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1. 64 79 476 D3607 68 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 7 Settings Operating Instructions and Installation Instructions XIOS Scan 7 1 Opening the settings dialog Settings Opening the settings dialog In this dialog the following device settings are possible e Time to standby e Display brightness e Keystroke SIDEXIS Manager startup for SIDEXIS 4 1 Click on the toothed wheel icon A in the header line The Gereral Setting window opens 2 Open the SIDEXIS Manager SIDEXIS Manager startup for SIDEXIS XG gt Start the SIDEXIS Manager via start gt Programs gt SIDEXIS gt SIDEXIS Manager 64 79 476 D3607 D3607 201 01 01 02 04 2015 69 7 Settings Sirona Dental Systems GmbH 7 2 Setting the time to standby Operating Instructions and Installation Instructions XIOS Scan Opening the settings dialog 1 Click on SIDEXIS Manager in the X OS Scan Configuration 2 Click the Properties button in the dialog that appears Tray Cleani biesen The settings dialog is displayed on the scanner display Properties Erase Plates sirona XIOS Scan Properties Setting the time to standby 1 Press the Standby time key The Standby time dialog window is displayed XIOS Scan Standby time 2 Press the Increase or Decrease key to change the time 3 Confirm the settings by pressing the Confirm button 64 79 476 D3607 70 D3607 201 01
2. 5 4 Turning on the scanner Operating Instructions and Installation Instructions XIOS Scan IMPORTANT Cleaning the transport box gt Clean and disinfect the transport box and mat regularly see Cleaning and disinfecting the transport case gt 67 Turning on the scanner gt Switch on the scanner Sirona XIOS Scan yg Sirona In the course of the boot process with self diagnosis the power LED will blink and the scanner will display the SIRONA logo The Dental Company Ga a A After the boot process the scanner is ready for use The standard sifona XIOS Scan display Scanner Name Ready will appear XIOS Scan Ready If the scanner has not been used for a predefined period it will switch to standby mode The time it takes to enter standby mode can be specified in the settings dialog See Settings gt 69 IMPORTANT The scanner will only switch to standby mode if there are no rescue exposures and no errors KOJ PIE a oe Reading imaging plates and sending them to SIDEXIS DICLE S The Scanner Name Ready report is displayed Jur XIOS Scan 1 Log the patient who is the subject of the exposure into SIDEXIS XIOS Scan Ready 2 Open the SIDEXIS Plugin for XIOS Scan Note the SIDEXIS Plugin Operator s Manual for XIOS Scan The PC is waiting for the scanned exposure 64 79 476 D3607 54 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation Operating Ins
3. 64 79 476 D3607 8 D3607 201 01 01 02 04 2015 Device variants Firmware 64 79 476 D3607 D3607 201 01 01 02 04 2015 Icon Designation Laser is in operation Do not stare directly into the laser beam Risk of electric shock when accessing areas of the system marked with this symbol Formats and symbols used The formats and symbols used in this document have the following meaning x Prerequisite Prompts you to do something 1 First action step 2 Second action step or gt Alternative action Result gt Individual action step see Formats and symbols Identifies a reference to another text used gt 9 passage and specifies its page number Command menu item Indicates commands menu items or quotations Notes to the repository It is mandatory to keep this operating manual in an easily accessible place for the purpose of later reference In the event of a sale of the device to another user make sure that the device is supplied along with the operating manual so that the new owner can get acquainted with the operation and the appropriate precautions and warnings scope of this operating manual This operating manual is valid for the following devices XIOS Scan This document is valid for a device with a firmware version from Version 1 1 1 1 Maintenance Exclusion of liability Certificate of work 10 Other relevant documents The X ray system includes other components such as
4. 2 Switch off the scanner 3 Lift the back side of the scanner using a suitable support until the slide is roughly level This prevents liquid from entering into the inside of the scanner 4 Clean the slide by spraying or wiping it Use isopropanol for this 5 Allow the slide to dry 65 6 Ifthe pin A was moved during cleaning push it back into the slide 7 Turn the scanner back on The slide will retract once again 8 Fit the collection tray once more The scanner is again ready for use Cleaning the power supply unit Use a dry soft cloth to remove dust from the power supply unit More stubborn spots can be removed with a damp cloth You can wipe the power supply unit to disinfectant it using all products that are normally used for electromedical devices Spray disinfection may allow liquids to penetrate into the power supply unit The power supply unit can only be disinfected using a wipe Never use a spray disinfectant on the power supply unit Observe the instructions provided by the manufacturers of these disinfectants 64 79 476 D3607 66 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 6 Cleaning and care by the dental assistants Operating Instructions and Installation Instructions XIOS Scan 6 2 Disinfection and cleaning 64 79 476 D3607 D3607 201 01 01 02 04 2015 Cleaning and disinfecting the hygiene protection covers Rub the hygienic protective sleeves with an ethanol ba
5. Image transfer error Explanation In case of an unexpected fault on the PC there may be problems with image transfer from the scan dialog to SIDEXIS The scans transmitted from the scanner must then be imported subsequently via the SIDEXIS import image function The X ray scans are in the PDATA directory of the SIDEXIS system under the following path lt PDATA gt Plugins XIOS Scan Backup lt Rechnername gt Import IMPORTANT Select the correct file JS The scanner will store the raw data and the image data filtered using the standard filter specified in the user settings in the backup directory gt Only select the files that have a filter description Neutra Unionis Duae or Filter at the end of the file name 1 Log the relevant patient into SIDEXIS 2 Import the missing X ray scans via the SIDEXIS image import function Error messages If a fault occurs an error code is issued on the display IMPORTANT An error during read out can render the images recorded unreadable The usability of the generated images can only be estimated by the user himself Error code Note the error code Note the instructions contained in the troubleshooting measures in chapter 9 4 64 79 476 D3607 D3607 201 01 01 02 04 2015 Faulty radiographs Errors Cause of error Corrective action Structures cannot be X X ray dose is too low X ray dose is too low is too low Check X ray parameters X ra
6. 6 2 39 CICANMING the Slide cyerst eevee cenevisinnsenly en awe duicwvaduededaewed pen sew EERTE ESN 6 2 4 Cleaning the power supply unit cc cecceceeseeceeeeeeeeeeeeeeeseeeteess 6 2 5 Cleaning and disinfecting the hygiene protection covers 6 2 6 Cleaning and disinfecting the transport case cccecceeeee sectors 6 2 7 Disinfecting imaging plates cccccccccccecccsececseeeceeeseeeseeeeseeesaeees 7 SENOS ease E E E E EE A 7 1 Opening the settings GialOG ccccecccseccceeeseececeeeeceeesneeseeeseeeseeesseseseeeens 7 2 Setting the time to Standby cc ccccccseeceeeeeseeeceeeeeeeeseeeeseeeseeseeeseees 7 3 Changing display DrontineSs 2 2 3itcis6 crit a ti fA Changing KEY SUOK Circe ctrcctetrnccnauntadatt E Guthtan ls e a e 8 Mantenan GC re sas teascoher ce e ccatatachons daoriceoa e i asin taeee 8 1 General ersen E E EE eaa aae EE AAE 8 1 1 Maintenance of the Unit ccc cccccseecsseeseeeeseeeseeseeeeseeeseeeens 8 2 Regular INSDECHONS ie xicxincccew erie cd con e E E aaa aie etens O30 Constancy tesia ra 8 4 Annual check performed by the system owner or authorized persons Q Troubleshooting and Yeepa eosin a aa oh eeeeencals 9 1 Resend non transmitted exposures to SIDEXIS 10 0 cece eeeeeeee eset eeeeaes Oe SEX DIAN ATION er A 9 1 2 Network fault with XIOS Scan ccc ccccceeccseeeeeeeeceeeeseeeeeeeesaees gT ImMadetransilerenor dsssn Ga
7. possibly impair diagnostics Note the error code and turn off the scanner If the error appears more often contact service tell them the error code and do not use the scanner Temperature increases Operate the scanner in a cooler location If the error cannot be corrected contact service and tell them the error code 64 79 476 D3607 80 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Errors Cause of error Corrective action 2002 2010 2011 2020 2021 Defective power supply unit Extraneous light Extraneous light during self test initiation Mechanical error Mechanical error Switch the scanner off wait 3 4 seconds and then switch it back on If the error cannot be corrected contact service tell them the error code and turn off the scanner Check whether items are preventing the slide door from closing Switch the scanner off wait 3 4 seconds and then switch it back on If the error cannot be corrected contact service tell them the error code and turn off the scanner Check whether items are preventing the slide door from closing Switch the scanner off wait 3 4 seconds and then switch it back on If the error cannot be corrected contact service tell them the error code and turn off the scanner Switch the scanner off wait 3 4 seconds and then switch it back on If the collection tray has been removed the position of the clamping jaws
8. 01 02 04 2015 Entsorgung elektrischer und elektronischer Ger te aus Optik uad Medizin 64 79 476 D3607 D3607 201 01 01 02 04 2015 Dismantling and disposal Disposal Your product is marked with the adjacent symbol Within the European Economic Area this product is subject to Directive 2002 96 EC as well as the corresponding national laws This directive requires environmentally sound recycling disposal of the product The product must not be disposed of as domestic refuse Please observe the disposal regulations applicable in your country Disposal procedure Please note that this product is subject to the stipulations in EC Directive 2002 96 governing waste electrical and electronic equipment and must be disposed of in line with these special requirements within the European Union EU Prior to disassembly disposal of the product it must be fully prepared cleaned disinfected sterilized When disposing of equipment permanently please proceed as follows In Germany To initiate return of the electrical device please send a disposal order to enretec GmbH 1 You can find a form for placing a disposal order on the company s homepage www enretec de under the menu item Entsorgung elektrischer und elektronischer Ger te Disposal of electric and electronic devices The form can either be downloaded or completed online 2 Fill out the form with the corresponding details and send it as an online order o
9. 01 02 04 2015 Sirona Dental Systems GmbH 7 Settings Operating Instructions and Installation Instructions XIOS Scan 7 3 Changing display brightness 4 Complete the process by pressing the Cancel button You can now adjust further settings gt To leave the settings dialog press the Cancel button once more The scanner is once again ready to accept the order Changing display brightness 1 Press the Display brightness key The Display brightness dialog window is displayed XIOS Scan 2 Press the Increase or Decrease key to change the brightness 3 Confirm the settings by pressing the Confirm button Complete the process by pressing the Cancel button You can now adjust further settings To leave the settings dialog press the Cancel button once more The scanner is once again ready to accept the order eyes 64 79 476 D3607 D3607 201 01 01 02 04 2015 71 7 Settings 7 4 Changing keystroke Sirona Dental Systems GmbH Operating Instructions and Installation Instructions XIOS Scan Changing keystroke 1 Press the Button sensitivity key The Button sensitivity dialog window is displayed Sirona XIOS Scan Button sensitivity d 1 CE oe o cE 2 Press the Increase or Decrease key to change the keystroke Confirm the settings by pressing the Confirm button Complete the process by pressing the Cancel button You can now adjust further settings To lea
