Technical Reference Manual
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GE Healthcare
Optima™ CT660 Technical Reference Manual 5366491-1EN Revision 1 GE Healthcare Japan Corporation does business as GE Healthcare
This product is certified as a OptimaTM CT660 CT System. The MHLW certified number is 222ACBZX00021000.
Optima™ CT660 Technical Reference Manual, English 5366491-1EN Revision: 1 © 2010 General Electric Company All rights reserved.
Revision History REV
DATE
1
02-10
REASON FOR CHANGE Initial Release
5366491-1EN Rev. 1 (02/10) © 2010 General Electric Company. All rights reserved.
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Revision History ...i-1
Before You Start User Information Description...1-2 Applications Help...1-2 iLinq...1-3
X-ray Protection Safety Introduction...3-1 What Do I Need to Know About...3-3 Warning Labels and Symbols ...3-3 Equipment Symbols...3-4 General Safety Guidelines ...3-8 Implantable Device Safety ...3-10 Radiation Safety ...3-10 Authorized Users...3-11 General Radiation Safety ...3-11 Scans Acquired at the Same Tomographic Plane...3-12 CTDIvol...3-15 Pediatric and Small Patient Imaging ...3-16 X-Ray Tubes ...3-16 Electrical Safety ...3-17 Mechanical Safety...3-18 General Mechanical Safety...3-18 Short Footprint Mode...3-19 Patient Positioning ...3-19 ASiR...3-24 VolumeShuttle™ (Axial) and Volume Helical Shuttle ...3-25 Cardiac safety ...3-27 Laser Safety...3-30 Reconstructed Image Orientation ...3-31 Data Safety...3-33 Application Software Safety ...3-36 Application Specific Safety Topics ...3-36 Helical scanning...3-36 Lung Algorithm ...3-37 Autoscan...3-37 SmartStep Safety...3-37 Interventional/biopsy Scanning...3-38 Treatment Planning...3-39 Advanced Applications Safety...3-39 Measurements...3-40 Segment Tools ...3-41 Filming and Saving Images...3-41 Image reliability...3-42 Window Width and Level (W/L) ...3-42 Volume Rendering...3-43 Image quality...3-43 Accuracy of Measurements...3-43 Measure Distance for Axial, Helical, and Cine Images...3-43 Measure Distance for Scout Images ...3-44
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Measure Angle ...3-45 ROI ...3-45 Reformat Plane Thickness...3-45 Operator Console Ergonomics ...3-46 Posture ...3-46 Equipment Adjustments...3-46 Accessories...3-47 GE Approved Accessories...3-49 IV Pole Safety...3-50 Table Tray Safety ...3-50 Systems With Metal-Free Cradles and Accessories...3-51 Xtream/Enhanced Xtream Injector Safety ...3-52 Limited Access Room Configuration ...3-52 Emergency Devices and Emergency Egress ... 3-52 Emergency Devices ...3-52 Emergency Stop...3-53 System Emergency OFF Buttons using Main Disconnect Control (For the system with MDC Only)3-55 Emergency Patient Care During X-Ray ON: ...3-55 Emergency Egress...3-55 To safely remove the patient: ...3-56 Maintenance and Cleaning...3-57 Cleaning Equipment (Bio Hazard) ...3-58 Environmental Concerns...3-58 Name and Concentration of Hazardous Substances ...3-59 Explanation of Pollution Control Label ...3-59 Precautions ...3-61
Operator Documentation Daily Fast Cal Procedure Tube Warmup Beam Quality Check...6-2
Prepare the System Check Disk Space Check Image Space...8-1
Reset the System System Shutdown/Reset Procedures...9-1
Stop/Start the Operating System Shutdown System ...10-1 If You Turn OFF the MDC at the End of the Scan Day:...10-2 For Systems with UPS (Uninterrupted Power Supply)...10-3
General Information System components: ...11-1 Emergency Stop:...11-1 CT Description ...11-1
