Air Techniques ScanX Edge Series Installation And Operating Instructions Manual

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ScanX Edge
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US
Installation and Operating Instructions
2160100287L41
*2160100287L41*
G8302

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Summary of Contents for Air Techniques ScanX Edge Series

  • Page 1 ScanX Edge Installation and Operating Instructions 2160100287L41 *2160100287L41* G8302...
  • Page 3: Table Of Contents

    Contents Contents Phosphor storage plate ..Barrier envelope ... . . Important information About this document ....Warnings and symbols .
  • Page 4 Contents Troubleshooting 13 Tips for operators and service techni- cians ......13.1 Poor X-ray image ... . 13.2 Software error .
  • Page 5: Important Information

    These installation and operating instructions are an integral part of the unit. – CAUTION Risk of minor injuries Air Techniques shall not be held liable and – NOTICE offers no guarantees of the safe and Risk of extensive material/property damage...
  • Page 6: Copyright Information

    Printing or copying these Installation and Operat- ing Instructions, including excerpts thereof, may Wear hand protection. only be carried out with the written approval of Air Techniques. Disconnect all power from the unit. Do not reuse DC current Non-ionizing electro-magnetic radiation Warning –...
  • Page 7: Safety

    The unit may be cleaned only with the disinfec- non-sterile and intended for single patient use tants and cleaning agents specified or approved only. by Air Techniques. Indication for use Improper use Disposable Barrier Envelope are intended to be Any other usage or usage beyond this scope is used as a disposable barrier for the Air Tech- deemed to be improper.
  • Page 8: General Safety Information

    All installation, resetting, alteration, expansion, ❯ and repair work must be carried out either by Air Techniques personnel or by a suitably quali- NOTICE fied person approved by Air Techniques. Erroneous operation mode due to use immediately adjacent to other devices...
  • Page 9: Essential Performance Charac- Teristics

    Important information radiate radio frequency energy and, if not Air Techniques accepts no liability for installed and used in accordance with the damage resulting from the use of non- instructions, may cause harmful interference to approved accessories, special acces- radio communications. However, there is no...
  • Page 10: Protection From Cybersecurity Threats

    Important information Rest of world Disposal of the units, electronic circuitry and PSPs must be accomplished only at the appro- priate facilities for recovery and recycling. Make sure to dispose of such items in accordance with current federal, national, state and local govern- ment rules and regulations.
  • Page 11: Product Description

    Product description Product description Overview ID X b a c k ScanX Edge phosphor storage plate scanner Cartridge for phosphor storage plates (S0 to S2) Phosphor storage plate IDX Barrier envelope VisionX imaging software DVD DBSWIN imaging software DVD Network cable (3 m) Power supply unit with country-specific adapter 2160100287L41 1911V006...
  • Page 12: Scope Of Delivery

    Product description Commissioning and intraoral constancy tests Scope of delivery 2D X-ray test phantom ....G8795 The following items are included in the scope of delivery (possible variations due to country-spe- Consumables cific requirements and/or import regulations): The following materials are consumed during...
  • Page 13: Technical Data

    Product description Technical data Imaging plate scanner Electrical data for the device Nominal voltage V DC Max. current consumption Max. power consumption < 12 Electrical data of the power supply unit Nominal input voltage V AC 100 - 240 Frequency 50/60 Nominal output voltage V DC...
  • Page 14 Product description Ambient conditions during storage and transport Temperature °C -18 to +60 °F -4 to +140 Humidity 10 - 95, non-condensing Air pressure 500 - 1060 Classification Medical device of class Class I FDA classification (CFR Title 21) Class II Laser class (unit) In accordance with IEC 60825-1 Laser source...
  • Page 15 Product description Electromagnetic compatibility (EMC) Interference immunity measurements on cover Immunity to interference by near fields of wireless HF communication devices IEC 61000-4-3:2006+A1:2007+A2:2010 Conforms See Table on immunity levels with respect to near fields of wireless HF communication devices Immunity levels with respect to near fields of wireless HF communication devices Radio service Frequency band Test level...
  • Page 16: Phosphor Storage Plate

    Product description Electromagnetic compatibility (EMC) Interference immunity measurements on supply input Immunity to interference, line-conducted disturbances induced by high-frequency fields – AC voltage grid IEC 61000-4-6:2013 0.15 - 80 MHz Conforms ISM frequency bands 0.15 - 80 MHz 80 % AM at 1 kHz Immunity to interference due to voltage dips, short inter- ruptions and voltage fluctuations Conforms...
  • Page 17: Barrier Envelope

    Product description Ambient conditions during storage and transport Temperature °C < 33 °F < 91 Relative humidity < 80 Dimensions of intraoral phosphor storage plates Size 0 22 x 35 inch 0.86 x 1.38 Size 1 24 x 40 inch 0.94 x 1.57 Size 2 31 x 41...
  • Page 18: Model Identification Plate

