Home

EVAsoft User Manual - at www.ImageWorksCorporation.com.

Contents

1. ImageWorks Generations of Imaging 9 paspoart Denes Pores em W EVAsSoft Dental Imaging Software EVAsoft Dental Imaging Software USERS MANUAL PN 0000062022 Revision Effective Date Description Ciel ge ae Not Applicable These revisions not released February 15 2012 Update to Version 2 3 Added description of feature and GUI changes Added regulatory information October 15 2012 Update to Version 3 0 Revised feature and GUI changes Revised regulatory information May 1 2013 Eliminated CE reference Included EVA Select Added EVA EVA Select Supplemental Information May 1 2014 Remove Durability Section August 1 2014 Update Address Updated Company name Updated GUI graphics Update to version 3 4 software Update Email Explain Study History Modes Eliminated EVA Classic Supplementary Information Appendix Copyright notice Copyright 2015 SMK Imaging LLC dba ImageWorks All Rights Reserved This manual shall not wholly or in part in any form or by any means be reproduced or transmitted without prior written authorization from ImageWorks This manual has been produced to assist in providing instruction for EVAsoft and EVA digital sensor products Every effort has been made to make the information in this guide as accurate as possible The authors of this guide shall have neither liability nor responsibility to any person or entity with respect to any loss or damages in
2. Contact Information Update Delete User Password To make changes to the User Login Preferences go to Tools gt Options For further explanations of the Options Window see Appendix D in the General preferences area User Login Preferences Disable Use of Passwords Disable Login Entirely Undo Redo Settings Undo Redo Operations DETAILED TAB DESCRIPTION PATIENT TAB The Patient Tab is the entry point into the software In this tab the user can create new patients find existing patients and edit patient information There are two sub tabs in the working area These are Patient Information and Results of Last Search When the program is Launched the default view is Recent Patients which can be found among the buttons that are on the right hand side This will display only the patients that were accessed the last time the program was run Clicking on Show All Patients in the right hand Stack will bring Up all existing patients EVAsoft Default Facility View Station Administrator E _ R gt een File Edit Image Devices Tools Preview Help 3 I Current Patient None 4 SE al A gt Quick Search Patient Information Results of Last Search DICOM Worklist Patients Deleted Patients Only Flagged Patients Patient Id DOB r Last Study Studies Dentist Anonymous Patients Only
3. 3 2 1 Recommended practices The EVA CLASSIC dental intra oral X ray sensor is NOT supplied as a sterile medical device Disinfect the sensor before first use and subsequently before using with every new patient Always use protecting gloves when using cleaning or disinfecting the sensor Use a new disposable protection barrier at every sensor usage This protection must be biocompatible following the standard ISO 10993 1 54 Cleaning by wiping the sensor s head and the first 5 inches 10 cm of the sensor cable with a compress moistened with a disinfecting solution is permitted Do NOT immerse the EVA Classic sensor 3 2 2 Warnings The EVA CLASSIC dental intra oral X ray sensor is not designed for high temperatures DO NOT sterilize the sensor using an autoclave or a UV oven The sensor housing and the cable are made out plastic materials Bleach or alcohol content solutions will damage it Please refer to the recommended disinfecting products list below The sensor head and the cable are watertight but the Gray Connector Section is NOT DO NOT immerse the connector section in the disinfectant for cleaning The sensor housing is fragile DO NOT clean using inappropriate instruments 3 2 5 Recommended disinfecting solutions Do not use aggressive products that may degrade the sensor Preferred disinfectants ANIOXY TWIN ANIOS Laboratories PHAGOCID D PHAGOGENE DEC Laboratories Other authorized disinfectants CIDE
4. Patients Over Last Month rs eb 24 1963 2 1 12 3 19 PM l3 Einstein Albert 1 1 Pantomime Cephina 365236523 Nov 27 1977 2 1 12 3 19 PM l2 Einstein Albert Recent Patients Show All Patients Patient Name Search S Exact Name first last Patient ID Search g Image Comment Search a H Search by Tooth Number 3 Date Range Search Start Date End Date Dentist Name Search Default Dentist please update z STACK AND WORK AREAS Each tab has two main working areas On the right hand side of the area is what is called the Stack The Stack may be collapsed and expanded as needed and has various subjects that are applicable to whatever tab is selected For example in the Patient tab the Stack on the right has search criteria for sorting through patients ID numbers etc One of the features of this Stack is the ability to display DICOM Worklist Patients The area on the left is the working area Both the working area and that Stack area have their own smaller tabs The Diagnosis View tab in particular has a number of smaller tabs in the Stack area that pertain to tools demographics annotations etc Create a New Patient To create a new Patient click the New Patient button cytes SSCS Sean aoc Mobile Phone Mies O O Meee City State Provice ef ag pasta Coes Country e Male Female al Create an Emergency Patient To create an
5. S Tooth Number Editor GN Sch db ae aech Dee S dh e A Den Sc fd FY F EY FJ Fg WEI FJ EEJ ke af ke oe K KE K KA KEEN Jeff 1a 1g CHART VIEW TAB Once a study of images is captured they can be viewed in the Chart View Tab If the images were acquired using one of the Acquisition Templates then they can be viewed in a predefined layout that has been designed for that template This will allow the user to see the images as if they were in an image chart The user can also select any study for the active patient from the study drop down list located in the upper tool bar The rotate and mirror buttons only apply for images that are selected as denoted by a green checkmark K EVAsoft Default Facility please u Demonstration mini 1 eto fF File Edit Image Devices Tools Preview Help Patien Sinatra Frank ie Select patient study to view ec Adjust chart by dragging images within chart or from filmstrip kl DE CHART VIEW TAB TOOLBAR Select patient study to view Current Patient Frank Sinatra EN ICH I KS cl Study May 30 1975 5 54PM Ei mouth Mouth Examination Adds Empty Study Drop Down Current Patient amp Study Layout to study Removes Print Chart Current LayoutFrom Reload Study Images Expand amp Collapse Film Strip wan 20 Send Image An Individual image can be removed from the layout by right clicking on the image and select All selecting the Remove from
6. Send Image or Send Images option is clicked It provides for copying previewing printing e mailing and exporting in a variety of file formats as well as other options Custom Enhancement emer TRANSFER IMAGES WINDOW In order to transfer images from tab to tab between patients into other file formats across the internet andto Send Image EE other locations the Image Transfer System was created SCH e Select All l i l Select All To send an image to a different location right click on the Deselect All image or thumbnail and select the Send Image s item Remove from Chart from the pop up menu HEN 7 C ea 3 Send to Recycle Bin o Send to Recycle Bin This will open the Transfer Images window The selected image s will be shown as well as the options for where that those image s can be sent Click on the location to which you wish to send the image s and it they will be sent directly as in the case of Copy to system clipboard Preview to preview window or Diagnosis View where it lands directly into and launches the Diagnosis View Tab Ta Other options launch further windows from EE S ees es which to work Send Email launches the E available e mail client configure email in Options Atthe same time all the selected images are exported as JPG files placed DICOM Send ina ZIP archive and put on the computer desktop File Export opens a Save dialog Image s
7. connection with or arising from the information contained in this manual Trademarks EVA Dent X and ImageWorks are registered trademarks of SMK Imaging LLC Any additional software products named in this document are claimed as trademarks or registered trademarks of their respective companies Regulatory Notes ImageWorks provides you with the following information regarding the regulatory status of EVAsoft EVA and EVA Select United States of America EVAsoft Digital Imaging Software the application software is included in the premarket notification 510 k for the EVA and EVA Select products which were submitted to the United States Food and Drug Administration and received clearance as Class II Medical Devices The K number for the EVA product is KO30647 The K number for the EVA Select product is K1243419 Canada EVA EVA Select and the application software EVAsoft as EVA Digital Dental X Ray System is licensed for sale and use in Canada This product possesses a Class 2 Medical Device License issued 12 41 2010 by the Therapeutic Products Programme of Health Canada Computer Requirements The computer requirements are documented separately Please contact your dealer ImageWorks or our website at www ImageWorksCorporation com for a copy of these requirements Responsibility for equipment management attributable to the user Each state province and country may have specific requirements to operate the equi
8. Default Facility Demonstration Mode Administrator File Edit Image Devices Tools Preview Help cquir opens j gen lagnosis View A zone Capture Device Configuration jee n Acqusition EE Patient Information Coco Chanel Patient ID 512985698745 Date of Birth May 3 1978 Enter values before exposure Kilo Volts KVP Exposure mAmps Time sec mAs Exposure mAs Source Image Distance Image Laterality Unpaired NOTE If desired enter kVp mAs etc prior to taking the X Ray Caputring an Image The user must complete four steps in order to capture a digital X Ray image The following steps will demonstrate using an EVA sensor After opening the EVAsoft software and logging in the user must l Select the active patient in the Patient Tab 2 Select the correct hardware from the Image Devices drop down menu 5 Go to the Acquire Tab area and select an acquisition template from the menu in the Stack if something other than the default tooth template Is a 4 Select the acquisition mode Either single shot or sequential FMX ro Single Shot Sequential FMX 12 The first step Selecting a patient In the Patient Tab find the desired patient and double click on the patient s name This patient is now Set as the Active Patient See page 13 for detailed description of setting the active patient The second step Select the hardware device that you will be using
