Eighteeth Fast-Fill User Manual
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0197
Fast-Fill
USER MANUAL

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Summary of Contents for Eighteeth Fast-Fill

  • Page 1 0197 Fast-Fill USER MANUAL...
  • Page 2: Table Of Contents

    Content 1. Scope of Fast-Fill ......................Parts Identification ................. Components and Accessories............Options (sold separately) ............... 2. Symbols used in the User Manual ................3. Before Use ........................Intended Use .................. Contraindications ................4. Installing the Fast-Fill ....................Installation of Gutta-percha ............
  • Page 3: Scope Of Fast-Fill

    1 Scope of Fast-Fill 1. Scope of Fast-Fill Parts Identification 1.Charge Base 2.Handpiece 3.Cartridge nut (2PCS) 4.Silver tube (2PCS) 5. Adapter 6.Bending Tool 4 / 37...
  • Page 4: Components And Accessories

    1 Scope of Fast-Fill Components and Accessories Fast-Fill Handpiece Charge Base (1pcs) Adapter (1pcs) (1pcs) Part Cartridge nut (2pcs) Bending tool (1pcs) Silver tube (1pcs) Silver tube (1pcs) Size: 25Ga Size: 23Ga Color: Black Color: Natural (Disposable) (Disposable) 5 / 37...
  • Page 5: Options (Sold Separately)

    1 Scope of Fast-Fill Options (sold separately) Handpiece Base 6 / 37...
  • Page 6: Symbols Used In The User Manual

    2 Symbols used in the User Manual 2. Symbols used in the User Manual If the instructions are not followed properly, operation may lead to hazards for the product or WARNING the user/patient. Additional information, explanation of operation NOTE and performance. Serial number Catalogue number Manufacturer...
  • Page 7 2 Symbols used in the User Manual Community 55 C Temperature limitation 20 C Humidity limitation 106kPa Atmospheric pressure limitation 70kPa Manufacturer’s LOGO Consult instructions for use Washer-disinfector for thermal disinfection Caution, hot surface Do not reuse 8 / 37...
  • Page 8: Before Use

    3 Before Use 3.Before Use Intended Use Fast-Fill is intended for heating and extruding Gutta-percha into cleaned and shaped canals during root canal treatment. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.
  • Page 9: Installing The Fast-Fill

    4 Installing the Fast-Fill 4.Installing the Fast-Fill Installation of Gutta-percha Push the Gutta-percha into the handpiece. Unscrew cartridge from handpiece to disassemble. NOTE This product included Gutta-percha. Please use the Gutta-percha WARNING that is recommended by Sifary. Refer to the To remove the cartridge.
  • Page 10: Installation Of Adapter

    4 Installing the Fast-Fill Installation of adapter NOTE Only the original adapter can be used. Plug the head into the base if they are Put the handpiece all the way into the separated in the package. charge base. The charge state will show on the screen.
  • Page 11: Use Interface

    5 Use Interface 5.Use Interface Turn Power On Long press Change Memory Shot press to change temperature memory from T1 to T3. Memory Parameter Setting During standby state, holding down press more than 2 seconds to enter memory parameter setting. Parameter T1 to T3 can be set independently.
  • Page 12: Setting

    6 Setting 6.Setting Memory Parameter Setting Fast-Fill has 3 memory programs (T1,T2,T3), press to change during standby state, the memory number will change accordingly. During any memory, holding down press in 2 seconds, the “Temperature” of this memory can be changed.
  • Page 13: Advanced Setting

    6 Setting Advanced Setting During power off state, holding down press then press to enter advanced setting, the “AutoPowerOff” will appear on the display A ut o P ow e r Of f screen. Press to adjust, the auto power M in off time can be set to 5, 10 and 15 minutes.
  • Page 14: Operation

    7 Operation 7.Operation Charge Display the present remaining amount of the battery. Less than 15% remains, please charge. NOTE If the power if less than 15%, the device must be recharged within 30 days, otherwise the battery will be damaged. Charge without charge base is also available, connect adapter to handpiece directly, the charge state will show on the screen.
  • Page 15: Heating And Using

    8 Maintenance Heating and Using Shot press to heat the cartridge during standby state. NOTE Push out insufficiently warmed Gutta-percha about 10mm before each use. The LED flashes in blue slowly during heating. When up to target temperature, the flash will stop and stay in blue.
  • Page 16: Changing Gutta-Percha

    8 Maintenance NOTE If there is a little residual Gutta-percha in handpiece or cartridge, tighten the cartridge again to prevent leak Gutta-percha after heating. If there is too much residual Gutta-percha in handpiece or cartridge, please refer to daily cleaning process. Please use good mobility Gutta-percha, otherwise the Gutta-percha will leak.
  • Page 17 8 Maintenance After pushing the Gutta-percha bar into handpiece with medical forceps, screw down the cartridge. NOTE If there is some Gutta-percha in the handpiece, it is inconvenient to install the Gutta-percha bar. Push the residue to the bottom of cavity with the pin on bending tool.
  • Page 18: Piston Cleaning

