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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

Safety degree of application in the presence of a

flammable anesthetic mixture with air, oxygen,

or nitrous oxide

Equipment not suitable

Operation Mode

Continuous

9.2.DEVICE INFORMATION

GENERAL INFORMATION

Connection to proper power supply network

External power supply

Network voltage

100-240 Vac (Bivolt)

Power

5 Vcc

Power network frequency

50 / 60 Hz

Current

4 A

Permissible fluctuation

+/- 10 %

Number of phases

Biphasic

Power consumption (VA)

120 VA - Momentary

Maximum network impedance

0,2 Ω

Base dimensions

Size: L 306mm, W 98mm, H 98mm

Scanner dimensions

Size: L 256mm, W 43mm, H 43mm

Scanner weight

150 grams

Scanner tip

Reusable, sterilized using steam autoclave (See

item 6 of this manual)

Acquisition method

Intraoral camera - active stereo imaging

Color scanning

24-bit (8 bits per channel)

Содержание eagle.IOS

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Страница 2: ...2 THIS PAGE IS INTENTIONALLY BLANK...

Страница 3: ...el R de Camargo CREA SP 5062199650 ANVISA Registration n 10101130093 Alliage S A Ind strias M dico Odontol gica Rodovia Abr o Assed Km 53 450m CEP 14097 500 Ribeir o Preto SP Brasil Tel 55 16 3512 121...

Страница 4: ...n 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 t...

Страница 5: ...oftware 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...

Страница 6: ...ITIONS 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 ELE...

Страница 7: ...7 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 1 GENERAL INFORMATION...

Страница 8: ...mportant 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 INDICAT...

Страница 9: ...tect from rain Temperature limit This side Up Protect from sunlight Manufacturer Manufacture Date ON OFF button Turning the equipment on off Scanning process Stand by USB plug General warning Attentio...

Страница 10: ...log 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...

Страница 11: ...11 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 2 WARNINGS CAUTIONS AND RECOMMENDATIONS...

Страница 12: ...troyed 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...

Страница 13: ...cessive vibration or shock including during transport and handling This equipment is not designed for use in the presence of flammable anesthetic mixture vapors or nitrous oxide Recommendations must b...

Страница 14: ...ful 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 ope...

Страница 15: ...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...

Страница 16: ...o 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 mini...

Страница 17: ...17 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 3 SYSTEM GENERAL DESCRIPTION...

Страница 18: ...to the patient and operator and damage to the system 3 2 1 User Profile The Eagle IOS Intraoral Scanner can be used by both sexes with a minimum level of literacy with the ability to read and underst...

Страница 19: ...ower 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 sh...

Страница 20: ...20 4 INSTALLATION Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil...

Страница 21: ...ommended Processador gr fico NVIDIA GeForce 10 Series GTX 1070 ou superior 10 Series GTX 1070 ou superior Pelo menos 6 GB de mem ria de v deo S rie 20 RTX 2060 ou superior Pelo menos 6 GB de mem ria d...

Страница 22: ...cal 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 certif...

Страница 23: ...lowing steps Step 5 Connect the other end of the USB cable to the computer It is highly recommended to connect the USB cable to a USB port located on the back of the computer failure to do so may resu...

Страница 24: ...E The Workflow Fast Scan can be enabled if Patient or If not required F View software version copy function on the right G View UL version copy function on the right H View scanner serial number I Man...

Страница 25: ...25 A B System C D...

Страница 26: ...delete users with name and image it is also possible to add password to the user D Lab Connections Configure and select connections to the Lab Also set the preferred lab as the default E Order Form Se...

Страница 27: ...iles 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 The interface support...

Страница 28: ...n change the appearance of the case view C Edit profile allows you to edit data like name and email A B C Opening a case from the list will show all the necessary information Possibilities to change s...

Страница 29: ...9 If you need installation assistance contact Alliage authorized technical support Phone 55 16 3512 1212 Address Rodovia Abr o Assed Km 53 450m Recreio Anhang era Ribeir o Preto SP Brazil CEP 14097 50...

Страница 30: ...30 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 5 OPERATION...

Страница 31: ...new account 5 1 1 Communication with the laboratory The EagleClinic application contains two internal methods of communicating with the laboratory You can also 1 Access the scans directly by clicking...

Страница 32: ...abs 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 s...

Страница 33: ...erview 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...

Страница 34: ...main part of the screen Settings The settings are found in the upper right corner by clicking on the gearwheel C By clicking on the user in the upper right corner D you will be given the option to lo...

Страница 35: ...ame 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 Note th...

Страница 36: ...eate a new case for the same patient by pressing add case 5 2 WORKFLOW INDICATIONS EagleClinic supports the following restorations and equipment Anatomical crowns Copings Temporary crowns Anatomical p...

Страница 37: ...ed Verify the correct patient selected laboratory and desired laboratory due date Selecting the restoration Select the teeth and choose the type of procedure Teeth are selected by clicking on them and...

Страница 38: ...ts 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...

