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Poldent Endostar, Instructions For Use Manual, Page: 5 / 40

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Instructions for Use  2019-03-20

 

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Poldent Co. Ltd. will not be responsible for accidents, equipment damage, or bodily injury resulting from:

1.  Repairs made by personnel 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 procedures in this manual or in a 

manner inconsistent with the safety precautions and warnings in this manual.

6. Workplace, environmental, or installation conditions that do not conform to those stated in this manual, 

such as an improper electrical power supply.

7. Fires, earthquakes, floods, lightning, natural disasters, or forces majeure.

 

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The useful life of the Endostar Navigator is 6 years from the date of installation provided it is regularly and 

properly inspected and maintained. 

If an accident occurs, the Endostar Navigator must not be used until repairs have been completed by a qualified 

and trained technician authorized by the manufacturer.

Intended Operator Profile
a) Qualification 

: Legally qualified person such as dentists for endodontic device operation (it may 

differs among countries).

b) Education and Knowledge : It is assumed that the understands the risks of root canal measuring and treat-

ment. It is also assumed the user is thoroughly familiar with root canal measuring 

and treatment including the prevention of cross contamination.

c) Language Understanding : English (Intended for professional use as described above)
d) Experience 

: Experienced person with operating endodontic device. 

No special training is required except in cases where this is required by legal regu-

lations of the relevant country or region.

Disclaimers

In Case of Accident

User Qualifications

Patient Population

Age

Child to Elderly

Weight

N/A

Nationality

N/A

Sex

N/A

Health

It is not intended for use on patients wearing pacemakers or ICDs.

Condition

Conscious and mentally alert person. (Person who can stay still during treatment.)

•  The Endostar Navigator is not recommended for use in children under 12 years of age.

Summary of Contents for Endostar

Page 1: ...chasing the Endostar Navigator For optimum safety and 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 ...

Page 2: ... the Endostar Navigator 10 Operation Panel Display and Switches 10 Settings 11 Meter Display 13 Operating Procedures 14 Root Canal Not Suitable for Electronic Measurement 16 Endostar Navigator Meter Reading and Radiography 18 3 After Using the Endostar Navigator 19 4 Replacing Batteries 20 Maintenance 22 Autoclavable Components 22 Other Components Wiping with Ethanol 70 vol to 80 vol 27 Replacemen...

Page 3: ...ical Specifications 33 Specifications 33 Symbols 34 Electromagnetic Disturbances EMD 35 Electromagnetic Disturbances EMD 35 Essential Performance 38 Cable List 38 Trademarks and Registered Trademarks The names of companies products services etc used in this manual are either trademarks or registered trade marks owned by each company ...

Page 4: ...accident 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 faci...

Page 5: ... and maintained If an accident occurs the Endostar Navigator must not be used until repairs have been completed by a qualified and trained technician authorized by the manufacturer Intended Operator Profile a Qualification Legally qualified person such as dentists for endodontic device operation it may differs among countries b Education and Knowledge It is assumed that the understands the risks o...

Page 6: ...f the device is allowed Poldent Co Ltd is not responsible for any accidents or other types of trouble that are caused by not following the precautions noted below Do not use the device in conjunction with an electric scalpel or on patients who have a pacemaker Blocked canals cannot be accurately measured Except for ways described in this manual the device must not be connected to or used in combin...

Page 7: ...Switch Data Output Port to transmit display data Probe Cord Strap Hole LCD Screen Accompanying Items Parts of Device and Consumables Standard Parts Parts Identification Probe Cord Qty 1 File Holder Qty 3 Contrary Electrode Qty 5 Tester Qty 1 Alkaline Dry Cells Qty 3 Long File Holder Qty 1 LR03 AAA size batteries Optional Parts ...

Page 8: ...rely attached 1 Before Using the Endostar Navigator 1 Slide the cover in the direction by the arrow in the illustration and remove it from the device Before using the device be sure that all autoclavable components have been sterilized p 22 Autoclavable Components 2 Insert three LR03 AAA size batteries included in the package 1 Insert the batteries by first pressing center of the minus end against...

Page 9: ...ft side of the device 1 Press the Power Switch to turn the device on The display will appear in the LCD screen The device turns itself off if it is not used for 10 minutes 2 Check that the probe cord is properly plugged into the jack 3 Check that the file holder and contrary electrode are properly connected to the probe cord 4 Touch the metal part of the file holder with the contrary elec trode Ch...

