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FONA CDRelite Sensor and USB Interface User Guide B1057003 Sirona Dental, Inc. 30-30 47 Avenue, Suite 500 Long Island City, NY 11101 (718) 937-5765 (718) 937-5962 (fax) Sirona Dental GmbH Fabrikstr. 31 D-64625, Bensheim Germany PART NUMBER B1057003 REV. 3...
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Copyright 2017 by Sirona Dental, Inc. All Rights Reserved Sirona Dental, Inc. products are covered by one or more US patents. For a current listing, please refer to the following page on our website: http://www.schickbysirona.com/items.php?itemid=13112 August 7, 2017 Printed in the United States of America This document was originally prepared in English...
1.5. PC Workstation Description ...................... 2 1.6. Relationship with Current FONA Sensors ................4 2. Hardware ..................5 2.1. Connecting Cables to the FONA CDRelite USB Interface Module ......... 5 2.2. Installing the FONA CDRelite USB Interface Module Holder..........6 3. Software ..................8 3.1.
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Figure 3. Enhancements: Smooth (top) and Edge High (bottom) ............ 13 Figure 4. Enhancements: Edge Low (top) and None Applied (bottom) ........... 14 Figure 5. FONA CDRelite USB Interface Module LED and Connector Views ......22 List of Tables Table 1. Description of FONA CDRelite USB Interface Module Cable Connections ....... 5 Table 2.
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Safety Issues Check FONA CDRelite Sensor and USB Interface Module before Using Them Before each usage, check the outer surface of the FONA CDRelite Sensor and USB Interface Module for any signs of physical damage or defect. FONA CDRelite Sensor and USB Interface Module surfaces should have a smooth finish, with no evidence of chipping or damage.
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(meaning, electricity transformer rooms, static continuity units, two-way amateur radios and cellular phones) can be used only at a minimum distance of 5 feet (1.5m) from any part of the FONA CDRelite Sensor and Interface Module. Any instrumentation or equipment for professional use located near...
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Operate the FONA CDRelite Sensor and USB Interface Module as Directed Always use the FONA CDRelite Sensor and USB Interface Module in accordance with the directions and recommendations contained in this User Guide.
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Protective sheaths are single-use devices and must not be reused under any circumstance. Reuse of single-use devices/instruments may cause them to become contaminated, compromise their intended function, and result in patient and user infection, injury and/or illness. B1057003 Rev. 3 FONA CDRelite System User Guide...
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Label Location This label can be found on the FONA CDRelite Interface Module. FONA CDRelite System User Guide B1057003 Rev. 3...
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Reporting According to the WEEE Directive, Sirona Dental or its Dealers will ensure that information needed to calculate the financial obligations with respect to EEE products will be provided as required. viii B1057003 Rev. 3 FONA CDRelite System User Guide...
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The information will be provided as a printed document or in electronic media (on CD-ROM or by web download, for example). FONA CDRelite System User Guide B1057003 Rev. 3...
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FONA CDRelite Sensor and USB Interface Module FONA CDRelite Sensor with FONA CDRelite USB Interface Module B1057003 Rev. 3 FONA CDRelite System User Guide...
Serviceable Sensor cable is standard with all FONA CDRelite Sensors New options for image enhancement. 1.2. Indications for Use The FONA CDRelite Sensor is to be used as part of an intraoral image acquisition system and is indicated for individuals requiring intraoral dental examinations. 1.3. System Description...
1.4. Replaceable Cable The FONA CDRelite Sensor Imaging System is designed to meet the practical, timely needs of dental professionals. For this reason, FONA CDRelite Sensor sizes 1 and 2 support a replaceable-cable design that enables customers to make immediate, in-office replacements of failed cables.
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Getting the best results from your FONA CDRelite system begins with having a computer system suitable for capturing and displaying intraoral images. For optimum performance, we recommend the following: 1.5.1. Client or Standalone Windows 7 and Windows 7 x64, Windows Vista SP2, and Vista x64 ...
FONA CDRelite Sensor to the workstation via USB 2.0 cable is unique to the FONA CDRelite Sensor type, however. This means that you will not be able to swap FONA CDR Remote Modules with FONA CDRelite Interface Modules. To avoid any possible...
2.1. Connecting Cables to the FONA CDRelite USB Interface Module IMPORTANT! Do not connect the FONA CDRelite USB Interface Module and cable to your computer until after you have successfully run the setup program. Procedures for installing these files are supplied in Section 3, "Software."...
2.2. Installing the FONA CDRelite USB Interface Module Holder The FONA CDRelite USB Interface Module holder is designed for several mounting options: (1) Wall-mounted with fastening hardware, or (2) Attached to a wall or other acceptable bonding surface with Velcro adhesive. When installing your FONA CDRelite USB Interface Module choose a location that offers easy access and visibility during patient exams.
