LightSpeed Plus 2.X Technical Reference Manual Rev 7 July 2005

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Table of Contents REVISION HISTORY LIST OF EFFECTIVE PAGES ... i-2 Chapter 1: BEFORE YOU START User Information Description ... 1-2 Applications Help ... 1-2 Chapter 2: X-RAY PROTECTION Chapter 3: CT SAFETY General Safety ... 3-2 Operator Console Ergonomics ... 3-2 Posture... 3-2 Equipment Adjustments ... 3-2 Electrical Safety ... 3-4 Regulatory Requirements ... 3-4 Electromagnetic Compatibility (EMC) ... 3-5 EMI/EMC Glossary Terms: ... 3-6 Emergency Stop ... 3-7 All Systems... 3-7 Emergency Power Shutdown ... 3-8 Emergency Patient Care During X-Ray ON:... 3-8 Restore System After Emergency Stop ... 3-8 Systems With Gantry Control Panels... 3-8 Restore System Emergency OFF ... 3-9 Systems With Gantry Control Panels Only... 3-9 Radiation Safety ... 3-9 SmartStep Safety ... 3-10 Table Float ... 3-10 SmartStep Scanning ... 3-10 Mechanical Safety ... 3-11 IV Pole Safety ... 3-13 Table Tray Safety... 3-13 Systems With Metal-Free Cradles and Accessories... 3-13 If the Cradle Fails to Advance: ... 3-14 Laser Safety: Warning Labels ... 3-15 Operator Console ... 3-16 Location of Emergency Stop... 3-16

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Gantry and Table ... 3-18 Location of Emergency Stop... 3-18 Prepare the Cradle/Patient ... 3-18 Prepare the Cradle ... 3-18 Prepare the Patient... 3-18 Helical Safety ... 3-19 Cardiac Imaging Safety ... 3-20 Accuracy of Measurements ... 3-21 Reformat Plane Thickness ... 3-22 Lung Algorithm ... 3-23 Chapter 4: ACCESSING THE LEARNING AND REFERENCE GUIDE Chapter 5: TUBE WARMUP Chapter 6: DAILY FAST CAL PROCEDURE Chapter 7: PREPARE THE SYSTEM Chapter 8: CHECK DISK SPACE Check Image Space ... 8-1 Chapter 9: RESET THE SYSTEM System Shutdown/Reset Procedures ... 9-1 Chapter 10: STOP/START THE OPERATING SYSTEM Octane Based Systems... 10-1 PC Based System... 10-2 If You Turn OFF the MDC at the End of the Scan Day:... 10-3 Systems with Gantry Control Panels:... 10-3 Chapter 11: GENERAL INFORMATION System components: ... 11-1 Emergency Stop:... 11-1 Intended Use ... 11-1 CT Description ... 11-1 CT Operation Theory ... 11-2 DICOM Print ... 11-2 X-Ray ... 11-3 Tube Warmup ... 11-3 LightSpeed 2.X Theory of Operation ... 11-3 System Characteristics ... 11-4 Network ... 11-5

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2281207-100 Rev. 7 (07/05) © 2005 General Electric Company. All rights reserved.

System Data and Control Flow ... 11-8 X-ray Generation and Detection Details ... 11-9 AutomA Theory ... 11-13 AutomA Theory... 11-14 Understanding AutomA Behavior... 11-15 System Operational Modes ... 11-17 System Image Quality Features ... 11-20 Current X-Ray Tube Capacity Effects Prescriptions and Interscan Delays ... 11-21 Focal Spot ... 11-21 Filament Selection ... 11-22 Data Collection ... 11-22 Reconstruction ... 11-23 Helical Scan Data Usage ... 11-24 Channel Utilization Table ... 11-25 Slice Thickness ... 11-25 Cardiac Helical Slice Profiles ... 11-25 Calibration Scans ... 11-26 Warm-up Required ... 11-26 Data Storage ... 11-26 Image Display ... 11-27 Gray Scale ... 11-27 CT Number ... 11-28 Variables You Cannot Control ... 11-29 Pixels ... 11-29 Pixel Coordinates ... 11-29 RAS Coordinates ... 11-30 Pixels and CT Numbers ... 11-32 Window Width ... 11-33 Window Level ... 11-34 Chapter 12: QUALITY ASSURANCE QA Phantom ... 12-1 QA Schedule ... 12-3 System Performance ... 12-4 High Contrast Spatial Resolution ... 12-8 MTF (optional) ... 12-9 Noise and Uniformity... 12-11 Alignment Light Accuracy (Crucial During Biopsies) ... 12-14 Prescribe the QA Series for Alignment Light Accuracy - Phantom Section #1... 12-15 Typical Results and Allowable Variations... 12-17

