User Manual - Ashtel Dental
Contents
1. Nah TCO LE CONCENTR DE TECHNOLOGIE DIGITAL IMAGING MADE SIMPLE pa lt Owandy TEO 2ieme G n ration INSTALLATION AND USER MANUAL Version 03 July 18 2012 Owandy EN Index 1 INTRODUCTION cccecec cece ce eecesececeneeeeeeeeeececeneeeeeeaeaeaeaeaeaeaeaeasensnenenenenseeneaneneeeeeeeeeneuennuaneneneesananans 3 1 1 COMPLIANCE WITH STANDARDS ccecececcccecececcccccccccecccecscecececucucaeacceuauaeneneneuenenenstetetstetststacetesuenenenenenens 3 12 POWER 21 ae ai aaa a SN a a a Ba ar BO aa aa Bag rear ene a alaa aa ee oe 3 1 3 INSTALLATION PRECAUTIONS ecw 4 1 4 LIABILITY AND OPE RAT ORS oii 4 1 5 PACKAGING AND ENVIRONMENT 2 0ccccccccoccccccccccccccecccecscscececacacacacceucucucececececenenstetstetscstscueatsstenenenenenens 5 1 6 MARKING AND LABELLING SYMBOLG cccccececececececccccnccececucucucucucucucreuauauaeaeneaenenenscetecetecstscatatasuenenenenenens 5 2 N AO 6 INSTALLATHON oreren ee a ee ee ee 7 PRE AUTON 1 7 EQUPMENTINSTALLA EA BA a KASEK BAN SOR wasn AGA BAGAN TAG A aga KA DG TO BAANG Na E KAT BAN O A a a Bag a 8 393 OI ARE ING ag BA aa An Naga Tg aaa 9 34 CONFIGURATION IN OWANDY IMAGING SOFTWARE ssscecececececceccccecececenecenenucetecacueececececesue2. Navigate to the setups CMOS_XRAYS_BOX_W2000_WXP directory on the CD ROM Launch setup exe Click on Install or Reinstall and follow the instructions on screen na le ar 3 4 Configuration in the Owandy imaging 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 Configuration QuickVision version 3 2 Click on the Configuration button in the main screen 3 Select OWANDY DSX amp Krystal X under the Intra Oral sensor option in the window that appears XRAY and IMAGING CONFIGURATION E Fi esi path WG teak ge E 7 4 Click on Configure at the right of the menu Configuration QuickVision version 4 2 Select the Settings menu in the menu bar then click on Preferences then select the Equipment tab 3 Select the manufacturer OWANDY under the Intra oral sensors 4 Click on the configuration button at the right of the menu Fabricant Owandy 7 f 9 a Owandy EN CONFIGURATION In the configuration window x Mod le sihe lt Check the USB type 5 Opteo Opteo 2 lt Select the Opteo 2 kit am C Krystal Easy 520 Da C DSX600 522 C DSX 800 521 D F aga t Krystal 500 amp 502 DSX730Evo3 501 a
3. AM and FM radio broadcasting and TV broadcasting cannot be theoretically foreseen with exactitude In order to assess the electromagnetic environment produced by fixed RF transmitters an on site electronic investigation must be considered If the field intensity measured at the location where OPTEO is used exceeds the applicable RF compliance level below OPTEO must be observed to check that its operation is normal If abnormal performance is observed additional steps may be necessary like reorienting or repositioning OPTEO b For the frequency range from 150 kHz to 80 MHz field intensities must be below 3 V m Owandy EN Table 4 Recommended separation distances between portable and mobile RF communications equipment and OPTEO OPTEO is designed for use in the electromagnetic environment where radiated RF interference is controlled The OPTEO customer or user can help to prevent electromagnetic interference by keeping a minimum distance between the portable and mobile RF communications transmission device and OPTEO as recommended below based on the maximum transmission power of the communications device Assigned maximum Separation distance by transmitter frequency output power of transmitter From 150 kHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2 5 GHz D 1 16 P D 1 16VP D 2 33 P For transmitters whose assigned maximum transmission power is not given above the recommended separation distance d in metres m can
4. The colour of the sensor toolbar indicates the state of the sensor A Red sensor inactive Yellow sensor initialising Green sensor ready for acquisition lt Orientation of the sensor vertical or horizontal double click the icon to change the orientation of the sensor 4 Activate deactivate the sensor 4 Iconize the toolbar in the taskbar The sensor automatically switches to standby mode after a few minutes of not being used the sensor toolbar turns red Check that the sensor toolbar is displayed in green before each acquisition Owandy EN 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 Start when Windows starts Configuration Display new images for Remaining images Exit 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 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 4 9 4 Image transfer interface REMAINING IMAGES 2006 07 07 10 25 27 2006 07 OF 10 42 40 bmo Delete D
