Surgical Mobile C-Arm Imaging System OPESCOPE ACTENO Operation en

M516-E040C
Apr. 2014
Surgical Mobile C-arm Imaging System
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 an imminently hazardous situation which, if not

DANGER avoided, will result in serious injury or death.
Indicates a potentially hazardous situation which, if not

WARNING avoided, could result in serious injury or possibly death.
Indicates a potentially hazardous situation which, if not

CAUTION avoided, may result in minor to moderate injury or
equipment damage.
States information which helps to use the equipment

NOTE correctly.
Indicates references.
Gives information to make using the Opescope easier.
Gives information for reference when using the Opescope.
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.
© 2013-2014 Shimadzu Corporation. All rights reserved.

Introduction
Operating Precautions
“Operating Precaution (for Both the Safety and the Prevention of

Danger) in the Use of Electric Medical Equipment”
1. Nobody without the following experience and knowledge should use the equipment.
(1) Medical (radiographic) training (if particular qualifications are required in the
country concerned, those qualifications must be held).
(2) The capacity to read and understand the instruction manual.
2. When installing the equipment, pay attention to the following items:
(1) Do NOT install it near water faucet or similar equipment.
(2) Install it away from potential sources of problems such as abnormal pressure,
temperature or humidity, drafts, direct sunlight, dust, or locations where the air
has a high concentration of salt or sulfur.
(3) During transportation and operation of the equipment, avoid tilting, vibration
and sharp impact against it.
(4) Keep the equipment away from the areas where chemicals or gases are stored.
(5) Use only the correct electrical power source with matching frequency, voltage
and current (or wattage).
(6) Check the conditions of the battery power source (power and polarity) before
operating the equipment.
(7) Properly ground the equipment.
3. Before operating the equipment, pay attention to the following items:
(1) Check the conditions of switch contacts, polarity, dial settings, and meters, and
make sure the equipment performs correctly.
(2) Confirm that the ground is connected properly.
(3) Check all wiring for proper and correct connections.
(4) Pay attention when using more than one unit at a time, because it may lead to
an incorrect diagnosis and cause danger.
(5) Check the condition of the external electric circuit that will be directly connected
to a patient.
(6) Check the condition of the battery power source.
4. While operating the equipment, pay attention to the following items:
(1) Do NOT over-exceed time or the amount of equipment use needed for
diagnosis or therapy.
(2) Observe the equipment and patient continuously for early detection of
problems.
(3) When a problem is detected with the equipment or patient, take proper action to
stop the equipment without harming the patient.
(4) Do NOT let the equipment touch the patient.
Introduction-2 OPESCOPE ACTENO Instruction Manual

Introduction
5. After operating the equipment, pay attention to the following items:

(1) Turn off the switches and return the dial to their original before use in the
prescribed order. Then, turn off the main power switch.
(2) Do NOT pull the power cable forcibly from the outlet.
(3) When storing the equipment, pay attention to the following items:
(i) Keep it away from the water.
(ii) Store it away from the potential causes of problems such as abnormal
pressure, temperature and humidity, draft, direct sunlight, dust, or
locations where the air has a high concentration of salt or sulfur.
(iii) During transportation and storage of the equipment, avoid tilting,
vibration and sharp impact against it.
(iv) Store the equipment away from areas where chemicals and gases are
stored.
(4) Clean all attachments, cables and contacts, and store them in one place.
(5) Keep the equipment clean to avoid problems during the next use.
6. When the equipment is found to be out of order, do not try to repair it.
Display an appropriate sign to indicate that the equipment is out of order, and
contact your Shimadzu Service Representative for repair.
7. Do NOT modify any part of the equipment.
8. Preventive maintenance
(1) The equipment and its parts should be periodically checked.
(2) If the equipment has not been in operation for an extended period of time, test it
prior to actual operation to make sure it works correctly and safely.
9. Concerning other items, operate properly according to the instruction manual.
OPESCOPE ACTENO Instruction Manual Introduction-3

Introduction
Precautions for Use
WARNING
The responsibility for management of use and maintenance of medical equipment

lies with the user.
This equipment is restricted to use by, or under supervision of, a diagnostic radiology
technician or a person with a certificate indicating equal proficiency. Repair and
inspection of the inside of the equipment is dangerous. Be sure to contact your Shimadzu
service representative for repair and inspection.
WARNING
Never modify the equipment.

In general, modifications are strictly prohibited by the Regulatory requirements of the law
of the country where the device is installed. Please contact your Shimadzu service
representative if it is necessary to modify the equipment.
WARNING
Perform periodic inspection.

Preventive maintenance is required to maintain long-term safety and performance of the
equipment.
The 6 "Maintenance and Inspections" chapter in this manual gives detailed descriptions
of daily and periodic maintenance and inspection that a user should perform.
As for the maintenance and inspection that only specially trained experts can perform,
utilize the maintenance agreement program offered by Shimadzu.
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.

Introduction
WARNING
Prepare alternative system with fluoroscopy function, in case any trouble happens
and fluoroscopy/radiography can not be operated normally.
CAUTION
If the operator has no experience in operating the equipment, be sure that he or

she receives instruction on how to operate it from Shimadzu service personnel or
someone who has adequate experience in using the equipment.
In order to operate the equipment safely, an explanation of the operation needs to be
given. When installing the equipment, Shimadzu service personnel explain the operating
procedure using this instruction manual. Follow their directions and operate the
equipment correctly.
1.7 "Operator Profile" (page 1-10)

Introduction
Be Sure to Read the Following to Prevent Explosion, Electric Shock,

or Injury
DANGER
Do NOT use any potentially flammable or explosive gas, such as

disinfectant sprays, near the equipment.
Use of such gas may cause an explosion.
WARNING
Check the condition of the patient before conducting a study.

If equipment usage is deemed to put the patient at risk due to the his or
her condition, refrain from conducting the study or treatment.
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
If an abnormality occurs during operation, or if an unusual odor or

smoke is emitted during operation, stop using the equipment
immediately and contact your Shimadzu service representative.
Continued use may damage the equipment and cause injury.

Introduction
WARNING
Do NOT open the covers of the equipment.

Otherwise, electric shock may result. When opening the covers for
maintenance, contact your Shimadzu service representative.
WARNING
Always be very careful when moving the equipment to avoid

contact with the patient or operator and to ensure that the patient
or operator does not become caught between the equipment and
any neighboring devices.
Otherwise, it may cause injury.
WARNING
When performing CPR, immediately move this equipment away so

it does not obstruct CPR.
CAUTION
When moving the C-arm, hold each of the handles to operate it.
Otherwise, you may trap your fingers, causing injury.
3.6 "Positioning (How to Operate the C-arm)" (page 3-26)

Introduction
CAUTION
When opening and closing the monitors, be careful not to trap

your fingers.
Otherwise, it may cause injury.
CAUTION
Do NOT place peripheral devices or any other object within the

range of motion of the equipment.
If you place peripheral devices such as monitors within the range
indicated below, the equipment could strike or contact them.
(Units: mm)

Introduction
Cautions on Environmental Conditions
WARNING
Use the equipment in an environment that meets the stipulations

stated here.
Use the equipment only in a room or area that conforms to the laws (or
regulations with legal force) that govern the electrical safety of this kind
of equipment.
WARNING
Do NOT use the equipment in an oxygen-rich environment.

The use in an oxygen-rich environment may cause fatal or serious
injuries or damage to the equipment due to easy ignition.
WARNING
Be sure to connect the equipment only to a (commercial) power

outlet with a ground terminal.
Do NOT connect the equipment to power stripes, extension cords,
or overloaded electrical circuits.
Doing so may cause the electric shock.

Introduction
CAUTION
Be sure to use the equipment under the following environmental

conditions:
The installation of a dedicated air-conditioner in the examination room
is recommended if the building air-conditioner cannot meet the
necessary environmental conditions.
 Atmosphere: No explosive or corrosive gases
 Ambient temperature: 10 C to 35 C
 Relative humidity: 30 % to 80 % (no condensation)
 Atmospheric pressure: 800 hPa to 1060 hPa (800 mbar to
1060 mbar)
 Environment luminosity: 150 lx to 500 lx
 Ambient noise level: Under 70 dB
Note also that there must be no sudden change in temperature or
humidity.
This causes condensation, which can lead to equipment failure.
CAUTION
Provide the equipment with a suitable ground.

The equipment needs a ground.
An unsuitable ground could cause electric shocks.
See 1.4 "Environmental Conditions" (page 1-5).
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.

Introduction
WARNING
The equipment must only be operated by qualified personnel,

such as radiology technicians or those with equivalent
qualifications.
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
Perform X-ray irradiation carefully and according to the doctor's

directions when using the equipment with expectant mothers,
women who suspect they are pregnant, lactating women, or
children.
Particular ways of using the equipment may increase the scatter dose
absorbed into the patient, which may cause a radiation hazard.
WARNING
During X-ray irradiation, ensure that the X-rays irradiate the

necessary region only.
To avoid unnecessary exposure, narrow down the collimator and take
protection measures, such as wearing a protective apron.

Introduction
WARNING
Do NOT place any unnecessary object in the location within the

X-ray exposure region.
Doing so may result in unnecessary radiation exposure to the patient.
CAUTION
Be sure to warm-up the equipment (running-in operation of the

X-ray tube unit) before fluoroscopy or radiography.
If the equipment is not used for a prolonged period, perform warm-up
(running-in operation of the X-ray tube unit) periodically (approximately
once a week).
See 3.5 "Warm-Up" (page 3-25).
CAUTION
Perform the warm-up if an arc occurs.

Suddenly using the X-ray tube unit near the nominal X-ray tube voltage
(above 100 kV) after using the unit at a relatively low tube voltage
(80 kV max.) for a prolonged period may result in arc. This arc occurs
due to loss of the warm-up effect at high tube voltage after the X-ray
tube unit is used at a relatively low tube voltage for a prolonged period.
In this case, warm-up the X-ray tube unit by referring to the procedure
described in the X-ray high voltage generator operation manual.
CAUTION
Do NOT perform unnecessary standby operations.

If standby status continues after the radiography preparation button is
pressed, wire disconnection or withstand voltage failure may occur due
to the evaporation of the X-ray tube filament.

Introduction
CAUTION
In order to minimize the radiation dose on the patient, make the

distance between the focus and the patient’s body surface as long
as possible (Minimum 45 cm).
The shorter the distance becomes, the greater the amount of scatter
dose absorbed into the patient, which may cause a radiation hazard.
CAUTION
Pay extra attention when irradiating X-rays for a long time or

repeatedly.
It may cause a radiation hazard.
CAUTION
Do NOT confuse the fluoroscopy and radiography.

If the radiography mode is misused on purpose by the operator for
real-time imaging, the image display delay may be longer than in the
fluoroscopy.
NOTE
Objects such as the operating table or surgical instruments in the X-ray

exposure area may adversely affect the image quality or dose.
NOTE
The radiation dose changes when changing tube voltage, dose mode,
pulse rate, etc.

Introduction
Cautions Relating to the Laser Beam
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
Never look directly into the laser beam.

Doing so can cause injuries such as damage to the eyes.
The laser pointer (option) can be used only under the supervision of
a person with medical knowledge who understands the dangers
associated with using a laser beam.
Only switch the laser pointer ON when necessary. Avoid
unnecessary irradiation.
Do NOT attempt any operation, adjustment or procedure that is not
described in this manual. This could result in dangerous laser
radiation.

Introduction
Cautions on Moving the Equipment
WARNING
Take care to avoid impacts and overturning of the equipment.

The unit alone weighs more than 200 kg.
Impacts and overturning will not only damage the equipment, but could
also cause serious injuries.
When moving the equipment, pay attention to the following points.
 Check that the C-arm is at its home position.
 Check that the cable work has been done correctly.
 When traversing slopes and entrances, and negotiating obstacles,
move the equipment as gently as possible. Take particular care on
steep slopes.
 Always apply the brake when you stop moving the equipment.
 Do NOT move the equipment over any steps or bumps greater than
2 cm, or slopes steeper than 5 degrees.
 Always stop the equipment on a level surface and avoid sloped
surfaces. Failure to do so may cause the equipment to roll down the
slope or tip over.
 In places where moving the equipment generates strong vibrations,
for example outdoor paths, avoid rapid progress, deep steps, and
steep slopes. Do NOT stop moving on inclined routes.
 While wheeling the equipment, watch out for obstacles ahead.
Measurement Accuracy
WARNING
When used in combination with the DR option, values are

displayed as "mm" and "deg" when the DR option measurement
function is used.
Do NOT attempt to use the measurement function for purposes
other than references for evaluation because precise image
measurement is not possible.

Introduction
Cautions on the System and Software
CAUTION
Observe the following precautions:

 Do NOT attempt to alter any system software.
Doing so could disrupt the functioning of the system and result in
loss of images.
 Do NOT attempt to alter any system hardware components.
Doing so could disrupt the functioning of the system and result in
loss of images. Use of any hardware components not provided by
Shimadzu is strictly prohibited. This includes peripherals (mouse,
keyboard, monitor, etc.).
 Pay careful attention to other high frequency-generating equipment
in the room. The monitar cart should be as far as possible from any
such device to prevent noise from affecting the image video signal.
 Do NOT disconnect the cables connected to this system.
Otherwise the image may not be displayed, the data may be
damaged and the system may fail to start up.
 Do NOT move any system component.
If necessary, move it carefully to avoid damage.
 Do NOT apply any shocks to the system components.
 Do NOT place anything which may generate magnetic fields near the
system components.
 Do NOT alter the system setting. Do NOT install any software to the
system other than that provided by Shimadzu for this system.
Otherwise, the system may fail to start up.
NOTE
 Before performing an exposure, always identify the patient based on

the patient information displayed on the equipment.
 Do NOT delete the program conditions or move the saved location.
The program conditions set on the X-ray high voltage generator are
linked with the DR console.
If you do delete them, a system malfunction may occur.

Introduction
Cautions on Data Loss
CAUTION
The important image data or original data should be archived

(backup) in an external file system such as an optical magnet disc
or printed on film.
A system hard ware failure, misoperation, or contingent accidents may
cause loss of, or damage to the image data or the original data stored
in the magnetic disc of the equipment.
 Shimadzu accepts no responsibility for loss or damaged image data
or original data.
 Shimadzu accepts no responsibility whatsoever for incidental,
consequential, or indirect damages (destruction to property, loss of
opportunities, tangible and intangible damages such as lost profits,
etc.) resulting from or arising out of using, not using, or inability to
use the equipment.
 External file systems, such as media, could also be damaged.
Create multiple backups to avoid data loss.
CAUTION
Do NOT disconnect the LAN cable when transferring of image

data to the DICOM storage server.
Doing so may cause loss of or damage to the image data or the original
data stored on the magnetic disc of the equipment.

Introduction
Cautions on Network Connections
CAUTION
Shimadzu accepts no responsibility for any of the following items

due to infection by malware (i.e. malicious software, including
computer viruses and worms, which cause damage to the infected
computer):
 Loss, alteration, and leakage of data, including images, recorded on
this equipment
 Accidents due to the malfunction of this equipment
 Infection of other equipment via this equipment and any damages
incurred due to the infection
 Other issues including all events caused by malware infection

Introduction
CAUTION
When using the networks described below, the customer must

implement security measures to prevent infection by malware (i.e.
malicious software, including computer viruses and worms, which
causes damage to the infected computer).
 Networks that lack security management
 Networks that may be subject to malware intrusion
 Networks that are connected to or have the ability to connect to the
following devices
(1) Devices that lack security management by the customer
(2) Devices that can be used by persons unauthorized by the
customer
(3) Wireless communication devices
Examples of security management are as follows ;

 NOT connecting to networks that lack security management
 NOT connecting to the internet
 Checking whether media (such as CDs, DVDs, and external storage
devices) are infected with malware before use.
 Avoiding actions that may result in malware infection
 NOT connecting to the network of another PC connectable to the
internet.
Any viral infection or leakage of hospital information or patient

information via internet connections is not covered under warranty.

Introduction
CAUTION
The customer should identify, analyze, evaluate and control RISK

by Network.
The customer connection of this machine to a NETWORK that includes
other equipment could result in previously unidentified RISKS to
PATIENTS, OPERATORS or third parties;
Subsequent changes to the NETWORK could introduce new RISKS
and require additional analysis.
Changes to the NETWORK include:

 Changes in NETWORK configuration
 Connection of additional items to the NETWORK
 Disconnecting items from the NETWORK
 Update of equipment connected to the NETWORK
 Upgrade of equipment connected to the NETWORK
Cautions on Cleaning and Disinfection
WARNING
Be sure to turn the equipment power OFF before cleaning and

disinfecting the equipment.
Otherwise, a malfunction may occur in the equipment, or the equipment
may operate in an unintended way.
Also, thoroughly ventilate the room before turning ON the power after
disinfection work is complete.
CAUTION
Be sure to clean and disinfect the equipment.

Cleaning and disinfection is very important to ensure that the
equipment can be used hygienically and safely. Strictly follow the
methods prescribed.

