SAEVO Sonic Duo Owner's Manual
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SAEVO Sonic Duo Owner's Manual

Equipment for prophylaxis by ultrasound / bicarbonate jet
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Summary of Contents for SAEVO Sonic Duo

  • Page 2 [THIS PAGE IS INTENTIONALLY LEFT BLANK]...
  • Page 3 MANUAL PRESENTATION Trade Name: Equipment for Prophylaxis by Ultrasound / Bicarbonate Jet Models: Sonic Duo / Sonic Duo Fit / Sonic / Sonic Fit Brand: Saevo Technical Responsible: Daniel R. de Camargo CREA-SP: 5062199650 ANVISA Registration Nº: 10069210086 Alliage S/A Industrias Médico Odontológico Rodovia Abrão Assed, Km 53 - CEP 14097-500...
  • Page 4 TRADEMARKS All terms mentioned in this manual that are known trademarks, registered trademarks or service marks have been appropriately labeled as such. Other products, services or terms that are mentioned in this manual may be trademarks, registered trademarks or service marks of their respective owners. Alliage S / A makes no claims regarding these trademarks.

  • Page 5: Table Of Contents

    3.3.2. Sonic Duo Fit 3.3.3. Sonic 3.3.4. Sonic Fit 3.4. SETS AND ACCESSORIES 3.5. APPLIED PARTS 3.6. USER INTERFACE 3.6.1. Sonic Duo / Sonic Duo Fit 3.6.2. Sonic 3.6.3. Sonic Fit 3.7. LABEL POSITIONING 3.8. SYSTEM REQUIREMENTS 3.8.1. Compressor requirements 3.8.2. System layout 3.9.
  • Page 6 10.3. SPECIFIC INFORMATION 10.4. ULTRASOUND SPECIFICATIONS 10.5. ENVIRONMENTAL CONDITIONS 10.6. EQUIPMENT DIMENSIONS 10.6.1. Sonic Duo 10.6.2. Sonic Duo Fit 10.6.3. Sonic 10.6.4. Sonic Fit ELECTROMAGNETIC COMPATIBILITY 11.1. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS 11.2. ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY...
  • Page 7 GENERAL INFORMATION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 8: General Information

    This manual must be read in full and kept for future reference. 1.2.INDICATIONS FOR USE The Saevo Ultrasound / Bicarbonate Jet Prophylaxis Equipment is intended to assist in dental treatments such as removing plaque and residual stains; tartar removal; periodontal treatment;...
  • Page 9 Sterilizable in a steam sterilizer Catalog number ( a u t o c l a v e ) a t s p e c i f i e d temperature Indicates that the product must be taken to a special waste collection Type B applied parts site at the end of its useful life.
  • Page 10 Manufacturer Manufacturing date Model Ultrasound P o w e r – U l t r a s o n i c p o w e r Bicarbonate jet adjustment knob Water – Water flow regulation Air – Air flow regulation button button Scaling function Periodontal function...
  • Page 11 WARNINGS, CAUTIONS AND RECOMMENDATIONS Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 12: Warnings, Cautions And Recommendations

    Use only the equipment in perfect condition and protect yourself, patients and others against possible dangers. The Saevo Ultrasound / Bicarbonate Jet Prophylaxis Equipment has 4 different interactions with the user, they are: - Identification label: Located on the side of the equipment;...
  • Page 13 • The equipment must be installed only by authorized technical assistants. • The service manual's recommendations regarding the mandatory existence of protective earth must be followed. • The recommendations in the service manual regarding the mandatory existence of a protective circuit breaker must be followed.
  • Page 14 of any damaged, loose or removed enclosures or parts of the equipment before using the equipment again. • Do not touch the equipment or use it if it is being repaired or if the equipment's cabinets have been removed. • Do not open or remove any of the equipment's cabinets. No internal parts can be repaired by the user.
  • Page 15 Precautions for reducing environmental impact Alliage S / A aims to achieve an environmental policy to promote the supply of environmentally conscious medical and dental products that continually minimize environmental impact and are more friendly to the environment and human health. To maintain a minimal impact on the environment, observe the recommendations below: •...
  • Page 16 SYSTEM OVERVIEW Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 17: System Overview

    3.SYSTEM OVERVIEW 3.1.SYSTEM DESCRIPTION Equipment for prophylaxis by ultrasound and Bicarbonate Jet, modern and bold design, assembled together composed of body and cover made of ABS (Acrylonitrile, butadiene, styrene) and digital control panel in polycarbonate. Available in cart and bench models. Synchronized electropneumatic system, with valves that provide cuts and aspirations of water instantly, thus avoiding water contact with bicarbonate at the tip of the handpiece.

