DIGIRAY CRSCANNER3 Computed Radiography Scanner User Manual
3D IMAGING & SIMULATIONS CORP. Computed Radiography Scanner Users Manual
DIGIRAY >
Users Manual
Spark
User Manual
Computed Radiography Reader
Doc No. : TM-901-EN
Rev 0.1.1 Jun 2013
Part No. : CR-FPM-31-001-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.
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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
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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.
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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 Spark system.
The following symbols will be used throughout this manual:
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.
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.
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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.
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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 reader, 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 Spark is not approved for the acquisition of mammographic image data.
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Index of contents
Chapter 1. Introduction ..................................................................... 9
Chapter 2. Unpacking ......................................................................11
2.1. Inspection for Damage .................................................................... 11
2.2. Identify the Components .................................................................. 11
Chapter 3. Setting Up ..................................................................... 13
3.1. Tabletop Mount ............................................................................... 13
3.2. Wall Mount (Option) ........................................................................ 14
3.3. Identify Important Features ............................................................. 15
3.1. 15
3.3.1. Reader Connecting Part ........................................................... 15
3.3.2. Reader Reset Button ................................................................ 15
3.4. Computer Requirements ................................................................ 16
3.4.1. Recommended Requirement .................................................... 16
3.4.2. Minimum Requirement ............................................................. 16
3.5. Installation of Acquisition and Diagnostic Software ......................... 16
3.6. Connect the Cable and Power Cord ............................................... 16
3.6.1. Connect Interface Cable ........................................................... 16
3.6.2. Connect the Power Cord .......................................................... 17
3.6.3. Installation Report ..................................................................... 18
Chapter 4. Operating ...................................................................... 19
4.1. System Specifications .................................................................... 19
4.2. Operation Conditions ...................................................................... 20
4.3. Operating Instructions .................................................................... 21
4.3.1. Turn on the Reader ................................................................... 21
4.3.2. Turn on the Computer ............................................................... 21
4.3.3. Cassette Insert and Eject ......................................................... 21
4.3.4. Getting a Scanned Image ......................................................... 21
4.3.5. Circuit Functions ....................................................................... 22
Chapter 5. Symbols ........................................................................ 23
5.1. Manufacturer’s Declaration - Electromagnetic Emission .............. 24
5.2. Manufacturer’s Declaration - Electromagnetic Immunity ................ 25
5.3. Guidance and Manufacturer’s Declaration – Electromagnetic
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Immunity ..................................................................................................... 27
5.4. Laser Safety Statement .................................................................. 29
Chapter 6. Warranty and Repair Service ........................................ 30
6.1. Standard Warranty .......................................................................... 30
6.2. Repair Service ................................................................................ 30
6.3. Out of Warranty Repair Service ...................................................... 30
6.4. Shipping ......................................................................................... 31
Chapter 7. Technical Assistance ..................................................... 32
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Chapter 1. Introduction
Thank you very much for deciding on FireCR Spark – Computed Radiography Reader.
The FireCR Spark System is ideal for a wide range of Computed Radiography examinations in
specialty practices such as chiropractors, podiatrists and orthopedists.
The FireCR Spark 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 Spark 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 Spark System is ideal for Computed Radiography examinations in busy clinics and
specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark
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 Spark Computed Radiography solution with enhanced workflow and improved
productivity are the best solution for medium sized healthcare facilities and clinics. The FireCR
Spark System complements centralized CR and DR environments such as clinics, ER and OR
departments.
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Main Features
State-of-the-Art Scanning Mechanism
FireCR Spark adopts state-of-the-art scanning mechanisms using high beam delivery efficiency
optics module 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 Spark delivers high gain, wide dynamic
range and high speed response for radiographic imaging.
Powerful Acquisition and Diagnostic Software
Acquisition and Diagnostic Software designed for the FireCR Spark, and its accurate and rapid
data processing make the reader more powerful.
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Chapter 2. Unpacking
2.1. Inspection for Damage
FireCR Spark 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
Identify each of these components.
Part No. Item
CR-FP-31-001 FireCR Spark
CR-FP-02-003 Universal Cassette 35cm x 43cm containing IP size 35cm x 43cm
CR-FP-02-004 Universal Cassette 25cm x 30cm containing IP size 24cm x 30cm
CR-FP-22-001 Universal Cassette 24cm x 30cm containing IP size 24cm x 30cm
CR-FP-22-002 Universal Cassette 18cm x 24cm containing IP size 18cm x 24cm
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-34-001 FireCR Spark User Manual
WARNING
If the FireCR Spark needs to be returned to manufacturer or one
of its representatives, the scanner must be repacked in the
original container with all accessories.
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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.
WARNING
Use the device passed IEC60950-1 or IEC60601-1 for the product
connected via USB port.
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Chapter 3. Setting Up
3.1. Tabletop Mount
The reader must be placed on a rigid and flat desk or tabletop with at least 10 cm (4 inch) free
space on both sides, 20 cm (8 inch) on rear side and 50 cm (20 inch) on front side for cassette
insertion. Its space requirements are shown below.
In case that desk or table is not flat, adjust feet under the reader for leveling. The reader
weighs approximately 15 kg (33 lbs) and requires two persons to lift. Carefully place the
reader into its final position.
DANGER
Never place the reader on the floor.
Sliding the reader 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 reader 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 tableto
p
.
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
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3.2. Wall Mount (Option)
The FireCR Spark can be mounted on the wall to save space occupancy. When purchasing
the wall mount kit, a detailed installation guide and all parts necessary for assembly are
provided.
WARNING
Do not place anything on top of the scanner.
WARNING
This equipment may be interfered or interfere by electromagnetic
or other interference.
