Guilin Woodpecker Medical Instrument Ai-Pex Instruction Manual Download Page 33 | Manualshive

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Power on / off

Serial number

Mode key

Temperature limitation

Humidity limitation

CE marked product

Adjustment key

Follow Instructions for Use

Appliance compliance WEEE directive

Atmospheric pressure for storage

Authorised Representative in the EUROPEAN COMMUNITY

12 Statement

All rights of modifying the product are reserved to the manufacturer without

further notice. The pictures are only for reference. The final interpretation rights

belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.

The industrial design, inner structure, etc, have claimed for several patents by

WOODPECKER, any copy or fake product must undertake legal responsibilities.

13 EMC - Declaration of conformity

The device has been tested and homologated in accordance with EN 60601-1-

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Summary of Contents for Ai-Pex

Page 1: ...Please read this manual before operating Industrial design patent No ZL 201930704918 8 Apex locator Instruction Manual ...

Page 2: ...oduct function and operation 17 5 Trouble shooting 22 6 Cleaning Disinfection and Sterilization 25 7 Storage maintenance and transportation 28 8 Environmental protection 30 9 European authorized representative 30 10 After service 30 11 Symbol instruction 30 12 Statement 31 13 EMC Declaration of conformity 31 ...

Page 3: ... to finish the endodontic treatment Features of the device a Equipped with clear bright LCD clear image and different colors indicate the trajectory of the file clearly b Based on advanced multiple frequency network impedance measurement technology and automatic calibrating ensures the measurements are accurate c The File clip Lip hook Touch probe and Pulp tester probe can be autoclaved under high...

Page 4: ...2 1 4 Components 1 4 1 Picture of the main unit Picture 1 1 5 1 0 0 5 0 0 OVER APEX R Picture 1 ...

Page 5: ...ouch probe adapter Pulp tester probe etc 1 6 Intended use This equipment applies to the measurements below 1 6 1 Used to help determine the working length of various types of dental root canals during root canal treatment 1 6 2 Used to test pulp vitality 1 6 3 The device must be operated in hospital and clinic by the qualified dentists ...

Page 6: ... equipment IPX0 1 8 4 Device not suitable for being used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide 1 8 5 Operation mode Continous operation 1 8 6 Applied part Touch probe Lip hook File clip Pulp tester probe 1 9 The main technical specifications 1 9 1 Battery 3 7V 2000mAh Model 18500 1 9 2 Adapter Model DJ 0500100 A5 ADS 6AM 06N 05050 Input 100V 240...

Page 7: ...display OVER in the upper part of the canal continue slightly towards the apex so the signal returns to normal 2 5 In order to prevent leakage or interference between the root canal and resulting in inaccurate measurements dry the access cavity with a cotton pellet or air blower before each use 2 6 Use a file size adapted to the root canal diameter The selected file is too small for a large root c...

Page 8: ...n the apex locator is too low please check whether the endo is too dry and confirm it with X ray 2 15 This device have electromagnetic interference the patient or doctor who with a heart pace maker are forbidden to use this device and the device is susceptible to other device which produces electromagnetic interference Dentists should be cautious about operation under such environment 2 16 The gua...

Page 9: ...l in the groove of the base 3 Installation of the device 3 1 Apex Locator Mode 3 1 1 Preparation Insert the plug of the measuring wire into the right side socket of the unit Attention a Please be careful to use the device keep it stable and avoid hit Incautious use will lead to the damage or the failure of the machine b Measurement can not be proceeded without the complete insertion of the plug c ...

Page 10: ...e sure not to pull the wire when inserting or pulling out the the measuring wire and the file clip Picture 4 a Correct operation showed as in picture 4 b 3 1 2 Test the wire connecting Test before each use a Press the power switch Make sure the scene of measuring the length of the root canal displayed on the LCD screen The device will shutdown automatically after 5 minutes without operation b Make...

Page 11: ... means that the file clip or the measuring wire is damaged should be replaced 3 1 3 Determine the working length a When the indicating bar reaches the position of the dial 0 0 Picture 7 a Picture 7 b and there is APEX on screen the endo file has reached the anatomical apical foramen On the basis of measured length subtract 0 5 1 0 mm to get the working length b When the indicating bar reaches the ...

Page 12: ...ncy must be judged by the dentist as he she works on the tooth Make sure to take an X ray to check the results 3 1 4 Apical Stop Setting Set the Apical Stop between 0 0 and 0 5 by pressing the middle button and the set parameter will be automatically saved When the file reaches the Apical Stop the device will beep continually ...

