RomiApex™ A-15
Contents
1. Storage Keep devices in Sterility cannot be guaranteed if sterilization packaging packaging is open or damaged in a dry and clean check the packaging before using environment the instruments 7 Certification RomiApex A 15 is tested for compliance with IEC 60601 1 1988 safety standard and IEC 60601 1 2 2007 Electromagnetic compatibility including conducted and radiated immunity tests as specified for equipment of Group 1 Class B RomiApex A 15 is covered by the CE Marking of Conformity Certificate reference number 5017 04 01 0 issued on 09 06 2006 and delivered by MDC Medical Device Certification GmbH Notified Body Identification number 0483 The device bears following CE identification mark CE 0483 8 European Authorized Representative European Authorized Representative who has been empowered to enter into commitments on our behalf Romidan UK LTD 122 126 Tooly Street London Bridge London SE1 2TU United Kingdom Fax 44 0 207 403 1026 1028 Email export romidan com Website www romidan dental com Contact Person Mr Eitan Margalit General Manager 9 Limited Warranty RomiApex A 15 is warranted for 24 months from the date of purchase The accessories cables battery etc 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 by2. Cleaning Manual Disinfection Soak the required accessories in a disinfectant solution combined with proteolytic enzyme if possible Rinse well the accessories in flowing water Drying No particular requirements Maintenance inspection and testing of the accessories No particular requirements Pack the devices in sterilization pouches Packaging Steam sterilization at 135 C 275 F during 10 minutes in gravity fed type autoclave Table Top N type Drying time after sterilization 30 minutes Sterilization Page 10 of 12 6 2 Disinfection and sterilization procedure RT MM ME Details and Warnings The file clip should be activated during cleaning process pressed and released several times After cleaning no visible impurities should remain on the accessories Follow instructions given by the disinfectant manufacturer concentration immersion time etc Do not use disinfectant solution containing aldehyde phenol or any products which may damage the Check the validity period of the pouch given by the manufacturer to determine the shelf 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 The only sterilization parameters to be used are those that have been validated and provided to the user in this User Manual 10
3. correct battery polarity is marked inside the battery compartment Pic 1b close the battery compartment cover and secure it with its screw Pic 1a Pic 1b e Prior to battery replacement the device must be turned off e Before replacing the batteries measuring cable should be disconnected from the patient and removed from the RomiAPEX A 15 device Rev 05 Page 4 of 12 09 10 5 2 2 When the battery is depleted blinking Low Battery indicator will appear on the screen Pic 2 RomiApex A 15 will continue normal operation even with low battery but the battery should be replaced before it becomes flat as described in section 5 2 1 above Pic 2 5 3 Device operation 5 3 1 Plug in the measurement cable into the device and connect the lip clip and the file clip to the cable i 5 3 2 Press the On Off O button to turn the device on The initial image appears on the display Pic 3 The small tooth image will blink indicating no measurement signal Pic 3 Rev 05 Page 5 of 12 09 10 Rev 05 9 9 9 5 3 4 0 3 5 5 3 6 5 3 7 Put the lip clip on the patient s lip Insert the endodontic file into the root canal and connect the file clip to the endodontic file Make sure that irrigation solution blood or saliva are not overflowing from the tooth cavity dry the cavity before perform
4. RomiApex A 15 APEX LOCATOR User Manual UR 1 dento quality products Rev 05 Ot es n PE Table of Contents MOGUCOM RR TETTE TET 2 Indications for use cc ccc cece cece ee ee cena ee eeaeeeeeeeeaeaees 3 Precautions sax ov ied ekuvexe tances se ox DURER Hebe Dexia venatu 1 3 Adverse Reactions esses nenne 3 Package COnleriIs Sido rid a p Orbe qe eL tactu det aad 3 Selling SIAM CG ous ceno liio erste aden p Ue E a ELI Sdn 4 od eneralscs de eei e A Cb Ss ek a Aas qut ke 4 5 2 Installing Replacing the Battery 4 5 9 DEVICE OperatlOn e Seed res Detector een 5 9 4 Audio fGedDacK uc erre Ere Reo eit 9 5 5 Automatic Sh tdoW 2 55 exec Face Ex eee al 9 Maintenance cleaning and sterilization 9 Orte alo espina eft attesa cru A reese ee NS ae 11 European Authorized Representative 11 Limited Wan aniy a ecini s deua n uua eque qi p DER abt ako Ee modo dogs 11 Bite RHINITE TOT OI TIL TID 12 Technical Specifications 0 cccccee cece eneeeeeneeeeeenaes 12 Standard symbolS esis oet we sec rime Sedan se sete een ete eie tak 12 Page 1 of 12 09 10 FOR DENTAL USE ONLY Introduction We congratulate you for making the right choice of preferring our new and advanced Apex Locator RomiApex A 15 over other good quality and known devices available on the market Utilizing the advantages
5. 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 Rev 05 Page 11 of 12 09 10 10 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 or 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 11 Technical Specifications RomiApex A 15 electronic apex locator 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 devi
6. ce 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 51 x 38 mm Supply AAA 1 5V alkaline battery 12 Standard symbols On the device label appear standard symbols as follows Direct current 4 Type BF applied part 1 5V Consult instructions for use pt Manufacturer Recycling PLEASE DO NOT THROW AWAY This product and all its components must be recycled through your supplier Caution Federal law restricts this device to sale by or on the order of a physician or licensed dental practitioner ys Bx ea Page 12 of 12 09 10 RomiApex A15 Rev 05 09 10 Manufacturer Romidan Ltd A 5 Simcha Holzberg St R 55022 Kiryat Ono Israel q Email export romidan com denta quality products www romidan com