9. Emergency patient click the Anonymous Patient button You are about to create an anonymous patient Details about this patient should be filled in later This will create a patient with the Date and Time as the patient s name Use this patient to capture images right away and then update the patient information afterwards Quickly find emergency patients by selecting the Anonymous Patients Only quick search button from the right hand Stack area Patient Image Searching Search tools are divided into two categories quick search buttons and detailed sea Quick Search The user can search for the Patient Name and or Patient ID by entering the text in the corresponding text box and clicking the Find button ie ZE e Only patients with the matching criteria will be displayed The user can also choose dates that images were captured on or in between again clicking the Find button to apply the search Only patients with images captured on the selected date or in the selected date range will be displayed e Use the Dentist Tooth Number and Image Comment searches to only display patients that match those criteria gt e Once a search is complete the list of patients will be displayed Click on the Plus sign next the patient s name to see that Patient Study patient s list of studies and images ga A Monroe Marilyn j en A Search Results S Monroe Marily
10. Export Settings window allows one to choose between the dic and dcm extensions OR no file extension at all when exporting an image in the DICOM format The Patient Setup window allows one to choose whether or not there is automatic incrementing of Patient ID s and what number they start with A Note This is for new patients only A drop down menu allows you to set the default patients displayed in the patient tab Options are Recent Patients Show All Patients Patients Over Last Month Al APPENDIX D conr p TOOLS gt OPTIONS me Chart View Sr Chart View DICOM Export Enable Slow Treatments 3 C Use Thumbnail Images Patient Setup Diii Chart View EVA Preferences Eva Preferences Eva Preferences Use custom EVA filter Create RAW tiff files Poly Filter H Saa a Both On DICOM Export P i Both OPT 2 E Poly Of Patient Setup Chart View Eva Preferences The Chart View options window contains a checkbox that will turn on or off filters that may have been applied from the Diagnosis View Tab Asecond check box allows image thumbnails to be displayed in the chart positions Having this box unchecked allows the charts to load faster EVA Preferences in the Options menu is for technical support only 42 APPENDIX D conr p TOOLS gt OPTIONS Patient Setup EVA Select EVA Preferences W Panoura 185 Re Bet Email Prefere
11. This step is not often required because the software remembers the last device that was selected Go to the Imaging Devices drop down menu and the following window will open Image Devices Tools Preview Help m Select the desired hardware for example EVA The active hardware will be Gs displayed in the title bar of EVAsoft Panoramic e TWAIN 7300 192 168 0 105 TWAIN Note Only hardware that is available on the system will be displayed in this window TWAIN WIA HP Officejet 7300 J Demonstration Mode View Station The third step Select an acquisition template This must be done from within the Acquire Tab The user can choose an Acquisition Template from the drop down list Once a template has been selected the user can remain with the default sequence ofexposures or change the sequence The default template is determined based on the age of the active patient If a patient 12 years old or younger is active the pedo template is shown A Important Note When a template is displayed the first region to be taken will have the numeral 1 shown on it This will be the first of a predetermined order of exposures that are determined in the Layout Editor which will be discussed later This order may be altered immediately prior to taking exposures by clicking on the regions desired Then upon entering the Sequential mode the X rays will be taken in that new order In Single Shot mode subsequent exposures
12. for opening existing reports creating new reports saving as an EVAsoft file printing a PDF file or closing the window Font and Color drop down menus are for font sizing and color bb WS U m WE IE l Ve i 8 d _ Ms Ge Coco Chanell Date of Birth May 3 1978 987 Fancy Lane New York N 55555 55 555 5555 Date of Birth May 3 1978 987 Fancy Lane New York NY 55555 3995 955 5959 Coco Chanel Date of Birth May 3 1978 987 Fancy Lane New York NY 55555 555 555 5555 Date of Birth May 3 1978 987 Fancy Lane New York NY 55555 555 555 5555 a dack 32 APPENDIX C conto NETWORK SETUP EVAsoft can be set up to run in two 2 modes Stand Alone OR Network The mode of operation should be decided atthe time of installation Stand Alone mode Used for any installation that will only use one computer to acquire and view images using EVAsoft Network mode Step One Step Two A NOTE Simply select the Stand Alone mode during the InstallShield window as shown below No additional Steps are required Used for installations where several different computers will be used to acquire and view images with EVAsoft To have multiple computers connect to ONE Shared EVAsoft database one installation must HOST the database The Host computer must ALWAYS be on and EVAsoft must ALWAYS be running The only registration required in network mode is the host This should be d
13. to highlight in the image The user can also Threzhoki select different colors and how far from the original pixel value to highlight This Center filter applies only in a temporary manner and cannot be saved 29 APPENDIX A LAYOUT EDITOR Select Layout Editor from the Edit menu The following window will open Layout Editor EE Erm Layout does not contain a schematic Layout Commands Layout has not been saved New Layout Set Schematic Delete Layou View Region Commands To create a custom layout click on the New Layout button rs If there is an image file you wish to use as the background to the layout select File gt Import Image and import the image into EVAsoft to any tab Then in the layout editor click on the Schematic button and select the imported image file Now add Regions Each region must have a unique name Move the Region marker to the corresponding region in the schematic 30 APPENDIX B PRINT PDF REPORTS From the Patient Tab clicking on the PDF report button will bring up a small word processor as shown File Font Color m 31 APPENDIX B conto PRINT PDF REPORTS There is a filmstrip atthe bottom of this window that contains the radiographs of the current patient study Patient Provider and Facility Information tabs allow this information to be entered easily The File drop down menu provides
14. 2 Created on Mar 20 2015 61 imageWorks Generations of Imaging 8 Westchester Plaza Suite 112 Elmsford NY 10523 Tel 914 592 6100 www ImageWorksCorporation com 62
15. 2 bit 0 to 4095 og APPENDIX E SETTING UP EMAIL Contact your email provider and record the following information for SMTP Your email address Your email Provider s Account Host Your Email Provider s Account Port If youremail using SSL yes no Email password authentication user name typically just the email address Your email password Enter the information into the Email Preferences Dialog accessed through the EVAsoft menu Tools Options email Options GIS gt Outgoing Email Preferences Outgoing Email Preferences Patient Setup Account Description Default Account Email Address EVA Select Account Host Account Port 465 EVA Preferences Use Secure Sockets Layer SSL Password Authentication Username Account Password Email account status Not Verified Email Preferences Click the Verify button to check your connection to the email server Click OK to save the settings and return to EVAsoft 60 APPENDIX E conto USING EMAIL In the filmstrip select one or more images Send the following images from To Custom Enhancement Edit DICOM Header Tags Add the destination email address s and modify the body of the email text as required Click send To Cc BCC Subject EVAsoft Images Attachment s ExamplePatient zip Patient Example Patient Birthday Mar 20 2015 ImageWorks 250 Clearbrook Rad Created on Mar 20 2015 Image
16. Chart option in the pop up menu ee y Send to Recycle Bin Multiple images may be dragged When it says Send Images the plural of Image E Se rd Images on v S from the filmstrip to a single position i means there is more than one image By clicking on on any given chart To reveal select All Send Images the Transfer Images Window should multiple images in a given position Deselect All appear right click on the thumbnail mag EERE E TE The following box should appear i _ 2 Send to Recycle Bin Send Images Clicking above any image in the filmstrip will show this dialogue which allows one to create a filmstrip window that can float above all open applications This is handy for charting etc Send Image Select All Clear Selections Create Filmstrip Window S Filmstrip Window x Send to Recycle Bin The following information applies only when one is in the Chart View Tab Double clicking a radiograph that is on the chart will send all radiographs taken on that chart location to the Diagnosis View Tab in History Mode Only these same images will be displayed in the filmstrip History Mode films is indicated by a blue background on the filmstrip in the Diagnosis View Tab This applies to all studies taken on a given patient TRANSFER IMAGES WINDOW S Transfer Images 53 This window appears when the user right clicks on an image and then the
