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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: +55 (16) 3512-1212
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.

Содержание new IDA

Страница 1: ...1 ...

Страница 2: ...50 ANVISA Register 10101139025 Alliage S A Industrias Médico Odontológico Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil Telephone 55 16 3512 1212 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 ...

Страница 3: ...demarks 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...

Страница 4: ...STRUCTION 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...

Страница 5: ...ocess 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 COMPATIBI...

Страница 6: ...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 temp...

Страница 7: ...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 ...

Страница 8: ...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 complian...

Страница 9: ...ienic 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 ca...

Страница 10: ...sor 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 th...

Страница 11: ... be stored in a yellow bag properly labeled with the symbol of biological hazard stored in a container resistant to perforation tight and even recollection and incineration The packaging1 of the New IDA sensor is composed of cardboard and plastic which are 100 recyclable materials 1 DIMENSIONS 185 x 160 x 71 5 mm WEIGHT Approximately 100g PRECAUTIONS IN CASE OF DESTRUCTION OF THE EQUIPMENT To avoi...

Страница 12: ...ON SYSTEM STRUCTURE 1 Intraoral sensor 2 Computer system1 USB interface 3 Installation flash drive Software Drivers Manuals 4 Intraoral sensor holder 5 Consumables Plastic Protective Covers1 1 Don t accompany the product ...

Страница 13: ...the two supplied screws or other mounting material Alternatively it may be glued to a uniform surface using the supplied double sided adhesive tape COMPUTER SYSTEM Software requirements For the correct performance of the New IDA software some basic software described below is necessary Net Framework 4 5 1 The NET Framework is essential to run several programs that were developed through the use of...

Страница 14: ...New IDA sensor doesn t require an external power supply since its power is supplied through the USB connection of the computer and it has approximate consumption of 300mA Don t use USB ports available in keyboards or in the front or lateral side of the computer These connections are frequently unable to deliver sufficient power for the proper operation of the sensor Installation site To meet the s...

Страница 15: ...printing among other functions Software installation Insert the sensor in the USB port of the computer Connect the flash drive that accompanies the New IDA in the USB port open the device and click on the file setup_New_IDA_2_0_0_X Select the desired language and click on OK Read and understand the End User License Agreement and if you accept click on I accept the terms of the Contract Click Next ...

Страница 16: ...16 Select the dialog box if you want to create an icon on Desktop and click Next Click Install to begin the installation process ...

Страница 17: ...17 Setup will install NET 4 5 1 Setup will install the necessary tools to generate reports Click I Agree to accept the terms of the software Click Install ...

Страница 18: ...18 Wait for the end of installation and click Close Setup will install the USB driver Press Install to begin the installation process Click Finish to end installation ...

Страница 19: ...19 ...

Страница 20: ...in full screen 15 Full Screen 16 Save 17 Delete 18 Export image 19 Print 20 Sharpen 21 Brightness setting 22 Invert colors 23 Contrast setting 24 Histogram 25 Gamma setting 26 Insert Text 27 Insert Arrow 28 Insert circle 29 Insert drawing 30 Select 31 Cropping 32 Angular measurement 33 Calibrate 34 Multiple measurement 35 Single Measurement 36 Rotate 37 Undo 38 Open images 39 Opening the Patient s...

Страница 21: ...e access to the folder record showed on the interface and open previously saved files Browse up Allows sliding images showed in the vertical library Browse down Allows to slide images showed in the vertical library Sequential capture Defines the number of sequential captures to be done Zoom x1 To show the whole cliché in the viewing window Zoom x2 To expand the image Compare images Compare images ...

Страница 22: ...s Available only for TIFF images without marking It is recommended to apply it right after the image capturing Brightness setting Allows setting the brightness of the image Inversion of colors Invert the color of the image Contrast Setting Allows adjusting the contrast of the image Histogram Allows the setting of the image histogram Gamma Setting Allows the setting of the image gamma Insert text I...

