DIGIRAY CRSCANNER2 Computed Radiography Scanner User Manual

3D IMAGING & SIMULATIONS CORP. Computed Radiography Scanner

User manual

       User Manual Dental Computed Radiography Reader     Doc No. : TM-801-EN Rev 0.1.2 Nov. 2012 Part No. : CR-FPM-11-001-EN  3DISC, FireCR, Quantor and the 3D Cube are trademarks of 3D Imaging & 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 & 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  &  Simulations  Corp.  strives  to  provide  as  accurate information as possible, but shall not be responsible for any typographical error.  © Copyright 2010 3D Imaging & Simulations Corp, all rights reserved, printed, and published in South Korea by 3D Imaging & Simulations Corp.
User  Manual  FireCR  Dental    TM-801-EN   2                  3DISC Americas 22560 Glenn Dr, Suite 116 Sterling, VA 20164 USA Tel : 1-703-430-6080 E-mail : info@3DISCimaging.com   Contact          815, Tamnip-Dong, Yuseong-Gu,   Daejeon, Korea    Tel : 82-42-931-2100   Fax : 82-42-931-2299    Website : www.3DISCimaging.com   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   3  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 A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residentialarea is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Modifications not expressly approved by the manufacturer could void the user's authority to operated the equipment under FCC rules.
User  Manual  FireCR  Dental    TM-801-EN   4  Warnings and Used Symbols  To ensure the safety of patients, staff and other persons, any changes to software and hardware delivered by 3D Imaging & Simulations Corp. may only be made with prior written permission from 3D Imaging & Simulations Corp.  Please  read  the  respective  manuals  of  the  connected  software,  such  as  acquisition  and diagnostic software, before starting to use the FireCR Dental system.  The following symbols will be used throughout this manual:                                  DANGER 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  &  Simulations  Corp. becomes void.    3D Imaging & Simulations Corp. 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. DANGER This  equipment  is  indoor  use  only  and  all  the  communication wirings are limited to inside of the building.
User  Manual  FireCR  Dental    TM-801-EN   5  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 to  with safety guidelines may result in injury to service personnel, operator, or patient.   3D Imaging & 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 a normal condition only.  Installation, service and operation of this device should only be undertaken by qualified trained personnel.    The operator should study instructions and precautions carefully before starting to use the device listed here and throughout the manual.      There are no 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 & Simulations Corp. or authorized dealer.  Do not spill liquids on the device, and never operate the device in a wet environment.  Keep the device 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   6  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 Radiography System and intended for use in producing digital X-Ray images for dental radiography purposes.    It 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.
User  Manual  FireCR  Dental    TM-801-EN   7  Index of contents  Chapter 1. Introduction .................................................................... 9  Chapter 2. Unpacking .................................................................... 10 2.1. Inspection for Damage ................................................................... 10 2.2. Identify the Components ................................................................. 10  Chapter 3. Setting Up .................................................................... 12 3.1. Positioning ...................................................................................... 12 3.2. Identify Important Features ............................................................. 13 3.2.1. Reader Connecting Part ........................................................... 13 3.2.2. Touch Display Panel ................................................................. 14 3.3. Computer Requirements ................................................................ 18 3.3.1. Recommended Requirement .................................................... 18 3.3.2. Minimum Requirement ............................................................. 18 3.4. Installation of Acquisition and Diagnostic Software......................... 19 3.5. Connect the Cable and Power Cord ............................................... 19 3.5.1. Connect USB Interface Cable................................................... 19 3.5.2. Connect Ethernet Cable ........................................................... 20 3.5.3. Connect the Power Cord .......................................................... 21 3.5.4. Installation Report ..................................................................... 22  Chapter 4. Operating ..................................................................... 23 4.1. System Specifications .................................................................... 23 4.2. Operation Conditions ...................................................................... 24 4.3. Operating Instructions .................................................................... 25 4.3.1. Turn on the Reader ................................................................... 25 4.3.2. Turn on the Computer ............................................................... 25 4.3.3. Imaging Plate Placement and Removal .................................... 25 4.3.4. Getting a Scanned Image ......................................................... 26 4.3.5. Circuit Functions ....................................................................... 26