7. ing measurements RomiApex A 15 detects automatically beginning of measurements checks the quality of the electrical contact and the conductivity of the root canal When the electrical contact is good an audio signal of two beeps indicates beginning of normal measurement cycle Tooth image will stop blinking If there are no beeps clean the file clip and the file irrigate the canal if required and continue the measurements It is not recommended to continue measurements if the tooth image blinks Movement of the file inside the canal is reflected by the DOWN Pic 4 and UP Pic 5 arrows on the screen Pic 4 Pic 5 Page 6 of 12 09 10 5 3 8 File position in the median and the apical zones is visually indicated by color segments inside the root canal image and numerical readings 2 0 1 5 1 0 0 75 0 5 0 25 0 0 Apex Foramen accompanied by audio signals with varied frequency Pic 6 9 Median Zone Blue Pic 6 Beginning of the Mid Apical Zone Apical Zone Blue Green Pic 7 Pic 8 Rev 05 Page 7 of 12 09 10 5 3 9 Atthe apical file position 0 0 solid audio tone is emitted Pic 9 Apex Red Pic 9 5 3 10 In the case of over instrumentation the red OVER indicator is turned on accompanied by alarm beeps Fo reading indicates Foramen over instrumentation appears in the numerical field Pic 10 OVER Red Pic 10 5 3 11 The file clip may be disconnected f
8. mable 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 104 F Caution Federal law restricts this device to sale by or on the order of a physician or licensed dental practitioner Adverse Reactions None Package Contents Check the contents of the package before use Rev 05 1 RomiApex A 15 apex locator 1 Cradle 1 AAA 1 5V alkaline battery 1 Measurement cable 2 File clips 5 Lip clips 1 Touch Probe 1 Screwdriver for battery compartment 1 User Manual Page 3 of 12 09 10 5 Getting Started 5 1 General On the front panel two pushbuttons are placed On Off 4 Sound adjustment Measuring cable receptacle is placed on the left side of the device Battery compartment is located on the rear side of the device The device can be used with or without its cradle Prior the first use it is recommended to sterilize the Lip Clip the Touch Probe and the File Clip Please refer to section 6 for further information regarding maintenance of RomiApex A 15 5 2 Installing Replacing the Battery RomiApex A 15 is powered by standard AAA size 1 5V alkaline battery 5 2 1 To install replace the battery release the screw and remove the battery compartment cover on the rear side of the device Pic 1a Remove the old battery if was installed using the built in strip insert the new battery
9. of its well proven patented technology RomiApex A 15 offers both the highly skilled endodontic and the general practitioner performing root canal treatments a precise user friendly easy to use 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 Rev 05 Page 2 of 12 09 10 2 Indications for use RomiApex 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 relatively to the root apex This product must only be used in hospital environments clinics or dental offices by qualified dental personnel Precautions RomiApex A 15 was not tested on patients with implanted electro medical devices pacemakers etc Use of RomiApex A 15 on patients or by personnel with such devices should be avoided Do not use RomiApex A 15 near devices emitting electromagnetic noise such as fluorescent lamps film viewers ultrasonic devices etc Cellular phones remote controls or other devices generating electromagnetic waves may cause abnormal operation of RomiApex A 15 Such devices should be turned off 3 4 RomiAPEX A 15 should not be used in the presence of flam
10. rom the file and connected back during measurement cycle without affecting normal device operation for instance when the file is changed to a larger number during root canal treatment or when another canal should 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 Rev 05 Page 8 of 12 09 10 5 3 12 RomiApex A 15 operates completely automatically No manual adjustments are required The microcomputer analyzes parameters and the status of the canal and provides automatic adjustment to ensure optimal performance RomiApex A 15 enables precise apex localization independently of root canal conditions dry wet with blood pulp gangrene etc In case of very dry canal or during restoration you may use irrigation solution as hypochlorite or sodium chloride etc to provide conductive path during measurements 5 4 Audio feedback RomiApex A 15 is equipped with an audio indicator which enables monitoring of the progression of the file within the canal in the apical zone This function is activated in parallel with progression of the file It enables monitoring of file advance 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 4 5 5 A
11. utomatic Shutdown RomiApex A 15 automatically shuts down after 5 minutes without use In order to prolong the battery life after completing the measurements it is recommended to switch the device off by pressing the On Off key 6 Maintenance cleaning and sterilization 6 7 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 between treatments Please follow Disinfection and sterilization procedure described in section 6 2 Measurement 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 cannot be autoclaved A Use of agents other than specified above may cause damage to the equipment and its accessories Rev 05 Page 9 of 12 09 10 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 adequate brush or towel soaked in a disinfectant solution
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