Krystal-X Easy - Installation and User Manual
Contents
1. this Only the part of the sensor manual that is inserted in the mouth complies with this standard The CE marking certifies that Class 11 this product complies with meaning of standard NF 0459 EN IEC 60601 1 1 reinforced European directive 93 42 CEE or double insulation Equipment subject to a selective collection in accordance with Directive 2002 96 EC on waste electrical and electronic equipment WEEE and with Decree 2005 829 of the 20 July 2005 regarding the composition of electrical and electronic equipment and the elimination of waste coming from this equipment 2 Contents Your Krystal X Easy kit consists of the following elements illustrations may vary from items supplied KRYSTAL X EASY 7 Gwandy Af o A Krystal X sensor A Krystal X Easy box size 1 or size 2 compatible with Krystal X size 1 or 2 sensors cable of 80cm or 2 95m 2 6ft or 9 7ft 1 sensor wall support 1 box wall support with 2 screws 2 plugs 1 box base plate with 4 self tapping screws 4 transparent plastic feet 1 strap 1 box adaptor for sensor size 2 gt size 1 An introductory pack of positioners A bag of disposable single use hygienic protective size 1 or 2 depending on your sensor sleeves for size 1 and 2 sensors An O S P installation CD ROM drivers diagnostic tools A CD ROM with the installation files of the sensor A manual2. button Deletes the selected image Deletes the selected image from the list after it has been transferred to Delete on load option a software program 4 4 Acquisition of an image 441 Acquisition procedure The image acquisition goes through several steps 1 Before being able to acquire an image with the sensor you need to start the computer with which the box will be used and start the imaging software Check that the sensor toolbar or the sensor icon is green and that the green light on the box is lit and the yellow light is not lit Program the different parameters exposure time etc on the X ray generator see 4 5 Exposure time for more information Cover the sensor with a hygienic protective sheath making sure to cover a sufficient length of cable A set of positioners is provided with the kit to place the sensor in the different parts of the mouth their use is recommended to ensure the sensor is positioned perpendicularly to the X ray beam The sensor can also be positioned manually maintained by the patient as with conventional film This can be necessary for children with a small oral cavity Position the sensor in the mouth behind the tooth of which you want to acquire an image If you do not use a positioner a cotton roll can be helpful to position the sensor parallel to the tooth Turn the sensitive surface of the sensor the flat surface towards the generator if it is facing the other way the
3. The box does not require any particular maintenance it should be cleaned using a cloth and non abrasive detergents 5 1 2 Sensor To avoid cross contamination between patients during use it is necessary to protect the sensor with hygienic single use protective sheaths FDA cleared for the USA CE marked for Europe Some hygienic protective sheaths suited for your region are provided with each system Before each use on a patient the used sheath should be thrown away and the sensor disinfected applying a high level disinfection procedure see 5 2 Recommended disinfection procedure A new protective sheath is applied to the sensor for each new patient We recommend the disposal of the hygienic protective sheaths with the biologically hazardous waste of your practice Validated protections for North America BANTA HEALTHCARE TIDI PRODUCTS X ray sensor sheaths STERI SHIELD PRODUCTS RS barriers Do not pull on the cable when removing the used protective sheath 5 1 3 Cables The cable can be cleaned with caution by using a disinfecting wipe Hold the sensor with one hand and with the other hand apply a disinfecting wipe from the side of the sensor along the first 20cm 8inch of the cable without pulling on the cable subsequently clean the remainder of the cable in segments of 20 30cm 8 12inch with as little pinching of the cable as possible the wipe should slide without applying force 5 1 4 Positioners The positione
4. 801 120 correctly exposed image 120 to 200 over exposed image Check the parameters of your monitor contrast and brightness and avoid reflections on the screen Check the quality and parameters of the monitor Check the connection of the cable of the screen at the side of the graphics card and the monitor Check the screen configuration under Windows screen configuration panel it must display colours in at least 24bits Re acquire the image The patient has moved during the exposure The generator head was not stabilised and has moved 7 Specifications Krystal X size 1 sensor External dimensions size 1 sensor CCD matrix size 1 sensor e Sensitive area in size e Sensitive area in pixels e Pixel dimensions Krystal X size 2 sensor External dimensions size 2 sensor CCD matrix size 2 sensor e Sensitive area in size e Sensitive area in pixels e Pixel dimensions Technical specifications size 1 and 2 sensors Maximum external dimensions of connection box Length sensor cable in polyurethane Grey levels Connection Consumption kit Input voltage connection box Input current connection box Operating temperature Lifespan CCD Standards Sealing standard sensor Conformity to standards 38 9 x 26 5 x 7 4mm 1 5x 1 0 x 0 3inch 30 x 20mm 600mm 1 2 x 0 8inch 0 9inch 1500 x 1000pixels 20 x 20 42 7 28 5 x 7 4mm 1 7 x 1 1 x 0 3inch 34 x 24mm 816mm7 1 3
