DEXIS Scan eXam One User Manual

Digital intraoral imaging plate system

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Scan eXam™ One

Digital Intraoral Imaging Plate System

User Manual

224301-PTU rev. 3

ENGLISH

Table of Contents

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Summary of Contents for DEXIS Scan eXam One

Page 1 Scan eXam™ One Digital Intraoral Imaging Plate System User Manual 224301-PTU rev. 3 ENGLISH...
Page 3 Scan eXam™, CLINIVIEW™ and IDOT™ are either registered trademarks or trademarks of PaloDEx Group Oy in the United States and/or other countries. DEXIS™ is a registered trademark or a common law trademark of Dental Imaging Technologies Corporation. DTX Studio™ is a registered trademark or a trademark of Nobel Biocare Services AG.
Page 5: Table Of Contents
2.1 Preparing the imaging plates ................9 2.2 Positioning and exposure..................10 2.3 Processing the imaging plates ................11 Advanced use ......................13 3.1 Scan eXam One setup options with CLINIVIEW™ ..........13 3.1.1 Scanner....................14 3.1.1.1 Status ..................14 3.1.1.2 Image Scanning................. 14 3.1.1.3 Image Processing ..............
Page 6 6.1 Positioning the unit....................41 6.2 Connecting the unit to a network................. 42 6.3 Install the Application software................43 6.4 Accessing the unit from CLINIVIEW ..............44 6.4.1 Direct connection method (uses the unit s/n)........... 44 6.4.2 IP method (using the unit static address)..........45 6.4.3 EXPRESS Share..................
Page 7: Introduction
Only use the power supply delivered with the unit or an approved spare power supply supplied by an author- ized distributor (See chapter 9 Tech- nical specifications). Documentation and imaging application software media Hygiene accessories Imaging plates 10. Imaging plate storage box Scan eXam One...
Page 8: System Setup
Internet connection (optional, recommended) Optional workstation (WS) computers (not included) For more options and details of installing and setting up the Scan eXam™ One system see chapters 6 Installation of the imaging plate system and 9 Technical specifications. Scan eXam One...
Page 9: Controls And Indicators
• to start processing in the manual mode or to cancel (skip) the 2nd plate in the Occlusal 4C mode. • to access startup screen-information (IP, serial number) when the scanner is not reserved by any user. Scan eXam One...
Page 10 The unit is not reserved by any workstation in the sys- tem. Unit is activated The unit is activated for image processing. The name of the current patient is shown. The green plate feeding indicator is showing readiness for plate insert. Scan eXam One...
Page 11 Remove plate Remove the imaging plate from the plate carrier. Rotate the plate Rotate the imaging plate. Light blue side to the left. Remove cover Remove the hygienic cover gently leaving the imaging plate in the plate carrier. Scan eXam One...
Page 12 Unit disconnected Missing ethernet connection. Check the connectors, ca- bles and the network. Error Error ID and a short description is displayed. Contact service. Press START Press the START button to wake the unit from a standby mode. Scan eXam One...
Page 13: Basic Use
2 Basic use Basic use Prepare imaging plates. See chapter 2.1 for more information. Activate the Scan eXam One from the imaging ap- plication. Refer to the application software manual for more information. Position and take an exposure. See chapter 2.2 for more information.
Page 14 24 hours. • Imaging plates have stored in dark (not exposed to ambient light) susceptible for background radiation for more than 24 hours. This will remove any potential fogging due to collected natural background radiation. Scan eXam One...
Page 15: Preparing The Imaging Plates
Active side of the imaging plate has a light blue color. NOTICE! Keep the imaging plates packed max. 24 hours before using. Packaged plates accumulate radiation from the background. Plates can be erased by reading the plate. Scan eXam One...
Page 16: Positioning And Exposure
DC X-ray unit in the table below. Correct exposure settings depend on the X-ray unit type in use. For an AC-unit or for a low tube current (i.e. portable X-ray) apply higher exposure times. Exposure factors close to F-speed film are often appropriate. Scan eXam One...
Page 17: Processing The Imaging Plates
NOTICE! Do not partially slide the imaging plate from the cover. You can place the plate with cover and leave it to the plate carrier. Unit will not start the processing before removing the cover. Remove the cover. Scan eXam One...
Page 18 2 Basic use The image appears on the imaging application screen. NOTICE! Process within one hour after exposure. Processed imaging plate is ready to be packed and exposed again. Scan eXam One...
Page 19: Advanced Use
Advanced use 3.1 Scan eXam One setup options with CLINIVIEW™ The Scan eXam One setup options allow you to configure the Scan eXam One to the user’s clinical preferences. From the imaging application software you are using select unit Setup/Scanner page (for more instruction on how to access setup page review application software manual).
Page 20: Scanner
