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Dabi Atlante eagle.IOS Owner's Manual

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  • Page 2 THIS PAGE IS INTENTIONALLY BLANK...
  • Page 3 INTRODUCTION TO THE MANUAL Technical Name: Intra-Oral/Extra-Oral Camera Trade Name: Intraoral Scanner Model: Eagle IOS Brand: Dabi Atlante Technical Responsible: Daniel R. de Camargo CREA-SP: 5062199650 ANVISA Registration nº: 10101130093 Alliage S/A Indústrias Médico Odontológica Rodovia Abrão Assed, Km 53 + 450m - CEP 14097-500 Ribeirão Preto - SP - Brasil...
  • Page 4 Alliage S/A makes no claims to these marks. The use of a term in this manual should not be considered to influence the validity of any trademark, registered trademark, or service mark. Dabi Atlante, Eagle IOS and EagleClinic are trademarks registered by Alliage S/A. Copyright © 2021 Alliage S/A. All rights reserved.

  • Page 5: Table Of Contents

    CONTENTS GENERAL INFORMATION 1.1. DEAR CUSTOMER 1.2. INDICATION FOR USE 1.3. CONTRAINDICATION 1.4. SYMBOLOGY WARNINGS, CAUTIONS AND RECOMMENDATIONS SYSTEM GENERAL DESCRIPTION 3.1. SYSTEM DESCRIPTION 3.2. PRINCIPLES OF OPERATION 3.2.1. User Profile 3.3. MAIN PRODUCT COMPONENTS 3.3.1. Parts that come with the product INSTALLATION 4.1.
  • Page 6 9.4. ENVIRONMENTAL CONDITIONS WARRANTY ALLIAGE'S SERVICES AUTHORIZED ELECTROMAGNETIC COMPATIBILITY 12.1. ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS 12.2. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY...
  • Page 7 GENERAL INFORMATION Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 8: General Information

    1.GENERAL INFORMATION 1.1.DEAR CUSTOMER Congratulations on the excellent choice. When purchasing equipment with ALLIAGE quality, you can be assured of acquiring products with technology compatible with the world's best in its class. This manual gives you an overview of your equipment, describing important details that can guide you in its correct use, as well as in solving small problems that may eventually occur.

  • Page 9: Symbology

    1.4. SYMBOLOGY The following symbols are used throughout this manual and on the product. Make sure you fully understand each symbol and follow the instructions that come with it. Fragile, handle with care Maximum stacking Protect from rain Temperature limit This side Up Protect from sunlight Manufacturer...
  • Page 10 Optical radiation Direct current Sterilizable in a steam sterilizer Type B applied parts ( a u t o c l a v e ) a t s p e c i f i e d temperature Serial number Recyclable Model number Model Electrostatic sensitive devices Catalog number...
  • Page 11 WARNINGS, CAUTIONS AND RECOMMENDATIONS Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 12: Warnings, Cautions And Recommendations

    2. WARNINGS, CAUTIONS AND RECOMMENDATIONS General warnings Read and understand all instructions contained in these instructions for use before installing or operating this equipment. Only use the equipment in perfect condition and protect yourself, patients and third parties against possible dangers. This equipment must be installed and operated by personnel familiar with the necessary precautions.
  • Page 13 In the event of a system malfunction or failure, you must: Prevent any contact between the system and the patient. Unplug the system from the electrical outlet and the computer. Store the system away so that it cannot be used by someone else. Contact the technical service.
  • Page 14 • If this product is exposed to water, moisture, or foreign substances, turn it off immediately and contact an Alliage's Authorized Service Center. • In case of damage or defect, do not use the equipment and contact an Alliage's Authorized Service Center.
  • Page 15 During operation, the system emits a bright, flashing light at the tip. Although the system complies with IEC 62471 (Phenomenological Safety of Lamps and Lamp Systems), prolonged exposure to flashing light may result in discomfort, seizure, or eye irritation. Prevention of cross contamination Appropriate cleaning and disinfection measures must be taken to avoid crosscontamination between patients, users, and other people.
  • Page 16 Precautions in case of equipment failure To avoid environmental contamination or misuse of the equipment, when it is rendered useless, they must be discarded (according to current legislation) in an appropriate place, as the materials inside can contaminate the environment. For the European Economic Area (EEA), this product is subject to Directive 2012/19/EU as well as corresponding national laws.
  • Page 17 SYSTEM GENERAL DESCRIPTION Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 18: System General Description

    3. SYSTEM GENERAL DESCRIPTION 3.1. SYSTEM DESCRIPTION The Eagle IOS Intraoral Scanner is designed and developed to produce high quality digital intraoral exams or models for dental restoration or analysis. The Scanner is light, small, and easy to use, allowing for fast and accurate scanning. The Eagle IOS must be handled by qualified and properly trained healthcare professionals, it can be used for the following indications: ·...

