Vatech EzSensor Classic Installation & User Manual Download Page 10

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Operation mode

Global shutter

Ambient Temperature

℃

to 30

℃

(Usage)

-20

℃

to 60

℃

(Transportation and Storage)

Relative Humidity

30% to 95% (Usage)

10% to 95% (Transportation and Storage)

Air Pressure

700 to 1060 hPa

EU classification

Medical Devices 93/42/EEC as a class IIa

Protection against shock

Type B applied part

Protection against matter/water

IP 68

The Product has to be installed, transported and stored in the permissible

environmental conditions. Use the provided protective package for transporting or

storage. Also, the Product should not operate in oxygen rich or explosive

environments.

Summary of Contents for EzSensor Classic

Page 1: ...Installation User Manual IOS U20VB IOS U15VB IOS U10VB IOS U20IB IOS U15IB IOS U10IB ...

Page 2: ...tallation 12 3 3 Installation of the EzSensor Classic Holder 14 CHAPTER 4 IMAGE ACQUISITION BY USING EASYDENT 15 4 1 Installation of EasyDent 15 4 2 Image Acquisition Overview 20 4 3 Running the EasyDent 21 4 3 1 Patient Registration and Device Selection 21 4 3 2 Single Shot 23 4 3 3 Multi Shot 27 4 3 4 Sequence Shot 31 CHAPTER 5 IMAGE ACQUISITION BY USING EZDENT I 34 5 1 Installation EzDent i 34 ...

Page 3: ...2 6 2 1 Test List 53 6 2 2 Connection 53 6 2 3 Cable 54 6 2 4 Resolution 54 6 3 Care and Cleaning 55 6 4 Precautions 55 6 5 Product complaint 56 APPENDIX 57 A 1 X ray Exposure Guide 57 A 2 Error Message 59 A 3 Troubleshooting 61 A 4 Electromagnetic Compatibility Information 62 ...

Page 4: ...ts of this manual depending on individual Product specifications 1 2 Conventions and Symbols 1 Convention The following symbols are used throughout this manual to provide instructions on the effective use of this Product Indicates useful information and tips on how to use our software and Products Indicates important instructions If not observed malfunction or damage to the Product or other proper...

Page 5: ...DD 93 42 EEC European Communities concerning medical devices 4 Waste Electrical and Electronic Equipment 5 Manufacturer 6 Date of manufacture 7 Serial number 8 Authorized representative in the European Community 9 Handling procedures for Electro Static Discharge ESD 9 Handle with care 10 Fragile handle with care 11 This way up ...

Page 6: ... distributor for further instructions on how to proceed To ensure the correct usage of the EzSensor Classic device in a clinical environment for which the intended purposes correspond to its design and application only dentists or their designated operators are authorized to operate this Product Modifications and or additions to the device must be conducted exclusively by MANUFACTURER or by partie...

Page 7: ...void penetration of the Product Liquids may cause corrosion or the Product to short circuit No protection is offered against liquid penetration Explosion safety This Product is not recommended for use in the presence of flammable gases or vapours Some disinfectants evaporate and form explosive or flammable mixtures If disinfectants of this kind are used it is important to let the vapours disperse ...

Page 8: ...er can return the Product to the seller on a one to one basis as long as he or she is buying a new one of equivalent type and that fulfils the same functions as the old one Disposing of the Product separately avoids possible negative consequences for the environment and health deriving from inappropriate disposal and enables the constituent materials to be recovered to obtain significant savings i...

Page 9: ...pecifications Parameter Description Detector Structure CMOS Photodiode Array Dimensions W x L x T Size 1 0 1 44 x 1 00 x 0 19 inch 36 8 x 25 4 x 4 8 mm Size 1 5 1 55 x 1 15 x 0 19 inch 39 5 x 29 2 x 4 8mm Size 2 0 1 69 x 1 28 x 0 19 inch 42 9 x 31 3 x 4 8 mm Pixel Pitch 0 0296 mm Active Pixel Array Size 1 0 1014 x 676 pixels 30 01 x 20 01 mm Size 1 5 1115 x 810 pixels 33 00 x 23 98 mm Size 2 0 121...

