Dabi Atlante eagle.IOS User manual

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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
Tel: [phone]
77000001633 - Rev.: 08 - September/22
CINTERQUAL – Soluções de Comércio
Internacional, Lda.
Avenida Defensores de Chaves, Nº 4
Escritório Idea Spaces
1000-117 Lisboa, Portugal

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TRADEMARKS
All terms mentioned in this manual are well-known trademarks, registered trademarks, or service
marks that have been properly 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 to these marks. The use of a term in this manual should not
be considered to inuence 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.

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CONTENTS
01 GENERAL INFORMATION 08
1.1. DEAR CUSTOMER 08
1.2. INDICATION FOR USE 08
1.3. CONTRAINDICATION 08
1.4. SYMBOLOGY 09
02 WARNINGS, CAUTIONS AND RECOMMENDATIONS 12
03 SYSTEM GENERAL DESCRIPTION 18
3.1. SYSTEM DESCRIPTION 18
3.2. PRINCIPLES OF OPERATION 18
3.2.1. User Prole 18
3.3. MAIN PRODUCT COMPONENTS 19
3.3.1. Parts that come with the product 19
04 INSTALLATION 21
4.1. EAGLE IOS CONFIGURATION AND CONNECTION 21
4.2. SETTINGS 24
05 OPERATION 31
5.1. INTRODUCTION 31
5.1.1. Communication with the laboratory 31
5.1.2. Case management software overview 33
5.2. WORKFLOW INDICATIONS 36
5.2.1. Create new case 37
5.3. IMPORTANT TIPS BEFORE SCANNING 39
5.4. OPERATE THE SCANNER 39
5.4.1. Scanning Strategy 39
5.4.2. Scanning 40
5.4.3. Mandibular and maxillary scanning 41
5.4.4. Bite alignment 42
5.4.5. Tip 44
5.5. SCANNING TOOLS 45
06 CLEANING, DISINFECTION AND STERILIZATION 47
6.1. INTRODUCTION 47
6.2. CLEANING THE HANDPIECE 47
6.3. CLEANING AND STERILIZATION OF THE TIP 48
07 PROBLEM DIAGNOSIS, INSPECTION AND MAINTENANCE 51
7.1. TROUBLESHOOTING 51
7.2. PERIODIC INSPECTION 51
7.3. PREVENTIVE MAINTENANCE 52
7.4. CORRECTIVE MAINTENANCE 52
08 STANDARDS AND REGULATIONS 55
09 TECHNICAL SPECIFICATIONS 57
9.1. EQUIPMENT CLASSIFICATION 57
9.2. DEVICE INFORMATION 57
9.3. COMPUTER REQUIREMENTS 59

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9.4. ENVIRONMENTAL CONDITIONS 59
10 WARRANTY 61
11. ALLIAGE'S SERVICES AUTHORIZED 63
12 ELECTROMAGNETIC COMPATIBILITY 65
12.1. ORIENTATION AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS 65
12.2. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY 66

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Alliage S/A Industrias Médico Odontológica
Telefone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
1
GENERAL INFORMATION

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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.
This manual must be read in its entirety and kept for future reference.
1.2.INDICATION FOR USE
The Intraoral Scanner is a dental 3D scanner intended to be used to digitally record topographical
characteristics of teeth and surrounding tissues. The system produces 3D scans for use in computer-
assisted design and manufacturing of dentalrestorations.
1.3.CONTRAINDICATION
None known.

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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 Manufacture Date
ON/OFF button
Turning the equipment on/o Scanning process
Stand by USB plug
General warning Attention
Mandatory action Follow instructions for use
It indicates that the product
must be taken to a special waste
collection point at the end of
its useful life. It applies to both
device and accessories.
Non-sterile (scanner tips)

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Optical radiation Direct current
Type B applied parts
Sterilizable in a steam sterilizer
(autoclave) at specified
temperature
Recyclable Serial number
Model number Model
Catalog number Electrostatic sensitive devices
(ESD)
Class II
Indicates that equipment complies
with the regulation (EU) 2017/745
of the European Parliament and
Council (MDR)
Indicates which equipment
complies with Directives 2011/65/
EU and 2015/863/EU on the
Restriction of Use of Certain
Hazardous Substances in Electrical
and Electronic Equipment.
Authorized representative in the
European community

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Alliage S/A Industrias Médico Odontológica
Telefone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
2
WARNINGS, CAUTIONS AND RECOMMENDATIONS

