DIGIRAY CRSCANNER Computed Radiography Scanner User Manual

3D IMAGING & SIMULATIONS CORP. Computed Radiography Scanner

User Manual

       User Manual  human  Computed Radiography   Scanner       Rev 0.0.9      February 2010  Part No. : CR-FPM-01-001  ©Copyright 2010 by 3D Imaging & Simulations Corp.  All rights reserved.  No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of 3D Imaging & Simulations Corp.  Terms denoted by the trademark symbol (TM or ®) used in this publication are trademarks or service marks registered in the United States or other countries.    FireCR, VetCR, Quantor and QuantorVet are registered trademarks of 3D Imaging & Simulations Corp.
User Manual  FireCR            Contact          49-3, Moonpyung-Dong, Daedeok-Gu  Daejeon, Korea    Tel : 82-42-931-2100   Fax : 82-42-931-2299    Website : www.3-disc.com   E-mail : sales@3-disc.com                    2
User Manual  FireCR  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 dose cause 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 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.                                3
User Manual  FireCR     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 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 proper functioning oh 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.  PRACTICAL HINT A hint on how the work flow could be made easier within the system.            4
User Manual  FireCR  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.    5
User Manual  FireCR  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. z  The power cord or power adapter is damaged. z  An object has fallen into the device. z  The device has been exposed to water. z  The device has been dropped or damaged. z  The device does not operate correctly when the operating instructions are followed.     Intended Use  This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes.  It comprises of scanner, cassette with reusable imaging plate and workstation software.    It scans X-Ray exposed image 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.  FireCR is not approved for the acquisition of mammographic image data.                   6
User Manual  FireCR  Index of contents   Chapter 1. Introduction ..................................................................... 9  Chapter 2. Unpacking ......................................................................11 2.1. Inspection for Damage .................................................................... 11 2.2. Unpack the Shipping Container ....................................................... 11 2.3. Identify the Components .................................................................  13  Chapter 3. Setting Up ..................................................................... 16 3.1. Tabletop Mount ............................................................................... 16 3.2. Identify Important Features ............................................................. 18 3.2.1. Scanner Connecting Part ............................................................................... 18 3.2.2. Scanner Status Indication LED ....................................................................... 19 3.3. Computer Requirements ................................................................ 20 3.3.1. Computer ........................................................................................................  20 3.3.2. Monitor ............................................................................................................ 20 3.4. Installation of Quantor .................................................................... 21 3.5. Connect the Cable and Power Cord ............................................... 22 3.5.1. Connect Interface Cable ................................................................................. 22 3.5.2. Connect the Power Cord ................................................................................ 23 3.5.3. Installation Report ........................................................................................... 24  Chapter 4. Operating ...................................................................... 25 4.1. System Specifications .................................................................... 25 4.2. Operation Conditions ...................................................................... 26 4.3. Operating Instructions .................................................................... 27 4.3.1. Turn on the Scanner ....................................................................................... 27 4.3.2. Turn on the Computer ..................................................................................... 27 4.3.3. Cassette Insert and Eject ............................................................................... 27 4.3.4. Getting a Scanned Image ............................................................................... 27 4.3.5. Circuit Functions ............................................................................................. 28    7
User Manual  FireCR  Chapter 5. Symbols ........................................................................ 29 5.1. Manufacturer’s Declaration - Electromagnetic Emission .............. 30 5.2. Manufacturer’s Declaration - Electromagnetic Immunity ................ 30 5.3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity .....................................................................................................  33  Chapter 6. Warranty and Repair Service ........................................ 34 6.1. Standard Warranty .......................................................................... 34 6.2. Repair Service ................................................................................ 34 6.3. Out of Warranty Repair Service ...................................................... 34 6.4. Shipping ......................................................................................... 35  Chapter 7. Technical Assistance ..................................................... 36                               8