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DOSIMETRY ... 12-20 General Information ... 12-20 CTDI ... 12-21 CTDIw ... 12-23 CTDI100 Typical Technique ... 12-24 Other Dosimetry Information ... 12-27 DLP... 12-27 Dose Efficiency ... 12-28 Scout Dose ... 12-28 Phantoms for Performance Testing ... 12-28 Noise ... 12-28 Noise ... 12-29 Nominal Slice Thickness ... 12-29 Sensitivity Profile... 12-29 Modulation Transfer Function (MTF) ... 12-33 Maximum Deviation ... 12-34 Typical Dose 1020.33 (C) (2) i, ii and iii ... 12-34 Dose Profile 1020.33 (C) (2) iv... 12-34 Performance 1020.33 (C) (3)... 12-35 Radiation Protection ... 12-35 Chapter 13: Performix Ultra X-Ray Tube Specifications Environmental Specifications ... 13-1 Non-Operating Environment... 13-1 Operating Environment ... 13-1 Diagnostic Source Assembly ... 13-2 Leakage Technique Factors... 13-2 Quality Equivalent Filtration ... 13-2 CT Scan Ratings ... 13-2 Performix Ultra Tube Assembly ... 13-3 Marking... 13-3 Reference Axis... 13-3 Maximum Potential Difference... 13-3 Principle Dimensions (with mounting bracket) ... 13-4 Weight (without mounting bracket) ... 13-4 Performix Ultra Tube Insert ... 13-4 Target Material... 13-4 Maximum Potential Difference... 13-4 Dual Focal Spots:... 13-4 Target Angle... 13-4 Rotor Speed ... 13-4 Anode Heat Capacity... 13-4 Serial Exposure Rating... 13-5

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Performix Ultra Tube Assembly ... 13-7 Maximum Heat Capacity... 13-8 Maximum Tube Assembly Heat Dissipation ... 13-8 Focal Spot Modulation Transfer Function... 13-9 Chapter 14: SYSTEM SPECIFICATIONS Helical Low-Contrast Detectability - Statistical ... 14-2 Axial Low-Contrast Detectability - Statistical ... 14-3 Dose Performance ... 14-4 Axial Dose ... 14-5 Subsystem Specifications ... 14-5 Operator Console... 14-5 Host Computer... 14-5 Image Processor ... 14-6 Image Reconstruction Engine (Pegasus) ... 14-7 Image Reconstruction Engine (Global Recon Engine) ... 14-7 4-Row Detector ... 14-7 4-Row DAS ... 14-8 Table ... 14-8 Gantry ... 14-8 X-Ray Tube ... 14-9 Focal Spots ... 14-9 Laser Alignment Lights ... 14-10 Maximum Output Power ... 14-10 Power Supply... 14-10 Maintenance ... 14-10 Generator Subsystem Specifications ... 14-10 Main Power Supply ... 14-10 kV, mA, and Time Accuracy ... 14-11 Kilovolts ... 14-11 Milliamperes ... 14-12 Exposure Time ... 14-12 Measuring Tool Variance ... 14-12 Accuracy Subject to Following Conditions ... 14-13 Measurement Basis ... 14-13 Kilovolts ... 14-13 Milliamperes ... 14-14 Exposure Time ... 14-14 Environmental Specifications ... 14-14 System Cooling Requirements ... 14-15

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Temperature and Humidity Specifications ... 14-15 Lighting ... 14-17 Chapter 15: Planned Maintenance

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2281207-100 Rev. 7 (07/05) © 2005 General Electric Company. All rights reserved.

REVISION HISTORY

REVISION HISTORY REV

DATE

REASON FOR CHANGE

A

9-20-00

Initial Draft

0

9-22-00

First Release for LightSpeed Plus

1

4-5-00

Updates for H2M4.1 Release

2

6-20-01

Additions for H3-4 and H2.1

3

10-23-01

Page 143

4

05-05-02

Update for LS2002 Release

5

10-20-02

Update for LS2002 M4 Release

6

04/04

Updated for New Information

7

07/05

New WEEE Rules

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BEFORE YOU START

Chapter 1

BEFORE YOU START Anyone who operates this system should have received prior training before they attempt to scan or diagnose patients. This training should include medical and X-Ray education, in addition to GE applications training. This guide does not provide medical explanations, but it does suggest potential applications for some of the software features. It describes potential Safety problems, and how to avoid them. Everyone who uses this equipment must read and understand all instructions, precautions and warnings. This manual should be kept near the equipment. Procedures and safety precautions should be viewed periodically. This Guide addresses three safety classifications:

DANGER:

The most severe label describes conditions or actions which result in a specific hazard. You will cause severe or fatal personal injury, or substantial property damage, if you ignore these instructions.

WARNING: This label identifies conditions or actions for which result in a specific hazard. You may cause severe personal injury, or substantial property damage, if you ignore these instructions.

CAUTION:

This label applies to conditions or actions that have potential hazard. You can cause minor injury or property damage if you ignore these instructions.

Various parts of your system will have the icon. This icon on the equipment indicates that the user manual contains additional information and should be consulted

2281207-100 Rev. 7 (07/05) © 2005 General Electric Company. All rights reserved.

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LightSpeed ™ 2.X This Manual uses pictures, or icons, to reinforce the printed message. It uses the corresponding international symbol or icon next to the danger, warning or caution message. For example, the upright hand with the lightning bolt across it warns of electrical hazards. Federal law restricts this device to sale by or on the order of a physician. Do not use the equipment if a known safety problem exists. Call your local service provider and have the system repaired.

