RomiApex™ A-15
Contents
1. Fig 1a Fig 1b e Prior to battery replacement the device must be turned off e Before replacing the battery the measuring cable should be disconnected from the patient and removed from the RomiApex A 15 device 9 2 2 When the battery level is low the flashing Low Battery indicator will appear on the screen Fig 2 RomiApex A 15 will continue normal operation even with a low battery but the battery should be replaced before it loses all power 5 3 Cable connection test Prior to each use the RomiApex A 15 should be checked for functionality The RomiApex A 15 has a connection test feature in order to check the cables 5 3 1 5 3 2 5 3 3 Connect the measuring cable to the device Connect the file clip and the lip clip to the measuring cable Touch file clip contact to the lip clip Connection icon should appear on the display indicating proper connection Fig 3 If the symbol does not appear the measuring cable or file clip should be replaced Fig 3 5 4 Device operation A Do not use this unit with patients who have a pacemaker as its effect has not been evaluated 5 4 1 5 4 2 5 4 3 5 4 4 5 4 5 5 4 6 5 4 7 5 4 8 5 4 9 5 4 10 Place rubber dam prior to beginning endodontic treatment Obtain an initial radiograph and measure the distance between a reference point i e incisal edge peak of the cusp etc to the image of th2. A Use of agents other than specified above may cause damage to the equipment and its accessories 7 2 Disinfection and sterilization procedure Preparation at the point of use prior to processing No particular requirements Preparation for decontamination preparation before cleaning No particular requirements The accessories are not intended for automated cleaning Cleaning Automated Clean the accessories with an appropriate brush or towel soaked in a disinfectant solution Cleaning Manual Soak the accessories in a disinfectant solution that contains a proteolytic enzyme if possible Rinse accessories thoroughly in running water Drvin No particular ying requirements Maintenance inspection and testing of the accessories No particular requirements Pack the devices in Packaging sterilization pouches Steam sterilization at 135 C 275 F for 10 minutes in table top N type autoclave Sterilization 7 The file clip should be pressed and released several times during cleaning to assure all debris is removed After cleaning there should be no visible debris on the accessories Follow manufacturer s instructions on the disinfectant concentration immersion time etc Do not use disinfectant containing aldehyde phenol or any products which may damage the items Check the expiration date of the pouch given by the manufacturer to determine the shel
3. Do not use dry heat sterilization on the file clips and touch probes The LCD screen readings 2 0 1 75 1 5 1 25 1 0 0 75 0 5 and 0 25 do not correspond to any actual distance in mm They serve as a convenient reference to estimate the file tip position in relation to the apical foramen NOTE Sometimes the RomiApex A 15 reading and the x ray image will not correspond This can be due to the actual location of the apical foramen and inaccuracies of the x ray angulation made before and during endodontic treatment 3 Precautions e Verify that the canal has been properly isolated and that there are no metallic restorations present which may contact the file e Normally RomiApex A 15 provides accurate measurements during foramen location in dry and wet canals in presence of various electrolytic solutions Sodium Hypochlorite EDTA saline etc e A 15 endodontic K file 15 is the minimum recommended file size for apical foramen localization However smaller or larger files may be used when anatomically necessary e For convenience of use it is recommended that selected file will be about 5mm longer than the radiographic working length e Before measuring check the accessories and verify good connectivity e RomiApex A 15 should not be dropped or subjected to other manners of impact or shock as this could result in malfunction of the device and voiding of the warranty e When disconnecting the lip clip file clip or m
