M516-E011l Wha-200 Pleno Om PDF

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Manual No.

: M516-E011
Revision :L

SURGICAL MOBILE C-ARM IMAGING SYSTEM


WHA-200

OPERATION MANUAL

Read this manual carefully to ensure appropriate use, and keep


it with the unit.
About the symbols appearing in this operation 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

States a direct danger that may cause death or serious injury


DANGER if it is not avoided.

States an indirect or potential danger that may cause death or


WARNING serious injury if it is not avoided.

States a danger that may cause slight or medium injury or


CAUTION may cause damage in equipment or fire if it is not avoided.

NOTE States information which helps to use the system correctly.

Indicates references.

Gives information to make using the Opescope easier.

Gives information for reference when using the Opescope.

Term Abbreviations and special terms

Revision History

Revision Date Changes

First revision 2004

"8.6 EMC (Electro-Magnetic


Compatibility)" revised.
L Sep., 2011
Added descriptions regarding the 19 inch
LCD monitor.
Introduction

Thank you for selecting the Surgical Mobile C-arm Imaging System
WHA-200 OPESCOPE PLENO (hereafter “the system”).
Before using the system, read the operation manual and make sure you
understand its contents.
After reading the manual, keep it safely somewhere where it can be
accessed easily.

Copyright
SHIMADZU Corporation reserves the copyright of this manual and the
whole or a part of the contents may not be copied or reproduced without
the company’s permission.
The contents of this manual may be changed for improvement without
notice.

© 2004-2011 Shimadzu Corporation. All rights reserved.


Operating Precautions

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


Danger) in the Use of Electric Medical Equipment”
1. The operator should receive the education related to the (X-ray) medical treatment.
(Have the qualification of medical when the qualification is necessary in each
country.) The operator should understand description matter of the label and the
manual. The operator should receive the education of operating the system before
using the system first.
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, chlorine or sulphur gas.
(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, which 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 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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, chlorine
or sulphur gas.
(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 the 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 operation manual.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-3


Using the System Safely...

WARNING

The operator should receive the education related to the (X-ray) medical treatment.
(Have the qualification of medical when the qualification is necessary in each
country.)
The operator should understand description matter of the label and the manual.
The operator should receive the education of operating the system before using the
system first.

WARNING

Only qualified personnel should use the system.


The responsibility for controlling the use and maintenance of medical equipment lies with
the user(s) of the system.
Only qualified personnel or their subordinates should use the system.
It is dangerous to attempt internal repairs or inspections; contact our service agent if
such repairs/inspections are necessary.

WARNING

Do not modify the system.


In general, almost all of the modifications are strictly prohibited by the Regulatory
requirements of the low of the country where device is installed.
Please contact our service agency if it is needed to modify the device.

Introduction-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


WARNING

Carry out periodic inspections.


In order to maintain the safety and performance of the system over the long term,
preventive maintenance is necessary.
Details on the maintenance and inspection activities that the user must attend to as
necessary and periodically are provided in this manual.
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.

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 the Shimadzu
Service Representative for repair and maintenance.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-5


Principle Points to Observe

DANGER

Read the operation manual and make sure you understand its
contents.
Operating the system without having read this manual, or with an
incomplete understanding of the information it contains, can cause
serious injuries or damage to equipment.

• Do not switch on the power or touch the switches and other controls
without first having read the operation manual.
• If you do not fully understand the information in the operation manual,
please contact our service personnel. The contact details are given at the
end of this manual.
• Keep the operation manual safely in a place where it can be accessed
immediately whenever it is required.
• Familiarize yourself with the locations of hazards and the nature of the
hazards. Make sure you have a thorough grasp of how to avoid these
hazards, and the corrective action to take in the event that such a hazard
is actually realized.

WARNING

Only qualified personnel should use the system.


The responsibility for controlling the use and maintenance of medical
equipment lies with the user(s) of the system.
Only qualified personnel or their subordinates should use the system.
It is dangerous to attempt internal repairs or inspections; contact our
service agent if such repairs/inspections are necessary.

WARNING

Do not modify the system.


In general, almost all of the modifications are strictly prohibited by the
Regulatory requirements of the law of the country where device is
installed.
Please contact our service agency if it is needed to modify the device.

Introduction-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Locations of Hazards

♦ Live section

DANGER

Never touch anything inside the live section.


The region indicated in the figure below contains high-voltage
terminals. Do not remove the cover or touch internal devices. This
could result in serious accidents including death by electrocution.

Fig. Introduction-1 Live section

DANGER

Inspect the cable using the system.


Check for damage to the cable insulation before using the system.
Damaged insulation could lead to serious accidents including death by
electrocution.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-7


♦ Moving section

CAUTION

Be aware of the danger of being struck or trapped.


Your arms or legs could become trapped between the C-arm and the
rest of the structure, injuring you.
When moving the C-arm, hold it at the proper points and operate it
carefully.

3.5 “Positioning (How to Operate the C-arm)” (page 3-24)

CAUTION

Do not place peripheral devices or any other object within the


range of motion of the system.
If you place peripheral devices such as monitors within the range
indicated below, the system could strike or contact them.

(Units: mm)
2146

880

660
450
1755

R55
0

775 1685

Fig. Introduction-2 Range of motion

Introduction-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Notes on Preventive Maintenance

WARNING

Carry out periodic inspections.


In order to maintain the safety and performance of the system over the
long term, preventive maintenance is necessary.
Details on the maintenance and inspection activities that the user must
attend to as necessary and periodically are provided in this manual.
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.

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
the Shimadzu Service Representative for repair and maintenance.

Cautions on Radiation

WARNING

Be aware of the potential for X-ray irradiation.


If X-ray equipment is not used correctly the operator, the subject, and
other persons may receive a greater dose of radiation than is
necessary. Nobody other than the subject should remain in the
examination room during irradiation. If for some reason another person
has to be in the examination room, that person must take adequate
measures to protect themselves against radiation (protective apron,
screen, etc.).

CAUTION

In order to minimize the absorbed dose, make the focus-skin


distance as long as possible.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-9


CAUTION

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, and
children.

Cautions on Pacemakers

WARNING

Observe the following precautions when conducting studies in


which consecutive pulse-shaped X-ray fluxes are irradiated onto
the implanted region of an implantable pacemaker or implantable
defibrillator.
Clinical Condition/
Medical Device Name Mechanism/Risk Factor
Appropriate Measures
Conducting studies in which Fluoroscopy or
consecutive pulse-shaped radiography performed by
X-ray fluxes are irradiated irradiating consecutive
onto the implanted region of pulse-shaped X-ray fluxes
an implantable pacemaker or (such as consecutive
implantable defibrillator may radiography within a few
cause these devices to seconds, pulsed
malfunction. fluoroscopy, DA
Refer to the "Important radiography, DSA
General Cautions," radiography, or
Implantable pacemaker
"Interactions," or other cineradiography) can
Implantable defibrillator
relevant sections in the adversely affect the CMOS
accompanying circuit in implantable
documentation of the pacemakers and
implantable pacemaker or implantable defibrillators.
implantable defibrillator and Such affects may cause
take the prescribed measures oversensing in these
before irradiating the devices that can
implanted region of these temporarily inhibit pacing
devices with consecutive pulse output and result in
pulse-shaped X-ray fluxes. an inappropriate heart rate.

Introduction-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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.

Cautions on Explosions

WARNING

Do not use the system in an atmosphere containing combustible


gas.
The system is not an AP device. Its use in an atmosphere containing
combustible gas carries the risk of fire or explosion.

WARNING

Exercise caution in the use of disinfectant sprays.


Do not use disinfectant sprays that are flammable or could cause an
explosion.
The vapor from a disinfectant spray may ignite, causing life-threatening
or serious injuries and damage to the system.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-11


Cautions on Naked Flames

WARNING

Implement measures to eliminate naked flames.


Using the system in an inappropriate environment could lead to a fire or
explosion. Install suitable fire extinguishing apparatus and ensure that
the procedure for dealing with fires is widely and well known.
Use the appropriate fire extinguishers for electrical and chemical fires.
Using water or other liquids to combat an electrical fire could lead to
serious injuries.

Cautions Relating to Cellular Telephones

WARNING

Do not bring cellular telephones or related devices into the


examination room.
Do not bring mobile devices that emit electromagnetic waves (e.g.
cellular telephones) into the examination room unless they are
switched OFF. Such devices can exceed the EMC electromagnetic
wave standards, and under some conditions this can impair the proper
functioning of the system. In the worst case, this can cause serious
injuries or clinical errors.

Introduction-12 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Cautions on the Compatibility of Electromagnetic Fields

WARNING

WHA-200 needs special precautions regarding EMC and needs to be


installed and use according to the EMC information provided in this
operation manual.

8.6 “EMC (Electro-Magnetic Compatibility)” (page 8-21)

WARNING

Check that the electromagnetic fields are compatible.


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

8.6 “EMC (Electro-Magnetic Compatibility)” (page 8-21)

WARNING

WHA-200 should not be used adjacent to or stacked with other


equipment and that if adjacent or stacked use is necessary, WHA-200
should be observed to verify normal operation in the configuration in
which it will be used.

8.6 “EMC (Electro-Magnetic Compatibility)” (page 8-21)

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-13


Cautions on Cleaning and Disinfection

CAUTION

Clean and disinfect the system.


Cleaning and disinfection is very important to ensure that the system
can be used hygienically and safely. You must strictly follow the
methods prescribed.

CAUTION

Disconnect the main power cable before starting cleaning.


You must disconnect the system’s main power cable before starting
cleaning and disinfection.
Check that the green lamp of the system switch is unlit before
disconnecting the main power cable.
Otherwise there will be a risk of electric shock and current leaks.

CAUTION

Do not use any water on the system.


Clean the system by wiping its surface with a cloth soaked in
disinfectant.
Using water to clean the system could cause electric shock or current
leakage.

CAUTION

Do not apply disinfectant directly, or spray it, onto the system.


If disinfectant gets inside the system, it can cause trouble or accidents.

Introduction-14 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Cautions on Use and Storage

CAUTION

Provide the system with a suitable ground.


The system needs a ground.
An unsuitable ground could cause electric shocks.

See 3.3 “Connecting and Dismantling the System” (page 3-9).

WARNING

Use the system in an environment that meets the stipulations


stated here.
Use the system 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.

CAUTION

Abide by the conditions for correct use and storage.


The locations where this unit is used and stored must meet the
following conditions.
• Atmosphere: No explosive or corrosive gases
• Temperature for use: 10°C to 35°C
• Temperature for storage: 10°C to 40°C
• Relative humidity: 30% to 85% (no condensation)
• Atmospheric pressure: 700 hPa to 1060 hPa
• Visibility conditions for use:150 lx to 500 lx (no direct sunlight)
Note also that there must be no sudden changes in temperature or
humidity. This causes condensation, which can lead to trouble.

See 1.3 “Environmental Conditions” (page 1-6).

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-15


Cautions on Moving the System

WARNING

Take care to avoid impacts and overturning of the system.


The system weighs more than 200 kg.
Impacts and overturning will not only damage the system, but could
also cause serious injuries.
When moving the system, 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 system as gently as possible. Take particular care on steep
slopes.
• Always apply the brake when you stop moving the system.
• On slopes with an inclination of greater than 5°, the system could
overturn. Do not move or operate the system in places where the
gradient exceeds 5°.
• In places where moving the system 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 system, watch out for obstacles ahead.

Introduction-16 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Warning Labels

WARNING

Do not remove or soil the warning labels.


The warning labels indicate important cautions on using the system.
If a warning label becomes illegible because it is peeling off or soiled,
contact our service agent.

(7) (1)
(2)

(4)
(5) (8)
(6)

(2)

(3)

Fig. Introduction-3 Warning labels

(1)

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-17


(2)

Do not put a hand here.

503-59829

(3)

(4)

(5)

(6)

(7) (Option)

CAUTION
LASER RADIATION
DO NOT STARE INTO BEAM.
1.0 mW Max. CW 645 nm
CLASS 2 LASER PRODUCT IEC60825-1(2001)

Introduction-18 WHA-200 OPESCOPE PLENO OPERATION MANUAL


(8)

Guarantee
The guarantee period of this system is once year from the date of purchase.
Our company is not responsible for the following failures and damages.

1. Failure/damage caused by installation, movement, maintenance and repair


performed by anyone other than our company and companies specified by our
company.

2. Failure/damage in a product of our company caused by a product of other


company which is not delivered by our company.

3. Failure/damage based on maintenance, repair, etc. using a spare part other than
the genuine parts specified by our company.

4. Failure/damage based on a result caused by disobedience to the cautions and


operating procedures described in this instruction manual.

5. Failure/damage caused by the ambient condition beyond the service condition


of this system such as the power supply and installation requirements
described in this instruction manual.

6. Failure/damage caused by natural disaster such as fire, earthquake, flood


damage and thunderbolt.

The servicing after expiration of the guarantee period will be offered with charge.
Contact Shimadzu Service Representative nearest to you.

Service Life
The system's service life is 10 years (based on Shimadzu's criteria), and is limited to
systems that receive the prescribed maintenance checks.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-19


Exclusion of Liability

This system uses a computer connectable to the network. To avoid infection by a


computer virus, please use this system in an environment isolated from a network
connected to an external network such as the Internet. The network connected to this
system should not be connected to any network devices such as computers that might
become virus-infected. This system might become virus-infected due to the connected
network devices.
Shimadzu is not responsible for failure and damages due to computer viruses.
Do not attempt to install any software, alter, or connect peripheral devices to the
computer used for this system unless supplied by Shimadzu for the use of this system.
The system may not run due to environmental changes of operating system and driver
conflicts.
Shimadzu is not responsible for failure and damages due to these operations.

Safeguarding Data

Shimadzu is not responsible for the recovery of damaged or deleted data, even though,
Shimadzu can adjust the system setting for recurrence prevention if data is damaged or
deleted for any reason.
Keep in mind that there is always a possibility that data stored in the system disk might
be deleted or damaged. The data deletion or damage may occur due to the malfunction
or failure of devices, and also performance deterioration (secular variation) of
components.
Our company suggests saving the necessary data to film in order to create a hardcopy,
or transferring the data to the external recording media (CD-R, DVD-R) for safekeeping.
However, since data stored in the external recording media may also be deleted or
damaged, a periodic check should be done for the data content.

Introduction-20 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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-4 WEEE Mark

Contact 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 Shimadzu service representative, if you require further
information.

Language of Approved Version


Original version of this manual is approved in English.

Software Revision
This manual applies to the software revision 1.19.

