mobileart_plus_mux-100h_operation_manual_rev_h.pdf
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Manual No. : M503-E020
Revision
:H
Mobile X-ray System: MUX-100H
OPERATION MANUAL
Read this manual carefully for correct product use.
Keep it with the equipment.
Medical Systems Division
Page 3
Thank you for purchasing a SHIMADZU medical system. Before using the
system, please read this manual thoroughly and use the system correctly.
The meanings of the following precaution and prohibition terms used in the
operation manual are defined as below:
DANGER
States a direct danger that may cause death or
serious injury if it is not avoided.
WARNING
States an indirect or potential danger that may
cause death or serious injury if it is not avoided.
CAUTION
States a danger that may cause slight or
medium injury or may cause damage in
equipment or fire if it is not avoided.
NOTE
States the information which helps to use the
system correctly.
Original version is approved in English.
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Operating Precautions
User and professional service engineers should take care the following general operating
precautions. In actual, each operation precautions depended on each product, therefore,
please read carefully the operation manual or Installation manual. Item 2. and 3. are only for
professional service engineers.
“Operating Precautions (for Both the Safety and the Prevention
of Danger) in the Use of Electric Medical Equipment”
1.
Only a qualified radiographic staff should operate the equipment.
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
sulfur 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 condition 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.
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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.
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 factors:
(i)
Keep it away from the water.
(ii) Store it away from the potential causes of problems such as abnormal
pressure, temperature or humidity, draft, direct sunlight, dust, chlorine or
sulfur gas.
(iii) During transportation and storage of the equipment, avoid tilting,
vibration and sharp impact against it.
(vi) 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.
7.
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 call a certified repair technician for repair.
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 safety.
9.
Concerning other items, operate properly according to the operating
manual.
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WARNING
The responsibility for correct management of use and maintenance
of medical equipment lies with the user.
The equipment should not be used by other than a qualified person
or under the direct supervision of a qualified person.
Unauthorized repair and inspection of the equipment may be
dangerous. Make sure that service is carried out by authorized
Shimadzu Service center.
NEVER MODIFY THE EQUIPMENT!
The Drugs, Cosmetics and Medical Instruments Act of Japan makes
it compulsory that a manufacturer should apply and get approval for
any modifications to the equipment. Have in mind that modifications
without approval are prohibited.
PERFORM PERIODIC INSPECTION!
Preventive maintenance is required to maintain operational safety
and long term performance of this system.
This manual gives detailed description of occasional and periodic
maintenance and inspections that a user should perform.
As to the maintenance and inspections that specially trained
specialists must perform, utilize the maintenance agreement offered
by your nearest authorized Shimadzu service center.
CAUTION
Federal law restricts this device to sale by or on the order of
physician.
(This caution is the prescribed language required by Federal
Regulations in U.S.A.)
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GUARANTEE
The guarantee period of this system is one year from the date of purchase.
Shimadzu Corporation is not responsible for the following failures or damage.
1. Failure/damage caused by improper installation, movement, maintenance or
repair performed by anyone other than your nearest authorized Shimadzu
service personnel.
2. Failure/damage to a product of Shimadzu caused by a product from other
company which was not delivered by an authorized Shimadzu subsidiary,
Distributor or Dealer.
3. Failure/damage resulting from maintenance, repair, etc., using
spare parts
other than genuine parts specified by Shimadzu.
4. Failure/damage resulting from improper use or operating procedures described
in this instruction manual.
5. Failure/damage caused by the ambient or environmental conditions beyond the
recommended service conditions applicable to this system
in which are
described in this instruction manual.
6. Failure/damage caused by any natural disaster such as fire, earthquake, flood
damage and thunderbolt.
7. Failure/damage of the system resulting from installing the system in vehicles,
ships, or aircrafts without Shimadzu’s consent.
8. Failure/damage of the system caused by use of the system in countries not
specified by Shimadzu.
9. Failure/damage of the system when the system has been purchased from
dealers other than Shimadzu and authorized Shimadzu distributors.
10. Failure/damage of the system caused by hitting or dropping the unit or
exposing it to a shock.