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CT Operation Theory ...11-2 DICOM Print ...11-2 X-Ray ...11-2 Tube Warmup ...11-3 Optima™ CT660 Theory of Operation...11-4 System Characteristics ...11-4 Network...11-6 System Data and Control Flow...11-10 ...X-ray Generation and Detection Details ...11-11 System Operational Modes...11-14 Overview ...11-14 Scout (Reference YY310)...11-15 Axial...11-15 VolumeShuttle (Axial) Mode ...11-16 Helical...11-16 Image Interval ...11-17 Volume Helical Shuttle ...11-18 System Image Quality Features...11-20 Current X-Ray Tube Capacity Affects Prescriptions and Interscan Delays ...11-21 Focal Spot ...11-21 Filament Selection ...11-21 Data Collection ...11-22 Reconstruction...11-23 Adaptive Statistical Iterative Reconstruction (ASiR)...11-24 Helical Scan Data Usage...11-24 Calibration Scans ...11-24 Warm-up Required ...11-25 Warm-up Required ...11-25 Data Storage...11-25 Image Display...11-25 Gray Scale ...11-26 CT Number...11-26 Variables You Cannot Control ...11-27 Pixels...11-28 Pixel Coordinates ...11-28 RAS Coordinates...11-29 Pixels and CT Numbers ...11-31 Window Width...11-31 Window Level ...11-32
Quality Assurance QA Phantom (Reference 21CFR 1020.33 (d)(1)) ...12-1 QA Schedule (Reference 21CFR 1020.33 (d)(2)) ...12-3 System Performance (Reference 21CFR 1020.33 (d)(2))...12-3 Contrast Scale...12-6 High Contrast Spatial Resolution ...12-8 MTF (optional) ...12-9 Low Contrast Detectability...12-10 Noise and Uniformity ...12-12
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Slice Thickness ...12-14 Alignment Light Accuracy (Crucial During Biopsies) ...12-17 Prescribe the QA Series for Alignment Light Accuracy - Phantom Section 1... 12-17 Typical Results and Allowable Variations... 12-19 DOSIMETRY ...12-22 General Information...12-22 CTDIw ...12-24 CTDIvol (Reference IEC 60601-2-44)...12-28 CTDI (Reference U.S. Federal Regulation 21CFR 1020.33 (C))...12-30 Scanning Mode Specific Dosimetry Information ...12-30 Volume Helical Shuttle ...12-30 Other Dosimetry Information...12-31 Dose Length Product (DLP)...12-31 Dose Efficiency (Reference IEC 60601-2-44)...12-31 Dose Profile (Reference IEC 60601-2-44 and 21CFR 1020.33 (c)(iv))...12-32 Scout Dose...12-33 Phantoms for Performance Testing...12-33 Noise...12-33 Noise (Reference 21CFR 1020.33 (c)(3)(i) ...12-34 Typical Images and Image Noise Values (Reference 21CFR 1020.33 (c)(3)(i))... 12-34 Digital Representative Images (Reference 1020.33 (d)(3)(ii))...12-36 Nominal Slice Thickness and Sensitivity Profile...12-36 Modulation Transfer Function (MTF) ...12-38 Maximum Deviation ...12-39 Typical Dose (Reference 21CFR 1020.33 (c)(2)(i)(ii) and (iii)) ...12-39 Dose Profile (Reference 21CFR 1020.33 (c)(2)(iv))...12-39 Performance (Reference 21CFR 1020.33 (c)(3)(v)) ...12-39 Scatter Radiation ...12-40 Radiation Field ...12-44
CT Acceptance Testing Positioning of The Patient Support...13-1 Patient Positioning Accuracy ...13-2 Test Equipment...13-2 Test Procedure for Internal/external Laser Light Accuracy (Reference 21CFR1020.33 (g) (4))13-2 Test Procedure for Sagittal and Coronal Light Accuracy ...13-3 Data Evaluation ...13-3 Tomographic Section Thickness...13-6 Tomograhic Section Thickness for Axial Scan ...13-6 Test Equipment ...13-6 Test Procedure...13-8 Data Evaluation...13-10 A Step-by-step Example for Slice Thickness Measurement Using GE Performance Phantom13-11 Tomographic Section Thickness for Helical Scan ...13-14 Dose ...13-14 Scan Protocols and Dose Specifications for CTDIw ...13-15 Scan Protocols and Dose Specifications for CTDIfree air ...13-15 Noise, Mean CT Number and Uniformity...13-17 Test Equipment...13-17 Test Procedure...13-17 Expected Results and Variations for Noise, Mean CT number and Uniformity ... 13-17
