Apex ID - Profident
Contents
1. Figure 4 8 Figure 4 9 Figure 4 10 Figure 5 1 This manual provides instruction on how to measure the working length of root canals using the Apex ID Electronic Apex Locator e This instruction manual has been prepared for use by dental professionals e This manual and the product may be subject to change without notice If required e The product has been tested for electromagnetic application test compliance with EN60601 1 2 and is designed to protect against harmful interference when installed and operated according to instructions This product could produce use and discharge wireless wavelength energy and it may cause harmful interference with other equipment nearby In this event the user should resolve the interference using one or more of the recommendations described below o Increase the distance between the Apex ID and the device which is experiencing interference o Reinstall and restart the Apex ID again o Contact your distributor or SybronEndo SAFETY PRECAUTIONS Please read this manual carefully The purpose of this instruction manual is to provide effective amp safe operation of the Apex ID for users and patients SAFE OPERATION Symbols This instruction manual contains various symbols to assist the operator in correct and safe operation of the device and to protect against injury damage or loss of property The symbols and meanings are as follows A DANGER A CAUTION A NOTICE Could result in2. eee SybronEndo Instructions For Use TABLE OF CONTENTS English Fran ais Deutsch Espa ol Italiano Portugu s Nederlands Dansk Norsk Suomi Svenska Cesky Magyar Polski Pycckun Hrvatski jezik Srpski Slovensky Eesti Lietuvi kai Rom n T rk e E nviKQ ae rh x el 01 H RE du si 12 21 30 39 48 57 66 75 84 93 102 111 120 129 138 147 156 165 174 183 192 201 210 219 228 237 FIGURES Figure 1 1 Figure 1 2 gt Figure 1 3 4177 Figure 1 4 Figure 1 5 Figure 1 7 Figure 1 8 i Er Figure 1 9 FIGURES Figure 2 1 Figure 2 2 e Figure 2 3 e Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 2 10 Figure 2 11 Figure 2 13 Figure 3 2 Figure 3 1 a N N 2 2 5 5 D LL LL Figure 2 12 Figure 2 14 Figure 3 3 Figure 3 4 n Le N 1 AN NN s f A I Figure 3 5 Figure 3 6 FIGURES Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 A Anatomical Radiographic apex or apex apical foramen Physiological apex or apical constriction Figure 5 2 A Distance between radiographic apex and anatomical apex B Distance between physiological apex and anatomic apex C Distance between radiographic apex and physiological apex
3. Fig 2 5 Connect to probe cord for measuring working length of root canal Up button 4 Fig 2 6 Push the button to increase the root apex standard value by 0 1 and the volume of buzzer is increased 1 step up Push the button to decrease the root apex standard value Down button N Fig 2 7 by 0 1 and the volume of buzzer is decreased 1 step down Push the button to fix the setting mode Setting button Fig 2 8 Power button Fig 2 9 Push the button to turn the unit ON OFF Buzzer volume signal Fig 2 10 Indicates the volume of the Buzzer Graph signal Fig 2 11 Graph shows the distance between the end of file and root apex Battery signal Fig 2 12 Indicates remaining battery life Root apex signal Fig 2 13 Indicates when file has reached the apical foramen or the O point set by the operator Numeric signal Fig 2 14 Indicates the distance between the end of file amp root apex 3 PRODUCT SYMBOLS Un 2 Serial Number REPI Authorized Representative in the European Community REF Part Number BA Consult Instructions for Use Manufacturing Date GBs CSA Marking C US Type B Applied Part Manufacturer CE Markin Dispose of Properly mm Caution 4 BEFORE USE 4 1 Check contents e Confirm that all the components listed in the Contents are in the box before using the device for the first time Please refer to Kit Contents in section 2 e Please check the exterior of the de
4. The microprocessor of the unit calculates the change in micro signals to convert the difference into a distance value which will be displayed on the Apex ID LCD display A NOTICE Use the device to measure the working length of root canals only 1 2 Principle of operation Micro signals consisting of dual frequencies sent from 2 DEVICE CONTENTS AND FUNCTIONS 2 1 Device contents and functions Contents of product Apex ID Unit 1 Fig 1 1 File Holder B 2 Fig 1 6 AAA Alkaline Batteries 3 Fig 1 2 Instructions For Use 1 Fig 1 7 Stand 1 Fig 1 3 Probe Cord 1 Fig 1 8 Lip Hooks 5 Fig 1 4 Checker 1 Fig 1 9 File Holder A 1 Fig 1 5 2 2 Accessories and their functions Probe cord Fig 1 8 Connects between the Apex ID amp file holder amp Lip Hook Lip Hook Fig 1 4 For contact to patients lip File holder A Fig 1 5 Touch to file designed for molar teeth File holder B Fig 1 6 Holds File Checker Fig 1 9 Confirms that the Apex ID is functioning correctly 2 3 The features of the Apex ID and their functions LCD Screen Fig 2 1 Shows the status of settings and indicates the distance between the end of file inserted in root canal amp root apex Control panel Fig 2 2 Select power ON OFF amp control functions Stand Fig 2 3 Placing the Apex ID on a counter Battery compartment Fig 2 4 Contains batteries 1 5V x 3 DC 4 5V Probe cord jack
