Fuji Film 01000004 Flat Panel Sensor User Manual Short Term Confidential 1 1

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Document ID	2716512
Application ID	euJedyA24pJIQShrT4mnkA==
Document Description	(Short-Term Confidential) User Manual_1-1
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	260.3kB (3253804 bits)
Date Submitted	2015-08-17 00:00:00
Date Available	2015-09-24 00:00:00
Creation Date	2015-07-24 09:28:09
Document Lastmod	2015-07-24 09:29:01
Document Title	(Short-Term Confidential) User Manual_1-1

FUJIFILM
DIGITAL RADIOGRAPHY F°' 53“ °P°'a"°"
System |
FUJIFILM DR —~—-~
Configuration
FIBR D'EVO QBEEEEQYE‘L'EWL
(DR-ID 600)
Basic Operation
Operation Manual
18th Edition : January 2014
Dally Inspection and _
Maintenance !
Appendix
Maintenance and H
Inspection I !
This Operation Manual describes details on how to operate the FDR D-EVO and cautions
to be observed when operating it. Please read the Operation Manual thoroughly belore
actually operating the FDR D-EVO along with “DR-lD :50ch Operation Manual’ and
other manuals for the related products.
F UJ | F I LM Corporation 32:22:39 this manual, store it nearbythe FDR D-EVO sothatyou can see itwhenever
asmmu‘laR
FDR D—EVO Opemim Mam-I an7N1o1473R
I Introduction
This Operation Manual includes descriptions of matters necessary when using the FDR D-EVO.
such as the equipment overview, operation procedures and precautions to observe. as well as daily
Inspections and maintenance.
Accompanying documents were originally drafted In the English language
Installation may only be conducted by authorized servlce personal.
Indications for use (for U.S.)
The Wired/\Mreless FDR D-EVO flat panel sensor system Is Intended to capture for display
radiographic images of human anatomy. It Is Intended for use in general projection radiographic
applications including pediatric and neonatal exams wherever conventional film/screen or
CR systems may be used. The FDR D-EVO Is not intended for mammography, tluoroscopy.
tomography, and angiography applications.
Intended use (for European Union and other countries.)
The FDR D-EVO flat panel detector system Is Intended to capture for display radiographic images
of human anatomy. It is intended for use in general projection radiographic applications wherever
conventional film/screen or CR systems may be used.
Note : The above statements were determined by applicable medical device regulations which vary
throughout the world. These statements are subject to revision when additional clearance or
approval is obtained.
(2&7 CAUT_ION_S )
1.
3.
4.
No part or all of this manual may be reproduced In any form without prior pennlsslon.
. The information contained In this manual may be subject to change without prior notice.
FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
Installation, relocation, remodeling, maintenance, and repair performed by other than dealers
specified by FUJIFILM Corporation.
FUJIFILM Corporation shall not be liable for malfunctions and damages of FUJIFILM Corporation
products due to products of other manufacturers not supplied by FUJIFILM Corporation.
. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from remodeling,
maintenance, and repair using repair parts other than those specified by FUJIFILM Corporation.
. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
negligence of precautions and operating methods contained In this manual.
. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from use
under environment conditions outside the range of using conditions for this product such as
power supply, Installation environment, etc. contained In this manual.
. FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from natural
disasters such as fires, earthquakes, floods, lightning, etc.
This system Is classified as a medical device under EC Directive 93/42IEEC.
caution : Rx Only In the United states (Federal law restricts this device to sale by or on the order
of a physician.)
Open-Source Software Contained in This Product
This product contains third party‘s software that is made available as open source software orfree sottware.
This software is provided “as is" with no warranty of any kind as to its merchantability or fitness for any
particular purpose.
For the Information on open source software contained in this product, please see the attached DVD.
Source codes for certain type of open source soltware used in this product are available at delivery cost.
If you would like to receive such source codes, please contact FUJIFILM dealer or the service
representatives at the agency from which you purchased this product. (Please be noted that any inquiries
concemlng the contents of source codes should be directed to original licensors of open source software.)
Note : FUJIFILM has successfully performed verification and validation testing on all third party
software and has confirmed its suitability to be used in this system.
Trademarks
All company names and product names described in this manual are the trademarks or registered
trademarks of FUJIFILM Corporation or their respective holders.
Nndows Is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries.
Copyright 0 2010-2014 FUJIFILM Corporation. All rights reserved.
FDR DEVO Operation Mum-I semiomsR iii
I FDR D-EVO System Operation Manuals
iv
For the us. For other countries
DIGITAL RADIOGRAPHY
FDR D-EVO (DR-lD 600) Operation Manual
DIGITAL RA DIOGRA PHV
FDR D-EVO (DR-ID 600] Operation Manual
DR-ID GDDPU Operation Manual
DR-ID GOOFU Operation Manual
DR-ID GOOCL Operation Manual
DR-lD SUOCL Operation Manual
Access Point Operation Manual“
*1 See the operation manual for the designated access point.
0 See "DR-ID SUOCL Operation Manual" along with the manuals for the related products
0 The DR—ID GOOMC mns on a commercially available personal computer, However, operations
are not required to use the FDR D-EVO. For operations of a oommerclally available personal
computer. see the operation manual provided by the manufacturer.
Manage and store all the Operation Manuals of the devices constituting the system together as a set.
