Definium 6000 Learning and Reference Guide Rev 5 April 2009

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

X-ray protection and statement

IMPORTANT! . . . X-RAY PROTECTION X-Ray equipment if not properly used may cause injury. Accordingly the instructions herein contained should be thoroughly read and understood before you attempt to place this equipment in operation. The General Electric Company, Healthcare Division, will be glad to assist and cooperate in placing this equipment in use.

Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator or his assistant to take adequate precautions to prevent the possibility of authorized or unauthorized persons carelessly, unwisely, or unknowingly exposing themselves or others to direct or secondary radiation.

It is important that everyone having anything to do with x-radiation be fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Ave., Bethesda, MD 20814, and of the International commission on Radiation Protection, and take adequate steps to insure protection against injury.

It is assumed that all persons authorized to use the equipment are cognizant of the danger of excessive exposure to x-radiation and the equipment is sold with the understanding that the General Electric Company, Medical Systems Division, its agents, and representatives have no responsibility for injury or damage which may result from exposure to x-radiation.

Various protective materials and devices are available. It is urged that such materials and devices be used.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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X-ray protection and statement If you have any comments, suggestions or corrections to the information in this document, please write them down, include the document title and document number, and send them to: GENERAL ELECTRIC HEALTHCARE ADDRESS: NO.1 YONGCHANG NORTH ROAD BEIJING ECONOMIC&TECHNOLOGIC DEVELOPMENT AREA, 100176 CHINA TELE: 86-10-58068888 FAX: 86-10-67881908

CERTIFIED ELECTRICAL CONTRACTOR STATEMENT All electrical installations that are preliminary to positioning of the equipment at the site prepared for the equipment shall be performed by licensed electrical contractors. In addition, electrical feeds into the Power Distribution Unit shall be performed by licensed electrical contractors. Other connections between pieces of electrical equipment, calibrations, and testing shall be performed by qualified GE Medical personnel. The products involved (and the accompanying electrical installations) are highly sophisticated, and special engineering competence is required. In performing all electrical work on these products, GE will use its own specially trained field engineers. All of GE's electrical work on these products will comply with the requirements of the applicable electrical codes.

The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE's field engineers, personnel of third-party service companies with equivalent training, or licensed electricians) to perform electrical servicing on the equipment.

CAUTION: This manual is prepared, approved in English, English version is the original version, manuals in any other language are translated by GE approved suppliers. Always refer to the English version if non-consistency is found.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Medical Device Directive This product complies with the following requirements when it bears the following CE marking of conformity: Council Directive 93/42/EEC concerning medical devices :

The location of the CE mark label on the equipment is in the service system manual. European registered place of business: GE Healthcare Europe Quality Assurance Manager BP 34 F 78533 BUC CEDEX FRANCED Tel: +33 (0) 1 30 70 40 40

Manufacturer: GE Healthcare China No. 1, Yong Chang North Road, Economic & Technologic Development Area, Beijing, PR China 100176

Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK). Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA). Underwriters' Laboratories, Inc. (UL), an independent testing laboratory. Canadian Standards Association (CSA). International Electrotechnical Commission (IEC), international standards organization, when applicable.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Table of Contents IMPORTANT! . . . X-RAY PROTECTION...3 Medical Device Directive ...5 Chapter 1: About This Guide Safety Information ...14 Graphic Conventions and Legends...14 Safety Notices ...15

Chapter 2: Safety and Regulatory Indications for Use ...18 Safety ...19 Know the Equipment ...21 Electromagnetic Compatibility...21 Radiation Safety...23 Emergency Procedures...24 Safe Operation Precautions ...24 General Use Warnings ...24 Patient Positioning Warnings ...25 X-ray Tube ...26 Power ON and OFF ...28 Electrical Type...28 Electrical Current...29 Ground ...29 Collimator ...30 Identification and Compliance Plates ...31 Identification Plate...31 NRTL Listed Label ...32 Identification and Compliance Plate Locations ...33 Regulatory Requirements ...33 Disposal of Waste ...35 Dose Chart ...35 X-ray Source Assembly Filtration...36