Page 10: ...k device performance with the tester once a week 1 Press the Power Switch to turn the device on 2 Insert the tester into the probe cord jack Check that the meter indicates within 3 bars away from above or below 1 The meter may jump when the tester is inserted If it does wait for about 1 second until the meter stabilizes and then check the reading If the reading is 4 or more bars away from 1 the de...

Page 11: ...again Operation Panel Display and Switches Sound Volume Canal Length Indicator Bars Meter Power Switch Set Switch Battery Power Indicator Flash Bar Memory Bar Information Display OFF Soft or Loud This bar graph indicates remaining battery power Replace the batteries when this indicator begins flashing When battery power falls too much alarm will sound and the device will automatically turn itself ...

Page 12: ...ted when the device is turned off is the one that will be selected when is it turned back on again 2 Set the Flash Bar The flash bar can be set anywhere from 2 to the APEX 0 Use it as an estimate of the canal s working length Method When the file is not inserted hold down the Power Switch and then press the Set Switch at the same time Each press of the Set Switch will move the flash bar one bar to...

Page 13: ...ethod Hold down the Set Switch and turn the device on This will change the setting of the beep from Loud to OFF Repeat the procedure to change it from OFF to Soft The setting will be memorized and stay the same the next time you turn the device on The memory bar should only be used as an estimate You may need to change it during enlargement and cleaning If there seems to be some problem stop using...

Page 14: ...ot Suit able for Electronic Measurement Always check the measurement with an X ray In some cases an accurate measurement cannot be made because of the canal shape unusual cases or poor performance of the device p 18 Endostar Navigator Meter Reading and Radiography Stop using the device immediately if you sense something odd or abnormal while taking a measurement Do not let the file touch the gums ...

Page 15: ...ormalin cresol FC or sodium hypochlorite do not get on the contrary elec trode or the file holder These could cause an adverse reaction such as inflammation Always clip the file holder to the upper part of the file shaft near the handle The metal and plastic part of the file holder can be damaged if they are attached to the file s cutting part or the transition to the cutting part Operating Proced...

Page 16: ...y to check the results Make sure the long file holder does not prick or pierce the patient s oral mucosa 4 Press the Set Switch to select memory 01 02 or 03 5 Insert the file up to the flash bar this point can also be recog nized by the change in the beeping Position the rubber stop per on the tooth surface as a reference point to determine the root canal s working length Use the 0 5 reading on th...

Page 17: ... for bleeding to stop completely Clean the inside and opening of the canal thoroughly to get rid of all blood saliva and chemical solutions and then make a measurement Broken crown If the crown is broken and a section of the gingival tissue intrudes into the cavity surrounding the canal opening contact between the gingival tissue and the file will result in electrical leakage and an accurate measu...

Page 18: ...e all cutting debris on the tooth Thoroughly remove all the pulp inside the canal otherwise an ac curate measurement cannot be made Caries touching the gums In this case electrical leakage through the caries infected area to the gums will make it impossible to obtain an accurate measure ment Blocked canal The meter will not move if the canal is blocked Open the canal all the way to the apical cons...

Page 19: ...tly than it actually is Endostar Navigator Meter Reading and Radiography Sometimes the device meter reading and the X ray image will not correspond This does not mean that the device is not working properly or that the X ray exposure is a failure Occasionally the actual apical foramen does not correspond exactly The actual apical foramen may be lo cated up towards the crown In these cases the X ra...

Page 20: ...minutes of non use 2 Disconnect the probe cord and other cords or cables Do not pull directly on the cords when connecting or disconnecting the probe and file holder Always grip the connectors to connect and disconnect cords Do not wrap the probe cord around the main unit Cord Always grip the connectors to con nect and disconnect cords Wrong ...

Page 21: ...f the battery power indicator is flashing on and off The device may not function properly if the bat tery power is low Do not reverse the plus and minus poles Never allow the spring contact to push against the edge of the battery This could damage the outer cover causing a short or a leakage of battery liquid 2 Insert three LR03 AAA size batteries included in the package 1 Insert the batteries by ...

Page 22: ...Always use LR03 alkaline Oxyride or manganese dry cells Manganese dry cells will not last as long as Oxyride or alkaline dry cells Never use rechargeable nickel hydrogen or nickel cadmium batteries All the dry cells should be of the same type i e all alkaline all Oxyride or all manganese Replace all three batteries at the same time Never use batteries that are leaky deformed discolored or otherwis...