User  Manual  FireCR  Dental    TM-801-EN   8  Chapter 5. Symbols ....................................................................... 28 5.1. Manufacturer’s  Declaration ............................................................ 29 5.1. -  Electromagnetic  Emission ........................................................... 29 5.2. Manufacturer’s Declaration - Electromagnetic Immunity ................ 30 5.3. Guidance  and  Manufacturer ’s  Declaration  –  Electromagnetic Immunity ..................................................................................................... 33 5.4. Laser Safety Statement .................................................................. 34  Chapter 6. Warranty and Repair Service ....................................... 35 6.1. Standard Warranty.......................................................................... 35 6.2. Repair Service ................................................................................ 35 6.3. Out of Warranty Repair Service ...................................................... 35 6.4. Shipping ......................................................................................... 36  Chapter 7. Technical Assistance .................................................... 37
User  Manual  FireCR  Dental    TM-801-EN   9  Chapter 1. Introduction  FireCR Dental Reader •  Rapidly view high-quality digital images •  Easy-to-use system increases patient throughput •  Full-featured, affordable dental solution  Experience the Benefits of Digital Imaging The  full-featured  Fire CR  Dental Reader  from  3D  Imaging & Simulations Corp.  rapidly  and affordably delivers high-quality digital images for busy dental practices.  Compact & Affordable The  FireCR Dental Reader is compact and affordable, helping  to increase  patient  throughput and  improve  the  overall  productivity  of  your  practice.  With  its  small  footprint,  the  reader  fits seamlessly into even the most space-challenged dental offices and exam rooms.  Elegant Design & Streamlined Operation The FireCR Dental Reader’s elegant design belies a powerful yet easy-to-use system that gets the job done day in and day out.    The  reader is DICOM 3.0  compatible  with  existing  systems and  uses  a full  range  of low-cost, reusable  bitewing  and  intraoral  imaging  plates  that  are  easier  and  faster  to  position  than intraoral digital sensors.    Unique Touch Screen Panel The  FireCR  Dental  Reader  features  a  unique  color  touch-screen  LCD  panel  for  seamless device  operation.  With  no  physical  push  buttons  on  the  unit  and  an  intuitive  user  interface, entering operator instructions has never been easier.  Built-in Erase & UV Sterilization A built-in erase function eliminates the need to purchase an additional device to erase imaging plates prior to reuse, improving efficiency and reducing costs. And, an integrated UV disinfection system sterilizes imaging plates that may be contaminated during handling, ensuring a hygienic workflow and protecting the safety of patients and staff.  Unmatched Flexibility to Help Your Practice Grow In this increasingly competitive environment, show patients that your practice offers the latest in digital  imaging  technology  for  improved  patient  results.  Whether  you’re  looking  for  a  central reader  that  can  distribute  images  throughout  your  facility,  or  an  affordable  exam-room  based solution, the next-generation FireCR Dental Reader is the natural choice for practices looking for a full-featured system that delivers high-quality digital images—along with the flexibility that helps them grow.
User  Manual  FireCR  Dental    TM-801-EN   10  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.  Part No.  Item CR-FP-11-001  FireCR Dental Reader CR-FPA-01-002  Power Adapter CR-FPA-02-001  USB 2.0 Interface Cable CR-FPA-02-002  RJ45 CAT.6 UTP Cable 2M (direct type) CR-FPA-03-00X  Power Cord CR-FPM-11-001  FireCR Dental User Manual CR-PKM-11-004  IP Storage Case CR-FP-12-001  Size 0 Imaging Plate (22mm x 31mm) CR-FP-12-002 Size 1 Imaging Plate (24mm x 40mm) CR-FP-12-003 Size 2 Imaging Plate (31mm x 41mm) CR-FP-12-004 Size 3 Imaging Plate (27mm x 54mm) CR-FP-12-005 Size 4c Imaging Plate (48mm x 54mm) CR-FPA-15-001  Size 0 IP Hygienic Bag CR-FPA-15-002 Size 1 IP Hygienic Bag CR-FPA-15-003 Size 2 IP Hygienic Bag CR-FPA-15-004 Size 3 IP Hygienic Bag CR-FPA-15-005 Size 4c IP Hygienic Bag           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.
User  Manual  FireCR  Dental    TM-801-EN   11                                              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 supply not in USA, make sure the power cord is the correct type that is required in your area. WARNING Improper  disposal  of  this  product  may  result  in  environmental contamination.    When  disposing  of  this  equipment,  contact  3D Imaging & Simulations Corp.’s representative or related organs of  government.    Do  not  dispose  of  any  part  of  this  equipment without  consulting  a  3D  Imaging  &  Simulations  Corp.’s representative first.  3D  Imaging  &  Simulations  Corp.  does  not  assume  any responsibility for damage resulting from disposal of this equipment without consulting 3D imaging & Simulations Corp. NOTE AC/DC Adapter Manufacturer : Bridge Power corp. Model : BPM050X24XXX   This adapter is passed by IEC60601-1. WARNING Use the device passed IEC60950-1 or IEC60601-1 for the product connected via USB port.
User  Manual  FireCR  Dental    TM-801-EN   12  Chapter 3. Setting Up            3.1.  Positioning The reader must be placed on a rigid and flat desk or tabletop with at least 5 cm (2 inch) free space on both sides, 10 cm (4 inch) on rear side and 15 cm (6 inch) on front side for imaging plate insertion.    Its space requirements are shown below.     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  accident,  or  deterioration  in  image quality. Free space of 10 cm (4 inch) on  backside,  at  least,  to allow  the  power  switch, power  cord  and  interface cable to be reached by hand at all times. Free  space of 15 cm (6 inch) on  front  side,  at  least,  for imaging  plate  insertion  and removal. Front Side  Backside 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
User  Manual  FireCR  Dental    TM-801-EN   13                    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.  Reader  Connecting  Part     Figure 2. Reader Connecting Part WARNING Sliding 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  rigid,  flat  and  reinforced desk or tabletop. WARNING Do not place anything on top of the reader. WARNING This equipment may be  interfered or interfere  by electromagnetic or other interference.  Assure a distance of minimum 1.0 m with neighboring equipment.  USB 2.0 Power Inlet Power Switch 100Mbps Ethernet port
User  Manual  FireCR  Dental    TM-801-EN   14  3.2.2.  Touch Display Panel  Screen displays reader’s status and control of the reader can be done by touch screen.       Figure 3. Touch Display Panel  display  Status  Remark  Booting screen When the reader is turned on, booting screen is displayed during system initialization.  Sleeping Power saving mode – IP tray moves back into the reader and door will be closed.    Touch display panel
User  Manual  FireCR  Dental    TM-801-EN   15  Disconnection  USB / Ethernet is disconnected.  No software  Software is not running on PC.  Updating Firmware  Firmware is being updated.  Ready for scan, but no IP The reader is ready for scan, but IP is not placed on the tray.  Ready for Scan  IP size is recognized and the reader is ready.
User  Manual  FireCR  Dental    TM-801-EN   16  Scanning  Scanning is in progress.  Manual Erasing  Erasing image from IP manually.  Preview  Preview of scanned image.  Setting mode  Shows information and settings of the reader.    Scanning resolution setting  Choosing scanning resolution.
User  Manual  FireCR  Dental    TM-801-EN   17  Auto sleep setting  Choosing time duration until sleep mode.  Network setting  Manual input for network related settings.  DHCP setting  Choosing DHCP mode for automatic network settings.  IP Address setting  Type in IP address manually.  Subnet mask setting  Type in subnet mask manually.