10. EN 60601 1 by combining it with other equipment is responsible for ensuring that the requirements of this regulation are met to their full extent for the safety of the patients the operators and the environment 64 79 476 D3607 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Radiotelephones Mobile RF communications equipment can affect electro medical equipment Therefore the use of mobile wireless phones in medical office or hospital environments must be prohibited Electrostatic discharge Protective measures Electrostatic discharge abbreviated ESD ElectroStatic Discharge Electrostatic discharge from people can damage electronic components when the components are touched Damaged components usually have to be replaced Repairs must be performed by qualified personnel Measures to protect against ESD include e Procedures to avoid electrostatic charging via air conditioning air humidification conductive floor coverings non synthetic clothing e discharging the electrostatic charges from your own body through contact with ametallic unit casing alarger metallic object any other metal part grounded with the protective earth Endangered regions are indicated on the unit by the ESD warning label We recommend that all persons working with this system are made aware of the significance of the ESD warning label A training course should also be held to inform use
11. Network installation IP Address 192 168 15 245 Gain 71 IP Gateway 92 168 15 24 Resolution 43776 Subnet Mask 255 255 255 0 FPGA Version 1 0 4 1 Port 6668 Firmware Version 1 1 0 0 Default Plate Size 2 Hardware Info 0001 Serial Number 741 0102 Status Scan Number Transfer screen number 5 Language de The data entered are transferred automatically During the data transfer a status dialog window is displayed Once all the data has been transmitted the status dialog window closes automatically and a confirmation dialog is displayed 10 Click the OA button in the confirmation dialog that appears 11 Click the OK button to close SixABCon The Maintenance message appears on the scanner display The scanner reboots 64 79 476 D3607 D3607 201 01 01 02 04 2015 45 46 Connecting the PC to a network 1 Disconnect the LAN cable from the PC and connect it to the network via hub switch 2 Connect the PC to the network 3 Reassign the PC to the original IP address The scanner configuration is complete IMPORTANT Each time the configuration is modified carry out a functional check of the scanner To do so scan in an imaging plate that has not been exposed with a patient acquisition See Reading imaging plates and sending them to SIDEXIS gt 54 The scan process must execute without errors IMPORTANT Reset the scanner to the default network configuration gt Pres
12. a matching connecting cable can be connected to the power supply instead of an adapter IMPORTANT Changing tight fitting adapters gt Note that the correct country specific adapter is connected gt Itis possible to change the adapter by strongly pressing down the locking mechanism 64 79 476 D3607 D3607 201 01 01 02 04 2015 31 4 Installation and startup Sirona Dental Systems GmbH 4 4 Electrical connection Operating Instructions and Installation Instructions XIOS Scan Electrical connection 1 Remove the cover on the back of the scanner 2 Route the cable of the power supply unit through the cable routing clip provided NOTICE Ensure that all cables are routed without kinks 3 Plug the power supply unit into the socket of the scanner 4 Plug the power supply unit into the outlet 64 79 476 D3607 32 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Fitting a second protective ground conductor on the PC Depending on whether the PC is operated inside or outside of the patient environment up to 1 5 m around the patient an additional protective ground conductor must be provided on the PC housing Leakage currents from the PC are transmitted to the scanner If a PC is not sufficiently grounded there is a risk of electric shock for both the patient and the user gt gt The PC must be connected to a grounded electric outlet when in operation An
13. assume any liability for resulting damage We suggest that you request a certificate showing the nature and extent of the work performed from those who carry out such work and specify that the certificate show any changes in rated parameters or working ranges as well as the date the name of the firm and a signature Normal use XIOS Scan allows the creation of digital intraoral X ray scans generated by way of exposed imaging plates 64 79 476 D3607 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Indications and contraindications The XIOS Scan System consists of the following components The XIOS Scan System consists of the following components e Scanner e Power supply e Imaging plates various sizes e Accessories e SIDEXIS Plugin for XIOS Scan This system when combined with an intraoral X ray tube assembly is used to create digital intraoral X ray scans To do so imaging plates of different sizes depending on the indication are positioned in the patient s mouth and exposed with an intraoral X ray device The plate is removed from the mouth and placed in the scanner while maintaining the hygienic measures This reads the X ray information from the imaging plate and sends it to a computer via a LAN connection On the computer the image data is processed using image processing algorithms and displayed on a monitor in the SIDEXIS image processing software After the data is transmitted the i
14. e Never touch the patient and an open plug connection of the scanner at the same time Mechanical safety Mechanical safety precautions S When the slide is retracted this prevents the operator from coming into contact with moving parts Never touch the lid during operation Never tamper with the safety sensors of the lid Do not insert the imaging plates in the slide or remove them from the scanner by force Protection against laser radiation Laser Safety The laser is not accessible during normal operation Allow the scanner to be opened only by trained personnel for performing maintenance work Eye Injury due to Laser Radiation The scanner is classified as laser class 1 casing and optics in front of the laser beam Do not stare directly into the laser beam If the laser beam is incident directly on the eye eyesight may be damaged Never open the lid in front of the slide during scanning Instructions for service personnel If the scanner is opened and disassembled for maintenance laser beams of class 3B are accessible Take appropriate precautions Do not stare directly into the laser beam During maintenance no persons other than the customer service engineer are allowed to stay in the room Wear safety glasses all the time The imaging plates are scanned and read by laser The laser is located in the housing and is not visible during normal operation The casing may only be opened by authorized personne
15. environment 8 KV air discharge 8 KV air discharge Electrical fast transient burst according to IEC 61000 4 4 1kV for input and output lines 1 kV for input and output lines 2 kV for power supply lines 2 kV for power supply lines Surge voltages according to IEC 61000 dA eERGAOGE KD conmon eae should be that of a typical 4 5 commercial or hospital environment 1 kV differential mode 1 kV differential mode The quality of the line power supply Voltage dips short interruptions and variations of the power supply according to IEC 61000 4 11 Magnetic field of power frequencies 50 60 Hz according to IEC 61000 4 8 voltage lt 5 U7 for period gt 95 dip of Uy 40 U7 for 5 periods 60 dip of U7 70 U for 25 periods 30 dip of U7 lt 5 Us for 5sec gt 95 dip of Uy voltage lt 5 U7 for period gt 95 dip of Uy 40 U for 5 periods 60 dip of Ur 70 U for 25 periods 30 dip of U7 lt 5 U for 5sec gt 95 dip of Uy Note Uz is the AC supply voltage prior to application of the test level 90 The quality of the line power supply should be that of a typical commercial or hospital environment If the user of the UNIT requires it to continue functioning following interruptions of the power supply it is recommended to have the UNIT powered by an uninterruptible power supply or a battery Power frequency magnetic fields sho
16. on the OA button The scanner is once again ready to accept exposures Switch off the scanner NOTICE Do not turn off the scanner during the scan process Turning off the scanner will cancel the scan process SIDEXIS may show an incomplete scan on the PC The imaging plate may become unusable J All scan processes have been finished J There is no imaging plate in the scanner The slide is retracted gt Press the power switch on the back of the scanner 64 79 476 D3607 62 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 6 Cleaning and care by the dental assistants Operating Instructions and Installation Instructions XIOS Scan 6 1 Care cleaning and disinfecting agents 64 79 476 D3607 D3607 201 01 01 02 04 2015 Cleaning and care by the dental assistants Care cleaning and disinfecting agents NOTICE Approved care cleaning and disinfecting agents Use only care cleaning and disinfecting agents approved by Sirona For a continuously updated list of approved agents please visit www sirona com To access the online portal for technical documentation follow the SERVICE I Technical Documentation menu items in the navigation bar The portal can also be accessed directly via the following address http www sirona com manuals Click on the menu item General documents and then open the Care cleaning and disinfection agents document If you do not have any acces
17. 1 02 04 2015 19 Shadows or stripes on the Imaging plate exposed to light before itis Do not handle imaging plate without X ray image read hygiene protection cover Keep imaging plate in hygiene protection cover Quickly place the imaging plate on the scanner slide Darken the room Place the scanner such that no direct light falls on the input unit Imaging plate pre exposed e g by natural When the imaging plate was stored for radiation or scattered X ray radiation more than a week erase it again before use Dirty or scratched imaging plate Clean the imaging plate see Disinfection and cleaning 39 Replace scratched imaging plate Radiograph shows Imaging plate pre exposed e g by natural When the imaging plate was stored for stripes radiation or scattered X ray radiation more than a week erase it again before Parts of the imaging plate were exposed to Do not keep exposed imaging plates under light when handling bright light Read image data within half an hour after exposure Dirty or scratched imaging plate Clean imaging plate see Disinfection and cleaning gt 63 Replace scratched imaging plate X ray image with small Micro scratches on the imaging plate Replace the imaging plate bright lines and spots Dirty or scratched imaging plate Replace scratched imaging plate Error Messages Errors Cause of error Corrective action Line error Attention The X ray image 1030 may be missing lines This may
18. 239 Data and SuUpply cables roenan a E a 21 0 A EY 2 G2 1 Sk SONO aaa E E E eee 22 Se CONSUIMADICS aeran a a A e a otennd peas eee keeeneeaabenal 23 S6 lt SCODE Of delve nensis a e dive ah a Ea aE 24 of Tecnnicaldala nsan Meee nee eee ata Rea 25 IAN SCIE aenda OR n scandens teeseeateeets 25 Sela Mado Pial O an N N 26 3 7 3 Operating and transport conditions ensonnennonnonnennsrrnrsrrerrereen 26 29 Cenficalohs aranana a a a a 27 39 SYMDOS masea T E EA 27 Hstalation and StanUD en 29 4 1 TRANSDON and PACKAGING sissien beast ecedccwsteaest tiated eaeacede et 29 A 2 Fe 6 ene ee ae OT Re ea een OTE ee ee 29 AS FUN MMS CONCCIONMNAY heii ieuiatt cree ae deat aa eee erties 30 4 4 Electrical CONNECTION cns A A A A 30 4 5 Fitting a second protective ground conductor on the PC cceceseeeeeeees 33 AO Network INSTAIAUON sanane a 36 4 6 1 System description for the system administrator ccccceeeee 36 4 6 2 Analysis and evaluation ccccccccccecceccsseceeeceeceeeseeeseeteeeseeteeeeeees 36 Oo ASAT a T a a a a 37 4 6 4 Configuring the scanner aeea a a 38 4 6 4 1 Configuring the scanner with a direct connection toa PC 38 4 6 4 2 Configuring the scanner when connected to a network 41 A OU aaa a A aaalene 46 4 7 1 Setting the X ray device cece cceccceeeceeeeceeeesaeeeeeeeseeesseeeseeeeseeeeas 46 4 7 2 Perform acceptance test during COMMISSIONING 00c
19. 3607 201 01 01 02 04 2015 23 3 System description Sirona Dental Systems GmbH 3 6 Scope of delivery Operating Instructions and Installation Instructions XIOS Scan Scope of delivery IMPORTANT Ordering spare parts and accessories For the required order numbers refer to the chapter Spare parts and consumables gt 86 Check whether the packaging is intact at delivery e Check the delivery for completeness e Dispose of packaging in an environment friendly manner The delivery contents include e Scanner e Collection tray e Power supply unit e LAN cable with ferrite e SIDEXIS Plugin for XIOS Scan e Imaging plates size 0 1x 2 pcs e Imaging plates size 2 2x 2 pcs e Bite guard size 0 1x 100 pcs e Bite guard size 2 1x 100 pcs e Hygienic protective sleeves size O 1x 100 pcs e Hygienic protective sleeves size 2 1x 100 pcs e Transport case with mat e Technical documentation 64 79 476 D3607 24 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Technical data Scanner General data Dimensions L x W x H 363 x 163 x 286 weigh Heat dissipation Self heating about 35 C At ambient temperature 25 C Pixel size Pixel size user selectable ym 23 or 230r 30 Gaela a pairs mm 17 or oe LP mm See the Operator s Manual SIDEXIS Plugin for XIOS Scan for instructions on changing the resolution and pixel size Electrical data of the scanner P
