Bomedent iRoot pro Operation Manual Download Page 4 | Manualshive

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Type B applied part

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Summary of Contents for iRoot pro

Page 1: ...Operation Manual for iRoot pro Endo motor for root canal preparation with integrated apex locator Read this Operation carefully before use Keep this Operation Manual for future reference ...

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Page 3: ...t apex locator measurement is possible using the separate file clamp for measuring file User This device is only allowed to be used in hospital environments clinics or dental offices by qualified dentists and other legally licensed professionals Do not use this device for anything other than its specified dental purpose Prohibition The product cannot be used to expand the grossly twisted root cana...

Page 4: ...c equipment WEEE Directive to dispose of the product and accessories ClassⅡequipment Type B applied part Refer to the instruction Manual Consult accompanying documents user manual Manufacturer Serial number Direct current Date of manufacture Authorized representative in the European Community ...

Page 5: ...nation 15 4 2 3 Optional Apical Line 15 4 2 4 Operation of Apex Locator Auto Start Auto reverse exit 16 4 3 Rotation and settings in different modes 18 4 3 1 Rotation in different modes 18 4 3 2 Rotation Mode setting 19 4 4 Speed Torque Settings 19 4 5 Convenient function 20 4 5 1 Program 20 4 5 2 Alarm Sound Setting 20 4 5 3 OTR Settings Normal reciprocating mode 20 4 5 4 Wireless Transmission Op...

Page 6: ... explanation on operation and performance 1 1 General Warnings and Conditions for Operation Warning CONTRAINDICATION Use of the device is contraindicated in patients and in users with pacemaker General Warnings Use the specified battery for this product Never use any other battery than manufacturer specifies High pressure from the outside will cause a liquid leakage or explosion Keeping the centra...

Page 7: ...ect Medical Electrical equipment Do not use RF equipment outskirts for the product Follow the instruction of file manufacture to set the rotation and speed of the motor If the Central unit has not been used for long time check it before use There is electric circuit which control the torque TORQUE LIMITER Function to prevent files from breaking however files may still break due to metal fatigue if...

Page 8: ...lly stop when exiting the root canal The device automatically identifies whether the lip hook cable is inserted Inserting the lip hook cable means that the user needs to start the root canal measurement and root canal preparation at the same time Apex locator function When start only apex locator mode the user can insert the measuring cable to start root canal measurement Endo motor function Quick...

Page 9: ...tion Anti Clockwise Rotation mode I standby in Reciprocating Clockwise Rotation Anti Clockwise Rotation mode II Rotation in Reciprocating Clockwise Rotation Anti Clockwise Rotation mode II in sequence Operation setting details please refer to 4 1 2 When the motor is in quick start mode you can long press P to change the reciprocating speed and direction Second press rotation in reciprocating mode ...

Page 10: ...al optional BMWP0001 1PC Remarks Measuring cable A to connect lip hook and file clamp for only apex locator mode Measuring cable B to connect lip hook Apex locator control motor mode or separately working together 2 3 Installation contra angle The contra angle can be connected with the central unit at 6 adjustable head positions Align the positioning pins of the contra angle with the positioning s...

Page 11: ...s played on the oled screen charging is completed The central unit can be charged directly by USB cable Please ensure the central unit and the battery charger is placed in dry and clean condition Never use the battery charger for anything other than the device of this product by manufacturer The charging normally takes approx 90 minutes but it depends on battery use conditions battery freshness am...

Page 12: ...umerals on the meter gauge do not represent millimeters The icons flashes when the file tip is beyond the root apical point ON OFF KEY SELECT KEY Program No Speed Rotation speed of the file Digital display Independent apex locator Battery Indicator OLED Screen PROGRAM KEY Wireless transmission Alarm Symbol Working mode Speed Torque Rotation Mode POWER KEY OLED Screen Speed display Independent endo...

Page 13: ... key to start other operation setting when the machine is on To adjust the icon of Volume Reciprocating Apex Bluetooth Factory Default Left Hander Right Hander Auto Calibration by key the settings will be saved automatically and press P to exit PROGRAM Key A program can be selected QS Quick Start Key setting The details to see 4 1 2 The QS quick start key setting Key Use these keys to increase or ...

Page 14: ...tip reaches the apical foramen a single sustained beep will sound and the word APEX and the little triangle next to the Flash Bar will start to flash ON and OFF Rotation mode Forward Rotation is in clockwise motion When the load is beyond the set torque limit or reach the apical it will automatically reverse out when the load is removed it will start normal rotation again Reverse Rotation is in an...

Page 15: ...ess key to enter in quick start function 1 Standby in reciprocating mode I 2 Rotation in reciprocating mode I 3 Standby in reciprocating mode II 4 Rotation in reciprocating mode II 4 1 2 QS quick start key setting The default setting in the quick start mode Machine standby in Reciprocating mode I Rotation in Reciprocating mode I Standby in Reciprocating mode II Rotation in Reciprocating Power off ...

Page 16: ...unction Exit setting Long press P key or short press on off key to exit the setting 4 2 Integrated Apex Locator iRoot pro is equipped with an integrated apex locator WARNING Combined apical length measurement by using the contra angle and lip clip give only accurate results when using the original contra angle by manufacturer supplied Use only endodontic NiTi files with a metal handle for this typ...

Page 17: ...the apex locator 4 2 2 Useful tips for accurate length determination Gloves and rubber dam are recommended in order to isolate the tooth Dry the access cavity with the suction pump or a cotton pellet Avoid any direct contact between the contra angle file and mucosa Use the silicone sleeve for the contra angle 4 2 3 Optional Apical Line This feature is convenient for users to make marks of the rela...

