User Manual

Computed Radiography Reader

Doc No. : TM-401-EN

Rev 1.2.3 Jan 2020
Part No. : CR-FPM-44-001-EN

Digiray, FireCR, Quantor are trademarks of Digiray, 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 Digiray. 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. Digiray Corp. strives to provide as accurate
information as possible, but shall not be responsible for any typographical error.

© Copyright 2019 Digiray Corp. All rights reserved.

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Contact

DIGIRAY Corp.

Headquarter
#825, Unitech vill, 1141-2, Baeksuk-dong, IlsanDong-
Gu, Goyang-si, Gyeonggi-do, 410-380, Rep of Korea

Tel : +82-31-8078-7784~5, Fax : +82-31-927-9988

Daejeon Factory
2F, 43, Munpyeongdong-ro, Daedeok-gu, Daejeon,
34302, Korea
Tel : 82-42-931-2100, Fax : 82-42-931-2299
Website : www.digiray.co.kr
E-mail : service1@digiray.co.kr

TechLink International

16445 COLLINS AVE # 522

SUNNY ISLES BEACH, FLORIDA, 33160,
UNITED STATES
Tel : 1-305-206-6777
E-mail : lilian@techlinkusa.net

Obelis s.a.
Bd. Général Wahis 53 B-1030 Brussels, Belgium
Tel : 32-2-732-59-54
E-mail : mail@obelis.net

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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 Digiray Corp. may only be made with prior written permission from
Digiray Corp.

Please read the respective manuals of the connected software, such as acquisition and
diagnostic software, before starting to use the system.

The following symbols will be used throughout this manual:

DANGER
General prohibition indication.
The functionality of the system can be destroyed in the case of
incorrect use.
If unauthorized changes have been made to delivered system and
accessories, the warranty by Digiray Corp. becomes void.
Digiray Corp. will not accept any responsibility or liability for
the proper functioning of the product in such a case.

DANGER
General mandatory action manual.
The functionality of the system can be destroyed in the case
of incorrect use.
If unauthorized changes have been made to delivered system
and accessories, the warranty by Digiray Corp. becomes void.
Digiray 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.

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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. Digiray 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 Digiray 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.
 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.

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 ............................................................. 16
3.3.1. Reader Connecting Part ........................................................... 16
3.3.2. Reader Status Indication LED................................................... 17
3.3.3. Reader Reset Button ................................................................ 17
3.4. Computer Requirements ................................................................ 18
3.4.1. Recommended Requirement .................................................... 18
3.4.2. Minimum Requirement ............................................................. 18
3.5. Installation of Acquisition and Diagnostic Software (Option) ........... 18
3.6. Connect the Cable and Power Cord ............................................... 18
3.6.1. Connect Interface Cable ........................................................... 18
3.6.2. Connect the Power Cord .......................................................... 19
3.6.3. Installation Report ..................................................................... 20

Chapter 4. Operating ...................................................................... 21

4.1. System Specifications .................................................................... 21
4.2. Operation Conditions ...................................................................... 22
4.3. Operating Instructions .................................................................... 23
4.3.1. Turn on the Reader ................................................................... 23
4.3.2. Turn on the Computer ............................................................... 23
4.3.3. Cassette Insert and Eject ......................................................... 23
4.3.4. Getting a Scanned Image ......................................................... 23
4.3.5. Circuit Functions ....................................................................... 24

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Chapter 5. Symbols ........................................................................ 25

5.1. Manufacturer’s Declaration – Electromagnetic Emission................ 26
5.2. Manufacturer’s Declaration - Electromagnetic Immunity ................ 27
5.3. Guidance and Manufacturer ’s Declaration – Electromagnetic
Immunity ..................................................................................................... 30
5.4. Laser Safety Statement .................................................................. 31

Chapter 6. Warranty and Repair Service ........................................ 32

6.1. Standard Warranty.......................................................................... 32
6.2. Repair Service ................................................................................ 32
6.3. Out of Warranty Repair Service ...................................................... 32
6.4. Shipping ......................................................................................... 33

Chapter 7. Technical Assistance ..................................................... 34

