Chapter 1 Introduction Notice For the improvement of Product performance, supplementation, and the follow-up of information, the contents of this manual are subject to change without prior notice. Please note that our company bears no responsibility for accidental damage nor will we be obligated to provide warranty service for any damage to equipment due to user error.
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2. Symbols Descriptions Item Symbol Description Type B applied part Refer to instruction manual/ booklet Conforms to CE MDD 93/42/EEC (European Communities) concerning medical devices Waste Electrical and Electronic Equipment Manufacturer Date of manufacture Serial number Authorized representative in the European Community Handling procedures for Electro-Static Discharge (ESD).
Before each usage, check the outer surface of the EzSensor Classic for any signs of physical damage or defect. The surface of the EzSensor Classic should have a smooth finish, with no evidence of chipping or damage.
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Electrical safety The covers of the Product may be removed only by qualified and authorized technical personnel. This Product can only be used in rooms or areas that comply with all laws and regulations applicable to electrical safety on medical premises, such as IEC standards for the use of an additional ground terminal for equipotential connections.
Who disposes any Electric and Electronic Equipment, reporting the above symbol, as unsorted municipal waste, instead of collecting it separately, incurs the administrative sanctions in accordance with law. 2. Label Location The label can be found on the EzSensor Classic device.
Chapter 2 SYSTEM OVERVIEW System Description This manual covers the installation and operating procedures of the EzSensor Classic( IOS- “collectively or individually U20VB, IOS-U15VB, IOS-U10VB, IOS-U20IB, IOS-U15IB, IOS-U10IB) referred to as EzSensor or Product”. Unless otherwise specified, all the information contained in this manual is applicable equally to all EzSensor Classic types.
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Operation mode Global shutter 10℃ to 30℃ (Usage) Ambient Temperature -20℃ to 60℃ (Transportation and Storage) 30% to 95% (Usage) Relative Humidity 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...
Product Components The EzSensor Classic device installer should check the following items listed in the table below before Productinstallation. If the serial numbers of the individual parts do not match, do not install the Product. Contact your local distributor or agent for support.
Chapter 3 INSTALLATION PC Specifications 1. Recommended Server PC Specifications Workstation Operating System: Window 2000 server or higher RAM: 4GB or Higher HDD: 1TB or higher 2. Recommended Client PC Specifications CPU: Core DUO CPU 1.8GHz or Higher Main Memory: 2GB of Higher Graphic Card : 512MB or Higher HDD: 2GB free space Display: 1280x1024x32bpp...
Installation of Software Driver Installation of Software Driver To operate the intraoral sensor, you need to install the To operate the intraoral sensor, you need to install the EzSensor Classic EzSensor Classic Driver. This Product should be connected with the product...
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Step 3 Check the EzSensor Classic installation directory and then 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.
3.2.2 Cable connection & Driver Installation 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.
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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.
Installation of the EzSensor Classic Holder The EzSensor Classic holder is used for mounting the EzSensor Classic to the 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.
Chapter 4 Image Acquisition by using EasyDent Installation of EasyDent In this step, 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 .
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Step 3 The ‘EasyDentV4 Install Shield Wizard’ will appear. Click the ‘Next’ button. Step 4 Select the setup type that best suits your needs. Click the ‘Next’ button. Basic : Installs the basic version of EasyDent V4 CD-Publishing : Installs the basic version of EasyDent V4 along with CD-Publishing capabilities (optional)
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Select the features that you want to install. Click the ‘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’.
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Step 7 Installing 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.
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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’.
④ Before use the sensor, shooting the X-ray with putting the coin on flat receptor of the sensor is recommend as an operation test. ⑤ Position the EzSensor Classic (IOS-U20IB, IOS-U15IB, IOS-U10IB) at the appropriate area in the mouth. The flat receptor side of the sensor must face the X-ray source. Note...
Running the EasyDent Shot functions are available after patient registration 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.
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Step 2 The new patient registration window will appear. You are asked to register the new patient and click “Add”. Step 3 Click ‘Help > Intra-Oral Sensor Setting > Select Device’ on the menu bar. Select your capture device. At this time, you are asked to select the device and image quality.
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.
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Step 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.
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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.
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Step7 After checking the sensor 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.
4.3.3 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.
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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.
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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.
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Step 6 If you want to acquire more images, continue to expose 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.