20. IMPORTANT Get the installation and configuration performed only by personnel trained and certified by Sirona or our Customer Service Ambient conditions IMPORTANT Place the scanner on a vibration free surface to avoid errors when scanning the image data Place the scanner in a shaded place To this end refer to Protection from sunlight gt 15 The light intensity should be no more than 1000 Lux in the following situations Unpacking the imaging plates Placing the imaging plate in the scanner The scanner and the power supply unit must be set up within the patient environment Additional setup criteria apply for the PC see Fitting a second protective ground conductor on the PC gt 33 Place the scanner in a dry well ventilated area The installation room must be at room temperature Do not expose the scanner to direct sunlight Do not place the scanner in the direct vicinity of devices with large electromagnetic interference fields See also Working clearances gt 92 Place the scanner only on a stable level and vibration free surface Do not install the scanner in rooms that are exposed to volatile gases or vapors 29 4 Installation and startup Sirona Dental Systems GmbH 4 3 Fitting the collection tray Operating Instructions and Installation Instructions XIOS Scan e Do not install the scanner if you are in doubt about its operation or state Get the operating safety previously con
21. New as of 04 2015 irona The Dental Company XIOS Scan Operating Instructions and Installation Instructions Table of Contents 1 SSMS Kal TATONMIAU OM essien N EE 1 1 ISGP ITORMIAUOU yaccccidsctcisssie vs rece iads ances de Scudencacdur oniedaskausieseeoendaeteues ears 1 2 General information about this operating manual ccccecceseeeeeeeeeee ees 1 3 General conventions and structure of the document ccccseeseeeeeeeees 1 3 1 Structure of the COCUMENS cecccceccesecceseeceeeeeeeeeeeeseseeseeeseaeees 1 3 1 1 Identification of danger levelS ccccccceeceseeeeeeeeseeeeeees 1 3 1 2 Designation of hazard symbols cccecceececeeeeee scene es 1 3 1 3 Formats and symbols used ccccceceeeeeeeeeeeeeeeeeaeeees 1 3 2 Notes to the repository ccccccccecccsceceeeceecseeseeeseeeseeeseeesseeseeess 1 4 Scope of this operating MANUAl ccccccecccecceeeeceeceeteeeeeeeeeseeeseessneeees Tto Otherfelevant documents oniri r a tO Waraniy and aDility siera e ae a ke NOMI US Eie ee tanelanlide Meee daas eee daigt ean ee 1 8 Indications ANd contraindications cece eecccecceeeeceeeaeeeseeeseeeseeeseeeseeeaneeaes 1 9 Qualifications of Operating personnel ccccccecceceseeeceeeceeeeeeseeeseeeeeeenes IO ACOMACEIMIOFMAUOR anuer ra Gaaemaweianenenion 2 Safety IRSMUCHONS arcs a a a a extant 2 1 General safety INTOrMaAUON sesss
22. Note 1 The higher frequency range applies at 80 MHz and 800 MHz Note 2 These guidelines may not apply in all cases The propagation of electromagnetic waves is influenced by their absorption and reflection by buildings objects and persons Data sizes uncompressed The data size depends on the imaging plate format and the pixel size The sizes stated are rounded approximate values Theoretical Resolution 22 LP mm 17 LP mm Pixel size um 23 um 29 um High image quality High scan speed For instructions on changing the resolution and pixel size see the Operator Manual SIDEXIS Plugin for XIOS Scan 64 79 476 D3607 92 D3607 201 01 01 02 04 2015 We reserve the right to make any alterations which may be required due to technical improvements Sirona Dental Systems GmbH 2015 Sprache englisch Printed in Germany D3607 201 01 01 02 04 2015 A Nr 000 000 R Sirona Dental Systems GmbH in the USA Fabrikstra e 31 Sirona Dental Systems LLC Order No 64 79 476 D3607 D 64625 Bensheim 4835 Sirona Drive Suite 100 Germany Charlotte NC 28273 www sirona com USA
23. PC software which are detailed in other documents Instructions and warning and safety information provided in the following documents must be taken into account e Installation Instructions SIDEXIS REF 64 47 200 e User Manual SIDEXIS REF 64 47 028 e User Manual SIDEXIS plug in for XIOS Scan REF 64 83 171 e Operator Manual for imaging plate REF 64 79 583 Keep these documents handy at all times file them in the X ray System Logbook in the FR of Germany The system installer must complete the enclosed declaration of conformity Warranty and liability In the interest of the safety and health of patients users and other persons inspection and preventive maintenance must be performed at scheduled intervals to ensure the operational reliability and functional safety of your product IEC 60601 1 DIN EN 60601 1 etc The system owner must ensure that all inspections and maintenance events take place As manufacturers of medical electrical equipment we can assume responsibility for the safety properties of the system only if maintenance and repair work on the system is performed by ourselves or by agencies expressly authorized by us and if components affecting safe operation of the system are replaced by original spare parts in case of failure If the system owner fails to fulfill the obligation to have inspections and maintenance work performed or ignores error messages Sirona Dental Systems GmbH and its authorized dealers cannot
24. PORTANT Each time the configuration is modified carry out a functional check of the scanner To do so scan in an imaging plate that has not been exposed with a patient acquisition See Reading imaging plates and sending them to SIDEXIS gt 54 The scan process must execute without errors 64 79 476 D3607 40 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 4 Installation and startup Operating Instructions and Installation Instructions XIOS Scan 4 6 Network installation Configuring the scanner when connected to a network Connecting the scanner to a PC IMPORTANT The SIDEXIS plugin for XIOS Scan is installed See the Operator s Manual SIDEXIS Plugin for XIOS Scan for installation instructions 1 Read the IP address of your practice network using the system options Note the IP address 2 Prepare the scanner for operation in your practice network by assigning the IP address of the scanner to the PC IMPORTANT Reading the IP address of the scanner gt In order to read the default IP address of the scanner turn the scanner on and hold the function button i down for 3 seconds The IP address of the scanner is shown on the display of the scanner 3 Start SIXABCon using the SIDEXIS Manager 4 If several X ray components are listed in SiXABCon mark the scanner that is to be configured 5 Select the Aftributes tab 6 Click on the Configure button 7 Enter the service
25. The display E shows different information e g the status of the scanner or patient data The display is not a touchscreen The scanner is controlled using the control buttons D beneath the display The functions that can be performed by pressing the keys depending on the operating screen are displayed on the display directly above the keys As soon as the scan process Is complete the imaging plate is ejected and falls into the collection tray B Multiple imaging plates can be caught in the collection tray The imaging plate is transported to the scanner via the slide C The slide extends to allow the user to insert and eject the imaging plates There is a lid in front of the slide to protect the slide The lid opens and closes automatically 64 79 476 D3607 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Data and supply cables LAN cable with ferrite Only connect the scanner to the network using the LAN cable with ferrite provided Power supply unit With the power supply unit the scanner is plugged into an outlet and supplied with power The adapters provided can be used to adjust the power supply unit to the country specific voltage values and connection systems 21 3 System description 3 4 Accessories Sirona Dental Systems GmbH 22 Operating Instructions and Installation Instructions XIOS Scan Accessories Imaging plate The imaging plate is used as a med
26. XIOS Scan bite 100 pc 6490572 guard size 0 XIOS Scan bite 100 pc 6490580 guard size 1 XIOS Scan bite 100 pc 6490598 guard size 2 XIOS Scan bite 100 pc 6490606 guard size 3 87 12 Spare parts and consumables Sirona Dental Systems GmbH Operating Instructions and Installation Instructions XIOS Scan Spare parts Designation Lot size Purchase order number XIOS Scan clamping 1 pc 6531300 mechanism kit XIOS Scan collection 1 pc 6531268 tray XIOS Scan collection 1 pc 6531276 tray support XIOS Scan cover for 1 pc 6531243 connector compartment XIOS Scan erasing 1 pc 6531342 lamp XIOS Scan rear casing 1 pc 6531250 section 64 79 476 D3607 88 D3607 201 01 01 02 04 2015 Appendix Electromagnetic compatibility XIOS Scan complies with the requirements for electromagnetic compatibility EMC according to IEC 60601 1 2 XIOS Scan is hereinafter referred to as UNIT Observance of the following information is necessary to ensure safe operation regarding EMC aspects Accessories Designation of the interface cable Ethernet cable 2 m with ferrite The UNIT may be operated only with accessories and spare parts approved by Sirona Unapproved accessories and spare parts may lead to an increased emission or to a reduced immunity to interference The unit should not be operated in the immediate vicinity of other devices If this proves to be unavoidable the unit should be monitore
27. a Sirona Log XIOSScan20150506 Backup Directory Scanner Initialize scanner with English Demo Mode Use Blank Plates only Scanner firmware update Alive telegram pause p Cancel 7 Enter the IP address the subnet mas k and the port of the scanner in the service dialog as shown on the display 8 For initial installation Place a check mark in the checkbox Initialize scanner with English 9 Inthe service dialog click the OAK button 64 79 476 D3607 D3607 201 01 01 02 04 2015 39 4 Installation and startup Sirona Dental Systems GmbH 4 6 Network installation Operating Instructions and Installation Instructions XIOS Scan IP Address 192 168 15 245 Gain 171 IP Gateway 192 168 115 245 Resolution 43776 Subnet Mask 255 255 255 0 FPGA Version 1 0 4 1 Port 6668 Firmware Version 1 1 0 0 Default Plate Size 2 Hardware Info 0001 Serial Number 741 0102 Status Scan Number Transfer screen number 5 Language de The data entered are transferred automatically During the data transfer a status dialog window is displayed Once all the data has been transmitted the status dialog window closes automatically and a confirmation dialog is displayed 10 Click the OK button in the confirmation dialog that appears 11 Click the OK button to close SiXABCon The Maintenance message appears on the scanner display The scanner reboots The scanner configuration is complete IM
28. ature e Protect them against dust and moisture e Do not expose them to direct sunlight Risk of contamination and spreading of illness The hygienic protective sleeves are single use items gt Use anew hygienic protective sleeve for each exposure 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation Operating Instructions and Installation Instructions XIOS Scan 5 2 Preparing the imaging plate for an exposure Push the imaging plate with bite guard into the hygienic protective sleeve 1 Select the correct sized bite guard for the imaging plate 2 Push the imaging plate over the bite guard 3 Select the correct sized hygienic protective sleeve for the imaging plate Insert the imaging plate with bite guard into the hygienic protective sleeve 4 Remove the adhesive strip from the strap 5 Close the hygienic protective sleeve by pressing the straps together 64 79 476 D3607 D3607 201 01 01 02 04 2015 49 5 Operation Sirona Dental Systems GmbH 5 2 Preparing the imaging plate for an exposure Operating Instructions and Installation Instructions XIOS Scan 6 We recommend keeping the imaging plate in the bite guard and hygienic protective sleeve inside a suitable container until it is next used 64 79 476 D3607 50 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation Operating Instructions and Installation Instructions XIOS Scan 5 3 Positioning and exposin
29. ble lighting conditions PC system and software The data connection to the PC must be secured during the scan process Under Power Options on the control panel set the PC so that it never switches to stand by operation or goes to sleep SIDEXIS may not be terminated until the end of the scan process Before image acquisition close all programs that are not required for the operation of SIDEXIS Any programs running in the background such as media players print managers backup software etc may cause SIDEXIS to crash during the scan In cases of doubt consult your system administrator These operating instructions are based on the assumption that you are familiar with the SIDEXIS software Allocation of acquisition system to patient During routine practice the clear allocation of the acquisition system to the patient to be examined is ensured This also applies to the allocation of the X rays to the patient data stored by SIDEXIS XG 15 16 IT security Unexpected problems and risks may occur through connecting your scanner to your IT network and these may require additional analyses Measure gt Have the scanner incorporated into your IT network by the responsible system administrator They will need to implement the measures described in the Network installation gt 36 section Trouble free operation Use of this device is only permitted if it is working correctly If trouble free operation cannot be guara
