Discovery CT750HD Technical Reference Manual Rev 1 July 2013

Table of Contents i

Revision History...i-1 Revision History... i-2

1

Before You Start... 1-1 Introduction... 1-2 User Information Description... 1-3 Applications Help... 1-4 iLinq... 1-5

2

X-ray Protection... 2-1 Radiation Protection (Reference 21CFR 1020.30 (h)(1)(i))... 2-2

3

Safety... 3-1 Introduction... 3-2 What Do I Need to Know About... 3-3 Warning Labels and Symbols... 3-4 Equipment Warning Labels... 3-6 General Safety Guidelines... 3-12 Implantable Device Safety... 3-14 Recommendations prior to scanning:... 3-14 Recommendations after scanning... 3-14 Radiation Safety... 3-15 Authorized Users... 3-15 General Radiation Safety... 3-16 Scans Acquired at the Same Tomographic Plane... 3-16 mA Mode Changes... 3-19 kV Mode Changes... 3-21 GSI Mode Changes... 3-23 CTDIvol... 3-26 Pediatric and Small Patient Imaging... 3-27 X-ray Tubes... 3-27 Electrical Safety... 3-27 Mechanical Safety... 3-29 General Mechanical Safety... 3-29 Patient Positioning... 3-30 VolumeShuttle™ (Axial) and Volume Helical Shuttle... 3-35 Cardiac Safety... 3-37

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Laser Safety (Reference 21CFR 1040.10 (h))... 3-40 Reconstructed Image Orientation... 3-40 Data Safety... 3-42 Application Software Safety... 3-44 Application Specific Safety Topics... 3-45 Helical Scanning... 3-45 Lung Algorithm... 3-45 Auto Scan... 3-45 SmartStep and SmartView Safety... 3-46 Table Float... 3-48 SmartStep and SmartView Scanning... 3-48 Interventional / Biopsy Scanning... 3-49 Treatment Planning... 3-49 Advanced Applications Safety... 3-50 Measurements... 3-50 Segment Tools... 3-51 Filming and Saving Images... 3-51 Image reliability... 3-52 Window Width and Level (W/L)... 3-52 Volume Rendering... 3-52 Image quality... 3-52 Gemstone Spectral Imaging (GSI) Viewer... 3-53 Image Reliability... 3-53 Image Quality... 3-54 Measurements... 3-55 Film and save... 3-55 Window Width and Window Level... 3-55 Accuracy of Measurements... 3-56 Measure Distance for Axial, Helical, and Cine Images... 3-56 Measure Distance for Scout Images... 3-56 Measure Angle... 3-57 ROI... 3-57 Reformat Plane Thickness... 3-57 Operator Console Ergonomics... 3-58 Posture... 3-58 Equipment Adjustments... 3-58 Chair... 3-58 Keyboard... 3-59 Screen... 3-59 Comfort... 3-59 Other considerations:... 3-59 Accessories... 3-59 GE Approved Accessories... 3-61 IV Pole Safety... 3-62 Table Tray Safety... 3-62 Systems With Metal-Free Cradles and Accessories... 3-63 Xtream/Enhanced Xtream Injector Safety... 3-64 Limited Access Room Configuration... 3-64 Emergency Devices and Emergency Egress... 3-64 Emergency Devices... 3-64 Emergency Stop... 3-65 Emergency Stop Button Symbols... 3-66 System Emergency OFF Buttons using Main Disconnect Control... 3-66 Reset the Emergency OFF Button... 3-66

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Emergency Patient Care During X-ray ON:... 3-67 Emergency Egress... 3-67 To safely remove the patient:... 3-67 Maintenance and Cleaning... 3-68 Cleaning Equipment (Bio Hazard)... 3-68 Environmental Concerns... 3-69 Name and Concentration of Hazardous Substances... 3-69 Explanation of Pollution Control Label... 3-69 Precautions... 3-70

4

Operator Documentation... 4-1 Introduction... 4-2

5

Tube Warmup... 5-1 Beam Quality Check... 5-5 Perform Tube Warmup... 5-5

6

Daily Fast Cal Procedure... 6-1 Fast Cal Procedure... 6-2

7

Prepare the System... 7-1 Introduction... 7-2

8

Check Disk Space... 8-1 Check Image Space... 8-2

9

Reset the System... 9-1 System Shutdown/Reset Procedures... 9-2

10

Stop/Start the Operating System... 10-1 Shutdown System... 10-2 If You Turn OFF the MDC at the End of the Scan Day:... 10-3 For Systems with UPS (Uninterrupted Power Supply)... 10-4

