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Eighteeth E-FLOW User Manual

Dental anesthetic delivery system
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E-FLOW
Dental Anesthetic Delivery System
USER MANUAL
Changzhou Sifary Medical Technology Co.,Ltd.

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Summary of Contents for Eighteeth E-FLOW

  • Page 1 E-FLOW Dental Anesthetic Delivery System USER MANUAL Changzhou Sifary Medical Technology Co.,Ltd.
  • Page 2 Part NO: IFU-7235003 Version: 02 Issued: 2024.03.06 Size: 197mm×140mm...

  • Page 3: Table Of Contents

    Content 1 Scope of E-FLOW ....................5 1.1 Parts Identification ..................... 5 1.2 Components ...................... 6 2 Symbol Instruction ....................8 3 Foreword ........................ 10 3.1 Scope of application ..................10 3.2 Contraindications .................... 10 3.3 Intended user ....................10 4 Basic operation .......................
  • Page 4 5.3.2 Injection mode switching ................22 5.3.4 Foot pedal calibration ................23 5.3.5 Auto injection ................... 23 5.3.6 Dosage setting injection ................24 5.3.7 Pressure feedback ................... 24 5.3.8 Smart reminder ..................25 5.3.9 Trainning mode ..................26 5.3.10 Aspiration ....................26 5.3.11 Change anesthetic .................

  • Page 5: Scope Of E-Flow

    1 Scope of E-FLOW 1.1 Parts Identification 1. Main unit 2. Foot pedal 3. Adapter 4. Handpiece holder 5. Sleeve-M 6. Sleeve-UN 7. O-ring...

  • Page 6: Components

    1.2 Components Main unit (1pc) Foot pedal (1pc) Handpiece holder (1pc) Sleeve -M (1pc) Sleeve -UN (1pc) O-ring(5pcs) For different regions, there are several different adapter options to be selected as follows. Standard Adapter Power plug Adapter (1pc) European standard power plug European (1pc) standard...
  • Page 7 British standard power plug (1pc) Adapter (1pc) Australian standard power plug Multi- (1pc) standard Argentina standard power plug (1pc)

  • Page 8: Symbol Instruction

    2 Symbol Instruction General warning sign Caution Serial number Catalogue number Batch code Medical device Authorized representative in the European Community Manufacturer Country of manufacture Washer-disinfector for thermal disinfection Class II equipment Type B applied part Keep dry Dispose of in accordance with the WEEE directive Direct current Consult instructions for use...
  • Page 9 Manufacturer’s LOGO Sterilizable in a steam sterilizer (autoclave) at the temperature specified 5 5℃ Temperature limit -2 0℃ Humidity limit Atmospheric pressure limit...

  • Page 10: Foreword

    3 Foreword 3.1 Scope of application E-FLOW is intended for use only in subcutaneous or intramuscular injections of local anesthetic agents for dental applications. It should not be used for intravascular (IV) or other routes of administration. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel and not used in the oxygen- rich environment.
  • Page 11 be operated and stored in a safe environment.  The device requires special precautions with regard to electromagnetic compatibility (EMC) and must be installed and operated in strict compliance with the EMC information. In particular, do not use the device in the vicinity of fluorescent lamps, radio transmitters, remote controls and do not use this system near the active HF Surgical Equipment in the hospital.
  • Page 12  It must be charged before first use.  Batteries should be replaced only by trained service personnel, otherwise, the device may be damaged.  If the package or equipment is damaged, contact the supplier or manufacturer.  Use only original component...

  • Page 13: Basic Operation

    4 Basic operation 4.1 Charge  Only original 4.1.1 Installation of adapter adapter could be used. Plug the head into the base if they are  Do not position the separated in the package. device where it is difficult to disconnect the device quickly.

  • Page 14: Preparation For Injection

    4.2.2 Startup Press the power icon on the front of main unit to enable the E-FLOW system. At this time, the LOGO will appear on the screen accompanied by startup music.

