PSPIX USER'S MANUAL
Contents
1. OSDIXx USER MANUAL 5 ACTEON imaging 00000000000 ENGLISH CONTENTS FOREWORD E EEE R 2 PSPIX INTRODUCTION 2 PRECAUTIONS FOR USE 5 STANDARDS AND REGULATIONS 7 suis sade eed awed sebieden saunas 13 INSTALLATION AND 14 18 IMAGING PLATE 26 MAINTENANCE 30 AFTER SALES SERVICE 32 TECHNICAL 34 PSPIX user manual 1 ENGLISH FOREWORD Congratulations on your purchase of PSPIX To optimize the use of this device whilst taking all the necessary precautions we recommended you carefully read and follow this owner s manual Please carefully consider the messages CAUTION WARNING and NOTE when using the system A CAUTION the term CAUTION describes potential incidents likely to jeopardize safety WARNING the term WARNING refers to the incidents likely to disturb the smooth running of the imaging system NOTE the term NOTE highlights particular points in order to facilitate the system maintenance or to clarify important information PSPIX INTRODUCTION 2 1 FUNCTIONS AND PERFOR2. s user manual The following message may appear the PC screen during or after read out Degraded image quality If the image looks okay no action 15 necessary the message appears frequently contact your authorized distributor for assistance In case of failure not mentioned above please send the PSPIX system back to the SOPRO dealer or after sales department A CAUTION No maintenance should be performed by a third party PSPIX user manual 33 ENGLISH TECHNICAL SPECIFICATIONS PSPIX Dimensions H x W x D 203 mm x 246 mm x 411 mm Weight 9 5 kg Operating voltage 24 VDC PSU 100 240VAC 50 60Hz Operating current less than 1 5 Pixel size selectable 35 super 64 high Bit depth 14 bits grayscale Clinical Resolution 10 Spatial Resolution 14 3 lp mm Operating environment 10 C to 40 C 30 to 90 RH 700 to 1060 mbar e Storage transportation environment 10 C to 50 C 0 to 90 RH 500 to 1080 mbar e Interface cable For Ethernet connections use an unshielded CAT6 LAN cable so that multiple chassis must not be connected The PC Ethernet switch to which scanner is connected to should be approved appropriately e g EN 60950 IEC 60950 UL 60950 Continuous service Not protected against water chutes IPXO Class 1 or 2 equipment depending on the classification of the PSU No applied part Power supply POW
3. user manual 24 ENGLISH To retrieve the last image 1 Correct the problem that caused the communication failure and the connection will be re established and the last read image should automatically be transferred to the PC 2 If it is not select File menu gt Setup gt PSPIX tab from Sopro Imaging software 3 In the Retrieve Last Image field click the check box to retrieve the last read image NOTE If required you can select different parameters e g resolution setting show image preview etc for the image to be retrieved 4 Click OK to close the Setup window The last read image will appear on the patient card 7 7 SHUTTING DOWN THE SCANNER 1 Press and hold power on off key until the indicator light goes off NOTE If there is an untransferred image in the unit s memory the unit cannot be shut down Refer to the chapter Retrieve last image PSPIX user manual 25 ENGLISH IMAGING PLATE 8 1 GENERAL INFORMATION An Imaging Plate is a flexible intraoral x ray image receptor comprising a layer of very small particles of photo stimulable phosphor uniformly coated onto a polyester support film and shielded with a top coat protective layer Phosphor phosphorous Phosphorous phosphorus P is not used in our plates In our application we consider phosphor as a substance that exhibits the phenomenon of phosphorescence sustained glowing after exposure to stimulating l
4. Show possible problems and guide the user to correct the problem Guide user to check the application W on the workstation if user action is required Show any error codes The basics symbols are shown below Startup animation and unit information Startup 1222 15 Unit door Protective cover and imaging plate White remove protective cover Imaging plate White wrong way round rotate PSPIX user manual 16 a Progress animation Error A Lees SS PSPIX user manual ENGLISH Protective cover Remove disconnect Insert connect Multiconnect wait Multiconnect configuration but the scanner has not been reserved Waiting to be reserved form the PC Multiconnect reservation e g PC number 2 has reserved the scanner Busy Scanner in operation Scanner in erasing mode Check something wrong or take alternative action Dental imaging software not open not ready or waiting for user action Scanner not connected or connection not working Rotate Erase state and error number Check documentation supplied with the scanner Scanner in service mode for service technical only ENGLISH USE 7 1 PREPARING THE PSPIX AND THE IMAGING PLATE 1 Switch on the computer that is connected to the scanner 2 Open Sopro Imaging and then either create a new patient or open an existing one NOTE If you are using the system for the first time you
5. correct diagnostic purposes NOTE If the exposure times are too long Images may become too dark Images may be blurred because of patient movement Patient is exposed to too much X ray radiation If the exposure times are too short Images may become too noisy and thus unclear Images may be different sizes than the actual objects 3 Protect yourself from radiation when taking the exposure 4 After the exposure remove the sealed hygiene bag and imaging plate from the patient s mouth CAUTION If there is a risk of cross contamination wash disinfect and dry the hygiene bag prior to opening it 7 4 READING THE IMAGING PLATE Single user configuration e sure that the scanner is ready for IMAGING PLATE readout The status light is green A CAUTION If the status light is orange the scanner is in standby mode Press the Start key to exit the standby mode NOTE If the scanner is operated in a multiconnect configuration please refer to the end of this section for multiconnect operations 7 1 Pull the flap to open the hygiene bag PSPIX user manual 21 ENGLISH 2 Slide the protective cover and imaging plate out of the hygiene bag Keep the imaging plate in the plate cover so that you do not touch the imaging plate or allow it to be exposed to ambient light 3 Hold the protective cover and imaging plate