17. EESE 30 Een tee 30 Equalization SEENEN 30 Flip Rotate eebe 30 Gamma EE 40 Tei pe oiea e z0 ET 7 CH d 9 Ree EEE ERLE EE SEE ESESSESOTESSOSESSSSOSSSSSSOESSSSORESSSSORISSISOSSSSOSOSISSSSOSTOSOSOTSSOSOLISSOSOSISSOSOSTSSOSOSES 3 local linear Seleh aeeiiaii EE e EE S a EEE E EE Or EA E EEES 31 ENRON a ee ree ee 3 Image EENHEETEN 41 Sharpen EE 21 a E 31 Ebene 31 Window Lleve Gamma EE 31 Pseudo COOL EE Treno psec tree cette reese eee ee 31 APPENDIX A TEE 55 Layout Editor sce heute EE Eelere EE EE EEN 33 APPENDICE Gane inerea EREE ES iaia EAEE E SASE ERR AES Z4 Print PDF Reports a EE 24 35 APPENDIX C ee E ee 46 NetWork SETUD xen ger ena ease gogo encom cco tinct este cece rie ee cece 26 37 APPENDIX D edel 48 Tools gt options EE 58 45 EISE eiert 46 EVASE AE EE 46 54 TORN eege ES ERNA ETAST GET 55 60 ABOUT THIS PRODUCT THEORY OF PERFORMANCE The EVAsoft Dental Imaging Software application is designed to acquire display organize store and output digital radiographic images for dental diagnostics The software is a useful interface for all ImageWorks digital dental X Ray imaging equipment In order to capture radiographic and other images EVAsoft must have an active patient selected Once the digital radiographic image and or images are acquired EVAsoft will store the images in the patient database as DICOM files After an image has Deen acquired it is automatically saved and displayed on a computer monitor A suite of
18. File System window allows one to choose the location of the volume and its maximum capacity E APPENDIX D conr p TOOLS gt OPTIONS 4 EVAsoft Claims d V LF Dentist Database Demographics Mai DICOM Export EVAsoft Claims folder C Wsers engtest Desktop dist Demographics Display KN Demographics Display Horizontal Offset 0 00 Vertical Offset 0 00 Line Spacing 0 00 Font Size 0 00 Maximum Lines Per Corner The EVAsoft Claims window allows one to determine the default path where a folder called Claims is located Whenever an image is sent to EVAsoft Claims a new folder is generated under the Claims folder that is the patient s name A file type of JPEG TIFF PNG or DICOM may also be chosen This helps facilitate insurance claims The Demographics Display window allows one to set the horizontal and vertical offsets for type Line spacing relative font size and maximum number of lines for the corner of the image may be specified 40 APPENDIX D conr p TOOLS gt OPTIONS DICOM Export Settings File Extension Type Alternate DICOM Format dc Standard DICOM Format dcm No Extension Chart View Eva Preferences Patient Setup C Automatically increment Patient IDs EVAcoft Claims Starting ID number 100 Demographics Ki Select the default search Recent Patients So F DICOM Export d Patient Setup The DICOM
19. Numbers Default Layout Full Mouth Examination Default Pedo Age 12 Jl Enable System Sounds Sound Types Beeps Automatically restart TWAIN devices Preview Window for Acquire Image Keep On Top The Practice Management Bridge window allows one to choose whether or not the program will be operating in Practice Management Mode as well as whether the program Starts in the Patient Tab or Acquire Tab The Acquire Tab Options window allows one to choose between FDI or US tooth numbering The default layout as well as default age for the pedo toothchart and enabling of systems sounds along with desired sound type may be chosen There is also a check box that can be used to automatically restart Twain devices This is most useful in eliminating the need to constantly click the start button with devices such as cameras 36 APPENDIX D conr p TOOLS gt OPTIONS The Practice Management Bridge window allows one to choose whether or not the program will be operating in Practice Management Mode as Practice Management Bridge well as whether the program Starts in the Patient Tab or Acquire Tab Practice Management Bridge er Enable Practice Management Mode Diagnosis View Select which Tab to start in Patient we PM Bridge The Acquire Tab Options window allows one to choose between FDI or US tooth numbering The default layout as well as default age for the pedo toothchart and enabling of systems sounds along r
20. PORT PROIMAGE DATABASE DICOM SETTINGS OPTIONS Updates launches a web browser and goes to the ImageWorks webpage containing the latest EVAsoft software version Allows the user to select a location to back up all necessary files in case of a Hardware Failure This tool should be used regularly Will verify that a network database connection Is healthy Refreshes the thumbnail images Prompts the Host to fetch all images from this workstation now Will remove deleted image files from the hard drive to free up space for new images Is used for Network Mode It will create copies of all Image files locally to improve the image loading time Can be used to toggle between English and other languages Can be used to adjust your monitor settings for ideal viewing For current Prolmage customers who have upgraded to EVAsoft This will import all Patient and image information into EVAsoft This tool will create NEW image files in DICOM format in the EVAsoft database Please check that you have enough Hard drive space before using this tool It is strongly recommended to contact Tech Support at ImageWorks before attempting to use this tool Additional charges will apply Allows the user to edit the information needed to configure Send Receive and Worklist functions for multiple servers This tool contains a number of general settings that the user can choose from See Appendix D 24 SEND Settings DICOM Conf
21. X OPA JOHNSON amp JOHNSON DENTASEPT ultra ANIOS Laboratories RELYON PERASAFE Phagogene DEC Labs Forbidden products ALCOHOLS Isopropyl Alcohol Methanol SEKUSID N ECOLAB PARAGERM Laboratories SEKUSEPT Easy or Aktiv Ecolab Paragerm Labs FD333 or FD322 DURR DENTAL Laboratories 3 3 Instructions for use handling Please ensure that ALL personnel who use or handle and work around the sensor carefully read and understand the instructions below Following these recommendations will ensure you handle the sensor safely and will ensure you do not shorten the sensor s lifespan 3 3 1 Recommended practices Handling o Always handle and manipulate the sensor with utmost care o Plug and unplug the sensor holding the gray plastic connector not the cable o Ensure that the sensor head never strikes a hard surface for example falls to the floor from a counter o NEVER pull the cable carefully lift the sensor head o Ensure that the cable is not tangled when using It DO NOT bend the cable too severely this can cause permanent damage to the sensor oo Disposables o Use the holders Aiming Aid protection barriers and other disposables supplied with the sensor or recommended by your dealer o Always use the sensor with a holder and protection cap of the proper size o To remove the sensor from the holder grip the sensor carefully and withdraw holder do not pull out by the cable 3 3 2 W
22. anew image is opened in the Diagnosis View Tab the user can click on the Apply Custom Enhancements button under the All Tools wrench icon button and select the name of the group to apply to the image The Apply Custom Enhancements button will remember the last group that was used and show that one at the top of the list until a different group is selected This Grouping also applies to Demographic Information Overlays Add the Demographic information to the Stack and then right click on the image In the Transfer Image window choose the Custom Overlay button Enter a name and click OK DIAGNOSIS VIEW TAB TOOLBARS UPPER j el Size E SEA zl t image y Image dE Save Current Zoom Percentage Image Drag Zoom Print Current Undo Redo Zoom In Magnificatio Image Spotlight View Orignia Zoom Out Modi i Image DIAGNOSIS VIEW TAB TOOLBARS uPPER conT D Fees les Spotli CL Increase L Gamma Image Decrease Measure Gamma Ga All Tools View All Tools Clicking on the View All E 7 Tools button brings up the View All Tools Window Shown Below 18 VIEW ALL TOOLS WINDOW The View All Tools Window features a comprehensive Set of tools Two unique tools are the Toggle Annotations On Off and the Edit Tooth Numbers tools SS All Tools Edit Tooth Numbers Toggle Annotations On Off Clicking on the Edit Tooth Numbers button brings up the following window
23. arnings While in use most accidental damage to the sensor occurs when the cable is lying on the floor or is run across a hallway or other passageway Configuration The installation should be configured in order to avoid e Cables lying on the floor when in use o Running cables across a hallway or other trafficked area Handling The following handling errors could damage your sensor permanently o Pinch sensor or cable severely ex cable pinched in a drawer Pull or bend cable severely Unplug the sensor by pulling the cable Drop sensor see above Rolling over the cable with a chair or walking over it see above Bite sensor or cable The following handling errors could be harmful to the operator and or the patient o Connecting or disconnecting the sensor while electronic interface is powered up o Touching the connector pins o Liquid on the connector for example for cleaning Using a sensor which is nicked cracked deeply scratched on the sensor s head or on the cable or otherwise obviously damaged Disposables The following handling errors could damage your sensor permanently o Removing the protection barrier by pulling the cable o Coiling the cable around the holder during use 3 4 Instructions for storage Please carefully read and follow the instructions below to ensure you handle the sensor safely and do not shorten the sensor s lifespan 3 4 1 Recommended practices Sensor storage between two expos
24. ation among many other features Here are the options offered i General preferences User Login Preferences Disable Use of Passwords Disable Login Entirely Undo Redo Settings Diagnosis View ap PM Bridge Undo Redo Operations L Facility Diagnosis View Settings Grid Layout EC 1 HAT CC 4XRAYS 2XRAYS Sy Feces C Automatically add Custom Overlays ne Select a Custom Overlay General Information PM Bridge Show Stack mm per Screen Pixel Facility The General preferences option allows you to set the number of undo redo operations It also will let you choose whether or not a login is required and if so whether or not a password is required The Diagnosis View window allows one to set the number of millimeters per screen pixel The choice can be made as to whether or nota custom overlay demographics will be displayed on acquired images as a default If so the type of overlay can be specified here as well In addition there are radio buttons at the bottom that allows one to choose the grid layout The grid layout can be set to display one two or four images atatime 35 APPENDIX D cour n TOOLS gt OPTIONS Practice Management Bridge Practice Management Bridge Enable Practice Management Mode Diagnosis View ive Select which Tab to start in Patient we PM Bridge Acquire Tab Options Default Tooth Numbering 0 Use FDI Tooth Numbers Use US Tooth
