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Instructions for Use  2019-03-20

Symbols

Marking of electrical equipment in 
accordance with the European Directive 
2012/19/EU (WEEE)

Date of manufacture

Type BF applied part  
(Contra angle, Motor handpiece)

Class II Equipment

CE(0197) marking

Conforms with the European Directive,  

93/42/EEC.

CE marking

Conforms with the European Directive,  

2011/65/EU.

EU authorized representative under the 
European Directive 93/42/EEC

Manufacturer

Supports high-temperature cleaning and 
disinfection.

Serial number 

Autoclavable up to +135°C (+275°F)

Temperature limitation

Fragile

Humidity limitation

Keep away from rain

Refer to instructions for use

This way up

Atmospheric pressure limitation

* Some symbols may not be used.

GS1 DataMatrix

Summary of Contents for Endostar Provider

Page 1: ... performance read this manual thoroughly before using the unit and pay close attention to warnings and notes Keep this manual in a readily accessible place for quick and easy reference Poldent Co Ltd INSTRUCTIONS FOR USE Cordless Endodontic Treatment Motorized Handpiece ...

Page 2: ...4 Memory Settings Additional Operation Settings Normal Mode 15 Memory Settings Other Settings 16 Restoring the Initial Settings 17 4 After Using the Endostar Provider 17 Removing the File 17 Operation with Endostar Navigator 18 Installing the File Electrode 18 Connecting the Transmission Cable 19 Operation Check 19 Meter Display 20 Operation 20 Cleaning the Rotor Axle and the Built in Electrode 22...

Page 3: ...and Warranty 35 Regular Inspection 35 Inspection Items 35 Warranty 36 Troubleshooting 37 Technical Specifications 39 Specifications 39 Symbols 40 Electromagnetic Disturbances EMD 41 Electromagnetic Disturbances EMD 41 Essential Performance 44 Cable List 44 Trademarks and Registered Trademarks The names of companies products services etc used in this manual are either trademarks or registered trade...

Page 4: ...dent prevention Then operate the device with the utmost caution to prevent either damaging the device itself or causing bodily injury The following symbols and expressions indicate the degree of danger and harm that could result from ignoring the corresponding instructions This alerts the user of important points concerning operation or the risk of equipment damage The user e g healthcare facility...

Page 5: ...not authorized by Poldent Co Ltd 2 Any changes modifications or alterations of its products 3 The use of products made by other manufacturers except for those procured by Poldent Co Ltd 4 Maintenance or repairs using parts or components other than those specified by Poldent Co Ltd or other than in their original condition 5 Operating the device in a manner other than described in the operating pro...

Page 6: ...e electrical noise Do not use the device on patients who have a pacemaker or an Implantable Cardioverter Defibrillator ICD It could cause the pacemaker or the Implantable Cardioverter Defibrillator ICD to function abnormally Illumination devices such as fluorescent lights and film viewers which use an inverter can cause the Endostar Provider to operate erratically Do not use the Endostar Pro vider...

Page 7: ...low Speed 100 300 and 500 rpm Torque Setting 0 2 0 4 0 6 0 8 and 1 0 Ncm Auto Start Stop The file starts when it is inserted in the canal and stops when it is taken out Apical Reverse or Stop The motor reverses or stops when the tip of the file reaches a preset position inside the canal Normal Mode If the file torque is less than the set value the file will keep rotating in the forward direction W...

Page 8: ...d Accompanying Items Standard Parts Optional Parts Parts Identification Accompanying Items Parts of Device and Consumables Power Supply Cord Qty 1 Guide Bar Qty 1 LS OIL Qty 1 Use the guide bar when replacing the built in electrode or external file electrode pp 22 and 23 Cleaning the Rotor Axle and the Built in Electrode p 33 Replacing the Built in Electrode Handpiece Rest Qty 1 Transmission Cable...

Page 9: ...piece is put into the charger the battery is probably fully charged To make sure take the motor handpiece out and put it back in again Make sure the contact areas for the motor handpiece and charger are free of debris especially metal fragments Wipe with ethanol 70 vol to 80 vol to remove any foreign debris Do not press down too hard to wipe the charging areas this could bend the electrical contac...