Super gives a pixel size of 30 μm. This results in images with better resolution, but may require longer exposure time to compensate. High (recommended default) gives a pixel size of 60 μm. This results in images with less noise especially if short exposure times are used. Scan eXam One...
Page 21: Image Processing
Workstation: If the image is not automatically trans- ferred to the workstation, select the Setup > Scanner page from the imaging application software your are using. Scan eXam One...
Page 22: Scanner Unit Serial Number
3.1.1.5 Scanner Unit Serial number Adds the unit serial number to all new images. 3.1.2 Settings See chapter 6 Installation of the imaging plate system for more information on connecting the unit to a workstation/ LAN. Scan eXam One...
Page 23: Workflow
• After Cover removal: after the imaging plate and protective cover have been inserted into the plate carrier, processing starts automatically when the protective cover is removed. Scan eXam One...
Page 24 NOTICE! Processing starts even if the plate is: • Wrong way round • Not detected • Not inserted at all NOTICE! Unit turns off in manual mode if user is pressing ON/ OFF key regardless of imaging plate sensing in the plate carrier. Scan eXam One...
Page 25: Plate Eject Mode
The Leave in plate carrier option is recommended for us- ers who want to handle the imaging plates with more care and reduce wear and tear on them. This option extends ser- vice life of the imaging plates and allows greater hygiene standards to be observed. Scan eXam One...
Page 26: Power Options
Beep when entering standby mode: Audible signal is heard before the unit enters the standby mode. Shutdown after (minutes): Allows you to select the period of time the unit remains in standby mode before automatically switching itself off. Scan eXam One...
Page 27: Occlusal 4C Projection Imaging (Not Included In Delivery)
Occlusal 4C hygiene bag. Seal the bag. Place the sealed Occlusal 4C hygiene bag into the patient’s mouth and take an exposure. Remove the sealed Occlusal 4C hygiene bag from the patient’s mouth. Open it. Scan eXam One...
Page 28: Scan Exam™ One Settings With Dtx Studio™ Core
NOTICE! For most accurate and up to date information, refer to DTX Studio™ Instructions for Use. Sign into DTX Studio™ Core with the same user cre- dentials as you use to login to DTX Studio™. Select Manage devices menu. Scan eXam One...
Page 29 Click on the device image to open Device details. Status: Shows the status of the device (default: Avail- able) Device model: Shows the model of the device (Scan eXam™ One). IP address: Shows the IP address of the device. Scan eXam One...
Page 30: Device Settings
• Device name: Device identification shown in DTX Studio. • Image processing computer: Normally, the work- station where DTX Studio™ Core is installed. • Device color: Device identification shown in DTX Studio. • Autorelease timeout: 40s default Scan eXam One...
Page 31: Power Settings
• Add default exposure values to metadata: Ena- ble or disable if the device’s default exposure val- ues (kV, mA, s) are saved to image metadata. Scan eXam One...
Page 32: Workflow Settings
Plate ejection mode: • Drop in plate collector: The imaging plate is ejected and dropped into the plate collector after the imaging plate has been processed. Scan eXam One...
Page 33 Size 3/occlusal: • Size 3: Size 3 imaging plates are processed as in- dividual images. • Occlusal 4C: Two sequential size 3 imaging plates are stitched together to create a single occlusal im- age. Scan eXam One...
Page 34 3 Advanced use Scan eXam One...
Page 35: Accessories
THE MANUFACTURER to ensure the optimal clinical results, safe use of the system and long service life for the imaging plates. 4.1 Hygiene covers NOTICE! Never use hygiene accessories more than once. Risk of infection. Protective covers Hygiene bags Scan eXam One...
Page 36: Imaging Plates
1, 2, 3 and Occlusal 4C, all with film-like usability. IDOT™ imaging plates have individual identification marking that appear on the images. Standard (STD) imaging plates (optional) have no identification mark on the sensitive side of the plate. Scan eXam One...
Page 37: Imaging Plate Handling
You can bend. Do not fold or bend exces- sively. Touch the edges Do not touch only. the sensitive surface. Do not scratch. Do not stab. Avoid moist and Do not sink. water. Allowed Avoid dust. temperature. Scan eXam One...
Page 38: Imaging Plate Cleaning
UV radiation. 4.2.2 Imaging plate cleaning Use ONLY > 70% Ethanol Do not apply Ethanol directly on the plate. Apply Ethanol on lint free soft fabric. Wipe the plate gently. Wipe dry or let dry for 1 minute. Scan eXam One...
Page 39: Imaging Plate Storage Box
(which may decrease image quality) • Ultraviolet radiation (which is harmful for the imaging plates) Base part of the storage box is autoclavable at 121°C (250 F) or 134°C (272 F). The top cover cannot be autoclaved. Scan eXam One...
Page 40: Holders
For more information see instructions provided with the Occlusal 4C kit and on chapter 3 Advanced use. 4.6 Microfiber cloth Imaging plate microfiber cloth is used for dry cleaning of the imaging plates (comparable to eyeglasses cleaning). Scan eXam One...
Page 41: Introduction To Imaging Plate Technique
