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34 

USER’S GUIDE

 

www.geosoft.ru/en                                                              

DECLARATION OF CONFORMITY 

European Community Council Directive  

93/42/EEC, 2007/47/

ЕС

 

 

 

 

JSC “Geosoft-Dent” 

5-6a, 2

nd

 Troitsky per., Moscow 129090 Russia 

 

Authorized Representative in European Union 

BIOLOREN S.A.S. di Ratti Andrea Alessandro 

via Prealpi 44, 21047, Saronno VA, Italy 

 

Declares that the products listed below comply with the requirements of Medical 
Device Directive Communities 93/42/EEC on medical equipment (taking into 
account the Directive amendments 2007/47/EC of the European Parliament) 
transposed in Italy by Dlgs. n. 46 of 24/2/1997 and by Dlgs. n. 37 of 25/1/2010, 
Annex II excluded point 3.4

 

 

The compliance with the 93/42/EEC and 2007/47/

ЕС

 Directive is under the 

monitoring of the Notified Body: 

CERMET Soc. Cons. a.r.l.

 

Via Cadriano, 23 – 40057 Cadriano di Granarolo Emilia (BO) – Italy 

 

Equipment: 

Apexlocator

 

Model names: 

Endoest-3D

 

Serial number: 

_____________

 

Quality System: 

ISO 13485/2012

 

Classification 

Class IIa

 

Signature: __________________

 

                   Data _________________

 

 

 

Name: Gofshteyn Vladimir A 
Position: General Director 

 

Summary of Contents for ENDOEST-3D

Page 1: ... Geosoft Dent USER S GUIDE DENTAL MULTIFUNCTIONAL DEVICE ENDOEST 3D ...

Page 2: ...arranty Card filling the acceptance certificate and product selling marks Please thoroughly read the user s guide before using the device Keep the User s guide for future use Please address to the manufacturer if you have some questions when using the device Hotline 7 495 663 22 11 extension 170 E mail hotline geosoft ru CJSC GEOSOFT DENT Russia ...

Page 3: ...the apexlocator 7 Makeready and using АPEX mode EOD mode PULP mode 8 The device sterilization and disinfection 9 Maintenance 10 Troubleshooting 11 Storage conditions transportation and use 12 Information on utilization 13 Information on certification 14 Warranty 15 Symbol descriptions Appendix Electromagnetic Emissions and Immunity 4 6 8 9 10 12 16 20 22 24 27 28 29 31 31 31 35 36 37 ...

Page 4: ...ield of application The device is designed for use in dentistry endodontics and can be used only in hospitals by medical specialists licensed to practice dentistry The manufacturer is not responsible for the device misuse 1 3 Contraindications Do not use the device on patients with pacemakers 1 4 Safety measures and warnings Use the device only with the Geosoft Dent authentic accessories see part ...

Page 5: ...nnect the cable from the control unit keeping only the isolating part of the cable plug Don t pull out the cable from the control unit in any case In some cases the apexlocator indications may be not enough accurate and reliable see part 6 The fundamental operating instructions of the apexlocator Before the electronic apexlocator use it is recommended to make an X ray and base on the information f...

Page 6: ...magnetic waves emitting equipment Malfunctions may take place close to the equipment marked with symbol Do not use this device in conjunction with other equipment or as part of other equipment The device normally operates at temperatures 10 35 С relative air humidity not more than 80 atmosphere pressure 101 3 kPa Any violation of the pointed restrictions may lead to the device misoperation 1 5 Sid...

Page 7: ...7 ENDOEST 3D hotline geosoft ru 5 Lip clip Oral Hook 1 pc 6 Cable USB A USB B for the accumulator charging 1 pc 7 Charger USB socket 1 pc User s guide 1 pc Figure 1 Delivery set 2 5 4 3 1 6 7 ...

Page 8: ...as a clutch of the active electrode file during apexlocation 2 EOD probe Ø2 0 mm 3 pcs 1 pc GE99 059 000 GE99 122 000 It is used as an active electrode during EOD and dentometry procedures 3 Lip clip Oral Hook 3 pcs 1 pc GЕ99 062 000 GЕ99 123 000 It is used as passive electrode during apexlocation EOD and dentometry It is fixed on patient s lip 4 Cable Signal Line USBВ plug GЕ99 169 000 Cable for ...