25. ay plastic connector Running over the cable with chair wheels Catching a loop of the cable in a chair leg 4 DISPOSAL INSTRUCTIONS The sensor head contains potentially hazardous substances material of the scintillator It must to be treated specifically at disposal The cable and connector have to be recycled as electronic waste 5 SAFETY INSTRUCTIONS 5 1 General safety recommendations Carefully read understand and follow the instructions and warnings in section 3 of this document 5 2 Specific safety recommendations a The computer and any associated equipment such as a USB hub shall be placed outside the patient s environment specifically it must be placed more than 5 feet 1 5 meters away from the patient chair The operator shall not touch or hold the patient and such other devices at the same time b The computer and any other associated equipment shall be compliant with IEC 60950 or IEC 60601 c The maximum temperature of the applied part The total surface of the sensor and the first 5 feet 1 5meters of the cable are considered as BF applied part is below 48 degrees Celsius 118 F The applied part shall be in contact with patient less than 10 minutes 48 5 3 Markings BF applied part Warning symbol The accompanying documentation may contain warnings and instructions regarding the safety of the device IP67 symbol The casing of the sensor is IP67 This means that sensor is IP67 totally protect
26. ctromagnetic environment as described below Recommended separation distance for portable and mobile RF communications equipment IEC 60601 4 2 Frequency of 150kHz to 80Mhz 80MHz to 800Mhz 800MHz to 2 5GHz Transmitter d 3 5 V1 eP G55 ieee HSH Gleich Equation Separation distance Separation distance Separation distance Rated Maximum output power of transmitter watts 0 01 0 12 0 12 0 253 0 1 0 37 0 37 0 74 1 ial 117 2 54 10 SO 507 56 100 keem 11 67 25 54 For transmitters with maximum output powered not in the above table the recommended separation distance in meter can be estimated using the formula at the proper frequency where P Is the maximum power in watts W El is 3 V m and V1 is 3 V NOTE 1 At 80 MHz and at 800 MHz the distance of the above frequency range will apply NOTE 2 These guidelines may not apply in every situation Electromagnetic propagation is affected by absorption and reflection from structures objects and people 51 The EVA SELECT sensor is suitable for use in the specified electromagnetic environment The purchaser or user should assure that It is used in an electromagnetic environment as described below Immunity Test Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 IEC 60601 1 2 Test level 3V 150kHz to 80Mhz 3V m 80MHz to 2 5GhZ Compliance Level V1 3V Ells Sug Electromagnetic Environment Portable and mobile RF communication equipments are used no clos
27. e EVA SELECT Digital Dental Imaging by or on the order of a licensed medical professional System is intended to be used with standard dental Other jurisdictions may have similar laws Ensure that X ray systems and computer stations for system you are in compliance with the legal requirements for operation archive data storage digital dental image medical devices in your country and locality input capture and enhancement and patient data and support l COMPUTER REQUIREMENTS See website www imageworkscorporation com for detailed Computer Requirements IMPORTANT If the package or the contents were damaged in shipping do not use Document the damage and contacted the shipper immediately 2 INSTALLATION See installation instructions supplied with the sensor 5 CARE INSTRUCTIONS 3 1 General Precautions The EVA CLASSIC dental intra oral X ray sensor is a sophisticated electronic product incorporating advanced technologies As such it is to be handled with a high degree of care Moreover by design the EVA CLASSIC dental intra oral X ray sensor cannot be used in certain conditions A Note This device cannot be used in anesthetic gas environment 3 2 Cleaning instructions Ensure that ALL personnel who use or handle the sensor carefully read and understand the cleaning and disinfection instructions below Following these recommendations will allow you to clean the sensor Safely for both the sensor and your patients and your staff
28. ed against dust protected against the effect of immersion between 15cm and 1m 5 4 EMC The EVA SELECT sensor is considered as non life supporting equipment While using EVA SELECT sensors adjacent to other equipment attention must be given to ensure that electromagnetic interference EMI does not degrade the performance In particular mobile RF communications equipment can affect medical electrical equipment Please refer to EMC table below Usage limitation The EVA SELECT sensor shall be used with an IEC 60950 or IEC 60601 compliant computer Any other devices connected between the EVA SELECT sensor and the computer for example a USB Hub shall also be compliant with IEC 60950 or IEC 60601 Failure to conform to this may result in degraded electromagnetic compatibility 5 5 FCC Compliant with FCC part 15 class B rules Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment NOTE This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction may cause harmful interference to radio communications However there is no guara
29. ends the image to the printer Save as will open a dialog box that allows you to move the image s to an alternate patient under a new study No demographic data will be changed in this instance Edit DICOM Header Tags will allow you to change metadata embedded within the image but it is strongly recommended that this be done only by those experienced with those features The EVAsoft Claims button will create a folder under the patient s name which in turn will be located in the Claims folder The location of the claims folder is determined by the EVAsoft Claims preferences window under Tools gt Options The selected image s will then be deposited in the folder designated by the patient s name In addition the file type may be JPEG TIFF PNG or DICOM as determined in the EVAsoft Claims preferences window 22 EVAsoft FILE MENU IMPORT IMAGE Can be used to import an image file bass IMPORT DICOM DIR Can be used to import DICOM Import Image directory patient information and Import DICOM Dir image files SWITCH USERS Allows the user to change the user account that is logged in Switch Users CHANGE PASSWORD Can only be used by the Change Password administrator user to change user account passwords Exit EXIT Will close the software EVAsoft EDIT MENU UNDO REDO Will undo or redo the last changes made Undo TRACEABILITY LOGS Brings up a window that facilitates tracking activi
30. er to any part of EVA SELECT sensor including cables than the recommended Separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended separation distance d 3 5 V1 eP d 3 5 E1 eP 80 MHz to 800 MHz d S ENGR S00 MEZ t02 5 GHZ Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m File strengths from fixed RF transmitters as determined by electromagnetic site survey are less that the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and at 800 MHz the distance of the above frequency range will apply NOTE 2 These guidelines may not apply in all the situations Electromagnetic propagation Is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for cellular telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be estimated accurately To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be performed If the measured field strength exceeds the RF compliance level above observe EVA SELECT sensors to verify normal operation in each use location If abnormal performance I
31. es transfer studies 1 f Edit Patient Delete Patient a r Click once on a study and the Thumbnail images will be displayed in the Filmstrip and the patient associated with that study will become the Active Patient as well Patient Tab Toolbar Current Patient Coco Chanelito study selected Patient Information Results of Last Search Print PDF Report Status Box Deselect Patient Button Add Emergency Patient Button Add Patient Button DICOM send must have account server setup Exports a DICOM Directory Exports Files LI Patient selected No Study selected e B Current Patient Coco ChaneliMo study selected BENENE Information Results of Last Search No Patient or Study selected eg B Current Patient Mone Patient Information Results of Last Search Expands the Stack WM Collapses the Stack ACQUIRE TAB The Acquire Tab is where the user can acquire images for the active patient If no active patient is selected the Acquire Module will prompt the user to select a patient or create an anonymous patient to continue In order to acquire images there must be a selected hardware device If a device has already Deen selected it will be displayed in the title bar of the EVAsoft window If no device has been selected the title bar will display View Station See below for more details on selecting a device S EVAsoft
32. et with desired sound type may be chosen Default Tooth Numbering Se There is also a check box that can be used to automatically restart Twain devices This is most usefulin eliminating the need to constantly click the start button with devices such as cameras Use US Tooth Numbers Default Layout Full Mouth Examination Sal Default Pedo Age 2 Jl Enable System Sounds Sound Types Beeps Automatically restart TWAIN devices Preview Window for Acquire Image Keep On Top APPENDIX D conr p TOOLS gt OPTIONS Default Facility Default Facility General Diagnosis View PM Bridge ity that this application is working in Facility Default Dentist Default Dentist Dentist Database Det E eh DICOM Export The Default Facility window allows one to choose a facility from the drop down list The Default Dentist window allows one to choose a dentist from the drop down list 38 APPENDIX D conr p TOOLS gt OPTIONS Ne Dentist nd DICOM Export Database Options User name for database Mode of Operation Network Mode SERVER HOST Network Mode WORKSTATION CLIENT Stand Alone Mode Distributed File System Distributed File System Path for Volume C EVAsoft 2 3 dfs1 Maximum Capacity Value for Volume These options should not be altered except by authorized technical support or IT personnel The Distributed