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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 100m and 200m 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 Reader

CR-FP-42-001 Cassette including IP 35cm x 43cm

CR-FP-42-002 Cassette including IP 24cm x 30cm

CR-FPA-02-001 USB 2.0 Interface Cable

CR-FPA-03-00X Power Cord

CR-FPM-34-001 FireCR Spark User Manual

Optional items
Part No. Item
CR-FP-42-003 Cassette including IP 18cm x 24cm

CR-FP-46-001 Wall Mounting Kit for FireCR Spark

CR-FP-05-001 FireKit Field Upgrade Kit

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
Digiray Corp.’s representative or related organs of government.
Do not dispose of any part of this equipment without
consulting a Digiray Corp.’s representative first.

Digiray Corp. does not assume any responsibility for

damage resulting from disposal of this equipment without
consulting Digiray 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

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. 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 19.5 kg (42.4 lbs) and requires two persons to lift. Carefully place the
reader into its final position.

Free space of 20 cm (8

Free space of 50 cm (20 inch) on backside, at

inch) on front side, at least, to allow the power

least, for cassette insertion switch, power cord and

and ejection. USB cord to be reached

by hand at all times.

Front Side Backside

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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 tabletop.

DANGER
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.

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.

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Free space of 50 cm (20 inch) on top side, at least, for cassette

insertion and ejection.

Front Side

Free space of 10 cm

(4 inch) on both

sides, at least.

Back Side

Free space of 20 cm (8 inch) on back side, at least, to allow the

power switch, power cord and USB cord to be reached by hand

at all times.

DANGER
Only authorized or trained personnel should set wall mount
installation.

NOTE
Refer to Wall Mount Installation Guide provided with Wall Mount
Installation Kit.

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DANGER
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.

DANGER
Digiray 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.

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

USB 2.0 Port

Power Inlet Power Switch
Ethernet Port

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3.3.2. Reader Status Indication LED

Indication LED shows the status of the reader as described below.

LED
Status Remark
Green Blue
On System On
Cassette is in initial position, and
On Ready to Scan
ready to scan.
Blinking Scanning
Blinking Erasing
Blinking Blinking Error

3.3.3. Reader Reset Button

In case that the reader is stuck during scanning, push reader reset button by sharp pin to
initialize the reader.

Reader Reset Button

WARNING
Do not push scanner reset button during scanning.

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3.4. Computer Requirements

3.4.1. Recommended Requirement

Operating System Microsoft Windows 7, 8, 10

CPU Intel CORE i5
Memory RAM 4 GB or more
Hard Disk 500 GB Free Hard Disk Space
Network 1 Gbps Ethernet
Video 32-bit Color Display
Video Resolution 1920 x 1080, 1440 x 900

3.4.2. Minimum Requirement

Operating System Microsoft Windows 7
CPU Intel Processor
Memory RAM 2 GB or more
Hard Disk 80 GB Free Hard Disk Space
Network 1 Gbps Ethernet
Video 32-bit Color Display
Video Resolution 1366 x 768, 1280 x 800, 1600 x 900, 1280 x 1024

3.5. Installation of Acquisition and Diagnostic Software

(Option)
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.5E FTP)

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
reader.
3. Connect the other end of the cable to the USB2.0 / Ethernet port on the computer.

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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 / Ethernet cable during scanning.

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 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 any power cord other than the power cord included
with the system. Doing so may lead to fire, electrical shock, or
electrocution.

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.

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3.6.3. Installation Report

After installation of the reader, fill in Installation Report from (Appendix I) and send to
3Digiray Corp. service department by fax or e-mail.

Fax : +82-31-927-9988
E-mail : service1@digiray.co.kr

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Chapter 4. Operating

4.1. System Specifications

Standard 200um
Sampling Pixel Pitch
High 100um
Standard 1750 x 2150
Pixel Matrix (IP 35cm x 43cm)
High 3500 x 4300
Standard 1200 x 1500
Pixel Matrix (IP 24cm x 30cm)
High 2400 x 3000
Standard 900 x 1200
Pixel Matrix (IP 18cm x 24cm)
High 1800 x 2400
35cm x 43cm, 24cm x 30cm, 18cm x
Accepted Cassette Size
24cm
AD Convert Resolution 16 bit
Eraser Embedded
Computer Interface USB 2.0 / Ethernet
456 x 803 x 136mm
Dimensions
17.9 x 31.6 x 5.4inch
21.5kg
Weight
47.4lbs
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
Digiray 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.