Page 13: ...8 3 1 5 Testing the device by tester Test every two weeks Users can use the tester to check if the device work properly specific operation is as follows a Pulling out the the measuring wire and turn off the device ...

Page 14: ...please contact authorized distributor or manufacturer for help 3 1 6 Connect to compatible Endo Motor Optional Plug one end of the USB line into the USB socket on the right side of the device and connect the other end with compatible Endo Motor as shown in Picture 10 a There is no difference between those two ends As shown in Picture 10 b when the Contra angle icon is lit the Apex locator and Endo...

Page 15: ...e Apex locator cannot communicate with the Endo Motor After plugging the USB wire into the USB socket please do not drop anything on it and do not hit the USB socket 3 2 Pulp test mode This mode is a method to determine pulp condition by observing the tolerance of the teeth to pulse signals of different intensities The pulse signal intensity of pulp automatically increases from low to high with va...

Page 16: ...d to raise his or her hand immediately when there is a feeling of tingling 2 Insert the measuring wire into the corresponding interface of the machine and insert the pulp tester probe and the lip hook into any two sockets of the measuring wire respectively 3 Power on and long press the mode button for more than 2s to switch to the pulp test mode PT mode as shown in Figure 11 1 5 1 0 0 5 0 0 OVER A...

Page 17: ...erence between the two values the third test should be performed and then the average of two similar values should be taken 8 If the contact with the tooth to be tested is interrupted and contact is made again within 1s the pulse value will not be cleared and the test can be continued without resetting 9 Before testing the affected tooth a normal control tooth needs to be tested to obtain a relati...

Page 18: ... a response when the probe first touches the tooth surface or when he she is asked about feelings 3 2 3 Possible causes of false negative results of pulp test 1 The patient has had prior use of analgesics narcotics or alcoholic etc that prevent the teeth from perceiving electrical stimulation properly 2 The pulp test probe fails to effectively contact the tooth surface preventing the transmission ...

Page 19: ...6 Mark an anatomized symbol on the diseased tooth and memorize it on the case history This symbol should be marked on the health bridge or on the tooth filled integrated The position of the mark should be on the incisal edge of the anterior tooth or on the spire of the molars For those bridge that s broken obviously this symbol should be on the tooth surface supported by the dentin instead of on t...

Page 20: ...ll cause inaccuracy because of the electronic conduction The measurement can be continued when the crown is fixed by gypsum or other insulators Picture 14 Picture12 Picture13 Picture14 d There is a crack on the tooth root In this case the crack may cause the electric leakage which will affect the accuracy of measurement Picture 15 e A retreatment to an endo which was filled with gutta percha Clean...

Page 21: ...l cause illusion that the front tip of the root canal haven t reached the canal tip Picture 18 Because of the angle of X rays sometimes it can t take photo of the apical foramen properly so it can t show the accurate position of the apical foramen 4 2 Instruction 4 2 1 Insert the plug of measuring wire into the socket in the side of main unit Turn it on The battery is on the left of screen 4 2 2 T...

Page 22: ...21 b When measuring the length of root canal please use the canal file with the resinous handle If you operate the device without the dentistry glove it will cause leakage and the result of measurement will be inaccurate Therefore please use the resin needle file and remember don t touch the metal part with finger c Please don t use the worn file clip and it will make the result of measurement ina...

Page 23: ...d this is the working length of the tooth It also can be use with the touch probe instead of file clip when it is inconvenient to measure the back teeth Picture 23 Picture 23 4 2 7 Please remove the lip hook file clip or touch probe after shutting down 4 2 8 The components that touch body must be autoclaved under high temperature and high pressure The shell and measuring wire should be cleaned by ...

Page 24: ...onfirm the measuring wire is plugged firmly link the lip hook with the file clip to check if the measuring wire is broken No sound of alarm If the volume is set at mute Adjust the sound level The charging LED indicator goes out 1 The adapter is not connected well 2 Have used faulty adapter with excessive output 3 The battery is not installed well 4 The battery has been damaged 1 Reconnect the adap...

Page 25: ...e crown or the tooth neck will cause short circuit then cause the in normal phenomena Clean the blood and the liquid If the root canal is filled with blood liquid Once the endo needle contact the surface of the root canal which is filled with blood liquid it will display OVER immediately In this case push the needle to the apical root canal then the display will be normal you can measure the lengt...

