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Refine 2000 Series Instruction Manual

Ultrasonic scaler
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(Seriel 2000/3000 )
RF-SN2-M002 Edition: V2.2 Modify: 20210810

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Summary of Contents for Refine 2000 Series

  • Page 1 (Seriel 2000/3000 ) RF-SN2-M002 Edition: V2.2 Modify: 20210810...

  • Page 3: Table Of Contents

    Contents 1 Product introduction ················································································ 4 2 Installation and adjustment ········································································ 8 3 Function and Operation ············································································1 4 4 Cleaning, disinfecting and sterilizing ···························································1 6 5 Transportation, storage and maintenance ···················································1 7 6 Trouble shooting ····················································································1 8 7 Environmental protection ··········································································2 0 8 European authorized representative ···························································2 0 9 EMC - Declaration of conformity ································································2 1 10 Manufacturer’s right ···············································································2 6...
  • Page 4 Safety Precautions WARNING: If you neglect these safety precautions, you may cause personal injury such as electric shock, fire or damage to the product. 1.Use a separate, grounded power outlet. Never use wet hands to unplug the power cord. 2.Please do not use other than the specified voltage.Before connecting the built-in ultrasonic scaler without transformer to power supply, please check the output voltage is 24VAC, in case of connecting to wrong power supply and that may break the unit.
  • Page 5 • The changed components are original of our company and operated correctly according to instruction manual. 12.This product is intended for use in hospitals and dental clinics only. The user must be professionally trained and qualified dentists. WARNING: No modification of this equipment is allowed. WARNING: If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.
  • Page 6 Symbol instruction Symbol Instruction Symbol Instruction Warning, Caution and Important! Consult the accompanying Check the Instruction Manual documents Date of manufacture Manufacturer According to the type of According to the degree of protection against electric shock: protection against electric CLASS II EQUIPMENT shock:Type B applied part Protected against dripping water Used indoor only...

  • Page 7: Product Introduction

    1 Product introduction 1.1 Product overview The built-in ultrasonic scaler is used along with dental unit for teeth cleaning and root canal treatment. They are also indispensable equipments for tooth disease prevention and treatment. The ultrasonic scaler is intended to be built in a dental unit which shall comply with IEC 60601- 1 and IEC 80601-2-60.
  • Page 8 4) Applied part of the equipment: Tip 5) Degree of protection against harmful ingress of water: Ordinary equipment 6) Degree of protection against harmful ingress of water: protection degree against water (used on foot switch ): IPX1 7) Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: Equipment can not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
  • Page 9 Table 1: Technical Parameters of each model ( Serial 2 ) Parameters N2000 N2000L V2000 V2000L Compatible Brand Satelec Satelec HP-3H (without HP-5L(with HS-7H(without HS-7L(with Handpiece LED lamp, LED lamp, LED lamp, LED lamp, Detachable) Detachable) Detachable) Detachable) G, P G, P G, P G, P...
  • Page 10 Table 2: Technical Parameters of each model ( Serial 3 ) Parameters N3000 N3000L V3000 V3000L Compatible Brand Satelec Satelec HP-3H (without HP-5L(with HS-7H(without HS-7L(with Handpiece LED lamp, LED lamp, LED lamp, LED lamp, Detachable) Detachable) Detachable) Detachable) G, P, E G, P, E G, P, E G, P, E...

  • Page 11: Installation And Adjustment

    2 Installation and adjustment 2.1 Working principle 2.1.1 Summarization: the built-in ultrasonic scaler is consist of ultrasonic generator (circuit), cable, handpiece (energy-transformed instrument), scaling tip, pneumatic switch (the power switch of pneumatic penstock and the circuit’s commutating and filtering, is controlled by pneumatic foot pedal of dental unit and switch for handpiece rack of ultrasonic scaler at the same time) and switch for handpiece rack (it controls the air supply which gets through pneumatic penstock and pneumatic power switch.
  • Page 12 2.2 Installation 2.2.1 Cutting sleeve use instruction a) Put the cutting sleeve through the water pipe, keep it 10mm to 20mm away from the entrance. 10-20mm Cutting sleeve Water pipe (End of the handpiece cable) Water exit connector b) Put the water pipe in the middle of the water exit connector(about 3mm), then push the cutting sleeve forward to the front edge of the water exit connector.
  • Page 13 2.2.2 The main components of this equipment and installation are showed as picture 1: Notice: a) Please connect power and pneumatic switch (or foot switch) showed as picture 1. b) The No.7 lead and No.8 lead should be connected with 24VAC, and this circuit isn’t allowed to act as switch circuit.
  • Page 14 ⑥ The frequency of ultrasonic scaler is extremely high. Under normal water supply, a light touch and a certain to-and-fro motion will eliminate the tartar without obvious heat. Overexertion and longtime lingering are forbidden. picture 1 2.3 Instruction for main components of handpiece (showed in picture 2).
  • Page 15 Picture 2-A The detachable handpiece without LED lamp Picture 2-B The detachable handpiece with LED lamp a) Cap: The Cap can be removed. You can screw out the Cap and clean the pole with alcohol termly.
  • Page 16 b) Decorative ring: can be disassembled and cleaned with alcohol regularly, can be autoclaved under the high temperature and pressure. c) Handpiece: The main part of the whole handpiece, can be autoclaved under the high temperature and pressure. d) Symbol: Autoclaved (134°C,0.22MPa) e) The connector of the cable: Connect the handpiece with the water source and power of the main unit.