Page 10: ...o 1060 hPa EU classification Medical Devices 93 42 EEC as a class IIa Protection against shock Type B applied part Protection against matter water IP 68 The Product has to be installed transported and stored in the permissible environmental conditions Use the provided protective package for transporting or storage Also the Product should not operate in oxygen rich or explosive environments ...

Page 11: ...Components Remarks 1 Sensor Module 2 7m USB cable is all in one 2 Wrap Hygienic Sleeves 3 Holder for Sensor 4 Silicon cover 5 S W Installation CD or USB EasyDent or EzDent i 6 Driver Installation CD USB Device Driver 7 EzSensor Classic Manual Document Patient applied part Inside Patient environment Sensor Module Consists of a special CMOS sensor specifically designed for use in radiography and enc...

Page 12: ...pp 3 Operating System Window 34 64bit XP SP1 Vista 7 8 8 1 We cannot guarantee that EasyDent EzDent i will work properly with an unregistered copy of Microsoft Windows Therefore you should use a registered genuine version of Microsoft Windows Turn off the Windows Firewall service for proper communication across the network for the installed database and file servers If you need to install addition...

Page 13: ...d to install the Driver This Product should be connected with the product complied with IEC60601 10 Installation of Software Driver EzSensor Classic IOS U20VB IOS U15VB IOS U10VB Driver Setup for the installation of EzSensor Classic Capturing software and EzSensor Classic will be installed and downloaded A Twain driver is also installed during this step Installation CD in Setup should start setup ...

Page 14: ...ory and then click the Next button Step 4 The Install shield Wizard will start configuring the installation parameters The Install shield wizard will Copy the calibration files To your work station PC Step 5 The Install shield wizard will be done 11 then ...

Page 15: ...rt on the PC directly Be sure to connect the USB port on backside for accurate operation Do not connect the EzSensor Classic and USB PC Interface cable to your computer until you have successfully installed the setup program Only connect the item that has been specified as part of the Medical Equipment System ...

Page 16: ...ecurity System Device Manager Windows XP Settings Control Panel System Hardware Device manager Select VH EzSensor N x x located under Imaging Devices You should see the message This device is working properly EzSensor Classic is supplied to the power and transports data via the USB port of the PC Do not disconnect during usage ...

Page 17: ...e wall when not in use When choosing where to install the EzSensor Classic locate an area that offers easy access and visibility during patient examinations Position the holder on a stable flat surface Using the holes at the back of the holder as guides fasten the holder securely to the wall using two dry wall screws included ...

Page 18: ...ep EasyDent will be installed Alternatively software which supports the Twain interface can be used instead of EasyDent Step 1 Insert the S W installation CD in the CD ROM drive Homedirectory EasyDent setup exe Press Enter Step 2 Select the language you want to install and then click Next ...

Page 19: ...xt button Basic Installs the basic version of EasyDent V4 CD Publishing Installs the basic version of EasyDent V4 along with CD Publishing capabilities optional For the EasyDent server select all items For PC being used for viewer Select only the items except for DB File servers For the detailed installation refer to the EasyDent installation manual ...

Page 20: ...Next button EasyDent Viewer is the minimum requirement for EzSensor Classic use Step 6 Now you are ready to install If you would like to review any of your installation settings click Back To proceed with the installation click Install Click Cancel to exit the wizard ...

Page 21: ...ling EasyDentV4 Step 8 The program compatibility and Windows Firewall alarm messages are shown Click Run program button on the program compatibility message And click Allow access button on the windows security message ...

Page 22: ...19 Step 9 MSDE Microsoft SQL server Desktop Engine is installed automatically Close the SQL Server Service Manager Step 10 Select No I will restart my computer later and then click Finish ...