30. canner are undamaged and legible 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 9 Troubleshooting and repair Operating Instructions and Installation Instructions XIOS Scan 9 1 Resend non transmitted exposures to SIDEXIS 64 79 476 D3607 D3607 201 01 01 02 04 2015 Troubleshooting and repair Resend non transmitted exposures to SIDEXIS Explanation General The X ray scans read in with the scanner are not transmitted to the database in the event of a rescue There are two different cases and procedures for this e Network fault with XIOS Scan gt 75 e Image transfer error gt 78 Network fault with XIOS Scan Explanation In case of unexpected network errors there may be problems with image transfer between the scanner and SIDEXIS In this case the system closes the connection after a while Time out settings and enters the so called Rescue state PC Connection Lost This means that the image is not lost but is kept in the RAM of the scanner by a safety mechanism until it is retrieved by SIDEXIS Loss of the X ray scan The scanner may not be switched off while in the Rescue state If the scanner is turned off despite this the images will be lost The scanner is once again ready for use after it is turned back on 15 9 Troubleshooting and repair Sirona Dental Systems GmbH 9 1 Resend non transmitted exposures to SIDEXIS Operating Instructions and Installation In
31. ceeeeeeeees 46 ODS ATOM aen a A a e E 47 5 1 CORTOS aaora a ode summit sanctaucedies 47 5 2 Preparing the imaging plate for AN exposure ccccceecceeecceeeeteeeeeeeeaeeeeees 48 5 3 Positioning and exposing imaging plates ee cccccceecceeeceeeseeeeeeeeeeeeaees 51 Doe Alining IMAGING plates wari inst ctesepaaeinntancekeiestenenhetiancietalanesnceees 51 5 3 2 Positioning imaging plates cece ccc cece eeeteeeeaeeceeeseeeeeeeeaeeeeess 52 9 9 9 JEXPOSING IMAGING Plates oei a aa AE 53 Oe Tumo onthe scanne sesa e a a tees 54 5 5 Reading imaging plates and sending them to SIDEXIS aanonnannoennnnnnnnnnnns 54 5 6 Further processing of exposures on the PC cccceccceeeceeeceeeeeeeeeeeeeeteees 60 64 79 476 D3607 D3607 201 01 01 02 04 2015 5 7 Erasing imaging plates MaNnuallly cece eecceeeeeeeeeeeee seca eeseeeteeeeeeesaeees 509 OWICMOIM NG SCANMEM etaa ds lies creed ehsnduntiasstam se eee aGolalons 6 Cleaning and care by the dental asSSistants ccccccccececeeeeeeeseeeeseeeeeeeseeeeaeees 6 1 Care Cleaning and disinfecting agents cccccecccecccseeeceeeeeeeeeeeeteeeeaeees 6 2 Disinfection and cleaning cccccccceccceeeeceeeceeeeesececeeeceeeeseuseseeeeaeeeseeeesaees 6 2 1 Cleaning and disinfecting the scanner cccceececeeeeceeeeeeeeeaeees 6 2 2 Cleaning the collection tray cccccccccccceecceeeeceeeeeeeeeeeeeseeeeseeesseeees
32. ct bears the CE mark in accordance with the provisions of the Council Directive 1993 42 EEC of June 14 1993 concerning medical devices Original language of the present document German Symbols Symbols attached to the unit and their meaning Unit with protection class II in accordance with IEC 60601 1 Please refer to manual first CE mark in accordance with Council Directive 93 42 EEC stating the manufacturer s Notified Body Year of manufacture with manufacturer s address Denotes thermally disinfectable accessories 2 3 System description 3 9 Symbols 28 Sirona Dental Systems GmbH Operating Instructions and Installation Instructions XIOS Scan Item is only approved for one off use Refers to Directive 2002 96 EC and EN 50419 Do not dispose of device with domestic waste Observe accompanying documents Alternating current Direct current PE protective ground conductor symbol grounding for protection class Only suitable for indoor applications 64 79 476 D3607 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Installation and startup Transport and packaging IMPORTANT Only trained personnel may erect install and put the system into operation The scanner weighs 7 3 kg Do not subject the scanner to strong impacts as this may damage it Check the delivery for completeness and transportation damage Empty the packaging completely Installation
33. ctions as possible on these chips This leads to structure thicknesses as low as a few ten thousandths of a millimeter Integrated circuits that are connected to wires leading externally are therefore particularly at risk from electrostatic discharge Even voltages that are imperceptible to the user can cause breakdown of the structures thus leading to a discharge current that melts the chip in the affected areas Damage to individual integrated circuits may cause malfunction or failure of the unit 64 79 476 D3607 18 D3607 201 01 01 02 04 2015 System description system design L yk E LW N wg ig o SE 180 or C z 18 SD B_ _ Collection tray Slide id iD Control keys Power supply unit with adapters Display Adapter Ready LED CN LAN cable with ferrite Ready LED Power switch rear side o CD with SIDEXIS Plugin for XIOS Scan 64 79 476 D3607 D3607 201 01 01 02 04 2015 19 3 System description Sirona Dental Systems GmbH 3 2 XIOS Scan Scanner Ready LED Display Control buttons Collection tray Slide lid 20 Operating Instructions and Installation Instructions XIOS Scan XIOS Scan Scanner The power LED F indicates the operating status of the scanner e LED is lit up The scanner is turned on and is ready for operation or is in standby mode e LED is not lit The scanner is switched off e LED flashes The scanner has an error
34. d test specimen and the description of the constancy test come with the device Results monitor In Germany a regular constancy test of the results monitor is required by the X ray Ordinance in accordance with DIN 6868 157 Sirona provides the software SIMOCON for the simple conducting of this statutory requirement You can find this software and the operating instructions that belong to it on your SIDEXIS CD under the section Tools 73 8 Maintenance Sirona Dental Systems GmbH 8 4 Annual check performed by the system owner or authorized persons Operating Instructions and Installation Instructions XIOS Scan Checking image quality Labeling 74 Annual check performed by the system owner or authorized persons The image quality should be assessed by the system owner at regular intervals at least once a year If imaging plates and scanners are used an increasing number of image post processing operations performed with the brightness or contrast control in the image processing software e g SIDEXIS is employed as an assessment criterion If these assessment criteria are regarded as given irrespective of the patient s anatomy and or possible sources of error such as patient positioning a service engineer should be called in immediately to rectify any possible system faults Observe any possible additional country specific requirements e Perform a visual check to make sure that all labels on the underside of the s
35. d to ensure that it is operating properly Electromagnetic emission The UNIT is intended for operation in the electromagnetic environment specified below The customer or user of the UNIT should make sure that it is used in such an environment Emission measurement Conformity Electromagnetic environment guidelines RF emissions according to CISPR 11 The UNIT uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The UNIT is intended for use in all facilities Harmonics Class A including residential areas and in any facilities providing electricity to buildings used for residential to IEC 61000 3 3 64 79 476 D3607 D3607 201 01 01 02 04 2015 89 Interference immunity The UNIT is intended for operation in the electromagnetic environment specified below The customer or user of the UNIT should make sure that it is used in such an environment Interference immunity IEC 60601 1 2 test Compliance level Electromagnetic environment tests level guidelines Electrostatic discharge 6 KV contact 6 KV contact Floors should be made of wood or ESD according to IEC discharge discharge concrete or finished with ceramic 61000 4 2 tiling If the floor is covered with synthetic material the relative humidity should be at least 30 The quality of the line power supply should be that of a typical commercial or hospital
36. e imaging plate packaged in the bite guard and hygienic protective sleeve must always face towards the X ray tube assembly 64 79 476 D3607 52 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Exposing imaging plates 1 Trigger the radiation to expose the imaging plates IMPORTANT Recommended dose for XIOS Scan imaging plates For exposure parameters please refer to the operating instructions supplied with the X ray tube assembly For XIOS Scan imaging plates observe the preprogrammed exposure times for films of sensitivity class 2 After the exposure remove the packaged imaging plate from the patient s mouth and rub it with a disinfectant wipe 3 Allow the disinfectant to fully take effect and dry 4 Store the exposed imaging plate still in its packaging in the transport case provided To do so insert the imaging plates from back to front in the transport case mat The imaging plate is ready for the scan process IMPORTANT In order to achieve optimal image quality read the imaging plate immediately after creating the exposure but no later than one hour after the exposure Risk of contamination gt Do not store exposed unpackaged imaging plates and non exposed packaged imaging plates in the same transport case at the same time gt Store non exposed imaging plates only in a disinfected transport case 53 5 Operation Sirona Dental Systems GmbH
37. emove the packaged imaging plates from the transport case individually 2 Gently tear open the hygiene protection cover at the perforation to remove the imaging plate with the bite guard IMPORTANT The bite guard helps protect the imaging plate from light and damage 3 Let the imaging plate slip out of the bite guard directly into the slide Make sure that the blue exposed side is facing up IMPORTANT Make sure that the correct imaging plate size has been selected before placing the imaging plate into the scanner IMPORTANT If the imaging plate is inserted with the non exposed side facing upwards the scanner will issue an error message and the imaging plate will be ejected IMPORTANT Correct alignment for imaging plate 0 Imaging plate 0 may not be placed into the slide with the short side upright gt Always place imaging plate 0 into the slide with the long side IMPORTANT Make sure that the positioning spot is positioned properly The positioning spot must be facing towards the user After the imaging plate is inserted the slide will automatically retract The panel is closed and the scan process will start 64 79 476 D3607 56 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation 5 5 Reading imaging plates and sending them to SIDEXIS Operating Instructions and Installation Instructions XIOS Scan A sand timer will show that the imaging plate is being scanned Scanni
38. firmed by a service technician e Inform the dentist about the recommendation to use only imaging slides from Sirona Show the user where the information on cleaning transport storage use and safety of the Sirona imaging plates is available Fitting the collection tray gt Attach the collection tray The collection tray is located in the accessories box Electrical connection Electric shock Only connect the scanner to a mains network with a ground conductor Electric shock For safety reasons use of multiple sockets is not permitted NOTICE Only use the original power pack gt Manufacturer GlobTek gt Model number GTM91099 6024 T34 NOTICE Only medical electrical system components can be connected to XIOS Scan Following requirements must be met for the electrical connection of the scanner e A properly installed power outlet is available in the vicinity of the scanner e The power outlet is easily accessible e Mains voltage is in accordance with the specifications on the nameplate 64 79 476 D3607 30 D3607 201 01 01 02 04 2015 4 Installation and startup 4 4 Electrical connection Sirona Dental Systems GmbH Operating Instructions and Installation Instructions XIOS Scan Connecting the adapter to the power supply 1 Remove the power supply cover cap 2 Connect the applicable country specific adapter to the power supply The locking mechanism can be heard 3 Alternatively