    Product description Function Model identification plate The model identification plate is located on the Imaging plate scanner rear of the device. Input unit Cover (open) User interface Collection tray REF Order number The phosphor storage plate scanner is used to read image data stored on a phosphorus storage Serial number plate and to transfer the data to an imaging soft-...
  • Page 19: Cartridges (S0-S2)

    Product description Operating elements Cartridge for PSP S1 is inside the device Cartridge for PSP S2 is inside the device Status LED flashes Connections The connections are located on the rear of the unit, underneath the cover. On/off switch Error display yellow Read display blue Green status LED Communication/standby display white...
  • Page 20: Phosphor Storage Plate

    Product description Phosphor storage plate The PSP stores X-ray energy, which is re-emitted in the form of light after excitation by the laser. This light is then converted into image informa- tion in the phosphor storage plate scanner. The PSP has an active side and an inactive side. The PSP must always be exposed on the active side.
  • Page 21: Installation

    Installation Installation Only qualified specialists or persons trained by Air Techniques may install, connect, and commission the unit. Requirements Installation/setup room The room chosen for set up must meet the fol- lowing requirements: – Closed, dry, well-ventilated room – It should not be a room made for another pur- pose (e.g.
  • Page 22: System Requirements

    Installation System requirements The system requirements of the software being used to operate the device must always be met during its operation. If third-party software is being used to operate the device, compliance with its system requirements must be assured. The following additional system requirements must also be met: Interface: Ethernet ≥...
  • Page 23: Monitor

    Installation Installation Monitor The monitor must meet the requirements for digi- Setting up the unit tal X-ray with a high light intensity and wide con- trast range. NOTICE Strong ambient light, sunlight impinging directly Damage to sensitive components of onto the monitor and reflections can make it the unit due to shocks or vibrations more difficult or even impossible to perform a Do not expose the unit to any strong...
  • Page 24: Electrical Connection

    Installation Electrical connection Remove the screw covers and screws from the ❯ bottom of the device. Electrical safety when making connections Connect the device to a correctly installed ❯ power outlet only. Do not place non-fixed multi-socket units on ❯ the floor.
  • Page 25: Connecting The Unit To The Network

    Installation Plug the connecting plug of the power supply Combining devices safely ❯ unit into the connection socket of the unit. – Safety and essential performance features are independent of the network. – Faulty manual configuration can lead to signifi- cant network problems.
  • Page 26: Commissioning And First Start-Up

    The unit supports the following imaging pro- grams: – VisionX manufactured for Air Techniques – DBSWIN manufactured for Air Techniques The cover on the rear must be properly – Please inquire about third-party software...
  • Page 27: Configuring The Unit In Visionx

    The configuration is done with VistaConfig, which is automatically installed during the installation of Configuring the unit in DBSWIN or VistaEasy. Start > All Programs > Air Techniques > Vis- ❯ VisionX taEasy > VistaConfig. Configuration is performed directly in VisionX.
  • Page 28 Installation Entering a fixed IP address (recommended) To reset the network settings, keep the unit reset button pressed for 15 - 20 sec- onds while switching on. Deactivate DHCP. ❯ Enter the IP address, subnet mask and gate- ❯ way. Click on Apply.
  • Page 29: X-Ray Unit Settings

    Installation X-ray unit settings A setting of 60 kV is preferred provided it can be set on the X-ray unit. The standard exposure values for F-speed film (e. g. Kodak Insight) can be used. Intraoral X-ray units for an adult patient The following table shows the standard values for the exposure time and the dose area product of a PSP for an adult patient.
  • Page 30: Commissioning Tests

    Installation DC emitter, 6 mA Tube length 30 cm without X-ray field X-ray field limitation X-ray field limitation limitation 60 kV 60 kV 60 kV mGycm mGycm mGycm Incisor 0.10 s 0.10 s 0.10 s Premolar 0.13 s 11.8 0.13 s 0.13 s Molar 0.16 s...
  • Page 31: Usage

    Usage Usage CAUTION Phosphor storage plates (PSP) are toxic Correct use of phosphor PSPs that are not used with a barrier storage plates envelope can lead to poisoning when placed in the mouth or swallowed. WARNING Only place PSPs in the patient's mouth ❯...
  • Page 32: 10 Operation

    Usage 10 Operation Protect the phosphor storage plates from sun- ❯ light and ultraviolet light. Store phosphor storage plates in a barrier CAUTION envelope of the correct size. Image data on the phosphor storage Phosphor storage plates will be pre-exposed ❯...
  • Page 33: X-Ray