Chapter 3: Hardware Overview COMPATIBLE SYSTEM COMPONENTS ...38 Acquisition Workstation...39

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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...40 Radiology Console Interface Module (RCIM)...41 X-ray Exposure Lamp ...44 Hand-switch ...45 Bar Code Reader(Option) ...46 Monitor ...47 Overhead Tube Suspension ...47 User Interface (OTS Console)...48 Overhead Rail System ...57 Telescopic Column and Carriage...57 Longitudinal and Lateral Detents ...58 Vertical Detent...59 Tube Support Unit ...59 Tube Angulation ...59 Adjust the Overhead Tube Suspension (OTS) Position ...61 Adjust the Tube Position ...62 Multi-Leaf Collimator ...63 Automatic or Manual Collimator Modes ...64 Multi-leaf Collimator Display...65 Locking Lever ...65 Rotating the Multi-leaf Collimator ...66 Rotate the Multi-Leaf Collimator...66 Digital Wall Stand...66 Tilting the Digital Wall Stand Detector...68 The Lateral Positioning Bar ...70 Hand Grip(PA bar) ...72 Grids(Option)...72 Operator Override Switch...76 Tube Warm-up Misalignment ...76 Vertical Drive Manual Override ...77 Wallstand Remote Control ...77 Radiographic stretcher Table(Option) ...79 Accessories(Option)...82 System Interlocks...85 Grid Interlock ...85 Automatic Exposure Control (AEC) Interlock ...85 Tube Position Interlock...85

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Chapter 4: Detector Overview Description ...86 Detector Safety Labels ...90

Chapter 5: Automatic Exposure Control (AEC) Console Screens...95 Ion Chamber Detectors ...97 Applications for Detector Sensing Areas...97 Areas 1 and 3...97 Area 2...98 Applications ...98 AEC Limitation Messages ...100 Acquire AEC Images...101

Chapter 6: Worklist Overview ...104 Patient List Columns ...109 Messages ...110 Manage List / Find Procedures ...111 Search By...111 Sort by Column ...112 Filter List...113 Refresh...116 Select Procedures...117 Select a Single Procedure...117 Select Multiple Procedures ...117 Delete Procedures ...118 Delete a Single Procedure ...118 Delete All Completed, Discontinued and Local Procedures...119 Delete Suspended Procedures ...119 Add Patient / Edit Patient Information ...120 Overview ...120 Add Patient...124 Edit Patient Information...125

Chapter 7: Image Acquisition Overview ...126 Patient Dose Reporting ...133 Re-start Completed or Discontinued Exams ...134

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Resume Suspended Exams...135 Select or Change Protocols ...135 Conduct a Radiographic Stretcher Table Exam...137 Conduct a Wall Stand Exam ...139 Conduct a Cassette Exam ...141 Conduct an Emergency Exam ...143 End Exam...144 Suspend ...144 Close ...144 Discontinue ...144 Automatic Protocol Recognition (APR) ...146

Chapter 8: Image Management Overview ...148 Select Image Database Source ...151 Load Images from a Network Host...152 Load Images from a CD ...152 Search List ...153 Sort by Column ...154 Open Exams and Images...154 Copy Exams and Images ...155 Copy Exams to a Network Host ...155 Copy Images to Another Exam ...156 Copy Exams to a CD...157 Delete Exams, Series, or Images...159 Lock Exams from Deletion ...160 Make Patient Anonymous ...160

Chapter 9: Image Viewer Overview ...162 Tool Selection List...165 Select Images ...166 Change Viewing Format and Size...167 Adjust Images ...168 Annotate Images ...171 Customize Annotations ...175 Add Image Annotations ...176 Delete Image Annotations ...178 Re-process Images ...179

