Professional Documents
Culture Documents
M516-E011l Wha-200 Pleno Om PDF
M516-E011l Wha-200 Pleno Om PDF
M516-E011l Wha-200 Pleno Om PDF
: M516-E011
Revision :L
OPERATION MANUAL
Mark Description
Indicates references.
Revision History
Thank you for selecting the Surgical Mobile C-arm Imaging System
WHA-200 OPESCOPE PLENO (hereafter “the system”).
Before using the system, read the operation manual and make sure you
understand its contents.
After reading the manual, keep it safely somewhere where it can be
accessed easily.
Copyright
SHIMADZU Corporation reserves the copyright of this manual and the
whole or a part of the contents may not be copied or reproduced without
the company’s permission.
The contents of this manual may be changed for improvement without
notice.
WARNING
The operator should receive the education related to the (X-ray) medical treatment.
(Have the qualification of medical when the qualification is necessary in each
country.)
The operator should understand description matter of the label and the manual.
The operator should receive the education of operating the system before using the
system first.
WARNING
WARNING
WARNING
DANGER
Read the operation manual and make sure you understand its
contents.
Operating the system without having read this manual, or with an
incomplete understanding of the information it contains, can cause
serious injuries or damage to equipment.
• Do not switch on the power or touch the switches and other controls
without first having read the operation manual.
• If you do not fully understand the information in the operation manual,
please contact our service personnel. The contact details are given at the
end of this manual.
• Keep the operation manual safely in a place where it can be accessed
immediately whenever it is required.
• Familiarize yourself with the locations of hazards and the nature of the
hazards. Make sure you have a thorough grasp of how to avoid these
hazards, and the corrective action to take in the event that such a hazard
is actually realized.
WARNING
WARNING
♦ Live section
DANGER
DANGER
CAUTION
CAUTION
(Units: mm)
2146
880
660
450
1755
R55
0
775 1685
WARNING
WARNING
Cautions on Radiation
WARNING
CAUTION
Cautions on Pacemakers
WARNING
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
Cautions on Explosions
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
WARNING
CAUTION
WARNING
WARNING
(7) (1)
(2)
(4)
(5) (8)
(6)
(2)
(3)
(1)
503-59829
(3)
(4)
(5)
(6)
(7) (Option)
CAUTION
LASER RADIATION
DO NOT STARE INTO BEAM.
1.0 mW Max. CW 645 nm
CLASS 2 LASER PRODUCT IEC60825-1(2001)
Guarantee
The guarantee period of this system is once year from the date of purchase.
Our company is not responsible for the following failures and damages.
3. Failure/damage based on maintenance, repair, etc. using a spare part other than
the genuine parts specified by our company.
The servicing after expiration of the guarantee period will be offered with charge.
Contact Shimadzu Service Representative nearest to you.
Service Life
The system's service life is 10 years (based on Shimadzu's criteria), and is limited to
systems that receive the prescribed maintenance checks.
Safeguarding Data
Shimadzu is not responsible for the recovery of damaged or deleted data, even though,
Shimadzu can adjust the system setting for recurrence prevention if data is damaged or
deleted for any reason.
Keep in mind that there is always a possibility that data stored in the system disk might
be deleted or damaged. The data deletion or damage may occur due to the malfunction
or failure of devices, and also performance deterioration (secular variation) of
components.
Our company suggests saving the necessary data to film in order to create a hardcopy,
or transferring the data to the external recording media (CD-R, DVD-R) for safekeeping.
However, since data stored in the external recording media may also be deleted or
damaged, a periodic check should be done for the data content.
Software Revision
This manual applies to the software revision 1.19.
Introduction
Chapter 7 Options
Contents
Introduction
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-2
Using the System Safely... . . . . . . . . . . . . . . . . . . . . . Introduction-4
Warning Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-17
Guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-19
Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-19
Exclusion of Liability . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-20
Safeguarding Data . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-20
Action for Environment (WEEE)
To all user of Shimadzu equipment in the European Union:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-21
Language of Approved Version . . . . . . . . . . . . . . . . . Introduction-21
Software Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-21
Organization of This Manual and How to Use It . . . . Introduction-22
Chapter 5 Troubleshooting
5.1 Responding to Problems . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 Where Errors are Displayed . . . . . . . . . . . . . . . . . . . . . . . 5-4
Chapter 7 Options
7.1 Cassette Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2 Hand Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.3 Laser Pointer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.4 Fitting and Removing the Sterilization Cover . . . . . . . . . . 7-8
7.4.1 When Using the Washable (Cloth) Type . . . . . . . . . . . . 7-9
7.4.2 When Using the Disposable Type . . . . . . . . . . . . . . . . 7-10
7.5 Touch Panel Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
7.6 Dose Area Product Display . . . . . . . . . . . . . . . . . . . . . . . 7-12
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
9.3.1 Brightness Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
9.3.2 Contrast Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
NO TEXT
Chapter 5 Troubleshooting 5
Chapter 7 Options 7
Chapter 9 Appendix 9
1.1 Outline
♦ Medical purpose
This equipment is a mobile system that aims to make shape and properties in the
inside of the body visible by using X-rays, and to offer the image information for
the X-ray diagnosis.
