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1. ooooW oom 37 5 1 Cleaning NE UN en Ea aa ea ena ab 37 5 2 USI SC UNUMI sesers teen E 37 6 Maintenance repair and disposal coooooWo WoWo cu 38 6 1 Meintengnge eR ee eee eee 38 6 2 FSAI asean anna RB Sae edad jasa ban dna ana ad 38 6 3 DISD OSA san masa Gema anaan 38 7 Symbols that appear on the Unit ooooo Woo 39 8 Technical Specifications Joo anna maa 40 op EO Time Unit an ere nce ere mre ne come reas tment a Retiree EE Mere 40 8 2 Imaging Plates ss as smg mmk ama ai eea enint 41 8 3 Main de Aa 42 IV User s manual 8201146 Introduction 1 Introduction 1 1 The OpTime User s manual 8201146 OpTime This manual describes how to operate the OpTime intraoral imaging plate unit The unit is designed to read 0 1 2 and 3 size intraoral imaging plates supplied by Soredex The unit works in conjunction with a PC in which compatible dental imaging software such as Digora for Windows 2 5 or above has been installed The OpTime can be configured to work with a single PC the Standard version or in a shared environment where the unit is accessed from different PCs the Multi Connect version Only the manufacturer s authorized personnel are allowed to install and configure the OpTime intraoral imaging plate unit OpTime Introduction 1 2 Warnings and precautions CAUTION CLASS 3B LASER RADIATION WHEN OPEN AVOID EXPOSURE TO BEAM CAUTION Use of controls or adjustments or perf
2. 3 OpTime Multi Connect version 3 1 Main parts and controls ag PCs with dental imaging software e g Digora for Windows 2 5 or above Single or Network connection via Ethernet RJ 45 cable Indicator lights Red Error Yellow Warning Green Waiting Ready Read out View of rear Power connector PC connector Hub connector 20 User s manual 8201146 3 Multi Connect Version OpTime 3 2 Indicator lights The different statuses of the indicator lights are de scribed below Stand by light on Unit is shut down OFF Press stand by key to switch unit on GREEN on Unit is reserved and ready to read an imaging plate Insert imaging plate GREEN slow flashing Unit in the waiting mode Click the Multi connect icon to reserve the unit GREEN fast flashing Unit is reading erasing an imaging plate YELLOW on Imaging software not opened or untransferred image in unit Open imaging software and retrieve the pending image if necessary YELLOW slow flashing There is no Ethernet link YELLOW fast flashing Unit carrying out its selftest User s manual 8201146 21 22 3 Multi Connect Version GREEN on YELLOW on Unit is in the Erase mode GREEN flashing YELLOW on Unit is in the Erase mode and is erasing an imaging plate GREEN on YELLOW flashing Unit is exiting the reserved mode If reguired again click the Multi connect icon to reserve the unit RED flashi
3. a a E rene sen mete 8 Preparing the image read out SySteM ooo oo 8 Preparing the imaging plate ooooocoooooooo ooooccccccci 9 Taking an exposure using the imaging plate oooooooo 10 Reading the imaging plate ooooorcooco rcoocoooooooomomoomo oo o o o 11 Retrieve AS ANS Lena bean ties vada vans Yada dees BNN Banana 15 Image quality warning MESSAGE iioooooocoWcooc oo oo Woo 16 Removing imaging plates from the plate Collector oomm 17 Shutting down the UMN a Rea aa en Basa ena anne ak aan ia 17 Erasing an Imaging Plate Lionel ms 18 3 OpTime Multi Connect Version ooWo WWW 20 Si Main parts ANG Controls serena an BK DE 20 3 2 Indicator QMS ae 2 25 nona an tees tate sess baie AAA E OEEO NA HAB 21 Sid US TNS NII e A E RnB anna 23 Preparing the image read out system Lean rne 23 Preparing the imaging Paten beam 24 Taking an exposure using the imaging plate cooocoo como oo 25 Reading the imaging plate sein Ym mn mmk 26 Retneve AS IMAGE EA 30 Image quality warning Message aan 31 User s manual 8201146 II OpTime Removing imaging plates from the plate Collector oo 31 Shutting down Ih ANA BLN AR AA 32 Eresinganlihoging Plate sms 32 4 Setup ON oa tata 35 4 1 Show Image Preview and Dental Chaft oooocooooooocooo momo 35 4 2 FSS MT I ee RN EE EEEREN EENET 35 4 3 NOS Knee E EEEE 36 5 Cleaning and disinfecting the unit