4. testing for this is not lines applicable applicable Interconnecting cables are not longer than 3m therefore testing is Surge 1 kV line to line Not not applicable IEC 61000 4 5 applicable 2 kV line to earth Not applicable Voltage dips lt 5 U Not The RomiApex A 15 does not have shorts gt 95 dip in U for 0 5 applicable AC power input or AC power output interruptions and cycle therefore testing for this is not variations on the 40 U Not applicable power supply input lines IEC 61000 4 11 60 dip in U for 5 applicable cycles 70 U Not 30 dip in U for 25 applicable Not applicable Power Power frequency magnetic fields should frequency be at levels characteristic of a typical 50 60 Hz location in a typical residential magnetic field commercial hospital or military IEC 61000 4 8 environment U is the AC mains voltage prior to application of the test level The RomiApex A 15 is not equipped with any ports or any accessible I O lines The RomiApex A 15 may be susceptible to strong magnetic fields or static electric fields higher than the limits specified in testing which could interrupt normal operation If there is a reason to believe that this type of interference has occurred simply remove and re insert the batteries and the unit should reset 21 IEC 60601 1 2 Table 4 Guidance and Manufacture s Declaration for Electromagnetic Immunity for non life support systems The RomiAp
5. 5 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of SANE 150 kHz to 80 MHz 80MHzto800MHz 800 MHz to 2 5 GHz d 0 35 P d 0 35 P d 0 7 P For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the higher frequency range applies Note 1 At 80 MHz and 800 MHz the separation distance fort the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 23 15 Standard symbols On the device labeling appear standard symbols as follows Special disposal of waste Follow instructions electrical and electronic for use equipment E Type BF applied 1 5V Direct current part paed Manufacturer SN Serial Number Caution Federal law restricts this device to sale by or on the order of a physician or licensed dental practitioner 24 RomiApex A15 Rev 07 04 14 Manufacturer Romidan Ltd 5 Simcha Holzberg St i 55022 Kiryat Ono Israel Email export romidan com MISA Wwww romidan com DENTAL QUALIT
6. RomiApex A 15 APEX LOCATOR User Manual pir Mii La PATS Please scan the QR code to DENTAL QUALITY PRODUCTS view RomiApex A 15 additional m p instructions Lu Table of Contents Introduction si eee 1 Indications for use Warnings Precautions 2 3 4 Package Contents 5 Getting Started 5 1 General 5 2 Installing Replacing the Battery 5 3 Cable connection test 0 N N N OORA HR O 54 Device operation 5 5 Audio feedback lt 2 2 2222 5 6 Automatic Shutdown Demo mode Maintenance cleaning and sterilization 6 7 8 Troubleshooting guide 9 Certification 10 European Authorized Representative 11 Limited Warranty 12 Disclaimer 13 Technical Specifications 14 Electromagnetic declarations 15 Standard symbols Introduction Congratulations on the purchase of your RomiApex A 15 Apex Locator The RomiApex A 15 Apex Locator is a battery operated portable device which uses the frequency dependent impedance method and proprietary algorithms to determine the position of the apical foramen Utilizing the advantages of its well proven patented technology RomiApex A 15 offers the operator performing root canal treatments an accurate reliable and user friendly apex locator Custom color graphic display of RomiApex A 15 helps to achieve optimal endodontic performance required during your root canal treatments RomiApex A 15 Apex Locator 1 Indications for use Ro
7. Y PRODUCTS
8. e anatomical apex for the canal you will be working on Subtract 0 5mm to establish your TEMPORARY working length Preflare the canal to partially remove canal contents and establish patency to your TEMPORARY working length To ensure proper measurements verify that the canal is not completely dry or calcified If needed fill the canal with an electrolytic solution i e Sodium Hypochlorite Saline etc Depending on the size of the canal insert a 15 hand K file or other appropriate file into the canal Fig 4 Press the On Off O button to turn the device on The initial image appears on the display Plug the measuring cable into the device and make sure that the cable icon appears on the display Fig 4 Connect the lip clip and the file clip touch probe to the measuring cable Put the lip clip onto the patient s lip Connect the file clip to the file The RomiApex A 15 will automatically detect that root canal measurement has started If the electrical contact is good and the conductivity of the root canal is sufficient the file icon inside the small tooth image will stop blinking and a double beep audio signal will sound A If there are no beeps stop measurements clean the file clip and the file irrigate the canal if required and resume measurements A Make sure that irrigation solutions blood or saliva don t fill the access cavity Dry the cavity if required before performing measurements 5 4 11 M