39. g imaging plates Positioning and exposing imaging plates Aligning imaging plates Information To aid in the alignment a letter s pos A is printed on the side of the imaging plate to be exposed The same position is marked with a spot on the side of the imaging plate not to be exposed B and on the black side of the bite guard C The same position is also marked on the X ray image with a letter s pos D gt Position the imaging plate such that the strap of the hygienic protective sleeve does not go into the patient s mouth Patient s left side lao o Upper jaw Lower jaw 2L0 AO Lower jaw anterior teeth 64 79 476 D3607 D3607 201 01 01 02 04 2015 51 5 Operation Sirona Dental Systems GmbH 5 3 Positioning and exposing imaging plates Operating Instructions and Installation Instructions XIOS Scan Positioning imaging plates 1 Take the packaged imaging plate and rub it with an ethanol based disinfectant wipe 2 Position the packaged imaging plate in the patient s mouth See Aligning imaging plates gt 51 IMPORTANT Using the bracket system Position the imaging plates with a commercially available bracket system Since the positioning of the imaging plates in the beam path of the cone strongly influences the image quality using the parallel technique with film holders is recommended for optimal positioning of the imaging plates IMPORTANT The active blue surface of th
40. he info box row contains information on the order Action box The action box displays ongoing or pending actions Icon box The icon field shows the function of keys below the display Depending on the action in progress the function of the buttons changes Keypad The scanner is controlled by pressing the buttons on the keypad IMPORTANT The display is not a touchscreen The scanner is operated solely using the keypad 47 5 Operation Sirona Dental Systems GmbH 5 2 Preparing the imaging plate for an exposure 48 Operating Instructions and Installation Instructions XIOS Scan Preparing the imaging plate for an exposure General instructions and safety instructions for working with the imaging plates e Always wear gloves when working with imaging plates e Marks on the active blue side can reduce the image quality Hold the imaging plate at the edges only e Wipe off moisture and dirt on the imaging plate gently with a dry cotton cloth e Protect the imaging plates from sunlight light from fluorescent bulbs and light from halogen lamps General instructions and safety instructions for working with the bite guard Risk of contamination and spreading of illness The bite guard is a single use item gt Use anew bite guard for each exposure General instructions and safety instructions for working with the hygienic protective sleeves e Store the hygienic protective sleeves at room temper
41. hese Operating Instructions along with other documents Please complete the online form if you would like a hard copy of a particular document We will then be happy to send you a printed copy free of charge If you reach an impasse despite having thoroughly studied the operating instructions please contact your dental depot 1 General Information Sirona Dental Systems GmbH 1 3 General conventions and structure of the document Operating Instructions and Installation Instructions XIOS Scan General conventions and structure of the document Structure of the document Identification of danger levels To prevent personal injury and material damage please observe the warning and safety information provided in this document Such information is highlighted as follows DANGER An imminent danger that could result in serious bodily injury or death A possibly dangerous situation that could result in serious bodily injury or death A possibly dangerous situation that could result in slight bodily injury NOTICE A possibly harmful situation which could lead to damage of the product or an object in its environment IMPORTANT Application instructions and other important information Tip Information on making work easier Designation of hazard symbols Failure to follow the instructions may have an adverse affect on the functions of the system Incorrect operation by the user may cause malfunctions and hazards
42. ia 92 13 2 Data sizes uncompressed ices cwes ewesdunzveedesedsuebesineddvedeevexsedveueeertiearsdeneudensee 92 64 79 476 D3607 D3607 201 01 01 02 04 2015 Observe the Operating Instructions Keep documents safe Online portal for technical documents Help 64 79 476 D3607 D3607 201 01 01 02 04 2015 General Information User information We are pleased that you have equipped your dental office with the XIOS Scan from Sirona These Operating Instructions are designed to assist you prior to initial use and whenever you require information later on We wish you much success and joy with XIOS Scan Your XIOS Scan Team General information about this operating manual Please familiarize yourself with the unit by reading through these Operating Instructions before putting it into operation It is essential that you comply with the specified warning and safety information Always keep the Operating Instructions handy in case you or another user require s information at a later point in time Save the Operating Instructions on the PC or print them out If you sell the unit make sure that the Operating Instructions are included with it either as a hard copy or on an electronic storage device so that the new owner can familiarize himself with its functions and the specified warning and safety information We have set up an online portal for the Technical Documents at http www sirona com manuals From here you can download t
43. iasieieitencitedsldccedethaietdeabotahdalnteaet be veemleeiiiwd 2 2 Protection against electric current ccc ccccccecec sees cece eeteeeseeeseeseeeseeeaaeeaes 239 Mechanical safety ccitieei cstetw ted wedi cthe nike i enk a aa 2 4 Protection against laser radiation ccceccceccceeece cece eeseeeseeeseeseeeaeeeaeeaes 29 HYJNE eoem n a T E meaner eeneeeeceat 20 Protection rom Sunlighten eavertei tae etieetaieatiealtien 2 f PC system and software ccccccccccecccseecceeeeseeeceeeseeeceueessueeseeesseeeseeeeaaees 2 8 Allocation of acquisition system to patient cc cccceececseeeeeeeeseeeeeeeeaeees 29 IT SeECUTUV sesethe ach eit een A 210 Touple iec operato eenen ar a T 2 Manea e aa A N 2 12 Changes and extensions to the device cc cece cecccececeeeeceeeeeeeeeeeeeeeeeeaeees 2 13 Combination Withother UNITS seissen a e T a ZANE COMPIaNCE mos a esaest elise etna 219 FRAGIOICICDNONCS eT N tee aee Renesas 210 JEICCIFOSTALIC CISC ANG S sx ciacaciets Monette dit a a a Suda etestdee 3 DV SECTS SCI UOM eisai vis oti needinc ate ope acta yevedginsauel ade cutentnneg esos eaen ea nadine 64 79 476 D3607 D3607 201 01 01 02 04 2015 Oo CO CO CON N N aS 8 28 ok a fea N Na O O O O OO ox oa stk OR a wees eas GSE a SS Geass ea ee SS Rs NN DODO DODO DOO A aoa fk A OOU CO 3 1 System designo a te ee E teen Shad eE AE T EEE 19 32 NOS OCEAN SCANNE esie A a tealeee 20
44. ing Properties Erase Plates The Erase plate message appears on the scanner display Sirona XIOS Scan Erase Plate Plate data Erasing Vv x 3 Press the Confirm button check mark on the scanner to confirm 64 79 476 D3607 60 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation Operating Instructions and Installation Instructions XIOS Scan 5 7 Erasing imaging plates manually The slide will move to the preset imaging plate size Imaging plate XIOS Scan size 2 is set as the default factory settings Patient Information 4 Ifthe imaging plate is not the preselected size select the size of your imaging plate using the arrow buttons and confirm this with the check mark button The slide will move to the selected imaging plate size The XIOS Scan selected imaging plate size will be shown in blue on the scanner s display Patient Information SET X 5 Insert the imaging plate to be erased in the extended slide The scanner will start the erase process and the image data on the imaging plates is erased You can then erase further imaging plates 64 79 476 D3607 D3607 201 01 01 02 04 2015 61 Sirona Dental Systems GmbH 5 Operation 5 8 Switch off the scanner Operating Instructions and Installation Instructions XIOS Scan 6 Finish the erase process by pressing the Cancel button on the scanner 7 Close user settings for XIOS Scan by clicking
45. ing the slide Clean the slide on a regular basis every 1 4 weeks as required IMPORTANT Always comply with the exposure time Liquids can damage the scanner Cleaning fluids must be completely evaporated SIDEXIS Manager startup for SIDEXIS 4 1 Click on the toothed wheel icon A in the header line The Gereral Setting window opens 2 Open the SIDEXIS Manager SIDEXIS Manager startup for SIDEXIS XG gt Start the SIDEXIS Manager via start gt Programs gt SIDEXIS gt SIDEXIS Manager 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 6 Cleaning and care by the dental assistants Operating Instructions and Installation Instructions XIOS Scan 6 2 Disinfection and cleaning Tray Cleaning Properties Erase Plates 64 79 476 D3607 D3607 201 01 01 02 04 2015 Calling the action Cleaning the slide 1 Click on S DEXIS Manager in the XIOS Scan Configuration 2 Click the 7ray Cleaning button in the dialog that appears The message will appear in the display Use approved cleaner only Do Not Insert Plate 3 Press the Confirm button check mark on the scanner The slide will completely retract The scanner is in cleaning mode Cleaning the slide IMPORTANT Turn off the scanner before the start of cleaning It is prohibited for any imaging plates to be located in the scanner slide during the cleaning 1 Pull off the collection tray
46. ium for exposure to X ray radiation and stores the image data The imaging plate has an active blue and an inactive printed side The imaging plate must always be exposed on the active side The image data can be erased from the imaging plate IMPORTANT IMPORTANT If the imaging plates are not used for longer than one week erase them manually before they are next used See Erasing imaging plates manually gt 60 Transport case The transport case is used to transport and store packaged imaging plates before their next use 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 3 System description Operating Instructions and Installation Instructions XIOS Scan 3 5 Consumables Risk of contamination gt Do not store exposed unpackaged imaging plates and non exposed packaged imaging plates in the same transport case at the same time gt Store non exposed imaging plates only in a disinfected transport case Consumables Bite guard The bite guard serves as additional mechanical protection for the imaging plate as well as protection against direct sunlight when inserting the imaging plate into the scanner Hygienic protective sleeves The hygienic protective sleeves protect the imaging plates against contamination and dirt from the outside environment In addition they protect the image data on the imaging plates from being erased by the ambient light 64 79 476 D3607 D
47. l e Laser beams can damage your eyesight Do not stare directly into the laser beam e Always wear safety glasses when working with the casing open e Never open the casing while scanning 64 79 476 D3607 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Hygiene Suitable hygienic measures must be taken to prevent cross contamination between patients users and other persons Before each exposure sanitary covers single use devices must be attached Single use devices are identified with the symbol shown on the left They must be disposed of immediately after use Do not use single use devices more than once The imaging plate is disinfected before each patient See operating manual for imaging plate chapter Disinfection and cleaning gt 63 Protection from sunlight The imaging plate is light sensitive Environmental requirements and measures e Do not expose the scanner to direct sunlight e Do not expose the imaging plates to sunlight light from fluorescent bulbs or light from halogen lamps when placing them in the scanner e In order to avoid bright ambient light the scanner should not be placed near windows e Work with low ambient lighting in the following situations the light intensity should be 1000 Lux maximum Unpacking the imaging plates Using the bite guard Placing the imaging plate in the scanner Tip Using the bite guard is recommended with bright or changea