4. cover off of the imaging plate leaving the imaging plate in position WRONG 12 User s manual 8201146 2 Standard Version User s manual 8201146 OpTime After the plate cover has been removed the plate carrier with imaging plate will automatically slide into the unit and the unit door will close The GREEN light will start to flash which indicates that the imaging plate is being read CAUTION If the plate carrier does not slide into the unit after the plate cover has been removed the imaging plate is misaligned or has been placed in the unit the wrong way round Re insert the imaging plate correctly A read out progress window will appear on the PC display After a few seconds the new image will appear on the patient card CAUTION If a small round disk can be seen on the image it indicates that the imaging plate was exposed from the wrong the black side The image from an imaging plate exposed from the wrong side will be a mirror image and will have decreased image quality because the back of the imaging plate is metal and includes a metal disk If the image is not suitable for its clinical purpose another exposure should be taken IMPORTANT NOTE RETRIEVING IMAGES If an image is not transferred to the PC because of a network PC or software failure the image can be retrieved For information on how to do this see section Retrieve last image 13 OpTime 2 Standard Version 6 After the
5. door will stay open The unit is now ready to read the next imaging plate If no new imaging plate is inserted into the unit within a certain time period configured during installation the unit door will close and the unit will exit the reserved mode and enter the waiting mode A few seconds before the unit enters the waiting mode the YELLOW warning light will start to flash and the unit will start to beep User s manual 8201146 29 OpTime 3 Multi Connect Version After a few seconds the plate carrier will slide back inside the unit the door will close the YEL LOW light will go out and the GREEN light will start to flash The unit is now in the wait mode 30 Retrieve last image If the last image read is not transferred to the PC because of a network PC or software failure the image can be retrieved IMPORTANT NOTE The LAST read image can only be retrieved if the unit has been left connected to the power supply If the unit has been disconnected the image will be lost To retrieve the last image 1 YELLOW 2 Correct the problem that caused the network failure and then reopen the new or existing pa tient card The multi connect icon will be YELLOW and the tool tip will say Image pending which means that there is an untransferred image in the unit Click the Icon and the Optime Multi Connect window will appear Click the Read Pending Image button to retrieve the last read image The last read
6. icon will start to flash This indicates that you have now reserved the scanner 32 User s manual 8201146 3 Multi Connect Version OpTime 3 Press and hold down the Start key the GREEN light will flash until the YELLOW light comes on When both lights are on the unit is in the Erase mode 4 Slide the imaging plate into the plate carrier as far as it will go The back of the imaging plate the black side with the metal disk must face the plate Carrier A magnet will hold the imaging plate in position Image plate WRONG Release the imaging plate and the plate carrier will slide into the unit and the unit door will close The YELLOW light will stay on and the GREEN light will start to flash which indicates that the imaging plate is being erased User s manual 8201146 33 OpTime 34 3 Multi Connect Version After the imaging plate has been erased it will be automatically ejected from the unit into the plate collector The imaging plate can now be used to take an exposure To exit the Erasing mode either wait 15 seconds for the unit to automatically exit the mode or press and hold down the Start key until the YELLOW light goes out User s manual 8201146 4 Setup options 4 Setup options OpTime The unit has several setup options that allow you to set the image quality to your requirements To select the setup options 1 From the dental imaging software you are using sele
7. or butylalcohol or ethanol ethyl alcohol 96 to clean the unit After cleaning wipe the unit with a non abrasive cloth moistened with plain water Never use solvents or abrasive cleaners to clean the unit Never use unfamiliar or untested cleaning agents If you are not sure what the cleaning agent contains DO NOT use it If you use a Spray cleaning agent DO NOT spray it directly at the open or closed unit door 5 2 Disinfecting unit User s manual 8201146 CAUTION Wear gloves and other protective clothing when disin fecting the unit Wipe the unit with a cloth dampened with a suitable disinfectant solution such as ethanol 96 Never use abrasive corrosive or solvent disinfectants All sur faces must be dried before the unit is used WARNING Do not use any disinfecting sprays as the vapor could ignite causing injury Disinfecting techniques for both the unit and the room where the unit is used must comply with all local and national regulations and laws concerning such equip ment and its location 37 OpTime 6 Maintenance repair and disposal 6 Maintenance repair and disposal 6 1 Maintenance The unit does not reguire any regular maintenance 6 2 Repair If the unit is damaged or malfunctions in any way repairs must only by carried out by a service repre sentative authorized by the manufacturer 6 3 Disposal At the end of useful service life of the device its spare parts its replacement parts and i
8. or change the setup options See section 4 Setup options for more informa tion 4 Open the patient card where you wish to place the new image or open a new patient card 5 Press the Stand by key to switch the unit on The YELLOW stand by light will turn off and unit will carry out a selftest during which the YELLOW warning light will flash The selftest will last about 30 seconds When the plate carrier slides out of the unit door and the GREEN light comes on the unit is ready to use carrier NOTE If the GREEN light does not come on it indicates that the unit is not connected to the PC If the RED light comes on contact your dealer for advice 8 User s manual 8201146 2 Standard Version OpTime Preparing the imaging plate IMPORTANT NOTE If the imaging plate is being used for the very first time or if it has not been used within the last five days it MUST be erased See section 3 Erasing an imaging plate for information on how to do this CAUTION When handling imaging plates plate covers and protective bags always take the appropriate hygiene measures and precautions to prevent cross contami nation IDot identification code 1 Hold imaging plates by their edges and avoid Metal disk touching the surfaces of the plates Place the imaging plate you plan to use onto the Imaging plate long half of the plate cover The blue active side of the imaging plate must face the plate cover and Long Y the meta
9. radiation and take the expo sure 10 User s manual 8201146 2 Standard Version OpTime Reading the imaging plate 1 Remove the sealed protective bag from the pa tient s mouth NOTE If a risk of cross contamination exists wash disinfect and dry the protective bag before open ing it gt 2 Open the sealed protective bag Flap 3 Slide the plate cover and imaging plate out of the protective bag Keep the imaging plate in the plate cover so that you do not touch the imaging plate or allow it to be exposed to bright light Protective bag Plate cover and imaging plate 4 unit dooris closed and the GREEN light is flashing the unit is in the energy save mode Press the Start key The unit door will open the plate carrier will slide out and the GREEN light will stop flashing and remain on User s manual 8201146 11 2 Standard Version CAUTION If the GREEN and YELLOW lights are both on itindicates that the unit is in the Erase mode DO NOT attempt to read an imaging plate when the unit is in the erase mode To exit the Erase mode press and hold down the Start key until the YELLOW light goes out 5 Slide the imaging plate and plate cover into the plate carrier as far as they will go The back of the imaging plate the black side with the metal disk must face the plate carrier A magnet will hold the imaging plate in position Imaging plate and plate cover WRONG Slide the plate
10. the imaging plate Read the imaging plate as guickly as possible after it has been exposed Do not leave read or unread imaging plates in their protective bags for long periods of time When imaging plates are not being used store them in their protective box below 33 C OpTime Introduction 1 5 Cleaning Imaging Plates Ifthe Imaging Plates are handled with care they will not need to be cleaned see 1 4 Handling Imaging Plates above If the Imaging Plates are dusty the dust can be care fully wiped off using lint free cotton or a lens cleaner If there are finger prints or other marks on the active pale blue surface they can be removed by very gently wiping the surface with a lint free cloth damp ened with ethanol anhydride DO NOT rub the active surface and DO NOT use any other cleaning agents NEVER use abrasive cleaners to clean Imaging Plates 1 6 IDot identification code The IDot allows you to identify individual imaging plates It also serves as an orientation marker Active side Non active side se Al IDot identification code 4 User s manual 8201146 2 Standard Version OpTime 2 OpTime Standard version 2 1 Main parts and controls PC with dental imaging software e g Digora for Windows 2 5 or above Single or network connection via Ethernet RJ 45 cable Unit door Plate collector Control panel Stand by key Start key Indicator lights Red Error Yellow Warni
