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106 views316 pages

LightSpeed Series Technical Reference Manual - UM - 5478900-2-1EN - 3

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Andrew Sinyagin

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GE Healthcare

LightSpeedTM Series
Technical Reference Manual
GE Hangwei Medical Systems does business as GE Healthcare

This Manual Supports the Following Product Names:

LightSpeed Plus
LightSpeed Ultra
LightSpeed16

LightSpeedTM Series
Technical Reference Manual, English
original draft in English
5478900-2-1EN
Revision: 3
© 2016 General Electric Company
All rights reserved.
REVISION HISTORY

REV DATE REASON FOR CHANGE

1 May 2013 Initial Release
2 November 2013 Information Update
3 October 2016 Information Update

5478900-2-1EN Rev. 3 (October 2016) i-1

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i-2 5478900-2-1EN Rev. 3 (October 2016)

© 2016 General Electric Company. All rights reserved.
Table of Contents
REVISION HISTORY................................................................................................................................ i-1

Chapter 1: Before You Start

User Information Description ................................................................................................1-2
Applications Help.........................................................................................................................1-2

Chapter 2: X-ray Protection

Chapter 3: Safety
Introduction............................................................................................................................................3-1
What Do I Need to Know About....................................................................................................3-3
Warning Labels and Symbols................................................................................................3-3
Equipment Warning Labels ............................................................................................3-9
General Safety Guidelines .................................................................................................... 3-12
Implantable Device Safety........................................................................................... 3-14
Radiation Safety........................................................................................................................ 3-15
Authorized Users .............................................................................................................. 3-16
General Radiation Safety.............................................................................................. 3-16
Scans Acquired at the Same Tomographic Plane ............................................ 3-17
Geometric Efficiency....................................................................................................... 3-18
CTDIvol .................................................................................................................................. 3-19
Pediatric and Small Patient Imaging....................................................................... 3-19
X-Ray Tubes........................................................................................................................ 3-19
Electrical Safety ................................................................................................... 3-20
Mechanical Safety.................................................................................................................... 3-22
General Mechanical Safety ......................................................................................... 3-22
Short Footprint Mode ..................................................................................................... 3-22
Patient Positioning........................................................................................................... 3-23
Table capacity ................................................................................................................... 3-23
Laser Safety (Reference 21CFR 1040.10 (h))................................................................. 3-27
Reconstructed Image Orientation.................................................................................... 3-27
Data Safety.................................................................................................................................. 3-29
Application Software Safety................................................................................................ 3-32
Application Specific Safety Topics.................................................................................... 3-32
Helical Scanning ............................................................................................................... 3-32
Cardiac Imaging ............................................................................................................... 3-33
Patient Preparation ......................................................................................................... 3-34
Lung Algorithm.................................................................................................................. 3-35
Autoscan .............................................................................................................................. 3-36

5478900-2-1EN Rev. 3 (October 2016) TOC-1

SmartStep/SmartView Safety..................................................................................... 3-36

Interventional / Biopsy Scanning.............................................................................. 3-37
Advanced Applications Safety ................................................................................... 3-38
Segment Tools ................................................................................................................... 3-40
Filming and Saving Images ......................................................................................... 3-40
Image reliability................................................................................................................. 3-41
Window Width and Level (W/L).................................................................................. 3-41
Volume Rendering ........................................................................................................... 3-41
Image quality ..................................................................................................................... 3-42
Accuracy of Measurements ................................................................................................ 3-42
Measure Distance for Axial, Helical, and Cine Images ................................... 3-42
Measure Distance for Scout Images....................................................................... 3-42
Measure Angle................................................................................................................... 3-44
ROI........................................................................................................................................... 3-44
Reformat Plane Thickness............................................................................................ 3-44
Operator Console Ergonomics ........................................................................................... 3-44
Posture .................................................................................................................................. 3-45
Equipment Adjustments................................................................................................ 3-45
Accessories.................................................................................................................................. 3-46
GE Approved Accessories............................................................................................. 3-47
IV Pole Safety...................................................................................................................... 3-48
Table Tray Safety.............................................................................................................. 3-49
Systems With Metal-Free Cradles and Accessories......................................... 3-50
Xtream/Enhanced Xtream Injector Safety ........................................................... 3-50
Limited Access Room Configuration....................................................................... 3-51
Emergency Devices and Emergency Egress ............................................................... 3-51
Emergency Devices......................................................................................................... 3-51
Emergency Stop................................................................................................................ 3-51
Emergency Stop Button Symbols ............................................................................. 3-54
System Emergency OFF Buttons using Main Disconnect Control............. 3-54
Emergency Patient Care During X-Ray ON: ......................................................... 3-54
Emergency Egress ........................................................................................................... 3-55
Maintenance and Cleaning.................................................................................................. 3-56
Cleaning Equipment (Bio Hazard) ..................................................................................... 3-57
Environmental Concerns ...................................................................................................... 3-57
Name and Concentration of Hazardous Substances ............................................. 3-58
Explanation of Pollution Control Label................................................................... 3-58
Precautions ......................................................................................................................... 3-60
................................................................................................................................................................... 3-60

Chapter 4: Accessing the Learning and Reference Guide

Chapter 5: Tube Warmup

Chapter 6: Daily Fast Cal Procedure

TOC-2 5478900-2-1EN Rev. 3 (October 2016)

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

Shutdown System. ................................................................................................................... 10-1
If You Turn OFF the MDC at the End of the Scan Day:............................................. 10-5
For Systems with UPS (Uninterrupted Power Supply).............................................. 10-5

Chapter 11: General Information

System components:...................................................................................................... 11-1
Emergency Stop:............................................................................................................... 11-1
CT Description............................................................................................................................ 11-1
CT Operation Theory ............................................................................................................... 11-2
DICOM Print................................................................................................................................. 11-2
X-Ray .............................................................................................................................................. 11-2
Tube Warmup ........................................................................................................................... 11-3
LightSpeed Series Theory of Operation ......................................................................... 11-3
System Characteristics.................................................................................................. 11-3
Network......................................................................................................................................... 11-7
DICOM IEC Network Form.................................................................................................. 11-10
Purpose of LightSpeed scanner connection to network ............................ 11-10
Network interface technical specifications ...................................................... 11-11
Network information flows specifications......................................................... 11-11
Required characteristics and configuration of network
for support of LightSpeed Scanner specifications ........................................ 11-15
System Data and Control Flow ....................................................................................... 11-15
X-ray Generation and Detection Details .................................................................... 11-16
System Operational Modes .............................................................................................. 11-20
Current X-Ray Tube Capacity Effects Prescriptions and Interscan Delays 11-24
Focal Spot ................................................................................................................................ 11-24
Filament Selection ............................................................................................................... 11-24
Data Collection ....................................................................................................................... 11-25
Reconstruction ....................................................................................................................... 11-26
Helical Scan Data Usage ................................................................................................... 11-27
Channel Utilization Table-Full Modes........................................................................... 11-27
Channel Utilization Table-Plus Modes ......................................................................... 11-28

5478900-2-1EN Rev. 3 (October 2016) TOC-3

Slice Thickness Full Mode .................................................................................................. 11-28

Slice Thickness Plus Mode ................................................................................................. 11-29
Cardiac Helical Slice Profiles.................................................................................... 11-29
Calibration Scans ................................................................................................................. 11-30
Warm-up Required............................................................................................................... 11-30
Data Storage ........................................................................................................................... 11-30
NIO16 console ................................................................................................................ 11-30
GOC4 console.................................................................................................................. 11-31
Image Display ......................................................................................................................... 11-31
Gray Scale................................................................................................................................. 11-31
CT Number................................................................................................................................ 11-32
Variables You Cannot Control ........................................................................................ 11-33
Pixels............................................................................................................................................ 11-33
Pixel Coordinates .................................................................................................................. 11-33
RAS Coordinates .................................................................................................................... 11-34
Pixels and CT Numbers ...................................................................................................... 11-36
Window Width ........................................................................................................................ 11-37
Window Level .......................................................................................................................... 11-37

Chapter 12: Quality Assurance

QA Phantom (Reference 21CFR 1020.33 (d)(1)) ........................................................... 12-1
QA Schedule (Reference 21CFR 1020.33 (d)(2))................................................... 12-3
Handling the QA Phantom........................................................................................... 12-4
System Performance (Reference 21CFR 1020.33 (d)(2)) ................................. 12-5
High Contrast Spatial Resolution.............................................................................. 12-8
MTF (optional)..................................................................................................................... 12-9
Noise and Uniformity (Reference 21CFR 1020.33 (j)) .................................... 12-11
Analyze the Slice Thickness in Images ................................................................ 12-15
Alignment Light Accuracy (Reference 21CFR 1020.33(g)(2)) .................... 12-15
Prescribe the QA Series for Alignment Light Accuracy -
Phantom Section #1 .................................................................................................... 12-16
Typical Results and Allowable Variations .......................................................... 12-18
DOSIMETRY ............................................................................................................................... 12-19
General Information .................................................................................................... 12-19
CTDIw (Reference IEC 60601-2-44 and 21 CFR 1020.33 (c))...................... 12-21
CTDIvol (Reference IEC 60601-2-44) .................................................................... 12-26
Peak Skin Dose ....................................................................................................................... 12-28
Deterministic effect (refer to IEC60601-2-44:2009 Clause 203.5.2.4.5) ....... 12-31
Other Dosimetry Information........................................................................................... 12-32
Dose Length Product (DLP) ....................................................................................... 12-32
Dose Efficiency (Reference IEC 60601-2-44) .................................................... 12-32
Scout Dose ....................................................................................................................... 12-33
Phantoms for Performance Testing (Reference 21CFR 1020.33 (c)(3)(v))..... 12-33

TOC-4 5478900-2-1EN Rev. 3 (October 2016)

© 2016 General Electric Company. All rights reserved.
Noise ................................................................................................................................... 12-34
Noise ................................................................................................................................... 12-34
Representative Images (Reference 21CFR 1020.33 (d)(3)(i))............................... 12-35
Nominal Slice Thickness (Reference 21CFR 1020.33 (c)(3)(iii))................... 12-37
Sensitivity Profile (Reference 21CFR 1020.33 (c)(3)(iv)).................................. 12-37
Modulation Transfer Function (MTF) (Reference 21CFR 1020.33 (c)(3)(ii)) .... 12-42
Maximum Deviation (Reference 21CFR 1020.33 (c)).............................................. 12-43
Tomographic section thickness ............................................................................. 12-43
Typical Dose (Reference IEC 60601-2-44 and 21CFR 1020.33 (c)(2)(v)) 12-44
Dose Profile (Reference 21CFR 1020.33 (c)(2)(v)) ............................................. 12-44
Performance (Reference 21CFR 1020.33 (c)(3)(v))........................................... 12-44
Frequency of constancy tests (Reference IEC 61223-2-6 section 4.7)......... 12-44
Radiation Protection ............................................................................................................ 12-45

