2415169-100 OM-En-Rev 6

GE Healthcare

EverView 7500 C-Arm X-Ray Imaging System Operator Manual

0459

2415169-100 Rev 6 © 2005, 2006, 2007, 2008 GE HUALUN Medical Systems All Rights Reserved

Revision History Rev

Date

0 1 2 3 4 5 6

July Nov Feb Sep Mar Jan Jun

CAUTION

Change Description 2005 2005 2006 2006 2007 2008 2008

Initial Release Add labels Update for M3 to M4 design change Update for M4 to M5 design change Update for M4 to M5 design change Update for M4 to M5 design change Update contents

US Federal law restricts this device to sale by, or on the order of , a physician.

IMPORTANT SAVE THESE INSTRUCTIONS. . PLEASE READ THIS MANUAL BEFORE USING EverView 7500 C-Arm X-Ray Imaging System. This manual may not be reproduced, in whole or in part, without the written permission of GE Healthcare. Other product and company names mentioned herein are the property of their respective owners. The contents of this document are accurate at the time of publication. However, changes in design and additional features can, at any time, be incorporated in the hardware and software and may not be reflected in this version of the document. Contact GE Healthcare Technical Support for clarification, if discrepancies arise. The text of this manual was originally written, approved and published by the manufacturer in English. GE HUALUN Medical Systems Co. Ltd, a General Electric company, going to market as GE Healthcare. GE HUALUN Medical Systems Co. Ltd No. 1 Yongchang North Road Beijing Economic & Technological Development Area Beijing, P.R. China 100176 Tel: 8610-58068888 Fax: 8610-67881850

Page ii

Table of Contents

REGULATORY REQUIREMENTS This product complies with the regulatory requirements of the following: Council Directive 93/42/EEC concerning medical devices: the CE 0459 label affixed to the product testifies compliance to the Directive. The location of the CE 0459 label is described in page 6-8. European registered place of business: GE Medical System Europe Quality Assurance and safety Regulatory Manager BP34 Address: 283 Rue de la Miniere 78533 Buc Cedex France Tel:+33 (0) 1 30 70 40 40 International Electrotechnical Commission (IEC), international standards organization, when applicable.

Page iii

EverView 7500 C-Arm X-Ray Imaging System

Table of Contents

Chapter 1

Introduction and Safety............................................ 1-1

1.1 1.2

Overview ............................................................................................................................ 1-2 Owner Responsibilities................................................................................................. 1-2 1.2.1 System Compatibility........................................................................................... 1-2 1.2.2 Operator Qualifications...................................................................................... 1-2 1.2.3 Continued Compliance ....................................................................................... 1-2 1.2.4 Unauthorized Modifications ............................................................................. 1-2 1.3 GE HUALUN Responsibilities...................................................................................... 1-3 1.3.1 X-ray Equipment Certification ......................................................................... 1-3 1.3.2 After-sale Operating and Safety Practices ................................................ 1-3 1.4 Communication Center Telephone Numbers and Fax.................................. 1-3 1.5 Safety Hazards ................................................................................................................ 1-4 1.5.1 Safety Hazard Alerts ............................................................................................ 1-4 1.5.2 Emergency Procedures....................................................................................... 1-4 1.5.3 Explosion ................................................................................................................... 1-5 1.5.4 Implosion................................................................................................................... 1-5 1.5.5 Equipment Stability and Positioning ............................................................. 1-5 1.5.6 Motorized Mechanical Movement ................................................................. 1-6 1.5.7 Improperly Attached Equipment .................................................................... 1-6 1.5.8 Electrical Shock ...................................................................................................... 1-6 1.5.9 Electrical Fire ........................................................................................................... 1-7 1.5.10 Ground Fault ................................................................................................... 1-7 1.5.11 Improper Access ........................................................................................... 1-7 1.6 Radiation Exposure ....................................................................................................... 1-8 1.6.1 General Protection................................................................................................ 1-8 1.6.2 Source-to-Skin Distance..................................................................................... 1-8 1.7 Ingress of Fluids .............................................................................................................. 1-8 1.8 Cooling Efficiency........................................................................................................... 1-8 1.9 Burns.................................................................................................................................... 1-9 1.10 Electromagnetic Compatibility Statement ......................................................... 1-9 1.11 Equipment Malfunction .............................................................................................1-15 1.12 External Devices ...........................................................................................................1-15 1.13 Patient Environment ...................................................................................................1-16 1.13.1 Within the United States .........................................................................1-16 1.13.2 Outside the United States.......................................................................1-16

Chapter 2 2.1

Operating Controls and Indicators...................... 2-1

System Overview............................................................................................................ 2-2 2.1.1 General Description.............................................................................................. 2-2 2.1.2 Components Identification of C-Arm ........................................................... 2-4 2.1.3 Components Identification of Workstation ............................................... 2-6 2.2 Overview ............................................................................................................................ 2-8 2.3 System Start-up.............................................................................................................. 2-8 2.4 Control Panel of the Console..................................................................................... 2-9 Page iv

Table of Contents

2.5 2.6 2.7 2.8

2.4.1 System On / Off Controls and Indicators ................................................. 2-10 2.4.2 Controls and Indicators in fluoroscopy mode........................................ 2-11 2.4.3 Controls and Indicators in Radiography mode ..................................... 2-13 2.4.4 Collimator Control .............................................................................................. 2-14 2.4.5 The recursive factor key and indicators ................................................... 2-14 2.4.6 Image Intensifier Field Size............................................................................. 2-15 2.4.7 Image Orientation .............................................................................................. 2-15 2.4.8 Vertical Column Operation ............................................................................. 2-16 Modes of Operations.................................................................................................. 2-17 2.5.1 Modes and Keys .................................................................................................. 2-17 2.5.2 Imaging Modes Summary............................................................................... 2-18 Radiography .................................................................................................................. 2-21 2.6.1 Overview................................................................................................................. 2-21 2.6.2 Setup and Making a Film Exposure ............................................................ 2-21 Footswitch and HandSwitch .................................................................................. 2-22 WorkStation Controls................................................................................................. 2-23 2.8.1 Overview................................................................................................................. 2-23 2.8.2 Workstation Keyboard...................................................................................... 2-23

Chapter 3 3.1

3.2

3.3

3.4

3.5

Software Instructions ................................................ 3-1

Patient Management .................................................................................................... 3-2 3.1.1 Overview.................................................................................................................... 3-2 3.1.2 Add a New Patient................................................................................................. 3-3 3.1.3 Select and review a saved patient................................................................. 3-7 3.1.4 Delete a saved patient ..................................................................................... 3-11 3.1.5 Edit a saved patient ........................................................................................... 3-12 Image Producing.......................................................................................................... 3-14 3.2.1 Capture an Image............................................................................................... 3-14 3.2.2 Saving Images...................................................................................................... 3-15 3.2.3 Process Images.................................................................................................... 3-16 Image Review and Archive...................................................................................... 3-17 3.3.1 Overview................................................................................................................. 3-17 3.3.2 Image Directory................................................................................................... 3-17 3.3.3 Retrieve a Saved Exam Image ...................................................................... 3-19 3.3.4 Image Review ....................................................................................................... 3-21 3.3.5 Archive Images .................................................................................................... 3-23 3.3.6 Delete Image......................................................................................................... 3-40 Customize ....................................................................................................................... 3-41 3.4.1 Overview................................................................................................................. 3-41 3.4.2 Customize Screen ............................................................................................... 3-41 3.4.3 Workstation Options Screen .......................................................................... 3-42 3.4.4 Time and Date...................................................................................................... 3-43 3.4.5 Adjust Contrast/Brightness ............................................................................ 3-44 3.4.6 Change Language.............................................................................................. 3-45 3.4.7 Help ........................................................................................................................... 3-47 3.4.8 About ........................................................................................................................ 3-48 3.4.9 WorkStation Shut Off (F12).............................................................................. 3-49 Print Function ................................................................................................................ 3-50

Page v


Chapter 4

Mechanical Movement.............................................. 4-1

Chapter 5

Maintenance.................................................................. 5-1

4.1

Mechanical Movement of C-Arm ............................................................................ 4-2 4.1.1 C-Arm rotation........................................................................................................ 4-2 4.1.2 Orbital Movement.................................................................................................. 4-3 4.1.3 Horizontal Movement .......................................................................................... 4-4 4.1.4 Wig-Wag Movement............................................................................................ 4-5 4.1.5 Vertical Movement................................................................................................ 4-6 4.1.6 Mobil C-Arm Steering Handle........................................................................... 4-7 4.2 Wheel Brakes of Mobil C-Arm................................................................................... 4-8 4.3 Wheel Brakes of WorkStation.................................................................................4-10 4.4 Moving the C-Arm and WorkStation....................................................................4-11

5.1 5.2

Overview ............................................................................................................................ 5-2 Performance Checks .................................................................................................... 5-3 5.2.1 Mechanical Performance Check..................................................................... 5-3 5.2.2 Electrical Performance Check.......................................................................... 5-3 5.2.3 Emergency Stop Performance Check .......................................................... 5-4 5.2.4 Fluoro Mode Performance Check................................................................... 5-5 5.2.5 Radiographic Mode Performance Check.................................................... 5-5 5.3 Planned Maintenance and User Checks.............................................................. 5-6 5.3.1 Planned Maintenance Items ............................................................................ 5-6 5.3.2 User Routine Checks Items ............................................................................... 5-7 5.4 Cleaning and Disinfections ........................................................................................ 5-8 5.4.1 Cleaning..................................................................................................................... 5-8 5.4.2 Disinfections ............................................................................................................ 5-9 5.5 Fault Isolation ................................................................................................................5-10 5.5.1 Overview..................................................................................................................5-10 5.5.2 Fault Isolation........................................................................................................5-10

Chapter 6

Labels and Symbols.................................................... 6-1

Chapter 7

Technical Reference................................................... 7-1

6.1 6.2

Overview ............................................................................................................................ 6-2 Labels and Location...................................................................................................... 6-2 6.2.1 Overview.................................................................................................................... 6-2 6.2.2 Labels.......................................................................................................................... 6-3 6.2.3 Location of the labels .......................................................................................... 6-8 6.3 Symbols ............................................................................................................................6-10

7.1 7.2

Overview ............................................................................................................................ 7-2 System Specifications.................................................................................................. 7-2 7.2.1 Classification Type ................................................................................................ 7-2 7.2.2 Power Requirements............................................................................................ 7-2 7.2.3 Dimensions and Weights................................................................................... 7-3 7.2.4 Filtration..................................................................................................................... 7-3 7.2.5 Ambient Conditions .............................................................................................. 7-3 7.3 Specification of Key Components .......................................................................... 7-4

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Table of Contents

7.4 7.5 7.6

7.7 7.8

7.3.1 Generator .................................................................................................................. 7-4 7.3.2 X-ray Tube................................................................................................................. 7-4 7.3.3 Camera Output Video Signal ............................................................................ 7-5 7.3.4 Collimator.................................................................................................................. 7-5 7.3.5 C-Arm Movement................................................................................................... 7-5 7.3.6 Others.......................................................................................................................... 7-6 Tube Rating Charts ........................................................................................................ 7-7 Scatter Radiation Chart ............................................................................................ 7-11 Options ............................................................................................................................. 7-12 7.6.1 Sony Thermal printer......................................................................................... 7-12 7.6.2 DAP(Dose Area Product) (Option 1).............................................................. 7-13 7.6.3 DAP(Dose Area Product) (Option 2).............................................................. 7-14 7.6.4 Film Cassette Dimensions............................................................................... 7-15 Material Safety Data sheets .................................................................................. 7-15 Material recycling........................................................................................................ 7-15

Chapter 8 8.1 8.2 8.3 8.4

8.5

Options ............................................................................. 8-1

Cassette Holder Installation ...................................................................................... 8-2 8.1.1 Cassette Holder Installation.............................................................................. 8-2 8.1.2 Cassette Holder For Metric Casstette........................................................... 8-3 Sony UP-D897 (Option)................................................................................................. 8-4 KermaX plus DAP (Dose Area Product) (option 1)............................................. 8-4 KermaX plus C DAP (Dose Area Product) (option 2)........................................ 8-6 8.4.1 Main Functions........................................................................................................ 8-6 8.4.2 Measurement .......................................................................................................... 8-7 8.4.3 Quality Assurance Tests...................................................................................... 8-8 30 cm Spacer Replacement....................................................................................... 8-9

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Page viii

Chapter 1

Introduction and Safety


1.1 Overview This manual describes operation for EverView 7500 C-Arm X-Ray imaging system only. It is intended for qualified medical personnel who have been trained in the use of medical imaging equipment. It is not designed to replace or substitute for certified training in the radiological or medical field. Functional capabilities and operation of the equipment are described here which can be used in a variety of diagnostic and surgical applications.

1.2 Owner Responsibilities The owner has the responsibility to ensure system compatibility, operator qualifications and the continued compliance of equipment and operating specifications. Systems should only be used in designated use areas with approved AC receptacles. Unauthorized changes or modifications to any part of the system could have hazardous consequences. Changes or modifications must not be made unless specifically authorized by GE HUALUN Medical Systems Co,Ltd.

1.2.1

System Compatibility

Damage may result to the system if incompatible components are connected. Read your operator manual thoroughly prior to connecting components that you are not certain are compatible.

1.2.2

Operator Qualifications

It is the responsibility of the owner to ensure that the system is operated only by properly trained , qualified personnel who have obtained credentials from the appropriate authorities.

1.2.3

Continued Compliance

The owner is responsible for verifying continued compliance with all applicable regulations and standards. Consult local, state, federal and/or international agencies regarding specific requirements and regulations applicable to the use of this type of medical electronic equipment.

1.2.4

Unauthorized Modifications

When properly assembled this equipment meets US Federal regulations and International standards. Unauthorized modifications to the equipment may impact adherence to these standards and make the equipment unsafe to operate. Never make any modifications or adjustments to the equipment unless directed by a qualified GE Healthcare representative.

CAUTION

Page 1-2

Federal law restricts this device to sale by, or on the order of, a physician.


1.3 GE HUALUN Responsibilities GE HUALUN Medical Systems, Co.Ltd certifies each system and X-ray source assembly. After-sales operating practices and safety are the responsibility of the owner/operator.

1.3.1

X-ray Equipment Certification

GE HUALUN Medical Systems, Co.Ltd certifies that when assembled according to manufacturer's instructions, the X-ray equipment complies with the US Federal Performance standard 21 CFR Subchapter J and applicable international standards.

1.3.2

After-sale Operating and Safety Practices

GE HUALUN Medical Systems, Co.Ltd assumes no responsibility or liability for after-sale operating and safety practices; nor can it be responsible for personal injury or damage resulting from misuse of its systems.

