000 3 2 voltage power supply that supplies buildings used Voltage fluctuation Complies for domestic purposes Flicker emissions IEC 61000 3 3 Page 8 of 54 4 2 Gu
8. annex A when taken Faulty contra angle or Check the handpiece contra from the holder handpiece blocked or angle and the chuck locking ceased up system Optical detection Clean the optical sensors Control panel displays sensor in holder is dirty with a cotton swab still in the previous status I Send device to repair no Defect of electronics self help possible Check filling level of the Ronai Fill water tank water tank Check the spray switch Spray switch not Switch on spray selector activated switch No pressure built up in Check by activating the the water tank Screw the cap tightly on the vent valve if air escapes because either screw water tank and or clean the at activation cap is not closed tightly seal or seal is missing Check Spray adjuster 3 u Adjust to the desired volume Lever at closed Move lever to suction handpiece position open position clean or replace if necessary Foot pedal not connected or defective Connect or check footswitch Spray function does not work Check Sieve Sieve is clogged Lid isn t tightly screwed on or missing seal Check the seal ring clean Effect vacuum is not and screw the cap tightly building up Check the screw cap Suction does not work or only with Check the O ring seals on the coupling plug from Seals missing or the tank and the suction damaged hose neck filling eyalorlne Waste container full Empty waste container waste container mis
9. at the side of the power inlet between the main switch and the power socket Before changing the fuse always disconnect the power cable from the power socket For opening the fuse box you require a flat screwdriver by which you carefully take out the link Attention Only use fuses with the correct rating After that push back the fuse in the holder until it is securely held Page 29 of 54 NSK 11 4 Manual unlocking the console A Attention Please only use this mechanical unlocking option of the console in case of defect or power failure For manual emergency unlocking remove the cover cap at the housing fig 18 Then turn the slotted screw with a screwdriver by approximately turn clockwise until the console is unlocked fig 19 while a second person gently pushes the console downwards The locking in the transport position is automatically carried out LEVEL ENSOR fig 18 fig 19 12 Disposal advices The device and its packaging were made from materials which can be recycled This reduces the waste and protects the environment Discard the packaging separately for recycling in accordance with local recycling options Devices that are marked with this symbol must not be disposed as household waste You are legally obliged to dispose old devices separately from the household waste European Directive 2002 96 EC Get free information about the disposal of your product from your NSK dealer WEEE Reg No DE 72356056
10. be cleaned see also section 9 After cleaning and screwing the lid back on the reservoir can be placed back on the quick release connector ready to be used again Please make sure it is securely held in place by listening out for noticeable locking click indicating that it is securely in place ALWAYS check the safe and secure fastening of the reservoir before use Re insert the plug of the level sensor in the contact socket level sensor A filter is installed in the front part of the saliva ejector This is accessible by careful removing the rubber adapter for the suction nozzle Clogging the strainer may cause a malfunction or power reduction of extraction Therefore the strainer should be checked after each treatment and daily cleaned Page 23 of 54 NSK 9 Cleaning maintenance disinfection and sterilization 9 1 General e When cleaning the Dentalone protective gloves MUST be worn at all times for health and safety compliance e Objects which cannot be sterilized and disinfected MUST NOT be handled with the same gloves When interrupting cleaning process the gloves have to be taken off A A treatment area is defined as an area where the recommendations regarding the hygiene requirements in the reprocessing of medical devices of the Division of Hospital Hygiene Infection Prevention and Control of the Robert Koch Institute and The Federal Institute for Drugs and Medical Devices apply Cleaning intervals Between patients
11. connect or use non NSK scaler handpieces Page 45 of 54 NSK B5 Attaching or removing a scaler tip 1 Place tip inside tip wrench Tip is placed in tip wrench from bottom fig 2 2 Align tip thread and handpiece thread and turn it clockwise until the Wrench clicks fig 3 Do not twist the handpiece cord always hold on to handpiece body Pay attention to the top of tip as some extend beyond the tip wrench and may cause injury To remove the tip place tip wrench over tip and turn counter clockwise with the tip wrench until tip and handpiece are separated Tip Wrench Top Loosen Tighten Bottom ous fig 2 fig 3 A Caution for Tip Usage Check the tip before use Dirt Damage Bending or Rust Do not exceed Maximum Power Level for tip as this may damage the tooth structure and or tip Do not hit ceramic prosthesis with tip during scaling as this may damage the restoration and or the tip Do not touch metal or prosthetic crowns except for removing them as tip could break and fall into patient s mouth and could be inhaled Do not touch gingival mucosa and or skin as It could cause damage and or burn injury e Do not sharpen and or bend the tip Tip may damage and not generate enough vibration during scaling e During use tip will gradually wear away As the tip wears the tip movement will change and decrease operating efficiency When performance level drops too far change the Tip Use tip guide check card for re
12. damage the tooth but also the tip Do not contact ceramic prostheses during the treatment because it could damage the prostheses and or tip DO NOT contact ceramic or metal crowns except when removing The tip could break and fall out Never sharpen or bend tips Tips could be damaged and not generate sufficient vibrations Use tip guide to check tip is fit for purpose Do not directly use the tip on the gums mucous membrane or skin This implies the danger of injuries or combustions The tip is subject to general wear and tear and natural material fatigue which will result in reduced performance In this case the tip should be replaced Tips MUST NOT be changed while the scaler is in operation Always use NSK tip wrench to carefully attach the tip Otherwise only a reduced vibration could be produced Before use check the screw thread of the tip for potential contaminations and clean if contaminated Use only NSK scaler tips because scaler perforance may be affected or handpiece may be damaged by using tips NOT made by NSK For more information refer to annex B section B5 and B6 Do not sterilize the instrument with ultraviolet radiation because the handpiece may change colour due to this Unplug the handpiece at the hose coupling only after the tip has been removed Risk of injury The user is responsible for a constant functional supervision maintenance and inspection of the scaler For the storage of the instrument the following lim
13. his education or skills and be familiar with the operation of the device Before operating the unit the user must ensure the reliability and orderly condition of the device For safety reasons the equipment must remain switched off when it is unattended In that case the power switch is always to be turned off The unit is not suitable for operation in potentially explosive areas The product is subject to regular safety checks The medical devices Act MPG and the corresponding regulations are to be observed by the operator fully Scope and deadlines of the technical safety checks are prescribed as follows At least every 12 months must be carried out following listed safety controls in compliance with DIN VDE 0750 and DIN VDE 0751 like perform Visual inspection of device and accessories protection ground conductor checking according to DIN VDE 0751 equivalent leakage current measurement according to DIN VDE 0751 functional testing of the unit in accordance with the accompanying documents We recommend keeping a medical book in which the test results of the safety checks are documented As manufacturer of the device we can assume responsibility for the safety properties of the unit only if maintenance and repair is performed by us or an authorised agent if the prescribed service intervals are observed and the device is used in accordance with the operating instructions A further condition is that components affecting the safety of the d
14. of the patient If you determine abnormalities immediately interrupt the use and contact your NSK dealer or authorised service partner Avoid hard impacts on the handpiece or dropping the instrument and tips on hard surfaces Always work with sufficient coolant water in order to avoid damages of the tooth or an overheating of the instrument itself Tips and Handpiece cannot be cleaned and disinfected with a Thermo Disinfector Sterilize the Tip Handpiece and Tip Wrench by autoclaving Wipe the Handpiece Cord including the connectors Disinfect handpiece cable according to the instructions after each treatment with a VAH listed no protein fixing and Aldehyde free disinfectants If chemical solvent or antiseptic solution is deposited on this product immediately wipe it away Discoloration or deformation may occur if left Do not disassemble or change the handpiece DO NOT USE on patients with a pacemaker DO NOT use near explosive substances or combustible materials DO NOT use the instrument on patients anesthetized with nitrous oxide ZA Caution The instrument may only be used by qualified personnel Patient safety MUST ALWAYS have the highest priority Before using check the vibration of the instrument outside the oral If you determine abnormalities immediately interrupt the use and contact your NSK dealer or an authorised service partner Do not exceed the recommended performance area for the applied tools because it could not only
15. scaler or micro motor please refer to the related sections in annex B and C A When replacing the multifunction syringe any remaining pressure and water in the system will escape from the open hose please keep an absorbent cloth for drying to hand The multi function syringe together with the hose can be separated from the unit and completely replaced together with the hose or seperately A The unit may only be put into operation if all outlets are properly connected Please check that the connectors are tight after they have been changed In case of any leaks please liaise with manufacturer appointed dealer or the manufacturer Page 27 of 54 NSK 11 Malfunctions and trouble shooting 11 1 Fault diagnosis Please see below information for help should you come across any issues In case problems cannot be resolved please contact manufacturer appointed dealer or the manufacturer Malfunction Searchforproblem Cause Measures Please check power cable Main switch does not No power from mains connection check device Device does not light up electricity fuses if necessary check work socket Main switch light works Possibly power supply but no display in the defect internal device operating part fault Send device for repair no self help possible Motor is not Check connection of the connected handpiece to the device Control panel displays fault code see Micro motor operating instructions does not work