48. l queries please use our online contact form at www sirona com In the navigation bar go to the menu commands CONTACT Customer Service Center and then click the CONTACT FORM FOR TECHNICAL QUESTIONS button Sirona Dental Systems GmbH Fabrikstrasse 31 64625 Bensheim Germany Phone 49 0 6251 16 0 Fax 49 0 6251 16 2591 e mail contact sirona com www sirona com 64 79 476 D3607 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Safety Instructions General safety information Read this operating manual carefully before operating the device and observe the safety instructions Observe the applicable documents listed in this operating manual Observe the local laws and regulations when operating the device The operator is responsible for the trouble free use of the device for the purpose of compliance with the regulations and guidelines The installation and commissioning may only be performed by trained or instructed personnel Repair and maintenance works which are not described in this operating manual may only be performed by trained and instructed personnel Before each use check the functional safety and proper condition of the device The device must not be operated in explosive or combustive areas e g when using flammable anesthetics skin cleansers or oxygen Protection against electric current IMPORTANT Interference immunity and interference resistance Jv g
49. maging plate is automatically erased and ejected from the scanner Thus the imaging plate becomes available again for a new exposure The underlying indications for intraoral X ray scans and thus for the use of the X ray imaging plates are determined by the dentist Sirona makes corresponding recommendations on the exposure parameters kV mA time needed for customized exposures see Exposing imaging plates gt 53 The dentist subsequently diagnoses the individual radiographs Indications in the areas e Conservative dentistry e Caries diagnosis especially of proximal lesions e Endodontics e Periodontology e Prosthodontics e Functional diagnosis and therapy of craniomandibular dysfunctions e Surgical dentistry e Implantology e Oral and maxillofacial surgery e Orthodontics Contraindications e Display of cartilage structures e Display of soft tissue 11 1 General Information Sirona Dental Systems GmbH 1 9 Qualifications of operating personnel Customer service center Manufacturer s address 12 Operating Instructions and Installation Instructions XIOS Scan Qualifications of operating personnel The system may only be operated by skilled or properly trained personnel Personnel undergoing education or training or who are using the unit as part of general training may only operate the unit under the constant supervision of an experienced person Contact information In the event of technica
50. must be checked If the error cannot be corrected contact service tell them the error code and turn off the scanner Switch the scanner off wait 3 4 seconds and then switch it back on If the error cannot be corrected contact service tell them the error code and turn off the scanner 81 82 Errors Cause of error Corrective action 2030 Mechanical error during Switch the scanner off wait 3 4 the erase process seconds and then switch it back on Please note that the imaging plate may not have been completely erased If the error cannot be corrected contact service tell them the error code and turn off the scanner Electronic error Note the error code and turn off the scanner Contact service and tell them the error code Extraordinary situations Scanner not responding If the scanner is not responding proceed as follows 1 Make sure that there is no imaging plate in the scanner 2 Switch off the scanner 3 Wait 3 4s 4 Turn the scanner back on Scanner in demo mode The scanner has a demo mode which can be activated by the service technician The demo mode is shown by the text Demo Mode on the scanner display IMPORTANT Exposures not transferred to SIDEXIS If the scanner is in demo mode a demo exposure will be displayed No imaging plates can be scanned in demo mode gt If the scanner is in demo mode contact your service technician 64 79 476 D3607 D3607 201 01
51. na Dental Systems GmbH 11 Packaging symbols Operating Instructions and Installation Instructions XIOS Scan C 4 CE Mark 0123 64 79 476 D3607 D3607 201 01 01 02 04 2015 85 12 Spare parts and consumables Sirona Dental Systems GmbH Operating Instructions and Installation Instructions XIOS Scan Spare parts and consumables Hardware Illustration Designation size ae order ee ee XIOS Scan 6492701 Scanner replacement Designation Lot size Purchase order number XIOS Scanner 1 pc 6492503 transport case XIOS Scan 1 pc 6526730 transport case mat XIOS Scan 1 pc 6492727 power supply unit with connection for UK EU Japan Australia Cat 6 LAN cable 1 pc 2m 6547421 with ferrite 64 79 476 D3607 86 D3607 201 01 01 02 04 2015 64 79 476 D3607 D3607 201 01 01 02 04 2015 Consumables Imaging plates Illustration Designation Lot size Purchase order number XIOS Scan 6479039 imaging plate size 0 XIOS Scan C 6479047 imaging plate size 1 XIOS Scan 2 pc 6479054 imaging plate size 2 XIOS Scan 2 pc 6479062 imaging plate size 3 Hygienic protective sleeves Illustration Designation Lot size Purchase order number Hygienic 100 pc 6479278 protective sleeve 0 Hygienic 100 pc 6479286 protective sleeve 1 Hygienic 100 pc 6479294 protective sleeve 2 Hygienic 100 pc 6479302 protective sleeve 3 Bite guard Illustration Designation Lot size Purchase order number
52. ng plate XIOS Scan Neutral Sharp i Smooth The scanned image will appear in the SIDEXIS Plugin for XIOS Scan on the PC monitor For further information see the Operator s Manual SIDEXIS Plugin for XIOS Scan 64 79 476 D3607 D3607 201 01 01 02 04 2015 57 5 Operation Sirona Dental Systems GmbH 5 5 Reading imaging plates and sending them to SIDEXIS Operating Instructions and Installation Instructions XIOS Scan As soon as the exposure has been scanned it is automatically erased The erase process is visible as the erasing lamp lights up above the retracted slide As soon as the exposure has been erased the imaging plate is ejected The scanner is once again ready to accept exposures Further imaging plates can be scanned 4 To scan further imaging plates repeat steps 1 4 Finishing the scan process After scanning the last imaging plate the scan process on the scanner is complete 1 Press the Cancel key The scan process is finished and the slide will retract XIOS Scan A progress bar relating to the logoff process is shown on the display of the scanner 2 Press the Stop button on the control panel of the scanner to cancel the logoff process on the scanner The patient will then remain logged on and further imaging plates can be scanned 64 79 476 D3607 58 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation Operating Instructions and Installa
53. nnecting the scanner to your IT network 2 Analyze and assess whether any potential new risks may arise for the IT system through changes to the IT network 3 Please evaluate whether security measures need to be taken for the IT network Analysis and evaluation aids e Have the minimum requirements been met NOTICE Faultless operation cannot be ensured if the minimum requirements are not met The following points must be observed when integrating the scanner into your existing IT network T network with a minimum 100 Mbit s transmission rate Free IP address e Can changes to the IT network result in problems Examples Changes to the IT network configuration Connection of additional devices Removal of devices Updates and upgrades of devices that are connected to the IT network 64 79 476 D3607 36 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 4 Installation and startup Operating Instructions and Installation Instructions XIOS Scan 4 6 Network installation Installation gna ag ay Route the LAN cable with ferrite through the cable routing clip provided The end of the cable with the ferrite core must be facing towards the scanner NOTICE Ensure that all cables are routed without kinks NOTICE Ensure that the end of the cable with the ferrite core reaches the scanner NOTICE Use only the LAN cable with ferrite provided 2 Connect the other end
54. nteed the device must be shut down checked by authorized service personnel for malfunctions and repaired if necessary Maintenance We suggest that you request a certificate showing the nature and extent of the work performed from those who carry out such work it must contain any changes in rated parameters or working ranges if applicable as well as the date the name of the company and a signature Changes and extensions to the device Modifications to this unit which might affect the safety of the system owner patients or other persons are prohibited by law For reasons of product safety this product may be operated only with original Sirona accessories or third party accessories expressly approved by Sirona The user assumes the risk of using non approved accessories If any units not approved by Sirona are connected they must comply with the applicable standards e g e Any PC which is set up within the patient environment must be approved for medical units in accordance with IEC 60601 1 e Any PC which is set up outside the patient environment may be approved for data processing units in accordance with IEC 60950 1 In case of doubt contact the manufacturer of the system components Combination with other units Permissible combinations are specified in the Declaration of Conformity by the system integrator Compliance Any person who assembles or modifies a medical electrical system complying with the standard
55. oadcast and TV broadcast cannot be predicted theoretically with accuracy A site survey is recommended to assess the electromagnetic environment due to fixed RF transmitters If the measured field strength in the location in which the UNIT is used exceeds the applicable RF compliance level above the UNIT should be observed to verify normal operation If unusual performance characteristics are observed it may be necessary to take additional measures such as reorientation or repositioning of the UNIT Over the frequency range 150kHz to 80 MHz field strengths should be less than 3 V m 91 Working clearances Recommended working clearances The UNIT is intended for operation in an electromagnetic environment between portable and mobile HF where radiated RF interference is checked The customer or the user of communication devices and the UNIT the UNIT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the UNIT depending on the maximum output power of the communication device as shown below O O O nae enak erae The recommended safety distance din meters m can be determined for transmitters whose maximum power rating is not specified in the above table using the equation that belongs to the corresponding column wherein P is the maximum power rating of the transmitter in watts W according to the transmitter manufacturer
56. of the LAN cable to the PC 3 Replace the cover 64 79 476 D3607 D3607 201 01 01 02 04 2015 37 38 Configuring the scanner IMPORTANT A scanner can be controlled by more than one PC But only one PC can be configured for a scanner Configuring the scanner with a direct connection to a PC IMPORTANT The SIDEXIS plugin for XIOS Scan is installed See the Operator s Manual SIDEXIS Plugin for XIOS Scan for installation instructions Stellen Sie eine Verbindung zwischen dem Scanner und Ihrem PC her indem Sie dem PC die IP Adresse des Scanners zuweisen IMPORTANT Reading the IP address of the scanner gt In order to read the default IP address of the scanner turn the scanner on and hold the function button i down for 3 seconds The IP address of the scanner is shown on the display of the scanner 2 Start SiXABCon using the SIDEXIS Manager 3 If several X ray components are listed in SiIXABCon mark the scanner that is to be configured 4 Select the Attributes tab 5 Click on the Configure button 6 Enter the service password when prompted The service dialog for XIOS Scan is displayed The information is shown on the display of the scanner 64 79 476 D3607 D3607 201 01 01 02 04 2015 Local Area Network Scanner IP Address Preset Change IP Address to this Address IP Adresse IP Gateway Subnet mask o Name Directory Log Directory CAProgramDat
57. oubleshooting and repair Operating Instructions and Installation Instructions XIOS Scan 9 1 Resend non transmitted exposures to SIDEXIS 64 79 476 D3607 D3607 201 01 01 02 04 2015 Scenario 2 Incorrect patient accidentally logged on or more than 15 minutes have passed since the network fault This scenario takes place in the following cases e Within 15 minutes of the network fault another patient was logged on to SIDEXIS accidentally or e Over 15 minutes have passed since the network fault occurred The X ray scan is automatically copied to a back up directory under the following path lt PDATA gt Plugins XlOScan Backup lt Computer name gt LostImage The following message is issued Untransferred image found on scanner Saved in C PDATA Plugins X1OScan Backup PCxX00125 Lostlmage 2015 02 24 18 542 t f 1 Confirm this message with OK 2 Log the correct patient into SIDEXIS 3 Import the missing X ray scans via the SIDEXIS image import function IMPORTANT Select the correct file JS The scanner will store the raw data and the image data filtered using the standard filter specified in the user settings in the backup directory gt Only select the files that have a filter description NWeutral Unionis Duae or Filter at the end of the file name Restarting the scanner prior to further use Switch the scanner off and on again for approx 5 s prior to further use T 78
