User Manual.Rx Only
Contents
1. Network 100Mbps Ethernet USB 2 0 High peed Video 32 bit Color Display 3 3 2 Minimum Requirement 3 4 Installation of Acquisition and Diagnostic Software Refer to Acquisition and Diagnostic Software manual User Manual FireCR Dental TM 801 EN 3 5 Connect the Cable and Power Cord FireCR Dental supports direct connection mode for single reader with single computer and network sharing mode for multiple readers with multiple computers This manual describes direct connection mode only Network sharing mode requires additional FirelD Kit RFID reader and detailed instruction for network sharing mode is provided with FirelD Kit 3 5 1 Connecting the USB Interface Cable The reader interfaces with computer via USB2 0 cable 1 Use the supplied USB cable 2 Connect the cable to the reader s USB2 0 port located on the connection panel 3 Connect the other end of the cable to the USB2 0 port on the computer Figure 4 USB Connection DANGER This equipment is for indoor use only and all the communication wiring is limited to inside of the building WARNING Do not pull out the USB cable during scanning User Manual FireCR Dental TM 801 EN 3 5 2 Connecting the Ethernet Cable The reader interfaces with the computer via Ethernet cable RJ45 CAT 5E FTP 1 Connect the cable to the reader s Ethernet port located on the connection panel 2 Connect the other end of the cable to the Ethernet port of the Ethernet h2. 5 2 Manufacturer s Declaration Electromagnetic Immunity 37 5 8 Guidance and Manufacturer s Declaration Electromagnetic Jl 40 5 4 Laser Safety Statement sessi sees eene 41 Chapter 6 Warranty and Repair Service esseuss 42 6 1 Standard Warranty aaa 42 6 2 Repair Service aaa 42 6 3 Out of Warranty Repair Service aaa aaa 42 bA BAONG aaa tee 43 Chapter 7 Technical Assistance 2 aamaaaaaa anan 44 User Manual FireCR Dental TM 801 EN Chapter 1 Introduction Dear Customer Thank you for choosing the 3DISC Imaging FireCR Dental Reader as your new dental solution The advanced CR technology of the FireCR Dental Reader enables you to produce high quality digital images for diagnosing the patients in your facility The reader can be used as a central reader which distributes images throughout your facility or as an exam room based solution The reader is DICOM 3 0 compatible with existing systems and uses a full range of low cost reusable bitewings and intraoral imaging plates The design features a built in erase function and a color touch screen LCD panel without physical push buttons for seamless device operation Please read and follow the instructions given in this User Manual carefully prior to usin
3. including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d IMP V1 Recommended separation distance a5 r d HMW P 80 MHz to 800 MHz E1 d P 800 MHz to 2 5 GHz 11 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey a Should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people User Manual FireCR Dental TM 801 EN a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the EUT is used exceeds the applicable RF compliance level above the EUT should be obser
4. Its space requirements are shown below Allow a minimum free space of 10 cm 4 inches on the backside to allow the power switch power cord and interface cable to be reached by hand at all times Allow a minimum free space of 15 cm 6 inches on the front side for imaging plate insertion and removal dr a m m4 Front Side Backside Figure 1 Space Requirements Top View DANGER Never place the reader on the floor Install in a location that is level and stable Installation in an unsuitable location can cause accidents or deterioration in image quality User Manual FireCR Dental TM 801 EN WARNING Sliding of the reader may result in internal damage or misalignment of the optics External vibration or shock during scanning may affect image quality The reader must be placed on a rigid flat and reinforced desk or tabletop DANGER Do not place anything on top of the reader WARNING This equipment may be interfered with or may interfere with electromagnetic or other interferences Assure a distance of minimum 1 0m between reader and neighboring equipment 3 2 Identify Important Features Look over the reader and features shown in this section User will need to know where these features are when user operates the reader in later chapters 3 2 1 Header Connection Panel Power Switch Power Inlet 100Mbps Ethernet port USB 2 0 Figure 2 Reader Connection Panel User Man