Chapter 13: CT Acceptance Testing

Positioning of The Patient Support................................................................................... 13-1
Patient Positioning Accuracy .............................................................................................. 13-2
Internal/external Laser Light Accuracy; Preview
Tomographic Accuracy; Sagittal and Coronal Light Accuracy Test......... 13-2
Tomographic Section Thickness........................................................................................ 13-7
Tomographic Section Thickness for Axial Scan ................................................. 13-7
Tomographic Section Thickness for Helical Scan .......................................... 13-14
Dose............................................................................................................................................. 13-14
Scan Protocols and Dose Specifications for CTDIw ...................................... 13-14
Scan Protocols and Dose Specifications for CTDIfree air........................... 13-15
Noise, Mean CT Number and Uniformity.................................................................... 13-17
Test Equipment .............................................................................................................. 13-18
Test Procedure ............................................................................................................... 13-18
Expected Results and Variations for Noise, Mean CT number
and Uniformity................................................................................................................ 13-18
Spatial Resolution.................................................................................................................. 13-18
Test Equipment .............................................................................................................. 13-19
Test Procedure and Data Evaluation................................................................... 13-19
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
Expected Results and Variations ........................................................................... 13-23

Chapter 14: X-Ray Tube Specifications

Performix Ultra X-Ray Tube MAXIRay CT ULTRA X-Ray Tube....................................... 14-1
Environmental Specifications ............................................................................................. 14-2
Non-Operating Environment (Reference IEC 60601-1) .................................. 14-2

5478900-2-1EN Rev. 3 (October 2016) TOC-5

Operating Environment................................................................................................. 14-2

Diagnostic Source Assembly............................................................................................... 14-2
Leakage Technique Factors........................................................................................ 14-2
Quality Equivalent Filtration ........................................................................................ 14-2
Half Value Layer ( Reference 21CFR 1020.30 (m)(1),
IEC 60601-2-44 and IEC 60601-1-3)................................................................................ 14-3
CT Scan Ratings ........................................................................................................................ 14-3
Performix Ultra Tube Assembly ......................................................................................... 14-4
Classification and Compliance (Reference IEC 60601-1)............................... 14-4
Marking(Reference IEC 60601-2-28) ....................................................................... 14-4
Reference Axis for Target Angle and Focal Track............................................. 14-4
Maximum High Voltage (Reference IEC 60613) ................................................. 14-5
High Voltage Connection.............................................................................................. 14-6
Principle Dimensions (with mounting bracket)................................................... 14-6
Weight ................................................................................................................................... 14-6
X-Ray Tube Assembly Heating and Cooling Curves
(Reference IEC 60613 and 21CFR 1020.30 (h) (2) (ii)) ........................................ 14-7
Thermal Characteristics of X-Ray Tube Assembly
(Reference IEC 60613) .................................................................................................... 14-7
Performix Ultra Tube Insert.................................................................................................. 14-8
Target Material.................................................................................................................. 14-8
Maximum High Voltage (Reference IEC 60613) ................................................. 14-8
Dual Focal Spots: (Reference IEC 60336)............................................................... 14-8
Target Angle with respect to Reference Axis
(Reference IEC 60601-2-28)......................................................................................... 14-8
Rotor Speed ........................................................................................................................ 14-8
Data Required for Driving the Rotating Anode
(Reference IEC 60601-2-28)......................................................................................... 14-9
Maximum Anode Heat Capacity
(Reference IEC 60613 and 21CFR 1020.30 (h) (2) (ii)) ........................................ 14-9
Serial Exposure Rating (Reference IEC 60613).................................................... 14-9
Single Exposure Load Rating (Reference IEC 60613).................................... 14-10
Nominal Anode Input Power (Reference IEC 60613)..................................... 14-12
Maximum Filament Current (Reference IEC 60613)...................................... 14-12
Electron Emission Curves (Reference IEC 60613) ........................................... 14-12
Focal Spot Modulation Transfer Function ......................................................... 14-14
Environmental Health & Safety (EHS) Information................................................. 14-16
Hazardous Materials ................................................................................................... 14-16
Precautions ...................................................................................................................... 14-16
Performix Plus X-Ray Tube ........................................................................................................ 14-17
X-Ray Tube Model Numbers............................................................................................. 14-17
Environmental Specifications .......................................................................................... 14-17
Non-Operating Environment ................................................................................... 14-17
Operating Environment.............................................................................................. 14-17
X-ray Characteristics ........................................................................................................... 14-18

TOC-6 5478900-2-1EN Rev. 3 (October 2016)

© 2016 General Electric Company. All rights reserved.
Leakage Technique Factors..................................................................................... 14-18
Total Filtration................................................................................................................. 14-18
Permanent Filtration.................................................................................................... 14-18
Applicable Regulations and Standards....................................................................... 14-18
Applicable Regulations and Standards............................................................... 14-18
Classification ................................................................................................................... 14-19
Reference Axis for Target Angle and Focal Spots.......................................... 14-19
HV Connection................................................................................................................ 14-20
Focal Spot Location and Principal Dimensions............................................... 14-20
Pressure and Thermal Management ................................................................... 14-21
Nominal Tube Voltage ................................................................................................ 14-22
Construction .................................................................................................................... 14-22
PerformixTM Plus X-Ray Tube Assembly Heating and
Cooling Curves .............................................................................................................. 14-23
Thermal characteristics ............................................................................................. 14-23
Maximum Continuous Dissipation ........................................................................ 14-23
Nominal Continuous Input Power ......................................................................... 14-24
Beam Limiting Devices ............................................................................................... 14-24
Nominal CT Scan Power Index................................................................................ 14-24
Envelope Voltage........................................................................................................... 14-24
Envelope Current........................................................................................................... 14-24
PerformixTM Plus X-Ray Tube (Insert) .......................................................................... 14-25
Target Material............................................................................................................... 14-25
Nominal Anode Input Power.................................................................................... 14-25
Maximum Anode Heat Content.............................................................................. 14-25
Nominal CT Anode Input Power ............................................................................. 14-25
Continuous Anode Input Power ............................................................................. 14-25
Focal Spots....................................................................................................................... 14-25
Target Angle with Respect to Reference Axis .................................................. 14-26
Anode Rotation ............................................................................................................. 14-26
X-ray Tube Minimum Inherent Filtration ............................................................ 14-26
Anode Heating and Cooling Curve........................................................................ 14-26
Single Load Ratings...................................................................................................... 14-27
Serial Load Ratings....................................................................................................... 14-27
Maximum Filament Current ..................................................................................... 14-28
Cathode Emission Characteristics ........................................................................ 14-28
Environmental Health & Safety (EHS) Information................................................. 14-30
Hazardous Materials ................................................................................................... 14-30
Precautions ...................................................................................................................... 14-31
Explanation of Symbols Used in Markings ................................................................ 14-31
Routine Maintenance .......................................................................................................... 14-32
Manufacturer Address ........................................................................................................ 14-33

Chapter 15: Regulatory Information

Applicable Regulations and Standards:......................................................................... 15-1

5478900-2-1EN Rev. 3 (October 2016) TOC-7

Intended Use ...................................................................................................................... 15-3

Indications For Use .................................................................................................................. 15-3

Chapter 16: Electromagnetic Compatibility

1.0 GENERAL SCOPE........................................................................................................ 16-2
2.0 ELECTROMAGNETIC EMISSION............................................................................ 16-3
3.0 ELECTROMAGNETIC IMMUNITY........................................................................... 16-4
4.0 USE LIMITATION:........................................................................................................ 16-7
5.0 INSTALLATION REQUIREMENTS & ENVIRONMENT CONTROL: .............. 16-7

Chapter 17: System Specifications

Gantry Labeling (Reference 1010.3) ........................................................................ 17-2
PDU Labeling (Reference 1010.3).............................................................................. 17-4
Console Labeling (Reference 1010.3)...................................................................... 17-5
Helical High-Contrast Spatial Resolution ...................................................................... 17-8
Axial High-Contrast Spatial Resolution .......................................................................... 17-9
Helical Low-Contrast Detectability - Statistical.......................................................... 17-9
Standard Algorithm......................................................................................................... 17-9
ASiR Reconstruction..................................................................................................... 17-10
Axial Low-Contrast Detectability - Statistical........................................................... 17-10
Standard Algorithm...................................................................................................... 17-10
ASiR Reconstruction..................................................................................................... 17-11
Helical Image Noise (Reference 21CFR 1020.33 (c) (3) (i) and YY0310) ......... 17-11
Standard Algorithm...................................................................................................... 17-11
ASiR Reconstruction..................................................................................................... 17-12
Axial Image Noise / Uniformity / Mean CT Number
(Reference 21CFR 1020.33 (c) (3) (i) and YY0310)..................................................... 17-12
Head.................................................................................................................................... 17-12
Body..................................................................................................................................... 17-13
Dose Performance ................................................................................................................ 17-13
Volumetric Helical Scan Image Quality:...................................................................... 17-17
Subsystem Specifications.................................................................................................. 17-18
Operator Console NIO16............................................................................................ 17-18
Operator Console GOC4............................................................................................. 17-19
DAS/Detector .................................................................................................................. 17-20
Table.................................................................................................................................... 17-21
Gantry................................................................................................................................. 17-21
X-Ray Tube ....................................................................................................................... 17-22
Focal Spots....................................................................................................................... 17-22
Laser Alignment Lights............................................................................................... 17-23
Main Power Supply....................................................................................................... 17-23
Generator Subsystem Specifications........................................................................... 17-24
kV, mA, and Time Accuracy .............................................................................................. 17-24

TOC-8 5478900-2-1EN Rev. 3 (October 2016)

© 2016 General Electric Company. All rights reserved.
Kilovolts.............................................................................................................................. 17-24
Milliamperes .................................................................................................................... 17-25
Exposure Time ................................................................................................................ 17-25
Measuring Tool Variance........................................................................................... 17-25
Accuracy Subject to Following Conditions........................................................ 17-26
Measurement Basis.............................................................................................................. 17-26
Kilovolts.............................................................................................................................. 17-26
Milliamperes .................................................................................................................... 17-27
Exposure Time ................................................................................................................ 17-27
Class 1 Equipment ........................................................................................................ 17-29
Type B Equipment........................................................................................................ 17-29
Ordinary Equipment..................................................................................................... 17-29
Operation of Equipment ............................................................................................ 17-30
Environmental Specifications .......................................................................................... 17-30
System Cooling Requirements................................................................................ 17-30
Temperature and Humidity Specifications................................................................ 17-31
Ambient Temperature................................................................................................. 17-31
Electromagnetic Interference ................................................................................. 17-32
Pollution............................................................................................................................. 17-32
Cleaning............................................................................................................................. 17-32
Carpeting .......................................................................................................................... 17-33
Lighting .............................................................................................................................. 17-33

Chapter 18: Planned Maintenance

Chapter 19: Product Manufacturer

Chapter 20: Abbreviations

Reference Noise Index 1
Dose Information Reference 1
Purchasable Options 1
Option Descriptions................................................................................................................... C-2

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TOC-10 5478900-2-1EN Rev. 3 (October 2016)

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.
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.