1.4 Communication Center Telephone Numbers and Fax If the system does not operate properly or fails to respond to the controls as described in your operator’s manual, call GE HUALUN Medical Systems, Co.Ltd to request service. The communication center's telephone and fax numbers are listed below: GE HUALUN MEDICAL SYSTEMS CO. Ltd. No 1 Yong Chang North Road Beijing Economic-Technological Development Area 100176 Beijing CHINA. P.O. : 100176 Tel:

8610-58068888

Fax: 8610-67881850 Hot Line: 800-810-8188, 8610-67882652 European Representative: GE Medical System-Europe Address: 283 Rue de la Miniere 78533 Buc Cedex France You may also call or fax these numbers to order circuit diagrams, component part lists, calibration instructions or other information which will assist qualified service engineers to repair the system.

Page 1-3


1.5 Safety Hazards Potential hazards exist in the use of EverView 7500 C-Arm X-ray Imaging system. Operators using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided. The following pages describe hazardous and potentially hazardous conditions, and how to adequately protect yourself and others from possible injury.

1.5.1

Safety Hazard Alerts

Before operating the equipment, please read this manual thoroughly, paying particular attention to all warnings, cautions and notes incorporated herein. There are three classifications of alerts, which are denoted and prioritized as follows:

WARNING

CAUTION

NOTE

1.5.2

WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION indicates a potentially hazardous situation which, if not avoided, may result in moderate to minor injury, equipment damage or loss of data. NOTE is given in situation requiring special attention.

Emergency Procedures

When emergency situation occurs, press the emergency pushbutton on the console of C-Arm. The system will stop the emission of X-ray and the motorized movement of the column. The fault indicator will light up. The display of kV will be 40kV, and that of mA will be 0.1mA. To reset the system, the following steps should be followed: 1. Press the system power off key. You should Press F12 on the WorkStation keyboard at first to shut off the WorkStation. After the monitor turns off, you can press the system off key to power off the system.

NOTE

2. Insert the share key in the hole then rotate it (Rotate the emergency pushbutton upward) in the direction according to the arrow on the pushbutton. 3. Press the system power on key to reboot.

Page 1-4


If the emergency pushbutton fails to work, disconnect the power cord. Disconnection of the power cord is the only means available to ensure that the supply power is completely removed from the system.

WARNING

NOTE

Reserve the share key carefully in case the system could not be reset.

1.5.3

Explosion

WARNING

The system is not designed for use in explosive atmosphere (e.g. anesthetic gases).

EverView 7500 system complies with the requirements of IEC 60601-1 . If an abnormal condition occurs, such as the room fills with flammable gas, steps must be taken to prevent the gas from coming in contact with the equipment. Follow these guidelines: •

Do not turn the system off or unplug it from the AC receptacle.

•

Do not operate any other electrically powered equipment.

•

Evacuate all personnel from the area and ventilate with fresh air. Avoid operating any automated (electrically operated) doors or windows.

•

Contact your local fire department as soon as possible.

1.5.4

Implosion

EverView 7500 system has several Cathode Ray Tubes (CRT) .Do not locate objects so that they might fall and strike the tube causing it to implode. Use caution when working around the tubes. The coating on the glass can also produce toxic dust and fumes. If a CRT implodes: •

Remove power immediately.

•

Evacuate the area.

•

Contact an appropriate staff member that is familiar with hazardous material disposal.

•

Request service to replace the monitor.

1.5.5

Equipment Stability and Positioning

EverView 7500 X-Arm X-Ray Imaging system is mounted on wheels. If it is moved or operated improperly it could roll out of control. Follow these guidelines: •

Two people should maintain control of the equipment when moving up or down an incline.

•

Place all mechanical assemblies in their most compact (transport) position and lock brake handles prior to moving the equipment. Refer to chapter 6 for detailed information of transportation label.

•

Use the handles designed for moving the equipment and mechanical assemblies.

Page 1-5


•

Never attempt to move the system up or down steps.

•

Do not operate the equipment on unlevel floors.

•

Do not lock the wheel brakes and leave the equipment unattended on unlevel floors.

•

Always apply the wheel locks when the system is in its final position.

•

Do not move the equipment if the casters or wheels are not functioning properly.

•

Mechanical shocks to the equipment while disk drives are accessing information may cause damage to the disk drive.

1.5.6

Motorized Mechanical Movement

EverView 7500 C-Arm X-Ray imaging system has motorized mechanical assemblies. Please follow these guidelines: •

Always observe mechanical assemblies when operating the motor to avoid pinching or collision with a person or object.

•

Take care when working around equipment to avoid unintentional motor actuation. Do not carelessly place objects on the equipment or bump or lean against the equipment.

•

Observe and prevent articles of clothing from getting caught in moving parts.

1.5.7

Improperly Attached Equipment

EverView 7500 C-Arm X-Ray Imaging System accommodates a film cassette holder and some other piece of equipment that can be attached or removed. Please follow these guidelines: •

Use only equipment supplied by GE HUALUN Medical Systems Co.,Ltd.

•

Attach the equipment properly. Incorrectly attached equipment could fall, causing injury to the patient or operator.

NOTE

1.5.8 WARNING

WARNING

Refer to the Technical Reference Chapter for the correct dimensions of items that may be used in conjunction with this equipment, such as radiographic film cassettes.

Electrical Shock Electrical circuits inside the equipment may use voltages which are capable of causing serious injury or death from electric shock. To avoid this hazard, never remove any of the cabinet covers. EverView 7500 C-Arm X-Ray imaging system is not waterproof. If water, soap or other liquids drip into the equipment, this can cause short circuit leading to electric shock and fire hazards. If liquids are accidentally spilled into the system, do not power or turn on the system until the liquids dry or evaporate completely.

Observe the following safety procedures to avoid electric shock or serious injury to operators and patients and to avoid system malfunction. •

Make all electrical connections to equipment while outside the patient environment. Do not touch a connector and the patient at the same time.

•

Do not bypass, jumper or otherwise disable the safety interlocks.

Page 1-6


•

Do not remove any of the assembly covers. Only trained service representatives should perform repairs.

•

Do not place food or beverage containers on any part of the equipment. If spilled they can cause short circuits.

•

Always remove power to the equipment before cleaning. Use a slightly damp cloth or sponge for cleaning.

•

Only qualified service engineers are allowed to service or repair a system.

1.5.9

Electrical Fire

In the event of electrical fire perform the following emergency procedure: NOTE

Any emergency procedure developed by the owner, for the area in which the system is used, should include these safety measures:

•

Remove electrical power to the system by placing the power switch in the off position.

•

Unplug the power cord from the AC receptacle.

•

Evacuate personnel from the area.

•

Only use a fire extinguisher that is approved for use on electrical fires.

•

Call your local fire department for help if necessary.

WARNING

1.5.10

The use of the wrong type of fire extinguisher presents electrical shock and burn hazards. To avoid these hazards, a fire extinguisher which meets applicable egulations and standards must be available in the room where the equipment is being used.

Ground Fault

If the operating room has a ground fault alarm and the alarm is actuated: •

Do not operate the system.

•

Call a qualified service technician.

1.5.11

WARNING

Improper Access Improper access into the cabinet and covers of the system may cause injury to your hand or fingers.

Page 1-7


1.6 Radiation Exposure 1.6.1

General Protection

WARNING

This equipment produces ionizing radiation. Observe proper safety practices during operation.

•

The owner must designate areas suitable for safe operation and service of the equipment and ensure they are only used in those areas.

•

The owner must ensure that all personnel wear appropriate protective clothing and radiation monitoring devices while using the equipment.

•

Remain alert for visual indicators and audible alarms that are activated when ionizing radiation is being produced by equipment in the work area.

1.6.2

Source-to-Skin Distance

International regulations specify that a minimum source-skin distance be maintained, except for specific surgical applications. EverView 7500 C-Arm X-Ray imaging system has a skin spacer attached in order to meet this requirement. The system is prefabricated with a 20 cm spacer. A 30 cm spacer is provided by the manufacture. For the replacement information, please refer to section 8.4 for details. WARNING

Keep as far as possible away form the X-Ray source. Removing the skin spacer may result in increased radiation exposure to the patient. The rate of exposure increases exponentially as the anatomy is positioned closer to the X-ray tube.

The skin spacer should only be removed on the instructions of a physician. The spacer should be reattached to the collimator assembly immediately following the procedure.

1.7 Ingress of Fluids WARNING

The X-ray system is not rated for water-tight operation. If liquids drip into the equipment, disconnect the power cord and do not operate the system until it can be cleaned and inspected by a qualified service engineer.

Excessive amounts of fluids such as antiseptics, cleaning solutions or bodily fluids may damage internal components if they are allowed inside the equipment. Use drapes, if necessary, to protect equipment when performing procedures and do not apply excessive amounts of fluid when cleaning.

1.8 Cooling Efficiency Draping EverView 7500 C-Arm X-Ray imaging system may restrict airflow to components that provide heat sinking and to vents designed to cool the equipment. Drape equipment and cover vents only when exposure to excessive fluids is unavoidable and extended use of the equipment is not required.

Page 1-8


1.9 Burns Extended use of imaging equipment may cause components such as X-ray tubes to reach temperatures capable of inflicting burns. Use care when positioning equipment to avoid placing hot components in close proximity to patients and personnel. An anesthetized or unconscious patient is incapable of sensing and reacting to a hot component.

1.10 Electromagnetic Compatibility Statement This equipment may generate and use radio frequency energy. The equipment must be installed and used according to the manufacturer’s instructions in order to avoid radio frequency interference. If this equipment generates or receives interference do the following to correct the problem: •

Verify that the equipment is the cause by turning the system on and off.

•

In the event of unintended motor actuation, immediately remove power to the equipment.

•

In the event of unintended X-ray actuation, immediately remove power to the equipment.

•

Reorient the equipment until the interference stops.

•

Relocate the equipment with respect to other equipment in the room.

•

Plug the equipment into a different outlet so that the equipment and the receiver are on different branch circuits.

• Use only input/output (I/O) cables supplied by GE HUALUN Medical Systems Co. Ltd. This product conforms with IEC60601-1-2:2001 (ed2) EMC standard for medical devices.

NOTE

This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause or be subject to radio frequency interference with other medical and non–medical devices and radio communications. To provide reasonable protection against such interference, the EverView 7500 system complies with emissions limits for a Group 1, Class A Medical Devices and has applicable immunity level as stated in EN 60601-1-2:2001. However, there is no guarantee that interference will not occur in a particular installation. Special precautions and other information regarding EMC provided in the accompanying documents of this equipment shall be observed during installation and operation of this equipment.

Page 1-9


NOTE

If this equipment is found to cause interference (which may be determined by switching the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s): 1. Reorient or relocate the affected device(s). 2. Increase the separating space between the equipments and the affected device. 3. Power the equipment from a source different from that of the affected device. 4. Consult the point of purchase or service representative for further suggestions.

WARNING

NOTE

Use of accessories, transducers, cables and other parts other than those specified by the manufacturer of this equipment may result in increased emissions or decreased immunity of the equipment. The manufacturer is not responsible for any interference caused either by the use of interconnect cables other than those recommended, or unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment. To comply with the regulations applicable to an electromagn etic interface for a Group 1, Class A Medical Device, and to minimize interference risks, the following requirements shall be applied: 1. All interconnect cables to peripheral devices must be shielded and properly grounded. The use of cables which are not properly shielded and grounded may result in the equipment causing radio frequency interference in violation of the European Union Medical Device directive and FCC regulations. 2. All of those recommended guidance regarding electromagnetic environment shall be followed.

WARNING

Page 1-10

Do not use devices which intentionally transmit RF signals (Cellular Phones, Transceivers, or Radio Controlled Products) in the vicinity of this equipment as it may cause performance outside the published specifications. Keep the power to these types of devices turned off when near the equipment. The medical staff in charge of this equipment is required to instruct technicians, patients, and others.


Guidance and manufacturer’s declaration – Electromagnetic Emissions The EverView 7500 system is suitable for use in the specified electromagnetic environment. The purchaser or user of the EverView 7500 system should assure that it is used in an electromagnetic environment as described below: Emissions Test RF Emissions

Compliance

Electromagnetic Environment

Group1

The EverView 7500 system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

CISPR11

RF Emissions

Class A

The EverView 7500 system is suitable for use in all

Not applicable

establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Not applicable

IEC 61000-3-3

Page 1-11


Guidance and manufacturer’s declaration - Electromagnetic Immunity (1) The EverView 7500 system is suitable for use in the specified electromagnetic environment. The purchaser or user of the EverView 7500 system should assure that it is used in an electromagnetic environment as described below: Immunity Test

IEC 60601-1-2

Compliance Level

Test Level Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

±2 kV for power supply lines

±2 kV for power supply lines ±1 kV for

IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

±1 kV for input/output lines

Surge IEC 61000-4-5

input/output lines

±1 kV differential mode

±1kV differential mode

±2 kV common

±2 kV common

mode

mode

Voltage dips, short interruptions and voltage variations on power supply input lines

< 5 % UT

IEC 61000-4-11

for 5 cycles

(> 95 % dip in UT)

0 % UT for 5 sec

for 0.5 cycle 40 % UT (60 % dip in UT)


Floors are wood, concrete, or ceramic tile, or floors are covered with synthetic material and the relative humidity is at least 30 %.

Mains power quality is that of a typical commercial and/or hospital environment

Mains power quality is that of a typical commercial and/or hospital environment.

Mains power quality is that of a typical commercial and/or hospital environment. If the user of the EverView 7500 system requires continued operation during power mains interruptions, it is recommended that the EverView 7500 system be powered from an uninterruptible power supply or a battery.

70 % UT (30 % dip in UT) for 25 cycles < 5 % UT (> 95 % dip in UT) for 5 s Power frequency(50Hz)

3 A/m

3 A/m

magnetic field IEC 61000-4-8 Note: These are guidelines. Actual conditions may vary.

Page 1-12

Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and/or hospital environment.


Guidance and manufacturer’s declaration - Electromagnetic Immunity (2) The EverView 7500 system is suitable for use in the specified electromagnetic environment. The purchaser or user of the EverView 7500 system should assure that it is used in an electromagnetic environment as described below: IEC 60601-1-2 Test Level Conducted RF

3V

IEC 61000-4-6

150 kHz to

Compliance Level [V1 =] 3 V

80 MHz


Portable and mobile RF communications equipment are used no closer to any part of the [EQUIPMENT and/or SYSTEM], including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distance

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

d =[

[E1=] 3 V/m

d =[

3,5 ] P 3

7 d =[ ] P 3

3,5 ] P 3

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Note: P is the power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,* are less than the compliance level in each frequency range.**

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. *Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field strength exceeds the RF compliance level above, observe the EverView 7500 system to verify normal operation in each use location. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [EQUIPMENT and/or SYSTEM].

Page 1-13


**Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m. The Recommended Separation Distances are listed in the next table. Note: These are guidelines. Actual conditions may vary.

Recommended Separation Distances for Portable and Mobile RF Communications Equipment and the EverView 7500 system

Frequency of Transmitter

150KHz to 80 MHz

Equation

d =[

80 MHz to 800 MHz

3,5 ] P 3

d =[

3,5 ] P 3

800 MHz to 2,5 GHz

7 d =[ ] P 3

Rated Power of Transmitter

DISTANCE

DISTANCE

DISTANCE

(W)

(meters)

(meters)

(meters)

0.01

0.12

0.12

0.23

0.38

0.38

0.73

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

0.1 1

For transmitters rated at a power not listed above, the DISTANCE can be estimated using the equation in the corresponding column, where P is the power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note: These are guidelines. Actual conditions may vary.