5. The generator head was not stabilised and has moved Owandy 7 Specifications 7 1 General specifications Opteo Sensor Size 1 External dimensions size 1 sensor CMOS matrix size 1 sensor cut corners e Sensitive area in size e Sensitive area in pixels e Pixel dimensions Opteo Sensor Size 2 External dimensions size 2 sensor CMOS matrix size 2 sensor cut corners e Sensitive area in size e Sensitive area in pixels e Pixel dimensions Technical specifications size 1 and 2 sensors Length sensor cable Grey levels Connection Consumption kit Input voltage sensor Input current sensor Operating temperature Lifespan CMOS Standards Conformity to standards EN 38 6 x 24 7 x 5 2mm 1 6 x 1 0 x 0 2inch 30 x 20mm 600mm 1 2 x 0 8inch 1 0inch 1500 x 1000pixels 20 x 20um 43 2 x 30 8 x 5 2mm 1 7x 1 2 x 0 2inch 34 x 26mm 900mm 1 3 x 1 0inch 1 3inch 1700 x 1300pixels 20 x 20um 3m 9 9ft 14bits 16384 grey levels USB standard USB 2 0 High Speed 480Mbit s and USB 3 0 0 5 under 5V USB port 0 15A Max 10 C to 40 C 50 F to 104 F Min 100 000 cycles NF EN IEC60601 1 NF EN IEC60601 1 2 Owandy 7 2 Regulatory Declarations Table 1 EN Manufacturer s instructions and declaration electromagnetic emissions The OPTEO model is designed for use in the electromagnetic environment specified below The OPTEO customer or user must ensure that it is u
6. C DSX730 1 100 DSX730 3 104 C DSX730V2 100 DSX730V3Evo1 2 103 C UPIX 102 Barre d outils Vv 7 Comportement Activation pendant 5 j minutes lt Set the activation time of the box Date et heure dans limage q default omin 7 Exosiion dans i Taille texte SCO Or ns mage 5 Traitements lt Set the inlay and size of the date amp dimage A time and exposure parameters in the aaa me acquired image Radio film Contraste C Mode test auto lt Select the image treatment Fitre 4 Configure the Owandy software V1 1 8 0 DIV 1 0 0 2 USB Software 0 0 Protocol 0 0 Logic 0 0 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 3 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 on OK to confirm your choice 6 Then click on the Save button QuickVision 3 or on the Validate button QuickVision 4 to validate the settings The use of the kit is identical
7. dose sufficient for the acquisition of a good image with enough grey levels Make sure 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 2 1 Connection The Opteo sensor is fitted directly to a cable equipped with a USB connector linking it directly to the computer If the distance between the sensor and the computer is greater than the 3m 9 8ft of USB cable it is possible to add USB cables by using a USB distributor hub connected to an external mains power supply between each cable Connection without hub Connection with power supplied hub 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 not use self powered hubs drawing the power from the USB cable Each USB cable should not be longer than 3m 9 8ft The kit is compatible with USB 1 1 ports but with reduced image transmission speed The USB cable can be connected disconnected without the need to power down the computer Check that the sensor is correctly connected if the sensor toolbar turns
8. green after removing the sensor from its support it is powered correctly 3 2 2 Sensor support The sensor can be placed on its self adhesive support supplied with the kit The support is compatible with sensors of size 1 or size 2 This Support can be fixed on any type of flat surface worktop or a part of the chair The sensor will then be inserted into the fork of the support taking care not to impede the cable Do not mount the wall support upside down or horizontally the sensor could fall on the ground and be damaged Owandy EN 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 The Opteo drivers are only compatible with the Windows XP service pack 2 or higher Windows Vista and Windows Seven operating systems 32 and 64 bits Automatic installation 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 launch automatically 1 Select the desired language in the main screen The tabs at the top of the page li
9. thermal Keyboard and mouse At acquisition workstation Opteo kit with appropriate drivers Imaging software X ray generator with electronic timer lf your computer does not possess USB 2 0 ports these can be added as PCI PCI express 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 placed 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 Owandy EN 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
10. Opteo V2 USB drivers are displayed in the list see opposite click on Next 10 Click on Continue in the warning window Device installation that appears 11 Finally click on Exit in the last window of the wizard eo V2 USB ay Ce pilote n a pas t signe num nquement Disque foun Armer The Opteo V2 USB is installed under Universal Serial Bus controllers in the Device manager To reach this window click on the Workstation icon wiith the right mouse button and select Manage in the drop down menu In the window that appears select Device manager 3 3 2 Installation of the O S P Automatic installation the installation of the O S P tools is automatically proposed after the installation of the drivers Refer to the procedure below 1 Select the desired language in 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 Opteo V2 USB in the list t