    Usage Use the the display (S0, S1, S2) to check if the Remove cartridge. ❯ ❯ correct cartridge has been inserted. If the wrong cartridge is inserted, it must be removed and the correct cartridge inserted. Open the cover. ❯ The green status LED flashes.
  • Page 34 Usage Pull off the adhesive strip and close the barrier ❯ WARNING envelope tightly by pressing together firmly. Risk of cross contamination when not using the barrier envelope or when using the barrier envelope more than once Do not use an phosphor storage plate ❯...
  • Page 35: Scanning The Image Data

    Usage Preparing for scanning NOTICE CAUTION Powder from the protective gloves on the PSP damages the unit during Light erases the image data on the scanning phosphor storage plate Completely clean all traces of the pro- ❯ Never handle exposed phosphor stor- ❯...
  • Page 36 Usage Open the cover. Slide the phosphor storage plate out of the ❯ ❯ barrier envelope downwards into the unit. The phosphor storage plate must be inserted fully into the input unit. Place the barrier envelope with the PSP cen- ❯...
  • Page 37: Erasing The Imaging Plate

    Usage 10.4 Erasing the imaging plate Once the phosphor storage plate has been ❯ inserted into the unit, close the cover and leave The image data is erased automatically after it closed throughout the entire scanning pro- scanning. cess. The special ERASE mode only activates the era- sure unit of the image plate scanner.
  • Page 38: 11 Cleaning And Disinfection

    Clean the Barrier Envelope after being removed ❯ The use of unsuitable agents and from the patient’s mouth with a disinfectant methods can damage the unit and wipe, such as Air Techniques Monarch Surface accessories Wipes. Only use the disinfection and cleaning ❯...
  • Page 39: Maintenance

    Usage 12 Maintenance 12.1 Recommended maintenance schedule Prior to working on the unit or in case of danger, disconnect it from the mains. The recommended maintenance intervals are based on using the unit for 25 intraoral images per day and 220 working days per year. Maintenance Maintenance work interval...
  • Page 40 Usage Check X-ray system Check the PSP with a homogeneous test To check the X-ray system, take an X-ray image image with the 2D X-ray test phantom (refer to "3.3 Scratches on the surface of the PSP may be visi- Optional items").
  • Page 41: Troubleshooting

    Phosphor storage plate falls IDX phosphor storage plate was ❯ Only use Air Techniques IDX out of the unit and no image not used phosphor storage plates. appears on the monitor...
  • Page 42 Troubleshooting Error Possible cause Remedy Unsuitable scanning mode ❯ Select a suitable scanning selected mode. Ghosting or double exposure PSP exposed twice ❯ Only expose the PSP once. on X-ray image PSP not sufficiently erased ❯ Check the erasure unit for proper function.
  • Page 43 Troubleshooting Error Possible cause Remedy The setting for the threshold ❯ Reduce the threshold value. value is too high X-ray image has stripes on Phosphor storage plate has ❯ If the phosphor storage plate image been pre-exposed, e.g. by natu- has been stored for more than ral radiation or stray X-ray radia- one week, erase the phos-...
  • Page 44: Software Error

    Troubleshooting Error Possible cause Remedy The X-ray image shows a pre- After the barrier envelope has ❯ Do not push out the phosphor erasure at one end been torn open, the image plate storage plate until the torn-off is pushed out of barrier envelope barrier envelope has been prior to scanning.
  • Page 45: Fault On The Unit

    Troubleshooting Error Possible cause Remedy Error message "E2490" The connection to the unit was ❯ Restore the connection to the interrupted while the software unit. was still attempting to communi- ❯ Repeat the process. cate with the unit Connecting cable used is incor- ❯...
  • Page 46 IP address to each unit. ❯ Inform a service technician, if the problem persists. IDX phosphor storage plate was ❯ Only use Air Techniques IDX Unit ejects the phosphor stor- age plate without the image not used phosphor storage plates.
  • Page 47: Appendix

    Appendix Appendix 14 Scanning times The scanning time is the time required for complete scanning of image data and depends on PSP for- mat and pixel size. The time to image depends mainly on the computer system used and its work load. Times stated are approximate.
  • Page 48: File Sizes (Uncompressed)

    Appendix 15 File sizes (uncompressed) The file sizes depend on the PSP format and the pixel size. File sizes stated are approximate and have been rounded upwards. Suitable compression methods can considerably reduce the file size without loss of data. Max.
  • Page 49: 16 Handover Record

    Appendix 16 Handover record This document confirms that a qualified handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN)
  • Page 54 For over 50 years, Air Techniques has been a leading innovator and manufacturer of dental products. Our priority is ensuring complete satisfaction by manufacturing reliable products and providing excel- lent customer and technical support. Whether the need is digital imaging, utility room equipment or merchandise, Air Techniques can provide the solution via our network of authorized professional deal- ers.

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