WHA-200 OPESCOPE PLENO OPERATION MANUAL Introduction-21


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 WHA-200


OPESCOPE PLENO
When assuring operating safety

Chapter 2 Configuration of the


System

Chapter 3 Basic Operation

When using the system


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-22 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Contents

Contents
Introduction
Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-2
Using the System Safely... . . . . . . . . . . . . . . . . . . . . . Introduction-4
Warning Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-17
Guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-19
Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-19
Exclusion of Liability . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-20
Safeguarding Data . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-20
Action for Environment (WEEE)
To all user of Shimadzu equipment in the European Union:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-21
Language of Approved Version . . . . . . . . . . . . . . . . . Introduction-21
Software Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction-21
Organization of This Manual and How to Use It . . . . Introduction-22

Chapter 1 Overview of the WHA-200 OPESCOPE PLENO


1.1 Outline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.1.1 About the WHA-200 OPESCOPE PLENO . . . . . . . . . . 1-3
1.2 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.3 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.3.1 Conditions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.3.2 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.4 Classification of Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.4.1 Classification according to the Type for Protection against
Electric Shocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.4.2 Classification according to the Degree of Protection against
Electric Shocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.4.3 Classification according to the Degree of Protection against
the Harmful Entry of Water . . . . . . . . . . . . . . . . . . . . . . 1-9

WHA-200 OPESCOPE PLENO OPERATION MANUAL i


Contents

1.4.4 Classification according to the Degree of Safety when Used


in an Environment Containing Air/Combustible Anesthetic
Gas or Oxygen/Nitrous Oxide / Combustible Anesthetic Gas
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
1.4.5 Classification according to Operation Mode . . . . . . . . . 1-9
1.5 Symbols and Manufacturer’s Nameplate . . . . . . . . . . . . 1-10
1.5.1 Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
1.5.2 Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1.6 Operator Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Chapter 2 Configuration of the System


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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
2.2.1 Function of Each Switch . . . . . . . . . . . . . . . . . . . . . . . . 2-9
2.2.2 LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.3 Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.3.1 C-arm Lock Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.3.2 Control Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Chapter 3 Basic Operation


3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.2.1 Moving the C-arm Cart . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.2.2 Moving the Monitor Cart . . . . . . . . . . . . . . . . . . . . . . . . 3-8
3.3 Connecting and Dismantling the System . . . . . . . . . . . . . 3-9
3.3.1 System Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
3.3.2 Disconnection Procedure . . . . . . . . . . . . . . . . . . . . . . 3-11
3.4 Turn the Power ON / OFF . . . . . . . . . . . . . . . . . . . . . . . . 3-12
3.4.1 Turning the Power ON . . . . . . . . . . . . . . . . . . . . . . . . 3-12
3.4.2 Turning the Power OFF . . . . . . . . . . . . . . . . . . . . . . . 3-18
3.4.3 How to Execute HDD Optimization (Defragmentation) 3-21

ii WHA-200 OPESCOPE PLENO OPERATION MANUAL


Contents

3.5 Positioning (How to Operate the C-arm) . . . . . . . . . . . . . . 3-24


3.5.1 C-arm Longitudinal Movement . . . . . . . . . . . . . . . . . . . 3-27
3.5.2 C-arm Forward/Back and Lateral Swiveling Movement 3-28
3.5.3 C-arm Slide Motion . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
3.5.4 C-arm Rotational Motion . . . . . . . . . . . . . . . . . . . . . . . 3-29
3.5.5 Lock Release Switches on the I.I. Handle . . . . . . . . . . 3-30
3.5.6 About the Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
3.6 Selecting the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
3.6.1 Selecting a Patient from the Patient List . . . . . . . . . . . 3-33
3.6.2 Registering the Patient Information and Making the Selection
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
3.6.3 Selecting Emergency Patient . . . . . . . . . . . . . . . . . . . . 3-38
• Correcting the Patient Information . . . . . . . . . . . . . . . . . . . . . 3-40
3.7 Selecting the APR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42
3.7.1 Selecting the APR . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42
• To Switch the APR Selection Screen . . . . . . . . . . . . . . . . . . 3-44
• To Change the Combination of Fluoroscopy APR and Acquisition
APR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45
3.8 Fluoroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48
• Changing the Fluoroscopy Conditions 1 (Fluoroscopy Program)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-52
• Changing the Fluoroscopy Conditions 2 (Fluoroscopy Mode) 3-54
• Changing the Fluoroscopy Conditions 3 (Pulse Rate) . . . . . . 3-55
3.9 Camera Rotation, Image Reverse, Collimator Operation . 3-57
3.9.1 Camera Rotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-57
3.9.2 Image Reverse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-59
3.9.3 Collimator Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 3-60
3.10 Digital Radiography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-62
• To Change the Radiography Program (Acquisition Program) 3-64
• To Change the Acquisition Rate . . . . . . . . . . . . . . . . . . . . . . 3-66
• To Change the Program Sequence . . . . . . . . . . . . . . . . . . . . 3-68
• Changing the Delay Time . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-70
3.11 Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-71
3.12 Film Radiography (General Radiography) . . . . . . . . . . . . 3-72
3.13 Useful Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-74
3.13.1 Memory Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-74
• To Differentiate the Use of Two Memory Switches . . . . . . . . 3-75
3.13.2 Image display on LCD Display function (Option) . . . . . 3-76

WHA-200 OPESCOPE PLENO OPERATION MANUAL iii


Contents

3.14 System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-77


3.14.1 Calibrating the Touch Panel . . . . . . . . . . . . . . . . . . . . 3-78
3.14.2 Sound Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-79
3.14.3 Fluoroscopy Timer Setting . . . . . . . . . . . . . . . . . . . . . 3-80
3.14.4 Setting Temp. Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-82
3.15 Ending the Examination . . . . . . . . . . . . . . . . . . . . . . . . . 3-83

Chapter 4 Image Processing


4.1 Adjusting Contrast and Brightness (Main Panel) . . . . . . . . 4-2
4.2 Display Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Chapter 5 Troubleshooting
5.1 Responding to Problems . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 Where Errors are Displayed . . . . . . . . . . . . . . . . . . . . . . . 5-4

Chapter 6 Maintenance and Inspections


6.1 Maintenance and Inspections . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2 Daily Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.3 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.4 Returning the System or System Component . . . . . . . . . . 6-7
6.5 Periodic Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.6 Regularly Replaced Components . . . . . . . . . . . . . . . . . . . 6-9

Chapter 7 Options
7.1 Cassette Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2 Hand Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.3 Laser Pointer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.4 Fitting and Removing the Sterilization Cover . . . . . . . . . . 7-8
7.4.1 When Using the Washable (Cloth) Type . . . . . . . . . . . . 7-9
7.4.2 When Using the Disposable Type . . . . . . . . . . . . . . . . 7-10
7.5 Touch Panel Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
7.6 Dose Area Product Display . . . . . . . . . . . . . . . . . . . . . . . 7-12

iv WHA-200 OPESCOPE PLENO OPERATION MANUAL


Contents

Chapter 8 Technical Data


8.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.2 Conditions for Installation and Use . . . . . . . . . . . . . . . . . . 8-11
8.3 Storage Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
8.4 KV-mA Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
8.5 Dose Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
8.5.1 Location of Significant Zone of Occupancy . . . . . . . . . 8-14
8.5.2 Test Report Stray Radiation for WHA-200 . . . . . . . . . . 8-18
8.6 EMC (Electro-Magnetic Compatibility) . . . . . . . . . . . . . . . 8-21
8.7 Statement of Compliance [For Europe] . . . . . . . . . . . . . . 8-26
8.7.1 Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . 8-26
8.7.2 Company's Quality System . . . . . . . . . . . . . . . . . . . . . 8-26
8.7.3 International Standards . . . . . . . . . . . . . . . . . . . . . . . . 8-26
8.8 Manufacturer Information . . . . . . . . . . . . . . . . . . . . . . . . . 8-27

Chapter 9 Appendix
9.1 Starting Inspection Checklist . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.2 Ending Inspection Checklist . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3 Monitor Brightness Adjustment, Contrast Adjustment . . . . 9-5
9.3.1 Brightness Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
9.3.2 Contrast Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7

WHA-200 OPESCOPE PLENO OPERATION MANUAL v


Contents

NO TEXT

vi WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO 1

Chapter 2 Configuration of the System 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

WHA-200 OPESCOPE PLENO OPERATION MANUAL vii


NO TEXT

viii WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 1
Overview of the WHA-200
OPESCOPE PLENO

This chapter gives an overview of the WHA-200 OPESCOPE PLENO


and describes its characteristics and the environmental conditions in
which it should be used.
Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

1.1 Outline

♦ Medical purpose
This equipment is a mobile system that aims to make shape and properties in the
inside of the body visible by using X-rays, and to offer the image information for
the X-ray diagnosis.
This system aims at the fluoroscopy. It is a system that offers the human body image
information for the diagnosis and treatment by using a fluorescent action and the
photograph action of X-rays.
This equipment is a mobile imaging system for X-ray fluoroscopy and radiography
to be used during surgery as well as in X-ray examination rooms.

NOTE

Please attach “Extension kit for source-skin distance” option when the system
is used for an application other than surgical purposes.

♦ Operating principle
This equipment irradiates X-rays from an X-ray tube assembly. The X-ray
absorption data after the human body is penetrated is converted into light with X-ray
Image Intensifier device. The X-ray absorption data converted into light is input to
the TV device, and a plane-image of the human body is obtained. The image is
displayed in the monitor, and the image data is recorded in the device of the Image
processing section (option). Cassette-holder (option) takes a general radiography.

1-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


1.1 Outline

1.1.1 About the WHA-200 OPESCOPE PLENO

For details on the function of each part, see Chapter 2 “Configuration of the
System”. 1

X-ray I.I. unit

Live monitor Reference monitor

C-arm

I.I. handle

X-ray tube assembly

Monitor cart

C-arm cart

Fig. 1.1 System overall

WHA-200 OPESCOPE PLENO OPERATION MANUAL 1-3


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

1.2 Features
This unit incorporates the following support features to allow smooth fluoroscopy
and radiography while ensuring the functionality and safety required in operating
theaters and E.R. facilities.

♦ 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 High Quality mode in pulse fluoroscopy, you can obtain
high-quality images at the standard continuous fluoroscopy dose. The 18 inch
(19 inch) liquid crystal monitor gives a large visual field for convenient
viewing.

♦ Dose Reduction
Term 1. A “last image hold” (LIH) function is provided for cases where fluoroscopy is
not necessary for confirmation.
Last image hold
(LIH) 2. The virtual rotation function and virtual collimator function allow you to
rotate, and perform virtual collimator operations on, the last image hold (LIH)
The last X-ray
image is displayed image.
on the monitor. 3. Pulse fluoroscopy generates reduced radiation since the X-rays are emitted in
pulse form. You can obtain high-resolution images in pulse fluoroscopy at the
maximum frame rate (15 fps).

1-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


1.2 Features

♦ Speedy
1. The C-arm is a manually-operated, balanced type and the brake is an
electromagnetic locking type.
2. The freedom of motion makes it easy to position the system for work on any
limb or on the spinal cord, which helps to reduce both the positioning time and 1
the time required for surgery.
3. There is a C-arm lock switch located on the I.I. handle. This allows the
physician to release the lock quickly.
4. The “touch panel” format is adopted for the monitors and the main panel.
An intuitive and easy to understand GUI is used. To operate it all you have to
do is directly press the buttons that appear on the screen. (Note that the touch
panel for the monitor is an option.)

7.5 “Touch Panel Monitor” (page 7-11)

5. From the main panel, you can perform operations such as post-processing and
image transmission. You can perform almost all operations during
examinations from the C-arm.
6. By using APRs (anatomical programs), you can call up the optimum
fluoroscopy and radiography conditions for each part of the body in a
one-touch operation.

♦ Compact and light


1. Because the system 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 system to be used safely.
2. The design is rounded and simple. Care work such as cleaning and disinfection
can be done easily, ensuring continued hygiene.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 1-5


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

1.3 Environmental Conditions

1.3.1 Conditions of Use

In order that the system can achieve its intended performance, it must be used under
the stipulated conditions.

♦ Environmental conditions
Use the system in an environment with the following conditions.

CAUTION

Even when the following conditions are met, make sure that there
are no sudden changes in temperature or humidity. This leads to
condensation, which can cause trouble.

Condition Stipulation

Temperature +10°C to +35°C

Relative humidity 30% to 85% (no condensation)

Atmospheric pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar)

Atmospheric conditions The atmosphere must be free of explosive and corrosive gases.

Visibility conditions 150 lx to 500 lx (no direct sunlight)

♦ Power supply
The power supply must have the following characteristics.

Phases Voltage Capacity Frequency

3.5 kVA or
Single phase 100, 110, 120, 200, 220, 230, 240 VAC 50/60 Hz
greater

Set one of the voltages listed above at installation.

1-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


1.3 Environmental Conditions

WARNING

Do not use a power supply that does not conform to the above
requirements.
1
Using a power supply that does not conform to these requirements can
cause serious accidents involving fire, generation of smoke, and
explosion.

♦ Grounding requirements
Grounding resistance less than 100 ohm

CAUTION

Use a leak current breaker that is suitable for the inverter system.

1.3.2 Storage

CAUTION

Even when the following conditions are met, make sure that there
are no sudden changes in temperature or humidity. This leads to
condensation, which can cause trouble.

Condition Stipulation

Temperature +10°C to +40°C

Relative humidity 30% to 85% (no condensation)

Atmospheric pressure 700 hPa to 1060 hPa (700 mbar to 1060 mbar)

Atmospheric conditions The atmosphere must be free of explosive and corrosive gases.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 1-7


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

1.4 Classification of Devices

1.4.1 Classification according to the Type for Protection against


Electric Shocks

Class I devices

NOTE

Class I devices are those that depend solely on basic insulation for protection
against electric shocks; in order to ensure that metal parts that could come into
contact if this basic insulation failed do not become live, a means for
connecting the device to the earth conductor in the fixed wiring of the
equipment is provided as an additional safety measure. (International
standard IEC60601-1: 1988, AMENDMENT 1: 1991, AMENDMENT 2: 1995)

1.4.2 Classification according to the Degree of Protection against


Electric Shocks

Type B devices

NOTE

Type B devices are devices that provide a particular level of protection against
electric shock, and this applies especially to the reliability of the allowable
leakage current and protective ground connections. (International standard
IEC60601-1: 1988, AMENDMENT 1: 1991, AMENDMENT 2: 1995)

1-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


1.4 Classification of Devices

1.4.3 Classification according to the Degree of Protection against


the Harmful Entry of Water

Normal devices 1

CAUTION

Use the system in a location where there is no danger of water


entry.
If water does enter inside the system there will be an electric shock
danger. Do not allow water to get onto the surface of the system or get
inside it. If water does get onto the system, turn the power OFF
immediately and contact our service agent.

1.4.4 Classification according to the Degree of Safety when Used


in an Environment Containing Air/Combustible Anesthetic
Gas or Oxygen/Nitrous Oxide / Combustible Anesthetic Gas

Devices unsuitable for use in an environment containing air/combustible anesthetic


gas or oxygen/nitrous oxide / combustible anesthetic gas

WARNING

Use in an environment containing combustible anesthetic gas


carries the risk of explosion.

1.4.5 Classification according to Operation Mode

Continuous operation with intermittent load


(Continuous operation depends on the specification of X-ray tube assembly.)

WHA-200 OPESCOPE PLENO OPERATION MANUAL 1-9


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

1.5 Symbols and Manufacturer’s Nameplate

1.5.1 Symbol

The symbols used with the system are indicated below.

Symbol Location Meaning

Nameplate affixed to the cover AC current

Power supply cable protective


Protective ground
ground unit inside the device

Safety classification:
Nameplate affixed to the cover
Type B device

Warning / Caution label Instruction manual reference

Potential equalization
Potential equalization conductor
conductor

1-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


1.5 Symbols and Manufacturer’s Nameplate

1.5.2 Labeling

♦ Manufacturer’s Nameplate
Manufacturer’s nameplates are affixed at the locations indicated below. 1
(2)

(1)

(3)

Fig. 1.2 Position of Labeling

WHA-200 OPESCOPE PLENO OPERATION MANUAL 1-11


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

(1)

(2)

(3)

Fig. 1.3 Manufacturer’s nameplate

1-12 WHA-200 OPESCOPE PLENO OPERATION MANUAL


1.5 Symbols and Manufacturer’s Nameplate

♦ Others
Certificated labels for Europe are affixed at the location (1) shown in Fig1.2.
• TUV approval label

• CE mark

• Company label

• WEEE label

Fig. 1.4 Certificated labels for Europe

♦ Package for transport


Label that is described about storage environment and transport environment on
package for transport is shown.