This system aims at the fluoroscopy. It is a system that offers the human body image
information for the diagnosis and treatment by using a fluorescent action and the
photograph action of X-rays.
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 system
is used for an application other than surgical purposes.
♦ Operating 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 device of the Image
processing section (option). Cassette-holder (option) takes a general radiography.
For details on the function of each part, see Chapter 2 “Configuration of the
System”. 1
C-arm
I.I. handle
Monitor cart
C-arm cart
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
theaters and E.R. facilities.
♦ Dose Reduction
Term 1. A “last image hold” (LIH) function is provided for cases where fluoroscopy is
not necessary for confirmation.
Last image hold
(LIH) 2. The virtual rotation function and virtual collimator function allow you to
rotate, and perform virtual collimator operations on, the last image hold (LIH)
The last X-ray
image is displayed image.
on the monitor. 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).
♦ 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 system for work on any
limb or on the spinal cord, which helps to reduce both the positioning time and 1
the time required for surgery.
3. There is a C-arm lock switch located on the I.I. handle. This allows the
physician to release the lock quickly.
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. (Note that the touch
panel for the monitor is an option.)
5. From the main panel, you can perform operations such as post-processing and
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 system 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.
In order that the system can achieve its intended performance, it must be used under
the stipulated conditions.
♦ Environmental conditions
Use the system in an environment with the following conditions.
CAUTION
Even when the following conditions are met, make sure that there
are no sudden changes in temperature or humidity. This leads to
condensation, which can cause trouble.
Condition Stipulation
Atmospheric pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar)
Atmospheric conditions The atmosphere must be free of explosive and corrosive gases.
♦ Power supply
The power supply must have the following characteristics.
3.5 kVA or
Single phase 100, 110, 120, 200, 220, 230, 240 VAC 50/60 Hz
greater
WARNING
Do not use a power supply that does not conform to the above
requirements.
1
Using a power supply that does not conform to these requirements can
cause serious accidents involving fire, generation of smoke, and
explosion.
♦ Grounding requirements
Grounding resistance less than 100 ohm
CAUTION
Use a leak current breaker that is suitable for the inverter system.
1.3.2 Storage
CAUTION
Even when the following conditions are met, make sure that there
are no sudden changes in temperature or humidity. This leads to
condensation, which can cause trouble.
Condition Stipulation
Atmospheric pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar)
Atmospheric conditions The atmosphere must be free of explosive and corrosive gases.
Class I devices
NOTE
Class I devices are those that depend solely on basic insulation for protection
against electric shocks; in order to ensure that metal parts that could come into
contact if this basic insulation failed do not become live, a means for
connecting the device to the earth conductor in the fixed wiring of the
equipment is provided as an additional safety measure. (International
standard IEC60601-1: 1988, AMENDMENT 1: 1991, AMENDMENT 2: 1995)
Type B devices
NOTE
Type B devices are devices that provide a particular level of protection against
electric shock, and this applies especially to the reliability of the allowable
leakage current and protective ground connections. (International standard
IEC60601-1: 1988, AMENDMENT 1: 1991, AMENDMENT 2: 1995)
Normal devices 1
CAUTION
WARNING
1.5.1 Symbol
Safety classification:
Nameplate affixed to the cover
Type B device
Potential equalization
Potential equalization conductor
conductor
1.5.2 Labeling
♦ Manufacturer’s Nameplate
Manufacturer’s nameplates are affixed at the locations indicated below. 1
(2)
(1)
(3)
(1)
(2)
(3)
♦ Others
Certificated labels for Europe are affixed at the location (1) shown in Fig1.2.
• TUV approval label
• CE mark
• Company label
• WEEE label
Item Details
Sex No limitation
Nationality No limitation
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 system.
(6) C-arm
For details, see 3.5.5 “Lock Release Switches on the I.I. Handle” (page 3-30).
(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 3-3).
For details, see 3.2.1 “Moving the C-arm Cart” (page 3-3).
(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 3-12).
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 WHA-200 system.
NOTE
For details, see 3.4 “Turn the Power ON / OFF” (page 3-12).