6. covers from other manufacturers This unit and its accessories must not be modified altered or remanufactured in any way Only the manufacturer s approved service personnel are authorized to conduct maintenance and or repair procedures There are no user serviceable parts inside the unit Infection control procedures must be observed when using accessories such as film holders x ray tube guides and imaging plates When using accessories always follow the manufacturer s instructions on how to use said accessory and prevent cross contamination risk from one patient to another This device can interfere with other devices due to its EMC characteristics Other devices can interfere with this device due to their EMC characteristics This device complies with IEC 60601 1 standard Accessory equipment connected to this device must be in compliance with the local IEC standards This equipment is not suitable for use in the presence of flammable anaesthetic mixture with air oxygen or nitrous oxide In order to maintain safe and correct function of the unit only the power supply PSU supplied with the scanner or distributed from authorized dealer can be used Please refer to the scanner s technical specifications for a list of compatible PSUs PSPIX user manual 5 ENGLISH Only use Imaging plates protective covers and hygiene bags designed for this scanner and supplied by an authorized distribu
7. information loss Proper handling is the main factor that extends the service life of imaging plates PSPIX user manual 26 ENGLISH 8 2 HANDLING IMAGING PLATES The correct use handling cleaning and storage of imaging plates guarantees the best image quality and maximum service life of the imaging plates X ray exposures DO NOT cause IMAGING PLATES to age The light blue side of the imaging plate is the side which stores the x ray image It is the SENSITIVE side Only hold imaging plates by their edges with your fingers eUnprotected IMAGING PLATES should not come in contact with the patient the patient s saliva or any other bodily fluids Protect the SENSITIVE side of the IMAGING PLATE from Scratches wear and other mechanical abrasion or damage Stains dirt dust particles etc Fingerprints Stains fingerprints on the sensitive side can degrade the diagnostic value of the image Dust wear on the sensitive side can appear as white grey spots on the image Image information stored on an imaging plate after an exposure is sensitive to light Always use hygiene bags and protective covers with imaging plates when taking exposures to eliminate cross contamination maintain image quality maximize IMAGING PLATE service life Precautions for use Handle Imaging plate with the same care as you would handle intraoral film CD or DVD disks Only hold IMAGING PLATEs f
8. it is possible to browse the whole content of the CD ROM At the CD ROM root are files allowing an automatic launch and or a manual setup Located in the Document directory are all manuals related to Sopro Imaging software digital x ray systems intra oral cameras and SOPROLIFE systems These documents are in PDF format Make sure Adobe Acrobat is correctly installed prior to opening any of those files The drivers directories contain all the drivers necessary to pilot Sopro devices PSPIX Sopix system SOPRO cameras in USB 1 and USB 2 Hasp protection SOPRO Imaging directory contains the SOPRO Imaging installation program The Tools directory contains Microsoft Direct X 9 0 and ADOBE Acrobat Reader installation programs e Click on Install SOPRO Imaging A window appears select the desired language to be used during the installation process A dialog box opens it displays the software license and terms of use to be entirely read in order to continue with the installation Once read click on Next e default the SOPRO Imaging software will install in the C Program Files SOPRO Imaging directory It is possible in this dialogue to change the installation path To start the installation click on Next the installation is completed a dialogue box displays Click on Finish PSPIX user manual 14 ENGLISH NOTE To obtain the be
9. may wish to check and or change the setup options Please refer to chapter 6 3 3 Turn PSPIX on by pressing the on off button A startup animation will appear on the display The scanner will carry out self tests and an initialization sequence during which time the plate carrier will slide out of the scanner door When the status light turns green and the ready animation showing the imaging plate insertion appears on the unit s display the scanner is ready for use NOTE If the ready animation does not appear check the system setup described in the chapter 6 3 4 The motion sensor allows hands free operations of the unit When the scanner is in idle mode the motion sensor detects the user s hand as it approaches the scanner and automatically wakes the scanner from idle to ready state 5 Place the imaging plate you wish to use onto the plate cover The active side of the imaging plate blue colour must face the corresponding side of the protective cover 0 WARNING If the imaging plate is being used for the very first time or has not been used within the last 24 hours it MUST initially be erased in order to avoid possible fogging caused by background radiation Please refer to chapter 8 5 PSPIX user manual 18 ENGLISH A CAUTION When handling imaging plates protective covers and hygiene bags take all appropriate measures and precautions in order to prevent cross contaminat
10. 4 hours it may be necessary to initially erase the IMAGING PLATEs before using them for patient exposures This can be done by reading the IMAGING PLATE normally with unit before using the IMAGING PLATE for patient exposure from the image you can see whether there is fogging on the IMAGING PLATE OR Select the dedicated erasing mode Whether the initial erasing is required depends on the ambient conditions in which the IMAGING PLATEs are stored PSPIX user manual 28 ENGLISH 8 5 IMAGING PLATE ERASING MODE INITIAL ERASING OF THE IMAGING PLATES If an imaging plate is being used for the very first time or has not been used for the last 24 hours the erasing procedure must be carried out in order to remove any fogging due to background radiation The dedicated erasing mode erases Imaging Plates quickly and efficiently and does not send a blank image to Sopro Imaging software 1 Press and hold down the Start key for several seconds until the erase mode animation appears on the unit display The unit is now in the erase mode 2 Hold the IMAGING PLATE by its sides or use a protective cover and position it so that the back of the imaging plate the BLACK side is on the right Insert the IMAGING PLATE into the unit door remove the protective cover if used A magnet will hold the imaging plate in position and then automatically slide the IMAGING PLATE into the unit NOTE It may take longer to erase IMAGING PLA
