MobileArt Plus MUX-100H Operation Manual Rev H

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.

Mobile Art Plus Operation Manual

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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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Mobile Art Plus Operation Manual

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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Mobile Art Plus Operation Manual

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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Mobile Art Plus Operation Manual

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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Mobile Art Plus Operation Manual

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

11

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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7-2 7-3

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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Mobile Art Plus Operation Manual

Chapter

1

Introduction

Chapter Contents Introduction

Mobile Art Plus Operation Manual

1-1

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

Mobile Art Plus Operation Manual

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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2-1

Chapter 2

Outline

2.1 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

Use Conditions

2.3 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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