Page 9: ...surement range in the PULP mode from 3 0 to 0 mm Accuracy of measurement in the PULP mode in the range from 1 0 to 0 0 mm 0 2 mm Range of the diagnostic current in the EOD mode from 0 to 80mcA step 1 mcA Max voltage on applied part in the EOD mode 160V 10 in a short term impulse Effective max voltage on applied part in the EOD mode 6 5V 10 Time of the device operation in the sleep mode until the d...

Page 10: ...nd liquid penetration IP51 The device life time 5 years 4 2 Charger Input voltage 100 240 V 50 60Hz Output voltage 5V 1А 5 THE DEVICE OUTWARD APPEARANCE Outward appearance of the device EndoEst 3D is represented in the figure 2 2 1 3 6 5 4 11 Figure 2 7 8 9 10 11 ...

Page 11: ...f accumulator charge 9 button RESET 10 information label serial number date of manufacturing firmware version 11 special groove with the rubber sleeve for placement and fixing of a working cable Figure 3 LCD display 1 indicator of the APEX mode 2 indicator of the EOD mode 3 indicator of the PULP mode 4 graphic scale of the distance to the apex point in canal in the APEX mode or to the over pulpal ...

Page 12: ...es 5 Use electroconductive gel for root canals e g RC Prep Сanal recommended 6 Prevent any contact of an instrument with metals in oral cavity amalgam restorations crowns brackets etc 7 Do not touch the working file metallic parts and patient s mucosa with wet hands 8 Provide wet contact of lip clip electrode with cavity Attention There is a possibility of measurements accuracy fall off in the fol...

Page 13: ...mical solutions and then make a measurement 3 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 l e a k a g e a n d a n a c c u r a t e measurement cannot be obtained In this case build up the tooth with a suitable material to insulate the gingiva...

Page 14: ...e canal opening 6 Crown or metal prosthesis touching gingival tissue Accurate measurement cannot be obtained if the file touches a metal prosthesis that is touching gingival tissue In this case widen the opening at the top of the crown so that the file will not touch the metal prosthesis before taking a measurement 7 Cutting debris on tooth Pulp inside canal Thoroughly remove all cutting debris on...

Page 15: ...ossible to obtain an accurate measurement 9 Blocked canal The meter will not move if the canal is blocked Open the canal all the way to the apical constriction to measure it 10 Extremely dry canal If the canal is extremely dry the meter will not move until it is quite close to the apex In this case try to moisten a canal with saline Fig 11 Fig 12 Fig 13 ...

Page 16: ...ulator One may charge the accumulator from the mains 110 240 V or from the PC USB port The accumulator should be charged in the following way Connect the cable for accumulator charging 6 fig 1 to the device EndoEst 3D Insert the USB B cable plug to the APEX CHARGE socket 7 fig 2 on the device Variant 1 Charging from the mains Connect the open plug of the cable for the accumulator charging to the U...

Page 17: ...ngful reduction of the device operation duration you should address to the service department to replace the old accumulator for a new one Remove the charger plug from the mains socket and disconnect the cable from the device and PC when the device is charged 7 2 Indication of the accumulator discharge When the accumulator charge is lower than minimally allowable level 20 warning LB indicator 7 fi...

Page 18: ...onnect the cable Signal Line 2 fig 1 to the device EndoEst 3D Insert the USB B cable plug to the APEX CHARGE socket 7 fig 2 on the device Note For ensuring the maximum usability of the device in the process as well as to prevent breakage of the working cable it is possible to output a working cable on the front side of the device To do it you need to disconnect a cable from the control unit to pla...

Page 19: ...tion and disinfection Note To disconnect the cable or the file clip from the device case take the insulating part of the necessary component plug and pull with a small effort Attention Do not disconnect the cable or the file clip holding their wires to avoid break Avoid wires kinking 7 5 Switching on of the device and choosing of an operating mode Switch on the device and choose one of the three o...

Page 20: ...ady for work in the APEX or PULP mode by closing the passive and active electrodes against each other At this moment LED indicator 3 fig 2 has to light RED color and a continuous sound signal appears If the lighting of indicator doesn t appear or it is flashing on and off this means that the circuit continuity is broken and the device is out of service In this case you should replace the cable rar...