5
1 9 2
6
2 10
7
8
11
4
Reference
No. Switch Name Function
page
Fluoroscopy timer
3 Stops the fluoroscopy timer alarm tone 3-51
alarm reset switch
Image display
Used to switch the content of the LCD
4 switching switch 3-76
display (image / operation screen).
(option)
Window adjustment
6 Adjusts the contrast of the image. 4-2
switch
Reference
No. Switch Name Function
page
Level adjustment
7 Adjusts the brightness of the image. 4-2
switch
Edge adjustment
8 Adjusts the edge of the image. 4-2
switch
End examination
9 Press this switch to end an examination. 3-83
switch
3 4 5 6 7 8 2
9
1
2
18
14
10
11
12
13
15 16 17
Fluoroscopy mode
1 Lit in the fluoroscopy mode.
display
IBS (image brightness Press this button to switch the IBS function (the image
2 stabilization function) brightness stabilization function) ON and OFF. The button is
switching button lit when the IBS function is ON.
Used to select the filter. Each time you press the button the
7 Filter switching button filter changes. The order of filter thicknesses is Filter 1 <
Filter 2 < Filter 3.
X-ray tube assembly temperature Indicates the temperature of the X-ray tube assembly. As the
9
display temperature increases, the bar in the display extends.
Fluoroscope image Saves the fluoroscopy image displayed on the live monitor
12
save button (including loops) on the hard disk.
The C-arm lock switch is used to secure and release the C-arm.
2
3
4
Reference
No. Switch Lock location Function
page
C-arm longitudinal
4
movement
1
2
3 4 5 6
7 8
Reference
No. Switch Name Function
page
1
Used to store the fluoroscopy conditions
Memory switch 3-74
and the collimator settings.
2
Octagonal collimator
3 Opens/closes the octagonal collimator.
open/close
3-60
Parallel collimator
4 Opens/closes the parallel collimator.
open/close
Parallel collimator
5 Rotates the parallel collimator.
rotation
Octagonal collimator
Parallel collimator
Reference
No. Switch Name Function
page
This chapter explains the basic procedure for using the system.
Chapter 3 Basic Operation
3.1 Introduction
This section describes the basic operation flow and provides references.
3.2 Transport
WARNING
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
Fig. 3.5 Position of the right handle and direction of motion (straight ahead)
♦ To move diagonally
Fig. 3.6 Position of the right handle and direction of motion (a diagonal course)
♦ Parallel motion
Fig. 3.7 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
1 Check that the main power cable, the additional protective earth
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.
Fig. 3.12 Connection of the additional protective earth cable and main power cable
CAUTION
1 Before moving the C-arm cart, disconnect the main power cable, the
additional protective earth 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
Open the connector
cover and turn the lever
to the “OPEN” position.
Remove the cart cable
and close the cover.
Fig. 3.13 Disconnecting the cart cable Fig. 3.14 Mounting cart connector cover
2 Wind the main power cable, additional protective earth 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
System switch
CAUTION
CAUTION
When you turn the power OFF and back ON, leave an interval of at
least 10 seconds.
CAUTION
After turning the power ON, do not open the connector cover on
the body of the C-arm. This will actuate the interlock function and
disable X-ray radiation.
• While the connector cover is open the message “You can’t take
exposures until closing connector cover.” will be displayed on the
C-arm's main panel: close the connector cover.
• After closing the connector cover, it may take some time to initialize
the camera and iris; message for the camera or iris may be
displayed. Displaying those messages does not mean that the
system is damaged. If a message such as “No camera detected!” is
displayed on the reference monitor, either click “OK” with the mouse
or depress the foot switch.
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 system switch lamp blinks for about 5 seconds after turning on the power
switch on the back side of the monitor cart. Even if you press the system
switch while the system switch is blinking, the system does not start. Wait until
the system switch lamp is stopped blinking and turned off.
NOTE
It takes a short while for the system to start up (before you can start an
examination).
Wait until the new examination standby screen is displayed.
However, in an emergency you can perform emergency fluoroscopy.
Emergency fluoroscopy
The system can display the emergency fluoroscopy image after the system
turned on and the image process unit becomes ready for fluoroscopy before
selecting patient. Press [Releasing the restriction on X-ray exposure] and
depress the left foot switch to start fluoroscopy.
NOTE
When you start up the system, messages prompting you to record information about
the patient at the main panel will be displayed. (New examination standby screen)
NOTE
CAUTION
You must strictly follow the procedure below to turn the power
OFF.
Turn the power switch OFF on the back of the monitor cart or
disconnect the main power cable after the shutdown process is
completed. Otherwise, the system and data will be destroyed.
Also, if the power is turned OFF during transfer of image data to media
(CD-R/DVD-R), the image data will be lost.