5. The FireCR Dental system uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Model FireCR Dental is suitable for use in CISPR 1 1 all establishments including domestic A Harmonics emission establishments and those directly connected to ax T the public low voltage power supply network that Voltage fluctuation Complies supplies buildings used for domestic purposes reoowmoas o User Manual FireCR Dental TM 801 EN 5 2 Manufacturer s Declaration Electromagnetic Immunity The FireCR Dental system is intended for use in the electromagnetic environment specified below The customer or the user of FireCR Dental system should assure that it is used in such an environment Immunity test Compliance level Test level Environment guidance Electrostatic 6 kV Contact 6 kV Contact Floors should be wood discharge ESD 8 kV Air 8 kV Air concrete or ceramic tile If IEC 61000 4 2 floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2kV for power supply lines 2kV for power supply lines Main power quality should be Transient burst 1kV for input output lines 1KV for input output lines that of a typical commercial or IEC 61000 4 4 hospital environment Surge 1 kV differential mode 1 kV differential mode Main power quality should be
6. receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help User Manual FireCR Dental TM 801 EN Warnings and Used Symbols To ensure the safety of patients staff and other persons any changes to software and hardware delivered by 3D Imaging amp Simulations Corp may only be made with prior written permission from 3D Imaging amp Simulations Corp Please read the respective manuals of the connected software such as acquisition and diagnostic software before starting to use the system The following symbols will be used throughout this manual DANGER General prohibition indication The functionality of the system can be destroyed in the case of incorrect use If unauthorized changes have been made to delivered system and accessories the warranty by 3D Imaging amp Simulations Corp becomes void 3D Imaging amp Simulations Corp will not accept any responsibility or liability for the improper functioning of the product in such a case DANGER General mandatory action manual The functionality of the system can be destroyed in the case of incorrect use If unauthorized changes have been made to delivered system and accessories the warranty by 3D Imaging amp Simulations Corp becomes void 3D Imaging 8 Simulations Corp
7. turn the power switch off during scanning 3 5 4 Installation Report After installation of the reader fill in Installation Report from Appendix I and send to 3D Imaging amp Simulations Corp s service department by fax or e mail m Fax 82 42 931 2299 m E mail support 3DISCimaging com User Manual FireCR Dental TM 801 EN Chapter 4 Operating System Specifications Sampling Pixel Pitch Pixel Matrix Size 0 m 628 x 885 X 3 5 x 625 Pixel Matrix Size 2 Pixel Matrix Size 3 Pixel Matrix Size 4c Accepted Imaging Plate Size 0 1 2 3 4c Gray Scale Resolution 16 bit Embedded Computer Interface USB 2 0 100Mbps Ethernet 265 H x 120 W x 318 D m 10 4 H x 4 7 W x 12 5 D Vn 5 5 kg SIGA 12 1 Ibs Power PowerRequirement 1007 100 240V 50 60Hz 50 gt 60Hz File Format E E 3 0 TIFF BMP JPEG Specifications subject to change without notice Specific results may vary since operating conditions fluctuate Pixel Matrix Size 1 Dimensions User Manual FireCR Dental TM 801 EN 4 2 Operation Conditions Indoor use only Operating Temperature 15 C gt 30 C 59 F gt 86 F Temperature Gradient Relative Humidity 15 95 non condensing Storage Temperature 10 C 50 C 14 F 122 F Storage Humidity 15 95 non condensing Storage Atmospheric Pressure Transportation Temperature 10 C 50 C 14 F 122 F Transportation Hu
8. HireCh Dental User Manual Rx Only Dental Computed Radiography Reader Intended Use The FireCR Dental Imaging System is indicated for capture digitization and processing of intra oral x ray images stored on imaging plate recording media Doc No TM 801 EN Rev 1 2 1 Nov 2014 Part No CR FPM 11 001 EN 3DISC FireCR Quantor and the 3D Cube are trademarks of 3D Imaging amp Simulations Corp South Korea and its affiliates All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement The data in this publication are for illustration purposes only and do not necessarily represent standards or specifications which must be met by 3D Imaging amp Simulations Corp All information contained herein is intended for guidance purposes only and characteristics of the products and services described in this publication can be changed at any time without notice Products and services may not be available in your local area Please contact your local sales representative for availability information 3D Imaging 8 Simulations Corp strives to provide as accurate information as possible but shall not be responsible for any typographical error Copyright 2014 3D Imaging amp Simulations Corp All rights reserved 3DIS IMAGING User Manual FireCR Dental TM 801 EN Contact 3DIS IMAGING 3D Imaging amp Simulations Corp Bldg 1 48 Yuseong daero 1184 beon gil Yuseon
