Air Techniques ScanX Swift 2.0 Installation And Operating Instructions Manual

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ScanX Swift 2.0
XPS07.1A...
EN-US Installation and Operating Instructions

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Summary of Contents for Air Techniques ScanX Swift 2.0

  • Page 1 ScanX Swift 2.0 XPS07.1A... EN-US Installation and Operating Instructions...
  • Page 3: Table Of Contents

    Contents Contents Function ......Phophor storage plate scanner . . Phosphor storage plate ..Important information Barrier envelope .
  • Page 4 Contents 11.2 Barrier envelope ... . . 11.3 Phosphor storage plate ..11.4 Dust cover ....35 12 Maintenance .
  • Page 5: Important Information

    These installation and operating instructions are an integral part of the unit. Part number Air Techniques shall not be held liable and offers no guarantees of the safe and Serial number smooth operation of this unit if you fail to...
  • Page 6: Copyright Information

    Fragile, handle with care ScanX Swift 2.0 - XPS07.1A... Indications for use The ScanX Swift 2.0 is intended to be used for Keep away from sunlight during storage scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental Copyright information applications.
  • Page 7: Specialist Personnel

    If this is unavoidable, the unit and other and repair work must be carried out either by ❯ devices should be monitored in order Air Techniques personnel or by a suitably quali- to ensure that they are working cor- fied person approved by Air Techniques. rectly.
  • Page 8: Ised Statement

    Important information particular installation. If this equipment does ISED Statement cause harmful interference to radio or television reception, which can be determined by turning This device contains licence-exempt transmit- the equipment off and on, the user is encouraged ter(s)/receiver(s) that comply with Innovation, Sci- to try to correct the interference by one or more ence and Economic Development Canada’s of the following measures:...
  • Page 9: Essential Performance Charac- Teristics

    ❯ Only use accessories and optional items speci- ❯ users, e.g. by means of user name and pass- fied or approved by Air Techniques. word. Only use original working parts and spare ❯ Make sure that only trustworthy contents are ❯...
  • Page 10: Product Description

    Product description Product description Overview ID X b a c k ScanX Swift 2.0 PSP scanner Plate guides (S0 and S2) Phosphor storage plate IDX Barrier envelope Network cable (3 m) Power supply unit with country-specific adapter EN-US 2144100140L29 G8802...
  • Page 11: Scope Of Delivery

    Phosphor storage plate scanner ..G8800A Commissioning and intraoral constancy tests – ScanX Swift 2.0 Basic unit 2D X-ray test phantom ....G8795 –...
  • Page 12: Wear Parts And Spare Parts

    Product description Wear parts and spare parts Phosphor storage plates (PSPs) Phosphor Storage Plate Pack IDX, Size #0 Phosphor Storage Plate IDX S0 (2 pcs.) Barrier Envelope S0 (1000 pcs.) ..G8240-0 Phosphor Storage Plate Pack IDX, Size #1 Phosphor Storage Plate IDX S1 (2 pcs.) Barrier Envelope S1 (1000 pcs.) .
  • Page 13: Technical Data

    Product description Technical data Phosphor storage plate scanner (XPS07.1A...) Electrical data of the device Voltage V DC Max. current consumption 1.25 Output < 30 Type of protection IP20 Electrical data of the power supply unit Nominal input voltage V AC 100 - 240 Frequency 50/60...
  • Page 14 Product description Ambient conditions during storage and transport Temperature °C -20 to + 60 °F -4 to +140 Relative humidity 10 - 95 Air pressure 750 - 1060 Classification Medical Device Class (MDR) FDA classification (CFR Title 21) Laser class (unit) in accordance with IEC 60825-1:2014 Laser source Laser class...
  • 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 Scanner

    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 < 45 °F < 113 Relative humidity < 80 Dimensions of phosphor storage plates 22 x 35 0.87 x 1.38 24 x 40 0.94 x 1.57 31 x 41 1.22 x 1.61 27 x 54 1.06 x 2.13 57 x 76...
  • Page 18: Model Identification Plate

    Product description Function Model identification plate The type plate is located on the back cover of Phophor storage plate scan- the device. Plate guide REF Order number Control elements and display Serial number Collection tray The phosphor storage plate scanner is used to scan image data stored on a phosphor storage Conformity assessment plate and transfer the data to the imaging soft-...
  • Page 19: Phosphor Storage Plate