11

General Information... 11-1 System components:... 11-2 Emergency Stop:... 11-2 CT Description... 11-2 CT Operation Theory... 11-2 X-ray Source... 11-2 CT Detector and DAS... 11-3 Power Distribution Unit... 11-3

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Operator's Console... 11-3 DICOM Print... 11-3 X-ray... 11-3 Tube Warmup... 11-4 Theory of Operation... 11-5 System Overview... 11-5 System Characteristics... 11-5 Performix™ HD X-ray Tube... 11-5 Gemstone Detector... 11-5 Scaleable Data Acquisition Sub-System (Volara™ HD DAS)... 11-5 General Information... 11-6 Patient Scanning... 11-6 ... EMI/EMC11-6 Network... 11-6 Purpose of Discovery CT750 HD Scanner Connection to Network . 11-6 Network Interface Technical Specifications... 11-7 Network Information Flows Specifications... 11-7 Required characteristics and configuration for network support of Discovery CT750 HD Scanner specifications... 11-10 Remote Host Parameters... 11-10 Network Compatibility... 11-10 System Data and Control Flow... 11-13 X-ray Generation and Detection Details... 11-14 Overview... 11-14 Gantry Coordinate System... 11-14 Components... 11-15 Collimator Theory... 11-16 Z-Axis Tracking... 11-16 Dynamic Z-Axis Tracking... 11-18 Automatic Exposure Control... 11-19 How AEC Works... 11-19 Adaptation to Anatomy... 11-19 When to Use AEC... 11-20 When NOT to Use AEC... 11-20 AEC does not guarantee reduction of radiation doses in all patients . 1120 Effect of AEC Control Setting... 11-20 AEC Considerations of Patient Size, Shape, Composition, and Age . 1121 Dynamic AEC Scanning... 11-21 How to tell if the dose has changed... 11-21 Summary... 11-21 Scout Based Attenuation Characterization... 11-22 AutomA... 11-25 Background... 11-25 AutomA Theory... 11-28 AutomA FAQs... 11-29 kV Assist... 11-32 Background... 11-32 Theory... 11-33 Image Display... 11-36 kV Assist FAQs... 11-39 Electrocardiograph Tube Current Modulation... 11-42 ECG-modulated mA Theory... 11-42

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Overview... 11-44 Scout (Reference YY0310)... 11-44 Pediatric Imaging... 11-45 Axial and Cine Scans... 11-45 VolumeShuttle (Axial)... 11-46 Helical Scans... 11-46 Image Interval... 11-46 Volume Helical Shuttle... 11-47 Cardiac Overview... 11-48 Gemstone Spectral Imaging... 11-49 High Resolution Scanning Capability... 11-51 Adaptive Statistical Iterative Reconstruction (ASiR)... 11-54 Overlapped Recon (Axial)... 11-54 System Image Quality Features... 11-55 Calibration Scans... 11-55 Tube Capacity and ISD... 11-55 Focal Spot... 11-56 Focal Spot Selection... 11-56 Focal Spot Selection Table... 11-56 Data Collection... 11-57 Reconstruction... 11-57 Conjugate Cone-Beam Backprojection... 11-58 Helical Scan Data Usage... 11-59 Calibration Scans... 11-59 Warmup Required... 11-59 Data Storage... 11-60 Image Display... 11-60 Gray Scale... 11-60 CT Number... 11-61 Variables You Cannot Control... 11-62 Pixels... 11-62 Pixel Coordinates... 11-63 RAS Coordinates... 11-64 Pixels and CT Numbers... 11-65 Window Width... 11-66 Window Level... 11-66

12

Quality Assurance... 12-1 Introduction... 12-2 QA Phantom (Reference 21CFR 1020.33(d)(1))... 12-3 QA Schedule (Reference 21CFR 1020.33 (d)(2))... 12-5 Maintain Image Quality... 12-7 Position the QA Phantom... 12-7 Prescribe the QA Series for the Resolution, Low Contrast Detectability, and Noise and Uniformity Tests... 12-8 Analyze the QA Images... 12-8 Contrast Scale... 12-9 High Contrast Spatial Resolution... 12-11 MTF (optional)... 12-12 Low Contrast Detectability... 12-12 Noise and Uniformity (Reference 21CFR 1020.33(j))... 12-15 Slice Thickness... 12-16