16. the top of the Tip wears 1 mm and approximately 50 when it is has worn 2 mm In addition the vibration condition changes owing to the wear which may damage tooth surfaces Check the tip wear condition with the Varios Tip Card periodically and replace tips frequently 2mm 25 Decrease 50 Ly Decrease Efficiency Fig 8 B7 Use of the optional tip cover S Grip the tip cover S and put it over the tip To remove grip the tip cover S and the handpiece and pull gently apart fig 9 The tip cover S is not designed for use as a tip changing tool Caution Carefully put the tip cover S over the tip Pay particular attention to avoid injuring fingers Tip Cover Tip Handpiece Joint Page 48 of 54 NSK B8 Care and Maintenance B8 1 Cleaning of Optic Outlets Varios 170 Optic Fiber End Face Wipe the debris off the end of the Optic Outlets at the handpiece with alcohol soaked cotton swab fig 10 m 4 In case the light degradation contact your NSK dealer Caution Do not use any sharp pointy tools to clean the Optic Outlets fig 10 B8 2 Changing the O Ring An O ring is located in the Handpiece Cord Connector Use a pointed tool to remove and mount a new one into the O Ring groove fig 11 Optional O Ring Order No 0311020080 j fig 11 B9 Sterilization e Autoclave sterilization is recommended e Autoclave sterilization required prior to first time of use and after e
17. 0 ml min has to be guaranteed Insufficient water cooling causes irreversible damage of the tooth and tissue In case of failure of the compressed air generation the treatment must be stopped immediately Blunt burs generate excessive heat and cause damage of the pulp Bent instruments not running smoothly have to be disposed of immediately Disinfection and sterilisation has to performed in accordance with Manufacturers recommendations and applicable guidelines Before the first use and immediately after each use rotating instruments have to be cleaned and where appropriate sterilized autoclaved Until the first use the instruments should be stored in the original packaging or transport container at room temperature in a dust und humidity protected manner Rotating instruments should be stored hygienically on suitable stands or containers The same applies to sterilized instruments and instruments in sterilized packaging Instruments MUST be stored in a dust humidity free environment with no risk of recontamination In case of non corrosion resistant instruments disinfection and cleaning agents with corrosion protection non corrosive have to be used The contact with H20 hydrogen peroxide has to be avoided Hard metal working components are attacked and damaged Reduction of lifetime Avoid temperature over 180 C Exceeding 180 Cleads to a reduced lifetime Rotating instruments made from metal and non rust proof instruments are attac
18. E DENTALONE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the DENTALONE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the DENTALONE as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power of transmitter W 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHZ to 2 5 GHz u For transmitters rated at a maximum output power not listed above the recommended separation distance in metres m can be determined using the equation applicable to the frequency of the transmitter where is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer Note1 At 80 MHz and 800 MHz the separation distance of the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 4 4 Essential performance In accordance with EN 60601 1 2 section 6 2 1 10 are essential features which under the terms of the immunity guarantee fault free device functions of the DENTALONE as listed below Function of Supply of compressed air Control of micro motor Control of ultrasonic
19. If the DENTALONE is used for the first time or after a long period out of operation the internal compressor is working initially until the operating pressure is reached This process can take up to 20 seconds At this stage the console has to be brought into the working position The procedure is as follows In the recessed grips at the left and right side of the console there are unlocking switches 17 and through the activation of the rocker switches Fig 10 the console 4 can be electrically unlocked works only when the DENTALONE is turned on and the device has power Page 15 of 54 NSK By activating the rocker switches see illustration fig 10 and pulling at the recessed grips on both sides the operating console 4 can manually be moved upwards until it is audibly locked in the working position aS soon After pressing both locking switches 17 and unlocking the console 4 audible click the console has to be lifted within 1 5 seconds to raise it from the lower position into the upper position Otherwise the lock function is activated automatically again In this case both locking switch 17 must be released again and process must be repeated The same applies to lowering the console You should remove the moulded foam part 16 which is placed on the console 4 for protecting and safeguarding the instruments and store it for future transports Please check after transport whether the instruments are still placed properly and i
20. NSK Dentalone Operating instructions Edition V3 6 5 2 NSK Inhalt 1 IMIBOr AN NOLS S ee ee ee ee ae esse een 3 1 1 General safety guidelines c cccccccssececceseecceseeeceeeeeccsececseueeecsuseeesaeeesseececsuueeessueeesssnaesessseesssuesessaaeees 3 1 2 USE S VINO S insert seat ae E E E EE O TEE EE EEST 4 1 3 Intendend use 200224022400nsnenenenennnnnnennnnnennnnnnnnenenenunnnenenunnnnnnenenenunnnnnnnnensnunsnnnnsnensnnnsnnnnsnensnensennensnensnnnnnn 5 1 4 SIMONE oe DIOT een nennen 5 19 Combination with other products ccccccccecccceeccceeceeeeeceeeececeeeeseeceeseeceseeeeseeesseeeseeeseusessueeeesseessueeeseeesaes 5 1 6 Fy NS SS CAIN vn een nee rennen ee ee 6 1 7 standards and guidelines een neue eier era nee 6 1 8 VO ee 6 2 SCOPE OL TENNIS eig 7 2 1 BA IC All ers ee ee ee ee ee T 2 2 EE a EEE AAA E E A E E E T 2 3 Accessories consumables spare parts service partner us sus2sssnenennnnennnenennnnnnennnenennnnnnnnenenenennnennnnnnen 7 3 NN AE A A EEE Sante sacs ace ceed E E ahs ene FIIR EREEERRSIE RR NSSSENEER HERDER E T 4 ENC NOCO aiea ee A aeineteaceheceoaneds eanecetaaeseneeseseeeeeaw 7 4 1 Guidance and manufacturer s declaration electromagnetic emissions us024440Bnenne nennen nennen nenne 8 4 2 Guidance and manufacturer s declaration electric immunity us224400444440 Rennen nennen nennen nnnnne nennen 9 4 3 Electromagnetic Environm
21. Operation manual Micromotor NLX nano 2220022200020000nnnnnnnnennnnennnnnnnnnnnnennennnnennnnnnnnnnennnnennnnnnensnnennnnnnnnnnenn 52 Page 2 of 54 NSK 1 Important notes In order to get to know the advantages of the treatment unit and to guarantee patient safety it is absolutely necessary to thoroughly read the instructions for use before putting the device into operation 1 1 1 10 11 12 13 14 15 General safety guidelines The unit is built under consideration of the requirements of the German Act of Medical Devices or the guideline 93 42 EWG for medical devices and meets the essential requirements of annex I The product is a device of class Ila according to annex IX of regulation 9 of guideline 93 42 EEC for medical devices The safety technical standard is based on the VDE regulation for electromedical devices DIN IEC 60601 part 1 DIN VDE 0750 part 1 Caution To avoid the risk of electric shock the device is to be connected with supply networks which are installed according to the regulations for medically used rooms IEC 60364 7 710 2002 11 or DIN VDE 0100 710 The device has to be located in such a way that a separation from the mains by pulling the mains plug is easily possible in the event of a fault The product is a medical device and must be used in accordance with the rules of the medical devices Act MPG by authorized personnel only The user must guarantee proper handling due to
22. ach patient as noted below Take handpiece out of the packaging before sterilization e ONLY the tip Arios handpiece and tip wrench can be autoclaved Autoclave procedure 1 Clean and remove the Tip after use Refer to section B4 2 Wipe dirt and debris from the products and wipe clean with alcohol immersed cotton swab or cloth Do not use a wire brush 3 Place items into the sterilization cassette or an autoclave pouch Seal the pouch 4 Autoclavable up to max 135 C Ex Autoclave for 20 min at 121 C or 15 min at 132 C 5 Keep the products in the sterilization cassette or autoclave pouch to keep it clean until you use it Sterilization at 121 C for more than 15 minutes is recommended by IS017664 and ISO17665 1 Caution e Tip and Handpiece can not be cleaned and disinfected with a Thermo Disinfector e Do not sterilize by ultraviolet ray The handpiece could be discoloured e f autoclaved with other instruments stained with chemical solution it could strip the plating and make the surface black e Do not wipe with or clean or immerse in high acid water or sterilizing solutions e Clean and disinfect the handpiece cord with alcohol after every treatment Sterilization cassette The Varios handpiece tip and tip wrench can be sterilized together using the sterilization cassette Fig 12 1 Remove the tip from the Varios handpiece by using tip wrench 2 Place the tip wrench with the tip inside into the sterilization c
23. age of thread ridge of handpiece o You must use the tip within the power range described on the Tip Power Guide If you use it out of the power range the tip might break or damage an operative site When operating the product always consider the safety of the patient Only use by dental professionals such as dentists therapists or dental hygienist is intended Check the vibration outside the patient s oral cavity before use If any abnormalities are found stop using immediately and contact your NSK dealer Do not drop or exert an excessive shock to the scaler handpiece and cord To prevent possible tooth plane damage and handpiece overheating always use with sufficient water Do not sterilize with ultraviolet light as handpiece could be discoloured Sterilize the scaler tip Varios handpiece and tip wrench by autoclaving Wipe the handpiece cord including the cover Disinfect the hand piece cable according to the instructions after each treatment with a VAH listed disinfectants If chemical solvent or antiseptic solution is deposited on this product immediately wipe it away Page 43 of 54 NSK Discoloration or deformation may occur if left Do not disassemble or alter the handpiece DO NOT USE on patients with cardiac pacemakers Keep away from explosive substances and flammable materials Do not use for patients anesthetized with Nitrous Oxide This product needs special precautions regarding EMC and needs to be installed and put into s
24. ance of the 30 dip in UT 30 dip in UT installed battery backup lt 5 UT for 5 lt 5 UT for 5 seconds seconds gt 95 dip in UT gt 95 dip in UT Power frequency 3 Alm 3 Alm Power frequency magnetic fields 50 60 Hz magnetic should be at level characteristic of field a typical location in a typical commercial or hospital environment NOTE Uris the A C mains voltage prior to application of the test level IEC 61000 4 8 Page 9 of 54 Guidance and manufacturer s declaration electromagnetic immunity The DENTALONE is intended for use in the electromagnetic environment specified below The customer or the user of the DENTALONE should assure that it is used in such an environment Immunity Test IEC 60601 1 2 Compliance Electromagnetic environment Test level guidance Conducted RF 3 V rms 3 V Portable and mobile RF IEC 61000 4 6 150 kHz to 80 MHz communications equipment should outside be used no closer to any part of the Radiated RF ISM bands a Avea Ventilator including cables IEC 61000 4 3 than the recommended separation 3 V rms 3 V m distance calculated from the 150 kHz to 80 MHz equation applicable to the In ISM bands a frequency of the transmitter Recommended separation distance d 1 17 4P d 1 17 VP on 80 MHz until 800 MHz d 2 33 P on 800 MHZ until 2 5 GHz Where is P the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is the
25. assette You can put up to four tip wrenches with tips inside the cassette 3 Disconnect Varios handpiece from the handpiece cord refer to section B3 and clean refer to section 8 4 Place the handpiece into the sterilization cassette 5 Autoclavable up to max 135 C ex Autoclave for 20 min at 121 C or 15 min at 132 C 6 Keep the products in the sterilization cassette or autoclave pouch to keep them clean until you use it fig 12 Page 49 of 54 NSK B10 Troubleshooting In case of any functional problems please verify to following points before you contact your NSK Dealer Term to check The tip is not tightened ee nn the tip until the firmly _ tip wrench clicks Replace the tip Power setting has not been correctly adjusted The tip does not generate vibration in spite of depressing the Foot Control No Poor vibration The tip is bent or broken Adjust the power setting according to the power guide or tip case label Do not exceed maximum power Failure of vibrator in the Contact your NSK dealer handpiece Power has not been Adjust the power level properly adjusted for the the power guide or tip tip case label Do not exceed for the tip The tip is flying The tip is not tightened Tighten the tip until the away firmly tip wrench clicks Noise from the handpiece The handpiece is overheating The water does not reach to the handpiece Remove the handpiece