Fig. 1.5 Label on package for transport

WHA-200 OPESCOPE PLENO OPERATION MANUAL 1-13


Chapter 1 Overview of the WHA-200 OPESCOPE PLENO

1.6 Operator Profile

Item Details

The lower age of the operator is an age in which the


Age qualification described to the level of education/business can
be acquired.

Sex No limitation

Nationality No limitation

The operator should receive the education related to the


(X-ray) medical treatment. (Have the qualification of medical
Level of education/
when the qualification is necessary in each country.)
business
The operator should understand description matter of the label
and the manual.

The operator should receive the education related to the


(X-ray) medical treatment. (Have the qualification of medical
when the qualification is necessary in each country.)
Experience/knowledge The operator should understand description matter of the label
and the manual.
The operator should receive the education of operating the
system before using the system first.

Can read and understand English.


Language
The operator should understand description matter of the label
understanding
and the manual.

The operator should receive the education related to the


(X-ray) medical treatment. (Have the qualification of medical
when the qualification is necessary in each country.)
Experience The operator should understand description matter of the label
and the manual.
The operator should receive the education of operating the
system before using the system first.

Corrected visibility is 0.7 or more in the decimal number.


There is no obstacle in the operation and mobile of the system,
Level of disability
even if limbs or the body executive of the operator has the
trouble.

Over 140 cm tall.


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

1-14 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 2
Configuration of the
System

This chapter explains the configuration of the system.


Chapter 2 Configuration of the System

2.1 Standard Configuration


The two major components of the system are the C-arm cart and the monitor cart.

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 system.

(1) I.I. handle

(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 (part revealed by opening the connector cover)

(11) Foot switch

Fig. 2.1 C-arm cart

2-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.1 Standard Configuration

(1) I.I. handle


This is a handle used by the surgeon to operate the system.
The handle is provided with a switch for unlocking the C-arm.

For details, see 3.5.5 “Lock Release Switches on the I.I. Handle” (page 3-30).

(2) X-ray I.I. unit


This is the abbreviation for the X-ray image intensifier.
2
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, collimator operation and memory switches.

Fig. 2.2 Side panel

For details, see 2.3 “Side Panel” (page 2-14).

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-3


Chapter 2 Configuration of the System

(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 2-9).

(8) Maneuvering handles


Used to move the C-arm.

For details, see 3.2.1 “Moving the C-arm Cart” (page 3-3).

2-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.1 Standard Configuration

(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 3-3).

(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 3-12).

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-5


Chapter 2 Configuration of the System

(11) Foot switch


Left foot switch: Continuous fluoroscopy, pulse fluoroscopy, map
Right foot switch: Radiography, map image acquisition

Right foot switch


Left foot switch (For taking radiographs)
(For continuous fluoroscopy,
pulse fluoroscopy)

Fig. 2.6 Foot switch

2-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.1 Standard Configuration

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 WHA-200 system.

(1) Live monitor (2) Reference monitor (6) Irradiation indicator

(3) Handle for adjusting


monitor position
(7) Auxiliary stopper

(4) Keyboard shelf

(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 system 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.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-7


Chapter 2 Configuration of the System

(1) Live monitor


Shows the fluoroscopic image during fluoroscopy, radiography images, and last
image hold (LIH) images, review images.

(2) Reference monitor


Displays reference images.
Allows you to register patient information and make various settings for
examinations (fluoroscopy, radiography), post-processing and so on.
In addition to operations with the mouse and keyboard, you can also perform
operations on a touch panel (optional).

(3) Handle for adjusting monitor position


Grasp this handle and move it upward or downward to adjust the monitor position.

(4) Keyboard shelf


Accommodates the keyboard, mouse, etc.

(5) System switch


Turns the power ON.

For details, see 3.4 “Turn the Power ON / OFF” (page 3-12).

(6) Irradiation indicator


The indicator is lit during X-ray radiation.

(7) Auxiliary stopper


Fixes the position of the monitor in the vertical direction. To adjust this position,
first loosen the auxiliary stopper.

(8) Power switch


Close and open power supply circuit.
Term
Last image hold For details, see 3.4 “Turn the Power ON / OFF” (page 3-12).
(LIH)
The last X-ray image
is displayed on the
monitor.

2-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.2 Main Panel

2.2 Main Panel

2.2.1 Function of Each Switch

5
1 9 2
6
2 10
7
8

11
4

Fig. 2.8 Main panel

Reference
No. Switch Name Function
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
1 restriction on X-ray 3-49
switch.
exposure switch
X-rays can be radiated only when the
switch is lit.

X-ray exposure Press this switch to start X-ray


2 (fluoroscopy) fluoroscopy. 3-50
switch X-rays will be radiated.

Fluoroscopy timer
3 Stops the fluoroscopy timer alarm tone 3-51
alarm reset switch

Image display
Used to switch the content of the LCD
4 switching switch 3-76
display (image / operation screen).
(option)

Automatically adjusts the contrast and


Window/Level
brightness of the radiography image.
5 automatic 4-2
(This function can work for the image
adjustment switch
acquired with AIO ON. )

Window adjustment
6 Adjusts the contrast of the image. 4-2
switch

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-9


Chapter 2 Configuration of the System

Reference
No. Switch Name Function
page

Level adjustment
7 Adjusts the brightness of the image. 4-2
switch

Edge adjustment
8 Adjusts the edge of the image. 4-2
switch

End examination
9 Press this switch to end an examination. 3-83
switch

Used to display the system settings menu.


From here you can calibrate the touch
10 Menu switch panel, make sound settings, set the 3-77
fluoroscopy timer, and list the Temp.Data
(memory switch data).

Used in combination with the


Multipurpose [Multi-purpose switch mode switching]
11 4-6
switch button displayed on the image processing
dialog on the LCD.

2-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.2 Main Panel

2.2.2 LCD Display

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


on the display.
The buttons displayed differ according to the screen. The basic screen is shown
below.

3 4 5 6 7 8 2
9
1
2

18
14
10

11

12

13

15 16 17

No. Name Function

Fluoroscopy mode
1 Lit in the fluoroscopy mode.
display

IBS (image brightness Press this button to switch the IBS function (the image
2 stabilization function) brightness stabilization function) ON and OFF. The button is
switching button lit when the IBS function is ON.

Indicates the tube voltage. The setting range is 40 to 110 kV.


Press [+]/[−] to change the value manually. However, note
3 X-ray tube voltage display that you cannot change this setting when IBS (the image
brightness stabilization function) is ON (when the display is
highlighted).

In the fluoroscopy mode, the tube current is set automatically.


4 X-ray tube current display
This value cannot be changed manually.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-11


Chapter 2 Configuration of the System

No. Name Function

Displays the system status.

When fluoroscope radiography is possible:

5 System status indicator When X-rays are being radiated:

When the X-ray tube is in the


“high temperature” or “HU over” status:

In the fluoroscopy mode the cumulative fluoroscopy time is


6 Cumulative fluoroscopy time indicated here. When the time exceeds 99 minutes, 59
seconds, the indication switches to minute units.

Used to select the filter. Each time you press the button the
7 Filter switching button filter changes. The order of filter thicknesses is Filter 1 <
Filter 2 < Filter 3.

Press this button when you want to perform film radiography.


Film radiography mode The film radiography screen will be displayed.
8
button 3.12 “Film Radiography (General Radiography)” (page
3-72)

X-ray tube assembly temperature Indicates the temperature of the X-ray tube assembly. As the
9
display temperature increases, the bar in the display extends.

Displays the display mode dialog.


This menu allows you to select the type of display, display
10 Display mode button thumbnail images, perform zoom operations, invert the image
polarity, invert the image vertically, or “remask” the image.
4.2 “Display Mode” (page 4-3)

Press to send the image displayed on the live monitor to the


11 REF send button
reference monitor.

Fluoroscope image Saves the fluoroscopy image displayed on the live monitor
12
save button (including loops) on the hard disk.

Press to print out the image displayed on the live monitor at


13 Video printer button the video printer. (Displayed only when the specified printer
is connected.)

APR selection screen


14 Displays the APR selection screen.
display button

Press to select 16 cm (6 inches) or 23 cm (9 inches) as the I.I.


I.I. field size selection
15 field size.
button
Highlighted when the 16 cm (6 inch) field size is selected.

2-12 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.2 Main Panel

No. Name Function

Used to record a fluoroscopy image in the memory.


Fluoroscopy loop
16 (Maximum of 100 images before completion of fluoroscopy)
button
Highlighted when the fluoroscopy loop function is ON.

Turns the laser pointer ON and OFF. If the laser pointer


17 Laser pointer button option is not featured this button is not displayed.
7.3 “Laser Pointer” (page 7-6)

18 Dose area product display


Indicates the dose area product detected by a sensor. 2
7.6 “Dose Area Product Display” (page 7-12)

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-13


Chapter 2 Configuration of the System

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.

2
3
4

Fig. 2.9 C-arm lock switch

Reference
No. Switch Lock location Function
page

1 C-arm slide motion

2 C-arm rotary motion


Switch lit:
The C-arm is unlocked.
3-24
Switch unlit:
C-arm forward/back The C-arm is locked.
3 and lateral swiveling
movement

C-arm longitudinal
4
movement

2-14 WHA-200 OPESCOPE PLENO OPERATION MANUAL


2.3 Side Panel

2.3.2 Control Switch

1
2
3 4 5 6

7 8

Fig. 2.10 Control switch

Reference
No. Switch Name Function
page

1
Used to store the fluoroscopy conditions
Memory switch 3-74
and the collimator settings.
2

Octagonal collimator
3 Opens/closes the octagonal collimator.
open/close

3-60
Parallel collimator
4 Opens/closes the parallel collimator.
open/close

Parallel collimator
5 Rotates the parallel collimator.
rotation

WHA-200 OPESCOPE PLENO OPERATION MANUAL 2-15


Chapter 2 Configuration of the System

Octagonal collimator

Parallel collimator

Fig. 2.11 Octagonal collimator and parallel collimator

Reference
No. Switch Name Function
page

Holding this switch down while pressing


[parallel collimator rotation] or 3-57
6 Rapid feed
[camera rotation] speeds up the 3-60
rotation operations.

7 Camera rotation Used to rotate the camera. 3-57

Used to reverse the image displayed on


the monitor.
Note that you can only reverse the
Monitor image fluoroscopic image in live fluoroscopy
8 3-59
reverse and LIH fluoroscopic image.
The subsequent fluoroscopy has the
same orientation as the operations used
to control it.

2-16 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 3
Basic Operation

This chapter explains the basic procedure for using the system.
Chapter 3 Basic Operation

3.1 Introduction
This section describes the basic operation flow and provides references.

Transport [3.2] / Connection [3.3]

Turning the power ON [3.4.1]

Positioning (How to operate the C-arm) [3.5]

Selecting the patient data [3.6]

Selecting the APR [3.7]

Examination Fluoroscopy [3.8]

Digital radiography [3.10] Film radiography [3.11]

Turning the power OFF [3.4.2]

[ ] indicates the location of a reference.

3-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.2 Transport

3.2 Transport

3.2.1 Moving the C-arm Cart

WARNING

Take care to avoid impacts and overturning of the system.


The system weighs more than 200 kg.
Impacts and overturning will not only damage the system, but could
3
also cause serious injuries.
When moving the system, 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 system as gently as possible. Take particular care on steep
slopes.
• Always apply the brake when you stop moving the system.
• On slopes with an inclination of greater than 5°, the system could
overturn. Do not move or operate the system in places where the
gradient exceeds 5°.
• In places where moving the system 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 system, watch out for obstacles ahead.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-3


Chapter 3 Basic Operation

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 3.5.6 “About the Scales” (page 3-31).

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

3-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.2 Transport

3 Check that the cart cable is disconnected.

See 3.3 “Connecting and Dismantling the System” (page 3-9).

4 Depress the brake pedal on the side to release the brake.

Situation with the brake applied Situation with the brake released

Fig. 3.3 Brake pedal

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. 3.4 Maneuvering handles

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-5


Chapter 3 Basic Operation

♦ To move straight ahead

Fig. 3.5 Position of the right handle and direction of motion (straight ahead)

♦ To move diagonally

Fig. 3.6 Position of the right handle and direction of motion (a diagonal course)

♦ Parallel motion

Fig. 3.7 Position of the right handle and direction of motion (parallel)

3-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.2 Transport

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.

6 On completing the intended motion, depress the brake pedal to


to apply the brake. 3

Situation with the brake applied Situation with the brake released

Fig. 3.8 Brake pedal

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-7


Chapter 3 Basic Operation

3.2.2 Moving the Monitor Cart

1 Check that the main power cable, the additional protective earth
cable and the cart cable are correctly wound on the cable guides of
the monitor cart.

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

Situation with the brake applied Situation with the brake released

Fig. 3.9 Moving the monitor cart

Next, 3.3.1 “System Connections”

3-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.3 Connecting and Dismantling the System

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

Open the connector cover and turn


the lever to the “LOCK” position.
Connect the cart cable then close the
connector cover.

Fig. 3.10 Connecting the cart cable

2 Connect the C-arm cart’s potential equalization conductor.

WARNING

The potential equalization conductor is necessary to ensure the


safety of the patient and the operators.

Potential equalization
conductor

Fig. 3.11 Potential equalization conductor

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-9


Chapter 3 Basic Operation

3 Connect the monitor cart’s main power cable to the power outlet.

Additional protective earth cable

Cart cable Main power cable

Fig. 3.12 Connection of the additional protective earth cable and main power cable

CAUTION

Connect to a power outlet that has a ground terminal (3-pin).


If the power outlet’s ground is insufficient, use the additional protective
earth cable; you must make a good ground.

Next, 3.4.1 “Turning the Power ON”

3-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.3 Connecting and Dismantling the System

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, the
additional protective earth cable, and the cart cable. When the cart
cable is released, always the associated cart connector cover should
be mounted to protect the connector pin of that cable.

3
Open the connector
cover and turn the lever
to the “OPEN” position.
Remove the cart cable
and close the cover.

Cart connector cover

Fig. 3.13 Disconnecting the cart cable Fig. 3.14 Mounting cart connector cover

2 Wind the main power cable, additional protective earth cable, and
cart cable onto the cable guides of the monitor cart.

Cable guide

Fig. 3.15 Cable guide

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-11


Chapter 3 Basic Operation

3.4 Turn the Power ON / OFF


To ensure that no trouble occurs with the system 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. 3.16 Power switch

3-12 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.4 Turn the Power ON / OFF

2 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, camera rotation, etc. will continue for
about 30 seconds.
• Power is supplied to the getter (vacuum pump) of the X-ray I.I. unit for
Term
ten minutes.
X-ray I.I. unit
X-ray image
intensifier unit

System switch

Fig. 3.17 System switch

CAUTION

This system is equipped with the I.I. vacuum deterioration


prevention device that automatically activates for ten minutes
when the system has been started up.If any symptom (a spot in
the center of the image) resulting from I.I. vacuum deterioration,
follow the steps described below.
(1)Turn the power switch ON.
(2)Leave the system without X-ray radiation for ten minutes.You can
perform any operation other than X-ray radiation.
(3)When ten minutes have been elapsed, the vacuum deterioration
prevention device is automatically stopped. Use the system in the
usual manner.