11. AL EQUIPMENT WITH RESPECT TO ELEC TRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 CAN CSA C22 2 NO 601 1 5D42 if the unit contains the UL symbol This symbol indicates that the waste of electrical and electronic eguipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your eguipment 39 OpTime 8 Technical Specifications 8 Technical Specifications 8 1 OpTime Unit Digital Optime Unit DXR 50 Classification Class 1 eguipment No applied part IEC60601 1 Continuous operation IPXO enclosed eguipment without protection against ingress of liguids EN 60825 1 A1 2002 A2 2001 Image on screen time 6 98 gt O Interface cable UTP RJ 45 Ethernet required not supplied max 2 5m Connection to the PC must meet IEC 60601 1 and or corresponding IEC harmonized national standard Operating environment 10 C 40 C 30 90 RH 700 1060 mbar Operating position Horizontal on a stable vibration free surface Storage transportation 10 C 50 C 0 90 RH 500 1080 mbar environment 40 User s manual 8201146 8 Technical Specifications OpTime 8 2 Imaging Plates Soredex imaging plates Size ISizeo Sze1 Siie2 Size3 Image size KB 64ym 1325 458 6o6e 695 Storage environment Imaging plat
12. To retrieve the last image 1 User s manual 8201146 Correct the problem that caused the network failure and then reopen the new or existing pa tient card The last scanned image should automatically be transferred If it is not from the dental imaging software your are using select Digora Optime Setup gt Scan ner page In the Retrieve Last Image field click the check box to retrieve the last read image Click OK to close the Digora Optime Setup window will close The last read image will appear on the patient card 15 OpTime 2 Standard Version Image guality warning message The following WARNING message may appear on the PC display during or after read out Degraded image guality PROBLEM Some of the read out lines on the image are not within the factory set guality limits SOLUTION If the image looks okay no action is necessary If the message appears frequently contact your dealer for assistance 16 User s manual 8201146 2 Standard Version OpTime Removing imaging plates from the plate collector 1 Slide the plate collector out of the unit and tip the imaging plates out onto a flat surface If they are not to be used again store them in the optional storage box Shutting down the unit 1 User s manual 8201146 Press and hold down the stand by key until the stand by light comes on NOTE If the unit remains in the energy save mode for several hours door close
13. User s Manual for the OpTime Standard version and the OpTime Multiconnect version Number 8201146 rev 414 0711 User s Manual for the OpTime Standard version and the OpTime Multiconnect version CE 0537 This unit is marked according to the Medical Device Directive 93 42 EEC if the unit contains the CE mark User s Manual for the OpTime Number 8201146 rev 414 0711 Original approved English language version Manufactured by SOREDEX Nahkelantie 160 Tuusula P O BOX 148 FI 04301 Tuusula Finland Tel 358 45 7882 2000 Fax 358 9 701 5261 OpTime Soredex endeavours to produce product documentation that is accurate and up to date However our policy of continual product development may result in changes to products that are not reflected in the product documentation There fore this document should not be regarded as an infallible guide to current product specifications Soredex maintains the right to make changes and alterations without prior notice II User s manual 8201146 OpTime Contents Tenan ai 1 Ia ee ee ka 1 1 2 Warnings and precautions sea en en na asia ue na 2 1 3 Positioning NE UN na AA SAN AS SN SA Geet 3 1 4 Handling Imaging Plates en 3 1 5 Cleaning IMagingP IOteSo o co Womom tas mmm aa 4 10 er Wiel ial iii tele 1 0 ags 9 0 seen Re be ere Lena 4 2 Op Time Standard Version mom Ain makanmana 5 2 1 Mainiparts and COMMONS sosisini iian 5 2 2 Ndicator ONS salaman 6 2 USMINE Ne EE
14. When handling imaging plates plate covers and protective bags always take the appropriate hygiene measures and precautions to prevent cross contami nation IDot identification code 1 Hold imaging plates by their edges and avoid Metal disk touching the surfaces of the plates f Place the imaging plate you plan to use onto the Imaging plate long half of the plate cover The blue active side of the imaging plate must face the plate cover and Long Y the metal disk on the back of the imaging plate half must be positioned near the outer edge of the plate cover Plate cover Short half 7 2 Fold the short half of the plate cover over onto the 4 2 i imaging plate Metal disk y n N ti 1 3 Slide the plate cover and imaging plate into the protective bag asfar as it will go CORRECT v i 1 Tape Imaging plate Protective bag in plate cover 24 User s manual 8201146 3 Multi Connect Version OpTime The black side of the plate cover must be against the black side of the protective bag bag 4 Remove the cover paper from the sealing tape Fold the flap over onto the sealing tape and smooth the flap from the centre out to ensure that the seal does not wrinkle Cover paper Sealing tape Flap Taking an exposure using the imaging plate 1 Place the sealed protective bag in the patient s mouth in the reguired position for the image you wish to take The back of the protective bag t