9. IEC 61000 4 5 2 kV common mode 2 kV common mode that of a typical commercial or hospital environment Power frequency Power frequency magnetic 50 60Hz fields should be at levels Magnetic field characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment Voltage dips short lt 5 Ur gt 95 dip in Ur 5976 Ur 595746 dip in Ur Main power quality should be Interruptions and for O 5cycle for 0 5cycle that of a typical commercial or Voltage variations hospital environment If the on power supply 40 Ur 6096 dip in Ur 40 Ur 60 dip in Ur user of the BSVD 1000 system input lines for 5 cycle for 5 cycle requires continued operation IEC 61000 4 11 during power main 70 Ur 3096 dip in UT 70 Ur 3096 dip in UT interruptions it is for 25 cycle for 25 cycle recommended that the FireCR Dental system be powered lt 5 Ur 959 dip in UT 596 Ur 9596 dip in UT from an uninterruptible power for5s for5s supply or a battery User Manual FireCR Dental Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz 150 kHz to 80 MHz Hadiated RF 3 V m 3 V m IEC 61000 4 3 80 0 MHz to 2 5 GHz 80 0 MHz to 2 5 GHz Note 1 Ur is the A C mains voltage prior to application of the test level Note 2 At 80 MHz and 800 MHz the higher frequency range applies TM 801 EN Portable and mobile RF communications equipment should be used no closer to any part of the FireCR Dental system
10. ader If the carton is dropped by the shipper there is a good chance that the device will shift within the loose pellet packing and be damaged If user needs to ship the FireCR Dental Reader to another location or back to the factory it is the user s responsibility to package the system properly before shipping If the packaging is inadequate and the system is damaged during shipping the shipper will not honor the user s claim for compensation If the user does not have a means to adequately package it additional shipping containers may be purchased from 3D Imaging amp Simulations Corp User Manual FireCR Dental TM 801 EN Chapter 7 Technical Assistance If user has any questions about installing or using the device contact your 3D Imaging amp Simulations Corp representative or your local dealer 3D Imaging amp Simulations Corp Bldg 1 48 Yuseong daero 1184 beon gil Yuseong gu Daejeon 305 345 Korea Tel 82 42 931 2100 Fax 82 42 931 2299 www 3DlSCimaging com User Manual FireCR Dental TM 801 EN Appendix Installation Report Please complete this report at the time of installation and submit the completed form signed by customer to m Fax 82 42 931 2299 E mail support 3DISCimaging com Date of Installation Customer Information Hospital Institute Installer Information Company 4 2000000000000 O Name O Fa E mail System Information FireCR Dental Reader Sys
11. adiography System and intended for use in producing digital X Ray images for dental radiography purposes t comprises of reader reusable imaging plate and workstation software It scans X Ray exposed imaging plate and produces X Ray image in digital form Then digital image is transferred to workstation for further processing and routing This device is intended to be operated in a radiological environment by qualified staff WARNING Pay particular attention to use care maintenance and infection control of Imaging Plate Chapter 4 3 User Manual FireCR Dental TM 801 EN Index of contents Chapter 1 Introduction aaa a aasa nnn nnns 9 Chapter 2 Unpacking 1ccccccccceeccnsccceeccsessnsceseessesensessssesseeseeeses 10 2 1 Inspection for Damage Lawaan nama ganapan vue xa apex XR RUF REED RS 10 2 2 Identify the Components ssesssessssesss esee nnne nnn nnns 10 Chapter 3 Setting Up 2 maana anan eene nnn 13 Dida OSO ER 13 3 2 Identify Important Features anan 14 3 2 1 Reader Connection Panel sessi 14 O22 WOUCH IDA PANG aaa de ea ee eee 15 3 9 Computer Requirements aaa 21 3 3 1 Recommended Configuration sees 21 3 3 2 Minimum Requirement esses sese 21 3 4 Installation of Acquisition and Diagnostic Software 21 3 5 Connect the Cable and Po
12. c bags should be removed after use on each patient to prevent cross contamination The hygienic bags are for single patient use only Never reuse a hygienic bag DANGER Never reuse a hygienic bag Hygienic bag is for single patient use only 4 3 1 Use Protective Cover Put protective cover on active side of imaging plate and fold tail of protective cover to backside of imaging plate Figure 7 Protective Cover Figure 7 Put protective cover on imaging plate a Back side of imaging plate b Front active side of imaging plate c Put protective cover on active side of imaging plate d Fold the tail of protective cover to opposite side of imaging plate User Manual FireCR Dental TM 801 EN 4 3 2 Use Hygienic Bag Insert prepared imaging plate with protective cover into hygienic bag Please beware of correct side of imaging plate as shown in Figure 8 d Figure 8 Hygienic Bag Figure 8 Insertion of imaging plate into hygienic bag a Blank side should face to X ray source b Insert imaging plate with hygienic bag into hygienic bag correctly c Peel off the adhesive strip and seal the hygienic bag d Prepare imaging plate for X ray exposure WARNING Active side of the imaging plate should face to blank side of the hygienic bag WARNING Active side of the imaging plate and blank side of the hygienic bag should face to X ray source User Manual FireCR Dental TM 801 EN 4 3 3 Cleaning of the T