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Dose Exposure Indicator (DEI) Function...181 Change Mouse Controls ...182 Quality Check...183 Print Images ...184 Auto Print ...184 Manual Print ...184 Save Changes to Images...189

Chapter 10: General Information System Start up and Shut Down ...190 Start up...190 Shutdown ...191 System Login and Log Off...192 Standard Login...192 Change Password...193 Emergency Login ...194 Log Off ...194 System Reset...194 Tube Warm Up...195 Lead Markers ...197 System Status and Messages...198 Expose Hold...198 X-ray Tube Heat Units Remaining ...199 System Status Area ...199 Message Log...199 Audio Indicators ...200

Chapter 11: Dual-energy Exposure Overview ...202 Technical setup and image quaulity...202 Patient size...203 High KVp ...203 Low KVp...203 Acquisition and image operation ...204 Patient dose ...209

Chapter 12: Quality Assurance Process When to Perform QAP ...211 QAP Preparation ...211

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Perform Normal QAP ...211 Failed Normal QAP ...216 Result History...217

Chapter 13: Quick Step Guides Hardware...220 Hand-switch ...220 Emergency Stop button...220 Radiographic Stretcher Table ...220 Adjust the Overhead Tube Suspension (OTS) Position ...221 Adjust the Tube Position ...222 Rotate the Multi-Leaf Collimator...222 General Acquisition ...222 Manual Patient Entry...225 Add Patient...225 Edit Patient Information...225

Chapter 14: Login Administration Enabling EA3 Login...227 Understanding Local and Enterprise Environments...227 Understanding Privileges, Groups, and Users ...227 Administering Groups and Users ...229 Accessing the Login Administration Screens ...229 Working with Groups ...230 Working with Users ...233 Viewing the Audit Log ...237 Administering System Configuration ...238 Change Display Settings and Enable Enterprise Authorization ...238 Configure Enterprise Authorization ...240 Configure Audit Log ...241 Use LDAP Console ...242

Chapter 15: Set Preferences System ...245 Network Connections ...245 Printers ...250 Worklist ...255 Default Query ...256 Preset Names ...258

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Image Management ...260 Copy Exam...260 Auto Tag (Quality Check) ...261 Auto Print ...261 Auto Push...265 Auto Delete ...266 Viewer Pre-set Annotations...269 Image Processing ...272 Build Custom Looks ...273 Change Default Factory Looks for Exams ...278 Tissue Equalization Overview ...279 Protocols ...282 Backup Protocol Database to CD ...282 Retrieve Protocol Database from CD ...283 Edit Protocol Database ...284 Protocol Editor Copy Functions...292

Chapter 16: System Specifications General Input Power Specifications ...299 Generator Output Power(See Table 16-2) ...299 Collimator Specifications(See Table 16-3) ...300 MX100 Tube specifications(See Table16-4) ...302 OTS specifications(See Table 16-5) ...305 Wallstand specifications(See Table 16-6) ...306 Radiographic stretcher table specification(See table 16-7)...307

Chapter 17: Maintenance Periodic Maintenance...308 Qualified Service ...308 Cleaning and Disinfecting ...309

Appendix A: Glossary of Terms and Acronyms

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About This Guide

Chapter 1

About This Guide This chapter explains the purpose and design of this Learning and Reference Guide. It is an introduction to the guide, providing information on the purpose, prerequisite skills, guide organization, chapter format, and graphic conventions that identify the visual symbols used throughout the guide.

Safety Information Please refer to Chapter 2: Safety and Regulatory in this Learning and Reference Guide. The Safety chapter describes the safety information you and the physicians must understand thoroughly before you begin to use the system. Note that you will find additional safety information throughout your Learning and Reference Guide. If you need additional training, seek assistance from qualified GE Healthcare personnel. The equipment is intended for use by qualified personnel only. This guide should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions. It is important for you to read and understand the contents of this guide before attempting to use this product.