5. temperatures ranging from 8 TROUBLE SHOOTING 20 50 C atmospheric pressure 70 106 Kpa and relative humidity 5 90 7 7 Disposal Dispose of the product in accordance with your local waste disposal regulations and or laws If any problems occur refer to the table below If there are any further problems or issues please contact your distributor or SybronEndo Problem No power No power No buzzer sound Power ON but no measurements show Power ON but not measured 9 PRODUCT SPECIFICATIONS e Rated voltage DC4 5V 1 5V Alkaline Battery AAA x 3EA e Input current less than DC 60mA e Power consumption less than 0 27VA e Patient auxiliary current less than AC 10uA e Oscillation frequency 500Hz 0 2Hz 5kHz 0 002kHz e Size W70mm 1mm x D25mm 1mm x H100mm 1mm Low Battery No Battery Replace the batteries Battery replacement does not solve Check the connection to the batteries the problem Probe cord disconnected from the Check the connection of Probe cord main unit and the main unit File holder disconnected from Probe Check the connection of file holder cord and Probe cord e Weight 390g 15g including stand except battery e Protection type and level against electric shock Type B applied part e Internally powered equipment Ordinary equipment IPX0 e Continuous operation time 62hours at 1250mAh Battery x 3EA 10 GUIDANCE AND MANUFACTURER S DECLARATION Guidance and manufact
6. If the warranty claim provides to be justified the product will be returned to the user freight prepaid Warranty claims other than those indicated herein are expressly excluded Exclusions Damages and defects caused by the following conditions are not covered by the warranty e Improper handling disassembly modifying neglect or failure to operate the unit in compliance with the instructions given in the Instruction for Use User Manual e Force majeure or any other condition that is beyond the control of SybronEndo e This device is manufactured for the uses specified in this Instruction for Use SybronEndo shall not be responsible for any damages caused by customer misuse or uses other than those specified Responsibility SybronEndo shall not be responsible for damages or injuries caused by any of the following e Use by unauthorized personnel e Changes to or modifications of the device e Use of other manufacturer s devices or parts with the Apex ID e Use of unapproved parts or repair of the device by unauthorized parties e Disregard of the care or cautions listed in the instruction manual e Use of the device for any applications not included in the instruction manual e Use of a power supply other than that specified in the instruction manual e Fire flood lightning or from natural disasters e Customer carelessness or intentional misuse 11 Apex ID D Manufactured for SybronEndo 1332 S Lone Hill Avenue Glend
7. e into the canal Fig 4 6 Attach the file holder B to the file If using holder A touch the file below the handle with the file holder Fig 4 7 Insert the file slowly into the root canal while checking the graph and the number value on the screen Stop insertion when the distance between the file and root apex reaches the standard value of the root apex pre set factory setting at 0 0mm or your chosen value As the file nears the apical constriction the unit will beep more rapidly When the apex is reached the file is touching the periodontal membrane and a red bar will appear at the Apex on the screen As it goes past the apical constriction the frequency of beeps increases until the screen reads 0 5 Then the sound will remain steady and the entire screen will flash Continue inserting the file to 0 1 if the standard value of the root apex is set at 0 0 then move the file back until 0 0 is displayed on the screen This helps to confirm the location of the apex Fig 4 8 Fig 4 10 After positioning the rubber stop of file on the tooth at the reference point the file should be removed from the canal Measure the working length from the tip of the file to the rubber stop with a ruler After positioning the rubber stop on the file to a reference point the file should be removed from the tooth A NOTICE The measurement result shown by the Apex ID and the length of file may vary depending on the operator s angle
8. easurement value of the working length may be shorter than the actual measurement value 7 3 Method used to validate recommended sterilization method Sterility Assurance Level SAL 10 1 Sterilization validation samples are wrapped with Bls 2 3 times of sterilization cycles as a half cycle are carried out at 121 C for 15 minutes 3 1 time of sterilization cycle as a full cycle is carried out at 121 C for 30 minutes 4 Incubate Bls at 55 60 C for 7days 74 Sterilizer used for validation e Manufacturer DAIHAN LABTECH CO LTD e Model name LAC 5105SP e Serial No 20101202138 e Control No TE 10 23 e Valuable room 100 liter e Power supply AC 220V 50 60Hz e Pressure 2 6kgf cm2 e Range of sterilization temperature 105 C 135 C 7 5 Cleaning Clean the Apex ID or probe cord with dry gauze and a small amount of ethanol Any ethanol left on the product after cleaning should be completely wiped off with a dry cloth A CAUTION Use protective sleeves on the cords and Apex ID during operation followed by removal of the sleeve and wiping with alcohol after operation A CAUTION Do not use the Apex ID when wet with ethanol There is a possibility of electric shock or product damage 7 6 Operating Storage Transport The Apex ID should be operated in temperatures ranging from 10 40 C atmospheric pressure 70 106 Kpa and relative humidity 30 75 The Apex ID should be stored and transported in
9. erved additional measures may be necessary such as re orienting or relocating the Apex ID b Over the frequency range 150kHz to 80MHz field strengths should be less than V1 V m Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Main power quality should be that of a typical commercial or hospital environment Main power quality should be that of a typical commercial or hospital environment Main power quality should be that of a typical commercial or hospital environment If the user of the Apex ID requires continued operation during power main interruptions it is recommended that the model Apex ID be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the Apex ID including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 V1 P d 3 5 E1 P 80MHz to 800MHz d 7 E1 yP 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths fro
10. injury or death Could result in injury or death May result in injury or death May result in incorrect data Do not use on patients with pacemakers Do not use with electrosurgery devices Products or parts which have not been approved by SybronEndo shall not be connected or attached to this product Use of un approved products or parts may result in malfunction of the device and injury to the patient Do not use this device in the presence of oxygen oxidized substances nitrogen oxidized substances or combustible anesthetic mixtures Caution Federal law restricts this device to sale by or on the order of a dentist This device is not waterproof Exposure to moisture could result in electric shock or damage to the device Do not disassemble the device Disassembly and touching the inside of the device could result in electric shock or burn If you disassemble the product intentionally warranty shall not be honored irrespective of guarantee period Disassembly or repair should only be done by those authorized by SybronEndo This product is for dental operative use only Confirm the device is operating normally prior to use When the volume of battery is low discontinue use and replace the batteries Do not try to use in high humidity conditions Protect the device from the effects of atmospheric pressure wind sun and Salt Do not use where explosive products or gases are stored Stop using if not operating correctly Not indicated fo
11. m fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol ke 11 QUALITY GUARANTEE AND RESPONSIBILITY Ouality Certificate Product Name Electronic Apex Locator Model Apex ID Consumer Date of Purchase Guarantee period Device 3 years Accessory 6 Months Manufactured for SybronEndo Contact 714 516 7979 Address 1332 S Lone Hill Ave Glendora CA 91740 5339 If a problem has occurred during the guarantee period due to manufacturing or natural failures please contact SybronEndo Warranty service shall be provided without charge during the guarantee period WARRANTY AND EXCLUSIONS Warranty SybronEndo warrants the Apex ID electronic apex locator to be free from defects in materials and workmanship for a period of 3 years from the original date of purchase and consumables excluding batteries for 6 months from date of purchase in accordance with SybronEndo s warranty regulations If the Apex ID shows any defect within the specified warranty period that are not excluded from this warranty SybronEndo shall at its discretion either replace or repair Apex ID using suitable new or reconditioned parts In the case other parts are used which constitute an improvement SybronEndo may at its discretion charge the customer for the additional cost of these parts