5478900-2-1EN Rev. 3 (October 2016) 1-1

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.
• Tips & Workarounds: The precautions listed in TWA contain information and tips that
may be useful for certain situations encountered while using the system.
• Manufacturing Matrix: It is an addendum to the Technical Reference Manual to list the
manufacturers by product that are authorized to CE mark the products listed.

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.
1-800-682-5327 Select 1 for Applications Answer line.
Select 3 for CT Application assistance.
If your system fails, or you have an emergency, call
GE Cares at 1-800-437-1171.

1-2 5478900-2-1EN Rev. 3 (October 2016)

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.

5478900-2-1EN Rev. 3 (October 2016) 1-3

Please keep User Information readily available.

Send your comments to:
General Electric Healthcare
CT Application (NB-911)
P. O. Box 414
Milwaukee, WI 53201-0414
U.S.A.

1-4 5478900-2-1EN Rev. 3 (October 2016)

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.
If you fail to follow safe X-Ray practices or ignore the advice presented in the
manual, you and your patient risk exposure to hazardous radiation. The
General Electric Company, Healthcare 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

5478900-2-1EN Rev. 3 (October 2016) 2-1

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, Healthcare 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.

2-2 5478900-2-1EN Rev. 3 (October 2016)

Chapter 3
Safety

Introduction
This 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. 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, 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.

WARNING: Modification of any existing patient data on the system must follow the
guidelines specified in the User Manual. (Reference 21CFR 801.109)

5478900-2-1EN Rev. 3 (October 2016) 3-1

The system is classified as a Class I, IPX0 equipment, not suitable for use in the presence of a
flammable anesthetic mixture with oxygen or nitrous oxide. It is rated for continuous
operation with intermittent loading. No sterilization is applied. The patient table cradle and
cradle accessories are considered Type B applied parts.
The system is intended to be used for head and whole body computed tomography. Refer to
each Technical Reference Manual for the detail information.
United States Federal Regulation 21CFR 801.109

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

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.
Watch for electromagnetic compatibility from other hardware. Detailed information can be
found in the Electromagnetic Compatibility chapter in the Technical Reference manual.

3-2 5478900-2-1EN Rev. 3 (October 2016)

What Do I Need to Know About ...

The Learning and Reference Guide and Technical Reference Manual include information
required for the safe use of the equipment. This chapter summarizes the most important
safety issues. Some of the concepts you need to understand:
• Warning Labels and Symbols
• General Safety Guidelines
• Radiation Safety
• Electrical Safety
• Mechanical Safety
• Laser Safety (Reference 21CFR 1040.10 (h))
• Reconstructed Image Orientation
• Data Safety
• Application Software Safety
• Application Specific Safety Topics
• Accuracy of Measurements
• Operator Console Ergonomics
• Accessories
• Emergency Devices and Emergency Egress
• Maintenance and Cleaning
• Cleaning Equipment (Bio Hazard)
• Environmental Concerns
• Name and Concentration of Hazardous Substances

Warning Labels and Symbols

This chapter 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 which result in a specific hazard.
You will cause severe personal injury, or substantial property damage if you
ignore these instructions.

5478900-2-1EN Rev. 3 (October 2016) 3-3

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 chapter uses the international symbol or icon along with the danger, warning or caution
message.
Table 3-1 IEC Standards

Symbol Description

Alternating current

Protective earthing point

ON / Power

OFF / Power OFF

Input Power

Output Power

Type B Equipment

Functional Earth Ground

3-4 5478900-2-1EN Rev. 3 (October 2016)

Symbol Description (Continued)

Warning, Caution - consult accompanying documents

Electrical Shock Hazard

Table 3-2 Symbols used in Labeling

Symbol Definition

Made for Indicates the Manufacturer (responsible design owner)

by (Made
Indicates the Manufacturing Location
by)

ISO 7010 Graphic W001 General Warning Sign

Refer to instruction manual/ booklet

Pushing prohibited

Model Number

Serial Number

5478900-2-1EN Rev. 3 (October 2016) 3-5

Symbol Definition (Continued)

Date of Manufacture

X-Ray Filtration (Al Equivalent

Filtration)

Minimum Filtration

Radiation of Laser Apparatus

Large Focal Spot

Small Focal Spot

Figure 3-1 The following warning labels are located at the bottom of the gantry cover
(Reference 21CFR 1040.10 (h))

CAUTION: LASER RADIATION

DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT

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Figure 3-2 Labels on the front of the gantry (Reference 21CFR 1040.10(h)):

CAUTION: LASER APERTURE

Do not stare into beam
Figure 3-3 The following warning label is located on the table

CAUTION: Finger Pinching Can Cause physical injury.

To Prevent pinching of fingers, keep fingers away from this area before operating the
switch for Elevation Down and IMS IN.

Figure 3-4 The following warning label is located on the table

5478900-2-1EN Rev. 3 (October 2016) 3-7

CAUTION: Finger Pinching Can Cause physical injury.

To Prevent pinching of fingers, keep fingers away from this area before
operating the switch for cradle OUT.

Figure 3-5 Label on the side of the table

CAUTION: Do not grasp the side of the cradle.

Figure 3-6 The following label is located on the operators console for systems
manufactured after June 10, 2006 (Reference 21CFR 1020.30 (j))

WARNING: This x-ray unit may be dangerous to patient and operator unless safe
exposure factors, operating instructions and maintenance schedules are
observed. To be used by authorized personnel only.

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Figure 3-7 The following label is located on the operators console for systems
manufactured before June 10, 2006 (Reference 21CFR 1020.30 (j))

WARNING: This x-ray unit may be dangerous to patient and operator unless safe
exposure factors and operating instructions are observed. To be used by
authorized personnel only.

Equipment Warning Labels

The following Warning Labels are used on the equipment per IEC60601-1:2005:
Figure 3-8 Warning label on lower left side and lower right of front and rear covers of gantry

! CAUTION
PINCH POINT.
Keep hands clear
when tilting.

CAUTION: PINCH POINT. Keep hands clear when tilting.

WARNING: Do not place your hands inside the gantry opening when tilting the gantry.
The gantry can pinch or crush your hands!

5478900-2-1EN Rev. 3 (October 2016) 3-9

Figure 3-9 Warning label on gantry front cover, table, operator console, and PDU

! CAUTION
AVOID INJURY.
Read and understand
information in manuals
before operating product.

CAUTION: AVOID INJURY. Read and understand information in manuals before operating
product.
Figure 3-10 Warning label located on PDU

! CAUTION
PDU CAN MOVE AND
DAMAGE CABLES.
Do not lean on or move
when connected to power.

CAUTION: PDU CAN MOVE AND DAMAGE CABLES. Do not lean on or move when
connected to power.
Figure 3-11 Warning label on the table

! CAUTION
AVOID INJURY.
Do Not Exceed Table
>205kg Maximum Capacity
of 205 kg (450 lb).

CAUTION: AVOID INJURY. Do Not Exceed Table Maximum Capacity of 205 kg (450 lb).

3-10 5478900-2-1EN Rev. 3 (October 2016)

Figure 3-12 Load Limits

CAUTION: Excessive weight can break accessory and cause injury. Do not load more than
34 kg or 75 pounds.

Figure 3-13 Accessory

CAUTION: Do not hit the accessory against the gantry. Patient injury or equipment
damage could result.

Figure 3-14 IV Pole Load Limits

CAUTION: Do not load more than 4,5 kg or 10 pounds. Verify that extension collar is
securely tightened before use.

5478900-2-1EN Rev. 3 (October 2016) 3-11

Figure 3-15 Tray Load Limits

CAUTION: Do not load more than 9 kg or 20 pounds.

Figure 3-16 Accessory

CAUTION: Accessory may fall and cause injury if not latched to cradle. Make sure that
accessory is latched to underside of cradle.

General Safety Guidelines

• This product was designed and manufactured to ensure maximum safety of operation.
It should be operated and maintained in strict compliance with the safety precautions,
warnings and operating instructions contained herein, and in any other documentation
specific to the product.
• The system has been designed to meet all the safety requirements applicable to medical
equipment. However, anyone attempting to operate the system must be fully aware of
potential safety hazards.
• The manufacturer or vendor of the equipment makes no representation, however, that
the act of reading this manual renders the reader qualified to operate, test or calibrate
the system.
• The owner should make certain that only properly trained, fully qualified personnel are
authorized to operate the equipment. A list of authorized operators should be
maintained.
• This manual should be kept at hand, studied carefully and reviewed periodically by the
authorized operators.
• Unauthorized personnel should not be allowed access to the system.

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• Do not leave the patient unobserved at any time.