2. Press .
3. The patient file will close and a confirmation dialog asking if you want
to exit the application is displayed: select [Yes].
4. During the system shutdown sequence, the following dialog appears
asking whether to start the defragmentation tool.
• In case that you execute the defragmentation of the hard disc drive
Click [OK]. The defragmentation tool in Windows starts and the disk
defragmenter dialog (Fig. 3.24) appears. Refer to 3.4.3 “How to Execute
HDD Optimization (Defragmentation)” for executing the
defragmentation.
If you do not click [OK] within about 10 seconds after the dialog of Fig.
3.21 appears, the system automatically restarts to shut down.
• In case that you don't need the defragmentation (You need system
shutdown)
Click [Cancel]. The system automatically restarts to shut down.
3 Check that the green lamp on the system switch on the front of the
monitor cart goes out.
4 Turn the power switch at the back of the monitor cart OFF.
Power switch
Images and patient information are stored in the hard disk drive. The fragmentation
of the hard disk drive causes performance degradation. This section provides the
information how to optimize the HDD (defragmentation) using the HDD
defragmentation tool.
1 Click [OK] in the start defragmentation tool dialog that appears during
the system shutdown sequence.
NOTE
CAUTION
Do not turn off the power switch on the back side of the monitor
cart, and Do not remove power cable plug from outlet during
defragmentation.
The system and data may be damaged. Moreover, system may fail to
start. Wait strictly until shut down completed.
NOTE
NOTE 3
• Defragmentation may need several hours. Perform defragmentation when
the system is not scheduled for use.
• Defragmentation may need long hours when available disk space is low.
Delete unnecessary patient files and images. Available disk space of about
50% or more is recommended for system operations. The status dialog
displays the available disk space. Refer to "Status Dialog" in the section A
sub-section 1.6 in "M516-E013 WHA-200 PLENO Image Processing
Section Instruction Manual".
WARNING
CAUTION
I.I. handle
C-arm handle
Slide handle
Hazardous
locations
CAUTION
2146
880
660
450
1755
R55
0
775 1685
(Units: mm)
C-arm slide
motion
C-arm rotary
motion
C-arm forward/
back and lateral
C-arm longitudinal
swiveling
movement
movement
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).
I.I. handle
450 mm
3
CAUTION Trapping
m m
200
I.I. handle
CAUTION Trapping
I.I. 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
Operation Location
If you are dealing with a patient who has already been registered, select the name
from the patient list.
This selection is only possible on the reference monitor.
2 Press [Open].
• The patient list window on the reference monitor will close and the APR
selection window will be displayed.
The patient’s name will be displayed on the live monitor.
Patient’s name
NOTE
In the patient list dialog displayed at first after the system turned on, it takes
several seconds to be able to select buttons in the dialog.
When dealing with a new patient, register information about the patient to be
examined. This can only be done on the reference monitor.
Fig. 3.38
NOTE
Enter all the patient information requested in boxes that are marked “*”.
You can change the asterisked patient information by making new settings.
Consult our service agent about this.
3 Press [Open].
• The patient list window on the reference monitor will close and the APR
selection window will be displayed. 3
The patient’s name will be displayed on the live monitor.
[Close]: Closes the patient information entry window without saving the
registration information.
[Save]: Closes the patient information entry window and saves the
registration information. This information is added in the patient list
window.
The screen display at the main panel changes from the new examination
standby screen to the APR selection screen.
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.
For operations on the reference monitor, see Section B of the separate Image
Processing Section Instruction Manual.
NOTE
After completing the examination, replace the provisional data (patient ID,
patient name, etc.) with the correct patient information.
• The patient list window on the reference monitor will close and the APR
selection window will be displayed.
The patient’s name will be displayed on the live monitor.
• The patient ID and patient name are set automatically.
NOTE
After completing the examination, replace the provisional data (patient ID,
patient name, etc.) with the correct patient information.
3 Press [Edit].
• The patient information editing window will be displayed.
For details on the operation at the reference monitor, see Section C of the
separate Image Processing Section Instruction Manual.
After you have registered a patient at the reference monitor, or on pressing [APR
selection screen display] on the main panel, the APR selection screen is displayed.
1 Check [APR].
• To change the APR, press the relevant [APR].
• The selected APR will be highlighted.
2 Press [OK].
• The basic screen will be displayed.
NOTE
Pressing [OK] on the APR selection screen sets the registered parameters for
the APR. The fluoroscopy conditions, acquisition conditions, image processing
conditions, and camera rotation and collimator adjustment statuses before
[OK] was pressed are updated.
[APR]
3
[OK]
Basic screen
[APR selection
screen display]
Six [APR] buttons are displayed simultaneously on the APR selection screen.