11. at it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment instructions Test level seve Conducted RF 3 Veff Portable and mobile RF communications equipment interference from 150 kHz to must not be used nearer to any part of OPTEO IEC 61000 4 6 80 MHz including the cables than the recommended separation distance calculated on the basis of the equation applicable to the frequency of the transmitter Radiated RF 3 V m interference from 80 MHz to 3 V m Recommended separation distance IEC 61000 4 3 2 5 GHz d 1 16 VP d 1 16 P from 80 MHz to 800 MHz d 2 33 P from 800MHz to 2 5 GHz where P is the transmitters maximum output power rating in watts W according to the transmitter s manufacturer and d is the recommended separation distance in metres m The field intensities of fixed RF transmitters determined by an on site electromagnetic investigation must be below the compliance level in each frequency range Interference can occur near a device marked with the following symbol Ko NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These directives may not apply in all situations Electromagnetic propagation is affected by absorption and reflection by structures objects and people a The field intensities of fixed transmitters like base stations for radiotelephones cellular cordless and mobile land radios amateur radio
12. be estimated using the equation applicable to the transmitter frequency where P is the transmitter s maximum transmission power rating in watts W according to its manufacturer NOTE 1 at 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 these directives may not apply in all situations Electromagnetic propagation is affected by absorption and reflection by structures objects and people The essential performance of the OPTEO intra oral sensor in terms of image transfer remains complete in an electromagnetic environment that respects the regulatory limits Owandy 8 Accessories _ gt ae ll wandy x ray Sensor Me EN Refill packs of 10 positioners DORT1ANGUBW Size 1 bitewing DORT 1ANGUZE Size 1 endo DORT1ANGUZP Size 1 posterior DORT1ANGUZPA Size 1 peri apical DORT2ANGUBW Size 2 bitewing DORT2ANGUZE Size 2 endo DORT2ANGUZP Size 2 posterior DORT2ANGUZPA Size 2 peri apical Metal positioner kit DA207 Size 1 only Hygienic single use disposable protection sleeves for size 1 and 2 sensors DOPROTECCAPXL20 Bag of 20 pieces Hygienic single use disposable protection sleeves for size 1 and 2 sensors DOPROTECAPL500 Bag of 500 pieces Mounting accessories DOSUPCAP730 Self adhesive wall support
13. cee seek este sees cs di ence Seng E eevee cece ces eee ene ees 20 0A IMAGE 07 1 a ee ee eee er aba a kaag aaa 21 1 SG IG ONS arses 22 7 1 22 7 2 REGULATORY DECLARATIONG ccccccccccececcecccecececececececucucueucueueaeueesneneneneneneneneneneataeueueaeetececeuueneneneness 23 8 ACCESSORIES ec a aana akan La a A naa oe ene eee eee a eee oe er oe eee ae RE a A Kana A NSK 26 The manufacturer OWANDY reserves the right to make modifications to its products or to their specifications in order to improve 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 Language of original document French OWANDY Le Coruscant 2 rue des Vieilles Vignes 77183 Croissy Beaubourg FRANCE 0459 Telephone 33 1 64 11 18 18 Year CE marking assigned 2012 Fax 33 1 64 11 18 10 Owandy EN 1 Introduction You have just received your Opteo new generation digital intra oral radiology kit with direct USB connection 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 u
14. e 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 o Oto 80 under exposed image o 80 120 correctly exposed image o 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 o Oto 80 under exposed image o 80 120 correctly exposed image o 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 Winidows screen configuration panel it must display colours in at least 24bits Re acquire the image The patient has moved during the exposure
15. elete on load ka 18 Options of the image transfer interface Image display Load button Cancel button Preview button Email button Delete button Delete on load option When an image is selected it is displayed on a blue background Transfers the selected image to the software program Cancels the image selection and starts the toolbar for a new acquisition only when in a software program Displays the selected image full screen Opens a blank email and attaches the image in a Zip file Deletes the selected image Deletes the selected image from the list after it has been transferred to a software program Owandy EN 4 4 Acquisition of an image 4 4 1 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 to which it is connected and start the imaging software Check that the sensor toolbar or the sensor icon in the task bar is green Program the different parameters exposure time etc on the X ray generator see 4 5 Exposure times 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