User  Manual  FireCR  Dental    TM-801-EN   18  Default gateway Setting Type in gateway address manually.   3.3.  Computer Requirements  3.3.1.  Recommended  Requirement  Operation System  Microsoft Windows 7 (32 bit or 64 bit) CPU  Core Duo / Core2 Processor Memory  RAM 4GB or more Hard Disk  300GB Free Hard Disk Space Network  1Gbps Ethernet Video  32 bit Color Display Video Resolution  1280 x 1024   3.3.2.  Minimum  Requirement  Operation System  Microsoft Windows 7 (32 bit or 64 bit) CPU  Core Duo / Core2 Processor Memory  RAM 2GB or more Hard Disk  80GB Free Hard Disk Space Network  1Gbps Ethernet Video  32 bit Color Display Video Resolution  1280 x 900
User  Manual  FireCR  Dental    TM-801-EN   19 3.4.  Installation of Acquisition and Diagnostic Software  Refer to Acquisition and Diagnostic Software manual.  3.5.  Connect the Cable and Power Cord  3.5.1.  Connect  USB Interface  Cable  The reader interfaces with computer via USB2.0 cable.  1.  Use the USB cable inside the shipping container. 2.  Connect the cable to the reader’s USB2.0 port, located on the rear of the reader. 3.  Connect the other end of the cable to the USB2.0 port on the computer.    Figure 4. USB Connection            DANGER This  equipment  is  indoor  use  only  and  all  the  communication wirings are limited to inside of the building.  WARNING Do not pull out the USB cable during scanning.
User  Manual  FireCR  Dental    TM-801-EN   20  3.5.2.  Connect  Ethernet  Cable  The reader interfaces with computer via Ethernet cable (RJ45 CAT.6 UTP).  1.  Connect the cable to the reader’s Ethernet port, located on the rear of the reader. 2.  Connect the other end of the cable to the Ethernet port of the Ethernet-hub. 3.  If you want to connect to PC directly, use crossed type cable instead of normal Ethernet cable.    Figure 5. Ethernet Connection                 DANGER This  equipment  is  indoor  use  only  and  all  the  communication wirings are limited to inside of the building. WARNING Do not pull out the Ethernet cable during scanning.
User  Manual  FireCR  Dental    TM-801-EN   21 3.5.3.  Connect  the  Power  Cord  1.  Connect the power cord to the reader, located on the rear side. 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.   Do not defeat the safety purpose of the grounding-type plug. DANGER Do not use with any electrical power supply that does not meet the ratings  displayed  on  the  power  adapter.    Use  with  any  other power adapter may lead to fire or electrocution. DANGER Do  not  use  any  power  adapter  and  power  cord  other  than  the power  adapter and  power  cord included  with the system.    Doing so may lead to fire, electrical shock, or electrocution.
User  Manual  FireCR  Dental    TM-801-EN   22              3.5.4.  Installation  Report  After  installation  of  the  reader,  fill  in  Installation  Report  from  (Appendix  I)  and  send  to  3D Imaging & Simulations Corp. service department by fax or e-mail.    Fax : +82-42-931-2299   E-mail : support@3DISCimaging.com                          WARNING Socket-outlet shall be installed near the device and shall be easily accessible.  Do not place the device where difficult to access to appliance inlet.  Do not unplug the power cord or turn the power switch off during scanning.
User  Manual  FireCR  Dental    TM-801-EN   23  Chapter 4. Operating  4.1.  System Specifications  Sampling Pixel Pitch  SD  64um   HD  35um   Pixel Matrix (Size 0) SD  343 x 484 HD  628 x 885 Pixel Matrix (Size 1) SD  375 x 625 HD  685 x 1143 Pixel Matrix (Size 2) SD  484 x 640 HD  886 x 1171 Pixel Matrix (Size 3) SD  421 x 843 HD  771 x 1542 Pixel Matrix (Size 4c)  SD  750 x 843 HD  1370 x 1542 Accepted Imaging Plate Size    0, 1, 2, 3, 4c Gray Scale Resolution    16 bit   Eraser    Embedded   UV Sterilizer  Embedded Computer Interface    USB 2.0 / 100Mbps Ethernet Dimensions    265 (H) x 120 (W) x 318 (D) mm   10.4 (H) x 4.7 (W) x 12.5 (D) inch   Weight    4.7 kg 10.4 lbs Power Requirement    100 ~ 240V / 50 ~ 60Hz   Image File Format    DICOM 3.0, TIFF, BMP, JPEG  * Specifications subject to change without notice. ** Specific results may vary since operating conditions fluctuate.