Servicing following the expiration of the guarantee period will be offered with
charge. Contact your nearest authorized Shimadzu service center.
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WARNING
NEVER REPAIR OR CHECK INSIDE THE EQUIPMENT !
Responsibility for maintenance of medical equipment is the responsibility of the
user. This equipment should only be operated by, or under the direct supervision
of, a suitably qualified person.
For any repair or maintenance of this equipment contact your nearest authorized
Shimadzu service center.
WARNING
NEVER MODIFY THE EQUIPMEHT !
Modification of the equipment by a user is prohibited as detailed in paragraph 7 of
the “Operating Precautions (for both the Safety and Prevention of Danger) in the
Use of Medical Equipment” (the Notification No.495 by the Chief of the
Pharmaceutical Affairs Bureau, the Ministry of Health and Welfare dated June 1,
1972).
Please Note: The Pharmaceutical Affairs Law of Japan prevents unauthorized
modification of this equipment without authorisation.
WARNING
PERFORM PERIODICAL INSPECTIONS !
Preventive maintenance is essential to ensure the long term operational safety
and performance of this system.
This instruction manual gives detailed description of the periodical maintenance
and inspections that should be performed on this equipment.
For the maintenance and inspections that require qualified specialists to perform
the “Maintenance Agreement” offered by authorized Shimadzu service center is
recommended.
WARNING
PRECAUTIONS FOR X-RAY IRRADIATION
When using X-ray equipment incorrectly, The operator and patient may become
exposed to unnecessary irradiation. Special care to ensure that only the patient
stays in the examination room when X-rays are exposed. If it is necessary for
another person, other than patient, to be in the examination room, ensure that
appropriate protective measures are provided.
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WARNING
PRODUCT SAFETY
Do not operate this equipment if there is any uncertainty as to the proper
functioning of the system. Refer all servicing to qualified service personnel.
WARNING
CONSIDERATION FOR MECHANICAL SAFETY
Be careful when operating this equipment. Be aware operators and patient’s body
- hand, foot, etc. - may not be got jammed between moving parts of the system or
between the unit and other equipment when moving a part of the unit
Be especially careful when near a wall,changing the direction of the system or
moving it backwards.
WARNING
NEVER USE THIS SYSTEM AT A PLACE WHERE FLAMMABLE OR
EXPLOSIVE GASES MAY BE PRESENT.
This system is not explosion-proof. Never use this equipment at a place where
flammable or explosive gases may be present.
WARNING
ABOUT ELECTRICAL EARTHING
Connect the power cord plug to a socket with an electrical earthing terminal.
CAUTION
DO NOT SPLASH WATER ON THIS EQUIPMENT !
Do not splash water on this equipment, because there is a risk of electric shock.
To clean the equipment, wipe the surfaces with a cloth dampened with
antibacterial solution.
CAUTION
THE SYSTEM MAY FALL OVER, IF IT IS OPERATED ON A SURFACE
INCLINED MORE THAN 5 DEGREES.
When operating the tube arm of the equipment make sure the equipment is
located on level ground or floor where the slope is less than 5 degrees.
CAUTION
The operator should set the focal spot to skin distance as large as practible
to ensure the absorbed dose to the patient is as low as possible.
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CAUTION
PAY ATTENTION TO OBSTACLES DURING DRIVING THE UNIT!
If the unit hits obstacles during driving and the force applied to the bumper switch
by the hitting is less than 2 kg, the front bumper switch will not detect the obstacle.
CAUTION
Protection from ionizing radiation :
Use protective devices and protective clothing as necessary.
CAUTION
Please be sure to aging the X-ray tube!
When using an X-ray tube, a running-in operation called aging is required.
Please aging the X-ray tube with reference to "6.3 Aging the X-ray tube."
CAUTION
When moving the system is not normally such as the operation is do not
continue using and contact your authorized Shimadzu service center.
NOTE
Use the following cassettes for the bucky device.Other cassettes should not be
used.
CM or INCH size cassettes based on IEC standard 60406.
Attenuation equivalent not greater than 1.6mm Al.
