FujiFilm FCR PRIMA T2 User manual

This Operation Manual describes details on how to operate the FCR PRIMA
T2 (CR-IR 392) and cautions to be observed when operating it.
Please read the Operation Manual thoroughly before actually operating the
FCR PRIMA T2 (CR-IR 392) system. After reading this manual, store it nearby
the FCR PRIMA T2 (CR-IR 392) so that you can see it whenever necessary.
(CR-IR 392)
Operation Manual
1st Edition
For Safe Operation
Product Overview
Basic Operation
Care and
Maintenance
Appendix
Maintenance and
Inspection
897N102546

ii FCR PRIMA T2 Operation Manual 897N102546

iii
FCR PRIMA T2 Operation Manual 897N102546
Introduction
This Operation Manual is applicable to the following software.
• FCRPRIMAT2mainunitsoftwareV2.0orlater
The FCR PRIMA T2 (CR-IR 392) is equipment designed to scan an X-ray image formed on an
imaging plate (IP), being an image reading unit used for the CR-IR 392 Fuji Computed Radiography
system.
An IP is used as an X-ray image detector. It records the image information of an image captured by
an X-ray exposure.
Accompanying documents were originally drafted in the English language.
Installation may only be conducted by authorized service personal.
CAUTION
1 No part or all of this manual may be reproduced in any form without prior permission.
2 The information contained in this manual may be subject to change without prior notice.
3 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.
4
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.
5 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.
6 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
negligence of precautions and operating methods contained in this manual.
7 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.
8 FUJIFILM Corporation shall not be liable for malfunctions and damages resulting from
natural disasters such as fires, earthquakes, floods, lightning, etc.
Caution: Rx Only in the United States (Federal law restricts this device to sale by or on the
order of a physician).
How to Read This Manual
Marks
Information items to be observed when you are operating this system and the supplementary
remarks are described in this manual with the respective marks.
For the safe system operation, be sure to observe Warning/Caution.
WARNING
Indicates hazardous situations that may lead to serious injury or
even death if the precaution is not or could not be followed.
CAUTION
Indicates hazardous situations that may lead to mild or moderate
injury or physical damages if the caution is not or cannot be followed.
HINT
Shows an item helpful for further effective system operation.
Shows a more detailed operation method or an item that describes
additional information.
Trademark
FCR is a trademark or a registered trademark of FUJIFILM Corporation.
Copyright © 2012 FUJIFILM Corporation. All rights reserved.

iv FCR PRIMA T2 Operation Manual 897N102546
Contents
Introduction...........................................................................................................................iii
How to Read This Manual ....................................................................................................iii
Chapter 1 For Safe Operation
1.1 Precautions Before Operating This Equipment ....................................................... 1-1
1.2 Precautions to be Observed When Using the Electric Medical Equipment............. 1-2
1.3 Safety ...................................................................................................................... 1-3
1.4 Electromagnetic Compatibility (EMC)...................................................................... 1-5
1.5 Precautions to Take When Using the FCR PRIMA T2 (CR-IR 392) ........................ 1-9
1.6 Location of Each Label and Mark.......................................................................... 1-10
1.6.1 Locations ............................................................................................................... 1-10
1.6.2 Safety and Other Signs ......................................................................................... 1-12
Chapter 2 Product Overview
2.1 Features of the FCR PRIMA T2 (CR-IR 392) .......................................................... 2-1
2.2 Units Names and the Functions .............................................................................. 2-2
2.2.1 FCR PRIMA T2 (CR-IR 392) Main Unit ...................................................................2-2
2.2.2 Operation Panel.......................................................................................................2-3
2.2.3 Operation Panel Display at the Time of Startup/Shutdown.....................................2-4
Chapter 3 Basic Operation
3.1 Performing Erasure Before Use IPs ........................................................................ 3-1
3.2 System Startup/Shutdown and Image Reading (Console) ......................................3-2
3.2.1 Starting Up the System ...........................................................................................3-2
3.2.2 Shutting Down the System ......................................................................................3-3
3.2.3 Reading Cassette IP Images.................................................................................. 3-4
3.3 Starting Up/Shutting Down the FCR PRIMA T2 Main Unit......................................3-5
3.3.1 Starting up the FCR PRIMA T2 main unit ...............................................................3-5
3.3.2 Shutting down the FCR PRIMA T2 main unit ......................................................... 3-6
Chapter 4 Care and Maintenance
4.1 About Performing Daily Checks and Maintenance.................................................. 4-1
4.2 Cleaning the Cassette Set Unit ............................................................................... 4-1
4.3 Users Check Sheet ................................................................................................. 4-2
4.4 About Preventive Maintenance................................................................................4-3
Appendix A Specifications
A.1 Specications ..........................................................................................................A-1
A.1.1 DetailsofEquipmentSpecications ....................................................................... A-1
Maintenance and Inspection