Page 10: ...y Contra Angle Motor Handpiece Approx 290 Do not force the contra angle to rotate beyond its limit The rotation range of the contra angle is about 290 Set it so that it reaches the treatment area and the display is easy to see Push the contra angle onto the motor handpiece until there is an audible click The contra angle must be lubricated with the LS OIL before using for the first time p 28 Lubri...

Page 11: ...re using right after purchase whenever the motor handpiece or contra angle has been replaced or if the motor alternates between for ward and reverse rotation outside the canal calibrate the device in the following way 1 Turn the device on 2 Make sure the battery is fully charged three bars are displayed 3 Put a commonly used file into the contra angle 4 Press the Plus or Minus Switch and then sele...

Page 12: ...ap depending on the curvature and shape of the canal stop using the file if you notice or feel anything amiss Files will eventually break due to metal fatigue and should be replaced before they reach this point Electric noise or a malfunction could interfere with the motor control Do not depend entirely on the device controlling itself always watch the display and be aware of tactile feed back Fil...

Page 13: ...s running by pressing the Plus or Minus Switch This works only for normal mode The color of the backlight changes depending on the load applied to the file The backlight starts blinking when the load approaches the reverse setting While the OTR is triggered the backlight does not blink 4 Stop Motor Press the Main Switch again The standby display will reappear 5 Turn Endostar Provider Off Hold the ...

Page 14: ...ons are available only when connected to the Endostar Navigator If the torque limit is too high the file could jam inside the canal and break The torque settings must be changed depending on the root canal condition and the file If the torque reverse seems to be activated too frequently increase its value When OTR mode motor runs back and forth continuously seems to be triggered too frequently or ...

Page 15: ...go back to the standby display if 5 seconds initial setting elapses without a switch being pressed Standby Display Linked Function When this is set to ON Apical Reverse or Stop function be activated Apical Reverse or Stop The file will reverse or stop when the file tip reaches the Flash Bar When Linked Function is set to ON this display will be skipped Auto Start Stop When this is set to ON the fi...

Page 16: ...ical Reverse or Stop function be activated Apical Reverse or Stop The file will reverse or stop when the file tip reaches the Flash Bar When Apical Action Function is set to OFF this display will be skipped Auto Start Stop When this is set to ON the file starts rotating when it is inserted and stops when it is taken out of the canal Apical Slow Down When this is set to ON the file slows down as it...

Page 17: ...per Volume Press Plus or Minus Switch to set beep volume used for switch operation and alarms at off Low or Big Auto Power Off Time The time lapse for automatic shut off when the device is not used can be set from 1 to 15 minutes Press the Plus or Minus Switch to set the time Positive or Negative Display Set display for black on white background or vice versa Right or Left Handed Set display for r...

Page 18: ... operation 3 Wait until the Finished display appears and then press the Main Switch to go to the standby display Take care not to injure your fingers when inserting and removing files Never insert or remove files without holding down the button this will damage the chuck Make sure the device is turned off before inserting or removing files 1 Hold down the Select Switch and press the Main Switch to...

Page 19: ...shanks larger than the ISO standard Diameter 2 334 to 2 350 mm After use be sure to take the file out Some files cannot use the built in electrode to make measurement always check for conductivity before using a file Make sure the file goes all the way in Give the file a light tug to confirm it is securely held in place If the file is not securely placed it could come out and injure the patient Ne...

Page 20: ...because the motor might start up when you do this Make sure the plugs go straight in After insertion give plugs a light tug to make sure they are securely connected Otherwise data may not be transmitted accurately Do not bump the plugs or drop anything on them when they are plugged in Use only the special cable provided Other cable could be electrically risky and result in damage or injury Make su...

Page 21: ... measurement is not always possible especially in cases of abnormal or unusual root canal morphology always take an X ray to check the measurement results If the meter does not move when the file is inserted the device may be malfunctioning and must not be used Do not use an ultra sonic scaler while the contrary electrode is hooked in the patient s mouth noise from the scaler could cause the motor...

Page 22: ...the Apical Reverse or Stop function is set to Rev the motor will run backwards after it stops If the load on the file exceeds the reverse torque setting the motor will stop and then reverse its rotation A rapid repeated three toned beep will sound when this happens The motor will stop when the file is taken out of the canal Gradually increase the size of the file until the root canal preparation i...