Страница 39: ...etract the lips cheecks and tongue for a better experience First path Occlusal is Key spend a sec per tooth To be precise keep the scanner steady and steady Extra Tips For Maxillary rotate the tip so...

Страница 40: ...n stay steady and precise with your movements 3 Red Image In the case of a red box the scan has lost track and is no longer scanning This is caused by jerky unsteady handpiece movements as well as a l...

Страница 41: ...n the viewport with little or no cheek or tissue present 3 When finished scanning the occlusal starting at the terminal molar slightly rotate the scanner 45 degrees scanning the entire lingual surface...

Страница 42: ...egin scanning the central molars capturing the mandibular and maxillary teeth on the first pass Then scan only the maxillary molars and gum up to the arc 1 b When the arc is locked the arc will get th...

Страница 43: ...scans and order form can be exported to a different location on the PC 3D Viewer Each of the scans can be opened in the full screen 3D viewer for further investigation 3 If you wanted to export the c...

Страница 44: ...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 3 Rotate the tip 180 degrees for maxillary scanning by pressing the...

Страница 45: ...scanning Moves the scan to the center of the screen E Color on off Switches between color scanning and thermal vision highlighting poorly scanned areas F Brush tool Used to mark areas in the scan for...

Страница 46: ...46 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 6 CLEANING DISINFECTION AND STERILIZATION...

Страница 47: ...ggles All scanner components except tips must be clean and not sprayed Avoid moisture alcohol or disinfectant inside the scanner s open chamber 6 2 CLEANING THE HANDPIECE For the disinfection process...

Страница 48: ...of visible debris or water spots Step 3 Insert and seal the tip in a sterilization package with the tip facing down so that water droplets do not accumulate on the mirror Make sure the seal is airtig...

Страница 49: ...the tip wrapped in a sealed sterilization bag failure to do so will result in permanent smudges on the mirror Do not autoclave the device handpiece Tips should not be placed in an ultrasonic cleaner...

Страница 50: ...50 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 7 PROBLEM DIAGNOSIS INSPECTION AND MAINTENANCE...

Страница 51: ...act your local reseller for support There are dots in the live view window Check and clean the tip mirror Where can I get Eagle IOS software and manuals The Software accompanies the product and the ma...

Страница 52: ...r equipment it is important to perform preventive maintenance in a maximum period of three 3 years Contact the Alliage Service Department about our periodic review and preventive maintenance program 7...

Страница 53: ...ision 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 Alliag...

Страница 54: ...54 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 8 STANDARDS AND REGULATIONS...

Страница 55: ...General requirements for basic security and essential performance Collateral standard Usability EN 60601 1 9 2008 A2 2020 Medical electrical equipment Part 1 9 General requirements for basic security...

Страница 56: ...56 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 9 TECHNICAL SPECIFICATIONS...

Страница 57: ...thetic mixture with air oxygen or nitrous oxide Equipment not suitable Operation Mode Continuous 9 2 DEVICE INFORMATION GENERAL INFORMATION Connection to proper power supply network External power sup...

Страница 58: ...depending on hardware configuration Operator accessible part Handpiece Possible duration of patient contact T 10 min Patient accessible part type B applied part Tip Computer Scanner Interface USB 3 0...

Страница 59: ...At least 6GB of video memory AMD GPUs are not compatible with Eagle IOS Failure to meet the minimum hardware requirements will affect scanner performance 9 4 ENVIRONMENTAL CONDITIONS ENVIRONMENTAL CON...

Страница 60: ...60 10 WARRANTY Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil...

Страница 61: ...61 10 WARRANTY This equipment is covered by the warranty periods terms and conditions contained in the Warranty Certificate that accompanies the product...

Страница 62: ...62 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 11 ALLIAGE S AUTHORIZED SERVICES...

Страница 63: ...erwise 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 Servi...

Страница 64: ...64 Alliage S A Industrias M dico Odontol gica Telefone 55 16 3512 1212 Rodovia Abr o Assed Km 53 CEP 14097 500 Ribeir o Preto SP Brasil 12 ELECTROMAGNETIC COMPATIBILITY...

Страница 65: ...CTROMAGNETICENVIRONMENTS GUIDELINES RF emissions CISPR 11 Group 1 The Intraoral Scanner use RF energy only for their internal functions Therefore its RF emissions are extremely low and are unlikely to...

Страница 66: ...repetition frequency 2 kV 100 kHz repetition frequency IEC 61000 4 4 signal input output 1 kV 100 kHz repetition frequency 1 kV 100 kHz repetition frequency Outbreak Line by line IEC 61000 4 5 0 5 kV...

Страница 67: ...BAND MHZ SERVICE MODULATION M A X I M U M POWER W DISTANCE M IMMUNITY TEST LEVEL V M 385 380 390 TETRA 400 1 8 H z p u l s e modulation 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM deviation of 5 kHz 1...

Страница 68: ...ncluding peripherals such as antenna cables and external antennas should not be used less than 30 cm from any part of the Intraoral Scanner including cables specified by the manufacturer Otherwise per...

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