15. ct Digora Optime Setup Scanner page 4 1 Show Image Preview and Dental Chart 4 2 Resolution User s manual 8201146 If you click the Show Image Preview and Dental Chart check box to select this option an image preview window will appear after an image has been read In the preview window there are severals controls that allow you to manipulate the image and adjust the image quality before the image is saved Tooth numbers can also be assigned to the tooth teeth that appear on the image NOTE Your dental imaging software may not support this feature Refer to the documentation supplied with your dental imaging software for more information In the Image Scanning section you can select either Super or High Super gives a pixel size of 40u High a pixel size of 64y Super will give you better resolution images but you will use more memory space as the image files are larger 35 OpTime 4 Setup options 4 3 Noise filtering By default noise filtering is selected It makes the images appear smoother when they are taken at lower doses 36 User s manual 8201146 5 Cleaning and disinfecting the unit OpTime 5 Cleaning and disinfecting the unit WARNING Switch off and disconnect the unit before cleaning or disinfecting it Do not allow any liguid to enter the unit 5 1 Cleaning the unit Use anon abrasive cloth moistened with either cool or lukewarm water or soapy water or mild detergent
16. d and green light flash ing it will automatically shut down NOTE If there is an untransferred image in the unit the unit will not automatically shut down 17 OpTime 2 Standard Version Erasing an Imaging Plate 1 Press the Stand by key to switch the unit on After 60 seconds the plate carrier will slide out of the unit carrier 2 Press and hold down the Start key the GREEN light will flash until the YELLOW light comes on When both lights are on the unit is in the Erase mode 3 Slide the imaging plate into the plate carrier as far as it will go The back of the imaging plate the black side with the metal disk must face the plate Carrier A magnet will hold the imaging plate in position Image plate WRONG 18 User s manual 8201146 2 Standard Version OpTime Release the imaging plate and the plate carrier will slide into the unit and the unit door will close The YELLOW light will stay on and the GREEN light will start to flash which indicates that the imaging plate is being erased 4 After the imaging plate has been erased it will be automatically ejected from the unit into the plate collector The imaging plate can now be used to take an exposure 5 To exit the Erasing mode either wait 15 seconds for the unit to automatically exit the mode or press and hold down the Start key until the YELLOW light goes out User s manual 8201146 19 OpTime 3 Multi Connect Version
17. es must be stored in their protective box below 33 C The box must be kept closed to remain dust free Cleaning Use lint free cotton or a lens cleaner to wipe the imaging plates Use a lint free cloth dampened with ethanol anhydride to remove stains that do not come off easily Do not use any other cleaning solvents Material Europium activated barium fluorohalide Disposal Imaging plates are problem waste Return them to the manufacturer for disposal Never use damaged imaging plates Material Polyethylene S User s manual 8201146 41 8 Technical Specifications OpTime 8 3 Main dimensions 221mm 8 7in 191mm 7 5in User s manual 8201146 42
18. hat the unit has been reserved by someone else Wait until the unit is free NOTE If the multi connect icon is GRAY it indicates that the unit has not been switched on or is just starting up and is not ready for use Switch the unit on and or wait until the unit is ready for use User s manual 8201146 3 Multi Connect Version OpTime gt 4 Open the sealed protective bag Flap 5 Slide the plate cover and imaging plate out of the protective bag Keep the imaging plate in the plate cover so that you do not touch the imaging plate or allow it to be exposed to bright light Protective bag Plate cover and imaging plate 6 Slide the imaging plate and plate cover into the plate carrier as far as they will go The back of the imaging plate the black side with the metal disk must face the plate carrier A magnet will hold the imaging plate in position Imaging plate and plate cover WRONG Slide the plate cover off of the imaging plate leaving the imaging plate in position User s manual 8201146 27 OpTime 28 3 Multi Connect Version IMPORTANT NOTE If the YELLOW light starts to flash and the unit starts to beep as you are inserting the imaging plate it indicates that the reserved time has elapsed and the unit is exiting the reserved mode DO NOT continue to insert the imaging plate Reserve the unit again and then re insert the imaging plate After the cover has been removed the plate car
