FCR Prima t2
FCR Prima t2
FCR Prima t2
(CR-IR 392)
Product Overview
Operation Manual
1st Edition
Basic Operation
Care and
Maintenance
Appendix
Maintenance and
Inspection
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.
897N102546
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ii FCR PRIMA T2 Operation Manual 897N102546
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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).
Trademark
FCR is a trademark or a registered trademark of FUJIFILM Corporation.
Appendix A Specifications
A.1 Specifications����������������������������������������������������������������������������������������������������������A-1
A.1.1 Details of Equipment Specifications����������������������������������������������������������������������� A-1
Process waste correctly, as stipulated by local law or any regulations that apply.
1. This equipment should be used only by people who have the proper skills.
1 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,
For Safe Operation
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 confirm that the
equipment is functioning properly.
3-2. Confirm 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 fix 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.
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.
Note, however, that UL certification 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 flammable anesthetics
mixture with air or with oxygen or nitrous oxide.
Equipment not suitable for use in the presence of a flammable anesthetics mixture with air or
with oxygen or nitrous oxide.
5) According to the mode of operation
CONTINUOUS OPERATION
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.
1 ● 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.
For Safe Operation
● 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.
• The use of accessories, transducers and cables other than those specified, 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 configuration in which it will be used.
The CR-IR 392 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CR-IR 392 should assure that it is used in such an environment.
The CR-IR 392 is suitable for use in all establishments other than
IEC 61000-3-2 Class A
domestic and those directly connected to the public low-voltage power
EN 61000-3-2
supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions
Complies
IEC 61000-3-3
EN 61000-3-3
The CR-IR 392 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CR-IR 392 should assure that it is used in such an environment.
Electromagnetic environment -
Immunity test IEC 60601 test level Compliance level
guidance
±2 kV contact
Electrostatic discharge ±4 kV contact Floors should be wood, concrete or
(ESD) ±6 kV contact ±6 kV contact ceramic tile. If floors are covered with
IEC 61000-4-2 ±8 kV air ±2 kV air synthetic material, the relative humidity
EN 61000-4-2 ±4 kV air should be at least 30%.
±8 kV air
Electrical fast ±2 kV for power supply ±2 kV for power supply
Mains power quality should be that
transient/burst lines lines
of a typical commercial or hospital
IEC 61000-4-4 ±1 kV for input/output ±1kV for input/output
environment.
EN 61000-4-4 lines lines
Surge Mains power quality should be that
±1kV Line to Line ±1 kV Line to Line
IEC 61000-4-5 of a typical commercial or hospital
±2kV Line to Ground ±2 kV Line to Ground
EN 61000-4-5 environment.
<5% UT <5% UT
(>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% UT 40% UT of a typical commercial or hospital
interruptions and
(60% dip in UT) (60% dip in UT) environment. If the user of the CR-
voltage variations on
for 5 cycles for 5 cycles IR 392 requires continued operation
power supply input
70% UT 70% UT during power mains interruptions, it is
lines
(30% dip in UT) (30% dip in UT) recommended that the CR-IR 392 be
IEC 61000-4-11
for 25 cycles for 25 cycles powered from an uninterruptible power
EN 61000-4-11
<5% UT <5% UT supply or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s
Power frequency
Power frequency magnetic fields should
(50/60 Hz) magnetic
be at levels characteristic of a typical
field 3 A/m 3 A/m
location in a typical commercial or
IEC 61000-4-8
hospital environment.
EN 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
The CR-IR 392 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CR-IR 392 should assure that it is used in such an environment.
Immunity test IEC/EN 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
IEC 61000-4-6 150 kHz to 80 MHz equipment should be used no closer to any part
1
EN 61000-4-6 of the CR-IR 392, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
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 affected by absorption and
reflection from structures, objects and people.
a Field strength 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 CR-IR 392 is used exceeds the applicable RF
compliance, the CR-IR 392 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the CR-IR 392.
b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
The CR-IR 392 is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled.
The customer or the user of the CR-IR 392 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the CR-IR 392 as
recommended below, according to the maximum output power of the communications equipment.
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.
1.6.1 Locations
● For USA only
1 IEC 60825-1:2007 Class 3B
Caution Label 1
IEC 60825-1:2007 Class 3B
Panel Label Panel Label
For Safe Operation
HHS Certification and Cassette Insertion Label Caution Label 3 Hazardous Substances
Identification Label Compliance Label
Rating Label
IEC 60825-1:2007 Class 3B
Caution Label 2 Panel Label
Additional Protective
Ground Mark
Be sure to use the power cord Use this terminal to connect the
our official dealer additional protective ground wire.
or local presentative provided.
Caution Label 2 Additional Protective Ground Mark Cassette Insertion Label
Additional Protective
Ground Mark
Rating Label
Be sure to use the power cord Use this terminal to connect the
our official dealer additional protective ground wire.
or local presentative provided.
Caution Label 2 Additional Protective Ground Mark Cassette Insertion Label
Sign Description
1
Attention, consult ACCOMPANYING DOCUMENTS.
For Safe Operation
Power-OFF
Power-ON
Alternating current
This symbol indicates that this product is not to be disposed of with your household waste,
according to the WEEE Directive (2002/96/EC) and your national law. This product should
be handed over to a designated collection point.
Improper handling of this type of waste could have a possible negative impact on the
environment and human health due to potentially hazardous substances that are generally
associated with EEE.
At the same time, your cooperation in the correct disposal of this product will contribute to
the effective usage of natural resources.
For more information about waste, please contact FUJIFILM dealers.
Year of manufacture
Stand-by switch
Product Overview
X-ray tomography.
1 By virtue of the effects of digital image processing, the system produces radiographs that
have a high diagnostic value and are easy to interpret.
2 The system has a wide latitude for incident X-rays so that a large amount of X-ray
diagnostic information can be obtained.
3 The system features high sensitivity, making it possible to reduce X-ray radiation doses or
exposure to patients.
5 Exposure information items that include patient information, anatomical regions and
exposure menus can be entered on the console connected to the FCR PRIMA T2 (CR-IR
392).
6 Due to the compact size of the system, it can be installed in a relatively tight space.
7 The cassette can be inserted horizontally, making it easy to operate the system on the
table.
2 Left-side
cover
Product Overview
Right-side
Front cover cover Rear cover
Name Function
Operation Panel Operation panel for the FCR PRIMA T2 (CR-IR 392).
Cassette Set Unit Used for inserting cassette that contains an exposed IP.
Main Power Switch Leave it turned ON.
ON ( I ): Main Power ON
OFF ( O ): Main Power OFF
Power Inlet Power inlet for this equipment.
External Device Connector Used for network-connecting the external device.
(I/F Cable)
Scanner Cleaning Handle Used for cleaning the Scanner.
CAUTION
● Do not connect telephone lines to LAN connector.
Only the IEC 60950-1/EN 60950-1 standard non-shielded cables are appropriate for
connection to this connector.
● Plug the power cord firmly into the power inlet.
● When plugging/unplugging the power cord, hold its connector to avoid excessive force to
the cord.
Name Function
Stand-by Switch Turns on/off the power to the FCR PRIMA T2 (CR-IR 392). This switch
is used when the FCR PRIMA T2 (CR-IR 392) is started up singly.
When the buzzer sounds because of an error or detection of excessive
amount of X-rays and this switch is pressed, the buzzer stops and the
2
cassette lock is released.
To turn off the unit, keep pressing the switch for about four seconds.
Product Overview
Status Display LED Indicates status of the unit.
Status
Status
Stand-by switch is OFF OFF
Stand-by switch is ON/
During Console application startup/
FCR PRIMA T2 initialization
FCR PRIMA T2 initialization
OFF
completion/Console not connected
FCR PRIMA T2 initialization ON(green) OFF OFF
completion/Console connected
FCR PRIMA T2 initialization completed/
Study by Console not yet started
FCR PRIMA T2 initialization
completed/Study by Console started ON
cassette insertion possible
Status
FCR PRIMA T2 initialization
completion/Console connected
FCR PRIMA T2 is in shutting down ON(green) OFF OFF OFF
operation
Stand-by switch is OFF OFF
Basic Operation
and walls. If such an energy-loaded IP is used as-
is, image degradation may result.
Precautions to observe before using an IP or when
deleting images from an over-exposed IP
See [Z.1.2 Precautions to Observe Before
Using an IP] in the Reference Guide.
By using the following procedure, perform erasure
of the image on the IP.
2 Insert a cassette.
Erasure will be performed.
Upon completion of the erasure, the cassette
removal lamp will blink.
2 Firstly, press the power ON/OFF switch of Status when the console has been
connected and study has been
the Console’s monitor, and secondly press started
the power ON/OFF switch of the Console Status Display Cassette Ready Lamp
itself. LED
Console connected:
The Cassette
Removal Lamp
should be
blinking.
Basic Operation
On a screen from which the console can be
shut down, select .
HINT
For the operation of the User Utility, refer to the
appropriate sections of the Console’s Operation
Manual.
Cassette
the appropriate sections of the Console’s Operation guide
Manual.
Barcode
window
HINT
For details of available image reading mode, refer to
the Operation Manual that describes the User Utility
functions of the connected Console. Insert straight carefully.
CAUTION
2 Subject a patient to X-ray exposure.
● Insert the cassette in the FCR PRIMA
T2 after confirming the sides and the
3 Read the exposed image with the FCR direction of the cassette. Moreover,
PRIMA T2. insert the cassette straight and slowly.
If a cassette is inserted incorrectly
Explained below is the procedure to read IP images wrong side or direction, like at a slant,
of a cassette inserted into the FCR PRIMA T2. the Image Reader can be damaged.
1. Confirm that the Cassette Ready Lamp is lit ● When inserting the cassette, be careful
not to pinch your finger between the
(green) on the operation panel.
cassette and the cassette set unit.
Cassette Ready Lamp ● Do not turn the scanner cleaning
handle during IP processing.
When the main power switch is OFF When the main power switch is ON
1 Turn ON the Main Power Switch of the FCR 1 Press the Stand-by Switch on the operation 3
PRIMA T2. panel to turn the power ON.
Basic Operation
Main Power
Switch Stand-by
Switch
Press.
The power/erasing mode indicator lamp lights on the The FCR PRIMA T2 starts initialization operation.
operation panel and the FCR PRIMA T2 starts When the FCR PRIMA T2 is up and running, the
initialization operation. cassette ready lamp lights on the operation panel.
When the FCR PRIMA T2 is up and running, the
cassette ready lamp lights on the operation panel.
Cassette
Ready Lamp
Cassette
Ready Lamp
Stand-by
Switch
3
The status display LED changes from off-line to
shutdown processing. When FCR PRIMA T2 shuts
Basic Operation
As for the daily checks, make certain that the FCR PRIMA T2 starts up normally and all equipment
that is connected to the FCR PRIMA T2 can communicate normally with the FCR PRIMA T2.
For daily care, clean the cassette set unit everyday.
Use the “Users Checksheet” when performing daily checks and maintenance. Enter the following
items of information into the “Users Checksheet”:
● Checkups: Enter the date checks were performed.
● S value confirmation: Enter the date the S value was checked.
● Cassette set unit: Enter the date the cassette set unit was cleaned. 4
CAUTION
Do not use organic solvents such as thinner, benzine, etc.
● Verification
Details Frequency Date of verification
4
Is the communication
possible normally with the Daily
connected equipment?
Care and Maintenance
● Cleaning
Unit for cleaning Frequency Date of cleaning
Every three
Cassette set unit
months
• Light-collecting guide
• Covers, shutter
Checking the Machine
• Erasure lamp lighting time
• Protective grounding
• Image/conveyance
• S value
• Error log
A.1 Specifications
A.1.1 Details of Equipment Specifications
Power Supply Conditions
Input voltage: 100-240 V~ Allowable variations in voltage: ±10%
Rated current: 1.9-0.8 A
Frequency: 50-60 Hz
Phase: Single
Environmental Conditions Humidity
(1) Operating conditions 80%
Temperature: 15˚C (40% RH) - 30˚C (80% RH)
Humidity: 15% RH (30˚C) - 80% RH (30˚C)
(no dew condensation) 40%
Atmospheric pressure: 750 hPa-1060 hPa
(2) Non-operating conditions
Temperature: 0˚C-45˚C (no freeze condensation) 15%
Options
Table fix kit, stand wagon, add stand for monitor, cassette rack, cassette rack for the long-view
cassette, arm for monitor, stand wall fix kit, CPU floor mount kit, support bar for the long-view
Appendix A Specifications
cassette.