Страница 23: ...the image Simple measurement Perform a distance measurement of two points on the image Multiple measurement Perform a distance measurement of multiple points on the image Angular measurement Perform an angular measurement on the image Calibration Perform the calibration of the distance of the image Image rotation Allows 90 degrees rotation of the image Undo Undo all Partial undo Show hide toolbar ...

Страница 24: ...heck the tooth teeth showed in the image Accompany delete button to undo checking Setting Allows the access to the parameters of your computer format and file path of database of images downloads Help Shows tutorial on how to perform an acquisition Setting screen To set the application press the icon The following screen will appear ...

Страница 25: ...nd width of the arrow 08 Color and width of free hand drawing 09 Color width and filling of the circle 10 Distance measurement Color and size of the text font 11 Angular measurement Color and size of font 12 Cancel changes 13 Confirm changes 14 Preprocessing of image 15 Histogram 16 Background color 17 Monitor test Measurement unit in pixels ...

Страница 26: ...ilding image record to each tooth and generating reports of the treatments It s possible to view the image records or start the capture of a new image by clicking the right button of the mouse on the desired tooth To access the odontogram click on the icon The following screen will appear ...

Страница 27: ...e capturing Select numbering of the tooth you want to associate with the image If you want insert diagnosis information in the text field Click on to associate the image with the patient record The tooth whose image is associated will be pointed in YELLOW ...

Страница 28: ...28 b Capture through odontogram To start a capture click the right button of the mouse and after that on start capture ...

Страница 29: ...image on the odontogram with the right button of the mouse Select the day and time of the image you want to open Click with right button to open an image d Help odontogram The icon opens a window with an illustrated guide to help with the use of tools on the Odontogram ...

Страница 30: ...n will be displayed a Print report f Selection of report model with images or without images b Send by email g Select the image to be inserted in the report c Save report on pdf h Add logo d Delete report i Preview logo e Preview report j Clinic data In case of more than an image associated with the tooth ...

Страница 31: ...s are single use consumables that should be discarded for each new patient The protective plastic covers don t accompany the product When buying a protective plastic cover make sure they are CE approved always follow the items listed below Always use protective plastic covers manufactured with non cytotoxic non irritant and non sensitizing polyethylene film in accordance with ISO 10993 1 Always us...

Страница 32: ...LABELS Identification DEMONSTRATIVE PICTURE REAL DIMENSIONS 100 x 63 mm Safety DEMONSTRATIVE PICTURE REAL DIMENSIONS 50 x 23 mm Refer to instruction manual DEMONSTRATIVE PICTURE REAL DIMENSIONS DIAM 10 mm ...

Страница 33: ...ent standards EN 60601 1 EN 60601 1 2 EN 60601 1 3 and IEC 60601 2 65 and meets the following requirements The intraoral X ray generator must operate at a voltage between 60 and 70 kV and an anode current of 7mA The intraoral X ray generator must be installed according to the manufacturer s instructions and requirements Don t use generators with power of less than 60KV ...

Страница 34: ...infiltrations and particulate matter Degree of application security in presence of one flammable anesthetic mixture with the air oxygen or nitrous oxide Inappropriate equipment Operation Mode Continuous operation Input Voltage 5 Vdc Input Current 300 mA Power Consumption 1 5 W Cable length 3 m Characteristics of the sensor Size 0 1 2 Sensor resolution pl mm 25 25 25 External dimensions mm 21 7 x 3...

Страница 35: ...r transportation and storage 85 RH Atmospheric pressure band 797 hPa to 1013 hPa 598 mmHg to 760 mmHg Conditions for installation and operation of the equipment Operating room temperature band 10ºC to 30ºC Operating relative humidity range non condensing 75 RH Atmospheric pressure band 797 hPa to 1013 hPa 598 mmHg to 760 mmHg Operating altitude 2000 m ...

Страница 36: ...ssential performance EN 60601 1 2 2015 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests Usability EN 60601 1 6 2010 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability EN 62366 2008 Medical devic...

Страница 37: ...or with the disposable plastic cover also covering the cable to ensure that it will not be in contact with the patient The sensor must be positioned manually In the case of manual placing introduce the sensor in the mouth of the patient in the deeper possible part The active surface of the sensor must be placed towards the source of X Rays By inserting the sensor into the patient s mouth be carefu...

Страница 38: ...r cable ACQUISITION OF RADIOGRAPHIC IMAGES To use the Intraoral dental digital imaging sensor New IDA start the computer and verify if it s on Start the software of image capturing clicking on the shortcut icon on the Desktop or Start All programs New IDA The home screen of the application will appear ...

Страница 39: ... shown Next click on icon Fill the fields to do the registration of the new patient Name and Last name are obligatory fields Next click OK Select the file that you created and click OK The name of the folder appears in the capture window The images will be stored in this folder ...

Страница 40: ...go back to the initial interface Changing a patient registration Click on the icon Select the patient directory that you want to open Click on the information tab and fill the fields you want to change Click on to save the changes Click on to confirm or click on to go back to the initial interface Sensor status Symbol Color Sensor status ...

Страница 41: ...ween the sensor font and location of the sensor in the oral cavity As a reference it must be considered that the New IDA sensor requires an 85 dose less that the movie Tipo D On the application interface click on INITIATE CAPTURE The icon of the sensor turns GREEN The sensor will be activated and waiting for the X Ray exposure being kept active during 120 seconds An indicative progress bar shows t...

Страница 42: ... otherwise delete the image clicking on the icon and perform new exposure At the end of the exam remove the sensor from the mouth of the patient and dispose the plastic protection following the recommendations included in this manual Keep the sensor in its box when it s not in use Images of the patient s registration To access the registered images of a patient open the register of him clicking on...

Страница 43: ...43 Select the patient folder and after click on the icon The following screen will be displayed All images with date information and time of the capture will be exhibited ...

Страница 44: ...f metric calibration must be performed at least one time after installation The metric calibration depends on the radiographic technique used The metric technique must be performed every time the technique is changed The intraoral calibration is unique for any device and it depends on the radiographic technique used There are two basic periapical radiographic techniques the Bisector Technique and ...

Страница 45: ...the sensor capture surface according to the isometric law from Cieszinski For this the focal point of the X Ray generator must be placed at a distance of approximately 20cm of the sensor This technique produces radiographs with distortion regardless of the technique and precision of the operated However it also provides a relatively simple fast and comfortable positioning to the patient b Metric c...

Страница 46: ...46 After this phase click on Calibration icon Draw a line between the two points that will be measured later The system will show a standard distance in pixel and mm ...

Страница 47: ...ysical measurement of the x rayed object Type the distance measured in mm After entering the distance click on Precision of the measurement Parameter Range Precision Distance 0 to 99 9 mm 0 1mm Angle 0 00 to 179 99 0 01 ...

Страница 48: ...aphy Individualized radiographic exam which consists of posterior bitewings with panoramical exam or posterior bitewings and selected periapical images Individualized radiographic exam which consists of posterior bitewings with panoramical exam or posterior bitewings and selected periapical images A complete intraoral radiography exam from the mouth is preferable when the patient has clinical evid...

Страница 49: ... craniofacial pathologies restoration endodontic care treatment for periodontal diseases and remineralization of the decay Clinical judgment about the need and type of radiographic images for evaluation and or control of these conditions This recommendation is subjected to the clinical judgment and is not applicable to every patient It is the dentist responsibility to follow the ALARA principle as...

Страница 50: ...rease the risk for caries can be available using the ADA forms for caries risk assessment 0 6 years old and older than 6 years old 1 U S Department of Health and Human Services Dental Radiographic Examinations Recommendations for Patient Selection and Limiting Radiation Exposure Available in http www ada org media ADA Member 20Center FIles Dental_Radiographic_Examinations_2012 as hx Accessed on No...