Less than 15mm thickness.
All parts of the cassette such as hinges, locks and marking device shall be
within the minimum radii for carners and edges.
Flatness shall be less than 1mm warp.
Language of Approved Version
NOTE
Original version of this manual is approved in English.
Software Revision
This manual applies to the software revision 1.6
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Disposal of the Products and Parts
This system contains materials that can contaminate the environment if disposed of
without care. For the disposal of this product or the attachments, contact your nearest
authorized Shimadzu service center.
Action for Environment
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.
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.
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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.
Cautions on the Compatibility of Electromagnetic Fields
WARNING
This equipment needs special precautions regarding EMC and needs to be
installed and use according to the EMC information provided in this operation
manual.
Reference "9.6 Environmental Conditions of EMC (Electro-Magnetic
Compatibility)" P.9-11
WARNING
CHECK THAT THE ELECTROMAGNETIC FIELDS ARE COMPATUBLE.
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.
Reference "9.6 Environmental Conditions of EMC (Electro-Magnetic
Compatibility)" P.9-11
WARNING
This equipment should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, This equipment should be
observed to verify normal operation in the configuration in which it will be used.
Reference "9.6 Environmental Conditions of EMC (Electro-Magnetic
Compatibility)" P.9-11
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Contents
Chapter 1
Introduction
Introduction
Chapter 2
2.1
2.2
2.3
2.4
2.5
2.6
Chapter 3
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
Chapter 4
4.1
4.2
4.3
4.4
1-2
Outline
Purpose
Features
Use conditions
2.3.1 Environmental conditions
2.3.2 EMC(Electro-Magnetic Compatibility)
Conformity to IEC Standards
Classification of equipment
Safety Symbols for System
2-2
2-2
2-3
2-3
2-4
2-5
2-6
2-7
Descriptions of Each Part
Outside View
X-ray Control Panel
Power Supply Panel
Hand Switch
Driving Handle section
X-ray Tube Operating Section and Collimator
Operation Handle
Tube Arm Joint Section
Main Circuit Breaker and Additional Protective Electrical Earthing Wire
Cassettebox
Apron hanger
Switch for activating the emergency brake release function
Operational state indicator lamp
3-2
3-3
3-6
3-7
3-8
3-9
3-11
3-12
3-13
3-15
3-16
3-17
3-18
How to Operate
Starting and Stopping the System
4.1.1 Starting the System
4.1.2 Stopping the System
Moving the System
4.2.1 Normal Travel Mode
4.2.2 Slow Travel Mode
4.2.3 Small Movement Switch
4.2.4 Bumper Switch
Emergency Stop Switch
Tube Arm Operations
4.4.1 Tube Arm Lock
4.4.2 Positioning the X-ray tube assembly
4.4.3 Setting the Irradiation Field
Mobile Art Plus Operation Manual
4-2
4-2
4-3
4-4
4-6
4-6
4-7
4-8
4-10
4-11
4-11
4-13
4-14
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4.5
4.6
4.7
4.8
4.9
Chapter 5
5.1
5.2
5.3
5.4
5.5
Chapter 6
6.1
6.2
6.3
6.4
Chapter 7
7.1
7.2
12
How to Change Exposure Condition
4.5.1 How to Set Exposure Condition
4.5.2 Manual Setting Method
4.5.3 Setting Method with Anatomical Programs
4.5.4 Registration of Anatomical Programs
4.5.5 Delete of Anatomical Programs
X-ray Filming
4.6.1 Filming Procedures
4.6.2 Filming with Insufficient Battery Charge
Charging the Battery
User Setting
4.8.1 Setting and Registering User Setting
4.8.2 Power-assist setting
4.8.3 Acceleration setting
4.8.4 Steer control setting
4.8.5 Backward power-assist setting
4.8.6 Auto-power-off Time Setting
4.8.7 Buzzer settings
4.8.8 Setting collimator lamp control
4.8.9 Setting APR at the time of starting the apparatus
4.8.10 Setting apparatus ID
Emergency brake release
4.9.1 How to activate the emergency brake release function
4.9.2 Releasing the emergency brake
4-15
4-15
4-15
4-16
4-17
4-18
4-20
4-21
4-22
4-23
4-25
4-26
4-28
4-28
4-29
4-29
4-30
4-30
4-31
4-32
4-32
4-33
4-33
4-33
Options
Remote Controller