Even when packed properly, the image starts to fade out slightly within time. NOTICE! If imaging plates show any signs of deterioration affecting image quality, do not use them. Scan eXam One...
Page 42: Hygiene Accessories
Magnet on the plate carrier grabs the imaging plate. Processing starts automatically after you remove the protective cover. The hygiene bag should be disinfected after an exposure and must be disposed of after a single use. Scan eXam One...
Page 43: Processing
The imaging plate is dropped out of the unit. X-ray exposures and processing are not aging the imaging plate, so it is re-usable hundreds of times. In practice, mechanical wearing limits the service life of the plate. Scan eXam One...
Page 44: Background Radiation
Imaging plates gather radiation also during transportation from the manufacturer. Therefore it is recommended to perform initial erasing for the new plates. This means that all imaging plates should be processed once prior to use. Scan eXam One...
Page 45: Light
Ambient light is good when storing the imaging plates: it keeps the plates clean from background radiation “fogging”. NOTICE! Ambient light is harmful for the image information on the plate between the exposure and processing. NOTICE! UV light is harmful for the imaging plates. Scan eXam One...
Page 46 5 Introduction to imaging plate technique Scan eXam One...
Page 47: Installation Of The Imaging Plate System
Typical location for a scanner unit in a shared use by multiple operators is somewhere in a common space for all users having an easy access to. Scan eXam One...
Page 48: Connecting The Unit To A Network
The unit can obtain an IP address automatically (DHCP) or it can be set manually (static IP). The unit will show its IP number during the boot up sequence when powered on. Scan eXam One...
Page 49: Install The Application Software
Insert the software installation media (DVD) and launch the software installer if it does not start automatically. Read the software installation manual. Follow the instructions of the installation wizard to complete the software installation. Refer the software installation manual for details. Scan eXam One...
Page 50: Accessing The Unit From Cliniview
Workstation: Select Direct Connection. Key the serial number of the unit into the Scanner serial number field. The serial number of the unit appears on the type label on the back of the unit. Make sure that the Scan eXam One...
Page 51: Ip Method (Using The Unit Static Address)
OK to connect the workstation to the unit (it is not necessary to hold down the Start key and click Send to Scanner with the other workstations once the unit has already got an IP address). Scan eXam One...
Page 52: Express Share
Workstation identifier. Check the installation by starting image capture using the imaging application software. If the Use Multicon- nect was selected the Workstation identifier of the workstation (1 - 4) being used appears on the unit user interface. Scan eXam One...
Page 53: Accessing The Unit From Dtx Studio™ Core
If the device does not appear on the list, click Scan network. • If the device still does not appear on the list, add the device manually by clicking Manually search device and fill the prompted device information fields. Scan eXam One...
Page 54: Other Devices
The workstation connected to the unit should not be used in the patient environment. The minimum horizontal distance between the patient and the workstation is 1.5 m (4.5 ft). The minimum vertical distance between the patient and the workstation is 2.5 m (6.5 ft). Scan eXam One...
Page 55: Troubleshooting
- Plate has been stored in the bag or in dark too long • Use dedicated imaging plate storage box to avoid these. • Alternatively, perform initial erasing for the plate(s) if they have been stored in dark and/or near X-ray unit. Scan eXam One...
Page 56: Application Errors
Too long exposure time/too high X-ray dose. Too light, noisy image with decreased diagnostic value. Showing only part of the image. Showing wrong size of the image (Image smaller than im- aging plate). • Too short exposure time / Too low X-ray dose. Scan eXam One...
Page 57 Cone cut X-ray beam has exposed only part of the imaging plate surface. Image may show on different (smaller) size than the imaging plate used. • Check exposure procedure. • Use of proper holder avoids this. Scan eXam One...
Page 58 Geometry distortion Improper patient positioning. • Use proper holders to avoid this. NOTICE! Never do accurate measurements on intraoral images unless having known size of reference object in the imaging plane. Scan eXam One...
Page 59: Imaging Plate Wearing
Can be caused by moisture or improper cleaning. • Clean the plate(s), ONLY >70% ETHANOL MUST BE USED. • Replace if cleaning does not help. • Pay attention on handling, storing and maintenance. Ensure that only the genuine hy- giene accessories are used. Scan eXam One...
Page 60: Error Messages
/ not detect- K400 control panel error (control panel button defected / stuck) 1234 Other, see driver status window Turn power off and on to see if the unit recovers. If not, please contact local dealer or distributor. Scan eXam One...
Page 61: Other Information
Never use unfamiliar or untested cleaning agents. If you are not sure what the cleaning agent contains, DO NOT use it. If you use a spray cleaning agent DO NOT spray it directly into the unit door. Scan eXam One...