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2.2.2. Wall-Mounting Option (with Adhesive) Install the FONA CDRelite USB Interface Module by attaching it with Velcro adhesive to a wall or other flat surface, as follows: Remove the FONA CDRelite USB Interface Module from its holder. Cut and trim a piece of Velcro adhesive (not supplied) to the size of the back of the Remote.
USB 2.0 A-B Cable (supplied separately) 3.2. Before You Start Installing Software IMPORTANT! Please do not connect the FONA CDRelite USB Interface Module and USB cable to your computer until after you have installed the device driver. Procedures for installing these files can be found on the following pages.
3.3. Setup with Windows Vista A. Insert the FONA CDRelite USB Remote Driver CD. B. Click Run setup.exe when prompted at the Autoplay message window. C. Click “Allow” when the message, “An unidentified program wants access to your computer” is displayed.
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Setup will copy the drivers to your workstation. A. Click Finish. B. Connect the FONA CDRelite USB Interface Module to your computer. When you do, you will receive a momentary message saying that new hardware has been installed and is ready for use.
Sensor so a separate calibration disk CD is no longer needed. To install the calibration file, perform the following steps. Verify that all FONA CDRelite system cables are connected securely. Start imaging software, which will automatically detect the Sensor and determine whether a calibration file has been installed for this Sensor previously.
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3.5.2. Disabling Image Enhancement Image Enhancement can be disabled at any time by clicking the “Apply Image Enhancement” checkbox again, which removes the checkmark. When the checkbox is cleared, all of the enhancements are unavailable. B1057003 Rev. 3 FONA CDRelite System User Guide...
The CDR AutoDetect feature instantly recognizes when a different Schick intraoral USB device used with X-ray image acquisition is connected — including standard, high-speed (HS), and FONA CDRelite modules — skipping the step of manually selecting a new Schick USB device before using it.
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3.6.3. How FONA USB Devices are Detected CDR AutoDetect requires that the FONA CDRelite USB (or Remote HS) device be connected for the system to recognize it. Once the USB device is connected, we say that it is “known” by CDR AutoDetect, which informs the imaging program to begin using that device.
A sample screen of the CDR Elite Utility is shown below. (Please note that the version numbers shown in the picture below are examples only and may differ from those reported for your system.) FONA CDRelite System User Guide B1057003 Rev. 3...
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There may be one or more reasons for poor test patterns, which can be the result of a problem with the FONA CDRelite device or its USB connector, or the USB cable and / or port, or corrupt firmware inside the FONA CDRelite device.
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Interface and the Sensor to which it is connected. There may be one or more reasons for poor test patterns, which can be the result of a problem with the FONA CDRelite device or its Sensor connector, or the Sensor cable, or corrupt firmware inside the FONA CDRelite device.
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Whenever version information is displayed with red lettering, we recommend that you perform the upgrade, referring to the procedure that follows. Perform the following steps to upgrade FONA CDRelite USB firmware. CTION IMPORTANT! Close CDR DICOM (if running). Verify that FONA CDRelite USB Interface is connected to the host computer.
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Whenever version information is displayed with red lettering, we recommend that you perform the upgrade, referring to the following procedure. Peform the following steps to upgrade FONA CDRelite Sensor firmware. CTION IMPORTANT! Close CDR DICOM (if running). Verify that FONA CDRelite USB Interface is connected to the host computer.
Replace Sensor if problem persists. Connect Sensor and connected running start CDR DICOM NOTE: FONA CDRelite USB Interface Module is considered connected for the cases described in the above table. B1057003 Rev. 3 FONA CDRelite System User Guide...
5.1. Operating the System 5.1.1. Power On Turn on the PC workstation used with imaging applications. Connect the “B-type” end of the USB cable to the FONA CDRelite Interface Module. Connect the “A-type” end of the USB cable to the PC workstation.
Sensor: all of these contribute towards obtaining quality digital X-ray images. For proper placement and usage of FONA Sensor holders, please refer to the FONA Positioning System User Guide, distributed with Sensor Holder kits and also available on our website.
4. As the Sensor is pushed into the wider area of the sheath, be careful to prevent the Sensor from falling on the floor. Handle both Sensor and cable gently. FONA CDRelite System User Guide B1057003 Rev. 3...
Table 4. Examples of FONA CDRelite Sensor-to-Image Orientation Sensor Inverse Pixels (Circled) and Sensor Orientation Location Image Orientation Patient's left side Left Bitewing Patient's upper Anterior Periapical, Maxillary B1057003 Rev. 3 FONA CDRelite System User Guide...
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Enter a name for this X-ray series. Click OK. A. Slide an appropriately-sized sheath over the Sensor. Select a FONA positioning holder specific to the intraoral area intended for exposure and place it on the sheath. Attach a positioning arm and aiming ring, as needed B.
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To acquire the next X-ray image, repeat this procedure starting at Step 7. B. In manual mode, close the exam window. To acquire the next X-ray image, repeat this procedure starting at Step 5. B1057003 Rev. 3 FONA CDRelite System User Guide...
