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Fast-Pack pro
USER MANUAL

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Summary of Contents for Eighteeth Fast-Pack pro

  • Page 1 Fast-Pack pro USER MANUAL...
  • Page 2 P/N: IFU-6335007 Version: 01 Issued: Nov 04, 2020 Size: 85mm×119mm...
  • Page 3: Table Of Contents

    Content 1. Scope of Fast-Pack pro ..................4 Parts Identification ............4 Components and Accessories ........5 Options (sold separately) ..........5 2. Symbols used in the User Manual ..............6 3. Before Use ......................... 8 Intended Use ..............8 Contraindications ..............
  • Page 4: Scope Of Fast-Pack Pro

    1 Scope of Fast-Pack pro 1. Scope of Fast-Pack pro Parts Identification 1.Charge Base 2.Handpiece 3.Heating Needle(3PCS) 4.Adapter 4 / 31...
  • Page 5: Components And Accessories

    1 Scope of Fast-Pack pro Components and Accessories Fast-Pack Charge Base Adapter (1pcs) Handpiece (1pcs) (1pcs) Heating Needle S Heating Needle M Heating Needle (1pcs) (1pcs) (1pcs) Size: 40/0.025 Size: 50/0.05 Size: 60/0.06 Color: Black Color: Yellow Color: Blue Options (sold separately)
  • 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 the WARNING user/patient. Additional information, explanation of operation and NOTE performance.
  • 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 7 / 31...
  • Page 8: Before Use

    3 Before Use 3. Before Use Intended Use Fast-Pack pro is intended for warming and softening gutta-percha master cones and searing off gutta-percha cones. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
  • Page 9 3 Before Use otherwise, void the warranty. Do not use the device in the presence of free oxygen, flammable anesthetic gas mixtures or flammable substances. If there is any liquid leaked, it indicates that the battery is leaked. Remove all of the leaked liquid and contact the local agency.
  • Page 10: Installing The Fast-Pack Pro

    4 Installing the Fast-Pack pro 4. Installing the Fast-Pack pro WARNING Installation After the operation is completed, wait heating needle for the heating needle to cool down and Make sure the hexagon plum remove it to prevent the heating needle blossom groove on heating needle from being damaged accidentally.
  • Page 11: Connecting Charge Base

    4 Installing the Fast-Pack pro Connecting charge base Plug the USB of adapter into the charge base, and plug the other end into a power outlet. NOTE Put the handpiece into the charge base in the right direction, otherwise the The Power LED on charge base will handpiece will not be charged.
  • Page 12: Use Interface

    5 Use Interface 5.Use Interface Turn Power On Long press Change Memory Shot press to change temperature memory from T1 to T5 Memory Parameter Setting During standby state, holding down press then press for 2 seconds to enter memory parameter setting.
  • Page 13: Setting

    6 Setting 6.Setting Memory Parameter Setting Fast-Pack pro has 5 memory programs, press to change during standby state, the memory 90℃ number T1 will change accordingly. During any memory, holding down press then press for 2 seconds, the “Temperature” of this memory can be changed.
  • Page 14: 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 off M in time can be set to 5, 10 and 15 minutes.
  • Page 15: Operation

    7 Operation 7.Operation Charge Display the present remaining amount of the battery. When the battery icon appears and flashes on the screen, it means the remaining battery power is less than 15%. Please charge the device in time. NOTE If the power is less than 15%, the device must be recharged within 30 days, otherwise the battery will be damaged.
  • Page 16: Heating

    7 Operation Heating Press to heat the heating needle. The indicator LED lights up during heating. WARNING Do not place the heated heating needle in the root canal for more than 4 seconds to prevent thermal injury to the patient. Only the end of the heating needle (about 4-5mm) can be heated.
  • Page 17: Maintenance

    8 Maintenance 8.Maintenance Foreword The part for clinical application contamination is the outer surface of the heating needle. For hygiene and sanitary safety purpose, the component must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well as the subsequent uses.
  • Page 18: Autoclavable Components

    8 Maintenance Autoclavable Components Autoclavable Components Heating needle WARNING Only the components above can be autoclaved.  Before first use and after each use, sterilize the above components.  Reprocessing Instructions Before cleaning, disconnect the heating needles from the handpiece. Refer to Chapter 4.1 of this manual for disassembly instructions.
  • Page 19 8 Maintenance seconds. Clean the surfaces with a soft bristol brush. 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 due to the better standardizing potential and industrial safety.
  • Page 20 8 Maintenance immediately. A manual disinfection is not recommended. Please use fully demineralized water. Automated Drying: Drying: Drying instruments according drying cycle washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air. Functional Visual inspection for cleanliness of the instruments and reassembling.
  • Page 21 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). The sterilization procedure must comply with EN ISO 17665.
  • Page 22: Disinfection Components

    8 Maintenance Disinfection components Disinfection components Fast-Pack Charge Base Adapter Handpiece 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 23: 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 24: Technical Data

    10 Technical Data 10.Technical Data Manufacturer Changzhou Sifary Medical Technology Co.,Ltd Model Fast-Pack pro Dimensions 20cm x 10cm x 11cm±1cm (Outer box) Weight 1kg±10% Power supply Lithium ion battery: 3.7V, 2600mAh, ±10% Charger power supply AC 100-240 V, ±10% Charger power output Frequency 50/60Hz, ±10%...
  • Page 25: Emc Tables

    Guidance and manufacturer’s declaration – electromagnetic emissions The Fast-Pack pro is intended for use in the electromagnetic environment specified below. The customer or the user of the Fast-Pack pro should assure that it is used in such an environment. Complian...
  • Page 26 11 EMC Tables Electrical fast ±2kV ±2kV Mains power quality should transients/burst 100kHz 100kHz be that of a typical repetition repetition commercial or hospital IEC 61000-4-4 frequency frequency environment. Surge Line line: Line line: Mains power quality should IEC 61000-4-5 ±0.5kV, ±1kV ±0.5kV, ±1kV be that of a typical...
  • Page 27 RF 6 V in ISM bands be- be usedno closer to any part of the fields tween 0.15 MHz and Fast-Pack pro, including cables, than IEC 61000-4-6 80 MHz, 80 % AM at the recommended separation 1 kHz...
  • Page 28 11 EMC Tables requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance between RF wireless communications equipments and the Fast-Pack as recommended below. Maxi- Immunit Test Band Dis- frequency (MHz Service Modulation powe tance Test (MHz) level (V/m)
  • Page 29 Remark Adapter Cable Use of Fast-Pack pro adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, Fast-Pack pro and the other equipment should be observed to verify that they are operating normally.
  • Page 30: 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 31 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 31 / 31...

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