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Chapter 1 For Safe Operation
1.1 Precautions Before Operating This
Equipment
Before using this equipment, please read this page carefully so that you can operate it correctly.
Whenever you operate this equipment, be sure to observe those precautions. Failure to do so may
cause you to subject to injuries or property damage to occur.
ThissystemisclassiedasamedicaldeviceunderECDirective93/42/EEC.
This equipment has been designed on the assumption that the patient would not
come into direct contact with it or for operation by appropriately trained operator.
Process waste correctly, as stipulated by local law or any regulations that apply.

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1.2 Precautions to be Observed When
Using the Electric Medical Equipment
We ask that you observe these usage precautions and use the equipment correctly.
1. This equipment should be used only by people who have the proper skills.
2. Observe the following precautions when installing the equipment.
2-1. Install the equipment where water will not splash it.
2-2. Install the equipment where it will not be adversely affected by air pressure, temperature,
humidity, ventilation, sunlight, dust or the presence of salt, sulfur or like substances in the
atmosphere.
2-3. Make sure the equipment will remain in stable condition on a level surface and not be
subjected to vibration or shock.
2-4. Do not install the equipment in places where chemicals are stored or gases emitted.
2-5. Make sure that the power frequency, voltage and power consumption are appropriate.
2-6. Connect the ground wire correctly.
3. Observe the following precautions before beginning to use the device.
3-1.Inspecttheswitchcontacts,polarities,dialsettingsandmetersandconrmthatthe
equipment is functioning properly.
3-2.Conrmthatthegroundwirehasbeencompletelyconnected.
3-3. Make sure that all cords have been connected properly and safely.
3-4. Be aware that correct diagnosis can be hindered and danger can result from using different
pieces of equipment together.
4. Observe the following precautions after using the equipment.
4-1. Using the established procedure, restore the operation switches, dials, etc., to what they
were prior to use and then turn the power off.
4-2. When unplugging cords, do not pull on the body of the cord itself or apply unnecessary
force.
4-3. After using the accessories, recollect them and put them back in order.
5. Ifthereistroublewiththeequipment,donotattempttoxitrandomly.Instead,dowhatis
indicated and entrust repairs to a professional.
6. Do not remodel the equipment.
7. Maintenance and Inspection
7-1. Make inspect the equipment and parts periodically.
7-2. If the equipment has not been used for a long time, make sure that it operates normally and
safely prior to using it again.
8. Other Items
8-1. When subjecting patients (particularly infants and pregnant women) to radiation, make sure
not to exceed the necessary time and dose. Also, ensure that radiation is contained within
the region for exposure.
8-2. Follow the Operation Manual and operate the equipment correctly.

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1.3 Safety
Prior to using this equipment, please carefully read safety precautions presented herein for you to
operate it correctly.
Laser Handling Precautions
This equipment is a Class 1 laser product (IEC 60825-1:2007).
FCRPRIMAT2(CR-IR392)LaserUnitSpecications
Class : 3B
Medium : Semiconductor laser
Wavelength : 659 nm
Maximum output : 68.2 mW (CW)
Maximum output under Fault condition : 130 mW (CW)
Beam divergence (parallel) : 7°~12°
(perpendicular) : 14°~20°
WARNING
The FCR PRIMA T2 (CR-IR 392) incorporates a Class 3B laser with maximum output of 68.2 mW.
To prevent exposure to its laser beams, observe the following precautions.
● Never open or remove the protective covers.
● Always contact a qualified service engineer immediately if you suspect there is a
malfunction.
CAUTION
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
Authorized Safety Standards
UL 60601-1:2003 (UL approved)
EN 60601-1:1990 + A1:1993 + A2:1995
Note,however,thatULcerticationdoesnottakeeffectifthisequipmentisusedmountedonboard
a vehicle because it has not been applied for appropriate approval from UL-PS.
Classification
1) According to the type of protection against electrical shock
CLASS 1 EQUIPMENT
2) According to the degree of protection against electric shock
NO APPLIED PART
3) Protection against harmful ingress of water
IPXO
4)Accordingtothedegreeofsafetyofapplicationinthepresenceofaammableanesthetics
mixture with air or with oxygen or nitrous oxide.
Equipmentnotsuitableforuseinthepresenceofaammableanestheticsmixturewithairor
with oxygen or nitrous oxide.
5) According to the mode of operation
CONTINUOUS OPERATION