33. face Each tab is designated a specific set of tasks There are two general areas within each tabbed area To the left is the main imaging area or screen To the right is an expandable and collapsible smaller area referred to as the Stack The Stack usually contains certain tools or options that directly pertain to the purpose of the main tab that it falls under For example patient search criteria are found under the Stack of the PATIENT tab Tooth charts patient information exposure details etc are found under the Stack of the ACQUIRE tab Tools demographics and annotation tools are found under the Stack of the DIAGNOSIS tab There are also SuD tabs present in both the main window and sub windows as well as in the Stack areas The Patient Tab is designed for designating the active patients as well as accompanying active studies Additions of new patients either with full information or emergency patients whereby their information may be filled in later editing existing patient information and conducting various searches under a wide variety of criteria are all possible within this section The Acquire Tab is designed for the purpose of acquiring images The user is presented with a number of acquisition templates from which to choose from a drop down list in the Stack From the template the user may decide to remain with the default sequence of exposures or select a new one In addition to sequential mode is the Endo mode This all
34. ffect medical electrical equipment Please refer to EMC table below Usage limitation The EVA CLASSIC sensor shall be used with an IEC 60950 or IEC 60601 compliant computer Any other devices connected between the EVA CLASSIC sensor and the computer for example a USB Hub shall also be compliant with IEC 60950 or IEC 60601 Failure to conform to this may result in degraded electromagnetic compatibility OPERATING RANGE AND ABSOLUTE MAXIMUM RATING 6 1 Operating range Room temperature 5 Cto 35 C Room humidity 5 to 85 Operating temperature 5 C to 40 C 6 2 Absolute maximum ratings Storage temperature 10 Cto 50 C Storage humidity 10 to 80 Transport temperature 10 C to 50 C Transport humidity 10 to 80 Transport ambient pressure 50 kPa to 106 kPa Maximum applied voltages 5V USB Maximum total dose irradiation 20 Gy over product life Perishablity Not applicable products are not perishable Foodstuffs 58 TECHNICAL SPECIFICATIONS subject to change Sensor Type CMOS Interface Type USB 1 1 Sensor Sizes Size 1 Pedeo 38 4 mm L x 25 6 mm W xX 5 mm Thick Size 2 Adult 44 mm L x 30 8 mm W x 5 mm Thick Image Acquisition Area Size 1 Pedeo 30 mm L x 20 mm W Size 2 Adult 36 mm L x 25 8 mm W Capsule Cable length 2 meters 6 feet Pixel Size 30 microns Sensor Resolution 16 6 p mm theoretical optical 12 0 p mm actual Sensor Dynamic Range 1
35. iguration Settings Windows Server Information DICOM Auto Send Enable Name for Server Remote AE Title DICOM Server Address DICOM Server Port Local AE Title Revy Wat Tene mien Recieve Settings DICOM Configuration Settings Changes to these setting will take effect the next time you start the Software Folder Name EVAsoft PREVIEW MENU Preview Manage Clear All Windows keep On Top Herb 1 Chr Ctri 1 EVAsoft PREVIEW MENU Online Documents and Videos User s Manual Remote Technical Support License Registration About EVAsoft MANAGE CLEAR ALL WINDOWS ONLINE DOCUMENTS AND VIDEO USER S MANUAL REMOTE TECHNICAL SUPPORT LICENSE REGISTRATION ABOUT EVASOFT Allows the user to create or delete preview windows As the windows are created they will be appended to the preview menu Will clear all images from the active preview windows Will launch the default internet browser and open the www ImageWorksCorporation com website and the EVAsoft support page Requires internet connection Launches the User Manual Opens the remote support login page manned by ImageWorks technical support representatives during normal business hours Requires internet connection Allows the user to enter the serial number that came with the EVAsoft CD Based on this number the software generates a Challenge Code Both numbers must be supplied to ImageWorks either o
36. image processing tools are available for the operator to enhance the displayed image for their particular diagnostic analysis Such enhancement tools include but are not limited to Magnify Gamma Window and Level Linear Stretch and Equalize Each anatomical template used to acquire digital X ray images has a layout for viewing the images together The Chart View tab allows the user to view the selected patient s images in these pre defined layouts EVAsoft also implements specific DICOM operations Please refer to the EVAsoft DICOM Conformance Statement for details IMPORTANT CONSIDERATIONS The software is intended for dental professionals and not intended to replace the skill and judgment of a qualified dental practitioner The software should only be used by people who have been appropriately trained in the software s functions capabilities and limitations The users should be aware of the limitations in the accuracy and correctness of the output data displayed on the screen printed or exported from EVAsoft The quality of the image and text data is dependent on quality and accuracy of the input data the user s interaction with the data the quality characteristics and settings of the display device or printer and the necessity to interpolate the data for display purposes While EVAsoft has been extensively tested it is impossible to completely test any piece of software and errors may remain in the software It is possible that an error co
37. llimeters USM between two points on the image This y is a relative calibration which is not Windows Leed Gamma traceable IMAGE MEASUREMENT Measures the distance between up to 10 points on a calibrated image Due to the possibility of geometric distortion in the radiograph use caution when interpreting measurements SHARPEN Performs a High Pass filter operation SOFTEN Performs a Low Pass filter operation USM Unsharpen Mask A technique used to enhance the edges of an image The unsharpen mask tends to show more details in areas of an image that are normally more difficult to see WINDOW LEVEL GAMMA Adjusts window level and gamma settings in one user interface e Window Level Gamma D CT SOME FILTER ANALOGIES LOW PASS HIGH PASS e Dass e treble e Opaque e transparent e muted dull e intense vivid e Soft e harsh edgy e blurry e Sharp e pliable e brittle 28 ENHANCEMENT TOOL DESCRIPTION conto RGB 8 bit per channel PSEUDO COLOR AND THRESHOLD May be found in the All Tools Window accessed by clicking on this icon found in the Diagnosis View Tab PSEUDO COLOR Apply color to a grayscale image with RGB 8 bitper channe matching grayscale intensities assigned one color This filter applies only in a temporary manner and cannot be saved HISTOGRAM This shows a graphical representation of the image data THRESHOLD Selects a pixel intensity value
38. m m Gamma cama w g U1 LU al 1 00 2 45 6 00 Bone Soft Tissue Angle Measurement Brightness Contrast Gamma Crop Salt amp Pepper Filter Edge Enhance Equalization Flip Rotate Gamma Invert Linear Stretch Local Linear Stretch Physical Image Calibration Physical Image Measurement Sharpen Soften LSM WindowyLevel Gamma After each tool has been adjusted the user can click on the red bar and it will become gray and inactive The user can click on the Enable All or Disable All buttons which will toggle all enhancements on and off 16 ANNOTATION TOOLS TAB To apply annotation tools click on the Annotations Tab in the Stack area Then click the Add button and you will get a list of Annotation tools to choose from E De Annotations Pointer Mote Text Mote Box Applied Tools Tools Demographic Info Line Annotations Tab Demographic Info Tab Left Marker Right Marker Oval Annotations List DEMOGRAPHIC DATA OVERLAYS ion To apply demographic data overlays onto the image click on the Demographic Info Tab in the Stack area Then click on the Add button and select the Demographic Overlay menu item The demographic overlay tool will be added to the Stack The user can choose what data information to display from the Demographic Overlay Window drop down list The user can also choose what corner of the image to display the information Click on Done to fini
39. ministrator ooo ii File Edit Image Devices Tools Preview Help Diagnosis View Ge lt q lt lt Manily n Name Mor TOS faril er Kn Date P Coure d February 1 204 Qe ime Image Acquired 3 49 255PM EST SC OAR TRY RET Above the image are several tool buttons To the right of the image is the Stack The Stack contains all the image manipulation tools annotation tools and demographic information overlay tools The Stack area Is minimized by default to allow the image to have maximum viewing area Bg Simply click on the collapse expand buttons d To apply an enhancement tool from the Toolbox click onthe add Dutton and select the tool from the list that appears This will add the tool to the Stack The Stack performs each tool in order from top to bottom Full _ descriptions of each tool can be found in the Enhancement Tool Descriptions section of this document 15 Drop down list of tools that appears in the Stack from clicking on the Add a new operator to the Stack Dutton Enable all operators in the Stack Disable all operators in the Stack e lk Remove all operators from the Stack APPLIED TOOLS TAB EE Applied Tools annotations Demographic Info Physical Image Calibration windowiLevel gamma Flip Rotat Here is an example of the Gees Gamma tool being chosen Note bar that indicates it is active P P P P hd ORO n
40. n Ee Pantomime Cephina Selecting the Active Patient and Study eStart in the Results of Last Search sub tab e To select the Active Patient the user must double click on the patient s name To select the Active Study the user must single click on the study name e To launch the study in the Chart View Tab the user must double click on the study eRight clicking on an active study will bring up the Edit Study Name button and display the DICOM Study accession number for PACs Worklist Integrations eLeft clicking on that button will bring up the Edit Study Name window e Use the Clear button to deselect the Active patient and study 10 Click on the Patient Information sub tab to edit or delete that information The Merge Study button allows one to combine multiple Studies into a single study The Transfer Study button allows one to transfer a study from one patient to another Results of Last Search Coco Chanel Patient ID 512985698745 Number of studies 2 Last study on Wednesday February 1 2012 3 19 PM 2nd to last study on Wednesday February 1 2012 3 19 PM Dentist Einstein Albert Gender F Social Security Number Date of Birth May 3 1978 Referring Physician Name Dr Roberts Comments Address 987 Fancy Lane New York NY 55555 Phone Day 555 555 5555 Phone Evening Phone Mobile E mail cchanel imageworkscorporation com Insurance merge studi
41. nces Patient Setup EVA Select EVA Preferences Email Preferences eo EVA SELECT CONTROLS EVA SELECT CONTROLS Integer Mode Max between TWI and X Detection m Integration Time ms 350 ep E Auto Re Arm Binning Mode E Chaining Offset Manual Chain Offset mv 0 Gain 45 m Trigger Mode XVIS Detection aa Trigger Level 250 mw e Panoura 18S Preferences Panoura 185 Preferences Device Name Panoura 185 Program to launch WWOSHIDA DENTAL mageWorks PANOURA Software S Starter XSRun exe Apply pre treatments to all Panoura 185 images The EVA Select Controls are for technical support use only The Panoura 18S Controls are for technical Support use only 43 APPENDIX D conr p TOOLS gt OPTIONS E Options el I Ea E d Outgoing Email Preferences Outgoing Email Preferences serie OO Account Email Address Pe EE Account Port 5 EVA Preferences Use Secure Sockets Layer 55L Account Password Email account status Not Verified EVA Select Email Preferences Enter the email settings for your account as Supplied by your provider such as gmail Click the Verify button to connect to the email account and check the settings 44 EVA SELECT amp EVAsoft SUPLLEMENTAL INFO APPENDIX ImageWorks Seu z CT Generations of Imaging Caution US Federal Law restricts this device to sale Indicati
42. nline or by phone to receive the activation code that will register the software installation Tells the user information about the software 26 ENHANCEMENT TOOL DESCRIPTION Angle Measurement Brnghtness Contrast Gamma Crop Despeckbe Filter Edge Enhance Equalization Hip Rotate Gamma Invert Linear Stretch Local Linear Stretch Image Calibration image Measurernert Soften Windows Leve Gamma Sa Brightness Contrast Gamma deu ffe ny ANGLE MEASUREMENT BRIGHTNESS CONTRAST GAMMA CROP DESPECKLE FILTER EDGE ENHANCE EQUALIZATION FLIP ROTATE GAMMA INVERT LINEAR STRETCH LOCAL LINEAR STRETCH IMAGE CALIBRATION IMAGE MEASUREMENT Measures a single angle on the image This is a combination tool that allows the user to adjust the contrast and brightness without saturating the image The gamma level can also be adjusted in this tool Select an area of the image to which to apply the image manipulation tools Smooth areas in which noise is noticeable while leaving complex areas of the image untouched The effect is that grain or other Salt amp Pepper noise is reduced without severely affecting edges Enhances the local discontinuities atthe boundaries of different objects edges in the image to make the edges more visible to the human eye Linearizes the number of pixels in an image based on the specified RGB YUV or GRAY color space This can be u
43. ntee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver 49 Connect the equipment into an outlet on circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help 5 5 FCC Table according to IEC60601 1 2 Ed2 consists of The EVA SELECT sensor is suitable for use in the specified electromagnetic environment The purchaser or user should assure that it is used in an electromagnetic environment as described below Emmissions Test Compliance Electromagnetic Environment Radio Frequency Group 1 The EVA SELECT sensor does not use Emissions radio frequency energy Therefore radio CISPR11 frequency emissions are very low and will not interfere with other nearby electronic products Radio Frequency Class B Emissions The EVA SELECT sensor is suitable for use CISPR LIL in all establishments including domestic establishments and those directly Harmonic Not Applicable connected to the public low voltage Emissions power supply networks that supply IEC 61000 3 2 buildings used for domestic purposes Voltage fluctuati
44. olutions Do not use aggressive products that may degrade the sensor Preferred disinfectants ANIOXY TWIN ANIOS Laboratories PHAGOCID D PHAGOGENE DEC Laboratories Other authorized disinfectants CIDEX OPA JOHNSON amp JOHNSON DENTASEPT ultra ANIOS Laboratories RELYON PERASAFE Phagogene DEC Labs Forbidden products ALCOHOLS Isopropyl Alcohol Methanol SEKUSID N ECOLAB PARAGERM Laboratories SEKUSEPT Easy or Aktiv Ecolab Paragerm Labs FD333 or FD322 D RR DENTAL Laboratories 3 3 Instructions for use handling Please ensure that ALL personnel who use or handle and work around the sensor carefully read and understand the instructions below Following these recommendations will ensure you handle the sensor safely and will ensure you do not shorten the sensor s lifespan 3 3 1 Recommended practices Handling o Always handle and manipulate the sensor with utmost care Plug and unplug the sensor holding the gray plastic connector not the cable e Ensure that the sensor head never strikes a hard surface for example falls to the floor from a counter o NEVER pull the cable carefully lift the sensor head o Ensure that the cable is not tangled when using It DO NOT bend the cable too severely this can cause permanent damage to the sensor 46 Disposables o Use the holders Aiming Aid protection barriers and other disposables supplied with the sensor or recommended by you
45. on and flicker test IEC 61000 3 3 Not Applicable The EVA SELECT sensor is suitable for use in the specified electromagnetic environment The purchaser or user should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Compliance Electromagnetic Environment test level test level Electronic 6kV contact 6kV contact Floors are wood concrete or ceramic discharge discharges discharges tile or floors are covered with synthetic ESD IEC 8kV air 8kV air material and the relative humidity is at 61000 4 2 discharges discharges least 30 percent Electronic fast 2kV power 2KV power Mains power quality is that of a transient supply lines supply lines typical commercial and or hospital IEC61000 4 4 f 1kV input environment input output lines output lines Power 3 A m 3 A m Power frequency magnetic fields are at frequency level characteristics of a typical location 50 60HZz in a typical commercial and or hospital magnetic field environment IEC61000 4 8 Surge 1kV differential NotApplicable IEC61000 4 5 mode 2KV common mode 50 Voltage dips gt 95 dip during Not Applicable and short 0 5cycle interruption 60 dip during 5 IEC61000 4 11 cycles 30 dip during 25 cycles gt 95 dip during 5s The EVA SELECT sensor is suitable for use in the specified electromagnetic environment The purchaser or user should assure that it is used in an ele
46. one first before installing any of the clients The first installation should be done on the computer preferably a server that will be hosting the Database Choose the Network Mode and Host the database option during the InstallShield window as shown below All additional computers should be installed as clients to do that select Network Mode and connect to already hosted database option during the InstallShield window as shown below The mode of operation whether it is Network or Stand Alone has nothing to do with EVAsoft s ability to send DICOM images over an existing network Network mode is simply to ensure that multiple installations of EVAsoft can utilize a central or common HOST database Setup Type Select the setup type that best suits Your needs Ev soft can be installed as a stand alone system or op a network system For Each network svstem exaclty ONE installation must HOST the shared database All other systems should be installed in network mode connecting to the already hosted database Please make your selection and click Next to continue C Network Mode and Host the database Server C Network Mode and connect to already hosted database Client InstallShield 33 APPENDIX C cont d In order for all the CLIENT computers to find the HOST the user may need to enter the computer name of the Host computer server To find the computer name right click on My Computer and select Properties f
47. onencendanused vaste dadGeneendasamdtngdaedensnbisha Miedo neebayutencpanage paaieneoaiuend iadgdahe cnpbhmepbndddadendendananiubdeecennte 4 5 ABOUT THIS PRODUCT ee e Product Registration Eder 6 EVASOETOVERVIEIU EE 7 EVASOFT LOG IN FEATURE ccc ctr ttt ttt titer et eerie ieee ieee nceaciaceaciataeiseiseiseiseiseiseiceaciacscatatiseiseieeieein ey 8 9 ETAL TAD DESCRIPTIONS ererek eee 10 Patient Tab e E E E A E N A EE E EE E E E E ncaa 10 SCAK WOK ATOT Eos ea E E arse aoe eet me ede 10 reJ ea Now Paen secese EEEE EES 11 Patient Image Searching EE 12 Selecting the Active Patient and Study E 13 Patient Tab Toolbar E E 14 Acquire Tab E E E echte gert gege hee deed AE dee 15 EE phe 62 ret aE E Aaa EE aree 15 Acquire TU EE eE ect ee cece sence eee eect EEE O EEEE E E 17 Diagnosis EQUA Er E 18 eerste Rer E 20 Diagnosis EE Care ae e 21 View All Tools and Tooth Number Editor WMG OWS eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeereseeeernssseensssseenssssseenrsssseeene 22 CPE VII DS TOO ea E E A E E 23 THE IMAGE TRANSFER SYSTEM emeng 25 EUASOFT FEMEN NET 26 Cs gy EDIT NENU eege 26 EVASOFT IMAGE DEVICES MENU EEN 26 PURSOET TOOLS MENG ET 27 DICOM Configuration Settings Menu EE 28 EVASOFT PREVIEW amd HELE MENI EE 29 ENHANCEMENT TOOL DESCRIPTIONS ccc errr inseseiseieersereeresnesnessesenseseseneey z0 PAV ATG Comm L t D I CT LEI 30 Brightness Contrast Gamma EE 30 Crop ee 40 Despeckle POT rena EE A E EEEE E EEE EEE EEEE E
48. ons The EVA SELECT Digital Dental Imaging by or on the order of a licensed medical professional System is intended to be used with standard dental Other jurisdictions may have similar laws Ensure that X ray systems and computer stations for system you are in compliance with the legal requirements for operation archive data storage digital dental image medical devices in your country and locality input capture and enhancement and patient data and support l COMPUTER REQUIREMENTS See website www imageworkscorporation com for detailed Computer Requirements IMPORTANT If the package or the contents were damaged in shipping do not use Document the damage and contacted the shipper immediately 2 INSTALLATION See installation instructions supplied with the sensor 5 CARE INSTRUCTIONS 3 1 General Precautions The EVA SELECT dental intra oral X ray sensor is a sophisticated electronic product incorporating advanced technologies As such itis to be handled with a high degree of care Moreover by design the EVA SELECT dental intra Oral X ray sensor cannot be used in certain conditions A Note This device cannot be used in anesthetic gas environment 3 2 Cleaning instructions Ensure that ALL personnel who use or handle the sensor carefully read and understand the cleaning and disinfection instructions below Following these recommendations will allow you to clean the sensor Safely for both the sensor and your patients and your s
49. ows the user to take exposures on a given tooth one ata time or select the sequence on the fly The Stack Under the Acquire Tab also has flelds for entering information about exposure data This information should be entered just prior to each exposure if desired and as such will then be automatically added to each image in their corresponding DICOM tags The Diagnosis View Tab is designed to allow the user to view and edit one image at atime All of the image enhancement tools and filters are located in this tab as well as annotation tools and demographic data overlays The Chart View Tab is designed to view images from a study in a predefined layout The user can also drag and drop images into different positions on the chaft EVASOFT LOG IN FEATURE EVAsoft has the optional use of login accounts It is recommended that each user create an account name and password At start up EVAsoft displays the Login window shown below The login system can be set up to require user names and passwords user names without passwords or no user name OF Password Welcome To begin please login Username admin Use of login password and or use of logins can be disabled in the Tools gt Options dialog under general settings Note Must be logged in as the admin user to adjust these settings To add user accounts and or edit user accounts including setting up passwords go to Edit gt User Accounts G Edit Users LEI tse
50. pment The intended users of this equipment should be medical professionals who are familiar with and comply with the relevant local laws and regulations when operating the equipment The user is also required to use and maintain this equipment as described in this manual Required Maintenance and Inspection EVAsoft Software is designed to be operated on a PC type computer running one of the approved operating system versions Daily Backup data database and images at a minimum Monthly Upload and apply Operating system patches and security fixes Check the free capacity of the hard drives particularly on the server host Check the validity of the daily backups Annually Check for updates on the ImageWorksCorporation com web site Review the list of users and if necessary passwords Actions To Be Taken In The Case Of An Accident In the event of an accident immediately stop using the equipment Provide appropriate first aid and other emergency medical assistance as required by the accident conditions If necessary turn off and disconnect the equipment Shutdown and power down the computer Immediately contact the dealer where the equipment was purchased If you cannot contact the dealer contact ImageWorks ay Ds TABLE OF CONT REVISION RECORD and REGULATORY NOTES 2 COMPUTER REQUIREMENTS EE z REQUIRED MAINTENANCE ee Z Ainea WR ene cect E A OEE E E EAA A AE EE E z TABLE OF CONTENTS ici riiecscecciweiepactencerdavac
51. r dealer o Always use the sensor with a holder and protection cap of the proper size o To remove the sensor from the holder grip the sensor carefully and withdraw holder do not pull out by the cable 3 3 2 Warnings While in use most accidental damage to the sensor occurs when the cable is lying on the floor or is run across a hallway or other passageway Configuration The installation should be configured in order to avoid e Cables lying on the floor when in use e Running cables across a hallway or other trafficked area Handling The following handling errors could damage your sensor permanently o Pinch sensor or cable severely ex cable pinched in a drawer Pull or bend cable severely Unplug the sensor by pulling the cable Drop sensor see above Rolling over the cable with a chair or walking over it see above Bite sensor or cable The following handling errors could be harmful to the operator and or the patient e Connecting or disconnecting the sensor while electronic interface is powered up e Touching the connector pins o Liquid on the connector for example for cleaning e Using a sensor which is nicked cracked deeply scratched on the sensor s head or on the cable or otherwise obviously damaged Disposables The following handling errors could damage your sensor permanently o Removing the protection barrier by pulling the cable o Coiling the cable around the holder during use 3 4 Instructions fo
52. r storage Please carefully read and follow the instructions below to ensure you handle the sensor safely and do not shorten the sensor s lifespan 3 4 1 Recommended practices Sensor storage between two exposures e Leave the sensor plugged into the PC o Store the sensor in a holder or a hook fixed on the wall o Coil the cable in large loops one or two loops in order to avoid the cable lying on the floor Sensor storage between two patients or for the night o If possible leave the sensor plugged into the PC same as above 4 o If you have to move the sensor to another room O Unplug the sensor carefully O Coil the cable in large loops in order to avoid the cable lying on the floor O Store the sensor in a holder or a hook fixed on the wall o If you have to store the sensor on a shelf or drawer package the sensor well to provide cushioning and avoid shifting and make large loops with the cable nine inches or 20cm diameter if possible 3 4 2 Warnings When notin use most accidental damage to the sensor occurs when the sensor falls off a counter or the cable is too tightly coiled Please make sure to avoid the following configurations Using a very tight box to store the sensor Storing the sensor freely on a table countertop or a shelf Running or looping the cable near or over drawers you could pinch the cable Storing several sensors on the same hook Curling the cable in tight loops for example around gr
53. rom the pop up menu Click on the Computer Name tab as shown below The full computer name should be entered on the client computers if EVAsoft cannot automatically find the Host fe eeng Gur t Control Panel All Control Panel Items rt System Control Panel Home View basic information about your computer Kl Device Manager Windows edition D Remote settings Windows 7 Professional DN System protection Copyright 2009 Microsoft Corporation All rights reserved e Advanced system settings Service Pack 1 Get more features with a new edition of Windows 7 System Rating EI Windows Experience Index Processor Intel R Core TM 17 2600K CPU 3 40GHz 3 40 GHz Installed memory RAM 16 0 GB System type 64 bit Operating System Pen and Touch Pen Input Available Computer name domain and workgroup settings Com D uter Computer name HERR bt Change settings Name Full computer name HERR DC Computer description Workgroup WORKGROUP See also Kian Center Windows activation Windows Update Windows is activated ask Tor 5 Cnuine Performance Information and Product ID 00371 177 8807595 85198 Change product key g Microsoft Tools Ce Learn more online 34 APPENDIX D TOOLS gt OPTIONS EVAsoft has a set of option preferences that can be set for various default values used within the software These can range from pixel sizing on the monitor used to acquisition preferences to login and password inform
54. s observed additional measures may be necessary such as reorientation or relocation of the EVA SELECT sensors slo gle ae Over the frequency range 150kHz to 80Mhz field strength is less than V1 V m 32 OPERATING RANGE AND ABSOLUTE MAXIMUM RATING 6 1 Operating range Room temperature 5 Cto 35 C Room humidity 5 to 85 Operating temperature 5 C to 40 C 6 2 Absolute maximum ratings Storage temperature 10 Cto 50 C Storage humidity 10 to 80 Transport temperature 10 C to 50 C Transport humidity 10 to 80 Transport ambient pressure 50 kPa to 106 kPa Maximum applied voltages 5V USB Maximum total dose irradiation 20 Gy over product life Perishablity Not applicable products are not perishable Foodstuffs TECHNICAL SPECIFICATIONS subject to change Sensor Type CMOS Interface Type USB 2 0 Sensor Sizes Size 1 Pedeo 36 73 mm L x 24 35 mm W x 5 41 mm Thick Size 2 Adult 42 80 mm L x 30 49 mm W x 5 41 mm Thick Image Acquisition Area Size 1 Pedeo 30 02 mm L x 19 95 mm W Size 2 Adult 36 00 mm L x 25 99 mm W Capsule Cable length 3 meters 9 8 feet Pixel Size 19 microns Sensor Resolution 26 5 lp mm theoretical optical 20 0 lp mm actual Sensor Dynamic Range 12 bit 0 to 4095 53 EVA amp EVAsoft SUPLLEMENTAL INFO ImageWorks Generations of Imaging Caution US Federal Law restricts this device to sale Indications Th
55. sed to bring out the detail in dark areas of an image Change the orientation of the image Options include mirroring horizontally and vertically as well as rotating by 90 180 or 270 degrees Increase or decrease the level of Gamma correction which changes the contrast of the mid range image data This helps distinguish bone from soft tissue Inverts the colors in the image so that a positive image becomes a negative and a negative image becomes a positive Maximize the contrast of the image by stretching a selected portion of the image histogram across all possible values in a linear fashion Avery sophisticated linear stretch performed on multiple smaller overlapping areas of the image Enter the known distance in millimeters between two points on the image This is a relative calibration which is not traceable Measures the distance between up to 10 points on a calibrated image Due to the possibility of geometric distortion inthe radiograph use caution when interpreting measurements 27 ENHANCEMENT TOOL DESCRIPTION cont LINEAR STRETCH Maximize the contrast of the image Linear stretch by stretching a selected portion of the Local Linear Stretch image histogram across all possible Image Calibration values in a linear fashion ECKE LOCAL LINEAR STRETCH Avery sophisticated linear stretch performed on multiple smaller Sharpen overlapping areas of the image Soften IMAGE CALIBRATION Enter the known distance in mi
56. sh the operation After the desired operators have been applied to the image click the savebutton to save the changes This save action will add the tools from the Stack into the patient database The next time the user opens that image the tools will automatically be re applied to the image and added to the Stack s Demographic Overlay Ad Important Note No changes are ever made to the actual Image Location Upper Left Image File All tools that are applied to the image are saved in the database When the image is opened again the tools are re applied to the original image data Note Demographic information goes here A To see the original image again the user can simply turn off all the items in the Stack by clicking on either the Disable all Stack items button or Modified Original button 17 GROUPING ENHANCEMENT TOOLS FOR FUTURE RE USE lh The user can save the enhancement tools and the adjustments made to those tools so that they can be applied to other images To save the grouped set of the enhancement tools which are currently in the Stack simply right click on the image and select the Send to option from the pop up menu The Transfer Image window will open Click on the Custom Enhancement button Add New will appear The Custom Enhancement Label window will open where the user can assign a name to the new group of enhancements Then click OK When
