FKG Rooter Universal User Manual Download Page 53

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Foshan COXO Medical Instrument Co., Ltd

BLDG 4, District A, Guangdong New Light Source Industrial Base, South

of Luocun Avenue Nanhai District, Foshan 528226 Guangdong, China

Wellkang Ltd

The Black Church, St. Mary's Place, Dublin 7, D07 P4AX, Ireland

Ver 1.1

Revision Date: 20200723

Summary of Contents for Rooter Universal

Page 1: ...User Manual EN ...

Page 2: ...nings and notes Keep this manual in a handy place for quick and easy reference Notice The trademarks mentioned in this manual are the property of their legally registered companies The file manufacturers file system names and the file names referred to in this manual are for identification purposes only and are the property of their respective manufacturer or brands ...

Page 3: ...1 type I 50 0007 010 type G Tester CX265 67 Test Wire A CX265 63 Test Wire B CX265 64 File Clip CX265 52 Lip Hook CX265 17 16 1 Contra angle C4 2M Lighting Device CX265 23F Protective Sleeve CX265 65 Fig B Handpiece and Switch Main switch LCD Display Switch Program switch Select Set switch Adjust switch ...

Page 4: ...Fig C Contra Angle File connection Fig D Accessory Connection Install Remove ...

Page 5: ...Fig E Apex Locator Mode Test Wire Jack Fig F Multi function Mode ...

Page 6: ...Fig G Charging Fig H Replace the battery Rubber Cover ...

Page 7: ...Used 4 2 Usage 5 2 1 Operation and Storage Environments 5 2 2 Operation Modes 5 2 3 Power On Off 5 2 4 Endo Motor Mode 6 2 5 Apex Locator Mode 14 2 6 Multi function Mode 19 3 EMR 21 4 Operation Check 23 4 1 Check with Tester 23 4 2 Check Canal Measurement Function 23 5 Battery and Charging 25 5 1 Battery Power 25 5 2 Battery Charging 25 5 3 Replacement Battery 27 ...

Page 8: ... Calibration 28 6 3 Set Dominant Hand 29 6 4 Reset Memories to Original Default Settings 30 7 Cleaning Disinfection and Sterilization 31 8 Troubleshooting 36 9 Technical Specifications 37 10 Symbols 38 11 Guarantee 39 12 Disposal of Medical Devices 39 13 EMC 40 ...

Page 9: ... and operating the device in accordance with the manufacturer s recommendations First thoroughly read all precautions and instructions pertaining to safety and accident prevention then operate the device with the utmost caution to prevent either damaging the device itself or causing bodily injury WARNING This alerts the user of possibility of extremely serious injury or complete destruction of the...

Page 10: ...e wireless transmission devices listed below in the examination area a Cell phone terminals b Wireless transmitting devices such as ham radios walkie talkies and transceivers c Personal Handy phone System d Routers for intra building paging systems wireless LAN cordless analogue telephones and other electric wireless devices This device might be adversely affect by the electromagnetic radiation pr...

Page 11: ...bserved e Workplace conditions and environment or installation conditions which do not conform to those stated in this manual such as improper electrical power supply f Fires earthquakes floods lightning natural disasters or acts of God 1 4 In Case of Accident If an accident occurs the device must not be used until repairs have been completed by a qualified and trained technician authorized by the...

Page 12: ...erienced person with operating endodontic instrument 1 6 Intended use The Rooter Universal is an electro medical device intended to drive mechanical instruments intended for dental root canal treatment files In addition it is intended to help to determine the working length apex locator functionality ...

Page 13: ...erating Temperature 5 C to 40 C Humidity 20 to 80 without condensation Atmospheric Pressure 80 kPa to 106 kPa Transport and Storage Temperature 10 C to 55 C Humidity 93 without condensation Atmospheric pressure 50 kPa to 106 kPa 2 2 Operation Modes The device has 3 modes Endo motor Prepare the root canal without apex locator function Apex Locator Measure the length of the root canal without motor ...