Page 26: ... measurement from the gums to the periodontal tissue loss the screen will display OVER If the adjacent surface has caries Current measurement flow from caries of the adjacent surface to gums then the root canal length can t be measured correctly Whether there is collateral or the tooth root is broken Once the needle reached the collateral or the broken part of the tooth root current measurement wi...

Page 27: ...ot canal is occlusive The display will be normal after penetrating the narrow part of apical If the root canal is too dry Wet the root canal with normal saline solution or sodium hypochlorite solution If the endo file is too small for a large root canal Replace the current endo file with a larger one If all above measures do not work please contact us 6 Cleaning Disinfection and Sterilization The ...

Page 28: ... may influence the result of the reprocessing process Store the instruments in a humid surrounding 6 2 Transportation Safe storage and transportation to reprocessing area to avoid any damage and contamination to environment 6 3 Preparation for Decontamination The devices must be reprocessed in a disassembled state 6 4 Pre Cleaning Do a manual pre cleaning until the instruments are visually clean S...

Page 29: ...cleaning processes have been validated by using 0 5 neodisher MediClean forte Dr Weigert Note Acc to EN ISO 17664 no manual reprocessing methods are required for these devices If a manual reprocessing method has to be used please validate it prior to use 6 6 Disinfection Automated Thermal Disinfection in washer disinfector under consideration of national requirements in regards to A0 value see EN ...

Page 30: ...ation Sterilization of instruments by applying a fractionated pre vacuum steam sterilization process according to EN 285 EN 13060 EN ISO17665 under consideration of the respective country requirements Minimum requirements 3 min at 134 C in EU 5 min at 134 C Maximum sterilization temperature 137 C Note Flash sterilization is not allowed on lumen instruments 6 11 Storage Storage of sterilized instru...

Page 31: ...h pigments 7 2 5 Replace the battery if it seems to be running out of power sooner than it should Please use the original lithium battery The procedure for battery replacement is as follows a Turn the power oﬀ b Remove the battery cover c Remove the old battery and disconnect the connector d Connect the new battery and put it in the Battery compartment e Replace the battery cover It is recommended...

Page 32: ... equipment has been sold based on the warranty card we will repair this equipment free of charge if there are quality problems Please refer to the warranty card for the warranty period 11 Symbol instruction ClassⅡequipment Date of manufacture Manufacturer Type B applied part Recovery Ordinary equipment Keep dry Used indoor only Handle with care ...

Page 33: ...ent All rights of modifying the product are reserved to the manufacturer without further notice The pictures are only for reference The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO LTD The industrial design inner structure etc have claimed for several patents by WOODPECKER any copy or fake product must undertake legal responsibilities 13 EMC Declaration of conformi...

Page 34: ...h an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The model use 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 B The model is suitable for used in domestic establishment and in establishment directly con...

Page 35: ...vironment guidance E l e c t r o s t a t i c discharge ESD IEC 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 Electrical fast tansient burst IEC 61000 4 4 2kV for power supply lines 1 kV for lnput output lines 2kV for power supply lines 1kV for interconnec...

Page 36: ...ins power quality should be that of a typical commercial or hospital environment If the user of the model require continued operation during power ma ns 1n terrupt1ons t 1s recommended that the model be powered from anuninter ruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3A m 3A m PONer frequency magnetic fields should be at levels characteristic of a typ...

Page 37: ...0 MHz to 800 MHz d 2 3 P1 2 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter In watts W according to the transmitter manufacturer and d Is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occu...

Page 38: ... Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the model The model is intended for use in electromagnetic environment in which radiated RF disturbances is controlled The customer or the user of the model can help prevent electromagnetic interference by maintaining a mi...

Page 39: ... 1 Measurement of pulpitis pulp necrosis periapical periodontitis and tooth length 2 Measurement of the tooth length before restoration of post crown 3 Measurement of the tooth length of transplantation and retransplantation Cautions 1 Cautions User must regard EMC please install and put in service the model according to the EMC information provided in the accompanying documents 2 Cautions Portabl...

Page 40: ...components may result in increased Emissions or decreased Immunity of the model 5 The model should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the model should be observed to verify normal operation in the configuration in which it will be used 6 The accessories adapter battery measuring wire file clip of Apex locator the model may affec...

Page 41: ...ZMN SM 272 V1 1 20210702 ...

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