  • Page 18: User Profile

    3.2.3.User profile The user to operate and handle the Ultrasound and Bicarbonate Jet must be aged between 18 and 70 years old, both sexes, with the ability to read and understand images, symbols, icons, western Arabic characters (Arial font), alpha numeric characters, to know distinguish intraoral part of the human body, not being able to present a degree of visual imperfection for reading or seeing and an average degree of impairment of recent memory, not being clearly able to perform the activities and functions of the product in a correct manner to the profession.

  • Page 19: Main Product Components

    3.3.MAIN PRODUCT COMPONENTS 3.3.1.Sonic Duo 01. On/Off switch 02. Ultrasound selection button or bicarbonate jet 03. Ultrasound function selection key (PES) 04. Ultrasonic variation regulator 05. Water flow regulator 06. Air flow regulator 07. Bicarbonate jet pen 08. Ultrasound pen 09.

  • Page 20: Sonic Duo Fit

    3.3.2.Sonic Duo Fit 01. On/Off switch 02. Ultrasound selection button or bicarbonate jet 03. Ultrasound function selection key (PES) 04. Ultrasonic variation regulator 05. Water flow regulator 06. Air flow regulator 07. Bicarbonate jet pen 08. Ultrasound pen 09. Tip support 10.

  • Page 21: Sonic

    3.3.3.Sonic 01. On/Off switch 02. Ultrasound function selection key (PES) 03. Ultrasonic variation regulator 04. Water flow regulator 05. Ultrasound pen 06. Tip support 07. Activation pedal 08. Power input cable 09. Reservoir for peristaltic pump...

  • Page 22: Sonic Fit

    3.3.4.Sonic Fit 01. Ultrasonic variation regulator 02. Tip support 03. Ultrasound pen 04. Activation pedal...

  • Page 23: Sets And Accessories

    The use of any parts, accessories or materials not specified in this manual is the sole responsibility of the user. Accessories that accompany the product The Sonic Duo Kit consists of: 01. Tip Periodontal Supra (1 units) 02. Tip Periodontal Sub (2 units) 03.
  • Page 24 Accessories that do not accompany the product...
  • Page 25 01. Tip Endo L 10. Tip Retro R3 02. Tip Remo C 11. Tip Retro R5 03. Tip Remo N 12. Tip Dent C1 04. Tip Endo G 13. Tip Dent C2 05. Tip Periodontal E 14. Tip Dent C4 06.

  • Page 26: Applied Parts

    Consumables 01. Sodium bicarbonate 3.5.APPLIED PARTS The following item is used in the treatment of the patient Contact Type of parts Contact type Classification duration Mucous membrane/ Type B TIPs Removable <60s Bone structure Transducer cover Removable Mucous membrane <60s Type B Bicarbonate Jet Transducer cover...

  • Page 27: User Interface

    3.6.USER INTERFACE 3.6.1.Sonic Duo/ Sonic Duo Fit Buttons / Indicators Function A On Indicates that the machine is on B Function Selection Selects function (Ultrasound / Bicarbonate Jet) C Ultrasound Indicates selected Ultrasound function D Bicarbonate Jet Indicates selected Bicarbonate Jet function...

  • Page 28: Sonic

    3.6.2.Sonic Buttons / Indicators Function A On Indicates that the machine is on B Power Adjustment of ultrasonic power C Water Water flow regulation Selects ultrasound function D US Mode Selection (periodontics, endodontics and scaling) G Periodontics Indicates selected Periodontics mode F Endodontics Indicates selected Endodontics mode E Scaling...

  • Page 29: Sonic Fit

    3.6.3.Sonic Fit Buttons / Indicators Function A Water Water flow regulation B Power Adjustment of ultrasonic power C On Indicates that the machine is on 3.7.LABEL POSITIONING The following figure illustrates the location of the labels on the equipment components. Demonstrative image Real dimensions 100 x 63 mm Demonstrative image...

  • Page 30: System Requirements

    3.8.SYSTEM REQUIREMENTS 3.8.1.Compressor requirements The compressor is required to provide compressed air for clinical and laboratory use, having stable performance and flow capacity in accordance with the minimum requirements for the installation of the Ultrasound / Bicarbonate Jet Prophylaxis Equipment, in addition to being oil and emission free.