    Product description Operating elements USB port (additional accessories) Network connection Reset button On/off switch Connection for power supply unit Confirmation key Display Phosphor storage plate On/off switch The PSP stores X-ray energy, which is re-emitted in the form of light after excitation by the laser. The On/Of button indicates different states of the This light is then converted into image informa- device:...
  • Page 20: Barrier Envelope

    The unit is unable to read any other types of PSP. Barrier envelope Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non- sterile and intended for single patient use only. Dust cover...
  • Page 21: Installation

    Installation Setting up the unit Only qualified specialists or persons NOTICE trained by Air Techniques may install, Damage to sensitive components of connect, and commission the unit. the unit due to shocks or vibrations Do not expose the unit to any strong ❯...
  • Page 22: Electrical Connection

    Installation Electrical connection Remove the cover on the rear of the device ❯ using a suitable tool (e.g. slot screwdriver). Electrical safety when making connections Connect the device to a correctly installed ❯ power outlet only. Do not place non-fixed multi-socket units on ❯...
  • Page 23: Connecting The Unit To The Network

    Installation Replace the cover. Combining devices safely ❯ – Safety and essential performance features are independent of the network. – Faulty manual configuration can lead to signifi- cant network problems. The expert knowledge of a network administrator is required for con- figuration.
  • Page 24 Installation Connecting the unit via the network cable Replace the cover. ❯ Remove the cover on the rear of the device ❯ using a suitable tool (e.g. slot screwdriver). When operating the device, the cover on the rear must be mounted. Plug the enclosed network cable into the net- ❯...
  • Page 25: Commissioning And First Start-Up

    The unit supports the following imaging pro- If the connected device is not included in grams: the list, check if the device is switched on – VisionX made by Air Techniques and connected to the network. Then click Find again. – VisionX Connect –...
  • Page 26 Installation Select the acquisition type (e. g. Intraoral). ❯ To scan a PSP, see "10 Operation". ❯ EN-US 2144100140L29 G8802 2310V007...
  • Page 27: 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. The following table shows the standard values for the exposure time and the dose area product of an phosphor storage plate for an adult patient.
  • Page 28 Installation Carry out and document the instruction and handover for the unit. ❯ A sample handover report is included in the attachment. EN-US 2144100140L29 G8802 2310V007...
  • Page 29: 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 30: 10 Operation

    Usage 10 Operation Phosphor storage plates will be pre-exposed ❯ on exposure to natural radiation and stray x-ray radiation. Protect erased and exposed phos- CAUTION phor storage plates from X-ray interference. Image data on the phosphor storage If the phosphor storage plate has been stored plate is not permanent for longer than one week, erase the phosphor storage plate prior to use.
  • Page 31: Switch The Device On

    Usage 10.1 Switch the device on The plate guy can be switched at any time. To prevent a loss of image quality Tapping the On/Off switch turns on the ❯ do not switch the plate guide during a device. scanning process. The On/Off button lights up briefly and the device starts up.
  • Page 32: X-Ray

    Usage 10.3 X-ray Completely slide the phosphor storage plate ❯ into the barrier envelope. The white (inactive) The workflow is described using an IDX side of the phosphor storage plate must be S2 phosphor storage plate as an exam- visible. ple.
  • Page 33 Usage Place the phosphor storage plate in the barrier Disinfect the barrier envelope and protective ❯ ❯ envelope into the patient's mouth. gloves with a suitable disinfection wipe; see In doing this, make sure that the active side of "11 Cleaning and disinfection"). the phosphor storage plate faces the X-ray Alternatively, use a spray disinfectant on a soft, tube.
  • Page 34: Scanning The Image Data Via A Computer

    Usage 10.4 Scanning the image data via Place the barrier envelope containing the phos- ❯ phor storage plate in the plate guide such that a computer it is aligned in the middle and straight. The opened side of the barrier envelope faces Starting the phosphor storage plate scanner down, the inactive side of the PSP faces the and software...
  • Page 35: Erasing The Phosphor Storage Plate

    Usage Remove the phosphor storage plate and pre- 10.6 Switching the unit off ❯ pare to take a new X-ray. Tap the On/Off switch to turn the device Off. ❯ The On/Off button lights up briefly and the device powers down. As soon as the unit has shut down it switches off completely.
  • Page 36: 11 Cleaning And Disinfection

    Usage 11 Cleaning and disinfection Store the dust cover in a clean place when it is ❯ not in use. When cleaning and disinfecting the unit and its accessories, comply with national directives, standards and specifications for medical prod- ucts as well as the specific specifications for dental practices or clinics.
  • Page 37: Barrier Envelope