57. taff 3 2 1 Recommended practices e The EVA SELECT dental intra oral X ray sensor is NOT supplied as a sterile medical device Disinfect the sensor before first use and subsequently before using with every new patient e Always use protecting gloves when using cleaning or disinfecting the sensor e Use anew disposable protection barrier at every sensor usage This protection must be biocompatible following the standard ISO 10993 1 45 Cleaning by wiping the sensor s head and the first 5 inches 10 cm of the sensor cable with a compress moistened with a disinfecting solution is permitted Disinfection by immersion in a disinfecting solution is allowed for the EVA Select Do not immerse the sensor if there are nicks or deep scratches on the sensor head Only immerse the sensor head and cable NOT the gray plastic connector section 3 2 2 Warnings The EVA SELECT dental intra oral X ray sensor is not designed for high temperatures DO NOT sterilize the sensor using an autoclave or a UV oven The sensor housing and the cable are made out plastic materials Bleach or alcohol content solutions will damage it Please refer to the recommended disinfecting products list below The sensor head and the cable are watertight but the Gray Connector Section is NOT DO NOT immerse the connector section in the disinfectant for cleaning The sensor housing is fragile DO NOT clean using inappropriate instruments 3 2 5 Recommended disinfecting s
58. tillator It must to be treated specifically at disposal The cable and connector have to be recycled as electronic waste 5 SAFETY INSTRUCTIONS 5 1 General safety recommendations Carefully read understand and follow the instructions and warnings in section 3 of this document 5 2 Specific safety recommendations a The computer and any associated equipment such as a USB hub shall be placed outside the patient s environment specifically it must be placed more than 5 feet 1 5 meters away from the patient chair The operator shall not touch or hold the patient and such other devices at the same time b The computer and any other associated equipment shall be compliant with IEC 60950 or IEC 60601 c The maximum temperature of the applied part The total surface of the sensor and the first 5 feet 1 5meters of the cable are considered as BF applied part is below 48 degrees Celsius 118 F The applied part shall be in contact with patient less than 10 minutes 5 5 3 Markings BF applied part Warning symbol The accompanying documentation may contain warnings and instructions regarding the safety of the device 5 4 EMC The EVA CLASSIC sensor is considered as non life supporting equipment While using EVA CLASSIC sensors adjacent to other equipment attention must be given to ensure that electromagnetic interference EMI does not degrade the performance In particular mobile RF communications equipment can a
59. ty within the program such as log ins and outs new image Tracability Logs acquisitions etc See Appendix A for USER ACCOUNTS more details een DENTIST LIST AND Allows the user to edit the Dentist List FACILITY LIST information and add new items Facility List LAYOUT EDITOR Tool is useful for creating new Acquire Template layouts See Appendix A for more details IMAGE RECYCLE BIN Allows the user to undelete images Image Recycle Bin or completely remove images from CUSTOM OVERLAYS the EVAsoft database CUSTOM ENHANCEMENTS Overlays and Enhancements that have been created by a user can be edited Layouk Editor Custom Overlays Custom Enhancements EVAsoft IMAGE DEVICES MENU Image Devices IMAGE DEVICES Used to select a hardware device to i capture images with This is where you switch between input devices such as x ray sensors intra oral cameras or digital panoramic x rays Demonstration Mode view Station 23 EVAsoft TOOLS MENU Is Preview Help Check For Updates Back up Utility Check Database Connection Hard Drive Clean up Update Thumbnails Sync Images Now Replicate All Files Locally Change Language Monitor Calibration Import Prolmage Database DICOM Settings Options CHECK FOR UPDATES BACK UP UTILITY CHECK DATABASE CONNECTION UPDATE THUMBNAILS SYNC IMAGES NOW HARD DRIVE CLEAN UP REPLICATE ALL FILES LOCALLY CHANGE LANGUAGE MONITOR CALIBRATION IM
60. uld manifest as an incorrect measurement or image Users must be aware of the potential for errors EVAsoft saves images together with patient information as DICOM files both when saving to the local database and when exporting from EVASoft It is important and in some jurisdictions legally required that this data is protected from access by unauthorized persons Users should be aware that certain views make use of interpolated data This is data that is created by EVAsoft based on the original data set Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the imaging display resolution may be present On occasion interpolated data may also include image artifacts which should not be interpreted as real pathology PRODUCT REGISTRATION EVASoft requires a license to use beyond the 40 day full version trial period To register your EVAsoft Software via the internet go to Help gt License Registration or call ImageWorks technical support and register over the phone Note if you are using EVAsoft in networked mode only the Host requires registration FOR MOST CURRENT INFORMATION ON THIS SOFTWARE PLEASE VISIT OUR EVASOFT SUPPORT PAGE AT WWW IMAGEWORKSCORPORATION COM EVASOFTSUP CONTACT INFORMATION Technical Support 1 914 592 6100 E mail support imageworkscoroporation com Web www ImageWorksCorporation com EVASOFT OVERVIEW EVAsSoft has been designed using a tabbed inter
61. ure or capture Next BitevVing Auto capture mode stopped ACQUIRE TAB STACK Select an Acqusition Template Full Mouth Examination w Anatomical Schematic AUDE IT TRI 5 j TET AUT Bite wing hd Patient Information Herb L Clay Patient ID 26160629364481 Date of Birth Nov 1 1960 hd Capture Device Configuration Eva Control Panel For EVA Mo controls are available For this device Exposure Data Enter values before exposure tee OOOO O OS Source Image Distance Po lt gt z Expand Collapse Stack Buttons 14 ACQUIRE TAB TOOLBAR At any time the user can double click on a thumbnail from any filmstrip and it will automatically open in the Diagnosis View Tab in Study Mode Thumbnails for all the images in the currently selected study are displayed in the filmstrip along the bottom of the screen To view images of the same tooth position from different studies for example from this year and last year double click on an image position in the Chart Tab and the image will open in Diagnosis View Tab in History Mode Study Mode has a Gray filmstrip and History Mode has a Blue filmstrip Images can be loaded into the viewing panel s by clicking on the panel until a green border is displayed then clicking on the tooth image from the film strip NOTE If desired enter kVp MAS etc prior to taking the X Ray 6 EVAsoft Default Facility View Station Ad
62. ures o Leave the sensor plugged into the PC o Store the sensor in a holder or a hook fixed on the wall o Coil the cable in large loops one or two loops in order to avoid the cable lying on the floor Sensor storage between two patients or for the night o If possible leave the sensor plugged into the PC same as above 56 4 o If you have to move the sensor to another room O Unplug the sensor carefully O Coil the cable in large loops in order to avoid the cable lying on the floor O Store the sensor in a holder or a hook fixed on the wall o If you have to store the sensor on a shelf or drawer package the sensor well to provide cushioning and avoid shifting and make large loops with the cable 9 inches 20cm diameter if possible 3 4 2 Warnings When not in use most accidental damage to the sensor occurs when the sensor falls off a counter or the cable is too tightly coiled Please make sure to avoid the following configurations Using a very tight box to store the sensor Storing the sensor freely on a table countertop or a shelf Running or looping the cable near or over drawers you could pinch the cable Storing several sensors on the same hook Curling the cable in tight loops for example around gray plastic connector Running over the cable with chair wheels Catching a loop of the cable in a chair leg DISPOSAL INSTRUCTIONS The sensor head contains potentially hazardous substances material of the scin
63. will be taken on the same tooth position until unless a different position is chosen prior to the next exposure The fourth step in acquiring an image is to select an acquisition mode Single Shot or Sequential lf the user wants to change this simply click on the Stop Acquisition button in the Acquire Tab and reselect the mode desired Once an Acquire button is pressed the software will tell the hardware to be ready to acquire an image and the Acquire Status traffic light signal will change to green when ready Now the user can operate the X Ray Once the image data is received it is displayed and a thumbnail of the image is added to the filmstrip Each acquire session will be saved as a new study for the Active Patient The exception to this rule is if the Active Patient has a study that is not more than 32 hours old In this case the user This Icon sert Status Toggles will be asked upon entering the Acquire Tab to append to the last study or start a new one Traffic Light Acquire Status Traffic Light on Or off 13 ACQUIRE TAB TOOLBAR aR Rotate CCW Rotate Cw Mirror L R Start Single Acquisition Mode Button Start Continuous Acquisition Mode Button Stop Acquisition Button Retake Exposure Button Skip Ahead to Next Exposure Button Re Set Exposure Sequence Button Acquire Status Stoplight ON OFF Button Next Bitevving Device ready for expos

Download Pdf Manuals

Related Search

Related Contents

  取扱説明書 - 株式会社エンベデッドテクノロジー  DeLonghi ECAM23.450.S coffee maker  

Copyright © All rights reserved. Failed to retrieve file