For the U.S. For other countries
DR—ID coo ’
DR-ID 600
DR-ID sooRU DR-ID GOORU
DR-ID GODPU DR-ID SUOPU
Flat panel sensor lFletpenel lenwr Fletpenel sensor Flai panel sensor [Flat panel lenw Flat panel sanscr
Flat panel sansarI lFlat panet sensor IFlstpanal sensor 1 Fill panel mam
Power supply unit Pawar supp» mitt
DR-lD some DMD snow
"“39“ Control oebiiet" anile "m”
n!
pmoessiu uni processing will
I DRJDJWCL DMD mm mm” DR—iD wocL
Huh Hub
image processing unit of other dlgltel raaicgragny system Access image piooessing unit of other digital raglcgrsgny system
DR-ID waCL lnaint-2 DR—lD clonCL
The configuration of the system varies depending on the country.
There are six types of flat panel sensors: DR-ID 601SE, DR-ID GOZSE, DR-ID 611$E, DR-ID 6125E
and DR-ID 613$E (wireless/wired communlcation mode) and DR-ID GOOSE (wired communication
mode), Although the contents of this manual are described by taking the example oi DR-ID 601SE,
the same can also be applied to other flat panel sensors. Vinth regard to the description specific to a
certain type of flat panel sensor, the product name is given in the description. '
*1 Depending on the configuration, the control cabinet (DR-ID BOOMC) may not be Included in the system.
If not included. the software for the control cabinet can be Installed on the image processing unit (DR-ID
300m).
For detail specification of image processing unit, please refer to “DR-ID SOOCL Operation Manual”.
*2 Wm regard to the access point, consult our official dealer or FUJIFlLM Representative.
FDR D-EVO Oversilm Manual comma?“
I Contents at a Glance
(linemen 1
{ditzigltar 5
Appendix
For Safe Operation
This chapter presents Warnings and Cautions we wish you to observe tor safe
operation of the FDR D-EVOt
System Configuration (Product Overview)
This chapter gives the various unit names and describes their functions and
features 0' the FDR D CAUTIONS
"some“ , ,_) __._.___
For veterinary or mobile applications, contact a FUJIFILM dealer.
Q8 7 CAUTIONs 7 W
.s_._. , , ,,,,,,,, , / __._._—
Use the system Indoor in wireless communication mode. For details, contact a FUJIFILM dealer.
($77 ,,9AgT,!9!§,. ,1 _______
Do not place any object In a place where removal of the power cable Is prevented.
Connec n lnstructi
A WARNING ___——
Make sure that the devices to be connected to the equipment are authorized for connection.
A ‘ WARNING
Connect the DR-ID GOOPU only to the designated control cabinet (DR-ID GOOMC). When the DR-ID
GonPU ls connected to X-ray equipment, make sure that the equipment complies with IEC 60601-1.
FDR DEVO Operation Manuel mmmmn | 1.5
uopuado 91's 10$ m
s on External Network C
Qt: CAUTIONS )
When a setting of the network to which the equipment Is connected has been changed, check
that the change does not affect the system operation and take measures If necessary.
The setting change may Include the following:
o Change of connection destination
Addition of devices
Removal of devices
Update of devices
Upgrade of devices
ons on Network
( CAUTIONS
Connect to the Ethernet Network of 1000BASE-T, 1OOBASE-TX, or 1OBASE-T prescribed in the
IEEE standard 802.3.
Do not connect telephone lines to LAN connector. Only UTP-type straight LAN cables of A-pair
Category 5 cable (CAT 5E) or higher are appropriate for connection to this connector.
W J
After connecting this system to the network with other systems, confirm that the other systems
are not affected. If they are affected, take countermeasures such as network separation.
System Isolation Instructlo
A , WARNING
To ensure complete system isolation, never Install any unauthoflzed accessories or other such items.
When it Is necessary to Install authorized accessories or optional items, contact a FUJIFILM dealer.
A 7, ,,,, WARNING
Keep equipment other than those used for patients out of their reach to ensure appropriate
system isolation.
A WARNING
Do not move the Image processing unIt from where It Is Installed.
A , WARNING
In normal use, have a patient take a proper positioning for exposure. The operator should
operate the system In a place where safety from radiation ls ensured. The operator should
also make sure before exposure that no one but the patient is in the exposure area and the
operating area of the system.
1.6 ‘ FDR oEvo Operlllen Minuet mmomsk
Software Free
«LA—c
Do not Install additional software to the system. Do not unlnstall any of the software
prelnstalled In the system.
The system Is prelnstalled with the appropriate software. If other software Is Installed or If the
existing software Is unlnstailed, various operational errors may result.
Disinfection Ins ctions
A , fiIVIIIARNINGV
OI'IS
Conf m that the respiratory density of disinfectant Including solvent Is under legal regulation.
Certain disinfectants may damage health. When using a disinfectant, follow Instructions
supplied by the manufacturers.
A, WARNING
Do not use the following disinfectants or ster rs at the time of dlslnfectlon. Quality,
performance and safety of the equipment cannot be assured.
e Chlorlc disinfectant which is strongly corrosive to metals and rubber parts.
0 Disinfectant whose uses on metals, plastics, and coating are forbidden according to the
Instructions supplied with the disinfectant.
- Formalln gas and disinfectant sprays that may get inside the equipment.
- Ultraviolet sterilizers
Disinfectant ethanol ls recommended for disinfection. Carefully read the instructions and
cautions supplied with the disinfectant before use.
For details on the disinfectant, contact a FUJIFILM dealer or the service representatives at the
agency from which you purchased the disinfectant.