Page 23: ...lectrode to remove any remaining moisture Cleaning the Rotor Axle and the Built in Electrode If the bars flicker during use or if all the bars in the meter do not light up when the file touches the contrary electrode clean the rotor axle and the built in electrode in the following way Do not bend or deform the electrode Always use the guide bar and make sure it will not come out If the guide bar i...

Page 24: ...erly placed Tighten the screw up securely and then hold down the file release button and pull out the guide bar Cleaning the Rotor Axle and the Built in Electrode Make sure the screw is tight enough Otherwise it might come out and be swallowed Also measurements might not be accurate Contact is too high Right Wrong 10 Autoclave the contra angle p 26 Autoclavable Components ...

Page 25: ...s into the head properly Contact is too high Right Wrong Replacing the Built in Electrode with the External File Electrode If there is no electrical conductivity between the file and its shank replace the cap with the one that has an external file electrode sold separately Always use the guide bar and make sure it will not come out If the guide bar is not properly fix in place the internal contact...

Page 26: ...ing part of the file touch the electrode this will wear it out very quickly Some files cannot be used with this electrode Also the Ni Ti files noted below cannot be used Those with a file diameter of more than 1 2 mm Those with chuck shanks that are nor perfectly round Gates Glidden Drills Those that have cutting sections with large diameters such as largo burs To use these types of files do not c...

Page 27: ... Transmission Cable Charger Motor Handpiece There are three ways to clean and disinfect components depending on the component Be sure to follow the procedure below when performing daily maintenance Guide Bar Other Components Wash and Wipe with Ethanol 70 vol to 80 vol Contra Angle Components maintained this way Contra Angle Must be autoclaved after use for each patient Maintenance Procedure Only t...

Page 28: ... threeway syringe etc to blow out any moisture remaining inside the contra angle Wipe the components with a piece of gauze that has been dampened with ethanol 70 vol to 80 vol and wrung out thoroughly Disinfection Operating Conditions for High Temperature Washer Disinfectors When using a high temperature washer disinfector to clean the contra angle strictly adhere to the conditions specified below...

Page 29: ...em off immediately if they accidentally get on the contra angle Do not immerse in any fluid Do not connect the contra angle to the motor handpiece immediately after lubrication for use or charging Otherwise the oil seep inside the motor handpiece and it might malfunction Only the contra angle needs to be lubricated Lubrication Before autoclaving the contra angle must be lubricated with the LS OIL ...

Page 30: ...autoclaving If chemical solutions or foreign debris are not removed autoclaving could damage or deform the components The sterilization and drying temperatures must not exceed 135 C 275 F No components can be autoclaved other than the contra angle and the handpiece rest Take the file out of the contra angle before autoclaving Be sure to lubricate the contra angle with the LS OIL before autoclaving...

Page 31: ...dual medical agent to the components Never clean the components with chemicals such as formalin cresol FC and sodium hypochlorite These will damage the plastic parts of the components If any of these liquids being applied to the components use dry gauze etc to wipe it off Use only ethanol 70 vol to 80 vol and OPTI CIDE 3 Surface Wipes for cleaning Any other cleaning chemical or products should not...

Page 32: ...electrolyzed water strong alkaline solution or ozone water medical agents glutaral etc or any other special types of water or commercial cleaning liquids Such liquids may result in metal corrosion and adhesion of the residual medical agent to the component Never clean the component with chemicals such as formalin cresol FC and sodium hypochlorite These will damage the plastic parts of the componen...

Page 33: ...nd Storage Environments Connector Battery Cover Screw Connect the battery cord and then slide the battery along the bot tom Replace the cover and its screw Turn power off Remove the screw and slide the battery cover off a Remove an old cushion b Peel off the paper shield from the sticky side of the cushion and stick it to the bottom of the battery space Take out the old battery and disconnect it B...

Page 34: ...guide bar inserted this could damage the device Take out the screw and then take out the built in electrode Hold the File Release Button and slide the guide bar straight in as shown in the illustration Then rotate it left and right Put a little ethanol 70 vol to 80 vol on a brush and clean the rotor axle with it Slide the built in electrode onto the guide bar and line up the screw holes Blow air o...