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Spatial Resolution...13-18 Test Equipment...13-18 Test Procedure and Data Evaluation ...13-18 Expected Results and Tolerance ...13-20 Low Contrast Resolution (or low contrast detectability (LCD))...13-21 Test Equipment...13-21 Test Procedure and Data Evaluation Using Catphan 600...13-21 Test Procedure and Data Evaluation Using GE QA Phantom ...13-23 Expected Results and Variations...13-24
PerformixTM 40 X-Ray Tube Specifications X-Ray Tube Model Numbers...14-1 Environmental Specifications ...14-2 Non-Operating Environment (Reference: IEC 60601-2-28) ...14-2 Operating Environment ...14-2 X-ray Characteristics ...14-2 Leakage Technique Factors (Reference: IEC 60601-1-3, IEC 60601-2-28 and 21CFR 1020.30(h)(2))...14-2 Quality Equivalent Filtration (Reference: IEC 60601-1-3 and 21 CFR 1020.30(h)(4))...14-3 Half Value Layer (Reference: IEC 60601-1-3 and 21 CFR 1020.30(m)(1)) ...14-3 CT Scan Ratings...14-4 PerformixTM 40 X-Ray Tube Assembly...14-5 Classification and Compliance (Reference: IEC 60601-2-28) ...14-5 Labeling...14-5 Marking...14-5 Reference Axis for Target Angle and Focal Track Spots (Reference IEC 60601-2-28) ...14-6 HV Connection (Reference: IEC 60601-2-28; IEC60526) ...14-6 Nominal Tube Voltage (Reference: IEC 60613)...14-7 Principal Dimensions (with mounting bracket) (Reference: IEC 60601-2-28) ...14-7 Construction (Reference: IEC 60601-2-28) ...14-8 PerformixTM 40 X-Ray Tube Assembly Heating and Cooling Curves (Reference: IEC 60613 and 21 CFR 1020.30(h))...14-8 Thermal characteristics (Reference IEC 60613)...14-8 Beam Limiting Devices...14-9 PerformixTM 40 X-Ray Tube (Insert) ...14-9 Target Material (Reference: IEC 60601-2-28) ...14-9 Nominal Anode Input Power (Reference IEC 60613)...14-9 Maximum Anode Heat Content
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(Reference IEC 60613)...14-9 Focal Spots (Reference: IEC 60336)...14-9 Target Angle with Respect to Reference Axis (Reference IEC 60601-2-28) ...14-10 Anode Rotation (Reference IEC 60601-2-28) ...14-10 X-ray Tube Minimum Inherent Filtration (Reference: IEC 60601-1-3)...14-10 Anode Heating and Cooling Curve (Reference: IEC 60613 and 21 CFR 1020.30(h)(2))...14-11 Single Load Ratings (Reference: IEC 60613 and 21 CFR 1020.30(h)(2)(iii)) ...14-12 Serial Load Ratings (Reference: IEC 60613 and 21 CFR 1020.30(h)(2)(iii)) ...14-12 Maximum Filament Current (Reference: IEC 60601-2-28) ...14-12 Cathode Emission Characteristics (Reference: IEC 60613)...14-13 Environmental Health & Safety (EHS) Information...14-15 Hazardous Materials...14-15 Precautions ...14-15 References to IEC Standards...14-16
Regulatory Information Applicable Regulations and Standards: ...15-1 Intended use of the system ...15-2 Indications for use of the system...15-2 Intended purpose and medical effectiveness (MHLW) ...15-3
Electromagnetic Compatibility Electromagnetic Compatibility (Reference IEC 60601-1-2 ) (Reference IEC 60601-1-2 6.8.2.201 a) & 6.8.3.201) ...16-1 1.0 GENERAL SCOPE (Reference IEC 60601-1-2 6.8.3.201 ) ...16-2 2.0 ELECTROMAGNETIC EMISSION (Reference IEC 60601-1-2 6.8.3.201 ) ...16-3 3.0 ELECTROMAGNETIC IMMUNITY (Reference IEC 60601-1-2 6.8.3.201 ) ...16-4 4.0 USE LIMITATION: (Reference IEC 60601-1-2 6.8.3.201 g))...16-7 5.0 INSTALLATION REQUIREMENTS & ENVIRONMENT CONTROL: (Reference IEC 60601-1-2 6.8.3.201 a) & g)) ...16-7