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General warnings
2. WARNINGS, CAUTIONS AND RECOMMENDATIONS
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.
• Do not spill liquids on the device body.
• Never operate the device in a humid environment.
• Keep the device away from radiators and heat sources.
• Use the device only with the supplied accessories.
• Do not alter the device or open the cabinets.
General prohibition statement. System functionality can be destroyed in case
of misuse. If unauthorized changes have been made to the supplied system and
accessories, the manufacturer's warranty will be void. Alliage will not accept
any responsibility or liability for the improper functioning of the product in
this case.
If one of the following conditions occurs, unplug the device from the electrical outlet and contact
authorized service personnel:
• The power cord or power adapter is damaged.
• The device has been exposed to water.
• The device has been damaged.
• The device does not work properly when the operating instructions are followed.
Modication of the system could result in physical injury to the patient and
operator and damage to the system.
The Eagle IOS scanner should only be used with compatible and approved
software. The Eagle IOS device is designed to operate with EagleClinic software.
The intraoral scanner is sensitive to electrostatic discharge.

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During transport
The equipment must be transported and stored, observing the following:
• Handle with care to avoid falls, excessive vibrations and impacts;
• The arrows on the package must be pointing up;
• Do not stack above the amount indicated on the package;
• Protect against sunlight, moisture, water and dust;
• Observe temperature, pressure, and relative humidity limits.
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.
To help ensure proper hygiene and protect against infectious disease, before rst use, equipment should
be cleaned and disinfected following the instructions in this manual.
Before using the equipment
During equipment installation
• Place the equipment in a location where it will not be in contact with moisture or water.
• Install the unit in a location where it will not be damaged by pressure, temperature, humidity,
direct sunlight, dust, salts, or corrosive products.
• The equipment must not be subjected to excessive vibration or shock (including during transport
and handling).
• This equipment is not designed for use in the presence of ammable anesthetic mixture vapors
or nitrous oxide.
• Recommendations must be followed.
• Eagle IOS is factory calibrated and therefore does not require calibration when installed. If Eagle
IOS starts having problems scanning and recognizing the tooth models, the system should be
examined which may result in the system returning for repair/calibration.
While using the equipment
• Under no circumstances can the patient operate the equipment.
• The equipment should only be operated by qualied healthcare professionals.
• To operate the equipment, operating personnel must:
- Read and understand the user's manual.
- Be familiar with the structure and fundamental functions of this equipment.
- Be familiar with the emergency protocols of this equipment.
- Be able to recognize irregularities in equipment operation and implement appropriate measures,
when necessary.
• The patient should not touch parts other than those specied to be attended to.
There is a risk of electric shock when opening or attempting to open any part of
the system; only qualied service personnel should open parts of the system.
Do not position the Intraoral Scanner in such a way that it is dicult to
disconnect between the source and the power supply.

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• If this product is exposed to water, moisture, or foreign substances, turn it o 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.
• Do not use the equipment if any of its compartments or parts are damaged, lose or removed.
Contact an Alliage's Authorized Service Center and request repair or replacement of any damaged,
loose, or removed cabinets or parts from the equipment before using the equipment again.
• Do not touch the equipment or use it if it is being repaired or if the equipment cabinets have
been removed.
• Do not open or remove any of the equipment cabinets. No internal parts are user serviceable.
• All moving parts are inside the handheld scanner, so do not open the unit.
• When not in use, always rest the handpiece on the base. Do not place the base on an inclined
surface. Place cables (power cord and USB cable) where people cannot accidentally get caught in
them and potentially damage the system.
• In case of a fall or impact of moving parts causing them to break, be careful when handling them,
there may be sharp parts.
• The operator cannot contact the patient when in contact with accessible connectors.
• The operator cannot use tools to open the equipment.
• During system operation, the handpiece and tip may become slightly hot; this is normal.
If the scanner tip falls, check that the mirror is not damaged and not shifted; if
the tip is damaged, it must be discarded immediately. If the scanner handpiece
falls or collides, check that no part of the system is damaged as this may
aect performance.
The Eagle IOS system contains delicate optical and mechanical elements
and therefore must be handled with care. Do not drop, bump, or shake the
handpiece or tip. Always place the handpiece on the base when not in use. Do
not force the cable connecting the handpiece to the Base. Do not submerge
the Handpiece or Base in any liquid. Do not place the handpiece or base on
wet or heated surfaces. Hold the handpiece with a rm grip when handling.
To prevent the system from overheating, the ventilation opening at the bottom
of the handpiece must never be obstructed.
Care must be taken not to apply unnecessary strain to the system cables,
whether the power cable, the USB cable, or the cable between the handpiece
and the Base.
Only use the power adapter provided as part of the system.