13. e Starter Kit Veterinary Sal Contains 4 x IP size 2 and 1 x IP size 4c Size 2 IP Hygienic Bag CR FPA 15 003 Box of 100 pcs Size 4c IP Hygienic Bag option CR FPA 15 005 Box of 100 pcs User Manual FireCR Dental TM 801 EN e Optional items Size 0 Imaging Plate Kit R FP 12 012 M 2 Contains 4x IP size 0 Size 1 Imaging Plate Kit Size 2 Imaging Plate Kit Size 3 Imaging Plate Kit Size 4c Imaging Plate Kit Hygienic Bags Size 0 Hygienic Bags Size 1 Hygienic Bags Size 2 Hygienic Bags Size 2 Hygienic Bags Size 3 Hygienic Bags Size 4c Protective Cover Size 0 Protective Cover Size 1 Protective Cover Size 2 Protective Cover Size 2 Protective Cover Size 3 Protective Cover Size 4c GELO Box of 100 pcs CR FP 51 010 FirelD Kit RFID Reader mini USB cable WARNING If the FireCR Dental needs to be returned to manufacturer or one of its representatives the reader must be repacked in the original container with all accessories gt User Manual FireCR Dental TM 801 EN WARNING Use of Power Cord Type SJT or SVT min 18AWG 3 Conductor VW 1 125V min 10A or 250V 10A Max 3 0m long one end with Hospital Grade Type NEMA 5 15P for 125V or NEMA 6 15P for 250V Other end with appliance coupler CAUTION Grounding reliability can only be achieved when the equipment is connected to an equipment receptacle marked Hospital Only or Hospital Grade For connection to a supply not located in the USA make sur
14. e the power cord meets the requirements for your area WARNING Improper disposal of this product may result in environmental contamination When disposing of this equipment contact 3D Imaging amp Simulations Corp s representative or related government agencies Do not dispose of any part of this equipment without consulting a 3D Imaging amp Simulations Corp representative first 3D Imaging amp Simulations Corp does not assume any responsibility for damage resulting from disposal of this equipment without consulting 3D imaging amp Simulations Corp NOTE AC DC Adapter Manufacturer Bridge Power corp Model BPM050X24XXX This adapter meets the requirements of IEC60601 1 WARNING Use only devices meeting the requirements of IEC60950 1 or IEC60601 1 when connecting to the FireCR Dental via the USB port User Manual FireCR Dental TM 801 EN Chapter 3 Setting Up WARNING Unsuitable Installation Sites Locations with excessive humidity or dust Locations subject to high temperature Locations subject to shaking or vibration Locations exposed to considerable electrical or magnetic noise or other forms of electromagnetic energy Locations with poor heat radiation 3 1 Positioning The reader must be placed on a rigid and flat desk or tabletop with at least 5 cm 2 inches free space on both of the sides 10 cm 4 inches on rear side and 15 cm 6 inches on front side for imaging plate insertion
15. g gu Daejeon 305 345 Korea Tel 82 42 931 2100 Fax 82 42 931 2299 Website www 3DISCimaging com E mail info 3DISCimaging com 3DISC Americas 22560 Glenn Dr Suite 116 Sterling VA 20164 USA Tel 1 703 430 6080 E mail info 3DISCimaging com 3DISC Europe Gydevang 39 41 3450 Alleroed Denmark Tel 45 88 276 650 E mail info 3DISCimaging com User Manual FireCR Dental TM 801 EN The device complies with DHHS Radiation Safety Standards in effect as of the date of manufacture The device complies with Part 15 of the FCC Rules Operation is subject to the condition that this device does not cause harmful interference NOTE This equipment has been tested and found to comply with the limits for a Class B Digital Device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction may cause harmful interference to radio communication However there is no guarantee that interference will not occur in a particular installation If this equipment causes harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the
16. g the FireCR Dental Reader and keep this manual within reach for future reference The purpose of this manual is to direct you through the main functions and interfaces of the FireCR Dental Reader You will be guided through the procedures of Unpacking Setting Up and Operating the FireCR Dental Reader You can also learn about Symbols Warranty and Repair Service and Technical Assistance It is important to observe all safety information to prevent potential personal injury or material damage Please complete and submit the Installation Report Appendix 1 when installing the device User Manual FireCR Dental TM 801 EN Chapter 2 Unpacking 2 1 Inspection for Damage FireCR Dental Reader is shipped in a custom designed container to protect the reader from external shock Before unpacking the reader inspect the shipping container for damage In case the container is damaged notify the shipper immediately 2 2 Identify the Components Open the shipping container and identify each of these components e Common items CR FP 11 001 FireCR Dental Reader CR FPA 01 002 Power Adapter CR FPA 02 001 USB 2 0 Interface Cable e Medical application items Imaging Plate Starter Kit Dental SHE PICO Contains 2 x IP size O and 4 x IP size2 Size 0 IP Hygienic Bag R FPA 15 001 in Box of 100 pcs Size 2 IP Hygienic Bag CR FPA 15 003 Box of 100 pcs Veterinary application items Imaging Plat