16. function is available only to users of the Owandy imaging software 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 Owandy 4 5 Exposure times Recommended exposure times in seconds for the Owandy X ray generators EN Description Owandy Owandy RX Owandy Elios AC Current Voltage 7mA 65KV SMA 70KV Lower incisor canine 0 06 0 09 0 04 0 08 Lower premolar 0 06 0 10 0 06 0 10 Lower molar 0 07 0 11 0 07 0 12 Upper incisor canine 0 08 0 10 0 06 0 10 Upper premolar 0 08 0 11 0 08 0 12 Upper molar 0 11 0 16 0 10 0 14 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 lf an image is over or under exposed it can 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 Descr
17. h size 1 and 2 sensors drivers diagnostic tools A CD ROM with the installation files of the sensor A manual A packaging checklist Owandy EN 3 Installation 3 1 Precautions not step or roll on the cable Do not pull on the cable itself but on the connection plug to disconnect the The kit must be handled with care minimise the twisting pulling and bending of the attachment cable Do USB cable To avoid interferences in the image do not use the system close to strong magnetic fields and avoid proximity to electrostatic emission sources A Read paragraph 0 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 Windows XP SP2 Vista or Seven 32 and 64 bits Computer Compliant CE IEC950 Motherboard Intel 1 4GHz chipset and processor USB port USB 2 0 High Speed 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
18. hat 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 window if it is still displayed on screen Manual installation if you have followed the manual installation of the drivers 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 CMOS_XRAYS BOX _W2000 WXP directory on the O S P CD ROM 3 Launch setup exe 4 Refer to the automatic installation of the O S P mentioned above Owandy EN 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 and on the connection box You can therefore not use the same CD ROM to install several sensors each sensor requires its own CD ROM 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 Insert the O S P CD ROM
19. hough 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 Use of a mobile phone or an RF communications device near the Opteo sensor may affect the sensor gt gt gt 4 2 Sensor principles 4 2 1 Sensor The sensor s sensitive area is delimited by a horizontal line the area below this line is not sensitive to X rays When the sensor is placed in the mouth it is necessary to check that this area is turned towards the radiation source and that the whole sensitive area is irradiated Active surface Sensor s rear shell inactive surface 4 2 2 Sensor activation The sensor automatically puts itself on standby after a period which can be configured in the configuration window see 3 4 Configuration in the Owandy imaging software the default period is 5 minutes The sensor s toolbar is then in its red state To activate your sensor physically just remove it from its support and or give it a slight jerk The Opteo is equipped with a gravity sensor which will detect this movement and will so activate the embedded electronics The sensors sensitivity to gravity is programmed so as not to activate the Opteo intra oral sensor inopportunely by an involuntary movement When activating the sensor physically take care to ho
20. ice requiring special precautions regarding electromagnetic compatibility Please observe the recommendations in this manual during the commissioning and use of the equipment The use of cables or accessories other than those specified in this manual can cause an increase in the emissions or a reduction in the immunity of the Opteo sensor gt gt 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 sensor should never be opened by the user Only the manufacturer is authorised to open and make repairs to the sensor 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 Any modification of the Opteo device is forbidden All repairs of this same device can only be performed by OWANDY personnel gt gt 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 complian
21. image appears on the screen The sensor is slightly warm Cause Solution Check that the active surface of the sensor is directed towards the X ray generator and is positioned correctly in the field of the X ray beam Check that the kit is correctly configured in the imaging software and that the drivers are correctly installed Check the connection between the sensor and the PC and ensure that the PC is powered externally Check that the generator is emitting X rays with another sensor or with conventional film An error has occurred during acquisition disconnect the cable and wait a few seconds before reconnecting it Check that the outer sheath of the cable connection from the sensor does not show any signs of tearing This is normal The temperature of the sensor can exceed 12 C 54 F when the kit is activated for a prollonged period e g when taking many consecutive images and has no bearing on the functioning of the kit Reduce the standby time in the configuration screen Owandy 6 2 Image quality Symptom The images are cut off e g a 4 b The images are too light or contain noise 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 sur
22. in the meaning of the European Directive 93 42 CEE concerning CE markings The Opteo kit complies with the EN IEC60601 1 medical standard Under certain conditions see chap 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 EN60950 and that the installation complies with the EN IEC60601 1 standard The intra oral sensor is contained within a hermetic and sealed case resistant to immersion There is no physical or electrical connection between the Opteo kit and the X ray generator 1 2 Power supply The power to the Opteo box is provided directly by the power supply of the USB cable connecting it to the computer Owandy EN 1 9 Installation precautions 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 sensor to your computer without additional precautions once your complete installation is compliant with standard EN IEC60601 1 If the computer is not situated in the patient environment and is not compliant with standard EN IEC60601 1 it is necessary to place the sensor in non conductive packaging As the intra oral sensor is situated inside the patient environment less than 1 5m 4 9ft from the patient The Opteo sensor is an electrical medical dev
23. iption Adult Child Lower incisor canine Lower premolar Lower molar Upper incisor canine Upper premolar Upper molar Owandy EN 5 Hygiene and maintenance 5 1 Hygiene and disinfection 5 1 1 USB Connector The connector 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 cleaning and decontamination procedureErreur Aucun nom n a ete donn au signet Erreur Aucun nom n a t donn au signet 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 or 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 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 d
24. isinfecting 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 positioners 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 cleaning and decontamination procedureErreur Aucun nom n a ete donn au signet Erreur Aucun nom n a t donn au signet They can be sterilised either in an autoclave classic steam sterilizeir 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 Owandy EN 5 2 Recommended cleaning and decontamination procedure Remove the hygienic protective sheath dispose of it appropriately with the contaminated waste Vigorously wipe down the sensor to remove any visible residues If necessary rinse with copious amounts of water Then place the sensor in the disinfecting agent cable in the disinfectant for 15min never immerse the connector on the box Only imme
25. ld the sensor by both sides of its shells and not by the cable in order to avoid any risk of the cable connections breaking or the sensor falling and breaking Owandy EN 4 3 Use of the Owandy StandAlone software 4 3 1 Modes of operation The sensor kit can function in two ways Through the Twain protocol for scanners to use this mode select Owandy Intra Oral X rays 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 i a In independent mode the independent software program can be started with the w 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 XRAYS BOX STANDALONE StandAlone Datta directory on the hard disk A sensor icon appears in the Windows taskbar next to the clock The colour of the icon indicates the state of the sensor m 44 10 23 Red sensor inactive amp 10 23 Yellow sensor initialising 4 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
26. ment specified below The OPTEO customer or user must ensure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment instructions Test level level 6 kV at contact 8 kV in the air Not applicable Not applicable Not applicable Floors must be of wood concrete or ceramic tiles If floors are covered with synthetic materials the relative humidity must be at least 30 The quality of the electricity supply network must be that of a typical commercial or hospital environment The quality of the electricity supply network must be that of a typical commercial or hospital environment The quality of the electricity supply network must be that of a typical commercial or hospital environment lf the OPTEO user requires continuous operation during power cuts in the electricity supply network it is recommended to supply OPTEO irom an uninterruptible energy supply or a battery Magnetic fields at the frequency of the electricity network must have the same characteristic levels as a representative place located in a typical commercial or hospital environment NOTE Uris the voltage of the alternative network before application of the test level Owandy EN Table 3 Manufacturer s instructions and declaration electromagnetic immunity The OPTEO model is designed for use in the electromagnetic environment specified below The OPTEO customer or user must ensure th
27. neneneners 11 3 5 SHARING THE SENSOR AND BOX BETWEEN DIFFERENT WORKSTATIONS ccscccccceceeccececececececececeseececeneness 12 a ose eee teen cas a a a a Na nan a EEN Ba aa aa a aan a b a aa aa aaa 13 A EBEG TONS sasi saa aa sete aaa aa see E a NG AE ses E E aa NG a Daeng EEE aan aan ad da soca 13 A SENSOR PBINGIPLES kakang a et gag a cdg a a a estes ence a aaa a a aaa A aa aa a setae Ba A Ba aaa 13 4 3 USE OF THE OWANDY STANDALONE SOFTWARE ccecececececccccccececececececucucucecasuecuauauauauauauecsersceceees 14 44 ACQUISITION AN IMAGE ccccccececececcccecececececccucccuccucucucucucececenecsetetenstetsustauaca cauauauauauaucuuautanstanseaeas 16 ras at ne re en eae en ee en nee ee ne ve en ene ee ee eee ree 17 5 HYGIENE AND MAINTENANCE ccccececececececececescececececeeucueneuceusaeaeaeneeeeeeeneeeeaeeeaeeeaeaeeneneneneaeneans 18 5 1 HYGIENE AND acted dat anlybada ws denawawd vadusamed dvea decdedeawalwdadensecved 18 5 2 RECOMMENDED CLEANING AND DECONTAMINATION PROCEDURE ccccoccccccecececeeccecececucececececustenenenenens 19 53 MAINTENANGE screech ees cies cnt 19 6 TROUBLESHOOTING cccccececececececececmccecececeeeceeeeneeneeaeaeaeeeaueneueaseusaeaeaeeensneneanaueeeeeeaeaeaeauanenenenenensans 20 6 1 aac
28. nk to different pages of the Owandy website and provide more information regarding Owandy 2 Select USB in the menu that appears 3 Connect the USB cable to the connection box and the USB 2 0 port of the computer Windows will automatically detect your box 4 Cancel the window Add hardware wizard that appears then click on Click here in the window of the O S P installer 5 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 5 CD ROM The driver files are then copied to your hard disk 6 Click on Continue in the message window Equipment installation that appears 7 A confirmation window is displayed after the files have been copied it confirms the drivers have been installed correctly by displaying Opteo V2 USB Installed Click on OK to close this window 8 Then continue the installation of the O S P with reference to paragraph 3 3 2 Installation of the O S P 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 si
29. ou about the compliance with standards and the technical specifications of the component Type B equipment EN IEC 60 601 1 Direct current annexes and Il The CE marking certifies that Important information follow the this product complies with instructions printed in this 0459 manual European directive 93 42 CEE Sensor waterproofness standard 60529 regulation IPX7 Storage condition temperature Only the part of the sensor putted limitations in month complies with this standard Storage condition relative humidity limitations Storage condition Atmospheric pressure limitations Qs OF 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 Owandy EN 2 Contents Your Opteo kit consists of the following elements illustrations may vary from items supplied 1 self adhesive sensor wall support An Opteo sensor size 1 or size 2 cable of 3m 9 9foot An introductory pack of plastic positioners available for size 2 sensor as default Metal positioner kit available for size 1 sensor as default A bag of disposable single use hygienic protective An O S P installation CD ROM sleeves compatible wit
30. rse the sensor and the head of the positioner or sensor connection side of the positioner or sensor connection cable in the liquid During the immersion brush the submerged parts with a soft brush Then rinse thoroughly the sensor and the positioner or the sensor connection cable with copious amounts of fresh water Do not put the sensor in a sterilizer or an autoclave the high temperature and excessive high pressure will seriously damage the electronics of the sensor and connectors Do not clean the sensor with inappropriate instruments knife If the sensor positioner or sensor connection cable are not being used immediately upon rinsing as in the case of allowing them to air dry overnight at the end of a working day they should be rinsed with sterile water When the sensor positioner or sensor connection cable are not being used to protect them from any damage it is recommended to store them in their box or to hang them in the sensor wall support Even when using protective sheaths the sensor should be disinfected regularly 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 2 1 Recommended decontaminating product for North America The sensor being sealed watertight and to minimize the potential for device associated infections the sensor and the part of the po
31. sage 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 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 Opteo kit is class IIA equipment with
32. sed in such an environment Compliance Electromagnetic environment instructions The OPTEO model only uses RF energy for its internal functions Consequently its RF emissions are very low and are not capable of causing interference in nearby electronic equipment RF emissions CISPR 11 RF emissions CISPR 11 Voltage fluctuations flicker IEC 61000 3 3 Table 2 Electrostatic discharge ESD IEC 61000 4 2 Rapid transients in bursts IEC 61000 4 4 Transient overvoltage IEC 61000 4 5 Voltage dips brief power cuts and variations in voltage on electricity supply input lines IEC 61000 4 1 1 Magnetic field at the frequency of the electricity network 50 60 Hz IEC 61000 4 8 Group 1 Class B 6 kV at contact 8 kV in the air 2 kV for electricity supply lines 1 kV for input output lines 1 kV between phases 2 kV between phase and earth 5 Ut gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Urt 30 dip in Ur for 25 cycles 5 Ut gt 95 dip in Ur for 5s The OPTEO model is suitable for use in all premises including domestic premises and those directly connected to the low voltage public electricity supply network supplying buildings for IEC 61000 3 2 domestic use Not applicable Manufacturer s instructions and declaration electromagnetic immunity The OPTEO model is designed for use in the electromagnetic environ
33. 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 sensor will not be able to acquire 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 sensor toolbar turns yellow to indicate the treatment and transmission of the acquired image Once the image treated it appears in the imaging software and the sensor toolbar turns green allowing a new acquisition 4 4 2 Imaging software functions An exposure percentage is displayed in the acquired image 0 to 80 under exposed image the X ray dose is too low increase the X ray dose on the generator 80 to 120 correctly exposed image 120 to 200 over exposed image the X ray dose is too high reduce the X ray dose on the generator 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 This
34. sitioner or sensor connection cable inserted in the mouth 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 decontaminating products outside North America The following disinfectants are compatible with the sensor and the part of the positioner or sensor connection cable that is inserted in the mouth e 2 Sodium Hypochlorite maximum immersion time of 24 hours e Ethyl alcohol maximum immersion time of 24 hours e Quaternary ammonium 5 3 Maintenance 5 3 1 Computer data protection Your patient and image database must be backed up 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 Owandy 6 Troubleshooting EN 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 The kit does not power up or it does not acquire images No
35. t 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 the kit in normal conditions of use and in compliance with its intended purpose Owandy EN 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 lt 95 without condensation 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 y
36. te 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 Opteo V2 USB 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 click on Show All Devices then click on the Have Disk button 6 The next window will allow you to navigate to the directory that contains the required files click on Browse Owandy EN 7 Navigate to the drivers WIN_2000_XP OWandy USB Assitant Hateriel detects directory on the 5 CD ROM this directory contains the Choisissez le pilote de p riph rique installer pour ce mat riel file ow_usb inf Click on OK to select this directory 8 The previous window now displays the location of the files to o abort ot le modile de vo pbs mail than So be installed E drivers WIN_2000_ XP OWandy USB E representing the letter of your CD ROM drive this can be different depending on your computer configuration Click on el Alfachyer kes mahknels compatibles mole to start the installation 9 The
37. to the use of the Owandy XIO StandAlone software described below 3 5 Sharing the sensor and box between different workstations Sharing the sensor 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 port must be plugged into each workstation to allow for an easy 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 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 with which your Opteo will be used Owandy EN 4 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 gt gt Do not pull on the cable itself but on the plug to disconnect the USB cable Even t
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