Introduction
CAUTION
Do NOT directly apply or spray rubbing alcohol or water onto the

equipment.
Wipe the surface of the equipment with a cloth soaked with rubbing
alcohol.
If rubbing alcohol gets inside the equipment, it can cause failure or
accidents.
CAUTION
Use the following disinfectants:

 Rubbing alcohol
 2-propanol (Isopropyl alcohol (abrasive free))
 Glass cleaner (non ammonia-based)
 Water solution of neutral detergent
 Only onto the touch panel
CAUTION
Do NOT use the following disinfectants:

 Chlorine-based disinfectants
 Disinfectants that corrode metals, plastics, rubber, or paint
 Disinfectants unsuitable for metals, plastics, rubber, or paint
 Spray-gas type disinfectants
 Volatile disinfectants
 Disinfectants that may enter the equipment
CAUTION
Do NOT use an organic solvent.

Organic solvents may change the surface color. If an organic solvent
adheres to the surface, wipe it off immediately.

Introduction
CAUTION
Use disinfectants at a minimum.

Repeated disinfection over a long time may lead to discoloring and
cracking on the equipment surface, and deterioration of rubber and
plastic. If any abnormality is found on the equipment after disinfection,
stop using the equipment immediately. Contact your Shimadzu service
representative for repair.
CAUTION
Observe the following precautions when cleaning and disinfecting

the touch panel:
 Disconnect the main power cable before cleaning and disinfecting.
 Clean and disinfect the touch panel periodically. The applicable
cleaners include, isopropyl alcohol (abrasive free), glass cleaner
(non ammonia-based), water solution of neutral detergent.
 Handle the touch panel with care when cleaning and disinfecting. Do
NOT rub or hit the panel surface because it tends to scar easily.
 Wipe gently with moistened soft close to remove the dust from the
panel surface.
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.

Introduction
Cautions Relating to Cellular Telephones
WARNING
Do NOT bring any cellular telephones or related devices into the

examination room with their power ON.
Such devices can exceed the EMC standard limitations, and under
some conditions this can impair the proper functioning of the
equipment. In the worst case, this can cause serious injuries or clinical
errors.
Cautions on Electromagnetic Compatibility (EMC)
WARNING
This equipment needs special precautions regarding EMC.

Install and use the equipment according to the EMC information
provided in this instruction manual.
See 8.1 "Environmental Conditions of EMC (Electromagnetic

Compatibility)" (page 8-2).
WARNING
Make sure that electromagnetic compatibility is obtained.

All peripheral devices must satisfy EMC standards regarding emission
of electromagnetic energy and susceptibility to electromagnetic
environment.
Devices that do not satisfy these standards may disturb the correct
functioning of the equipment. In the worst case, this can cause serious
injuries or clinical errors.


Introduction
WARNING
Do NOT use this equipment adjacent to, or stacked with, other

equipment.
If adjacent or stacked use is necessary, check to be sure that this
equipment works properly in the environment.

Cautions When Irradiating Consecutive Pulse X-rays
WARNING
Observe the following precautions when irradiating consecutive

pulse X-rays:
 Conducting studies involving irradiating consecutive pulse X-rays
onto the region where an implantable pacemaker or defibrillator is
implanted may cause these devices to malfunction.
 Refer to the "Important General Cautions," "Interactions," or other
relevant sections in the accompanying documentation of the
implantable pacemaker or defibrillator and take the prescribed
measures before irradiating the implanted region of these devices
with consecutive pulse X-rays.
Fluoroscopy or radiography performed by irradiating consecutive pulse
X-rays (such as serial radiography with a few second intervals, pulsed
fluoroscopy, digital angiography, DSA, or cineradiography) can
adversely affect the CMOS circuit in implantable pacemakers and
defibrillators. Such affects may cause oversensing in these devices
that can temporarily inhibit pacing pulse output and result in an
inappropriate heart rate.

Introduction
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.

Introduction
Software License Agreement
NOTE
1. Definition of licensed software

The licensed software ("software") refers to all computer programs
used by the product, in addition to all related documentation.
2. Ownership of license
The software used in this product is copyrighted by Shimadzu
Corporation ("Shimadzu") who possesses all rights, including
sublicenses for those rights (for copyrights, etc.) held by third
parties.
The equipment with the installed software is sold on the basis of
Shimadzu licensing the software ownership to the customer.
Accordingly, when the customer uses the software, the customer
must observe the items outlined below:
(1) The customer shall only use the software for use with a single
equipment.
(2) The intellectual property rights for the software are not
transferred to the customer.
(3) The customer, or any third party, is prohibited from performing
any of the following actions:
 Duplicating the software.
 Changing the software, in whole or part.
 Transferring, loaning, or sublicensing the software.
 Transferring the software outside Japan without prior permission
of the Japanese or U.S. government.
Service Life
The equipment lifetime is 10 years (based on Shimadzu's criteria) assuming the
specified maintenance checks are performed.

Introduction
Disposal Precautions
CAUTION
When disposing of the equipment, contact your Shimadzu service

representative.
An improper disposal of this equipment may pollute the environment by
substances contained in parts.
Action for Environment (WEEE)

To all user of Shimadzu equipment in the European
Union:
Equipment marked with this symbol indicates that it was sold on or after 13th
August 2005, which means it should not be disposed of with general household
waste. Note that our equipment is for industrial/professional use only.
Fig. Introduction-1 WEEE Mark
Contact your Shimadzu service representative when the equipment

has reached the end of its life. They will advise you regarding the
equipment take-back.
With your co-operation we are aiming to reduce contamination from waste
electronic and electrical equipment and preserve natural resource through re-use and
recycling.
Do not hesitate to ask your Shimadzu service representative, if you require further
information.

Introduction
Software Version
This manual is compatible with the software version NEE.
Warning and Caution Labels

The following safety labels, which describe handling precautions, are attached to
the equipment. With adequate understanding of the contents on these labels and the
warning/caution items in this manual, operate the equipment safely.
Inspect the safety labels periodically (once a year).
If any label is peeled or unreadable by stain or scratch, replace it with a new one.
For new labels, contact your Shimadzu service representative.
(1) (9)
(5) (7)
(8)
(2)
(3)
(4) (6)
Fig. Introduction-2 Warning labels
(1)

Introduction
(2)
(3)
(4)
(5)
(6) (Option)
(7) (Option)

Introduction
(8) (Option)
(9) (Option)

Introduction
Organization of This Manual and How to Use It

The chart below shows how this manual is organized and how to use it.
Introduction
First use Chapter 1 Overview of the

OPESCOPE ACTENO
When assuring operating safety
Chapter 2 Configuration of the

Equipment
Chapter 3 Basic Operation
When using the equipment

Chapter 4 Image Processing
Chapter 7 Options
When troubleshooting Chapter 5 Troubleshooting
Chapter 6 Maintenance and

When carrying out maintenance Inspections
and inspection
Chapter 7 Options
When looking for technical information Chapter 8 Technical Data

Introduction
Related Instruction Manuals
Document Name Document No.
OPESCOPE ACTENO Quick Guide M517-E244
OPESCOPE ACTENO Operation Guide (for Digital) M516-E042
OPESCOPE ACTENO Emergency Guide M517-E245
LCD monitor Monochrome ML19001 Color CL19194

M517-E202
OPERATION MANUAL
Abbreviations
Abbreviations Description
EMC Electro Magnetic Compatibility
LIH Last Image Hold
X-ray I.I. unit X-ray Image Intensifier
LCD Liquid-Crystal Display
APR Anatomical Program
DSA Digital Subtraction Angiography
IBS Image Brightness Stabilizer
HU Heat Unit
LED Light-Emitting Diode
AEC Automatic Exposure Control
CPR Cardiopulmonary resuscitation

Contents
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 1 Overview of the OPESCOPE ACTENO

1.1 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.1.1 About the OPESCOPE ACTENO . . . . . . . . . . . . . . . . . . 1-2
1.2 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.4 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.4.1 Operation Environment . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.4.2 Transportation and Storage Environment . . . . . . . . . . . 1-6
1.4.3 Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.4.4 Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.5 Classification of Equipment . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.6 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
1.7 Operator Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
OPESCOPE ACTENO Instruction Manual i

Contents
Chapter 2 Configuration of the Equipment

2.1 Standard Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1.1 C-arm Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1.2 Configuration of the Monitor Cart . . . . . . . . . . . . . . . . . . 2-7
2.2 Main Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
2.2.1 Function of Each Switch . . . . . . . . . . . . . . . . . . . . . . . . 2-10
2.2.2 LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
2.3 Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
2.3.1 C-arm Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
2.3.2 Control Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
2.4 Live Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.2.1 Moving the C-arm Cart . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.2.2 Moving the Monitor Cart . . . . . . . . . . . . . . . . . . . . . . . . 3-10
3.3 Connecting and Dismantling the System . . . . . . . . . . . . . 3-11
3.3.1 System Connections . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
3.3.2 Disconnection Procedure . . . . . . . . . . . . . . . . . . . . . . . 3-13
3.4 Turn the Power ON / OFF . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
3.4.1 Turning the Power ON . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
3.4.2 Emergency Fluoroscopy
(when the DR option is combined) . . . . . . . . . . . . . . . 3-17
3.4.3 Turning the Power OFF . . . . . . . . . . . . . . . . . . . . . . . . 3-20
3.5 Warm-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
3.6 Positioning (How to Operate the C-arm) . . . . . . . . . . . . . . 3-26
 Operating the C-arm Without Starting the DR Option
(when combined with the DR option) . . . . . . . . . . . . . . . . . . 3-29
3.6.1 C-arm Longitudinal Movement . . . . . . . . . . . . . . . . . . . 3-31
3.6.2 C-arm Forward/Back
and Lateral Swiveling Movement . . . . . . . . . . . . . . . . 3-32
3.6.3 C-arm Slide Motion . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
3.6.4 C-arm Rotational Motion . . . . . . . . . . . . . . . . . . . . . . . 3-33
ii OPESCOPE ACTENO Instruction Manual

Contents
3.6.5 Lock Release Switches on the Doctor handle

(Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34
3.6.6 About the Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
3.7 Starting the Study (when the DR option is combined) . . . 3-36
3.7.1 Select a Study from the Study List and Start the Study 3-37
3.7.2 Register the Study Information, Select a Study,
and Start the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39
3.7.3 Start an Emergency Study . . . . . . . . . . . . . . . . . . . . . . 3-42
 Correcting the Study Information . . . . . . . . . . . . . . . . . . . . . . 3-44
3.8 Selecting the APR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46
 To Change Fluoroscopy APR . . . . . . . . . . . . . . . . . . . . . . . . 3-49
 To Change Acquisition APR
(when the DR option is combined) . . . . . . . . . . . . . . . . . . . . 3-53
3.9 Fluoroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-57
 Changing the Fluoroscopy Conditions 1 (Dose) . . . . . . . . . . 3-62
 Changing the Fluoroscopy Conditions 2 (Pulse rate) . . . . . . 3-63
 Changing the Fluoroscopy Conditions 3
(Fluoroscopy Tube Voltage) . . . . . . . . . . . . . . . . . . . . . . . . . 3-64
3.10 Changing I.I. Field Size (Zooming-up Images) . . . . . . . . . 3-65
3.11 Camera Rotation, Image Reverse, Collimator,
Compensating Filter Operation . . . . . . . . . . . . . . . . . . . . 3-66
3.11.1 Camera Rotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-66
3.11.2 Image Reverse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-68
3.11.3 Collimator and Compensating Filter Operation . . . . . . 3-69
3.11.4 Setting the Beam Hardening Filter . . . . . . . . . . . . . . . . 3-71
3.12 Taking a Super Shot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-72
3.13 Digital Radiography (when the DR option is combined) . . 3-74
 To Change the Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-77
 To Change the Acquisition Rate . . . . . . . . . . . . . . . . . . . . . . 3-78
 To Change the Photo Timer . . . . . . . . . . . . . . . . . . . . . . . . . 3-79
3.14 Film Radiography (General Radiography) . . . . . . . . . . . . 3-80
3.15 Useful Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-83
3.15.1 Smart C Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-83
 To Differentiate the Use of Two Smart C Memory . . . . . . . . . 3-84
3.15.2 Live Monitor Image Display on the C-arm Main Panel
(Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-85
OPESCOPE ACTENO Instruction Manual iii

Contents
3.16 System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-86

3.16.1 Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-87
3.16.2 Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-88
3.16.3 Touch Panel Calibration . . . . . . . . . . . . . . . . . . . . . . . . 3-90
3.17 Ending the Examination . . . . . . . . . . . . . . . . . . . . . . . . . . 3-92
3.18 Dose Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-93

4.1 Adjusting Contrast and Brightness (C-arm Main Panel) . . . 4-2
4.2 Saving/Selecting/Navigating Images . . . . . . . . . . . . . . . . . . 4-3
4.2.1 Saving Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.2.2 Selecting/Navigating the Images . . . . . . . . . . . . . . . . . . 4-8
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 6 Maintenance and Inspections

6.1 Maintenance and Inspections . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2 Daily Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.3 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.4 Inspection for Warning and Caution Labels . . . . . . . . . . . . 6-7
6.5 Checking organization of the dose information . . . . . . . . . . 6-8
6.6 Periodic Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.7 Regularly Replaced Components . . . . . . . . . . . . . . . . . . . 6-10
iv OPESCOPE ACTENO Instruction Manual

Contents
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 8 Technical Data

8.1 Environmental Conditions of EMC
(Electromagnetic Compatibility) . . . . . . . . . . . . . . . . . . . . . 8-2
8.2 Statement of Compliance [For Europe] . . . . . . . . . . . . . . . 8-8
8.2.1 Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
8.2.2 Company's Quality System . . . . . . . . . . . . . . . . . . . . . . 8-8
8.2.3 International Standards . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
8.3 Statement of Compliance with Standards . . . . . . . . . . . . . . 8-9
8.4 Manufacturer Information . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
8.5 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
8.6 Initial Setting Values for APR . . . . . . . . . . . . . . . . . . . . . . 8-23
8.7 Conditions for Installation and Use . . . . . . . . . . . . . . . . . . 8-26
8.8 Storage Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-26
8.9 KV-mA Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
8.10 Information on Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
8.10.1 Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
8.10.2 Stray Radiation in the Significant Zone of Occupancy . 8-30
8.10.3 Test Report Stray Radiation
for OPESCOPE ACTENO . . . . . . . . . . . . . . . . . . . . . . 8-33
8.10.4 Deterministic Effect . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-35
8.10.5 Reference Air Kerma (Rate) . . . . . . . . . . . . . . . . . . . . 8-36
8.10.6 Distribution Map of Stray Radiation . . . . . . . . . . . . . . . 8-42
8.11 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-46
OPESCOPE ACTENO Instruction Manual v

Contents
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
vi OPESCOPE ACTENO Instruction Manual

Chapter 1 Overview of the OPESCOPE ACTENO 1
Chapter 2 Configuration of the Equipment 2
Chapter 3 Basic Operation 3
Chapter 4 Image Processing 4
Chapter 5 Troubleshooting 5
Chapter 6 Maintenance and Inspections 6
Chapter 7 Options 7
Chapter 8 Technical Data 8
Chapter 9 Appendix 9
OPESCOPE ACTENO Instruction Manual vii

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viii OPESCOPE ACTENO Instruction Manual

Chapter 1
Overview of
the OPESCOPE ACTENO
This chapter gives an overview of the OPESCOPE ACTENO and

describes its characteristics and the environmental conditions in which
it should be used.
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.
1.1.1 About the OPESCOPE ACTENO
For details on the function of each part, see Chapter 2 "Configuration of the
Equipment".
X-ray I.I. unit

Live monitor Reference monitor
C-arm
Doctor handle
X-ray tube assembly
C-arm cart Monitor cart
Fig. 1.1 System overall
1-2 OPESCOPE ACTENO Instruction Manual

1.2 Features
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.
 High image quality

1. It is equipped with a 1-million pixel CCD camera and a 100 kHU X-ray tube.
2. When you select the Boost pulse mode in pulse fluoroscopy, you can obtain
high-quality images at a continuous fluoroscopy dose lower than the standard.
The 19 inch liquid crystal monitor gives a large visual field for convenient
viewing.
 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.
OPESCOPE ACTENO Instruction Manual 1-3

 Compact and light

1. Because the equipment has been made compact and lightweight, it is easy to
set up in all kinds of locations.
2. The large wheels equipped with cable guards allow the unit to be moved easily
even in confined spaces.
 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.