• Become familiar with the functional hardware so that you can recognize serious
problems. Do not use the system if it appears damaged or fails. Wait for qualified
personnel to correct the problem.
• Abbreviations used in the operator manuals can be found in the Learning and Reference
Guide.
• If the product does not operate properly or if it fails to respond to the controls as
described in this manual, the operator should:
– First ensure the safety of the patient.
– Next ensure the protection of the equipment.
– Evacuate the area as quickly as possible in any potentially unsafe situation.
– Follow the safety precautions and procedures as specified in this manual.
– Immediately contact the local service office, report the incident and await further
instructions.
• The images and calculations provided by this system are intended as tools for the
competent user. They are explicitly not to be regarded as a sole incontrovertible basis for
clinical diagnosis. Users are encouraged to study the literature and reach their own
professional conclusions regarding the clinical utility of the system.
• Understand the product specifications, system accuracy, and stability limitations. These
limitations must be considered before making any decision based on quantitative
values. In case of doubt, please consult your sales representative.
• Do not block the ventilation ports of the electronic equipment. Always maintain at least
6 inches (15 cm) clearance around the ventilation ports to prevent overheating and
damage to the electronic hardware.

CAUTION: Prior to powering on the system, the room environmental operating

conditions found in the System Specification chapter must be maintained for
at least 24 hours. These conditions must be constantly maintained when the
system is energized and/or in use.

CAUTION: Do not load any non GE approved software onto the computer.

DANGER: Make sure all covers are in place before you use the equipment. The covers
protect you and your patient from moving parts or electrical shock. The
covers also protect the equipment.
NOTE: Only qualified Service personnel should service the system with the covers off.

5478900-2-1EN Rev. 3 (October 2016) 3-13

DANGER: Information on internal gantry components is provided for user education.

The gantry contains dangerous voltages and moving parts. TO PREVENT
ELECTRICAL SHOCK OR CRUSHING INJURIES, DO NOT REMOVE COVERS OR
ENTER THE GANTRY. ONLY TRAINED, QUALIFIED SERVICE PERSONEL MAY
REMOVE GANTRY OR OTHER EQUIPMENT COVERS.

WARNING: This system is intended for use by healthcare professionals only. This system
may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as
reorienting or relocating the system or shielding the location.

CAUTION: Installation of the system shall be performed by qualified persons designated

by the Manufacturer. To be certain of the proper installation of the equipment,
please contact your local GE Healthcare Service representative.
NOTE: The installation instructions can be found in the Pre-Installation and Installation
manual that is supplied and accompanies the equipment.

WARNING: No modification of this equipment is allowed without authorization of the

manufacturer.

Implantable Device Safety

WARNING: CT Scans may cause interference with implanted or externally worn electronic
medical devices such as pacemakers, defibrillators, neuro stimulators and
drug infusion pumps. The interference could cause operational changes or
malfunction of the electronic medical device.

3-14 5478900-2-1EN Rev. 3 (October 2016)

Recommendations prior to scanning:

 If practical try to move external devices out of the scan range.
 Ask patients with neurostimulators to shut off the device temporarily while the scan
is performed.
 Minimize the x-ray exposure to the electronic medical device.
 Use the lowest possible x-ray tube current consistent with obtaining the required
image quality.
 Do not scan directly over the electronic device for more than a few seconds.
NOTE: For procedures such as CT Perfusion or CT Interventional scans that require scanning
over the electronic medical device for more than a few seconds, attending staff
should be ready to take emergency measures to treat adverse reactions if they occur.

Recommendations after scanning

 Have the patient turn the device back on if it had been turned off prior to scanning.
 Have the patient check the device for proper functioning, even if the device was
turned off.
 Advise patients to contact their healthcare provider as soon as possible if they
suspect their device is not functioning properly after a CT scan.
NOTE: Recommendations from FDA Preliminary Public Health Notification: Possible
Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT)
Scanning date July 14, 2008.

Radiation Safety
(Reference 21CFR 1020.30 (h) (1) (i))

WARNING: Improperly used X-Ray equipment may cause injury. Read and understand
the instructions in this book before you attempt to operate this equipment.
If you fail to follow safe X-Ray practices or ignore the advice presented in the
manual, you and your patient risk exposure to hazardous radiation.

5478900-2-1EN Rev. 3 (October 2016) 3-15

Authorized Users
This equipment incorporates a high degree of protection against X-Ray radiation outside the
useful beam. But this equipment can not substitute the essential requirement that every
user must 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 equipment 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

WARNING: Everyone having anything to do with X-Ray equipment must take adequate
steps to insure protection against injury.
All persons authorized to use the equipment must understand the dangers posed by X-Ray
exposure so that they can prevent any injury or damage that may result from such
exposure. GE urges you to use protective materials and devices to prevent any injury or
damage from X-Ray exposure.

General Radiation Safety

WARNING: Never scan a patient with unauthorized personnel in the scan room. Warn
visitors and patients about potential for harm if they fail to follow
instructions.

WARNING: Never calibrate, test the system, or warm the tube with patients or personnel
present in the scan room without adequate radiation safety precautions
being utilized.
– Stay behind a lead screen or lead glass shield during each X-Ray exposure.
– Use technique factors prescribed by the radiologist or diagnostician. Use a dose that
produces the best diagnostic results with the least X-Ray exposure.
– Amber indicator lights on the gantry display panel, and rear of the gantry, illuminate
during X-Ray exposure.

3-16 5478900-2-1EN Rev. 3 (October 2016)

CAUTION: Use of controls or adjustments, or performance of procedures other than

those specified herein, may result in hazardous radiation exposure.

Scans Acquired at the Same Tomographic Plane

IEC standard 60601-2-44 section 29.105 paragraph states that you must be warned when
scans are acquired at the same tomographic plane, i.e. same scan location. The need for the
warning is to make users aware of the potential dose that can be given to the patient when
acquiring scans at the same table location.
When acquiring scans in this mode:
– Utilize the dose information displayed on the View Edit screen. The dose information
displayed is covered in the next section, CTDIvol.
– An optional DICOM Structured Report (SR) Dose Report is saved in Series 997.
– Use proper techniques for the application and anatomy you are scanning.
A warning message (Figure 3-17) is posted when [Confirm] is selected for the following scan
types:
– SmartStep/SmartView
– SmartPrep Baseline and Monitor scans
– Cine scans
– Axial scans with zero table increment (interval)
Figure 3-17 Warning Message when scanning on the same tomographic plane: Axial, Cine
and Helical

5478900-2-1EN Rev. 3 (October 2016) 3-17

WARNING: This series contains one or more groups with multiple scans at the same
tomographic plane, i.e. same location.
Do you want to continue?

CAUTION: Prolonged exposure to x-ray in one spot may cause reddening or radiation
burns. Users must be aware of the techniques used and exposure time to
insure safe operation.

Geometric Efficiency
IEC60601-1 third edition and related standards, such as IEC600601-2-44 third edition, state
that when a prescribed scanning parameter has the detector coverage with dose efficiency
of less than 70 %, a warning pop-up shall be displayed and confirmed.
A warning message is posted when the Geometric Efficiency in the Z-direction is less than
70%. Geometric Efficiency is a measure of how much of the X-ray beam in the Z-direction is
used by the system.
Figure 3-18 Warning message when dose efficiency less than 70 %.

WARNING: The Geometric Efficiency in the Z direction is less than 70% for image 1-73.
After reading the message, if you wish to continue with the scan, click [Continue].
NOTE: The image number of 1-73 is just for example.

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CTDIvol
As you setup the scan parameters from the view/edit screen, the Dose Information area at
the upper right of the scan monitor contains updated dose information. This dose
information is based on a measurement of the CTDI or CT Dose Index, which is the current
standard for CT dosimetry and performance. By using a measurement called CTDIvol, a
single value is provided to estimate the relative dose for an exam.
The CTDIvol is a weighted average measurement in a reference phantom. This dose is
expressed in milliGrays. For additional information on specific CTDIvol doses and their
calculations, refer to your Technical Reference manual.
The DLP or Dose Length Product is the product of the CTDIvol and the scan length for a
group of scans. This number can be summed over the entire exam to give an estimate of the
total dose. The value is expressed in milliGray centimeters.
The Projected Series DLP shows the DLP that would result from scanning the current group
or groups.
The Accumulated Exam DLP displays the total exam DLP up to the current point in time.
Scout dose is not included in the DLP totals since standards for reporting scout dose are not
yet defined. Scout dose is generally a very small part of the exam.
The dose information updates when technique values such as kV, mA, scan time, slice
thickness, and scan field of view are changed.
Dose information is saved as screen save image in Series 999 upon End Exam and Series
997 contains the DICOM Dose Structured Report.

Pediatric and Small Patient Imaging

Adult techniques and protocols should not be used on pediatric patients (under 2 years of
age.) The National Cancer Institute and The Society for Pediatric Radiology developed a
brochure, http://www.cancer.gov/cancertopics/causes/radiation-risks-pediatric-CT and the
FDA issued a Public Health Notification, http://www.fda.gov/cdrh/safety/110201-ct.html,
that discuss the value of CT and the importance of minimizing the radiation dose, especially
in children. More information can also be obtained at http://www.fda.gov/cdrh/ct/.

X-Ray Tubes
The system uses cooling and reconstruction algorithms specifically designed for GE X-Ray
tubes.
You risk three dangers when you do not use GE X-Ray tubes.
• A non GE tube could cause destructive component failure if the cooling delays do not
meet its design requirements.
• The images could exhibit reduced performance or artifacts if your x-ray tube fails to
conform with GE tube performance specifications.

5478900-2-1EN Rev. 3 (October 2016) 3-19

• Radiation leakage may exceed GE specifications when a non GE X-Ray tube is installed
in the system.

CAUTION: We cannot guarantee performance or safety if you use a non GE X-Ray tube
because the cooling and reconstruction algorithms depend upon the tube
design. Radiation leakage may exceed GE specifications when a non GE X-Ray
tube is installed in the system.

Electrical Safety

DANGER: ELECTRICAL SHOCK HAZARD. Avoid all contact with any electrical conductor.
Do not remove or open system covers or plugs. Internal circuits use high
voltage capable of causing serious injury.
To guarantee safe, reliable equipment performance, prepare the site
according to GE Medical Systems requirements. This includes making sure
the equipment is connected to a power supply main with a protective earth
ground. If you have any questions about these requirements, contact GE
Medical Systems.
An electrical hazard may exist if any light, monitor or visual indicator stays
on after the system is shut down. To prevent possible injury, turn off the
main power supply wall switch, and contact your service office immediately.

DANGER: NO USER SERVICEABLE PARTS. Refer service to qualified service personnel.

Only allow people who know the proper procedures, and use of the proper
tools, to install, adjust, repair, or modify the equipment.
To guarantee safe, reliable equipment performance, prepare the site
according to GE requirements. If you have any questions about these
requirements, contact GEs.
Fuses blown within 36 hours of being replaced may indicate malfunctioning
electrical circuits within the system. Have the system checked by qualified
service personnel, and do not attempt to replace any fuse.