Page 1-14


1.11 Equipment Malfunction If either the hospital or equipment circuit breakers trip, an equipment malfunction may be indicated. Do not attempt to operate the equipment until it has been checked by a qualified service engineer. If any of the equipment controls fail to respond as indicated in this manual, you should:

1. Remove power to the equipment by placing the power switch in the off position and unplugging the power cord from the AC receptacle.

2. Notify a qualified service engineer. 3. Do not operate the equipment until the service technician advises that it is operating properly.

1.12 External Devices To ensure patient safety, only connect external equipment that has been approved by GE HUALUN Medical Systems Co,Ltd. All equipment attached to the external interface connections must meet the requirements of IEC 60601-1 when operated within the patient environment. When used outside of the patient environment, each externally connected device must comply with the relevant IEC/ISO requirements for that device. In any case, the combination of all externally connected equipment shall not cause the leakage current of any device used within the patient environment to exceed the limits stated in IEC 60601-1.

Page 1-15


1.13 Patient Environment 1.13.1

Within the United States

Within the US the Patient Environment is defined by NFPA 99 and UL 2601-1. In areas in which patients are normally cared for, the patient environment is the space with surfaces likely to be contacted by the patient or an attendant who can touch the patient. This encloses a space within the room 6 ft. beyond the perimeter of the bed (examination table, dental chair, treatment booth, etc.) in its intended location, and extending vertically 7.5 ft. above the floor.

6.00 ft.

6.00 ft.

6.00 ft.

7.50 ft.

Patient Environment Inside United States

1.13.2

Outside the United States

Outside the US the patient environment is defined by IEC 60601-1-1. In areas in which patients are normally cared for, the patient environment is the space with surfaces likely to be contacted by the patient or an attendant who can touch the patient. This encloses a space within the room 1.5 m beyond the perimeter of the bed (examination table, dental chair, treatment booth, etc.) in its intended location, and extending vertically 2.5 m above the floor.

1,5 m

1,5 m

1,5 m

2,5 m

Patient Environment Outside United States

Page 1-16

Chapter 2

Operating Controls and Indicators


2.1 System Overview 2.1.1

General Description

The EverView 7500 C-Arm X-Ray Imaging System is intended to provide fluoroscopic and film imaging of the patient in diagnostic and surgical applications. Clinical applications may include, but are not limited to, surgery, critical care and emergency room procedures. This system will be used on a daily basis by such users. The system may be used for other imaging applications at the physician’s discretion.

WARNING

Only properly trained persons can operate this equipment.

EverView 7500 C-Arm X-Ray imaging system includes: •

Mobile C-Arm Includes X-Ray generator, image intensifier, CCD camera and console

•

Mobile WorkStation Includes 2 monitors, 1 computer harddisk, keyboard, etc.

•

Options Sony Thermal Printer DAP Cassette holder, 10×12” (24×30 cm) You can refer to Chapter 8 Options for details.

Page 2-2


Page 2-3


2.1.2

Components Identification of C-Arm

The items listed below identify the location of components used during setup and positioning.

10

3

6 5 17 20

11 8 2

14

15 13

21 1 4 19 12

9 7 16

18

Page 2-4


1.

X-Ray tube head ( X-Ray tube and collimator)

2.

Spacer (for patient protection)

3.

Image receiver (image intensifier and CCD-camera)

4.

Power cable

5.

Rotation movement brake handle

6.

Steering handle

7.

Driving handle

8.

Orbital movement brake handle

9.

Horizontal movement brake handle

10.

Wig-Wag movement brake handle

11.

Safety lock of rotation

12.

Front wheels

13.

Rear wheels

14.

Brake release pedal

15.

Brake pedal

16.

Emergency stop pushbutton

17.

Control panel

18.

Female sockets (for integrated cable and footswitch)

19.

Incoming circuit breaker and power on indicator

20.

Handswitch

21.

Focal Spot

Page 2-5


2.1.3

Components Identification of Workstation 1

10 6

6 5

4

3

2

2 1

7 9

8

Page 2-6

8


The items are listed as follows: 1.

Exposure indicator

2.

Front wheels (with brakes)

3.

CD Driver

4.

USB interface

5.

Cabinet for printer

6.

Handles for movement

7.

Wire rolling support

8.

Back wheels (no brakes)

9.

Integrated cable

10.

Keyboard and mouse

Page 2-7


2.2 Overview This chapter describes the EverView 7500 C-Arm X-Ray Imaging System’s operating controls and indicators. Before you begin imaging, familiarize yourself with the following controls: •

System start -up

•

Control Panel of the Console

•

FootSwitch

•

HandSwitch

•

WorkStation Controls

2.3 System Start-up Integrated Cable Socket

Footswitch Socket

The WorkStation receives power from the Mobil C-Arm through the integrated cable attached to the WorkStation. 1. Insert the male socket of the WorkStation’s integrated cable into the female socket located on the right side of the C-Arm’s cover. Push the socket in and lock it in position. 2. Connect the footswitch to the sockets on the interface panel of C-Arm. 3. Plug the C-Arm power plug into a properly rated AC receptacle. 4. You can operate the system as the descriptions of the operating keys below.

Page 2-8


2.4 Control Panel of the Console

The Mobil C-Arm’s Control panel allows you to control the generation and display of images, adjust the parameters of fluoroscopy and radiography. The keys and indicators on the Control Panel are grouped according to their functions. These groups of keys allow you to: •

Control system on/off

•

Control fluoroscopy mode

•

Control radiography mode

•

Control the collimator shutter or iris collimator

•

Adjust the recursive factor

•

Select the image field size

•

Control the image orientation

•

Rise or lower the C-Arm

CAUTION

Only functions applicable to the mode selected are active. If any function is active, then the corresponding indicator lights. The fluoroscopy mode is the default setting.

Page 2-9


2.4.1

System On / Off Controls and Indicators System On key and indicator

Press this key to power on the system, the LED will light. NOTE

Please check and confirm that the integrated cable is connected to the C-Arm. Otherwise press this key will not power on the system.

The auto fluoroscopy mode is selected and the power on indicator lights. The display of the KVp is 40 KV, the display of mA is 0.1 mA, the display of the recursive factor is 8. The field size is in its maximum. The left monitor of workstation will light on and displays nothing. The right monitor will enter into the PATIENT INFORMATION Screen automatically.

System Off key and indicators Press this key to power off the system. You should Press F12 on the WorkStation keyboard at first to shut off the NOTE WorkStation. After the monitor turns off, you can press the system off key to power off the system. NOTE

Please wait 2 minutes before restarting the system after a shutdown. Otherwise, there will be damages to the systems and the fault indicator will light on.

Reset timer After 4 min 45 sec fluoroscopy, the buzzer emits a continuous audible signal. Press this button to reset the timer, otherwise, fluoroscopy would be stopped after 2 min 30 sec. At this time ,the exposure indicator will light off and the LED on the top left of the reset timer key will light to indicate the fluoroscopy is too long.

Fault Indicator This indicator (red) will light if there are faults in system. Power off the system, restart after 10 minutes. If the indicator is still on, call your service representative immediately. NOTE

When the emergency stop pushbutton is pressed, the indicator will light on.

X-ray emission Indicator In the working mode, when the footswitch/hand switch is activated to take an exposure, the indictor (yellow) will light.

Page 2-10


2.4.2

Controls and Indicators in fluoroscopy mode

WARNING

In case of an emergency case or unexpected radiation, press the emergency stop pushbutton on the C-Arm console.

Manual Fluoroscopy Press this key to enable a manual Fluoroscopy image. The LED lights when this key is enabled.

Auto Fluoroscopy Press this key to enable an auto Fluoroscopy image. The LED lights when this key is enabled.

KV Display Display KV values.

mA Display Display mA values. NOTE

The display of mA value will change with the variety of KV values at the same time.

KVp In Manual Fluoroscopy mode, press the left key to decrease KVp or press the right key to increase the KVp. The corresponding value of mA will be changed at the same time.

Pulse Press this key to enable pulsed imaging mode with the pulse rate of 2 pulses/3 seconds. The pulse LED lights up when Pulse is enabled. Press this key again to disable pulsed imaging. Pulsed X-Rays can be used to reduce total radiation dose. Pulse mode can be used with Manual Fluoroscopy mode and auto Fluoroscopy mode. It cannot be used with Radiography Mode.

Page 2-11


High Level Fluoroscopy (HLF) Press this key to enable a High Level Fluoroscopy(HLF).The LED lights when this key is enabled. Press this key again to disable HLF. The mA values in this mode are 2 times more than in the standard mode. HLF should be used only for special applications that require good image quality. During HLF, an audible alarm is given.

Fluoroscopy combination mode

Specification

Low dose

High dose

Continuous Fluoro

Single

Multi-

Pulse

Pulse

Auto

Manual

Combinations MANUAL

￭

￭

AUTO

￭

￭

￭￭

MANUAL+HLF

￭

￭

AUTO+HLF

￭

￭

￭￭

MANUAL+PULSE

￭

￭

AUTO+PULSE

￭

￭

MANUAL+ PULSE+HLF

￭

￭

AUTO+ PULSE+HLF

￭

￭

Page 2-12

￭￭￭￭


2.4.3

Controls and Indicators in Radiography mode

NOTE

For radiography, a cassette holder should be on the front face of the image intensifier.

NOTE

The standard cassette size is 10 inches X 12 inches. If your cassette size is 24 cm X 30 cm, you should remove the 4 nylon blocks outside of the cassette holder and install them inside. Please refer to Option Chapter 8 in this manual for details.

Cassette holder size: 10 inches X 12 inches (24cm×30 cm) is available . X-ray field on plane of cassette: Φ24 cm Beam limitation: Φ21cm WARNING

Only Φ21 cm X-ray field for radiography mode can be selected by operator .

Radiography Key Press this key to enable Radiography operation. The Radiography LED illuminates when Radiography mode is enabled. In this mode, KVp and mAs values can be adjusted manually. For details, please refer to the description of KVp.

mAs display Display mAs values.

mAs Key Manually adjusts mAs for radiography. Press the left key to decrease mAs value and press the right key to increase the mAs value.

Page 2-13


2.4.4

Collimator Control

The X-Ray beam may be collimated by using either the iris collimator or the semitransparent shutter collimator. Press the key until the shutters or iris are in the position you desire.

Collimator shutter Rotation Press the left key to rotate the collimator shutters clockwise. Press the right key to rotate the collimator shutters counter-clockwise.

Collimator shutter Open/Close Press the collimator shutter keys to open and close the semitransparent collimator shutters. Press the left key to open the shutters and press the right key to close the shutters.

Iris Collimator Open/Close Press the iris collimation key to open or close the collimator iris. Press the left key to open the iris or the right key to close the iris. When the system is transferred to radiography mode, Iris opens fully, and the parameters sets in the radiography mode are memorized. When return to fluoroscopy mode, it can be restored until a reset is made.

NOTE

2.4.5

Proper use of the iris can decrease the X-ray radiation to the patient and improve image quality.

The recursive factor key and indicators Recursive Factor

Press this key to select relative recursive factor. After you press this key, the relative LED will light to indicate the factor. The default value is 8.

Indicator These LEDs indicate the current recursive factor. Recursive Filter function provides image noise reduction to create a smoother Last Image Hold (LIH) radiograph on the main monitor. Recursive Filter can be applied during live fluoro for all image modalities. Higher levels of recursive filtering produce a smoother (or less noisy) LIH radiograph, but it need longer exposure time and cause more lag when imaging moving objects or anatomy. You may choose from low, medium and high levels of filtering. Page 2-14


Motion detect Press this key to enable the motion detect function and the LED lights when this key is enabled. This function can detect the motion of diagnosed object and give better image quality.

2.4.6

Image Intensifier Field Size Field Size

Selects the X-ray field size. The illuminated LED indicates which field size is selected. Press the FIELD SIZE key until the field size you want is selected. Refer to the table below: TEXT

ICON

9-INCH II

NORM

9-inch(23cm )

MAG1

6-inch(15cm)

MAG2

4.5-inch(11cm)

2.4.7 NOTE

Image Orientation These keys can only affect the live image on the left monitor.

Use these keys to rotate or reverse the image produced while X-Rays are being generated and live video is present on the left WorkStation monitor. Image Rotation and Image Reversal are useful for displaying the image in any orientation that you desire.

Image Rotation Press the left portion of the key to rotate the image counter-clockwise or press the right portion of the key to rotate the image clockwise. The rotation speed is approximately 45°/ s.

Page 2-15


Image Reversal Use these keys to change the orientation of the image displayed on the WorkStation’s left monitor. Press the left key to reverse the image from left to right. Press the right key to invert the image from top to bottom.

2.4.8

Vertical Column Operation

Use the vertical column to elevate the C-Arm upward and downward.

WARNING

WARNING

A possible pinch point exists between the C-Arm and the tip of the T base. Do not place your foot on the tip of the T-base while operating the vertical column or positioning the C- Arm. Set all brakes and watch carefully when you move the motorized Vertical Column. Even a low-speed collision can result in significant personal injury or equipment damage.

Raise C-arm Command Press this key to activate the vertical column motor, thus to raise the height of the C-Arm.

Lower C-arm Command Press this key to activate the vertical column motor to lower the height of C-Arm.

Override command When C-Arm can’t be driven down by only pressing lower key, please make sure there are no obstacles between the C-Arm and the T-base. Press and hold the 2 keys (Lower and compulsive keys) together. It will lower C-Arm to the lowest position.

Page 2-16


2.5 Modes of Operations The EverView 7500 C-Arm X-Ray Imaging System employs a variety of modes of operation for maximum flexibility in a number of imaging procedures. This section contains information on the various modes of operation, their suggested uses and technical information.

2.5.1

Modes and Keys

Engaging and disengaging All modes used on the EverView 7500 C-Arm X-Ray Imaging System can be selected by pressing mode keys on the Control Panel of the C-Arm Console. Pressing a mode key or a combination of keys will select an X-rays mode. The indicator LED of the selected mode lights at the same time. Press another mode key or combination of keys to disengage current mode and switch to a new one. Modes and Keys Table

Modes

Standard Fluoro Manual

Auto

HLF

Pulsed Fluoro

Pulsed HLF Manual

Auto

+

+

+

+

Radiography

Keys

Page 2-17


2.5.2

Imaging Modes Summary

The following table summarizes the modes available on the system. It shows the X-ray techniques, system controls and a brief list of suggested uses for each mode.

NOTE

The suggested uses list is not exhaustive and other uses may be as valid as the suggested uses. The user may be aware of the techniques associated with the various modes for each patient.