11. ERBOX EMX 805121 Class 1 laser product EN 60825 1 2007 Complies with IEC 60601 1 IMAGING PLATES Imaging plate Size 0 Dimensions 22 x 31 mm Image size pixels 35 628 x 885 pixels Image size 35 1085 KB Image size pixels 64 um 484 x 344 pixels Image size 64 um 325 KB Imaging plate Size 1 Dimensions 24 x 40 mm Image size pixels 35 685 x 1143 pixels Image size 35 1529 KB Image size pixels 64 um 625 x 375 pixels Image size 64 um 458 KB PSPIX user manual 34 ENGLISH Imaging plate Size 2 Dimensions 31 x 41 mm Image size pixels 35 886 x 1171 pixels Image size 35 2026 KB Image size pixels 64 641 x 484 pixels Image size 64 606 KB Imaging plate Size 3 Dimensions 27 x 54 mm Image size pixels 35 771 x 1542 pixels Image size 35 2322 KB Image size pixels 64 844 x 422 pixels Image size 64 695 STORAGE Unpacked exposed to ambient light in the dedicated storage box The box must be kept closed to remain dust free Below 33 C 80 RH and shielded from X ray or ultraviolet radiation MATERIAL Photo stimulable phosphor uniformly coated on a support plastic material Shielded with a top coat layer on active surface and encapsulated with lacquer around edges DISPOSAL Imaging plates are industrial waste and must be disposed of in accordance with local and national regulations concerning the disp
12. ING PLATE if microfibre tissues SOLUTIONS FOR Phenol based may leave there are any optics are excellent IMAGING cleaning liquids residue on the visible artefacts e First wipe ina back PLATES e Isopropyl active surface which are not and forth direction and 70 to 96 2 propanol which will appear obvious scratches then with circular ethanol 70 96 as artefacts on on the image movement EtOH 30 4DI the If there s still stains WATER alcohol images after wiping with dry Ethanol Acetone etc Unsuitable tissue dampen one anhydride solvents cleaning corner of the tissue Anhydrous Autoclave solutions method with 70 96 ethanol alcohol e Disinfectant s may damage also called ethyl Single use foil baths or destroy the alcohol and wipe packed or e Abrasive imaging plate described above dispenser cleaning agents Wipe the active packed surface dry with the etc cleaning dry part of your tissue tissues containing Clean the sensitive side of the IMAGING PLATE if there are any visible marks or artifacts which are not obvious scratches on the image Use a dry lint free cloth a microfibre cloth used for cleaning lenses or similar First very gently wipe the IMAGING PLATE in a backwards forward in both the vertical horizontal direction and then finish with a circular
13. MANCE PSPIX is a laser scanning device designed to automatically scan read and erase reusable dental intraoral imaging plates PSPIX works in conjunction with a PC installed with compatible dental imaging software The scanner can either be connected directly to the PC or to the network via a LAN cable PSPIX can be set up to work with a single PC the single user configuration or with multiple PCs the multiconnect multiple users configuration The multiple user configuration allows up to eight PCs to control the scanner there is no software limitations in consulting the image one PC at a time PSPIX user manual 2 ENGLISH 2 2 PARTS LIST The PSPIX digital intraoral imaging plate system is composed of the following elements PSPIX scanner 2 standard imaging plates size 0 2 standard imaging plates size 1 5 standard imaging plates size 2 1 standard imaging plates size 3 100 protective covers for each size of imaging plate 100 hygiene bags for each size of imaging plate A microfiber cloth for cleaning imaging plates An imaging plate storage box An imaging plate collector Power supply 100 240 VAC Optional e IDOT imaging plates size 0 size1 size 2 size 3 for individually marked plates e Imaging plate holders for bitewing periapical and endodontic exposures NOTE The device has been designed and developed with its accessories in order to guarantee maximum safety and performance The use of non ge
14. OFTWARE The PSPIX system is provided with Sopro Imaging dental imaging software compatible with Microsoft Windows see table above for compatible versions Sopro imaging software captures processes and stores x rays acquired from the PSPIX system allowing images to be shared on the network Sopro Imaging can also link together with most popular management software available on the market For more information please contact your local distributor 5 3 COMPATIBILITY WITH X RAY GENERATORS The PSPIX system is compatible with all intraoral x ray generators Nevertheless we recommend X Mind AC DC generators that are perfectly adapted to the PSPIX system to ensure very good performance with reliable x ray images PSPIX user manual 13 ENGLISH INSTALLATION AND CONNECTION 6 1 SOPRO IMAGING SOFTWARE INSTALLATION Insert the SOPRO Imaging CD ROM into the driver The CD ROM will start automatically WARNING If the CD ROM does not execute automatically or if the operating system is prior to Windows XP SP1 follow these instructions Go to the Start menu gt Execute Type D setup exe replace D with the letter of your CD drive Click on OK the installation process starts A dialog box opens it is the main menu window allowing the installation of a certain number of programs related to SOPRO Imaging NOTE Clicking on the key Browse this CD ROM opens an explorer window from which