Page 21: ...le into the root canal of the studied tooth in patient s oral cavity in the following order the lip clip 5 fig 1 is placed on patient s lip the file clip 3 fig 1 is connected to the file s metallic part inserted into the root canal of the studied tooth Depending on the distance between the file tip and the canal apical constriction the corresponding graphic and numerical information will appear on...

Page 22: ...he studied tooth by the tip of active electrode EOD probe 4 fig 1 After placing the electrodes be sure to warn patient of pain reaction and ask him her to give a sign when first feeling pain Now you can start diagnosing 3 Press or press and hold the touch button START STOP 5 fig 2 The device will start gradually increasing the voltage and displaying the running value of diagnostic current in mcA p...

Page 23: ...in table 2 is based on average data and can serve only as a reference point for the dentist Dentist takes final decision of the using data of the anamnesis survey and inspection of the patient by means of additional methods of diagnostics The reset of measurements result happens automatically later 6 7 sec For compulsory reset of result of measurements press the touch button START STOP 5 fig 2 Cur...

Page 24: ...ding on the measured value of the over pulpal dentin thickness the corresponding graphic and numerical information will be initiated on the display In addition the measurement process will be accompanied with sound and light indication see fig 20 and table 3 Table 3 Over pulpal dentin thickness mm Sound indication Color of indicator 3 fig 2 Conclusion from 3 0 to 2 5 GREEN Further preparation is p...

Page 25: ...ce with cold water after each preparation stage before repeated examination Spray water with the help of compressed air for 1 2 seconds Attention The results of examination may only serve to be a guideline for dentist Dentist takes final decision of the preparation depth on the basis of complex examination and doctor s personal experience Contraindications of this method presence of fillings parts...

Page 26: ...ange of sound settings occurs according to the cyclic scheme sound off quiet signal medium signal loud signal sound off etc Each change of settings is followed by change of lighting indication switching on or changing of sound volume the LED indicator 3 fig 2 blinks by GREEN color switching off of sound volume the LED indicator blinks by RED color 7 11 The device switching off The device switches ...

Page 27: ...nt It is recommended to use ultrasound baths UltraEst UltraEst FSM or UltraEst M manufactured by the Geosoft Dent The belongings sterilization should be carried out directly before the first device use and after every patient to avoid cross infection All the belongings pointed should have autoclave sterilization The vapor pressure in the sterilization chamber is 0 20 MPa at the temperature equal t...

Page 28: ... To avoid the disinfectant ingress into the device it s expressly prohibited to disinfect the device by dipping it into any solutions 9 MAINTENANCE When discharged charge the accumulator in due time see p 7 1 and 7 2 Exclude the accumulator full discharge Replace the accumulator in due time in the case of durability yield Note Replace the accumulators once in two years period for its optimal opera...

Page 29: ...e moment of accumulator repeated charging dropped off The accumulator resources are exhausted The accumulator is out of use Address to the service department to change the accumulator Problems with sound Sound signal volume level is improperly set See p 7 10 The accumulator does not charge There is a bad contact between the control unit cable and charger There is no voltage in the power line Cable...

Page 30: ...ne There are no indications on the display or they are not stable in APEX or PULP mode Electrical circuit continuity of the device is broken Check the electrical circuit continuity see p 7 6 if necessary replace the cable and or file clip The device does not react at the control unit buttons pressing The program is hung Restart the program Press Reset 9 fig 2 button using any thin subject e g a ne...

Page 31: ...th relative air humidity not more than 100 25 С in the authentic package of the manufacturer The device should be used only in heated and ventilated locations at temperature from 10 С to 35 С with the relative air humidity not more than 80 at atmosphere pressure of 101 3 kPa 12 INFORMATION ON UTILIZATION Do not throw the device into the system of household rubbish Utilize the device according to t...

Page 32: ...32 USER S GUIDE www geosoft ru en ...

Page 33: ...33 ENDOEST 3D hotline geosoft ru ...