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During operation, the system emits a bright, ashing light at the tip. Although
the system complies with IEC 62471 (Phenomenological Safety of Lamps and
Lamp Systems), prolonged exposure to ashing light may result in discomfort,
seizure, or eye irritation.
Prevention of cross contamination
• For each new patient, perform cleaning and disinfection procedures as instructed in this manual.
Appropriate cleaning and disinfection measures must be taken to avoid
crosscontamination between patients, users, and other people.
To maintain patient safety, wear surgical gloves when handling any part of the
system. Always verify that the tip is mounted on the handpiece before inserting
it into the patient's mouth. Before using the system with a new patient, ensure
the system is disinfected and the tip sterilized.
After using / operating the equipment
• Turn o the equipment if not in use for a long time.
• All parts that have come into contact with the patient must be cleaned and disinfected with each
new patient to prevent transmission of infectious agents that can cause serious illness.
• Carry out cleaning and disinfection according to the instructions contained in this manual.
• Do not disconnect the cable or other connections unnecessarily.
• Do not modify any part of the equipment.
• When not in use, always rest the handpiece on the base. Do not place the base on an inclined
surface. Place cables (power cord and USB cable) where people cannot accidentally get caught in
them and potentially damage the system.
Precautions in case of alteration of the equipment operation
If the equipment shows any abnormality, check if the problem is related to any item listed in the
“Troubleshooting” topic of this user manual.
If it is not possible to solve the problem, turn o the equipment, contact an Alliage's Authorized
Technical Assistance.
The manufacturer is NOT responsible for:
• The equipment is used for purposes other than those for which it was designed.
• Damage caused to the equipment, the operator and/or patient, because of
incorrect installation and maintenance procedures not in accordance with the
operating instructions accompanying the equipment.

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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. This directive requires that the product must be taken to a special
waste collection site at the end of its useful life. It applies to both device and accessories. Contact
your dealer if nal disposal of the product is required.
The Intraoral Scanner packaging consists of cardboard, plastic and expanded
polystyrene (EPS) which are 100% recyclable materials.
Alliage S/A aims to achieve an environmental policy to promote supply of environmentally conscious
medical and dental products that continuously minimize environmental impact and that are friendlier
to the environment and human health.
To maintain a minimal impact to the environment, consider the recommendations below:
• After installation, send the recyclable materials to the recycling process.
• During the life cycle of the equipment, turn it o when not in use.
• To prevent environmental contamination, the disposal of plastic protective covers and other
consumables should follow the normal procedure for biomedical waste. Biomedical waste shall
include non-acute materials which may cause diseases or suspicions of sheltering pathogenic
organisms which should be stored in a yellow bag, duly labeled with a biohazard symbol, stored in
a leak-tight, watertight container until collection and incineration.
DIMENSIONS: 140 x 360 x 370mm / MASS: Approximately: 5 kg
Precautions for reducing environmental impact
This equipment must not be disposed of as household waste.

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Alliage S/A Industrias Médico Odontológica
Telefone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil
3
SYSTEM GENERAL DESCRIPTION

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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 qualied and properly trained healthcare professionals, it
can be used for the following indications:
3.2. PRINCIPLES OF OPERATION
Eagle IOS is an optical printing system. It is used to record the topographical features of teeth,
dental impressions, or physical models for use in computer-drawn projects (CAD) and assisted by
computerized manufacturing (CAM) of dental restorative prosthetic devices.
Unintentional use of the system can result in physical injury to the patient
and operator and damage to the system.
3.2.1. User Prole
The Eagle IOS Intraoral Scanner can be used by both sexes, with a minimum level of literacy
with the ability to read and understand images, symbols, icons, western characters (Arial font),
alpha numeric characters, and cannot present a degree of visual imperfection. for reading or vision
and average degree of impairment of recent memory, not being in a clear capacity to perform
the activities and functions of the product in a correct way for the profession. The user must be a
qualied and trained health professional to perform the activities, functions frequently used in the
application of the Intraoral Scanner and its primary operations functions.
· Anatomical crowns
· Copings
· Temporary crowns
· Anatomical pontics
· Reduced pontics
· Temporary pontics
· Inlays / Onlays
· Pillars for implants
· 3-unit implant bridges
· Bridges of up to 5 units
· Orthodontic aligners
· “Nightguards”
· Splints
· Retainers
· Bleach trays
· Sleep device

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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
01 02
03 04
Store the box: It is highly recommended that you store the box in a safe place
and do not throw it away. The box is ideal for any necessary transportation
or shipping of Eagle IOS.
The scanner body consists of the Base and Handpiece, connected by a exible,
non-removable cable.

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4
INSTALLATION
Alliage S/A Industrias Médico Odontológica
Telefone: [phone]
Rodovia Abrão Assed, Km 53 – CEP 14097-500 –Ribeirão Preto – SP –Brasil