1.4 Environmental Conditions
1.4 Environmental Conditions

To obtain proper performance, be sure to use the equipment under the specified
environmental conditions. 1
1.4.1 Operation Environment
Use the equipment under the environmental conditions listed below:

The installation of a dedicated air-conditioner in the examination room is
recommended if the building air-conditioning cannot meet the necessary
environmental conditions.
WARNING

The use of the equipment in an oxygen-rich environment may cause
fatal or serious injuries or damage to the equipment due to easy
ignition.
CAUTION
Even under the prescribed conditions, avoid rapid changes of

temperature or humidity.
Condensation may occur and cause failure. Also, rust or corrosion may
occur inside the equipment.
Item Specifications
Atmosphere No explosive or corrosive gases
Ambient temperature 10 C to 35 C
Relative humidity 30 % to 80 % (no condensation)
Atmospheric pressure 800 hPa to 1060 hPa (800 mbar to 1060 mbar)
Environment luminosity 150 lx to 500 lx
Ambient noise level Under 70 dB

1.4.2 Transportation and Storage Environment
Item Specifications
Temperature 0 C to 40 C
Relative humidity 10 % to 80 % (no condensation)
Atmospheric pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar)
Atmosphere No explosive or corrosive gases
1.4.3 Power Supply
Item Specifications
Phase Single phase AC
Frequency 50/60 Hz
Standard voltages 100, 110, 120, 200, 220, 230, 240 VAC
Permitted voltage range ±10 % of standard voltage
Supply capacity 4.0 kVA
Power supply 100, 110, 120 V : 0.2  max.

impedance 200, 220, 230, 240 V : 0.8  max.
DANGER
Be sure to use the power supply specified in the instruction

manual.
Using a power supply other than the one specified may cause
equipment malfunction or serious accidents such as fire, smoke
emission, or explosions.

1.5 Classification of Equipment
1.4.4 Grounding
Class D grounding
1
WARNING

1.5 Classification of Equipment

This equipment is classified as follows, based on safety standards for electrical
medical equipment.
 Protection Method Against Electric Shock

Class I equipment
 Classification of Applied Parts

• Equipment including Type B Applied Parts according to
IEC60601-1:1988+A1:1991+A2:1995
• No Applied Parts according to IEC60601-1:2005
 Operation Mode
Continuous operation with intermittent load

 Degree of Protection Against Liquid Ingress

• Ordinary equipment
CAUTION
Use the equipment in a location where there is no danger of water

entry.
If water does enter inside the equipment there will be an electric shock
danger. Do NOT allow water to get onto the surface of the equipment
or get inside it. If water does get onto the equipment, turn the power
OFF immediately and contact your Shimadzu service representative.
• IPX8* (immersion beyond 1 m)

* : The IPX Waterproof Specification, specified by the International
Electrotechnical Commission, indicates waterproof/drip-proof performance on
instruments and equipment.
 For Use in an Oxygen-rich Environment
WARNING

The use in an oxygen-rich environment may cause fatal or serious
injuries or damage to the equipment due to easy ignition.
 For Use in Flammable Atmosphere
DANGER
Do NOT use the equipment in the presence of flammable

anesthetic gas.
Doing so may cause an explosion.
 Classification of Installation Type

Mobile equipment

1.6 Symbols
1.6 Symbols
The symbols used on the equipment are shown below:
1
Symbol Location Meaning
On name plate Alternating current
Inside the equipment, where

protective earth conductor in power Protective earth ground
cord is connected
Observe described items, or

On warning and caution labels
refer to instruction manual.
On name plate Refer to instruction manual
Potential equalization
Potential equalization conductor
conductor
On name plate Refer to instruction manual
On name plate Serial number
Year and month of

On name plate
manufacture
On name plate Manufacturer
On the back of the monitor cart Refer to instruction manual

Symbol Location Meaning
On X-ray tube, X-ray I.I. unit Safety classification: Type B
NOTE
The TYPE B Applied Part symbol is indicated to meet the requirements of

IEC60601-1:1988+A1:1991+A2:1995 as this may come into contact with
patients.
1.7 Operator Profile
Item Details
Age that which a person can obtain the license of Radiological

Age
Technologist or a license equal to it.
Sex No limitation
Nationality No limitation
Radiological Technologist or person who has a license equal to it.

Education
The capacity to read and understand the instruction manual.
Knowledge Radiological Technologist or person who has a license equal to it.
Language Can read and understand English.
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.
Over 140 cm tall.

Others Person who can confirm the safety by looking ahead of the
equipment.

Chapter 2
Configuration of
the Equipment
This chapter explains the configuration of the equipment.

2.1 Standard Configuration

The two major components of the equipment are the C-arm cart and the monitor
cart.
Both the C-arm cart and the monitor cart are suitable for use in patient environment.
2.1.1 C-arm Cart
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.
(1) Doctor handle (option)
(6) C-arm
(2) X-ray I.I. unit
(3) Beam limiting device

(7) Main panel
(4) X-ray tube assembly

(8) Maneuvering handles
(5) Side panel
(9) Brake pedal

(10) Connector
(11) Foot switch
Fig. 2.1 C-arm cart

(1) Doctor handle (Option)

This is a handle used by the surgeon to operate the equipment.
The handle is provided with a switch for unlocking the C-arm.
For details, see 3.6.5 "Lock Release Switches on the Doctor handle (Option)"
(page 3-34).
(2) X-ray I.I. unit 2

This is the abbreviation for the X-ray image intensifier.
The X-rays are converted to a visible image on the input fluorescent screen, this
fluorescent image is converted to photo electrons by the photo cathode, and the
photo electrons are accelerated and converged by an electrostatic lens, directing
them onto the output fluorescent screen.
(3) Beam limiting device

Controls the range of X-ray radiation when performing fluoroscopy or taking a
radiograph.
(4) X-ray tube assembly

This is the unit that generates X-rays. A fixed anode type X-ray tube is used.
X-ray high voltage generator is incorporated.
(5) Side panel

It features functions such as fixing and releasing the C-arm, camera rotation, image
reverse and smart C memory.
Fig. 2.2 Side panel
For details, see 2.3 "Side Panel" (page 2-21).

(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.
(7) Main panel

Used to set the loading factor and perform image-processing operations. The unit is
equipped with a compact LCD monitor with a touch panel and you can perform
operations from this touch panel.
Fig. 2.3 Main panel
For details, see 2.2.1 "Function of Each Switch" (page 2-10).
(8) Maneuvering handles

Used to move the C-arm.
For details, see 3.2.1 "Moving the C-arm Cart" (page 3-4).

(9) Brake pedal

This is the brake for the C-arm.
Fig. 2.4 Brake pedal
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.
Fig. 2.5 Connector
For details, see 3.4 "Turn the Power ON / OFF" (page 3-14).

(11) Foot switch

Left foot switch: Continuous fluoroscopy, pulse fluoroscopy
Right foot switch: Radiography
Right foot switch

Left foot switch (For taking radiographs)
(For continuous fluoroscopy,
pulse fluoroscopy)
Fig. 2.6 Foot switch

2.1.2 Configuration of the Monitor Cart
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.
(1) Live monitor (2) Reference monitor1 (6) Irradiation indicator
(7) Auxiliary stopper2

(3) Handle for adjusting
monitor position2
(4) Keyboard shelf3
(5) System switch
(8) Power switch
Fig. 2.7 Monitor cart
NOTE
About the monitor display

 Depending on the display conditions you may see very small spots or
irregularities, but this does not indicate a fault.
 Some pixels may exhibit a display defect (they may be missing, or always
lit).
 In cold locations the image may appear to leave a trace or may look dim,
but this is not a fault. The equipment will return to normal once the
temperature has risen.
 Do NOT leave a still image displayed for a long time since this can cause
an afterimage.
 The image may appear with different tones of color on the live monitor and
the reference monitor.

(1) Live monitor

Shows the fluoroscopic image during fluoroscopy, radiography images, and last
image hold (LIH) images, review images.
For details, see 2.4 "Live Monitor" (page 2-23).
(2) Reference monitor1

Displays reference images.
Allows you to register examinations information and make various settings for
examinations, post-processing and so on.
You can perform operations with the mouse and keyboard.
(3) Handle for adjusting monitor position2

Grasp this handle and move it upward or downward to adjust the monitor position.
(4) Keyboard shelf3

Accommodates the keyboard, mouse, etc.
(5) System switch

Turns the power ON.
Switch Status Fluoroscopy Description
Power OFF/Monitor cart startup

Unlit Unavailable
completed.
When power is only supplied to the

monitor cart (cart cable is not
Slow blinking connected or there is a connection
(1 second Unavailable fault to the C-arm unit). To enable
interval) fluoroscopy, turn the system switch
OFF, connect the cart cable and then
turn the system switch ON.
Monitor cart preparing for startup.

Fast blinking
The system switch does not respond
(0.25 second Unavailable
when pressed in this state.
interval)
Wait for the switch to stop blinking.
Lit Available Power ON

(6) Irradiation indicator

The indicator is lit in yellow during X-ray radiation.
(7) Auxiliary stopper2

Fixes the position of the monitor in the vertical direction. To adjust this position,
first loosen the auxiliary stopper.
2
(8) Power switch
Close and open power supply circuit.
*1 : Not included in single-monitor system.

*2 : Included only when the monitor up/down movement option is combined.
*3 : Included only when the DR option is combined.

2.2 Main Panel
2.2.1 Function of Each Switch
1 1
2 2
8
3
9
4
10
5
11
6 12
Fig. 2.8 Main panel
Reference
No. Switch Name Description
page
Fluoroscopy timer
Stops the fluoroscopy timer beep sound
1 beep sound reset 3-60
tone
switch
X-ray exposure Press this switch to start X-ray fluoroscopy.

2 3-59
(fluoroscopy) switch X-rays will be radiated.
Opens/closes Octagonal collimator

Parallel compensating
3 the parallel
filter open/close
compensating filter.
Parallel compensating Rotates the parallel

4
filter rotation compensating filter. 3-69
Opens/closes the
Octagonal collimator
5 octagonal
open/close Parallel
collimator.
compensating filter

2.2 Main Panel
Reference
page
Press this switch to release the restriction

on X-ray fluoroscopy and radiography for
Releasing the
the X-ray exposure switch or the foot
6 restriction on X-ray 3-58
switch.
exposure switch
X-rays can be radiated only when the
switch is lit.
Image display
Used to switch the content of the LCD
2
7 switching switch 3-85
display (image / operation screen).
(option)
Automatically adjusts the contrast and

brightness of the image in 7 stages (-2 to
Image brightness
8 +4).
adjustment switch
The set image brightness is displayed at the
4-2
top right of the LCD display.
Resets the image brightness setting to the

9 Reset switch
default value.
For frame memory images, selects the

saved image.
10 Next/Previous switch For fluoroscopy loop images, switches to 4-8
,
the next/previous fluoroscopy continuous
image (loop).
Starts/stops playback of the series of

11 Playback/Stop switch fluoroscopic images (loop) when the loop 4-8
memory function is selected.
You can view the guidance, check and

12 Menu switch change the initial setting and the touch 3-86
panel calibration.

2.2.2 LCD Display
A touch panel is incorporated, allowing operation by directly pressing the buttons

on the display.
Displayed buttons differ depending on the screen.
 Startup Screen
Fig. 2.9 Startup screen
No. Description
: When the DR option is not combined.

1
: When the DR option is combined.
Displays the status of the fluoroscopic image display function of the device.
2
: In preparation : Ready

2.2 Main Panel
 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
Switches the X-ray adjustment mode.

Auto/Manual switching button
1 (Auto) : Adjust X-rays automatically. 3-64
(Manual) : Adjust X-rays manually.
Indicates the tube voltage. The setting range is 40 to

110 kV. Press (+)/ (-) to change the value
2 X-ray tube voltage display -
manually.
This cannot be changed when auto is set.

Reference
page
In the fluoroscopy, the tube current is set

automatically.
X-ray tube current display / This value cannot be changed manually.
3 X-ray tube current product When using digital radiography (when used in 3-76
display combination with the DR option), the tube current
time product (mAs) is displayed during X-ray
radiography.
Used to select the beam hardening filter. Each time

Beam hardening filter switching you press the button the beam hardening filter
button changes.
4 Each time you press the button, the beam hardening 3-71
filter display changes in the following order:
[NONE]  [Filter 1] [Filter 2][Filter 3]
[NONE].
Displays the system status.
(lits yellow): When X-rays are being radiated

5 System status display -
(lits green): When fluoroscope radiography is
possible
6 Image brightness display The set image brightness is displayed. 4-2
X-ray tube assembly Indicates the temperature of the X-ray tube

7 -
temperature display assembly.
Indicates fluoroscopy time, reference air kerma rate,

accumulated reference air kerma and total dose area
8 Dose display product. 3-93
: Only displayed when combined with the dose

display function (option).
Fluoroscopy mode selection

button
Displays the fluoroscopy mode selection screen. 3-49
9
Set [Dose], [Pulse rate] and [Loop]. 3-57
APR selection button

Displays the APR selection screen.
10 3-48
Select APR or overwrite save.

2.2 Main Panel
Reference
page
Super shot
Only displayed when not combined with the DR
option. 3-72
Displayed when Super Shot is used.
Emergency case
option.
2
3-42
11 The patient ID and patient name are set
automatically when the study is started.
Acquisition mode selection

button
Only displayed when combined with the DR option.
3-53
Displays the acquisition mode selection screen.
3-74
Set [Dose], [Acq Rate] and [Photo Timer].
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.
Save button : When not combined with the DR option

Saves the image in the equipment memory.
14 4-3
/ : When combined with the DR option

Saves the image to the hard disk.
Displays the dose report.

Dose Info. button Indicates [Accumulated DAP], [Accumulated
15 AK], [Time]. 3-93

Setting screen switch button

button
16 Switches between Simple mode and Expert mode. -
End examination button

Completes the study and displays the "New
17 3-92
examination standby screen".

Reference
page
Laser pointer button

Displays or hides the cross lines from the laser
18 7-8
projector.
(Option)

2.2 Main Panel
 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
page
Switches the X-ray adjustment mode.

Auto/Manual switching button
1 (Auto) : Adjust X-rays automatically. 3-64
(Manual) : Adjust X-rays manually.
Indicates the tube voltage. The setting range is 40 to

110 kV. Press (+)/ (-) to change the value
2 X-ray tube voltage display -
manually.
This cannot be changed when auto is set.
In the fluoroscopy, the tube current is set

automatically.
X-ray tube current display / This value cannot be changed manually.
3 X-ray tube current product When using digital radiography (when used in 3-76
display combination with the DR option), the tube current
time product (mAs) is displayed during X-ray
radiography.

Reference
page
Used to select the beam hardening filter. Each time

Beam hardening filter switching you press the button the beam hardening filter
button changes.
4 Each time you press the button, the beam hardening 3-71
filter display changes in the following order:
[NONE]  [Filter 1] [Filter 2][Filter 3]
[NONE].
Displays the system status.
(lits yellow): When X-rays are being radiated

5 System status display -
(lits green): When fluoroscope radiography is
possible
6 Image brightness display The set image brightness is displayed. 4-2
X-ray tube assembly Indicates the temperature of the X-ray tube

7 -
temperature display assembly.
Indicates fluoroscopy time, reference air kerma rate,

accumulated reference air kerma and total dose area
8 Dose display product. 3-93

Sets the dose.

• [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]:
Dose selection button
Irradiates a low dose of X-rays to minimize the
radiation dose to the patient.
• [Low Dose 2]:
9 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.

2.2 Main Panel
Reference
page
Pulse rate selection button
Set the fluoroscopy pulse rate.

Select [Continuous] to perform continuous
10 fluoroscopy. Select the [15 fps], [10 fps], [7.5 fps] or -
[3.75 fps] button to switch to pulsed fluoroscopy and
change the pulse rate to the selected value.
2
loop button
11 Saves a series of fluoroscopic images (loop). 4-5
APR selection button

Displays APR selection screen.
12 3-48
Select APR or overwrite save.
Super shot Only displayed when not combined with the DR

option. 3-72
Displayed when Super Shot is used.
Emergency case
option.
3-42
The patient ID and patient name are set
automatically when the study is started.
Acquisition mode selection

13 button Only displayed when combined with the DR option.
Sets the dose.

• [Spot]: Radiography with one irradiation
• [Serial]: Radiography with continuous -
irradiation
• [DSA]: DSA radiography
Set the acquisition rate only when [Serial] or [DSA]
is selected.
Photo timer button Only displayed when combined with the DR option.
Set the photo timer ([ON] / [OFF]).

14 -
When the photo timer is set to [ON], select the photo
timer ([-3]  [-2]  [-1] [0]  [+1]  [+2]  [+3] 
[OFF]).

Reference
page
Film radiography mode button

15 Used for film radiography (general radiography). 3-80
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.
Save button : When not combined with the DR option

Saves the image in the equipment memory.
18 4-3
/ : When combined with the DR option
Saves the image to the hard disk.
Displays the dose report.

Dose Info. button Indicates [Accumulated DAP], [Accumulated
19 AK], [Time]. 3-93


20 Switches between Simple mode and Expert mode. -
End examination button

Completes the study and displays the "New
21 3-92
examination standby screen".
Laser pointer button

Displays or hides the cross lines from the laser
22 7-8
projector.
(Option)

2.3 Side Panel
2.3 Side Panel
2.3.1 C-arm Lock Switch
The C-arm lock switch is used to secure and release the C-arm.
1
2 3
4
Fig. 2.12 C-arm lock switch
Reference
No. Switch Lock location Description
page
1 C-arm slide motion
2 C-arm rotary motion

Switch lit:
The C-arm is unlocked.
3-26
Switch unlit:
C-arm forward/back The C-arm is locked.
3 and lateral swiveling
movement
C-arm longitudinal
4
movement

2.3.2 Control Switch
1 2
4 3
Fig. 2.13 Control switch
Reference
page
Used to reverse the image displayed on

the monitor.
Note that you can only reverse the
Monitor image fluoroscopic image in live fluoroscopy
1 3-68
reverse and LIH fluoroscopic image.
The subsequent fluoroscopy has the
same orientation as the operations used
to control it.
Holding this switch down while pressing
2 Rapid feed [camera rotation] speeds up 3-66
the rotation operations.
3 Camera rotation Used to rotate the camera. 3-66
Used to store the fluoroscopy conditions,

the camera rotation position, the
4 Smart C memory 3-83
collimator and the compensating filter
settings.