Page 23: ... before cleaning the file holder or the long file holder File Holder File Holder Main Unit Contrary Electrode Contrary Electrode Probe Cord Long File Holder option Long File Holder option Tester Autoclavable Components Be careful to avoid cross contamination when performing maintenance Other Components Wipe with Ethanol 70 vol to 80 vol Autoclavable Components Components maintained this way Must b...

Page 24: ...ater Do not clean the components ultrasonically After washing is complete check to see if the file holder or long file holder including its inside is completely dry If any water remains inside the component expel it with an air gun or another such tool Failure to do so could result in the re maining water coming out during use and cause malfunction or poor sterilization If dust or other impurities...

Page 25: ...or wipe it with any of the following functional water acidic electrolyzed water strong alkaline solution or ozone water medical agents glutaral etc or any other special types of water or commercial clean ing liquids Such liquids may result in metal corrosion and adhesion of the residual medical agent to the components Never clean the components with chemicals such as formalin cresol FC and sodium ...

Page 26: ...holder or the long file holder before autoclaving Clean everything throughly before autoclaving Any chemicals or foreign debris left on components could cause them to malfunction or could cause discoloration Do not leave the file holder long file holder and contrary electrode in the autoclave For sterilizing files follow the manufacturer s recommendations To prevent the spread of serious life thre...

Page 27: ...any other special types of water or commercial clean ing liquids Such liquids may result in metal corrosion and adhesion of the residual 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 wash it off in running water...

Page 28: ...Co Ltd 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 X rays or direct sunlight frequently or for long times If the device has not been used for a long time make sure it works properly before using Always remove the batteries prior to storing or shipping the device Replacement Parts Transport and Storage ...

Page 29: ...at the indicator is within 3 lines of 1 on the meter 3 Check that the Set Switch changes the memory from 01 to 02 to 03 4 Check that the probe cord can be properly plugged into its jack 5 Check that the file holder s plug can be connected properly to the probe cord and that the file holder can be clipped onto a file Check the contrary electrode can be plugged into its probe cord connector 6 Touch ...

Page 30: ...more details Warranty 2 Year Limited 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 loca...

Page 31: ...akes good contact with the oral mucosa Is the file holder dirty Clean the file holder with ethanol 70 vol to 80 vol Canal Length Indica tor overreacts or is too sensitive Measurements are too short Poor accu racy Erratic results Is blood or saliva overflowing from the opening of the crown If blood or other fluids overflow the canal the current will leak to the gums and the meter will jump to the A...

Page 32: ...asurement cannot be obtained Is the file holder broken or dirty Replace or clean the file holder Canal Length Indica tor does not move at all or only when the file tip is close to the apical foramen Is the canal blocked Open the passage all the way through the apical constriction first and then take the measurement Is the apical foramen very large and open If the apical foramen is large or wide op...

Page 33: ... The Endostar Navigator is intended to detect the apex of the root canal Operating Principle The impedance in the root canal is measured by measuring at two frequencies and the position of the treatment instruments in the root canal is detected Essential Performance None There is no unacceptable risk Main Unit Rated Input Voltage DC 4 5 V Three alkaline dry cells LR03 AAA size batteries Dimensions...

Page 34: ...ent Keep away from rain Serial Number Manufacturer CE 0197 marking Conforms with the European Directive 93 42 EEC CE marking Conforms with the European Directive 2011 65 EU EU Authorized Representative un der the European Directive 93 42 EEC Attention consult accompanying documents Marking of electrical equipment in accordance with the European Directive 2012 19 EU WEEE Date of manufacture Some sy...

Page 35: ... 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 inductive and or capacitive coupling for the treatment of material or inspection analysis purpose and that it is s...

Page 36: ...s 0 5 kV 1 kV 2 kV line s to earth Signal input output 2 kV line s to earth Mains power quality should be that of a typical com mercial or hospital environ ment Voltage dips short interruptions and voltage variations on power supply lines 1 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 ...

Page 37: ...eld RF transmitters as determined by an electromagnetic site survey a should be less than the compli ance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following sym bol 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 38: ...37 Instructions for Use 2019 03 20 No Interface s Max Cable Length Shielding Cable Classification 1 Probe Cord 1 7 m Un shielded Signal Line Patient Coupled Cable None Essential Performance Cable List ...

Page 39: ...Memo ...

Page 40: ...bal 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 work of the authorized representative wit...

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