26. ate the product safely and prevent danger to you or others They are classified by degree and or severity of danger All contents relating to safety should be observed Classification Degree and severity of danger or damage Provides an instruction where death or the instructions may occur Danger Provides an instruction where personal injury or physical damage may Warning occur A l Provides an instruction where minor to medium injury or physical damage Caution may occur A Notice Provides an instruction that should be observed for safety reasons banger e Do not attempt to disassemble the product or tamper with the mechanism it may cause an electric shock or fire e Do not use the productfor implant surgery e The product is designed only for clinical dental use by qualified personnel The multi control panel is not water proof and should not be exposed to water Do not use the multi control panel as a handle when you want to move the dental unit Do not pull the instrument cords and suction tubing with an excessive force Be sure to press the buttons with a finger When operating always consider the safety of the patient Should the product function abnormally cancel the operation immediately and send it to your NSK dealer for repair Care should be taken not to place the motor cord near a gas burner Never attempt to repair a burnt motor cord Always replace damaged cords with a new one Do not exceed the drive
27. ates an automatic diagnosis feature that can help to diagnose the cause of a problem in the event of failure mode When the system has failed the display will show the E code and message Details of each error code are listed below ee ee ee Code Over setting torque Too much torque is loaded Remove the load from motor value Over current Soft1 Too much torque is loaded Release the foot control E 02 Over current Soft2 Abnormal electric current Release the foot control applied to motor and circuit Overheat E 08 Over load error The state of the load that Remove the load from motor handpiece and exceeded the limits continued release foot control during the fixed time E 09 Motor start is failure Handpiece motor cord Check if the handpiece cord has been disconnected connected on oe eee on motor and device Lamp under voltage Lamp circuit under voltage ontact NEK dee o o o ooo NSK dealer E13 Over control range Over motor control range Remove the load from motor handpiece and release foot control EEPROM error Memory read write data error Contact NSK dealer A8 2 SCALER BT Code handpiece properly Over current Soft1 Contact NSK dealer A9 Other settings For each setting follow the process below 1 Ensure the Motor and the Scaler are completely stopped 2 For normal display press and hold SET UP key for 3 seconds or longer then User setting menu will be displayed 3 Use A V key to select the
28. automatically switched on as soon as the suction hose is taken from the instrument holder and vice versa the suction is switched off when the suction hose is put back in the in the holder Please note the position of the lever on the suction handpiece Lever position forwards closed Lever position backwards open The suction is automatically switched off as well when the waste water reservoir 12 is full and has to be emptied The waste reservoir has a maximum volume of 1 litre It is located on the front or the unit See section 8 1 fig 7 Cleaning e Before disconnecting the reservoir the saliva ejector has to be emptied by holding the saliva ejector as high as possible and by doing so slightly stretching the suction tubing to allow any residual liquid to drain out of the tubing into the reservoir e Pull out the plug of the filling level sensor socket fig 16 e After that the reservoir has to be released from the connector by pressing the release lever fame Connector Level Sensor unlocking lever on quick release connector suction tube connector fig 16 After that the reservoir can be removed from the connector and be emptied To remove lid unscrew from the reservoir and empty content into an amalgam separator waster container or sewer system in accordance with applicable regulations Additional waste water reservoir containers with lids are available as an accessory Before reuse the reservoir should
29. cy Motor Cord is not connected Contact your NSK dealer correctly Water is leaking from the motor Replace with new O ring Water leakage Page 54 of 54
30. d overheating outside the patient s oral cavity before use If any abnormalities are found stop using the motor immediately and contact authorized NSK dealer Do not exceed the motor speed over recommended speed for the handpiece Option Prior to use always check the handpiece tightness vibration noise and overheating If any abnormalities are detected stop using immediately and contact authorized NSK dealer Do not use the motor under heavy load for extended periods of time as this will cause overheating The time for continuous use should be not more than 3 minutes Do not connect or disconnect the cord until the motor has completely stopped Do not connect disconnect the handpiece from the motor during operation Air Requirements dry free from contamination and oil Use a compressor with a dry air system Install an air filter if necessary This point is not applicable for the Dentalone because there is an internal air supply e Do not autoclave the motor cord or any other high temperature sterilization e The user shall be responsible for operation and maintenance e The operator is responsible for correct operational control maintenance and inspection C2 Technical data Max Rotation Speed 1 000 40 000 min Page 52 of 54 NSK C3 Connecting Disconnecting the Motor and Handpiece C3 1 Connecting Disconnecting the Motor and the Motor Cord Align and insert firmly the motor pin into the pin holes of the Mot
31. d the connector socket for the foot switch 2 fig 3 fig 4 At the rear of the housing a removable water tank 8 with a capacity of 500 ml is located see fig 5 fig 5 Page 14 of 54 At the front is placed a removable waste water container 12 for suction waste fig 6 fig 7 fig 8 Power switch power inlet safety switch Foot pedal connection 16 Foot pedal Console Pillar guide 17 17 Housing m Compressed air filter Water tank Power cord 10 Base 11 Foot stand with handle 12 Waste water container 13 Spray adjuster for Scaler 14 Spray adjuster for Motor 15 Spray ON OFF Switch 16 Moulded foam insert 17 2 x electrical unlocking switches for console 18 Instrument holder 19 Ultrasonic Scaler 20 Micro motor 21 Multifunction control panel 18 2 ev 21 22 23 22 Multifunction syringe Abb 9 23 Saliva ejector Ce Soe ae DD 8 2 Preparation initial operation First of all the DENTALONE has to be connected to a suitable power supply using the power cord provided 9 at the power inlet 1 Please correspondingly consider the regulations for medically used rooms in accordance with DIN VDE 0107 The instrument tubings and suction hoses have to be taken from the lower storage space and to be structured in such a way that the loops are not entwined with each other Now the power switch 1 at the left side of the device can be switched on The indicator lamp shows a green light
32. dpiece is controlled At the same time by activating the footswitch also the instrument lighting of the active handpiece is switched on or off Only the scaler function ON OFF and the motor with functions ON OFF speed are controlled by the foot pedal For multi function syringe 22 and saliva ejector 23 the foot switch has no function These two instruments are simply ready for operation as soon as you take them out of the holder 8 6 Instruments All instruments have been developed and constructed for their specific applications Improper use will lead to injury premature wear and tear destruction of instruments and hazard for the user patient or third party Please thoroughly read the corresponding instructions for use of the instruments before putting the device into operation Annex A C General information e YOU MUST ONLY USE technically perfect and hygienically cleaned and sterilized handpieces and contra angles scaler and scaler tips not included in the scope of delivery e Do not touch rotating instruments Risk of injury e Change of drill During the treatment pause The footswitch may not be activated during the change of drill because otherwise there is the risk of injury For safety reasons the device has to be brought into stand by position During the treatment e Exchange of the bur or instrument only if the motor has stopped e Insert drill and abrasive tool as deeply as possible in the chuck system of the instr
33. e Contaminated instruments have to be changed between patients to be cleaned disinfected and sterilized in accordance with applicable guidelines following the manufacturer s instructions For disinfection and sterilization the selected procedure MUST be suitable for the respective instrument you will find relevant information also in the detailed operating instructions for the micro motor contra angles handpieces and ultrasonic scaler in annex B und C e Before the first use and immediately after each use rotating instruments have to be cleaned and sterilized Until the first use the storage has to be conducted in the original package at room temperature in a dust und humidity protected manner e Rotating instruments should be stored on hygienically maintained stands autoclaving pouches or other suitable containers The same applies to sterilized instruments and instruments in sterile packaging The storage has to be in a dust humidity and recontamination protected environment e Incase of non corrosion protected instruments disinfection and cleaning agents with corrosion protection have to be applied e The contact with H202 hydrogen peroxide has to be avoided as this will attack and damage hard metal working components invalidate the product warranty and shorten the product life e Avoid temperature over 180 C as this will reduce the product s life e Rotating instruments out of hard metal and non rust proof instruments are attacked by t
34. e Rinse the water tank and fill with fresh drinking quality water e Connect suction hose and saliva ejector to the waste container and then rinse by sucking approximately 0 2 litre drinking water e Change the saliva ejector cannula consumables the multi function syringe tip Autoclavable and scaler including scaler tip e Disinfection of all parts which were touched during the treatment or came into contact with the patient These include especially hose coupling piece and saliva handpiece console upper part with instrument holder multifunction syringe scaler motor patient chair At the end of the working day e All of the aforementioned items as between patients e Sterilisation of the water tank the water tank cap only to clean and disinfect e Clean and disinfect suction handpiece suction hose and waste water collection tank including cap with disinfectant solutions in accordance with the manufacturer s instructions e Disassemble saliva ejector and suction hose attachment wash and lay in disinfection solution overnight e Clean sieve of suction hose e Cleaning and disinfection of the unit Once per week e All of the aforementioned steps as per the end of the working day procedures e Autoclaving of the water tanks and the waste water collection container clean and disinfect the caps as the caps are not autoclavable Page 24 of 54 9 2 Disinfection cleaning and sterilization of instruments and handpieces
