MobileArt Evolution Operation Manual Rev A

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 per the following: Mark

Description

States a direct danger that may cause death or serious injury if it is not avoided.

States an indirect or potential danger that may cause death or serious injury if it is not avoided.

States a danger that may cause slight or medium injury or may cause damage in equipment or fire if it is not avoided.

States information which helps to use the system correctly.

*

Provides useful information about operation of this system. Please read the description when required.

^ Reference

Provides reference information.

Revision History Revision

Date

First Edition

Apr. 2009

Changes ⎯ Added "CXDI-55G/55C and 60C", "8.9 Manufacturer Information", "9 FPD Upgrade", "9.5.3 Second FPD Kit", "9.5.4 FPD Bag".

A

Nov. 2009

Correct "2.4 X-Ray Control Panel", "3.3 Moving the System", "3.6 X-Ray Radiography", "4.1 User Settings", "4.3 Changing Anatomical Program Parameters", "8.1 Environmental Conditions of EMC (Electro-Magnetic Compatibility)", "8.2 Specifications", "8.3 Dimensional Drawings", "8.6 Anatomical Program", "8.7 Labels", "8.8 Statement of Compliance [For Europe]", "9.1 Overview of FPD Upgrade", "9.2 Part Names and Descriptions", "9.3 Basic Operation", "9.5 Optional Features".

Preface Thank you for purchasing Shimadzu's mobile X-ray system, the MobileArt Evolution High Power Type (32 kW) (herein referred to as "the system"). This Operation Manual is designed to explain the correct operation of this system. Be sure that you have fully read and understood this Operation Manual prior to using the system. Be sure only to use this system after you have fully read and understood all warnings, cautions, and notes contained in this Operation Manual. This manual does not cover the X-ray tube unit. Read the following manual for the X-ray tube unit and Heating & Cooling Curve: X-ray Tube Unit Model Name

X-ray Tube Unit Document Number

0.7/1.3U163C-36

M535-E318

Be sure to keep this manual nearby for future reference.

Notice All copyrights regarding this material are property of Shimadzu Corporation. All or part of these contents shall not be reproduced or duplicated without the express permission of Shimadzu Corporation. Content of this manual may be changed or improved without warning. Although every possible effort has been made to avoid errors while creating this manual, immediate revision may not be possible in the event that errors or missing information are detected. Screen images and illustrations contained in this manual may differ from those in actual use and are intended for example purposes only. Illustrations may also use partial images.

Copyright Mobile Art and Mobile DaRt are registered trademarks of Shimadzu Corporation. This manual does not use the TM or the ® symbol.

©2009 Shimadzu Corporation. All rights reserved.

Preface

Operating Precautions

"Operating Precautions (for Both Safety and the Prevention of Danger) in the Use of Electric Medical Equipment"

1.

Only an experienced technician 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 sulphur gas. (3) During transportation and operation of the equipment, avoid tilting, vibration and sharp impact against it. (4) Keep the equipment away from 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.

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1 4.

While operating the equipment, pay attention to the following items:

1

(1) Do not 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.

1

(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.

1

After operating the equipment, pay attention to the following items: (1) Turn off the switches and return the dial to their original positions before use in the prescribed order. Then, turn off the main power switch.

1

(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 water.

(ii)

Store it away from potential causes of problems such as abnormal pressure, temperature and humidity, draft, direct sunlight, dust, chlorine or sulphur gas.

1

(iii) During transportation and storage of the equipment, avoid tilting, vibration and sharp impact against it.

1

(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.

1

(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 a Shimadzu service representative for repair.

7.

Do not modify any part of the equipment.

8.

Preventive maintenance

1 1

(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.

1

Concerning other items, operate properly according to the operation manual.

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Preface

Precautions in Use When using this equipment, please observe the following precautions for the safety of the operator and patient.

The responsibility for management of use and maintenance of medical equipment lies in a user. This device is restricted to use by, or under supervision of, a diagnostic radiology technician or a person with a certificate indicating equal proficiency. Repair and inspection of the inside of the equipment is dangerous. Make sure to contact our service agency for repair and inspection.

NEVER MODIFY THE EQUIPMENT! In general, 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 necessary to modify the device.

PERFORM PERIODIC INSPECTION! Preventive maintenance is required to maintain long-term safety and performance of this system. This manual gives detailed description of occasional and periodic maintenance and inspection that a user should perform. As to the maintenance and inspection that specially trained specialists exclusively can perform, utilize the maintenance agreement offered by our company.

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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.

1 1

If the operator has no experience in operating the equipment, be sure that he or she receives instruction on how to operate it from our engineers or someone who has enough experience to use the equipment.

1

In order to operate the equipment safely, an explanation of the operation needs to be lectured. When installing the equipment, our engineers explain the operating procedure using this operation manual. Follow their directions and operate the equipment correctly.

1

^ Reference "1.5 Operator Profile" P.1-7

1 1

Be sure to Read the Safety Items to Prevent from Explosion or Electric Shock

1 1

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.

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Preface

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.