C13,," EAUTIONS, _ W)
Clean the sensor u
to prevent Infection.
of the flat panel sensor with ethanol for disinfection, etc. for each patient
Precautions for Charging the Battery
(2:3 ,,,,,gwrms; J
Observe the following precautions when charging the battery pack (optional) using the battery
charger (optional).
- Do not use the battery pack (126N100050) or battery charger In combination with any battery
pack or battery charger (Including the Ac adapter) other than those recommended by
FUJIFILM Corporation.
Do not disassemble or convert the battery pack or battery charger.
If the battery pack or battery charger becomes faulty, consult our official dealer.
Do not cover the holes In the battery charger with foreign matter.
Avoid the accumulation of dust on the battery charger.
Insert the battery pack into the battery charger securely.
if the insertion direction or position of the battery pack ls Incorrect, the battery is not
charged properly.
- When lnsertlng the battery pack, prevent foreign matter from getting Into the battery charger.
FDR D-EVD Onerllion Manual se‘lemaR ‘ 1.7
uoguedo ens we aim
unnuado we we can-Am
0 While charging the battery, do not allow the battery pack or battery charger get wet or dusty.
0 Do not step on the AC adapter of the battery charger. Also, be careful not to trip over the
power cable.
o Do not subject the battery and battery charger to severe shock (by dropping them, etc.).
0 Do not place the battery charger within the reach of patients.
a Do not charge the battery pack near fire or under strong sunshine. If the built-In protection
mechanisms are activated by a high temperature, the battery pack cannot be charged. Also,
If the built-In protection mechanisms are damaged, the battery pack may be charged with
extremely high current and voltage, and abnormal chemical reactions may occur inside the
battery pack, causing it to overheat, emlt smoke, explode or Ignite.
c To charge the battery pack, be sure to use the designated battery charger and to observe
the charging conditions specified by FUJIFILM Corporation. If the battery pack Is charged In
other conditions (temperature or voltage/current higher than specified, remodeled battery
charger, etc.), the battery pack may be overcharged or charged with extremely high current,
and abnormal chemical reactions may occur Inside the battery pack, causing it to overheat,
emlt smoke, explode or ignite.
0 Immediately stop charging the battery pack, If charging is not completed within the specified
time. Otherwise, the battery pack may overheat, emit smoke, explode or Ignite.
a Do not use the flat panel sensor near the AC adapter.
0 Do not use the broken battery charger.
ttery Pack (Optional) Instruct
A WARNING 7
lfthls equipment is not In use for while, store it with the battery pack removed. Not removing the
battery pack may cause malfunction.
(ZS CAUTIONS )
Observe the following precautions when using the battery pack (optional).
- The battery pack (126N100050) ls exclusively for the flat panel sensor (DR-ID 6015i,
DR-ID 602$E, DR-ID 611SE, DR-ID 61st and DR-ID 613$E). Do not use them In other
combinations.
0 Charge the battery pack only with the designated battery charger. If the battery pack is
charged under the charging conditions (voltage, current and charging method) different
from those specified by FUJIFILM Corporation. the battery pack may emit smoke, Ignite,
explode or leak fluid.
- When storing the battery pack for a long period, charge the battery fully, remove it from the flat
panel sensor and then store It in a cool and dark place. Recharge the stored battery every six
months or every year. Otherwise a decrease In battery capacity or other problems may result.
a Do not leave the removed battery pack In the car or other places exposed to high
temperature. If the battery pack is used or stored In a place where it is exposed to high
temperature, the battery pack may emit smoke, Ignite, explode or leak fluid.
- Use or store the battery pack only In the envlronmenml conditions specified by FUJIFILM
Corporation. It the battery pack Is used or stored In a place where It Is exposed to high
temperature, the battery pack may emlt smoke, ignite, explode or leak fluid.
- When disposing of the battery pack, consult our official dealer.
0 Do not disassemble or remodel the battery pack. The battery pack Is equipped with built-in
safety and protection mechanisms. If they are damaged, the battery pack may overheat, emit
smoke, explode or Ignlte.
- Do not connect the positive (+) and negative (-) terminals with a wire or any metal object.
Do not carry or store the battery pack together with metal objects such as necklaces or
hairpins. Otherwise, the battery pack may short-circuit and overcurrent may flew, causing
the battery pack to overheat, emit smoke, explode or Ignite. Metal objects such as necklaces
or hairpins may also become hot.
a Do not throw the battery pack into fire or expose It to excessive heat. Otherwise, Its Insulator
may melt, its gas release vent or safety mechanisms may be damaged, and/or Its electrolyte
may catch fire, causing the battery pack to overheat, emlt smoke, explode or Ignite.
1.3 ‘ FDR D-EVO Operdllon Manual mNIoIflaR
Do not use or leave the battery pack In a place where it Is exposed to high temperature (”'0
or higher), such as fire or a heater. If the resin separator is damaged due to heat, the battery
pack may short-circuit, causlng It to overheat, emit smoke, explode or Ignlte.
Do not Immerse the battery pack In water or seawater, and do not allow It to become wet.
If the buIIt-ln protection mechanisms are damaged, the battery pack may overheat, emit
smoke. explode or Ignite.
Do not pierce the battery pack with a hall, hit It with a hammer, or step on It. Otherwise, the
battery pack may be damaged or deformed and short-circuit. causing it to overheat, emlt
smoke, explode or Ignite.