5. The box automatically switches to standby mode after a period that can be set in the configuration window see below the default period is 5 minutes All lights off when the box is in standby mode and the sensor toolbar turns red To reactivate the box you only need to push the button on the box The lights inform the user about the state of the box e Green light only sensor ready for image acquisition e Yellow light sensor not available in preparation or transmitting e Red light only an error occurred restart the box 4 3 Use of the Owandy StandAlone software 4 3 1 Modes of operation The sensor kit can function in two ways e Through the Twain protocol for scanners to use this mode select Owandy USB Intra Oral Twain drivers in the TWAIN acquisition option of your imaging software Subsequently start the TWAIN acquisition the interface is identical to that of the independent mode described below e In independent mode the independent software program can be started with the I icon on the Windows desktop or by starting an Owandy software program This memory resident software package allows the use of the sensor outside any software program If an image is acquired without a program ready to receive it the resident program will display the image on screen for a few seconds and save it in the C Program Files OWandy OSP USB XRAYS BOX standalone Data directory on the hard disk A sensor icon
6. kit with appropriate drivers Imaging software X ray generator with electronic timer If your computer does not possess USB 2 0 ports these can be added as PCI cards for desktop computers or PCMCIA cards for laptops If the USB ports do not provide enough current please use a powered hub with its own power supply The PCMCIA cards need to be powered by an external power supply or connected to a powered hub if they do not provide enough current Please contact your IT specialist for further information 3 1 2 Setup guidelines The computer and the screen with which the sensor and the box are used should preferably be situated close to the chair within the field of vision of the practitioner to allow for immediate use Provide visual access for the patient to be able to share the radiological information with him her The screen must be place so as to avoid any reflections or direct overhead illuminations that could be detrimental to the visualization of the radiological images It must be set up contrast and brightness to display as many grey levels as possible in the image The X ray generator has a great influence on the quality of the acquired images The kit is compatible with any kind of generator be it high frequency or conventional The generator must be equipped with an electronic timer allowing for very short exposure times and must emit a dose sufficient for the acquisition of a good image with enough grey levels Make sure
7. of the box The wall support can be mounted on a wall a worktop or object either by using the screws or by using the strap passing it through the slits provided for that purpose in the wall support of the box To mount the wall support of the box drill 2 holes according to the outline opposite Insert the plugs screw in the screws and hook on the wall support to these attachments Slide the box in the wall support using the base plate 33mm 1 3inch of space Do not mount the wall support of the box upside down or horizontally the box and sensor could fall on the ground and be damaged Storing the sensor it is possible to store the sensor in the space provided in the box An adapter is included to store the size 1 sensors H E J P D a in the box s storage area Remove the protective 77 Z 2 _ from the double sided adhesive at the back of ris a 2 the adapter before inserting it in the sensor lt A by storage space The part of the adapter with the adhesive must be inserted last this to allow you to remove the adapter at a later date The adapter can be removed by applying a lever on the inserted 2 4 adapter and the side of the compartment to detach the adapter and eject it The kit is also provided with a wall support for the sensor this support is compatible with size 1 and 2 sensors and can be mounted to a wall a wor
8. rinsing as the case of allowing it to air dry overnight at the end of a working day it should be rinsed with sterile water When the sensor is not being used and to protect it from any damage it is recommended to store it in its protective case or to hang it in the sensor wall support 5 21 Recommended disinfectants for North America The sensor being sealed watertight and to minimize the potential for device associated infections the device shall be disinfected with an FDA cleared high level disinfection agent following the instructions of the manufacturer for use storage handling and warning The following disinfectant agent has been validated with the sensor CIDEX OPA solution 0 55 Ortho phthalaldehyde solution The maximum soaking period is 24 hours 5 2 2 Recommended disinfectants outside North America The following disinfectants are compatible with the sensor e 2 Glutaraldehydes maximum immersion time of 24 hours e 2 Sodium Hypochlorite maximum immersion time of 24 hours e Ethyl alcohol maximum immersion time of 24 hours e CIDEX Even when using protective sheaths the sensor should be disinfected each evening Immerse the sensor in cold sterilisation fluid in accordance with the instructions of the manufacturer after having cleaned it from all residues Never leave the sensor immersed for longer than necessary 5 3 Maintenance 5 3 1 Computer data protection Your patient and image database must be backed u
9. support DORSANGKW Strap 3 pieces DOADAPTW 2V 1 Box adaptor size 2 gt 1 USB 2 0 cable iN 2 COCABUSB2 3 3m 9 8ft cable
