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Eighteeth Ultra X User Manual

Ultrasonic endo activation device
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0197
X
Ultra
Ultrasonic Endo Activation Device
USER MANUAL
Changzhou Sifary Medical Technology Co.,Ltd.

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Summary of Contents for Eighteeth Ultra X

  • Page 1 0197 Ultra Ultrasonic Endo Activation Device USER MANUAL Changzhou Sifary Medical Technology Co.,Ltd.
  • Page 2 Version:09 IFU-6235001 Issued:20231110 Size: 130mm×85mm Page 2 / 44...
  • Page 3 Page 3 / 44...

  • Page 4: Parts Identification

    1 Scope of Ultra X Scope of Ultra X Parts identification ○ 1 Tips (6pcs) ○ 2 Wrench ○ 3 Insulating Sleeve ○ 4 Main Unit ○ 5 Adapter ○ 6 Main Unit Base Page 4 / 44...
  • Page 5 1 Scope of Ultra X Components Main unit (1pcs) Tip: SBG20(1pcs) Tip: SBG25(1pcs) 6251001 6251127 6251129 S20(6201032), S20(6201032), B20(6251031), B25(6251033), G20(6251021) G25(6251023) Wrench (1pcs) Insulating sleeve Main unit base 6251007 (1pcs) (1pcs) 6204002 6005002 For different regions, there are several different adapter options to be selected as follows.
  • Page 6 1 Scope of Ultra X British standard power plug (1pcs) 6016009 Australian standard power plug (1pcs) Adapter (1pcs) 6016010 6016007 Multi- standard Argentina standard power plug (1pcs) 6016014 Page 6 / 44...

  • Page 7: Symbols Used

    2 Symbols Used Symbols Used General warning sign Caution Serial number Catalogue number Batch code Manufacturer Country of manufacture Class II equipment Type B applied part CE marking Direct current Dispose of in accordance with the WEEE directive Keep dry Refer to instruction manual Sterilizable in a steam sterilizer (autoclave) 134 C...
  • Page 8 2 Symbols Used Authorized Representative in the European Community Temperature limit Humidity limitation Atmospheric pressure limitation Washer-disinfector for thermal disinfection Manufacturer’s Logo Medical Device Page 8 / 44...

  • Page 9: Before Use

    3 Before Use Before Use Intended purpose Ultra X is used in endodontic treatment by application of ultrasonic energy. The Ultra X can provide the energy for tip oscillation and vibration in frequency (45kHz 5kHz) required to ± create sufficient acoustical streaming and cavitation necessary to effectively clean, penetrate, and remove vapor lock.
  • Page 10 (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Ultra X, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Please charge at least 4 hours before first use.

  • Page 11: Intended User Profile

    3 Before Use Intended user profile Considerations Requirement Description A licensed dentist, dental hygienist and graduates of relevant bachelor’s degree Education (national qualifications). The operator must have understood: 1.treatment and diagnosis of dental disease; Knowledge 2.terms and guidance of diagnostic medical devices;...
  • Page 12 4 Setting up the Ultra X Setting up the Ultra X Installing the  Clean and disinfect the sleeve Activator tips before every Always use a silicone use. sleeve. Tighten the tip clockwise with provided wrench until the tip secure.
  • Page 13 4 Setting up the Ultra X  Make sure the device stopped when inserting removing tips.  Estimated case number of uses per tip: 20, taking 2  Pull the tip gently to root canals per case as a make sure that the tip reference.

  • Page 14: Connecting The Adapter

    Only original accessories can be used. Main unit base recommended to be used to place the Ultra X to protect the tip when the device is not in use.  position Don’t device where it is difficult to operate the disconnection device.
  • Page 15 Turn Power Off Press to turn off the output during working. The Ultra X will turn off the output and enters the standby state. The Ultra X will shut down after 1 minute of standby automatically. Page 15 / 44...
  • Page 16 6 Operation Operation Charge Power LED light up Battery power is >50%. in “GREEN” Power LED light up Battery power is 15%~50%. in “YELLOW” Battery power is <15%. Power LED light up in “RED”  If the power is less than 15%, the device must be recharged within 30 days, otherwise the battery will be damaged.
  • Page 17 6 Operation  Only the original adapter can be used. Charging indication appears on the power LED, flashes “YELLOW”(③), when the battery is fully charged or in a state near full charge, the flash will stop and light up in “GREEN” (③). Fully charged will take about 4 hours, depending on residual battery power and battery state.

  • Page 18: Operation

    6 Operation Operation Turn on the device: Press on main switch to turn on the device. Power LED will light up. Turn on the device: Press on main switch to turn power on. Power LED and Mode LED will light up. ...
  • Page 19 5s during the work.  Use the Ultra X outside the oral cavity to make sure that the device is functioning properly.  Replace the tip on time to avoid file separation within the canal.
  • Page 20  Do not forget to remove the tip from the device after its use.  Place the Ultra X on the Main unit base to prevent accidental drop when the device is not in use. Page 20 / 44...