9. e is operating normally See manufacturer s declaration of electromagnetic compatibility 4 Package Contents Check the contents of the package before use e 1 RomiApex A 15 e 1 Cradle e 1 AAA 1 5V Alkaline Battery e 1 Measuring cable e 2 File clips e 5 Lip clips e 1 Touch probe e 1 Screwdriver for battery compartment e 1 User Manual 1 Measuring cable 2 File clips 5 Lip clips 1 Touch Probe 5 Getting Started 5 1 General There are two buttons on the front panel f O On Off g gt Volume adjustment The measuring cable receptacle is located on the left side of the device The battery compartment is located on back of the device The RomiApex A 15 may be placed in or out of the cradle The lip clip the touch probe and the file clip should be sterilized before use Please refer to Maintenance Cleaning and Sterilization section 7 page 13 for further information regarding maintenance of the RomiApex A 15 5 2 Installing Replacing the Battery The RomiApex A 15 is powered by a standard AAA size 1 5V alkaline battery included 5 2 1 To install replace the battery unscrew and remove the battery compartment cover on the back of the device Fig 1a Remove the old battery if one is present using the built in cloth strip insert the new battery following polarity indications marked inside the battery compartment Fig 1b replace cover and tighten screw
10. easuring cable always grip the connectors Do not pull directly on the wires to disconnect e Discard any old damaged or leaky battery Battery should be disposed of according to local codes and regulations Battery cannot be disposed of as municipal waste within the European Union e Ensure the battery is installed with correct polarity e Do not immerse RomiApex A 15 unit This may damage the device and will void the warranty e Only use recommended cleaning solutions on the device See the Maintenance cleaning and sterilization section 7 page 13 for recommended cleaning and Sterilization e The items which may contact the patient during intended use of the device lip clip file clip and touch probe must be cleaned and sterilized before the first use and between patients to avoid the risk of cross contamination e Care should be exercised when the RomiApex A 15 is used around devices emitting electromagnetic noise such as fluorescent lamps film viewers ultrasonic devices radio frequency transmitters cell phones remote controls or devices that radiate electromagnetic EM fields areas where there are strong magnetic fields or conditions where there is high static electricity ESD While the RomiApex A 15 has been built to withstand these conditions EM and ESD fields may interfere with the device s proper operation If the RomiApex A 15 must be used under these conditions take care to see that the devic
11. evice off 6 2 To start Demo mode press and hold the On Off key for about 1 sec until the second beep sounds and Demo indication appears on the screen 6 3 During Demo cycle the operating sequence of the device is shown on the screen Press On Off key to pause the simulation press On Off key again to resume 6 4 When Demo cycle is completed it is repeated automatically until interrupted by the operator 6 5 To exit Demo mode press and hold the On Off key O for about 1 sec until a beep sounds Note If measuring cable is inserted into the device receptacle during Demo cycle RomiApex A 15 exits Demo mode and switches automatically to regular operation mode 7 Maintenance Cleaning and Sterilization 7 1 General e The device does not contain user serviceable parts The service and repair should be provided by factory trained service personnel only e All objects that were in contact with potentially infectious agents should be cleaned after each use Lip clip file clip and touch probe should be disinfected and sterilized by autoclaving before the first use and between treatments Please follow Disinfection and sterilization procedure described in next section Measuring cable the device and its cradle should be cleaned using tissue or soft cloth impregnated with aldehyde free disinfecting and detergent solution a bactericidal and fungicidal A The measuring cable should not be autoclaved
12. ex A 15 is intended for use in the electromagnetic environment specified below The customer or user should ensure that it is used in such an environment IMMUNITY IEC 60601 test Electromagnetic environment Conduction RF 3 Vrms 3 Vrms RomiApex A 15 is not affected IEC 61000 4 6 150 kHz to 80 MHz 150 kHz to 80 MHz by portable and mobile RF communications equipment in close proximity There is no recommended separation distance from Radiated RF 3 V m 3 V m transmission sources IEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 2 5 GHz RomiApex A 15 will operate safely and effectively near cell towers and radio TV transmitters Note 1 The RomiApex A 15 may be susceptible strong magnetic fields or static electric fields higher than the limits specified in testing which could interrupt programming If there is a reason to believe that this type of interference has occurred simply re insert the battery and the unit should reset 22 IEC 60601 1 2 Table 6 Recommended separation distances between portable and mobile RF communications equipment and not life supporting equipment The RomiApex A 15 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the RomiApex A 15 can help prevent electromagnet interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the RomiApex A 1
