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Belmont CLESTA eIII Instructions For Use Manual

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CLESTA  eIII SWING
INSTRUCTIONS FOR USE

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Summary of Contents for Belmont CLESTA eIII

  • Page 1 CLESTA  eIII SWING INSTRUCTIONS FOR USE...

  • Page 2: Dear Customers

    Dear Customers Dear Customers Thank you for purchasing our product. This booklet explains how to use CLESTA eIII SWING. Before using CLESTA eIII SWING, carefully read the operating instructions and make sure to use the product correctly. Using the product without reading these instructions may lead to an accident.

  • Page 3: Table Of Contents

    Table of Contents Dear Customers ....................1 General Information Intended Purpose of the Product ............4 Compliance with Regulations and Directives ........4 Declaration of Conformity ..............4 Compatible Medical devices ..............5 How to Dispose of the Device ............... 5 Disposal of Residues ................

  • Page 4: Doctor Unit

    Table of Contents Chair lock function .................46 Adjustment Doctor Unit ..................4 Cuspidor Unit ..................4 Maintenance and Cleaning Doctor Unit.....................4 Cuspidor Unit..................4 Washing and sterilizing the HVE and saliva ejector ......................5 Washing and sterilizing the 3WAY syringe ..........53 Junction Unit ..................58 Exterior ....................58 Maintenance and inspection ..............59 Detachable parts .................62...

  • Page 5: General Information

    8 of Annex I. Product Type: DENTAL UNIT (CLASS II a) Product Name: CLESTA eIII SWING " CLESTA eIII SWING " has been defined by the rule 9 of MDR Annex VIII. The product has been designed and manufactured in accordance with the European standards as listed in the Declaration of Conformity.

  • Page 6: Compatible Medical Devices

    However, there still could be a case that the connectors of turbines or air motors may not fit into some handpieces due to the manufacturing tolerances. Have your local authorized Belmont dealer to check the connectability before purchasing the handpiece. Except for our recommended handpieces, we shall not be liable for any problems deriving from bad connectability or their performance.

  • Page 7: Symbols

    1 General Information Symbols The symbols listed below are used on this product, on label- ing, and in this booklet. Check the meaning of each symbol. Switch Switch (OFF) (ON) Switch for Protective earthing manual operation Switch for returning Automatic return to the last position switch Preset switch 1...
  • Page 8 1 General Information General warining sign Caution The base color yellow. The base color yellow. An autoclave symbol that Type B Applied Parts indicates parts can be contacting the sterilized in an autoclave patient’s body at temperatures up to surface only 135°C Serial number Catalog number...

  • Page 9: Safety Consideration

    2 Safety Consideration   Risk Level Interpretation Precautions before use Make sure to carefully read the Safety Precautions and Operating Precautions and use the product correctly. These precautions are intended to ensure the safe use of the product and prevent harm or damage to users or other people. According to the magnitude of harm and damage and the degree of urgency, an incident that may be caused by misuse of the product is classified into one of the following categories: CON-...

  • Page 10: Safety Precautions

    HF surgical equipment may cause incorrect operation of this product. Never disassemble, repair or modify the product. Individuals other than your local authorized Belmont dealer should not disassemble or repair this product. This could lead to an accident, failure, electric shock, or fire.
  • Page 11 If any abnormality occurs, immediately turn off the main switch and discontinue use of the product. CLESTA eIII SWING may affect the function of the pacemaker or defibrillator, leading to an accident. Action taken for power failure If the chair stopped at elevated position, chair will not go down. Help a patient to get off from the chair while paying attention to avoid patient’s injury.
  • Page 12 In the event of a water leak, close the main water valve, turn off the main switch and breaker for devices used in the clinic, and contact your local authorized Belmont dealer. A load exceeding the weight limit (2kg) must not be applied to the doctor table This may cause damage or injury.
  • Page 13 If you feel something is wrong, immediately discontinue use of the product and turn off the main switch. Then, contact your local authorized Belmont dealer. Read the accompanying documents for each device.
  • Page 14 2 Safety Consideration CAUTION Do not hit or rub the product This may cause damage to the cover or operational failure. Be sure to operate switches manually Make sure to operate the switches manually, except for the foot controller operated by the foot and stick switches.
  • Page 15 2 Safety Consideration CAUTION Precautions concerning the table position Handle In cases like cleaning, do not operate the chair while the table position (handle direction) is as shown in the figure because it may cause property damage. Precautions concerning the foot controller position When using the foot controller, it may come in contact with the doctor arm, causing property damage.
  • Page 16 Precautions when using a handpiece In the event of heat or smoky smell, stop using the handpiece, turn off the main switch, and contact your local authorized Belmont dealer. This may cause burns or have an adverse effect on the dental pulp.
  • Page 17 2 Safety Consideration CAUTION Precautions when using a water bottle The water bottle is intended only for use with purified water, distilled water and pure water. Do not use mouthwash or electrolyzed water, such as ConCool or povidone iodine, as they may cause clogged tubing or affect internal valves and equipment.
  • Page 18 Troubleshooting and contact information In the case of any problems, discontinue use, turn off the main switch and contact your local authorized Belmont dealer. Check the operation of the compressor. This product will not work unless air is supplied. Switch on the com-pressor before operating...