User  Manual  FireCR  Dental    TM-801-EN   24  4.2.  Operation Conditions  Indoor use only Operating Temperature  15°C ~ 30°C (59°F ~ 86°F) Temperature Gradient  0.5°C / Min 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  500 ~ 1,060 hPa Transportation Temperature  - 10°C ~ 50°C (14°F ~ 122°F) Transportation Humidity  15% ~ 95% (non-condensing) Transportation Atmospheric Pressure  500 ~ 1,060 hPa Installation Category  II Pollution Degree  2 Ingress of Liquids  IPX0 Altitude  Up to 2,000m Protective Class  Class 1 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 & Simulations Corp. or authorized dealer.
User  Manual  FireCR  Dental    TM-801-EN   25 4.3.  Operating Instructions  4.3.1.  Turn  on  the  Reader  Turn on the reader.    Power switch is on the rear side of the reader.        4.3.2.  Turn  on  the  Computer  Turn on the  computer.   Acquisition  and  Diagnostic  Software  must  be installed  before  operate the reader.  4.3.3.  Imaging  Plate  Placement  and  Removal  Place  the  imaging  plate  on  the  tray  to  start  scan.    The  imaging  plate  can  be  removed  when scanning and erasing are completed.    Gently pull up the imaging plate.    Figure 7. Imaging Plate Placement and Removal        DANGER This device uses laser.    Avoid looking inside of the reader.  WARNING Do not place the imaging plate in wrong direction or upside down when it is being placed on the tray.  Tray
User  Manual  FireCR  Dental    TM-801-EN   26  In order to  scan or  erase  the IP, locate the  IP on  the tray correctly and  push  the  tray into the reader fully until interlock holds the tray.              4.3.4.  Getting  a  Scanned  Image  To getting a scanned image, refer to Acquisition and Diagnostic Software manual.   4.3.5.  Circuit  Functions    WARNING Locate the IP in correct position. WARNING Do not reuse hygienic bag.
User  Manual  FireCR  Dental    TM-801-EN   28  Chapter 5. Symbols   Symbol  Description  .Manufacturer    Date of Manufacture  Equipment Power ON    Equipment Power OFF   Warning, Consult Accompany Documents      General mandatory action manual   General prohibition indication   User Manual Reference  Directive on Waste Electrical and Electronic Equipment  Authorised Representative in the European Community  Keep Dry
User  Manual  FireCR  Dental    TM-801-EN   29  Fragile  Handle with care  This side up  Non-ionizing electromagnetic radiation FCC ID : X68CRSCANNER2  FCC Mark  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  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 RF emissions CISPR 11 Group 1  The FireCR Dental system 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 RF emissions CISPR 11 Class B  The Model FireCR Dental is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonics emission IEC 61000-3-2 A Voltage fluctuation IEC 61000-3-3 Complies
User  Manual  FireCR  Dental    TM-801-EN   30 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 IEC 60601 Test level Compliance level Electromagnetic Environment -guidance Electrostatic discharge (ESD) IEC 61000-4-2 6 kV Contact 8 kV Air 6 kV Contact 8 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Electrical fast Transient / burst IEC 61000-4-4  2kV for power supply lines 1kV for input/output lines 2kV for power supply lines 1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5  1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Power frequency (50/60Hz) Magnetic field IEC 61000-4-8 3.0 A/m  3.0 A/m  Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short Interruptions and Voltage variations on power supply input lines IEC 61000-4-11  <5% Uт (>95% dip in Uт) for 0.5cycle  40% Uт (60% dip in Uт ) for 5 cycle  70% Uт (30% dip in Uт) for 25 cycle  <5% Uт (<95% dip in Uт ) for 5 s <5% Uт (>95% dip in Uт) for 0.5cycle  40% Uт (60% dip in Uт ) for 5 cycle  70% Uт (30% dip in Uт) for 25 cycle  <5% Uт (<95% dip in Uт ) for 5 s Mains power quality should be that of a typical commercial or hospital environment. If the user of the BSVD-1000 system requires continued operation during power mains interruptions, it is recommended that the FireCR Dental system be powered from an uninterruptible power supply or a battery