  • Page 15: Installation Of Anesthetic, Sleeve And Needle

    Please use sterile single 4.2.3 Installation of anesthetic, Sleeve and injection needle needle that fits the Sleeve. Turn the needle with needle cover onto the Sleeve clockwise. Insert the handpiece into the Handpiece holder when not in use. Do not Insert the piston end of the oral local insert handpiece...

  • Page 16: Remove The Needle Cap

    4.2.5 Remove the needle cap Before injection, the needle cover should be removed as follows: Hold the Sleeve, insert the handpiece with the needle cover into the needle cover hole with appropriate force, and pull out the handpiece so that the needle cover remains in the needle cover hole .
  • Page 17 Then place the handpiece in the storage brackets and remove the Handpiece holder; Finally, press the power icon on the front of the main unit to shut down the E-FLOW system.

  • Page 18: Function And Use

    5 Function and use 5.1 User interface...

  • Page 19: Icon

    5.2 Icon Area Name Icon Paraphrase Low and medium speed Normal mode injection mode Medium and fast speed Fast mode injection mode Only low speed injection PDL mode mode Dosage Dosage setting injection mode mode Change Control pushrod back to the anesthetic bottom, change anesthetic Aspiration on/off...
  • Page 20 Dosage Set injection dosage setting remaining Anesthetic Indicate capacity dose Anesthetic Setting System parameter setting Unconnected Foot pedal Connected but not be state pressed Connected and be pressed Display the power state, when Battery the red is displayed, it means capacity that the power is very low and needs to be charged...
  • Page 21 Trainning Trainning mode on/off mode O-ring maintenance follow Check o-ring the system prompts Foot pedal Calibrate the stroke of the calibration foot pedal Start Start calibration calibration Finish Finish calibration calibration Cancel Cancel calibration calibration Confirm the information Confirm and go to the next step Power Press it to turn the power on/power off...

  • Page 22: Product Function

    The injection mode can be switched during injection. 5.3.3 Foot pedal control E-FLOW controls the start stop and injection speed by the foot pedal, press the foot pedal to start the In PDL mode, the injection, and release the foot pedal to stop the "front section"...

  • Page 23: Foot Pedal Calibration

    5.3.4 Foot pedal calibration Recalibrate the foot 1) Click the "Foot pedal correction" icon pedal after enter the "Foot pedal correction" interface; replacement 2) Click the icon , press the foot pedal and hold it for more than 1 second. If you want to shorten the pedal stroke, please press the pedal shorter, or press deeper;...

  • Page 24: Dosage Setting Injection

    auto injection; Note: 3) If you do not want to use the "auto injection" function, do not take your foot off the foot pedal within 3 seconds after the "auto injection" voice; 4) If you need to exit the "auto injection" function, press down the foot until the pedal status shows and release it.

  • Page 25: Smart Reminder

    2) In "PDL mode", when the displayed "pressure value" is bigger than the value set in the system, the prompt tone "beep" becomes higher, and the green cell of the "pressure bar chart" is light up. 3) When the system pressure is too high, the system will sound a sharp prompt tone, and the last orange cell of "pressure bar chart"...

  • Page 26: Trainning Mode

    system will sound "over pressure". 5.3.9 Trainning mode Click the icon with your finger to turn this function on and off. "Training mode" includes all the prompt tone of "smart mode," as well as some additional prompt tone. 5.3.10 Aspiration Click the icon with your finger to turn this function on and off.

  • Page 27: Charging

    until the foot pedal state shows and release, the pushrod will automatically return to the bottom, and then the anesthetic can be removed according to the steps in Chapter 5.3; When the "auto injection" function is not enabled and the anesthetic is exhausted, the pushrod will stop extending automatically, release the foot pedal, and the pushrod will automatically retract to the bottom.
  • Page 28 charge, the flash will stop. Fully charged will take use a wrong battery about 4 hours, depending on residual battery or install in a wrong power and battery state. way. It can be recharged 300-500 times, depending on the operating conditions of the device.