  • Page 19: Points To Remember When Operating The Product

    2 Safety Consideration Points to remember when operating the product Meaning of a symbol Point to remember (locations requiring attention including moving parts, rotating parts, and detachable parts) Point to remember where an emergency stop mechanism is available Meanings of each point to remember ①Pay attention to prevent contact with the assis- tant holder.

  • Page 20: Emc Information

    4. Electromagnetic emission declaration Guidance and manufacturer’s declaration—electromagnetic emissions CLESTA eIII SWING is intended for use in the electromagnetic environment specified below. The customer or user of CLESTA eIII SWING should ensure that it is used in such an environment. Compliance...
  • Page 21 5. Electromagnetic immunity declaration 1 Guidance and manufacturer’s declaration—electromagnetic immunity CLESTA eIII SWING is intended for use in the electromagnetic environment specified below.The customer or user of CLESTA eIII SWING should ensure that it is used in such an environment. IEC 60601...

  • Page 22: Essential Performance

    6. Electromagnetic immunity declaration 2 Guidance and manufacturer’s declaration—electromagnetic immunity CLESTA eIII SWING is intended for use in the electromagnetic environment specified below.The customer or user of CLESTA eIII SWING should ensure that it is used in such an environment. IEC 60601...
  • Page 23 2 Safety Consideration Near electromagnetic field caused by RF wireless communication devices Test frequency IEC 60601 Modulation IEC 60601 compliance level test level (MHz) Pulse modulation a) 27V/m 27V/m 18Hz Frequency modulation 28V/m 28V/m ±5kHz shift 1kHz sine wave Pulse modulation 9V/m 9V/m 217Hz...

  • Page 24: Compatible Handpieces

    2 Safety Consideration Compatible Handpieces The following handpieces are compatible with this product: SYR-20 Syringe BT14 DCI 3Way NSK Ti-Max Z Series NSK Ti-Max X Series Air Turbine NSK S-Max M Series NSK Pana Max Plus Series NSK Pana Max 2 Series NSK EX-203 Series NSK FX205 Series Air motor...

  • Page 25: Safety Precautions Regarding Water Quality

    2 Safety Consideration Safety precautions regarding water quality CAUTION Conduct flushing before treatment. If this product is not used for a long time, water retained in ducts and in the water heater will be susceptible to bacterial growth. To provide safe treatment and operate the handpiece without any trouble, never forget to perform flushing (discharge) of the water lines before starting treatment.

  • Page 26: Precautions For Use

    3 Precautions for Use Operating Precautions Do not apply heat to the product. This may cause deterioration or discoloration. Precautions for cleaning the product exterior ・If the exterior is excessively dirty, moisten a soft cloth with water containing approx. 10% neutral detergent, and wipe the exterior with the cloth. Then, wipe it with a cloth moistened with water and then dry it completely with a dry cloth.

  • Page 27: Product Specifications

    4 Product Specifications Technical Data Catalog number AU-E3S-SWE23CE/AU-E3S-SW23VCE/ AU-E3S-SWCUS Classification for protec- Class I Equipment tion against electric shock Classification according to Type B Applied the degree of protection Parts (handpiece) against electric shock Classification according to Foot controller IPX1 the degree of protection against ingress of water or particulate matter...
  • Page 28 4 Product Specifications 4 本製品の仕様 Dimensional drawing (standard values are provided) 1208 (longest value) Unit: mm Tolerance in dimensions: ±10%...