User  Manual  FireCR  Dental    TM-801-EN   31 Conducted RF IEC 61000-4-6               3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the FireCR Dental system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.  Recommended separation distance   Radiated RF IEC 61000-4-3  3 V/m 80.0 MHz to 2.5 GHz 3 V/m 80.0 MHz to 2.5 GHz Recommended separation distance   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 1) Uт 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.  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   32 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  observed  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.  Recommended  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 RF communications  equipment (transmitters)  and the  FireCR Dental system as  recommended below, according to the maximum output power of the communications equipment. Rated maximum output power (W) of transmitter Separation distance (m) according to frequency of transmitter 150 kHz to 80 MHz  80 MHz to 800 MHz  800 MHz to 2.5 GHz 0.01  0.12  0.12  0.23 0.1  0.37  0.37  0.74 1  1.17  1.17  2.33 10  3.70  3.70  7.37 100  11.70  11.70  23.30 For transmitters rated at a maximum output power not listed above, 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. Electromagnetic 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 IEC 61000-4-6 3 Vrms, 150 kHz to 80 MHz 3 Vrms, 150 kHz to 80 MHz 3 Vrms, 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 3 V/m, 80 MHz to 2.5 GHz 3 V/m, 80 MHz to 2.5 GHz 3 V/m, 80 MHz to 2.5 GHz
User  Manual  FireCR  Dental    TM-801-EN   33  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 Immunity test IEC 60601 Test level Compliance level Electromagnetic environment -guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80MHz 3 Vrms 150 kHz to 80 MHz FireCR Dental system must be used only in a shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location with a minimum RF shielding effectiveness and, for each cable that enters the shielded location Radiated RF IEC 61000-4-3  3 V/m 80.0 MHz to 2.5GHz 3 V/m 80.0 MHz to 2.5GHz Field strengths outside the shielded 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:  Note 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected by 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   34  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 I(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  above  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   35  Chapter 6. Warranty and Repair Service  6.1.  Standard Warranty  3D Imaging & 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 long 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 without written permission from 3D Imaging & 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   36  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.    If this  is  no longer  available,  we  recommend that  user  carefully wraps the FireCR Dental  Reader  in  at  least  75  mm  (3  inch)  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 Reader.    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, and user  does  not  have  a  means  to  adequately  package  it,  user  can  order  additional  shipping container.    This may seem an expense user would like to avoid, but it is inexpensive compared to the cost of repairing an instrument that has sustained shipping damage.  It is 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 user’s claim for compensation.
User  Manual  FireCR  Dental    TM-801-EN   37  Chapter 7. Technical Assistance If  user  has  any  questions  about  installing  or  using  the  device,  contact  your  3D  Imaging  & Simulations Corp representative or your local dealer.            3D Imaging & Simulations Corp. 815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Tel : 82-42-931-2100          Fax : 82-42-931-2299 www.3DISCimaging.com
User  Manual  FireCR  Dental    TM-801-EN   38  Appendix I  Installation Report  Please  complete  this  report  at  the  time  of  installation  and  submit  the completed form signed by customer to:  Fax : +82-42-931-2299  E-mail : support@3DISCimaging.com  Date of Installation :    Customer Information Hospital / Institute   Name   Address   Tel   Fax   E-mail    Installer Information Company   Name   Address   Tel   Fax   E-mail    System Information Model  FireCR Dental Reader System S/N     Installer’s Signature:        Date:  Customer’s Signature:       Date:

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