Page 35: ...screw up securely and then hold down the File Release Button and pull out the guide bar Make sure the built in electrode is properly placed 2 Transport and Storage Environments Temperature 10 C to 45 C 14 F to 113 F Humidity 10 to 85 without condensation Atmospheric Pressure 70 kPa to 106 kPa Do not expose to direct sunlight frequently or for long times If the device has not been used for a long t...

Page 36: ... Minus Switches changes the memory number from M1 through M6 4 Check that the settings for each memory can be changed 5 Make sure the connection end of the motor handpiece is not damaged or dirty 6 Make sure that the connection end of the contra angle is not damaged or dirty and that it can be securely connected to the motor hand piece Make sure that the file release button operates properly and t...

Page 37: ...Items Warranty 1 Poldent Co Ltd gives a guarantee for two years beginning from the date of purchase Within this period any defect that is due to faulty manufacturing or material will be remedied by repair or replacement at the judgment of Poldent Co Ltd 2 Warranty repair and service in the event of a claim under this warranty please contact with Poldent Co Ltd s local dealer 3 In the case of damag...

Page 38: ...ry electrode in the corner of the pa tient s mouth Is the Apical Action Function set to OFF Set it to ON Is the Auto Start Stop set to OFF Set it to ON Has the meter gone past the Flash Bar Set the Apical Reverse or Stop to Rev reverse Motor starts but then stops right away Did you hold down the Main Switch for more than 1 second If you hold the Main Switch down for more than 1 sec ond the motor r...

Page 39: ...time Auto power off was probably activated Press the Main Switch to turn the device back on Does Please Charge appear in the display Battery must be charged right away This can happen if the battery is very low and a large load is applied to the file Battery must be charged right away Error 01 Turn the device off and disconnect the transmis sion cable does the same error message appear when the de...

Page 40: ...V Frequency 50 Hz 60 Hz Power Consumption 19 VA Protection against Electric Shock Class II No applied part Dimensions Approx Height 85 mm Width 68 mm Length 108 mm Weight Approx 330 g Name Endostar Provider Model TR CM Degree of Protection IEC 60529 IPX0 Intended Use The Endostar Provider is a compact and cordless endodontic treatment mo torized handpiece for preparation and enlargement of root ca...

Page 41: ...e European Directive 93 42 EEC CE marking Conforms with the European Directive 2011 65 EU EU authorized representative under the European Directive 93 42 EEC Manufacturer Supports high temperature cleaning and disinfection Serial number Autoclavable up to 135 C 275 F Temperature limitation Fragile Humidity limitation Keep away from rain Refer to instructions for use This way up Atmospheric pressur...

Page 42: ...r s Declaration which is required by IEC 60601 1 2 2014 Ed 4 0 the relevant international standard for electromagnetic disturbances This is a Group 1 Class B product according to EN 55011 CISPR 11 This means that this device does not generate and or use internationally radio frequency energy in the form of electromagnetic radiation in ductive and or capacitive coupling for the treatment of materia...

Page 43: ... earth Mains power quality should be that of a typical commercial or hospital envi ronment Voltage dips short inter ruptions and voltage variations on power supply lines IEC 61000 4 11 dips 0 U T 0 5 cycle at 0 45 90 135 180 225 270 315 0 U T 1 cycle at 0 70 U T 25 30 cycles at 0 25 50 Hz 30 60 Hz short interruptions 0 U T 250 300 cycles 250 50 Hz 300 60 Hz dips 0 U T 0 5 cycle at 0 45 90 135 180 ...

Page 44: ...field RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b 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 an...

Page 45: ... Max Cable Length Shielding Cable Classification 1 AC Power Cable 1 5 m Un shielded AC Power Line 2 Probe Cord 1 7 m Un shielded Signal Line Patient Coupled Cable 3 Transmission Cable 1 6 m Un shielded Signal Line None Essential Performance Cable List ...

Page 46: ...Memo ...

Page 47: ...Memo ...

Page 48: ... 75 611 2141 F 81 0 75 622 4595 Morita Global Website www morita com EU Authorized Representative under the European Directive 93 42 EEC MEDICAL TECHNOLOGY PROMEDT CONSULTING GmbH Altenhofstraße 80 66386 St Ingbert Germany T 49 6894 581020 F 49 6894 581021 The authority granted to the authorized representative MEDICAL TECHNOLOGY PROMEDT Consulting GmbH by J MORITA MFG CORP is solely limited to the...

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