13. f life Use packaging which is resistant up to a temperature of 141 C 286 F Follow maintenance and operation procedures of the autoclave provided by the manufacturer Drying time after The only sterilization Sterilization 30 parameters to be used are minutes those that have been provided in this Manual Keep devices in Sterility cannot be guaranteed if 1 Storage sterilization packaging packaging is open or damaged 0 in adry and clean check the packaging before environment using the instruments 8 Troubleshooting Guide Blank screen after use The device automatically shuts down after 5 minutes without use press the On Off button to turn the device on Battery is completely dead replace with fresh battery ensure the battery is installed with proper polarity Realign if necessary Device has malfunctioned contact your supplier Display showing no If already in use this may indicate a poor connection progression of the file check all connections and ensure lip clip is contacting the towards the apical oral mucosa and file clip is clean and free of debris area foramen Fill the canal with an electrolytic solution if required i e Sodium Hypochlorite Saline etc The endodontic file is not touching the internal canal walls replace the file using a larger diameter file If the behavior persists the measuring cable or file clip may need to be replaced and or the device sh
14. miApex A 15 is an electronic device used for apex localization and working length determination during root canal treatment RomiApex A 15 is indicated for patients who need to undergo root canal treatment which requires precise determination of position of the dental file in the canal relative to the root apex This product must only be used in hospital environments clinics or dental offices by qualified dental personnel 2 Warnings Read all instructions before operating this unit The manufacturer accepts no liability for any damage resulting from improper use of this unit and or for any purpose other than those covered by these instructions U S A Only US Federal law restricts this unit to sale by or on the order of a dentist As per Endodontic Standards of Care always use a rubber dam when performing endodontic treatment Do not use this unit with patients who have a pacemaker as its effect has not been evaluated RomiApex A 15 should not be used in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide RomiApex A 15 must be stored in a dry place at temperatures between 10 C and 50 C 50 F and 122 F Verify the measurements with a file and radiograph as abnormal canal anatomy or unusual canal morphology may cause inaccurate measurements i e blocked canals immature teeth Do not use damaged file clips or any accessory because an inaccurate measurement could result
15. n or is the tooth fractured Does a broken crown cause incorrect measurements Is there a lesion at the apex If a large amount of vital inflamed pulp tissue is left inside the canal particularly in wide canals such as upper incisors and canines it may cause incorrect measurements Touching a metal prosthesis of filling with the file may create a conductive path outside the canal and cause incorrect measurements OVER indication unstable readings etc Deep caries may create a conductive path outside the canal and cause incorrect measurements OVER indication unstable readings etc The canal length indicator may jump to OVER position when it reaches a resorption area ora fractured root tooth Build up an insulating barrier to isolate the file from the crown A chronic lesion can destroy the apical foramen through resorption and cause incorrect measurements Is the file clip holder Replace or clean the file clip broken or dirty If the problem persists please contact your supplier 9 Certification The RomiApex A 15 complies with the following standards IEC 60601 1 Safety and IEC 60601 1 2 Electromagnetic compatibility including conducted and radiated immunity tests as specified for equipment of Group 1 Class B The RomiApex A 15 is covered by the CE Marking of Conformity certificate The device bears the following CE identification mark CE 0483 10 Eu