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Prescribe the QA Series for the Slice Thickness Test - Phantom Section #1 . 12-17 Alignment Light Accuracy... 12-18 (Reference 21CFR 1020.33(g)(2))... 12-18 Prescribe the QA Series for Alignment Light Accuracy - Phantom Section 1 . 12-19 Typical Results and Allowable Variations... 12-21 Contrast Scale... 12-22 High Contrast Spatial Resolution... 12-22 Axial Scan Slice Thickness... 12-22 Noise & CT Number of Water... 12-22 References... 12-22 Low Contrast Detectability... 12-23 QA Phantom - Representative Images (Reference 21CFR 1020.33 (d)(3)(i) . 12-23 Digital Representative Images (Reference 1020.33 (d)(3)(ii))... 12-23 ... 12-28 QA Phantom... 12-29 Position the QA Phantom... 12-29 Prescribe the GSI QA Series for the CT Number Accuracy and Noise and Uniformity Tests... 12-29 Analyze the GSI QA Images... 12-30 GSI QA Data Form... 12-31 QA Phantom - Representative Image for GSI QA... 12-31 Dosimetry... 12-32 General Information... 12-32 CTDIw... 12-33 (Reference IEC 60601-2-44 and 21 CFR 1020.33 (c))... 12-33 CTDIvol (Reference IEC 60601-2-44)... 12-40 CTDI (Reference 21CFR 1020.33 (c)(2)) Dose Calculations... 12-44 ... 12-44 Scanning Mode Specific Dosimetry Information... 12-44 Volume Helical Shuttle... 12-44 Peak Skin Dose... 12-45 Other Dosimetry Information... 12-47 Dose Length Product (DLP)... 12-47 Max Z Location CTDIvol... 12-47 Dose Efficiency (Reference IEC 60601-2-44)... 12-48 Dose Profile (Reference IEC 60601-2-44, IEC 60601-2-44: 2002 clause 29.1.103.1/2 and 2009 clause 203.110/111 and 21CFR 1020.33 (c)(2)(iv) and (c)(3)(iv))... 12-48 Dose Deterministic Effects (IEC 60601-2-44:2009 Clause 203.5.2.4.5) . . 12-52 Scout Dose... 12-53 Phantoms for Performance Testing (Reference 21CFR 1020.33(c)(3)(v)) 12-53 Noise (Reference 21CFR 1020.33 (c)(3)(i))... 12-53 Nominal Slice Thickness and Sensitivity Profile... 12-55 (Reference 21CFR 1020.33 (c)(3)(iii) and (c)(3)(iv))... 12-55 Modulation Transfer Function (MTF)... 12-57 (Reference 21CFR 1020.33 (c)(3)(ii))... 12-57 Maximum Deviation... 12-58 (Reference IEC 60601-2-44 and 21CFR 1020.33 (c))... 12-58

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Typical Dose (Reference IEC 60601-2-44 and 21CFR 1020.33 (c)(2)(v)) 12-58 Dose Profile (Reference 21CFR 1020.33 (c)(2)(v))... 12-58 Performance (Reference 21CFR 1020.33 (c)(3)(v))... 12-59 Frequency of constancy tests (Refer to Section 4.7 of IEC 61223-2-6) . . 12-59 Stray Radiation... 12-59 Radiation Field... 12-61

13

Performix™ HD X-ray Tube Specifications... 13-1 X-ray Tube Model Numbers... 13-2 Beam Limiting Devices... 13-2 Environmental Specifications... 13-2 Non-Operating Environment (Reference IEC 60601-1 and IEC 60601-228)... 13-2 Operating Environment... 13-2 X-ray Characteristics... 13-3 Leakage Technique Factors... 13-3 Quality Equivalent Filtration... 13-3 CT Scan Ratings... 13-4 Performix™ HD X-ray Tube Assembly... 13-5 Labeling... 13-5 Marking... 13-5 Reference Axis for Target Angle and Focal Track... 13-5 Focal Spot Location... 13-6 High Voltage (HV) Connection... 13-7 Nominal Tube Voltage... 13-7 Maximum High Voltage... 13-8 Envelope Voltage... 13-8 Principal Dimensions (with mounting bracket)... 13-8 Construction... 13-8 Performix™ HD X-ray Tube Assembly Heating and Cooling Curves 13-8 Thermal characteristics... 13-9 Heat Storage Capacity and Continuous Dissipation (Reference YY310 and IEC 60613)... 13-9 Maximum Continuous Dissipation... 13-9 Nominal Continuous Input Power... 13-9 Pressure and Thermal Management... 13-10 Beam Limiting Devices... 13-10 Performix™ HD X-ray Tube Insert... 13-10 Target Material... 13-10 Nominal Anode Input Power... 13-10 Nominal CT Anode Input Power... 13-10 Nominal CT Scan Power Index... 13-10 Maximum Anode Heat Capacity... 13-11 Focal Spots... 13-11 Small Focal Spot:... 13-11 Large Focal Spot:... 13-11 GSI Focal Spot:... 13-11 Zero Bias Focal Spot:... 13-11 Reference Axis:... 13-11 Target Angle with Respect to Reference Axis... 13-11 Anode Rotation... 13-11