System Specifications System Component Labeling...17-1 Purchasable Options...17-5 Purchasable Option Descriptions ...17-6 Helical High-Contrast Spatial Resolution (Reference YY310) ...17-9 3D MTF...17-9 Axial High Contrast Spatial Resolution (Reference 21CFR1020.33 (c) (3) (ii) and YY310)... 17-10 Helical Low-Contrast Detectability - Statistical...17-13
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Axial Low-Contrast Detectability - Statistical...17-14 Helical Image Noise (Reference 21CFR 1020.33 (c) (3) (i) and YY310) ...17-15 Axial Image Noise (Reference 21CFR 1020.33 (c) (3) (i) and YY310) ...17-16 Dose Performance ...17-18 Subsystem Specifications...17-18 Operator Console ...17-18 For console size and weight, refer to Table 17-3...17-18 PC Based System ...17-18 LCD Monitor...17-19 Image Processor ...17-19 Image Reconstruction Engine ...17-19 OptimaTM CT660 Operator Console user interface features...17-19 Data Acquisition ...17-19 64-Row Detector...17-19 64-Row DAS (64 Slice Configuration)...17-20 500 Pounds (227 kg) Table...17-20 Load Capacity ...17-20 Cradle Range ...17-20 Cradle Speeds ...17-20 Cradle Position Accuracy ...17-20 Elevation Range***...17-21 Elevation Speed...17-21 Full Range...17-21 Elevation Accuracy ...17-21 450 Pounds (205 kg) Table...17-21 Load Capacity ...17-21 Cradle Range ...17-21 Cradle Speeds ...17-21 Cradle Position Accuracy (Reference 21CFR1020.33 (i)) ...17-22 Elevation Range** ...17-22 Elevation Speed...17-22 Elevation Accuracy ...17-22 Gantry ...17-22 Tilt Limits...17-22 Tilt Speed ...17-22 Gantry Opening Diameter ...17-22 Isocenter to Tube Distance ...17-22 Tube Focus to Detector Distance...17-22 Acoustical Running Noise (Reference YY310)...17-23 Rotational Speeds ...17-23 X-Ray Tube...17-23 Laser Alignment Lights...17-23 Maximum Output Power ...17-23 Maintenance...17-23 Laser Alignment Light Accuracy (Reference 21CFR1020.33 (g) (3) and YY310) ...17-23 Generator Subsystem Specifications (Reference 21CFR1020.30 (h) (3)) ...17-23 Main Power Supply ...17-23 Line Voltage...17-23 3-Phase 50/60 Hz ± 3Hz...17-24 Maximum 3-Phase Power Demand at Full Rated Output ...17-24
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Maximum Line Current Demand...17-24 Generator Rating and Duty Cycle ...17-24 Maximum Output Power (IEC60601-2-44)...17-24 Highest Constant Load at 4s (Reference: IEC 60601-2-44 6.8.2)...17-24 kV Choices...17-24 Maximum mA ...17-24 Regulation...17-24 Rise Time...17-25 Fall Time...17-25 Generator Duty Cycle ...17-25 kV, mA, and Time Accuracy...17-25 Kilovolts ...17-25 Milliamperes...17-25 Exposure Time...17-25 Accuracy Subject to Following Conditions ...17-26 Gantry LCD Display...17-27 Measurement Basis...17-27 Kilovolts ...17-27 Milliamperes...17-27 Exposure Time...17-27 Environmental Specifications ...17-28 System Cooling Requirements ...17-28 Temperature and Humidity Specifications...17-29 Ambient Temperature ...17-29 Scan Room...17-29 Control Room (including Console/Computer)...17-29 Table and Gantry In Exam Room (when room is unoccupied)...17-29 Equipment Room (if separate room to hold PDU) ...17-29 Rate of Change...17-29 Room Temperature Uniformity...17-29 Relative Humidity (All Areas) ...17-30 Electromagnetic Interference...17-30 Pollution ...17-30 Carpeting...17-30 Lighting...17-31 Patient Comfort ...17-31 Control Room...17-31 Equipment Room ...17-31 Altitude ...17-31
Planned Maintenance
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5366491-1EN Rev. 1 (02/10) © 2010 General Electric Company. All rights reserved.