10. the kit in normal conditions of use and in compliance with its intended purpose 1 5 Packaging and environment Transport storage and environment the kit is supplied in protective packaging protection against physical impacts and antistatic packaging It must be stored under the following conditions Ambient temperature 10 C to 70 C 14 F to 158 F Relative humidity 10 to 100 Atmospheric pressure 500hPa to 1060hPa Operation in compliance with the international safety standard EN IEC601 1 section 2 the kit has been designed for normal use under the following conditions Ambient temperature 10 C to 40 C 50 F to 104 F Relative humidity 30 to 75 Atmospheric pressure 700hPa to 1060hPa Equipment packaging for return to distributor should a return to the distributor be necessary make sure to package the sensor and box kit in its original packaging after having cleaned it thoroughly Documentation loss all kits are shipped with its documentation Please contact your distributor for a replacement manual if this documentation is lost 1 6 Marking and labelling symbols These symbols are used on the product labels and inform you about the compliance with standards and the technical specifications of the component BF equipment EN IEC mn 60 601 1 annexes and II Sealing standard of the sensor regulation EN IEC 60529 Important information follow the instructions printed
11. under exposed image the X ray dose is too low increase the X ray dose on the generator e 80 to 120 correctly exposed image e 120 to 200 over exposed image the X ray dose is too high reduce the X ray dose on the generator 4 5 Exposure time Recommended exposure times in seconds for the Owandy X ray generators Description Owandy Altis DC Owandy Elios AC Current Voltage 4mA 65KV 8mA 70KV Lower incisor canine 0 06 0 10 0 02 0 06 Lower premolar 0 06 0 10 0 04 0 08 Lower molar 0 10 0 14 0 08 0 12 Upper incisor canine 0 06 0 10 0 04 0 08 Upper premolar 0 08 0 12 0 06 0 10 Upper molar 0 10 0 14 0 08 0 12 Reference conditions e Adult patient young man or woman of average size e Distance focal spot to sensor 250mm 9 8inch e Total inherent filtration equivalent to 2mm 0 08inch Al The values indicated in the table above can vary from one generator to another It is the responsibility of each user to calibrate his her doses before use If an image is over or under exposed it be corrected afterwards with the imaging software contrast brightness etc to improve its visualisation The table below allows you to note the exposure times specific to your generator Description Adult Child Lower incisor canine Lower premolar Lower molar Upper incisor canine Upper premolar Upper molar 5 Hygiene and maintenance 5 1 Hygiene and disinfection 5 1 1 Box
12. x 0 9inch 1 3inch 1790 x 1260pixels 19 x 19 18 6 x 8 4 x 2 4cm 7 3 x 3 3 x 0 9inch 80cm or 2 95m 2 6ft or 9 7ft 12bits 4096 grey levels USB standard USB 2 0 High Speed 480Mbit s and USB 1 1 Full Speed 11Mbit s 2W 5V through USB connection 0 4A 10 C to 40 C 50 F to 104 F Min 100 000 cycles IPX 7 NF 60601 1 NF 60601 1 1 NF EN CEI60601 1 2 8 Optional kits and accessories 8 1 Optional kits The optional kits allow you to add a sensor or box to your kit to evolve according to your needs Each optional kit is supplied with its accessories Optional connection box kit with its accessories compatible with Krystal X size 1 2 sensors KAYSTAL EASY Uber y a Contact your distributor eS Optional Krystal X size 1 or 2 sensor kit with its accessories Contact your distributor 8 2 Accessories Refill packs of 10 positionners St es DORT1ANGUBW Size 1 bitewing DORT1ANGUZE Size 1 endo DORT1ANGUZP Size 1 posterior DORT1ANGUZPA Size 1 peri apical DORT2ANGUBW Size 2 bitewing a DORT2ANGUZE Size 2 endo DORT2ZANGUZP Size 2 posterior DORT2ZANGUZPA Size 2 peri apical Hygienic single use disposable protection sleeves for size 1 and 2 sensors DOPROTECCAPXL Bag of 20 pieces Supports and adaptors DOSUPCAP730 Sensor wall support D1IKSPKW Box wall support with strap and screws DOSUPKW Box wall
13. 0601 1 it is necessary to apply appropriate installation precautions to make sure the box is inaccessible to the patient when the box is installed inside the dental chair or to place the box in non conductive packaging 1 4 Liability and operators Installer the installation of the kit requires computer skills relating to both equipment and software Follow the recommendations and guidelines of the installation chapter to install the equipment and software User the kit must be used by a dental practitioner The connection box should never be opened by the user Only the manufacturer is authorised to open and make repairs to the sensor or box Return the equipment to the distributor in case of malfunction and or if the documentation you possess does not contain the necessary information for the authorised maintenance of the malfunctioning equipment The manufacturer will not be liable if e Interventions or repairs have been made by persons without the authorization of the manufacturer or distributor and are not part of accepted interventions e The equipment is used with an installation that is not compliant with the applicable standards and decrees in particular when not compliant with the EN IEC60601 1 1 standard relating to the security rules for electro medical systems Make sure the installation of the equipment is compliant with the applicable regulations e Used in ways other than those mentioned specifically in this manual use of
14. A packaging checklist 3 Installation 3 1 Precautions The kit must be handled with care minimise the twisting pulling and bending of the attachment cable Do not step or roll on the cable Do not pull on the cable itself but on the connection plug to disconnect the attachment cable avoid proximity to electrostatic emission sources To avoid interferences the image do not use the system close to strong magnetic fields and Read paragraph 1 3 Installation precautions to ensure the installation complies with the standards Install your imaging software before the installation of the kit its drivers and O S P tools and the installation files of the sensor 3 1 1 Recommended minimal configuration Any computer configuration that does not comply with the minimal recommended configuration can prevent the starting or proper functioning of the sensor kit Verify the specifications of the computer s before the installation Operating system Vista Windows XP service pack 1 Millennium or 98 second edition Computer Compliant CE IEC950 Motherboard Intel 1 2GHz chipset and processor USB port Compatible USB 1 1 USB 2 0 High Speed recommended Graphics card 64MB Monitor High resolution 1024x768 15inch RAM memory 256MB Hard disk 10GB CD ROM drive 24x Backup system External removable disk Zip or Jaz system CD ROM DVD Printer Laser inkjet thermal Keyboard and mouse At acquisition workstation Krystal X Easy