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Minimum Inherent Filtration... 13-12 Anode Heating and Cooling Curve... 13-12 Single Load Rating... 13-13 Serial Load Rating... 13-14 Highest Constant Load at 4s (Reference IEC 60601-2-44)... 13-15 Maximum Filament Current... 13-15 Cathode Emission Characteristics... 13-15

14

Regulatory Information... 14-1 Applicable Regulations and Standards:... 14-2 Intended Use of the System... 14-3 Indications for Use of the System... 14-3

15

Electromagnetic Compatibility... 15-1 Introduction... 15-2 GENERAL SCOPE... 15-2 ELECTROMAGNETIC EMISSION... 15-3 ELECTROMAGNETIC IMMUNITY... 15-3 LIMITATIONS MANAGEMENT:... 15-5 USE LIMITATION:... 15-5 External components... 15-5 INSTALLATION REQUIREMENTS & ENVIRONMENT CONTROL:... 15-5 Cable shielding & grounding... 15-6 This product complies the radiated emission as per CISPR11 Group1 Class A standard limits... 15-6 Subsystem & accessories Power supply distribution... 15-6 Stacked components & equipment... 15-6 Low frequency magnetic field... 15-6 Static magnetic field limits... 15-6 Electrostatic discharge environment & recommendations... 15-6

16

System Specifications... 16-1 System Component Labeling... 16-2 (Reference 1010.3)... 16-3 Purchasable Options... 16-7 Purchasable Option Descriptions... 16-7 Helical High-Contrast Spatial Resolution... 16-10 3D MTF... 16-10 Axial High Contrast Spatial Resolution... 16-11 Helical Low-Contrast Detectability - Statistical (Reference YY310) 16-12 Axial Low-Contrast Detectability - Statistical (Reference YY310) . . 16-14 Helical Image Noise... 16-15 Axial Image Noise... 16-15 CT Number Linearity... 16-16 CT Number Uniformity... 16-16 Dose Performance... 16-16 Subsystem Specifications... 16-17 Operator Console... 16-17 Host Computer... 16-17 The Discovery™ CT750 HD Operator Console User Interface... 16-18

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Data Acquisition... 16-18 64-Row Detector... 16-18 Table... 16-18 Load Capacity (Reference YY310)... 16-18 Maximum Cradle Travel (Reference YY310)... 16-18 Cradle Speeds... 16-19 Scan Location Accuracy (Reference YY310 and 21CFR 1020.33 (i)) 1619 Elevation Travel Time... 16-19 Full Range... 16-19 Elevation Accuracy... 16-19 Elevation Range (Reference YY310)... 16-19 Gantry... 16-19 Tilt Limits (Reference YY310)... 16-19 Tilt Speed... 16-19 Gantry Opening Diameter (Reference YY310)... 16-20 Isocenter to Tube Distance... 16-20 Tube Focus to Detector Distance... 16-20 Running Noise (Reference YY310)... 16-20 Rotational Speeds (Reference YY310)... 16-20 Scout Orientation (Reference YY310)... 16-20 Rotational Freedom... 16-20 Laser Alignment Lights (Reference 21CFR 1040.10 (h))... 16-20 X-ray Tube: Performix™ HD... 16-21 Heat Storage (Reference YY310)... 16-21 Focal Spots (Reference YY310)... 16-21 Main Power Supply (Reference IEC 60601-2-44)... 16-21 Generator Subsystem Specifications... 16-22 Generator Duty Cycle (Reference 21CFR 1020.30 (h)(3)(v))... 16-22 kV, mA, Linearity, and Time Accuracy... 16-22 Kilovolts... 16-22 Basic kV Accuracy... 16-22 kV Accuracy for GSI... 16-23 kV Accuracy for GSI SnapShot Pulse / GSI Cardiac presets... 16-23 Milliamperes... 16-23 mA Accuracy... 16-23 Exposure Time... 16-24 Accuracy Subject to Following Conditions... 16-26 Measurement Basis... 16-26 (Reference 21CFR 1020.30 (h)(3)(viii))... 16-26 Kilovolts... 16-26 Milliamperes... 16-27 Exposure Time... 16-27 Environmental Specifications... 16-27 System Cooling Requirements... 16-27 Temperature and Humidity Specifications... 16-28 Ambient Temperature... 16-28 Scan Room (Recommended for Patient Comfort)... 16-28 Control Room (including Console/Computer)... 16-28 Table and Gantry In Exam Room (when room is unoccupied)... 16-28 Equipment Room (if separate room to hold PDU)... 16-28 Rate of Change... 16-28 Room Temperature Uniformity... 16-28 Media (disks/tapes)... 16-28