16. ould be sent in for service contact your supplier The cable icon c Make sure the measuring cable is properly connected does not appear If the behavior persists the measuring cable may need to be replaced and or the device should be sent in for service contact your supplier file Check all connections and ensure lip clip is contacting the oral mucosa and file clip is clean and free of debris If the behavior persists the measuring cable may need to be replaced and or the device should be sent in for service contact your supplier The connection icon Try connecting another file clip to the measuring cable mko does not appear keeps blinking The File icon The file clip is not properly connected with the endodontic jl Problem Possible Solution when touching the file If the behavior persists the measuring cable may need to clip and the lip clip be replaced and or the device should be sent in for service contact your supplier The OVER 9 over The file tip has progressed beyond the apical foramen indication appears move the file back until the OVER indication disappears accompanied by frequent audio beeps No audio tones The volume was adjusted to mute press the volume key until the desired volume level is reached Device has malfunctioned contact your supplier 1 File position indication Is second electrode Make sure the lip clip makes good is unstable er
17. ovement of the file inside the canal is reflected by the DOWN Fig 5 and UP Fig 6 arrows on the screen 5 4 12 Continue to advance the file moving it smoothly in a watch winding motion As the instrument progresses toward the foramen color segments inside the root canal image accompanied by audio signals with varied frequency will indicate the file s progress Numerical readings 2 0 1 75 1 5 1 25 1 0 0 75 0 5 0 25 0 0 Foramen or OVER appear under the tooth icon Figs 7 11 A Erratic movement of the file may cause unstable readings Fig 5 Fig 6 Beginning of the Median Zone Blue Apical Zone Blue Mid Apical Zone Fig 7 Fig 8 Fig 9 5 4 13 Reaching the apical foramen 0 0 is indicated by a red color segment inside the root canal image Fig 10 and a constant audio tone Determine the electronically obtained length using an endodontic ruler To establish the working length subtract 0 5 1 0mm from the electronic length Foramen red Fig 10 A The red OVER indication accompanied by frequent beeps indicates that the file tip have progressed beyond the foramen into the periapical region Foramen over instrumentation Fig 11 OVER Red 5 4 14 The file clip may be disconnected from the file and connected back during measurement without affecting normal device operation for instance when the file is changed to a larger number during root canal treatment or when another canal sho
18. r operation of the equipment The manufacturer reserves the right to implement changes and modifications of the product at any time to revise this publication and to make changes in the contents hereof without obligation to notify any person of such changes modifications or revisions 13 Technical Specifications The RomiApex A 15 belongs to the following category of medical devices Internally powered equipment AAA 1 5V alkaline battery Type BF applied parts Not suitable for use in presence of flammable anesthetic mixtures with air oxygen or nitrous oxide Continuous operation Ingress of liquids not protected The device is intended for indoor use only Environmental conditions during transportation temperature 20 C to 60 C 0 to 140 F relative humidity 10 to 90 non condensing RomiApex A 15 is intended for use in electromagnetic environment specified for equipment of Group 1 Class B Specifications Dimensions W55 x H92 x T16 mm Weight 100 gr Type of screen Custom Color Graphic LCD Screen dimensions 51x 38mm Supply AAA 1 5V alkaline battery 14 Electromagnetic declarations IEC 60601 1 2 Table 1 Guidance and Manufacture s Declaration for Electromagnetic Emissions The RomiApex A 15 is intended for use in the electromagnetic environment specified below The customer or user should ensure that it is used in such an environment Electromagnetic environment Emi
19. ratic lip clip making good contact with the oral mucosa results contact with mucosa Is the file clip dirty Clean the file clip with Ethanol 70 80 vol Is blood or other If blood or other fluids are fluids over flowing the overflowing the access cavity they access cavity of the may create a conductive path tooth outside the canal and cause incorrect measurements OVER indication unstable readings etc Check the rubber dam isolation use OraSeal Caulking or Putty to repair rubber dam leaks You may use ViscoStat or Astrigedent for control the gingival tissue bleeding Clean and dry the pulp chamber and tooth crown thoroughly 2 Measurements are too short or too long poor accuracy Is the canal filled with The canal length indicator may blood or chemical suddenly swing when it breaks the solutions surface of fluids inside the canal but it will return to normal as the file is advanced toward the apex Is the tooth surface Clean entire tooth surface covered with tooth debris smear layer or chemical solutions Is the file touching This might lead to incorrect the gingival tissue readings or cause the canal length indicator suddenly to jump all the way to the OVER position Problem Is there vital inflamed pulp tissue left inside the canal Is the file touching metal prosthesis or filling Are proximal surfaces infected with caries Are there external resorptio