35. e components es 2 Optional 8 er eo 2 Description Quantity Varios2 LUX handpiece optic Handpiece Cord optic Sterilization Cassette Tip Wrench Tip Type G4 Tip Type G6 Tip Type G8 O Ring Tip Cover S Option OONOORWNHA FD Nann Operation principle The sinusoidal electrical signal at ultrasonic frequency f gt 20 kHz is generated by the generator This signal is applied to the piezoelectric ceramic located inside the transducer The piezoelectric ceramic converts this signal into mechanical vibrations These vibrations are at the same ultrasonic frequency as the electrical signal The mechanical vibrations are propagated towards the distal end of the transducer The Tip insert which is attached at the distal end of the transducer vibrates at ultrasonic frequencies and makes it possible to achieve the aimed purpose B4 Assembling or disassembling of the handpiece Align the dots on the handpiece and the handpiece cord Push the handpiece into the Dots connector To remove the handpiece grip the handpiece and handpiece cord and pull to separate handpiece and cord fig 1 Handpiece Handpiece backend Handpiece Cord fig 1 A Warning To avoid electrical shock do not touch the electrical connector pins at the rear of the Varios handpiece and the Varios scaler cord Caution e Always ensure that the handpiece is properly connected and securely held in place e Do not
36. e substances and flammable materials 1 4 Short description Dentalone is a self contained dental unit with an integrated water and compressed air supply as well as a low volume suction The essential features include e Mobile unit Ergonomic design due to height adjustable console Compact construction minimal space requirement Equipped with Ultrasonic Scaler Electric Micro motor Multifunction syringe and Saliva ejector LED Light on Motor Scaler and Multifunction syringe for better illumination of the treatment area Motor control with stable tractive power in each speed range Ergonomic operation of handpieces contra angles in combination with NLXnano electric micro motor No suck back spray supply on micro motor ultrasonic scaler and multifunction syringe Clearly arranged work console with integrated swivelling instrument holder centrally arranged multi function control panel and storage space for accessories Automatic instrument recognition of active instrument Clearly visible graphic display of the device status and the set parameter Quick release connection of all instrument hoses for easy exchange Easy care housing Base with wheels combined with the cover and integrated telescopic handle makes transport comfortable as a trolley 1 5 Combination with other products The dental micro motor NLXnano can be used with instruments from NSK but also with instruments from other manufacturers with E type fitting Furthermore there is no i
37. ect the instruments and fold down instrument holder Stow instrument hoses and accessories in the device and fasten with webbing Make sure instruction for use manual is always kept with the DENTALONE A Attention Before transport at minus temperatures the device has to be completely emptied from water which means in addition to the water tank also all internal water ways until no spray mist escapes at the hand pieces anymore as otherwise frost damage may occur The same also applies to waste container and suction hose All internal waterways MUST be drained completely before any period of disuse to prevent the formation and development of germs In a final step the cover has to be pushed over the device and locked at 3 points see fig 1 Page 12 of 54 NSK Ensure suitability of the premises with regard to the level and stability of flooring cleanliness of the room and the climatic conditions and power supply compare section 1 4 and 5 The DENTALONE should only be unpacked once suitability of the environment has been established At the first operation please control the outer packaging of the device case for potential external damages 7 Installation instructions removal of cover When determining transport damages please contact your NSK dealer and clarify further procedures First the outer packaging box must be removed by lifting the device from the box using the handle attached to the middle of the cover We recomm
38. ed parameters and operating conditions for the Varios scaler and NLX micro motor is carried out by the multi control panel 21 located in the centre of the console 4 and the footswitch 3 connected to the device Please thoroughly read the instructions for use in annex A before putting the device into operation Spray function The spray function is switched on and off by means of the rocker switch 15 located at the lower side of the console The spray intensity can separately be adjusted for the NLX micro motor and the Varios scaler at the adjusters 13 and 14 at the lower side of the console Multifunction syringe Regardless of the NLX micro motor or the Varios scaler the 3 in 1 syringe 22 can be used by activating their separate buttons on the syringe body Water air or spray is controlled manually The syringe will operate as long as the corresponding buttons are depressed Optionally air or water can be discharged By simultaneously pressing both buttons spray is released The discharged water or air flow can be regulated by more or less intense pressure of the buttons Footswitch The footswitch 3 has to be connected to the corresponding socket at the rear of the left side panel 2 fig 3 By activating the footswitch the respectively active instrument which has been taken from the instrument holder is switched on at the end of activation again switched off Dead man s control and the rotation speed of the han
39. end that you keep the packaging Afterward the telescopic handle can be pulled out and the device can be rolled to the location where it will be used fig 1 There the cover can be removed after opening the three clips see fig 2 4 ig i fig 1 Unlocking the trolley handle fig 2 Opening the cover e Check that the device has been set up on a flat and stable surface If this is not the case change the location e The ventilation slits in the housing MUST NOT be adjusted or covered Sufficient ventilation of the device is required to avoid that overheating of internal components occurs Attention Wait before switching on and using the DENTALONE until it has adapted to the ambient temperature E g after a cold night in the car Note the admissible operation conditions See section 5 e Attention in order to avoid the risk of an electric shock this device may only be connected to a supply network with protective earth e The device has to be installed in such a way that in case of failure a separation from the supply network is easily possible by pulling the power plug e Use only the supplied power cord Page 13 of 54 NSK 8 Use 8 1 Description of components The DENTALONE consists of a base 10 and height adjustable console 4 which can be pulled out upwards at two columns 5 and locked On the left side of the DENTALONE are the power inlet with the power switch the fuse holder 1 fig 3 an
40. ental Recommendations Separation distances between portable and mobile RF communications equipment and DENTALONE 2u02222002snunennennnnnnnnnnnnnnnnnennennnnennnnnnnnnnnnennennnne nenne nennen 11 4 4 Essential DETOLMIANE Sn ee ae 11 5 Environmental conditions 024s022400200020n0nnno nenn nano nnnu nenn nano nnne nenn nun nnnennnnnnnnennnennnenennnennnensnnnnnnennnenn 12 6 Storage and Ian pOr zen ee ee 12 ig Use and removal of transport cover ccccccccccsseccceecece cece ceeseeeeseeeeceueessaeesseeeesecessucesssesseaeeetseeesaeeesees 13 8 AS secs cece pase A eae anc ecac teeta ce E OE E E EE EAA USER EIERN E AA E E RR A TE EUREN E 14 8 1 Description of COMPONENES cccccceeccceeeecceececececeeeeeseeeeceeeseeeesseeeeseeeessucessaeessaeeesseessaeseeseesseeesneessaees 14 8 2 Preparation initial ODEratiON ccccccccsecccceeecceececeeeeseeeeceuceceacesseeeeseueessucessueesseeceseueeseseueesaeesseeeseneessaees 15 8 3 FINO DE WAE ANK na E E E neste E EE 16 8 4 Completion and arrangement of instruments us0444400Bnennnnnnnnn nennen nennen nnnnnn nennen nennen nnnnnene nennen 17 8 9 Operating elements displays cccceececcssececceeececseeeecceuscecseuececseueeessuueeeseeeesseeeessuueeessuseessuaaeeessaseeeseges 18 8 6 als 816 VN e E E see eeonee cae eenecacecean uae cena DEN ceaue cence RNEIVDRIERSENERERERINESRNEORRE 18 8 6 1 Straight handpieces and contra a
41. er gt 1 0 5 0 sec 6 Endo alert 7 Others Adjustable range A Notice The setting items of Intensity and Delay timer will be displayed only the when it is ON Page 40 of 54 A9 1 4 4 Endo mode Endo endodontics mode setting This setting is not applicable to the NLX nano motor and Dentalone A9 1 5 5 Air Calibration for air driven foot control This setting is not applicable to the Dentalone A9 1 6 6 Endo alert Settings the alarm in Endo Endodontics mode These settings are not reflected in the case of the NLX nano motor A9 1 7 7 Others Other settings At setup mode select Others on the screen Then you will see the next screen shown below e LCD contrast Setting the contrast of the LCD display Select the LCD contrast that you want to use 2 1 0 1 2 Default is 0 e Backlight timer Setting the timeer up to OFF of the backlight of the LCD display Select the Backlight timer that you want to use 1 minute to 30 minutes or infinite Default is 10 min e Motor acceleration time e Setting the time for the motor rotation speed to arrive at the maximum speed value Select the acceleration time that you want to use 0 5 seconds to 3 0 seconds Default is 0 5 sec e Default setting Back NLX BF to the factory default setting When you select Default setting by pressing key you will see the menu of Rec
42. ervice according to the EMC information The use of ACCESSORIES and cables other than those specified may result in increased EMISSIONS or decreased IMMUNITY of this product If any water drops remain on the handpiece after autoclaving wipe them off Staining may result if left This device must not be used by the patients themselves Caution During operation high frequency oscillations in the handpiece and handpiece cord may affect computer and LAN cables Noise may be heard during operation near a radio receiver Users are responsible for operational control maintenance and inspection Clean sterilize the product immediately after use before you store it Leaving it non sterile might lead to failure When you have not used the product for a long time and use it again check the operation before use Eye damage may result if the LED is shone directly into the eyes Do not look into or turn it to the eyes of the patient This product s use is not restricted by patient s age except infants gender weight or race No special training is required for this device but it may only be used by qualified personnel Applied parts for patient and or operator are is Tip and handpiece B2 Technical data Use Environment Temperature 15 40 C Humidity 30 75 Atmospheric pressure 700 1060 hPa Storage Environment Temperature 10 60 C Humidity 10 85 Atmospheric pressure 500 1060 hPa Page 44 of 54 B3 Description of th
43. evice are replaced only with original parts Technical service documents are available for companies authorized by us for the service and repair Warning Any change of the device is NOT permitted In case of maintenance inspection or repair you should request a certificate of type and scope of work of the company The certificate must contain the date of implementation as well as name of the company with signature see also MDD DIN VDE 0750 DIN VDE 0751 The user has to comply with all valid laws and directives for medical devices as well as national regulations in particular the work safety regulations and accident prevention measures Portable communication devices which emit radio waves E g mobile phones can affect the medical equipment Don t use such devices near the Dentalone refer page 8 table 4 3 The instruments Motor Scaler and Syringe are equipped with LED light Eye damage may result if the LED is directed straight into the eyes Do not look into or turn it to the eyes of the patient Page 3 of 54 NSK 1 2 Used symbols A Caution check for specific warnings or precautions v Read the instructions for use Caution line voltage A disposal through household waste residual waste is not allowed Note recycling information K Application components type B device with earth connection pel Manufacturer IP30 Device is protected against penetration of solid bodies gt 2 5 mm Device is