2.4 Live Monitor
2.4 Live Monitor
1 8
2
9 2
3 10
4 11
12
13
5 14
6
7 15
Fig. 2.14 Live monitor
No. Switch Name Ref.
Accumulated reference air kerma The accumulated reference air kerma of the
1 3-93
(AK)*1 examination currently running is indicated.
The reference air kerma rate is indicated. It is

2 *1 indicated only while fluoroscopy or serial 3-93
Reference air kerma rate (AKR)
radiography is performed.
The total dose area product of the examination

3 Total dose area product (DAP)*1 3-93
currently running is indicated.
4 Laser pointer display*2 The cross lines are displayed. 7-8
5 X-ray tube voltage display Indicates the tube voltage. -
6 X-ray tube current display Indicates the tube current. -
When using digital radiography (when used in

7 Exposure time display*3 combination with the DR option), the exposure 3-76
time (ms) is displayed during X-ray radiography.
: 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.

No. Switch Name Ref.
LIH display
This is displayed when a fluoroscopy last image
3-66
hold (LIH) image is displayed.
X-ray irradiating display

This is displayed when X-ray is irradiating. -
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
Loop memory display

9 This is displayed when the loop memory is used. 4-5
This displays the loop memory status.
Loop memory status display :Saving

4-5
10
4-8
/ / :Playback
:Paused
This displays warnings or limitations for the

rotation limits of the camera rotation.
Camera rotation display
11 :Warning (30 before the rotation limit) 3-66
/
:Limitations (Rotation limitation reached)
This is displayed when the following functions are

Display during mechanical operating.
operation • Collimator
12 3-66
• Camera rotation
• BH filter
• Compensating filter
This is displayed when an image is being saved.

Display during image saving
13 : When not combined with the DR option 4-4
/
: When combined with the DR option
Image brightness display

14 This displays the set image brightness. 4-2
The total fluoroscopy time of the examination 3-59

15 Fluoroscopy time
currently running is indicated. 3-93

Chapter 3
Basic Operation
This chapter explains the basic procedure for using the equipment.
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
Transport [3.2] / Connection [3.3]
Turning the power ON [3.4.1]
Positioning (How to operate the C-arm) [3.6]
Selecting the APR [3.8]
Examination Fluoroscopy [3.9]
Film radiography [3.14]
Turning the power OFF [3.4.3]
[ ] indicates the location of a reference.

3.1 Introduction
 When the DR option is combined
Transport [3.2] / Connection [3.3]
Turning the power ON [3.4.1]
Positioning (How to operate the C-arm) [3.6]
3
Selecting the Study [3.7]
Selecting the APR [3.8]
Examination Fluoroscopy [3.9]
Digital radiography [3.13] Film radiography [3.14]
Ending the examination [3.17]
Turning the power OFF [3.4.3]
[ ] indicates the location of a reference.

3.2 Transport
3.2.1 Moving the C-arm Cart
WARNING
Take care to avoid impacts and overturning of the equipment.

The equipment weighs more than 200 kg.
Impacts and overturning will not only damage the equipment, but could
also cause serious injuries.
When moving the equipment, pay attention to the following points.
 Check that the C-arm is at its home position.
 Check that the cable work has been done correctly.
 When traversing slopes and entrances, and negotiating obstacles,
move the equipment as gently as possible. Take particular care on
steep slopes.
 Always apply the brake when you stop moving the equipment.
 On slopes with an inclination of greater than 5, the equipment could
overturn. Do NOT move or operate the equipment in places where
the gradient exceeds 5.
 In places where moving the equipment generates strong vibrations,
for example outdoor paths, avoid rapid progress, deep steps, and
steep slopes. Do NOT stop moving on inclined routes.
 While wheeling the equipment, watch out for obstacles ahead.
 When driving the equipment where people are present, near
equipment, or close to a wall, drive slowly to be able to stop
immediately and maintain safety in the surroundings.

3.2 Transport
1 Check that the C-arm is at its home position (fixed position).

• The home position (fixed position) is the position where all scales register
zero.
See 3.6.6 "About the Scales" (page 3-35).
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).
2 Check that the foot switch is enclosed.
Fig. 3.2

3 Check that the cart cable is disconnected.
See 3.3 "Connecting and Dismantling the System" (page 3-11).
4 Release the brake.

• Rear brake
Step on the side of the brake pedal to release the brake.
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. 3.4 Front caster

3.2 Transport
5 Hold the maneuvering handles while moving the C-arm cart.

To change the direction of motion, raise the right maneuvering handle
and turn it in the direction you want to go. The rear casters move in
accordance with this handle motion.
• The maneuvering handles can be fixed at the 0 and 90 positions.
Right handle (90, fixed)
Right handle (0, fixed)
Fig. 3.5 Maneuvering handles
 To move straight ahead
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.

3.2 Transport
6 Engage the brake after moving the equipment.

• Rear brake
Step on the side of the brake pedal to engage the brake.
• Front brake
Lock the front caster and engage the brake.
Lock
Fig. 3.10 Front caster

3.2.2 Moving the Monitor Cart
1 Check that the main power cable and the cart cable are correctly
wound on the cable guides of the monitor cart.
2 Release the caster brake (front casters only).
3 Hold the handles and move the monitor cart.
4 After completing the motion, apply the caster brake (front casters
only).
Handle
Cable guide
Casters with brakes
Fig. 3.11 Moving the monitor cart
Next, 3.3.1 "System Connections"

3.3 Connecting and Dismantling the System

When you have arranged the C-arm cart and the monitor cart in the required
positions, make the following power supply connections.
3.3.1 System Connections
1 Connect the cart cable from the monitor cart to the C-arm cart.
3
Turn the lever to the “LOCK”

position. Connect the cart cable then
close the connector cover.
Fig. 3.12 Connecting the cart cable
2 Connect the C-arm cart’s potential equalization conductor.
WARNING
When using an electrocautery knife or an operating table etc., the

potential equalization conductor is necessary to ensure the safety
of the patient and the operators.
Potential equalization
conductor
Fig. 3.13 Potential equalization conductor

3 Connect the monitor cart’s main power cable to the power outlet.
Cart cable Main power cable
Fig. 3.14 Connection of the main power cable
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.
Next, 3.4.1 "Turning the Power ON"

3.3.2 Disconnection Procedure
To disconnect, follow the connection procedure in reverse.
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.
Cart connector 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
Fig. 3.17 Cable guide

3.4 Turn the Power ON / OFF

To ensure that no trouble occurs with the equipment while examining a patient,
always carry out a starting inspection in advance to check that everything is normal
for the examination.
Details of the starting inspection are summarized in Chapter 9 "Appendix"

“Starting Inspection Checklist.” Make a copy of this checklist and refer to it
while performing inspections.
3.4.1 Turning the Power ON
CAUTION
Strictly follow the prescribed procedure.

When turning the power ON, strictly follow the procedure set out below.
1 Turn the power switch at the back of the monitor cart ON.
Power switch
Fig. 3.18 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
Fig. 3.19 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.
At this time, (display during mechanical operation) is displayed on the

right side of the live monitor.
For details on operations, see 3.11 "Camera Rotation, Image Reverse,

Collimator, Compensating Filter Operation" (page 3-66).
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.

3.4.2 Emergency Fluoroscopy (when the DR option is combined)
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.
Perform emergency fluoroscopy by following the same procedure as normal

fluoroscopy as shown below.
1 Turn (Releasing the restriction on X-ray exposure) ON (lit). 3

Currently only fluoroscopy is possible.
Fig. 3.20 Before starting up
2 Select the APR.
APR selection screen
APR
Fig. 3.21 Selecting the APR

3 Press X-ray exposure (fluoroscopy) switch or depress the left foot

switch.
• X-rays for fluoroscopy will be radiated.
• During radiation, X-ray exposure (fluoroscopy) switch is lit and
(X-rays being radiated) lights yellow.
• During radiation, the irradiation indicator on the monitor cart is lit. The
fluoroscopic image is displayed on the live monitor.
When X-ray exposure (fluoroscopy) switch is pressed:
(X-rays being radiated) lights yellow
The fluoroscopy time

Press is displayed.
When the foot switch is depressed:
Depress
Fig. 3.22 Fluoroscopy

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.
For details on operations, see 3.11 "Camera Rotation, Image Reverse,

Collimator, Compensating Filter Operation" (page 3-66).
When the DR option has completely started, the "New examination standby screen" 3
is displayed.
New examination standby screen
Fig. 3.23 Starting up the main panel
The [Study List] is displayed on the reference monitor.
Next, 3.6 "Positioning (How to Operate the C-arm)"

3.4.3 Turning the Power OFF
CAUTION
You must strictly follow the procedure below to turn the power
OFF.
After completing the work to be done, always perform an ending inspection.
Details of the ending inspection are summarized in Chapter 9 "Appendix"

“Ending Inspection Checklist.” Make a copy of this checklist and refer to it
while performing inspections.
 When the DR option is not combined
1 Check that the C-arm is at its home position.

• The home position is the position where all scales register zero.
Fig. 3.24 Home position of the C-arm

2 Press the system switch on the front of the monitor cart.
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
4 Disconnect the main power cable.

 When the DR option is combined
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.
1 Check that the C-arm is at its home position.

• The home position is the position where all scales register zero.
Fig. 3.27 Home position of the C-arm

2 End the Examination
See 3.17 "Ending the Examination" (page 3-92).
3 Click the [System Menu] button at the top right of the window.
[System Menu]
button
Fig. 3.28 Turning the power OFF 1

3
• The system menu is displayed.
System menu
4 Click [Shutdown].
5 The [Confirmation] dialog box appears. Click [Shutdown] and then

[OK].

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
8 Disconnect the main power cable.

3.5 Warm-Up
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.
1 Turn (Releasing the restriction on X-ray exposure switch) ON

(lit) and select [Standard] for APR.
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.
3 Set the fluoroscopy conditions as shown below.

• Dose: [Normal]
• Pulse Rate: [Continuous]
• Fluoroscopy tube voltage: 40 kV
Fluoroscopy mode selection screen
Fluoroscopy
tube voltage
(kV)
[Dose] [Pulse Rate]
Fig. 3.33 Warm-up
4 Gradually increase the tube voltage at a rate of 10 kV/1 minute while

performing fluoroscopy.
Perform fluoroscopy until the maximum tube voltage for fluoroscopy
(110 kV).
For details, see 3.9 "Fluoroscopy" (page 3-57).

3.6 Positioning (How to Operate the C-arm)

Operate the C-arm to position it for the required fluoroscopy / radiography range.
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
Doctor handle
C-arm handle
Slide handle
Hazardous
locations

CAUTION
Do NOT place peripheral devices or any other object within the

range of motion of the equipment.
If peripheral devices such as the monitor cart are placed within the
range indicated in the figure below, there will be a danger of collision or
contact.
(Units: mm)

1 Press the lock release switch.

• The C-arm is unlocked. (The switch will light.)
C-arm lock switch
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
2 Move the C-arm with its handles.
For details on operations, see 3.6.1 "C-arm Longitudinal Movement" (page

3-31) through to 3.6.4 "C-arm Rotational Motion" (page 3-33).
3 When you reach the right position, press the lock switch again.
• The C-arm will be locked. (The switch will go out.)
4 Check that the C-arm is locked.
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).
Next, 3.7 "Starting the Study (when the DR option is combined)"

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.
For details, see 3.3.1 "System Connections" (page 3-11).
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.

3.6.1 C-arm Longitudinal Movement
Move the C-arm while holding the C-arm

handles or slide handles.
Doctor handle
3
450 mm
CAUTION Trapping
Fig. 3.37 C-arm longitudinal movement

3.6.2 C-arm Forward/Back and Lateral Swiveling Movement

m m
Doctor handle 200
CAUTION Trapping

Doctor handle
12.5
CAUTION Trapping
Fig. 3.38 C-arm forward/back and lateral swiveling movement

3.6.3 C-arm Slide Motion
30
Move the C-arm while holding the

C-arm handles.
CAUTION Trapping
90
CAUTION Trapping CAUTION Trapping
Fig. 3.39 C-arm slide motion
3.6.4 C-arm Rotational Motion
120
300
Move the C-arm while holding the
C-arm handles.
CAUTION Trapping
Fig. 3.40 C-arm rotational motion

3.6.5 Lock Release Switches on the Doctor handle (Option)
There are two lock release switches on the doctor handle.

On shipment from the factory, these switches are configured so that the forward/
back and lateral swiveling movement or longitudinal movement of the C-arm is
released while the switch is held down.
NOTE
If you need to change the setting, contact your Shimadzu Service

Representative.
Switch Lock location
C-arm forward/back and lateral swiveling movement
C-arm longitudinal movement
Switch
Switch
Fig. 3.41 Release switches on the doctor handle

3.6.6 About the Scales
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 slide motion 3
C-arm rotary
motion
C-arm forward/back movement
C-arm lateral swiveling

movement
C-arm longitudinal
movement
Fig. 3.42 Scale

3.7 Starting the Study (when the DR option is

combined)
NOTE
This function is available only when the DR option is combined.
Select the study before starting the examination. There are three ways to do this.
Operation Location
Select a Study from the Study

For a registered study List and Start the Study Reference monitor
( 3.7.1)
Register the Study

Information, Select a Study,
and Start the Study Reference monitor
For a new study ( 3.7.2)
Start an Emergency Study Reference monitor or

( 3.7.3) C-arm main panel

3.7 Starting the Study (when the DR option is combined)
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.
For details, see the manual, “Image Acquisition” of “OPESCOPE ACTENO

DR Option SDR-120 Instruction Manual”.
If the [Study List] window is not displayed, click .
1 Click the target study in the [Study List] window. 3

• The selected list is highlighted.
• The study information is displayed in the lower part of the window.
• Check the study information.
Select the
study.
The study
information
is displayed.
Fig. 3.43 Selecting a study

2 Select [APR] and [Modality], and click [Start Study].

• The study starts.
[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.

If the [Study List] window is not displayed, click .
1 Click the [Create Study] button in the [Study List] window. 3
Fig. 3.45 Registering study 1

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

3.7.3 Start an Emergency Study
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.

 Operation at the main panel
1 Press [Emergency case].

• The patient ID and patient name are set automatically.
Fig. 3.48 Registration of an emergency case (main panel)
NOTE
After completing the emergency case, replace the provisional data (patient ID,
patient name, etc.) with the correct patient information.

 Operation at the reference monitor
1 Click the [Emergency Study] button in the [Study List] window.
Fig. 3.49 Registering an emergency case (reference monitor)
• During an emergency study, the patient ID and patient's name are

automatically generated as follows:
Item Description
The patient ID is generated using the current date/time and

Patient ID
an automatic number.
The patient's name is generated using the current date/time

Patient's name
and an automatic number.
During emergency study, standard is selected for [APR], and RF is selected

for [Modality].
In the case of an emergency study, only items that require entry are
displayed.
The patient information of images acquired in an emergency study can be

changed later on by updating the patient information in the [Image List]
window.

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.
Correcting the Study Information
1 Display the [Study List] window on the reference monitor.
• If the [Study List] is not displayed, click .
2 Select the target study and click the [Modify] button.
Select
the study.
[Modify]
Fig. 3.50

3 The [Edit] dialog box appears. Add to or correct the information of the
registered study.
Fig. 3.51 Study information correction
4 Click [OK].
• The corrected information is saved and the [Study List] window returns.


3.8 Selecting the APR

The optimum fluoroscopy and radiography (acquisition) conditions for each part of
the body are preset in APR. By selecting an APR, the necessity for manual
adjustment is cut to a minimum.
When the DR option is combined, you can perform the following operations.
• Editing APR for digital radiography (acquisition)
• Selecting the APR from the reference monitor
The following is an explanation of the operation at the C-arm main panel.
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.
3.9 "Fluoroscopy" (page 3-57)

"To Change Acquisition APR (when the DR option is combined)" (page
3-53)

 Selecting APR Directly After Startup
1 Turn (Releasing the restriction on X-ray exposure switch) ON

(lit).
• The APR selection screen (Immediate) is displayed.
3
Releasing the restriction
on X-ray exposure
switch
Fig. 3.52 Releasing the restriction on X-ray exposure switch
2 Select the APR.

• The basic screen will be displayed.
APR selection screen (Immediate)
APR
Fig. 3.53 Selecting the APR (Immediate)
The parameters registered in the APR are loaded.
Next, 3.9 "Fluoroscopy"

 Selecting APR from the basic screen
1 Press the APR selection button.

• The APR selection screen is displayed.
Basic screen
Fig. 3.54 Selecting the APR 1
2 Select the APR.