  • Page 31: Equipment Installation

    • Connect the power input cable (17). b. Procedures for electrical installation: Plug the equipment into the outlet and proceed according to the sequence of operations that follow. Only available for models: Sonic Duo / Sonic Duo Fit...
  • Page 32 OPERATION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 33: Operation

    To isolate the equipment from the mains, use the general switch. To start operating the equipment, follow the instructions below. 4.1.1.Sonic Duo / Sonic Duo Fit 1. Switch on the device by pressing the on / off switch (a); 2. Select the function Ultrasound or Bicarbonate Jet (b);...

  • Page 34: Sonic

    4.1.2.Sonic 1. Switch on the device by pressing the on / off switch (a); 2. Select the operation mode - periodontics, endodontics and scaling (c); 3. Operate the pedal (d). 4.1.3.Sonic Fit 1. Switch on the device by pressing the on / off switch (a); 2.

  • Page 35: Using The Ultrasound

    4.2.USING THE ULTRASOUND 4.2.1.Operation After choosing the desired function, proceed according to the instructions below: 1. Fill the reservoir of the peristaltic pump (only for models with peristaltic pump). 2. Remove the ultrasound pen from the holder. 3. Choose the appropriate tip for the desired operation according to the techniques and application 4.

  • Page 36: Techniques And Applications

    4.2.2.Techniques and applications All the tips of the ultrasound have the peculiarity of vibrating in a single plane (vibrations from front to back, and on the tip axis). The lateral vibrations common to other scalers do not exist, the straight displacement favors a more precise approximation of the tooth and gum.
  • Page 37 use of a mask and glasses to apply the bicarbonate jet. 1. Pressing the (01) key a second time the Bicarbonate Jet function (B) will be activated. Proceed according to the instructions below. 2. Remove the top cap (G) by unscrewing it (according to the drawing) and add enough sodium bicarbonate for a section of prophylaxis, that is, from 20 to 40g (do not exceed the level indicated on the container).

  • Page 38: Supply Of The Bicarbonate Jet

    4.3.2.Supply of the bicarbonate jet To supply your equipment, we recommend the use of “Clean Okta” sodium bicarbonate (Reg. ANVISA 80339810002) or one that has similar characteristics: Product composition: Sodium Bicarbonate (99.6%), Silicic Anhydrous, Essence - 105 microns spherical pattern. For more information about the product, see the manufacturer's instructions on the product.
  • Page 39 CLEANING, DISINFECTION AND STERILIZATION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 40: Cleaning, Disinfection And Sterilization

    5.CLEANING, DISINFECTION AND STERILIZATION Before starting the cleaning and disinfection procedure, turn off the main switch of the equipment to avoid permanent damage. For your protection, during the cleaning and disinfection process of the equipment use PPE such as disposable gloves and goggles. 5.1.EQUIPMENT The cleaning and disinfection process must be performed at each patient change.

  • Page 41: Bicarbonate Container

    All accessories suitable for sterilization must be sterilized only in an autoclave at 135 ° C with at least 3 minutes of waiting time and pressure of 2.2 bar. If these items are autoclaved, disinfection by alternative methods is not necessary. There is no limit on cycles or application time that the equipment and its parts can tolerate during the cleaning, disinfection and / or sterilization process, following the instructions in this manual.
  • Page 42 TROUBLESHOOTING Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 43: Troubleshooting

    6.TROUBLESHOOTING 6.1.SOLUTION OF PROBLEMS Occasionally, malfunctions may occur during use. In the event of an error, restart the equipment and resume operation. If the problem persists, follow the instructions below. Failures Probable causes Solutions - Inoperative Equipment. - Plug disconnected. - Connect the plug to the outlet.
  • Page 44 INSPECTION AND MAINTENANCE Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 45: Inspection And Maintenance

    7.INSPECTION AND MAINTENANCE Maintenance or service procedures may only be carried out by a technical service authorized by the manufacturer. All instructions for using the equipment as intended are provided in this user guide. If a problem is detected and cannot be corrected with the instructions in the problem diagnostics section, contact the Alliage Service Department.

  • Page 46: Corrective Maintenance

    7.3.CORRECTIVE MAINTENANCE The corrective maintenance that can be performed by the user Ultrasound / Bicarbonate Jet Prophylaxis equipment is limited to unblocking the bicarbonate jet pen. Do not open the equipment or attempt to repair it yourself or with the help of someone without training or authorization.