Page 14: ...ush button on the contra angle and insert the file Turn the file back and force until it is lined up with interior latch groove and slips into place Release the button to lock the file into the contra angle c Connect lighting device Insert the lighting device into the motor handpiece and clip the electrode on the file WARNING Make sure the connection ends of the motor handpiece and the contra angl...

Page 15: ...ION Be careful when inserting and removing files to avoid injury to fingers Inserting and removing files without holding the push button may damage the chuck When installing removing the lighting device do not shake them at will to avoid damaging the plug Take care not to touch when installing or removing the file This will cause the file to rotate NOTE Hold down the push button on the contra angl...

Page 16: ...r File File System Standby 1 Battery Power Speed Rotary Direction Torque Limit Standby 2 NOTE Some preset files have automatic parameters If such a file has been selected the speed and torque value will display auto Current Torque Working ...

Page 17: ...library NOTE The change will be saved automatically Press or to exit the selection interface b Press to choose the file system c Press to choose the file WARNING Follow the file manufacturer s instructions for use of endodontic files Do not use files designed for reciprocating motion in Continuous Rotary File Mode The file system shown on the display must always match the file in use ...

Page 18: ...button is pressed against the teeth opposite the one being treated the file could come out and injure the patient Before use run the device outside the oral cavity to make sure it is operating normally b Change Motor direction of rotation Only in User file systems press to change the motor direction of rotation NOTE The screen is red when the motor rotates in the reverse direction Means forward ro...

Page 19: ...ion When the load is reduced the motor handpiece returns to normal forward rotation automatically Load within the torque limit value Load beyond the torque limit value When the load is reduced the motor is automatically restored CAUTION Do not apply excessive force Even when using the torque reverse function files may break depending on the torque setting ...

Page 20: ...rotation direction speed torque and rotation angle cannot be changed fixed settings a Hold down until the Speed flash and press again to select speed or torque to adjust b Press to adjust desired value c The change will be saved automatically Press to exit the setting or exit the setting automatically after a few seconds NOTE When the user changes the default parameter its value will prompt ...

Page 21: ...selves a Rotary File 4 memories preset at original default settings 1000rpm FW 1 5Ncm To change speed and torque refer to 2 4 6 b Recipro File 1 memory preset at original default settings 30 150 150rpm speed and rotation angle To change rotation angle follow the next step a Hold down until the Rotation angle flash b Press to adjust desired value ...

Page 22: ... onto the cutting part or transition part of the file or reamer This will cause the file clip to wear out very quickly Do not bang or bump the plugs when they are inserted Make sure the plug is all the way in Otherwise canal measurements cannot be made Do not wind the probe cord around the device NOTE To measure a root canal use a file or reamer with a plastic handle If you do not wear gloves do n...

Page 23: ...e such as a power outlet This will result in an electric shock If connections are not securely plugged in the device may not make an accurate measurement If the meter does not change as the file goes down the canal stop using the device immediately and make sure all the connectors are securely inserted CAUTION The lip hook could cause an adverse reaction if the patient has an allergy to metals Ask...

Page 24: ... canal Bar in meter show the location of the file tip The color of the display There is slow beeping sound between bars 6 11 There is fast beeping sound between bars 15 17 A sustained beep sounds when the file tip reaches or exceeds the DR s CHOICE ...

Page 25: ...ust not be used CAUTION If the canal is too dry the meter may not move until the file is near the apex If the meter does not move stop the measurement Moisten the canal with oxydol hydrogen peroxide or saline and then try measuring again Occasionally the meter will make a sudden and large movement as soon as the file is inserted into the root canal but it will return to normal as the file is advan...

Page 26: ...ICE apical arrow is set clear visual and audio indication is given that the file has reached this pre selected position To set the DR s CHOICE follow the next step Hold down until the apex setting icon flash Press to adjust the apex position NOTE The apex position set by the user will be saved automatically Exit the setting automatically after a few second ...

Page 27: ...a angle holder lighting device CAUTION Do not bang or bump the plugs when they are inserted Make sure the plug is all the way in Otherwise canal measurements cannot be made Do not wind the probe cord around the device Always clip the electrode on the file when using it Otherwise measurements may not be accurate or rotation may not be properly controlled It may not be possible to measure a canal if...