User Information Description We have divided the current User Information into two parts: •

Learning and Reference Guide: The Learning and Reference Guide contains all the user information required to operate the scanner. It has detailed information as well as step-by-step procedures. The Learning and Reference Guide is displayed on the Display monitor.

•

Technical Reference Manual: This manual details safety information and specifications of the system and includes power off and on procedures.

Applications Help Although we try to make this guide complete and accurate, undocumented changes or unexpected results do occur. If you can't find the answer to your application question, you may call the Customer Center. Use this phone number for non emergency purposes only, because you may not receive an immediate response. 1. Dial 1-800-682-5327. 2. Select 1 for Applications Answer line. 3. Select 3 for CT Application assistance. If your system fails, or you have an emergency, call GE Cares at 1-800-437-1171.

CAUTION:

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This system was designed for use by individuals trained in CT system operation by GE Medical Systems. Study the Safety Tab of this Manual before you scan the first patient. Use the Index to find the section and page number of an item of interest. Periodically review the Learning and Reference Guide and the Technical Reference Manual.

2281207-100 Rev. 7 (07/05) © 2005 General Electric Company. All rights reserved.

BEFORE YOU START

CAUTION:

Improper system usage could void your warranty. More importantly, you could endanger your patients and yourself if you don't follow the correct procedures.

Please keep User Information readily available. Send your comments to: General Electric Medical Systems CT Application (NB-911) P. O. Box 414 Milwaukee, WI 53201-0414 U.S.A.

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X-RAY PROTECTION

Chapter 2

X-RAY PROTECTION

CAUTION:

Improperly used X-Ray equipment may cause injury. Read and understand the instructions in this book before you attempt to operate this equipment. The General Electric Company, Medical Systems Group, will gladly assist and cooperate in placing this equipment into use.

Although this equipment incorporates a high degree of protection against X-Ray outside the useful beam, no practical design can provide complete protection. Nor can any practical design compel a user to take adequate precautions to prevent the possibility of any person carelessly, unwisely, or unknowingly exposing themselves or others to radiation. Everyone having anything to do with X-Ray must receive proper training and become fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements, and the International Commission on Radiation Protection. NCRP reports are available from: NCRP Publications 7910 Woodmont Avenue Room 1016 Bethesda, Maryland 20814

CAUTION:

Everyone having anything to do with X-Ray must take adequate steps to insure protection against injury.

All persons authorized to use the equipment must understand the dangers posed by excessive X-Ray exposure. We sell the equipment with the understanding that the General Electric Company, Medical Systems Group, its agents, and representatives have no responsibility for injury or damage which may result from exposure to X-Ray. GE urges you to use protective materials and devices.

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CT SAFETY

Chapter 3

CT SAFETY This Technical Reference Manual explains how to operate the scanner safely. This chapter summarizes the most important safety issues. This manual addresses three safety classifications:

DANGER:

The most severe label describes conditions or actions which result in a specific hazard. You will cause severe or fatal personal injury, or substantial property damage, if you ignore these instructions.

WARNING: This label identifies conditions or actions for which result in a specific hazard. You may cause severe personal injury, or substantial property damage, if you ignore these instructions.

CAUTION:

This label applies to conditions or actions that have potential hazard. You may cause minor injury or property damage if you ignore these instructions.

This manual uses pictures, or icons, to reinforce the printed message. It uses the corresponding international symbol or icon next to the danger, warning or caution message. For example, the upright hand with the lightning bolt across it warns of electrical hazards.

CAUTION:

Observe safe exposure factors and operating procedures to protect your patient and yourself from physical harm during contact with this x-ray scanner.

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General Safety Observe the basic rules of safety when you use this equipment. •

Replace all covers before you use the equipment. The covers protect you and your patient from moving parts or electrical shock. The covers also protect the equipment.

•

Keep the equipment clean. Remove body fluids to prevent a health risk and damage to internal parts.

•

The table and gantry surfaces may be cleaned with a mild cleaning solution and water. General purpose liquid disinfectant may also be used as necessary.

•

Become familiar with the functional hardware, so you can recognize serious problems. Do not use the scanner if it appears damaged or fails. – Wait for qualified personnel to correct the problem.

Operator Console Ergonomics To optimally use your LightSpeed 2.X and reduce the chance of physical strain and fatigue, the following steps are recommended regarding how you use your operator console.

Posture Correct posture is very important. To ensure correct posture while sitting at your operator console, follow these basic steps: 1. Face the monitors and keyboard without twisting your body. 2. Sit comfortably erect with the small of your back well supported. 3. Position your forearms parallel to the floor, with your wrists straight. 4. Position the screen so that your eyes are nearly level with the top of the screen. 5. Keep both feet flat on the footrest, with your thighs parallel to the floor. If you cannot comfortably maintain this position while working at your operator console, you should make the necessary adjustments to your operator console environment.

Equipment Adjustments Chair Adjusting the fit and height of your chair is very important for comfort. Follow these basic guidelines: 1. Fit the backrest snugly against your back. People with shorter legs might need a back cushion.

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2281207-100 Rev. 7 (07/05) © 2005 General Electric Company. All rights reserved.