CAUTION

When you turn the power OFF and back ON, leave an interval of at
least 10 seconds.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-13


Chapter 3 Basic Operation

CAUTION

After turning the power ON, do not open the connector cover on
the body of the C-arm. This will actuate the interlock function and
disable X-ray radiation.
• While the connector cover is open the message “You can’t take
exposures until closing connector cover.” will be displayed on the
C-arm's main panel: close the connector cover.
• After closing the connector cover, it may take some time to initialize
the camera and iris; message for the camera or iris may be
displayed. Displaying those messages does not mean that the
system is damaged. If a message such as “No camera detected!” is
displayed on the reference monitor, either click “OK” with the mouse
or depress the foot switch.

CAUTION

After switching the power ON, do not turn the lever of the cart
cable connector on the monitor cart in the OPEN direction. This
will shut off the power to the C-arm.
• To carry out normal operation, turn the power OFF (shut down) and then
back ON.

NOTE

The system switch lamp blinks for about 5 seconds after turning on the power
switch on the back side of the monitor cart. Even if you press the system
switch while the system switch is blinking, the system does not start. Wait until
the system switch lamp is stopped blinking and turned off.

NOTE

It takes a short while for the system to start up (before you can start an
examination).
Wait until the new examination standby screen is displayed.
However, in an emergency you can perform emergency fluoroscopy.

3-14 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.4 Turn the Power ON / OFF

Emergency fluoroscopy
The system can display the emergency fluoroscopy image after the system
turned on and the image process unit becomes ready for fluoroscopy before
selecting patient. Press [Releasing the restriction on X-ray exposure] and
depress the left foot switch to start fluoroscopy.

NOTE

The following restrictions apply to emergency fluoroscopy.


• Even if the message "Please wait a moment. Only Fluoroscopy is
available." is displayed on the main panel of the C-arm cart after the
3
system turned on, emergency fluoroscopy image can not be displayed until
when the image process unit becomes ready for emergency fluoroscopy.
Displaying image might be interrupted sometimes for a few seconds during
emergency fluoroscopy.
• The image process functions including adjusting brightness, contrast and
edge enhancement can not be performed in emergency fluoroscopy. And
continuous fluoroscopy is automatically selected, and pulse fluoroscopy
can not be selected in emergency fluoroscopy.
• As calibration for Camera iris is performed for about 1 minute after system
turned on, brightness of the image may be changed during emergency
fluoroscopy. Changing fluoroscopy tube voltage by manual is
recommended when the brightness is changed.
• The collimator movement and camera rotation are automatically performed
due to the calibration for about 30 seconds after the system turned on.
Adjusting collimator and camera rotation can not be performed until when
the calibration is finished.

For details on operations, see 3.9 “Camera Rotation, Image Reverse,


Collimator Operation” (page 3-57).

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-15


Chapter 3 Basic Operation

Currently only fluoroscopy is possible.

Fig. 3.18 Before starting up

When you start up the system, messages prompting you to record information about
the patient at the main panel will be displayed. (New examination standby screen)

New examination standby screen

Fig. 3.19 Starting up the main panel

3-16 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.4 Turn the Power ON / OFF

NOTE

• If fluoroscopy has been in progress before the new examination standby


screen is displayed, fluoroscopy stops momentarily when this screen is
displayed. You can restart fluoroscopy with the normal start operation.
• Fluoroscopy is possible even while the new examination standby screen is
displayed.

The patient list is displayed on the reference monitor.

Next, 3.5 “Positioning (How to Operate the C-arm)”


3

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-17


Chapter 3 Basic Operation

3.4.2 Turning the Power OFF

CAUTION

You must strictly follow the procedure below to turn the power
OFF.
Turn the power switch OFF on the back of the monitor cart or
disconnect the main power cable after the shutdown process is
completed. Otherwise, the system and data will be destroyed.
Also, if the power is turned OFF during transfer of image data to media
(CD-R/DVD-R), the image data will be lost.

1 Check that the C-arm is at its home position.


• The home position is the position where all scales register zero.

See 3.5.6 “About the Scales” (page 3-31).

Fig. 3.20 Home position of the C-arm

3-18 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.4 Turn the Power ON / OFF

2 Perform the shut-down operation at the reference monitor.

1. Press [function key ON/OFF] to display the function keys on


the monitor.

2. Press .
3. The patient file will close and a confirmation dialog asking if you want
to exit the application is displayed: select [Yes].
4. During the system shutdown sequence, the following dialog appears
asking whether to start the defragmentation tool.

Fig. 3.21 Start defragmentation tool dialog

• In case that you execute the defragmentation of the hard disc drive
Click [OK]. The defragmentation tool in Windows starts and the disk
defragmenter dialog (Fig. 3.24) appears. Refer to 3.4.3 “How to Execute
HDD Optimization (Defragmentation)” for executing the
defragmentation.
If you do not click [OK] within about 10 seconds after the dialog of Fig.
3.21 appears, the system automatically restarts to shut down.
• In case that you don't need the defragmentation (You need system
shutdown)
Click [Cancel]. The system automatically restarts to shut down.

3 Check that the green lamp on the system switch on the front of the
monitor cart goes out.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-19


Chapter 3 Basic Operation

4 Turn the power switch at the back of the monitor cart OFF.

Power switch

Fig. 3.22 Power switch

5 Disconnect the main power cable.

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.

3-20 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.4 Turn the Power ON / OFF

3.4.3 How to Execute HDD Optimization (Defragmentation)

Images and patient information are stored in the hard disk drive. The fragmentation
of the hard disk drive causes performance degradation. This section provides the
information how to optimize the HDD (defragmentation) using the HDD
defragmentation tool.

1 Click [OK] in the start defragmentation tool dialog that appears during
the system shutdown sequence.

Fig. 3.23 Start defragmentation tool dialog

• The disk defragmenter dialog (Fig. 3.24) appears.

2 Click [Defragment] in the disk defragmenter dialog.

• Defragmentation starts. If you want to shut down the system before


starting defragmentation, click at the upper right of the dialog.

Fig. 3.24 Disk defragmenter dialog (before defragmentation)

NOTE

If you click [Analyze], the system shutdown sequence automatically restarts


after the Analyze process. Click [Defragment] in order to execute the
defragmentation.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-21


Chapter 3 Basic Operation

• Click [Stop] when stopping the defragmentation. Click at the upper


right of the dialog when restarting the system shut down.

Fig. 3.25 Button of disk defragmenter dialog (during defragmentation)

• The following dialog is displayed for a few second after completion of


defragmentation. Then, after several seconds, the disk defragmenter
dialog automatically closes and the system automatically restarts to shut
down.

Fig. 3.26 Defragmentation complete dialog

CAUTION

Do not turn off the power switch on the back side of the monitor
cart, and Do not remove power cable plug from outlet during
defragmentation.
The system and data may be damaged. Moreover, system may fail to
start. Wait strictly until shut down completed.

One of the following procedures is required for restarting to shut down


in case that the disk defragmenter dialog (Fig. 3.24) appears once.
• Click at the upper right of the dialog in case that the [Defragment]
has not been clicked yet.
• Wait until completing defragmentation in case that [Defragment] has
been clicked.
• Stop the defragmentation by clicking [Stop] and then click at the
upper right of the dialog in case that it is impossible to wait until
completing defragmentation.

3-22 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.4 Turn the Power ON / OFF

NOTE

Perform defragmentation earlier case between the following cases.


• Once a month
• Once every 5000 images increase in HDD

NOTE 3
• Defragmentation may need several hours. Perform defragmentation when
the system is not scheduled for use.
• Defragmentation may need long hours when available disk space is low.
Delete unnecessary patient files and images. Available disk space of about
50% or more is recommended for system operations. The status dialog
displays the available disk space. Refer to "Status Dialog" in the section A
sub-section 1.6 in "M516-E013 WHA-200 PLENO Image Processing
Section Instruction Manual".

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-23


Chapter 3 Basic Operation

3.5 Positioning (How to Operate the C-arm)


Operate the C-arm to position it for the required fluoroscopy / radiography range.

WARNING

Be aware of the danger of being struck.


When you operate the C-arm, take care that the C-arm, the X-ray
generator at either end, and the X-ray I.I. unit do not strike the patient
or peripheral devices.
When the C-arm has been positioned, press the C-arm lock switch
to lock the C-arm.
If you do not lock the C-arm, the C-arm, the X-ray generator at either
end, or the X-ray I.I. unit may strike the patient or peripheral devices.

CAUTION

Be aware of the danger of being trapped.


Operate the C-arm by holding the handles. If you do not hold the
handles you could trap your fingers and sustain injuries.

I.I. handle

C-arm handle

Slide handle

Hazardous
locations

Fig. 3.27 Location where your fingers could get trapped

3-24 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.5 Positioning (How to Operate the C-arm)

CAUTION

Do not place peripheral devices or any other object within the


range of motion of the system.
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.

2146

880
660
450
1755

R55
0

775 1685

(Units: mm)

Fig. 3.28 Range of motion

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-25


Chapter 3 Basic Operation

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 and lateral
C-arm longitudinal
swiveling
movement
movement

Fig. 3.29 C-arm lock switch

2 Move the C-arm with its handles.

For details on operations, see 3.5.1 “C-arm Longitudinal Movement” (page


3-27) through to 3.5.4 “C-arm Rotational Motion” (page 3-29).

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, 3.6 “Selecting the Patient”

3-26 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.5 Positioning (How to Operate the C-arm)

3.5.1 C-arm Longitudinal Movement

Move the C-arm while holding the C-arm


handles or slide handles.

I.I. handle

450 mm
3

CAUTION Trapping

Fig. 3.30 C-arm longitudinal movement

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-27


Chapter 3 Basic Operation

3.5.2 C-arm Forward/Back and Lateral Swiveling Movement

Move the C-arm while holding the C-arm


handles or slide handles.

m m
200

I.I. handle

CAUTION Trapping

Move the C-arm while holding the C-arm


handles or slide handles.

I.I. handle

±12.5°

CAUTION Trapping

Fig. 3.31 C-arm forward/back and lateral swiveling movement

3-28 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.5 Positioning (How to Operate the C-arm)

3.5.3 C-arm Slide Motion

30°

Move the C-arm while holding the


C-arm handles.

CAUTION Trapping

90°

CAUTION Trapping CAUTION Trapping

Fig. 3.32 C-arm slide motion

3.5.4 C-arm Rotational Motion

120°

300°
Move the C-arm while holding the
C-arm handles.

CAUTION Trapping

Fig. 3.33 C-arm rotational motion

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-29


Chapter 3 Basic Operation

3.5.5 Lock Release Switches on the I.I. Handle

There are two lock release switches on the I.I. 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 the Shimadzu Service


Representative.

C-arm forward/back and lateral swiveling movement

C-arm longitudinal movement

Switch

Switch

Fig. 3.34 Release switches on the I.I. handle

3-30 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.5 Positioning (How to Operate the C-arm)

3.5.6 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. 3.35 Scale

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-31


Chapter 3 Basic Operation

3.6 Selecting the Patient


Select the patient before starting the examination. There are three ways to do this.

Operation Location

Selecting a Patient from the


For a registered patient Patient List Reference monitor
[3.6.1]

Registering the Patient


Information and Making the
Reference monitor
Selection
For a new patient [3.6.2]

Selecting Emergency Patient Reference monitor or main


[3.6.3] panel

• [ ] indicates the location of a reference.

3-32 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.6 Selecting the Patient

3.6.1 Selecting a Patient from the Patient List

If you are dealing with a patient who has already been registered, select the name
from the patient list.
This selection is only possible on the reference monitor.

For details, see Section B of the separate Image Processing Section


Instruction Manual.

If the patient list window is not displayed, click .

1 Select the patient name from the patient list window. 3


• The selected line is highlighted.

Patient list window

Fig. 3.36 Patient selection 1

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-33


Chapter 3 Basic Operation

2 Press [Open].
• The patient list window on the reference monitor will close and the APR
selection window will be displayed.
The patient’s name will be displayed on the live monitor.

Live monitor Reference monitor


(APR selection window)

Patient’s name

Fig. 3.37 Patient selection 2

Next, 3.7 “Selecting the APR”

NOTE

In the patient list dialog displayed at first after the system turned on, it takes
several seconds to be able to select buttons in the dialog.

3-34 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.6 Selecting the Patient

3.6.2 Registering the Patient Information and Making the Selection

When dealing with a new patient, register information about the patient to be
examined. This can only be done on the reference monitor.

For details, see Section B of the separate Image Processing Section


Instruction Manual.

If the patient list window is not displayed, click .

Patient list window (reference monitor)


3

Fig. 3.38

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-35


Chapter 3 Basic Operation

1 Press [New] in the patient list window.


• The patient information entry window will be displayed.

Patient list window

Fig. 3.39 Patient registration 1

2 Enter the patient information.


• Entry from the keyboard
• Use the mouse or the tab key to move among entry fields.

Patient lnformation window

Fig. 3.40 Patient registration 2

3-36 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.6 Selecting the Patient

NOTE

Enter all the patient information requested in boxes that are marked “*”.
You can change the asterisked patient information by making new settings.
Consult our service agent about this.

3 Press [Open].
• The patient list window on the reference monitor will close and the APR
selection window will be displayed. 3
The patient’s name will be displayed on the live monitor.

Fig. 3.41 Patient registration 3

[Close]: Closes the patient information entry window without saving the
registration information.

[Save]: Closes the patient information entry window and saves the
registration information. This information is added in the patient list
window.

The screen display at the main panel changes from the new examination
standby screen to the APR selection screen.

Next, 3.7 “Selecting the APR”

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-37


Chapter 3 Basic Operation

3.6.3 Selecting Emergency Patient

If the patient is a new one and there is no time to enter patient information, or there
is no patient information, the system sets a patient ID and patient name
automatically. You can do this either from the main panel or the reference monitor.

For operations on the reference monitor, see Section B of the separate Image
Processing Section Instruction Manual.

♦ Operation at the main panel

1 Press [Emergency Patient].


• The APR selection screen will be displayed.
• The patient ID and patient name are set automatically.

New examination standby screen

APR selection screen

Fig. 3.42 Registration of an emergency case (main panel)

3-38 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.6 Selecting the Patient

NOTE

After completing the examination, replace the provisional data (patient ID,
patient name, etc.) with the correct patient information.

Next, 3.7 “Selecting the APR”

♦ Operation at the reference monitor

1 Press [Emergency Study] in the patient list window.


3
Patient list window

Fig. 3.43 Registering an emergency case (reference monitor)

• The patient list window on the reference monitor will close and the APR
selection window will be displayed.
The patient’s name will be displayed on the live monitor.
• The patient ID and patient name are set automatically.

NOTE

After completing the examination, replace the provisional data (patient ID,
patient name, etc.) with the correct patient information.

Next, 3.7 “Selecting the APR”

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-39


Chapter 3 Basic Operation

Correcting the Patient Information

1 Display the patient list window on the reference monitor.

• If the patient list is not displayed, click .