• The basic screen is displayed.
APR
Fig. 3.55 Selecting the APR 2
The parameters registered in the APR are loaded.
Next, 3.9 "Fluoroscopy"

To Change Fluoroscopy APR
1 Press the fluoroscopy selection button.

• The fluoroscopy mode selection screen is displayed.
Basic screen
Fig. 3.56 Changing the fluoroscopy APR 1
2 Set [Dose], [Pulse Rate] and [Loop], and press [Close].

[Loop]
[Close]
[Dose] [Pulse Rate]
Fig. 3.57 Changing the fluoroscopy APR 2

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.
Select [Continuous] to perform continuous fluoroscopy.

Select the [15 fps], [10 fps], [7.5 fps] or [3.75 fps] button to
[Pulse Rate]
switch to pulsed fluoroscopy and change the pulse rate to the
selected value.
[Loop] Saves a series of fluoroscopic images (loop).

• To overwrite save in an existing APR

The changes you made on fluoroscopy APR are temporary. Overwrite save in
an existing APR following the steps below if it is necessary.

Basic screen
Fig. 3.58 Overwriting the APR 1
2 Press [Setting change].

• The overwrite confirmation screen is displayed.

3 Press [OK].
• APR is overwritten and saved, and the basic screen is displayed.
Overwrite confirmation screen

To Change Acquisition APR (when the DR option is combined)
NOTE
1 Press the acquisition mode selection button.

• The acquisition mode selection screen is displayed.
Basic screen
3
Fig. 3.61 Changing acquisition APR 1

2 Set [Dose], [Acq Rate] and [Photo Timer], and press [Close].
Acquisition mode selection screen
[Close]
[Dose] [Acq Rate] [Photo Timer]
Fig. 3.62 Changing acquisition APR 2
Item Description
• [Spot]: Radiography with one irradiation

[Dose] • [Serial]: Radiography with continuous irradiation
• [DSA]: DSA radiography
Each time the button is pressed, the acquisition rate switches

[Acq Rate] in the following order: [7.5 fps]  [5 fps]  [3.75 fps]  [3
fps]  [2 fps]  [1 fps]  [0.5 fps].
Set the photo timer ([ON] / [OFF]).

[Photo Timer] When the photo timer is set to [ON], select the photo timer
([-3] / [-2] / [-1] / [0] / [+1] / [+2] / [+3]).

• To overwrite save in an existing APR

The changes you made on fluoroscopy APR are temporary. Overwrite save in
an existing APR following the steps below if it is necessary.

Basic screen
2 Press [Setting change].

• The overwrite confirmation screen is displayed.

3 Press [OK].
• APR is overwritten and saved, and the basic screen is displayed.
Overwrite confirmation screen

3.9 Fluoroscopy
3.9 Fluoroscopy
1 Check the fluoroscopy conditions.

• The fluoroscopy conditions are set automatically in accordance with the
selected APR.
• Check the Dose control mode (Auto/Manual).
(Auto) :
Tube voltage falls within a rage of 40 to 110 kV automatically.
(Manual) :
3
Tube voltage can be changed manually. ( page 3-64)
"Changing the Fluoroscopy Conditions 1 (Dose)" (page 3-62)

"Changing the Fluoroscopy Conditions 2 (Pulse rate)" (page 3-63)
"Changing the Fluoroscopy Conditions 3 (Fluoroscopy Tube Voltage)" (page
3-64)

Tube voltage (kV) Tube current (mA)
Dose control mode
[Dose]
[Zoom]
[Pulse Rate] [Loop]
Fig. 3.66 Checking the fluoroscopy conditions

2 If Releasing the restriction on X-ray exposure switch is unlit, Turn
(Releasing the restriction on X-ray exposure) ON (lit).

• It is only possible to radiate X-rays when Releasing the restriction on
X-ray exposure switch is lit.
Releasing the restriction

on X-ray exposure
switch
Fig. 3.67 Releasing the restriction on X-ray exposure switch
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.

3.9 Fluoroscopy
3 Press X-ray exposure (fluoroscopy) switch or depress the left foot

switch.
• X-rays for fluoroscopy will be radiated.
• During radiation, X-ray exposure (fluoroscopy) switch is lit and
(X-rays being radiated) lights yellow.
• During radiation, the irradiation indicator on the monitor cart is lit. The
fluoroscopic image is displayed on the live monitor.
When X-ray exposure (fluoroscopy) switch is pressed:
3
(X-rays being radiated) lights yellow
The fluoroscopy time

Press is displayed.
When the foot switch is depressed:
Depress
Fig. 3.68 Fluoroscopy

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.
Fluoroscopy timer beep

sound reset switch
Fig. 3.69 Fluoroscopy timer beep sound reset switch
For details on setting the timer value, see 3.16.2 "Default Settings" (page
3-88).

3.9 Fluoroscopy
NOTE
After film radiography or digital radiography, it is not possible to perform boost

pulse fluoroscopy while a radiography pause message is displayed on the
C-arm main panel.
When performing fluoroscopy, select a dose setting other than boost pulse
while a radiography pause message is displayed.

Changing the Fluoroscopy Conditions 1 (Dose)
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.
"To Change Fluoroscopy APR" (page 3-49)
1 Select [Dose].
• The selected button will be highlighted.
[Dose]
Fig. 3.70 Changing the dose
Item Description
Irradiates a high dose of X-rays to generate a high quality

[High Quality]
image.
[Normal] Irradiates a standard dose of X-rays.
Irradiates a low dose of X-rays to minimize the radiation

[Low Dose 1]
dose to the patient.
Irradiates a lower dose of X-rays than in [Low Dose 1] to

[Low Dose 2]
minimize the radiation dose to the patient.
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
[Boost Pulse] 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.

3.9 Fluoroscopy
Changing the Fluoroscopy Conditions 2 (Pulse rate)
NOTE
"To Change Fluoroscopy APR" (page 3-49)
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.
Fig. 3.71 Changing the pulse rate
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.

Changing the Fluoroscopy Conditions 3 (Fluoroscopy Tube Voltage)
1 Press the Auto/Manual switching button to switch to the manual

mode.
• lights.
Basic screen
Auto/Manual
switching button
Fig. 3.72 Changing the fluoroscopy tube voltage 1
2 Press or to select the tube voltage.
Basic screen (manual)
Fig. 3.73 Changing the fluoroscopy tube voltage 2

3.10 Changing I.I. Field Size (Zooming-up Images)
3.10 Changing I.I. Field Size (Zooming-up Images)

Press (Zoom button) to change the field size. (The images are zoomed up.)
When combined When combined

Field size Button (color)
with 9” I.I. with 6” I.I.
Normal 9” (23 cm) 6” (15 cm)

(Gray)
Zoomed 6” (16 cm) 4” (10 cm)

(Blue)
3

3.11 Camera Rotation, Image Reverse, Collimator,

Compensating Filter Operation
You can use the following functions during fluoroscopy and while the last image
hold (LIH) image is displayed.
(display during mechanical operation) is displayed on the right side of the live
monitor during operation of the following functions.
3.11.1 Camera Rotation
Rapid feed
Camera rotation
Fig. 3.74 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.
Rotation during fluoroscopy

During fluoroscopy, the display of the subject rotates in accordance with the camera
rotation.
• :Warning (30 before the rotation limit)
• :Limitations (Rotation limitation reached)
Operation during last image hold (LIH) display in fluoroscopy (virtual

rotation)
Pressing this switch while the last image hold (LIH) image from fluoroscopy is
displayed rotates the image by image processing. After you have released the
switch, the camera starts rotating.

3.11 Camera Rotation, Image Reverse, Collimator, Compensating Filter Operation
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.
 is displayed in the top right of the monitor when a fluoroscopy last

image hold (LIH) image is displayed.
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.

3.11.2 Image Reverse
V reverse H reverse
(vertical reverse) (horizontal reverse)
Fig. 3.75 Image 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.
H reverse (horizontal reverse)
V reverse (vertical reverse)

3.11.3 Collimator and Compensating Filter Operation
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
Fig. 3.76 Collimator and compensating filter operation
Item Description
Pressing the switch opens the parallel compensating

Parallel
filter.
1 compensating filter
open/close Pressing the switch closes the parallel compensating
filter.
Pressing the switch rotates the parallel

Parallel compensating filter counter-clockwise.
2 compensating filter Pressing the switch rotates the parallel
rotation
compensating filter clockwise.
The parallel compensating filter can be rotated endlessly.
Octagonal collimator Pressing the switch opens the octagonal collimator.

3
open/close Pressing the switch closes the octagonal collimator.
 Operations during fluoroscopy

During fluoroscopy, collimator adjustments and rotation follow the collimator and
compensating filter operations.

 Operation in the fluoroscopy last image hold (LIH) status (virtual

collimator)
If you perform any collimator operation while the last image hold (LIH) image from
fluoroscopy is displayed, the positions of the octagonal collimator and parallel
compensating filter are indicated by lines on the LIH image.
Hexagonal collimator: circular indication, Parallel compensating filter: two-line
indication
NOTE
If you start fluoroscopy acquisition immediately after releasing the switch,

collimator and compensating filter open/close operation or rotation may still be
in progress.
filter
NOTE
The virtual collimator operation can only be used for fluoroscopy last image
hold (LIH) images. It cannot be used with other images.
 is displayed in the top right of the monitor when a fluoroscopy last

image hold (LIH) image is displayed.

3.11.4 Setting the Beam Hardening Filter
 Types of Beam Hardening Filter
Display Material Applications
NONE - -
Filter 1 Cu0.1 mm The limbs, etc.
Filter 2 Cu0.2 mm Trunk, vertebral body, etc.
Filter 3 Cu0.3 mm Chest, abdomen, etc.

3
 Selecting a Beam Hardening Filter
Press the beam hardening filter selection button.
Each time you press the button, the beam hardening filter display changes in the
following order: [NONE]  [Cu0.1 mm]  [Cu0.2 mm]  [Cu0.3 mm] 
[NONE].
Beam hardening filter selection button
Fig. 3.77 Selecting a beam hardening filter

3.12 Taking a Super Shot

When using Super Shot, high dose irradiation is used to display a high quality
fluoroscopy last image hold (LIH) image. (Super Shot is an original Shimadzu
name.) Follow the instructions on the main panel and leave the appropriate interval
when repeatedly using Super Shot.
NOTE
This function cannot be used in combination with the DR option.
1 Check that is displayed.
Basic screen
Fig. 3.78 Super Shot 1
2 Depress the left foot switch.

• X-rays for fluoroscopy will be radiated and the fluoroscopic image is
displayed on the live monitor.
Depress

3.12 Taking a Super Shot
3 Depress the right foot switch.

• High-dose fluoroscopy is started and the fluoroscopic image is displayed
on the live monitor.
• About one second later from the start of high-dose fluoroscopy, X-ray
radiation is automatically stopped.
3
Depress
NOTE
In the case of the subject with movements, an afterimage may be displayed.
NOTE
When using Super Shot, the X-ray tube voltage is automatically adjusted to
optimize the image.

3.13 Digital Radiography (when the DR option is

combined)
NOTE
NOTE
The digital radiography conditions are set automatically based on the

fluoroscopy conditions. For this reason, before taking a radiograph you should
turn the IBS function ON and perform fluoroscopy until the fluoroscopy image
is stabilized.
1 Press acquisition mode selection button.
Basic screen
Fig. 3.81 Digital radiography 1

3.13 Digital Radiography (when the DR option is combined)
2 Check the radiography conditions.
[Dose] [Acq Rate] [Photo Timer]
NOTE
[Acq Rate] is only displayed when a technique that involves serial radiography,
such as [Serial] or [DSA], is selected.


• During X-ray irradiation, the radiography image is displayed on the live
monitor, after which the same image is displayed on the reference
monitor.
Depress
NOTE
Releasing your foot from the foot switch during irradiation will end X-ray
irradiation partway through and stop radiography.
Acquisition mode selection screen (during X-ray irradiation)
Tube voltage Tube current

(kV) time product
(mAs)
The tube current time product (mAs) is only displayed during radiographic
exposure.

To Change the Dose
NOTE
"To Change Acquisition APR (when the DR option is combined)" (page

3-53)
3
1 Select [Dose].
[Dose] The selected [Dose] is displayed.
Fig. 3.85 Changing the Dose
Item Function
[Spot] Radiography is performed with 1 irradiation.
[Serial] Radiography is performed with continuous irradiation.
[DSA] Performs DSA radiography.

To Change the Acquisition Rate
1 Press or to select the acquisition rate.

• Each time you press the button, the acquisition rate changes in the
following order:
[7.5 fps]  [5 fps]  [3.75 fps]  [3 fps]  [2 fps]  [1 fps]  [0.5 fps]
Fig. 3.86 Changing the acquisition rate
NOTE
[Acq Rate] is only displayed when a technique that involves serial radiography,
such as “Serial” or “DSA”, is used.

To Change the Photo Timer
1 Press the photo timer button.
Fig. 3.87 Changing the acquisition rate 1
2 Set the photo timer ([ON] / [OFF]).

• When the photo timer is set to [ON], select the photo timer ([-3] / [-2] /
[-1] / [0] / [+1] / [+2] / [+3]).
Fig. 3.88 Changing the acquisition rate 2
NOTE
The dosage becomes higher with a higher phototimer value.

3.14 Film Radiography (General Radiography)

1 Mount the cassette holder (option).
For details, see 7.1 "Cassette Holder" (page 7-2).
NOTE
Before mounting the cassette, perform the fluoroscopy to confirm the X-ray
irradiation field and patient position.
2 Mount the cassette into the cassette holder (option).
3 When in simple mode, press the setting screen switch button to

switch to expert mode.
Basic screen

Fig. 3.89 Film radiography 1
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.

3.14 Film Radiography (General Radiography)
4 Press (Film radiography mode button).
Basic screen (expert mode)
3
Film
radiography
mode
5 Press / to adjust the tube voltage (kV) value and the tube
current time product (mAs) value.
Film radiography screen
Tube voltage Tube current

(kV) time product
(mAs)

Depress
7 Continue to depress the right foot switch.

• X-rays will be radiated. During radiation the irradiation indicator (on the
monitor cart) is lit.
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.
8 Check that the X-ray radiation is completed and finish radiography.
Press (Film radiography mode button) to return to the basic screen.

3.15 Useful Functions

3.15.1 Smart C Memory
Store the fluoroscopy conditions, the rotational position of the camera, the
collimator, compensating filter position, the loading factor and other information.
NOTE
 This operation is not possible during fluoroscopy. 3

 You cannot do this when X-ray exposure (fluoroscopy) switch is pressed.
 The information stored with this function is reset when the power is turned
OFF.
The following conditions can be stored.

• Fluoroscopy conditions
• Rotational position of the camera
• Open/close position and rotational angle of the collimators and compensating
filter
• Image reverse
• Filter
• I.I. field size
Smart C memory [F] Smart C memory [L]
Fig. 3.93 Smart C memory
1 Hold down Smart C memory (for about 1 second).

• The current conditions are stored.
When storing is completed the switch lights.

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.
2 Press the blinking Smart C memory, briefly.

• The conditions stored in the Smart C memory will be called up.
At the same time, the switch will change from blinking to continuously
lit.
To Differentiate the Use of Two Smart C Memory
Lit
1 Hold down (smart C memory [F]), for about 1 second.
• The current conditions will be stored in smart C memory [F].

Blink
2 Change conditions such as the rotational position of the camera.

• Smart C memory [F] will blink.
Lit
3 Briefly hold down (smart C memory [L]), for about 1second.
• The changed conditions are stored in smart C memory [L].

• Smart C memory [F] goes off.
Lit
4 Press (smart C memory [F]), briefly.
• 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
5 Press (smart C memory [L]), briefly.
• 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.

3.15.2 Live Monitor Image Display on the C-arm Main Panel

(Option)
By pressing (Image display switch), you can switch to image display

function on the LCD 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 3
on the LCD display.
 Lines of virtual collimation
 Annotation
Basic screen
Image display switch

Image display
Fig. 3.94 Switching the LCD display

3.16 System Settings

You can view the guidance, check and change the initial setting and the touch panel
calibration.
NOTE
The changes you make to the unit settings remain effective even if you restart
(they are not reset by turning the power OFF).
1 Press (Menu switch).

• The system setting menu screen is displayed.
2 Select the button for each menu.
Basic screen
Menu switch
Setting menu screen
Fig. 3.95 Setting menu screen

3.16.1 Guidance
1 Press [Guidance].
• The guidance screen is displayed.
Setting menu screen
3
[Guidance]
Fig. 3.96 Guidance
2 Press the button representing the control part.

• The guidance of the control part is displayed.
No. Screen Item Description
The C-arm main panel

1 [Main Panel]
guidance is displayed.
The C-arm side panel

2 [Side Panel]

No. Screen Item Description
The LCD display

3 [Display]
3.16.2 Default Settings
1 Press [Default Settings].