Press [Next] to go to the next page. You can set up to twelve APRs.
[Next]
Fluoroscopy/acquisition APR
selection dialog
[Close]
3 Press [OK].
• The basic screen will be displayed.
3
[OK]
Basic screen
NOTE
Neither fluoroscopy nor acquisition is possible while the APR selection screen
is displayed.
3.8 Fluoroscopy
Basic screen
[Fluoroscopy program]
[Fluoroscopy mode]
[Fluoroscopy loop]
[Releasing the
restriction on X-ray
exposure]
CAUTION
If you leave the unit for any substantial time, press [Releasing the
restriction on X-ray exposure] to turn this lamp out in order to
prevent malfunction.
Press
Depress
NOTE
If the fluoroscopy timer preset time is exceeded, an alarm sounds. You can
continue fluoroscopy during the time that the alarm 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)] on the main
panel. After that, you will be able to start fluoroscopy again.
• You can stop the alarm sounding by pressing [Fluoroscopy timer alarm
reset]. 3
[Fluoroscopy timer
alarm reset]
For details on setting the timer value, see 3.14.3 “Fluoroscopy Timer Setting”
(page 3-80).
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved.
Basic screen
[Fluoroscopy
program]
Fluoroscopy program
selection dialog
[Next]
NOTE
If you do not wish to change the fluoroscopy program selection, perform either
of the operations described below to return to the basic screen without
changing the fluoroscopy program.
•
•
Press [Close].
Carry out fluoroscopy.
3
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved.
Basic screen
[Fluoroscopy
mode]
NOTE
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved.
Basic screen
[Pulse rate]
NOTE
[1 fps] and [0.5 fps] fall into the “high pulse fluoroscopy” category. These are
distinct from the other selections.
You cannot switch between [CONTINUOUS]/[15 fps]/[7.5 fps]/[3.75 fps]/[2 fps]
and [1 fps]/[0.5 fps] while continuing fluoroscopy. You must stop fluoroscopy
before making this change.
NOTE
In high-pulse fluoroscopy ([1 fps] or [0.5 fps]), the maximum fluoroscopy tube
current is set at 16 mA regardless of the fluoroscopy mode. And the IBS
(image brightness stabilization) function is automatically switched OFF, so if
you want to adjust the tube voltage, do it manually.
3.9.3
3.9.1 3.9.2
Pressing the camera rotation switch 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.
NOTE
You can open/close and rotate the octagonal collimator and parallel collimator.
Fast-forward
NOTE
Octagonal collimator
3
Parallel collimator
NOTE
Basic screen
[Acquisition
program]
[Acquisition
rate]
[Acquisition
sequence
details]
[Number of
images that can
be acquired]
NOTE
Depress
3
NOTE
Changes made from the main panel are temporary, so the values after the
change are not saved.
Basic screen
[Acquisition
program
selection]
Acquisition
program
selection dialog
3
[Next]
NOTE
If you do not wish to change the acquisition program selection, perform either
of the operations described below to return to the basic screen without
changing the acquisition program.
• Press [Close].
• Start acquisition.
Basic screen
[Acquisition
rate]
NOTE
NOTE
If a program sequence has an acquisition rate that exceeds 5 fps, it falls into
the high-speed mode so the tube voltage may increase and the image quality
may change.
Acquisition rate
selection
dialog
3
Note that if any program sequence (page 3-68) has not already been set on
the reference monitor, [SEQUENCE] is not displayed, as shown below.
Press [SEQUENCE] in the acquisition rate selection dialog and make the selection.
You must set the program sequence at the reference monitor in advance. If no
sequence is set, [details] is not displayed.
1 Press [details].
• The program sequence selection dialog is displayed.
Basic screen
[Acquisition
sequence
details]
Program
sequence
selection dialog
3 Press [Close].
• The program sequence selection dialog is closed.
Name of the
selected
program
sequence
3
The acquisition
rate and time
are displayed.
The program sequence details screen displays details of the selected program
sequence. It shows the five registered levels of acquisition rate and the time.
NOTE
If X ray generation will become impossible part way through the program
sequence due to the HU calculations, the affected level is indicated in red.
1 Press [details].
• The delay time setting dialog is displayed.
3 Press [Close].
• The delay time setting dialog closes.
3.11 Map
1 Select the map technique for the acquisition program.
2 Depress the left foot switch to start fluoroscopy, and carry out
positioning.
4 Depressing the left foot switch at this point will display a subtraction 3
image generated from the map image and fluoroscopy image.
NOTE
NOTE
If you select a technique other than “map” (e.g. SPOT, SERIAL, or DSA) for
the acquisition program, the left foot switch will reassume its role in normal
fluoroscopy.