  • Page 17: Function And Operation

    the scaling tip installation properly and correctly. It also can guarantee the operator screw or unscrew the scaling tip effectively and keep their hands away from being scratched. b) Operation •Take the tip into the torque wrench then install or uninstall the scaling tip as picture 3 showed. •Installation: Hold the handpiece and turn the tip toward clockwise direction with the torque wrench.
  • Page 18 the water control switch to fine spray to cool down the handpiece and clean the teeth. 3.1.7 After finishing operation, keep the machine working for 30 seconds with the water supply to clean the handpiece and the tip. 3.1.8 Unscrew the scaling tip and sterilize it. Be sure not to make the end of the tip touch the teeth vertically, and not use too much force when the tip touch the surface of the teeth, in case of hurting the teeth and damaging the tip.

  • Page 19: Cleaning, Disinfecting And Sterilizing

    c) Don’t press it too hard when the ultrasonic file is in root canal. d) Don’t step on the foot switch until the ultrasonic file is in the root canal. 4 Cleaning, disinfecting and sterilizing 4.1 Please conform to the recommendations of the manual "Reprocessing Instructions of Cleaning, Disinfecting And Sterilizing"...

  • Page 20: Transportation, Storage And Maintenance

    Notice: We are not responsible for any damage caused in the above items. 5 Transportation, storage and maintenance 5.1 Transportation 5.1.1 Excessive impact and shake should be prevented in the transportation. Lay it carefully and lightly and don’t invert it. 5.1.2 Don’t put it together with dangerous goods during transportation.

  • Page 21: Trouble Shooting

    6 Trouble shooting Fault Possible causes Solutions The plug is in loose Connect as picture 1 showed. or wrong contact. Handpiece and the connector of Pull out handpiece and cable connect irrelevantly. insert it again. The scaling tip doesn’t Screw it on tightly with Scaling tip is loose.
  • Page 22 Fault Possible causes Solutions The water pipe of dental unit is Clean the water pipe. jammed. The water pipe of cable Clean the water pipe of the cable is jammed. with multi-function syringe. The amount of spouting water Clean the water pipe of the The water pipe of handpiec is too little.

  • Page 23: Environmental Protection

    Fault Possible causes Solutions Poor contact Contact tightly LED light don't work Something wrong Change a new one (The models that the with LED light handpiece without LED Please install the "+" of LED lamp installed lamp) the LED lamp to the "+" of the backwards handpiece There is noise coming...

  • Page 24: Emc - Declaration Of Conformity

    9 EMC - Declaration of conformity The device has been tested and homologated in accordance with EN 60601-1- 2 for EMC. This does not guarantee in any way that this device will not be effected by electromagnetic interference Avoid using the device in high electromagnetic environment.
  • Page 25 Guidance & Declaration — electromagnetic immunity The models Ultrasonic Scaler are intended for use in the electromagnetic environment specified below. The customer or the user of the models Ultrasonic Scaler should assure that It is used in such an environment. IEC 60601 test Electromagnetic environment Immunity test...
  • Page 26 <5 % UT <5 % UT Mains power quality should be (>95% dip in UT.) (>95% dip in UT.) for that of a typical commercial for 0.5 cycle 0.5 cycle or hospital environment. Voltage dips, short 40 % UT 40 % UT If the user of the models interruptions and (60% dip in UT) for...
  • Page 27 IEC 60601 Compliance Immunity test Electromagnetic environment - guidance test level level P o r t a b l e a n d m o b i l e R F c o m m u n i c a t i o n s equipment should be used no closer to any part of the models Ultrasonic Scaler, including cables, than the recommended separation distance calculated...
  • Page 28 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.