  • Page 29: Cleaning Disinfection Sterilization And Maintenance

    Cleaning disinfection sterilization and maintenance 6.1 Foreword For hygiene and sanitary safety purpose, the components (Sleeve, Handpiece holder) 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 30: Cleaning Disinfection Sterilization

    ● Do not use bleach or chloride disinfectant materials. 6.3 Cleaning disinfection sterilization Autoclavable Components Sleeve Handpiece holder  Only the components above can be autoclaved.  Before first use and after each use, clean disinfect and sterilize the above components.
  • Page 31 Cleaning Submerge the components in a cleaning solution and flush the lumens with a water jet pistol with cold tap water for at least 10 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.
  • Page 32 Drying: Automated Drying: Dry the outside of the components through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of the components by using sterile compressed air. Function Visual inspect the cleanliness of the components and reassemble them.
  • Page 33 digital records of cycles parameters).  The sterilization procedure must comply with EN ISO 17665.  Waiting for cooling before touching. Storage: Store the sterilized components in a dry, clean and dust free environment at modest temperatures, refer to labels and instructions for use.
  • Page 34 Disinfection components Main unit Adapter Foot pedal Preparation before Before cleaning and disinfecting, make sure the power is processing: off. Cleaning: Wipe all the exterior surfaces of the components thoroughly with a cloth lightly moistened with Ethanol (70- 80 vol% Ethanol) at least 3 min, repeat for 5 times. Click the icon , extend the pushrod, clean the surface of the pushrod.

  • Page 35: Maintenance

    instruction. Storage: Storage of the processed device in a dry, clean and dust free environment at modest temperatures, refer to label and instructions for use.  Before first use and after each use, clean and disinfect the above components.  Do not use anything except Ethanol (70- 80 vol% Ethanol).
  • Page 36 Cartridge of anesthetic damage The cartridge may be damaged during insertion or during injection. If the cartridge is damaged, thoroughly remove all glass debris and liquids around the pushrod. The remaining glass debris will cause a failure. You can clear it following the steps, 1) Take out the cartridge and large pieces of broken glass.

  • Page 37: 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. Problem Cause Solution...

  • Page 38: Technical Data

    8 Technical Data Manufacturer Changzhou Sifary Medical Technology Co., Ltd. Model E-FLOW Dimensions 26.5cm x 19.5cm x 14.5cm±1cm（package） Gross weight 1.8Kg±10% Power supply Lithium ion battery:DC11.1V，2600mAh，±10% Charger power AC100-240 V，±10% supply Input power 500mA Charger power 0.9A output Frequency 50/60Hz,±1Hz Low speed：0.3mL/min, ±10%...

  • Page 39: Emc Tables

    9 EMC Tables Guidance and manufacturer’s declaration – electromagnetic emissions E-FLOW is intended for use in the electromagnetic environment specified below. The E-FLOW customer or the user of the should assure that it is used in such an environment. Emissions test...
  • Page 40 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The E-FLOW is intended for use in the electromagnetic environment specified below. The customer or user of the E-FLOW should ensure that it is used in such an environment. Immunity IEC 60601 Electromagnetic environment -...
  • Page 41 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The E-FLOW is intended for use in the electromagnetic environment specified below. The customer or user of the E-FLOW should ensure that it is used in such an environment. Electromagnetic Environment – Immunity...
  • Page 42 Nowadays, many RF wireless equipments have being used in various healthcare locations where medical equipment and/or systems are used. When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety E-FLOW and essential performance may be affected. The has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1- 2:2020.
  • Page 43 Use of accessories and cables other than those specified or provided by the manufacturer E-FLOW could result in increased electromagnetic emissions or decreased E-FLOW electromagnetic immunity of and result in improper operation. Cable information: Cable Name Cable Length (m) Shielded or not...

  • Page 44: Statement

    The service life of E-FLOW series products is 5 years. Warranty Period E-FLOW has a 12-month warranty period starting from the date of delivery to the customer. If the damage is proved to be caused by the user's use error, warranty is voided.
  • Page 45 Changzhou Sifary Medical Technology Co., Ltd. Add: No.99 Qingyang Road, Xuejia County, Xinbei District, 213000 Changzhou, Jiangsu China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: Info @sifary.com Web: www.sifary.com NOTICE Any serious incident should be reported to manufacturer and competent authority.

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