19. he black side must face away from the X ray source a o Te j Tt up Ie TAN RIGHT B _ rv WRONG fa Bi X ray source gt NP X ray source Na A i S kn a C a Protective bag with imaging plate 2 Select an exposure value appropriate for the exposure you are taking The unit can read im ages taken with exposure times from 0 05 to 0 63 seconds at 7 mA 3 Protect yourself from radiation and take the expo sure User s manual 8201146 25 OpTime 3 Multi Connect Version Reading the imaging plate 1 3 GREEN On GREEN Flashing YELLOW Tel GRAY SI 26 Og TN 2 Remove the sealed protective bag from the pa tient s mouth NOTE If a risk of cross contamination exists wash disinfect and dry the protective bag before open ing it Click the GREEN multi connect icon which is in the System Tray in the bottom right hand corner of the PC display to reserve the unit The Optime Multi Connect window will appear Click the Reserve the Scanner button in the Optime Multi Connect window to reserve scan ner The window will disappear and the GREEN multi connect icon will start to blink This indicates that you have now reserved the scanner Note that when the scanner is in the reserved mode the GREEN light on the unit will stop flash ing and stay on and the scanner door will open NOTE If the multi connect icon is YELLOW it indicates t
20. image will appear on the patient card User s manual 8201146 3 Multi Connect Version OpTime NOTE Check the name associated with the pending image The unit will remain reserved for the op erator who scanned but was unable to transfer the pending image Image guality warning message The following WARNING message may appear on the PC display during or after read out Degraded image guality PROBLEM Some of the read out lines on the image are not within the factory set guality limits SOLUTION If the image looks okay no action is necessary If the message appears frequently contact your dealer for assistance Removing imaging plates from the plate collector Slide the plate collector out of the unit and tip the imaging plates out onto a flat surface If they are not to be used again store them in the optional storage box User s manual 8201146 31 OpTime 3 Multi Connect Version Shutting down the unit 1 Press and hold down the stand by key until the stand by light comes on NOTE If there is an untransferred image in the unit the unit will not automatically shut down Erasing an Imaging Plate 1 From the PC click the GREEN multi connect icon in the bottom right hand corner of the PC display to reserve the unit The Optime Multi Connect window will appear 2 Click the Reserve Scanner button to reserve scanner Tj The window will disappear and the GREEN multi a PAREREA Tel connect
21. imaging plate has been read it will be erased and then automatically ejected from the unit into the plate collector After the imaging plate has been ejected the GREEN light will remain on and the unit door will stay open The unit is now ready to read the next imaging plate If no new imaging plate is inserted into the unit within a certain time period the unit door will close and the unit will enter the energy save mode Five seconds before the unit enters the energy save mode the YELLOW warning light will start to flash and the unit will start to beep After five seconds the plate carrier will slide back inside the unit the door will close the YELLOW light will go out and the GREEN light will start to flash The unit is now in the energy save mode If the Start button is pressed while the YELLOW warning light is flashing the unit will not enter the energy save mode 14 User s manual 8201146 2 Standard Version OpTime To exit the energy save mode press the Start button The plate carrier will slide out and the GREEN light will stop flashing and stay on The unit is now in the ready mode Retrieve last image If the last image read is not transferred to the PC because of a network PC or software failure the image can be retrieved IMPORTANT NOTE The LAST read image can only be retrieved if the unit has been left connected to the power supply If the unit has been disconnected the image will be lost