Page 62: Disinfecting The Unit
The unit includes some or all of the following parts that are made of or include materials that non-environmentally friendly hazardous: • electronic circuit boards • electronic components • imaging plates Scan eXam One...
Page 63: Technical Specifications
Council Directive 93/42/EEC as amended by the Directive 2007/47/EC concerning medical devices. eXam6 Classification IEC60601- - CLASS II equipment - No applied part - Continuous operation - IPX0 (enclosed equipment without protection against ingress of liquids Scan eXam One...
Page 64 +10°C - +40°C, 30 – 90 RH%, 700 – 1060 mbar Storage / transportation -10°C – +50°C, 0 – 90 RH%, environment 500 – 1080 mbar Other Integrated Kensington security slot for securing unit with Microsaver series locks. Scan eXam One...
Page 65: System Requirements And Connections
When adding new devices to LAN, make sure they all have unique IP address, otherwise they may cause communication problems with existing LAN devices. Place unit and workstation with imaging application software to same subnet in LAN. Scan eXam One...
Page 66 Do not disconnect unit PSU adapter before network is operational and image has been transferred to imaging application software. For more details of the hardware requirements running the imaging application software please refer to the user manual of it. Scan eXam One...
Page 67: Imaging Plate Specifications
Never use damaged imaging plates! * High resolution mode image sizes are approximately half of the values in the table. Scan eXam One...
Page 68: Hygiene Bag Specifications
MYYXX). Extended storage time or exceeding the specified storage conditions may compromise the performance of the adhesive tape and/ or the plastic material from which the hygiene bags are made of. Single use only. Do not reuse. Disposal Observe relevant national requirements. Scan eXam One...
Page 69: Electromagnetic Compatibility (Emc) Tables
Exceptions for professional healthcare facility environment: Not to be used or installed near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high. Scan eXam One...
Page 70 IEC61000-3-3 Not to be used or installed near active HF SUR- GICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imag- ing, where the intensity of EM DISTURBANCES is high. Scan eXam One...
Page 71 61000-4-8 ment. The device shall not be used closer than 15cm to sourc- es of 50/60Hz magnetic field. NOTICE! UT is the a.c. mains voltage prior to application of the test level. Scan eXam One...
Page 72 RF transmit- ters, as determined by an electro- magnetic site survey,* are less than the compliance level in each frequency range.** Interference may occur in the vicinity of equipment marked with the following symbol: Scan eXam One...
Page 73 Recommended Separation Distances are listed in the next table. NOTICE! These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTICE! RF communications equipment can effect medical electrical equipment. Scan eXam One...
Page 74 WARNING! Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. Scan eXam One...
Page 75 Interference may occur in the vicinity of equipment marked with the following symbol: Scan eXam One...
Page 76 9 Technical specifications Scan eXam One...
Page 77: Symbols And Labeling
Do not reuse (Single use) Recyclable Operating instructions Refer to operating instructions for more information. The operating in- structions can be supplied electroni- cally or in paper format CLASS II equipment (Double insulated electrical appliance) UL symbol Scan eXam One...
Page 78 UKCA (UK Conformity Assessed) marking Swiss authorised representative Caution: Federal law restricts this to sale by or on the order of a licensed healthcare practitioner. NRTL Mark Conforms to U.S. and Canada national safety standards GOST-R symbol Importer Scan eXam One...
Page 79: Device Labels
The device labels are located at the rear of the device Type label: NOTICE! The type label shown below is for reference only. The texts may be different in the actual label. CLASS 1 Laser product warning label: Scan eXam One...
Page 80: Warnings And Precautions
Please refer to the unit technical specifications for a list of the PSUs. • For ethernet connections, use an unshielded CAT6 RJ-45 LAN cable, so that multiple chassis must not be connected! The workstation / Ethernet switch to Scan eXam One...
Page 81 Image is not transferred from unit to workstation imaging application software in case of connection lost during image processing. Image is stored in unit memory until it has been transferred to work- station. Unit cannot be turned off in that case. Scan eXam One...
Page 82 • Report any incident, related to the use of this de- vice, having a serious effect on the health of a pa- tient, user or other person to the manufacturer and the local competent authority. Scan eXam One...
Page 83 Contact your PaloDEx Group Oy representative for the most current information. Copyright © by PaloDEx Group Oy. All rights reserved. DEXIS™ is a registered trademark or a common law trademark of Dental Imaging Technologies Corporation. Headquarters PaloDEx Group Oy Nahkelantie 160 | FI-04300 Tuusula | FINLAND Tel.

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