2 Select the patient.


• The selected line is highlighted.

3 Press [Edit].
• The patient information editing window will be displayed.

Patient list window

Fig. 3.44 Patient information correction 1

3-40 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.6 Selecting the Patient

4 Enter the correct patient information and press [Save].


• The corrected information is saved.

For details, see Section B of the separate Image Processing Section


Instruction Manual.

Patient information editing window

Fig. 3.45 Patient information correction 2

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-41


Chapter 3 Basic Operation

3.7 Selecting the APR


The system parameters for fluoroscopy and radiography (acquisition) are already set
in the APR. By selecting an APR, the necessity for manual adjustment is cut to a
minimum.
You can select the APR at either the reference monitor or the main panel. However,
you can only register or edit an APR at the reference monitor: you cannot perform
these operations at the main panel.
The following is an explanation of the operation at the main panel.

For details on the operation at the reference monitor, see Section C of the
separate Image Processing Section Instruction Manual.

3.7.1 Selecting the APR

After you have registered a patient at the reference monitor, or on pressing [APR
selection screen display] on the main panel, the APR selection screen is displayed.

1 Check [APR].
• To change the APR, press the relevant [APR].
• The selected APR will be highlighted.

2 Press [OK].
• The basic screen will be displayed.

NOTE

Pressing [OK] on the APR selection screen sets the registered parameters for
the APR. The fluoroscopy conditions, acquisition conditions, image processing
conditions, and camera rotation and collimator adjustment statuses before
[OK] was pressed are updated.

3-42 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.7 Selecting the APR

APR selection screen

[APR]

3
[OK]

Displays the fluoroscopy APRs. Displays acquisition APRs.

Basic screen

[APR selection
screen display]

Fig. 3.46 Selecting an APR

Next, 3.8 “Fluoroscopy”

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-43


Chapter 3 Basic Operation

To Switch the APR Selection Screen

Six [APR] buttons are displayed simultaneously on the APR selection screen.
Press [Next] to go to the next page. You can set up to twelve APRs.

APR selection screen

[Next]

Fig. 3.47 Switching the APR selection screen

3-44 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.7 Selecting the APR

To Change the Combination of Fluoroscopy APR and Acquisition APR

1 Press [Fluoroscopy/acquisition APR display].


• The fluoroscopy/acquisition APR selection dialog is displayed.

APR selection screen

[Fluoroscopy/acquisition APR display]

Fluoroscopy/acquisition APR
selection dialog

Fig. 3.48 Changing the fluoroscopy/acquisition APR 1

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-45


Chapter 3 Basic Operation

2 Change the selection of the fluoroscopy APR and the acquisition


APR and press [Close].
• The APR selection screen will be redisplayed.
• The selected fluoroscopy APR and acquisition APR are indicated at
[Fluoroscopy/acquisition APR display].

[Close]

APR selection screen

Fig. 3.49 Changing the fluoroscopy/acquisition APR 2

3-46 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.7 Selecting the APR

3 Press [OK].
• The basic screen will be displayed.

APR selection screen

3
[OK]

Basic screen

Fig. 3.50 Changing the fluoroscopy/acquisition APR 3

NOTE

Neither fluoroscopy nor acquisition is possible while the APR selection screen
is displayed.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-47


Chapter 3 Basic Operation

3.8 Fluoroscopy

1 Check the fluoroscopy conditions.


• The fluoroscopy conditions are set automatically in accordance with the
selected APR.
• You can change these conditions manually.

“Changing the Fluoroscopy Conditions 1 (Fluoroscopy Program)” (page 3-52)


“Changing the Fluoroscopy Conditions 2 (Fluoroscopy Mode)” (page 3-54)
“Changing the Fluoroscopy Conditions 3 (Pulse Rate)” (page 3-55)

Basic screen

Tube voltage, filter, IBS, etc.

[Fluoroscopy program]

[Fluoroscopy mode]

[Fluoroscopy pulse rate]

[I.I. field size]

[Fluoroscopy loop]

Fig. 3.51 Checking the fluoroscopy conditions

3-48 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.8 Fluoroscopy

2 If [Releasing the restriction on X-ray exposure] is unlit, press the


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

[Releasing the
restriction on X-ray
exposure]

Fig. 3.52 [Release X-ray irradiation restriction] switch

CAUTION

If you leave the unit for any substantial time, press [Releasing the
restriction on X-ray exposure] to turn this lamp out in order to
prevent malfunction.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-49


Chapter 3 Basic Operation

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


• X-rays for fluoroscopy will be radiated.

• During the radiation of X-rays, (“X-rays being radiated”) is lit in the


main panel.
• While X-rays are being radiated, the irradiation indicator on the monitor
cart is lit. The fluoroscopic image is displayed on the live monitor.

When [X-ray exposure (fluoroscopy)] is pressed:


[X-ray exposure (fluoroscopy)] lights.
The fluoroscopy time is displayed.

Press

When the foot switch is depressed:

Depress

Fig. 3.53 Fluoroscopy 1

3-50 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.8 Fluoroscopy

NOTE

If the fluoroscopy timer preset time is exceeded, an alarm sounds. You can
continue fluoroscopy during the time that the alarm is sounding. However,
fluoroscopy can be continued for a maximum of ten minutes only; on
exceeding this limit X-ray radiation is automatically stopped.
• If you want to restart fluoroscopy, release the restriction by depressing the
left foot switch or releasing [X-ray exposure (fluoroscopy)] on the main
panel. After that, you will be able to start fluoroscopy again.
• You can stop the alarm sounding by pressing [Fluoroscopy timer alarm
reset]. 3

[Fluoroscopy timer
alarm reset]

Fig. 3.54 Fluoroscopy timer alarm reset switch

For details on setting the timer value, see 3.14.3 “Fluoroscopy Timer Setting”
(page 3-80).

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-51


Chapter 3 Basic Operation

Changing the Fluoroscopy Conditions 1 (Fluoroscopy Program)

NOTE

Changes made from the main panel are temporary, so the values after the
change are not saved.

1 Press [Fluoroscopy program].


• The fluoroscopy program selection dialog will be displayed.

Basic screen

[Fluoroscopy
program]

Fig. 3.55 Changing the fluoroscopy program 1

2 Select the fluoroscopy program.


• The select button is highlighted and the dialog closes.

Fluoroscopy program
selection dialog

[Next]

Fig. 3.56 Changing the fluoroscopy program 2

3-52 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.8 Fluoroscopy

[Next]: The fluoroscopy program selection dialog shows four fluoroscopy


programs on one page. Press [Next] to display the next page of the
fluoroscopy program selection dialog.

NOTE

If you do not wish to change the fluoroscopy program selection, perform either
of the operations described below to return to the basic screen without
changing the fluoroscopy program.


Press [Close].
Carry out fluoroscopy.
3

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-53


Chapter 3 Basic Operation

Changing the Fluoroscopy Conditions 2 (Fluoroscopy Mode)

NOTE

Changes made from the main panel are temporary, so the values after the
change are not saved.

1 Press [Fluoroscopy mode].


• The selected button will be highlighted.

[HQ]: HighQuality (high quality mode)


A high dose of X-rays is radiated to generate a high-quality image.
[N]: NORMAL (normal mode)
The standard X-ray dose is radiated.
[LD]: LowDose (low dose mode)
A low dose of X-rays is radiated, so the exposure is low.

Basic screen

[Fluoroscopy
mode]

Fig. 3.57 Changing the fluoroscopy mode

NOTE

If you select continuous fluoroscopy in the High Quality (high resolution)


mode, it will be at a high dose rate.

3-54 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.8 Fluoroscopy

Changing the Fluoroscopy Conditions 3 (Pulse Rate)

NOTE

Changes made from the main panel are temporary, so the values after the
change are not saved.

1 Press [Pulse rate].


3
• The pulse rate selection dialog will be displayed.

Basic screen

[Pulse rate]

Fig. 3.58 Changing the pulse rate 1

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-55


Chapter 3 Basic Operation

2 Select the fluoroscopy pulse rate.


• Select [CONTINUOUS] for continuous fluoroscopy.
If you select any other button, pulse fluoroscopy will be executed, and the
pulse rate will be changed to the selected value.
• If you do not wish to make a change, press [Close]. The button will be
highlighted and the dialog will close.

Pulse rate selection dialog

Fig. 3.59 Changing the pulse rate 2

NOTE

[1 fps] and [0.5 fps] fall into the “high pulse fluoroscopy” category. These are
distinct from the other selections.
You cannot switch between [CONTINUOUS]/[15 fps]/[7.5 fps]/[3.75 fps]/[2 fps]
and [1 fps]/[0.5 fps] while continuing fluoroscopy. You must stop fluoroscopy
before making this change.

NOTE

In high-pulse fluoroscopy ([1 fps] or [0.5 fps]), the maximum fluoroscopy tube
current is set at 16 mA regardless of the fluoroscopy mode. And the IBS
(image brightness stabilization) function is automatically switched OFF, so if
you want to adjust the tube voltage, do it manually.

3-56 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.9 Camera Rotation, Image Reverse, Collimator Operation

3.9 Camera Rotation, Image Reverse, Collimator


Operation
You can use the following functions during fluoroscopy and while the last image
hold (LIH) image is displayed.

3.9.3

3.9.1 3.9.2

3.9.1 Camera Rotation

Pressing the camera rotation switch causes the camera to rotate. Pressing this switch
while holding down the fast-forward switch causes the camera to rotate quickly.
The range of camera rotation is −170° to +170°.

Rotation during fluoroscopy


During fluoroscopy, the display of the subject rotates in accordance with the camera
rotation.

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.

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.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-57


Chapter 3 Basic Operation

NOTE

If you start fluoroscopy acquisition immediately after releasing the switch, the
subject may rotate while the camera is rotating.

NOTE

During virtual rotation operation, markings to indicate the ranges where


camera rotation is not possible above the circle blanking (−180° to −170° and
+170° to +180°) are shown. Camera operations are not possible at angles
where one of these markings is directly above (at the 12 o’clock position).

3-58 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.9 Camera Rotation, Image Reverse, Collimator Operation

3.9.2 Image Reverse

The image is 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 3
reversed, but the next image acquired
is reversed.

H reverse (horizontal reverse)

V reverse (vertical reverse)

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-59


Chapter 3 Basic Operation

3.9.3 Collimator Operation

You can open/close and rotate the octagonal collimator and parallel collimator.

Octagonal collimator open/close

Pressing the switch opens the octagonal collimator.

Pressing the switch closes the octagonal collimator.

Parallel collimator open/close

Pressing the switch opens the parallel collimator.

Pressing the switch closes the parallel collimator.

Parallel collimator rotation

Pressing the switch rotates the parallel collimator counter-clockwise.

Pressing the switch rotates the parallel collimator clockwise.


The parallel collimator can be rotated endlessly.

Fast-forward

Pressing or [Parallel collimator rotation] while holding down the


switch speeds up the rotation operation.

♦ Operations during fluoroscopy


During fluoroscopy, collimator adjustments and rotation follow the collimator
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
collimator are indicated by lines on the LIH image.
Hexagonal collimator: circular indication, Parallel collimator: two-line indication

3-60 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.9 Camera Rotation, Image Reverse, Collimator Operation

NOTE

If you start fluoroscopy acquisition immediately after releasing the switch,


collimator open/close operation or rotation may still be in progress.

Octagonal collimator

3
Parallel collimator

Fig. 3.60 Octagonal collimator and parallel collimator

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-61


Chapter 3 Basic Operation

3.10 Digital Radiography

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 Check the radiography conditions.

Basic screen

[Acquisition
program]

[Acquisition
rate]

[Acquisition
sequence
details]

[Number of
images that can
be acquired]

Fig. 3.61 Radiography screen display

NOTE

[Acquisition rate], [Acquisition sequence details], and [Number of images that


can be acquired] are only displayed when a technique that involves serial
radiography, such as “serial” or “DSA”, is selected.

3-62 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.10 Digital Radiography

2 Depress the left foot switch.


• X-rays will be radiated and the radiographic image will be displayed on
the live monitor.

Depress
3

Fig. 3.62 Taking the radiograph

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-63


Chapter 3 Basic Operation

To Change the Radiography Program (Acquisition Program)

NOTE

Changes made from the main panel are temporary, so the values after the
change are not saved.

1 Press [Acquisition program selection].


• The acquisition selection dialog is displayed.

Basic screen

[Acquisition
program
selection]

Fig. 3.63 Changing the acquisition program 1

3-64 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.10 Digital Radiography

2 Select the acquisition program.


• The button is highlighted and the dialog closes.

Acquisition
program
selection dialog

3
[Next]

Fig. 3.64 Changing the acquisition program 2

[Next]: The acquisition program selection dialog shows four acquisition


programs on one page. Press [Next] to display the next page of the
acquisition program selection dialog.

NOTE

If you do not wish to change the acquisition program selection, perform either
of the operations described below to return to the basic screen without
changing the acquisition program.
• Press [Close].
• Start acquisition.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-65


Chapter 3 Basic Operation

To Change the Acquisition Rate

1 Press [Acquisition rate].


• The acquisition rate selection dialog is displayed.

Basic screen

[Acquisition
rate]

Fig. 3.65 Changing the acquisition rate 1

NOTE

[Acquisition rate] is only displayed when a technique involving continuous


radiography, such as “serial” or “DSA”, is used.

NOTE

If a program sequence has an acquisition rate that exceeds 5 fps, it falls into
the high-speed mode so the tube voltage may increase and the image quality
may change.

3-66 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.10 Digital Radiography

2 Select the acquisition rate.


• The button is highlighted and the acquisition rate selection dialog closes.
• If you do not wish to change the acquisition rate, press [Close].

Acquisition rate
selection
dialog
3

Fig. 3.66 Changing the acquisition rate 2

Note that if any program sequence (page 3-68) has not already been set on
the reference monitor, [SEQUENCE] is not displayed, as shown below.

For details on program sequences, see Section C “4. Program Sequence” of


the separate Image Processing Section Instruction Manual.

Fig. 3.67 Changing the acquisition rate 3

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-67


Chapter 3 Basic Operation

To Change the Program Sequence

Press [SEQUENCE] in the acquisition rate selection dialog and make the selection.
You must set the program sequence at the reference monitor in advance. If no
sequence is set, [details] is not displayed.

For details on program sequences, see Section C “4. Program Sequence” of


the separate Image Processing Section Instruction Manual.

1 Press [details].
• The program sequence selection dialog is displayed.

Basic screen

[Acquisition
sequence
details]

Fig. 3.68 Changing the program sequence 1

2 Press [ ]/[ ] to select the program sequence.


• The selected program sequence is displayed.

Program
sequence
selection dialog

Fig. 3.69 Changing the program sequence 2

3-68 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.10 Digital Radiography

3 Press [Close].
• The program sequence selection dialog is closed.

♦ Program sequence details screen

Name of the
selected
program
sequence
3
The acquisition
rate and time
are displayed.

Fig. 3.70 Program sequence details screen

The program sequence details screen displays details of the selected program
sequence. It shows the five registered levels of acquisition rate and the time.

NOTE

If X ray generation will become impossible part way through the program
sequence due to the HU calculations, the affected level is indicated in red.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-69


Chapter 3 Basic Operation

Changing the Delay Time

♦ In case of a program sequence


The setting can only be changed on the reference monitor. Set a time of 0 fps within
the program sequence.