22. l disk on the back of the imaging plate half must be positioned near the outer edge of the plate cover Plate cover Short half 77 2 Fold the short half of the plate cover over onto the 2 Metal disk imaging plate 3 Slide the plate cover and imaging plate into the protective bag as far as it will go CORRECT WRONG WRONG WRONG Tr a i Tape Imaging plate Protective bag in plate cover User s manual 8201146 9 OpTime 2 Standard Version The black side of the plate cover must be against the black side of the protective bag 4 Remove the cover paper from the sealing tape Fold the flap over onto the sealing tape and smooth the flap from the centre out to ensure that the seal does not wrinkle Cover paper Sealing tape Flap Taking an exposure using the imaging plate 1 Place the sealed protective bag in the patient s mouth in the reguired position for the image you wish to take The back of the protective bag the black side must face away from the X ray source i 1 DD C T r Uh y UEV Xv RIGHT Li AI WRONG IKAN v A 5 X ray source gt b3 1 X ray source on O S ca Nang i eh bag with imaging plate i 2 Select an exposure value appropriate for the exposure you are taking The unit can read im ages taken with exposure times from 0 05 to 0 63 seconds at 7 mA 3 Protect yourself from
23. ng Green Ready Read out Energy save View of rear User s manual 8201146 5 OpTime 2 Standard Version 2 2 Indicator lights The different statuses of the indicator lights are de scribed below Stand by light on Unit is shut down OFF Press stand by key to switch unit on GREEN on Unit ready to read an imaging plate Insert imaging plate GREEN slow flashing Unit in the energy save mode Press the Start key to enter ready mode GREEN fast flashing Unit is reading erasing an imaging plate YELLOW on DfW not opened or untransferred image in unit Open DfW and the image will automatically appear YELLOW slow flashing There is no Ethernet link YELLOW fast flashing Unit carrying out its selftest 6 User s manual 8201146 2 Standard Version User s manual 8201146 OpTime GREEN on YELLOW on Unit is in the Erase mode GREEN flashing YELLOW on Unit is in the Erase mode and is erasing an imaging plate GREEN on YELLOW flashing Unit is entering the energy save mode RED flashing ERROR Switch the unit off and then on again If the red light comes on again contact your dealer for help OpTime 2 Standard Version 2 3 Using the unit Preparing the image read out system 1 Switch on the computer that is connected tothe unit 2 Open Digora for Windows or the dental imaging software you are using 3 If you are using the unit for the first time you may wish to check and
24. ng ERROR Switch the unit off and then on again If the red light comes on again contact your dealer for help User s manual 8201146 3 Multi Connect Version OpTime 3 3 Using the unit Preparing the image read out system 1 Switch onthe PC that is connected to the unit 2 Open Digora for Windows or the dental imaging software you are using 3 If you are using the unit for the first time you may wish to check and or change the setup options See section 4 Setup options for more informa tion 4 Open the patient card where you wish to place the new image or open a new patient card 5 Press the Stand by key to switch the unit on The YELLOW stand by light will turn off and unit will carry out a selftest during which the YELLOW warning light will flash and the unit door will open The selftest will last about 30 seconds When the unit door closes and the GREEN light starts to flash the unit is in the wait mode and is ready to be reserved NOTE If the GREEN light does not come on it indicates that the unit is not connected to the PCs If the RED light comes on contact your dealer for advice User s manual 8201146 23 OpTime 3 Multi Connect Version Preparing the imaging plate IMPORTANT NOTE If the imaging plate is being used for the very first time or if it has not been used within the last five days it MUST be erased See section 3 Erasing an imaging plate for information on how to do this CAUTION
25. onnected to this device must be in compliance with the related nationally harmonized IEC standards Equipment not suitable for use in the presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide Only use the SKYNET SNP PA59 M power supply unit that is supplied with the unit Do not use any other power supply units with the unit If this device will be used with 3rd party imaging application software not supplied by SOREDEX the 3rd party imaging application software must comply with all local laws on patient information software This includes for example the Medical Device Directive 93 42 EEC and or FDA if applicable User s manual 8201146 Introduction OpTime 1 3 Positioning the unit Do NOT position the unit so that the door is in or near very bright light Do NOT position the unit on a surface that can vi brate 1 4 Handling Imaging Plates User s manual 8201146 Handle imaging plates with care Hold them by their edges and avoid touching the active pale blue sur face Also avoid situations that could scratch the active surface For example NEVER leave imaging plates active side down on a surface Imaging Plates MUST always be used with plate covers and protective bags as described in this manual After exposing an imaging plate and removing the imaging plate and plate cover from the protective bag do NOT expose the imaging plate and plate cover to very bright light before reading