Imaging Table Mode

X-ray Techniques

System Controls

Suggested Uses

Standard Fluoro

KV: 40 to 110 auto/manual

Auto: KV controlled by ABC*, mA follows KV-mA table

General Fluoro Imaging

mA: 0.1 to 4 auto/manual

Manual: manually adjusted KV, mA follows KV-mA table













KV: 40 to 110 1.5mm focal spot

Manually adjusted KV and mAs,

mA: 20

mA is fixed at 20

HLF

Pulsed Fluoro

Pulsed HLF

Radiography

High quality and high-dose Imaging

Low-dose Imaging

High quality and low-dose Imaging

X-ray Films

mAs: 1 to 80 *ABC: Automatic Brightness Control, which automatically adjusts techniques to display the optimum image quality for most X-ray images.

Page 2-18


KV-mA Tables The following tables lists the mA value used by the system with selected KV settings in Standard and HLF Fluoro Modes. Standard Fluoro Mode KV selected mA used KV selected mA used KV selected mA used KV selected mA used 40 0.1 58 1.2 76 2.2 95 3.2 41 0.2 59 1.2 77 2.2 96 3.2 42 0.3 60 1.3 78 2.2 96 3.3 43 0.3 61 1.3 78 2.3 97 3.3 44 0.3 62 1.4 79 2.3 98 3.3 44 0.4 63 1.4 80 2.3 98 3.4 45 0.4 64 1.4 81 2.4 99 3.4 46 0.4 64 1.5 82 2.5 100 3.5 46 0.5 65 1.5 83 2.5 101 3.5 47 0.5 65 1.6 84 2.5 102 3.6 47 0.6 66 1.6 84 2.6 103 3.6 48 0.6 67 1.6 85 2.6 103 3.7 49 0.6 67 1.7 85 2.7 104 3.7 50 0.7 68 1.7 86 2.7 105 3.7 51 0.8 68 1.8 87 2.7 105 3.8 52 0.8 69 1.8 87 2.8 106 3.8 53 0.8 70 1.8 88 2.8 107 3.8 53 0.9 71 1.9 89 2.8 107 3.9 54 0.9 72 1.9 90 2.9 108 3.9 54 1 73 1.9 91 3 108 4 55 1 73 2 92 3 109 4 56 1 74 2 93 3 110 4 56 1.1 75 2 93 3.1 57 1.1 75 2.1 94 3.1 58 1.1 76 2.1 94 3.2

Page 2-19


HLF Fluoro Mode KV selected mA used KV selected mA used KV selected mA used KV selected mA used 40 0.2 58 2.4 76 4.4 94 6.3 41 0.4 58 2.5 77 4.4 95 6.3 42 0.6 59 2.5 77 4.5 95 6.4 43 0.6 60 2.6 78 4.5 96 6.5 44 0.6 60 2.7 78 4.6 96 6.6 44 0.8 61 2.8 78 4.7 97 6.6 45 0.8 62 2.9 79 4.7 97 6.7 45 0.9 63 3 80 4.8 98 6.7 46 0.9 64 3 81 4.9 98 6.8 46 1 64 3.1 82 5 99 6.8 47 1.1 65 3.2 83 5 100 6.9 47 1.2 65 3.3 83 5.1 100 7 48 1.2 66 3.3 84 5.1 101 7.1 48 1.3 66 3.4 84 5.2 102 7.2 49 1.3 67 3.4 85 5.2 103 7.2 49 1.4 67 3.5 85 5.3 103 7.3 50 1.5 68 3.5 86 5.3 104 7.3 51 1.6 68 3.6 86 5.4 104 7.4 51 1.7 69 3.6 87 5.5 105 7.5 52 1.8 69 3.7 87 5.6 105 7.6 53 1.8 70 3.8 88 5.6 106 7.7 53 1.9 71 3.9 88 5.7 107 7.7 54 1.9 72 4 89 5.7 107 7.8 54 2 73 4 90 5.8 108 7.8 55 2 73 4.1 91 5.9 108 7.9 55 2.1 74 4.1 91 6 109 7.9 56 2.2 74 4.2 92 6.1 110 8 56 2.3 75 4.2 93 6.1 57 2.3 75 4.3 93 6.2 57 2.4 76 4.3 94 6.2

Page 2-20


2.6 Radiography 2.6.1

Overview

Use Radiographic mode to produce radiographic films. The radiography cassette holder described in this section is available as an option and should be used if you use Radiography mode. This section describes how to setup and make a film exposure.

2.6.2

Setup and Making a Film Exposure

Perform the following steps to make a film exposure: 1. Press the radiography key on the C-Arm control panel. NOTE

Once film mode has been selected, the field size and collimator settings are locked. If further adjustments are required, you must first reenter into FLUORO mode.

2. Place the cassette holder over the face of the image intensifier with the handle opened out. 3. Rotate the cassette holder handle to securely attach the cassette holder to the image intensifier. Fasten the screws. WARNING

Verify that the cassette holder is securely attached to the image intensifier. Unsecured cassette holders may fall, injuring patients or personnel.

4. Insert a film cassette into the cassette holder and center it. 5. Adjust the radiography parameters (Kvp and mAs) to the desired values. 6. Press and hold the hand switch. NOTE

During the radiography, press the handswitch and hold on the switch until the exposure indicator lights off to start radiography. The system will give a continuous audible “Di…” alarm during the exposure. If the handswitch is loosen when exposuring , the system will give a audibe “Di-Di-Di-Di” alarm to warn that the exposure is interrupted.

7. Release the hand switch at the end of the exposure. 8. Remove the film cassette by pushing the cassette out of the cassette holder.

Page 2-21


2.7 Footswitch and HandSwitch WARNING

Before Exposure, please check and confirm the mode you selected to avoid unexpected X-Ray Exposure.

Footswitch Press footswitch to start fluoroscopy in the mode selected.

Hand switch Press hand switch to start fluoroscopy or radiography. NOTE

During the radiography, press the handswitch and hold on the switch until the exposure indicator lights off to start radiography. The system will give a continuous audible “Di…” alarm during the exposure. If the handswitch is loosen when exposuring , the system will give a audibe “Di-Di-Di-Di” alarm to warn that the exposure is interrupted.

Page 2-22


2.8 WorkStation Controls 2.8.1

Overview

This chapter describes how to use the WorkStation Controls for imaging and post-processing. Before using the WorkStation, you should be familiar with the controls located on the WorkStation keyboard and the monitor. The power supply to the monitor is switched on / off when the system power is switched on/off.

2.8.2

Workstation Keyboard

The WorkStation keyboard controls include navigation, text-entry and function keys.

Navigation and Text-Entry Keys WorkStation navigation keys allow you to move the cursor, edit text. The text-entry keys allow you to enter text in upper and lower case letters.

TAB Move the cursor to the next text entry field.

Backspace Deletes one character to the left of the cursor.

Page 2-23


Delete Deletes a selected marker or comment. Function Keys

F1

HELP

F3

CAPTURE

F4

SAVE IMAGE

F5

IMAGE DIRECTORY

F6

NEW PATIENT

F7

NEGATE IMAGE

F8

SMOOTH IMAGE

F9

GREY DEGREE STRETCH

F10

CUSTOMIZE

F12

SHUT OFF

Prt Sc SysRq

PRINT

Adjust Brightness/Contrast Please follow the steps below to adjust the Brightness/Contrast of the monitors: 1. Press the

2. Press the 3. Press the

4. Press the 5. Press

NOTE

Page 2-24

button on the monitor to activate OSD menu.

or

button to select the desired function (Brightness or Contrast).

button to activate the desired function.

or

button to decrease or increase the setting value.

button to exit OSD menu and save setting values.

If you want to return to factory settings of Brightness/ Contrast , you can follow the above steps and adjust the Brightness value to 50, Contrast to 70.

Chapter 3

Software Instructions


3.1 Patient Management 3.1.1

Overview

Patient Management provides following means for adding, reviewing and editing patients: • Add a new patient. •

Select and review a saved patient.

•

Delete a saved patient.

•

Edit a saved patient. For proper archiving of images, you should always set a current patient before beginning a new exam. Or the images might be saved under the wrong patient.

Through the following methods, you could set a patient who is ready for the exam as the current patient: • Adding a new patient. •

Selecting a saved patient.

•

Editing and saving a saved patient.

When a current patient is set, the system shall reset to prepare for examining this patient, and capture a new image for him/her automatically.

NOTE

Page 3-2

If you encounter abnormal characters when inputting, please make sure the Num lock state is right. If not, press the Num Lock key on the Workstation keyboard.


3.1.2

Add a New Patient

The PATIENT INFORMATION-NEW screen is displayed automatically when system starts up.

PATIENT INFORMATION-NEW screen

Press the F6 key on the Workstation keyboard or click ‘Patient Information’ on right-click menu in VIEWER screen to display this screen.

NOTE

You can see Accelerate Keys through pressing F1.

Page 3-3


Right-click Menu in ‘VIEWER’ screen

To add a new patient:

NOTE

Only English language input is supported, no matter what language is used on the user interface.

1. Using the keyboard, to input a new patient’s name. Patient Name: 255 characters can be recorded at maximum separately for Last Name and First Name. Total less than 18 characters are suggested for better display on images.

NOTE

Page 3-4

Patient Name cannot be null. If both FIRST NAME and LAST NAME are empty, a warning message will pop up, which says, “For a valid patient record, Patient Name shall not be empty.”


2. Move through the fields to complete other patient information. NOTE

A cursor indicates which field you are in. Use the TAB key, or use mouse to move the cursor to the next active field. Each field containing information will be saved and displayed on the patient’s images.

Sex: Select proper items from a drop-list box, which contain BLANK, MALE and FEMALE.

Birth date: 50 characters can be recorded at maximum. Total less than 11 characters are suggested for better display on images.

Patient ID: 255 characters can be recorded at maximum. Total less than 11 characters are suggested for better display on images.

NOTE

Patient ID cannot be left blank or the same with any saved patient. If you try to save a new patient with blank or existing Patient ID, a warning message will pop up, which says “For a valid patient record, Patient ID shall not be empty.” or “The patient ID already exists. It shall be unique. Please change one.”

Physician: 255 characters can be recorded at maximum, Total less than 11 characters are suggested for better display on images.

3. Finish entering patient information. a. If you click the OK button: The new patient will be saved into the system and set as the current patient. The PATIENT INFORMATION-NEW screen is closed and the VIEWER screen is displayed. The system is ready for you to begin taking X-rays for the current patient.

NOTE

When you go to the VIEWER screen for the first time after system starts up, the shortcut menu pops up automatically. You also can right-click the mouse to invoke this menu.

b. If you click the CANCEL button: You will discard the new inputs and escape the screen. The PATIENT INFORMATION-NEW screen will be closed and the VIEWER screen will be displayed with the previous state. While current patient remains unchanged.

Page 3-5


NOTE

NOTE

If there is no current patient yet, e.g. when the system powers on initially or the current patient has been deleted, the CANCEL will be disabled, which means you have to set a current patient before taking exam.

You can set current patient as UNNAMED by left “First name” “Last name” “Patient ID” blank.

c. If you click NEW PATIENT button: You will clear the new input. The PATIENT INFORMATION-NEW screen remains open with all fields blank.

Page 3-6


3.1.3

Select and review a saved patient

1. Click the SAVED PATIENTS… button on the PATIENT INFORMATION-NEW screen to view a list of patients examined.

PATIENT INFORMATION-NEW screen After this button is clicked, the SAVED PATIENT screen will be displayed with the latest 20 patients in the patients list.

Page 3-7


SAVED PATIENT screen

2. Input one or several fields of the following items and click FIND button

to query

the patients. You can also select the FIND button by pressing ALT+F keys.

•

Patient ID

•

First Name

•

Last Name

•

Exam Date

•

Physician

NOTE

Page 3-8

If you do not input query information and click on the FIND button directly, the patients on the day you operate the system will be displayed.


3. All patients who match the query condition(s) will be listed in the patients list.

The patient list can be sorted by LASTNAME, FIRSTNAME, PATIENT ID, SEX, and PHYSICIAN in alphabetical order via clicking corresponding header. The list can also be sorted by CREATE DATE in ascending or descending temporal order, but not by BIRTH DATE. The list order is indicated by the orientation of a triangle at the right side of the corresponding header.

4. Double click the left button of mouse on a patient field to display the PATIENT INFORMATION screen for that patient. You can also choose one patients from the patient list and click OK button. The PATIENT INFORMATION-SAVED screen now displays with all the information stored for the selected patient. But the selected patient information is not editable by default.

You can: • Press ‘Edit’ to edit information in the patient record you just retrieved. • Press ‘OK’ to set the selected patient as the current patient. Then you can produce additional X-rays under the patient. Page 3-9


• Press ‘CANCEL’ to return to ‘VIEWER’ screen, which displays the previous screen before going into “Patient Information”, without any change of the current patient.

NOTE

Always make sure that the correct patient is displayed on the PATIENT INFORMATION-SAVED screen before producing X-rays. Otherwise, images may be stored under the incorrect patient name.

PATIENT INFORMATION-SAVED screen

Page 3-10


3.1.4

Delete a saved patient

To delete a patient, •

Choose one or some patients from the patient list and select DELETE button.

•

Select YES button on the message box if you decide to delete it, otherwise select NO button.

NOTE

If a patient is deleted, all the information and images of the patient will be removed from the system permanently.

NOTE

If you try to delete the current patient, a warning message will pop up as follows. When you press OK to confirm the deleting, patient ‘UNNAMED’ will be set as current patient. And you can set another new current patient.

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NOTE

3.1.5

Patient ‘UNNAMED’ cannot be deleted. If you try to delete, a warning message will pop up as follows.

Edit a saved patient

By clicking EDIT button on the PATIENT INFORMATION-SAVED screen, all the fields will be changeable and the screen is changed to PATIENT INFORMATION-EDITING.

PATIENT INFORMATION-EDITING screen The “UNNAMED” patient cannot be edited. So when “UNNAMED” patient is retrieved, the EDIT is disabled.

Page 3-12


After modifying the information: 1. If you click OK: A warning message will pop up:

If click OK the changes will be saved, and the changed patient is set as the current patient. If click NO, the EDITING state remains, and the changes will not take effect. NOTE

After patient information is changed, the information displayed on image is updated at the same time, including patient information and image ID, but excluding hospital name and image date.

2. If you click CANCEL: You will discard the current PATIENT INFORMATION-SAVED screen and return to ‘VIEWER’ screen, which displays the previous screen before going into “Patient Information”. 3. If you click NEW PATIENT: You can discard the selection of saved patient and start inputting a new patient.

Page 3-13


3.2 Image Producing 3.2.1

Capture an Image Press F3 to capture the last image held on the left monitor and to display it on the right monitor.

The patient’s name, sex, birth date, patient ID and the physician’s name will be displayed on the top left corner of the image. The name of the hospital and the image saving date and time will be displayed on the top right corner of the image. All these information is displayed in inverse color to background.

NOTE

Page 3-14

Press F3 only to display the image, not to save it to the hard disc.


3.2.2

Saving Images Press the F4 key to save image to hard disk.

The image ID will be automatically generated and displayed on the bottom left corner of the image after saving in inverse color to background.

You can delete the saved image by pressing DEL key or clicking the shortcut menu.