♦ In case of fixed acquisition rate

1 Press [details].
• The delay time setting dialog is displayed.

2 Press [+]/[−] to set the delay time.

3 Press [Close].
• The delay time setting dialog closes.

Delay time setting


dialog

Fig. 3.71 Delay time setting dialog

3-70 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.11 Map

3.11 Map
1 Select the map technique for the acquisition program.

2 Depress the left foot switch to start fluoroscopy, and carry out
positioning.

3 Depress the right foot switch to acquire a map image.

4 Depressing the left foot switch at this point will display a subtraction 3
image generated from the map image and fluoroscopy image.

NOTE

To acquire a new map image, depress the right foot switch.

NOTE

If you select a technique other than “map” (e.g. SPOT, SERIAL, or DSA) for
the acquisition program, the left foot switch will reassume its role in normal
fluoroscopy.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-71


Chapter 3 Basic Operation

3.12 Film Radiography (General Radiography)


1 Mount the cassette holder.

For details, see 7.1 “Cassette Holder” (page 7-2).

2 Press [Film radiography mode].


• The button lights.

Basic screen

[Film
radiography
mode]

Fig. 3.72 Film radiography 1

3 Press [+]/[-] to adjust the tube voltage (kV) value and the tube current
time product (mAs) value.

Basic screen

Fig. 3.73 Film radiography 2

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3.12 Film Radiography (General Radiography)

4 Depress the right foot switch. Alternatively, press the hand switch
(option) to the first level.

Foot Switch Hand switch (option)

Depress
3

Fig. 3.74 Film radiography 3

5 Continue to depress the right foot switch, or press the hand switch to
the second level.
• X-rays will be radiated. During radiation the irradiation indicator (on the
monitor cart) is lit.

NOTE

Keep depressing the foot switch or holding down the hand switch until X-ray
radiation is completed. If you release it part way through X-ray radiation will
terminate prematurely.

6 Press [Film radiography mode].


• The button goes out and radiography ends. The basic screen is
redisplayed.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-73


Chapter 3 Basic Operation

3.13 Useful Functions


3.13.1 Memory Switch

Store the rotational position of the camera, the collimator position, the loading
factor and other information.

NOTE

• This operation is not possible during fluoroscopy.


• You cannot do this when [X-ray exposure (fluoroscopy)] is pressed.
• The information stored with this function is reset when the power is turned
OFF.

The following conditions can be stored.


• Rotational position of the camera
• Open/close position and rotational angle of the collimators
• Image reverse
• Filter
• I.I. field size

[Memory switch A] [Memory switch B]

Fig. 3.75 Memory switch

1 Hold down [Memory switch] (for about 1 second).


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

3-74 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.13 Useful Functions

NOTE

If any condition such as the rotational position of the camera is changed from
the stored condition in memory switch, the memory switch starts blinking.

2 Press the blinking [Memory switch], briefly.


• The conditions stored in the memory switch will be called up.
At the same time, the switch will change from blinking to continuously
lit. 3
To Differentiate the Use of Two Memory Switches

Lit
1 Hold down for about 1 second.
• The current conditions will be stored in memory switch A.
When storing is completed the switch lights.

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


• Memory switch A will blink.

3 Briefly hold down ,for about 1second.


Lit • The changed conditions are stored in memory switch B.
When storing is completed the switch lights.
• Switch A goes off.

Lit 4 Press ,briefly.


• Switch A will light, and the system will return to the conditions stored in
memory switch A.
• Switch B will go off.
Lit

5 Press ,briefly.
• Switch B will light, and the system will adopt the conditions stored in
memory switch B.
• Switch A goes off.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-75


Chapter 3 Basic Operation

3.13.2 Image display on LCD Display function (Option)

By pressing [Image display], you can switch to image display function on the LCD
display.

Basic screen

[Image display]

Image display

Fig. 3.76 Switching 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
on the LCD display.
• Lines of virtual collimation
• Annotation

3-76 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.14 System Settings

3.14 System Settings


You can calibrate the touch panel, set sounds, set the fluoroscopy timer, and list and
check the settings stored in the memory switches.

NOTE

• Check that [Releasing the restriction exposure] is OFF before you perform
this operation.
• The changes you make to the unit settings remain effective even if you
restart (they are not reset by turning the power OFF). 3
1 Press [Menu].
• The system setting menu screen is displayed.

Basic screen

[Menu]
System setting menu screen

Fig. 3.77 Setting menu screen

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-77


Chapter 3 Basic Operation

3.14.1 Calibrating the Touch Panel

1 Press [Touch Panel].


• The touch panel calibration screen is displayed.

Fig. 3.78 Touch panel calibration 1

2 Carry out operation by following the screen display.

• Press [Menu] while pressing the cross


symbol displayed at the upper left of Push Menu key with pressing the cross marker
the LCD panel. at the upper left corner.

• Press [Menu] while pressing the cross


symbol displayed at the lower right of Push Menu key with pressing the cross marker
the LCD panel. at the lower right corner.

• On completion of calibration the display returns to the setting menu


screen.

To exit the setting menu screen press [Close].

NOTE

If touch panel operations become unavailable, hold [Menu] down for 2 to 3


seconds.
The touch panel calibration screen will be displayed, allowing calibration.

3-78 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.14 System Settings

3.14.2 Sound Setting

1 Press [Sound].
• The sound setting screen is displayed.

Fig. 3.79 Sound setting 1

2 Press [Change] and set the various warning and operation tones.
• To actually hear sound, press [Test].
• Set the volume by pressing [+]/[−].

Fig. 3.80 Sound setting 2

3 To exit the sound setting screen, press [Menu].


• The display returns to the setting menu screen.

To exit the setting screen menu press [Close].

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-79


Chapter 3 Basic Operation

3.14.3 Fluoroscopy Timer Setting

This setting allows you to set the fluoroscopy timer.

1 Press [Fluo Timer Preset].


• The fluoroscopy timer setting screen is displayed.

Fig. 3.81 Fluoroscopy timer setting 1

2 Press [+]/[−] to set the time for the fluoroscopy preset timer time.
• You can make changes in 30-second increments.
• The maximum setting is 4 minutes, 30 seconds.

Fig. 3.82 Fluoroscopy timer setting 2

3-80 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.14 System Settings

If you set “0” for the fluoroscopy preset timer, the screen shown below is
displayed.

3
Fig. 3.83

3 To exit the fluoroscopy timer setting screen, press [Menu].


• The display returns to the setting menu screen.

To exit the setting menu screen press [Close].

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-81


Chapter 3 Basic Operation

3.14.4 Setting Temp. Data

You can view a list of the values stored in memory switches A and B, and the
loading factor and image processing conditions when stored in memory switch.
You can refer to the setting parameters when editing an APR on the reference
monitor.

Details on APR editing are given in the separate Image Processing Section
Instruction Manual.

1 Press [Temp. Data].


• The list screen is displayed.
• A list of the values recorded for memory switches A and B is displayed.

Fig. 3.84 Temp.Data1

2 To exit the list screen, press [Menu].


• The display returns to the setting menu screen.

To exit the setting menu screen press [Close].

3-82 WHA-200 OPESCOPE PLENO OPERATION MANUAL


3.15 Ending the Examination

3.15 Ending the Examination

CAUTION

Do not switch the power OFF during transmission of image data.


If the power goes off during transfer of image data to media (CD-R/
DVD-R), the image data is lost.

3
1 Release your foot from the foot switch.

2 Press [End examination] for about 1 second.


• The end confirmation screen is displayed.

[End
examination]

Fig. 3.85 End examination switch

3 Press [OK].
• The examination ends and the new examination standby screen is
displayed.

[Cancel]: Press to return to the initial screen.

You can also end examinations from the monitor cart (reference monitor).

For details, see Section B of the separate Image Processing Section


Instruction Manual.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 3-83


Chapter 3 Basic Operation

NO TEXT

3-84 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 4
Image Processing

This chapter explains how to perform image processing from the main
panel.
Chapter 4 Image Processing

4.1 Adjusting Contrast and Brightness


(Main Panel)

3
4

Fig. 4.1 Adjusting contrast and brightness

1. Window/Level automatic adjustment switch


Switches the contrast and brightness of the radiography image automatically
and manually. When the switch is turned automatically, the switch is lit ON.
When adjusting manually with Window/Level adjustment switch, light off the
switch prior to adjusting manually.
(The automatic adjustment is valid for the radiography image taken with the
AIO function ON. For details, see the separate Image Processing
Section Instruction Manual.)

2. Window adjustment switch


Adjusts the contrast of the image manually.

3. Level adjustment switch


Adjusts the image brightness manually.

4. Edge adjustment switch


Adjusts the edge of the image.

NOTE

All the above operations can only be performed on the image displayed on the
live monitor.

4-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


4.2 Display Mode

4.2 Display Mode


Pressing [Disp. mode] on the basic operation screen displays the display mode
processing dialog.

Basic screen

[Disp. mode]

Display mode dialog

8
1

2
10

3 7 4 5 6

Fig. 4.2 Display mode dialog

WHA-200 OPESCOPE PLENO OPERATION MANUAL 4-3


Chapter 4 Image Processing

1. [Display type selection]


Press this button to select the method for displaying the acquired images.
• [Live] This is the image without subtraction.
• [Sub] This is the image after subtraction.
• [RSM sub] This is the image after RSM-DSA processing.
• [Sub BM] This is a subtraction image generated by using a mask
created in the same way as RSM-DSA.

NOTE

When you press [Sub] or [Sub BM], subtraction processing is performed with
the image displayed on the live monitor as the mask.

2. [Thumbnail]
Press this button to switch multi image display ON and OFF on the reference
monitor.

Fig. 4.3 Thumbnail

4-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


4.2 Display Mode

At the main panel, the screen changes as shown below.


[Seq]: Displays the representative frame in the sequence.
[Frame]: Displays the selected sequence in frames.

Fig. 4.4 Display mode dialog


4
• To end thumbnail display, press .
• To close the display mode screen, press [Close].
3. [Zoom]
Press this button to switch the zoom (2×) feature ON and OFF.
When [Zoom] is selected, [Multi-purpose switch mode switching] is
automatically set in the zoom panning mode.
Pressing [Multi-purpose switch] will cause the image to move up and down
and to the right and left.

“[Multi-purpose switch mode switching]” (page 4-6)

4. [Image polarity inverse]


Press this button to switch inversion of image polarity ON and OFF.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 4-5


Chapter 4 Image Processing

5. [Horizontal reverse]
Press this button to switch horizontal reverse display ON and OFF.

6. [Vertical reverse]
Press this button to switch vertical reverse display ON and OFF.

NOTE

Horizontal and vertical reverse operation in the display mode are only applied
to the displayed image and other images in the same sequence. They are not
applied to the next fluoroscopy acquisition.

7. [Multi-purpose switch mode switching]


You can change the mode of the multi-purpose switches.
• Normal mode
Press this button to switch the image.
Next/previous Sequence and Next/previous Frame, Replay forward,
Replay backward operations are enabled.
Hold down [Previous Frame, Replay backward] to replay and [Next Frame,
Replay forward] to replay in reverse.

Previous Sequence

Previous Frame, Replay backward Next Frame, Replay forward

Next Sequence

• Pixel shift mode


Pressing this button establishes the pixel shift mode, in which you can shift the
image horizontally or vertically. Press the center switch to reset the image.

Reset Up

Left Right

Down

4-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


4.2 Display Mode

• Zoom panning mode


Pressing this switch establishes the zoom panning mode, in which you can
shift the image horizontally or vertically. Press the center switch to reset the
image.

Reset Up

Left Right

Down

8. [Close]
Press this button to close the image processing dialog.

9. [Fluoroscope image save]


4
When you press this button, the fluoroscopy image is stored on the hard disk.
When fluoroscopy loop display is in effect, all the loop images are stored on
the hard disk.

10. [REF send]


Press this button to transmit the live monitor image to the reference monitor.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 4-7


Chapter 4 Image Processing

NO TEXT

4-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 5
Troubleshooting

This chapter explains the corrective action to take if the system


develops trouble. When trouble occurs, take action calmly and
deliberately.
Chapter 5 Troubleshooting

5.1 Responding to Problems


When a problem occurs with the system, take action by following the steps in the
“Corrective procedure flowchart” (page 5-3).

WARNING

If you have any doubts about how to proceed, contact our service
agent.

WARNING

If you feel there is something wrong with the system, stop using it
immediately.
If you notice an abnormal operation or sound, stop using the system
immediately and contact our service agent.

WARNING

Repair and maintenance of equipment can only be performed by


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

5-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


5.1 Responding to Problems

♦ Corrective procedure flowchart

Occurrence of a problem

Is a message displayed?
Refer to 5.2 “Where Errors are Displayed”.

Have you remedied the problem?

No. Yes
5

End

Telephone our service agent.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 5-3


Chapter 5 Troubleshooting

5.2 Where Errors are Displayed


When the system’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 live


monitor on the monitor cart.

♦ Warning
You can reset and continue operation by following the instructions displayed on the
screen.
Example:

Fig. 5.1 Warning screen

1 Press [Close].
• The dialog closes.

2 Continue to operate the system by following the instructions


displayed on the screen.

5-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


5.2 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.
If you cannot continue operation, promptly turn the power OFF at the monitor cart
and contact our service agent.

5
Fig. 5.2 Error screen

Error Number Cause of error

1 to 9 Errors associated with CPU error

10 to 19 Errors associated Internal power supply error

20 to 29 Errors associated Control circuit error

30 to 39 Errors associated High voltage generating control system error

Errors associated with temperature detection and


40 to 49
communications

Errors associated with the mechanical control system, e.g. the


50 to 59
collimator

60 to 99 Errors associated with the system

X ray tube assembly high temperature, HU over, HU over



warning, connector cover open, door open

WHA-200 OPESCOPE PLENO OPERATION MANUAL 5-5


Chapter 5 Troubleshooting

NO TEXT

5-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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 system and ensure safety.
Chapter 6 Maintenance and Inspections

6.1 Maintenance and Inspections


By reliably maintaining the performance of the system, 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 system 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 system 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

Periodic inspections Our service agent Every 6 months

6.2 Daily Inspections


The daily inspections comprise the starting inspections and ending inspections.
Daily inspections are necessary in order to keep using the system for a long time.
Check that all inspections and corrective actions have been completed before using
the system.

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.

6-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


6.3 Cleaning and Disinfection

6.3 Cleaning and Disinfection

CAUTION

You must clean and disinfect the system.


Cleaning and disinfection is very important to ensure that the system
can be used hygienically and safely. You must strictly follow the
methods prescribed.

1 Check that the main power supply to the system is switched OFF,
and disconnect the main power cable.

See 3.4.2 “Turning the Power OFF” (page 3-18).

CAUTION

Disconnect the main power cable before starting cleaning.


You must disconnect the system’s main power cable before starting 6
cleaning and disinfection.
Turn the power switch OFF before disconnecting the main power cable.
Otherwise there will be a risk of electric shock and current leaks.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 6-3


Chapter 6 Maintenance and Inspections

2 Carry out cleaning and disinfection work.


• Wipe the outer surface of the system or system component over with a
cloth moistened with 2% glutaraldehyde solution.
• Refer to the following notes for details on cleaning and sterilizing the
touch panels.

See 7.5 “Touch Panel Monitor” (page 7-11).

CAUTION

Do not use any water on the system.