Page 28: ...hen the file reaches the apex position set by the user the motor will automatically rotate in the reverse direction 2 6 6 Set the DR s CHOICE and Change Speed and Torque Hold down can change the DR s CHOICE Speed and Torque Press again to choose the DR s CHOICE Speed or Torque to change a Set the DR s CHOICE Press to adjust the apex position b Change Speed and Torque Refer to chapter 2 4 6 ...

Page 29: ...to get rid of all blood and then make a measurement Root canal with a chemical solution overflowing from the opening An accurate measurement cannot be obtained if some chemical solution is overflowing from the canal opening In this case clean the canal and its opening It is important to get rid of any solution overflowing the opening Broken crown If the crown is broken and a section of the gingiva...

Page 30: ...that the file will not touch the metal prosthesis before taking a measurement Cutting debris on tooth Pulp inside canal Thoroughly remove all cutting debris on the tooth Thoroughly remove all the pulp inside the canal Otherwise an accurate measurement cannot be obtained Caries touching the gums In this case electrical leakage through the caries infected area to the gums will make it impossible to ...

Page 31: ...ber 0 5 WARNING If the canal length indicator bars does not light up between number 0 2 and number 0 5 an accurate measurement cannot be made In this case stop using the device immediately and have it repaired 4 2 Check Canal Measurement Function a Check Test Wire A Touch the lip hook with the clip on the end of the file clip and check that all the flash bars on the meter in the LCD display light ...

Page 32: ...and check that all the bars on the meter in the display light up WARNING Check the device s function before use with each patient If all the indicator bars do not light up an accurate measurement cannot be made In this case stop using the device immediately and have it repaired ...

Page 33: ... the DC end of the adapter cable all the way into the charger and plug the other end into a power outlet NOTE The battery is inside the motor handpiece WARNING Always use the adapter that comes with the device Using another adapter can result in electric shocks malfunctions fires etc The charger and its adapter must be located at least 2 meters away from the patient Do not use the battery charger ...

Page 34: ...ll result in an electric shock Do not use the battery charger in a place where it might get wet CAUTION Do not charge the handpiece with the probe cord connected or wrapped around the handpiece This could break a wire inside the cord or damage the jack NOTE If the Charge LED purple goes off immediately or doesn t light up when the handpiece is put into the charger the battery is already fully char...

Page 35: ... cover and its screw CAUTION Use only battery designed for the motor handpiece Other batteries could cause overheating Do not use a battery if it is leaking deformed discolored or if its label is peeled off It might overheat NOTE Do not leave the power on when disconnecting the battery Open the rubber cover carefully Don t pull too hard It might come off the motor handpiece Do not remove the batte...

Page 36: ...nter setting mode b Press again to enter setting interface c Press again to choose the function you need to set 6 2 Calibration a Press to choose the calibration function b Press to start the calibration process NOTE Press again to continue or press any other key to exit ...

Page 37: ...fault CAUTION NG message indicates that the device is not operating properly Please contact your local dealer or contact the factory directly for assistance Do not touch the file or apply pressure to the motor otherwise the calibration will fail 6 3 Set Dominant Hand This will rotate the display direction 180 Set this for right or left depending on the user s dominant hand a Press to choose the sc...

Page 38: ...as been pressed 6 4 Reset Memories to Original Default Settings NOTE All memories and handpiece settings will revert to their original default settings a Press to choose the reset function b Press to start the reset process NOTE Press again to continue or press any other key to exit c The reset process is completed ...

Page 39: ... the reusable parts should be immersed in tap water 40 C The quality of drinking water the water mentioned in this chapter is required to meet this standard to remove dirt Do not use a fixed detergent or warm water 40 C as this will cause the residue to be fixed and affect the post treatment effect Transportation Transport to the post processing area for safe storage to avoid any damage and enviro...