Page 23: ...de of the sensor must face the X ray source Note that the receptor side is marked with a label for ease of recognition The use of the sensor positioning aid is recommended to guarantee that the sensor is parallel to the tooth and is at the appropriate angle for exposure The use of the parallel technique with a positioning system or device if possible is highly recommended After preparing the senso...

Page 24: ...and device selection Single shot multi shot sequence shot are used frequently You must be fully aware of the explanations before capturing image 4 3 1 Patient Registration and Device Selection Step 1 Turn on the PC Run EasyDent4 Viewer Click the Patient button to register a new patient ...

Page 25: ...device At this time you are asked to select the device and image quality The Productand image processing setting information is stored internally Change these settings when using another sensor or changing the image processing option Level 4 is basic image processing option As the level no is higher the effect of contrast and enhancement get increased Level 1 Level 2 Level 3 Level 4 Level 5 Level ...

Page 26: ...23 4 3 2 Single Shot Capture a single image Step 1 Start EasyDent by clicking the EasyDent V4Viewer on the desktop Search and enter the appropriate patient information ...

Page 27: ...p 2 Click the Layouts tab Select your favorite layout from the Layout template list The Layout Template can be customized Please refer to the EasyDent manual Step 3 Select the Single from the Shoot Type list ...

Page 28: ...25 Step 4 Select the tooth position to capture The tooth box is selected in blue Step 5 Click the SENSOR button or Capture button Step 6 Position the sensor correctly ...

Page 29: ...nsor is in the correct position expose the X ray after the Please expose X ray message appears The message Optimizing Image Please wait appears while the image is being optimized The image will appear after optimization is complete ...

Page 30: ... 3 Multi Shot You can capture multiple images continuously until you click stop Click and drag the image to its appropriate position after stopping capture Step 1 Select the Multiple from the Shoot Type list ...

Page 31: ...28 Step 2 Select the tooth position to capture A blue rectangle will be drawn on the tooth box Step 3 Click the SENSOR button or Capture button Step 4 Position the sensor correctly ...

Page 32: ...29 Step5 Expose the X ray after the Please expose X ray message appears The message Optimizing Image Please wait appears while the image is being optimized ...

Page 33: ...xpose the x ray when the Press the X ray shot button message appears To finish double click on the Press the X ray shot button message box And then the image will appear after optimization is complete Step 7 Click and drag the image to its appropriate position ...

Page 34: ... ensure the images appear automatically in the correct positions Step 1 Select your favorite sequence from the Shoot Type list Red numbers represent the capture order The Sequence shot can be customized Please refer to the EasyDent manual Step 2 Click the SENSOR button or Capture button Step 3 Position the sensor correctly ...

Page 35: ...cording to the order the images appear automatically in the correct positions Expose the X ray after the Please expose X ray message appears The message Optimizing Image Please wait appears while the image is being optimized ...

Page 36: ...ot button message box And then according to the capturing order the images appear automatically in the correct positions All images are saved in the Database server automatically By double clicking on the image the image is shown as large size at any function s table ...

Page 37: ...natively software which supports the Twain interface can be used instead of EzDent i Step 1 Open Setup exe from Setup folder to install EzDent i Sever or Client for Windows Step 2 The window for selecting installation mode will be shown To setup the Server environment start the installation by clicking the Server button ...

Page 38: ...nd Implant DB click the EzServer button Step 4 To continue click the Next button followed by the install button to proceed When the installation of EzServer is complete the other components Consult Data and Implant DB will automatically start installing If users did not select any other components the installation is finished ...

Page 39: ...ture models select complete click the Next button to proceed Step 6 In case that Custom in implant DB is selected Select the name of manufacturers you want to install and click the Next button to go forward If users prefer to install the implant models separately select Custom and click the Next button ...