15. An error has occurred disconnect the USB cable and wait a few seconds before reconnecting it 6 2 Image quality Symptom The images are cut off e g b The images are too light e g Film alike mode Auto contrast mode The images are too dark e g Grey levels seem to be missing in the image flat areas of grey appear The image is blurred Cause Solution The sensor is badly positioned with regard to the X ray beam Reposition the sensor making sure it is well within the field of the X ray beam Use the positioners provided with the sensor for optimal positioning The image is under exposed the X ray dose is too low increase the X ray dose on the generator The percentage that is displayed in the image indicate the exposure level Oto 80 under exposed image 80 to 120 correctly exposed image 120 to 200 over exposed image Check the dose emitted by the X ray generator due to age the dose can be insufficient Have the generator checked by a technician when in doubt The generator is positioned too far from the patient with regard to the selected dose Check the parameters of your monitor contrast and brightness and avoid reflections on the screen The image is over exposed the X ray dose is too high reduce the X ray dose on the generator The percentage that is displayed in the image indicate the exposure level Oto 80 under exposed image
16. DOMANUKU GB DENTAL IMAGING SYSTEMS amp SOFTWARE Krystal X Easy INSTALLATION AND USER MANUAL Version 24 02 24 July 2007 Index 1 INTRODUCHON a a Geach 3 1 1 COMPLIANCE WITH STANDARDS baectaasaescaldeddachaaseteueeseeabwedcebsesaades 3 TA OV 4 1 3 INSTALLATION PRECAUTIONS deste 4 t4 ORERA VORS 4 1 5 PACKAGING AND ENVIRONMENT 5 1 6 MARKING AND LABELLING SYMBOLS 5 Z CONTENTS 6 S TINS TALEATION 7 Sod ORE CU ted 7 O22 EQUIPMENT INSTALLATION ciety dled acai nutes ue 8 3 93 SOFIWARE INSEALIAMION cd aint tad at ie Gage 11 3 4 CONFIGURATION IN THE OWANDY IMAGING SOFTWARE cccccccccecccececececececececececucucucucucucucucececuces 14 3 5 SHARING THE SENSOR AND BOX BETWEEN DIFFERENT WO
17. RKSTATIONS cscececececececececececececececes 15 4 USE ennaa TS ce Te a aa en Te Ae ee ee Oe ee ea 16 AeA TREC AUTON 16 4 2 LIGHTS AND BUTTON ON THE BOX 16 4 3 USE OF THE OWANDY XIO STANDALONE SOFTWARE cccccecececececececececececececaccuccuceuauaveuauavacaeaes 17 4 4 ACQUISITION OF AN IMAGE 19 20 5 HYGIENE AND MAINTENANCE ccceccccecscecescecececececnscecececncnseececuenecseeeueneuenecsesenenenseeaees 21 5 1 FAY GIENE AND DISINFEG 21 5 2 RECOMMENDED DISINFECTION PROCEDURE 22 a 22 6 TROUBLESHOOTING a 23 6 1 23 24 T SPECIFICATIONS a 25 8 OPTIONAL KITS AND ACCESSORIES 26 8 1 COP TIONAL TS 26 aan eRe a DER EMC RR PRA Co aE RN 26 The manufacturer Owandy S A S reserves the right to make modifications to its products or to their specifications order to i
18. appears the Windows taskbar next to the clock The colour of the icon indicates the state of the sensor 10 23 Red sensor inactive gt 10 23 Yellow sensor initialising 10 23 Green sensor ready for acquisition 4 3 2 Sensor toolbar It is possible to display the sensor toolbar by clicking with the right mouse button on the sensor icon in the taskbar The colour of the sensor toolbar indicates the state of the sensor Za x Red sensor inactive Yellow sensor initialising Green sensor ready for acquisition lt Orientation of the sensor vertical or horizontal double click on the icon to change the orientation of the sensor lt Activate deactivate the sensor lt Extension reduction of the toolbar to hide display the options lt Configuration of the resolution check the option to acquire images in full resolution uncheck the option to switch to standard resolution lt Iconize the toolbar in the taskbar The resolution and operation mode can only be modified when the green light of the box is on The box needs a few seconds to change the parameters The box automatically switches to standby mode after a few minutes of not being used the lights will switch off and the sensor toolbar turns red Push the button on the box to restart the kit Check the state of the lights on the box and the colour of the sensor toolbar before each acquisition the green light must be switched on and the t
19. ger than 3m 9 8ft The kit is compatible with USB 1 1 ports but with reduced image transmission speed Do not connect or disconnect the sensor waiting for an acquisition or during an acquisition you could damage the sensor Make sure the box is in standby mode before disconnecting the sensor The USB cable can be connected disconnected without the need to power down the computer Check that the box is correctly connected switch it on with the button if the green light on the box is switched on it is powered correctly 3 2 2 Box and sensor supports The box can be mounted or placed on different supports using the accessories provided with the box Place the box on a worktop stick the non slip feet provided with the kit to the back of the box if you want to place the box on a worktop Attach the box with the strap if you want to use the strap to position the box attach the base plate of the wall support to the back of the box using the 4 self tapping screws use only the screws provided with the kit or you could damage the box Pass the strap under the base plate as indicated in the drawing qe underneath and close it on itself to ensure the Velcro fastening holds Your box can now be attached to a support with the strap e g to the arm of your X ray generator to the headrest or armrest of your chair Mount the box using the wall support it is also possible to insert the box with the base plate in the wall support