User Manual  FireCR  Chapter 1. Introduction  Thank you very much for deciding on FireCR – Computed Radiography Scanner.  The  FireCR System is ideal for a wide range of Computed Radiography examinations in specialty practices such as chiropractors, podiatrists and orthopedists.      Also the FireCR is well suited for small clinics, and mobile units, performing directly at the patient with one compact and affordable package.      The  FireCR can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image.   All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution.  Combine the system with reusable phosphor screen equipped FireCR cassettes and portable X-ray equipment, it can be used for X-ray exams everywhere it is needed, e.g. nursing facilities, forensic institutions, employee screenings etc.  The  FireCR System is ideal for Computed Radiography examinations in busy clinics and specialty practices.    Affordable, rugged, compact, lightweight, fast and effective FireCR System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.      The FireCR Computed Radiography solution with enhanced workflow and improved productivity are the best solution for medium sized healthcare facilities and clinics.  The FireCR System complements centralized CR and DR environments such as clinics, ER and OR departments.                      9
User Manual  FireCR  Main Features  State-of-the-Art Scanning Mechanism FireCR adopts state-of-the-art scanning mechanism using swing mirror to construct its compact and rigid structure.  High Throughput  Its unique and patented dual direction scanning mechanism enables to improve the efficiency and high throughput.  Scanning Resolution  User selectable resolution of 100μm and 200μm allows user to make diagnosis on variable purposes.  Detector High sensitive photomultiplier tube equipped in FireCR delivers high gain, wide dynamic range and high speed response for radiographic imaging.  Powerful Acquisition and Diagnostic Software Quantor Acquisition and Diagnostic Software is supplied with every FireCR, and its accurate and rapid data processing make the scanner more powerful.                          10
User Manual  FireCR  Chapter 2. Unpacking  2.1.  Inspection for Damage  FireCR is shipped in a custom designed container to protect the scanner from external shock.   Before unpacking the scanner, inspect the shipping container for damage.  In case the container is damaged, notify the shipper immediately.       2.2.  Unpack the Shipping Container  Open the shipping container by rotating butterfly shape lock and remove items from the container.    Butterfly shape lock   FIGURE 1. Shipping container               11
User Manual  FireCR  Open the shipping container, and remove the scanner and accessories as described below.     Space for power adapter, power cord and USB cable Strap for scanner removal Pouch for cassette, manual and software CD     FIGURE 2. Inside of shipping container  Pull two straps to remove the scanner.    And remove the cassette, manuals and Quantor CD from the pouch attached to the lid.  If the FireCR needs to be returned to manufacturer or one of its representatives, the scanner must be repacked in the original container with all accessories. WARNING       Weight of the scanner is approximately 30kg (65lbs), and it requires two persons to lift. DANGER         12
User Manual  FireCR  2.3.  Identify the Components  Identify each of these components.  Item Part No. FireCR Computed Radiography Scanner CR-FP-01-001 Universal Cassette CR-FP-02-001 14” x 17” Imaging Plate (Installed in the cassette)  CR-FP-03-001 10” x 12” Imaging Plate (Installed in the cassette)  CR-FP-03-002 Quantor Acquisition and Diagnostic Software  CR-FP-04-001 USB 2.0 Interface Cable  CR-FPA-02-001 Power Adapter  CR-FPA-01-001 Power Cord  CR-FPA-03-001 FireCR User Manual  CR-FPM-01-001 Quantor User Manual  CR-FPM-02-001       FireCR Computed radiography scanner       13
User Manual  FireCR     14” x 17” Universal cassette with imaging plate     Quantor Acquisition and diagnostic software CD     USB 2.0 Interface cable      Power adapter     Power cord    FireCR User manual    Quantor User manual    14
User Manual  FireCR    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 Use of Power Cord;                3D Imaging & Simulations Corp. does not assume any responsibility for damage resulting from disposal of this equipment without consulting 3D imaging & Simulations Corp.  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. WARNING              NOTE AC/DC Adapter Manufacturer : Bridge Power corp. Model : JMW1150KA2423F51 This adapter is passed by IEC60601-1.         WARNING Use the device passed IEC60950-1 or IEC60601-1 for the product connected via USB port.          15
User Manual  FireCR  Chapter 3. Setting Up     Locations with poor heat radiation   Locations subject to shaking or vibration   Locations exposed to considerable electrical or magnetic noise, or other forms of electromagnetic energy   Locations with excessive humidity or dust   Locations subject to high or temperature WARNING Unsuitable Installation Sites           3.1.  Tabletop Mount  The scanner must be placed on a rigid and flat desk or tabletop with at least 10cm (4 inch) free space on both sides, 20cm (8 inch) on rear side and 50cm (20 inch) on front side for cassette insertion.    Its space requirements are shown below.       Free space of 20cm (8 inch) on backside, at least, to allow the power switch, power cord and USB cord to be reached by hand at all times. Free space of 50cm (20 inch) on front side, at least, for cassette insertion and ejection. Front Side  Backside  FIGURE 1. Space Requirements (Top View)      16