• The default settings screen is displayed.
Setting menu screen
[Default Settings]
Fig. 3.97 Default Settings 1

2 Check the following items and change if necessary.
Default settings screen
1 2
3 4
Fig. 3.98 Default settings 2
No. Item Description
1 [Operation sound] Adjust [Operation sound] using [] and [+].
2 [Beep sound] Adjust [Beep sound] using [] and [+].
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.
(Blue): Default setting

The camera rotation, collimator, filter, and image reverse
settings remain even when the APR is changed during
technique. Only X-ray conditions and image processing
4 [APR Setting]
parameters are changed.
(Gray)
All APR settings are changed to the initial setting values
when the APR is changed during technique.
5 [Default Mode] Select the default display ([Simple] or [Expert]).

3.16.3 Touch Panel Calibration
1 Press [Calibration].
• The calibration screen is displayed.
Setting menu screen
[Calibration]
Fig. 3.99 Calibration 1
2 Follow the on-screen messages and calibrate the touch panel.
• Press (reset switch) while holding down at the lower right of

the screen.
Calibration screen (start)
Reset Key

• Press (reset switch) while holding down at the upper left of the
screen.
Calibration is completed.
Calibration screen (complete)
Reset Key

3.17 Ending the Examination

1 Release your foot from the foot switch.
2 Press (End examination button) for about 1 second.

• The end confirmation screen is displayed.
Fig. 3.102 Ending the examination
You can also end examinations from the monitor cart (reference monitor).
For details, see the manual, "Image Acquisition" of "OPESCOPE ACTENO

DR Option SDR-120 Instruction Manual".

3.18 Dose Display
3.18 Dose Display

Fluoroscopy time, reference air kerma rate, accumulated reference air kerma and
total dose area product are indicated on the C-arm main panel and the live 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
Fig. 3.103 Main panel
1
Fig. 3.104 Live monitor

The total fluoroscopy time of the examination

1 Fluoroscopy time
The reference air kerma rate* is indicated. It is

2 Reference air kerma rate (AKR) indicated only while fluoroscopy or serial
radiography is performed.
Accumulated reference air The accumulated reference air kerma* of the

3
kerma (AK) examination currently running is indicated.
The total dose area product of the examination

4 Total dose area product (DAP)
 The air kerma (rate) at the position 46.5 cm above I.I.
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 report screen
[Dose Info.]
Fig. 3.105 Dose display
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.)

Chapter 4
Image Processing
This chapter explains how to perform image processing from the main
panel.
4.1 Adjusting Contrast and Brightness

(C-arm Main Panel)
Image brightness display
Fig. 4.1 Adjusting contrast and brightness
Automatically adjusts the contrast and

Image brightness adjustment brightness of the image in 7 stages (-2 to +4).
1
switch The set image brightness is displayed at the
top right of the LCD display and the monitor.
Resets the image brightness setting to the

2 Reset switch
default value.
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

4.2 Saving/Selecting/Navigating Images
4.2.1 Saving Images
This section explains how to save the fluoroscopic images temporarily.
NOTE
When the power is turned OFF, the saved image is deleted.
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.
No. Frame memory image Loop memory image
1 20 frames 152 frames

 Frame memory function

You can temporarily save the currently displayed images.
(display during image saving) is displayed on the monitor while an image is

being saved.
(frame memory display) is displayed on the monitor when a frame memory

image is being displayed on the monitor.
Basic screen
[Save]
Fig. 4.2 Frame memory
In the 1-monitor configuration

Frame memory images are displayed on the live monitor. Note, however, that during
fluoroscopy the live fluoroscopic image is displayed, but after fluoroscopy, the LIH
image is displayed. You can switch to frame memory display by executing frame
memory operations.
In the 2-monitor configuration

The frame memory image is always displayed on the reference monitor.
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 memory function

You can temporarily save a series of fluoroscopic images (loop).
1 Select [Loop] in the fluoroscopy mode selection screen.
• (loop memory display) is displayed on the monitor.
[Loop]
4
Fig. 4.3 Loop memory 1
2 Perform fluoroscopy.
For details, see 3.9 "Fluoroscopy" (page 3-57).
• The fluoroscopy continuous image is temporarily saved from when the

X-ray irradiation (fluoroscopy) switch or the left foot switch is pressed
until the switch is released.
• (loop memory status display (during saving)) is displayed on the

monitor.
NOTE
Only a series of fluoroscopic images captured during one fluoroscopy can be

saved temporarily, regardless of the duration of fluoroscopy (number of
frames).

3 Press [Save] to save a series of fluoroscopic images (loop) to the

hard disk drive.
• (display during image saving) is displayed on the monitor while an

image is being saved.

Saving the images in the hard disk drive of the digital image process unit
enables you to refer to the past series of fluoroscopic images (loop) even
after saving the newer series.
Basic screen
[Save]
Fig. 4.4 Loop memory 2
NOTE
Fluoroscopy and radiography cannot be performed while saving images to the

hard disk drive.
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.

4.2.2 Selecting/Navigating the Images
Press the Next/Previous switch or the Playback/Stop switch on the C-arm main
panel to select or navigate the image.
Fig. 4.5 Selecting/navigating the images
 When the frame memory image is selected
Press the Next/Previous switch to select the saved image.

Next/Previous [A/B] is displayed on the monitor.
1
switch A: Currently displayed image
B: Total number of recorded images
 When the fluoroscopic loop image is selected
Next/Previous Press the Next/Previous switch to display the next/previous

1
switch image in the fluoroscopic loop image.
Press the Playback/Stop switch to start/stop the playback of

the fluoroscopic loop image.
The following loop memory status display is displayed on
Playback/Stop the monitor.
2
switch
: Playback
: Paused

Chapter 5
Troubleshooting
This chapter explains the corrective action to take if the equipment

develops trouble. When trouble occurs, take action calmly and
deliberately.
5.1 Measures for Power Outages
 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
Front brake Rear brake
Fig. 5.1 C-arm cart
 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
Fig. 5.2 Monitor cart

5.2 When DR Option does not Respond
5.2 When DR Option does not Respond
1 Press and hold the system switch for more than 5 second.
• The system shuts down.
System switch
5
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.
3 Turn (Releasing the restriction on X-ray exposure) ON (lit).
For details, see 3.4.2 "Emergency Fluoroscopy (when the DR option is

combined)" (page 3-17).
4 Select the APR.

• Emergency fluoroscopy can be performed.
When the DR option recovers, it can be used as-is after recovery.
When the DR option does not recover, use the equipment for emergency
fluoroscopy.

5.3 Responding to Problems

When a problem occurs with the equipment, take action by following the steps in
the "Corrective procedure flowchart" (page 5-5).
WARNING
If you have any doubts about how to proceed, contact your

Shimadzu service representative.
WARNING
If you feel there is something wrong with the equipment, stop

using it immediately.
If you notice an abnormal operation or sound, stop using the equipment
immediately and contact your Shimadzu service representative.
WARNING
Repair and maintenance of equipment can only be performed by

engineers to whom Shimadzu assigns.
Maintenance must be assigned to specially trained experts. Contact
your Shimadzu service representative for repair and maintenance.

5.3 Responding to Problems
 Corrective procedure flowchart
Occurrence of a problem
Is a message displayed?
Refer to 5.4 "Where Errors are Displayed".
Have you remedied the problem?
No. Yes
5
End
Telephone your Shimadzu service

representative.

5.4 Where Errors are Displayed

When the equipment’s self-diagnosis circuit detects an abnormality, a dialog that
displays the nature of the abnormality appears on the LCD.
This dialog indicates two levels of abnormality: “warning” and “error”.
A dialog indicating details of the abnormality is also displayed on the

reference monitor on the monitor cart.
 Caution
This is not an equipment malfunction.
You can reset and continue operation by following the instructions displayed on the
screen.
Example:
Fig. 5.4 Caution screen
1 Press [OK].
2 Continue to operate the equipment by following the instructions

displayed on the screen.

5.4 Where Errors are Displayed
 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].
2 Continue to operate the equipment by following the instructions

displayed on the screen.

Operation cannot be continued

Promptly turn the power OFF at the monitor cart and contact your Shimadzu service
personnel.
Fig. 5.6 Error screen 2
Error (Caution)
Cause of error (caution) Action
Number
1 to 9 Errors associated with CPU error
Errors associated Internal power supply

100 to 199
error
200 to 299 Errors associated Control circuit error
Errors associated High voltage

300 to 399
generating control system error Contact your Shimadzu
Errors associated with temperature service representative.
400 to 499
detection and communications
Errors associated with the mechanical

500 to 599
control system, e.g. the collimator
600 to 699 Errors associated with the system
800 Errors associated with the monitor cart
Incompatibility of the combination of Check the combination

801 the monitor cart and C-arm unit when of the monitor cart and
two or more instruments are owned C-arm unit.
Exposure is prohibited because only the This is not a

802
C-arm unit is started malfunction.
803 to 899 Errors associated with the monitor cart Contact your Shimadzu
900 to 999 Errors associated with the DR option service representative.
X ray tube assembly high temperature,

1000 to Follow the instructions
HU over, HU over warning, door open,
(CAUTION) displayed on the screen.
etc.

Chapter 6
Maintenance and
Inspections
This chapter describes the daily and periodic inspections. The

inspections must be carried out in order to maintain the performance of
the equipment and ensure safety.
6.1 Maintenance and Inspections

By reliably maintaining the performance of the equipment, you can assure the safety
of the operator and the patients, and efficiently provide images of exceptional
diagnostic value.
Our thorough quality control and inspection procedures ensure that the equipment is
shipped in the optimum condition. In order to maintain this optimum condition, you
must implement maintenance and inspection in a deliberate way.
The maintenance and inspections for the equipment are classified as follows.
Type of maintenance/ Inspection

Implemented by
inspection interval
Starting At the start of

Operator or equipment manager
inspection work every day
Daily inspections
Ending At the end of
Operator or equipment manager
inspection work every day
Cleaning and disinfection Operator or equipment manager As required
Inspection for warning and

Operator or equipment manager Every year
caution labels
Checking organization of the

Operator or equipment manager Every year
dose information
Your Shimadzu service

Periodic inspections Every 6 months
representative

6.2 Daily Inspections
6.2 Daily Inspections

The daily inspections comprise the starting inspections and ending inspections.
Daily inspections are necessary in order to keep using the equipment for a long
time. Check that all inspections and corrective actions have been completed before
using the equipment.
Use the “Starting Inspection Checklist” and “Ending Inspection Checklist” in

Chapter 9 "Appendix".
We recommend that you retain filled out copies of the “Starting Inspection
Checklist” and “Ending Inspection Checklist” for a fixed time.
CAUTION
If an error is found in the inspection, stop using the equipment

and contact your Shimadzu service representative.
Be careful to ensure the safety when the maintenance and inspection
are carried out by the user.
Shimadzu accepts no responsibility for any failures and damages
caused by the inspection carried out by companies other than your
Shimadzu service representative or a SHIMADZU designated
contractor.
6

6.3 Cleaning and Disinfection
WARNING
Be sure to turn the equipment power OFF before cleaning and

disinfecting the equipment.
Otherwise, a malfunction may occur in the equipment, or the equipment
may operate in an unintended way.
Also, thoroughly ventilate the room before turning on the power after
disinfection work is complete.
CAUTION
Be sure to clean and disinfect the equipment.

Cleaning and disinfection are very important to ensure that the
equipment can be used hygienically and safely. Strictly follow the
methods prescribed.
CAUTION
Do NOT directly apply or spray rubbing alcohol or water onto the

equipment.
Wipe the surface of the equipment with a cloth soaked with rubbing
alcohol.
If rubbing alcohol gets inside the equipment, it can cause failure or
accidents.

6.3 Cleaning and Disinfection
CAUTION
Use the following disinfectants:

 Rubbing alcohol
 2-propanol (Isopropyl alcohol (abrasive free))
 Glass cleaner (non ammonia-based)
 Water solution of neutral detergent
 Only onto the touch panel
CAUTION
Do NOT use the following disinfectants:

If any of the following disinfectants are applied, the equipment
performance and safety cannot be guaranteed.
 Chlorine-based disinfectants
 Disinfectants that corrode metals, plastics, rubber, or paint
 Disinfectants unsuitable for metals, plastics, rubber, or paint
 Spray-gas type disinfectants 6
 Volatile disinfectants
 Disinfectants that may enter the equipment
CAUTION
Do NOT use an organic solvent.

Organic solvents may change the surface color. If an organic solvent
adheres to the surface, wipe it off immediately.

CAUTION
Use disinfectants at a minimum.

Repeated disinfection over a long time may lead to discoloring and
cracking on the equipment surface, and deterioration of rubber and
plastic. If any abnormality is found on the equipment after disinfection,
stop using the equipment immediately. Contact your Shimadzu service
representative for repair.
CAUTION
Observe the following precautions when cleaning and disinfecting

the touch panel:
 Disconnect the main power cable before cleaning and disinfecting.
 Clean and disinfect the touch panel periodically. The applicable
cleaners include, 2-propanol (Isopropyl alcohol (abrasive free)),
glass cleaner (non ammonia-based), water solution of neutral
detergent.
 Handle the touch panel with care when cleaning and disinfecting. Do
NOT rub or hit the panel surface because it tends to scar easily.
 Wipe gently with moistened soft close to remove the dust from the
panel surface.
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.
See 3.4 "Turn the Power ON / OFF" (page 3-14).

6.4 Inspection for Warning and Caution Labels
WARNING
When turning the power ON after cleaning, make sure the

examination room is properly ventilated.
Turning the power ON while any flammable gas remains in the
examination room could lead to fire, smoke, explosion or electrocution.
6.4 Inspection for Warning and Caution Labels

Periodically (once a year) inspect the labels attached on the equipment.
If any label is peeled or unreadable by stain or scratch, contact your Shimadzu
service representative for replacement of a new one.
See "Warning and Caution Labels" (page Introduction-28).

6.5 Checking organization of the dose

information
Once a year, use a calibrated dosimeter to check that the accuracy of the dose
display is within 35 %.
Contact your Shimadzu service representative if the accuracy is not within 35 %.
When performing measurement, be sure to follow the measurement conditions
below.
 Measurement Condition (Compliant with IEC 60601-2-54:2009

clause 203.5.2.4.5.102)
SID: 980 mm
Anti-scatter grid: Used
Phantom: PMMA , min.250 mm x min.250 mm x 200 mm
Geometry:
Focal Spot
Dosimeter
Patient Entrance
Reference Point
980
150
315
200
Phantom
120 Unit: mm
Comparison of dose
display values and
dosimeter values
Fig. 6.1 Checking organization of the dose information

6.6 Periodic Inspections
6.6 Periodic Inspections

This refers to the inspections performed by your Shimadzu service representative.
The periodic inspections focus on the performance of the equipment and the internal
mechanism. They require an adequate knowledge about the internal mechanism of
the equipment. The inspection work is dangerous and you must contact your
Shimadzu service representative about them. Carry out periodic inspections every
six months. After the warranty term, periodic inspections will be carried out on a
fee-paying basis.
WARNING
Carry out periodic inspections.

In order to maintain the safety and performance of the equipment over
the long term, preventive maintenance is necessary.
Full details are given on the maintenance inspections that the user
must perform as required and periodic maintenance inspections.
For maintenance and inspection work that has to be carried out by a
specialist who has undergone special training, use Shimadzu’s
“maintenance contract” system.
6
WARNING
Repair and maintenance of equipment can only be performed by

engineers to whom Shimadzu assigns.
Maintenance must be assigned to specially trained experts. Contact
your Shimadzu Service Representative for repair and maintenance.

6.7 Regularly Replaced Components

Some of the components of the equipment must be replaced regularly in order to
maintain its performance. These components are called regularly replaced
components.
The regularly replaced components should be replaced by your Shimadzu service
representative.
The regularly replaced components are listed below.
• List of regularly replaced components
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)

Chapter 7
Options
This chapter explains how to handle the options (their operation,

maintenance, adjustment, and so on).
Chapter 7 Options
7.1 Cassette Holder

You can mount a cassette holder on the I.I. unit. The cassette holder can also be set
from above the cover.
CAUTION
Install the cassette holder correctly so that it will not fall down.
CAUTION
Be careful not to confuse these accessories with similar products

of another company.
Misuse of these accessories may cause the accident.
Fitting the cassette holder
1 Unscrew the screw (1).
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.

7.1 Cassette Holder
4 Adjust the position of the cassette holder in accordance with the

radiography position.
(4)
(3)
(C) (A)
(1)
(5)
I.I. Unit
(2)
(B) (A)
Cassette holder
Fig. 7.1 Cassette holder
1. The internal dimensions of this cassette holder are finished to

accommodate a DIN size 24  30 cm cassette. If you use ASA size 10 
12" cassettes, remove the four internal spacers (A) on the grooves for
cassette insertion and relocate the stoppers (B) to the external mounting
holes to change the dimensions to accommodate 10  12" cassettes.
2. Use an ASA size 10  12" radiography grid regardless of the

specifications of the cassette used. Insert the radiography grid into the
grooves in front of the grooves for cassette insertion after first raising 7
stopper C.
3. The radiation field for radiography is the range obtained in the immediately
preceding fluoroscopy.