  • Page 19: Main Product Components

    3.3. MAIN PRODUCT COMPONENTS 3.3.1. Parts that come with the product 01 - Intraoral Scanner 02 - Scanner tip 03 - AC / DC power adapter 04 - 3.0 USB cable Store the box: It is highly recommended that you store the box in a safe place and do not throw it away.
  • Page 20 INSTALLATION Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 21: Installation

    4. INSTALLATION 4.1. EAGLE IOS CONFIGURATION AND CONNECTION COMPUTER REQUIREMENTS Operating system Windows 10 or higher (excluding Windows 10 S, now defunct) Administrative rights required Space on disk 100 GB of free disk space or more Port 1 x USB 3.0 port (SuperSpeed) CPU Type Intel i7 - 4 cores or better (e.g., i7 8700) CPU clock...
  • Page 22 It is recommended to perform periodic backups on patient files and data to avoid loss of history in the event of a computer system failure. To meet the safety regulations, don't operate non-medical equipment like personal computers inside the patient area. Outside the patient area, it's acceptable the presence of non-medical equipment as long as it's used computer equipment approved and certified.
  • Page 23 Install the system according to the following steps: Step 1: The installation will be done through technical support, with the opening of a ticket together with the customer. Step 2: Place the base on a flat, stable surface and place the Eagle IOS Handpiece firmly on its base. Step 3: Connecting the AC/DC power adapter cable to the database;...

  • Page 24: Settings

    4.2. SETTINGS General A. Language. B. The 3D output format can be STL, PLY, OBJ. C. Image formats can be PNG, JPG. D. The preferred homepage can be chosen as Recent Patients or Recent Cases. E. The Workflow Fast Scan can be enabled if Patient or If not required. F.
  • Page 25 System...
  • Page 26 A. System: The option to export or import the patient's database. B. Sounds: Select to use sound during scanning. Pre-select volume and select between different sound effects. C. Users: Add, edit, and delete users with name and image, it is also possible to add password to the user.
  • Page 27 Cloud Storage Eagle IOS has a file transfer cloud service which can be found at eagleioscloud.com. Labs and users create an account and share files for free via the cloud, cases are stored for a period of 03 months in the cloud. Login will provide an overview of user created cases or cases sent to user with current status.
  • Page 28 Options for the Cloud A. Groups can be created. B. Settings can change the appearance of the case view. C. Edit profile, allows you to edit data like name and email. Opening a case from the list will show all the necessary information. Possibilities to change status, view scans in 3D Viewer, download and add files are found.
  • Page 29 If you need installation assistance, contact Alliage authorized technical support. Phone: +55 (16) 3512-1212 Address: Rodovia Abrão Assed, Km 53 + 450m - Recreio Anhangüera – Ribeirão Preto-SP/ Brazil CEP 14097-500...
  • Page 30 OPERATION Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 31: Operation

    5. OPERATION 5.1. INTRODUCTION Log in and create a new account A new account must be created before it can be linked to a user in the software. On eagleioscloud. com, click "Create New Account". Fill in the required fields (marked with a red *) and click "Create". An email will be sent to confirm the email address.
  • Page 32 2.c. Add your cloud storage connection to the settings, your connected labs will now appear as options. 2.d. Submit cases via cloud storage on the checkout page, linking your cloud account to the software. Login screen The user login page is the first page when the software starts. Select the user and enter the password if it is already configured.

  • Page 33: Case Management Software Overview

    5.1.2. Case management software overview Patients on the home screen When logged in, you will have Patients or Cases as the default view (selected in settings). Select an already created patient on the left side of the screen to view and/or create new cases for the patient.
  • Page 34 Home screen cases Select an already created case to view the scans and proceed with all cases for the same patient. Create a new patient (A) or case (B) using the buttons on the main part of the screen. Settings The settings are found in the upper right corner by clicking on the gearwheel (C).
  • Page 35 Creating a new patient Creating a new patient will open the screen below. Fill in the data. The patient ID is created automatically, but you can switch to a different ID if necessary. First and Last name are required. When filled in, click create and you are ready to create cases. Delete a patient You can delete a patient by clicking on the 3 dots to the right of the name and selecting Delete.

  • Page 36: Workflow Indications

    Create a new case when the patient is selected When a patient is selected, a preview will be displayed with the name and the cases already existing in the patient. Here you also have the option to create a new case for the same patient by pressing "add case".

  • Page 37: Create New Case

    5.2.1. Create new case To create a new patient case for the above-mentioned indications, follow the steps below. When creating a new case, the order form will be displayed. Verify the correct patient, selected laboratory, and desired laboratory due date. Selecting the restoration Select the teeth and choose the type of procedure.
  • Page 38 After selecting the procedure Color and material are chosen. Note that a bridge is shown by the outer lines and dots beside the colored teeth. Press Next when the Order Form is complete. Scan Page The live view window in the lower left corner shows what Eagle IOS is seeing. It can be changed in size, Small, Medium, and Large.

  • Page 39: Important Tips Before Scanning

    5.3. IMPORTANT TIPS BEFORE SCANNING Before making a crown, prepare the tooth with a gum retraction cord. This is optional, but highly recommended. Prior to scanning, remove the retraction cord and dry the surface of any blood or saliva using an air/water syringe or 2x2 gauze. 5.4.

  • Page 40: Scanning

    5.4.2. Scanning 1. Start scanning: To start scanning, press the button at the top of the scanner or click 'scan' in the right toolbar window. The recommended tip-to-tooth distance is 0 to 12 2. Green Image: When the green box is present, it indicates that the scan is being performed successfully.

  • Page 41: Mandibular And Maxillary Scanning

    5.4.3. Mandibular and maxillary scanning 1. Start your scan starting at the arc of the chosen procedure. If you are scanning both arcs, you can select one of the arcs to start. 2.a. For a full arc, follow an occlusal, linear, and buccal scan path.

  • Page 42: Bite Alignment

    5.4.4. Bite alignment In the case of a quadrant sweep, you will be prompted to sweep only the side of the quadrilateral. When scanning the full arc, you will be prompted to scan bilaterally. When selecting "bite", wait a few seconds for the arc sweeps to load. 1.
  • Page 43 2. Wrapping Up When the scan is complete, we get the overview of the case, including the 3D preview of the scans. Additional notes can be added and figures or similar can be attached to the case. If connected to a lab via cloud storage, the entire case can now be sent to the lab.

  • Page 44: Tip

    5.4.5. Tip 1. Secure the end with the mirror side facing down. Firmly press the tip into the scanner until you hear a click. 2. Release the tip by pressing the button located on the bottom of the handpiece (1) while moving away from the scanner (2).

  • Page 45: Scanning Tools

    5.5. SCANNING TOOLS A. Scanning It allows scanning to start as well as scan pause. B. Reset Reset will delete the current scan. C. Adjust the zoom level You can change the zoom level (useful for touchscreens). D. Screen centered scanning Moves the scan to the center of the screen.
  • Page 46 CLEANING, DISINFECTION AND STERILIZATION Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 47: Cleaning, Disinfection And Sterilization

    6. CLEANING, DISINFECTION AND STERILIZATION 6.1. INTRODUCTION For your protection, during the cleaning and disinfection process of the equipment, use PPE such as disposable gloves and goggles. The cleaning and disinfection process must be carried out with each patient change. For cleaning, use a clean, soft cloth dampened with neutral soap and then dry with a clean, soft cloth or paper towel.

  • Page 48: Cleaning And Sterilization Of The Tip

    6.3. CLEANING AND STERILIZATION OF THE TIP The included tips must be autoclaved before use as they are not pre-sterilized. The scanner tip is autoclavable up to 250 times in a steam autoclave. Make sure the mirror surface does not show any residue, smudges, scratches, or any damage as this would affect the performance of the device.
  • Page 49 Step 4: Sterilize the wrapped tip in a steam autoclave. Sterilization time minimum 30 minutes at 121 °C or minimum 3 minutes at 135 °C, and equivalent temperature and time parameters may be used within this range. Maximum sterilization temperature 135 °C. Step 5: Make sure the drying cycle is complete before removing the tip from the autoclave.
  • Page 50 PROBLEM DIAGNOSIS, INSPECTION AND MAINTENANCE Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 51: Problem Diagnosis, Inspection And Maintenance

    7. PROBLEM DIAGNOSIS, INSPECTION AND MAINTENANCE 7.1. TROUBLESHOOTING If you encounter any problem in operation, please follow the instructions below to check and fix the problem, and/or contact your dealer. UNFORESEEN CIRCUMSTANCE SOLUTIONS There is a memory full error message that Clear some space on C Drive appears when the software is open.