Page 3-15


3.2.3

Process Images

To process the image held on the right monitor:

•

Negate: press F7 key

•

Smooth: press F8 key

•

Stretch: press F9 key

•

Mirror Horizontal: press LEFT or RIGHT key

•

Mirror Vertical: press UP or DOWN key

NOTE

NOTE

NOTE

Page 3-16

You can use the image processing function to get a better view of the saved images, but the processed images can’t be saved to the hard disk. The processed images displayed can be printed. Refer to Section 3.5 Print Function for more information . Press “Esc” key to exit processed view mode and return to the original saved image.


3.3 Image Review and Archive 3.3.1

Overview

IMAGE DIRECTORY screen allows you to review and archive images and patient summaries.

3.3.2

Image Directory

The IMAGE DIRECTORY screen allows you to query, display and modification exam images. Press the F5 key or click the shortcut menu to display the IMAGE DIRECTORY screen. The last saved 20 images will be displayed in the image list.

H

A

I B

K

J C

D E F G IMAGE DIRECTORY screen features

Page 3-17


A The SAVED PATIENT button is used to select the saved patient.

B The ACHIVE DEVICE button is used to select the drive to copy.

C The QUERY IMAGAE button is used to query the selected image to copy.

D This is list box of queued images.

E The COPY FORMAT button is used to select the image format to copy to the archive device.

F The COPY button is used to begin copy image files.

G The EXIT button is used to exit the image directory screen.

H The QUERY IMAGE field is used to query image by the range of saved date.

I The FIND button is used to begin to query image.

J This is the image list of query result.

K The list can be sorted by LASTNAME, FIRSTNAME, IMAGE ID, PATIENT ID, SEX, and PHYSICIAN in alphabetical order via clicking corresponding header. The list also can be sorted by IMAGES DATE in temporal order, but can’t by BIRTH DATE.

NOTE

NOTE

Page 3-18

The list order is indicated by the orientation of a triangle at the right side of the corresponding header. When the header is clicked at the first time, the list shall be sorted in increasing order. When clicked once again, this list order shall be reversed. When you access the saved patient list from Image Directory screen and select a patient, the current patient does not change. If you capture and save a new image while a saved patient’s images are displayed on the IMAGE DIRECTORY screen, the new image will be saved under the current patient, not the saved patient on the IMAGE DIRECTORY screen.


3.3.3

Retrieve a Saved Exam Image

When an exam is finished, images are saved in the saved patient of the system. You have two ways to query the saved images. The First way is to query the saved images from the IMAGE DIRECTORY screen by entering the range of saved date. (1)

Enter the date range of the saved images.

(2)

Select the button with magnifier icon.

(3)

The saved images within the date range will be listed.

SAVED EXAMS button

If you do not input date and click on FIND button, the intraday images will be displayed.

Page 3-19


The second way is to query all images belonging to a patient. (1) Press SAVED PATIENT button from IMAGE DIRECTORY screen. (2) Query a patient from the SAVED PATIENT screen. (3) Confirm the selected patient to return to the IMAGE DIRECTORY screen. (4) All the saved images belonging to the selected patient will be listed.

After you get an image list through either of the above two ways, you can do the following operations:

•

Review images in this list, refer to section 3.3.4;

•

Archive images in this list, refer to section 3.3.5;

•

Delete images in this list, refer to section 3.3.6.

NOTE

NOTE

Page 3-20

When you double click one item from the saved images list to view the image and return to IMAGE DIRECTORY screen by press F5 or by the shortcut menu again, the screen state will reconvert to previous including the query result, copy format, archive device. If you press EXIT button, those state information will be lost.

When you exit the IMAGE DIRECTORY sceen, which image shall be displayed on the screen depends on the system status, described as follows: 1)

System in the capture image status: if current patient exists, image displayed before is preserved, else if current patient is deleted (refer to 3.1.4), system will capture a new image with “UNNAMED” patient exam.

2)

System in the saved image status: if the image saved before exists, it’s preserved, else if the just image saved is deleted (refer to 3.3.6), system will capture a new image with current patient’s exam (or “UNNAMED” as described in the 1) item).

3)

System in the reviewing image status: if the image displayed before exists, it’s preserved, else if the displayed image is deleted (refer to 3.3.6), system will display the next image in the list, or capture a new image with current patient’s exam (or “UNNAMED” as described in the 1) item) for no other image available in the liist.


3.3.4

Image Review

When you double click one item of the list in IMAGE DIRECTORY screen, you will return to the VIEWER screen to view the clicked image, following information is displayed with the right monitor image:

A Information entered on the PATIENT INFORMATION screen.

B Hospital name and saved date and time.

C Image ID.

B

A

C

Sample Image

NOTE

In VIEWER screen, if patient information and Hospital Name are too long to display wholly, part of the text will be clipped and ellipsis appended at the end. Please go to SAVED PATIENT list to double check if you are reviewing the right patient’s image.

Page 3-21


3.3.4.1 Review the previous Image Press Page Up key to display the previous image in the list of IMAGE DIRECTORY screen.

3.3.4.2 Review the next image Press Page Down key to display the subsequence image in the list of IMAGE DIRECTORY screen.

3.3.4.3 Review Multiple Images (2×2 Layout) Pressing HOME key displays four images at one screen. The selected image is displayed on the top left of the screen, and the next three subsequence images in the list of IMAGE DIRECTOR screen are displayed in succession on the top right, bottom left and bottom right of the screen. Press HOME key again to exit 2×2 Layout, and the first image will be displayed full screen. Press PAGE DOWN key to display next four images at one screen. Press PAGE UP key to display previous four images at one screen.

Sample Image

Page 3-22


3.3.5

Archive Images

There are 2 kinds of system configuration: Standard Configuration Maximum 40,000 images to be saved. Not support USB/CDRW archiving.

Advanced Configuration Maximum 80,000 images to be saved. Support USB/CDRW archiving.

The “ARCHIVE DEVICE” button is disabled for the standard configuration. The USB/CDRW is unavailable and the image volume is 40,000. For USB/CDRW archiving and image volume of 80,000, please call GE service representatives for Advanced Configuration Option. Refer to Service Manual for details.

Page 3-23


The workstation supports a variety of archive device: Hard disk USB Stick CDRW There are two directions of archive: Download images: copy images from system to other device. Upload images: copy image from other device to system.

NOTE

Before use USB stick to download the images, the USB stick should be checked whether virus is exist. Make sure the USB stick is safe to workstation computer.

3.3.5.1 Download Images For the version earlier than Ver2.0, the image files are downloaded to the root directory of the target archive device (USB disk or CDRW). From Ver2.0, the application will create a new folder in the root of the target device automatically and then copy the image files to this folder. The format of the target folder name is: YYYY-MM-DD_X, such as ”2005-9-21_1”. YYYY ：year MM ：month DD ：day X ：index If there’s already a folder named as “2005-9-21_1”, a new folder will be created with the name of an increased index such as “2005-9-21_2”.

NOTE

Don’t click the area beyond the wizard dialog when you burn the image files to CDR or CDRW disc. Otherwise the CD-burn wizard dialog will turn to be invisible.

NOTE

When the system prompts that the copy is finished, please do not unplug the USB disk until the light of the USB disk does not blink. Otherwise the image data copied in USB disk may be incomplete.

Page 3-24


Select a Storage Device (1) Select ARCHIVE DEVICE button on IMAGE DIRECTORY screen to call the ACHIVE DEVICE screen.

(2) Select SYSTEM radio button within COPY FROM frame on ACHIVE DEVICE screen. (3) Select USB STICK or CDRW radio button within COPY TO frame on ACHIVE DEVICE screen.

Page 3-25


ARCHIVE DEVICE screen

NOTE

If the USB stick is not inserted, the radio button of USB STICK will be gray which means you can’t select USB STICK to download.

(4) Select OK to return to IMAGE DIRECTORY screen.

Queue the images (1) Select the image item in the image list. (2) Select the QUEUE IMAGE button and the image will be add into queue list box. (3) Keep step 2 to add the images into queue.

Page 3-26


Page 3-27


Select a Copy Format Select COPY FORMAT button to select an image format.

COPY FORMAT screen

There are two formats for archiving to choose from: bitmap (BMP) and JPEG. Select BMP to store the chosen images in BMP file format. BMP file formats can be read, saved, and enhanced by Workstation. Select JPEG to store the queued images in jpeg file format. JPEG images cannot be read by Workstation. This file format (.jpeg) is provided for use with PC software programs that use jpeg format. An image copied in jpeg format cannot be copied back to the Workstation.

NOTE

Page 3-28

If you select JPEG format, the display effect of the image may be not better than that of BMP format.


Select COPY button to begin download For downloading to USB stick the system will give warning message box in case of the USB stick not inserted or write protected. For downloading to CDR, follow the default CDR-burning guide of the OS, which will be described detailed in the following steps. NOTE

Don’t plug out the USB stick or take out the CDR during image copying to prevent unexpected hardware damage.

CD Writing Wizard

NOTE

The wizard is provide by operation system and only has English user interface.

(1) Enter the CD name you favorite.

NOTE

You may select the check box of “Close the wizard after the files have been written” if you don’t want to copy the files to another CDR.

Page 3-29


(2) Standby while copying.

Page 3-30


(3) Finish When finish copying, you may have the chance to write the same files to another CD if you didn’t select the check box at the first step. Otherwise the wizard will be closed.

NOTE

After downloading images to the CDR/CDRW discs, please check the discs under windows operation system, to make sure images have been copied correctly.

Page 3-31


WARNING

Not all CDR/CDRW discs are compatible with the current CD Writer in your unit. Please use high quality brand named CDR/CDRW discs. High quality CDs have proven to be more reliable. If low quality discs are used, we cannot guarantee that the writing operation will be successful. If the CD failure occurs, the following error prompt window will appear. If this problem is due to a bad CD, we recommend selecting the option “Eject this disc and try making another CD” and pressing the “Next” button. When the disc is ejected, simply replace the CD and write again. If this failure occurs on more than several attempts, please contact service.

Page 3-32


3.3.5.2 Uploading Images Select a Storage Device (1) Select ARCHIVE DEVICE button on IMAGE DIRECTORY screen to call the ACHIVE DEVICE screen.

(2) Select USB STICK or CDRW radio button within COPY FROM field on ACHIVE DEVICE screen. (3) Select SYSTEM radio button within COPY TO field on ARCHIVE DEVICE screen.

Page 3-33


(4) Select OK to return back to IMAGE DIRECTORY screen.

NOTE

Page 3-34

Don’t plug out the USB stick or take out the CDR during image copying to prevent unexpected hardware damage.


Upload Images

1.

After selecting “copy from USB/CDRW to system”, the “Select folder” file dialog will pop up as Fig-1. Double click the folder such as

in Fig-1 to open the folder.

A B

C

Fig-1 A : Click the backward button to return to the previous folder. B : Double-click to open the folder. C : Display the current folder.

2.

Click the “Select” button shown in Fig-2:

Fig-2

Page 3-35


3.

The application will search all the 7500 image files under the specified folder and list the results in the image list of the image directory dialog. As Fig-3 shows, the path of source files will be displayed in the column of “IMAGE ID”, and other related information will be displayed in other columns.

Fig-3

4.

You can remove the items not expect to upload by pressing “DEL” key on the keyboard .

5.

Press “COPY” button to start uploading.

NOTE

NOTE

For the software version Ver2.0 and above, the image files with Patient ID will be associated with the original patient owner automatically. But for the images with no Patient ID, the owner patient for each image must be selected before uploading images. For the software earlier than Ver2.0, the owner patient for each image must be selected before uploading images.

To select owner patient after pressing COPY button, you should follow steps below:

Page 3-36


1) ‘SELECT PATIENT’ screen is displayed for you to assign owner patient for each image. ”UNNAMED” patient is the default owner patient. You can click CHANGE PATIENTS… to change the owner patient to the proper one. If you click “Apply to all following images” checkbox, you should set the selected patient for all the images to be imported in batches.

SELECT PATIENT screen 2) If you press “CHANGE PATIENT…” the following dialog pops up.

Page 3-37


3) Select a saved patient as the owner of image. 4) The image is uploaded into system with patient information you selected. And the information on image is updated at the same time, including patient information and image ID, but excluding hospital name and image date.

Page 3-38


4. Images’ record is created in Database.

5. The uploaded image will be marked with a label “UL” at the right-bottom part to indicate it’s an uploaded image, not the original one. 6. To check the uploaded images immediately after copying, click

button when the

filed of "Query Image” is blank. The image list will display all the images uploaded and created today.

NOTE

(1) Only the image files created at the same workstation can be uploaded to the original patient owner. Otherwise they will be copied to the default patient named as UNNAMED. (2) The images will be copied to the default patient named as UNNAMED if their original patient owner has been removed from the workstation. (3) The images to be uploaded must be the ones created by 7500 workstation in BMP format. Do NOT attempt to upload other BMP files, otherwise unexpected result will occur. (4) The uploaded images file will be assigned a new index. And this new index on the bottom left corner of the image will be repainted. (5) If the patient’s information has been modified, his images downloaded before the change can only be uploaded to the right patient with the patient information data section modified and the text embedded in the image repainted accordingly.

Page 3-39


3.3.6

Delete Image

To delete a saved image, press the DEL key or press DELETE item on the shortcut menu while a saved image, which is selected from IMAGE DIRECTORY screen, displaying on the right monitor. Or you can select the image you preferred in the IMAGE DIRECTORY screen, then press the DEL key on the keyboard. You can also press the SHIFT key to select more than one image. When VIEWER screen display images in 2x2 layout mode, deleting image operation will be prohibited, including pressing DEL key and selecting Delete item on the shortcut menu.

NOTE

Page 3-40

You can only delete the image saved in the hard disk. You can’t delete the images on USB stick or CDRW.


3.4 Customize 3.4.1

Overview

This chapter explains how to use the Customize function to tailor the setup of Workstation operation to your specific requirements. Features such as how date is displayed, setting defaults time and date and languages are set through the customize function.

3.4.2

Customize Screen

To access Customize features Press the F10 key on the Workstation keyboard.

CUSTOMIZE screen Select the button for the function(s) you want to customize.

Page 3-41


3.4.3

Workstation Options Screen

Use the CUSTOMIZE WORKSTATION screen to:

Enter the hospital name. Select Language.

NOTE

For the Hospital Name, 255 characters can be recorded at maximum.

Customize Workstation screen

Page 3-42


3.4.4

Time and Date

Select the TIME / DATE button to enter the current date and time, and to specify the format of the date display. Set time and date. The CUSTOMIZE TIME/DATE screen will display.

TIME/DATE Screen 1.

Enter the current time in hours, minutes and seconds using the keyboard.

2.

Enter the current date in numeric characters for month, day, and year.

3.

Select either the MM/DD/YYYY or the DD/MM/YYYY or YYYY-MM-DD radio button to choose a format for the date display.

4.

Select the OK button to close the CUSTOMIZE TIME/DATE screen and return to the CUSTOMIZE screen.

NOTE

System default is MM/DD/YYYY.