  • Page 21: Cleaning,Disinfection And Sterilization

    7 Cleaning,Disinfection and Sterilization Cleaning,Disinfection and Sterilization Foreword For hygiene and sanitary safety purpose, the components (Tips, Wrench, and Insulating sleeve) must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well as the subsequent uses. Comply with your national guidelines, standards and requirements for cleaning, disinfection and sterilization.
  • Page 22 Before first use and after each use, sterilize the above components. Reprocessing Instructions Disconnect the components (Tips, Wrench, and Insulating sleeve) before cleaning. Refer to "Chapter 4- Setting up the Ultra X" of this manual for disassembly instructions. Remove Preparation at gross contaminations from the Point of Use: components with code water (<40°...
  • Page 23 7 Cleaning,Disinfection and Sterilization Store the instruments in a humid surrounding.  Do not submerge the components or wipe them with any of the following functional water (acidic electrolyzed water, strong alkaline solution, or ozone water), medical agents (glutaral, etc.), or any other special types water...
  • Page 24 7 Cleaning,Disinfection and Sterilization Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to be given to automated reprocessing methods, especially better standardizing potential and industrial safety. Automated Cleaning: Carefully put the components into the washer-disinfector on a tray and set the parameters as follows, then start the program:...
  • Page 25 7 Cleaning,Disinfection and Sterilization method has to be used, please valid-ate it prior to use.  only approved washer- disinfectors according to EN ISO 15883, maintain and calibrate it regularly.  Follow instructions and observe concentrations given manufacturer (see general recommendations).
  • Page 26 7 Cleaning,Disinfection and Sterilization Visual inspection for cleanliness of the instruments reassembling. Functional testing according instructions use. necessary, Functional perform reprocessing process again Testing, until instrument is visibly clean. Maintenance: Before packaging and autoclaving, make sure that the components have been maintained acc.
  • Page 27 7 Cleaning,Disinfection and Sterilization Drying time: at least 8mins. Flash sterilization is not allowed on lumen instruments!  only approved autoclave devices according to EN 13060 or EN 285.  Use a validated sterilization proce- dure according to EN ISO 17665. ...
  • Page 28 7 Cleaning,Disinfection and Sterilization packaging is open, damaged or wet.  Check the packaging before using it (packaging integrity, no humidity and validity period). above-mentioned reprocessing process (cleaning, disinfection, sterilization) has been successfully validated. Refer to test reports: Changzhou Sifary _Cleaning Reprocessing Disinfection...
  • Page 29 7 Cleaning,Disinfection and Sterilization Disinfection components Main unit Main unit Base Adapter Wipe all the surfaces with a cloth lightly moistened with Ethanol for Disinfection (Ethanol 70 to 80vol%) at least 2mins, repeat for 5 times.  Do not use anything except Ethanol for Disinfection (Ethanol 70 to 80 vol%).

  • Page 30: Error Indication

    8 Error Indication Error Indication device stops working and beeping The power is very low. Charge it with Power immediately. flashes in red. The main board is broken. Please Power LED lights up in stop using the device immediately “BLUE”. and remove the battery.

  • Page 31: Troubleshooting

    9 Troubleshooting Troubleshooting When trouble is found, check the following points before contacting your distributor. If none of these are applicable or the trouble is not remedied even after action has been taken, the product may have failed. Contact your distributor. Ref.
  • Page 32 9 Troubleshooting The LEDs Main The Main unit is Contact your unit do not broken. distributor. light up. Tip is not installed Check in place. installation. does Replace a new Tip is broken. not vibrate. tip. The main board is Contact your broken.

  • Page 33: Technical Data

    10 Technical Data Technical Data Changzhou Sifary Medical Manufacturer Technology Co., Ltd. Model Ultra X Dimensions 21.5cm×10cm×10cm 1cm (package) ± Gross weight 680g ± Lithium ion battery : 3.7V, 1500mAh Power supply ± Charger power AC100-240V, ± supply Charger power...
  • Page 34 10 Technical Data Ambient temperature: -20° C ~ +55° C Transport Relative humidity: 20%~80% storage conditions Atmospheric pressure: 70kPa~106 Page 34 / 44...

  • Page 35: Emc Tables

    – electromagnetic emissions The Ultra X is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultra X should assure that it is used in such an environment. Electromagnetic Emissions test Compliance environment...
  • Page 36 – declaration electromagnetic immunity The Ultra X is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultra X should assure that it is used in such an environment. Electromagnet Immunity IEC 60601...
  • Page 37 11 EMC Tables Surge Line to line: Line to line: Mains power IEC 61000- ±0.5kV, ±0.5kV, quality should ±1kV ±1kV be that of a typical commercial or hospital environment. Voltage 0% U ; 0.5 0% U ; 0.5 Mains power dips, cycle cycle...
  • Page 38 – electromagnetic immunity The Ultra X is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultra X should assure that it is used in such an environment. Proximity IEC 61000- Complianc...
  • Page 39 Guidance electromagnetic immunity The Ultra X is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultra X should assure that it is used in such an environment. Electromagnetic Immunity IEC 60601 Complia...
  • Page 40 The Ultra X has been tested with the immunity test level in the below table and meet the related requirements of IEC 606061-1-2:2014+A1:2020. The customer and/or user...
  • Page 41 Adapter Cable  Use of Ultra X adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, Ultra X and the other equipment should be observed to verify that they are operating normally.
  • Page 42 30 cm (12 inches) to any part of the Ultra X, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”...
  • Page 43 12 Statement Statement Service Life The service life of Main unit is 3 years. It is recommended that the equipment be checked and repaired at the dealer once a year. Disposal The package should be recycled. Metal parts of the device are disposed as scrap metal.
  • Page 44 Add: No.99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, 213000 Jiangsu, P.R. China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: Info@sifary.com Web: www.eighteeth.com Caretechion GmbH Tel: +49 211 2398 900 Add: Niederrheinstr. 71, 40474 Dü sseldorf, Germany Email：info@caretechion.de All rights reserved.