15. TEs using the erasing mode than the normal readout and erase mode This is to ensure that IMAGING PLATEs that have not been used recently are erased properly 3 After the imaging plate has been erased it will automatically be ejected from the scanner into the plate collector The imaging plate can now be used to take an exposure 4 To exit the Erasing mode either wait 15 seconds for the scanner to automatically exit the mode or press and hold down the Start key until the erase animation disappears PSPIX user manual 29 ENGLISH MAINTENANCE The PSPIX system does not need any maintenance if it is used according to the manufacturer s use and cleaning instructions Before first using any device from the PSPIX it is imperative to follow the complete disinfecting procedure Any device from the PSPIX returned to the manufacturer or distributor for servicing or maintenance should be carefully disinfected before shipping Any item of the PSPIX range coming back from servicing or maintenance operation should follow complete disinfecting procedures before being used Proper use handling cleaning amp storing guarantees the best image quality and maximize the lifetime of your imaging plates 9 1 CONTROLLER MAINTENANCE USE INSTRUCTIONS AND PRECAUTIONS DESCRIPTION RECOMMENDATIONS 7 WARNING Cleaning Use abrasive After cleaning wipe Never use Switch off and unit cloth moist
16. aser beam during readout Phosphor material sealing Phosphor material is properly sealed inside the top coat protective layer on the active side and the support material on the back side The edges are sealed with an edge reinforcement layer Phosphor substances cannot become detached from the other IMAGING PLATE components in normal use With imaging plates the phosphor particles are excited by X ray photons and store the X ray energy in the form of a latent image The latent image held by the phosphor particles is stable for hours and takes several days to finally decay When the imaging plate is read by the imaging plate scanner the latent image is stimulated by a laser activated and then converted to digital form The digital image can then be view on the PC After the latent image has been read and converted to digital form the image is automatically erased so that the IMAGING PLATE is ready for immediate re use The light blue side of the imaging plate is the side which stores the X ray image It is the SENSITIVE side X ray exposures DO NOT cause imaging plates to age Imaging plates can withstand thousands of exposures without degradation of performance After an imaging plate has been exposed it is sensitive to ambient light and should be protected from direct light and daylight by keeping it in its protective cover until the plate is read Read exposed images immediately after exposure to avoid image
17. cates that the scanner has not been switched on or is just starting up and is not yet ready for use Switch the scanner on and or wait until the scanner is ready for use 4 To release the scanner click the GREEN multiconnect icon 5 Then click the Free the scanner button Standby mode 1 If no imaging plate is inserted into the scanner within a certain period of time the unit will beep five times and the status light will start to flash When it turns orange the unit is in the standby mode 2 The unit will automatically exit the standby mode as soon as a new imaging plate is presented in front of the unit 3 Press the Start key to exit the standby mode 4 After four hours the unit will exit the standby mode and automatically shut down 7 5 REMOVING IMAGING PLATES FROM THE PLATE COLLECTOR 1 When picking up imaging plates hold them by the edge only 2 Alternatively pull the plate collector out of the scanner and tip the imaging plates out onto a flat surface If they are not to be used again immediately or within a short period of time store them in the dedicated storage box When picking up imaging plates lift them by their edges only 7 6 RETRIEVE LAST IMAGE Because of a network PC software or other communication failure the last image scanned can be retrieved NOTE The LAST read image can only be retrieved if the scanner is left on If the scanner is switched off the image will be lost PSPIX
18. ce by maintaining a minimal distance between the portable and mobile RF communication devices transmitters and the recommended PSPIX device such as recommended below depending on the maximum output power of the communication device Rated maximal output Separation distance depending on the transmitter frequency power of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d 1 2 P d 1 2 P d 2 3 P For the transmitters whose maximum output is not listed above the recommended separation distance d in metres m can be determined by using the equation applicable to the transmitter frequency where P is the maximum output of the transmitter in watts W rated by the transmitter manufacturer Note 1 At 80 MHz and at 800 MHz the separation distance given in the higher frequency band applies Note 2 These recommendations may not apply in every situation The electromagnetic wave propagation is modified by absorption and reflection due to the structures objects and persons PSPIX user manual 11 ENGLISH 4 6 SIGNIFICATION OF THE STANDARDISED SYMBOLS Indications symbols located on the label identifying the PSPIX digital intraoral imaging plate system are compliant with the international standards Dangerous voltage Laser radiation Caution please consult the ACCOMPANYING DOCUMENTS Continuous voltage J l DB Ethernet connector RJ 45 straight cable CE Product compliance accor
19. d THIS WARRANTY CONSTITUTES THE ONLY AND UNIQUE REMEDY IT REPLACES ANY OTHER WARRANTY FOR EXAMPLE WARRANTY OF ADEQUACY TO A PARTICULAR AIM WHETHER IT BE EXPLICIT OR IMPLICIT SOPRO SHALL NOT BE LIABLE FOR ANY PARTICULAR DAMAGE INDIRECT ACCIDENTAL OR CONSEQUENTIAL OR FOR ANY DETERIORATION OR DATA LOSS ON A CONTRACTUAL NON CONTRACTUAL OR OTHER BASIS The liability exclusion or limitation for direct or indirect damages does not apply under the regulatory or legal rules in force in some countries and the present exclusion may not apply to a purchaser in those countries PSPIX user manual 32 ENGLIS 10 3 IN CASE OF FAILURE H Problems Causes Solutions The unit won t wake up from sleep The motion sensor might have failed Press the 39 button on the unit in order to wake the unit up The tray won t come out A protective cover or imaging plate fell inside the unit Please contact our after sales service The screen instructs to plug in the Ethernet cable The cable is not connected to the network or the cable is faulty Check the hub or switch the unit to turned on and that the cable is fully inserted in the plug If nothing works change the cable The screen shows blinking application window There is a communication error between the unit and software Start restart the software and check the configuration of both the unit and the software refer to Sopro Imaging