  • Page 29: Name Of Each Part

    4 Product Specifications 4 本製品の仕様 Name of Each Part Light pole Cuspidor unit Doctor unit Cupfiller nozzle Bowl flush nozzle Doctor control panel Cuspidor bowl Solid collector Dental viewer Handle Table Assistant holder Oil mist separator Assistant Waste receptacle holder Water bottle Cuspidor arm Instrument holder Doctor arm...

  • Page 30: Operation

    5 Operation Preparation Before Use (1) With no air supplied, this product does not operate even after turning on the main switch. Junction cover Turn on the power of the compressor before turning on the main switch. (2) Remove the junction cover. Turn the main water valve knob clockwise to the open side.

  • Page 31: After Use

    5 Operation After Use Junction cover (1) Remove the junction cover. Turn off the power for chair. Press the main switch for chair. When turned off, the light goes off. main switch for chair. (2) Turn on the main switch to backward as viewed the doctor main switch table from the front.
  • Page 32 5 Operation Doctor Unit (1) Fluhing switch Fluhing switch is located underneath the doctor table. Pick up a handpiece from the handpiece holder, then turn on the flushing switch by pushing the lever to the ON side. While pushing the lever, coolant water from the handpiece keeps coming out.
  • Page 33 5 Operation Handpiece light switch (2) Handpiece light switch E Type ON   OFF Turns on/off the handpiece light. Switching between on and off of the handpiece light occurs each time when this switch is changed to forward (on) and backward (off) as viewed from the front. (3) Handpiece pressure gauge Displays the handpiece drive air pressure.
  • Page 34 5 Operation 3) BIEN AIR MCX OPTIMA INT OPTIMA INT For the operation of Bien Air OPTIMA INT, press the button with the thumb, holding the back of the controller with the other fingers. Pressing the button without holding the controller, the doctor table may move.
  • Page 35 5 Operation (6) Ultrasonic scaler 1) Ultrasonic scaler A Type E Type output power control knob 1) Ultrasonic scaler output power control knob The knob adjusts the output power of the ultrasonic decreases increases scaler. If the knob is turned right, the output power increase, and if left, the power decreases.
  • Page 36 5 Operation (7) Doctor control panel Manual operation switch Cupfiller switch Automatic operation switch Last position switch Automatic return switch Preset switch Cupfiller switch When this switch is pressed, water is released from the cupfiller nozzle. Water is also released from the bowl flush nozzle to flush the cuspidor bowl.
  • Page 37 5 Operation Automatic operation switch Last position switch The chair is moved to the preset “mouth rinsing position”. By pushing again after movement completion, the chair is Move the chair to mouth rinsing moved to the position prior to the “mouth rinsing position”. position by chair manual switch 【Setting the mouth rinsing position】...
  • Page 38 5 Operation (12) Table height adjustment Doctor table height can be adjusted 3 positions. Hold and slightly lift up the doctor table, rock ring will come up on table bracket. Slide up or down the rock ring to appropriate groove on upper table bracket.

  • Page 39: Water Bottle

    5 Operation 【Doctor side】 (13) Water bottle Doctor side Cuspidor side The water bottle CITY/BOTTLE select switch can be changed between municipal water and water bottle. CITY ..Tap water BOTTLE . . . Water bottle When the pressurization ON-OFF switch is set to ON, PRESSURE WATER...
  • Page 40 5 Operation (14) 3WAY Syringe SYR-20 SYR-20 A lever (Air) BT14 W lever (Water) (1) Spraying water / air Press W lever to have water come out. Press A lever to have air come out. Press both levers simultaneously to have spray come out.

  • Page 41: 5- Foot Controller

    5 Operation Foot controller Handle Pedal The pedal depressing extent can control the turbine and air motor rotation speed and air scaler output. Coolant water switch The micromotor rotation is activated when the pedal is depressed. Adjust upper limit speed by turning micromotor Decrease limit rotation speed control knob.