  • Page 52: Preventive Maintenance

    RECOMMENDED ITEM DESCRIPTION OF THE INSPECTION FREQUENCY Operation / Security Activation of the on / off button (Visual). Daily System Overheating/Noise/Burn Smell (Auditory and Electrical parts Monthly Visual). Operation/Noise/Vibration/Breaks (Auditory and Parts and pieces Monthly Visual). If problems are found during the inspection, contact the Alliage Service Department. 7.3.PREVENTIVE MAINTENANCE In addition to the annual inspection, to ensure a long durability and proper operation of your equipment, it is important to perform preventive maintenance in a maximum period of three (3) years.
  • Page 53 The service manual is only available for Authorized Technical Assistance. Alliage declares that the provision of circuit diagrams, component lists or any other information that provides technical assistance on behalf of the user may be requested provided that previously agreed between the user and Alliage. The warranty will be void if the original parts are removed/replaced by unauthorized service technicians.
  • Page 54 STANDARDS AND REGULATIONS Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 55: Standards And Regulations

    8. STANDARDS AND REGULATIONS This equipment has been designed and manufactured to meet the following standards: EN 60601-1:2006+A2:2021 Medical electrical equipment - Part 1: General basic safety and essential performance requirements EN 60601-1-2:2015+A1:2021 Medical Electrical Equipment - Part 1-2: General Basic Safety and Essential Performance Requirements - Collateral standard: electromagnetic disturbances EN 62471:2008...
  • Page 56 TECHNICAL SPECIFICATIONS Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...

  • Page 57: Technical Specifications

    9.TECHNICAL SPECIFICATIONS 9.1.EQUIPMENT CLASSIFICATION EQUIPMENT CLASSIFICATION Framing class according to ANVISA Class I Framing class according to CE Class I EQUIPMENT CLASSIFICATION ACCORDING TO EN IEC 60601-1 Product classification for applied parts Type B Protección Contra Descargas Eléctricas Class II Protection Against Harmful Water Penetration IPXO - Product not protected against harmful penetration of water and particulate matter...
  • Page 58 SCANNING PROCESS Tooth preparation No powder or spray needed Continuously digitizing and accumulating Scanning principle (stitching) depth and color data Scanner distance - tooth 0 - 12mm T ≤ 10 min Note: may vary depending on Possible duration of contact by the operator hardware configuration Operator accessible part Handpiece...

  • Page 59: Computer Requirements

    9.3.COMPUTER REQUIREMENTS NECESSARY AND MISCELLANEOUS SOFTWARE Operating system Windows 10 or higher (excluding Windows 10 S, now defunct) Administrative rights required Space on disk 100 GB of free disk space or more Port 1 x USB 3.0 port (SuperSpeed) REQUIRED HARDWARE CPU Type Intel i7 - 4 cores or better (e.g., i7 8700) CPU clock...
  • Page 60 WARRANTY Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...
  • Page 61 10.WARRANTY This equipment is covered by the warranty periods, terms and conditions contained in the Warranty Certificate that accompanies the product.
  • Page 62 ALLIAGE'S AUTHORIZED SERVICES Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...
  • Page 63 11.ALLIAGE'S AUTHORIZED SERVICES All services performed on the Intraoral Scanner must be performed by an Authorized Technical Assistant, otherwise they will not be covered by the warranty. If you need to request electrical diagrams and/or specification of components that are not stated in the user manual, please use Alliage's Customer Service to make the request.
  • Page 64 ELECTROMAGNETIC COMPATIBILITY Alliage S/A Industrias Médico Odontológica Telefone: +55 (16) 3512-1212 Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil...
  • Page 65 12. ELECTROMAGNETIC COMPATIBILITY The Intraoral Scanner is intended for use in the electromagnetic environment specified below. It is advisable that the buyer or user ensure that it is used in such an environment. The Intraoral Scanner is suitable for use in a professional healthcare environment, not including areas where there are sensitive equipment or sources of intense electromagnetic disturbances, such as the RF-shielded room of a system for magnetic resonance imaging, in operating rooms near active PA surgical equipment, electrophysiology laboratories, armored rooms, or areas where shortwave...
  • Page 66 12.2. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY PHENOMENON BASIC EMC STANDARD IMMUNITY TEST LEVEL COMPLIANCE LEVEL OR TEST METHOD Electrostatic discharge IEC 61000-4-2 ± 8 KV contact ± 8 KV contact ± 2 KV, ± 4 KV, ± 8 KV, ±...
  • Page 67 PROXIMITY FIELDS FROM WIRELESS RF COMMUNICATIONS EQUIPMENT TEST BAND SERVICE MODULATION M A X I M U M DISTANCE I M M U N I T Y FREQUENCY (MHZ) POWER TEST LEVEL (MHZ) (V/M) 380-390 TETRA 400 1 8 H z p u l s e modulation 430-470 GMRS...
  • Page 68 The use of this equipment adjacent to other equipment should be avoided as this may result in improper operation. If this use is necessary, it is advisable that this and other equipment be observed to verify that they are operating normally. Do not use accessories, transducers, internal parts of components and other cables other than those previously specified by the manufacturer.

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