This equipment has no protection against exposure to liquids. Do NOT operate this equipment at places with fear of exposure to liquids, otherwise electric shock may result. Pay attention so as not to spill liquids on the surface or the inside of this equipment. In case of liquid spillage on the equipment, stop the operation of the equipment at once, and contact our service department.

In case when any abnormality is found with the system operation, stop your operation at once and contact our service agents. Please leave the whole repair and inspection of the system to them.

Do NOT open the covers and so forth, otherwise electric shock may result.

Grounding Connect the power cable plug to a 3-pin grounded socket.

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Collision and Entanglement Operator or patient injury can occur if a body part becomes caught between the arm and the system's main unit. During arm movement, be sure to hold the specified position and operate the system carefully.

1 1

Charge the battery in a well-ventilated room. Do NOT cover the system while charging the battery.

1 1

Cautions on Use and Storage

1 Abide by the conditions for correct use and storage.

1

The locations where this system is used and stored must meet the following conditions. • Atmosphere:

No explosive or corrosive gases

1

• Using/Storage temperature: 10 to 40 °C (only with FPD upgrade: 10 to 35 °C) • Relative humidity: 30 to 85% (only with FPD upgrade: 30 to 75%) (no condensation) • Atmospheric pressure:

1

700 to 1060 hPa

1

Note also that there must be no sudden changes in temperature or humidity. This causes condensation, which can lead to trouble.

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Preface

Cautions on Cleaning and Disinfection

Be sure to turn OFF the system power before cleaning and disinfecting the system. Otherwise, a malfunction may occur in the system, or the system may operate in an unintended way.

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.

Do NOT apply disinfectant directly, or spray it, onto the system. If disinfectant gets inside the system, it can cause trouble or accidents.

Do NOT use an organic solvent. The organic solvent may change the surface in color. If adherent, wipe out the organic solvent immediately.

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Cautions Relating to Cellular Telephones

1 1

Do NOT bring cellular telephones or related devices into the examination room.

1

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.

1 1

Cautions on the Compatibility of Electromagnetic Fields

1 1

MobileArt Evolution High Power Type (32 kW) needs special precautions regarding EMC. The system needs to be installed and use according to the EMC information provided in this operation manual.

1

^ Reference "8.1 Environmental Conditions of EMC (Electro-Magnetic Compatibility)" P.8-2

1 1

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.

1

^ Reference "8.1 Environmental Conditions of EMC (Electro-Magnetic Compatibility)" P.8-2

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MobileArt Evolution High Power Type (32 kW) should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, MobileArt Evolution High Power Type (32 kW) should be observed to verify normal operation in the configuration in which it will be used. ^ Reference "8.1 Environmental Conditions of EMC (Electro-Magnetic Compatibility)" P.8-2

Cautions on Radiation

Do NOT allow operation of this apparatus by any person other than qualified personnel (physicians, radiotherapy engineers and clinical Xray engineers) or under observation by them.

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 control X-ray irradiation from a distance over 2 m from the focal spot and the X-ray beam and also must take adequate measures to protect themselves against radiation. During X-ray exposure, the status indicator lamp will illuminate, and a sound is emitted.

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1 1

In order to minimize the absorbed dose, make the focal spot to distance as long as possible. (Minimum 45 cm)

1 1 Be sure to carry out aging before taking an X-ray radiograph. Before taking an X-ray radiograph, running-in operation of the X-ray tube unit called "aging" is required.

1

^ Reference "3.2 Aging the X-Ray Tube Unit" P.3-6

1 1

Avoid unnecessary standby situations. In exposure, if a standby situation continues with the exposure ready key pressed, wire disconnection or dielectric strength failure may result owing to the vaporization of the X-ray tube filament.

1 1

After the X-ray tube unit is used for a long time at a relatively low tube voltage (below 80 kV), if it is used in the range near the nominal highest tube voltage (100 kV or more), discharge may result. This is an accidental arc caused by the weakened aging effect at high tube voltage after the X-ray tube unit is used for a long time at a lower tube voltage. In this case, carry out the aging procedure described in Chapter 5 before operating the apparatus.

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Preface

System Movement Cautions

When moving the arm unit or system, the operator must pay close attention to ensure that the limbs of both operator and patient are not caught between the system and any peripheral units. Be especially careful when near a wall, changing the direction of the system or moving it backwards.

Avoid collisions and overturning. Collisions and overturning can not only damage the system, but can also cause serious injury. Be careful of the following points when moving the system: • When on a slope, in an entrance, or encountering obstacles, move the system as slowly as possible. Be especially careful when descending/ ascending a steep slope. • Do NOT move the system on a slope steeper than 7 degrees or over steps higher than 2 cm. When stopping the system, always park the system on a level place, avoiding slopes, since there is a danger of the system rolling down the slope and overturning. • Moving the system along surfaces that cause strong vibrations, such as roads outdoors, over large steps and down steep slopes is dangerous. Avoid these if possible. Do NOT stop the system on a slope. • When moving the system, look out for any obstacles in front of it.

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Scope of Software License (Only with FPD Upgrade)

1 1

Do NOT change any of the OS settings.