26. ormance of procedures otherthan those specified herein may result in hazardous laser radiation exposure When handling imaging plates plate covers and protective bags always take the appropriate hygiene measures and precautions to prevent cross contamination The imaging plates are harmful if swallowed Do not move or knock the unit when it is reading an imaging plate The use of control or adjustment or performance of procedures other than those specified herein may result in hazardous laser radiation exposure This unit must only be used to read SOREDEX OPTIME image plates and must not be used for any other purpose NEVER use imaging plates or protective covers from other manufacturers This unit or its accessories must not be modified altered or remanufactured in any way Only the manufacturer s authorized service personnel are authorized to carry out maintenance and repair There are no user serviceable parts inside the unit Infection control procedures must be observed when using accessories such as film holders x ray tube guides and imaging plates When using accessories always follow the manufacturer s instructions on how to use the accessory and prevent cross contamination from one patient to another This device can interfere with other devices due to its EMC characteristics Other devices can interfere with this device due to their EMC characteristics This device complies with IEC 60601 1 standard Accessory equipment c
27. rier with imaging plate will automatically slide into the unit and the unit door will close The GREEN light will start to flash which indicates that the imaging plate is being read CAUTION If the plate carrier does not slide into the unit after the plate cover has been removed the imaging plate is misaligned or has been placed in the unit the wrong way round Re insert the imaging plate correctly A read out progress window will appear on the PC display After a few seconds the new image will appear on the patient card CAUTION If a small round disk can be seen on the image it indicates that the imaging plate was exposed from the wrong the black side The image from an imaging plate exposed from the wrong side will be a mirror image and will have decreased image quality because the back of the imaging plate is metal and includes a metal disk If the image is not suitable for its clinical purpose another exposure should be taken User s manual 8201146 3 Multi Connect Version OpTime IMPORTANT NOTE RETRIEVING IMAGES Ifan image is nottransferred to the PC because of a network PC or software failure the image can be retrieved For information on how to dothis see section Retrieve last image 7 After the imaging plate has been read it will be erased and then automatically ejected from the unit into the plate collector After the imaging plate has been ejected the GREEN light will remain on and the unit
28. ts accessories make sure that you follow all local national and international regulations regarding the correct and safe disposal and or recycling of the device its spare parts its replacement parts and its accessories The device its spare parts its replacement parts and its accessories may include parts that are made of or include materials that are non environmentally friendly or hazardous These parts must be disposed of in accordance with all local national and international regulations regarding the disposal of non environmentally friendly or hazardous materials The locations of all parts that are made of or include materials that are non environmentally friendly or hazardous can be found in the device service manual and or installation manual 38 User s manual 8201146 7 Symbols that appear on the unit OpTime 7 Symbols that appear on the unit BBB Je fC O DN w N alle ken in S gt e E a User s manual 8201146 DANGEROUS VOLTAGE LASER RADIATION IMPORTANT INFORMATION Refer to user s manual Direct current Connector for single user interface cable RJ45 straight cable transmit receive swapped at PTC connector Connector for multiuser interface cable RJ45 straight cable CE 0537 Symbol MDD 93 42 EEC This unit is marked according to the Medical Device Directive 93 42 EEC if the unit contains the CE mark Standby Start UL Classification symbol MEDIC
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