SAEVO Dental Light Owner's Manual
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SAEVO Dental Light Owner's Manual

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Summary of Contents for SAEVO Dental Light

  • Page 2 PAGE INTENTIONALLY LEFT BLANK...
  • Page 3 MANUAL PRESENTATION Technical Name: Dental Lights Commercial Name: Dental Light Models: Persus Led Persus Piso Brand: Saevo Technical Responsible: Daniel R. de Camargo CREA-SP: 5062199650 ANVISA Registration No.: 10069210069 Alliage S/A Industrias Médico Odontológico Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 Ribeirão Preto - SP - Brazil...
  • Page 4 TRADEMARKS All terms mentioned in this manual that are known trademarks, registered trademarks or service marks have been appropriately labeled as such. Further products, services or terms that are mentioned in this manual may be registered marks, registered trademarks or service marks of their respective owners.

  • Page 5: Table Of Contents

    WARRANTY TERMS ..........................34 8.2. WARRANTY PERIOD........................... 34 RULES AND REGULATIONS ....................36 TECHNICAL SPECIFICATIONS ....................38 10.1. EQUIPMENT CLASSIFICATION ......................38 10.2. DEVICE INFORMATION........................38 10.3. ENVIRONMENTAL CONDITIONS ......................39 10.4. LIGHT BEAM PROJECTION ........................ 39 10.5 DENTAL LIGHT DIMENSIONS ......................40...
  • Page 6 ELECTROMAGNETIC COMPATIBILITY..................45 11.1. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS ........45 11.2. GUIDELINES AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY ........46...
  • Page 7 GERENAL INFORMATION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 8: General Information

    This manual must be read in full and kept for future reference. 1.2. INDICATONS FOR USE The Dental Light is intended to assist in the treatment of the patient and in the performance of dental practices, and is for dental use only.
  • Page 9 Electrostatic sensitive (ESD) Protection ground devices Refer to the instructions manual Mandatory action Caution Overall warning Indicates that the equipment complies with Directives 2011/65/ Authorized representative in EU and 2015/863/EU on the European Union Restriction on the use of certain hazardous substances in electrical and electronic equipment.
  • Page 10 WARNINGS, PRECAUTIONS AND RECOMMENDATIONS Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 11: Warnings, Precautions And Recommendations

    This equipment must be installed and operated by personnel familiar with the necessary precautions. The Dental Light has 2 different interactions with the user, namely: - Identification label: Located on the side of the equipment; - Safety symbols: Located in risk areas and on its identification tag;...
  • Page 12 • The equipment must be installed only by authorized technicians. • The service manual's recommendations regarding the mandatory existence of protective grounding must be followed. • Install the equipment in a location where it will not be in contact with humidity, water, plants and animals.
  • Page 13 them, there may be sharp parts. • This equipment does not produce physiological effects that are not obvious to the operator. • The operator cannot come into contact with the patient when in contact with accessible connectors. • The operator cannot use tools to open the equipment. Cross-contamination prevention Adequate cleaning and disinfection measures should be taken to avoid cross- contamination between patients, users and others.
  • Page 14 The manufacturer is NOT responsible for: • The equipment being used for purposes other than those for which it was designed. • Damage caused to the equipment, the operator and/or patient, as a result of incorrect installation and maintenance procedures that are not in accordance with the operating instructions accompanying the equipment.
  • Page 15 SYSTEM GENERAL DESCRIPTION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 16: System General Description

    3. SYSTEM GENERAL DESCRIPTION 3.1. SYSTEM DESCRIPTION Focal dental reflector with multi intensity light ranging from 8.000 to 35.000 Lux. Composed by a new light emission system, using LED technology. This abbreviation is the acronym for Light Emitting Diode, a totally different form of emitting light, when compared to conventional devices with halogen light.

  • Page 17: User's Profile

    3.2.3. User’s profile The Dental Light can be used by both male and female, with the minimum level of literacy, and with the ability to read and understand images, symbols, icons, western characters (Arial font), and alphanumeric characters. People who use the Dental Light may not have a degree of visual imperfection for reading or seeing and an average degree of recent memory impairment, not being clearly able to perform the activities and functions of the product correctly in the profession.

  • Page 18: Main Product Components

    3.3. MAIN PRODUCT COMPONENTS 3.3.1. Light 01 - Switch Shaft On/Off 02 - Multi-sided glass mirror 03 - Protective cover 04 - Handles 05 - LED Heatsink 06 - Led lamp 07 - Hinged arm Optional items (Subject to commercial availability)

  • Page 19: Arm

    3.3.2 Arm Supports for coupling in the Support for floor/ cei- Articulated arm chair (allows the installation ling coupling (allows of the articulated arm) the installation of the articulated arm) Sleeve Kit - allows the fixation of the Light in offices with 38mm column Simple bench articulated double bench articulated arm...