44. ference DO ENSURE when securing tip to use the tip trench as supplied to avoid inefficient performance DO ENSURE before attaching tip cleanliness of the tip thread to avoid inefficient performance To avoid personal injury DO ENSURE tip is removed prior to disconnecting the handpiece If you feel the tip is not vibrating remove it from the operative site and press the foot control again If this does not improve the condition Ensure the Tip is secure turn the power off and restart it When attaching a tip always use gloves and NSK tip wrench as supplied e Ensure that water volume on the adjuster of the unit must be 0 when you use a tip which does not require irrigation e The tip wrench is a consumable item For reliable operation replace it annually Page 46 of 54 NSK The end of the Tip is thin and for supragingival fine scaling G A and interdental scaling The round cross section allows tooth d Surfaces to be finished without causing damage Set the level less than Power 5 at G mode Provided Scaler Tips Apply the top of the Tip on the tooth surface and gently move 2 it sideways in the same way as G8 Tip fig 4 MA fig 4 Removal of supra and subgingival calculus It provides easy access to interdental spaces and narrow pockets Set the level less than Power 5 at G mode Insert the top of the tip into the periodontal pocket and move R it slowly and gently The top of the tip is sharp so tha
45. he thermo disinfector This leads to discoloration and a short lifetime e Always refer to manufacturer s instructions before using any cleaning or disinfecting solutions 9 3 Cleaning and sterilization of drills and abrasive tools Drills and abrasive tools have to be cleaned disinfected and sterilized professionally Suitable cleaning and disinfection agents can be obtained from specialist dental suppliers Instructions for use have to be strictly followed 9 4 Cleaning of surfaces which cannot be sterilized Unit trays etc General procedure Disinfect by wiping with a cloth which is soaked in disinfectant solution Mechanical wiping movement with a wet however not dripping cloth is essential Do not wipe with a dry cloth afterwards Painted surfaces and all metal parts can be wiped with mild cleaning and disinfection agents Please only use ammonium chloride free agents because ammonium chloride would destroy the paintwork in the long run 9 5 Water pipes and water tank e After longer periods when the unit has not been used especially in the morning before first use all tubings pipes and hoses of the unit e The water tank without screw cap has to be autoclaved at 121 C once a day e The lid of the water tank should be disinfected with VAH listed disinfectants because it cannot be autoclaved e For disinfection and to prevent the formation of organic film it is recommended to flush all tubings pipes and hoses regularly
46. ial operation always check whether there is enough clean water in the water tank and the suction container 12 is empty 8 3 Filling the water tank A Before removing of the water tank 8 the DENTALONE has to be switched off at the main switch 1 or the spray switch 15 has to switch off Following that any remaining pressure in the system has to be drained by pressing the venting valve see fig 12 After that the fresh water tank can be pulled off the coupling pins by releasing the coupling See fig 13 Page 16 of 54 fig 12 fig 13 After unscrewing the screw cap from the bottle any remaining water should be disposed and the container has to be thoroughly cleaned according in accordance with applicable guidelines The water tank 8 should to be disinfected before refilling in accordance with applicable guidelines Refer to section 9 5 Only use drinking water quality water suitable for dental equipment must be used The maximum capacity of the tank is 500 ml Before closing the bottle also the screw cover has to be cleaned disinfected and checked for correct seating of the lid gasket Please screw the cap hand tight Do not overtighten Now the water tank can be attached again to the quick release fitting and the Spray switch 15 can be switched back on The compressor will start again to establish the operating pressure 8 4 Completion and arrangement of instruments During transport of the device all sterile parts of in
47. idance and manufacturer s declaration electric immunity The DENTALONE is intended for use in the electromagnetic environment specified below The customer or the user of the DENTALONE should assure that it is used in such an environment Immunity Test IEC 60601 1 2 Compliance Electromagnetic environment Test level level guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete ESD 8 kV air 8 kV air or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 Electrical fast transient 1 kV 1kV Mains power quality should be for input output for input output that of a typical commercial or burst lines lines hospital environment IEC 61000 4 4 2 kV 2 kV for power supply for power supply lines lines Surge 1 kV 1kV Mains power quality should be IEC 61000 4 5 differential mode differential mode thatof a typical commercial or 2 kV Common 2 kV hospital environment mode Common mode Voltage dips short lt 5 UT for 0 5 cycle lt 5 UT for 0 5 cycle Mains power quality should be interruptions and a ans that of a typical commercial or voltage variations on RAD N hospital environment power supply input 40 UT for 5 cycles 40 UT for 5 cycles lines 60 dip in Ur 60 dip in Ur Compliance is dependent on the IEC 61000 4 11 f operator following recommended 70 UT for 25 cycles 70 UT for 25 cycles charging and mainten
48. item you wish to change 4 Press ENT SAVE key Then straight away select the item Perform this process in order to decide change after a setup it indicates from 9 1 to 9 2 5 Press and hold ENT SAVE key for 3 seconds or longer to save the program A Notice At the setting mode to move back to the previous screen press the ESC key If you press ESC key without setting the menu below will appear Follow the instruction on the display Data ch nged LENT SAVE J S3Ve ESC Cancel Gear ratio 1 Page 39 of 54 NSK A9 1 Motor settings A9 1 1 1 Language Setting the display language English A9 1 2 2 Gear ratio 2 of 10 gear ratio settings can be set for customized settings To move the cursor press the key The gear ratio can be set 20 to 1 1 or 1 1 to 5 The right side or the left side should be 1 1 20 1 or 1 1 5 1 20 1 or 1 1 5 A9 1 3 3 Lamp For setting the function of the LED At setup mode select Lamp on the screen Then you will see the next selection shown below diagram Adjustable range e ON OFF Setting the Motor Lamp on off e Intensity Setting the intensity of the motor lamp 1 6 V 3 6 V Default is 3 5 V e Delay timer Setting the time delay of lighting after the motor has been used 1 0 5 0 seconds Default is 3 0 SEC 1 Language gt On Off gt On Off 4 Endo mode Intensity gt 1 6 3 6 V Delay tim
49. its apply air temperature 10 60 Cr humidity 10 85 and atmospheric pressure 500 1060hPa Air MUST be free of any contamination sulphur dioxide or salt To disconnect the handpiece from the handpiece cord for sterilization and or cleaning pull gently apart by holding the handpiece body in hand and the connector on the handpiece cord in the other hand Pull along the long axis of the handpiece and DO NOT twist Association for Applied Hygiene VAH Page 21 of 54 NSK A Warning DO NOT touch the connections at the end of the scaler cord as this can cause an electric shock A Caution Make sure that the scaler tip is removed before you disconnect the handpiece to avoid injury To disconnect the handpiece from the handpiece cord pull gently apart by holding the handpiece body in hand and the connector on the handpiece cord in the other hand 8 6 4 Multifunction syringe Short description The Multifunction syringe 22 is a device exclusively designed for the dental sector It serves to blow in air and water individually or as spray in order to clean and dry the operating field Handle f A Screw Cannula fig 14 fig 15 Characteristic features Ergonomic aspects were decisive for the choice of this Multifunction syringe for Dentalone This Multifunction syringe is easy to use simple to clean and sterilize An LED light positioned in the grip sleeve improves the visibility in the treatment area Both the Cann
50. ked by the thermo disinfector This leads to discoloration and a shortened lifetime Advices for use duration of exposure and suitability of disinfection and cleaning substances for certain types of instruments can be obtained from the manufacturer of the solution Store instruments in a dry place Protect instruments against sun and heat 8 6 1 Handpieces and contra angles Please obtain the description handling as well as maintenance and sterilization advices for the used instrument from the accompanying documents of the respective instrument Only handpieces and contra angles with ISO E type fitting can be used not included in the scope of delivery 8 6 2 Brushless motor Ti Max NLX nano Short description brushless micro motor 100 40 000 r min with light type ISO E with internal water Only instruments with ISO E type fitting can be used For further information please refer to annex C Motor Page 19 of 54 NSK Safety guidelines Please always consider the safety of the patient when operating the motor 20 The motor is only provided for dental application by qualified personnel The motor only works in conjunction with the control panel 21 Do not try to disassemble or manipulate the motor The user is responsible for regular maintenance and inspection of the motor Check the motor outside the mouth for vibration noises and overheating before commencing treatment If any irregularities occur immediately inter
51. lcohol Autoclave Plug Motor ap 4 Screw the Motor Cap on to the Motor Put the Autoclave plug ain on to the E type joint of the motor u 5 Insert into an autoclave pouch Seal the pouch 6 Autoclavable up to max 135 C ex Autoclave for 20 min at 121 C or 15 min at 132 C 7 Keep the Motor in the autoclave pouch to keep it clean during Fia 3 storage Sterilization at 121 C for more than 15 minutes is recommended by EN 13060 Page 53 of 54 NSK A Caution Do not autoclave or any other high temperature Sterilization motor cord Do not lubricate the motor Do not wipe nor immerse the motor in acidic water or acidic solutions Store the motor until the first use in the original packaging in suitable conditions as defined in section 5 of the manual in a dust und humidity protected manner and not in salty or sulphurous air Don t sterilize with dirt on the surface as this may cause corrosion e Keep the autoclave plug for E type joint and autoclave screw cap for motor base in a safe place so that they don t get lost e Don t hold the motor by the autoclave plug cover as they may be loose and you may drop the motor e Don t touch the motor after autoclaving as it can be very hot e We discourage plasma sterilization or EOG sterilization C5 Maintenance If the O Ring have worn to it becomes difficult to connect instruments or air or water might leak replace the O Ring Remove the O Ring from the E type join
52. lied standards Liste der Angewendeten Normen List of applied standards Gesetz uber Medizinprodukte Medizinproduktegesetz MPG EN 60601 1 Geratesicherheit EN 60601 1 2 EMV EN 60601 1 6 Gebrauchstauglichkeit Ergonomie DIN EN ISO 14971 Risikomanagement Benannte Stelle 4 Notified Body BSI Group Deutschland GmbH Eastgate 0535 Hanauer Landstra e 115 60314 Frankfurt Kenn Nummer Registration Number CE 595189 Konformit tsbewertungsverfahren Anhang II 3 93 42 EWG Diese Erkl rung gilt f r alle oben genannten Produkte die w hrend des Jahres 2014 und 2015 hergestellt sind und f r die eine interne Freigabe vorliegt This declaration applies to all above mentioned devices manufactured in 2014 and 2015 for which an internal release was given Die Technischen Unterlagen werden beim Hersteller aufbewahrt The technical data are kept by the manufacturer Taucha den Unterschrift und Angabe der Funktion Signature and function of the signing person Dieter Bauch a General Manager NSK WT GmbH Page 32 of 54 Annex A Operation manual Multi control panel Please read this Operation Manual carefully before use A1 General information A Precautions for the handling and operation e Read these safety cautions thoroughly before use and operate for their intended purpose according to this manual e Connect only NLXnano Motors Do not connect any other motor e These indicators will show you how to oper