17. lectromagnetic propagation is affected by absorption and reflection from structures objects and people Immunity and Compliance Level Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level Conducted RF 3 Vrms 150 kHz to 80 3 Vrms 150 kHz to 80 3 Vrms 150 kHz to 80 Radiated RF 3 V m 80 MHz to 2 5 3 V m 80 MHz to 2 5 3 V m 80 MHz to 2 5 User Manual FireCR Dental TM 801 EN 5 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The FireCR Dental system is intended for use in the electromagnetic environment specified below The customer or the user of FireCR Dental system should assure that it is used in such an environment IEC 60601 Electromagnetic environment Immunity test Compliance level Test level guidance Conducted RF 3 Vrms 3 Vrms FireCR Dental system must be used IEC 61000 4 6 150 kHz to 80MHz 150 kHz to 80 MHz only in a shielded location with the minimum RF shielding effectiveness and each cable should have the minimum RF shielding effectiveness Radiated RF 3 V m 3 V m Field strengths outside the shielded IEC 61000 4 3 80 0 MHz to 2 5GHz 80 0 MHz to 2 5GHz location from fixed RF transmitters as determined by an electromagnetic site survey should be less than 3V m a Interference may occur in the vicinity of equipment marked with the following symbol gt Note 1 These guidelines may not apply in all situations Electromagnetic propagation is affected b
18. m setting TM 801 EN Choose HD or SD HD High Definition SD Standard Definition System setting for Auto Sleep and Auto Trim Choosing time duration until sleep mode Choose Off or On Auto Trim Off Scan corresponding area of IP detected by the reader Auto trim on Scan whole tray area and crop the image automatically User Manual FireCR Dental TM 801 EN anguage Language Choose language Network Network setting menu Choose DHCP mode for automatic network setting DHCP setting When this setting is changed the system will restart automatically HD 2 255 255 255 255 Type in IP address manually 3 i IP Address system will restart automatically 0 pp i setting When this setting is changed the User Manual FireCR Dental TM 801 EN HD 2 255 255 255 255 Type in Subnet mask manually 3 Subnet mask system will restart automatically ia 6 22 setting When this setting is changed the 9 HD 2 255 255 255 255 p Default Type in Gateway address manually 3 3 2 yp y y Gateway 6 When this setting is changed the Setting system will restart automatically 0 d User Manual FireCR Dental TM 801 EN 3 3 Computer Requirements 3 3 1 Recommended Configuration Operation System Microsoft Windows 7 or Windows 8 32 bit or 64 bit CPU Core Duo Core2 Processor Memory RAM 4GB or more Hard Disk 300GB Free Hard Disk Space
19. midity 15 95 non condensing Transportation Atmospheric Pressure 500 1 060 hPa Installation Category Ingress of Liquids IPXO Altitude Up to 2 000m Equipment Maintenance No user maintenance is required and no user service is allowed Please contact technical support if there is a problem Cleaning Do not try to clean inside of the reader Wipe outside of the reader for dust removing with soft and dry cloth WARNING There are no user serviceable parts inside the reader The reader should only be opened and serviced by qualified service personnel Failure to heed this warning may result in injury to service personnel or damage to equipment and void any and all warranties If there is a service problem please contact 3D Imaging amp Simulations Corp or an authorized dealer User Manual FireCR Dental TM 801 EN 4 3 Use Care Maintenance and Infection Control Use proper dental aseptic techniques As with other radiographic procedures the use of imaging plate requires the same high standards of infection control Unfortunately imaging plates create a greater challenge since they are not disposable Another problem is that there is a higher potential for damaging them since they are reusable Damage can result in the production of artifacts that may interfere with the diagnosis of disease Hygienic bags have been found in most cases to be effective in protecting the imaging plate from becoming contaminated The hygieni