Page 3-43


3.4.5

Adjust Contrast/Brightness

To adjust contrast or brightness of image capturing: 1. Click right button of mouse to call the menu. 2. Select “Contrast/Brightness” item.

3. Use the adjust dialog to set contrast/brightness.

• • • • •

Press DEFAULT to restore the default values of contrast and brightness. Drag the slide bar to adjust contrast/brightness. Or input the value to adjust contrast/brightness. Press SAVE to apply the new setting. Press EXIT to quit the setting dialog.

NOTE

Page 3-44

The contrast/brightness adjust function will only take effect on the image. It can’t affect the hardware setting of the monitor.


3.4.6

Change Language

There are two ways to change the language of user interface:

(1) Use the CUSTOMIZE WORKSTATION screen.

NOTE

The language setting will take effective after you quit the CUSTOMIZE SCREEN.

(2) Use right-click menu Click the right button of mouse to call the menu and select the favorite language.

Page 3-45


NOTE

Page 3-46

The user interface language can be changed, but language of keyboard input is only English.


3.4.7

Help Press F1 key to call the help screen.

Page 3-47


3.4.8 1. 2. 3. 4.

About

Click right button of mouse to call the menu. Select “About” item. The information about the software will be displayed. Press “Esc” or “Enter” key to close this dialog.

Page 3-48


3.4.9

WorkStation Shut Off (F12)

Press F12 key to shut off the WorkStation. The system will remind you if you really want to shut off the WorkStation:

The user can click on the

icon to shut off the WorkStation. If you do not want to shut off

the WorkStation, click the cancel button.

Page 3-49


3.5 Print Function WARNING

Please check and verify that only the printers provided by GE Healthcare can be used.

WARNING

Please check and verify that the paper is available and the printer is ready to work.

When the image is displayed on the right monitor, you can press the “Prt Sc SysRq” key on the keyboard, and then the displayed image can be printed. The location of the key is as follows:

Page 3-50

Chapter 4

Mechanical Movement


4.1 Mechanical Movement of C-Arm 4.1.1

C-Arm rotation

Rotation Brake Handle WARNING

During rotation, there are accessible moving parts, keep hands/fingers away from the moving parts or the location that the moving parts may collide.

The C-Arm can be rotated radially a total of 205° on the C-Arm support axis. •

Turn the rotation brake handle upwards to release the rotation lock.

•

Turn the rotation brake handle to the horizontal position to lock the rotation of the C-Arm.

The rotation is blocked at 155° as a safety precaution. If you want to rotate the C-Arm beyond the limits, Push the safety switch forward (Refer to the picture below).

CAUTION

Page 4-2

With the C-arm being rotated to 180°(image intensifier is under table), the image intensifier cover may collide with the base of C-Arm during this movement. Do not rotate the C-arm more than 205°, otherwise, the cable is twisted excessively to be damaged.

Mechanical Movement

4.1.2

Orbital Movement

Orbital Brake Handle

The C-Arm can be rotated exceeding ±112°. •

Turn the orbital movement brake handle upwards to release the brake.

•

Rotate the handle to the horizontal position to lock the orbital movement of the C-Arm.

CAUTION

If the Image intensifier and the C-arm are in the lower position, when the C-Arm is moved close to the EverView 7500 Console, the image intensifier cover may collide with the T-base of the EverView 7500 during the movement.

Page 4-3


4.1.3

Horizontal Movement

Horizontal Movement Brake Handle The horizontal C-Arm extends a maximum of 200mm. •

Turn the horizontal movement brake handle to the horizontal position to enable the horizontal movement.

•

Turn the horizontal movement brake handle to the vertical position to lock the movement.

Page 4-4

Mechanical Movement

4.1.4

Wig-Wag Movement

Wig-Wag Brake Handle The movement range of the Wig-Wag movement is ≥ ±12.5° . •

Rotate the Wig-Wag movement brake handle upwards to the vertical position to enable the Wig-Wag movement of the C-Arm.

•

Rotate the Wig-Wag movement brake handle downwards to the horizontal position to lock the Wig-Wag movement of the C-Arm.

Page 4-5


4.1.5

Vertical Movement

The motorized vertical movement is controlled from the control panel on the C-Arm.

To raise or lower C-Arm, press key

or

. The upward or downward movement

continues until the key is released or the movement may reach its limits. The

and

keys are located on both sides of the control panel.

When C-Arm can’t be driven down by only pressing lower key, please make sure there are no

obstacles between the C-Arm and the T-base. Press and hold the 2 keys

(Lower

and compulsive keys) together. It will lower C-Arm to the lowest position.

WARNING

Page 4-6

When raising or lowering C-Arm, please make sure C-Arm including Tube and RIU won't be blocked by any other equipment. When collision happens, the protection fuse may be blown out to protect the elevating system. If any failure occurs, please contact GE Healthcare service engineer.

Mechanical Movement

4.1.6

NOTE

CAUTION

Mobil C-Arm Steering Handle The rear wheels can be positioned in this manner whether the wheel brakes are applied or not.

To avoid losing the control of the Mobile C-Arm, always reduce transport speed before moving the steering handle out of 0° position.

Rotate the right steering handle to turn the rear wheels from 0° to 90° to the right or left. Use this feature to position the C-Arm during clinical applications or sharp turns during transportation. The rear wheels turn at approximately the same angle as the right steering handle.

Steering Handle

Page 4-7


4.2 Wheel Brakes of Mobil C-Arm To release the wheel brake, press the brake release pedal . To lock the wheel brake, press the brake pedal .

Brake Release Pedal Brake Pedal

Page 4-8

Mechanical Movement

NOTE

When release the brake pedal, please operate in right manner, or it will cause large noise!

Right Operation

Wrong Operation

Page 4-9


4.3 Wheel Brakes of WorkStation When you move the WorkStation to the position you desire, press the front wheel brakes to prevent the WorkStation from moving.

To move the WorkStation, press the front wheel brakes and make them in the position as below figure.

Page 4-10

Mechanical Movement

4.4 Moving the C-Arm and WorkStation WARNING

Before transporting the system, please make sure the 4 brake handles: Rotation Brake Handle, Orbital Movement Brake Handle, Horizontal Movement Brake Handle and Wig-Wag Brake Handle are locked. If any of the brake can not be firmly locked, don’t transport the system, contact GE Healthcare Service Engineer

Familiarize yourself with the location and mechanical operation of all controls prior to moving the C-Arm. The C-arm weighs about 250 kg, and the WorkStation weighs about 150 kg. Neglecting the precautions during moving could cause the system to lose out of control and may cause injury to the operator and other persons.

Always: 1. Check and make sure there are no obstacles in the path. 2. Move the system slowly. 3. Use at least two people when moving over sloping floors. To move the mobile C-Arm from one place to another, operate as follows: 1. Return all moving assemblies to their most compact positions. Put the C-Arm to its lowest position and retract the extended parts entirely. (Do this before switching off the mobile C-Arm). WARNING

When the C-Arm is positioned on 10° incline, and the mechanical parts are extended to their greatest length, if the cassette holder is attached, The C-Arm will be unstable. Please be sure to put the C-Arm in it’s compact position.

2. Set the C-Arm to zero position by swinging C-arm with 12.5 and -12.5 degree angle. 3. Lock all movable mechanical assembly brakes :the C-Arm rotation brake, the C-Arm orbital rotation brake ,the horizontal rotation brake, the Wig-Wag brake etc. 4. Press the power off key to switch the system off. Open the circuit breaker on C-Arm .Unplug the power supply cable and secure the cable on the console. 5. Unplug the integrated cables between the C-Arm and the WorkStation and secure them . 6. Disconnect the green-yellow potential equalization lead if connected. 7. Disconnect the footswitch and secure it on the C-arm. 8. Remove the cassette holder if fitted.

Page 4-11


9. Check that the hand-switch is in its holder. 10. Press the small wheel brake pedal to unlock the wheels . 11. Guide the C-Arm by pushing with the steering handles, or by pulling with the image intensifier positioning handles. 12. When you reach your destination, place the C-Arm wheel brakes in the locked positions.

CAUTION

Do not move the C-Arm over inclines greater than 10°. Do not move the C-Arm up or down stairs or steps. Do not lock the C-Arm in place on an incline greater than 5°.

CAUTION

Transport the system at normal speed, cross ramps and thresholds as slow as possible.

NOTE

The steering handle may twist if the steering casters are not in the correct driving position and meet obstructions on the floor. The high-end of the handle indicates the direction of the rear casters.

To move the mobile WorkStation from one place to another, operate as follows: 1. Unlock the wheel brakes of the front wheels. 2. Push the WorkStation to the place you desire. 3. Lock the front wheels of the WorkStation.

WARNING

Page 4-12

Do not stretch integrated cable when moving the equipment. Disconnection of the integrated cable may result in Workstation failure.

Chapter 5

Maintenance


5.1 Overview This section describes routine performance checks that you can perform to ensure that the system is operating correctly. If problems are found during these checks , contact a qualified service engineer to troubleshoot and repair the system. Whenever the system is used, the operator must check that the unit is in good condition, particularly: •

That the surface condition of the mobile parts is undamaged and that there are no sharp parts or projections.

•

That the transport components, particularly the wheels, are in good condition and that their attachments offer no danger, and that there is no wear.

If in doubt, the operator must inform immediately the appropriate technical department and only use the system with greatest care before any repairs required are carried out. Prior to performing any of the performance checks in this section, it is important that potential hazards associated with these tasks are understood. Review the Introduction and Safety chapter of this manual before proceeding.

WARNING

Circuits inside the equipment use voltages that are capable of causing serious injury or death from electrical shock. Do not remove the covers or perform any types of service task.

Move the system into a safe operating area prior to beginning these checks and observe all radiation safety precautions. The performance checks should be performed as often as equipment use and circumstances warrant. Extensive use warrants increasing the frequency of performance checks. In addition circumstances such as accidents during transport or exposure to excessive fluids may warrant that performance checks be performed to verify operation of the equipment.

Page 5-2

Maintenance

5.2 Performance Checks 5.2.1

Mechanical Performance Check

1. Check the Wig-Wag brake operation. Check Wig-Wag for ease of movement (side to side swing ) without excessive play. 2. Check the Horizontal Cross-Arm brake operation. Extend and retract the Horizontal Cross-Arm. Check for ease of movement without excessive play. 3. Check the rotation brake operation. Check the rotation for ease of movement without excessive play. 4. Check the C-Arm orbital rotation brake operation. Check orbital rotation of the C-Arm for ease of movement without excessive play. 5. Check the operation of the rear wheel pedal brakes. 6. Check for proper operation of the steering handle and control of the rear wheels. Check for ease of movement without excessive play. 7. Check the operation of the brakes of workstation.

5.2.2

Electrical Performance Check

1. Inspect the high voltage cables for signs of wear and abrasion. 2. Inspect the footswitch and hand control cables for signs of wear and abrasion. 3. Inspect the integrated cable of the Workstation for signs of wear and abrasion. 4. Turn the system On and verify the system successfully completes the power-up sequences. 5. Raise and lower the vertical column by pressing the keys on the console keyboard.

Page 5-3


5.2.3

Emergency Stop Performance Check

This check is performed as a matter of routine operator maintenance to ensure that the Emergency Stop safety feature is functioning properly. Perform this check as often as conditions such as removal from long term storage and exposure to fluids warrant it. 1. Press and hold the vertical column control key and while motion is occurring press emergency stop pushbutton. 2. Verify that the mechanical motion stops and the fault indicator lights up. 3. Press any X-Ray switch and verify that X-Rays are disabled. 4. Press the system power off key. 5. Rotate the emergency pushbutton upward in the direction according to the arrow on the pushbutton. 6. Power on the system and verify the system is normal.

NOTE

Page 5-4

Images will be lost when the system is restarted unless you have saved them.

Maintenance

5.2.4

Fluoro Mode Performance Check

WARNING

This performance produces X-Rays. Take the appropriate precautions.

1. Position the C-Arm so that the X-Ray head is directly above the image intensifier. 2. Place a suitable test object on the face of the image intensifier tube. 3. Verify that AUTO mode is selected. The LED on the top left corner of the AUTO key on the C-Arm control panel will be illuminated. 4. Press the footswitch or the handswitch , verify that a digitalized fluoro image of the object appears on the left monitor and that it remains there after the exposure is terminated. 5. Press the footswitch or handswitch to verify the following: a) Verify operation of the C-Arm image orientation keys: rotation and image reversal. b) Verify operation of the field size selection keys: NORM, MAG1 and MAG2. c) Verify operation of the motorized collimation controls: collimator shutter rotation, shutter open/close, iris open/close.

5.2.5 WARNING

Radiographic Mode Performance Check This performance produces X-Rays. Take the appropriate precautions.

1. Press the radiography key on the C-Arm control panel to select radiography mode. 2. Install the film cassette holder on the image intensifier and load a film cassette. 3. Press the handswitch and hold on the switch until the exposure indicator lights off to start radiography. The system will give a continuous audible “Di…” alarm during the exposure. If the handswitch is loosen when exposuring , the system will give a audibe “Di-Di-Di-Di” alarm to warn that the exposure is interrupted. 4. Release the handswitch after the exposure indicator lights off. 5. Develop the film and inspect the exposure.

Page 5-5


5.3 Planned Maintenance and User Checks EverView 7500 C-Arm X-Ray Imaging System requires not only proper operation but also planned maintenance and user routine checks. Such planned maintenance and user routine checks are essential to keep the equipment operating safely, effectively and reliably.

5.3.1

Planned Maintenance Items

Planned maintenance must be carried out only by qualified and authorized service technicians. A summary of the planned maintenance program is given below.

Check

Reason

Frequency

Earth (Ground)

Check maximum earth of whole system

Annually

Power supplies

Check earth leakage current

Annually

Check internally- generated DC voltages

Annually

PCB’s and racks

Ensure secure fitting and check for dust and corrosion

Annually

Motorized movement

Check electrical and mechanical settings

Annually

Bearings

Check freedom from dust

Annually

Grease and oil

Annually

Drive chains

Check for wear and correct tension

Annually

Controls and Indicators

Check accuracy and functioning of:

Alignment Mechanical

Page 5-6

All controls

Biannually

All visible / audible indicators

Biannually

Movement

Biannually

Collimator alignment and field limitation

Biannually

Beam alignment and centering

Biannually

Counterweight fasteners and cables

Biannually

All mechanical stops

Biannually

Wheels and wheel alignment

Biannually

Brakes and locks

Biannually

Maintenance

5.3.2

User Routine Checks Items

The user of the equipment must follow the user routine checks’ items as detailed in the table below. It is for the operator of the equipment to ensure that all checks have been satisfactorily met before attempting to use the equipment. It is the operator’s responsibility to provide these checks:

Check

Description

Frequency

All accessories

Availability and integrity

Daily

Power supply check

Ensure correct functioning

Daily

Indicators and buzzer test


Daily

X-ray control check


Daily

Vertical movement check


Daily

Brakes and castors


Daily

Cabling

Inspect for kinks and / or cracks

Daily

Inscriptions and labels

Check for legibility

Annually

Hand-switch and foot-switch

Check functionality

Daily

CAUTION

Before using the equipment, verify that system operation is proper according to the check items above. System not fully functional may result in delays in medical treatment.