Page 40: ...ion metal type wring it out and wipe the Test Wire Lip Hoop File Clip Contra Angle Holder Lighting device and Contra Angle at least 3 times It is recommended to use the medical device cleaning solution metal type of LIRCON which with an effective chlorine content of 1 0 1 2 W V Warning Do not put the Test Wire Lip Hoop File Clip Contra Angle Holder Lighting device and Contra Angle into the disinfe...

Page 41: ...tap water less than 40 C for 1 minute e Disinfection The temperature is 80 C and the action time is 10 min f Drying The temperature is 100 C and the action time is 15 min Caution The user must follow the special instructions of the manufacturer of the fully automatic washing machine In order to ensure the cleaning and disinfection effect the cleaning and disinfection time should not be less than t...

Page 42: ...ction stop using it and purchase damaged parts from the manufacturer or dealer 7 8 Package Immediately after drying put the Lip Hook File Clip Contra Angle Holder Lighting device and Contra Angle into the steam sterilization bag for sealed packaging Caution Steam sterilization bag should comply with ISO 11607 1 and must be sealed with a sealing machine 7 9 Sterilization Use a high pressure steam s...

Page 43: ...aution Keep the accessories in a dry dust free environment after sterilization 7 10 Storage Store the sterilizing equipment in a dry clean and dust free environment at a suitable temperature of 5 C to 40 C ...

Page 44: ... Apex locator imprecise not sensitive Test wire connection unreliable Reconnect the test wire or you can contact the file clip to lip hook directly to check the connection status The test wire has an open circuit or a short circuit Replace test wire The root canal is in poor condition Refer to chapter 3 Cannot start the motor motor does not work Low voltage protection Please charge in time Contra ...

Page 45: ...d part Battery Lithium ion battery DC 3 7V Classification Safety according to IEC 60601 1 IEC 60601 1 2 European Directive 93 42 EEC IIa Degree of Protection IEC 60529 IPX 0 Battery Charger Rated Input Voltage DC10V Rated Input Current 1 5 A AC Adapter Rated Input Voltage AC100 240 V Rated Input Frequency 50 60 Hz Classification of Protection against Electric Shock Class II ...

Page 46: ...ep dry CE marked product Atmospheric pressure limit Humidity limit Fragile Vertical up Class II product DC current continuous current Authorized representa tive in the European community Thermo Disinfector Autoclave Special disposal of waste electrical and electronic equipment Directive2002 96 EEC Refer to the operation manual ...

Page 47: ...e The contra angle is guaranteed for 12 months from the date of purchase The accessories are guaranteed for 6 months from the date of purchase The guarantee is valid for normal usage conditions Any modification or accidental damage will render the guarantee void 12 Disposal of Medical Devices In accordance with the principles standards and requirement of the country region in which you are located...

Page 48: ...to verify normal operation in the configuration in which it will be used Guidance and manufacture s declaration electromagnetic emission The instrument is intended for use in the electromagnetic environment specified below The customer or the user of the instrument should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR ...

Page 49: ...ntial mode 0 5 kV 1 kV 2 kV common mode 0 5 kV 1 kV differential mode 0 5 kV 1 kV 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 100 100 dip in for 0 5 cycle 100 100 dip in for 1 cycle 30 70 dip in for 25 30 cycles 100 100 dip in UT for 250 300 cyc...

Page 50: ... 5785MHz Test specifications for ENCLOSUREPORT IMMUNITY to RF wireless communication equipment Refer to table 9 of IEC60601 1 2 2014 Portable and mobile RF communications equipment should be used no closer to any part of the instrument including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distanc...

Page 51: ...st and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the instrument is used exceeds the applicable RF compliance level above the instrument should be observed to verify normal operation If abnormal performa...

Page 52: ... Separation distance according to frequency of transmitter 150 kHz to 80 MHz d 1 2 80 Mhz to 800 MHZ d 1 2 80 MHz to 800 Mhz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the t...

Page 53: ...Ltd BLDG 4 District A Guangdong New Light Source Industrial Base South of Luocun Avenue Nanhai District Foshan 528226 Guangdong China Wellkang Ltd The Black Church St Mary s Place Dublin 7 D07 P4AX Ireland Ver 1 1 Revision Date 20200723 ...

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