20. ding to the European directive 93 42 EEC relative to medical devices 0459 W ETL symbol Disposal of electric and electronic equipment marketed after 13 August 2005 This symbol indicates that the product cannot be treated with domestic waste PSPIX user manual 12 ENGLISH SYSTEM CONFIGURATION 5 1 REQUIRED CONFIGURATION FOR THE COMPUTER To use the PSPIX system you must make sure the computer and its peripherals do not have any usage limitation that could endanger personal safety The computer should also meet the following requirements Minimal configuration Recommended configuration Operating system Windows XP Pro SP2 or VISTA Windows XP Pro SP3 VISTA Business 5 1 Business 5 1 Processor Intel Pentium III 500 MHz Intel Core 2 Memory 512 Mo 2 Go Hard disk 80 Go 320 Go Video board Graphic board 128 MB of unshared Graphic board with NVIDIA video RAM compatible with DirectX chipset or dedicated ATI video 9 board 512 MB of unshared video RAM compatible with DirectX 9 or higher Ethernet board 100 Mb s 1Gb s 1 Gb s Screen resolution 1024 x 768 1024 x 768 or more Standard IEC 60950 IEC 60601 1 WARNING For Ethernet connections use an unshielded CAT6 LAN cable so that multiple chassis must not be connected The PC Ethernet switch to which scanner is connected to should be approved appropriately e g EN 60950 IEC 60950 UL 60950 5 2 IMAGING S
21. ened with the scanner with a solvents or disconnect the either non abrasive cloth abrasive cleaners scanner before cool or lukewarm moistened with plain to clean the unit cleaning or water water eNever use disinfecting it soapy water unfamiliar or Do not allow mild detergent untested cleaning any liquid to butylalcohol agents If you use enter the unit ethanol ethyl a spray cleaning alcohol 70 96 agent NOT spray it directly at the open or closed scanner door Disinfecting Wipe the scanner All surfaces must be Never use Wear gloves the unit with a cloth dried before the abrasive and other dampened with a scanner is used corrosive or protective suitable disinfectant solvent clothing when solution such as disinfectants disinfecting the ethanol 96 unit Do not use any disinfecting sprays as the vapor could ignite causing injury PSPIX user manual 30 ENGLISH Disinfecting techniques for both the scanner and the room where the scanner is used must comply with all local and national regulations and laws concerning such equipment and its location 9 2 IMAGING PLATE MAINTENANCE USE INSTRUCTIONS AND DESCRIPTION RECOMMENDATIONS PRECAUTIONS WARNING x Clean the sensitive Use a soft lint free SUITABLE DO NOT USE Unsuitable side of the tissue for example CLEANING FOR CLEANING cleaning solution IMAG
22. er or a battery Magnetic field with the network frequency 50 60 Hz IEC 61000 4 8 3 A m 3 A m The magnetic field with the network frequency should be at a characteristic level of a location in a traditional commercial or hospital environment Note Ut is the power voltage nominal value applied during the trial PSPIX user manual ENGLISH Guide and declaration of the manufacturer electromagnetic immunity PSPIX device is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment Immunity trial Compliance i level Electromagnetic environment Guide evel Portable and mobile RF communication devices should not be used at a distance from PSPIX device including the cables lower than the recommended separation distance calculated with the applicable formulas depending on the emitter frequency Recommended separation distance Conducted RF 3 Vms d 1 2 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF IEC 3V m d 1 2 80 MHz to 800 MHz 61000 4 3 80 MHz to d 2 3 800 MHz to 2 5 GHz 2 5 GHz Where P is the maximum rated output of the transmitter in watts W by the transmitter manufacturer and d the recommended separation distance in metres m The field levels emitted by the fixed RF transmitters determined by an electromagnetic measurement of the site a should be lower than the compliance level
23. er system for holding the imaging plate guarantees optimally clear images Exact positioning of the imaging plate relative to the tooth No IMAGING PLATE bending and thus no distortion No IMAGING PLATE movement Standardized distortion free and reproducible images No overlapping No cone cutting No excessive wear or damage of the imaging plates No ocular guesswork Exclusive automatic reliance on the extra oral aiming and centering device Using the recommended holder system improves the quality Constant X ray quality over time Whoever takes the X ray Using the recommended holder system increases profitability Easy to use system saves time Delegate work to auxiliaries Contact your authorized distributor for more information on the holder systems 7 3 ACQUISITION OF AN X RAY IMAGE 1 Place the sealed protective bag in the patient s mouth in the required position for the image you wish to take The back of the hygiene bag black side must face the X ray source PSPIX user manual 20 ENGLISH 2 Select an exposure value appropriate for the image you are taking The scanner tolerates a relatively wide range of exposure values so in practice it should be possible to use the same settings for all imaging purposes However it is recommended that ALARA as low as reasonably achievable principle is observed Use the minimum radiation dose to obtain images of sufficient quality that can be used for
24. etails about the device treatment recuperation and recycling please contact your dental device distributor or failing that the group ACTEON site www acteongroup com so that you can be informed of the procedure 4 5 ELECTROMAGNETIC COMPATIBILITY Guide and declaration of the manufacturer electromagnetic emissions PSPIX device is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment Emission trial RF emissions CISPR 11 Compliance Electromagnetic environment Guide PSPIX device only uses radio energy for its internal functions Therefore its RF emissions are very low and are unlikely to cause interference with nearby electronic devices RF emissions CISPR 11 Class B Harmonic emissions EN 61000 3 2 Class A Voltage fluctuations Flicker EN 61000 3 3 PSPIX user manual Complies PSPIX device may be used in all domestic environments including the ones directly connected to the public low voltage power distribution network used to supply household buildings ENGLISH Guide and declaration of the manufacturer electromagnetic immunity PSPIX device is intended to be used in the electromagnetic environment specified below The user should make sure it is used in this environment Immunity trial Electrostatic discharges EN 61000 4 2 IEC 60601 Severity level 6 KV when contact 8 kV
25. in each frequency band b Interference may occur in the vicinity of the devices bearing the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency band applies Note 2 These recommendations may not apply in every situation Electromagnetic wave propagation is modified by the absorption and reflection due to the structures objects and persons The fixed transmitter field levels such as the base stations of the radio telephones cellular wireless and the terrestrial mobile radios domestic radio AM FM and TV radio communication cannot be theoretically assessed precisely To obtain the electromagnetic environment due to the fixed RF transmitters a site measurement should be performed If a field level measured in the use environment of PSPIX device exceeds the compliance levels above applicable the good operation of PSPIX device should be checked If abnormal operations are proved some further measures should be taken such as reorientation or relocation of the standard device b Above the 150 kHz to 80 MHz frequency band the field level should be lower than 3 V m PSPIX user manual 10 ENGLISH Recommended separation distances between the portable and mobile RF communication devices and PSPIX device PSPIX device is intended to be used in an electromagnetic environment in which the irradiated RF disturbances are checked The user of PSPIX device can help to avoid electromagnetic interferen
26. in the air Compliance level 6 kV when in contact 8 kV in the air Electromagnetic environment Guide The floor should be wooden concrete or tile If the floor is covered with a synthetic material the relative humidity should be at least 30 Far transient bursts EN 61000 4 4 2 for the power supply lines 1 kV for the input output lines 2 for the power supply lines 1 kV for the input output lines The main power supply quality should be one of a traditional commercial or hospital environment Voltage shocks EN 61000 4 5 1 Differential 1kV Differential mode The main power supply quality should be one of a traditional commercial or hospital environment Dips brief outages and power voltage variation EN 61000 4 11 e lt 5 gt 95 dip in U for 0 5 cycles e 40 gt 60 dip in for 5 cycles e 70 Ur gt 30 dip in for 25 cycles e lt 5 Ur gt 95 dip for 5 cycles e lt 5 Ur gt 95 dip in U for 0 5 cycle e 40 Ur gt 60 dip in for 5 cycles 70 Ur gt 30 dip in 25 cycles e lt 5 Ur gt 95 dip for 5 cycles The main power supply quality should be one of a traditional commercial or hospital environment If the user of PSPIX device requires it to continue to operate during main power supply outages it is recommended PSPIX device is fed by an invert
27. ion risks 6 Fold the other half of the protective cover with the semicircular cut out over the imaging plate The metal disk on the back black side of the imaging plate will follow the shape of the semicircular cut out 7 Tum the protective cover and imaging plate over so the black side of the protective cover is facing up This makes it easier to slide it into the hygiene bag 8 Slide the protective cover and imaging plate into the hygiene bag The black side of the protective cover must correspond to the black side of the hygiene bag 9 Peel off the cover paper from the sealing tape and fold the flap along the pre formed line over and onto the sealing tape 10 Press and slide your finger and thumb along the tape to ensure that the flap is tightly sealed 11 Turn the hygiene bag over and check that the imaging plate and protective cover are in the correct position You should be able to see the white side of the protective cover as well as the metal disk located on the back of the imaging plate PSPIX user manual 19 ENGLISH 7 2 IMAGING PLATE HOLDERS Correct positioning of the imaging plate as well as correct aiming of the X ray beam is essential for image consistency and quality Manually positioning the Imaging Plate and not using an X ray device aiming aid causes errors such as Incorrect vertical angulations Distortion Cone cutting Poor standardization Using a recommended hold
28. nce with radio communication services which can be determined by switching it off and on it is recommended to try to correct this phenomenon by taking whole or part of the following measures Change the receiving antenna orientation Reposition the product according to the receiver Take the computer away from the receiver PSPIX is designed and tested to be used in a home environment class B Group 1 according to CISPR11 standard 4 3 MEDICAL DEVICE VIGILANCE As with any medical device this device is subjected to medical device vigilance dispositions any serious dysfunction should then be the subject of a description to the competent authorities and to the manufacturer as soon as possible and as precisely as possible 4 4 END OF LIFE This device bears the recycling symbol according to the European directive 2002 96 EC about electric and electronic equipment waste DEEE or WEEE By correctly disposing of this device you will contribute to avoiding any damage to the environment and human health 4 The symbol present the device on the accompanying documentation indicates this product cannot in any case treated as household waste Therefore it should be transferred to PSPIX user manual 7 ENGLISH waste collection centre that handles electric and electronic equipment recycling Please respect the standards relative to waste disposal in force in the installation country For more d
29. nuine accessories may present a risk to you your patients and or your device WARNING USA only Federal law restricts this device to sale by order of a dentist or other qualified professional PSPIX user manual 3 ENGLISH 2 3 MAIN PARTS Motion sensor Display On Off Scanner door Status light green and plate on orange in carrier standby mode Erase key for imaging plate Start key Imaging plate collector Rear of scanner RJ 45 connector for Ethernet cable direct connection to PC network LAN connection Power supply connector Ethernet cable not included Please refer to technical specification PSPIX user manual 4 ENGLISH PRECAUTIONS FOR USE THE SCANNER IS A CLASS 1 LASER PRODUCT When covers are removed the scanner is a class laser product avoid exposure to the laser beam Use of controls adjustments or maintenance other than those specified herein may result in exposure to hazardous laser radiation When handling imaging plates plate covers and protective bags always take the appropriate hygiene measures and precautions in order to prevent cross contamination risks The imaging plates are harmful if swallowed Do not move or knock the PSPIX unit while it is performing its scanning process This scanner can only be used to read image plates supplied SOPRO NEVER use imaging plates or protective
30. osal of such material HYGIENE BAGS MATERIAL Food grade polyethylene Latex free PACKAGING Supplied in boxes DISPOSAL Observe relevant national requirements PSPIX user manual 35 Imaging ZAC Ath lialV Avenue des Gen vriers 13705 LA cedex FRANCE T l 33 0 442 98 01 01 Fax 33 0 442 71 76 90 E mail info sopro acteongroup com www sopro acteongroup com Non contractual document Ref 011297 Copyright 2009 SOPRO All rights reserved No information or part of this document may be reproduced or transmitted any form without the prior permission of SOPRO
31. rom the edges Never use tweezers pliers or any mechanical devices to pick up handle IMAGING PLATES Do not touch the sensitive surface of the IMAGING PLATE with fingers or nails Do not get fingerprints stains dirt or dust on the sensitive side of the IMAGING PLATE Protect the sensitive side of the IMAGING PLATE from scratches wear and other mechanical abrasion or damage Avoid excessive bending of the plate Avoid applying pressure to the IMAGING PLATE with anything that could mark or leave an imprint on the sensitive side Unprotected IMAGING PLATEs should not come in contact with the patient the patient s saliva or any other bodily fluids Always use protective covers and hygiene bags with IMAGING PLATES when taking exposures to eliminate cross contamination maintain image quality and maximize IMAGING PLATE service life e Any scratches stains dirt fingerprints or dust on the sensitive side of the IMAGING PLATE can affect image quality and can interfere with diagnostic value of the image Dust and wear on the IMAGING PLATE will appear on the image as white or grey dots PSPIX user manual 27 ENGLISH 8 3 REPLACING IMAGING PLATES An IMAGING PLATE should be replaced if e There is sign of active side damage wearing visible on the image so that it may interfere with a diagnosis There are clearly visible scratches There are clearly visible spots or dots which do not disappear b
32. so that the white side of the protective cover NOT THE BLACK faces right The black side back of the imaging plate will also be on the right 4 Insert the protective cover and imaging plate into the scanner door A magnet will hold the imaging plate in the correct position 5 Slide the plate cover off the imaging plate and leave the imaging plate in position half way in the unit door 6 The scanner has a motion sensor it detects when the imaging plate is near the unit door 7 After the protective cover has been removed the imaging plate will automatically slide into the unit 8 An animation will appear on the display which indicates the imaging plate is being read 9 After a few seconds a preview image will appear on the scanner display 10 A read out progress window will appear on the PC display After a few seconds the new image will appear in the dental imaging software 11 Save the image in accordance with the information given in the dental imaging software you are using PSPIX user manual 22 ENGLISH A CAUTION There is a metal disk on the rear of every imaging plate If the metal disk on the imaging plate can be seen on the digital image it indicates that the imaging plate was exposed from the wrong side CAUTION If an image is not transferred to the PC because of a network PC or software failure the last image taken can be retrieved from the unit s memory For information on how
33. st possible performance when using the SOPRO Imaging software it is recommended to install DirectX 9 0c In order to do this click on the button Install DirectX 9 0c and follow the displayed instructions DirectX 9 0c is a Microsoft product In case of difficulties when installing this product consult the information provided by Microsoft In order to ensure maximum compatibility with all the installed systems computers Windows and word processing version it was decided to provide the documents available on the CD ROM in PDF format This format developed by ADOBE can be read using the Acrobat Reader service program If Acrobat Reader is not installed on the computer or the version is not recent enough click on Install Acrobat Reader and follow the on screen instructions Acrobat Reader is an ADOBE product In case of difficulties when installing this product consult the information provided by ADOBE 6 2 PSPIX SYSTEM INSTALLATION Before installing the PSPIX system make sure the computer is connected to a correctly grounded outlet e Connect the PSPIX scanner to the computer using Cat Ethernet cable either directly to the computer or via a hub switch in case of a network setup WARNING e shouldn t be exposed to direct sunlight nor should bright light or sunlight shine directly onto the scanner door into which the imaging plates are inserted e PSPIX should be located on a s