    11.2 Barrier envelope Clean the Barrier Envelope after being removed ❯ from the patient’s mouth with a disinfectant wipe, such as Air Techniques Monarch Surface Wipes. Allow the Barrier Envelope to completely dry ❯ prior to ejecting the PSP. 11.3...
  • Page 38: 12 Maintenance

    12.1 Recommended maintenance schedule Only qualified personnel or personnel trained by Air Techniques is allowed to service the unit. Prior to working on the unit or in case of danger, disconnect it from the mains. The recommended maintenance intervals are based on operation of the device for 15 intraoral images per day on 220 working days per year.
  • Page 39: Troubleshooting

    Troubleshooting Troubleshooting 13 Tips for operators and service technicians Any repairs above and beyond routine maintenance may only be done by suitably qualified per- sonnel or by one of our service technicians. Prior to working on the unit or in case of danger, disconnect it from the mains. 13.1 Poor X-ray image Error...
  • Page 40 Troubleshooting Error Possible cause Remedy X-ray image only shadowy The X-ray dose on the PSP was Increase X-ray dose. ❯ insufficient Amplification (HV value) is set Increase amplification (HV ❯ too low in the software value). Unsuitable scanning mode Select a suitable scanning ❯...
  • Page 41 Troubleshooting Error Possible cause Remedy Shadow on the X-ray image PSP removed from the barrier Do not handle PSPs without a ❯ envelope before scanning barrier envelope. Store the PSP in a barrier ❯ envelope. X-ray image cut off, part miss- A metal part of the X-ray tube is Recording an X-ray image, ❯...
  • Page 42 Troubleshooting Error Possible cause Remedy Horizontal, grey lines in the X- Transport slipping Clean the transport mecha- ❯ nism, replace the transport ray image, extending beyond the left and right image edge belts if necessary. X-ray image is stretched Wrong barrier envelope or PSP Only use original accessories.
  • Page 43: Software Error

    Troubleshooting Error Possible cause Remedy Lamination of the PSP Wrong retainer system used Only use original PSP and film ❯ retainer systems. detaches at the edge PSP handled incorrectly. Use the PSP correctly. ❯ Comply with the operating ❯ instructions of the PSP and film retainer systems.
  • Page 44: Fault On The Unit

    Troubleshooting Error Possible cause Remedy Imaging software fails to rec- Unit not switched on Switch the device on. ❯ ognize the unit Connecting cable between unit Check the connecting cable. ❯ and computer not correctly con- nected Computer does not detect any Check the connecting cable.
  • Page 45 Troubleshooting Error Possible cause Remedy Unit switches off again after a Mains cable or power supply Check the mains cable and ❯ unit plug not inserted correctly plug connections. short time Hardware defect Contact technician. ❯ Mains supply voltage too low Check the mains supply volt- ❯...
  • Page 46 Troubleshooting Error Possible cause Remedy Network connection has been WLAN stick is not inserted Insert the WLAN stick into the ❯ device. disconnected Distance to WLAN router too far Set up the unit closer to the ❯ WLAN router. Walls between WLAN router and Set up the unit closer to the ❯...
  • Page 47: Error Messages On The Display

    Troubleshooting 13.4 Error messages on the display Error Possible cause Remedy Error code -1008 Internal connection disrupted Update firmware. ❯ Temperature of unit too high Allow the unit to cool down. Error code 1010 ❯ Contact technician. ❯ Error code 1022 Subassembly not initialized Fault in software, update the ❯...
  • Page 48 Troubleshooting Error Possible cause Remedy Error code 10009 Internal communication error Update the firmware. ❯ warning; unit remains ready for operation Error code 10017 Unit shuts down Wait until the unit has shut ❯ down completely Error code -10022 Plate guide is missing or was Insert plate guide.
  • Page 49 Troubleshooting Error Possible cause Remedy Error code -78 Storage medium (e. g. memory Transmit image data to the ❯ card or memory stick) is full computer. Insert an empty storage ❯ medium. Fault during memory cleanup Press and hold the reset but- ❯...
  • Page 50: 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 51: 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. Theoretical resolution (LP/mm) Pixel size (μm)
  • Page 52: 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 56 Hersteller / Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com Manufactured for / Distributed by: Air Techniques, Inc. 1295 Walt Whitman Road Melville, New York 11747-3062, USA Phone: 800-247-8324 Fax: 888-247-8481 www.airtechniques.com...

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