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Relative Humidity (All Areas)... 16-29 Electromagnetic Interference... 16-29 Pollution... 16-29 Carpeting... 16-29 Lighting... 16-29

17

Planned Maintenance... 17-1 (Reference 21CFR 1020.30 (h)(1)(ii) and IEC 60601-1 6.8.2))... 17-2

18

Product Manufacturer... 18-1 ... 18-2

19

CT Acceptance Testing... 19-1 ... 19-2 (Reference IEC 61223-3-5 Clause 5.1)... 19-3 Patient Positioning Accuracy... 19-3 (Reference IEC 61223-3-5 Clause 5.2)... 19-3 Test Equipment... 19-3 Test Procedure for Internal/external Laser Light Accuracy... 19-4 Test Procedure for Sagittal and Coronal Light Accuracy... 19-4 Data Evaluation... 19-4 Preview Image Accuracy Test... 19-6 (Reference IEC 61223-3-5 Clause 5.2.1.3.3)... 19-6 Test Equipment... 19-6 Test Procedure for Preview Image Accuracy Test... 19-6 Data Evaluation... 19-7 Tomographic Section Thickness... 19-9 (Reference IEC 61223-3-5 Clause 5.3)... 19-9 Tomographic Section Thickness for Axial Scan... 19-9 Dose... 19-15 (Reference IEC 61223-3-5 Clause 5.4 and IEC 60601-2-44: 2009 Clause 203.6.3.2)... 19-15 Scan Protocols and Dose Specifications for CTDIw... 19-16 Scan Protocols and Dose Specifications for CTDI free air... 19-16 Noise, Mean CT Number and Uniformity... 19-17 (Reference IEC 61223-3-5 Clause 5.5)... 19-17 Test Equipment... 19-17 Test Procedure... 19-18 Expected Results and Variations... 19-18 Spatial Resolution... 19-18 (Reference IEC 61223-3-5 Clause 5.6)... 19-18 Test Equipment... 19-19 Test Procedure and Data Evaluation... 19-19 Expected Results and Tolerance... 19-20 Low Contrast Resolution (or low contrast detectability (LCD))... 19-21 (Reference IEC 61223-3-5 Clause Optional)... 19-21 Test Equipment... 19-21 Test Procedure and Data Evaluation Using Catphan® 600... 19-21 Test Procedure and Data Evaluation Using GE QA Phantom... 19-23

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Expected Results and Variations... 19-24

20

Abbreviations... 20-1 ... 20-2

A

Dose Information Reference... A-1 ... A-2

B

Reference Noise Index... B-1 Reference Noise Index... B-2

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Discovery™ CT750 HD

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Chapter i



Revision History

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i-1

Revision History

Revision History

i-2

Revision

Date

Reason For Change

1

May 2013

Release for HDeIII program.

1

July 2013

Added new table data.

Discovery™ CT750 HD

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Chapter 1



Before You Start

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Before You Start

Introduction 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 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. 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.

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Before You Start

User Information Description We have divided the current User Information into three parts:· User Manual: The User Manual contains all the user information required to operate the scanner in a safe and proper manner. The User Manual can be displayed on Display monitor by clicking on the Learning Solutions icon in the desktop control area. The User Manual can be viewed on a PC with Adobe Reader® version 6 or higher. Technical Reference Manual: This manual details safety information and specification of the system and includes power off and on procedures. Application Tips and Workarounds: This manual details workaround information for software and system information.

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Before You Start

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 This system was designed for use by individuals trained in CT system operation. 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 User Manual and the Technical Reference Manual.

CAUTION There are no user-serviceable parts on the system. In order to obtain training or technical information on the system, please contact GE Service.

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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 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.

Figure 1-1 Contact GE Window



The Messages feature provides a record of previous Contact GE requests and resolution searches, and other valuable information that GE has sent. 

Keep track of your Contact GE service history.



Reference past questions for quicker answers.

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