Clean the system by wiping its surface with a cloth soaked in
disinfectant.
Using water to clean the system could cause electric shock or current
leakage.

CAUTION

Do not apply disinfectant directly, or spray it, onto the system.


If disinfectant gets inside the system, it can cause trouble or accidents.

6-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


6.3 Cleaning and Disinfection

CAUTION

Do not use the following disinfectants.


If you use the disinfectants listed below, we cannot guarantee the
performance or safety of the system.
• Disinfectants with a chlorine base
• Disinfectants that corrode metals, plastics, rubber, or paintwork
• Disinfectants that are not suited to metals, plastics, rubber, or
paintwork
• Atomized disinfectants
• Volatile disinfectants
• Disinfectants that could get inside the system

Use the minimum amount of disinfectant required


Over the long term, disinfection may cause damage such as fading and
cracking of the paintwork, or deterioration of resins such as plastics
and rubber. If you notice any changes in the product due to disinfection,
stop using the product immediately and request our service agent to
carry out repairs.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 6-5


Chapter 6 Maintenance and Inspections

3 On completing the work, check the following points before switching


the power ON again.
• There must be no water or disinfectant adhering to the system.
• The tools used in cleaning and disinfecting work must be tidied away.

See 3.4 “Turn the Power ON / OFF” (page 3-12).

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.

6-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


6.4 Returning the System or System Component

6.4 Returning the System or System Component

CAUTION

Before returning the system or system component, sterilize it


within the medical facility to avoid secondary contamination.

CAUTION

When returning the system or system component, always indicate


to the receiving contractor whether it has been sterilized or not.

CAUTION

When returning items that have not been sterilized, take


appropriate measures by referring to “Return of non-sterile items”
below.
6

CAUTION

Return of non-sterile items


• The items should be double-sealed in vinyl bags and the outside of
the bag should be clearly marked “Not sterile.”
• To prevent contamination, items that have blood on them should be
double-sealed in vinyl bags with “Blood contamination” clearly
marked on the bag.
• The bags must be packed in isolation. If you want to send documents
too, put the contaminated item and documents in different boxes
before packing.
• If it is discovered that an item has been used with a patient with an
infectious disease, the item must not be taken outside the medical
facility.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 6-7


Chapter 6 Maintenance and Inspections

6.5 Periodic Inspections


This refers to the inspections performed by our service agent.
The periodic inspections focus on the performance of the system and the internal
mechanism. They require an adequate knowledge about the internal mechanism of
the system. The inspection work is dangerous and you must contact our service
agent 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 system 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.

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
the Shimadzu Service Representative for repair and maintenance.

6-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


6.6 Regularly Replaced Components

6.6 Regularly Replaced Components


Some of the components of the system 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 our service agent.
The regularly replaced components are listed below.

• List of regularly replaced components

P/N Part name Replacement interval

074-73307-02 Battery, CR2450 2 years

072-01664-32 FUSE, 313 004 1 year

072-01664-34 FUSE, 313 6.25 1 year

072-01665-34 FUSE, 326010 1 year

072-01659-25 FUSE, FLM15 1 year

072-06035-24 FUSE, 660CF-20 1 year

503-58775 Brake axle ASSY 3 years

503-74656 Stopper rubber 3 years


6

WHA-200 OPESCOPE PLENO OPERATION MANUAL 6-9


Chapter 6 Maintenance and Inspections

NO TEXT

6-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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 sterilization cover.

CAUTION

Install the cassette holder correctly so that it will not fall down.

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.

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

7-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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
stopper C.

3. The radiation field for radiography is the range obtained in the immediately
preceding fluoroscopy.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 7-3


Chapter 7 Options

7.2 Hand Switch


This is the hand switch for X-ray radiation.

1 Press the hand switch (radiography preparation switch) to the first


level.
• Start preparations for radiography.

• (system standby) on the main panel will temporarily go out.

Radiography preparation
switch
First level

• On completion of preparations for radiography, (system standby)


lights again.

2 Press the hand switch (X-ray exposure switch) to the second level.
• X-ray radiation will start.

X-ray exposure
switch
Second
level

• During X-ray radiation, the irradiation indicator on the monitor cart will
be lit.

• (“X-rays being radiated”) is lit in the main panel.

7-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


7.2 Hand Switch

NOTE

Continue to hold down the hand switch to the second level until X-ray radiation
has finished. If you release them part way through, X-ray radiation will be
ended prematurely.

NOTE

Depending on the setting, the hand switch can be used for fluoroscopy.
Consult with the service personnel.
In this case, the hand switch can be operated as described below.
Other than film radiography:
• When the hand switch is pressed to the first level, fluoroscopy is carried out
(X-rays for fluoroscopy will be radiated while the switch is held down).
• To take a radiograph, press the right foot switch (you cannot take
radiographs by operating the hand switch).
Film radiography:
• Film radiography is carried out by operating the hand switch.

3.12 “Film Radiography (General Radiography)” (page 3-72)

WHA-200 OPESCOPE PLENO OPERATION MANUAL 7-5


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] on the main panel

• A laser beam is emitted and at the same time a cross mark appears on the
live monitor image.
• The button is highlighted.
• When you press this switch again, the laser beam is stopped.
• The cross mark on the live monitor image disappears.
• The laser beam continues to be emitted while the button is highlighted.

WARNING

Never look directly into the laser beam.

You can adjust the display position of the cross mark on the live monitor image
from the reference monitor.

For details on how to change the position of the laser pointer cross mark, see
Section C of the separate Image Processing Instruction Manual.

CAUTION

The center of the laser beam on the I.I. plane of incidence shifts as
the C-arm moves. Consequently, before each use and each time
you move the C-arm you must place an object like a pair of
scissors in such a way that the tip of the blade is at the center of
the laser beam, perform fluoroscopy, and adjust the display
position of the cross mark.

7-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


7.3 Laser Pointer

i.i.
X-ray tube
Live monitor

Marking the center of


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

Fig. 7.2

CAUTION

The position of the cross mark displayed on the live monitor


image is changed by calculations in accordance with changes in
the I.I. field size, rotation of the camera, and motion of the C-arm.
However, these calculations are approximations and you must
always adjust the display position of the cross mark after
changing the I.I. field size, rotating the camera, or moving the
C-arm.

7
NOTE

A cloth sterilization cover does not allow the passage of the laser beam. When
using the laser pointer, use a disposable sterilization cover made of
transparent vinyl.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 7-7


Chapter 7 Options

7.4 Fitting and Removing the Sterilization Cover


There are disposable and washable (cloth) types of sterilization cover. Either of
these can be fitted.
If you use the washable (cloth) type, use the disposable type on the C-arm.

CAUTION

Wear sterile clothing and gloves.

CAUTION

Make sure that the sterilization cover does not come into contact
with the floor or anything that is not sterile.

7-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


7.4 Fitting and Removing the Sterilization Cover

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) 7

Fig. 7.3 Sterilization cover (washable type)

WHA-200 OPESCOPE PLENO OPERATION MANUAL 7-9


Chapter 7 Options

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 (sterilization 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 (sterilization 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)

Monotank

Double-sided tape

Fig. 7.4 Mounting the C-arm cover

7-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


7.5 Touch Panel Monitor

7.5 Touch Panel Monitor


When you use a monitor with a touch panel as the reference monitor, you can
operate the image-processing unit by using touch operations.

CAUTION

Note the following points when using the monitor.


• Do not press strongly on, or scratch, the surface of a touch panel. Do
not rest anything on it either. This can cause uneven brightness of
the screen and in some cases can lead to faults.

CAUTION

Note the following points when cleaning and sterilizing touch


panels.
• To ensure safety, always disconnect the main power cable before
starting the work.
• Clean the touch panel at regular intervals. You can use the following
cleaners: isopropyl alcohol (use a product that contains no abrasive),
glass cleaners that are not ammonia-based, and neutral detergents
diluted with water.
• Exercise care when cleaning and sterilizing the touch panel. The 7
surface is easily scratched and you should not rub against it or knock
it with any hard object.
• If there is dust on the surface of the touch panel, remove it by wiping
with a soft damp cloth.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 7-11


Chapter 7 Options

7.6 Dose Area Product Display


The dose area product display on the C-arm main panel (see the figure below)
indicates the dose area product that is detected by a sensor mounted on top of the
collimator. The displayable range is 0.1 μGym2 to 9999 μGym2.

Dose area
product display

Fig. 7.5 Dose area product display

NOTE

When the patient file is closed, the dose area product is reset.

NOTE

The value given is only a reference value.


Calibration should be performed when you carry out periodic inspections.

7-12 WHA-200 OPESCOPE PLENO OPERATION MANUAL


Chapter 8
Technical Data
Chapter 8 Technical Data

8.1 Specifications
1. Classification of devices
Type of protection against electric shock:
Class 1 device
Degree of protection against electric shock:
Type B device
Operation mode: Continuous operation with intermittent load

2. X-ray control unit


Nominal maximum output: 2 kW (100 kV, 20 mA, 0.1 sec)
Nominal tube voltage, and the highest tube current obtainable with that
voltage:
Short time rating: 110 kV, 16 mA
Long time rating 110 kV, 5 mA
Highest tube current, and the highest tube voltage obtainable with that tube
current:
Short time rating 20 mA, 100 kV
Long time rating 9 mA, 60 kV
Combination of tube voltage and tube current which results in the highest
electric output power.
Short time rating 100 kV, 20 mA
Long time rating 110 kV, 5 mA
Tube voltage setting range: 40 to 110 kV (1 kV step)
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 - 125 mAs
50 - 60 kV 0.5 - 200 mAs
40 - 45 kV 0.5 - 125 mAs
Digital radiography:
Rating: 110 kV, 16 mA
Pulse fluoroscopy:
Pulse rates: 15, 7.5, 3.75, 2, 1, 0.5 fps

8-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.1 Specifications

Nominal tube voltage, and the highest peak tube current obtainable with that
voltage:
110 kV, 5 mA (15, 7.5, 3.75, 2 fps)
110 kV, 16 mA (1, 0.5 fps)
Highest peak tube current, and the highest tube voltage obtainable with that
tube current:
9 mA, 60 kV (15, 7.5, 3.75, 2 fps)
16 mA, 110 kV (1, 0.5 fps)

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 device
X-ray tube: SDO-0.6
Nominal focal spot: 0.6 mm
Measuring method of focal spot size: Slit camera method
Target angle: 8°
Target material: Tungsten
Anode type: Stationary anode
Nominal anode input power (1.0 sec): 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) 8
Maximum heat dissipation rate (X-ray tube assembly):226 HU/s (160 W)
X-ray tube assembly inherent filtration: Min. 2.9 mm Al eq.
X-ray tube inherent filtration: Min. 0.8 mm Al eq.
Leakage dose:
Leakage radiation in an hour from X-ray tube assembly and collimator is
less than 0.87 mGy at a distance of 1 meter from the focal spot. However,
leakage radiation in an hour from the collimator is less than 0.304 mGy.
• Leakage dose measurement conditions
110 kV, 330 W (465 HU/s) continuous
X-ray radiation field:
φ230 mm (With an SED distance of 900 mm)
Weight: 15 kg
Suitable supply equipment: WHA-200

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-3


Chapter 8 Technical Data

4. Beam limiting device


Octagonal collimator: Electrical driven (opening/closing), made of Pb
(lead)
Parallel collimator: 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
Inherent filtration: 0 mm Al equivalent.
Suitable supply equipment: WHA-200

Reference axis

Reference axis

Focal spot

Focal spot

UNIT : mm

Fig. 8.1 X-ray tube assembly

8-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.1 Specifications

X-RAY TUBE ASSEMBLY HEATING AND COOLING CURVE

0
330W 220W
175W
0
160W
0
100W
0

0
Cooling
0

0
0 20 40 60 80 100
Time (min)

ANODE HEATING AND COOLING CURVE


0
550W
0

0
250W
0

0
100W
0

8
0

0
Cooling
0

0
0 1 2 3 4 5 6 7 8 9 10
Time(min)
04/03/25

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-5


Chapter 8 Technical Data

SINGLE LOAD RATING CHARTS

X-ray tube Current [mA]

Time [min]

EMISSION AND FILAMENT CHARACTERISTICS

Filament Voltage [V]

Filament Current [A]

8-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.1 Specifications

5. C-arm cart
SED: 900 mm
Height of horizontal X-rays from the floor:
785 mm (When the C-arm is brought onto the bed)
1095 mm (When the C-arm is brought under the bed)
Rotation of the C-arm: 120°
Rotation of the C-arm’s holder: 300°/120°
Longitudinal movement of the C-arm: 450 mm
Lateral movement of the C-arm: 200 mm
Swing of the C-arm: ±12.5°

6. Image Intensifier
Nominal entrance field size:
Diameter of 23 cm / 16 cm 2-level switching(9/6 inch I.I)

7. X-ray television assembly


Camera Element: CCD
Effective pixels: 1024 (H) × 1024 (V) × 12-bit

8. Image processing section


Fluoroscopy 1024 × 1024× 12-bit Max. 30 fps
Digital Radiography 1024 × 1024 × 12-bit Max. 7.5 fps
Fluoroscopy / acquisition mode
Continuous Fluoroscopy, Pulse Fluoroscopy, Spot, Serial, DSA, Map

Image Processing:
Recursive Filtering, Edge Enhancement, Gamma, Window/Level 8
Polarity Inverse, Zooming(x2) & Panning, Multi Image Display (4x4)
Subtraction, Remask, Pixel shift, Landmarking,
Thumbnail View (reference), Measurement, Annotation

Others:
Virtual Camera rotation and Collimator positioning on the LIH image
without Radiation
NTSC type scan converter (top and bottom 32 scan lines are not output.)
Hard Disk Drive: min. 30,000 images (1024 x 1024 x 12 bit)
CD-R/DVD-R

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-7


Chapter 8 Technical Data

9. TV monitor
18 inch (19 inch) LCD display monitor

10. Grid
Ratio: 10:1
Line rate: 44 lines/cm
Intermediate material: Fiber

11. Options
a) Cassette holder
Applicable cassette size 24 × 30 cm (10" × 12") thickness less than
15 mm
b) Laser pointer
Fixed in X-ray tube side, Cross lines
c) Hand held switch for X-ray radiation
d) Sterilization cover
e) Touch panel monitor option
When you use a monitor with a touch panel as the reference monitor, you
can operate the image-processing unit by using touch operations.
f) DICOM
DICOM PRINT, DICOM STORAGE
g) Image display function
This function enables the live monitor image to be displayed on the LCD
on the C-arm's main panel.
h) Dose area product meter
The dose area product is displayed on the LCD on the C-arm's main
panel.
i) Extension kit for source-skin distance
This option extends the focal-spot-to-skin distance from 20 cm to 30 cm
for an application other than surgical purposes.
j) Monochrome LCD monitor option

12. Weight
Body of the C-arm cart: 250 kg
Monitor cart: 145 kg

8-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.1 Specifications

Fig. 8.2 C-arm Cart with 9 inch I.I

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-9


Chapter 8 Technical Data

Fig. 8.3 Monitor Cart

8-10 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.2 Conditions for Installation and Use

8.2 Conditions for Installation and Use


1. Environmental conditions
Temperature: 10°C to 35°C
Relative humidity: 30% to 85% (to be no condensation)
Atmospheric pressure: 700 hPa to 1060 hPa
State of the atmosphere: To contain no volatile vapors or corrosive gases

2. Power supply
System: Single phase AC
Frequency: 50 or 60 Hz
Capacity: 3.5 kVA
Voltage and power supply impedance:
100, 110, 120 V ± 10%, 0.2 Ω max.
200, 220, 230, 240 V ± 10%, 0.8 Ω max.
Ground: Type D grounding
Power supply breaker: Type suited to use with an inverter

3. Power comsumption
Momentary: 35 A(100, 110, 120 V), 17.5 A(200, 220, 230, 240 V)
Stand by: 15 A(100, 110, 120 V), 10A(200, 220, 230, 240V)

8.3 Storage Conditions


8
Temperature: 10°C to 40°C
Relative humidity: 30% to 85% (to be no condensation)
Atmospheric pressure: 700 hPa to 1060 hPa
State of the atmosphere: To contain no volatile vapors or corrosive gases

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-11


Chapter 8 Technical Data

8.4 KV-mA Curve

♦ kV-mA curve No:0

♦ kV-mA curve No:1

8-12 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.4 KV-mA Curve

♦ kV-mA curve No:2

♦ kV-mA curve No:3

8
♦ Standard kV-mA curve on shipment from the factory

Fluoroscopy mode KV-mA curve No.