20. ove a Class I 1 level during normal Operation user Maintenance or Prescribed Service Condition Wavelength 658 nm Typ Beam Divergence Paraller 9 5 degrees 2 5 2 5 Perpendicular 17 degrees 3 3 Maximum Power of Energy Output 80 mW CW WARNING Never operate or service the product with the protective cover removed from Laser Reader assembly The reflected beam although invisible can damage your eyes When using this product these basic safety precautions should always be followed to reduce risk of fire electric shock and personal injury CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure User Manual FireCR Dental TM 801 EN Chapter 6 Warranty and Repair Service 6 1 Standard Warranty 3D Imaging amp Simulations Corp warrants its non consumable hardware products to be free from defects in materials and workmanship The warranty covers the cost of parts and labor to repair the product Please keep the shipping container for future use Products returned to the factory for repair should be properly packaged To obtain warranty service follow the procedure described in the Repair Service section Failure to do so will cause delays and additional expense to the customer The warranty is valid when the product is used for its intended purpose and does not cover products which have been modified
21. ray Clean the tray using soft lint free cellulose cloth with Ethanol 99 7 Tray Figure 9 Imaging Plate Tray 4 4 Operating Instructions 4 4 1 Turn on the Header Turn on the reader Power switch is located on the connection panel DANGER This device uses laser Avoid looking inside of the reader 4 4 2 Turn on the Computer Turn on the computer Acquisition and Diagnostic Software must be installed before operating the reader User Manual FireCR Dental TM 801 EN 4 4 3 X ray exposure on imaging plate Blank side of hygienic bag active side of imaging plate must face the tooth and X ray source Figure 10 Direction of imaging plate for X ray exposure 4 4 4 Imaging Plate Placement and Removal Take imaging plate out of the hygienic bag after tearing off the seal Place the imaging plate towards the front and center of the tray as shown in Figure 11 and remove the protective cover Figure 11 Correct positioning of imaging plate User Manual FireCR Dental TM 801 EN Push tray in to start scan The imaging plate can be removed when scanning and erasing are completed Gently pull up the imaging plate not to scratch the active side Figure 12 Push left side or right side of tray gently to start scan WARNING Do not place the imaging plate in wrong direction or upside down when it is being placed on the tray In order to scan or erase the IP locate the IP on the tray correctly and push
22. s reader s status and control of the reader can be done using the touch display panel User Manual FireCR Dental TM 801 EN v Image Sensor PMT This Photomultiplier Tube receives the signal through scanning of the imaging plate and then sends the signal to the analog readout circuit v Power Adapter Supplies power to all modules of the system which are required for operation User Manual FireCR Dental TM 801 EN Chapter 5 Symbols wd c wo Equipment Power ON a A Warning Consult Accompanying Documents General mandatory action manual General prohibition indication O Directive on Waste Electrical and Electronic Equipment Authorized Representative in the European Community Keep Dry Fragile User Manual FireCR Dental TM 801 EN Handle with care This side up Non ionizing electromagnetic radiation IEC60825 Warning Laser beam FCC ID FCC Mark X68CRSCANNER2 Medical Equipment WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 CAN CSA CSS 2 No 601 1 3SE3 C 1120 CE Mark 5 1 Manufacturer s Declaration Electromagnetic Emission The FireCR Dental system is intended for use in the electromagnetic environment specified below The customer or the user of FireCR Dental system should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance HF emissions
23. tem S N Installer s Signature Date Customer s Signature Date
24. the tray into the reader fully until interlock holds the tray WARNING Locate the IP in correct position 4 4 5 Getting a scanned image To acquire an image refer to Acquisition and Diagnostic Software manual User Manual FireCR Dental TM 801 EN 4 4 6 Circuit Functions Peripheral I L 05V Photo Interrupters 15V v Base Board Core Board FirelD Mico Controller 10 100Mbps Inner Clock 188MHz 480Mbps Power Switch Adaptor 24V LCD Module AC DC Adaptor TEE Input 100 240V AC 50 60 Hz Output DC24V 50W E Power Adaptor RFID Board BLDC Board TFT LCD Board Figure 13 Circuit Diagram Base Board Base board is a controller of peripherals It controls peripherals upon command of core board Peripheral These are peripherals for image acquisition They consist of Eraser which erases residual images in imaging plate Step Motor which moves the stage PSD Edge Sensor which detects the laser beam rotating speed Door detect sensor which detects status of the door open or closed Photo Interrupters which detects the position of the stage and Laser which is required to radiate laser onto imaging plate Base Board Image Data Controller Core Board This part controls peripherals for image acquisition and delivers amplified digitized signal to PC via USB or Ethernet Touch Display Panel Screen display