3-20 5478900-2-1EN Rev. 3 (October 2016)

DANGER: ELECTRICAL FIRE. Conductive fluids that seep into the active circuit
components of the system may cause short circuits that can result in
electrical fires. Therefore, do not place any liquid or food on any part of the
system.
To avoid electrical shocks or burns caused by the use of wrong type of fire
extinguisher, make sure that only fire extinguishers approved for use on
electrical fires are used.

CAUTION: Gantry and console rear plug in panel Receptacles are not for general use.
• Surplus length of power cords or other cables from mobile accessory units that may be
used with some patient scanning should be stored in safe and isolated areas, such as
individually in a figure eight at the base of stationary equipment. This discourages signal
interference and protects cables from damage due to traffic.

CAUTION: Included power cord is only to be used when connecting GE approved

accessories to the gantry or operator console.

CAUTION: The outlets are not for General Use. Operator Console outlet has a rating for
2.5A at 120VAC. Gantry outlets have a rating for 2.0A at 120VAC. Accessories
should not exceed above rating.
A CT System combined with GE approved accessories complies with the IEC60601-1
standards related to safety and performance of medical electrical systems. Refer to the
standard for more information.
• Do not connect electric devices to the CT System that are not approved by GE. It may
create increased electrical leakage current and there is possibility of electric shock.
• The GE console monitors, modem, video amp, and media tower are intended to be
powered by the CT System using cables provided. Do not connect these devices to
power sources other than the CT system (for example, wall outlets or other electrical
equipment). It may create increased electrical leakage current and there is possibility of
electric shock.
• Note that some powered equipment may only be connected by a signal cable to GE
equipment (for example, a network hub). A separation device is required for equipment
that is powered by a different power source.

5478900-2-1EN Rev. 3 (October 2016) 3-21

Mechanical Safety

General Mechanical Safety

• Check for any obstruction around the equipment before attempting to move the table
and gantry. When performing table or gantry motions, always monitor the progress of
the motion.
• Be especially careful when tilting the gantry or moving the table when the cradle
extender or head holder is in place to avoid driving these accessories into the gantry
covers.
• The (Cradle Unlatch Indicator) is illuminated in green when the cradle is
unlocked. An unlocked cradle could potentially move unexpectedly.
•The (Interference) light illuminates when the cradle has reached a travel limit or
encountered interference.
If the table reaches one of the limits while actively pressing the controls, the limit light
will turn off when the controls are released.
Clear an interference by changing the gantry tilt, moving the cradle, or adjusting the
table height.

WARNING: Do not use the table base as a foot rest. You could entrap and injure your foot
while lowering the table. Do not place your hands between the table base and
the table side panels.

WARNING: Do not place your hands inside the gantry opening when tilting the gantry.
The gantry can pinch or crush your hands!

WARNING: Be sure that the Gantry will not touch the patient during Remote Tilt
operation. Pinching or crushing may happen if the Gantry touches the patient.
• Avoid any patient contact with the gantry during tilt or cradle movement (manual or
software driven).

Short Footprint Mode

• If the system is set to Short Footprint mode, scannable range is limited accordingly. This
should be approved by the customer during pre-installation.
• Only qualified Service personnel should change the setting of the Small Footprint Mode.
• Short Foot print Mode is available for LightSpeed Series.

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WARNING: The IN-limit position of cradle Short Footprint Mode should be set in order not
to pinch a patient’s foot between the cradle edge and the wall of the scan
room.

WARNING: To Prevent Pinching or Crushing of the Patient, Watch the Patient and
Equipment Carefully At All Times During Table Movement. If Unwanted Motion
Occurs or Motion Does Not Stop, Press the Emergency Stop Switches on the
Console or Gantry.

Patient Positioning

CAUTION: Keep the patient in view at all times.

– Never leave the patient unattended.

CAUTION: If the head is poorly positioned in the head holder and a tilt is used, images
with different CT numbers and intensities may be seen at the edges of two
rotational interfaces. Make sure the patient is properly position up in the head
holder, not positioned such that the head is at the junction of the head holder
attachment to the cradle. If a repeat scan is needed, make sure the locations
with different intensities are in the middle of the beam collimation. Do not
repeat using exactly same prescription.

DANGER: Do Not Place a Patient on the Table (except High Capacity Table) Weighing
More Than the Upper Limit Of 450 Pounds (205kg). This Could Cause the Table
to Fail and the Patient Could Fall.

Table capacity
For HP Table
 Up to 400 lb. (180kg) with ± 0.25 mm positional accuracy guaranteed.
 400 to 450 lb. (180 to 205 kg) maximum allowed with normal operation and ± 1 mm
positional accuracy.

5478900-2-1EN Rev. 3 (October 2016) 3-23

CAUTION: When using the external laser alignment light for patient positioning
purposes, be aware that the patient's elevation may be slightly lower with the
cradle extended than with the cradle fully retracted. This is because the cradle
may bend slightly under a patient's weight. This difference should be taken
into consideration for applications where patient position information is
critical, such as Treatment Planning. To minimize these affects, after using
the external laser alignment system to position the patient, advance the
patient to the CT scan plane. Turn on the CT alignment lights to determine if
they line up with the markers on the patient. If necessary, compensate for the
bend in the cradle by elevating the table. When the CT alignment lights line
up with the markers, set the landmark for the scan using the Internal laser
alignment light.

CAUTION: When using patient positioning accessories, make sure there are no areas,
which might cause a pinch point or interfere with patient tubing or IV.

CAUTION: Check to make sure the power injector has enough IV tubing to allow free
movement of the cradle. Make sure the unit itself does not interfere with table
travel.
Ensure excess tubing length is secured to the table top. DO NOT loop
additional IV tubing in the patient's fingers.
• Check the length of all patient health lines (IV tubing, oxygen line, etc.) and make sure
they accommodate cradle travel. Position these lines so they cannot catch on anything
within the patient vicinity or between the table and gantry during cradle travel or gantry
tilt.

CAUTION: The patient positioning straps provided with the system do not support the
full weight of the patient. Patient positioning straps should be used to aid in
patient positioning and are not meant to fully restrain the patient.

CAUTION: Care should be taken to ensure the patient positioning straps, patient
clothing, or other material will not be caught during table motion.
• The scannable range is not indicated by the black mark on the table, scannable range is
indicated by the Tilt and Travel limits button on the Gantry Controls.

3-24 5478900-2-1EN Rev. 3 (October 2016)

Figure 3-19 Table

CAUTION: If the table is lowered with anything in the red X area as indicated above, the
table could be damaged along with the equipment or object under the table.

CAUTION: Physically assist all patients on and off the table and into position on the
cradle.

CAUTION: The foot pedals at the base of the table for loading and unloading patients
are always active. Care should be taken not to activate the foot pedals once
the patient has been positioned on the cradle and an exam started.
• Return the gantry tilt to the 0 degree upright position, latch the cradle, and adjust the
table to a comfortable height for patient loading and unloading.
• Latch the cradle before you load or unload the patient (the Cradle Unlatch indicator
illuminates when the cradle is unlatched).

WARNING: To prevent pinching or crushing of the patient's extremities, keep the patient's
hands and feet away from the edge of the moving table top/cradle and its
surrounding equipment, or between table base and side panels of the table.
(Take special care when positioning physically large patients).

WARNING: To prevent pinching or crushing of the patient watch the patient and
equipment carefully at all times during gantry tilt or table movement. If
unwanted motion occurs or motion does not stop, press the emergency stop
switches on the console or gantry.

5478900-2-1EN Rev. 3 (October 2016) 3-25

WARNING: The head holder may crack, possibly injuring the patient's head or neck, if the
patient tries to brace himself or herself on the head holder during positioning.
The head holder and cradle extender are only designed to support 75 pounds
(34kg). Ask the patient to move up into the head holder or manually help the
patient into position.

CAUTION: The patient head holder or table extender should be adequately secured to
ensure stability. If they not secured properly, degradation of image quality
may result due to introduced motion of the head holder or table extender.

CAUTION: Use of any cradle extension accessories such as the table extension, head
holder, coronal head holder, and phantom holder are not accounted for in the
table gantry interference matrix. Therefore, additional care needs to be taken
to closely monitor any table up/down, in/out or gantry tilt movement to avoid
contact of the extended accessory with the gantry.
NOTE: Collision sensors are placed under the table surfaces to stop downward motion and
minimize the effects of a collision in most cases. Upward motion is still allowed if a
collision sensor has been activated.
• Check the accessory attachment plate fixed to the end of the cradle. Repair or replace if
loose or damaged.
• Use the cradle extender to support the patient's head or feet during a scan.
• To move the patient out of the gantry in an emergency, the cradle can be manually
withdrawn by applying a minimum of 40 lbs (178 N) of force.

CAUTION: Temporal sampling may be degraded due to changes in timing for the table
to move from location to location if proper positioning methods are not
followed. Make sure that the patient is securely positioned on the table and
their arms are not allowed to drag on the table or allow clothing, sheets or
blankets to get caught causing a table move problem.

WARNING: Temporal interval for some of the images exceeds 3.2 seconds. Use of this
data for processing of CT Perfusion maps may contain errors in the functional
information.

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Laser Safety (Reference 21CFR 1040.10 (h))

A laser alignment light system is available in order to accurately define the patient scan
region.

WARNING: THE LASER BEAM CAN CAUSE EYE INJURY.

- Tell all patients to close their eyes before you switch ON the alignment
lights.
- Instruct your patients to keep their eyes closed until you turn OFF the
alignment lights.
NOTE: Closely monitor infants and infirm patients, and prevent them from accidentally
staring into the beam.

CAUTION: The detector and DAS rotate to position the alignment lights over the laser
ports.
- Keep your hands away from the gantry opening.
- Make sure the gantry side covers are in place.

CAUTION: Use of controls or adjustments, or performance of procedures other than

those specified herein, may result in hazardous radiation exposure.
• The indicator on the gantry display panel lights when you turn ON the alignment lights.
• Warning labels regarding laser safety are provided on the gantry, as described in the
Warning Labels and Symbols section.

Reconstructed Image Orientation

CAUTION: If you plan to reconstruct images, you must first use the files that reside on
the disk. Either reserve the scan files you plan to retrospectively reconstruct,
or reconstruct unsaved scan files before the system overwrites the file with
new scan data. The system refuses to overwrite reserved scan files.
Remember to release the reserved scan files when you finish retrospective
reconstructions.