20. ropean Authorized Representative European Authorized Representative who has been empowered to enter into commitments on our behalf Obelis s a Bd G n ral Wahis 53 1030 Brussels BELGIUM Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net 11 Limited Warranty RomiApex A 15 is warranted for 24 months from the date of purchase The accessories Measuring cable file clips lip clips touch probe are warranted for 6 months from the date of purchase The warranty is valid for normal usage conditions Any damage caused by accident abuse misuse or as a result of service or modification other than by a person authorized by the manufacturer will render the warranty void The warranty is in lieu of any other warranty expressed or implied Any modifications made to the equipment without explicit approval from Romidan Ltd voids warranty obligations and poses a potential safety threat to both operator and patient With sales receipt indicating the date of sale to the dentist 12 Disclaimer The manufacturer its representatives and its dealers shall have no liability or responsibility to customers or any other person or entity with respect to any liability loss or damage caused or alleged to be caused directly or indirectly by equipment sold or furnished by us including but not limited to any interruption of service loss of business or anticipatory profits or consequential damages resulting from the use o
21. ssions Test Compliance f p guidance RF emissions EN 5011 The RomiApex A 15 uses low voltage European Norm equivalent to CISPR Group T and low current electrical and 11 electromagnetic energy only for its internal functions Therefore its RF emissions are RF emission very low and are not likely to cause EN 5011 interference in nearby electronic European Norm equivalent to CISPR equipment 11 Harmonic emissions IEC 61000 3 2 The RomiApex A 15 does not have AC Voltage fluctuations flicker emissions power Input OFAC power ouput therefore testing for this is not applicable IEC 61000 3 3 20 IEC 60601 1 2 Table 2 Guidance and Manufacture s Declaration for Electromagnetic Immunity The RomiApex A 15 is intended for use in the electromagnetic environment specified below The customer or user should ensure that it is used in such an environment IMMUNITY test IEC 60601 test Compliance Electromagnetic environment level level guidance Electrostatic 6kV contact 6kV The RomiApex A 15 has built in ESD discharge ESD contact protection The physical environment IEC 61000 4 2 li gky air salar should be restricted to the following 7 1 Humidity range 10 90 2 Temperatures range 10 C 42 C Electrical fast 2 kV for power Not The RomiApex A 15 does not have transient ourst supply lines applicable AC power input or AC power output IEC 61000 4 4 1kV for input output Not therefore
22. uld be measured In such cases the device detects automatically that the new measurement is initiated the electrical contact and conductivity of the root canal are checked again and two beeps are sounded Note The RomiApex A 15 operates completely automatically No manual adjustments are required The RomiApex A 15 enables accurate localization of apical foramen independently of root canal conditions dry wet with blood pulp In case of very dry canal or previous obturation retreatment cases you may use irrigation solution such as Sodium Hypochlorite Saline etc to provide a conductive electrical environment 5 5 Audio feedback The RomiApex A 15 is equipped with an audio indicator which is activated in parallel with progression of the file This function enables monitoring of the file progression within the canal in the apical zone even without seeing the display The volume can be adjusted to one of the four levels mute low normal and high The adjustment is performed by successive pressings of the volume key d gt 5 6 Automatic Shutdown The RomiApex A 15 automatically shuts off after 5 minutes without use In order to prolong the battery life after completing the measurements it is recommend switching the device off by pressing the On Off key 6 Demo mode The built in Demo mode is available to demonstrate operation of the device 6 1 Disconnect the measuring cable from the device and turn the d
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