  • Page 29: Manufacturer's Right

    For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) accordable to the transmitter manufacturer.

  • Page 30: Attachment 1. Table Of Operating Power Of The Tips (Compatible With Ems)

    Attachment 1. Table of operating power of the tips (Compatible with EMS) Scaling Cavity Preparation Periodontics Endodontics Tip Model Power Tip Model Power Tip Model Power Tip Model Power LOW-HIGH LOW-HIGH LOW-MID LOW-HIGH LOW-HIGH LOW-HIGH LOW-HIGH P2LD LOW-HIGH LOW-HIGH LOW-HIGH LOW-HIGH P2RD LOW-HIGH...

  • Page 31: Attachment 2. Table Of Operating Power Of The Tips (Compatible With Satelec)

    Attachment 2. Table of operating power of the tips (Compatible with SATELEC) Scaling Cavity Preparation Periodontics Endodontics Tip Model Power Tip Model Power Tip Model Power Tip Model Power LOW-HIGH SBD1 LOW-HIGH LOW-MID LOW-HIGH SBD2 LOW-HIGH PD2L LOW-HIGH SBD3 LOW-HIGH PD2LD LOW-HIGH SBDL...

  • Page 32: Attachment 3. Reprocessing Instructions Of Cleaning, Disinfecting And Sterilizing

    Attachment 3. Reprocessing Instructions of Cleaning, Disinfecting And Sterilizing 1. BEGINNING WORK! 1.1 Please read these operating instructions carefully as they explain all the most important details and procedures. Please pay special attention to the safety precautions. Always keep this instruction close at hand.
  • Page 33 2.6 We encourage you to report adverse events related to device reprocessing. Report such events directly to manufacturer. 3. REPROCESSING - INSTRUCTIONS FOR REUSABLE PRODUCTS The instructions are binding for the reprocessing of all reusable products (Here after called "products") of manufacturer.
  • Page 34 Steps: 1.Rinse away any surface soiling on the product with distilled deionized water or with a cleaning agent. 2.Rinse through all lumina (e.g. irrigation and aspiration connection) at least 3 times in the normal direction of flow (no back rinsing) using a disposable syringe (min. volume 50 ml) filled with distilled/deionized water applied to the back nozzle.
  • Page 35 attachment to product lumina. •The cleaning program is suitable for products to be processed and the rinsing cycle is sufficient. •Only low microbe count (<10 cfu/ml) distilled or deionized water is used for all rinsing steps. (E.g. Aqua purificata, as per the specifications of Pharm. Eur. or USP). •Air used for drying is HEPA filtered.
  • Page 36 3) After cleaning in the WD, examine the instruments visually. 4) Carefully place the products in the disinfection basket. Fastening of the products is only permissible if they are freely moveable in the fixture. The products are not permitted to make contact with one another. 5) Using a suitable rinsing adaptor, connect the product lumina to the rinsing connections of the disinfector.
  • Page 37 •Maintained on a regular basis. If double, single-use sterilization packaging (double bag) is to be used, this must also comply with EN ISO 11607 and be suitable for steam sterilization (temperature resistant to 138°C with adequate steam permeability). Use only the following listed steam sterilization procedures for sterilization; other sterilization procedures are not permissible: •Fractional pre-vacuum procedure (steam sterilization with repetitive pre-vacuum.) •Steam sterilizer in accordance with EN 13060 or EN 285 validated in compliance with EN IS0 17665,...
  • Page 38 9. SERVICE LIFE The products have been designed for a large number of sterilization cycles. The materials used in their manufacture were selected accordingly. However with every renewed preparation for use, thermal and chemical stresses will result in aging of the products. If the number of permissible re-sterilization cycles is restricted, this will be pointed out in the product specific instructions.
  • Page 39 After service and Warranty Instruction 1 Period validity: Two year’s free repair for the main unit, one year's free repair for the handpiece from the date of purchase. Lifetime maintenance. 2 Range of warranty: Within the warranty period of validity, we are responsible for any troubles caused by quality problems or products technique and structure.
  • Page 40 After service and Warranty Instruction Name of Customer Address Post Code E-mail Purchase Date Distributor Model Product No. Handpiece No. Production Date...

This manual is also suitable for:

3000 series

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