Do not subject the battery pack to strong impact or throw It. If the built-In protection
mechanlsms are damaged, the battery pack may be charged with extremely high current and
voltage, and abnormal chemical reactions may occur lnslde the battery pack, causing It to
overheat, emit smoke, explode or Ignlte.
Do not use an apparently damaged or deformed battery pack. othenuise, the battery pack
may overheat, emlt smoke, explode or Ignite.
Do not solder the battery pack directly. Otherwise, Its Insulator may melt, or Its gas release
vent or safety mechanisms may be damaged, causing the battery pack to overheat, emit
smoke, explode or Ignite.
Do not reverse the positive (+) and negative (-) terrnlnals. Othenulse, the battery pack may
be reverse-charged during charging. As a result, abnormal chemical reactions may occur
Inside the battery pack, or extremely high current may flow during dlscharging, causing it to
overheat, emit smoke, explode or Ignlte.
The battery pack has a predetermined polarity. If you cannot connect the battery pack to the
battery charger or other equipment, do not connect the battery pack forcefully. Make sure
that the terminals are correctly oriented. If the battery pack ls connected In reverse, It wIII
be reverse-charged, and abnormal chemlcal reactions may occur lnslde the battery pack,
causing It to overheat, emlt smoke, explode or ignite.
Do not connect the battery pack to an electrical outlet or cigarette lighter socket in a car.
Overcurrent may flow to the battery pack due to high voltage applied, causing the battery
pack to overheat, emit smoke, explode or Ignite.
Do not use the battery pack for equlpment other than those specified. Otherwise, the
guaranteed performance will be reduced and/or the service life will be shortened. Depending
on the equipment to which the battery pack Is connected, extremely high current may flow,
causing the battery pack to be damaged, overheat, emit smoke, explode or Ignite.
If the electrolyte leaked from the battery pack enters the eyes, do not rub them. Wash the
eyes Immediately wlth clean water such as tap water, and consult a doctor. Otheanse, eye
Injury may result.
Do not use the battery pack In comblnatlon wlth a primary battery such as a dry battery or
other battery of a different capacity, type and/or brand. Otherwise, the battery pack may
be overcharged during charging, and abnonnai chemlcal reactlons may occur inside the
battery pack, causing It to overheat, emit smoke, explode or Ignite.
Keep the equipment or battery pack out of the reach of small children to prevent them from
accldenmlly swallowing the battery pack. If swallowed, consult a doctor Immediately.
Do not put the battery pack In a microwave oven or high-pressure container. Othewvise, the
battery pack may be rapidly heated or damaged, causlng it to overheat, emit smoke, explode
or Ignite.
If the battery pack leaks or emlts an unusual odor, remove It from fire Immediately.
Otherwise, the leaked electrolyte may catch fire, causing the battery pack to overheat, emlt
smoke, explode or Ignite.
If you notice an unusual odor, heat, discoloration, deformation or any other abnormailty during
use, charglng or storage, remove the battery pack from the equipment or battery charger, and
stop using It. Othenuise, the battery pack may overheat, emit smoke, explode or Ignite.
Do not use the battery pack exposed to a strong magnetic field of an MRI system, etc.
Do not use the battery pack Immersed in liquid.
FDR D-EVO Operation Manual ae7N1nunR I 1.9
ulcer-Mo 3’95 ms mam
Warnings for Pediat c e
A ,,, ,,,,,vyAI3NI,NG ,, ,, —_
o If the exposure conditions for average-size adults are applied to children, It may cause excessive
radiation exposure.
0 Studies show that children are more radiosensitlve than adults (Le. children are at higher risk
of developing cancer compared to adults exposed to the same dose of Ionizing radiation).
Accordingly. In pediatric use, special attention needs to be paid to avoid unnecessary exposure.
0 Based on the clinical application, pathological conditions of the patient. patient slle, and
anatomical Imaging region, adjust the exposure conditions to use the minimum amount of
radi ion necessary to obtain appropriate medical images.
0 An additional filter can also be used for children to reduce unnecessary exposure further.
0 If children cannot be exposed at an appropriate dose with the AEC, do not use the AEC.
0 Adjust the exposure conditions to minimize the X-ray exposure time to avoid repeated exposure
due to body movement.
Other Warn ngs Cautlo
[A WARNING
main
uonuado ans :0;
No modification of this equipment is allowed.
Install the system In accordance with what is provided by IEC 60601-1-1:2000 and IEC 60601-
1:2005 Chapter 16. Contact a FUJIFILM dealer for Installation and relocation (except the flat
panel sensor) of the system.
” ,9m~:,,,,)
Do not hit or drop the equipment. OthenMise, injury or damage to Images, etc. may result.
CZS— ._, J
Be sure to Inspect the system periodically.
To assure optimum performance of the equipment. It Is necessary to systematically perform
maintenance and Inspection. For Information on maintenance and Inspection, contact a
FUJIFILM dealer.
Co
ndications and Prohi
No contraindications present.
1.10 l FDR osvo Dperilion Mew-l asvmmme
| 1.4 Electromagnetic Compatib ty (EMC)
Essential performance
(1) DR-ID GOOSE/DR-ID 601SE/DR-ID BO2SE/DR—ID 611SE/DR-ID 61ZSE/DR—ID 61SSE obtalns images.
(2) DR-ID GODMC stores Images.
(3) DR-ID GODMC corrects Images.
