Eagle new IDA User manual

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PRESENTATION OF MANUAL
GMDN: 44905 - Dental digital imaging sensor, intraoral
Model: New IDA
Brand: Dabi Atlante
Technical Responsible: Daniel R. de Camargo
CREA-SP:5062199650
ANVISA Register: 10101139025
Alliage S/A Industrias Médico Odontológico
Rodovia Abrão Assed, Km 53 - CEP 14097-500
Ribeirão Preto - SP - Brazil
Telephone: [phone]
CNPJ: 55.979.736/0001-45
CINTERQUAL –Soluções de Comércio
Internacional, Lda.
Rua Fran Pacheco N°220 2° And
2900-374 Setúbal
Portugal
77000000592 - Rev.: 14 –November/2019
Document originally written in Portuguese.

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TRADEMARKS
All terms stated in this manual that are from known trademarks, commercial trademarks
or service marks were properly labeled as such. Other products, services or terms that
are mentioned in this manual can be trademarks, commercial trademarks or service
marks of their respective owners. The Alliage S/A makes no claim in relation to these
trademarks. The use of a term in this manual must not be considered as influential over
any trademark, commercial trademark or service mark.
New IDA is a commercial trademark from Alliage S/A.
Microsoft, Windows and .NET Framework are commercial trademarks of Microsoft
Corporation in the United States and other countries.
GNU LESSER is a trademark from Free Software Foundation, Inc.
Copyright © 2017 Alliage S/A. All Rights Reserved.
The performance characteristics presented in this manual are only for reference and
mustn't be considered as secured specifications.

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TABLE OF CONTENTS
DEAR CUSTOMER.................................................................................................................................................. 6
USE INDICATION ................................................................................................................................................... 6
CONTRAINDICATIONS ........................................................................................................................................... 6
SYMBOLOGY ......................................................................................................................................................... 7
WARNINGS, CAUTIONS, AND RECOMMENDATIONS ............................................................................................. 8
DURING TRANSPORTATION AND STORAGE ............................................................................................................. 8
BEFORE USING THE EQUIPMENT ............................................................................................................................. 9
DURING THE INSTALLATION OF THE EQUIPMENT ................................................................................................... 9
DURING THE EQUIPMENT USE................................................................................................................................. 9
Prevention against cross contamination........................................................................................................... 10
AFTER USE / OPERATION OF THE EQUIPMENT ...................................................................................................... 10
PRECAUTIONS IN CASE OF CHANGE IN THE PERFORMANCE OF THE EQUIPMENT................................................ 10
PRECAUTIONS FOR THE REDUCTION OF ENVIRONMENTAL IMPACT..................................................................... 11
PRECAUTIONS IN CASE OF DESTRUCTION OF THE EQUIPMENT ............................................................................ 11
SYSTEM DESCRIPTION..........................................................................................................................................12
SYSTEM STRUCTURE .............................................................................................................................................. 12
INTRAORAL SENSOR............................................................................................................................................... 13
INTRAORAL SENSOR HOLDER................................................................................................................................. 13
COMPUTER SYSTEM............................................................................................................................................... 13
Software requirements...................................................................................................................................... 13
Hardware requirements .................................................................................................................................... 14
Electrical requirements ..................................................................................................................................... 14
Installation site.................................................................................................................................................. 14
SOFTWARE ............................................................................................................................................................. 15
Software installation ......................................................................................................................................... 15
Main screen....................................................................................................................................................... 20
Setting screen.................................................................................................................................................... 24
Odontogram...................................................................................................................................................... 26
CONSUMABLES ...................................................................................................................................................... 31
LABELS.................................................................................................................................................................... 32
Identification ..................................................................................................................................................... 32
Safety ................................................................................................................................................................ 32
Refer to instruction manual .............................................................................................................................. 32
INTRAORAL RADIOGRAPHY EQUIPMENT............................................................................................................... 33
SPECIFICATIONS AND TECHNICAL CHARACTERISTICS ............................................................................................ 34
General information.......................................................................................................................................... 34
Characteristics of the sensor ............................................................................................................................. 34
Environmental conditions for transportation and storage................................................................................ 35
Conditions for installation and operation of the equipment............................................................................. 35
CERTIFICATIONS AND STANDARDS ......................................................................................................................36