    8 Maintenance 8.Maintenance Piston cleaning Piston cleaning Heat to 150℃ to melt Gutta-percha, then remove the cartridge. NOTE 1 5 0℃ A small amount of Gutta-percha residue have no effect of function. Dispose of the silver tube and then clean the residue inside the cartridge nut with medical forceps.
  • Page 19: Changing Silver Tube Of Cartridge

    8 Maintenance Heat the handpiece to about 150℃. Then install the “Cleaning Nut” to the handpiece after cleaning is completed. Changing silver tube of cartridge The silver tubes of cartridge are single use only and should only be used on one patient. It can be replaced according to the following steps.
  • Page 20 8 Maintenance As shown, push out the silver tube completely with the cleaning rod. Insert the new silver tube as shown in the figure. NOTE Remove the protective cover before installation. There are two different specifications of the silver tube: Part number:6351208 size: silver tube (25Ga) Part number:6351209 size: silver tube (23Ga) Need to order from distributor.
  • Page 21: Cleaning, Disinfection And Sterilization

    8 Maintenance Push the protective cover into the silver tube. Cleaning, Disinfection and Sterilization 8.3.1 Foreword The parts for clinical application contamination are the outer surfaces of the cartridge and bending tool. For hygiene and sanitary safety purpose, the components (cartridge and bending tool) must be cleaned, disinfected and sterilized before each usage to prevent any contamination.
  • Page 22 8 Maintenance solution manufacturer. The water quality has to be convenient to the local regulations especially for the last  rinsing step or with a washer-disinfector. Thoroughly clean and wash the components before autoclaving.  Do not use bleach or chloride disinfectant materials. ...
  • Page 23 Remove and disconnect the Cartridge from handpiece. Refer to "Chapter 4-Installing the Fast-Fill" of this manual for disassembly instructions. Then, cut out the Silver Tube from Cartridge. Refer to “Chapter 8.2-Changing silver tube Preparatio of cartridge”.
  • Page 24 8 Maintenance use of the washer-disinfector for the program settings and cleanser that must be used. Rinse with demineralized water for 1 minute (Rinsing twice). (Validation was performed using Miele PG8581 with the program “Vario TD Dental”, the cleaner 0.5% neodisher® Mediclean Forte) Disinfectio Thermal disinfection at least 5 min at 93℃, make sure A0...
  • Page 25 8 Maintenance Respect the maintenance procedure of the autoclave  device given by the manufacturer. Use only this recommended sterilization procedure.  Control the efficiency (packaging integrity, no humidity,  color change sterilization indicators, physicochemical integrators, digital records of cycles parameters).
  • Page 26 8 Maintenance Fast-Fill Handpiece Charge Base Adapter Handpiece Base Wipe all the surfaces with a cloth lightly moistened with Ethanol for Disinfection (Ethanol 70 to 80 vol%) at least 2min, repeat for 5 times. NOTE Do not use anything except Ethanol for Disinfection (Ethanol 70 to 80 vol%).
  • Page 27: Troubleshooting

    9 Troubleshooting 9.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 28 9 Troubleshooting appear. distributor. No sound. Beep volume is set to 0. Set beep volume to 1, 2 or 3. gutta The cartridge is broken. Use a new cartridge. percha out. 29 / 37...
  • Page 29: Technical Data

    10 Technical Data 10.Technical Data Manufacturer Changzhou Sifary Medical Technology Co.,Ltd Model Fast-Fill Dimensions 25cm x 10cm x 11cm±1cm (Outer box) Diameter:2.5mm-2.8mm Gutta-percha size Length:14mm-16mm Applicable temperature: 100℃-200℃ Weight 1.1kg±10% Power supply Lithium ion battery: 3.7V, 2600mAh, ±10% Charger power supply AC 100-240 V, ±10%...
  • Page 30: Emc Tables

    Guidance and manufacturer’s declaration – electromagnetic emissions The Fast-Fill is intended for use in the electromagnetic environment specified below. The customer or the user of the Fast-Fill should assure that it is used in such an environment. Complian Emissions test...
  • Page 31 Guidance and manufacturer’s declaration – electromagnetic immunity The Fast-Fill is intended for use in the electromagnetic environment specified below. The customer or the user of the Fast-Fill should assure that it is used in such an environment. 32 / 37...
  • Page 32 When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected. The Fast-Fill has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2014.
  • Page 33 11 EMC Tables Maxi- Immunit Test Band Dis- frequency (MHz Service Modulation powe tance Test (MHz) level (V/m) Pulse 380- TETRA Modulation 18Hz FM± 5 kHz 430- GMRS 460 deviation FRS 460 1 kHz sine Pulse 704- LTE Band modulation 13, 17 217Hz GSM 800/900,...
  • Page 34 Remark Adapter Cable Use of Fast-Fill adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, Fast-Fill and the other equipment should be observed to verify that they are operating normally.
  • Page 35: Statement

    12 Statement 12.Statement Service Life The service life of Fast-Fill series products is 3 years. Maintenance MANUFACTURE will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to SERVICE PERSONNEL in parts repair. Disposal The package should be recycled. Metal parts of the device are disposed as scrap metal.
  • Page 36 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: ivy@sifary.com Web: www.eighteeth.com Caretechion GmbH Tel: +49 211 3003 6618 Add: Niederrheinstr. 71, 40474 Duesseldorf, Germany Email: info@caretechion.de 37 / 37...

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