(4) Image transfer in order from DR-ID GODSE/DR-ID 601 SE/DR-ID 602$EIDR-ID 611 SE/DR-ID E1ZSEI
DR-ID 613$E, DR~|D SOOMP, DR—lD BOOMC, to DR-ID 3000L
(5) DR-ID 3000L stores and displays images after correction.
(6) It shall fulfill and maintain the safety requirement of the standards.
DR-ID 600 Is consists of following components and conforms to IE0 60601-1-2 as a result of each component
conforms to following standards.
' DR-ID SOOPU
' DR-ID SOOMC — CISPR 22 ICISPR 24
' DR-ID 3000L —v—« CISPR 22 [CISPR 24
' Access polnt (BAP-2553) -- EMI : CE. FCC, IC (It is equivalent to CISPR 22.)
"09“910 WIS 10: m
IE060601-1-2
1.4.1 DR-ID GOOPU
DR-ID 600PU consisIs of DR-ID 600MP and DR-ID 6008E/DR-ID 601SE/DR-ID BOZSEIDR-ID 611SE/
DR-ID 61ZSEIDR-ID 613SE.
This equipment has been tested and found to comply wlth the Ilmlts for medical devices to the IEC
60601-1-2 (EN60601-1-2), Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful Interference in a typical
medical installation.
This equipment generates, uses and can radiate radio frequency energy and, If not Installed and
used In accordance with the instmctions, may cause harmful interference to other devlces In the
viclnlty.
However. there is no guarantee that Interference will not occur in a particular installation
If this equipment does cause harmful Interference to other devices, which can be determlned by
tunlng the equipment off and on, the user is encouraged to try to conect the Interference by one or
more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separatlon between the equipment.
' Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
If the problem cannot be solved with the above measures. stop using thls equlpment and consult
the manufacturer or our official dealer for help.
A ,, WARNING, , ,
a Do not place devices generating electromagnetlc wave near this equipment.
a If a devlce(s) other than those spaclfied is connected, predetermined EMC performance
cannot be guaranteed.
FDR oEvo oymtinn Menu-I ac'INtounR I 1.11
"anemic 959910! m
Further informa Ion for IEC 60601 (ENS 601 )
1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided In the accompanying documents.
2. Portable and mobile RF communications equipment can affect medical electrical equipment.
3. Information regarding the cable affecting EMC is as follows.
Name Connected Device Maximum Length Gananl Specification
Network Cable Between the DR-lD SOOPU 30m (98.4 it) Cat5e or more.
and the DR-ID 600MC UTP type and straight cable
Between the DR-ID SOOMC
and the DR-ID SOOCL
Power Cable DR-lD 600PU
100m (328.1 ft)
3m (9.8 it) Use a hospital grade power cable.
(for North America)
A non-hospital grade power cable
can be used. (for other countries)
4. The use of accessories. transducers and cables other than those specified, with the exception of
transducers and‘cables sold by FUJIFILM Corporation as replacement pans for internal components,
may result in increased emissions or decreased immunity of the DR-ID 600PU.
5. The DR-ID GOOPU should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the DR-ID 600PU should be observed to verify normal
operation In the configuration in which it will be used.
6, Basic performance of the equipment and the system
Alter image data are acquired from the DR-iD BOOPU, data correction is performed by the control cabinet
(DR-ID GOOMC). and the image is saved In and displayed on the image processing unit (DR-iD BGOCL).
7. Test items (Tables 1 to 4)
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
The DR-iD GOOPU is intended for use in the electromagnetic environment specified below.
The customer orthe user of the DR—ID BOOPU should assure that it Is used In such an environment.
Emissions test Compliance Electromagnetic environment - guidance
The DR-ID SOOPU uses RF energy only for their Internal
iunaion.
RF emissions
CISPR 11 Group 1 Therefore. their RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Th DR lD SOUPU ’ it bl f u e in all establishments
. 9 ~ IS SU E S OF S
Eg’é‘fggfgssw“ Complies DR-ID coopu: ClassA other than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
CIassA
Voltage liuciuations/
flicker emissions Complies
lecs1ooo-a-3
1.12 I FDR oEvo Opeminn Manual owmomaR
Table 2
Guidance and manufacturer‘s declaration -electroma9netlc Immunity
The DR-iD SDOPU is intended for use In the electromagnetic environment specified below.
The customer or the user of the DR-ID 600PU should assure that it is used In such an environment.
EC 60601-14 Electromagnetic environment -
Immunity test test level Compliance level gul dance
Electrostatic Floors should be wood, concrete or
discharge tskv contact :GkV contact oeramic tile. if floors are covered with
(ESD) 28W air tBkV air synthetic material, the relative humidity
|ECS1000-4-2 should be at least 30%i
Electrical fast :32: 7"" power Supply fig: for power supply Mains power quality should be that
transient/burst . oi a typical commercial or hospital
IE661000-4-4 *1kV for input/output s1kV for Input/output environment.
lines lines
. Mains power quality should be that
Surge 11W dlllerentlal mode s1kV differentlal mode .
oi a typical commercial or hospital
IECG1000-4-5 tZkV common mode sZkV common mode environment.
<5% u, <5% 0,
(>95% dip in UT) (>95% dip In UT)
for 0.5 cycle for 0.5 cycle Mains power quality should be that
Voltage dips. short 40% U, 40% Ur ofa typical commercial or hospital
Interruptions and (60% dip In Ur) (60% dip in Ur) environment. lithe user of the DR-ID
vohage variations on for 5 cycles tor 5 cycles 600FU requires continued operation
power supply input 70% Ur 70% Ur during power mains interruptionsI it Is
lines (30% dip in ”1) (30% dip in UT) recommended that the DR-lD 600PU be
lEC61000-441 for 25 cycles for 25 cycles powered from an unlnterruptlble power
<5% UT <5% UT supply or a battery.