DANGER
This device uses laser. Avoid looking inside of the scanner.

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.

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.

4.3.4. Getting a Scanned Image

To getting a scanned image, refer to Acquisition and Diagnostic Software manual.

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4.3.5. Circuit Functions

Figure 11. Circuit diagram

 Main Board :
This parts controls peripherals for image acquisition. And it delivers amplified digitized
signal to PC via USB or Ethernet.
Main board generated DC Power of +15V, -15V, +5V
 Photo Module :
This parts controls peripherals for PSD peak detect, Eraser control, high voltage
generation
 BLDC Board :
This parts controls BLDC Motor and square mirror spin
 Front Board
 This parts “DC Motor” which assures proper insertion of the cassette
 RFID Board :
This part communicates with the RFID tag. RFID tag is contain IP Cassette information
 Peripheral :
This is peripherals for image acquisition. It consists of “Eraser” which erases residual
images in imaging plate, “Step Motor and 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

Equipment Power OFF

Warning, Consult Accompany Documents

General mandatory action manual

General prohibition indication

User Manual Reference

Directive on Waste Electrical and Electronic Equipment

Authorized Representative in the European

Community

Keep Dry

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Fragile

Handle with care

This side up

Non-ionizing electromagnetic radiation

FCC ID :
FCC Mark
X68CRSCANNER5
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 Group 1 The FireCR Spark 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 Spark is suitable for use in all
CISPR 11 establishments, including domestic
Harmonics emission A establishments and those directly connected to
IEC 61000-3-2 the public low-voltage power supply network that
Voltage fluctuation Complies supplies buildings used for domestic purposes.
IEC 61000-3-3

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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
IEC 60601 Electromagnetic
Immunity test Compliance level
Test level Environment -guidance
Electrostatic 6 kV Contact 6 kV Contact Floors should be wood,
discharge (ESD) 8 kV Air 8 kV Air concrete or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least
30%
Electrical fast 2kV for power supply lines 2kV for power supply lines 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 hospital environment.

Surge 1 kV differential mode 1 kV differential mode Mains power quality should be

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) fields should be at levels
Magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
Voltage dips, short <5% Uт (>95% dip in Uт) <5% Uт (>95% dip in Uт) 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% Uт (60% dip in Uт ) 40% Uт (60% dip in Uт ) user of the BSVD-1000 system
input lines for 5 cycle for 5 cycle requires continued operation
IEC 61000-4-11 during power mains
70% Uт (30% dip in Uт) 70% Uт (30% dip in Uт) interruptions, it is
for 25 cycle for 25 cycle recommended that the FireCR
Spark system be powered
<5% Uт (<95% dip in Uт ) <5% Uт (<95% dip in Uт ) from an uninterruptible power
for 5 s for 5 s supply or a battery

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Conducted RF 3 Vrms 3 Vrms Portable and mobile RF

IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz 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

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) 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.

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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.
Separation distance (m) according to frequency of transmitter
Rated maximum output
800 MHz to 2.5
power (W) of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz
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 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

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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
IEC 60601 Electromagnetic environment -
Immunity test Compliance level
Test level guidance
Conducted RF 3 Vrms 3 Vrms FireCR Spark 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.

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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

Warning
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

Digiray 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 Digiray 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 Digiray Corp
representative or your local dealer.

Digiray Corp.
#825, Unitech Venture Town, 142, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, 10442 Republic of Korea
Tel : 82-31-932-8 4 0 1 Fax : 82-31-927-9988
www.digiray.co.kr

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Appendix I

Installation Report

Please complete this report at the time of installation and submit the
completed form signed by customer to:
Fax : +82-31-927-9988
E-mail : service1@digiray.co.kr

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:

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