KaVo EXPERTsurg LUX Instructions For Use Manual

KaVo EXPERTsurg LUX Instructions For Use Manual

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EXPERTsurg LUX – 1.008.3500

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Summary of Contents for KaVo EXPERTsurg LUX

  • Page 1 Instructions for use EXPERTsurg LUX – 1.008.3500...
  • Page 2 Manufacturer: Distribution: KaVo Dental GmbH KaVo Dental GmbH Bismarckring 39 Bismarckring 39 88400 Biberach 88400 Biberach Germany Germany Phone +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...
  • Page 3: Table Of Contents

    Instructions for use EXPERTsurg LUX – 1.008.3500 Table of contents Table of contents 1 User instructions ....................... 2 Safety..........................2.1 Explosion hazard ......................7 2.2 Infection hazard ......................7 2.3 Electrical shock......................7 2.4 Technical condition ......................8 2.5 Electromagnetic fields ....................8 2.6 Improper use ........................
  • Page 4 Instructions for use EXPERTsurg LUX – 1.008.3500 Table of contents 5.6.1 Manual rinsing function ..................42 5.6.2 Programme step Rinsing function ............... 43 5.7 Activating the one-touch calibration................. 43 5.8 Foot control ........................45 5.8.1 Changing the speed, coolant flow, and direction of motor rotation ......45 5.8.2...
  • Page 5: User Instructions

    1 User instructions 1 User instructions Dear user, Congratulations on purchasing this KaVo quality product. By following the notes below you will be able to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH KaVo and EXPERTsurg are either registered trademarks or trademarks of KaVo Dental GmbH.
  • Page 6 KaVo offers a fixed-price service check for the original factory maintenance. You can use a loaner device for the time of the service check. KaVo Original Factory Repair In the event of a repair, please ship your product to the KaVo Original Factory Repair using www.kavobox.com. 6 / 68...
  • Page 7: Safety

    Instructions for use EXPERTsurg LUX – 1.008.3500 2 Safety | 2.1 Explosion hazard 2 Safety NOTE All serious events occurring in relation to the product must be reported to the manufacturer and the competent authority of the member state, in which the user and/or patient resides.
  • Page 8: Technical Condition

    Instructions for use EXPERTsurg LUX – 1.008.3500 2 Safety | 2.4 Technical condition 2.4 Technical condition If damaged, the device or components could injure patients, users and third parties. 4 Only operate devices or components if they show no signs of damage on the outside.
  • Page 9: Improper Use

    Repairs and safety checks may only be performed by trained service personnel. The following persons are authorised to do this: ▪ Service technicians of KaVo branches after the appropriate product training ▪ Service technicians of KaVo authorised dealers after the appropriate product...
  • Page 10: Information About Electromagnetic Compatibility

    Instructions for use EXPERTsurg LUX – 1.008.3500 2 Safety | 2.10 Information about electromagnetic compatibility As a result of the use of NON-KaVo original spare parts during the repair, parts such as covers may become undone and injure the patient, user or other people.
  • Page 11: Description Of The Product

    NOTE The EXPERTsurg LUX is approved for use in surgical theatres. This KaVo product is intended only for use in the field of dentistry, for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. peri- odontal gap, gingiva, bone, jaw, extractions, implantations) and must be used by expert medical staff only.
  • Page 12: Scope Of Delivery

    Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.2 Scope of delivery 3.2 Scope of delivery The scope of delivery of the EXPERTsurg LUX includes the following: ▪ Device EXPERTsurg LUX ▪ Foot control ▪ Surgical motor INTRA LUX S600 LED ▪...
  • Page 13: Expertsurg Lux

    Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.3 EXPERTsurg LUX 3.3 EXPERTsurg LUX Product reference guide, front view ① Hand-held control panel ⑥ Surgical motor ② Bottle holder ⑦ Coolant hose ③ Hose pump ⑧...
  • Page 14 Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.3 EXPERTsurg LUX Rear Product reference guide, rear view ① Hose pump locking mechanism ⑤ Follow instructions for use ② On-button ⑥ SD card slot ③ Mains plug ⑦...
  • Page 15: Hand-Held Control Panel

    Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.4 Hand-held control panel 3.4 Hand-held control panel ① Programme step ⑩ Minus key, decrease value ② Display of the activity ⑪ Back key ③ Maximal torque reached ⑫...
  • Page 16: Foot Control

    Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.5 Foot control 3.5 Foot control ① Speed key (grey) ③ Programme key (grey) ② Pump key (blue) ④ Direction of motor rotation key (yellow) 16 / 68...
  • Page 17: Technical Specifications Expertsurg Lux

    Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.6 Technical Specifications EXPERTsurg LUX 3.6 Technical Specifications EXPERTsurg LUX Width 265 mm Depth 255 mm Altitude 100 mm Weight Approx 1.9 kg Weight Foot control Approx 1.1 kg Weight motor Approx. 125 g Input voltage 100 –...
  • Page 18: Symbols On Product, Packaging And Rating Plate

    3 Description of the product | 3.7 Symbols on product, packaging and rating plate 3.7 Symbols on product, packaging and rating plate The product, packaging or rating plates bear the following symbols. The rating plates of EXPERTsurg LUX and foot control are both affixed on the underside of the housing. Accompanying documents...
  • Page 19: Transport And Storage

    Instructions for use EXPERTsurg LUX – 1.008.3500 3 Description of the product | 3.8 Transport and storage Supply voltage Protection class II Transportation and storage conditions (temperature range) Transportation and storage conditions (air pressure) Transportation and storage conditions (Humidity) Protect from moisture (Keep dry)
  • Page 20 Terms and Conditions, Art. 28). Outside Germany NOTE KaVo shall not be held liable for damage arising from transportation. The shipment must be checked on arrival. If the packaging is visibly damaged on delivery, please proceed as follows: 1. The recipient of the package must record the loss or damage on the delivery receipt.
  • Page 21: Startup

    Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.1 Unpacking 4 Startup WARNING Hazard from contaminated products. Infection hazard to the dentist and patient. 4 Prior to initial startup and after each use, reprocess the product and ac- cessories.
  • Page 22: Connecting The Surgical Motor

    Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.4 Connecting the surgical motor 4 Slide the bracket into the designated recesses until it hits the end stop. 4.4 Connecting the surgical motor NOTE The parts as delivered are not sterile (except for the coolant hose). Before the first treatment of a patient, the surgical motor, motor cable, and handpiece holder need to be reprocessed.
  • Page 23: Connecting The Coolant Container And Hose Set

    Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.5 Connecting the coolant container and hose set ① Motor coupling ③ Handpiece holder ② Surgical motor ④ Plug of motor cable 4 Plug the surgical motor ② into the motor coupling ① and secure it with a union nut.
  • Page 24 Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.5 Connecting the coolant container and hose set NOTE The coolant must be selected to suit the planned application. The flow rate of the coolant is dependent on the instrument used. The user must set an ad- equate flow of coolant and check this.
  • Page 25 Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.5 Connecting the coolant container and hose set ① Coolant hose ⑤ Pump tubing ② Clips ⑥ Insertion needle ③ Hose fixation ⑦ Hose clamp ④ Lock 4 Close the hose clamp ⑦ of the hose set.
  • Page 26 Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.5 Connecting the coolant container and hose set ca.10 mm 4 Open the lock ④ and insert the pump tubing ⑤. 4 Close the lock ④. NOTE Make sure to place the pump hose in the pump appropriately such that the pump hose does not get clamped or pinched by the lock.
  • Page 27: Electrical Connection

    Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.6 Electrical connection 4 Stick the puncture needle ⑥ into the coolant container and hook-in the coolant container on the bottle holder. 4 Check the sealing and firm seating of the puncture needle ⑥. Prevent fluid from leaking above the device.
  • Page 28 Instructions for use EXPERTsurg LUX – 1.008.3500 4 Startup | 4.6 Electrical connection NOTE The unit must be set-up appropriately such that the mains plug and the elec- trical outlet are easily accessible. NOTE The protective earth conductor is used as functional earthing (FE) rather than as protective earthing (PE).
  • Page 29: Operation

    5.1 Turn the device on 4 Turn the device on. ð The device runs a self test. 4 KaVo recommends switching off the unit after use. NOTE Auto-Off function. After 10 minutes of inactivity, the light on the handpiece, the pump and the motor on the unit are turned off.
  • Page 30 Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.2 Make the device settings The following device settings need to be made once during the initial startup of the device and can be adapted according to need. The software version in use can only be displayed, but not changed in the device settings.
  • Page 31: Surgical Motor Intra Lux S600 Led

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.3 Surgical motor INTRA LUX S600 LED View Setting The LCD brightness determines the brightness of the display. The brightness can be set in 3 steps ranging from dark to maximum brightness.
  • Page 32: Attaching The Straight Or Contra-Angle Handpiece

    4 Pull on the KaVo handpiece to make sure that the KaVo handpiece is se- curely attached to the motor.
  • Page 33: Defining And Executing Programme Steps

    4 Twist the straight or contra-angle handpiece slightly to pull it off. 5.4 Defining and executing programme steps The EXPERTsurg LUX is based on programme steps and associated activities and can be operated intuitively using the graphical user interface. Programme step 1: Marking The current programme step is shown on the display as number ①...
  • Page 34: Factory Settings

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.4 Defining and executing programme steps 5.4.1 Factory settings The following programme steps are pre-set at the factory: Programme Symbol Activity Speed Torque Transmis- Coolant flow step [rpm] [Ncm] sion ratio Marking 200 –...
  • Page 35: Exemplary Programme Step Sequences

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.4 Defining and executing programme steps Programme Symbol Activity Speed Torque Transmis- Coolant flow step [rpm] [Ncm] sion ratio Treatment – – – – completed (can be set from pro-...
  • Page 36: Selecting The Programme Steps

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.4 Defining and executing programme steps Example 3: Activity "Free use" as step 1, screw dental implant in manually Step Activity Free use Marking Pilot drilling Template Treatment com- drilling...
  • Page 37: Selecting Activities

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.4 Defining and executing programme steps 5.4.4 Selecting activities 4 Press the arrow keys until the activities display is highlighted. 4 Press the plus or minus keys to select the desired activity.
  • Page 38: Changing Default Values

    5.5.2 Setting the torque limit NOTE The EXPERTsurg LUX reduces the power to prevent the maximal torque set- ting from being exceeded. This may lead to the motor coming to a standstill if the rotating handpiece is blocked. There is an audible signal as soon as the maximum torque is reached.
  • Page 39: Setting The Coolant Flow

    Tissue damage. 4 Please note the instructions for use of the attachment tool. 4 Set a sufficient coolant flow rate. The coolant flow rate of the KaVo surgical units can be set to 4 levels or switched off: Displayed informa-...
  • Page 40: Changing The Direction Of Motor Rotation

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.5 Changing default values 4 Press the arrow keys until the coolant display is highlighted. 4 Press the plus and minus keys to set the desired value. The step width de- pends on the transmission ratio and the range of values.
  • Page 41: Setting The Transmission Ratio

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.5 Changing default values 4 Press the plus and minus keys concurrently to change the direction of motor rotation. The direction of motor rotation can be changed during the treatment using the direction of motor rotation key of the foot control.
  • Page 42: Rinsing Function

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.6 Rinsing function 5.6 Rinsing function 5.6.1 Manual rinsing function The rinsing function serves to feed coolant and to startup the illumination on the handpiece. The motor is not activated during this process.
  • Page 43: Programme Step Rinsing Function

    NOTE The handpiece must be attached for calibration. One-touch calibration should be carried out only with KaVo surgical hand- pieces with a transmission ratio of 16:1, 20:1 or 27:1. The one-touch calibration cannot be run with third-party handpieces or hand- pieces with different transmission ratios.
  • Page 44 Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.7 Activating the one-touch calibration CAUTION The motor starts at full speed. Risk of injury. 4 Hold the motor firmly or put it in a safe holder during the calibration.
  • Page 45: Foot Control

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.8 Foot control 5.8 Foot control 5.8.1 Changing the speed, coolant flow, and direction of motor rotation Control element Function 4 Press the foot pedal of the foot control in order to start the motor and increase the speed.
  • Page 46: Changing The Coolant Container

    Instructions for use EXPERTsurg LUX – 1.008.3500 5 Operation | 5.8 Foot control 5.8.3 Changing the coolant container The coolant container can be changed during the treatment as follows: 4 Close the hose clamp. 4 Pull the hose and puncture needle out of the empty coolant container.
  • Page 47: Reprocessing Steps In Accordance With Iso 17664

    Instructions for use EXPERTsurg LUX – 1.008.3500 6 Reprocessing steps in accordance with ISO 17664 | 6.1 Manual reprocessing 6 Reprocessing steps in accordance with ISO 17664 NOTE The reprocessing steps for surgical motors with motor cable and for the straight and contra-angle handpieces are described in the corresponding In- structions for use.
  • Page 48 Instructions for use EXPERTsurg LUX – 1.008.3500 6 Reprocessing steps in accordance with ISO 17664 | 6.1 Manual reprocessing 4 Pull the button bar ① including the pump button, programme button, and motor direction button slightly upwards and take it off the foot control.
  • Page 49: Manual Disinfection

    Permissible disinfectants (application range in accordance with the available manufacturer's instructions for use and national guidelines. Please note material safety data sheets.) KaVo recommends the following products based on the compatibility of the materials. The microbiological efficacy must be confirmed by the disinfectant manufacturer.
  • Page 50: Automated Reprocessing

    "VARIO-TD" programme and the "neodisher MediClean" cleaner supplied by Dr. Weigert. In addition, KaVo recommends the use of a neutraliser and a rinsing agent. 4 For programme settings and the adaptation options to be used, please refer to the Instructions for Use of the washer disinfector.
  • Page 51: Sterilisation

    Instructions for use EXPERTsurg LUX – 1.008.3500 6 Reprocessing steps in accordance with ISO 17664 | 6.4 Sterilisation NOTE If potentially infectious liquids and particles can become deposited on the products, it is recommended to cover and protect these areas with sterile dis- posable products.
  • Page 52: Storage

    Instructions for use EXPERTsurg LUX – 1.008.3500 6 Reprocessing steps in accordance with ISO 17664 | 6.5 Storage ▪ Steriliser with triple pre-vacuum: – at least 3 minutes at 134 C -1 C / +4 C (273 F -1.6 F / +7.4 ▪...
  • Page 53: Run A Software Update

    Instructions for use EXPERTsurg LUX – 1.008.3500 7 Run a software update 7 Run a software update Please proceed as follows to update the software: 4 Download the current firmware file from www.kavo.com/uk/expertsurg. 4 Copy the firmware file to an SD card (storage capacity 1 - 32 GB, FAT format).
  • Page 54: Accessories

    Instructions for use EXPERTsurg LUX – 1.008.3500 8 Accessories 8 Accessories The following accessories are approved for the EXPERTsurg LUX: ▪ Hose set sterile S600 (10 pcs.) (1.009.8757) ▪ Hose set sterilisable S600 (1.011.0633) ▪ Handpiece holder (1.009.3411) ▪ Motor INTRA LUX S600 LED (1.008.8000) ▪...
  • Page 55: Safety Check

    The EXPERTsurg LUX should be subjected to a service check including a safety check every 2 years. The safety check may only be done by a professional trained by KaVo or in a shop trained by KaVo. Perform the safety check as de- scribed in the KaVo technician's instructions.
  • Page 56: 10Troubleshooting

    KaVo spare parts comply with the specification. NOTE If a repair is done with NON-KaVo original spare parts, this may constitute a product modification that leads to the loss of CE conformity. In the event of damage, the responsibility is with the service company or the operator.
  • Page 57 Instructions for use EXPERTsurg LUX – 1.008.3500 10 Troubleshooting Malfunction Cause Remedy 4 Clean the spray nozzles with the nozzle Insufficient coolant flow in the Spray nozzles are crusty instrument. or soiled. needle or reprocess the part. Also refer to: Instructions for use...
  • Page 58 4 Arrange a precautionary appointment at a KaVo subsidiary or with a KaVo authorised dealer. Service symbol is yellow. Service period is expired. 4 Arrange an appointment at a KaVo subsi- diary or with a KaVo authorised dealer. Service symbol is red. Service overdue: > 4...
  • Page 59: 11Decommissioning

    Instructions for use EXPERTsurg LUX – 1.008.3500 11 Decommissioning | 11.1 Disconnecting the electrical connection 11 Decommissioning WARNING Dispose of the product in appropriate manner. Infection hazard. 4 Reprocess the product and accessories before disposal. Also refer to: 6 Reprocessing steps in accordance with ISO 17664, Page 47 11.1 Disconnecting the electrical connection...
  • Page 60: Disconnecting The Surgical Motor

    Instructions for use EXPERTsurg LUX – 1.008.3500 11 Decommissioning | 11.3 Disconnecting the surgical motor 4 Close the hose clamp ①. 4 Pull the puncture needle ② out of the coolant container. 4 Open the lock ③ and remove the hose.
  • Page 61: Disconnecting The Foot Control

    Instructions for use EXPERTsurg LUX – 1.008.3500 11 Decommissioning | 11.4 Disconnecting the foot control 11.4 Disconnecting the foot control 4 Disconnect the plug of the foot control from the connector on the device. Make sure to grasp the plug as close to the housing as possible.
  • Page 62: 12Disposal

    Any waste produced must be recycled or disposed of in strict compliance with all applicable national regulations in a manner which is safe for both people and the environment. If you have any questions regarding the proper disposal of the KaVo product, please contact the KaVo branch office. NOTE A recycling pass can be downloaded from www.kavo.com.
  • Page 63: 13Information Concerning The Electromagnetic Compatibility According To En Iec

    Instructions for use EXPERTsurg LUX – 1.008.3500 13 Information concerning the electromagnetic compatibility according to EN IEC 60601-1-2 | 13.1 Operating envir- onment and EMC warning notes 13 Information concerning the electromagnetic compatibility according to EN IEC 60601-1-2 13.1 Operating environment and EMC warning notes This product is neither life-sustaining nor coupled to the patient.
  • Page 64 Instructions for use EXPERTsurg LUX – 1.008.3500 13 Information concerning the electromagnetic compatibility according to EN IEC 60601-1-2 | 13.2 Results of the electromagnetic tests Requirement Class / test level [30 MHz – 1000 MHz] DIN EN 61000-3-2 VDE 0838-2 / 03.2010...
  • Page 65 Instructions for use EXPERTsurg LUX – 1.008.3500 13 Information concerning the electromagnetic compatibility according to EN IEC 60601-1-2 | 13.2 Results of the electromagnetic tests Requirement Class / test level DIN EN 61000-4-11 VDE 0847-4-11 / 02.2005 Voltage interruptions, short-term interruptions and...
  • Page 66: 14Terms And Conditions Of Warranty

    12 months from the date of the invoice, subject to the following conditions: With regard to justified complaints KaVo grants warranty in the form of a free of charge repair or delivery of a replacement. Other claims of any kind whatso- ever, in particular with respect to compensation, are excluded.

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1.008.3500

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