FCC ID: X68CRSCANNER2 Computed Radiography Scanner

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 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 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 2 User Manual FireCR Dental TM-801-EN 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 residential area 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. 3 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 & 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 This equipment is indoor use only and all the communication wirings are limited to inside of the building. 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. 4 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 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 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 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. 6 User Manual FireCR Dental TM-801-EN Index of contents Chapter 1. Introduction .................................................................... 9 Chapter 2. Unpacking .................................................................... 10 Inspection for Damage ................................................................... 10 2.1. 2.2. Identify the Components ................................................................. 10 Chapter 3. Setting Up .................................................................... 12 Positioning ...................................................................................... 12 3.1. 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 System Specifications .................................................................... 23 4.1. 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 7 User Manual FireCR Dental TM-801-EN Chapter 5. Symbols ....................................................................... 28 5.1. Manufacturers Declaration ............................................................ 29 5.1.

- Electromagnetic Emission ........................................................... 29 5.2. Manufacturers 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 Standard Warranty.......................................................................... 35 6.1. 6.2. Repair Service ................................................................................ 35 6.3. Out of Warranty Repair Service ...................................................... 35 6.4. Shipping ......................................................................................... 36 Chapter 7. Technical Assistance .................................................... 37 8 User Manual FireCR Dental TM-801-EN 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 Readers 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 youre 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 imagesalong with the flexibility that helps them grow. 9 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. 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. 10 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 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. 11 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 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. 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. 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 accident, or deterioration in image quality. Free space of 15 cm (6 inch) on front side, at least, for imaging plate insertion and removal. Front Side 12 User Manual FireCR Dental TM-801-EN 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. 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 Power Switch 100Mbps Ethernet port Power Inlet USB 2.0 Figure 2. Reader Connecting Part 13 User Manual FireCR Dental TM-801-EN 3.2.2. Touch Display Panel Screen displays readers status and control of the reader can be done by touch screen. Touch display panel Figure 3. Touch Display Panel display Status Remark When the reader is turned on, Booting screen booting screen is displayed during system initialization. Sleeping moves back into the reader and Power saving mode IP tray door will be closed. 14 User Manual FireCR Dental TM-801-EN Disconnection USB / Ethernet is disconnected. No software Software is not running on PC. Updating Firmware Firmware is being updated. Ready for scan, The reader is ready for scan, but but no IP IP is not placed on the tray. Ready for Scan IP size is recognized and the reader is ready. 15 User Manual FireCR Dental TM-801-EN 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. 16 User Manual FireCR Dental TM-801-EN 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. 17 User Manual FireCR Dental TM-801-EN Default gateway Type in gateway address Setting 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 18 User Manual FireCR Dental TM-801-EN 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 readers 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. 19 User Manual FireCR Dental TM-801-EN 3.5.2. Connect Ethernet Cable The reader interfaces with computer via Ethernet cable (RJ45 CAT.6 UTP). 1. Connect the cable to the readers 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. 20 User Manual FireCR Dental TM-801-EN 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. 21 User Manual FireCR Dental TM-801-EN 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. 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 22 User Manual FireCR Dental TM-801-EN Chapter 4. Operating 4.1. System Specifications Sampling Pixel Pitch Pixel Matrix (Size 0) Pixel Matrix (Size 1) Pixel Matrix (Size 2) Pixel Matrix (Size 3) Pixel Matrix (Size 4c) Accepted Imaging Plate Size Gray Scale Resolution Eraser UV Sterilizer SD HD SD HD SD HD SD HD SD HD SD HD 64um 35um 343 x 484 628 x 885 375 x 625 685 x 1143 484 x 640 886 x 1171 421 x 843 771 x 1542 750 x 843 1370 x 1542 0, 1, 2, 3, 4c 16 bit Embedded Embedded Computer Interface USB 2.0 / 100Mbps Ethernet Dimensions Weight Power Requirement Image File Format 265 (H) x 120 (W) x 318 (D) mm 10.4 (H) x 4.7 (W) x 12.5 (D) inch 4.7 kg 10.4 lbs 100 ~ 240V / 50 ~ 60Hz DICOM 3.0, TIFF, BMP, JPEG

* Specifications subject to change without notice.