Chapter 7 Options
7.2 Grid Removable Kit

The grid can be removed when the exposure level must be reduced to perform
radiography for infants, etc.
CAUTION
Be careful not to confuse these accessories with similar products

of another company.
Misuse of these accessories may cause the accident.
7.2.1 Removing the Grid
1 Rotate the C-arm so that the grid faces up.
Grid
Fig. 7.2 C-arm rotation
See 3.6.4 "C-arm Rotational Motion" (page 3-33).
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
2 Release the locks (2 locations) on the grid mounting fixture.
Lock Lock
Fig. 7.3 Removing the grid 1
3 Remove the grid with the knob pulled.
Knob
Fig. 7.4 Removing the grid 2

Chapter 7 Options
7.2.2 Mounting the Grid
1 Fix the grid with the knob pulled.
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.
Center of the grid
Knob
Fig. 7.5 Mounting the grid 1

2 Engage the locks (2 locations) on the grid mounting fixture.
Lock Lock
Fig. 7.6 Mounting the grid 2

Chapter 7 Options
7.3 Laser Pointer

The laser pointer is constructed out of the laser projector at the X-ray tube side.
1 Press (Laser pointer button) on the main panel.
• The button lights blue.

• A laser beam is emitted.
2 Press the button again to the laser beam.

• The laser beam continues to be emitted while the button lights blue.
WARNING
Never look directly into the laser beam.
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
Marking the center of

Laser beam the laser beam with E.g. the tip of a pair of
e.g. the blade of a pair scissors (center of the
of scissors. laser beam)
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.

7.4 Fitting and Removing the Cover
CAUTION
Wear sterile clothing and gloves.
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.

Chapter 7 Options
7.4.1 When Using the Washable (Cloth) Type
1 Fit the image cover (1).

• Fit by tying with thread.
2 Fit the tank cover (2).

• Fit by tying with thread.
(1)
(2)
Fig. 7.7 Cover (washable type)

7.4.2 When Using the Disposable Type
1 Mount the C-arm covers.

The C-arm cover is rolled.
• Use double-sided tape provided on the cover, and attach the cover to the
C-arm from the monotank side.
2 Fit the image cover (cover D 125 cm).

The image cover is in the form of a bag.
• Put the cover onto the I.I. unit.
3 Fit the tank cover (cover D 105 cm).

The tank cover is in the form of a bag.
• Put the cover onto the monotank.
C-arm cover Unroll and stick

the cover.
Image (I.I. unit)
7
Monotank
Double-sided tape
Fig. 7.8 Mounting the C-arm cover

Chapter 7 Options

Chapter 8
Technical Data
8.1 Environmental Conditions of EMC

(Electromagnetic Compatibility)
The equipment satisfies the EMC (Electromagnetic Compatibility) standard below:
 IEC 60601-1-2:2007
CAUTION
Pay attention to the electromagnetic circumstances at the

installation site.
The equipment may be affected by the electromagnetic environment at
the installation site.
Also, the installation of the equipment may affect other existing
equipment.
 Classification of EMI in Accordance with EN/IEC 60601-1-2:2007

Group 1, Class A
The system uses radio-frequency energy only for its internal function and is not
intended to deliver energy to the patient. However, even a small amount of radio
frequency energy leakage does harm to highsensitive equipment.
The system main power line in the clinical site should be connected to the domestic
power sources which are separated from the public main network.
CAUTION
For replacement parts of internal components, make sure to apply

the cables supplied by Shimadzu.
The use of non-cable devices, accessories, or cables other than those
sold by Shimadzu as replacement parts for the internal components
may result in increased emissions or decreased immunity of the
equipment.
 Performance to be EMC immunity tested (Essential performance)

Essential performances of the equipment are as follows:
• Positioning of X-ray field
• Set of X-ray conditions
• X-ray exposure
• Recording patient information
• Radiography
• Displaying images

8.1 Environmental Conditions of EMC (Electromagnetic Compatibility)
 List of Cables
Cable Remarks
Cable Name Shield
Length (Manufacturer/Part No)
Power Supply Cable 14 m N Shimadzu/565-10945
Cart Cable 14 m Y Shimadzu/565-10914
Shimadzu/503-58422
(NOT RoHS)
Foot Switch Cable 6m N
Shimadzu/566-13143
(RoHS)
LAN Cable 20 m N Shimadzu/088-81104-24
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.)
Tube side handle Shimadzu/503-78470 (NOT RoHS)
Doctor handle Shimadzu/563-58795
Laser pointer Shimadzu/566-14582
Dose area product meter Shimadzu/562-23553 8

DR option Shimadzu/566-14806
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.

 Guidance and Manufacturer's Declaration - Electromagnetic

Emissions - for all EQUIPMENT and SYSTEMS
Guidance and manufacturer's declaration - electromagnetic emissions
The OPESCOPE ACTENO is intended for use in the electromagnetic environment

specified below. The customer or the user of the OPESCOPE ACTENO should assure
that it is used in such an environment
Emissions test Compliance Electromagnetic environment - guidance
The OPESCOPE ACTENO uses RF energy

RF emissions only for its internal function. Therefore, its RF
EN 55011/ Group 1 emissions are very low and are not likely to
CISPR 11 cause any interference in nearby electronic
equipment.
RF emissions
EN 55011/ Class A
CISPR 11
Harmonic emissions The OPESCOPE ACTENO is suitable for use

in all establishments other than domestic and
EN 61000-3-2/ Not applicable
those directly connected to the public
IEC 61000-3-2
low-voltage power supply network that
Voltage fluctuations/ supplies buildings used for domestic purposes.
flicker emissions
Not applicable
EN 61000-3-3/
IEC 61000-3-3

Immunity
Guidance and manufacturer's declaration - electromagnetic immunity

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%.

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.
± 1 kV line(s) ± 1kV line(s) Mains power quality

Surge
to line(s) to line(s) should be that of a
EN 61000-4-5/
± 2 kV line(s) ± 2kV line(s) typical commercial or
IEC 61000-4-5
to earth to earth 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.


Immunity-

that it is used in such an environment.
IEC 60601 Compliance Electromagnetic environment -

Immunity test
test level level guidance
Portable and mobile RF

communications equipment should
be used no closer to any part of the
OPESCOPE ACTENO, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms d = 1.2 P

EN 61000-4-6/ 150 kHz 150 kHz
IEC 61000-4-6 to 80 MHz to 80 MHz
Radiated RF 3 V/m 3 V/m d = 1.2 P

EN 61000-4-3 80 MHz 80 MHz 80 MHz to 800 MHz
IEC 61000-4-3 to 2.5 GHz to 2.5 GHz
d = 2.3 P
800 MHz to 2.5 GHz
where P is the maximum output

power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey*a,
should be less than the compliance
level in each frequency range*b.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
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.
 Recommended Separation Distances between Portable and

Mobile RF Communications Equipment and the EQUIPMENT or
SYSTEM
Recommended separation distances between portable and mobile

RF communications equipment and the OPESCOPE ACTENO
The OPESCOPE ACTENO is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the
OPESCOPE ACTENO can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment
(transmitters) and the OPESCOPE ACTENO as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter

Rated maximum d (m)
output power of
150 kHz 80 MHz 800 MHz
transmitter
to 80 MHz to 800 MHz to 2.5 GHz
P (W)
d = 1.2 P d = 1.2 P d = 2.3 P 8
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
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.

8.2 Statement of Compliance [For Europe]
8.2.1 Regulatory Information

For Europe:
The product complies with the requirement of the Medical Device Directive 93/42/
EEC and RoHS Directive 2011/65/EU
Product Name: Surgical X-ray TV System
Model Name: Surgical Mobile C-arm Imaging System OPESCOPE ACTENO
Parts Number: 503-78800 (MDD not RoHS), 566-18800 (MDD and RoHS)
Manufacturer: SHIMADZU CORPORATION

Medical Systems Division
Address: 1, NISHINOKYO-KUWABARACHO,
NAKAGYO-KU, KYOTO, 604-8511, JAPAN
Authorized
Representative in EU: SHIMADZU EUROPA GmbH
Address: Albert-Hahn-Strasse 6-10, 47269 Duisburg, F.R. Germany
8.2.2 Company's Quality System
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
8.2.3 International Standards
This equipment conforms the following international standards

• IEC 60601-1:2005 / EN 60601-1:2006
• IEC 60601-1-2:2007 / EN 60601-1-2:2007
• IEC 60601-1-3:2008 / EN 60601-1-3:2008
• IEC 60601-1-6:2010 / EN 60601-1-6:2010
• IEC 60601-2-54:2009 / EN 60601-2-54:2009
• IEC 60601-2-43:2010 / EN 60601-2-43:2010
• IEC 60627:2001 / EN 60627:2001
• ISO 10993-1:2009 / EN ISO 10993-1:2009
• ISO 14971:2007,Corrected version / EN ISO 14971:2009
• IEC 62304:2006 / EN 62304:2006+AC’2008
• IEC 62366:2007 / EN 62366:2008
• EN 980:2008
• EN 1041:2008
• EN 50581:2012

8.3 Statement of Compliance with Standards
8.3 Statement of Compliance with Standards

• X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY... SURGICAL
MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO
IEC 60601-2-54:2009
EN 60601-2-54:2009
• SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO with
radiation protection in accordance with IEC 60601-1-3:1994
• SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO with
radiation protection in accordance with EN 60601-1-3:1994
IEC 60601-2-43:2010
EN 60601-2-43:2010
8.4 Manufacturer Information

Manufacturer : SHIMADZU CORPORATION Medical Systems Division
Address : 1, NISHINOKYO-KUWABARACHO, NAKAGYO-KU, KYOTO,
604-8511, JAPAN

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
2. X-ray control unit123

Nominal maximum output:
2 kW (100 kV, 20 mA, 0.1 sec)
Factor depending on the waveform: 1.00
Nominal tube voltage, and the highest tube current obtainable with that
voltage:
200V specification: Short time rating: 110 kV, 16 mA
Long time rating: 110 kV, 5 mA
Long time rating: 110 kV, 3.6 mA
Highest tube current, and the highest tube voltage obtainable with that tube
current:
200V specification: Short time rating: 20 mA, 100 kV
Long time rating: 9 mA, 60 kV
100V specification: Short time rating: 20 mA, 100 kV
Long time rating: 5 mA, 80 kV
Combination of tube voltage and tube current which results in the highest
electric output power.
Factor depending on the waveform: 1.00
Long time rating: 110 kV, 5 mA
Long time rating: 110 kV, 3.6 mA
Tube voltage setting range:
40 to 110 kV (1 kV step)
Nominal min. exposure time (AEC radiography):
2 ms

8.5 Specifications
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
*1: Accuracy of each condition is given below (confirm to IEC standards).

Tube voltage (within ±10 %), tube current (within ±20 %)
mAs: within ±(10 %+0.2 mAs), time: within ±(10 %+1 ms)

*2: X-ray output stability is given below.

Variation coefficient: 0.005 or less
*3: The X-ray output stability with neighboring setting values satisfies the
following formula.
K1 K2
----------- + -----------
K1 K2 I1 t1 I2 t2
----------- – -----------  0.2 -----------------------------
I1 t1 I2 t2 2
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
t 1 t 2 : Neighboring radiography time setting values
3. X-ray tube assembly

Model name: AD110P-200H
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
X-ray tube: SDO-0.6
Nominal focal spot: 0.6 mm (IEC 60336)
Measuring method of focal spot size: Slit camera method
Target angle: 8
Target material: Tungsten
Anode type: Stationary anode
Nominal anode input power: 2.02 kW
Nominal X-ray tube voltage: 110 kV
Maximum anode heat content: 100,000 HU (71 kJ)
Maximum anode heat dissipation rate: 550 W
Maximum filament voltage: 4.2 V
Maximum filament current: 3.7 A
Filament heating frequency: 20 kHz
Maximum heat content (X-ray tube assembly): 680 kHU (480 kJ)
Maximum heat dissipation rate (X-ray tube assembly):226 HU/s (160 W)
X-ray tube assembly inherent filtration: Min. 5.0 mm Al eq/
75 kV

8.5 Specifications
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 kg5 kg
4. Beam limiting device

Octagonal collimator: Electrical driven (opening/closing), made of
Tungsten
Parallel compensating filter:
Electrical driven (opening/closing/rotation), made of
Cu
Beam hardening filter: Electrical driven (filter selection),
Made of Cu, 0.1, 0.2, 0.3 mm thick
Al equivalent for beam hardening filter
(70 kV/HVL, 2.5 mm Al)
Beam
Cu 0.1 mm Cu 0.2 mm Cu 0.3 mm
hardening filter
Al equivalent 3 mm Al 3.7 mm Al 3.8 mm Al
Inherent filtration: 0 mm Al equivalent.

8

Reference axis
Reference axis
Focal spot
Focal spot
UNIT : mm
Fig. 8.1 X-ray tube assembly
The reference axis which employed in normal operation of equipment means

the incident X-ray axis from X-ray tube unit to I.I. vertically as shown
above.
Fig. 8.2 X-ray tube assembly

8.5 Specifications
X-RAY TUBE ASSEMBLY HEATING AND COOLING CURVE
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)
ANODE HEATING AND COOLING CURVE

100
550W
90
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

SINGLE LOAD RATING CHARTS
X-ray tube Current [mA]
Time [min]
EMISSION AND FILAMENT CHARACTERISTICS

X-ray tube Current [mA]
Filament Voltage [V]
Filament Current [A]

8.5 Specifications
Table A.1 SERIAL LOAD RATING TABLE (For reference use only)
Tube load (kW) as a function of the flame rate (fps)

Number of exposure in of the individual radiographs of the series
Series (exp)
7.5 5 3.75 2 1
10 11.4 10.6 10.1 9.8 9.5
20 10.6 9.8 9.4 9.0 8.8
40 9.8 9.0 8.6 8.3 8.0
60 9.4 8.6 8.1 7.8 7.4
80 9.0 8.3 7.8 7.4 7.0
100 8.8 8.0 7.4 7.0 6.7
150 8.4 7.4 6.9 6.4 6.1
Refer to IEC 60613:2010
5. X-ray tube assembly operating principle

Operating principle is as follows.
a) The filament is heated by passing an electric current, and then thermo
electrons are emitted
b) A high voltage is applied between the cathode and anode to accelerate the
electrons.
c) The accelerated electrons strike the anode target and X-rays are
generated.
d) The filed size of X-ray beams are limited by the collimator.
Fig. 8.3 OPERATING PRINCIPLE

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
8. X-ray television assembly

Camera Element: CCD
Effective pixels: 1000 (H)  1000 (V)
Density gradation: 12-bit (4096 gradation)
9. Image processing section

Image Processing:
Shading Compensation, LUT (Input), Dynamic Range Processing,
Recursive, LUT (Display), AWC (Auto Window Control), Edge
Enhancement, HV Inversion
Others:
a) Frame memory/loop memory storage (172 images common)
b) Camera rotation display, collimator positioning display on fluoroscopy
LIH images
10. TV monitor
19 inch LCD display monitor (Live monitor/Reference monitor)
Color/monochrome selectable

8.5 Specifications
11. Grid
Ratio: 10:1
Line rate: 40 lines/cm (Aluminum), 44 lines/cm (Fiber)
Intermediate material: Aluminum/Fiber selectable
12. Fuse, Breaker
Rated Rated Acting Breaking

Name Location
voltage current speed capasity
250 V Slow Monitor

CP32V-15DN 15 1000
AC -Blow Cart
250 V Slow Monitor

FLM15 (ROHS) 15 10000
AC -Blow Cart
250 V Slow Monitor

021306.3P 6.3 63
AC -Blow Cart
660 V Very C-arm

660CF-20 20 10000
AC, DC Fast Cart
32 V Very C-arm
MFU0603FF00500P500 0.5 50
DC Quick Cart
13. Removable accessories

Grid (Aluminum / Fiber selectable)
Cassette holder (option)
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 kg10 kg
Monitor cart: 145 kg10 kg

8.5 Specifications
Fig. 8.4 C-arm Cart with 9” I.I.

Fig. 8.5 Monitor Cart

8.6 Initial Setting Values for APR
2 3 4 5
1 6 7 8 9
10 11 12
Fig. 8.6 APR Position 1
APR No. 1 2 3 4
Chest
APR Name Standard Head/Neck Shoulder
(IVH/PMI)
Dose Normal Normal Low Dose 1 Normal
Pulse rate 15fps 15fps Continuous 15fps
X-ray adjustment mode ON ON ON ON
Loop memory mode OFF OFF OFF OFF
Start fluoroscopy tube

50 60 60 50
voltage (kV)
I.I.Field size Normal Normal Normal Normal
BH filter None None None None
Image Brightness
0 0 0 0
Adjustment
Camera rotation angle 0 0 0 0
0 0 0 0
filter rotation angle
filter width
Max Max Max Max 8
Max Max Max Max
width
Image V reverse OFF OFF OFF OFF
Image H reverse OFF OFF OFF OFF
Laser pointer (OP) OFF OFF OFF OFF
Acquisition mode* SPOT SPOT SPOT SPOT
Acq Rate* - - - -
Photo Timer* 0 0 0 0
*: When combined with the DR option.