1

The system uses Windows XP as its operating system (OS). If the OS settings are changed, the system operation is not guaranteed.

1 1.

1

Definition of licensed software The licensed software ("software") refers to all computer programs used by the system, in addition to all related documentation.

2.

1

Ownership of license The software used in this system is copyrighted by Shimadzu Corporation ("Shimadzu"), who possesses all rights, including sublicenses for those rights (for copyrights, etc.) held by third parties.

1

The system with the installed software is sold on the basis of Shimadzu licensing the software ownership to the customer. Accordingly, when the customer uses the software, they must observe the items outlined below:

1

(1) The customer shall only use the software for use with a single system. (2) The intellectual property rights for the software are not transferred to the customer.

1

(3) The customer, or any third party, is prohibited from performing any of the following actions: • • • •

Duplicating the software. Changing the software, in whole or part. Transferring, loaning, or sublicensing the software. Transferring the software outside Japan without the prior permission of the Japanese or U.S. government.

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Preface

Data Security (Only with FPD Upgrade)

xiv

•

If individual data stored in the system is either lost or destroyed, Shimadzu may provide system maintenance to prevent future data loss. Shimadzu does not guarantee the retrieval of any lost or damaged data.

•

Data stored in the system is always subject to the risk of loss or damage. Loss of or damage to data may result from system failure or malfunction, and may also arise as a result of the deterioration of part performance due to age. To avoid data loss or damage, users are recommended to save all essential data to a hard media, such as film, or store it on an external file system. Data stored on external file systems are also subject to the risk of loss or damage. Regularly check the contents of data stored on external file systems.

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Precautions Regarding Connection with an External Device (Only

1

with FPD Upgrade)

1 1

Do NOT connect any other electrical device to the LAN connector and the USB connector of the equipment except following electrical devices:

1

• Medical electrical devices which conform to IEC60601-1 • Non-medical electrical devices which conform to related IEC safety standards

1

• Non-medical electrical devices which have safety equal to devices which conform to IEC safety standards In addition, please note the following: 1.

2.

When connecting medical electrical devices which conform to IEC60601-1

1

Connect the equipment and a connected device with a common protective ground, or connect an additional protective ground of the connected device when that device is in a room not used for treatment and diagnosis (office and storage room, etc.).

1

When connecting other electrical devices

1

(1) Connect an additional protective ground of the connected device, or supply electrical power to the connected device from an isolated power source when the connected device is in the room used for treatment and diagnosis.

1

(2) Connect the equipment and a connected device with common protective ground, or connect an additional protective ground of the connected device when that device is in a room not used for treatment and diagnosis (office and storage room, etc.).

1

Table. Necessary measures when connecting electrical device to this equipment Location of Connected Device

1

Connected Device Diagnosis and Treatment Room Medical electrical devices which conform to IEC60601-1

Other electrical devices

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Other

⎯⎯⎯⎯⎯⎯ Additional protective ground or power supply from an isolated power source

1

Common protective ground or additional protective ground or separation device

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Guarantee The guarantee period of this system is one (1) year from the date of purchase.

Shimadzu bears no responsibility for loss of or damage to data, or for any of the failures or systemrelated damage due to the following reasons:

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 caused by natural disaster such as fire, earthquake, flood and thunder.

5.

Installing the system in vehicles, ships, or aircraft, without Shimadzu's permission.

6.

Use of the system in countries not specified by Shimadzu.

7.

Purchasing of the system from dealers other than Shimadzu or Shimadzu's authorized distributors.

8.

Collisions, falls or strong impacts.

9.

Failure/damage caused by not following the cautions and operation instructions described in this Operation Manual or in the Operation Manual for Canon parts to be used for FPD upgrade.

10. Failure/damage caused by ambient or environmental conditions far from the area of instrument usage (power source and installation requirements) described in this Operation Manual or in the Operation Manual for Canon parts to be used for FPD upgrade. 11. Failure/damage caused by installing software or connecting peripheral devices not specified by Shimadzu if FPD is upgraded. 12. Failure/damage caused by changing or deleting the basic software's configuration files (autoexec.bat, config.sys, etc.) or DR system specialuse files if FPD is upgraded.

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Shimadzu bears no responsibility for any failure or damage of the Canon CXDI-50G/50C/55G/55C/ 60G/60C due to the following reasons, especially if FPD is upgraded.

1.

Hitting or dropping the CXDI-50G/50C/55G/55C/60G/60C sensor.

2.

One or more of the four shock detectors changed color to red.

3.

Overloading the unit beyond the specified range.

4.

Leakages of water, solutions, or large quantities of blood on the unit.

5.

Not following the operating procedure stipulated in the Operation Manual.

6.

Use of the unit for purposes other than its intended use.

7.

Making alterations to the unit.

8.

Environmental pollution, fire, and natural disasters such as earthquakes, flooding, lighting, as well as power supply problems.

1 1 1 1 1 1

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

1

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. It is 7 years if FPD is upgraded.

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Action for Environment (WEEE) To all users 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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