20. hat appears select Device manager 3 3 2 Installation of the O S P Automatic installation for Windows 2000 XP and Vista the installation of the O S P tools is automatically proposed after the installation of the drivers Refer to the procedure below Automatic installation for Windows 98SE and Millennium insert the O S P CD ROM in the CD ROM drive The interface will launch automatically click on the button and follow the installation procedure below Refer to the Windows help if the CD Rom does not automatically launch 1 Select the desired language the window that appears and click on Next 2 Inthe welcome screen click on Next 3 Select the target directory the directory where the software will be installed by clicking on Browse and by navigating to the desired directory If you use the QuickVision imaging software select the directory where you installed QuickVision proposed by default After having selected the target directory click on Next 4 Click on Install to start the copying the files 5 After the files have been copied select Krystal X Easy V1 in the list that appears and click on OK 6 A window will inform you of the successful installation close it by clicking on Exit 7 The last window displays the location of the O S P tools close this window by clicking on the red cross of the window top right 8 Close the main O S P installation wi
21. ick on Show All Devices then click on the Have Disk button 6 next window will allow you to navigate to the directory that contains the required files click on Browse 7 Navigate to the drivers WIN 2000 XP OWandy USB directory on the O S P CD ROM this 9 d i rectory contains the fi le ow usb i nf ick on Select the device driver you want to install for this hardware ey to select this directory 8 The previous window now displays the location of op il lai ie a the files to be installed E drivers WIN_ 2000 _XP OWandy USB Mshowcompatble hardware representing the letter of your CD ROM drive this Ne NEw can be different depending on your computer configuration Click on OK to start the installation This dives is not digitally signed Have Disk Disk 9 The Krystal X Easy drivers are displayed in the eeu dive ineas list see opposite click on Next 10 Click on Continue the warning window Device installation that appears 11 Finally click on Exit in the last window of the wizard The Krystal X Easy is installed under Universal Serial Bus controllers in the Device manager To reach this window click on the Workstation icon with the right mouse button and select Manage in the drop down menu the window t
22. influences on image quality such as the type and age of the chemical product the temperature of the baths or the development time The sensor is available in two sizes depending on the kit you have ordered you received a size 1 a size 2 sensor or both e The size 1 sensor allows you to acquire the majority of intra oral images peri apical and retro coronary both vertically and horizontally e The size 2 sensor furthermore allows you to easily acquire horizontal bitewing images The instructions and information in this manual refer to both sensor sizes unless specifically stated The size of the sensor is marked on the sensor itself 1 1 Compliance with standards The Krystal X sensor is class IIA equipment within the meaning of the European Directive concerning CE markings annexe of book Vbis of the Public Health code supplementing Directive 93 42 CEE of the 14 of June 1993 The sensor complies with medical standard EN IEC60601 1 The Krystal X Easy kit complies with directive 93 42 CE annexe VII of decree 95 292 of the Public Health code Under certain conditions see 1 3 Installation precautions it is necessary that the other components of the system that are possibly connected computer and optional peripherals are also compliant to standard IEC950 EN60 950 and that the installation complies with directive 93 42 CE The intra oral sensor is contained within a hermetic case sealed in compliance with standa
23. ing software To be able to use your kit with the Owandy QuickVision imaging software you must configure your equipment 1 Start the imaging software double click on the desktop icon or use the link in Start Programs QuickVision 2 Click on the Configuration button in the main screen 3 Select OWANDY DSX amp Krystal X under the Intra Oral sensor option the window that appears XRAY and IMAGING CONFIGURATION Files path Digital Panoramic X Ray C WULIEWS Archives x Aay Camera Images C WULIEWS Archives Camera Images A Not installed Sensor gt 7 OWANDY DSX amp KrystalX 4 Click on Configure at the right of the menu CONFIGURATION Cancel In the configuration window Model Eryshalet Factory Setti ae amp actor Settings Kysta Easy 520 4 Check the USB model e Seam DSX 600 522 DSX 800 521 lt Select the Krystal X Easy 520 kit i C Kesta 500 502 C 09730 Evo 501 DS 730 V1 100 C DS M730 V3 104 C DS 730 V2 100 C Evol amp 2 103 J 102 Tool bar gt Activate during 5 innat E i lt Set the activation time of the box Date and time on image default omin Image processing E i 5 G amp G Film alike lw Filter Auto contrast lt Select