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 Technical Reference manual is originally written in English. 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
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Optima ™ CT660 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 All operator information can be reviewed on a PC with Adobe Reader® version 6 or higher. We have divided the current User Information into three 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 by clicking on the Learning Solutions icon.
•
Technical Reference Manual: This manual details safety information and specifications of the system and includes power off and on procedures.
•
Applications Tips and Workarounds: This manual details Workaround information for software and system information.
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.
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Before You Start
iLinq If your system has broadband connectivity to GE and a contract, you can click [iLinq] to receive help.
iLinq™ delivers tools to the console that help address the challenge of keeping you up to date and improving productivity. The iLinq tools are designed so you can help yourself. Instead of having to always rely on a FE or an Online Center Engineer, you can solve a greater number of your own problems. The Applications Self Help feature provides automated expert advice from a database of application problems and solutions. – Answer questions - Top 10 FAQ’s - updated daily. – Search the Knowledge Database. – Share the knowledge with co-workers by saving the results. Figure 1-1 Applications Self Help Window
The Contact GE feature puts technologists in touch with GE's technical experts at the Online Center for a fast response to maintenance and application questions. These calls receive top priority. – Request GE service without picking up the phone. – Auto-sends key status info to speed up the resolution process. – Fastest response time available from GE.
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Optima ™ CT660 Figure 1-2 Contact GE Window
The Messages feature provides a record of previous Contact GE requests, saved problems and resolution searches, and other valuable information that GE has sent. – Keep track of your Contact GE service history. – Share saved solutions with co-workers. – Reference past questions for quicker answers.
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Before You Start Figure 1-3 Message Window
GE Community located at gehealthcare.com allows access to eFlexTrial and a Directory of Global Members. – Want to know what’s new from GE; access the site for specific modality information. This site contains the latest information on clinical cases, software applications, and upgrade optimizers. – Clinical case studies available at the console. – Expand your clinical capabilities with eFlexTrial - 30 days risk free. Figure 1-4 Community Window
Please keep User Information readily available.
5366491-1EN Rev. 1 (02/10) © 2010 General Electric Company. All rights reserved.
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Optima ™ CT660 Send your comments to: GE Healthcare CT Application (W1120) 3000 N. Grandview Blvd. Waukesha, WI 53188 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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Safety
Chapter 3
Safety Introduction The Safety chapter provides information about safety precautions and procedures. It is important for you to read and understand the contents of this chapter so the correct precautions and procedures are followed. This manual should be kept near the console for easy access.
CAUTION: This system was designed for use by individuals trained in CT system operation by GE Medical Systems. Study the Safety Chapter 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 User Manual, Applications Tips and Workarounds, and the Technical Reference Manual. If necessary, additional training is available from a GE Applications Specialist. Contact your institution’s GE sales representative for additional information about further safety and operational training. The system complies with IEC 60601-1 and UL 60601-1.
WARNING: Modification of any existing patient data on the system must follow the guidelines specified in the User Manual. Detailed information concerning Electromagnetic Capability can be found in the Electromagnetic Capability chapter of the Technical Reference Manual. United States Federal Regulation 21CFR 801.109
5366491-1EN Rev. 1 (02/10) © 2010 General Electric Company. All rights reserved.
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