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EMC / Security ................................................................................................................................................... 36
Usability ............................................................................................................................................................ 36
Software ............................................................................................................................................................ 36
Quality............................................................................................................................................................... 36
SYSTEM OPERATION ............................................................................................................................................37
PREPARATION FOR USE.......................................................................................................................................... 37
ACQUISITION OF RADIOGRAPHIC IMAGES............................................................................................................. 38
Create a new registration of patient ................................................................................................................. 39
Opening a patient registration.......................................................................................................................... 40
Changing a patient registration ........................................................................................................................ 40
Sensor status ..................................................................................................................................................... 40
Process of image capturing ............................................................................................................................... 41
Images of the patient's registration.................................................................................................................. 42
Metric Calibration ............................................................................................................................................. 44
Precision of the measurement........................................................................................................................... 47
RECOMMENDATION FOR EXAMS.........................................................................................................................48
CLEANING AND DISINFECTION .............................................................................................................................51
MAINTENANCE ....................................................................................................................................................52
PERIODIC INSPECTION............................................................................................................................................ 52
PREVENTIVE MAINTENANCE.................................................................................................................................. 52
CORRECTIVE MAINTENANCE.................................................................................................................................. 52
ERROR DIAGNOSIS ................................................................................................................................................. 54
CABLE REPLACEMENT ............................................................................................................................................ 55
AUTHORIZED SERVICE NETWORK .......................................................................................................................... 58
WARRANTY TERM .................................................................................................................................................. 58
Warranty period................................................................................................................................................ 59
ELECTROMAGNETIC COMPATIBILITY....................................................................................................................60
GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY................................................................... 61

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EQUIPMENT IDENTIFICATION
DEAR CUSTOMER
Congratulations for your excellent choice. When buying equipment with the
"DABI ATLANTE" quality, you can be sure you purchased products with technology that
is compatible with the best in the world from its class.
This manual offers you a general presentation of your equipment, describing
important details that can guide you in its correct use, as well as in the solution of small
issues that can eventually occur. There is no need of any additional training besides its
own reading.
This manual must be read on the whole and preserved to future consultations.
USE INDICATION
The Intraoral dental digital imaging sensor New IDA is aimed at the acquisition of
intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental
use and must be handled by trained and qualified health professionals, observing the
instructions included in this manual.
CONTRAINDICATIONS
The intraoral dental digital imaging sensor New IDA is contraindicated to patients
with temporomandibular dysfunction that limited mouth opening and who have
anatomical characteristics that prevent their use as a low palate.
The protective plastic covers contain polyvinyl chloride (PVC) and should not be
use by people with allergies to polyvinyl chloride (PVC) or substances used in the
manufacturing process of the same such as bisphenol A, adipic polyester, propylene
glycol compound and ethylhexyl maleate

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SYMBOLOGY
Use the icons above to identify the symbology of your equipment.
Fragile, handle with care
Applied parts BF type
Keep dry
Equipment Class II
This side up
Attention
Keep away from sunlight
General warning
Maximum stacking
Mandatory action
Temperature limit
Follow the instructions
for operation
Humidity limit
USB connection
Recyclable
Catalog number
Do not re-use
Serial number
Indicates that the product must be taken to a
special waste collection site at the end of its
lifespan. Applies to the device and to the
accessories.
Part Number
IP00
This product is not protected against harmful
water infiltrations and particulate matter.
Authorized representative
in the European
Community
Indicates that the product has passed an
evaluation, and that standards or regulations
developed for the product category have been
observed in its design / manufacture / placing on
the market.
Manufacture date
Indicates that the equipment is in compliance with
Directive 2011/65 / EU on restriction of the use of
certain hazardous substances in electrical and
electronic equipment.
Manufacturer
Indicates that the equipment is in compliance with
the Guideline 93/42 / CEE of European Union
about Medical Devices (MDD)