  • Page 47: Equipment

    7.3.1.Equipment Alliage declares that the provision of circuit diagrams, component lists or any other information that provides technical assistance on behalf of the user, can be requested as long as previously agreed between the user and Alliage. The warranty will be void if the original parts are removed / replaced by unauthorized service technicians.
  • Page 48 WARRANTY Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 49: Warranty

    8.WARRANTY 8.1.WARRANTY TERMS This equipment is covered by the warranty terms in the Warranty Certificate that accompanies the product. The warranty is limited to the repair or replacement of parts with manufacturing defects, not including the repair of defects originating from: - Damage or loss caused by misuse or abuse;...
  • Page 50 STANDARDS AND REGULATIONS Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 51: Standards And Regulations

    9.STANDARDS AND REGULATIONS This equipment has been designed and manufactured to meet the following rules: A B N T N B R I E C 6 0 6 0 1 - 1 : 2 0 1 0 Medical Electrical Equipment - Part 1: General requirements Amendment 1:2016 for basic security and essential performance.
  • Page 52 TECHNICAL SPECIFICATIONS Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 53: Technical Specifications

    10.TECHNICAL SPECIFICATIONS 10.1.EQUIPMENT CLASSIFICATION Class of classification according to ANVISA Class I Classification of equipment according to standard EN IEC 60601-1 Product classification for applied parts - Type B Protection Against Electric Shock - Class I Protection Against Harmful Water Penetration Dental Prophylaxis by Sodium Bicarbonate / Ultrasound IP00 - Product not protected against harmful penetration of water and particulate material Pedal...

  • Page 54: Specific Information

    60 VA - Momentary Maximum grid impedance 0,2Ω Net weight Sonic Duo: 4 kg Sonic: 3.4 kg Sonic Duo Fit: 3.7 kg Sonic Fit: 1.0 Kg Gross weight Sonic Duo: 5 kg Sonic: 4.4 kg Sonic Duo Fit: 4.5 kg Sonic Fit: 1.8 Kg...

  • Page 55: Ultrasound Specifications

    10.4.ULTRASOUND SPECIFICATIONS Ultrasound Vibration Frequency 30.000 Hz Consumption of irrigating liquid 28 ml/min Power consumed 15 VA Transducer system Electric piezo ceramic Maximum tip temperature in normal use 114.2°C Maximum rate of temperature rise of tip 179.7°C 10.5.ENVIRONMENTAL CONDITIONS Environmental conditions of transport and storage Transport or storage ambient temperature range -29ºC to +60ºC Transport and storage relative humidity range...

  • Page 56: Equipment Dimensions

    10.6.EQUIPMENT DIMENSIONS 10.6.1. Sonic Duo...

  • Page 57: Sonic Duo Fit

    10.6.2.Sonic Duo Fit...

  • Page 58: Sonic

    10.6.3.Sonic...

  • Page 59: Sonic Fit

    10.6.4.Sonic Fit...
  • Page 60 ELECTROMAGNETIC COMPATIBILITY Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 61: Electromagnetic Compatibility

    11.ELECTROMAGNETIC COMPATIBILITY The Equipment for Prophylaxis by Ultrasound / Bicarbonate Jet is intended for use in the electromagnetic environment specified below. The buyer or user should ensure that it is used in such an environment. The Equipment for Prophylaxis by Ultrasound / Bicarbonate Jet is suitable for use in a professional health care environment, not including areas where sensitive equipment or sources of intense electromagnetic disturbances are present, such as the RF shielded room of a magnetic resonance imaging system.

  • Page 62: Orientation And Declaration For Electromagnetic Immunity

    11.2.ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY Basic EMC standard or Phenomenon Immunity test level Compliance level test method Electrostatic discharge IEC 61000-4-2 ±8 KV contact ±8 KV contact ± 2 KV, ± 4 KV, ± 8 ± 2 KV, ± 4 KV, ± 8 KV, ±...
  • Page 63 NOTE 1 At 80 MHz and 800MHz, the higher frequency range is applicable. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 3 UT is the AC mains voltage before applying the test level. Proximity fields from wireless RF communications equipment Test Band...
  • Page 64 Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should not be used within 30 cm of any part of the Sonic Duo / Sonic Duo Fit / Sonic / Sonic Prophylaxis / Bicarbonate Jet Equipment Fit, including cables specified by the manufacturer. Otherwise, performance degradation of this equipment may occur.

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