25. ual FireCR Dental TM 801 EN 3 2 2 Touch Display Panel Screen displays the status of the reader and control of the reader can be done through touch display panel Touch display panel Figure 3 Touch Display Panel When the reader is turned on C R Booting screen booting screen is displayed during dental system initialization Auto Sleep mode IP tray moves Sleeping back into the reader and door will be closed Touch to Awake User Manual FireCR Dental Description of icons at status bar Disconnection Ready for scan but no IP Ready for Scan TM 801 EN LEM EES ERZE Size of imaging plate ED High resolution standard resolution Temporarily toggles when it is touched EZ USB Ethernet no cable connection respectively USB cable is connected but no application program is running on computer Waiting for IP to be placed Scan will not start with an empty tray IP size is recognized and the reader is ready User Manual FireCR Dental TM 801 EN Scanning is in progress Erasing is in progress System error Unexpected system error Contact technical support Setting n Pecci When K button is selected from Syster ME AN REG mod main screen Setting mode is XE DENM displayed User Manual FireCR Dental CR Resolution Scanning mu resolution High Resolution setting System setting Auto Sleep setting Suto Trim Auto Tri
26. ub 3 To connect the PC directly use the supplied crossed cable Figure 5 Ethernet Connection DANGER This equipment is for indoor use only and all the communication wiring is limited to inside of the building WARNING Do not pull out the Ethernet cable during scanning User Manual FireCR Dental TM 801 EN 3 5 3 Connecting the Power Cord 1 Connect the power cord to the reader located on the connection panel 2 Connect the other end of the cord to a grounded power outlet Figure 6 Power Connection DANGER This equipment must only be connected to supply mains with protective earth Use only a three wire cord that has grounding This is a safety feature If you are unable to insert the plug into the outlet contact your electrician to replace your obsolete outlet For your safety do not remove the ground from the grounding type plug DANGER Do not use with any electrical power supply that does not meet the ratings displayed on the power adapter Usage of any other power adapter may lead to fire or electrocution DANGER Only use the supplied power adapter and power cord included with the system Not doing so may lead to fire electrical shock or electrocution User Manual FireCR Dental TM 801 EN WARNING Socket outlet should be installed near the device and should be easily accessible Do not place the device where access to appliance inlet is obstructed Do not unplug the power cord or
27. user serviceable parts inside this device The device should only be opened and serviced by qualified service personnel Failure to heed this warning may result in injury to service personnel or damage to equipment and void any and all warranties If there is a service problem please contact 3D Imaging amp Simulations Corp or an authorized dealer Do not spill liquids on the device and never operate the device in a wet environment Keep the device away from radiators and heat sources Use the device only with accessories supplied with this device This device is intended to be grounded Plug power cord into properly grounded electrical outlets This cord is equipped with three prong plugs to help ensure proper grounding This device contains static sensitive components Proper static handling procedures and equipment must be used when servicing this device User Manual FireCR Dental TM 801 EN Do not look inside of the device If any of the following conditions occur unplug the device from the electrical outlet and contact authorized service personnel The power cord or power adapter is damaged An object has fallen into the device The device has been exposed to water The device has been dropped or damaged The device does not operate correctly when the operating instructions are followed Federal law restricts this device to sale by or on the order or a physician Intended Use This device is a Dental Computed R
28. ved to verifynormal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the EUT b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m Hecommended Separation Distances Between Portable and Mobile RF Communications Equipment and the FireCR Dental system The FireCR Dental system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the FireCR Dental system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment transmitters and the FireCR Dental system as recommended below according to the maximum output power of the communications equipment Separation distance m according to frequency of transmitter Rated maximum output 800 pi to 2 5 power W of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 023 074 2 33 EL 2330 For transmitters rated at a maximum STENT power not listed TENTE the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations E
29. wer COr d 1ccccseccccsesecsneeersnenenssnenanes 22 3 5 1 Connecting the USB Interface Cable susss 22 3 5 2 Connecting the Ethernet Cable cccccssccccssseeeeeaneeeeneneeeesenees 23 3 5 3 Connecting the Power Cord esses 24 3 5 4 Installation 25 Chapter 4 Operating 002 anna naaawa naanakan 26 Git Veem SOCCIICAUONS RR 26 4 2 Operation CONAITIONS cccccseccccsececceeecsseecssueeesseeeessueeessueesssneeesanes 27 4 3 Use Care Maintenance and Infection Control 28 ABA USE ION COVE ME 28 Aa USE HVEN DAG stese deerit NAAN 29 4 3 3 Cleaning of the Tray esses eese enne nnn nnns 30 4 4 Operating Instructions a aaa eene 30 4 4 1 Turn on the Header esses essen nena nnn nna nnns 30 442 TUON NG COM dii SR E 30 4 4 8 X ray exposure on imaging plate a 31 User Manual FireCR Dental TM 801 EN 4 4 4 Imaging Plate Placement and Removal susss 31 4 4 5 Getting a scanned image 7 anan nns 32 4 4 6 Circuit FUNCTIONS ccccccccseccceeecsneecsueesaueessusessusesssesseesseesaneesan 33 Chapter 5 Symbols anan anan aanak 35 5 1 Manufacturer s Declaration sessi seen 36 5 1 Electromagnetic EmissiOn esses eene 36
30. will not accept any responsibility or liability for the improper functioning of the product in such a case WARNING The functionality of the system can be limited in the case of incorrect use Hints that require special attention NOTE Notes represent information that is important to know but which do not affect the functionality of the system User Manual FireCR Dental TM 801 EN General Safety Guidelines All the safety and operating instructions should be read carefully before this device is operated This device has been designed and tested to meet strict safety requirements applicable to medical equipment and has been supplied in a safe condition To ensure personnel and patient safety the device shall be operated and serviced in compliance with all procedures warnings and precautions during all phases of operation and service of this device Failure to comply with safety guidelines may result in injury to service personnel operator or patient 3D Imaging amp Simulations Corp assumes no liability for failure to comply If this device is not used as specified the protection provided by the device could be impaired This device must be used in normal conditions only Installation service and operation of this device should only be undertaken by qualified and trained personnel The operator should study instructions and precautions carefully here and throughout the manual before starting to use the device There are no
31. without written permission from 3D Imaging amp Simulations Corp or which have been damaged by abuse accident or connection to incompatible equipment This warranty is in lieu of all other warranties expressed or implied 6 2 Repair Service The company reserves the right to cease providing repair maintenance parts and technical support for its non consumable hardware products five years after a product is discontinued Technical support for old versions of software products will cease 12 months after they are upgraded or discontinued 6 3 Out of Warranty Repair Service Out of warranty repair service is available in selected geographical locations Contact the supplier for current terms and rates User Manual FireCR Dental TM 801 EN 6 4 Shipping The FireCR Dental Reader is a solidly built system designed to survive shipping around the world However in order to avoid damage during shipping the FireCR Dental Reader must be properly packaged In general the best way to package the FireCR Dental Reader is in the original factory container f this is no longer available we recommend that user carefully wraps the FireCR Dental Reader in at least 75 mms 3 inches of foam or bubble pack sheeting The wrapped device should then be placed in a sturdy cardboard carton Mark the outside of the box with word FRAGILE and an arrow showing which way is up We do not recommend using loose foam pellets to protect the FireCR Dental Re
32. y absorption and reflection from structures objects and people Note 2 It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength outside the shielded location in which the EUT is used exceeds 3V m the EUT should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as relocating the EUT or using a shielded location with a higher RF shielding effectiveness and filter attenuation User Manual FireCR Dental TM 801 EN 5 4 Laser Safety Statement The Computed Radiography Reader is Certified in the U S to Conform to the Requirements of DHHS 21 CFR chapter 1 Subchapter J for Class I 1 Laser Products and Elsewhere is Certified as a Class I 1 Laser Product Conforming to the Requirements of IEC 60825 1 2007 Class l 1 Laser Products are not Considered to be Hazardous The Laser System and Computed Radiography Reader are Designed so there is never any Human Access to Laser Radiation ab
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