Graphic Conventions and Legends Table 1-1 describes the conventions used when working with menus, buttons, text boxes and keyboard keys.

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About This Guide Table 1-1 Conventions for menus, buttons, text boxes, and keyboard keys Example

Describes

Select

• Marking an option in a group of check boxes or radial buttons • Choosing an option from a drop-down list • Activating a tab • Highlighting text • Highlighting row items

Press ENTER

Pressing a hard key on the keyboard.

Press CTRL+ALT+DELETE

Pressing a combination of keys on the keyboard. The key that should be pressed first is listed first.

Press and hold SHIFT

Pressing and holding down a hard key on the keyboard.

Click [START EXAM]

Clicking a button on a workstation screen.

In the Matrix text box,...

The name of text box in which you can select or type text or the name of a drop-down list from which you select an option.

Type Supine in the Patient Position text box (different font and bold)

Text you enter into a text box.

Select Sort > Sort by date

The pathway of selecting option(s) in a drop-down list.

Safety Notices The following safety notices are used to emphasize certain safety instructions. This guide uses the international symbol along with the danger, warning, or caution message. This section also describes the purpose of a Note.

DANGER: Danger is used to identify conditions or actions for which a specific hazard is known to exist which will cause severe personal injury, death, or substantial property damage if the instructions are ignored.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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About This Guide

WARNING:Warning is used to identify conditions or actions for which a specific hazard is known to exist which may cause severe personal injury, death, or substantial property damage if the instructions are ignored.

CAUTION: Caution is used to identify conditions or actions for which a potential hazard may exist which will or can cause minor personal injury or property damage if the instructions are ignored. NOTE: A Note provides additional information that is helpful to you. It may emphasize certain information regarding special tools or techniques, items to check before proceeding, or factors to consider about a concept or task.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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About This Guide

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Safety and Regulatory

Chapter 2

Safety and Regulatory This chapter explains the safety considerations, general equipment and patient related precautions, and the symbols used for the safe operation of your equipment. This chapter also includes information about the emergency procedures.

Indications for Use The Difinium 6000 is used to generate radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures for head, cervical part, thoracic part, abdomen, spine and extremities. It is applicable for all the patients who need any of these general purpose diagnostic procedures. This device is not intended for mammographic and dental applications.

WARNING:It is forbidden to use this device to take exposure repeatly and frequtently for a same patient.

WARNING:It is forbidden to use this device for a pregnant woman.

WARNING:This system is fully motorized and free to move for patient positioning flexibility and productivity, never leave patient on the table or in the examination room unattended during your examination. Otherwise, injury to the patient may occur.

WARNING:Do not load non-system software onto the system computer, operating system may crash down causing data lost.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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Safety and Regulatory

CAUTION: Please protect the families and any other company of the patients’ around this device from radiation. Please protect the technologists who is around this device from radiation.

This chapter presents the concepts necessary to successfully operate your system safely. •

Safety

•

Safe Operation Precautions

•

Know The Equipment

•

Electromagnetic Immunity

•

Symbols

•

Radiation Safety

•

Dose Chart

•

Emergency Procedures

– Warnings

Safety The electrical wiring of the relevant rooms complies with all national and local codes, as well as the Regulations for the electrical equipment of buildings published by the Institution of Electrical Engineers. All assembly operations, extensions, re-adjustments, modifications, or repairs are carried out by GE Healthcare Technologies authorized service representatives. The equipment must be used in accordance with the instructions for use.

WARNING:Electric Shock Hazard! Do not remove covers or panels. The Acquisition Console and cabinets contain high voltage circuits for generating and controlling X-rays. Prevent possible electric shock by leaving covers or panels on the equipment. There are no operator serviceable parts or adjustments inside the cabinets. Only trained and qualified personnel should be permitted access to the internal parts of this equipment.

WARNING:Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrous oxide.

DefiniumTM 6000 5135614-100 Rev.5 [04/09] © 2009 General Electric Company. All rights reserved.

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