4.3.4 Sequence Shot You can capture multiple images according to a pre-saved order. Capturing according to the order will 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.
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Step 4 Capturing according 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.
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Step5 If you want to finish, double click the ‘Press the X-ray (shot) 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.
Chapter 5 Image Acquisition by using EzDent-i Installation EzDent-i In this step, EzDent-i will be installed. Alternatively, 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.
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Step 3 The window for component setting will be displayed After selecting programs to install among EzServer, Consult Data, and 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.
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Step 5 Users can select the installation type of Implant DB, If users prefer to install multiple fixture models, select [complete], click the [Next] button to proceed. If users prefer to install the implant models separately, select [Custom] and click the [Next]button Step 6 In case that [Custom] in implant DB is selected, Select...
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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.
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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.
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Step 10 After installation of EzDent-i Console 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.
License Activation License Activation. Step 1 Connect the USB Dongle Key to the PC, and open VTNL. Opening VTNL To open VTNL program, install ADB.exe file first. If the executable file is To open VTNL program, install ADB.exe file first. If the executable file is To open VTNL program, install ADB.exe file first.
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Step 2 The following License Activation Wizard appears 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.
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Step 4 After clicking the [OK] button, the following VT License Activation Wizard window appears. Once the license has appears. Once the license has been activated, click on the [Finish] button to complete your activation. EzDent-i will then run automatically. Once the license has been activated, the user Once the license has been activated, the user’s PC will appear on the list s PC will appear on the list...
Consult DB License Activation 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. Step 1 Open[Setup.exe] from [Setup] folder to install EzDent-i Server or Client for Windows Step 2 After selecting the install modes, Click the [Consult...
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Step 3 After checking the license information 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.
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Step 5 Enter the EzDent-i user information and license key provided. 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.
⑤ Position the EzSensor Classic at the appropriate area in the mouth. The flat receptor side of the sensor must face the X-ray source. Note that the receptor side is marked...
Running the 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...
5.5.2 Acquiring Image Step 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.
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Step 3 Click the [Ready] button after positioning the patient. If the IO Sensor equipment is properly connected, the image acquisition mode will be initiated. By double clicking the workspace from the ACQUISITION tab, EzDent-i will be ready for image acquisition. The [Ready] button provides the same function.
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Step 5 Select the images from the thumbnails, and then click the [Save to DB] button. The captured images will be stored in the DB. If the user wants to select more than 2 images, hold the Ctrl key on the keyboard and click the desired images from the thumbnails.
5.5.3 Image View Step 1 Enter the 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.
Check that all cables connected to the EzSensor Classic are undamaged. Check for any external damage to the EzSensor Classic that may compromise its ability to be safely operated. If the EzSensor Classic is defective, the sensor should be returned to the manufacturer for repair.
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...
1. Arrange the sensor and the control box USB cable to prevent 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...
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.
Product complaint Any health care professional (e.g., a customer or user of Product or system) who has any complaints should notify his or her distributor first, who 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.
Appendix X-ray Exposure Guide The required X-ray dose for the best image is dependent on the following: X-ray source (tube assembly, manufacturer, AC/DC, etc.) Distance between beam focus and sensor Tooth (object) to be X-rayed Bone density and age of patient Miscellaneous circumstances, etc.
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.
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11. Wrong image processing parameters. Solution: 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.
Troubleshooting If you experience any problems regarding the EzSensor Classic during operation, please refer to the troubleshooting table below for corrective measures. If the problem persists, please contact your local Product distributor. <Table 5. Troubleshooting Table> Item Description Corrective Measure A ‘PID 2XXX NO;...
Electromagnetic Compatibility Information Guidance and manufacturer’s declaration – electromagnetic emissions The Product is intended for use in an electromagnetic environment as specified below. The customer or the user of the Product should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
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(50/60 Hz) be at levels characteristic of a typical IEC 61000-4-8 location in a typical commercial or hospital environment. Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications IEC61000-4-6 150 kHz to 80MHz 150 kHz to equipment should be used no closer to 80MHz any part of the Product, including cables, than the recommended separation...
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Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Product. The Product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user The Product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and The Product as recommended below, according to the maximum output power of the communications equipment.
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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 VATECH Dental Manufacturing Ltd. Chancery House, St. Nicholas Way, Sutton, SM1 1JB UK Tel: +44 020 8652 1900, Fax: +44 020 8652 1909 VATECH America Inc.
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