(>95% dlp In U1) (>95% dip in Uy)
_ for 5 s tor 5 a
Power frequency Power frequency magnetic tields should
(50/60Hz) magnetic be at levels characteristic of a typical
iield 3 N'" -‘ 3 N'“ location in a typical commercial or
IE061000—4-8 hospital environment.
NOTE: Urls the ac. mains voltage prior to application of the test level.
FDR oEvo Dyer-1m" Manual eomtou‘laR I 1.13
uonuado ems an; m
.fln
uontuario ops 105
Table 3
Guidance and manufacturer’s declaration -electromagnetlc Immunlty
The DR-lD MOPU is intended for use in the electromagnetic environment specified below.
The customer orthe user of the DR—ID 600PU should assure that It is used In such an environment.
Immunity test
IEO 60801-1-2 teat level
Compliance level
Electromagnetic environment - guidance
Conducted RF
|ECG1ODN-B
Radiated RF
|ECG1OOM3
3 Vrrne
150 kHz to 80 MHZ
3 Wm
80 MHz to 2.5 GHz
3 Vrma
Portable and mobile RF communications equipment
should be used no closerto any part of the DR-ID
GDOPU. Including cables. than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 12/;s
d =1.2/15 60 MHz to 800 MHz
d = zafi 800 MHz to 2.5 GHz
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 metres (m)i
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey.‘
should be less than the compliance level in each
frequency range.”
Interference may occur in the vicinity of equipment
marked with the following symbol:
(03))
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations Electromagnetic propagation is afiected by absorption and
reflection from structures, objects and people.
Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios. amateur radioI 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 DR-ID BMW is used exceeds
the applicable RF compliance, the DR—ID BOOPU should be observed to verify normal operation. if abnormal
performance is observed. additional measures may be necessary, such as reorienting or relocating the DR-iD
GOOPU.
Over the frequency range 150 kHz to 30 MHz. field strength should be less than 3 Vim.
1.14 | FDR oevo Opevaflon Mutual commune
Table 4
Recommended separatlon dletancee between
Portable and moblle RF communications equipment and the DR-ID snow
The DR-ID GOOPU is intended for use In the electromagnetic environment in which radiated RF disturbances are
controlled.
The customer or the user of the DR-ID SOOPU can help prevent elearomagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the DR-iD 600PU as
recommended below. according to the maximum output power ol the communications equipment.
Rated maxlmum output
power of transmitter
Separation distance according to frequency 9| transmitter
150 kHz to so MHz
d= 12/!S
50 MHz to 800 MHz
d: 1.2/15
aoo MHz to 2.5 5H:
d = 2M5
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
38
7.3
100
12
12
23
For transmitters rated at a maxlmum output power not listed above. the recommended separation distance din metres
(m) an be estimated using the equation applicable to the frequency of the transmitter, where P is the maxlmum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer
NOTE 1: A180 MHz and 800 MHz, the separation distance (or the higher frequency range applies.
NOTE 2: These guidelines may ncl apply In all situations,
Electromagnetic propagatlon is affected by absorption and reflecu'on from structures. objects and people.
arr-hm
uopeudo 3’23 105
FDR DEVO Openlion Menu-l mmamaa | 1.15
"unmade ates we m—
1.4.2 DR-ID GOOMC and DR-ID 3OOCL
This equipment has been tested and found to comply with the international standard for medical
devices below. according to the requirement of the IEC 60601-1-2/EN 60601-1-2.
EMC Standard : CISPR ZZIEN 55022
CISPR 2AIEN 55024
lECB1000-3-2IEN61000-3-2
|ECG1000—3—3/EN61000-3-3
This does not guarantee that there Is no harmful electromagnetic interference under any Installation
environment.
This equipment can generate, use and radiate radio frequency energy. Ifthe equipment is not
installed and used in accordance with the instructions. or If peripheral devices that are not complied
with the EMC standard, harmful interference may be generated under a particular environment
causing malfunction of the equipment and other devices.
If this equipment causes harmful interference to other devices, or If this equipment is affected by
interference from other devices. the user is encouraged to try to correct the interference by one or
more of the following measures:
- Reorient or relocate the receiving device.
' increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
If the problem cannot be solved with the above measures, stop using this equipment and consult
the manufacturer or our official dealer for help.
A , WARNING, ,
Do not place devices generating electromagnetic wave near this equipment.
er informa n for CISPR 22 I EN55022 and CISPR 24 I EN550
1. Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC Information provided in the accompanying documents.
2. Portable and mobile RF communications equipment can affect medical electrical equipment.
3. Information regarding the cable affecting EMC is as follows
Name Connected Device Maximum Length General Specification
Network Cable Between the DR-ID GOOPU and 30m (98.4 ft)
the DR-ID GDOMC Cai5e or more
Between the DvaD some and 100m (328.1 ft) UTF We 9"“ SW9” *b'e
the DR—ID 30ch
Power Cable DR-lD EDDMC and DR-ID 3DOCL Depends on the cable length of a personal computer.