53. lt of the cleaning process Control Within the examination of the treatment unit it has to be inspected e control of function and performance e examination of delivery volume of the water e Visual Control Integrity of the housing Integrity of hoses fuses and the power connection cable Labels symbols indicator lamps tightness of water and air channels Instrument wear Existence of the operation manual 10 3 Maintenance works at the compressed air reservoir The compressed air filter 7 is located on the left side next to the water tank In regular intervals during cleaning and maintenance drain condensate which may have accumulated in the filter The drain valve MUST ONLY be operated when the unit is turned OFF fig 17 Start by placing an absorbent cloth under the drainage valve and wipe the housing thoroughly dry afterwards Ifig 17 10 4 Replacing the hand piece cords Should the exchange of one of the motor or hand piece cords be required please follow the below steps e Switch off the unit on the main switch e After that release any remaining pressure in the water tank by pushing the release vent fig 12 and remove the tank e Unscrew the defective hose from the unit below the console and then disconnect it carefully gently pulling downwards e tis possible that some remaining fluids may drip from the connections please keep an absorbent cloth for drying to hand e For disconnecting the cord on the
54. motor speed recommended the bur file manufacturers Ensure the gear ratio on the display and gear ratio of the handpiece match Please ensure that rotation speed range is set correctly Don t use or leave the product in a high temperature environment such as under strong direct sunlight by a fire or near a radiator as this may cause a malfunction for inner circuit or sudden heat generation Page 33 of 54 NSK Summary of user setting menu Motor The following menus will be displayed on the LCD screen 1 Language gt English 2 Gear ratio Espanol 3 Lamp Italiano 14 Endo mode Francais 5 Air Deutsch 1 Language Gearratiot 1 SF ie 1 Language 4 Endo mode Display setting gt 6 Endo alert 7 Others Auto REV time Auto FWD time Endo mode setting is not reflected in the case of the NLX nano motor Adjustable range Adjustable range Adjustable range Display setting gt 6 Endo alert 7 Others Motor MIN pressure Motor MAX pressure Page 34 of 54 1 Language Endo mode alert On Off Alertsetting 40 80 Alert setting2 80 100 REVdert On Off Adjustable range Endo mode setting is not reflected in the case of the NLXnano motor Backlighttimer 1 30 minore Acceleration time B _ 0 5 3 0sec Default setting b _ No Yes _ Adjustable range 6 Endo alert 7 Others
55. n the correct order in the instrument holder 18 from left to right Scaler 19 Micro motor 20 Multifunction syringe 22 Saliva ejector 23 Refer to fig 9 Then swivel the instrument holder 18 by gently pulling on the control panel 21 in a comfortable working position until it is audibly locked fig 10 There are 2 additional stop positions which facilitate an individual positioning so that the instruments can comfortably be taken out and the display i of the control panel 21 can be easily seen fig 11 N iN Th TM fig 11 A 10 IN please check whether all instruments are completely assembled Check your device for completeness in accordance with the delivery notes The footswitch 3 is located in a holder mounted side on in the lower part of the device fig 7 Remove the foot switch from its holder and connect it to foot switch socket 2 at the left side of the device fig 3 and fig 4 Before every operation check the device for proper condition This concerns the stability of the unit the two sided lock in the extended position of the console as well as the measures described in the following sections of these instructions All cables tubings and the suctino hose should be checked for any damage Furthermore the instrument detection and function of the instruments and also the default settings on the control panel should be checked see section 8 5 and annex A control panel Before the init
56. ngles ceccceseeeececeeeeeeeeeeeeeeeeeeeseeeeeeaeeeeeseeeeeeseeeeesseeeeeeaeeeeesaneeeeas 19 8 6 2 Brushless motor Ti Max NLX NaNd a u anna ee 19 8 6 3 Ultrasrasonic scaler VARIOS 170 LUX nnannnannnannnennnennnnnnnnrnnnrnnnnrnnirsrrrsrrrsrrrnnrrerrrenrrenrrrrrnerrrnnrrnnrrne 20 8 6 4 Multifunction Syringe rn nee 22 8 6 5 10 611 6 1 PENO EE E E E E TEE E E ET 23 9 Cleaning maintenance disinfection and sterilization u 22002220002200nnnnnnnnnnnennennnne nenn nnnneennennnnnn 23 SERE a 2 ee ee ee ee ee 24 9 2 Disinfection cleaning and sterilization of instruments and handpieces cccccceececeeeeeaeeeeceeeeceeeesaneeesaeees 24 9 3 Cleaning and sterilization of drills and abrasive bodies ccceccccseeeeeeeeeeeeceeeeeeseeeeesaeeeeesaeeeeeseceeeesaeeeesaeees 25 9 4 Cleaning of surfaces which cannot be sterilized cece cceeeeeeceeeeeeeeeeeeeeeeeeeseeeeeseeeeesseeeeeseeeeesaeseeeesaaeeeeseeees 25 9 5 Water pipes and water tank cccccccsecccsceceeeceeecceeecseeceueeceecaueceueesaeeseessueeeaeesaessaeesseeseusesseesaueeseeessenssaeeneeess 25 To DAON Sy IE ee E E E E sete teesenaet earealeneiessdeiecee ce 26 9 7 Recommended disinfection and cleaning AGENL cceccccseeeeeceeeeeeceeeeeeeeeeeeeeeeeeeseeeeseeeeeesseeeeseeeeeesaneessaaeees 26 10 e aE a 19 E E E eee ee ee E een EE 26 10 1 Regular maintenance WOIKS vccssieicsecsussiesistendne
57. ntended combination with other products The ultrasonic scaler Varios 170 should be used exclusively with the correct tips from NSK The multi function syringe should only be used with tips of the manufacturer The saliva ejector can be used with any 6 mm or 7 tips which are approved as dental consumables CE sign For all accessories and consumables the hygiene regulations of the manufacturer shall apply Page 5 of 54 NSK 1 6 Hygiene standards 1 All objects which get into the oral cavity of a patient have to be pre treated to avoid any infection with any disease 2 All objects which directly or indirectly get in touch with the mouth of the patient are regarded as contaminated Contaminated objects MUST NOT get in contact with other patients without any disinfection sterilization 3 Direct unprotected contact with saliva or blood has to be avoided For your own safety you MUST wear suitable protective equipment during the treatment in accordance with country specific occupational safety and health regulations E g gloves goggles and face mask 4 Itis extremely important that any patient treatments planned in advance thus all necessary objects are available at the beginning of the treatment to save time and reduce the risk of cross contamination 5 To avoid cross contamination clean and dirty instruments must be kept separately 6 All objects which are directly or indirectly in contact with the patient must be either profe
58. onfirmation screen Use A Wkey to move to Yes then key for 3 seconds Then the all settings are initialized 6 Endo alert 7 Others LCD contrast gt 2 1 0 1 2 gt Backlight timer Acceleration time gt 0 5 3 0sec Default setting gt No Yes S O Adjustable range A9 1 8 8 Version Display product information LCD Software Version VA170 Software Version NLX Software Version Language Gear ratio Lamp Endo mode _ Air Endo alert Others gt LCD XXXX NLX XXXX VA170 XXXX NOOB WDNDN Page 41 of 54 NSK A9 2 SCALER SETTINGS 9 2 1 1 Version Display product information LCD Software Version VA170 Software Version NLX Software Version gt LCD XXXX VA170 XXXX NLX XXXX Page 42 of 54 Annex B Operation manual Ultrasonic Scaler Varios 170 Please read this Operation Manual carefully before use B1 General information Intended use This product is designed only for dental clinic dental office use This device generates ultrasonic waves intended for use in dental applications such as scaling root canal treatment periodontal and cavity preparation Precautions for the handling and operation Read these safety cautions thoroughly before use and operate for their intended purpose according to this manual These indicators will show you how to operate the product safely and prevent danger to you or others They are classified by degree and
59. or Cord Connector and fasten Motor the Motor Cord Nut securely fig 1 Motor Cord BEN To remove the motor cord from the Motor unscrew and detach the motor cord nut and gently pull out the motor cord connector i Motor Cord Fig 1 C3 2 Connecting Disconnecting the motor and the handpiece To attach the E type instrument to the Motor align handpiece and motor then turn until it clicks to align light source and light conductor in Positioning Pin Motor Insert case of fibre optic handpieces Positioning locator _ pin is aligned fig 2 To remove the handpiece gently pull motor and instrument apart Handpiece Option Handpiece is not included A Caution e Care should be taken when using instruments which require lubrication E Type Micromotor Following lubrication stand the handpiece vertically to allow the excess lubricant to drain away Wipe the instrument before you attach it to the Micromotor e Do not connect or disconnect the handpiece until the motor has completely stopped C4 Sterilization e For the sterilization method we recommend the autoclave sterilization method e Sterilization is required before first time of use and after each patient as noted below Steps for autoclaving 1 Turn off the power 2 Detach the motor from the Motor Cord Refer to section C3 1 3 Clean the surface of the Motor with brush Do not use a metal brush and wipe it with the cotton moistened with disinfecting a
60. or severity of danger All contents relating to safety should be observed Classification Degree and severity of danger or damage Provides an instruction where death or the instructions may occur Danger Provides an instruction where personal injury or physical damage may Warning occur A l Provides an instruction where minor to medium injury or physical damage Caution may occur A Notice Provides an instruction that should be observed for safety reasons A Warning TO PREVENT ELECTRIC SHOCK Do not touch the electrical connector pins at the rear of the Varios handpiece and the Varios scaler cord If you feel any abnormality such as vibration heat generation abnormal noise etc prior to or during use stop using it immediately This product is an electrical Medical Device The Electromagnetic Compatibility EMC is described in the operating instructions section 4 Portable and mobile RF communications equipment can affect electrical medical equipment Do not use RF equipment in close proximity to the product Use ONLY genuine NSK tips when using NSK Varios ultrasonic scaler Varios 170 LUX Problems such as damage and failure and accidents of scaler handpiece resulting from use of non NSK Tips are not included in the warranty The following describes possible failures that could happen when using the Non NSK tips o Vibration failure caused by using non conforming tip threads o Accidental ingestion of broken tips by the patient o Dam
61. protected against dripping water Vertically falling dripping water may not have any adverse effect Don t tread on Do not overload RO Do not use outside closed rooms w Eat cn Oo Autoclavable on max 135 C Direction up Protect from moisture Recycleable Caution fragile Handle with care kl S3 BaS 0535 Conformity according to all European Directives i orc A Temperature limits for storage and transport e a Limits of humidity for storage and transport a Some Limits of atmospheric air pressure for storage and transport Page 4 of 54 NSK 1 3 Intended use A The device Dentalone is a portable dental treatment unit and is used for outpatient and stationery general treatment of teeth The product is designed only for dental use by qualified personnel The NLX nano motor is for cutting polishing as required during general dental treatment The Scaler Varios 170 generates ultrasonic waves intended for use in dental applications such as scaling root canal treatment periodontal and cavity preparation For the choice of the treatment locations the information in the operating instructions are decisive Contra Indication Dentalone The device should NOT be used for surgical oral surgical treatments and implant surgery Scaler Do NOT use the scaler on patients with cardiac pacemakers Do not use for patients anesthetized under laughter gas Nitrous Oxide Keep away from explosiv
62. r of disinfectants and cleaning solutions 10 Maintenance It is recommended to maintain the DENTALONE according to the suggested intervals see below Maintenance and repair may only be carried out by authorized personnel by an appointed dealer or the manufacturer It is not permitted under any circumstances for unauthorized persons to open and interfere with the device Changes and repairs carried out by unauthorized persons invalidate the manufacturer s warranty and liability In addition to the inspection and functional examination during regular maintenance of the device an examination according to DIN VDE 0702 0751 has to be carried out All parts subject to normal wear and tear have to be replaced as required and are not covered by the warranty Advice For the disposal of packaging accessories and also the device you MUST COMPLY with applicable regulations 10 1 Regular maintenance works Scope and intervals of the safety technical checks should be in accordance with country specific regulations Recommended are At least once every 12 months the below mentioned safety technical checks have to be carried out under consideration of DIN VDE 0750 and DIN VDE 0751 Visual control of the device and accessories examination of the protective earthing according to DIN VDE 0751 equivalent leakage current measurement according to DIN VDE 0751 Functional checks of the device under consideration of accompanying documents I
63. rmal display when using scaler While the display shows the fig 2 you can control the ultrasonic scaler by pressing the foot control e Ultrasonic Vibration display fig 2 When the scaler is vibrating vibration icon will be displayed e Vibration Mode display fig 2 Selected ultrasonic mode is displayed Perio Endo or General e Power Level display fig 2 Selected ultrasonic power level is displayed POWER 0 10 A5 3 Selection of the instrument The selection of the instrument is done automatically by removing the respective instrument scaler or motor out of the instrument holder Page 37 of 54 NSK A6 Settings A6 1 MOTOR Functions you can set while the motor is rotating Maximum rotation speed rotation direction Functions you can set while the motor is stopping maximum rotation speed rotation direction gear ratio program PRG e Speed setting Press the A V key to set your desired speed in the motor function display Speed Range 1 000 40 000 min Notice Speed display changes faster as you press and hold the A V key e Gear ratio setting A maximum of 10 different gear ratios can be set 8 are fixed default settings 2 are for free settings Press SELECT key until Gear ratio on the display blinks at the normal display Press A V keys to choose an appropriate Gear ratio Press and hold key for 3 seconds or longer to save the set Gear ratio Notice The turn by A V key is sho
64. rupt the application and contact your NSK dealer In case of abnormal function of the motor immediately interrupt the application and send it for repair to your NSK dealer or NSK service partner Do not expose the housing to mechanical impacts Do not drop the motor This can lead to a malfunction Do not connect remove the motor cable or instrument as long as the motor drive has not come to a complete standstill Do not use the motor under full load for extended periods of time as this will cause it to overheat The time for continuous use should be not more than 3 minutes Do not exceed the motor speed recommended by the instrument Option manufacturers Ensure that the correct speed is set on the control panel Before use always ensure that the instrument is securely located on the motor Do not connect disconnect the instruments during operation The motor does not require lubrication After lubrication leave the handpiece at a suitable location for a certain time Only place on the motor when excessive oil has completely drained off If oil gets into the motor this leads to malfunctions of the motor Do not autoclave the motor cord or sterilize with another high temperature procedure Do not wipe off clean or immerse the motor with a disinfectant solution or acid water 8 6 3 Ultrasonic scaler VARIOS 170 LUX For further information see the operating instructions of the Ultrasonic Scaler 19 In Annex B Safety instr
65. scaler Operation function multi pad Suction of saliva ejector Automatic detection of removal of the instruments in operation Page 11 of 54 5 Environmental conditions Operation Bez Temperature area 15to 40 Relative air humidity non condensing no tropical protection 301075 Air pressure 860to 1060 Transport EEE Temperature area Relative air humidity non condensing no tropical protection Storage EEE Temperature area Technical changes reserved 6 Storage and transport For correct storage of the product please note the storage conditions see section 5 The device either has to be stored or transported in outer packaging original cardboard box or in transport packaging with cover For a stackability of several devices additional precautions have to be made Before t the DENTALONE also when relocating from one room into another the fresh water tank 4 and the waste water collection tank 7 have to be emptied Spilled water can damage the electronic components of the DENTALONE The footswitch can be stowed in the space next to the waste water tank Before a bigger transport from location to location it is recommended to additionally carry out the following measures e Cleaning disinfection and sterilization as required see section 9 Pull out the plug of the footswitch from the connector socket Bring console in transport position and lock Place foam insert on the console to prot
66. scasuinecatnaincs nn nn anna na hend 26 10 2 Maintenance intervals a u ie ande a ceed eae seubensueedndseadeeewodadeee 26 10 3 Maintenance of the compressed air reserVOir 222u0s2suusnenennnnennnnnnnennnnnnnennnnnnnnnnnnnnnennnnennnnnnnnnnnennnnnnennenenn 27 10 4 Replacing the hand piece cordsS cccccccceccc eee ceeee eee asec se eeeeeeeaeeeseeeseeeeseeeseeeeeeeeseeeseeeseeeeseeesseeeseeesseesaeeesaeess 27 11 Malfunctions and trouble shooting 2us04444ssRnennne nennen nnnnnn nennen nenne nnnnnennennnnnnennnnnnnnnennennnnnnenn 28 A Ace gcd IEE e Eala E lt o een ee 28 1122 FU SIGNS E E E 29 11 3 CHANGE OLTA E ee Be een 29 11 4 Manual unlocking the console u2z2z020000000000n0nnnnnnnn nennen nnnnnennnne nenn nnnnnennnnennnnnnnnnnnnnnnensnnnensnnenenenn 30 12 Disposal advices mctressedesceicctelcnhacseccdeadedsSebaedsedntann dens sausbenicedsdadelaueendasdesdoteecad eqdedadedetbhaaenncaneqeencusdensedsdaes 30 13 Technical GA nu iii 31 PUNO E i EPET EEE HEREIN A T E EURER RUNCHENEIEFENENEEEEEEENHUEEER NEBEN URRNESEEERURNIEEEE E ET 33 Operation manual Multi control panel u 2400044400RRnnnnn nennen nennen nnnnnnnnennnn nennen nnnnnnnnennnnnnnnennnnnnnnnnensnnnnnnn 33 PATER De a ee ee ee 43 Operation manual Ultrasonic Scaler Varios 170 cccccecccecseeeeeeeeeeeeeeeeeeeeeeeeseeeeeseeeeesseeesseeeeessaeeesaeseseesseeeeesaeees 43 E UR E ee a ee ee ee 52
67. sing signal from the filling level sensor isn t Check the connection Replace the seals restricted performance filling level sensor connected on the unit fig 15 Check the floating body floating body sluggish Clean the guiding surfaces and remains in the and check for smooth of the filling level sensor mn l upper position operation Page 28 of 54 Relieve the plunger of the locking mechanism by slightly lifting the console during activation of the unlocking button po Electric ale ee De press the unlocking unlocking of one ihe of the button on both sides of the no nes console is activated sr Locking mechanism jammed not work Use manual emergency Internal electric unlocking section 11 4 functional disturbance send device for repair to NSK service partner Main switch does not Please check power cable No voltage l light connection 11 2 Fault signals m me m permanent outside of the limits environment Acoustic signal Device temperature gt 70 C Move the machine into a cooler alternate outside of the limits environment treatment break Error code on the Refer to instruction of use for the Refer to instruction of use for the Control Panel control panel in annex A control panel in annex A 11 3 Change of fuse A Attention Only carry out change of fuse while unit is disconnected from the mains electricity supply Hazard of electric shock Hazard of electric shock The fuse box is located
68. ssionally disposed of following treatment or they need to be processed for cross infection control 7 The water tank should be filled with of drinking water quality or treated purified water As an additive the product ALPRON is recommended 1 7 Standards and guidelines DIN EN ISO 22374 EN ISO 10079 3 Medical suction equipment Part 3 Suction equipment powered from a vacuum or pressure source 1 8 Terms Electromagnetic Compatibility Applied part Applied part SS Page 6 of 54 NSK 2 Scope of delivery 2 1 Basic unit The scope of delivery of the basic unit additionally includes the following components 1 piece Cover with telescopic handle 1 piece Water tank incl screw cap 1 piece Waste container incl screw cap with integrated filling level sensor 1 piece Power Cord with non heating apparatuses plug 1 piece Instruction for use 1 piece Foot pedal Accessories not in the sense of the directive Motor 1 piece Autoclave plug 1 piece Motor Cap for autoclave 1 set O Rings 3 x black o rings 1 piece O Ring blue Scaler 1 piece Sterilization cassette 3 piece Tip Wrench 1 piece Scaler Tip type G4 1 piece Scaler Tip type G6 1 piece Scaler Tip type G8 2 pieces O Ring 2 2 Equipment Instrument holder equipped from the left to the right side Scaler with light VARIOS 170 LUX separately packed Micromotor NLX nano with light without handpiece contra angle Multi function Syringe Saliva ejector
69. struments i e Scaler and Scaler Tips motor handpiece the tips of the syringe and the saliva ejector have to be packed separately and must be fitted again by the user See the detailed instructions in section 8 6 and annex B Scaler and annex C Motor The instrument holders as already described in section 8 2 have been located with functionality and A operation in mind The instruments may not swapped between holders because this would cause malfunctions Each day before the first treatment each instrument should be activated 30 seconds in order to rinse stagnant water in instrument hoses Initial operation and practice interruption of more than 24 hours e Before the initial operation and before and after each treatment pause gt 10 hours disinfection cleaning sterilization has to be carried out See section 9 e Then fill the water tank 8 with fresh drinking water e Start rinsing process by switching on the spray function two times in succession for approximately 20 seconds all lines are rinsed with water The spray regulators 13 and 14 have to be adjusted to maximum flow setting By doing so any disinfection agents in the instrument hoses are thoroughly removed from the hoses For safety reasons the device is to be switched off at the power switch 1 before leaving the surgery Page 17 of 54 NSK 8 5 Operating elements displays Control panel The operation of the device which means the setting of defin
70. t is recommended to keep a log book in which the examination results of the safety technical checks are documented Clean liquid container regularly if necessary de scale and autoclave at 121 C 10 2 Maintenance intervals Daily maintenance by the user The fulfilment of requirements for hygiene and the maintenance of efficiency of the device is guaranteed by carefully observing the information for disinfection cleaning and maintenance of the instruments e Before the first treatment flush all tubings and hoses pipes for approximately 30 seconds by operating all outlets While doing this the spray controls 9 and 10 for motor and scaler have to be adjusted on maximum flow e Clean and maintain handpieces and contra angles in accordance with manufacturer s guidelines Important observe exactly the maintenance instructions of the instruments under section 8 6 and 9 Page 26 of 54 NSK A Instrument tubings CANNOT be cleaned in the thermo disinfector and MUST NOT be exposed to temperatures exceeding 40 C maximum Annual maintenance by authorised personnel Basic cleaning of the water lines A basic cleaning of the water lines to remove biofilm is necessary for the treatment unit which has been in operation for more than one year This has to be carried out by an authorised service technician Remove instruments from micro motor and scaler handpiece so that the water channels in these instruments do not get blocked as a resu
71. t it could remove tartar on long crowns and retracted gingival fig 5 Clean periodontal pocket at low power Set the level less than Power 5 at P mode fig 5 Removal of supragingival and interdental calculus This tip can be used in all quadrants and is very useful for the removal G8 of hard calculus Set the level less than Power 7 at G mode Apply the top of the tip on the tooth plane and move it sideways finely along the neck of tooth fig 6 ii fig 6 A Caution Tips are consumable products and subject to wear and tear We recommend periodical replacement Please use the Varios Tip Card to check when tips need to be replaced Page 47 of 54 NSK B6 How to use the Varios Tip Card 1 Place the neck of the tip in the cut out 2 Check wear of the tip 3 See the green yellow and red line to check wear of the tip See below what each colour means To guarantee effective and safe used we recommended to replace tips when they meet the yellow line wear of 1 mm Tip Card Green No wear Tip is OK Tip replacement is not necessary Yellow Wear of 1 mm Tip is showing some wear Tip replacement is recommended Red Wear of 2 mm Tip is badly worn Tip replacement is necessary The Varios Tip Card can be used to check the following tips G1 G4 G5 G6 G8 P1 P1D P10 and P20 A Caution Tips are consumable products The efficiency of dental scaling degreases approximately 25 when
72. t with a pointy tool and replace with new O Rings in the grooves O Ring Blue 0313 084070 O Ring Black 0312 074080 O Ring Autoclave plug 0312 457102 A Caution There are 4 O Rings on the E type joint The blue o ring is thinner than the other 3 o rings Make sure you order and replace the correct o rings Never use the autoclave plug without the correct o ring in place Missing o ring can lead to water and steam ingress during autoclave cycle and damage the motor beyond repair If the O ring is damaged replace it immediately An or damaged O rings can lead to Air Water leak Air Water spray does work properly Vibration Difficult to connect disconnect instruments O Ring Ble O RinglBluck C6 Troubleshooting If the motor stops due to an abnormality such as a malfunction overload break or incorrect usage it automatically checks the state of the Multifunction control panel and detects the cause of the malfunction and displays an error code on the display If an error code is displayed turn on the power again and check whether the same error code is displayed If the same error code is displayed take action by referring to the instructions provided in the Check Remedy column in the following table Check Remedy Cause Solution _____ Motor does not run Motor Cord is not connected Check the connection correctly LED does not illuminate Reached the end of lite Contact your NSK dealer expectan
73. uctions e Thoroughly read through these safety guidelines before use and use the instrument only for their intended purpose and in accordance with the operating instructions e These displays allow a safe use of the instrument and prevent danger and damages for you and other persons Indicating dangerous situations Warning Do not touch the connections at the end of the scaler cord This can cause an electric shock If you feel any abnormality such as vibration heat generation abnormal noise etc prior or during use stop immediately The Electromagnetic Compatibility EMC is described in the operating instructions section 4 Portable and mobile RF communications equipment can affect Electrical Medical equipment Do not use RF equipment in close proximity to the product USE ONLY NSK genuine tips when using NSK Varios Ultrasonic Scaler Varios 170 LUX problems such as damage failure and accident of Handpieces resulting from use of Non NSK Tips are not included in the warranty The following are the possible failure that could happen when using non NSK tips e Vibration failure caused by using incompatible tips E311 e Accidental ingestion of broken tips by the patient e Damage of thread ridge of handpiece Warning Page 20 of 54 When operating the product always consider safety of the patient The scaler is only to be used by qualified personnel Before using check the vibration of the instrument outside the oral cavity
74. ula and the handle are easy to dismantle perfect to disinfect and sterilize in an autoclave at 135 Ci e NSK iClave Use e For water only press the left key e For air only press the right key e For water air mixture spray press both keys at the same time e The LED light is automatically activated when you take the syringe out of the holder Cleaning and sterilization To constantly guarantee maximum hygiene you should clean and sterilize the multifunction syringe tip after each treatment To take the syringe apart please follow these instructions e Remove the syringe cannula by loosening the screw fig 14 e Toremove the complete syringe handle push the button at the lower end of the handle in axial direction upwards fig 14 e Wipe off potential contaminations with a clean cloth e The parts have to be sterilized in a steam autoclave at 134 C at least 3 minutes ie e NSK iClave Maintenance Except the described cleaning and sterilization no additional maintenance is required for the syringe DO NOT lubricate the multifunction syringe as this will cause irreparable damage Page 22 of 54 8 6 5 Suction The suction system offers the prerequisite for relaxed and ergonomic working without permanent interruptions due to the swallowing reflex of the patient The saliva ejector 23 allows the use of interchangeable flexible saliva ejector tips consumable material or autoclavable tips size 6 mm or 7 The suction is
75. ument Please observe the manufacturer s information Ensure chuck system is holding bur safely refer to separate instruction for use of the handpiece Bring instruments to full rotation speed before beginning to operate Avoid tilting or levering increased danger of breakage Use of safety glasses is recommended depending on the use Improper application leads to poor performance and an increased risk Note the separate operating instructions of the respective instruments in annex A C Page 18 of 54 NSK Observing the rotation speed recommendations leads to optimum performance When exceeding the maximum permissible rotation speed some instruments are prone to can lead to damage or destruction of instruments In case of work component diameters which are bigger than the shaft strength strong centrifugal forces can occur which can lead to deflections of the shaft and or breakage of the instrument Do not exceed the maximum permissible rotation speed Please refer to manufacturers instructions to ascertain the maximum permissible rotation speed of respective instrument Avoid excessive pressing forces because this causes damage of the cutting instruments and generates excessive heat Overheating is caused by excessive pressure on the instrument which leads damage of the pulp Excessive pressure can also lead to rough surfaces and breakages of instruments To avoid unwanted heat generation a sufficient cooling with an air water spray at least 5
76. with suitable solutions Please refer to section 9 7 e Afterwards rinse thoroughly by running each instrument twice for at least 20 seconds with the water spray function activated The spray controls 13 and 14 have to be turned on maximum flow Thus the remains of cleaning and disinfectant are rinsed from the hoses Remember that the cap of the water tank MUST NOT be autoclaved Page 25 of 54 NSK 9 6 Suction system e Wipe suction hose between patients with a disinfectant wipe To avoid blockages flush hose especially following procedures with bleeding with cold water but at least 4 to 6 times per day Attach suction hose to the waste water container 12 and rinse e Atthe end of the day s sessions flush suction hose as per manufacturer s instructions e The waste water collection reservoir wide neck glass bottle has to be thoroughly cleaned after emptying and if necessary to be autoclaved at 121 C except the screw cap which is NOT autoclavable The lid of the waste water reservoir MUST NOT be autoclaved 9 7 Recommended disinfection and cleaning agent BILPRON Agent for operating water disinfection ALPRON Agent for water treatment BIOTEST plus Agent to verify the bacterial load of liquids and surfaces AlproJet DD or D Highly effective concentrate for daily cleaning of suction systems AlproJet W Highly effective concentrate for the weekly cleaning of suction systems Always follow the instructions of the manufacture
77. without cannula 2 3 Accessories consumables spare parts service partner Consult your NSK dealer for more information about specifications accessories consumables spare parts and service partners 3 Warranty The manufacturer s warranty is 1 year from date of purchase for provided the unit has been properly commissioned and used in appropriate conditions The manufacturer reserves the right to determine the cause of any problems and to analyze Consumables parts and wearing parts are not covered by the warranty The warranty will lapse f non approved materials and liquids as described in the instruction for use are being used if any modification on the unit is made by the customer or other unauthorized persons if the device is used for any other purpose as its intended use if damage is caused by gross negligence or due to improper use 4 EMC Notice A The DENTALONE is subject to special precautions regarding EMC and must therefore be installed and used according to the EMC notes in this operation manual The Dentalone may cause radio interference or it can interfere with the operation of devices in the vicinity If the location in which the DENTALONE is used exceeds the applicable RF compliance level mentioned above the DENTALONE should be checked to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the DENTALONE Portable and mobile
78. wn below Akey 4 Y key 1 54 1 44 1 24 1 14 Gear ratio 2 lt Gear ratio 1 4 gt 20 14 18 1410 144 1 Gear ratio 1 und 2 only displayed when you set them in user setting menu For user setting menu refer to section A9 Other Settings e Rotation Direction setting To select the motor forward rotation press key until F appears at the normal display To select the motor reverse rotation press key until R appears at the normal display A6 2 SCALER e Treatment mode setting vee MODE key to select the different treatment modes at the ultrasonic scaler display Press key Perio Endo and General modes will be displayed as you press the key e Power level setting Use A Wkey to select the power level at the normal display Press A key for increase press V key for decrease Power 0 to 10 A7 Useful functions A7 1 MOTOR Up to 8 customized settings are available with the following selections e Maximum rotation speed e Rotation direction e Gear ratio e Program selection 1 Press SELECT key until program number is displayed blinks at the motor function display 2 Press A V key to select the program number that you want to use 3 Press IENT SAVE key for 3 seconds or longer the selection is completed Notice When the program you selected is modified the colour of PRG will inverse PRG Page 38 of 54 NSK A8 Error Codes A8 1 MOTOR The system incorpor

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