Страница 51: ...lly the New IDA sensor and the first 30cm of the USB cable For the cleaning use a clean and soft cloth damp with neutral soap and then perform the drying with a clean and soft cloth or with a paper towel For the disinfection process of the New IDA sensor use disinfectants towels that have active components based on Didecyldimethylammonium chloride respecting the contact time indicated by the manuf...

Страница 52: ... the equipment The following table shows a description of the main inspection items and recommended frequency Item Control description USB cable Connection Physical damage Intraoral sensor Communication Operation Overheating Physical Damage Accessories General damage that can cause risk In case are detected problems during the inspections contact us with the Alliage Service Department PREVENTIVE M...

Страница 53: ... can be requested if previously agreed between him and Alliage Enterprise The warrant will be annulled if the original parts are removed replaced by technicians from non authorized services The corrective maintenance that can be performed by the Intraoral dental digital imaging sensor New IDA user is limited to the replacement of the USB cable ...

Страница 54: ...s of the sensor and there s no image Verify the correct performance of the X Ray generator Make sure the active sensor surface is oriented to the x rays source and that is correctly aligned Error TransfersThread pre capture 0 SafeHandle was closed Fail in USB communication during the capture of the sensor Verify if the USB cable shows any damage indicative Verify USB connection with the computer V...

Страница 55: ...re time The tension of the generator is insufficient 60kV Adjustment of your monitor brightness and contrast Image completely dark The active area of the sensor was not exposed to the X Rays Insufficient X Ray dose Image with artifacts or lines Calibration file doesn t belong to the sensor Contact the technical support Image failure USB cable failure Verify if the USB cable shows any damage indica...

Страница 56: ...acement measures must be taken to protect the device against possible damage by ESD With the help of a screwdriver with the tip of 3 x 0 8mm remove the finishing cover of the screw With the screwdriver with the tip of 3 x 0 8mm remove the screws that attach the cable Remove the USB cable and perform the replacement Attach the screws again ...

Страница 57: ... is recommended the use of a torquemeter adjusted for 10 N cm Make sure there s no space between the plastic parts Place the cover of the screws available in the kit and press them until they fit in the plug ...

Страница 58: ... owner for confirmation of the equipment under warranty One of the remaining copies will stay with the distributor and the other one will be sent to the manufacturer The warranty is limited to the repair or replacement of manufacturing defect parts and it doesn t include the repair of defects caused by Damage or loss caused by improper use or abuse Damage or loss caused by non compliance of use an...

Страница 59: ...TO A PARTICULAR PURPOSE AND THE ONES RESULTING OF A TRANSACTION OR COMMERCIAL USE The express warranty is not applicable to the following items disposable parts defect or damage caused by negligence improper use operator mistake inappropriate installation changings or non specified operations of the product from the manufacturer hardware PERFORMING THE CONDITIONS STATED ABOVE THE MANUFACTURER WON ...

Страница 60: ...he following tables provide information on compliance of the equipment according to the standard EN 60601 1 2 2015 GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS Emission Essays Conformity Electromagnetic environments guidelines RF emissions CISPR 11 Group 1 The Intraoral Dental Digital Imaging Sensor uses RF energy only for its internal functions Therefore your RF emissions are very low a...

Страница 61: ...Hz 80 AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000 4 3 See table See table Electrical Fast Transients bursts IEC 61000 4 4 1 kV 100 kHz repetition frequency 1 kV 100 kHz repetition frequency Conducted disturbances induced by RF fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V m in ISM bands between 0 15MHz e 80MHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V m in ISM band...

Страница 62: ...se modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE 1 3 4 25 Band UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE 7 Band Pulse modulation 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9 5500 5785 The Intraoral Dental Digital Imaging Sensor is intended for the acquisition o...

Страница 63: ...ay result in increased emission or decreased electromagnetic immunity and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to any part of the Intraoral Dental Digital Imaging Sensor including cables specified by the manufacturer Otherwise degradation of the performance of this eq...

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