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WARNINGS, CAUTIONS, AND RECOMMENDATIONS
Read and understand the instructions contained in these instructions
for use before install or operate this equipment.
The operation of this device may be dangerous for patient and operator
unless safe exposure factors and operating instructions are observed.
Personal protective equipment must be used with this device.
Use the equipment only if in perfect conditions and protect yourself,
patients and third parties against possible dangers.
This equipment must be installed and operated by personal acquainted
to the necessary precautions to avoid excessive exposure to primary
and secondary radiation.
The New IDA sensor has three different interactions with the user. They
are:
Identification label: Placed in the lower part of the product package;
Security symbology: Placed in the upper part of the sensor on its
identification;
- Image acquisition software: Found installed with a computer where
the sensor is connected.
This equipment meets the requirements of the directive RoHS
(Restriction of Certain Hazardous Substances) (Directive 2011/65/UE)
and the Directive of Medical Devices (Directive 93/42/EEC). Please note
that the compliance with the directives RoHS is ensured by the
exclusive responsibility of the manufacturer.
Non-authorized modification of the product or of the configuration
invalidate the CE marking
DURING TRANSPORTATION AND STORAGE
The equipment must be shall be carried and stored according to the following:
Handle with care to avoid falls and impacts.
The arrows on the package must be pointing upwards.
Don't stack items above the quantity indicated on the packaging
Protect against sunlight, humidity, water and dust.
Observe the limit of temperature, pressure and relative humidity

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BEFORE USING THE EQUIPMENT
To help and ensure a proper hygiene and to protect against infectious diseases,
before first use, the equipment must be cleaned and disinfected according to the
instructions enclosed in this manual.
DURING THE INSTALLATION OF THE EQUIPMENT
Put the equipment in a place where it won't be in contact with humidity or
water.
Install the unity in a place where it won't be damaged by pressure,
temperature, humidity, direct sunlight, dust, salt or corrosive products.
The equipment must not be subjected to excessive vibration or shock
(including during transportation and handle).
This equipment was not designed for use in presence of vapors from
flammable anesthetics mixtures or nitrous oxide.
The recommendations of this manual must be followed regarding the EMC.
Communication equipment and sources that generate RF can affect the
performance of the equipment.
DURING THE EQUIPMENT USE
Proper hygienic measures must be taken to avoid cross contamination
among the patient, users and other people.
The equipment must be operated only by qualified healthy professionals
including safeguard knowledge against excessive exposure to radiation.
The equipment was manufactured to resist continuous and intermittent
operation; therefore, follow the cycles described in the Owner's Manual.
X-Ray exposure can cause damage to human body cells. It is
recommended that no one stays in the radiographic examination room
unless the containment of the patient is necessary. In this case, this person
must be properly protected against ray emissions.
Operators should follow all radiation protection guidelines for patients who
are pregnant or suspected of pregnancy, including the use of shielding of
the abdomen and thyroid.
The equipment was projected according to the electromagnetic
compatibility standards, but in very extreme conditions, it can cause
interference with other equipment. Don't use this equipment along with
other devices that are sensitive to interference or with devices that create
high electromagnetic disturbances.

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The manufacturer assumes NO liability:
• If the equipment is used for other purposes that are not the ones for
what it was originally designed.
• For damages caused to the equipment, operator and/or patient as
result of incorrect installation and maintenance procedures that are not
in compliance with the operation instructions that comes with the
equipment.
• For inappropriate operation of the equipment.
Prevention against cross contamination
To help to prevent the cross contamination among the patients, it is
mandatory the use of disposable protective plastic covers.
The covers must be properly disposed of for each new patient.
The protective plastic cover must cover the sensor and at least 10 cm of
the USB cable.
Don't ever use damaged protective plastic covers.
AFTER USE / OPERATION OF THE EQUIPMENT
Turn off the equipment when it is not being used for an extended period.
The protective plastic covers must be disposed for each new patient to
avoid the transmission of infectious agents that can cause serious
conditions.
Perform the cleaning and disinfection according to the instructions
contained in this manual.
Don't modify any part of the equipment.
PRECAUTIONS IN CASE OF CHANGE IN THE PERFORMANCE OF THE EQUIPMENT
If the equipment presents any abnormality, verify id the problem is related to any
item listed in the topic: "Error Diagnosis" of this user manual. If it is not possible to solve
the problem, turn off the equipment, disconnect the cables.
In the event of damage or defect do not use the equipment and contact
an Authorized Service Alliage.