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CAUTION: GE CT image reconstruction is in an orientation viewing from the patient's

feet. The reconstructed orientation is the orientation the image is installed in
the image data base and is the orientation images are networked with to a
remote viewing station.
Figure 3-20 Patient Orientation
A P

R L L R

P A
Head First Supine Head First Prone
A P

R L L R

P A
Feet First Supine Feet First Prone

The patient position information stored in the image header correctly reflects the orientation
(RAS) information for the patient. Viewing applications will correctly reflect Right (R), Left (L),
Anterior (A) and Posterior (P) of the patient.
The reconstructed image orientation may differ from preferred anatomical viewing
presentation in which the patient's Right is on the viewers Left and patient's Left is on the
viewers Right. For example when the patient is scanned Head First and Prone the patients’s
Left is on the viewer’s Left and the patient’s Right is on the viewer’s Right. The image
presentation will need to be modified to display preferred anatomical viewing. Some
viewing stations may not have the capability to flip the image presentation, but if the
capability exists, you must use display tools such as Flip to change the presentation of the
image.
Some remote viewing stations may have the capability to set default viewing protocols, this
is another tool that can be used to set an anatomical viewing presentation.
Post processing applications such as Direct MPR, Reformat and Volume Viewer
automatically orient images in anatomical viewing orientation. These applications create
axial images in anatomical viewing presentation. Please see Auto Applications (Option) of

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the Learning and Reference Guide for more information. The system also provides the
capability to create Gray Scale Presentation State Objects (GSPS) to flip the image
orientation.
Flip/Rotate in recon can be used to generate images where right/left or anterior/posterior
are flipped or where both R/L and A/P have been flipped to meet desired image display
preference. An Attention pop-up is displayed at Confirm for series where Flip/Rotate in recon
is selected. Attention: This scan prescription utilizes one of the reconstruction based image
flip and/or rotate options. Please ensure that this prescribed image orientation is displayed
appropriately on all remote viewing devices.
Figure 3-21 Flip Warning Message

CAUTION: The scan prescription utilizes one of the reconstruction based image flip
and/or rotate options. Please ensure the prescribed image orientation is
displayed correctly on all remote viewing devices.

Data Safety
To ensure data safety:
– Verify and record the patient's identification before starting a scan.
– Observe and record the patient's orientation, position and anatomical landmarks
before starting a scan. Ensure that the patient is positioned within the scan
parameters.
– Maintain system image quality by performing Daily QA and other maintenance.
Connectivity - Always verify that the data transferred to another system has been correctly
received.

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CAUTION: Incorrect data entries or procedures could result in misinterpretation or

misdiagnosis.

CAUTION: When entering Patient ID information the system may contain multiple
instances of the same Patient ID. Multiple schedule records can be due to
multiple procedures being ordered under separate accession numbers or
New and Completed records in the Patient schedule for the same Patient ID.
When entering the Patient ID verify that the correct Accession number and
Exam Description selected is what is desired. Scanning with an incorrect
accession number may cause problems reconciling exams on a PACS
system. Please see the Schedule Patients chapter for more information.

CAUTION: The system posts a warning message when expected disk space required to
store scan data from the prescribed exam is insufficient.

CAUTION: The system posts a warning message when expected image space required
to store images from prescribed reconstruction is insufficient.

CAUTION: The system posts a warning message when data was interpolated to generate
images.

CAUTION: The system posts a warning message if there is a failure during the archive
of patient data.

CAUTION: The system posts a warning message if there is a failure during the network
of patient image data.

CAUTION: The system posts a warning message when a scan is aborted due to a failure
in the acquisition chain.

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CAUTION: The system posts a warning message when the system has low disk space.
This is due to a partition on the system disk getting too full. Removing images
will not help. Contact service to help with recovery. If you reboot the system
and see the message asking if you want to run storelog, select the option to
remove the logs.

CAUTION: The system posts a warning message if patient orientation has been changed
or does not match after start of exam.

CAUTION: The system posts warning message prior to modifying any existing data set
by a software utility.

CAUTION: Do not remove images while scanning. Always remove images when the
system is idle. Removing images while the system is acquiring and
reconstructing data could cause the system to lock up and require a reboot
and/or force the system to go into data base recovery.

CAUTION: Saving images in Interchange (CD/DVD) while scanning may cause long
interscan delays (ISD) to be missed or may cause Auto Voice to fail to play. Do
not copy or restore images using CD-R or DVD-R while scanning.

CAUTION: When comparing GE CT images with other images, consult the DICOM
Conformance Statement for the details on the DICOM Image Position, Frame
of Reference UID and Slice location values stored.

CAUTION: Some annotation values are stored in private DICOM elements. When viewing
images on a remote station these annotation values may not be visible on the
image. Consult the DICOM conformance statement for information on private
DICOM data fields.

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CAUTION: If you plan to reconstruct images, you must use files that reside on the disk.
Either reserve the scan files you plan to retrospectively reconstruct, or
reconstruct unsaved scan files before the system overwrites the files with
new scan data. The system refuses to overwrite reserved scan files.
Remember to release the reserved scan files when you finish retrospective
reconstruction.

Application Software Safety

CAUTION: Do not initiate a QuickSnap if the system is actively collecting data with x-ray
on.

CAUTION: Do not initiate an IQ Snap while the system is actively scanning or

reconstructing data.

Application Specific Safety Topics

Helical Scanning

WARNING: Helical scanning has the inherent ability to produce artifacts when scanning
highly sloped anatomy (e.g. pediatric or adult heads). Factors which worsen
this effect are: faster table speeds, thicker image thickness, and gantry tilt.
In some cases these artifacts could be mistaken for a hemorrhage near the
cranium, or a thickening of the skull.
To reduce the occurrence of these artifacts you may prescribe slower table
speeds and/or thinner slices (such as 2.5mm) during helical scans near the
vertex of a pediatric or adult head.

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WARNING: It has been documented in radiology literature that an artifact may occur in
the chest that bears the double margin of the great vessels, which emulates
a dissection of the vessel during 0.5 - 1.0 second scans. This can occur in axial
or helical scans. If you have scanned axially with a 0.5 - 1.0 second rotation
time and observe this phenomenon, re-scan the area with a 2 second axial
scan to verify if it is artifact or patient pathology. Segment recon mode for
helical and cine acquisitions may be used in Retro recon to also assess if the
areas is artifact or pathology.

Cardiac Imaging

CAUTION: A patient with any of the conditions listed below may require additional
attention. If patients are scanned with these conditions, the software may not
be able to detect the R-Peaks and the images therefore may be produced as
ungated segment images.
- Patients with multiple pre-contractions or extra systole (e.g. PVC, PAC)
- Patients with persistent or extreme arrhythmia
- Patients with bi-ventricular lead (dual chamber) pacemakers

CAUTION: ECG signal clarity and integrity must be confirmed prior to performing
ECG-gated acquisitions. Items which may require adjustment of equipment
settings or positioning, or patient set-up include:
- External Interference
- Atypical Patient ECG (e.g. elevated T-Waves, low ECG amplitude or signal
strength)
- Suboptimal Patient Connection
ECG lead placement should follow recommended guidelines to optimize
results.
If the ECG lead is disconnected during the scan, or the heart rate drops
below 40 BPM, the images will be reconstructed as non-gated segment
images. This is done to avoid inaccuracy of the z-location of images where
necessary.

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CAUTION: The heart rate displayed on CT console is a 3-cycle average. You must review
the actual waveform pattern to determine ECG trace clarity, trigger location
and if any cycle to cycle variability or masked arrhythmias may be present in
order to adapt set up and conditions prior to proceeding with the scan
acquisition.

CAUTION: Cardiac helical scan modes of SnapShot Segment, Burst, and Burst Plus are
optimized for specific heart rate ranges. Select the appropriate scan mode
for each patient's heart rate pattern. If the incorrect mode is selected,
temporal resolution may be insufficient and degraded image quality could
result.

CAUTION: Patient motion, respiration, beat-to-beat variability of heart rate, heart

motion, or significant change in heart rate over the scan duration could cause
an ECG gated acquisition to have degraded image quality. It is important to
explain to the patient the pattern of breathing instructions to expect, the
warm feeling that can be felt from the contrast injection and to position the
patient comfortably such that the arms will not move with respect to the body
during the scan.
Heart rate information and phase location will be updated to indicate any
movement of trigger locations since heart rate and phase values are
calculated based on time between consecutive triggers and are not
diagnostic values.

Patient Preparation

CAUTION: Ensure the ECG patches are not past expiration date and that the gel on the
pads is still moist for proper conduction of the ECG signal for successful
gating.
Practice hyperventilation breathing instructions with the patient.
• It is important to explain to the patient the events that will occur during the acquisition
of the contrast enhanced cardiac data. Make sure to explain the warm feeling that may
occur during the injection of the contrast material.
• Use hyperventilation technique for all the series in a cardiac exam. Practice the
hyperventilation instructions with the patient prior to scanning.

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• During the practice breath hold, make sure to watch the ECG trigger monitor to
determine the average heart rate, minimum heart rate, and ECG pattern during the
breath hold.
• Position the patient's arm over the patient's head so they are comfortable and will not
move during the acquisition of data.

CAUTION: If, during the scan, the heart rate drops significantly lower than the prescribed
heart rate, there is a potential for gaps in the gated image location. To avoid
image location gaps, a non-gated image is reconstructed for the period where
the patient heart rate dropped below the expected or confirmed heart rate
at the start of the exam. A non-gated image may have more motion and may
not be reconstructed at the prescribed phase.

CAUTION: There is a possibility that the ECG signal may not be detected by the scanner
due to improper lead placements, or a lead falling off during the scan. It is
important to place new leads on the patient before the scan. Make sure the
leads are attached properly, and use only GE recommended ECG leads.
It is important to confirm ECG trace clarity before the scan.

CAUTION: The heart rate displayed on the CT console is a 3-cycle average. You must
review the actual waveform pattern to determine ECG trace clarity, trigger
locations, and if any cycle to cycle variability or masked arrhythmias may be
present in order to adapt set up and conditions prior to proceeding with the
scan acquisition.