Page 18: ...nnect the Measuring cable for apex locator to the Micro USB port at bottom of the central unit Insert the lip clip into one of the connectors insert the file clamp into another connector And ensure both the connection is solid Put the lip clip in the patient s mouth on the opposite side of the tooth undergoing therapy 4 2 4 2 Measuring loop detection A For combined apical length measurement Insert...

Page 19: ...hook and file climp or the lip hook and file is too short The file is in poor conductivity 4 2 4 3 Application steps Operation After setting above parameters connecting measuring cable detecting measurement loop hand the lip hook on the patient s lip the treatment can be started The response of motor 1 Putting the file into the root canal the file will self acting rotate as setting speed torque Or...

Page 20: ...clockwise motion When the load is beyond the set torque limit or reach the apical it will automatically reverse out when the load is removed it will start normal rotation again Reverse Rotation is in Anti clockwise Motion In the general condition when the Endo Motor Rotate in counter clockwise motion will be claim as reverse motion The traditional rotary files are drawing from the canal by reverse...

Page 21: ...uence by key To press P key to exit and all the settings will be saved automatically 4 4 Speed Torque Settings Start setting When the machine is on Speed To Press key to adjust the speed Torque To press S then to adjust the current torque in the select box by key To press P key to exit and all the settings will be saved automatically Load lower than the set torque limit value clockwise and anticlo...

Page 22: ...keep short press until OTR icon shows on the screen display as in the pictures short press S key to shift the direction of OTR adjust the angle data by key The angle difference is no less than 80 degree Long press S key or short press P key to exit the setting all data will be automatically saved 4 5 4 Wireless Transmission Optional We designed the product from the point of view of the doctor s us...

Page 23: ...rements of various radiation indicators Transmission distance is not more than 5 meters Display information is transmitted in milliseconds to avoid the delay problem The device wireless transmission connection settings Wireless transmission display features on and off Long press S key to enter into other operation mode short press S until the Bluetooth icon shows press to select Bluetooth turn on ...

Page 24: ...Install the fully lubricated contra angle on the central unit and place it on a flat platform When the device is on Long press S key to enter into other operation settings short press S key until in to Auto Calibration Press key to choose yes and enter in Auto Calibration Mode The motor starts running from the lowest to the highest speed for automatic calibration During the calibration the motor r...

Page 25: ...ntra angle and file clamp The lip hook contra angle sleeve contra angle and file clamp have biocompatibility in line with EN ISO 10993 1 Before using to every patient these parts must be disinfected It is suggested that the method of high temperature and high pressure steam disinfection be adopted The parameters of high temperature and high pressure steam disinfection are recommended as follows a ...

Page 26: ...angle Insert the spray nozzle into the contra angle head insert to the part connect to the central unit Insert the lubricants spray nozzle to the provided spray nozzle loop inject the lubricants for 1 2 seconds till the outlet liquid from the head of the contra angle clean WARNING Do not lubricate the micromotor in the central unit for any reason because lubricant contamination of the micromotor c...

Page 27: ...x 10 FREQUENCY 50 60 Hz 10 BATTERY CHARGER POWER RATING 2A ELECTRIC SAFETY CLASS Ⅱ APPLIED COMPONENT TYPE TYPE B LEVEL OF SAFETY IN PRESENCE OF INFLAMMABLE ANAESTHETIC MIXTURE OR OXYGEN NOT SUITABLE FOR USE IN PRESENCE OF INFLAMMABLE ANAESTHETIC MIXTURES OR OXYGEN OPERATING MODE CONTINUOUS ENVIRONMENT CONDITIONS FOR USE 10 40º C RH 10 70 Non condensing 700 1060h Pa PROTECTION AGAINST LIQUID PENETR...

Page 28: ...or anatomic other peculiarities before contacting your dealer If the problem persists please contact either your local dealer or manufacturer Problem Cause Solution The power is unable to turn on Battery has fully discharged Recharge the battery No battery inserted Insert battery The internal fuse has burnt Contact your dealer Charge failure Battery has been completely discharged Replace with new ...

Page 29: ...d instruction manual carefully put sleeve or rubber dam on the contra angle If contra angle is installed in place Read instruction manual carefully make sure the installation and connection is correct No warning sound Check if the sound is on Turn on the sound Electric Length Determination and X Ray Technique As radiographs only reproduce in a two dimensional way a three dimensional root canal sys...

Page 30: ...ure that it is used in such an environment Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that is used in such an environment Emission test Conformity Emission test Conformity Electromagnetic Environment guidance RF Emissions CISPR11 Group 1 The ...

Page 31: ...ifferential mode 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 5 UT 95 dip in UT For 0 5 cycles 40 UT 60 dip in UT for 5 cycles 5 UT 70 UT 30 dip in UT for 25 cycles 5 UT 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT For 0 5 cycles 40 UT 60 dip in U...

Page 32: ...itters as determined by an electromagnetic site survey 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 s...

Page 33: ... Meters m 150 kHz 80 MHz 1 2 d P 80 MHz 800 MHz 1 2 d P 800 MHz 2 5 GHz 2 3 d P 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 transmitter where P is the maximum output power rati...

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Page 35: ...___________________________________________________________ ____________________________________________________________ _______________________________________________________________________ Trouble Description ___________________________________________________________________________________ ___________________________________________________________________________________ ___________________...

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Page 37: ...QUALIFIED CERTIFICATE INSPECTOR DATE ...

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Page 40: ...g road West Taihu Science Technology Industrial Park Changzhou City jiangsu China Tel 0519 88991980 Landlink GmbH Address Dorfstrasse 2 4 79312 Emmendingen Germany Tel 0049 7641 9626855 Fax 0049 7641 9626855 File No RD RCT 037 Version A 2 Issue Date 2019 11 15 ...

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