34. table flat surface in order to avoid vibrations that could in turn degrade the image quality e PSPIX can also be attached to a wall under or shelf with the optional mounting kit e PSPIX can be positioned within the environment in which the patient is examined treated patient environment PSPIX must not be stacked nor positioned in contact with other equipment e PSPIX is connected to the PC or network you need to install the drivers located the Sopro Imaging CD 1 WARNING Insert the Sopro Imaging software CD into the drive in order to install the drivers e Click on Install PSPIX drivers e After a few moments the installation is completed click Finish gt PSPIX user manual 15 ENGLISH 1 WARNING The PC connected to the scanner should not be used in the patient environment The minimum horizontal distance between the patient and the PC is 1 5 m The minimum vertical distance between the patient and the PC is 2 5m 6 3 SOPRO IMAGING SOFTWARE CONFIGURATION WITH A PSPIX SYSTEM Refer to the Sopro Imaging owner s manual located on the Sopro Imaging CD in the Document directory in order to configure the system 6 4 DISPLAY SYMBOLS ON PSPIX SYSTEM Symbols and animations appear on the unit display during use These Indicate the status of the scanner Guide the user to operate the scanner correctly Display a preview image
35. to do this see section Retrieve last image 12 After the imaging plate has been read it will automatically be erased and ejected from the scanner into the plate collector After the imaging plate has been ejected the ready symbol will reappear on the display The scanner is now ready to read the next imaging plate A CAUTION If the imaging plate does not slide into the unit after the protective cover has been removed the imaging plate is misaligned or has been placed in the unit the wrong way round Re insert the imaging plate correctly Multiconnect configuration 1 To reserve the scanner click the GREEN multiconnect icon which isin the System Tray in the bottom right hand corner of the PC display The Connect window will appear 2 In the Connect window click the Reserve the Scanner button in order to reserve scanner 3 window will disappear the GREEN multiconnect icon will start to flash This indicates that you have now reserved the scanner NOTE If other users in the multiconnect configuration try to reserve the scanner the following message will display on their Scanner reserved by XXX is your multiconnect 10 NOTE If the multiconnect icon is YELLOW it indicates that someone else has already reserved the scanner Wait until the scanner is free PSPIX user manual 23 ENGLISH NOTE If the multiconnect icon is GRAY it indi
36. tor 3 2 SYSTEM OPERATING ENVIRONMENT Refer to chapter 11 Technical features 3 3 TRANSPORT AND OR STORAGE ENVIRONMENT OF THE SYSTEM Refer to chapter 11 Technical features 3 4 PRECAUTIONS RELATED TO THE ETHERNET CONNECTIONS For Ethemet connections use a CAT6 LAN cable while avoiding multiple switches or hubs to be connected in cascade The PC or Ethernet switch hub into which the scanner is connected should be standards compliant e g EN 60950 IEC 60950 UL 60950 After installation check that the IEC 60601 1 current leakage levels are not exceeded PSPIX user manual 6 ENGLISH STANDARDS AND REGULATIONS 4 1 COMPLIANCE WITH STANDARDS AND REGULATIONS This product was designed and manufactured by a company having an authorized quality system It meets the European directive 93 42 EEC requirements relative to medical devices Therefore it particularly meets electrical safety and electromagnetic compatibility standards IEC CEM 4 2 ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES Electromagnetic compatibility CEM is the ability of electronic device elements to correctly interact in an electronic environment Although PSPIX system was designed according to this compatibility and complies with the electromagnetic interference thresholds established by the regulatory agency there is no guarantee about interference likely to occur on a particular installation If the device generates interfere
37. wiping movement NOTE Avoid excessive wiping of the manufacturing batch and IDOT markings with alcohol Markings will withstand cleaning but may start to fade with repeated and excessive rubbing and wiping especially if alcohol is used for cleaning PSPIX user manual ENGLISH 10 AFTER SALES SERVICE 10 1 LIMITED LIABILITY The PSPIX system is designed to ensure the acquisition of dental x ray images their transfer in the form of computer data as well as their storage Nevertheless SOPRO cannot be liable for inappropriate use of this material or for any loss of data 10 2 WARRANTIES SOPRO insures the absence of material and manufacturing defects for its products during a period of one 1 year coming into effect at the purchase date This warranty does not apply to misused modified untended or accidentally damaged products or products subjected to abnormal use and handling conditions The distributors other than ACTEON Group s subsidiaries are not authorized to apply a warranty further extended on behalf of SOPRO The entire liability of SOPRO is limited to its convenience either when replacing or repairing free of charge the defective product if it has been sent to SOPRO After Sales Service This applies for the entirety of the warranty period Outside France access to the warranty is only possible if the product was bought in one of the Sopro authorized points in the country where it will be use
38. y proper cleaning The active surface is worn or damaged in any other way The above mentioned artefacts do not disappear with proper cleaning The protective layer of active surface is damaged The plate is torn or badly bent 8 4 GENERAL STORING AND INITIAL ERASING GUIDELINES e IMAGING PLATEs are sensitive to background radiation If an IMAGING PLATE that has been exposed to background radiation is used to take a patient exposure the image quality may be degraded for example reduced contrast When not in use IMAGING PLATEs should be stored in the supplied storage box away from bright ambient light Light will erase image fogging caused by background radiation from the IMAGING PLATEs Initial erasing of IMAGING PLATES before patient exposure is unnecessary if the IMAGING PLATESare properly stored as described above Storing IMAGING PLATEs in the storage box will also protect them from dust To avoid scratching IMAGING PLATES never leave unpacked IMAGING PLATEs lying on a surface especially with active side facing down Do not store IMAGING PLATEs in hot or humid conditions store below 33 C 80 RH Do not expose IMAGING PLATES to X ray radiation Do not expose IMAGING PLATES to ultraviolet radiation IMAGING PLATES can be stored in their protective covers and hygiene bags for briefs period of time if protected from background radiation However if they are stored in such conditions for more that 2
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