12. of view AN The insertion angle of the file after enlarging the canal may vary from the original working length measurement angle A Re confirm the working length after enlarging the canal Turn off the Apex ID by pushing the power button l The power will automatically shut off after 1 minute of non use The working length should be confirmed by radiograph A NOTICE A radiograph may show a different measurement result than the Apex ID This is not an indication of malfunction by the unit or the x ray Often the apical foramen is located coronal to the radiographic apex Fig 5 2 Another possibility is the angle of the xray beam and film may be off angle to the perpendicular 6 GUIDE FOR ACCURATE MEASUREMENT Turn on the Apex ID prior to use Plug the Checker Fig 1 9 provided in the original packaging into the probe cord jack Fig 2 5 and confirm the value on the LCD screen is 0 5 It is recommended to insert the file into the canal first and then connect the file to the file holder If the signals do not change as the file approaches the APEX it is possible the root canal is too dry therefore it should be filled with an irrigant Necrotic tissue or other matter in the root canal may affect accuracy It is advisable to take several measurements during enlargement of the canal Start with a larger file at first If the APEX indication graph and numeric signal on the screen does not reach the APEX gradually t
13. ora CA 91740 U S A 714 516 7979 sybronendo com MADE IN KOREA S Denti Co Ltd Rm 607 612 Byucksan Digital Valley 6 219 Manufacturer Gasandigital 1 ro Geumcheon gu Seoul 153 803 Korea a European 3 Rue des Rosiers 92340 Bourg la Reine C Representative France 01 20 007 0167 Rev C
14. packaging and see if the value on the LCD screen is 0 5 Fig 3 6 If 0 5 is displayed on the LCD screen the unit is ready for clinical usage Push the up button 4 and down button N simultane ously for about 3 seconds Fig 4 2 Set at 0 0 at this point by pushing the up button A gt or down button N Fig 4 2 Change back by following the same process Push the setting button er then the desired value of the root apex shall be fixed Fig 4 3 NOTICE The standard value for the apex of Apex ID is set as 0 0 at the factory This value means that the file has reached the anatomical foramen Fig 5 2 5 3 Setting of the buzzer volume Turn on the Apex ID by pushing the power button O Fig 4 1 Push the up button and down button eN simultane ously for about 3 seconds and push setting button Xs r once Fig 4 4 Adjust the volume of the buzzer by pressing the up button or the down button eN Fig 4 2 Push the setting button str to keep the set volume Fig 4 3 5 4 Measuring the working length of the root canal Turn on the Apex ID by pushing the power button CD Fig 4 1 A NOTICE Before use sterilize the lip hook using a steam sterilizer at 121 C for 30 minutes Place the lip hook on the patients lip Fig 4 5 A NOTICE Place the lip hook on the opposite side of the mouth from the tooth being measured Use with Stainless Steel hand file Insert the fil
15. r any use except for measuring the working length of root canals This product is for use by dental professionals only To avoid electrical shock or explosion keep the device away from high temperature or high humidity Keep the metal parts of this product away from conductors Fire electric shock or damage may result Do not put heavy items on the device Fire or electric shock may result Confirm all measurements of canal length with radiographs Blocked root canals cannot be measured correctly When you give this device to others include the Instructions For Use Remove the batteries if the Apex ID device is not likely to be used for sometime Label maintenance and repair e The label for notice or caution shall be maintained soundly with regular inspection e Replace If the label for notice or caution has been lost or damaged please contact SybronEndo for replacement 1 INDICATIONS FOR USE AND PRINCIPLE OF OPERATION 1 1 Indications for use the unit return to the unit after travelling along the electric Apex ID is an Electronic Apex Locator designed for use in circuit that is composed of unit probe cord file holder measuring the working length of root canals file patient lip holder probe cord The impedance of the electric circuit may be changed depending on the distance between the end of a file and the apex of the root canal which results in a change in the micro signals that are input back into the unit