Page 5-7


5.4 Cleaning and Disinfections EverView 7500 needs frequent cleaning and disinfection.

WARNING

CAUTION

5.4.1

Before cleaning and disinfecting the equipment, make sure the system is turned off and the power cord is unplugged to avoid electrical shock. The equipment is not waterproof .Be careful not to spill or splash liquids where they can enter electronic assemblies.

Cleaning

Protect against Water And Solutions The system, such as keyboard must never be operated or stored in locations where conductive fluids, such as saline solution might spill on the equipment. Always unplug the AC power cable from the wall outlet before cleaning the equipment. Do not allow water, soap, or other liquids to drip into the equipment and cause short circuits, electric shock and fire hazards.

Enameled parts and aluminium surface should only be wiped with a damp cloth and water, then rubbed down with a soft dry woolen cloth. Never use corrosive cleaning agents, solvent or abrasive detergents or polishes. If you are uncertain of the nature of a cleaning agent, do not use it. Chrome parts should be cleaned only with a dry woolen cloth. Do not use abrasive polishes. To preserve the finish, use non-abrasive wax.

Page 5-8

Maintenance

5.4.2

Disinfections

All parts of the equipment, including accessories and connecting cables, can be disinfected by wiping them with a cloth dampened with disinfectant, such as 75% alcohol. Never use corrosive or solvent disinfectants. If you are in doubt of the nature of a disinfecting agent, do not use it.

CAUTION

CAUTION

Flammable or potentially explosive disinfecting sprays must not be used since the mixed gas could ignite and cause personal injury and /or damage to equipment.

Disinfecting a medical equipment room by means of sprays is not recommended since the sprays can penetrate the equipment, which causes electrical short circuit or corrosion.

If nonflammable, non-explosive spray disinfectants are to be used, the equipment must be switched off and allowed to cool first, which prevents the disinfectant from spraying into the equipment due to convection. Plastic sheeting must be used to cover the equipment thoroughly, following which disinfectant spraying can take place. Once all traces of the disinfectant spray have dispersed, the plastic sheeting can be removed and the equipment itself can be disinfected in the recommended way. If a spray has been used, the operator must make sure that all traces of the vapor have been dispersed before switching the equipment on again. Disinfections techniques for both the equipment and the room must comply with all applicable laws and regulations that have the force of law within the jurisdiction in which the equipment is located.

Page 5-9


5.5 Fault Isolation 5.5.1

Overview

This chapter describes faults that appears in the daily operation of the EverView 7500 C-Arm X-Ray Imaging System. For some occasional faults, you can reset the system and the system will work normally. For some serious faults, you must stop operation and communicate with the service representative or local offices of GE Healthcare.

5.5.2

Fault Isolation Problem

The EverView 7500 system can not power up after pressing System On key

Possible Cause

Possible Solution

The integrated cable is not connected

Connect the integrated cable to the female socket on the C-Arm

No power supply

Check the power supply

The incoming circuit breaker on the C-Arm is tripped or in open state

Open the cover of the circuit breakers and close the circuit breaker

The fault indicator lights on

Check if the emergency stop pushbutton is pressed down. If it is pressed down, follow the reset steps to restart the system.

The EverView 7500 system can not power off after pressing System Off key

Page 5-10

The workstation is not powered off first

Press F2 first to power off the WorkStation , then power off the system

Chapter 6

Labels and Symbols


6.1 Overview This chapter describes labels and symbols that are located on the Mobile C-Arm and WorkStation.

6.2 Labels and Location 6.2.1

Overview

Two types of labels are described: warning labels and regulatory certification labels. Warning labels define potential hazards and advise against misuse that might result in personal injury. Familiarize yourself with these labels and their meanings in order to ensure a safe environment for both the patient and yourself. Regulatory labels indicate that the system meets the requirements of specific governmental, medical and industrial organizations. NOTE

Page 6-2

Even though this manual is supplied only in English, a foreign language equivalent of the following labels may appear on your system.

Labels and Symbols

6.2.2

Labels

1. Quantity: 1 This label indicates the position of the C-Arm Wig-Wag movement handle. When the handle is rotated to vertical position, the Wig-Wag brake is released. When the handle is in horizontal position, the Wig-Wag brake is locked.

2.

Quantity: 1 This label indicates the position of the C-Arm Wig-Wag movement handle. When the handle is rotated to vertical position, the Wig-Wag brake is released. When the handle is in horizontal position, the Wig-Wag brake is locked.

3. Quantity: 2 This label indicates the position of the C-Arm orbital movement and rotation handle. When the handle is rotated to the dashed position, the brake is released. When the handle is in horizontal position, the brake is locked.

4. Quantity: 2 This symbol indicates the position of the C-Arm orbital movement and rotation handle. When the handle is rotated to the dashed position, the brake is released. When the handle is in horizontal position, the brake is locked.

5. Quantity: 1 This symbol indicates the position of the C-Arm horizontal movement handle. When the handle is rotated to the horizontal position, the brake is released. When the handle is in vertical position, the brake is locked.

Page 6-3


6. Quantity: 1

This is the mark of image intensifier system.

7. Quantity: 1 This label indicates that the Mobile C-Arm’s mechanical subassemblies position should be placed in their most compact position before transporting or moving the system. Refer to chapter 4 Mechanical Movement for details.

CAUTION : Place all mechanical assemblies in their most compact (transport) position and lock brake handles prior to moving the equipment.

8. Quantity: 1

！

Attention, see accompanying documentation. This symbol on the tube housing means that you can refer to Service Manual for detailed information.

9. Quantity: 1

！

This label on the control panel of the C-Arm means that you can refer to Section 2.4 in this manual for instructions of the control panel.

10. Quantity: 1 This label near the orbital brake handle means that there is accessible moving parts and keep hands/fingers away.

Page 6-4

Labels and Symbols

11. Quantity: 1

！

This label near the safety switch means that you must take care to rotate the C-Arm larger than 155°.

12. Quantity: 1

！

This label on the Workstation means that you can refer to the WorkStation keyboard section in this manual for detailed information.

13. Quantity: 1

！

This label on the USB interface means you should open the USB cover then insert the USB stick. This port is only used for user to store patient image by USB stick. Any other equipment is forbidden to be connected strictly.

14. Quantity: 1

IPX8

This label on the footswitch means that the degree of protection of the footswitch is IP X8. The electrical mechanism within the footswitch is protected from the effects of continuous immersion in water.

15. Quantity: 1 This symbol indicates the location of Emergency Stop Switch on the EverView 7500 equipment. To UK and Ireland customer: the emergency switch with hard key provides one method to prevent unauthorized power up and generation of x-rays.

16. Quantity: 1 This mark means that there is ionization radiation.

Page 6-5


17. Quantity: 1 System nameplate. Indicates manufacture information and input power requirements.

This label indicates the system complies with the US Federal Performance standard 21 CFR Subchapter J and applicable international standards. It is only on the system mounted with DAP unit (Option 2).

18. Quantity: 1 X-ray Generator/Collimator

P.N.: 2397125 S.N.: RATING VOLTAGE: 110kV TUBE MODEL: 110/3 DF INH. FILTERATION: 3.5mm AL FOCAL SPOTS: 1.4mm 0.6mm COLLIMATOR ASSEMBLY: 2415086 MANUFACTURED:

TYPE B

This symbol Indicates manufacture information and input power requirements of X-Ray generator.

This equipment is certified to be in compliance with the applicable standards of the Code of Federal Regulations,Title 21, Subchapter J, as of the date of manufacture.

GE HUALUN MEDICAL SYSTEMS CO. Ltd.

No 1 Yong Chang North Road Beijing Economic-Technological Development Area 100176 BEIJING CHINA.

19. Quantity: 1

0459

This symbol indicates the system was tested by a Notified Body and was found to be in compliance with the requirements of all relevant directives and standards in effect within the European Union at the time of manufacture.

0459

This symbol indicates the generator was tested by a Notified Body and was found to be in compliance with the requirements of all relevant directives and standards in effect within the European Union at the time of manufacture.

20. Quantity: 1

21. Quantity: 1 2339039,CASSETTE HOLDER

Page 6-6

This is the mark of the cassette holder.

Labels and Symbols

22. Quantity: 1

This warning label is on the control panel . It is only on the system in America.

23. Quantity: 2 This label indicates that waste electronic and electrical equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

24. Quantity: 1

S

This symbol indicates the system was tested by CCC authorized body and was found to be in compliance with the requirements of all relevant directives and standards at the time of manufacture.

25. Quantity: 1 T ERT EK I N

ETL CLASSIFIED Medical Equipment

CM

C

L I S T E D

US

9801745

This label indicates the system was tested by ITS authorized body and was found to be in compliance with the requirements of all relevant directives and standards at the time of manufacture.

26. Quantity: 1

WARNING

Explosive hazard if used in the presence of flammable anesthetics.

27. Quantity: 1

！

WARNING

This label on the integrated cable interface of the Workstation means that you should not stretch integrated cable when moving the equipment. This may result in Workstation failure.

Page 6-7


6.2.3

Page 6-8

Location of the labels

Labels and Symbols

Page 6-9


6.3 Symbols Be familiar with the following symbols that may appear on equipment and schematics, so you can safely maintain and operate the system:

Dangerous Voltage This symbol identifies areas where hazardous voltages may be present. Use appropriate safety precautions.

Earth Ground Connection This symbol identifies an earth ground connection that is necessary to maintain grounding throughout the system.

X-Ray Source This X-Ray Source symbol can be found on the X-Ray generator. It indicates the location of the X-Ray source and the controls used to produce ionizing X-Radiation. Use appropriate precautions and protective equipment when using the system and at all times when X-Rays are present. This symbol is used to identify controls that will produce ionizing X-Radiation when activated. Always use appropriate precautions when generating X-Rays.

Potential Equalization Terminal This symbol identifies system terminals which, when connected together, are at the same potential (not necessarily earth ground). Green/yellow wires normally connect potential equalization terminals together.

Attention Attention, refer to accompanying documentation for information.

Type B This symbol indicates Type B applied parts. User is protected against electric shock by protective earth grounding of all accessible conductive parts or the use of non-conductive parts.

Page 6-10

Chapter 7

Technical Reference


7.1 Overview The policy of GE Healthcare is one of continual product development and improvement. For this reason, GE Healthcare reserves the right to change the operating characteristics and specifications of newer products at any time, without prior notice, and without incurring any obligation relating to previously manufactured items. The specifications listed are limited to general performance and physical data. Specifications of optional equipment provided by other manufacturers are given in the applicable manuals provided with those options.

7.2 System Specifications 7.2.1

Classification Type

Class I equipment (as defined by IEC60601-1) Type B protection against electric shock ( IEC60601-1) Degree of Protection: System: IPX0 Footswitch :IPX 8 Working Mode： Continuous and intermittent loading working mode

7.2.2

Power Requirements

Voltage:

AC 110 V/120 V /220 V/230 V/240 V; ±10%

Rated Continuous Power: 1.4 KVA Rated Momentary Power: 5 KVA (220 V/230 V/240 V) 4.5 KVA (110/120 V) Frequency :

50 Hz / 60Hz ( ±1Hz )

Power Supply resistance:

Page 7-2

0.6 Ω/0.3 Ω

Technical Reference

7.2.3

Dimensions and Weights

Dimensions: C-Arm:

1730mm x 760mm x 1700mm(Length x Width x Height )

WorkStation:

840mm x 650mm x 1630mm(Width x Depth x Height )

Weight: C-Arm:

480 Kg (with packing) 250Kg (net weight)

WorkStation: 225 Kg (with packing) 150Kg (net weight)

7.2.4

Filtration

Filtration in X-Ray Tube

0.55 mm Al

Filtration in X-Ray Tube Assembly

2.55 mm Al

Additional Filtration

1 mm Al

Total Filtration

3.55 mm Al

7.2.5

Ambient Conditions

Operating Conditions: Temperature

10°C ～ 40°C

Relative Humidity (non-condensing)

30％～ 75%

Atmospheric Pressure

700 hPa ～ 1060 hPa

Transportation and Storage: The packaged EverView 7500 system can be transported or storage under the following conditions: Temperature

-10°C ～ +55°C

Relative Humidity(non-condensing)

10%～95%

Atmospheric Pressure

500 hPa ～1060hPa

Shock and Vibration:

1G at 5-200 Hz for 2 hours

Page 7-3


7.3 Specification of Key Components 7.3.1

Generator

The following information is provided in accordance with IEC 60601-2-7. Type

converter

Voltage

Adjustable in steps of 1 kV from 40 to 110 kV

mAs values

from 1 to 80 mAs

mAs step

1.0, 1.3, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10, 13, 16, 20, 25, 32, 40, 50, 63, 80 mAs

Maximium energy in 1 hour

110 KV , 3200 mAs

Max. Fluoroscopy current

4.0 mA

Max. HLF current

8.0 mA

Duty cycle

83kV, 2.5mA, 5min, interruption 1.4min

7.3.2

X-ray Tube

Tube Voltage

110kV

Voltage Range

40kV ～ 110kV

Maximum anode heat content 53 kJ Target material Target angle

Tungsten 10°

Small focal spot

0.6 x 1.4 mm

Large focal spot

1.4 mm

Anode Stationary Typical filament specification

4.2 V, 3.5 A

Maximum filament current

4.6 A

Weight

0.65 kg

Page 7-4

Technical Reference

7.3.3

Camera Output Video Signal

Type

High resolution CCD sensor

CCD matrix:

752X582

Signal Output

1 Vpp (0.3 Vpp sync.) 75 ohms video outputs

Output Video number

1 video output at 50 Hz and 2 video outputs at 100 Hz

Lines (interlaced)

625 at 50 Hz

Preprocessing

fast, highlight control and ABC

Video standards

CCIR (50 Hz)

7.3.4

Collimator

Fluoroscopy Nominal diameter circle:

23/15/11cm(9”/6”/4.5”)

X-Ray beam continuously adjustable to an area of less than 4.5 x 4.5 cm at the image receptor Radiography Nominal diameter circle:

7.3.5 NOTE

23cm(9”)

C-Arm Movement The X-Ray datum axis from the collimator to the center of Image Intensifier is always in a line and cannot change with the movement of C-Arm.

Longitudinal travel

200mm. the tolerance: -10~+20mm.