  • Page 42: Cuspidor Unit

    5 Operation Cuspidor unit Cupfiller nozzle (1) Cupfiller switch Bowl When this switch is pressed, water is released from the flush Bowl flush nozzle cupfiller nozzle. button Water is also released from the bowl flush nozzle to flush the cuspidor bowl. Cupfiller operates by timer for a specified time period.
  • Page 43 5 Operation (7) dental light Before use, always read the Instructions for dental light to ensure correct usage. EURUS LIGHT (8) Dental light mode selection switch Junction cover Remove the junction cover. The Dental light mode selection switch can be changed between sensor mode and manual mode.

  • Page 44: 5- Right/Left Handed Dentistry Conversion

    5 Operation Right/Left handed dentistry conversion Please confirm before converting to right or left handed position. Bring the chair to the upper limit position and backrest upright position. Turn off the main switch for safety. Confirm that there are no obstacles around this product. Backrest CAUTION Doctor control panel...
  • Page 45 5 Operation 3) Swing the cuspidor unit and assistant holder behind the chair. CAUTION Take care so the cuspidor unit does not hit the doctor table during the conversion. 4) While moving the cuspidor unit from the rear to the right side, turn it clockwise.
  • Page 46 5 Operation Confirm the safety functions For safe use of this product, please confirm the safety func- tions as follows after every conversion. When excess pressure (upward or downward) is applied to the doctor table. When the doctor table is turned to the back side of the backrest.

  • Page 47: Chair Lock Function

    6 Chair lock function When the lock function is activated, the chair movement is stopped. The functions that become locked and the unlocking steps are as follows. How to unlock Condition 1 When the force is applied to the doctor table from After resolving the condition of interference, confirm the upward/downward direction during the safety, and operate the chair.

  • Page 48: Adjustment

    7 Adjustment Doctor unit (1) Adjusting the quantity of water supplied to the handpiece spray The quantity of water supplied to the handpiece spray from the doctor unit can be adjusted with the knobs (1) (with blue caps). (2) Adjusting the quantity of water /air supplied to the 3 way syringe spray The quantity of water and air supplied from the doctor unit can be adjusted with the knobs (2).

  • Page 49: Maintenance And Cleaning

    Turn the oil reservoir counterclockwise to remove. If the hygroscopic sponge (2) (consumable) is excessive- ly dirty or has excessive oil on it, replace it. Contact your local authorized Belmont dealer for a Line replacement for the hygroscopic sponge. (Replacement...

  • Page 50: Cuspidor Unit

    2) The filter can be removed from solid collector by collector pushing the bar from front side of the solid collector and clean with running water. Contact your local authorized Belmont dealer for a replacement for the filter. (Replacement will be Push charged for.) Clean the filter with running water.
  • Page 51 8 Maintenance and Cleaning (5) Suction line Handpieces for HVE and saliva ejector suction the secretions, saliva, or blood that contains bacteria. Therefore, always wash and sterilize them using MD555/ Orotol plus manufactured by Dürr after the procedure. Use Orotol Plus for daily care. In addition, we recommend using MD555 for weekly cleaning.

  • Page 52: Washing And Sterilizing The Hve And Saliva Ejector

    8 Maintenance and Cleaning Washing and sterilizing the HVE and saliva ejector (1) Disassembly Wash and sterilize the handpieces between patients. saliva ejector To properly sterilize the HVE and saliva ejector, it is necessary to wash them to remove dirt and immerse them in detergent. Then, rinse them to remove any remaining detergent.
  • Page 53 8 Maintenance and Cleaning (5) Sterilization Caution when assembling The HVE and saliva ejector are autoclavable. HVE before sterilization Reassemble the main body unit, and autoclave the HVE and saliva ejector. Body When assembling the HVE, align the two surfaces; a flat surface of the cap and the surface of the sliding groove of the body.