16. ry a smaller file to measure the working length of the root canal 7 MAINTENANCE AND STORAGE 7 1 Sterilization The Lip Hook and File holder A should be sterilized at 121 C for 30 minutes with high pressure steam The File holder B should be sterilized at a temperature of 121 C for 30 minutes with high pressure steam in a sterilization pouch then dried at least 10 minutes after sterilization A CAUTION Parts used in direct intraoral contact are to be steam sterilized A NOTICE It is highly recommended to place File holder B in a sterilization pouch for autoclaving e The metal of the File holder B may be corroded when it is in direct contact with steam e Temperature should not exceed 135 C during sterilization as the product may be damaged 7 2 Recommended sterilizer type e Sterilizer Vacuum type B e Sterilization temperature 121 C e Sterilization time 30min To minimize error it is recommended the working length be measured more than twice If root canals within a tooth are connected as in the case of multiple root canals with anastomoses or cracks miss measurement is possible It is recommended to verify the tooth s anatomy radiographically Contact with metal restorations by the file during measurements may result in errors Remove blood or exudate from the canal before measurement In cases where the foramen is not completely formed or the foramen has been overly expanded the m
17. urer s declaration electromagnetic emissions The Apex ID is intended for use in the electromagnetic environment specified below The customer or the user of the Apex ID should assure that it is used in such an environment Emissions test RF emissions CISPR 11 Group 1 Compliance Electromagnetic environment guidance The Apex ID uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 The Apex ID is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The Apex ID is intended for use in the electromagnetic environment specified below The customer or the user of the Apex ID should assure that it is used in such an environment Immunity test IEC 60601test level Compliance level Electromagnetic environment guidance 10 Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruption and voltage variations on power supply input lines IEC 60601 4 11 Power frequency 50 60 Hz IEC 61000 4 8 Conducted RF IEC61000 4 6 Radiated RF IEC 61000 4 3 6kV contact 8kV air 2kV for power suppl
18. vice for damage A NOTICE SybronEndo shall not be responsible for any damage caused by misuse of the product 4 2 Check connection between probe cord and file holder Insert lip hook and file holder B into probe cord Fig 3 1 Insert probe cord into probe cord jack of the main unit Fig 3 2 5 SET UP AND USE 5 1 Probe cord connection Connect the file holder and lip hook to the probe cord Fig 3 1 The probe cord should be connected to the probe cord jack of the main unit Fig 3 2 5 2 Setting the standard value for root apex Turn on the product by pushing the power button ch Fig 4 1 The position of the file tip is shown by the canal length indicator bar on the display Working Length The 0 5 reading indicates that the tip of the file is at or very near the apical construction physiological foramen Fig 5 2 After turning on the power make sure there is a complete circuit by touching file holder B to the lip hook The screen will show all bars lit and a dashed line on the lower light of the screen Fig 5 1 The tone will be steady Note If the power button doesn t work make sure that the insulation plastic is completely removed from the battery cover in the back of the product Remove the insulation plastic piece before use Fig 3 4 4 3 Performance inspection with checker Power on by pushing power button O Fig 3 5 Plug in Checker to the probe cord jack provided in the original
19. y lines 1kV for input output lines 1kV differential mode 2kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 10 UT 80 dip in UT lt 5 UT gt 95 dip in UT for 5s 3 V m 150 kHz to 80MHz 3V m 80 MHz to 2 5GHz 6kV contact 8kV air 2kV for power supply lines 1kV differential mode 2kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 80 dip in UT lt 5 UT gt 95 dip in UT for 5s 3 V ms 150 kHz to 80MHz 3V m 80 MHz to 2 5GHz Note UT is the A C mains voltage prior to application of the test level Note At 80MHz and 800MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Apex ID is used exceeds the applicable RF compliance level above the Apex ID should be observed to verify normal operation If abnormal performance is obs
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