Lung Algorithm
• The Lung algorithm setting provides edge enhancement between structures with large
density differences, such as calcium and air, resulting in a sharper lung field when
compared to Standard algorithm.
• For best image quality, prescribe a 5 mm scan thickness when you plan to use the Lung
algorithm. If you plan to prescribe a High Resolution Lung study with 3.75, 2.5, or
1.25 mm, use the Bone algorithm.
• The Lung setting enhances the contrast of small objects. For best viewing and film
quality, select a window width of 1000 to 1500 and a window level of -500 to -600.
• The Lung algorithm setting increases the CT number values at the edge of high contrast
objects. If you plan to take CT number measurements of vessels or nodules in the lung,
please check and compare your results with Standard algorithm images. (ROI and
Histogram functions use CT numbers.)

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• Remember: The edge enhancement provided by the Lung setting may not be
appropriate in some clinical cases. Please take individual viewing preferences into
account when you choose the Lung setting.

Autoscan
• Press and release Move to Scan on the console to advance the cradle.
• If Autoscan is disabled, Move to Scan must be pressed for every scan before Start Scan
will become ready.
• If you select Auto Scan during one group Rx, it remains ON for every group in that series.

SmartStep/SmartView Safety
The SmartStep option adds several components to the scan room. These are the In-Room
Monitor, Hand Held Control for table movement as well as image review, and the X-Ray
Control Foot pedal.
Each of the SmartStep components is connected to the system by a cable. When using the
system, ensure that the cables cannot catch on anything when the gantry or table is moved.

Table Float
During the scan the Clinician has the option to float the table between scans. When the
Table Float mode is selected, the table is unlatched and can be moved freely by anyone at
the bedside.

WARNING: Unintended table motion may cause a serious injury. Table may be bumped
or jarred during an interventional procedure. Care must be taken when
performing interventional procedures in the float mode. It is the clinician's
responsibility to ensure that they have control of the table when in this mode
of operation. Table must not be left unattended when in the float mode.
Ensure that the table is latched before leaving the table side.

SmartStep/SmartView Scanning
SmartStep scanning allows multiple scans at one location for interventional procedures. The
system allows up to 90 seconds of scanning in one place. After 90 seconds, the operator
must prescribe a new scan to continue. The accumulated scan time from a procedure is
displayed in the In-Room Monitor.

CAUTION: Expose time to the patient can be up to 90 seconds per confirm compared to
60 or 120 (option) seconds for all other scan modes.

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CAUTION: Prolonged exposure to x-ray in one spot may cause reddening or radiation
burns. User must be aware of the techniques used and exposure time to insure
safe operation.

CAUTION: The foot pedal is active if the system is in the “Prepped” state. Care should be
taken not to step on the foot pedal and make an unwanted exposure.

CAUTION: The cabling provided for the integrated Hand-Held Controller (HHC) and Foot
Pedal with the SmartView and SmartStep options may present a trip hazard.
Ensure that the cabling can not catch on anything when the gantry or table
is moved and that the cables are out of the way while loading and unloading
the patient.
Clinician's working in the scan room should wear appropriate protective clothing. Lead
aprons, groin and thyroid protection, as well as protective eye wear are available through
the GE Accessories Catalog.

Interventional / Biopsy Scanning

CAUTION: The continuous AutoView layout format should not be used for display of
images during an interventional study because it does not allow for quick
review of images in a free viewport.

WARNING: When scanning for interventional (biopsy) studies the scan mode, image
thickness, number of images per rotation and the display layout used affect
the display of the images. It is recommended to use the Biopsy Mode provided
on the system. If manually prescribing biopsy scans, Axial 1i scan mode or
Helical scan mode with a slice thickness greater than 2.5 mm must be used.
Do not use Cine scan mode for interventional (Biopsy) imaging. Do not use an
Auto view layout with more than one Auto View image viewport.
Refer to "Select a Multiple Image Display” in the Image Display Viewing Area chapter
of the Learning and Reference Guide for more information on how to set up the
desired viewing options.
Choose one of the following for the best auto view layouts.

5478900-2-1EN Rev. 3 (October 2016) 3-37

Figure 3-22 Auto View Layouts

Advanced Applications Safety

CAUTION: 3D or slab Reconstructions provide additional supplemental information,

complementing diagnosis that should be based on classical techniques.

WARNING: Non GE images acquired can be loaded in Volume Viewer but GE does not
guarantee the quality or reliability of any reconstruction, segmentation or
measurements performed on these images. Non-GE images can easily be
identified by the corresponding image annotation.
Follow the DICOM acquisition parameter guidelines listed in each
application user guide. Consult GE-published DICOM conformance
statement of Volume Viewer which is available on the GE Healthcare website
at
http://www.gehealthcare.com/usen/interoperability/dicom/products/workstati
on_dicom.html

WARNING: Before using any segmentation tool (threshold, scalpel, remove & keep object,
AutoSelect, “floater” filters…) always make sure that it will not remove
pathologies or other essential anatomical structures.

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WARNING: When using any Segmentation tools (AutoSelect, threshold, Paint on slice,
Quick Paint…), check contours to check the reliability of the segmentation.
Make sure the contours match the correct segmentation and volumes Check
segmented volumes match contours.

Measurements

WARNING: Do not use 3D or slab views only to perform any measurements (distance,
angle, Region of Interest, Report Cursor, Area, Volume…). Always check
measurement points position and refer to 2D baseline views (acquisition
images or reformatted images of minimal thickness) to confirm
measurements.

CAUTION: The software calculates and displays measurements with a resolution of one
decimal (such as 0.1 mm, 0.1 degree, etc.). You should be aware that the real
measurement accuracy is generally less for a number of different reasons
(image resolution, acquisition conditions…).
Distance, angle and area measurements are valid only if all trace segments
are longer than the inter- slice distance.

WARNING: Depending on WW/WL settings, objects may display differently. Check

WL/WW before depositing measurement points.

CAUTION: When filming or saving images for diagnostic purposes, always make sure
the patient name and geometry information is displayed on all views and
match information on reference view.

CAUTION: When saving images with a new series description, make sure this description
matches the saved images.

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WARNING: Check with original datasets the reliability of segmentations and

measurements performed in Saved objects after post processing and
reloading.

Segment Tools

Filming and Saving Images

CAUTION: When filming or saving images for diagnostic purposes, always make sure
the patient name and geometry information is displayed on all views and
match information on reference view.

CAUTION: When saving images with a new series description, make sure this description
matches the saved images.

CAUTION: Check with original datasets the reliability of segmentations and

measurements performed in Saved objects after post processing and
reloading

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Image reliability

CAUTION: 3D or slab Reconstructions provide additional supplemental information,

complementing diagnosis that should be based on classical techniques

WARNING: Always correlate any information (cursor position, image orientation,

measurements, image quality…) in any 3D reconstruction (reformatted plane,
oblique, MPVR, MIP, Volume Rendering, Navigator endoluminal views, Curved,
segmentations, measurements, tracking, saved images…) with the original
data (acquisition or baseline images).

WARNING: A 3D view is a two-dimensional projection on the screen of the 3D Volume.

There is no indication on a 3D view of how “deep “inside the 3D volume a 3D
cursor is. Always check the accuracy and consistency of 3D coordinates by
checking cursor position on original data (acquisition images)

Window Width and Level (W/L)

WARNING: The window width and level (W/L) determine how clearly pathologies and
other anatomical structures can be discerned. Incorrect W/L settings may
result in pathologies and other essential anatomical structures not being
displayed correctly. As a single W/L cannot display all features present in an
exam, use several different setting, when necessary to explore all exam data

Volume Rendering

WARNING: When using Volume Rendering, incorrect setting of opacity curve, opacity
threshold, transparency setting when merging VR objects can result in
pathology or essential anatomies not being visible. Always correlate Volume
Rendering images with original images.

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Image quality

WARNING: At all times, it remains the responsibility of the physician to determine

whether the inter- slice distance used for a particular exam is acceptable.

WARNING: Loading non-square pixels will results in bad quality image.

WARNING: Default Plaque Color Map preset is provided for information. You must check
and adjust Values and segment names.

Accuracy of Measurements

Measure Distance for Axial, Helical, and Cine Images

CAUTION: This section includes information on accuracy of measurements used when

reviewing images.
Measure error using the straight line distance graphic is less than two times the image pixel
size.

CAUTION: Note that the measurements are accurate only if the trace segments are
longer than the slice interval.

Measure Distance for Scout Images

Accuracy of measurements for scout images in the “X” direction varies with object thickness
and distance from ISO center in the “Y” direction. Note the orientations of the “X” and “Y” in
Figure 3-23 below assume a scout scan plane of 0 degrees. If the scout plane is rotated then
the “X” and “Y” orientation changes accordingly.
• For measurements of anatomy in the “X” direction that are at ISO center (“Y”):
– The measure error using the straight line distance graphic is less than 5 % of the
measured distance plus 2 mm.

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• For measurements of anatomy in the “X” direction that are NOT at ISO (“Y”):
– The measure error using the straight line distance graphic is less than 5 % of the
measured distance plus 2 mm plus 3 % of measured distance per centimeter from
ISO.
• For measurements of anatomy in the “Z” direction:
– Measure error using the straight line distance graphic is less than two times the
image pixel size.
Figure 3-23 Scout Scan Plane
X-Ray Tube
Focal Spot

Y-Axis

X-Axis Scan
ISO Center Plane

Z-Axis

Patient
Table

5478900-2-1EN Rev. 3 (October 2016) 3-43

Measure Angle
Measurement accuracy using the angle graphic is equal to the displayed angle value +/- 10
degrees for an angle measured between segments which are five times larger than the
image pixel size. Accuracy improves as the length of the segments increases.

ROI
Area measurement accuracy using a region of interest graphic (rectangle, smooth curve,
ellipse or free draw) is equal to the displayed area +/- the circumference of the region
multiplied by (image pixel size)2/2. Mean and standard deviation values for the intensity of
the pixels in the region are also affected by this accuracy. If the ROI is rotated, the area
measurement can vary up to 5%. Region of interest statistics are based on the pixels INSIDE
the graphic defining the region.

Reformat Plane Thickness

Reformat plane thickness equals 1 pixel.
• If each axial pixel represents 0.5mm of anatomy, then the reformat plane thickness
equals 0.5mm.
• If pixel size equals 0.9766mm (500mm/512), then the reformat plane represents a slice
of anatomy about one millimeter thick.