HQ: High Quality (high quality mode) 2

N: Normal (normal mode) 0

LD: Low Dose (low dose mode) 1

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-13


Chapter 8 Technical Data

8.5 Dose Information

8.5.1 Location of Significant Zone of Occupancy

The significant zones of occupancy are shown in Fig.1 to 3.

Fig No Beam direction PA or AP

Fig. 8.4 Vertical PA

Fig. 8.5 Vertical AP

Fig. 8.6 Horizontal NA

NOTE

This equipment is not specified for gastro-intestinal examinations.

8-14 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.5 Dose Information

Significant Zone of Occupancy

Phantom: 350x350x150

Fig. 8.4 Vertical Beam, PA position

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-15


Chapter 8 Technical Data

Significant Zone of Occupancy

Phantom: 350x350x150

Fig. 8.5 Vertical Beam, AP position

8-16 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.5 Dose Information

Significant Zone of Occupancy

Phantom: 350x350x150

8
Fig. 8.6 Horizontal Beam

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-17


Chapter 8 Technical Data

8.5.2 Test Report Stray Radiation for WHA-200

♦ Test method
The stray radiation in significant zone of occupancy was measured according to
IEC601-1-3 Annex AAA.

♦ Test conditions
1)General
Test Date:22 Mar, 2004
Tested by:T. Nakahara, H. Yagi
Instrument used for measurement:
Name:Victoreen660
Model:660-S1
Probe dimensions:100cm2x4cm
Latest calibration:Feb, 2002

2) X-ray conditions
X-ray tube voltage:110kV
X-ray tube current:3mA

3)Phantom
Outside dimensions:35[cm] x 35[cm] x 15[cm]
Material:Polymethyl-methacrylate

4) C-arm Position
Vertical Beam, PA position:Refer to Fig. 8.4
Vertical Beam, AP position:Refer to Fig. 8.5
Horizontal Beam:Refer to Fig. 8.6

5) Significant zone of occupancy and Measuring points


For detail, refer to Fig. 8.4 to Fig. 8.6

♦ Test data
Refer to Fig. 8.7 to Fig. 8.9

8-18 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.5 Dose Information

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. 8.7 Vertical Beam AP position

A B C D E F

200

150
Height above floor [cm]

100

50
8
0
10 100 1000 10000
Air K erma in one hour (work load:3600mAs) [µGy]

Fig. 8.8 Vertical Beam AP position

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-19


Chapter 8 Technical Data

A B C D E F

200

150
Height above floor [cm]

100

50

0
10 100 1000 10000
Air K erma in one hour (work load: 3600mAs) [µGy]

Fig. 8.9 Horizontal Beam

8-20 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.6 EMC (Electro-Magnetic Compatibility)

8.6 EMC (Electro-Magnetic Compatibility)


The device meets the standard of EMC (Electro-magnetic Compatibility) as below.
• IEC 60601-1-2:2001+A1:2004

CAUTION

• Pay attention the electro-magnetic circumstances at the site because


the device may be affected the electro-magnetic field at the site.
• Other equipment may be affected due to installation. The device
needs to be moved the location to avoid the problem.

♦ Classification of EMI in Accordance with


IEC 60601-1-2:2001+A1:2004
Group 1, Class A

CAUTION

The use of ACCESSORIES, transducers and cables other than those


specified, with the exception of transducers and cables sold by the
Shimadzu of the WHA-200 as replacement parts for internal
components, may result in increased EMISSIONS or decreased
IMMUNITY of the WHA-200.

♦ Performance to be EMC immunity tested (Essential performance)


Essential performances of this equipment are as followings;
• Positioning of X-ray field 8
• Set of X-ray conditions
• X-ray exposure

♦ List of Cables
Table A.1

Cable Note
Cable Type Shield
Length (Manufacturer/Part No)

Power Supply Cable 7m N Shimadzu/502-23835

Additional Protection Earth Cable 7m N Shimadzu/501-77255

Cart Cable 7m N Shimadzu/502-23290

Foot Switch Cable 6m N Shimadzu/503-58422

Hand Held Switch Cable (Optional) 4.5 m N Shimadzu/064-62902

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-21


Chapter 8 Technical Data

♦ Guidance and Manufacturer's Declaration - Electromagnetic


Emissions - for all EQUIPMENT and SYSTEMS
Table B.1

Guidance and manufacturer's declaration - electromagnetic emissions

The WHA-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the WHA-200 should assure that it is used in such an
environment

Emissions test Compliance Electromagnetic environment - guidance

The WHA-200 uses RF energy only for its


RF emissions
internal function. Therefore, its RF emissions
EN 55011/ Group 1
are very low and are not likely to cause any
CISPR 11
interference in nearby electronic equipment.

RF emissions
EN 55011/ Class A
CISPR 11
The WHA-200 is suitable for use in all
Harmonic emissions
establishments other than domestic and those
EN 61000-3-2/ Class A
directly connected to the public low-voltage
IEC 61000-3-2
power supply network that supplies buildings
Voltage fluctuations/ used for domestic purposes.
flicker emissions
Complies
EN 61000-3-3/
IEC 61000-3-3

♦ Guidance and Manufacturer's Declaration - Electromagnetic


Immunity
Table C.1
Guidance and manufacturer's declaration - electromagnetic immunity

The WHA-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the WHA-200 should assure that it is used in such an
environment.

Electromagnetic
IEC 60601 test Compliance
Immunity test environment -
level level
guidance

Recommended floor
material is wood,
Electrostatic concrete or ceramic tile.
discharge (ESD) ± 6 kV contact ± 6 kV contact If the floor is covered
EN 61000-4-2/ ± 8 kV air ± 8 kV air with synthetic material,
IEC 61000-4-2 preferred relative
humidity in the room is
at least 30%.

Electrical fast ± 2 kV for power ± 2kV for power Mains power quality
transient / burst supply lines supply lines should be that of a
EN 61000-4-4/ ± 1 kV for input/ ± 1kV for input/ typical commercial or
IEC 61000-4-4 output lines output lines hospital environment.

8-22 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.6 EMC (Electro-Magnetic Compatibility)

(Table C.1)

Guidance and manufacturer's declaration - electromagnetic immunity

Electromagnetic
IEC 60601 test Compliance
Immunity test environment -
level level
guidance

± 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
(60% dip in UT) (60% dip in UT) the user of the WHA-200
interruptions and
for 5 cycles for 5 cycles requires continued
voltage variations
operation during power
on power supply
70% UT 70% UT mains interruptions, it is
input lines
recommended that the
EN 61000-4-11/ (30% dip in UT) (30% dip in UT)
WHA-200 be powered
IEC 61000-4-11 for 25 cycles for 25 cycles from an uninterruptible
power supply or a
battery.
<5% UT 5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec

Power frequency Power frequency


magnetic fields should
(50/60 Hz)
be at levels characteristic
magnetic field 3 A/m 3 A/m
of a typical location in a
EN 61000-4-8/
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.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-23


Chapter 8 Technical Data

♦ Guidance and Manufacturer's Declaration - Electromagnetic


Immunity-
Table C.2

Guidance and manufacturer's declaration - electromagnetic immunity

The WHA-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the WHA-200 should assure that it is used in such an
environment.

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
WHA-200, 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
IEC 61000-4-6 to 80 MHz

Radiated RF 3 V/m 3 V/m d = 1.2 P


EN 61000-4-3 80 MHz 80 MHz to 800 MHz
IEC 61000-4-3 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*1,
should be less than the compliance
level in each frequency range*2.
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.

8-24 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.6 EMC (Electro-Magnetic Compatibility)

Guidance and manufacturer's declaration - electromagnetic immunity

*1 Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the WHA-200 is used exceeds the applicable RF compliance
level above, the WHA-200 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the WHA-200.
*2 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.

♦ Recommended Separation Distances between Portable and


Mobile RF Communications Equipment and the EQUIPMENT or
SYSTEM
Table D.2

Recommended separation distances between portable and mobile


RF communications equipment and the WHA-200

The WHA-200 is intended for use in an electromagnetic environment in which radiated


RF disturbances are controlled. The customer or the user of the WHA-200 can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the WHA-200 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.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-25


Chapter 8 Technical Data

8.7 Statement of Compliance [For Europe]

8.7.1 Regulatory Information


For Europe:
The product complies with the requirement of the Medical Device Directive 93/42/
EEC
Product Name: Surgical X-ray TV System

Model Name: Surgical Mobile C-arm Imaging System WHA-200

Parts Number: 503-58800

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

8.7.2 Company's Quality System


The company's Quality System is satisfied with Annex II, Article 3 for 93/42/EEC,
which is certified by TUV Rheinland Product Safety GmbH (Notified under
No.0197) as Registration No: HD 60011592 0001

8.7.3 International Standards


This unit conforms the following international standards
• IEC 62304:2006 / EN 62304:2006
• IEC 62366:2007 / EN 62366:2008
• IEC 60601-1-6:2004 / EN 60601-1-6:2004
• IEC 60601-1:1988+A1:1991+A2:1995 / EN
60601-1:1990+A1:1993+A2:1995+A13:1996
• IEC 60601-1-2:2001+A1:2004 / EN 60601-1-2:2001+A1:2006
• IEC 60601-1-3:1994 / EN 60601-1-3:2001
• IEC 60601-1-4:2000 Ed.1.1 / EN 60601-1-4:1996+A1:1999
• IEC 60601-2-7:1998 / EN 60601-2-7:1998
• IEC 60601-2-28:1993 / EN 60601-2-28:1993
• IEC 60601-2-32:1994 / EN 60601-2-32:1994
• IEC 60825-1:1993+A1:1997+A2:2001
• EN ISO 10993-1:2003
• EN 980:2008
• EN 1041:1998
• EN ISO 14971:2007 / ISO 14971:2007

8-26 WHA-200 OPESCOPE PLENO OPERATION MANUAL


8.8 Manufacturer Information

8.8 Manufacturer Information


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

WHA-200 OPESCOPE PLENO OPERATION MANUAL 8-27


Chapter 8 Technical Data

NO TEXT

8-28 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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 system.

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 system been cleared away? Clear them away.

Have previously used contrast media and drugs been removed from the
Clean up.
system?

Have you cleared away any rust and metal fragments from the moving
Clear them away.
parts of the system and the floor?

Are any cables trapped, twisted, or rubbing against anything? Correct this.

Have any cable connectors been wet with water? Clear them away.

Is there any damage to cable insulation? Contact our service agent.

2 Check the following points by hands-on examination before switching


the power ON. Correct any nonconformity.

Check points Corrective action

Do the casters, brakes, handles and other parts of the C-arm cart function
Contact our service agent.
correctly?

Do the brakes of the monitor cart function correctly? Contact our service agent.

Is the C-arm cart’s brake applied? Apply the brakes.

Are the monitor cart’s brakes applied? Apply the brakes.

9-2 WHA-200 OPESCOPE PLENO OPERATION MANUAL


9.1 Starting Inspection Checklist

3 Check visually that connections have been made correctly before


switching the power ON. Correct any nonconformity.

Check points Corrective action

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.
Correct any nonconformity.

Check points Corrective action

Is the operating noise after switching the power ON normal? Contact our service agent.

Have you checked if an error message is displayed on the main panel or


Contact our service agent.
on the monitor?

Have you checked if all of the switches on the main panel and side panel
Contact our service agent.
are lit?

5 Check the following points while operating the system. Correct any
nonconformity.

Check points Corrective action

Is there an abnormal noise when the C-arm is operated? Contact our service agent.

Does the C-arm lock switch function correctly? Contact our service agent.

Is the laser pointer focused correctly? Contact our service agent.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 9-3


Chapter 9 Appendix

9.2 Ending Inspection Checklist

Date implemented:
Implemented by:

Always check the following points before finishing use of the system.

1 Check the following points visually before switching the power OFF.
Correct any nonconformity.

Check points Corrective action

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.

Check points Corrective action

Have unnecessary items in the vicinity of the system been cleared away? Clear them away.

Have previously used contrast media and drugs been removed from the
Clean up.
system?

Are any cables trapped, twisted, or rubbing against anything? Correct this.

Have any cable connectors been wet with water? Clear them away.

Is there any damage to cable insulation? Contact our service agent.

3 Check the following points by hands-on examination. Correct any


nonconformity.

Check points Corrective action

Do the casters, brakes, handles and other parts of the C-arm cart function
Contact our service agent.
correctly?

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? Contact our service agent.

4 As necessary, clean and disinfect the system.

9-4 WHA-200 OPESCOPE PLENO OPERATION MANUAL


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.

9.3.1 Brightness Adjustment

1 Press the control dial on the left side of the monitor.


• The MENU screen will be displayed.

2 Turn the control dial to bring the cursor (indicated by characters


displayed in red) onto the “Brightness” adjustment option.

3 Press the control dial.


• The brightness bar graph will be displayed.

4 Turn the control dial to adjust the monitor's brightness.

5 Press the control dial.


• The MENU screen will be displayed.

WHA-200 OPESCOPE PLENO OPERATION MANUAL 9-5


Chapter 9 Appendix

6 Check that the cursor (indicated by characters displayed in red) is


located on “Exit” then press the control dial.
• The MENU screen is cleared.

Control dials

Fig. 9.1 Control dial

9-6 WHA-200 OPESCOPE PLENO OPERATION MANUAL


9.3 Monitor Brightness Adjustment, Contrast Adjustment

9.3.2 Contrast Adjustment

1 Press the control dial on the left side of the monitor.


• The MENU screen will be displayed.

2 Turn the control dial to bring the cursor (indicated by characters


displayed in red) onto the “Contrast” adjustment option.

3 Press the control dial.


• The contrast bar graph will be displayed.

4 Turn the control dial to adjust the monitor's contrast.

5 Press the control dial.


• The MENU screen will be displayed.

6 Check that the cursor (indicated by characters displayed in red) is


located on “Exit” then press the control dial.
• The MENU screen is cleared.

Control dials

9
Fig. 9.2 Control dial

WHA-200 OPESCOPE PLENO OPERATION MANUAL 9-7


Chapter 9 Appendix

NO TEXT

9-8 WHA-200 OPESCOPE PLENO OPERATION MANUAL

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