Transverse movement

±12.5°

Vertical movement

400mm, the tolerance: -10~+20mm

Rotation

±180°with safety stop at 155°

Angulations

﹣25°~﹢90°

SID

880 mm ± 10 mm

Page 7-5


7.3.6

Others

Semi-transparent Shutters Rotation

+/- 90°

Operation

Controlled on panel

Grid Type Material

Circular Aluminium

Lines/cm

40

SID Ratio

90cm 1: 8

Image Intensifier Type

3 Fields

2 Fields

Input field sizes

23cm (9 inch) 15cm(6inch)

Input screen

CsI

1 Fields 11 cm(4.5inch)

Monitor Type

High resolution

Size

17 inches

Digital Processor Function

LIH and noise reduction

Image storage: Capacity is 80,000 images with advanced configuration option Capacity is 40,000 images with standard configuration

Page 7-6

Technical Reference

7.4 Tube Rating Charts The following charts and data describes tube characteristics when operated with three-phase full-wave rectification, a reasonable approximation to the high frequency generator with minimal ripple. Single load ratings:

Page 7-7


Page 7-8

Technical Reference

Thermal Characteristics: Anode Heating and Cooling Characteristics: KJ

KHU

60

45

30

15

Time (minutes)

Page 7-9


Tube Housing Heating and Cooling Characteristics: Joules

Time (minutes)

Page 7-10

Technical Reference

7.5 Scatter Radiation Chart

Page 7-11


7.6 Options 7.6.1

Sony Thermal printer

UP-D897 Power requirement

100 to 240 V AC, 50/60Hz

Input Current

1.5 A to 0.8 A

Operating temperature

5 °C to 35 °C

Operating humidity

20% to 80%

Dimensions

154×88×240mm(w/h/d)

Mass

2.6 kg (5 lb 11 oz) (printer only)

Thermal Head

Thin-film thermal head, 1280 dots

Gradation

256-level gradation (8-bit)

Memory capacity

4096×1280×8 (bit)

Picture size

320×100 mm(max.)

Printing speed

About 2 sec./image (960×1280 dots) (printing at the high speed) About 3.3 sec./image (960×1280 dots) (printing at the normal speed)

Picture elements

4096×1280 dots(max.)

Dot density

H: 100 mm/1280 dots = 0.078 V: 100 mm/1280 dots = 0.078 Square dots

Interface

Page 7-12

Hi-Speed USB (USB 2.0)

Technical Reference

7.6.2

DAP(Dose Area Product) (Option 1)

The calculated Dose Area Product is a measure of radiation emitted by the X-Ray Tube. This doesn’t represent the radiation absorbed by the patient. The KermaX-plus DAP, comply with standard IEC 60601. It is sold for market outside North America. Working temperature range:

10 C° - 50 C°

Humidity:

30 - 75 % (no condensation)

Pressure:

700 hPa – 1060 hPa (According to IEC 60601.1 chapter 10.2.1)

Reproducability:

< 1% under constant pressure and temperature.

Energy dependence:

± 8 % related to 100kV (IEC60580)

Drift:

automatic reset procedure in intervals of 60 seconds.

Area kerma product rate: Minimum:

0.03 µGy m2 / s (on request 0,01µGy m2)

Maximum:

1000.0 µGy m2 / s (a version with a maximum rate of 300 00.0 µGy m2 / s is available too)

Minimal dose resolution:

0.1 µGy m2 (on request 0,01µGy m2)

Maximal measurable dose:

999999999,9 µGym2 with Wellhöfer display unit. (Depends on display capacity)

Dose rate linearity:

better than ± 2% IEC 60580 : <1 µGy m2/s = 5%, ≥1 µGy m2/s = 2%

Page 7-13


7.6.3

DAP(Dose Area Product) (Option 2)

The calculated Dose Area Product is a measure of radiation emitted by the X-Ray Tube. This doesn’t represent the radiation absorbed by the patient. The KermaX plus C DAP, comply with standard IEC 60601. It is sold for global market. Working temperature range:

10 C° - 50 C°

Humidity:

30 - 75 % (no condensation)

Pressure:

700 hPa – 1060 hPa

Warm up time

10 min

Energy dependence (0,5mm AL between chamber and reference point)

Dose - Rate: Minimum effective range of measurement:

6 mGy / min

Maximum effective range of measurement:

30000 mGy / min

Dose: Minimum effective range of measurement:

1 mGy

Maximum effective range of measurement:

99999,95 mGy

Dose resolution:

0,05 mGy

Dose rate linearity

Better than ± 5 %

Active diameter of chamber

70 mm

Input voltage range

15V DC – 22 V DC

Combined measurement uncertainty

± 35 %

Page 7-14

Technical Reference

7.6.4

Film Cassette Dimensions

Standard

10 inches X 12 inches

Metric

24 cm X 30 cm

7.7 Material Safety Data sheets Manufacturer’s Material Safety Data Sheets are available from the manufacture upon request. Contact the following manufacturers with regard to the materials listed: Oil

Sinkiang Kelamayi Lubricating Oil Plant Adress: Jinlong Town Youlong Road No. 8 , Kelamayi City ,Sinkiang Uigur Munisipality Post Code: 834003 Tel: 0990-6831426

7.8 Material recycling Parts or accessories at end–of–life: The disposing of parts and accessories must be in accordance with national regulations or local regulations for waste processing. All materials and components that could have risks to the environment must be removed from the end–of–life parts and accessories (For examples: transformer oil, etc...). Please consult your local GEMS representative before discarding these products. Packing materials: The materials used to pack our equipment are recycled. They must be collected and processed in accordance with the local regulations.

Page 7-15

Chapter 8

Options


8.1 Cassette Holder Installation 8.1.1

Cassette Holder Installation

Please follow the steps below to install and remove the cassette holder: 1. Rotate the tighten screw counter clockwise on the cassette holder to loose it. 2. Mount the cassette holder on the image intensifier and rotate to let the 2 white plastic location wheels into the slot of the image intensifier.

3. Rotate the tighten screw clockwise to tighten it. 4. Insert the cassette into the cassette holder. After the cassette is in it’s right position, you will hear a audible “Kite”. NOTE

The standard cassette size is 10 inches X 12 inches. If your cassette size is 24 cm X 30 cm, you should remove the 4 nylon blocks outside of the cassette holder and install them inside. Please refer to section 8.1.2 for details.

5. If you want to remove the cassette, simply lift the button on the right side of the cassette holder and draw it out.

Page 8-2

Options

8.1.2

Cassette Holder For Metric Casstette

The cassette holder is factory-prefabricated for 10″×12″ cassette. If the dimensions of the cassette is 24cm×30cm, please follow steps as below :

4 Nylon blocks outside

Nylon Blocks inside

1. Unscrew the fixing screws of the 4 Nylon blocks (on outside edge of the cassette holder). 2.

Take off the 4 Nylon blocks and fix them on the inside edge of the cassette holder.

3. Then tighten the screws of the 4 Nylon blocks (Note: The heads of the screws should be outside of the cassette holder). 4. Push the cassette in .

Page 8-3


8.2 Sony UP-D897 (Option) The UP-D897 is a digital graphic printer that can be used to print images displayed on a video monitor. 1. High definition, 12.8 dots/mm printing using a thermal head with a high-speed drive IC. 2. 256 gradations of black and white. 3. Stable printouts using temperature compensation technology, 4. A high quality image (960×1280 dots) single printout in about 2 seconds in high speed mode is available. 5. Equipped with USB connector, complying with the Hi-Speed USB (USB 2.0) 6. Easy printer settings using a menu 7. Easy and quick paper loading 8. Refer to the printer instruction manual for more information

8.3 KermaX plus DAP (Dose Area Product) (option 1) The KermaX plus is intended to be mounted on the face of diagnostic X ray collimators for the purpose of measuring air kerma product (AKP), sometimes known as dose area product (DAP). Before a user wants to measure a dose area product, he has to reset the display unit by pressing the “RESET” – button on the small remote display. After the exposure the display indicates the dose area product (DAP). For multiple exposures, the DAP value will accumulate. In this case it is necessary not to reset the system between the sub-exposures. When the system is switched off, the measured value will be lost.

Page 8-4

Options

Page 8-5


8.4 KermaX plus C DAP (Dose Area Product) (option 2) The KermaX plus C system consists of a chamber and a display unit. The chamber is intended to be mounted on the face of diagnostic X ray collimators for the purpose of measuring air kerma rate (AKR) and cumulative air kerma, sometimes known as dose rate and dose area product (DAP). And the display unit is located on the mobile C-Arm Console to indicate measured values. The displayed entrance air kerma rate or entrance air kerma values are based on a reference point 30cm from the image intensifier along the X-ray beam axis. The reference point location is based on the requirement of 21 CFR 1020.32 d (3) (iii), in a C-arm type of fluoroscope, the AKR shall be measured at 30cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID (source-image receptor distance), provided that the end of the beam-limiting device or spacer is no closer than 30cm from the input surface of the fluoroscopic imaging assembly.

8.4.1

Main Functions

To switch between DOSE and DAP-function press the Reset and Test-button at the same time. This can be done before or after a measurement.

1. DOSE Function

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Options

2. DAP Function

8.4.2

Measurement

1.

Before starting a measurement, always reset the display unit to zero using the “RESET” button.

2.

Make an exposure and read the value. The top line displays dose value, and the bottom line displays time and doserate value. Press “TIME/DOSERATE” button to switch between the time and doserate display.

3.

For multiple exposures, the dose value will accumulate. In this case it is necessary not to reset the system between the sub-exposures.

4.

When the system is switched off, the measured value will be lost.

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8.4.3

Quality Assurance Tests

Self-test: Press the TEST button and the display will initiate a self-test. Afterwards it must shortly (for a few seconds) indicate a dose value between 8,00 and 12,00 mGy.

QA tests should be carried out in regular intervals in order to verify the general functionality, safety and duly condition of the chamber and all accessories. Suggested timetable is stated below.

Suggested timetable for QA tests Type of test

Frequency

Tolerance

Self test

monthly

8,00 – 12,00.

Calibration

Every 5 years

+/- 20 %

Chamber is firmly fixed in collimator monthly rails and is free of damage together with exposed cables / connectors

NOTE

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The named quality assurance tests are recommendations only. International standards and national laws have to be observed.

Options

8.5 30 cm Spacer Replacement EverView 7500 C-Arm X-Ray Imaging System is equipped with a 20 cm spacer. If you want to use the 30 cm spacer. Please replace it as follows: 1. Remove the cover of the X-Ray tube head. 2. Turn the cover over and remove the screws of the 20 cm spacer, then remove the spacer.

3. Install the 30 cm spacer on the cover and tighten the screws.

4. Install the cover on the tube head.

For Systems with DAP, Please refer to Service manuals for details.

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Address

SERVICE OFFICES For service issues, contact the Service Office for your country.

AMERICAS UNITED STATES OF AMERICA GE Medical Systems Headquarters Tel: +1–414–544–3011 3000 North Grandview Blvd. WAUKESHA, WI 53188 Mail: P.O. Box 414 MILWAUKEE, WI 53201

LATIN AMERICA GE Medical Systems Tel: +1–305–497–1200 Latin America Headquarters 5101 NW 21st Avenue, Suite 350 FORT LAUDERDALE, FL 33309 USA

ASIA NIPPON (Japan) GEMSA Headquarters Tel: 81–426–48–2940 GE Medical Systems Asia Fax: 81–426–48–2905 67–4, Takakura, Hachioji TOKYO, 192–0033, JAPAN

REST OF ASIA GE Pacific Pte. Ltd (GEMS Asia) Tel: +65–291–8528 South East Asia Pacific Operations (SEAPO) Fax: +65–291–7006 298 Tiong Bahru Road #15–01/06 Tiong Bahru Plaza SINGAPORE 0316


EUROPE BELGIE/BELGIQUE (Belgium) GE Medical Systems Benelux NV/SA (NL) Tel:+32 2 644 09 38 Manhattan Center (F) Tel:+32 2 644 08 42 Bolwerklaan 21 b 9 Avenue du Boulevard (LUX) Tel:0800 2973 B–1210 BRUSSEL/BRUXELLES Fax: +32 2 207 73 33

DANMARK (Denmark) GE Medical Systems Danmark Tel: +45 45 51 00 55 Skovlytoften 4 Fax: +45 42 42 59 89 DK–2840 HOLTE

DEUTSCHLAND (Germany) GE Medical Systems Deutschland GmbH & Tel: 49–6102–36–0 Co. KG Fax: +49 610–36–2588 Martin–Behaim–Strasse 10 Deutschland GE Medical System Deutschland GmbH Beethovenstrasse 239 42655 Solingen

ESPAׁA (Spain) GE Medical Systems Espa‫ס‬a Tel: +34 1 663 25 00 Avda. de Europa 22 Fax: +34 1 663 25 01 Parque Empresarial la Moraleja E–28100 ALCOBENDAS

FRANCE (France) GE Medical Systems Tel: +33 (0)1 30 70 40 40 283 rue de la Mini‫ט‬re BP34 F–78533 BUC CEDEX

HELLAS (Greece) GE Medical Systems Hellas Tel: +30 1 93 24 582 41 Nikolaou Plastira Street Fax: +30 1 93 58 414 GR–171 21 NEA SMYRNI

Address ITALIA (Italy) GE Medical Systems Italia Tel: +39 02 64 22 01 Viale Fulvio Testi 28–B Fax: +39 02 64 22 0401 20126 MILANO

NEDERLAND (Netherlands) GE Medical Systems Nederland B.V. Tel: +31 73 6 457 457 Hambakenwetering 1 Fax: +31 73 6 441 233 NL–5231 DD S HERTOGENBOSCH

‫ײ‬STERREICH (Austria) GE GesmbH Medical Systems Austria Tel: 0660 8651 (geb　hrenfrei) Donau-City Strasse 6/10. Stock A-1220 Wien

Fax: +43 1 505 38 74

POLSKA (Poland) GE Medical Systems Polska Krzywickiego 34 Tel: +48 2 625 59 62 P–02–078 WARSZAWA Fax: +48 2 615 59 66

PORTUGAL (Portugal) GE Medical Systems Portuguesa S.A. Rua S‫ א‬da Bandeira, 585 Tel: +351 2 2007696/97 Apartado 4094 Fax: +351 2 2084494 P–4002 PORTO CODEX Tlx: 22804

ROSSIYA (Russia) GE Medical Systems Tel:+7 095 935 72 41 Kosmodamianskaya nab. 52, Bldg 1, 6th Floor Fax:+7 095 935 73 46 and 48 113054 MOSCOW Tel (satellite): +7 502 220 30 39 Fax (satellite): +7 502 220 32 59 Tlx:613020 GEMED SU

SVERIGE (Sweden) GE Medical Systems Tel: +46 8 457 95 20 Box 6768 Fax: +46 8 457 95 47 St. Eriksgatan 117 Tlx: 12228 CGRSWES S–113 85 STOCKHOLM

SCHWEIZ/SUISSE (Switzerland)


GE Medical Systems (Schweiz) AG Tel: 155 6958 (geb　hrenfrei) Sternmattweg 1 Fax: +41 41 421859 CH–6010 KRIENS

TRKIYE (Turkey) GE Medical Systems Turkiye A.S. Tel: +90 212 75 5552 Mevluk Pehliran Sodak Fax: +90 212 211 2571 Yilmaz Han, No 24 Kat 1 Gayretteppe ISTANBUL

UNITED KINGDOM IGE Medical Systems Coolidge House Tel: +44 753 874000 352 Buckingham Avenue Fax: +44 753 696067 SLOUGH Berkshire SL1 4ER

www.gehealthcare.com

Imagination at work

2415169-100 OM-En-Rev 6

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