Basic screen
[Film
radiography
mode]
3 Press [+]/[-] to adjust the tube voltage (kV) value and the tube current
time product (mAs) value.
Basic screen
4 Depress the right foot switch. Alternatively, press the hand switch
(option) to the first level.
Depress
3
5 Continue to depress the right foot switch, or press the hand switch to
the second level.
• X-rays will be radiated. During radiation the irradiation indicator (on the
monitor cart) is lit.
NOTE
Keep depressing the foot switch or holding down the hand switch until X-ray
radiation is completed. If you release it part way through X-ray radiation will
terminate prematurely.
Store the rotational position of the camera, the collimator 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 memory switch, the memory switch starts blinking.
Lit
1 Hold down for about 1 second.
• The current conditions will be stored in memory switch A.
When storing is completed the switch lights.
5 Press ,briefly.
• Switch B will light, and the system will adopt the conditions stored in
memory switch B.
• Switch A goes off.
By pressing [Image display], you can switch to image display function on the LCD
display.
Basic screen
[Image display]
Image display
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
on the LCD display.
• Lines of virtual collimation
• Annotation
NOTE
• Check that [Releasing the restriction exposure] is OFF before you perform
this operation.
• The changes you make to the unit settings remain effective even if you
restart (they are not reset by turning the power OFF). 3
1 Press [Menu].
• The system setting menu screen is displayed.
Basic screen
[Menu]
System setting menu screen
NOTE
1 Press [Sound].
• The sound setting screen is displayed.
2 Press [Change] and set the various warning and operation tones.
• To actually hear sound, press [Test].
• Set the volume by pressing [+]/[−].
2 Press [+]/[−] to set the time for the fluoroscopy preset timer time.
• You can make changes in 30-second increments.
• The maximum setting is 4 minutes, 30 seconds.
If you set “0” for the fluoroscopy preset timer, the screen shown below is
displayed.
3
Fig. 3.83
You can view a list of the values stored in memory switches A and B, and the
loading factor and image processing conditions when stored in memory switch.
You can refer to the setting parameters when editing an APR on the reference
monitor.
Details on APR editing are given in the separate Image Processing Section
Instruction Manual.
CAUTION
3
1 Release your foot from the foot switch.
[End
examination]
3 Press [OK].
• The examination ends and the new examination standby screen is
displayed.
You can also end examinations from the monitor cart (reference monitor).
NO TEXT
This chapter explains how to perform image processing from the main
panel.
Chapter 4 Image Processing
3
4
NOTE
All the above operations can only be performed on the image displayed on the
live monitor.
Basic screen
[Disp. mode]
8
1
2
10
3 7 4 5 6
NOTE
When you press [Sub] or [Sub BM], subtraction processing is performed with
the image displayed on the live monitor as the mask.
2. [Thumbnail]
Press this button to switch multi image display ON and OFF on the reference
monitor.
5. [Horizontal reverse]
Press this button to switch horizontal reverse display ON and OFF.
6. [Vertical reverse]
Press this button to switch vertical reverse display ON and OFF.
NOTE
Horizontal and vertical reverse operation in the display mode are only applied
to the displayed image and other images in the same sequence. They are not
applied to the next fluoroscopy acquisition.
Previous Sequence
Next Sequence
Reset Up
Left Right
Down
Reset Up
Left Right
Down
8. [Close]
Press this button to close the image processing dialog.
NO TEXT
WARNING
If you have any doubts about how to proceed, contact our service
agent.
WARNING
If you feel there is something wrong with the system, stop using it
immediately.
If you notice an abnormal operation or sound, stop using the system
immediately and contact our service agent.
WARNING
Occurrence of a problem
Is a message displayed?
Refer to 5.2 “Where Errors are Displayed”.
No. Yes
5
End
♦ Warning
You can reset and continue operation by following the instructions displayed on the
screen.
Example:
1 Press [Close].
• The dialog closes.
♦ Error
You may or may not be able to reset and continue operation by following the
instructions displayed on the screen.
If you cannot continue operation, promptly turn the power OFF at the monitor cart
and contact our service agent.
5
Fig. 5.2 Error screen
NO TEXT
CAUTION
1 Check that the main power supply to the system is switched OFF,
and disconnect the main power cable.
CAUTION
CAUTION
CAUTION
CAUTION
WARNING
CAUTION
CAUTION
CAUTION
CAUTION
WARNING
WARNING
NO TEXT
CAUTION
Install the cassette holder correctly so that it will not fall down.
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.
Radiography preparation
switch
First level
2 Press the hand switch (X-ray exposure switch) to the second level.
• X-ray radiation will start.