4. The use of accessories, transducers and cables other than those specified. with the exceptlon
of transducers and cables sold by FUJIFILM Corporation as replacement parts for intemai
components, may result In Increased emissions or decreased Immunity of the DR—ID GDOMC and
the DR-iD SDDCL.
5. The DR—ID GDDMC and the DR-ID SOOCL should not be used adjacent to or stacked with other
equipment.
If adjacent or stacked use is necessaw. the DR-ID BUOMC and the DR-ID 3OOCL should be
observed to verify normal operation in the configuration in which it will be used.
6. Basic performance of the equipment and the system
After Image data are acquired from the DR-ID BDDPU. data correction Is performed by the control
cabinet (DR-ID 600MB), and the image is saved In and displayed on the image processing unit
(DR-ID 3000L).
7. Test items (Tables 1 to 3)
1-16 I FDR DEVO ova-ton MIIIIMI ee7N1im73R
Table 1
Guidance and manufacturer‘s declaration - electromagnetic emissions
The pR—ID SDOMC and the DR-iD SDOCL are intended for use In the electromagnetic environment specified below
The customer or the user of the DR-ID SDOMC and the DR-iD SOOCL should assule that they are used In such an
environment.
Emissions test Compliance
Noise terminal voltage
CISPR 22 0'93”
EN55022
Electric field noise strength
CISPR 22 0'53”
EN55022
Harmonic emissions
EN61000-3-2 Class D
IE061000-3-2
Voltage fluctuations/flicker emissions
EN61000-3-8 Complies
IE061000-3-3
Table 2
Guidance and manufacturer‘s declaration -electramagneti immunity
The DR-ID GDDMC and the DR-ID 3000L are intended for use in the electromagnetic environment specified below.
The customer or the user of the DR-iD GOOMC and the DR-ID :50ch should assure that they are used In such an
environment.
immunity test ENIIEC test Compliance level
Electrostatic discharge (ESD)
i4kV Contact MkV contact
ENSi 000-4-2 *BkV air takV air
|EC61000-4»2
Electrical fast transientlburst
t1 W for power supply lines 21w for power supply lines
EN61000~4~4 *D.5kV for Input/output lines 20.5w for input/output lines
|ECG1 000—4-4
Surge
1:1.0kV dilferential mode 11.0kV differential mode
EN51000-4-5 22.0w common mode t2.0kV common mode
lE061000-4-5
Voltage dips, short interruptions and <5% UT <5% U7-
voltage variations on power supply (>95% dlp In Ur) (>95% dlp In UT)
Input lines for 0,5 cycle for 0.5 cycle
70% u, 70% U,
EN61000-4-11 (30% dlp In U,) (30% dip in U,)
lECe1OOU-4-11 (or 25 cycles tor 25 cycles
<5% UT <5% u,
(>95% dlp In UT) (>95% dlp In Uy)
for 250 cycles for 250 cycles
Power frequency (soleon)
magnetic field
1 Alm 1 Alm
EN61000-4-8
lECS1000-4-8
NOTE: U1 is the ac mains voltage priorto application at the test level.
FDR osvo spar-um Manual commune I 1.17
uonuado ms :05
“ORUWO ans 10$ “in
Table 3
Guidance and manufacturer’s declaration - electromagnetic immunlly
The DR-lD 600MB and the DR-ID SODCL are intended for use in the electromagnetlc environment specified below.
The customer or the user of the DR—ID BOOMC and the DR-ID SOOCL should assure that they are used in such an
environment.
llnvnunlly um ENIIEC Inst Compllance level
Conducted RF 3 Vrms 3 Vrms
EN51000-4-6 150 kHz lo 80 MHZ
IE061000-4-6
deialed RF 3 Wm 3 Wm
EN61000-44 30 MHz to 1 GHz
IE061000-4-3
1.13 ' rm D-EVD overallon Mum-1 asmmmk
| 1.5 Precautions in Using the FDR D-EVO
This section describes the precautions in using the FDR D-EVO.
1.5.1 Handling
Handle the flat panel sensor carefully since it Is
manufactured with precision.
If the flat panel sensor or the SE cable connector is hit or
dropped or ls subject to severe shock, it may be damaged.
it the front and rear of the flat panel sensor are subject to
Impact by a projection. It may be damaged.
DR-ID SOOSE is equipped with a shock sensor that detects
a severe impact. For details. see ‘I DR-ID 600PU" (page
2-3).
CA_ CMJT'ONS, , , ,,.>
ifthe shock sensor lights red. contact a FUJIFlLM dealer.
Do not pull the cable of the flat panel sensor (wired
communication mode). I
Also. do not pull the flat panel sensorwith something caught
by the cable.
Make sure that the cable is not trapped under the wheels of a
stretcher or wheelchair.
othenrvise. the cable will be damaged. causing electric shock
or fire.
When carrying the flat panel sensor (wired communication
mode), do not drag the sensor cable relay connector on the
floor or ground, Make also sure that no one or object comes
Into contact with the flat panel sensor. it is recommended to
hold the connector when carrying the flat panel sensor,
Unless these cautions are observed, the flat panel sensor
may be caught by an object, personal injury may result. or
properties or the connector may be damaged.
Do not hold the flat panel sensor In one hand when carrying it.
Hold It In both the hands or under the arm.
FDR oevo Opumou Manual mmomm l 1.19
nonmdo was we will:
mam
uonuado ans Jog
If any of "we screw caps on the flat panel sensor comes oil, Screw
attach a spare cap. Otherwise, artifacts may appear in the
Image due to static electricity. 0
To ensure optimal image quality, it is recommended that you do °
not use the flat panel sensor near devices (motor, transfonner,
switching supply, etc.) that generate electromagnetic noise.