Page 40: ... Step 7 Compile setup exe and click the button EzDent i The License Agreement window will be shown If the conditions are acceptable select I accept the terms of the license agreement and click Next button ...

Page 41: ...38 Step 8 Type in the company and user name and click the Next button Step 9 After specifying the location to install the program click the Next button to go forward ...

Page 42: ...onsole is complete select Yes I want to restart my computer now and click the Finish button Then the PC will be restarted It is strongly recommended to restart the PC to apply the changes occurring in the system during the EzDent i installation ...

Page 43: ...of ADB program will automatically start when opening VTNL program 40 License Activation To open VTNL program install ADB exe file first If the executable file is not installed the installation process of ADB program will automatically start when opening VTNL program To open VTNL program install ADB exe file first If the executable file is not installed the installation process of ADB program will ...

Page 44: ... if you have not activated a license previously Select the dongle key first item and then click the Next button Step 3 When the following VT License Plug in Option Window appears select the license key from the list and install by clicking the OK button 41 ...

Page 45: ...has been activated the user of Certifications in the VTNL window The dongle license key number appears on the list of Volume in the VTNL window 42 appears Once the license has Once the license has been activated the user s PC will appear on the list of Certifications in the VTNL window dongle license key number appears on the list of Volume in the s PC will appear on the list dongle license key nu...

Page 46: ...stall EzDent i Server or Client for Windows Step 2 After selecting the install modes Click the Consult License Activator button Consult DB is for the users who have a Consult Premium License After activating Consult DB License the user can utilize video contents for consultation use ...

Page 47: ...shown at the Consult Data License Activator window Click the Activate button Step 4 Select the second option from the VTLicense Activation Wizard window For activating license using the license key an internet connection must be available with the PC ...

Page 48: ...rovided And then click the Next button You must enter more than 3 characters to activate the Next button Step 6 Upon successful activation the VTLicense Activation Wizard window will appear including the remaining days Click the Finish button to end the activation ...

Page 49: ... sensor must face the X ray source Note that the receptor side is marked with a label for ease of recognition The use of the sensor positioning aid is recommended to guarantee that the sensor is parallel to the tooth and is at the appropriate angle for exposure The use of the parallel technique with a positioning system or device if possible is highly recommended After preparing the sensor for exp...

Page 50: ...he EzDent i 5 5 1 Patient Registration Step 1 Turn on the PC Run EzDent i Click the Patient button to register a new patient Step 2 The Add Patient registration window will appear Register the new patient and click Add ...

Page 51: ...ep 1 The Acquisition Tab allows the user to capture store images with the IO Sensor Step 2 Click the IO Sensor button in the Acquisition tab Once the IO sensor is connected the layout will change depending on the selected device ...

Page 52: ... acquisition mode will be initiated Step 4 Using the exposure switch shoot the x ray and the image will be acquired The process of acquiring the image is complete By double clicking the workspace from the ACQUISITION tab EzDent i will be ready for image acquisition The Ready button provides the same function Double Click ...

Page 53: ...user wants to select more than 2 images hold the Ctrl key on the keyboard and click the desired images from the thumbnails To change the way of storing the acquired images change the options in settings With the option Auto DB Save all acquired images are automatically stored in DB Another option Manual only stores selected images in DB ...

Page 54: ...name or chart number of the patient in the Patient Search window and click the Search button or press the Enter key The search result will appear Step 2 Double Click the selected Patient List The images will be displayed in the VIEWER tab ...

Page 55: ...d contact your local Product distributor for further instructions on how to proceed 6 2 Periodic Maintenance Periodic maintenance should be performed as necessary and in accordance with monitored frequency in the table below Maintenance should consist of various checks performed by the operator or by a qualified service technician Check that all cables connected to the EzSensor Classic are undamag...