User Manual  FireCR  In case that desk or table is not flat, adjust feet under the scanner for leveling.   The scanner weighs approximately 30kg (65 lbs) and requires two persons to lift.  Carefully place the scanner into its final position.           FIGURE 2. Scanner leveling DANGER Never place the scanner on the floor.  Sliding the scanner may result in internal damage or misalignment of the optics.  Install in a location that is level and stable.  Installation in an unsuitable location can cause accident, or deterioration in image quality. WARNING Sliding the scanner may result in internal damage or misalignment of the optics.  External vibration or shock during scanning may affect image quality.    The scanner must be placed on rigid, flat and reinforced desk or tabletop.Adjustable foot                          17
User Manual  FireCR   Do not place anything on top of the scanner. WARNING       Assure a distance of minimum 1.0m with neighboring equipment. WARNING This equipment may be interfered or interfere by electromagnetic or other interference.         3.2.  Identify Important Features  Look over the scanner and features shown in this section.    User will need to know where these features are when user operates the scanner in later chapters.   3.2.1.  Scanner Connecting Part     USB 2.0 Port Power Inlet Power Switch     FIGURE 3. Scanner important features     18
User Manual  FireCR  3.2.2.  Scanner Status Indication LED  Indication LED shows the status of the scanner as described below.   LED  Status Remark Green Blue On  System On     On  Ready to Scan  Cassette is in initial position, and ready to scan.       Blinking  Scanning & Erasing    On Scan Finished Cassette is in initial position, and can be ejected. Blinking Blinking  Error       Status Indication LED     FIGURE 4. Scanner status indication LED           19
User Manual  FireCR  3.3.  Computer Requirements  3.3.1.  Computer  Processor:   Intel Core Duo / Core 2 Duo or comparable with AMD Dual Core Processor RAM:    minimum 2GByte RAM HD:  minimum 80GByte for software and for the archive  a hard drive C;\ (for installation) and D:\ (for acquired data, minimum capacity of 25GByte) is preconditioned Network: minimum 100MBit Graphic card / Monitor: resolution of minimum 1,280 x 1,024 pixel using the true color mode  for embedded systems a resolution of 1,024 x 768 pixel are recommended OS: Windows XP Options:   please note the requirements for the different monitors and generators e.g. additional network cards or serial ports   3.3.2.  Monitor  If a diagnostic monitor is used, it should satisfy the following requirements:    1.  DVI connection (no VGA) 2.  Resolution of at least 1,280 x 1,024 pixels 3.  Special b/w monitors from 18.1” TFT with high luminance 4.  High fidelity of grey tones and optimal luminance distribution 5.  Preset DICOM LUT  A viewing monitor should satisfy the following requirements:    1.  VGA and / or DVI connection 2.  Resolution of at least 1,280 x 1,024 pixels 3.  TFT-Color from 17” with high contrast ratio (450:1) 4.  High fidelity of grey tones and good luminance distribution 5.  5. Preset DICOM LUT  For diagnostic and viewing workstations the use of b/w monitors, which satisfy the requirements of image display devices for medical use, are recommended.      20
User Manual  FireCR  3.4.  Installation of Quantor  Please run the included setup “*_setup.exe”.  The setup creates a version of the Quantor software on the drive C:\ of your PC.  After installation, a Quantor icon will be displayed on the desktop.   By double clicking on the icon the Quantor software starts.  If the software starts in the demo mode a information displays that the program uses a temporary license.    Please confirm this information by clicking on “OK”.    The demo license is only available for 20 days.    Refer to Quantor Acquisition and Diagnostic Software manual. NOTE                                  21
User Manual  FireCR  3.5.  Connect the Cable and Power Cord  3.5.1.  Connect Interface Cable  The scanner interfaces with computer via USB2.0 cable.  1.  Use the USB cable in the shipping container. 2.  Connect the cable to the scanner’s USB2.0 port, located on the rear of the scanner. 3.  Connect the other end of the cable to the USB2.0 port on the computer.      FIGURE 5. USB connection    DANGER This equipment is indoor use only and all the communication wirings are limited to inside of the building.             22
User Manual  FireCR 3.5.2.  Connect the Power Cord  1.  Connect the power cord to the scanner, 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.         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       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.        23
User Manual  FireCR   Do not place the device where difficult to access to appliance inlet. Socket-outlet shall be installed near the device and shall be easily accessible.  WARNING        3.5.3.  Installation Report  After installation of the scanner, 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 : service@3-disc.com                                24
User Manual  FireCR  Chapter 4. Operating  4.1.  System Specifications  Sampling Pixel Pitch  Standard 200um High 100um Pixel Matrix  Standard  1750 x 2150 High  3500 x 4300 Scanning Time  Standard 19 sec High 38 sec Accepted Cassette Size  14 ” x 17” Gray Scale Resolution  16 bit Eraser Embedded Erasing Time  30 sec (User Settable)   Scanning & Erasing Cycle Time Standard 49 sec High 68 sec Computer Interface  USB 2.0 Dimensions  120 (H) x 460 (W) x 703 (D) mm 4.8 (H) x 18.3 (W) x 27.7 (D) inch Weight 30kg (65lbs) Power Requirement  100 ~ 240V / 50 ~ 60Hz System Configuration  Tabletop or Wall Mount Application Software  Included Image File Format  DICOM 3.0  * Specifications subject to change without notice. ** Specific results may vary since operating conditions fluctuate.              25
User Manual  FireCR  4.2.  Operation Conditions  Indoor use only Operating Temperature  0°C ~ 35°C (32°F ~ 95°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 scanner. Wipe outside of the scanner for dust removing with soft and dry cloth.   DANGER There are no user serviceable parts inside the scanner.  The scanner 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.                    26