Protective Screen
Collapsible X-ray protective screen
Grid case
Large cassette box
5-2
5-5
5-7
5-9
5-10
Maintenance and Inspection
Inspection
Cleaning
Aging X-ray tubes
Expendable Parts List
6-2
6-11
6-12
6-14
Self-Diagnostic Function
Warning Indication Lamp
Fault Indication Lamp
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7-3
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Chapter 8
8.1
8.2
Chapter 9
9.1
9.2
9.3
9.4
9.5
9.6
Others
Name plate and labels
Regulatory information
8-2
8-15
Specifications
Specifications
Dimensional Drawing of the System
X-ray reference axis and focal spot position
Exposure condition
Heating & Cooling Curve of 0.7U163CS-36
Environmental Conditions of EMC (Electro-Magnetic Compatibility)
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9-2
9-6
9-7
9-8
9-10
9-11
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No Text
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Chapter
1
Introduction
Chapter Contents
Introduction
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Chapter 1
Introduction
Introduction
This manual provides information pertaining to the system’s description,
operation, and specifications.
Read this manual carefully to ensure correct use. Be sure that the warnings
(NOTES and CAUTIONS) detailed in this instruction manual are fully understood
when operating this product.
After reading this manual, retain it in a convenient location so that it may be
referred to at any time.
This manual does not cover the X-ray tube assembly. Read the following manual
for the X-ray tube assembly and Heating & Cooling Curve.
1-2
X-ray tube model name
0.7U163CS-36
X-ray tube
number
document
M535-E219
Heating & Cooling Curve
document number
M535-E274
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Chapter
2
Outline
Chapter Contents
2.1
Purpose
2.2
Features
2.3
Use conditions
2.4
Conformity to IEC Standards
2.5
Classification of equipment
2.6
Safety Symbols for System
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Chapter 2
2.1
Outline
Purpose
The mobile X-ray system has been designed to deliver exceptional mobile X-ray
performance and image quality. It will also ensure optimum operator and patient
safety.
CAUTION
Do not use the unit for any other purpose. Do not connect the unit to any other
equipment by electrical or mechanical means. Unauthorized modification to any
part of this equipment may compromise the patient and operator safety and will
void all the manufacturer's warranty conditions.
2.2
Features
Smooth and quiet movement
The system may be moved smoothly with its power assisted drive
mechanism.
Compact design
The unit, with its exceptional forward view, can be moved in limited spaces
confidently and with complete control.
Easy positioning
The unit may be moved into position easily and speedily with the unique
positioning central switches (Inch –mover) mounted on the x-ray tube head.
High-frequency inverter
Use of Shimadzu's high-frequency inverter technology, with a maximum
frequency of 60 kHz, generates the high voltage with the lowest ripple
factor available, ensuring efficient X-ray generation.
Anatomical programs
Anatomical programs are installed as standard, facilitating the setting of
optimum exposure conditions.
Cordless System
The built-in battery power-supply enables X-ray exposures to be generated
without requiring the equipment to be connected to the main electrical
supply.
Plain indicator
The large indicator provides a plain indication of proceeding from the
preparation to completion of an exposure.
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2.3
2.3
Use Conditions
Use Conditions
2.3.1 Environmental Conditions
Use environment
Ambient temperature
： 10℃ ～ 40℃
Relative humidity
： 30% ～ 85% (no dew condensation)
Atmospheric pressure
： 700 hPa
～ 1060 hPa
Storage environment ( not for transport and storage before delivery)
Ambient temperature
： -10℃ ～ 40℃
Relative humidity
： 30% ～ 85% (no dew condensation)
Atmospheric pressure
： 700 hPa ～ 1060 hPa
CAUTION
Charge the battery in the use environment.
Do not charge in the storage environment.