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General Precautions Against Electrical Shock
WARNING
The service voltage of this equipment is 100 to 240 VAC.
Instructions below must be followed to prevent an electrical shock to users.
● Never open equipment covers. Do not touch high-voltage units of the equipment with your
hand, otherwise you may receive an electrical shock.
● Install the equipment where no water may subject the equipment.
● Ensure that the equipment is properly grounded.
● Check that all the cables are properly and perfectly connected.
● When using the equipment within the environment where the patient may get into touch
with it, optionally connect additional protective earth conductor (FCR PRIMA T2 (CR-IR
392)).
● When using the equipment within the environment where the patient may get into touch
with it, the user must not touch the equipment’s exterior, such as covers and metal
sections, and the patient at the same time.

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1.4 Electromagnetic Compatibility (EMC)
This equipment has been tested and found to comply with the limits for medical devices to the IEC
60601-1-2:2001+Amd1:2004/EN 60601-1-2:2001+Amd1:2006.
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 instructions, may cause harmful interference to other devices in the
vicinity.
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 determined by
tuning 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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.
Consultthemanufactureroreldservicetechnicianforhelp.
Further information for IEC 60601-1-2:2001/EN 60601-1-2:2001
• 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.
• PortableandmobileRFcommunicationsequipmentcanaffectmedicalelectricalequipment.
• InformationregardingthecableaffectingEMCisasfollows.
Name General Specification
Network Cable Cat 5 or more, UTP type and straight cable.
• Theuseofaccessories,transducersandcablesotherthanthosespecied,withtheexception
of transducers and cables sold by FUJIFILM Corporation as replacement parts for internal
components, may result in increased emissions or decreased immunity of the FCR PRIMA T2
(CR-IR 392).
• TheFCRPRIMAT2(CR-IR392)shouldnotbeusedadjacenttoorstackedwithother
equipment.
If adjacent or stacked use is necessary, the FCR PRIMA T2 (CR-IR 392) should be observed to
verifynormaloperationinthecongurationinwhichitwillbeused.

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Guidance and manufacturer’s declaration - electromagnetic emissions
TheCR-IR392isintendedforuseintheelectromagneticenvironmentspeciedbelow.
The customer or the user of the CR-IR 392 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
EN 55011
Group 1
The CR-IR 392 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
EN 55011
Class A
The CR-IR 392 is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
EN 61000-3-2
Class A
Voltageuctuations/
ickeremissions
IEC 61000-3-3
EN 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
TheCR-IR392isintendedforuseintheelectromagneticenvironmentspeciedbelow.
The customer or the user of the CR-IR 392 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
EN 61000-4-2
±6kVcontact
±8kVair
±2kVcontact
±4kVcontact
±6kVcontact
±2kVair
±4kVair
±8kVair
Floors should be wood, concrete or
ceramictile.Ifoorsarecoveredwith
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
EN 61000-4-4
±2kVforpowersupply
lines
±1kVforinput/output
lines
±2kV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
EN 61000-4-5
±1kVLinetoLine
±2kVLinetoGround
±1kVLinetoLine
±2kVLinetoGround
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltagedips,short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
EN 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the CR-
IR 392 requires continued operation
during power mains interruptions, it is
recommended that the CR-IR 392 be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
eld
IEC 61000-4-8
EN 61000-4-8
3 A/m 3 A/m
Powerfrequencymagneticeldsshould
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level.