24. installation that appears 8 confirmation window is displayed after the files have been copied it confirms the drivers have been installed correctly by displaying Krystal X Easy Installed Click on OK to close this window 9 After the installation of the drivers click on Next in the main O S P window 10 Select USB X Ray to start the installation of the O S P tools Refer to paragraph 3 3 2 Installation of the O S P for installation instructions Manual installation it is also possible to install the drivers manually by using the New hardware detected assistant of Windows Follow these steps 1 Connect the connection box to the USB 2 0 port of the computer Windows will automatically detect your equipment and will display the Found New Hardware Wizard window 2 Ifthe wizard requests the authorization to connect to the Windows Update site select No not this time then click on Next This window does not appear depending on your version of Windows 3 The wizard will inform you it has detected your Krystal X Easy kit Select Install from a list or specific location then click on Next after making sure the O S P CD ROM is inserted in the CD ROM drive 4 Select Don t search will choose the driver to install and click on Next 5 Click on Have Disk under the list that is displayed If the window containing this list does not appear cl
25. ktop or to equipment It allows you to store the sensor within easy reach and to protect it against eventual impacts or drops 3 3 Software installation Install the Owandy QuickVision or third party imaging software and check its proper functioning before installing the equipment and its drivers Refer to the software manual for the installation instructions You need administrator rights for the installation and use of the software and equipment Please contact your IT specialist to create a suitable user account 3 3 1 Installation of the drivers Automatic installation for Windows 98SE and Millennium after having connected the box to the USB port of the computer Windows will detect automatically the new equipment and ask for the corresponding drivers 1 Insert the O S P CD ROM and click on the Next button the window Add new hardware that is displayed on screen 2 Check the box Search for the best driver for your device and click on Next In the new window do not check the box Search for location and click on Browse 4 the CD ROM navigate to the drivers WIN_ 98 ME Owandy USB directory in the navigation window that appears and click on OK 5 Windows will indicate is has found the drivers for the Krystal X Easy click on Next to start the installation 6 Click on Exit in the last window of the wizard to finalise the installation 7
26. mprove the performance quality or ease of production Specifications of products or accessories may be modified without prior notice No part of this manual may be reproduced without the prior consent of the manufacturer Owandy S A S Language of original document French OWANDY SA 6 All e Kepler F 77420 Champs sur Marne France 33 1 64 11 18 18 0459 Fax 33 1 64 11 18 10 1 Introduction You have just received your Krystal X Easy digital intra oral radiology kit We thank you for the confidence you have in us and hope that this product will give you entire satisfaction We recommend you to read this manual thoroughly before installation following the guidelines for installation and usage described in it will exclude risks to the patient and the care team Please keep it close to your equipment so you can refer to it at a later date Your sensor uses an X ray sensitive electronic detector the flat part at the bottom of the sensor that replaces the conventional film used for the acquisition of radiological intra oral images The X rays are automatically detected by the sensor which triggers image acquisition The acquired image is displayed almost instantaneously on the screen of the computer to which the sensor is connected These digital images can then be manipulated analysed saved as files or printed The development process of conventional films is thus completely eliminated as well as the possible
27. ndow if it is still displayed on screen Manual installation if you have followed the manual installation of the drivers or you are installing under Windows 98 or Millennium you must start the manual installation of the O S P tools 1 Insert the O S P CD ROM in the CD ROM drive 2 Navigate to the setups USB_XRAYS_ W98 WME_W2000_WXP directory on the O S P CD ROM 3 Launch setup exe 4 Click on USB X Ray to start the installation of the O S P tools Refer to the automatic installation of the O S P mentioned above 3 3 3 Sensor installation files Each kit is provided with a sensor installation CD ROM of its own the serial number of the sensor is written on the CD ROM You can therefore not use the same CD ROM to install several kits Before installing the sensor installation files make sure that e The drivers of the kit are installed e The imaging software is not started Insert the sensor installation CD ROM a window appears and the files are copied to the hard disk Close the window after the files have been copied by pushing any key of the keyboard when asked for 3 3 4 O S P update If you need to update your O S P 1 Insert the O S P CD ROM 2 Navigate to the setups USB XRAYS W98 WME_W2000 WXP directory on the CD ROM 3 Launch setup exe 4 Click on Install or Reinstall and be guided by the instructions on screen 3 4 Configuration in the Owandy imag
28. oolbar must be displayed in green 4 3 3 Configuration menu A right click on the sensor icon in the taskbar or on the sensor toolbar displays the configuration menu X ray sensor Displays the sensor toolbar Once checked the StandAlone program will be launched each time your computer is started Displays the configuration menu see 3 4 Configuration in the Owandy imaging software Start when Windows starts Configuration Display new image during Adjusts the display time of the image Allows you to browse through the images waiting to be transferred If no image is acquired this option is not displayed Closes the resident software program Warning the acquisition will no longer be available until the resident program is restarted Remaining images Exit 4 3 4 Image transfer interface T REMAINING IMAGES 2006 07 07 10 25 27 bmo Preview 4 2006 07 07 10 42 bmp Delete Delete on load hu 126 Options of the image transfer interface Image display When an image is selected it is displayed on a blue background Load button Transfers the selected image to the software program Cancels the image selection and starts the toolbar for a new acquisition Cancel button only when in a software program Preview button Displays the selected image full screen Email button Opens a blank email and attaches the image in a Zip file Delete