Power supply
AC power
System
： Single phase AC
Frequency
：
50/60 Hz
Standard voltages
：
100, 110, 120, 200, 220, 230, 240 V
(set one of the voltages when installing)
Voltage variation range
：
±10% of standard voltages
Supply capacity
：
1kVA
Power Supply Impedance ：100,110,120V：No more than 1.0Ω
200,220,230,240V：No more than 4.0Ω
Earth
Earth terminal
： Earth resistance of no more than 100Ω
Additional earth terminal ： Earth resistance of no more than 100Ω
Heat dissipation into the surrounding air
Stand-by mode
:
100W
Charging mode
:
120W
(Heating value of 1kW: 1kW = about 860 kcal/h.)
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Chapter 2
Outline
2.3.2 EMC ( Electro-Magnetic Compatibility )
This system belongs to Group 1 and Class A equipment in accordance with
EN60601-1-2：2001
The system uses radio-frequency energy for its internal function only and this is
not intended to deliver energy to the patient. However, radio-frequency energy
can affect other highly sensitive equipment.
The system main power line in the clinical site should be connected to the
domestic power sources which are separated from the public main network.
2.4
Conformity to IEC Standards
EN 60601-1 : 1990 +A1 : 1993 + A2 : 1995+A3 :1996
EN 60601-1-1 : 2001
EN 60601-1-2 : 2001
EN 60601-1-3 : 1994
EN 60601-1-4 : 1996 +A1: 1999
EN 60601-2-7 : 1998
EN 60601-2-28 : 1993
EN 60601-2-32 : 1994
EN ISO 10993-1 : 2003
EN 980 : 2003
EN 1041 : 1998
EN ISO 14971：2000
2-4
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2.5
2.5
Classification of equipment
Classification of equipment
The method of protection against electric shock
Internally powered equipment ( when powered by the battery )
Class I equipment ( during charging )
The degree of protection against electric shock
Type B equipment
The degree of protection against harmful ingress of water
Ordinary equipment
CAUTION
The main body of this system is not protected against immersion
of liquid. Never use this unit in a place in which immersion of liquid
may occur. Never spill liquid on the surface or in the inside of this
system. Otherwise, electrical shock may occur. When liquid is split,
contact your nearest authorized Shimadzu service center.
The degree of safety of application in the presence of a flammable
Anesthetic mixtures with air or with oxygen or nitrous oxide
Equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
WARNING
Risk of explosion if used in the presence of flammable anesthetics.
The mode of operation
Continuous operation with intermittent loading
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Chapter 2
2.6
Outline
Safety Symbols for System
Safety symbols displayed on the system are described below:
Symbol
Location
Meaning
In name plate on covers
Alternating current
Inside the instrument, where wiring
Earthing function
earth conductor is connected
Inside the instrument, where the
Protection earthing
protective earth conductor in the
power cord is connected
In the name plate on covers
Safety classification:
Type B
On the power supply panel
Power on
On the power supply panel
Power off
On warning/caution labels
Attention:
Refer to Operation Manual
2-6
Inside X-ray tube cover
Risk of electric shock
On X-ray tube cover
Ionizing radiation
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Chapter
3
Descriptions of Each Part
Chapter Contents
3.1
Outside View
3.2
X-ray Control Panel
3.3
Power Supply Panel
3.4
Hand Switch
3.5
Driving Handle Section
3.6
X-ray Tube Operating Section and Collimator
3.7
operation handle
3.8
Tube arm Joint Section
3.9
Main Circuit Breaker and Additional Protective Electrical Earthing
Wire
3.10 Cassettebox
3.11 Apron hanger
3.12 Switch for activating the emergency brake release function
3.13 Operational state indicator lamp
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Chapter 3
3.1
Descriptions of Each Part
Outside View
The outside view and each parts identification of the system are shown in
Fig. 3- 1.
X-ray tube assembly
Tube Arm
Support stand
Collimator
X-ray control panel
Driving handle
Power supply panel
Hand switch
Cassette box
Fig. 3- 1
3-2
Mobile Art Plus Operation Manual
Outside view of the system