58. p cctetec eet Petal a dane dies Rest eee reer 92 NOR IMCSSAQCS irate ss foes acces Sacacteceaaacceuensteee E bancesaasnas ov sathas hese cee O73 SIPAUIEY radiographs cas tics ieceieiac dete Muerte Sah OE 94 Eror Messages ssc sect costes con ccienistoiene E E 9 9 Extraordinary Situations cessor nize cpiueettware shawcnedGeanigectanenetuabetueduatiundnivbceeuunggous AQ Dismantling and OISPOS Al zsgssh eg elehcecetersd ane Yort oat ates ten a e VOGT sDISDOS al stesriectccactin lense ctcataaccecupensuacatacasaarsees a tame treet 11 PACKAGING SYIMDOIS 2 szintuctecebgecttashastesn old tonticiatendimeamtgebasaaiaths Mina aa aae 64 79 476 D3607 D3607 201 01 01 02 04 2015 60 62 63 63 63 63 64 64 66 67 67 68 69 69 70 71 72 73 73 73 73 73 74 19 19 19 19 78 78 19 80 82 83 83 84 Table of Contents Sirona Dental Systems GmbH 12 13 Operating Instructions and Installation Instructions XIOS Scan Spare parts and CONSUMADICS 2 ccc 2c5cccciaddstatoidadsusadavacasdavaiebiaastwadeieigiaddeccddetobsigadia ts 86 APPENOIX chvicd cates a ade ase aetasnnestan asic oakat aaa aan E 89 13 1 Electromagnetic Compatibility cc cccccccececeeceeeeeeeeseeeseeeeseeeeeeteeeeeeesaeees 89 Tehsil GACCCSSOMCS carae a a S 89 13 1 2 Electromagnetic emission ccccccccsseceeeceeeeeeeeeuecesecaueseeeseeeseeees 89 13 1 3 Interference imm n acr o 90 13214 Working clearance S anune pa a a a
59. password when prompted 64 79 476 D3607 D3607 201 01 01 02 04 2015 41 S Ji Inn XIOS Se Local Area Network Scanner IP Address Preset Change IP Address to this Address IP Adresse IP Gateway Subnet mask Directory Log Directory CA ProgramData Sirona Log xlOSScan 20150506 Backup Directory Tees Scanner Initialize scanner with English Demo Mode Use Blank Plates only Scanner firmware update Alive telegram pause p Cancel 8 For initial installation Place a check mark in the checkbox nitialize scanner with English 9 In the service dialog click the OK button 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 4 Installation and startup Operating Instructions and Installation Instructions XIOS Scan 4 6 Network installation IP Address 192 168 15 245 Gain 171 IP Gateway 192 168 15 245 Resolution 43776 Subnet Mask 255 255 255 0 FPGA Version 1 0 4 1 Port 6668 Firmware Version 1 1 0 0 Default Plate Size 2 Hardware Info 0001 Serial Number 741 0102 Status Scan Number Transfer screen number 5 Language de The data entered are transferred automatically During the data transfer a status dialog window is displayed Once all the data has been transmitted the status dialog window closes automatically and a confirmation dialog is displayed 10 Click the OA button in the confirmation dialog that appea
60. r fax it to enretec GmbH at 49 0 3304 3919 590 You can also get in touch with the following contacts for disposal orders and any questions relating to this you may have Phone 49 0 3304 3919 500 E mail pickup eomRECYCLING com Mailing address enretec GmbH Gesch ftsbereich eomRECYCLING Kanalstrasse 17 16727 Velten Any nonpermanently installed equipment will be picked up at its installation site in the practice Permanently installed equipment will be picked up curbside at your address by appointment All disassembly transport and packaging costs are to be borne by the owner operator of the equipment The disposal itself is free of charge Worldwide outside Germany Please contact your local dental equipment specialist for country specific information on disposal 83 11 Packaging symbols Sirona Dental Systems GmbH B a Q Q a mex Tae uy jo Ol O O 3 2 O gt y ie i K 00 N Operating Instructions and Installation Instructions XIOS Scan Packaging symbols Symbols on the packaging Take note of the following symbols on the packaging Top Protect from moisture Fragile handle with care Stack limit Temperature during storage and transport Relative humidity during storage and transport Air pressure during storage and transport Apply fork lift truck here Do not apply fork lift truck here 64 79 476 D3607 D3607 201 01 01 02 04 2015 Siro
61. rew down the protective ground conductor as shown 8 Affix the Grounding point label provided next to the protective ground conductor connection 9 Connect the protective ground conductor to a suitable equipotential bonding conductor 64 79 476 D3607 D3607 201 01 01 02 04 2015 35 4 Installation and startup Sirona Dental Systems GmbH 4 6 Network installation Operating Instructions and Installation Instructions XIOS Scan Network installation System description for the system administrator Operate the scanner only using the LAN cable with ferrite provided The IT network is required for communication between the PC software and the scanner and to transfer images from the imaging plate scanner to the acquisition PC NOTICE Potential problems when installing and operating the scanner on the network Unexpected problems and risks may occur through connecting the scanner to an IT network and these may require additional analyses Incorporating the scanner into an IT network which includes other devices may lead to previously unknown risks for patients operators or third parties gt The measures described for network installation may only be implemented by the system administrator responsible gt Please find further details in the document Installation Requirements XIOS Scan REF 65 28 140 Analysis and evaluation 1 Analyze and assess whether any potential new risks may arise for your IT system through co
62. roeciontype POO Prowcionciss Electrical data of power supply unit Model number Ls GTM91099 6024 T3A 100 240 2 1 5 24 2 2 5 50 60 Power Protection type m i IP20 Classification Medical device class Class lla Laser protection class 1 according to EN 60825 1 2007 03 A1 2002 07 A2 2001 03 20 26 Laser source Laser class according to EN 60825 1 2007 03 A1 2002 07 A2 2001 03 Dimensions of imaging plate for intraoral application Size 1 24 x 40 Size 2 31 x 41 Size 3 27 x 54 Classification Medical device class E Class lla Operating and transport conditions Scanner Relative humidity 0 90 Degree of contamination Max installation height Relative humidity 10 90 Max storage height 64 79 476 D3607 D3607 201 01 01 02 04 2015 0123 64 79 476 D3607 D3607 201 01 01 02 04 2015 Imaging plates Temperature 10 to 40 C Relative humidity 0 90 Storage and transport Temperature 40 C 70 C Relative humidity 10 90 Certification The unit among other things complies with the following standards It complies with the requirements of these regulations e IEC 60601 1 Electro Medical Devices Part 1 General Requirements for Safety e EC 60601 1 2 Medical electrical equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests This produ
63. rs 11 Click the OK button to close SiXABCon The Maintenance message appears on the scanner display The scanner reboots 64 79 476 D3607 D3607 201 01 01 02 04 2015 43 44 Jeraung nNstructions and installation Instr Changing the IP address of the scanner N p m p Start SiIXABCon using the SIDEXIS Manager If several X ray components are listed in SiXABCon mark the scanner that is to be configured Select the Attributes tab Click on the Configure button Enter the service password when prompted Change the IP address of the scanner to the IP address of your practice network asian WIV i 17 i 4 Local Area Network Scanner IP Address Preset Change IP Address to this Address IP Adresse IP Gateway Subnet mask o Port 6668 Name Scanner Directory Log Directory C ProgramData Sirona Log xlOSScan 20150506 Backup Directory Pe Scanner Initialize scanner with English Demo Mode Use Blank Plates only Scanner firmware update Alive telegram pause ll Cancel Enter the IP address the subnet mask and the port of the scanner in the service dialog Select the Change IP Address to this Address option button In the service dialog click the OK button 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 4 Installation and startup Operating Instructions and Installation Instructions XIOS Scan 4 6
64. rs about the physics of electrostatic charges 17 Physics of electrostatic charges An electrostatic discharge requires prior electrostatic charging There is a danger of electrostatic charges building up whenever two bodies rub against each other e g when e walking soles of shoes against the floor or e moving chair casters against floor The amount of charge depends on several factors The charge is e higher at low air humidity than at high air humidity and e higher with synthetic materials than with natural materials clothing floor coverings The following rule of thumb can be applied to assess the transient voltages resulting from an electrostatic discharge An electrostatic discharge is e perceptible at 3 000 V or higher e audible at 5 000 V or higher cracking crackling e visible at 10 000 V or higher arc over The transient currents resulting from these discharges have a magnitude of over 10 amps They are not hazardous for humans because they last for only several nanoseconds Tip 1 nanosecond 1 1 000 000 000 second 1 billionth of a second Voltage differentials exceeding 30 000 volts per centimeter may lead to a charge transfer electrostatic discharge lightning arc over Integrated circuits logical circuits and microprocessors are used in order to implement a wide variety of functions in a device The circuits must be miniaturized to a very high degree in order to include as many fun
65. s and hold the i button on the scanner until the network settings are displayed gt Also press the left button beneath the display not labeled The message Reset network Settings and the default network configuration are shown on the display gt In order to reset the network configuration of the scanner to the default values press the confirm button The network configuration of the scanner is reset to the default values and the scanner is restarted Startup Setting the X ray device Set the sensitivity of the x ray device to E Please refer to the manual for your intraoral X ray tube assembly for this Perform acceptance test during commissioning An acceptance test must be performed after installing the scanner An acceptance test must be completed by a service engineer from a specialist retailer in Germany Austria and Switzerland Take sample exposures on the XIOS Scan test specimen and insert the imaging plates into the scanner Follow the instructions in Chapter Reading imaging plates and sending them to SIDEXIS gt 54 64 79 476 D3607 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 5 Operation Operating Instructions and Installation Instructions XIOS Scan 5 1 Controls 64 79 476 D3607 D3607 201 01 01 02 04 2015 Operation Controls The control panel has the following structure Sirona XIOS Scan A _ C a S A mo e pon C Revpad Info box T
66. s to the Internet please contact your dental depot to order the list REF 59 70 905 Disinfection and cleaning NOTICE Damage caused by liquids Cleaning liquid must not enter the inside of the scanner Do not spray the scanner with disinfectant or cleaning solution IMPORTANT Always comply with the exposure time Liquids can damage the scanner Cleaning fluids must be completely evaporated Cleaning and disinfecting the scanner The casing of the scanner can be treated with the cleaning solutions and disinfectants recommended by Sirona 1 Remove the collection tray and clean it according to the instructions see Cleaning the collection tray gt 64 2 Gently wet the surface of the scanner with a damp cloth and rub it with a disinfectant wipe 63 We SIDEAIS Manager 64 Cleaning the collection tray Clean the collection tray every 1 4 weeks as required The collection tray and the stopper can be treated with the cleaning solutions and disinfectants recommended by Sirona IMPORTANT Always comply with the exposure time Liquids can damage the scanner The cleaning fluids must be completely evaporated before the collection tray is once again fitted to the scanner Pull the collection tray forward and out of the fastening clamp Spray the collection tray with disinfectant Leave the collection tray to dry a ae E a Fit the collection tray in the holder until it locks into place Clean
67. sed disinfectant wipe before and after placement in the patient s mouth IMPORTANT The exposure time must be adhered to The liquids must have dried up completely Cleaning and disinfecting the transport case Shell and cover of the transport case The shell and cover of the transport case can be treated with the cleaning solutions and disinfectants recommended by Sirona Transport case mat Risk of contamination The transport case mat will come into contact with packaged imaging plates which are wetted with bodily fluids gt Clean and disinfect the transport case mat on a regular basis Machine based treatment may take place with dental thermo disinfectants or automatic cleaning and disinfection systems The cleaning program must ensure a temperature of 93 C 200 F over a period of 75 minutes Fold out the mat during the cleaning as shown in the diagram 67 6 Cleaning and care by the dental assistants Sirona Dental Systems GmbH 6 2 Disinfection and cleaning Operating Instructions and Installation Instructions XIOS Scan Disinfecting imaging plates Disinfect XIOS Scan imaging plates after each application with Ethanol based cleaning solutions Clean imaging plates regularly with a soft lint free pulp or cotton cloth to remove dust and particles The imaging plate must be dry before packaging IMPORTANT To this end please refer to the operating manual for the imaging plate REF 64 79 583