2 3 4 5
1 6 7 8 9
10 11 12
APR No. 5 6 7 8
APR Name Arm Hand Spine Hip Joint
Dose Normal Normal Normal Normal
Pulse rate 15fps 15fps 15fps 15fps

40 40 60 60
voltage (kV)
Image Brightness
0 (+1)*1 0 (+2)*1 0 0 (+1)*1
Adjustment
0 0 0 0
Max Max Max Max
filter width
Max Max Max Max
width
Acquisition mode*2 SPOT SPOT SPOT SPOT
Acq Rate*2 - - - -
Photo Timer*2 0 0 0 0
*1: When combined with 6” I.I.

*2: When combined with the DR option.

2 3 4 5
1 6 7 8 9
10 11 12
APR No. 9 10 11 12
Spine/Hip Leg Vascular

APR Name Foot
(Thick) (Knee) access
Dose Normal Normal Normal Low Dose 1
Pulse rate 15fps 15fps 15fps Continuous

60 50 40 60
voltage (kV)
Image Brightness
0 0 0 (+1)*1 0
Adjustment
0 0 0 0
Max Max Max Max
filter width
width
Max Max Max Max
8
Acquisition mode*2 SPOT SPOT SPOT SPOT
Acq Rate*2 - - - -
Photo Timer*2 0 0 0 0
*1: When combined with 6” I.I.

*2: When combined with the DR option.

8.7 Conditions for Installation and Use

1. Environmental conditions
Temperature: 10 C to 35 C
Relative humidity: 30 % to 80 % (to be no condensation)
Atmospheric pressure: 800 hPa to 1060 hPa
State of the atmosphere: To contain no volatile vapors or corrosive gases
Ambient noise level: Under 70 dB
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
8.8 Storage Conditions

Temperature: 0 C to 40 C
Relative humidity: 10 % to 80 % (to be no condensation)
Atmospheric pressure: 700 hPa to 1060 hPa
State of the atmosphere: To contain no volatile vapors or corrosive gases

8.9 KV-mA Curve
8.9 KV-mA Curve

Initial setting value: 75 kV/Cu 3 mm

(for 100V and 200V)
(for 100V and 200V)
(for 100V and 200V)

8.10 Information on Radiation

8.10.1 Radiation Protection
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.
 For Radiation Protection of Patients

• If there is any possibility that the regions easily affected by radiation (eye balls,
gonad, etc.) are irradiated by X-ray, be sure to protect those regions.
• Adjust X-ray irradiation field appropriately to avoid X-ray irradiation to the area
other than the region of interest.
• Keep the focus-skin distance as long as possible.
• Always check the cumulative dose area product and the cumulative reference Air
Kerma displayed in the live monitor.
8
NOTE
The precision of the displayed dose value is ±35 %

Periodical calibration is required for the dose area product meter chamber and
the dose calculating function.
 For Radiation Protection of Medical Staff

• Limit the time of staying in the controlled area as short as possible. While in the
area, be sure to wear the radiation protective gear, such as protective apron,
gloves, glasses, etc.
• Keep the distance as far as possible from the X-ray source. The radiation dose is
inversely proportional to the square of the distance from the radiation source.
• Be sure to use a badge or pocket dosimeter to check your personal exposure dose.

8.10.2 Stray Radiation in the Significant Zone of Occupancy
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.
Fig. 8.9 Vertical Beam, PA position

Fig. 8.10 Vertical Beam, AP position

Fig. 8.11 Horizontal Beam

8.10.3 Test Report Stray Radiation for OPESCOPE ACTENO
 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
4) Significant zone of occupancy and Measuring points

For detail, refer to Fig. 8.9 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]
Fig. 8.12 Vertical Beam PA position
A B C D E F
200
150
100
50
0
10 100 1000 10000
Air K erma in one hour (work load:3600mAs) [µGy]
Fig. 8.13 Vertical Beam AP position

A B C D E F
200
150
100
50
0
10 100 1000 10000
Air K erma in one hour (work load: 3600mAs) [µGy]
8.10.4 Deterministic Effect
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

8.10.5 Reference Air Kerma (Rate)
This section describes representative values of reference air kerma rate of

fluoroscopy and reference air kerma of radiography.
These values might change by X-ray condition, etc.

clause 203.5.2.4.5.102)
SID: 980 mm
Anti-scatter grid: Used
Phantom: PMMA 400x400x200 mm
Geometry:
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.
Mode and Application

Low Dose
DC/Pulse Pulse (ms) Frame Rate Application
For study that needs decreasing

DC (Continuous) (Continuous)
dose.
For study that needs decreasing

Pulse 33 15/10/7.5/3.75
dose even more.
Normal
DC (Continuous) (Continuous) For normal study.
For normal study that needs

Pulse 33 15/10/7.5/3.75
decreasing dose.
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
Pulse 33 7.5/3.75 For study that needs high quality.

Curves of Tube Voltage-tube Current (mA)
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
Reference Air Kerma Rate

• FOV 9 inch
Beam hardening filter (Cu)

Dose DC/Pulse Reference AKR
None 0.1 0.2 0.3
kV 81 85 88 91
DC mA 1.9 1.8 1.8 1.7
AKR (mGy/min) 14.5 9.58 7.5 6.3
kV 79 83 86 89
15 mA 1.9 1.9 1.8 1.8
AKR (mGy/min) 7.9 5.25 3.95 3.3
kV 78 80 84 87
Low dose 2 10 mA 1.8 2 1.9 1.8
AKR (mGy/min) 5.3 3.7 2.8 2.3
kV 78 80 84 87
7.5 mA 1.8 2 1.9 1.8
AKR (mGy/min) 4.2 2.8 2.22 1.9
kV 78 80 84 86
3.75 mA 1.8 2 1.9 1.8
AKR (mGy/min) 2.3 1.63 1.25 1.05


None 0.1 0.2 0.3
kV 77 79 81 83
DC mA 2.4 2.7 2.7 2.7
AKR (mGy/min) 16.5 11.3 8.9 7.3
kV 77 78 80 82
15 mA 2.4 2.5 2.8 2.7
AKR (mGy/min) 8.5 5.6 4.5 3.7
kV 76 78 79 80
Low dose 1 10 mA 2.3 2.5 2.7 2.8
AKR (mGy/min) 5.8 4.15 3.1 2.6
kV 76 78 79 80
7.5 mA 2.3 2.5 2.7 2.8
AKR (mGy/min) 4.4 3.3 2.45 2.04
kV 76 77 79 80
3.75 mA 2.3 2.4 2.7 2.8
AKR (mGy/min) 2.5 1.7 1.35 1.15
kV 73 75 77 78
DC mA 3.1 3.4 3.7 3.9
AKR (mGy/min) 17.7 12.9 10.16 8.5
kV 73 74 75 77
15 mA 3.1 3.2 3.4 3.7
AKR (mGy/min) 9.5 6.2 4.9 4.1
kV 73 74 74 77 8
Normal 10 mA 3.1 3.2 3.2 3.7
AKR (mGy/min) 6.8 4.5 3.2 2.96
kV 73 74 74 76
7.5 mA 3.1 3.2 3.2 3.6
AKR (mGy/min) 5.15 3.5 2.5 2.36
kV 73 73 74 76
3.75 mA 3.1 3.1 3.2 3.6
AKR (mGy/min) 2.82 1.85 1.43 1.19


None 0.1 0.2 0.3
kV 74 76 77 79
DC(400W) mA 4 4.3 4.5 4.8
AKR (mGy/min) 24.9 16.9 13.25 11.12
kV 72 73 75 76
DC(550W) mA 4.9 5.1 5.6 5.8
AKR (mGy/min) 27.8 18.3 14.14 11.8
kV 72 73 74 76
15 mA 4.9 5.1 5.3 5.8
AKR (mGy/min) 15.3 10 7.7 6.5

High Quality
kV 72 73 74 76
10 mA 4.9 5.1 5.3 5.8
AKR (mGy/min) 11.1 7.15 5.48 4.6
kV 72 73 74 76
7.5 mA 4.9 5.1 5.3 5.8
AKR (mGy/min) 8.8 5.6 4.4 3.63
kV 72 73 74 76
3.75 mA 4.9 5.1 5.3 5.8
AKR (mGy/min) 5.1 3.1 2.3 2
kV 67 68 69 71
7.5 mA 7.6 8 8.5 9.3
AKR (mGy/min) 10.1 6.1 4.6 4.1

Boost Pulse
kV 67 68 69 71
3.75 mA 7.6 8 8.5 9.3
AKR (mGy/min) 5.1 3.4 2.65 2.2
Highest Reference Air Kerma Rate

69.8 mGy/min of High Quality DC, 110 kV 4.9 mA 9 FOV, no beam hardening
filter

Radiography
Reference Air Kerma
• FOV 9 inch
Beam X-ray condition

Reference AKR
hardening Tube voltage Tube current
Time (msec) (mGy/Frame)
filter (kV) (mA)
None 74 16 166 0.260
Cu 0.1 75 16 166 0.166
Cu 0.2 75 16 166 0.124
Cu 0.3 78 16 166 0.097
Highest Reference Air Kerma

23.52 mGy at film radiography mode, 110 kV, 12 mA, 8 s (100 mAs), 9 FOV, no
beam hardening filter.

8.10.6 Distribution Map of Stray Radiation

Clause 203.13.4)
X-ray condition: 110 kV, 3mA
Phantom: PMMA 250 x 250 x 250 mm
X-ray field size: 100 cm2 of entrance of phantom
Geometry:
Fig. 8.15 Vertical Beam, AP position

 Test data
Refer to Fig. 8.17 to Fig. 8.20. The unit in figures is [Gy].
NOTE
The measurements of stray radiation are normalized to a dose area product of

1 Gycm2.
8

Fig. 8.17 Isokerma map at 100 cm hight (AP position)
Fig. 8.18 Isokerma map at 150 cm hight (AP position)

Fig. 8.19 Isokerma map at 100 cm hight (Horizontal position)
Fig. 8.20 Isokerma map at 150 cm hight (Horizontal position)

8.11 Labels
 Manufacturer’s Nameplate (for RoHS is representative)
Manufacturer’s nameplates are affixed at the locations indicated below.
(2)
(1)
(3)
Fig. 8.21 Position of Labeling

8.11 Labels
(1)
(2)
(3)
Fig. 8.22 Manufacturer’s nameplate

 Warning and Caution Labels
(1) (8)
(5)
(7)
(2)
(3)
(4) (6)
(13) (9)
(12) (11)
(10)
Fig. 8-23 Warning, caution and other labels
(1)
(2)
(3)

8.11 Labels
(4)
(5)
(6) (Option)
(7) (Option)
(8) (Option)
8

 Others
(9)
• TUV approval label
• CE-MDD label (alternative)

Not RoHS RoHS
• EU Representative label
• WEEE label
• Label EMC
• Label Manual

8.11 Labels
• Installation and Use Condition label
(10) Foot switch IPX label
(11) TYPE B Applied Part Label
NOTE
The TYPE B Applied Part Label is indicated to meet the requirements of

IEC60601-1:1988+A1:1991+A2:1995 as this may come into contact with
patients.
8
(12) Permanent filter label
(13) Earth for potential equalization label

 Package for transportation

The following shows the label on the package for transportation, describing about
storage environment and transport environment.
Fig. 8.24 Label on package for transport

Chapter 9
Appendix
Chapter 9 Appendix
9.1 Starting Inspection Checklist
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.
Check points Corrective action
Have unnecessary items in the vicinity of the equipment been cleared

Clear them away.
away?
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.
Contact your Shimadzu

Is there any damage to cable insulation?
service representative.
2 Check the following points by hands-on examination before switching

the power ON. Correct any nonconformity.
Do the casters, brakes, handles and other parts of the C-arm cart function Contact your Shimadzu
correctly? service representative.

Do the brakes of the monitor cart function correctly?
Is the C-arm cart’s brake applied? Apply the brakes.
Are the monitor cart’s brakes applied? Apply the brakes.

9.1 Starting Inspection Checklist
3 Check visually that connections have been made correctly before

switching the power ON. Correct any nonconformity.
Is the cart cable connected correctly? Connect it.
Is the potential equalization conductor connected correctly? Connect it.
Is the main power cable connected correctly? Connect it.
4 Turn the power ON. Check the following points visually and aurally.

Is the operating noise after switching the power ON normal?
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.
5 Check the following points while operating the equipment. Correct

any nonconformity.

Is there an abnormal noise when the C-arm is operated?

Does the C-arm lock switch function correctly?

Is the laser pointer (option) focused correctly?

Chapter 9 Appendix
9.2 Ending Inspection Checklist
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.
Position it at its home

Is the C-arm at its home position (fixed position)?
position.
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.

Is there any damage to cable insulation?
3 Check the following points by hands-on examination. Correct any

nonconformity.
Do the casters, brakes, handles and other parts of the C-arm cart function Contact your Shimadzu
correctly? service representative.
Is the C-arm cart’s brake applied? Apply the brakes.
Are the monitor cart’s brakes applied? Apply the brakes.

Do the brakes of the monitor cart function correctly?
4 As necessary, clean and disinfect the equipment.

9.3 Monitor Brightness Adjustment, Contrast Adjustment
9.3 Monitor Brightness Adjustment, Contrast

Adjustment
NOTE
Normally there is no need to adjust the monitor's brightness or contrast.
Refer to "LCD monitor Monochrome ML19001 Color CL19194 OPERATION

MANUAL" for operation details.
Use [+], [-] and [MENU] buttons to adjust the monitor brightness and contrast.
Main menu
screen
[-] [+] [MENU]

Fig. 9.1
1 Press [MENU].
• The main menu screen of OSD adjustment is displayed.
2 Press [+] or [-] to select [Picture] and press [MENU].

9

Chapter 9 Appendix
• The Picture menu screen is displayed.
[Picture]
Fig. 9.2 Main menu screen
3 Press [+] or [-] to select [Contrast] to adjust the contrast or

[Brightness] to adjust the brightness and press [MENU].
• The adjustment screen is displayed.
[Contrast]
[Brightness]
Fig. 9.3 Picture menu screen
4 Press [+] or [-] to adjust.
Fig. 9.4 E.g. Brightness screen
5 Press [MENU] to finish adjustment.

• The Picture menu screen is displayed.

9.3 Monitor Brightness Adjustment, Contrast Adjustment
6 Check that [Exit] is selected and press [MENU].

• The main menu screen is displayed.
7 Check that [Exit] is selected and press [MENU].

• The main menu screen is closed.

Chapter 9 Appendix

Surgical Mobile C-Arm Imaging System OPESCOPE ACTENO Operation en

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M516-E040C

Surgical Mobile C-arm Imaging System

Indicates an imminently hazardous situation which, if not

Indicates a potentially hazardous situation which, if not

Indicates a potentially hazardous situation which, if not

States information which helps to use the equipment

Gives information to make using the Opescope easier.

Gives information for reference when using the Opescope.

© 2013-2014 Shimadzu Corporation. All rights reserved.

“Operating Precaution (for Both the Safety and the Prevention of

Introduction-2 OPESCOPE ACTENO Instruction Manual

5. After operating the equipment, pay attention to the following items:

OPESCOPE ACTENO Instruction Manual Introduction-3

Precautions for Use

The responsibility for management of use and maintenance of medical equipment

Never modify the equipment.

Perform periodic inspection.

Introduction-4 OPESCOPE ACTENO Instruction Manual

If the operator has no experience in operating the equipment, be sure that he or

1.7 "Operator Profile" (page 1-10)

OPESCOPE ACTENO Instruction Manual Introduction-5

Be Sure to Read the Following to Prevent Explosion, Electric Shock,

Do NOT use any potentially flammable or explosive gas, such as

Check the condition of the patient before conducting a study.

If an abnormality occurs during operation, or if an unusual odor or

Introduction-6 OPESCOPE ACTENO Instruction Manual

Do NOT open the covers of the equipment.

Always be very careful when moving the equipment to avoid

When performing CPR, immediately move this equipment away so

3.6 "Positioning (How to Operate the C-arm)" (page 3-26)

OPESCOPE ACTENO Instruction Manual Introduction-7

When opening and closing the monitors, be careful not to trap

Do NOT place peripheral devices or any other object within the

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Cautions on Environmental Conditions

Use the equipment in an environment that meets the stipulations

Do NOT use the equipment in an oxygen-rich environment.

Be sure to connect the equipment only to a (commercial) power

OPESCOPE ACTENO Instruction Manual Introduction-9

Be sure to use the equipment under the following environmental

Provide the equipment with a suitable ground.

See 1.4 "Environmental Conditions" (page 1-5).

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The equipment must only be operated by qualified personnel,

Perform X-ray irradiation carefully and according to the doctor's

During X-ray irradiation, ensure that the X-rays irradiate the

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Do NOT place any unnecessary object in the location within the

Be sure to warm-up the equipment (running-in operation of the

See 3.5 "Warm-Up" (page 3-25).

Perform the warm-up if an arc occurs.

Do NOT perform unnecessary standby operations.

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In order to minimize the radiation dose on the patient, make the

Pay extra attention when irradiating X-rays for a long time or

Do NOT confuse the fluoroscopy and radiography.

Objects such as the operating table or surgical instruments in the X-ray

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Cautions Relating to the Laser Beam

Never look directly into the laser beam.

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Cautions on Moving the Equipment

Take care to avoid impacts and overturning of the equipment.