Page 56: ... Object Check the normal operation of PC when the sensor is connected to the PC Procedure 1 Connect the EzSensor Classic USB Connector to the USB Port 2 Confirmation of Driver installation at the Device Manager Method of Confirmation Windows 7 Control Panel System and Security System Device Manager Windows XP Settings Control Panel System Hardware Device manager ...

Page 57: ...t damage of the cable s rubber tube They should not be stepped on nor bent and pressed under table legs 2 Check that all cables connected to the EzSensor Classic are undamaged 6 2 4 Resolution Object Verify the resolution of EzSensor Classic Procedure 1 Run EasyDent EzDent i with connecting EzSensor Classic 2 Attach resolution phantom on the center of the detector with diagonal direction 3 Set X r...

Page 58: ...ith a soft cotton swab dipped in one of the cleaning solutions listed above Gently wipe the surface end to end in straight lines without applying any pressure Make sure the liquid does not penetrate the Product through the USB cable or the sensor cable connectors After cleaning the surface of the EzSensor Classic use a clean lint free cloth to dry the Product as required until the surface is clean...

Page 59: ...ho will handle such issues If the Product may have caused or contributed to a serious injury of a patient your distributor should immediately notify the manufacturer by telephone fax or written correspondence The manufacturer will report it to the government according to their reporting process Do not modify this equipment without authorization of the manufacturer ...

Page 60: ...age processing reduces the difference between image qualities of different doses Users can adjust brightness and contrast in the option menu The recommended exposure dose is from 300µGy to 600µGy when measuring without an object Exposure time corresponding to the dose may vary depending on the X ray equipment used Recommended exposure times according to positions are as shown on the Exposure Time ...

Page 61: ... X ray exposure condition can be changed depending on the age gender and bone density of the patient in case of Pediatric X ray exposure condition can be changed by expert s judge For further information please refer to FDA Pediatric X ray Imaging webpage http www fda gov radiation emittingproducts radiationemittingproductsandprocedures medicalimaging ucm298899 htm The X ray dose required for imag...

Page 62: ...ustomer Service 6 Data communication error Solution Re connect the USB PC cable 7 Canceled image capturing This means that the user canceled image capture Please try again 8 Cannot find dark frame Solution Restore the EzSensor Classic s calibration data from the S W installation CD or re calibrate the sensor If the same message is displayed again contact Customer Service 9 Cannot find bright frame...

Page 63: ...on Check the X ray source If the problem persists call for technical assistance 12 Cannot load EzSensor dll Solution Please re install the acquisition software 13 Require EzSensor dll was damaged Solution Please re install the acquisition software ...

Page 64: ...If the problem persists please contact your local Product distributor Table 5 Troubleshooting Table Item Description Corrective Measure 1 A PID 2XXX NO 0 Check Connection error message is displayed Unplug the USB PC cable from the PC connector Open the Windows Device Manager and check that the device is installed correctly Alternatively try another USB port on your computer ...

Page 65: ...netic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tiles If floors are covered with synthetic material relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output l...

Page 66: ...ence may occur in the vicinity of equipment marked with the following symbol Note 1 Uт is the A C mains voltage prior to application of the test level Note2 At 80 MHz and 800 MHz the higher frequency range applies Note3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixe...

Page 67: ...nce m according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation di stance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where...

Page 68: ...f this manual If you do not properly set the Product which in turn causes the Product to malfunction or fail we cannot guarantee any responsibility Rayence Co Ltd Web Site www rayence com 14 Samsung 1 ro 1 gil Hwaseong si Gyeonggi do Korea CE symbol grants the product compliance to the European Directive for Medical Devices 93 42 EEC as a class IIa device Authorized by SGS United Kingdom Ltd VATEC...

Page 69: ...Document No R USM 711 Release Version 1 3 Dated Apr 5 2016 Distributed by Vatech Global 13 Samsung 1 0 Distributed by Vatech Global Samsung 1 ro 2 gil Hwaseong si Gyeonggi do Korea Korea ...

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