29. p regularly to be able to recuperate them if needed in case of hard disk or computer problems Ask the advice of your IT specialist with regard to the backup system that is best suited to your computer configuration external or removable hard disk Zip or Jaz system CD ROM or DVD writer etc Test and store the copies in a safe place 6 Troubleshooting If an error occurs during operation check the different items in this troubleshooting guide If you cannot resolve your problem please contact your distributor 6 1 General Symptom Cause Solution The kit does not power up the green e Check that the active surface of the sensor is directed light does not light up or it does not towards the X ray generator and is positioned correctly acquire images in the field of the X ray beam e Check that the kit is correctly configured in the imaging software and that the drivers are correctly installed e Check that the green light on the box is on and that the sensor toolbar is green if this is not the case reactivate the box by pushing on the button e Check that the USB cable is connected correctly to the box and to the computer and that the computer is switched on If you use a USB hub check its connections and make sure it is powered on e Check that the sensor is connected correctly to the box e Check that the generator is emitting X rays with another sensor or with conventional film The red light of the box lights up e
30. rd The secondary electrical insulation of the sensor is determined by the materials used There is no physical or electrical connection between the Krystal X Easy kit and the X ray generator 1 2 Power supply The power to the Krystal X Easy box is provided directly by the power supply of the USB cable 1 3 Installation precautions Regulation requires that your computer is at least compliant with standard IEC950 EN60 950 if it is not within the patient environment 1 3 1 Installation of the box outside the patient environment The Krystal X Easy kit has been developed so that the box is positioned outside the patient environment when in use meaning at a distance of at least 1 5m 4 9ft of the patient measured horizontally or at more than 2 5m 8 2ft of the ground measured vertically if the horizontal distance is not complied with 1 3 2 Installation of the box within the patient environment If the computer or the box are situated inside the patient environment less than 1 5m 4 9ft from the patient your computer must necessarily comply with standard EN IEC60601 1 or your installation including the computer must have been rendered compliant with standard EN IEC60601 1 1 You can connect the box to your computer without additional precautions once your complete installation is compliant with standard EN IEC60601 1 1 If the computer is not situated in the patient environment and is not compliant with standard EN IEC6
31. rs provided with the system should be covered by the hygienic protective sheath together with the sensor Do not pull on the cable when removing the sensor from the positioner They should be cleaned and disinfected according to the same procedure as for the sensor see 5 2 Recommended disinfection procedure They can be sterilised either in an autoclave classic steam sterilizer distilled water 134 C 273 F 3bar 4min or using cold sterilisation See product instructions They withstand a maximal temperature of 145 C 293 F A defective positioner can be thrown away with the regular waste 5 2 Recommended disinfection procedure Remove the hygienic protective sheath dispose of it appropriately with the contaminated waste Vigorously wipe down the sensor to remove visible 7 at residues If necessary rinse with copious amounts of water Then place the sensor in the disinfecting agent Only immerse the sensor and the beginning of the cable in the disinfectant for 15min never immerse the connector of the sensor or the connection box in the liquid Then rinse thoroughly the sensor with copious amounts of fresh water Do not put the sensor in a sterilizer an autoclave the high J temperature and excessive high pressure will seriously damage the electronics of the sensor Do not clean the sensor with inappropriate instruments knife If the sensor is not being used immediately upon
32. sensor will not be able to acquire images Refer to the poster provided with the positioners for more information regarding the positioning for anterior posterior endo and bitewing images Position the generator so as to cover the whole sensitive area of the sensor The paralleling technique is strongly recommended and the use of positioners allows you to correctly place the generator thanks to the aiming ring Activate the generator The green and yellow lights of the box will light up to indicate the treatment of the acquired image Once the image treated it appears in the imaging software and the green light of the box lights up allowing a new acquisition 4 4 2 Owandy imaging software functions This function is available only to users of the Owandy imaging software When the image is displayed in the Owandy QuickVision imaging software a coloured bar appears in the top part of the image this is the exposure bar A The white cursor displayed in this bar indicates the exposure level of the image If the cursor is in the green the image is correctly exposed If the cursor is in the red the image is over exposed reduce the exposure time on the generator If the cursor is in the blue the image is under exposed increase the exposure time on the generator 443 Third party imaging software functions If you do not possess the Owandy imaging software an exposure percentage is displayed the acquired image e to 80
33. start the installation of the O S P tools please refer to paragraph 3 3 2 Installation of the O S P The Krystal X Easy is installed under Universal Serial Bus controllers in the Device manager To reach this window click on the Workstation icon with the right mouse button and select Properties then Device manager Automatic installation for Windows 2000 XP and Vista insert the O S P CD ROM in the CD ROM drive The interface will launch automatically and will guide you through the different installation steps Refer to the Windows help if the CD Rom does not automatically launch 1 Select the desired language in the main screen The tabs at the top of the page link to different pages of the Owandy website and provide more information regarding Owandy 2 Click on Install then Next Select USB the menu that appears 4 Connect the USB cable to the connection box and the USB 2 0 port of the computer Windows will automatically detect your box 5 Cancel the window Add hardware wizard that appears then click on Click here in the window of the O S P installer 6 In the new window confirm the location of the drivers that is displayed by clicking on Install This location must correspond to the directory of the drivers on the O S P CD ROM The driver files are then copied to your hard disk 7 Click on Continue the message window Equipment
34. that your generator is not worn as the dose emitted will be insufficient and could influence the quality of the acquired image The energy emitted by a generator diminishes over time when in doubt have your generator checked by a qualified technician Make sure he had of the generator is stable any movement of the head will induce movement blur in the acquired image 3 2 Equipment installation 3 21 Connections The Krystal X Easy box provides connectors for the sensor the USB cable linking it to the computer It must be connected to the computer using the USB 2 0 cable provided with the kit If the distance between the box and the computer is greater than the 3m 9 8ft of USB cable provided with the kit it is possible to add USB cables by using powered USB hubs between each cable Connection without hub Connection with powered hub Connect the sensor cable connector to the box by aligning the red dot on the plug with the red dot on the socket of the box do not try to force the insertion of the plug it could damage the connector The Krystal X Easy box accepts size 1 or 2 Krystal X sensors a 1 T Make sure the USB port of the computer is preferably a USB 2 0 port Only use USB 2 0 cables and hubs with a USB 2 0 port and make sure that the hub has its own external power supply do J not use self powered hubs drawing the power from the USB cable Each USB cable should not t be lon
35. the image treatment lt Configure the Owandy software When the Film alike option is activated the contrast depends on the exposure time Adjust the X ray dose on the generator to obtain a good image When you select the option Auto contrast the contrast is constant Exposure errors are corrected automatically which reveals noise in badly exposed images In both cases the exposure bar blue green red helps to find the correct exposure of the images This option appears only when the sensor is used from certain Owandy software programs it allows the change of the sharpness setting or the high resolution for each acquired image 5 Click to confirm your choice 6 Then click the Save button to validate the settings The use of the kit is identical to the use of the Owandy XIO StandAlone software described below 3 5 Sharing the sensor and box between different workstations Sharing the sensor and the box allows you to use one or more sensors in turn in a practice with multiple chairs It is recommended to link the different workstations in a network to allow for the central storage and sharing of the images A USB cable must be plugged into each workstation for fast connection of the box Windows will automatically recognise the equipment when it is connected and it will be available immediately for image acquisition To enable the sharing of a kit between different
36. workstations it is necessary to first install the imaging software for the acquisition of the images the drivers O S P tools and sensor installation files on all the computers to which the box will have to be connected i gt Use 4 1 Precautions Make sure the sensitive surface the flat surface of the sensor is directed towards the X ray generator The active surface of the sensor is marked by a frame The back of the sensor rounded does not react to X rays and does not produce an image on screen The kit must be manipulated with care minimising the twisting pulling and bending of the attachment cable Do not step or roll on the cable Be careful not to pull on the cable when removing the hygienic protective sheaths Do not pull on the cable itself but on the plug to disconnect the attachment cable Do not connect or disconnect the sensor waiting for an acquisition or during an acquisition make sure the box is in standby mode before disconnecting the sensor Even though the sensor is resistant to impacts it is strongly recommended to not let it fall on the floor If a physical impact should exceptionally happen contact your distributor and do not try to intervene yourself Do not ask the patient to bite on the sensor or cable gt gt gt gt gt 4 2 Lights and button on the box During initialisation of the box the green and yellow lights light up once the initialisation finished only the green light remains lit
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