User Manual  FireCR   27  4.3.  Operating Instructions  4.3.1.  Turn on the Scanner  Turn on the scanner.    Power switch is on the rear side of the scanner.         4.3.2.  Turn on the Computer  Turn on the computer.   Quantor Acquisition and Diagnostic Software must be installed before operate the scanner.   4.3.3.  Cassette Insert and Eject  Insert the cassette to the entrance of the scanner and push gently until it reaches to the protection wall inside of the scanner.    Blue indication LED is on when the cassette is inserted correctly.    Insertion direction of the cassette must be parallel to the scanner.  Cassette can be ejected after scanning and erasing when blue indication LED is on.  Gently pull back the cassette and ejection direction of the cassette must be parallel to the scanner.         4.3.4.  Getting a Scanned Image  To getting a scanned image, refer to Quantor Acquisition and Diagnostic Software manual.     DANGER This device uses laser.    Avoid looking inside of the scanner.  WARNING Do not insert the cassette in wrong direction or upside down when it is being inserted.    Cassette insertion direction is marked on the cassette.
User Manual  FireCR   28  4.3.5.  Circuit Functions    FIGURE 7. Circuit diagram  1. Base Board:  Base board is a controller of peripherals.  It controls peripherals upon command of core board.  2. Peripheral: This is peripherals for image acquisition. It consists of “Eraser” which erases residual images in imaging plate, “Step Motor and Photo Interrupters” which moves stage, “Laser, Swing Mirror and DC Motor” which are required to radiate laser onto imaging plate, “Edge Switch and DC Motor” which assures proper insertion of the cassette, and “Indicator” which displays the status of the system.  3.  Base Board Image Data Controller (Core Board):   This parts controls peripherals for image acquisition.    And it delivers amplified digitized signal to PC via USB.  4.  Image Sensor (PMT):   This Photomultiplier Tube receives the signal through scanning of imaging plate, and it sends signal to analog readout circuit.  5. Power Adapter:  It supplies power to all modules of the system which are required for operation.
User Manual  FireCR  Chapter 5. Symbols  Symbol Description  Warning, Consult Accompany Documents.  Manufacturer ON  Equipment Power On OFF  Equipment Power Off  Date of Manufacture FCC ID : X68CRSCANNER  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        29
User Manual  FireCR  5.1.  Manufacturer’s Declaration - Electromagnetic Emission  The FireCR system is intended for use in the electromagnetic environment specified below. The customer or the user of FireCR 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 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 FireCR system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supplies buildings used for domestic purposes. Harmonics emission IEC 61000-3-2 A Voltage fluctuation IEC 61000-3-3 Complies  5.2.  Manufacturer’s Declaration - Electromagnetic Immunity    The FireCR system is intended for use in the electromagnetic environment specified below. The customer or the user of FireCR system should assure that it is used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic Environment -guidanceElectrostatic 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 linesMains 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.   30
User Manual  FireCR 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 BSVD-1000 system be powered from an uninterruptible power supply or a battery 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 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:    31
User Manual  FireCR 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. 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 system. The FireCR system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the FireCR system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FireCR 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     32
User Manual  FireCR  5.3.  Guidance and Manufacturer’s Declaration – Electromagnetic Immunity  The FireCR system is intended for use in the electromagnetic environment specified below. The customer or the user of FireCR 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 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 2.5GHzField 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.     33
User Manual  FireCR  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.    Contact the supplier for current rates.             34
User Manual  FireCR  6.4.  Shipping  The FireCR is a solidly built system designed to survive shipping around the world.    However, in order to avoid damage during shipping, the FireCR must be properly packaged.  In general, the best way to package the FireCR is in the original factory container.    If this is no longer available, we recommend that user carefully wraps the FireCR in at least 75mm (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.    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.  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.                            35
User Manual  FireCR  Chapter 7. Technical Assistance If user has any questions about installing or using the device, contact 3D Imaging & Simulations Corp. Technical Support.          3D Imaging & Simulations Corp. 49-3, Moonpyung-Dong, Daedeok-Gu, Daejeon, Korea Tel : 82-42-931-2100     Fax : 82-42-931-2299 www.3-disc.com                              36
User Manual  FireCR   37  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 : service@3-disc.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 Computed Radiography Scanner System S/N   Software Version   Software S/N    Installer’s Signature:    Date:  Customer’s Signature:       Date:

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