  • Page 54: Washing And Sterilizing The 3Way Syringe

    8 Maintenance and Cleaning Washing and sterilizing the 3WAY syringe Wash and sterilize the handpieces between patients. To properly sterilize the 3way syringe, it is necessary to wash them to remove dirt and immerse them in detergent. Then, rinse them to remove any remaining detergent. Follow the procedure below to wash and sterilize the hand- pieces.
  • Page 55 8 Maintenance and Cleaning (3) Sterilization (3) Sterilization Insert the nozzle in a sterilization bag and seal it. Choose the appropriate method from the following sterilization cycles depending on the type of the autoclave sterilizer in your clinic: [Dynamic-Air-Removal] Autoclave it at a temperature of 134ºC for 3 minutes with sterilization a 15-minute drying time.
  • Page 56 8 Maintenance and Cleaning BT14 BT14 (1) Cleaning inside the nozzle Insert the accompanied nozzle cleaning tool from the tip of the nozzle. Clean the inside of the nozzle and remove the residues by spraying water and air. If the nozzle is autoclaved with residues remained, the residues are clogged inside the nozzle, and water may not come out.
  • Page 57 8 Maintenance and Cleaning (4) Sterilization (4) Sterilization 1. Insert the handpiece in a sterilization bag and seal it. 2. Autoclave them at a temperature of 135ºC for 3 minutes. The handpieces can be autoclaved up to 250 times. sterilization Storage method: After sterilization, place the nozzle in the sterilization pouch, and store it in a dry, dark, cool place.
  • Page 58 8 Maintenance and Cleaning (6) Applying vaseline to the nozzle (6) Applying vaseline to Repeated detachment of the nozzle decreases the amount the nozzle of grease for O-ring, which may stiffen the operation of detachment. If the operation of detaching nozzle stiffens, apply a little of vaseline on the surface of nozzle inserting part shown in the left figure.

  • Page 59: Junction Unit

    8 Maintenance and Cleaning Junction unit (1) Air filter Junction cover Empty any water that has collected in the air filter at least once a week. 1. Remove the junction cover. 2. Prepare a cup to put the water in. 3.

  • Page 60: Maintenance And Inspection

    If the chair does not stop, please contact When the chair is in automatic Check the Before moves during procedure, your local authorized Belmont dealer. operation, it must stop when any cancel consulting resulting in an injury. The of the operation switches shown...
  • Page 61 The product does not Check the Before Water, air, and spray come out Contact your local authorized Belmont functioning consulting by pressing A lever and W lever. function properly, dealer. preventing proper...
  • Page 62 Maintenance and inspection can be outsourced to qualified persons such as authorized repairers of medical devices. If you have any question about periodic inspection, contact your local authorized Belmont dealer. List of service parts required for the periodic inspection Standard...

  • Page 63: Detachable Parts

    8 Maintenance and Cleaning Detachable parts Part name Part name HVE tip Handpiece Syringe nozzle Handpiece hose Drain outlet cover Cuspidor bowl strainer Saliva ejector Solid collector Water service coupler Solid collector filter Air service coupler Oil mist separator Storage method If the product is not used for an extended period of time after consulting hours or during holidays, make sure you observe the precautions below:...

  • Page 64: Maintenance By Service Engineers

    Refer to ‘Troubleshooting’ before you check the device. If the problem persists, turn off the main switch, and contact your local authorized Belmont dealer to request a repair. Service life The service life of this product is 10 years on condition that maintenance and inspection are properly conducted [according to our self-certification (our data)].

  • Page 65: Troubleshooting

    If you encounter any of the problems listed below, take the countermeasures described below before requesting a repair. If the problem persists even after troubleshooting, stop using the product immediately, turn off the main switch, and contact your local authorized Belmont dealer. Phenomenon Please check Remedy...

  • Page 66: Consumables

    11 Consumables Consumables are parts that will normally wear or deteriorate, change their appearance, or become damaged after use. Please note that repair or replacement of consumables are not covered by the warranty and will be charged for. (* Degree of wear, deterioration or damage and timing for replacement depends on the use environment and conditions at the customer’s premises.) Consumables (Parts listed below are out of the guarantee...
  • Page 67 TAKARA COMPANY EUROPE GmbH Berner Strasse 18, 60437 Frankfurt am Main, Germany TEL : +49-69-506878-0 FAX : +49-69-506878-20 0197 TAKARA BELMONT CORPORATION 2-1-1, Higashishinsaibashi, Chuo-ku, Osaka, 542-0083, Japan TEL : +81-6-6213-5945 FAX : +81-6-6212-3680...

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