Page 34: ...n medical equipment taking into account the Directive amendments 2007 47 EC of the European Parliament transposed in Italy by Dlgs n 46 of 24 2 1997 and by Dlgs n 37 of 25 1 2010 Annex II excluded point 3 4 The compliance with the 93 42 EEC and 2007 47 ЕС Directive is under the monitoring of the Notified Body CERMET Soc Cons a r l Via Cadriano 23 40057 Cadriano di Granarolo Emilia BO Italy Equipme...

Page 35: ...l defects or used improperly according to the user s guide invalidate the guarantee of repair 5 The manufacturer or other authorized service department repair the device The device delivery to service department for warranty or extended services is done at the expense of the device owner Before addressing to the service department connect to the manufacturer consultant on the hotline Phone 7 495 6...

Page 36: ...m electrical shock The device of type В IEC 878 02 02 EN 60601 1 Continuous current IEC 417 No 5031 EN 60601 1 Do not throw away the device into system of daily rubbish 2002 96 EC WEEE EN 50419 The device serial number ISO 15223 EN980 Date of the device manufacturing ISO 15223 EN980 Mark of conformity to product quality and safety standards of the European Union CE mark 93 42 EEC Conformity mark o...

Page 37: ...SPR11 Group 1 The device EndoEst 3D uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR11 Class В It is possible to use the device EndoEst 3D in all establishments including domestic establishments and those directly connected to the public low voltage power supply netwo...

Page 38: ...charge ESD EN 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Burst Fast Transient EN 61000 4 4 2 kV for scheme wire to wire 2 kV for scheme wire to wire Mains power quality should be that of a typical commercial or hospital environment Surge EN 61000 4 5 1...

Page 39: ...ds 120 of Un 20 voltage emission in Un for 25 periods 70 Un 30 voltage dip in Un for 25 periods 5 Un 95 voltage interrupt in Un for 5 periods 120 of Un 20 voltage emission in Un for 25 periods Mains power quality should be that of a typical commercial or hospital environment If the user of the device EndoEst 3D requires continued operation during power mains interruptions it is recommended that th...

Page 40: ...han the recommended separation distance calculated from that equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 Р from 150 kHz to 80 MHz d 1 2 Р from 80 MHz to 800 MHz d 2 3 Р from 800 MHz to 2 5 GHz where P the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d the recommended separation distance in ...

Page 41: ...tter W Separation distance according to frequency of the transmitter m from 150 kHz to 80 МHz d 1 2 Р from 80 MHz to 800 МHz d 1 2 Р from 800 MHz to 2 5 GHz d 2 3 Р 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 determined using the equation a...

Page 42: ...42 USER S GUIDE www geosoft ru en For notes ...

Page 43: ...Malfunction Service Master Quality Warranty Card 2 Date of repair Malfunction Service Master Quality Warranty Card 3 Date of repair Malfunction Service Master Stamp Stamp Stamp Quality Warranty Card 2 Date of repair Malfunction Service Master Quality Warranty Card 3 Date of repair Malfunction Service Master ...

Page 44: ...ST 3D Serial number Date of manufacture Date of sale Seller Stamp ENDOEST 3D Serial number Date of manufacture Date of sale Seller Stamp ENDOEST 3D Serial number Date of manufacture Date of sale Seller Stamp ...

Page 45: ...ales mark Date of sale Seller The stamp of the manufacturer Certificate of acceptance Serial number Date of manufacture Controller Version Stamp of trading organization Sales mark is obligatory The warranty is invalid without sales mark ...

Page 46: ...46 USER S GUIDE www geosoft ru en For notes ...

Page 47: ...scow Russia 129090 PHONE FAX 7 495 663 22 11 E mail mail geosoft ru Web www geosoft ru Hot line PHONE 7 495 663 22 11 ext 170 E mail hotline geosoft ru Representative in Europe via Volta 59 21047 Saronno VA Italy Phone Fax 39 02 96703261 Version of 31 10 14 CJSC GEOSOFT DENT Russia ...

Page 48: ...V M ULTRAEST TERMOEST GUTTAEST FOTEST LED TERMOEST CERAMIC ESTUS LED ALLADIN ENDOEST 3D ENDOEST MOTOR MINI ENDOEST ASSISTANT ENDOEST MOTOR ENDOEST APEX ENDOEST NANOEST PULPEST ULTRAEST FSM ULTRAEST М ESTUS LED ALLADIN MC LUMIEST GUTTAFILL ...

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