Refer to the following table for information. Table 5. Keyboard Shortcuts Desired Action Use Keys Select a view box [Spacebar] or [Page up] or [Page down] Take an X-ray (manual mode) [Insert] or [Enter] FONA CDRelite System User Guide B1057003 Rev. 3...
6. Protective Measures 6.1. Introduction IMPORTANT! Be sure to disconnect the FONA CDRelite USB Interface Module from the Sensor and the USB cable before performing any cleaning procedures. The FONA CDRelite Sensor should be thoroughly cleaned after each use. The following cleaning and disinfection recommendations are intended to accomplish intermediate-level disinfection and will prepare the product to be safely used and reused during its life.
The following surface disinfectant has been found to be effective in achieving a desired level of disinfection and is available from other dental product suppliers. Cavi-Wipes (Metrex Research, Kerr) or equivalent FONA CDRelite System User Guide B1057003 Rev. 3...
Check that the labels are intact, readable, and adhere well to the surfaces on which they are positioned Check that all of the cables that connect to the FONA CDRelite USB Interface Module are undamaged Check that there is no external damage to the FONA CDRelite...
ESD damage. Touching a metal surface prior to replacing the FONA CDRelite cable will reduce the risk of damaging Sensor components by accidental static discharge. The use of anti-static floor mats or floor treatments (for example Staticide 2005/2002) will also help eliminate static build-up in your office.
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NOTE: FONA CDRelite parts are blue. B. Using tweezers, take a new (blue) strip from the FONA CDRelite spare parts kit and insert the strip into its slot in the Sensor. C. After inserting the strip, apply a small amount of finger pressure to ensure the elastomer is seated squarely in the slot.
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Make sure that the gel material completely covers the screw. B. Remove another gel disk and repeat this action for the second screw. FONA CDRelite System User Guide B1057003 Rev. 3...
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B. When the tab completely covers the slot, snap it into place. C. Verify that the tab cover fits evenly in its slot. Cable replacement is complete. B1057003 Rev. 3 FONA CDRelite System User Guide...
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When inserted properly, the strip will fit securely inside the slot. Ensure proper seating by applying a small amount of finger pressure across the strip. FONA CDRelite System User Guide B1057003 Rev. 3...
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Do the same for the second screw. IMPORTANT! Make sure that both screws are securely tightened before continuing. B1057003 Rev. 3 FONA CDRelite System User Guide...
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You should hear a soft click when the cover closes. B. Verify that the tab cover fits evenly in its slot. Cable replacement is complete. FONA CDRelite System User Guide B1057003 Rev. 3...
Appendix A. Reference A-1. Removal and Replacement There are no user-serviceable parts in the FONA CDRelite USB Interface Module and service of FONA CDRelite sensors is limited to cable replacement of FONA CDRelite sensors. Should you experience problems with the FONA CDRelite products, please contact your local distributor.
A-3. Summary of Specifications FONA CDRelite USB Interface Module is ETL-certified and complies with EMC, safety, and quality standards listed below. Table 7. Specifications Item Value Medical Electrical Equipment – Part 1: General IEC60601-1:2005 +CORR.1(2006) Requirements for basic safety and essential performance +CORR.2(2007)
A-4. Leakage Current Statement FONA CDRelite USB Interface Module complies with the leakage current requirements of IEC 60601-1-1 safety standard. Variations, however, may exist in the construction of computers to which the FONA CDRelite USB Interface Module is connected. Customers are advised to have a qualified electrician perform a leakage test on their equipment before using the FONA CDRelite Interface Module.
Table 8. Guidance and Manufacturer's Declaration - Electromagnetic Emissions PLEASE NOTE: The FONA CDRelite USB Interface Module is intended for use in the electromagnetic environment specified below. The customer or user of the FONA CDRelite USB Interface Module must ensure that it is used in such an environment.
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(>95% dip in (>95% dip in voltage variations on cycle cycle environment. If the user of the FONA for 0.5 for 0.5 power supply input CDRelite USB Interface Module requires lines 40% U 40% U...
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FONA CDRelite USB Interface Module is used exceeds the applicable RF compliance above, the FONA CDRelite USB Interface Module should be observed to verify normal operation.
Appendix B. Troubleshooting Tips B-1. Introduction In the event you experience a problem with the FONA CDRelite Sensor or Interface Module, refer to the table of troubleshooting tips found on this page. If the problem persists, please contact your local distributor.
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Leakage Current Statement, 42 Cleaning and Disinfecting, 30 LED Indicators, 22 Dentists or Authorized Designees Only Are Permitted Operate FONA CDRelite Sensor and Interface Module to Operate the System, iv as Directed, v Disinfectants, 31 Operating the FONA CDRelite Sensor and Interface...
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Protect Sensor from Potential ESD Damage, v RF Interference Considerations, iv USB Cable Use USB Cables Approved for FONA CDRelite Picture of, 5 System, iii Wait for Prompts before Operating X-ray Source, v Setup, 5, 8 Summary of Specifications, 41...
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