To ensure optimal Image quality, it is recommended that you do DR'ID 6°1SE’DR'ID 611SE
not place the cables (power cable, communication cable, etc.) 5mm
of the equipment near devices (motor, transformer, switching °‘ “F
supply, etc.) that generate electromagnetic noise and their
cables.
around the battery section. Otherwise, the flat panel sensor
may be damaged
Make sure that no Ilquld enters the flat panel sensor trom j
DR-ID GOZSEIDR-ID 6128E
*7 Screw
cap
DR-ID 613$E
DR-ID GOOSE
Do not use a multiple tap connector or extension cable for
powering the devices constituting the system.
Up to five flat panel sensors can be connected. If you lntend to
use six or more flat panel sensors, only the first five that were
conneaed to the Image processing unit can be used. For this
reason, when six or more flat panel sensors are registered. be
careful not to use a wrong one, as you may confuse which flat
panel sensor is connected.
Make also sure, before making an exposure. that the color
label on the flat panel sensor to be used matches the color of
the panel icon selected on the Image processing unit.
Be sure to disconnect the wired connection of the panel in the first
room prior to connecting and imaging the patient with the same
panel In the second room to avoid mis-identification of the patient.
Do not place the cable terminal on the floor, as doing so may
cause infection.
Also, clean the cable and the terminal periodically
Do not Insert the flat panel sensor into a CR reader unit,
1.5.2 Before Exposure
The use of an air-conditioner may dramatically changes the temperature of the room where the
system Is installed. This may cause dew condensation on the system, resulting in quality problems.
When an air-conditioner is used, change the temperature gradually to avoid temperature variation
in order not to cause dew condensation.
1.20 I FDR oevo Operation Manual mmmma
if an exposure is made with the front and rear of the flat panel
sensor facing the other way round, re-exposure and electric
parts may be damaged.
Do not use the flat panel sensor, which is communicating with
the power supply unit in wired communication mode. for the
radiographic examination stand equipped with an automatic
loading function.
Exposure plane of the
flat panel sensor
1.5.3 During Exposure
Before making an exposure, make sure that exposure conditions most appropriate for this system
are set.
Do not apply an excessive force to the exposure planet
The sensor Inside the flat panel sensor may be damaged,
and It may not be possible to make an exposure properly.

Entire surface load : DR-ID GOOSE : 125kg (275.6 lb) \,
DR-ID 601 SE, DR-ID SOZSE. DR-ID 611 SE
and DR-ID 6128E : 150kg (330.8 lb)
DR-ID 613$E : 310kg (683.6 lb)
uonuado on; .log
Local load : DR-ID 60085 : 40kg (332 lb) I a40mm (1.6111,)
DR—ID 601SE, DR-ID GOZSE, DR-ID 51135 and
DR—ID 612$E : 100kg (220.5 lb) I b40mm (1.6in.)
DR-ID 613$E : 160kg (352.8 lb) / a40mm (1 sin.)
Use the flat panel sensor on a flat floor or platform
When an excessive force is applied to the unit when it
is tilted, the sensor inside the flat panel sensor may be
damaged.
Do not plaoe a metal plate, etc, which blocks radio waves,
before the antenna. Othenlvise, data may not be sent
correctly from the flat panel sensor.
Antenna Antenna
1.5.4 During Cleaning
To clean the outer surfaces, use commercially available ethanol papers for disinfection or a deaning
cloth tightly wrung out of ethanol (or diluted neutral detergent).
(”A sesame. >
a Do not use an excessive amount of ethanol (or neutral detergent), as doing so may allow the
liquid to enter from the gap on the outer surfaces, resulting In the damage to the flat panel
sensor, or cause the labels to come off. ‘
a Do not use a solvent such as thinner or benzlne, as It corrodes the outer surfaces.
o For other available disinfectants, consult our official dealer.
1.5.5 Storage
When the flat panel sensor is not in use, store the device in a place where It does not fall or drop
FDR oEvo Opeutiun Minuet es'mlomcla I 1.21
1.5.6 Precautions Related to the Load Applied to the Flat
Panel Sensor
It excessive load is applied to the flat panel sensor, use It on a flat lloor or platform
When maklng an exposure for the patient in a wheelchair or adjustable bed or on a stretcher, the
flat panel sensor may be deformed (deflection by some millimeters).
"unmade ails nu ma—
Flat panel sensor
If DR-ID GOOSE is used in such an exposure, insert the flat panel sensor Into the cassette holder
(optional).
Even when the cassette holder is used, however, avoid using the flat panel sensor if the applied
load is expected to exceed the limit (local load: 100kg (220.5 lb) I o40mm (1.5in.), entlre surface
load: 150kg (330.8 lb».
In case that the flat panel sensor is deformed. make sure that X-ray images are not adversely
affected before continuing the use of the flat panel sensor.
The precautions below must also be observed when maklng an exposure,
' Do not have the patient stand on the flat panel sensor. _
' Do not place the hard devices such as spine board on the flat panel sensor.
Excessive load is applied locally and the flat panel sensor may be damaged.
Splne board
Even when the flat panel sensor ls used on a flat floor or platform, it may be damaged it the applied
load exceeds the Ilmlt,
1.22 ‘ FDR D»EVO Operation Manual annmman

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