68. structions XIOS Scan IMPORTANT Eliminating network fault Determine and eliminate the cause of the network fault prior to using the scanner Check whether the LAN cable is correctly connected and free from damage If required notify a member of the IT team IMPORTANT Backing up an exposure on another computer The logical connection between the scanner and the control computer will remain intact for 15 minutes after the rescue After this it will be separated Only after this can the scanner be addressed by another computer e g in the case of a failure of the control computer Scenario 1 Collecting an X ray exposure within 15 minutes of the occurrence of a network fault This scenario takes place in the following case e Within 15 minutes of the occurrence of a network fault the patient is once again logged on to SIDEXIS via the same computer with the missing exposure 1 Log the patient with the missing X ray scan into SIDEXIS 2 Go to intraoral readiness to scan The exposure dialog box opens Untransferred image found on scanner 3 Confirm this message with OK The scanner transmits the missing X ray scans 4 Close the scan dialog The missing X ray scan is transmitted to SIDEXIS Restarting the scanner prior to further use Switch the scanner off and on again for approx 5 s prior to further use 64 79 476 D3607 16 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 9 Tr
69. t The scanner complies with the applicable IEC 60601 1 2 standard for interference immunity and interference resistance The scanner is developed and tested according to the requirements of CISPR 11 Class B It may cause radio interference in its vicinity In this case radio interference must be eliminated Before commissioning and operation of the scanner study the electromagnetic environment Do not use the scanner near sources of excessive electromagnetic radiation e g unshielded radio frequency sources that are consciously in continuous operation as they may affect the device function Follow the appropriate standards and safety regulations when performing electrical work on the scanner Have electrical work done on the scanner only by appropriately trained personnel Before working on electrical components disconnect the scanner from the power supply and secure it against unintentional restart The scanner may only be connected to a properly installed power outlet Before connecting the scanner check if the mains voltage and the mains frequency of the supply mains coincide with the values specified on the scanner 13 2 Safety Instructions 2 3 Mechanical safety Sirona Dental Systems GmbH Operating Instructions and Installation Instructions XIOS Scan 14 e Before commissioning check the scanner and the electrical leads for any damage Damaged cables plugs and sockets must be replaced immediately
70. t required The PC must not then be moved closer to the patient A distance of 1 5 m should be maintained at all times 64 79 476 D3607 34 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 4 Installation and startup Operating Instructions and Installation Instructions XIOS Scan 4 5 Fitting a second protective ground conductor on the PC Variant PC located inside the patient environment If the PC is operated inside the patient environment the system integrator must fit a second protective ground conductor on the PC housing To do this proceed as follows The PC is switched off and the mains cable removed 1 Putonan ESD wrist band or discharge your body by touching an equipotential bonding conductor 2 Loosen the PC housing screws and remove a PC cover Refer to the manual for the PC 3 Finda location to connect the protective ground conductor on the rear side of the metal PC housing that is readily accessible from the inside and from the outside Drilling may damage the PC gt When drilling ensure that no part of the PC is damaged and no swarf gets inside the PC 4 Drill a suitable hole for an M4 screw at this location 5 Remove any paint around the drill hole to achieve a good metal contact 6 Fasten the M4 connecting screw to the PC casing firmly with a toothed lock washer and nut 7 Sc
71. tion Instructions XIOS Scan 5 5 Reading imaging plates and sending them to SIDEXIS Ifthe transfer of the exposures to SIDEXIS has been successful a green check mark is displayed in the SIDEXIS Plugin for XIOS Scan 3 Click on the Green check mark in the SIDEXIS Plugin for XIOS Scan to finish the scan process You can click on the green check mark while the logoff process on the scanner is still running This will accelerate the logoff process The exposures are transferred to SIDEXIS and can now be processed as normal 64 79 476 D3607 D3607 201 01 01 02 04 2015 59 5 Operation Sirona Dental Systems GmbH 5 6 Further processing of exposures on the PC Operating Instructions and Installation Instructions XIOS Scan Further processing of exposures on the PC Note the SIDEXIS Plugin Operator s Manual for XIOS Scan Erasing imaging plates manually If the imaging plates are not used for longer than one week erase them manually SIDEXIS Manager startup for SIDEXIS 4 1 Click on the toothed wheel icon A in the header line The Gereral Setting window opens 2 Open the SIDEXIS Manager SIDEXIS Manager startup for SIDEXIS XG E i gt Startthe SIDEXIS Manager via start gt Programs gt SIDEXIS gt SIDEXTS Manager SIDEXIS Manager Erasing imaging plates 1 Click on SIDEXIS Manager in the X OS Scan Configuration 2 Click the Erase Plates button in the dialog that appears Tray Clean
72. tructions and Installation Instructions XIOS Scan 5 5 Reading imaging plates and sending them to SIDEXIS Patient information XIOS Scan Dr Miller John Doe 01 01 1960 11 Dr Demo Treatment 1 SoS sirona Patient Information XIOS Scan XIOS Scan 64 79 476 D3607 D3607 201 01 01 02 04 2015 The patient information is displayed Check that the patient s information is correct and confirm the order with the control button OK check mark Press the Cancel control button X to finish the process If the order is canceled the scanner will wait for a new order assignment from SIDEXIS The slide will move to the preset imaging plate size Imaging plate size 2 is set as the default factory settings 4 Ifthe imaging plate is not the preselected size select the size of your imaging plate using the arrow buttons and confirm this with the check mark button The slide will move to the selected imaging plate size The selected imaging plate size will be shown in blue on the scanner s display NOTICE Risk of damage to the slide The slide mechanism can be damaged by pushing or pulling gt Never push or pull the slide directly IMPORTANT Do not touch the imaging plates Hold the imaging plates at the edges only Make sure that the imaging plates are inserted only in a dry and clean condition into the slide Remove moisture and dirt on the imaging plate with a dry lint free cloth 55 1 R
73. uld be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile radio equipment must not be used within the recommended working clearance from the UNIT and its cables which is calculated based on the equation suitable for the relevant transmission frequency Recommended working clearance 64 79 476 D3607 D3607 201 01 01 02 04 2015 Interference immunity IEC 60601 1 2 test tests level Conducted RF 3 Vor pane 150 kHz to 80 MHz IEC 61000 4 6 Radiated RF interference 3 V m IEC 61000 4 3 80 MHz 800 MHz 3 V m 800 MHz 2 5 GHz 64 79 476 D3607 D3607 201 01 01 02 04 2015 Compliance level O environment oui d 1 2 VP at 80 MHz 800 MHz d 2 3 vP at 800 MHz 2 5 GHz with P as the power rating of the transmitter in watts W according to the transmitter manufacturer s specifications and das recommended safety distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference is possible in the vicinity of equipment bearing the following Co The higher frequency range applies at 80 MHz and 800 MHZ graphic symbol The field strengths of fixed transmitters such as base stations of radiotelephones and mobile agricultural radio broadcast services amateur radio stations AM and FM radio br
74. ve the settings dialog press the Cancel button once more The scanner is once again ready to accept the order B lt Os EV es 64 79 476 D3607 12 D3607 201 01 01 02 04 2015 Sirona Dental Systems GmbH 8 Maintenance Operating Instructions and Installation Instructions XIOS Scan 8 1 General 64 79 476 D3607 D3607 201 01 01 02 04 2015 Maintenance General Maintenance of the unit cleaning The unit should be cleaned regularly by the user Maintenance costs for the unit The unit is entirely maintenance free Service calls Service calls are only made upon demand in an emergency Regular inspections Inspections must be performed at regular intervals to protect the health and safety of patients users and other persons e The system owner must make sure that no changes are made to the second protective ground wire connection where available e The operator must ensure that the casing and the cable are undamaged NOTICE All parts of the device are maintenance free In case of malfunctioning please always contact your specialized dealer Constancy test Checking image quality Constancy test for Germany Austria Switzerland Device Please observe the regular checks of the image quality of your X ray device e g the X ray Ordinance required by law in your territory Sirona provides you with the SIDEXIS software for the simple conducting of this constancy test and for its documentation The require
75. y Check X ray parameters FA or can hardly be Exposed imaging plate was exposed to Read the imaging plate within 30 minutes identi ied l ambient light of the exposure where possible X ray image very noisy No image data on the imaging plate Expose the imaging plate Imaging plate not exposed X ray device is faulty Inform the technician X ray image too dark or Incorrect brightness contrast settings in the Adjust the brightness of the radiograph in too bright software the software Possible technical defect with the X ray Inform the technician if there is an device the imaging plate or the scanner __ impermissible deviation For clarification In Germany Austria Switzerland Perform consistency check in accordance with ROV German x ray ordinance Outside Germany Austria Switzerland Perform consistency check in accordance with quality inspection Radiograph is a mirror Imaging plate exposed from the wrong side The Mirror function is used to correct image previously scanned exposures See the Operator s Manual SIDEXIS Plugin for XIOS Scan Note When taking a radiograph make sure that active side points to the X ray tube Insert the imaging plates into the hygienic protective sleeves correctly see Figure xy Ghosting or multiple Imaging plate exposed twice Expose imaging plate only once ee on the Insufficient erasure Defective erasing unit raaiograp Inform a service technician 64 79 476 D3607 D3607 201 01 0
76. y PC which is set up within the patient environment up to 1 5 m around the patient must be approved for medical units in accordance with IEC 60601 1 If a PC is operated within the patient environment which is not approved according to IEC 60601 1 the PC must also be equipped with a second protective ground conductor The second protective ground conductor must have a minimum cross section of 1 5 mm the cable color must be yellow green For any PC which is set up outside the patient environment approval in accordance with IEC 60950 1 is sufficient for data processing units 33 4 Installation and startup Sirona Dental Systems GmbH 4 5 Fitting a second protective ground conductor on the PC Operating Instructions and Installation Instructions XIOS Scan Definition of the patient environment in accordance with IEC 60601 1 0 gran l 592M 45005 59 kam somm e A 500mm gt ee _ Within the patient environment A direct contact is only permissible with devices or system parts that are approved for use in the patient environment A This applies to all possible patient positions B during the examination or treatment Variant PC located outside the patient environment The scanner is connected to the IT network with at least one PC PCs can be operated outside of the patient environment In this case it is enough for the PC to be grounded via the socket outlet Additional measures are no

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