X-ray exposure
switch
Second
level
• During X-ray radiation, the irradiation indicator on the monitor cart will
be lit.
NOTE
Continue to hold down the hand switch to the second level until X-ray radiation
has finished. If you release them part way through, X-ray radiation will be
ended prematurely.
NOTE
Depending on the setting, the hand switch can be used for fluoroscopy.
Consult with the service personnel.
In this case, the hand switch can be operated as described below.
Other than film radiography:
• When the hand switch is pressed to the first level, fluoroscopy is carried out
(X-rays for fluoroscopy will be radiated while the switch is held down).
• To take a radiograph, press the right foot switch (you cannot take
radiographs by operating the hand switch).
Film radiography:
• Film radiography is carried out by operating the hand switch.
• A laser beam is emitted and at the same time a cross mark appears on the
live monitor image.
• The button is highlighted.
• When you press this switch again, the laser beam is stopped.
• The cross mark on the live monitor image disappears.
• The laser beam continues to be emitted while the button is highlighted.
WARNING
You can adjust the display position of the cross mark on the live monitor image
from the reference monitor.
For details on how to change the position of the laser pointer cross mark, see
Section C of the separate Image Processing Instruction Manual.
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, perform fluoroscopy, and adjust the display
position of the cross mark.
i.i.
X-ray tube
Live monitor
Fig. 7.2
CAUTION
7
NOTE
A cloth sterilization cover does not allow the passage of the laser beam. When
using the laser pointer, use a disposable sterilization cover made of
transparent vinyl.
CAUTION
CAUTION
Make sure that the sterilization cover does not come into contact
with the floor or anything that is not sterile.
(1)
(2) 7
Monotank
Double-sided tape
CAUTION
CAUTION
Dose area
product display
NOTE
When the patient file is closed, the dose area product is reset.
NOTE
8.1 Specifications
1. Classification of devices
Type of protection against electric shock:
Class 1 device
Degree of protection against electric shock:
Type B device
Operation mode: Continuous operation with intermittent load
Nominal tube voltage, and the highest peak tube current obtainable with that
voltage:
110 kV, 5 mA (15, 7.5, 3.75, 2 fps)
110 kV, 16 mA (1, 0.5 fps)
Highest peak tube current, and the highest tube voltage obtainable with that
tube current:
9 mA, 60 kV (15, 7.5, 3.75, 2 fps)
16 mA, 110 kV (1, 0.5 fps)
Reference axis
Reference axis
Focal spot
Focal spot
UNIT : mm
0
330W 220W
175W
0
160W
0
100W
0
0
Cooling
0
0
0 20 40 60 80 100
Time (min)
0
250W
0
0
100W
0
8
0
0
Cooling
0
0
0 1 2 3 4 5 6 7 8 9 10
Time(min)
04/03/25
Time [min]
5. C-arm cart
SED: 900 mm
Height of horizontal X-rays from the floor:
785 mm (When the C-arm is brought onto the bed)
1095 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°
6. Image Intensifier
Nominal entrance field size:
Diameter of 23 cm / 16 cm 2-level switching(9/6 inch I.I)
Image Processing:
Recursive Filtering, Edge Enhancement, Gamma, Window/Level 8
Polarity Inverse, Zooming(x2) & Panning, Multi Image Display (4x4)
Subtraction, Remask, Pixel shift, Landmarking,
Thumbnail View (reference), Measurement, Annotation
Others:
Virtual Camera rotation and Collimator positioning on the LIH image
without Radiation
NTSC type scan converter (top and bottom 32 scan lines are not output.)
Hard Disk Drive: min. 30,000 images (1024 x 1024 x 12 bit)
CD-R/DVD-R
9. TV monitor
18 inch (19 inch) LCD display monitor
10. Grid
Ratio: 10:1
Line rate: 44 lines/cm
Intermediate material: Fiber
11. Options
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) Hand held switch for X-ray radiation
d) Sterilization cover
e) Touch panel monitor option
When you use a monitor with a touch panel as the reference monitor, you
can operate the image-processing unit by using touch operations.
f) DICOM
DICOM PRINT, DICOM STORAGE
g) Image display function
This function enables the live monitor image to be displayed on the LCD
on the C-arm's main panel.
h) Dose area product meter
The dose area product is displayed on the LCD on the C-arm's main
panel.
i) 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.
j) Monochrome LCD monitor option
12. Weight
Body of the C-arm cart: 250 kg
Monitor cart: 145 kg
2. Power supply
System: Single phase AC
Frequency: 50 or 60 Hz
Capacity: 3.5 kVA
Voltage and power supply impedance:
100, 110, 120 V ± 10%, 0.2 Ω max.