** Specific results may vary since operating conditions fluctuate. 23 TM-801-EN User Manual FireCR Dental 4.2. Operation Conditions Indoor use only Operating Temperature 15C ~ 30C (59F ~ 86F) Temperature Gradient 0.5C / Min Relative Humidity Storage Temperature 15% ~ 95% (non-condensing)

- 10C ~ 50C (14F ~ 122F) Storage Humidity 15% ~ 95% (non-condensing) Storage Atmospheric Pressure 500 ~ 1,060 hPa Transportation Temperature

- 10C ~ 50C (14F ~ 122F) Transportation Humidity 15% ~ 95% (non-condensing) Transportation Atmospheric Pressure 500 ~ 1,060 hPa Installation Category Pollution Degree Ingress of Liquids Altitude Protective Class II 2 IPX0 Up to 2,000m Class 1 Equipment Maintenance No user maintenance is required and no user Cleaning service is allowed. Please contact technical support if there is a problem. 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. 24 User Manual FireCR Dental TM-801-EN 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. DANGER This device uses laser. Avoid looking inside 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. Tray Figure 7. Imaging Plate Placement and Removal WARNING Do not place the imaging plate in wrong direction or upside down when it is being placed on the tray. 25 User Manual FireCR Dental TM-801-EN 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. WARNING Locate the IP in correct position. WARNING Do not reuse hygienic bag. 4.3.4. Getting a Scanned Image To getting a scanned image, refer to Acquisition and Diagnostic Software manual. 4.3.5. Circuit Functions 26 User Manual FireCR Dental TM-801-EN 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 28 User Manual FireCR Dental TM-801-EN 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. Manufacturers 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 Group 1 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 11 Harmonics emission A IEC 61000-3-2 Voltage fluctuation Complies IEC 61000-3-3 all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 29 User Manual FireCR Dental TM-801-EN 5.2. Manufacturers 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 Electrostatic 6 kV Contact discharge (ESD) 8 kV Air 6 kV Contact 8 kV Air IEC 61000-4-2 Electromagnetic Environment -guidance 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 2kV for power supply lines 2kV for power supply lines Mains 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 Surge 1 kV differential mode 1 kV differential mode Mains power quality should be hospital environment. IEC 61000-4-5 2 kV common mode 2 kV common mode that of a typical commercial or hospital environment. Power frequency 3.0 A/m 3.0 A/m Power frequency magnetic

(50/60Hz) Magnetic field IEC 61000-4-8 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short

<5% U (>95% dip in U)

<5% U (>95% dip in U) Mains power quality should be Interruptions and for 0.5cycle for 0.5cycle that of a typical commercial or Voltage variations hospital environment. If the on power supply 40% U (60% dip in U ) 40% U (60% dip in U ) user of the BSVD-1000 system input lines for 5 cycle IEC 61000-4-11 for 5 cycle 70% U (30% dip in U) 70% U (30% dip in U) for 25 cycle for 25 cycle requires continued operation during power mains interruptions, it is recommended that the FireCR Dental system be powered

<5% U (<95% dip in U )

<5% U (<95% dip in U ) from an uninterruptible power for 5 s for 5 s supply or a battery 30 User Manual FireCR Dental TM-801-EN Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 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 3 V/m 3 V/m Recommended separation IEC 61000-4-3 80.0 MHz to 2.5 GHz 80.0 MHz to 2.5 GHz 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) U 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. 31 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 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 Separation distance (m) according to frequency of transmitter power (W) of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 0.01 0.1 1 10 100 0.12 0.37 1.17 3.70 11.70 0.12 0.37 1.17 3.70 11.70 800 MHz to 2.5 GHz 0.23 0.74 2.33 7.37 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 3 Vrms, 150 kHz to 80 3 Vrms, 150 kHz to 80 3 Vrms, 150 kHz to 80 IEC 61000-4-6 MHz MHz MHz 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 IEC 61000-4-3 GHz GHz GHz 32 User Manual FireCR Dental TM-801-EN 5.3. Guidanc e and Manufac turer s Dec laration 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 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 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 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:

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 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 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 34 User Manual FireCR Dental TM-801-EN 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. 35 TM-801-EN User Manual FireCR Dental 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 users 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 users claim for compensation. 36 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 &

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 37 User Manual FireCR Dental Appendix I TM-801-EN 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 System S/N FireCR Dental Reader Installers Signature:

Customers Signature:

Date:

Date:

38