  • Page 20: Applied Parts

    3.4. APPLIED PARTS This equipment does not have applied parts 3.5. LABEL POSITIONING The following figure illustrates the location of the labels on the equipment. Illustrative picture 3.6 SYSTEM REQUIREMENTS 3.6.1. Place of Installation In order to meet safety standards, do not operate non-medical equipment, such as personal computers, within the patient's area.
  • Page 21 OPERATION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 22: Operation

    Coupled to the chair with a “Joystick” paddle (7 keys) Press and release the key (02) to turn the dental light on or off. To switch the light intensity of the dental light, keep pressing the key until the reflector reaches the desired intensity.
  • Page 23 Coupled to the chair with a “7 keys” paddle To start the reflector, push button (02) through the dental chair’s control paddle and keep pressing it to change luminosity; luminosity will gradually change. To turn it off, Press button (02) once more. Coupled to the chair with a “Joystick”...

  • Page 24: Movement Of The Headstock

    4.3. MOVEMENT OF THE HEADSTOCK The movement of the headstock is made through the knob (08), totally ergonomic designed to provide absolute isolation. Position the headstock 70cm of the operative field. When handling the equipment, take care with the parts that could pinch fingers.
  • Page 25 CLEANING, DISINFECTION AND STERILIZATION Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 26: Cleaning And Disinfection

    5. CLEANING AND DISINFECTION Before starting the cleaning and disinfection procedure, turn off the main switch of the equipment to avoid permanent damage. For your protection, during the equipment cleaning and disinfection process, use PPE such as disposable gloves and goggles. The cleaning and disinfection process must be performed at each patient change.
  • Page 27 PROBLEMS DIAGNOSTIC Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 28: Problems Diagnostic

    6. PROBLEMS DIAGNOSTIC 6.1. PROBLEMS SOLUTION In case any problem is found in the operation, follow the instructions below to check and fix the problem, and/or contact your representative. Unforeseen events Probable Cause Solutions - The light does not turn on; - Lack of energy.
  • Page 29 INSPECTION AND MAINTENANCE Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 30: 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's guide. If a problem is detected and cannot be corrected with the instructions in the problem diagnostics section, contact the Alliage Service Department.

  • Page 31: Corrective Maintenance

    7.3. CORRECTIVE MAINTENANCE To repair or replace any part, see instructions in the service manual. Corrective maintenance cannot be performed by the user. Do not open the equipment or try to repair it yourself or with the help of someone without training or authorization. This can aggravate the problem or produce a failure that can compromise the safety of the equipment.

  • Page 32: Alliage Authorized Service Network

    7.4. ALLIAGE AUTHORIZED SERVICE NETWORK All services performed on the Alliage equipment must be performed by an Authorized Technical Assistant, as otherwise they will not be covered by the warranty. If you need to request electrical diagrams and or specification of components that is not stated in the user's manual, use the Alliage Customer Service to make the request.
  • Page 33 WARRANTY Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 34: 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, and does not include the repair of defects resulting from: - Damage or loss caused by misuse or abuse;...
  • Page 35 RULES AND REGULATIONS Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 36: Rules And Regulations

    9. RULES AND REGULATIONS This equipment has been designed and manufactured to meet the following standards: ABNT NBR IEC 60601-1:2010 Medical Electrical Equipment - Part 1: General requirements Amendment 1:2016 for basic safety and essential performance. Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral ABNT NBR IEC 60601-1-2:2017 standard: Electromagnetic interference - Requirements...
  • Page 37 TECHNICAL SPECIFICATIONS Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...

  • Page 38: Technical Specifications

    10. TECHNICAL SPECIFICATIONS 10.1. EQUIPMENT CLASSIFICATION Classification according to ANVISA Class I Classification according to CE/FDA Class I Equipment classification according to EN IEC 60601-1 Product classification for applied parts Protection Against Electric Shock Class I Protection Against Harmful Water Penetration IP00 - Product not protected against harmful penetration of water and particulate material Degree of safety of application in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide...

  • Page 39: Environmental Conditions

    SPECIFIC INFORMATION Luminosity 8.000 to 35.000 Lux (+/-10%) Color temperature 4500K to 6400K Distance between the headstock and the operative field 70cm 10.3.ENVIRONMENTAL CONDITIONS Environmental conditions for transport and storage Room temperature range for transport or storage -12ºC to +50ºC Relative humidity range for transport and storage <...

  • Page 40: Dental Light Dimensions

    10.5 DENTAL LIGHT DIMENSIONS Conventional Arm (Coupled to the chair)
  • Page 41 Floor...
  • Page 42 Simple bench...
  • Page 43 Double bench...
  • Page 44 ELECTROMAGNETIC COMPATIBILITY Alliage S/A Industrias Médico Odontológico Telephone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil...
  • Page 45 11. ELECTROMAGNETIC COMPATIBILITY The Dental Light 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 Dental Light is suitable for use in a professional healthcare environment, not including areas...
  • Page 46 11.2. GUIDELINES AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY Basic EMC standard or I m m u n i t y a s s a y Phenomenon Compliance level test method level Electrostatic discharge IEC 61000-4-2 ±8 KV contact ±8 KV contact ±...
  • Page 47 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 mains voltage c.a. before applying the test level. Fields close to RF wireless communication equipment Band Immunity...
  • Page 48 Plug 20A NBR 14136 2P+T, no female plug, Inmetro. (From the Chair). The Dental Light is intended to assist the healthcare professional, and it is for dental use only. In case of EMC disturbances, the operator may experience loss of communication between the equipment and controls.

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Persus ledPersus piso

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