200, 220, 230, 240 V ± 10%, 0.8 Ω max.
Ground: Type D grounding
Power supply breaker: Type suited to use with an inverter
3. Power comsumption
Momentary: 35 A(100, 110, 120 V), 17.5 A(200, 220, 230, 240 V)
Stand by: 15 A(100, 110, 120 V), 10A(200, 220, 230, 240V)
8
♦ Standard kV-mA curve on shipment from the factory
NOTE
Phantom: 350x350x150
Phantom: 350x350x150
Phantom: 350x350x150
8
Fig. 8.6 Horizontal Beam
♦ Test method
The stray radiation in significant zone of occupancy was measured according to
IEC601-1-3 Annex AAA.
♦ Test conditions
1)General
Test Date:22 Mar, 2004
Tested by:T. Nakahara, H. Yagi
Instrument used for measurement:
Name:Victoreen660
Model:660-S1
Probe dimensions:100cm2x4cm
Latest calibration:Feb, 2002
2) X-ray conditions
X-ray tube voltage:110kV
X-ray tube current:3mA
3)Phantom
Outside dimensions:35[cm] x 35[cm] x 15[cm]
Material:Polymethyl-methacrylate
4) C-arm Position
Vertical Beam, PA position:Refer to Fig. 8.4
Vertical Beam, AP position:Refer to Fig. 8.5
Horizontal Beam:Refer to Fig. 8.6
♦ Test data
Refer to Fig. 8.7 to Fig. 8.9
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
8
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]
CAUTION
CAUTION
♦ List of Cables
Table A.1
Cable Note
Cable Type Shield
Length (Manufacturer/Part No)
The WHA-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the WHA-200 should assure that it is used in such an
environment
RF emissions
EN 55011/ Class A
CISPR 11
The WHA-200 is suitable for use in all
Harmonic emissions
establishments other than domestic and those
EN 61000-3-2/ Class A
directly connected to the public low-voltage
IEC 61000-3-2
power supply network that supplies buildings
Voltage fluctuations/ used for domestic purposes.
flicker emissions
Complies
EN 61000-3-3/
IEC 61000-3-3
The WHA-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the WHA-200 should assure that it is used in such an
environment.
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%.
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.
(Table C.1)
Electromagnetic
IEC 60601 test Compliance
Immunity test environment -
level level
guidance
<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
(60% dip in UT) (60% dip in UT) the user of the WHA-200
interruptions and
for 5 cycles for 5 cycles requires continued
voltage variations
operation during power
on power supply
70% UT 70% UT mains interruptions, it is
input lines
recommended that the
EN 61000-4-11/ (30% dip in UT) (30% dip in UT)
WHA-200 be powered
IEC 61000-4-11 for 25 cycles for 25 cycles from an uninterruptible
power supply or a
battery.
<5% UT 5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
NOTE UT is the a.c. mains voltage prior to application of the test level.
The WHA-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the WHA-200 should assure that it is used in such an
environment.
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.
*1 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 WHA-200 is used exceeds the applicable RF compliance
level above, the WHA-200 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the WHA-200.
*2 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.
Address: 1, NISHINOKYO-KUWABARACHO,
NAKAGYO-KU, KYOTO, 604-8511, JAPAN
Authorized
Representative in EU: SHIMADZU EUROPA GmbH
NO TEXT
Date implemented:
Implemented by:
Always carry out the inspection described below before using the system.
1 Check the following points visually before switching the power ON.
Correct any nonconformity.
Have unnecessary items in the vicinity of the system been cleared away? Clear them away.
Have previously used contrast media and drugs been removed from the
Clean up.
system?
Have you cleared away any rust and metal fragments from the moving
Clear them away.
parts of the system 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 our service agent.
correctly?
Do the brakes of the monitor cart function correctly? Contact our service agent.
4 Turn the power ON. Check the following points visually and aurally.
Correct any nonconformity.
Is the operating noise after switching the power ON normal? Contact our service agent.
Have you checked if all of the switches on the main panel and side panel
Contact our service agent.
are lit?
5 Check the following points while operating the system. Correct any
nonconformity.
Is there an abnormal noise when the C-arm is operated? Contact our service agent.
Does the C-arm lock switch function correctly? Contact our service agent.
Date implemented:
Implemented by:
Always check the following points before finishing use of the system.
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 system been cleared away? Clear them away.
Have previously used contrast media and drugs been removed from the
Clean up.
system?
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 our service agent.
correctly?
Do the brakes of the monitor cart function correctly? Contact our service agent.
NOTE
Control dials
Control dials
9
Fig. 9.2 Control dial
NO TEXT