Assure a distance of minimum 1.0 m with neighboring equipment.
WARNING
Install the wall mount on a solid wall perpendicular to the floor.
When attaching to other building materials, please contact your
local dealer. If installed on a slanted wall, it may fall and result in
severe injury.
NOTE
Refer to Wall Mount Installation Guide provided with Wall Mount
Installation Kit.
WARNING
Only authorized or trained personnel should set wall mount
installation.
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3.3. 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.
3.3.1. Reader Connecting Part
3.3.2. Reader Reset Button
In case that the reader is stuck during scanning, push reader reset button by sharp pin to
initialize the reader.
WARNING
3D Imaging & Simulations Corp. is not liable for product damage or
personal injury when the user fails to follow the product installation
instruction.
WARNING
Pulling, pushing, or climbing on the system may cause the system
fall.
WARNING
Do not push scanner reset button during scanning.
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3.4. Computer Requirements
3.4.1. Recommended Requirement
Operation System Microsoft Windows XP or 7
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
3.4.2. Minimum Requirement
Operation System Microsoft Windows XP or 7
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 1024
3.5. Installation of Acquisition and Diagnostic Software
Refer to Acquisition and Diagnostic Software manual.
3.6. Connect the Cable and Power Cord
3.6.1. Connect Interface Cable
The reader interfaces with computer via USB2.0 cable or Ethernet cable. (RJ45 CAT.6 UTP)
1. Use the USB / Ethernet cable in the shipping container.
2. Connect the cable to the reader’s USB2.0 / Ethernet port, located on the rear of the
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reader.
3. Connect the other end of the cable to the USB2.0 / Ethernet port on the computer.
3.6.2. 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.
DANGER
This equipment is indoor use only and all the communication
wirings are limited to inside of the building.
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.
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.
DANGER
Do not use any power cord other than the power cord included
with the system. Doing so may lead to fire, electrical shock, or
electrocution.
WARNING
Do not pull out the USB / Ethernet cable during scanning.
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3.6.3. 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
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Chapter 4. Operating
4.1. System Specifications
Sampling Pixel Pitch Standard 200um
High 100um
Pixel Matrix (IP 35cm x 43cm) Standard 1750 x 2150
High 3500 x 4300
Pixel Matrix (IP 24cm x 30cm) Standard 1200 x 1500
High 2400 x 3000
Pixel Matrix (IP 18cm x 24cm) Standard 900 x 1200
High 1800 x 2400
Accepted Cassette Size 35cm x 43cm, 25cm x 30cm, 24cm x
30cm, 18cm x 24cm
Gray Scale Resolution 16 bit
Eraser Embedded
Computer Interface USB 2.0 / Ethernet
Dimensions 450 x 750x80mm
Weight 15Kg
Power Requirement 100 ~ 240V / 50 ~ 60Hz
System Configuration Tabletop or Wall Mount
Image File Format DICOM 3.0
* Specifications subject to change without notice.
** Specific results may vary since operating conditions fluctuate.
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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.
DANGER
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.
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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. Cassette Insert and Eject
Insert the cassette to the entrance of the reader and push gently until it reaches to the
protection wall inside of the reader. Green indication LED is on when the cassette is inserted
correctly. Insertion direction of the cassette must be parallel to the reader.
Cassette can be ejected when scanning and erasing are completed. Gently pull back the
cassette and ejection direction of the cassette must be parallel to the reader.
4.3.4. Getting a Scanned Image
To getting a scanned image, refer to 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.
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4.3.5. Circuit Functions
Figure 11. Circuit diagram
9 Power Board :
Power board generated DC Power of +15V, -15V, +5V
9 Main Board :
This parts controls peripherals for image acquisition. And it delivers amplified digitized
signal to PC via USB and Ethernet.
9 Driver Board :
This parts controls peripherals for PSD peak detect, Eraser control, high voltage
generation
9 BLDC Board :
This parts controls BLDC Motor and square mirror spin
9 RFID Board :
This part communicates with the RFID tag. RFID tag is contain IP Cassette information
9 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, Mirror and DC Motor” which are required to radiate laser onto imaging plate,
“ DC Motor” which assures proper insertion of the cassette.
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Chapter 5. Symbols
Symbol Description
Manufacturer
Date of Manufacture
Equipment Power ON
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
Fragile
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Handle with care
This side up
Non-ionizing electromagnetic radiation
FCC ID :
X68CRSCANNER3 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 Spark system is intended for use in the electromagnetic environment specified
below. The customer or the user of FireCR Spark 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 Spark 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 Spark 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
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5.2. Manufacturer’s Declaration - Electromagnetic Immunity
The FireCR Spark system is intended for use in the electromagnetic environment specified
below. The customer or the user of FireCR Spark 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 FireCR Spark
system requires continued
operation during power mains
interruptions, it is
recommended that the FireCR
Spark 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 Spark
system, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
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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.
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 Spark system.
The FireCR Spark system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The user of the FireCR Spark system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the FireCR Spark 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
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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:
A
t 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
5.3. Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The FireCR Spark system is intended for use in the electromagnetic environment specified below.
The customer or the user of FireCR Spark 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 Spark 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.
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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.
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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
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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.
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6.4. Shipping
The FireCR Spark is a solidly built system designed to survive shipping around the world.
However, in order to avoid damage during shipping, the FireCR Spark must be properly
packaged.
In general, the best way to package the FireCR Spark is in the original factory container. If
this is no longer available, we recommend that user carefully wraps the FireCR Spark 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 Spark. 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 Spark 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.
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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
Appendix I
Installation Report
Please complete this report at the time of installation and submit the
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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 Spark CR Reader
System S/N
Installer’s Signature: Date:
Customer’s Signature: Date: