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Surgical Mobile C Arm Imaging System OPESCOPE ACTENO Operation en
Surgical Mobile C Arm Imaging System OPESCOPE ACTENO Operation en
Apr. 2014
Instruction Manual
Read the manual thoroughly before you use the product.
Keep this manual for future reference.
About the Symbols Appearing in This Instruction Manual
Throughout the text in this manual, warnings and other information essential when
using this unit such as cautionary or prohibited items, appear classified as the
following:
Mark Description
Indicates references.
Revision History
Revision Date Changes
First revision Oct. 2013
A Feb. 2014 Added DR option.
B Mar. 2014 Changed Chapter 8 "Technical Data" for RoHS.
C Apr. 2014 Corrected errors regarding specifications.
Introduction
Thank you for selecting the Surgical Mobile C-arm Imaging System
OPESCOPE ACTENO (hereafter “the equipment”).
Before using the equipment, read the instruction manual and make sure
you understand its contents.
This manual should be kept available for future reference. If the user or
usage location changes, ensure that this instruction manual is always
kept together with the equipment. Periodically check to be sure that the
instruction manual and the warning labels are not missing or damaged.
If they are, contact your Shimadzu service representative for
replacement.
Original version is approved in English.
Notice
• All copyrights regarding this manual are property of Shimadzu Corporation.
Neither all nor part of these contents shall be reproduced or duplicated
without the express permission of Shimadzu Corporation.
• Content of this manual may be changed for improvement without notice.
Although every possible effort has been made to avoid errors while creating
this manual, immediate revision may not be possible in the event that errors
or missing information are detected.
• Screen images and illustrations contained in this manual may differ from
those in actual use, and are intended for example purposes only. Illustrations
may also use partial images.
• Other company names and product names mentioned in this manual are
trademarks or registered trademarks of their respective companies.
• The TM and symbols are omitted in this manual.
Operating Precautions
WARNING
WARNING
WARNING
WARNING
Repair and maintenance of the inside of the equipment can only be performed by
engineers assigned by Shimadzu.
Maintenance must be assigned to specially trained experts. Contact your Shimadzu
service representative for repair and maintenance.
WARNING
Prepare alternative system with fluoroscopy function, in case any trouble happens
and fluoroscopy/radiography can not be operated normally.
CAUTION
DANGER
WARNING
WARNING
Do NOT use the equipment at places where the liquid may enter.
Do NOT spill liquids onto the surface or the inside of the
equipment.
Otherwise, electric shock may occur.
In case of liquid spillage to the equipment, immediately turn off the
power, and contact your Shimadzu service representative.
WARNING
WARNING
WARNING
WARNING
CAUTION
When moving the C-arm, hold each of the handles to operate it.
Otherwise, you may trap your fingers, causing injury.
CAUTION
CAUTION
WARNING
WARNING
WARNING
CAUTION
CAUTION
Cautions on Radiography
DANGER
Restrict all persons other than the patient from accessing the
equipment in accordance with local regulations.
To avoid unnecessary exposure, acceptable distances (maximum
access values) to the equipment by any person other than the patient
are defined for each region.
WARNING
WARNING
No person but the operator and patient are allowed to stay in the
examination room during X-ray irradiation.
If the equipment is not used correctly, the operator, the patient, and
other persons may receive a greater dose of radiation than necessary.
The operator must control X-ray irradiation from a distance over 2 m
from the focal spot and the X-ray beam and also must take following
adequate measures to protect themselves against radiation:
Protective apron
Shielding screen
Protective glasses, etc.
During radiography, the radiography indicator illuminates and the
buzzer sounds an audible warning.
WARNING
WARNING
WARNING
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
NOTE
NOTE
The radiation dose changes when changing tube voltage, dose mode,
pulse rate, etc.
The laser beam emitted from the laser pointer (option) has a wavelength of 630 nm
(nanometers) and an output of less than 1 mW and consequently is categorized as a
class II laser by the FDA and as a class 3A laser by the IEC.
WARNING
WARNING
Measurement Accuracy
WARNING
CAUTION
NOTE
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
WARNING
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Before a study or operation, remove the dust from the X-ray I.I.
unit, C-arm, X-ray tube assembly, and the periphery.
WARNING
WARNING
WARNING
WARNING
WARNING
Warranty
The system is warranted to be free from defects in material and workmanship for
one year from the date of delivery. If found to be defective, the system must be
offered to Shimadzu for inspection and examination. Upon examination, Shimadzu,
at its sole option, will repair or replace at no charge, the system or any part found to
be defective. Components which wear are not warranted.
This warranty extends to original purchaser or the lessee of the new system only.
If the system is to be resold or delivered to a third party, such third party must be
provided with a copy of this manual, the installation manual and the technical
manual supplied with the system.
This warranty does not apply to the following:
1. Failure or damage due to any installation, relocation, or service not provided
by your Shimadzu service representative or a SHIMADZU designated
contractor.
2. Failure or damage caused by the product of other companies (except those
purchased from SHIMADZU).
3. Failure or damage due to repairs using non-SHIMADZU certified service
parts.
4. Failure or damage due to non-compliance with the notices and procedures set
forth in this manual.
5. Failure or damage due to any operating environment deviating from the
requirements set forth in this manual.
6. Failure or damage due to natural disasters such as power surge, rain, fire,
earthquake, flood, and thunder.
Service after the expiration of the warranty is available at a reasonable cost and
should be performed by your Shimadzu service representative.
IN NO EVENT SHALL SHIMADZU AND ITS AFFILIATED ENTITIES BE
LIABLE TO ANY PERSON OR ENTITY FOR ANY DIRECT, INDIRECT,
INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING,
WITHOUT LIMITATION, ANY DAMAGES RESULTING FROM LOSS OF
USE, BUSINESS INTERRUPTION, LOSS OF PROFITS, LOSS OF SAVINGS,
THE COST OF PROCUREMENT OF SUBSTITUTED GOODS, SERVICES OR
TECHNOLOGIES OR FOR ANY MATTER ARISING OUT OF OR IN
CONNECTION WITH THE USE OR INABILITY TO USE THE SYSTEMS.In
some jurisdictions, some of the foregoing warranty disclaimers or damage
limitations may not apply.
Shimadzu will be indemnified for any claim, liability, or damage arising out of the
misuse or non-compliance with this manual by the purchaser or lessee of the
system.
NOTE
Service Life
The equipment lifetime is 10 years (based on Shimadzu's criteria) assuming the
specified maintenance checks are performed.
Disposal Precautions
CAUTION
Software Version
This manual is compatible with the software version NEE.
(1) (9)
(5) (7)
(8)
(2)
(3)
(4) (6)
(1)
(2)
(3)
(4)
(5)
(6) (Option)
(7) (Option)
(8) (Option)
(9) (Option)
Introduction
Chapter 7 Options
Abbreviations
Abbreviations Description
HU Heat Unit
Contents
Introduction
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-2
Precautions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-4
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-25
Software License Agreement . . . . . . . . . . . . . . . . . . . Introduction-26
Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-26
Disposal Precautions . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-27
Action for Environment (WEEE)
To all user of Shimadzu equipment
in the European Union: . . . . . . . . . . . . . . . . . . . . . . . Introduction-27
Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-28
Warning and Caution Labels . . . . . . . . . . . . . . . . . . . Introduction-28
Organization of This Manual and How to Use It . . . . Introduction-31
Related Instruction Manuals . . . . . . . . . . . . . . . . . . . Introduction-32
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-32
Chapter 5 Troubleshooting
5.1 Measures for Power Outages . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 When DR Option does not Respond . . . . . . . . . . . . . . . . . . 5-3
5.3 Responding to Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.4 Where Errors are Displayed . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Chapter 7 Options
7.1 Cassette Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2 Grid Removable Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.2.1 Removing the Grid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.2.2 Mounting the Grid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.3 Laser Pointer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
7.4 Fitting and Removing the Cover . . . . . . . . . . . . . . . . . . . . . 7-9
7.4.1 When Using the Washable (Cloth) Type . . . . . . . . . . . 7-10
7.4.2 When Using the Disposable Type . . . . . . . . . . . . . . . . 7-11
Chapter 9 Appendix
9.1 Starting Inspection Checklist . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.2 Ending Inspection Checklist . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3 Monitor Brightness Adjustment, Contrast Adjustment . . . . 9-5
Chapter 5 Troubleshooting 5
Chapter 7 Options 7
Chapter 9 Appendix 9
1.1 Application
This equipment is a mobile imaging system for X-ray fluoroscopy and radiography
to be used during surgery as well as in X-ray examination rooms.
NOTE
Please attach “Extension kit for source-skin distance” option when the
equipment is used for an application other than surgical purposes.
For details on the function of each part, see Chapter 2 "Configuration of the
Equipment".
C-arm
Doctor handle
1.2 Features
This unit incorporates the following support features to allow smooth fluoroscopy
and radiography while ensuring the functionality and safety required in operating 1
theaters and E.R. facilities.
Dose Reduction
1. A “last image hold” (LIH) function is provided for cases where fluoroscopy is
not necessary for confirmation.
2. The virtual rotation function and virtual collimator function allow you to
rotate, and perform virtual collimator operations on, the last image hold (LIH)
image.
3. Pulse fluoroscopy generates reduced radiation since the X-rays are emitted in
pulse form. You can obtain high-resolution images in pulse fluoroscopy at the
maximum frame rate (15 fps).
4. The radiation exposure can be reduced by switching the filters.
Speedy
1. The C-arm is a manually-operated, balanced type and the brake is an
electromagnetic locking type.
2. The freedom of motion makes it easy to position the equipment for work on
any limb or on the spinal cord, which helps to reduce both the positioning time
and the time required for surgery.
3. There is a C-arm lock switch located on the doctor handle. This allows the
physician to release the lock quickly. (option)
4. The “touch panel” format is adopted for the monitors and the main panel.
An intuitive and easy to understand GUI is used. To operate it all you have to
do is directly press the buttons that appear on the screen.
5. From the main panel, you can perform operations such as image transmission.
You can perform almost all operations during examinations from the C-arm.
6. By using APRs (anatomical programs), you can call up the optimum
fluoroscopy and radiography conditions for each part of the body in a
one-touch operation.
Clean
1. The cables are incorporated into the C-arm, so they will not come into contact
with the patient or surgical instruments, allowing the equipment to be used
safely.
2. The design is rounded and simple. Care work such as cleaning and disinfection
can be done easily, ensuring continued hygiene.
1.3 Principle
• This equipment irradiates X-rays from an X-ray tube assembly. The X-ray
absorption data after the human body is penetrated is converted into light with
X-ray Image Intensifier device. The X-ray absorption data converted into light
is input to the TV device, and a plane-image of the human body is obtained.
• The image is displayed in the monitor, and the image data is recorded in the
equipment memory.
• Cassette-holder (option) takes a general radiography.
WARNING
CAUTION
Item Specifications
Ambient temperature 10 C to 35 C
Atmospheric pressure 800 hPa to 1060 hPa (800 mbar to 1060 mbar)
Item Specifications
Temperature 0 C to 40 C
Atmospheric pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar)
Item Specifications
Frequency 50/60 Hz
Standard voltages 100, 110, 120, 200, 220, 230, 240 VAC
DANGER
1.4.4 Grounding
Class D grounding
1
WARNING
Operation Mode
Continuous operation with intermittent load
CAUTION
WARNING
DANGER
1.6 Symbols
The symbols used on the equipment are shown below:
1
Symbol Location Meaning
Potential equalization
Potential equalization conductor
conductor
NOTE
Item Details
Sex No limitation
Nationality No limitation
Necessary.
Experience Every operator needs to take training for operating the equipment
before using the equipment.
Corrected eyesight is over 0.7 using the decimal system (70 %).
Permissible
Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to
impairments
2 kHz.
The C-arm cart can be operated to achieve the most suitable position for
fluoroscopy or radiography.
The C-arm cart is connected to the monitor cart before using the equipment.
(6) C-arm
For details, see 3.6.5 "Lock Release Switches on the Doctor handle (Option)"
(page 3-34).
(6) C-arm
The C-arm is balanced and is operated manually. Since the brake is an
electromagnetic locking type, it can be switched on and off with one touch. The
C-arm can easily be positioned however required.
For details, see 3.2.1 "Moving the C-arm Cart" (page 3-4).
For details, see 3.2.1 "Moving the C-arm Cart" (page 3-4).
(10) Connector
Open the connector cover and connect the cart cable from the monitor cart.
For details, see 3.4 "Turn the Power ON / OFF" (page 3-14).
This is the cart on which the monitors are installed. It is used while connected to the
C-arm cart and it controls the power supply to the OPESCOPE ACTENO system.
NOTE
For details, see 3.4 "Turn the Power ON / OFF" (page 3-14).
For details, see 3.4 "Turn the Power ON / OFF" (page 3-14).
1 1
2 2
8
3
9
4
10
5
11
6 12
Reference
No. Switch Name Description
page
Fluoroscopy timer
Stops the fluoroscopy timer beep sound
1 beep sound reset 3-60
tone
switch
Opens/closes the
Octagonal collimator
5 octagonal
open/close Parallel
collimator.
compensating filter
Reference
No. Switch Name Description
page
Image display
Used to switch the content of the LCD
2
7 switching switch 3-85
display (image / operation screen).
(option)
No. Description
Displays the status of the fluoroscopic image display function of the device.
2
: In preparation : Ready
Basic screen
There are two modes of operation display as explained below.
• Simple mode
Mode that uses a large, easy to view screen layout for users who do not change
settings frequently.
• Expert mode
Mode for users who expeditiously change all settings.
2
Simple mode
2 3 4 5
1
6
7
8
9 11
10
18
12 13 14 15 16 17
Fig. 2.10 Basic screen (Simple mode)
Reference
No. Name Description
page
Reference
No. Name Description
page
Reference
No. Name Description
page
Super shot
Only displayed when not combined with the DR
option. 3-72
Displayed when Super Shot is used.
Emergency case
Only displayed when not combined with the DR
option.
2
3-42
11 The patient ID and patient name are set
automatically when the study is started.
Zoom button
12 Changes the field size. (The images are zoomed up.) 3-65
Printer button
When a printer etc., is connected, the image
13 -
displayed on the monitor is printed.
Reference
No. Name Description
page
Expert mode
2 3 4 5
1
6
7 2
8
10 12
9 13
11 14
22
15 16 17 18 19 20 21
Fig. 2.11 Basic screen (Expert mode)
Reference
No. Name Description
page
Reference
No. Name Description
page
Reference
No. Name Description
page
Emergency case
Only displayed when not combined with the DR
option.
3-42
The patient ID and patient name are set
automatically when the study is started.
Photo timer button Only displayed when combined with the DR option.
Reference
No. Name Description
page
Zoom button
16 Changes the field size. (The images are zoomed up.) 3-65
Printer button
When a printer etc., is connected, the image
17 -
displayed on the monitor is printed.
The C-arm lock switch is used to secure and release the C-arm.
1
2 3
4
Reference
No. Switch Lock location Description
page
C-arm longitudinal
4
movement
1 2
4 3
Reference
No. Switch Name Description
page
1 8
2
9 2
3 10
4 11
12
13
5 14
6
7 15
Fig. 2.14 Live monitor
Accumulated reference air kerma The accumulated reference air kerma of the
1 3-93
(AK)*1 examination currently running is indicated.
: Only displayed when combined with the dose display function (option).
: Only displayed when combined with the laser pointer (option).
3:Only displayed when combined with the DR option.
LIH display
This is displayed when a fluoroscopy last image
3-66
hold (LIH) image is displayed.
8
This is displayed when the frame memory is used.
Frame memory display
:When not combined with the DR option
/ 4-4
: When combined with the DR option
[A/B] A: Currently displayed image
B: Total number of recorded images
:Paused
This chapter explains the basic procedure for using the equipment.
Chapter 3 Basic Operation
3.1 Introduction
NOTE
The operating methods and screens displayed on the LCD display differ
depending on the screen mode and combination of equipment.
This instruction manual explains operations based on the simple mode when
combined with the DR option.
This section describes the basic operation flow and provides references.
When the DR option is not combined
3
Selecting the Study [3.7]
3.2 Transport
WARNING
3
Fig. 3.1 Home position (fixed position) of the C-arm
NOTE
If the C-arm is not at its home position (fixed position), turn the power ON and
return it to the home position (fixed position).
Fig. 3.2
Situation with the brake applied Situation with the brake released
• Front brake
Release the lock on the front caster to release the brake.
Lock
Fig. 3.6 Position of the right handle and direction of motion (straight ahead)
To move diagonally
Fig. 3.7 Position of the right handle and direction of motion (a diagonal course)
Parallel motion
Fig. 3.8 Position of the right handle and direction of motion (parallel)
NOTE
When the rear casters are oriented at right angles to the direction in which you
want to proceed, the casters will stick and it will not be possible to move. If the
C-arm cart is difficult to move, check the orientations of the rear casters and
the maneuvering handles.
Situation with the brake applied Situation with the brake released
• Front brake
Lock the front caster and engage the brake.
Lock
1 Check that the main power cable and the cart cable are correctly
wound on the cable guides of the monitor cart.
4 After completing the motion, apply the caster brake (front casters
only).
Handle
Cable guide
Situation with the brake applied Situation with the brake released
1 Connect the cart cable from the monitor cart to the C-arm cart.
3
WARNING
Potential equalization
conductor
3 Connect the monitor cart’s main power cable to the power outlet.
WARNING
NOTE
The power to the monitor cart can be turned on even if the cart cable is not
connected. In this case, the system switch blinks in 1 second intervals (slow
blinking).
NOTE
Power is not supplied to the C-arm unit if the cart cable is connected to the
C-arm unit after the monitor cart power is switched on.
Turn the system switch OFF, connect the cart cable and then turn the system
switch ON.
1 Before moving the C-arm cart, disconnect the main power cable and
the cart cable. When the cart cable is released, always the
associated cart connector cover should be mounted to protect the
connector pin of that cable.
3
Turn the lever to the
“OPEN” position.
Remove the cart cable
and close the cover.
Fig. 3.15 Disconnecting the cart cable Fig. 3.16 Mounting cart connector cover
2 Wind the main power cable and cart cable onto the cable guides of
the monitor cart.
Cable guide
CAUTION
1 Turn the power switch at the back of the monitor cart ON.
Power switch
2 Wait for the system switch to stop flashing, and then press the
system switch on the front of the monitor cart.
• All of the switches on the main panel and side panel will light for
approximately one second.
• Initialization of the collimator, compensating filter camera rotation, etc.
will continue for about 30 seconds.
3
System switch
CAUTION
When turning the power OFF and back ON using the power switch
and system switch, leave an interval of at least 10 seconds after
turning the power OFF before turning the power switch on again.
CAUTION
After switching the power ON, do NOT turn the lever of the cart
cable connector on the monitor cart in the OPEN direction. This
will shut off the power to the C-arm.
To carry out normal operation, turn the power OFF (shut down) and then back
ON.
NOTE
The equioment initializes parts such as the collimator and camera rotation, etc.
for approximately 30 seconds after system startup. During initialization, the
fluoroscopy images may automatically rotate, and collimator leaf etc., may
automatically move within the fluoroscopy visual field.
NOTE
When the DR option is combined, it takes a short while for the system to start
up (before you can start an examination).
Wait until [In preparation] on the C-arm main panel disappears.
However, in an emergency you can perform emergency fluoroscopy.
If you forget to return the C-arm to the home position, press the system
switch for three seconds to apply power only to the C-arm (without starting
the DR option).
Afterward, press the system switch again to end this operation.
When the DR option is combined, it takes a short while for the system to start-up
(before you start an examination).
If the preparation of fluoroscopy image functions is completed before starting an
examination, you can perform emergency fluoroscopy.
APR
Depress
NOTE
The collimator and compensating filter movement and camera rotation are
automatically performed due to the calibration for about 30 seconds after the
system turned on. Adjusting collimator and compensating filter and camera
rotation can not be performed until when the calibration is finished.
When the DR option has completely started, the "New examination standby screen" 3
is displayed.
CAUTION
You must strictly follow the procedure below to turn the power
OFF.
System switch
3 Wait for the system switch to stop flashing, and then turn the power
switch OFF on the rear of monitor cart.
Power switch
CAUTION
Do NOT turn OFF the power switch on the back of the monitor cart
or disconnect the main power cable before shutdown process is
completed.
Doing so may damage the system and the data.
CAUTION
Do NOT turn off the power during transfer of image data to media
(CD-R/DVD-R) and DICOM storage server.
Doing so may cause loss of, or damage to the image data or the
original data stored in the magnetic disc of the equipment.
3 Click the [System Menu] button at the top right of the window.
[System Menu]
button
System menu
4 Click [Shutdown].
6 Check that the green lamp on the system switch on the front of the
monitor cart goes out.
7 Turn the power switch at the back of the monitor cart OFF.
Power switch
3.5 Warm-Up
Warm-up, breaking in the equipment, is required for the use of X-ray tube unit.
Performing fluoroscopy and radiography without warm-up may result in an X-ray
tube unit discharge. Before radiography, perform warm-up following the procedure
below.
For details, see "Selecting APR Directly After Startup" (page 3-47).
3
2 Press (Auto/Manual selection button) to switch the x-ray
adjustment mode to manual.
Fluoroscopy
tube voltage
(kV)
WARNING
When moving the C-arm, take care that the C-arm, X-ray
generators and X-ray I.I. unit at both ends do not strike the patient
or peripheral devices.
Also, after positioning the C-arm, be sure to press the C-arm lock
switch to lock the C-arm.
Failure to do so may cause injury or damage to the equipment.
CAUTION
When moving the C-arm, hold each of the handles to operate it.
Otherwise, you may trap your fingers, causing injury.
Doctor handle
C-arm handle
Slide handle
Hazardous
locations
CAUTION
C-arm slide
motion
C-arm rotary
motion C-arm forward/back C-arm longitudinal
and lateral swiveling movement
movement
Fig. 3.34 C-arm lock switch
3 When you reach the right position, press the lock switch again.
• The C-arm will be locked. (The switch will go out.)
Even when the lock is applied, the C-arm can be moved by applying a force
of 10 kgf or greater. This is to allow each part to be moved in an emergency,
for example in the event of a power outage.
NOTE
Even when the lock is released (the LED lights), it will be automatically applied
(the LED goes out) if no switch is pressed for the predetermined time (factory
default setting: one minute).
Operating the C-arm Without Starting the DR Option (when combined with the DR
option)
Follow the procedures below when you want to only operate the C-arm, such as for
storage when there is no need to perform fluoroscopy.
1 Connect the cart cable and main power cable of the monitor cart.
2 Turn the power switch at the back of the monitor cart ON.
3
Power switch
3 Wait for the system switch to stop flashing, and then press and hold
the system switch on the front of the monitor cart for at least 3
seconds.
• Power is supplied to the C-arm unit.
System switch
Power is supplied to the C-arm unit without waiting for the DR option to start,
and the C-arm can be operated.
When turning the power OFF, the system can be turned off without waiting for
the DR option to shut down by turning the system switch OFF.
Doctor handle
3
450 mm
CAUTION Trapping
m m
Doctor handle 200
CAUTION Trapping
Doctor handle
12.5
CAUTION Trapping
30
CAUTION Trapping
90
120
300
Move the C-arm while holding the
C-arm handles.
CAUTION Trapping
NOTE
Switch
Switch
Every moving part features a scale that you can use as a guide during motion. Note
that the color of the scale matches the color of the C-arm lock switch.
The zero on each scale is the C-arm’s home position.
C-arm rotary
motion
C-arm longitudinal
movement
NOTE
Select the study before starting the examination. There are three ways to do this.
Operation Location
3.7.1 Select a Study from the Study List and Start the Study
If you are dealing with a study that has already been registered, select the study in
the [Study List] window.
This selection is only possible on the reference monitor.
Select the
study.
The study
information
is displayed.
[Start Study]
[APR] [Modality]
Fig. 3.44
Clicking [Start Study] without selecting [APR] and [Modality], the study will
start with the following initial settings.
• APR: Standard
• Modality: RF
Next, 3.8 "Selecting the APR"
3.7.2 Register the Study Information, Select a Study, and Start the
Study
When dealing with a new study, register information about the patient and study to
be examined. This can only be done on the reference monitor.
2 The [Create new study] dialog box appears. Enter required items,
such as [Patient ID] and [Patient's name].
3 Click [OK].
• The new study is created, and is displayed in the [Reserve] tab.
NOTE
When study information is registered for the same patient ID but using a
different patient's name, the [Confirmation] window appears.
When study information is registered for the same patient's name but using a
different patient ID, a new study is created.
If the [Start study] button is clicked instead of the [OK] button, a new study is
registered and begun.
The screen display at the main panel changes from the New examination
standby screen to the APR selection screen.
3
4 Select [APR] and [Modality], and click [Start Study].
• The study starts.
[Start Study]
[APR] [Modality]
Clicking [Start Study] without selecting [APR] and [Modality], the study will
start with the following initial settings.
• APR: Standard
• Modality: RF
Next, 3.8 "Selecting the APR"
If the patient is a new one and there is no time to enter patient information, or there
is no patient information, the system sets a patient ID and patient name
automatically. You can do this either from the main panel or the reference monitor.
NOTE
After completing the emergency case, replace the provisional data (patient ID,
patient name, etc.) with the correct patient information.
Item Description
In the case of an emergency study, only items that require entry are
displayed.
NOTE
When the [Emergency Study] button is clicked during entry or display of the
study information, the currently entered or displayed study information is
discarded. If this happens, study begins with the patient ID and patient's name
that was set so that a new emergency study can be performed.
Select
the study.
[Modify]
Fig. 3.50
3 The [Edit] dialog box appears. Add to or correct the information of the
registered study.
4 Click [OK].
• The corrected information is saved and the [Study List] window returns.
For details on the operation at the reference monitor, see Section C of the
separate Image Processing Section Instruction Manual.
NOTE
APR is set using Shimadzu recommended values. If the values are not
appropriate for your specific needs, please change the values.
3
Releasing the restriction
on X-ray exposure
switch
APR
Basic screen
APR
Basic screen
[Loop]
[Close]
Item Description
• [High Quality]:
Irradiates a high dose of X-rays to generate a high
quality image.
• [Normal]:
Irradiates a standard dose of X-rays.
• [Low Dose 1]:
Irradiates a low dose of X-rays to minimize the
radiation dose to the patient.
• [Low Dose 2]:
[Dose] Irradiates a lower dose of X-rays than in [Low Dose 1]
to minimize the radiation dose to the patient.
• [Boost Pulse]:
Irradiates a high dose of X-rays to generate a high
quality image.
There are two types of pulse rate, 7.5 fps and 3.75 fps,
and high dose is irradiated with a tube current peak
value that is double that of the High Quality mode. For
this reason, it is useful for procedures on thick body
parts which are moved comparatively less than other
parts.
Basic screen
3 Press [OK].
• APR is overwritten and saved, and the basic screen is displayed.
NOTE
Basic screen
3
2 Set [Dose], [Acq Rate] and [Photo Timer], and press [Close].
• The basic screen is displayed.
[Close]
Item Description
Basic screen
3 Press [OK].
• APR is overwritten and saved, and the basic screen is displayed.
3.9 Fluoroscopy
(Auto) :
Tube voltage falls within a rage of 40 to 110 kV automatically.
(Manual) :
3
Tube voltage can be changed manually. ( page 3-64)
[Dose]
[Zoom]
CAUTION
If you leave the unit for any substantial time, press Releasing the
restriction on X-ray exposure switch to turn this lamp out in order
to prevent malfunction.
3
(X-rays being radiated) lights yellow
Depress
NOTE
When using boost pulse fluoroscopy, continue pressing the left foot switch and
the X-ray irradiation will automatically stop after 20 seconds. An alarm sounds
approximately 3 seconds before irradiation stops.
To continue performing boost pulse fluoroscopy, release the left foot switch
and step on the right foot switch again.
NOTE
If the fluoroscopy timer preset time is exceeded, a beep sounds. You can
continue fluoroscopy during the time that the beep sound is sounding.
However, fluoroscopy can be continued for a maximum of ten minutes only; on
exceeding this limit X-ray radiation is automatically stopped.
If you want to restart fluoroscopy, release the restriction by depressing the
left foot switch or releasing X-ray exposure (fluoroscopy) switch on the
main panel. After that, you will be able to start fluoroscopy again.
You can stop the beep sound sounding by pressing Fluoroscopy timer
beep sound reset switch.
For details on setting the timer value, see 3.16.2 "Default Settings" (page
3-88).
NOTE
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved. To save changes, press [Overwrite & Upload] in the
APR selection screen.
1 Select [Dose].
• The selected button will be highlighted.
[Dose]
Item Description
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved. To save changes, press [Overwrite & Upload] in the
APR selection screen.
3
1 Press or to select the fluoroscopy pulse rate.
• Select [CONTINUOUS] for continuous fluoroscopy.
If you select [15 fps], [10 fps], [7.5 fps] or [3.75 fps], pulse fluoroscopy
will be executed, and the pulse rate will be changed to the selected value.
NOTE
You cannot switch the pulse rate while continuing fluoroscopy. You must stop
fluoroscopy before making this change.
NOTE
When [Boost] is selected in [Dose], only [7.5 fps] or [3.75 fps] can be selected
for the pulse rate.
• lights.
Basic screen
Auto/Manual
switching button
(display during mechanical operation) is displayed on the right side of the live
monitor during operation of the following functions.
Rapid feed
Camera rotation
Pressing the camera rotation switch on the side panel causes the camera to rotate.
Pressing this switch while holding down the fast-forward switch causes the camera
to rotate quickly.
The range of camera rotation is 170 to +170.
NOTE
While the last image hold (LIH) image from fluoroscopy is displayed, the image
obtained by “rotating the camera” is actually achieved by image processing.
Use it for establishing the next fluoroscopy position, not for diagnosis.
NOTE
If you start fluoroscopy acquisition immediately after releasing the switch, the
subject may rotate while the camera is rotating.
3
NOTE
The virtual rotation operation can only be used for fluoroscopy last image hold
(LIH) images. It cannot be used with other images.
NOTE
The images obtained by the virtual rotation operation cannot be saved in the
frame memory.
To save the images in the frame memory, perform fluoroscopy after virtual
rotation is finished.
NOTE
In the virtual rotation operation, the monitor image reverse button may light
automatically. This is not a malfunction.
V reverse H reverse
(vertical reverse) (horizontal reverse)
Pressing this switch on the main panel causes the image to be reversed.
Fluoroscopy acquisition is performed based on the status of the image reverse
switch (lit or unlit).
• Fluoroscopy in progress: The fluoroscopic image is reversed.
• Fluoroscopy LIH applied: The LIH image is reversed. The next
fluoroscopy acquisition is done in this
reversed status.
• During acquisition: Reverse operations are not possible.
• During display of the acquired image: The currently displayed image is not
reversed, but the next image acquired
is reversed.
Press the switches on the C-arm main panel to open/close and rotate the octagonal
collimator and the parallel compensating filter.
1
2
3
3
Item Description
NOTE
Octagonal collimator
Parallel compensating
filter
NOTE
The virtual collimator operation can only be used for fluoroscopy last image
hold (LIH) images. It cannot be used with other images.
NONE - -
NOTE
Basic screen
Depress
3
Depress
NOTE
NOTE
When using Super Shot, the X-ray tube voltage is automatically adjusted to
optimize the image.
NOTE
NOTE
Basic screen
NOTE
[Acq Rate] is only displayed when a technique that involves serial radiography,
such as [Serial] or [DSA], is selected.
Depress
NOTE
Releasing your foot from the foot switch during irradiation will end X-ray
irradiation partway through and stop radiography.
The tube current time product (mAs) is only displayed during radiographic
exposure.
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved. To save changes, press [Overwrite & Upload] in the
APR selection screen.
Item Function
NOTE
[Acq Rate] is only displayed when a technique that involves serial radiography,
such as “Serial” or “DSA”, is used.
NOTE
NOTE
Before mounting the cassette, perform the fluoroscopy to confirm the X-ray
irradiation field and patient position.
Basic screen
WARNING
Do NOT stand to the rear side of the I.I. during film radiography.
Doing so may result in a radiation exposure from primary X-ray coming
from the outside of the I.I.
3
Film
radiography
mode
5 Press / to adjust the tube voltage (kV) value and the tube
current time product (mAs) value.
Depress
NOTE
Keep depressing the foot switch until X-ray radiation is completed. If you
release it part way through X-ray radiation will terminate prematurely.
Store the fluoroscopy conditions, the rotational position of the camera, the
collimator, compensating filter position, the loading factor and other information.
NOTE
NOTE
If any condition such as the rotational position of the camera is changed from
the stored condition in smart C memory, the smart C memory starts blinking.
Lit
• Smart C memory [F] will light, and the equipment will return to the
conditions stored in smart C memory [F].
• Smart C memory [L] will go off.
Lit
• Smart C memory [L] will light, and the equipment will adopt the
conditions stored in smart C memory [L].
• Smart C memory [F] goes off.
NOTE
The image on the live monitor is displayed on the LCD display of C-arm main
panel. The following live monitor display elements, however, are not displayed 3
on the LCD display.
Lines of virtual collimation
Annotation
Basic screen
NOTE
The changes you make to the unit settings remain effective even if you restart
(they are not reset by turning the power OFF).
Basic screen
Menu switch
Setting menu screen
3.16.1 Guidance
1 Press [Guidance].
• The guidance screen is displayed.
3
[Guidance]
[Default Settings]
1 2
3 4
Adjust the time of the fluoroscopy timer preset using [] and
[Fluoroscopy [+].
3
Timer] • You can make changes in 30-second increments.
• The maximum setting is 5 minutes.
(Gray)
All APR settings are changed to the initial setting values
when the APR is changed during technique.
1 Press [Calibration].
• The calibration screen is displayed.
[Calibration]
Reset Key
Fig. 3.100 Calibration 2
• Press (reset switch) while holding down at the upper left of the
screen.
Calibration is completed.
Reset Key
You can also end examinations from the monitor cart (reference monitor).
NOTE
The reference air kerma rate, accumulated reference air kerma and total dose
area product are displayed only when combined with the dose display function
(option).
3
Basic screen
1 4
2 3
1
Fig. 3.104 Live monitor
NOTE
When the examination is closed, all the indicated values are reset.
The dose report is displayed when [Dose Info.] on the C-arm main panel is pressed.
[Dose Info.]
NOTE
The indicated value of Dose Area Product has the maximum error of 35 %.
However, the error may be 35 % or more in AKR of less than 6 mGy/min and
Accumulated Reference Air Kerma of less than 100 mGy. (It is based on the
IEC-60601-2-54 clause 203.6.4.5.)
This chapter explains how to perform image processing from the main
panel.
Chapter 4 Image Processing
NOTE
All the above operations can only be performed on the following types of
images displayed on the live monitor. (They cannot be performed on frame
memory images and loop memory images.)
Fluoroscopic images
LIH images
NOTE
NOTE 4
The maximum number of frames for the frame memory image and the loop
memory image is set to one of the four combinations listed below.
If you want to change the setting, contact your Shimadzu service
representative.
3 86 frames 86 frames
Basic screen
[Save]
NOTE
After the number of frame memory images exceeds the maximum number of
frames, the oldest image is automatically deleted as a new image is saved.
[Loop]
4
2 Perform fluoroscopy.
NOTE
Basic screen
[Save]
NOTE
NOTE
After the number of loop memory images exceeds the maximum number of
frames, the oldest image is automatically deleted as a new image is saved.
NOTE
When performing Super Shot in loop memory mode, loop memory mode is
canceled automatically and Super Shot image is stored as frame memory
automatically.
When keep using loop memory mode after Super Shot, select the loop
memory mode again.
Press the Next/Previous switch or the Playback/Stop switch on the C-arm main
panel to select or navigate the image.
: Paused
C-arm Cart
To operate the C-arm during a power cut, operate it manually. Release the front and
rear brakes of the C-arm unit to move it.
C-arm
Monitor Cart
When emergency power can be used during a power cut, connect the emergency
power to the monitor cart.
Under emergency power, etc., to restart the device after power has been restored,
press the system switch on the front of the monitor cart.
All functions can be used after power has been restored.
System switch
1 Press and hold the system switch for more than 5 second.
• The system shuts down.
System switch
5
Fig. 5.3 System switch
2 Wait for the system switch to stop flashing, and then turn the system
switch ON. (Normal Procedure)
• It takes approximately 1 minute to be able to perform emergency
fluoroscopy from when the system is shut down.
When the DR option does not recover, use the equipment for emergency
fluoroscopy.
WARNING
WARNING
WARNING
Occurrence of a problem
Is a message displayed?
Refer to 5.4 "Where Errors are Displayed".
No. Yes
5
End
Caution
This is not an equipment malfunction.
You can reset and continue operation by following the instructions displayed on the
screen.
Example:
1 Press [OK].
Error
You may or may not be able to reset and continue operation by following the
instructions displayed on the screen.
Operation can be continued
You can reset and continue operation by following the instructions displayed on the
screen. After the end of operation turn the power OFF at the monitor cart and
contact your Shimadzu service personnel.
5
Fig. 5.5 Error screen 1
1 Press [OK].
Error (Caution)
Cause of error (caution) Action
Number
803 to 899 Errors associated with the monitor cart Contact your Shimadzu
900 to 999 Errors associated with the DR option service representative.
CAUTION
WARNING
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
Before a study or operation, remove the dust from the X-ray I.I.
unit, C-arm, X-ray tube assembly, and the periphery.
On completing the work, check the following points before switching the power ON
again.
• There must be no water or disinfectant adhering to the equipment.
• The tools used in cleaning and disinfecting work must be tidied away.
WARNING
Focal Spot
Dosimeter
Patient Entrance
Reference Point
980
150
315
200
Phantom
120 Unit: mm
Comparison of dose
display values and
dosimeter values
WARNING
6
WARNING
Replacement
P/N Part name Location Q'ty
interval
FUSE, MONITOR
072-01683-16 1 1 year
021306.3P PW-300
FUSE, MONITOR
072-01659-85 1 1 year
FLM15 PW-300
FUSE,
072-06035-24 INVERTER-300 1 1 year
660CF-20
Brake Shaft
563-58775 C-arm's holder 1 3 years
ASSY
Stopper 2
563-74656 Brake ASSY 3 years
rubber (right and left)
CAUTION
Install the cassette holder correctly so that it will not fall down.
CAUTION
2 Bring the movable guide (2) into contact with the mounting flange (3),
push the cassette holder forward and latch the fixed guide (4) onto
the mounting flange (3).
3 Tighten the set screw (1) until its tip makes contact with the rear end
face of the block (5).
• In this position the cassette holder can be mounted so that it rotates freely
at the apex of the I.I. unit.
(4)
(3)
(C) (A)
(1)
(5)
I.I. Unit
(2)
(B) (A)
Cassette holder
3. The radiation field for radiography is the range obtained in the immediately
preceding fluoroscopy.
CAUTION
Grid
WARNING
When moving the C-arm, take care that the C-arm, X-ray
generators and X-ray I.I. unit at both ends do not strike the patient
or peripheral devices.
Also, after positioning the C-arm, be sure to press the C-arm lock
switch to lock the C-arm.
Failure to do so may cause injury or damage to the equipment.
CAUTION
When moving the C-arm, hold each of the handles to operate it.
Otherwise, you may trap your fingers, causing injury.
Lock Lock
Knob
CAUTION
Be sure to attach the grid with the side with labels facing up.
If the mounting surface is incorrect, it will not be possible to acquire a
correct image.
NOTE
When installing the grid, align the center of the grid with the ▲ mark.
If the mounting angle is not correct, moiré may occur.
Knob
Lock Lock
WARNING
CAUTION
The center of the laser beam on the I.I. plane of incidence shifts as
the C-arm moves. Consequently, before each use and each time
you move the C-arm you must place an object like a pair of
scissors in such a way that the tip of the blade is at the center of
the laser beam and perform fluoroscopy to confirm the position of
the center of laser beam.
I.I.
X-ray tube
Live monitor
NOTE
A cloth cover does not allow the passage of the laser beam. When using the
laser pointer, use a disposable cover made of transparent vinyl.
CAUTION
CAUTION
Make sure that the cover does not come into contact with the floor
or anything that is not sterile.
There are disposable and washable (cloth) types of cover. Either of these can be
fitted.
If you use the washable (cloth) type, use the disposable type on the C-arm.
(1)
(2)
7
Monotank
Double-sided tape
CAUTION
CAUTION
List of Cables
Cable Remarks
Cable Name Shield
Length (Manufacturer/Part No)
Shimadzu/503-58422
(NOT RoHS)
Foot Switch Cable 6m N
Shimadzu/566-13143
(RoHS)
NOTE
The cables listed above are the parts specified to be compliant with the
standards.
These parts are not provided to the equipment.
List of Options
Remarks
Option Name
(Manufacturer/Part No.)
NOTE
Some of the options (*) listed above are the parts specified to be compliant
with the standards. These options are suitable for use in patient environment.
These options are not provided to the equipment.
RF emissions
EN 55011/ Class A
CISPR 11
Electromagnetic
IEC 60601 test Compliance
Immunity test environment -
level level
guidance
Recommended floor
material is wood,
Electrostatic concrete or ceramic tile.
discharge (ESD) ± 6 kV contact ± 6 kV contact If the floor is covered
EN 61000-4-2/ ± 8 kV air ± 8 kV air with synthetic material,
IEC 61000-4-2 preferred relative
humidity in the room is
at least 30%.
Electromagnetic
IEC 60601 test Compliance
Immunity test environment -
level level
guidance
Electrical fast ± 2 kV for power ± 2kV for power Mains power quality
transient / burst supply lines supply lines should be that of a
EN 61000-4-4/ ± 1 kV for input/ ± 1kV for input/ typical commercial or
IEC 61000-4-4 output lines output lines hospital environment.
<5% UT <5% UT
T(>95% dip in T(>95% dip in
UT) UT) Mains power quality
for 0.5 cycle for 0.5 cycle should be that of a
typical commercial or
Voltage dips, 40% UT 40% UT hospital environment. If
short the user of the
(60% dip in UT) (60% dip in UT)
interruptions and OPESCOPE ACTENO
voltage variations for 5 cycles for 5 cycles requires continued
on power supply operation during power
input lines 70% UT 70% UT mains interruptions, it is
EN 61000-4-11/ (30% dip in UT) (30% dip in UT) recommended that the
IEC 61000-4-11 for 25 cycles for 25 cycles OPESCOPE ACTENO
be powered from an
uninterruptible power
<5% UT 5% UT supply or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency
Power frequency
(50/60 Hz)
magnetic fields should
be at levels characteristic
8
magnetic field 3 A/m 3 A/m
of a typical location in a
EN 61000-4-8/
typical commercial or
IEC 61000-4-8 hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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 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 OPESCOPE ACTENO is used exceeds the applicable RF
compliance level above, the OPESCOPE ACTENO should be observed to verify
normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the OPESCOPE ACTENO.
*b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (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.
Parts Number: 503-78800 (MDD not RoHS), 566-18800 (MDD and RoHS)
Address: 1, NISHINOKYO-KUWABARACHO,
NAKAGYO-KU, KYOTO, 604-8511, JAPAN
Authorized
Representative in EU: SHIMADZU EUROPA GmbH
The company's Quality System is satisfied with Annex II, Article 3 for 93/42/EEC
as amended by 2007/47/EC, which is certified by TUV Rheinland LGA Products
GmbH; Tillystrasse 2, D-90431 Nurnberg, Germany (Notified under No. 0197) as
Registration No.: HD 60029841 0001
8.5 Specifications
1. Classification of devices
Type of protection against electric shock:
Class 1 device
Degree of protection against electric shock:
TYPE B equipment according to
IEC60601-1:1988+A1:1991+A2:1995
No Applied Parts according to
IEC60601-1:2005
Operation mode: Continuous operation with intermittent load
Film radiography:
Rating: 60 kV, 200 mAs (20 mA)
110 kV, 100 mAs (12 mA)
mAs setting range: 0.5 to 200 mAs (27 steps)
(0.5, 0.6, 0.8, 1.0, 1.2, 1.6, 2.0, 2.5, 3.2, 4.0,
5.0, 6.3, 8.0, 10, 12, 16, 20, 25, 32, 40, 50,
63, 80, 100, 125, 160, 200)
101 - 110 kV 0.5 - 100 mAs
61 - 100 kV 0.5 - 120 mAs
50 - 60 kV 0.5 - 200 mAs
40 - 49 kV 0.5 - 120 mAs
Digital radiography: Rating: 110 kV, 16 mA
mAs setting rage : 0.3 - 2.7 mAs, 16 mA
(Radiographic tube voltage and tube current are
automatically calculated by kV-mA curve.)
Same for AEC usage specifications
Pulse fluoroscopy:
Pulse rates: 15, 10, 7.5, 3.75 fps
Nominal tube voltage, and the highest peak tube current obtainable with that
voltage:
110 kV, 5 mA (200 V specification)
110 kV, 3.6 mA (100 V specification)
Highest peak tube current, and the highest tube voltage obtainable with that
tube current:
9 mA, 60 kV (200V specification)
5 mA, 80 kV (100V specification)
Boost pulse fluoroscopy:
Pulse rates: 7.5, 3.75 fps 8
Nominal tube voltage, and the highest peak tube current obtainable with that
voltage:
110 kV, 9.8 mA
Highest peak tube current, and the highest tube voltage obtainable with that
tube current:
13.5 mA, 80 kV
Continuous fluoroscopy time:
20 seconds
Standard model: IRF-1000-150
Where
K 1 K 2 : Mean value of measured X-ray output values obtained
using neighboring setting values
I 1 I 2 : Neighboring tube current setting values
Leakage dose:
Leakage radiation in an hour from X-ray tube assembly and collimator is
less than 1.0 mGy in an hour at a distance of 1 meter from the focal spot.
However, leakage radiation in an hour from the collimator is less than
0.5 mGy.
• Leakage dose measurement conditions
Fluoroscopy: 55 kV, 22 mA (121 W) continuous
Radiography: 110 kV, 16 mA, 100 ms, 45 frames,
exposure time 4.5 seconds, cooling time 60 seconds
(average load 123 W)
X-ray radiation field:
230 mm (With an SID distance of 980 mm)
Mass: 15 kg5 kg
Beam
Cu 0.1 mm Cu 0.2 mm Cu 0.3 mm
hardening filter
Reference axis
Reference axis
Focal spot
Focal spot
UNIT : mm
100
330W 220W
175W
90
160W
80
100W
Housing Heat Storage (%) 70
60
50
40
Cooling
30
20
10
0
0 20 40 60 80 100
Time (min)
80
250W
70
Heat Storage(%)
60
50
100W
40
8
30
20
Cooling
10
0
0 1 2 3 4 5 6 7 8 9 10
Time(min)
04/03/25
Time [min]
Table A.1 SERIAL LOAD RATING TABLE (For reference use only)
6. C-arm cart
SID: 980 mm
Height of horizontal X-rays from the floor:
775 mm (When the C-arm is brought onto the bed)
1105 mm (When the C-arm is brought under the bed)
Rotation of the C-arm: 120
Rotation of the C-arm’s holder: 300/120
Longitudinal movement of the C-arm: 450 mm
Lateral movement of the C-arm: 200 mm
Swing of the C-arm: 12.5
7. Image Intensifier
Nominal entrance field size:
9” I.I., Diameter of 23 cm / 16 cm 2-level switching
6” I.I., Diameter of 15 cm / 10 cm 2-level switching
11. Grid
Ratio: 10:1
Line rate: 40 lines/cm (Aluminum), 44 lines/cm (Fiber)
Intermediate material: Aluminum/Fiber selectable
32 V Very C-arm
MFU0603FF00500P500 0.5 50
DC Quick Cart
14. Options
a) DR option
1. Fluoroscopy / acquisition mode 8
Spot, Serial (0.5/1/2/3/3.75/5/7.5 fps), DSA (0.5/1/2/3/3.75/5/7.5 fps)
2. Image Processing
Edge Enhancement, Gamma, Window/Level, Polarity Inverse,
Zooming (max. x4) & Panning, Rotation, Density Adjustment, Multi
Image Display (2x2 or 4x4), Subtraction, Remask, Re-registration,
Peak Hold, Measurement, Annotation
3. DICOM
PRINT, STORAGE, RDSR, MWM, MPPS
4. Other functions
Collimator positioning display, Scan converter (NTSC type)
Hard Disk Drive: min. 30,000 images (1024 x 1024 x 12 bit)
DVD-R
a) Cassette holder
Applicable cassette size 24 30 cm (10" 12") thickness less than
15 mm
b) Laser pointer
Fixed in X-ray tube side, Cross lines
c) Cover
Covering C-arm, X-ray generator and I. I. Fabric type and disposable type
are available.
d) Dose area product meter
The dose area product is displayed on the LCD on the C-arm main panel.
e) Extension kit for source-skin distance
This option extends the focal-spot-to-skin distance from 20 cm to 30 cm
for an application other than surgical purposes.
f) Heat pipe option
This option accelerates the transfer of heat energy from the X-ray tube to
the C-arm.
g) Adjustable monitor kit
Monitor position is adjustable by height, tilting, and swiveling.
h) Image display function
This function enables the live monitor image to be displayed on the LCD
on the C-arm main panel.
i) Dose display function
Dose calculation (accumulative dose, dose rate) is displayed on the LCD
on the C-arm main panel.
j) Scan converter (NTSC type)
15. Mass
Body of the C-arm cart: 250 kg10 kg
Monitor cart: 145 kg10 kg
2 3 4 5
1 6 7 8 9
10 11 12
APR No. 1 2 3 4
Chest
APR Name Standard Head/Neck Shoulder
(IVH/PMI)
Image Brightness
0 0 0 0
Adjustment
Parallel compensating
0 0 0 0
filter rotation angle
Parallel compensating
filter width
Max Max Max Max 8
Octagonal collimator
Max Max Max Max
width
Acq Rate* - - - -
Photo Timer* 0 0 0 0
2 3 4 5
1 6 7 8 9
10 11 12
APR No. 5 6 7 8
Image Brightness
0 (+1)*1 0 (+2)*1 0 0 (+1)*1
Adjustment
Parallel compensating
0 0 0 0
filter rotation angle
Parallel compensating
Max Max Max Max
filter width
Octagonal collimator
Max Max Max Max
width
Acq Rate*2 - - - -
Photo Timer*2 0 0 0 0
2 3 4 5
1 6 7 8 9
10 11 12
APR No. 9 10 11 12
Image Brightness
0 0 0 (+1)*1 0
Adjustment
Parallel compensating
0 0 0 0
filter rotation angle
Parallel compensating
Max Max Max Max
filter width
Octagonal collimator
width
Max Max Max Max
8
Image V reverse OFF OFF OFF OFF
Acq Rate*2 - - - -
Photo Timer*2 0 0 0 0
2. Power supply
System: Single phase AC
Frequency: 50 or 60 Hz
Capacity: 4.0 kVA
Voltage and power supply impedance:
100, 110, 120 V 10 %, 0.2 max.
200, 220, 230, 240 V 10 %, 0.8 max.
Ground: Type D grounding
Power supply breaker: Type suited to use with an inverter
3. Power consumption
100/110/120 V 200/220/230/240 V
Long time 15 A 10 A
Momentary 45 A 20 A
To minimize X-ray exposure on patients and medical staff, the operator must
observe the local laws and regulations specified in each region, as well as the
following precautions. It is also highly recommended to study and know about the
recommendations of the International Commission on Radiological Protection
(ICRP).
Principle
• Limit X-ray irradiation to the minimum.
• Keep the fluoroscopy duration to the minimum and utilize the L.I.H. feature and
the virtual collimator.
• Use the fluoroscopy mode with low radiation dose.
• To avoid unintended X-ray irradiation, turn off the releasing the restriction on
X-ray exposure switch when unnecessary.
8
NOTE
The significant zone of occupancy to be used by the operator and medical staff for
examination/medical treatment shall be defined as follows: The operation requiring
a work in the significant zone of occupancy are orthopedics surgery, pacemaker
placement, etc.
Test method
The stray radiation in significant zone of occupancy was measured according to
IEC601-1-3 Annex AAA.
Test conditions
1) X-ray conditions
X-ray tube voltage:110kV
X-ray tube current:3mA
2)Phantom
Outside dimensions:35[cm] x 35[cm] x 15[cm]
Material:PMMA
3) C-arm Position
Vertical Beam, PA position:Refer to Fig. 8.9
Vertical Beam, AP position:Refer to Fig. 8.10
Horizontal Beam:Refer to Fig. 8.11
Test data
Refer to Fig. 8.12 to Fig. 8.14 8
A B C D E F
200
150
Height above floor [cm]
100
50
0
10 100 1000 10000
Air K er m in one hour (work load: 3600mAs) [µGy]
A B C D E F
200
150
Height above floor [cm]
100
50
0
10 100 1000 10000
Air K erma in one hour (work load:3600mAs) [µGy]
A B C D E F
200
150
Height above floor [cm]
100
50
0
10 100 1000 10000
Air K erma in one hour (work load: 3600mAs) [µGy]
In the examination using this equipment, there is a possibility that the cumulative
skin dose during the examination may reach the level that could bring a
deterministic effect on the patient. According to the ICRP60, the threshold at which
a deterministic effect appears on skin or crystalline lens is 1 to 3 Gy. The following
shows an example of X-ray conditions which could bring skin dose of 1 Gy during
the examination using this equipment.
Example: Performing 25 min of fluoroscopy under the parameters of SID980,
Fluoroscopy mode Normal DC, 110 kV, and 5.0 mA
Focal Spot
Dosimeter
Patient Entrance
Reference Point
980
150
315
200
Phantom
120 Unit: mm
Fluoroscopy
This unit has three or more fluoroscopy modes. Application and characteristics of
each modes are shown below.
Normal
High Quality
DC (100 V
specification)
(Continuous) (Continuous) For study that needs high quality.
DC (200 V
specification)
8
For study that needs high quality
Pulse 33 15/10/7.5/3.75
and decreasing dose.
Boost Pulse
40 50 60 70 80 90 100 110
Dose DC/Pulse
kV kV kV kV kV kV kV kV
Low dose 2 All 0.7 0.7 0.8 1.3 2.0 1.7 1.6 1.4
Low dose 1 All 1.0 1.0 1.0 1.8 2.8 2.4 2.2 2.0
Normal All 1.5 1.5 1.6 2.7 4.1 3.7 3.3 3.0
100V specification:
DC
2.0 2.0 2.2 3.3 5.0 4.4 4.0 3.6
High
100V specification:
Quality All (except DC)
200V specification:
2.0 2.0 2.7 4.4 6.8 6.0 5.4 4.9
All
Boost Pulse All 3.0 3.6 5.4 8.8 13.6 12.0 10.8 9.8
kV 81 85 88 91
kV 79 83 86 89
kV 78 80 84 87
kV 78 80 84 87
kV 78 80 84 86
kV 77 79 81 83
kV 77 78 80 82
kV 76 78 79 80
kV 76 78 79 80
kV 76 77 79 80
kV 73 75 77 78
kV 73 74 75 77
kV 73 74 74 77 8
Normal 10 mA 3.1 3.2 3.2 3.7
kV 73 74 74 76
kV 73 73 74 76
kV 74 76 77 79
kV 72 73 75 76
kV 72 73 74 76
kV 72 73 74 76
kV 72 73 74 76
kV 67 68 69 71
Radiography
Reference Air Kerma
• FOV 9 inch
Test data
Refer to Fig. 8.17 to Fig. 8.20. The unit in figures is [Gy].
NOTE
8.11 Labels
Manufacturer’s Nameplate (for RoHS is representative)
Manufacturer’s nameplates are affixed at the locations indicated below.
(2)
(1)
(3)
(1)
(2)
(3)
(1) (8)
(5)
(7)
(2)
(3)
(4) (6)
(13) (9)
(12) (11)
(10)
(1)
(2)
(3)
(4)
(5)
(6) (Option)
(7) (Option)
(8) (Option)
8
Others
(9)
• TUV approval label
• EU Representative label
• WEEE label
• Label EMC
• Label Manual
NOTE
Date implemented:
Implemented by:
Always carry out the inspection described below before using the equipment.
1 Check the following points visually before switching the power ON.
Correct any nonconformity.
Have previously used contrast media and drugs been removed from the
Clean up.
equipment?
Have you cleared away any rust and metal fragments from the moving
Clear them away.
parts of the equipment and the floor?
Are any cables trapped, twisted, or rubbing against anything? Correct this.
Have any cable connectors been wet with water? Clear them away.
Do the casters, brakes, handles and other parts of the C-arm cart function Contact your Shimadzu
correctly? service representative.
4 Turn the power ON. Check the following points visually and aurally.
Correct any nonconformity.
Have you checked if an error message is displayed on the main panel or Contact your Shimadzu
on the monitor? service representative.
Have you checked if all of the switches on the main panel and side panel Contact your Shimadzu
are lit? service representative.
Date implemented:
Implemented by:
Always check the following points before finishing use of the equipment.
1 Check the following points visually before switching the power OFF.
Correct any nonconformity.
2 Switch the power OFF. Check the following points visually. Correct
any nonconformity.
Have unnecessary items in the vicinity of the equipment been cleared away? Clear them away.
Have previously used contrast media and drugs been removed from the
Clean up.
equipment?
Are any cables trapped, twisted, or rubbing against anything? Correct this.
Have any cable connectors been wet with water? Clear them away.
Do the casters, brakes, handles and other parts of the C-arm cart function Contact your Shimadzu
correctly? service representative.
NOTE
Use [+], [-] and [MENU] buttons to adjust the monitor brightness and contrast.
Main menu
screen
1 Press [MENU].
• The main menu screen of OSD adjustment is displayed.
[Picture]
[Contrast]
[Brightness]