CAUTION: The limiting measurement resolution of the cursor is 1mm, i.e., the distance
less than 1mm but greater than 0.5mm is rounded to 1mm, therefore, the
accuracy of this testing is limited by the cursor measurement capability. This
is especially important for thin slice measurement where the FWHM is close
to 0.625mm. The results for these thin slice images will be not as accurate as
the thick slice ones. This is the limitation by this testing method.

Operator Console Ergonomics

To optimally use the system and reduce the chance of physical strain and fatigue, the
following steps are recommended regarding how you use your operator console.

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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.
2. Set your chair height to position your forearms parallel with the floor when your hands
are placed on the keyboard. If your feet dangle, you need a footrest.

Keyboard
Keyboard height is also important. When typing:
– Your wrists should be as straight as possible.
– Your forearms should be parallel to the floor.
– Your hands and fingers should float over the keys or mouse.

Screen
• The recommended viewing distance from the screen is 18 - 28 inches (45 - 70
centimeters).
• With your head straight, your eyes should be looking directly at the top of the screen.
• You should look at the screen straight-on, not at an angle from the side, top or bottom.
• Glare from the screen can disrupt your viewing and cause eyestrain. Do not face a
window, and position the screen at right angles to bright light sources.

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Comfort
Comfort at your operator console indicates you've set up your work area correctly. However
even a well-designed area needs frequent adjustment, especially for different users. Take
the time when positioning yourself at your operator console to ensure your comfort.
It is also recommended that if you use the operator console for extended periods of use
(several hours at a time), that you take short breaks to get away from your operator console
and perform simple stretching exercises to reduce the chance of fatigue.
Other considerations:
– Stay alert to your patient's condition.
– Use the speakers and microphones on the table, gantry, and console to stay in
constant communication, even while you sit at the console.
– Follow the exam procedures explained in the Chapters 13 and 14 of the Learning and
Reference Manual. Carefully enter patient information and position before
proceeding.

Accessories

WARNING: Do not connect accessories that are not approved as part of the system. Do
not use accessories from other modalities.

WARNING: None of the accessories support the full weight of a patient. If you sit, stand,
or otherwise apply excessive pressure to these devices, they break or come
off the cradle and may cause injury. Note if an accessory breaks, use caution
when picking it up and do not continue to use.

CAUTION: When using patient positioning accessories that are not GE options, make
sure there are no areas that might cause a pinch point or interfere with
patient tubing or IV.

WARNING: Accessories like arm boards and catheter bag holders are not secured to
gantry and may interfere with gantry if not positioned properly.

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WARNING: All non medical equipment connected to the USB port of the media tower on
the CT operator console must comply with IEC/EN/UL60950-1 and should be
approved by GE.

CAUTION: Do not use the USB or Ethernet port on the front cover of the CT operator
console, it is intended for service use only.

CAUTION: Using accessories which are not GE approved accessories might affect dose
and image quality.

GE Approved Accessories
Use only GE approved equipment together with this system.
With each use check all accessories for damage and remove them from service if damaged
or cracked.
Table 3-3 Types and Model

Type Manufacturer/Model
IVY 3100 with ethernet
IVY 3100 - A with ethernet
IVY 3100 - B with ethernet
Cardiac Monitor IVY 3150
IVY 3150 - A
IVY 3150 - B
IVY 7800
Varian 1.6
Respiratory Monitor
Varian 1.7
Partial UPS *1 9155-10GE
Honeywell 3800g
Bar Code Reader *1 Hand Held 3800
Opticon 6125

5478900-2-1EN Rev. 3 (October 2016) 3-47

Type (Continued) Manufacturer/Model (Continued)

SmartStep Monitor (includes LCD monitor,
GEHC 5115174-2
video splitter and mountings) *1
SmartStep Handheld Control *1 GEHC 2199947
SmartStep Foot pedal *1 GEHC 2199945-2
Nemoto Dual Shot Alpha (CIA425 Class I) /
GEHC 5328194
Nemoto Dual Shot Alpha (CIA425 Class IV) /
Patient contrast injector:
GEHC 5328195
For Xtream Injector option
Nemoto Dual Shot GX (CIA425 Class IV)
Medrad ISI900 (for Stellant D) (CiA425 Class
1 and Class IV) / GE 5335919
Nemoto Dual Shot Alpha (CIA425 Class IV) /
GEHC 5328195
Patient contrast injector:
Nemoto Dual Shot GX (CIA425 Class IV)
For Enhanced Xtream Injector option
Medrad ISI900 (for Stellant D) (CiA425 Class
1 and Class IV) / GE 5335919

NOTE: *1 is CT system component.

The following approved accessories were shipped with the system component:
• Patient comfort and workflow accessories such as the cradle pad, cradle extender,
patient arm board, catheter bag holder, table tray and IV pole attached to the cradle.
• Patient positioning accessories including Axial and Coronal head holders, positioning
straps and pads.
• System quality assurance accessories including imaging phantoms and phantom
holder.
Additional accessories and supplies approved for use with the system are available at
www.GEhealthcare.com.
With each use check all accessories for damage and remove them from service if damaged
or cracked.

IV Pole Safety
Care should be taken in the amount of weight and ensuring that the pole is tightened prior
to use.

CAUTION: The IV pole may bend when excessive weight is placed on the pole. Ensure no
more than 4.5 kg or 10 lb. is placed on the IV pole.

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CAUTION: Ensure that the IV pole extension collar is tightened prior to use to avoid the
pole height to move on it's own.
Figure 3-24 IV Pole Load Limits

CAUTION: Do not load more than 4,5 kg or 10 pounds. Verify that extension collar is
securely tightened before use.

Table Tray Safety

Care should be taken in the amount of weight and the objects that are placed on the tray.
Figure 3-25 Tray Load Limits

CAUTION: Do not load more than 9 kg or 20 pounds.

CAUTION: The maximum allowable weight on the table tray is 9kg or 20 lbs

CAUTION: Objects that may be susceptible to tipping should be strapped down with the
Velcro strap provided.

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Systems With Metal-Free Cradles and Accessories

CAUTION: Prevent damage to metal-free accessories! Carefully examine the metal-free

clasp assembly on the accessory and the catch on the cradle before
attempting to attach the accessory for the first time.
• To Latch an accessory:
– Align the accessory tongue with the pocket at the end of the cradle.
– Keep fingers clear of the cradle.
– Push the tongue all the way into the pocket until it latches into place.
– Rubber shims may have been installed on the head holder or foot extender to give it
a tighter fit. Please take care when latching the accessory to make sure that it is
completely latched. Push the latch forward until you hear a click. Verify that the latch
is fully latched.
• To Unlatch an accessory:
– Pinch the two L-shaped parts together and pull the accessory out of the cradle.
– An alternate method is to apply a light force to the catch in the direction to pull the
accessory out of the cradle.
• Proper operation:
– Keep the accessory “tongue” and cradle pocket clean and free of fluids and debris.
– Keep the latch and cradle pocket area clear of sheets, drapes, pads or any item that
could interfere with proper latching and cause damage.
• Positioning
– Positioning patient anatomy over the area where the head holder or cradle extension
attaches to the cradle may produce images where the contrast be between 2
adjacent rotations is different. Make sure the area of interest especially the head in
properly positioned in the head holder or on the cradle extension.

Xtream/Enhanced Xtream Injector Safety

CAUTION: The injector and the system are operated independently after the Start Scan
button is pressed. When you want to stop both the system and the injector,
use the Stop Scan button on the system SCIM and the stop injector function
on the injector.

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CAUTION: When you use Xtream Injector with SmartPrep, injection doesn't start at the
beginning of Baseline phase. It starts at Monitor phase. Going to Scan Phase
without Monitor phase, injection will not start.

Limited Access Room Configuration

CAUTION: Due to access limitations on the left side of the gantry, some procedures may
be affected when ancillary equipment is used. Assess the placement of the
equipment needed for the procedure before the placement of the patient on
the table. Access around the left side of the gantry may also be affected.

Emergency Devices and Emergency Egress

(Reference 21CFR 1020.33 (f) (2) (ii))

Emergency Devices
The system has two types of Emergency buttons:
1. Emergency Stop- when pressed, all table and gantry motions are halted, generation of
X-rays is stopped, laser alignment lights are turned off. The system aborts any data
acquisition in progress, and attempts to save all data acquired prior to the abort. Use
the Emergency Stop button for patient related emergencies.
2. System Emergency Off Button- when pressed, the power to all system components is
removed, stopping all table and gantry motion and generation of X-rays. The system
aborts any acquisitions in progress, and data obtained prior to the abort can become
corrupt or lost. Use the System Emergency OFF button for catastrophic emergencies,
such as fire or earthquake.

CAUTION: If you press the Emergency Stop or Emergency OFF buttons during a scan, the
system will abort the data acquisition.

Emergency Stop
NOTE: Every operator should take a few minutes to locate the Emergency Stops on his or
her system before he or she scans the first patient.

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The system has five Emergency Stop buttons:

– One on each control panel on the front of the gantry (Figure 3-26).
Figure 3-26 Front of gantry Emergency Stop Buttons

– Two on the rear cover of the gantry.

– One on the Acquisition Control (Figure 3-27).
Figure 3-27 Emergency Stop button on the Keyboard

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GOC4 console

NIO16 console

Press an Emergency Stop button in the event of a patient related emergency or if the cradle,
table or gantry starts to move unexpectedly.
• Once an Emergency Stop button is pressed, the Reset gantry key, on the gantry control
panel, flashes about once every two seconds.
• Press the Reset gantry key to restore power to the gantry and table.
When Emergency Stop is applied, the moving cradle and tilting gantry may overrun by less
than 10 mm and less than 0.5 degrees respectively.

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Emergency Stop Button Symbols

Emergency Stop buttons may be accompanied by one of the symbols below.

System Emergency OFF Buttons using Main Disconnect Control

(If there is MDC function)
In the event of a fire, flood, earthquake, or any other catastrophic emergency, all power to
the system should be turned off. Pressing the System Emergency OFF button immediately
removes all power to the system by removing power to the Main Disconnect Control (MDC).
Because the system has no time to save data, or shutdown in an orderly fashion, pressing
the System Emergency OFF button can corrupt system files or result in loss of patient data.
The facility designer determines the quantity and locations of the Emergency OFF buttons.
GE recommends placing an Emergency OFF button near the doorway of every room in the
system scan suite. Ask your supervisor to show you the location of all the Emergency OFF
buttons in the system suite. Follow facility guidelines to report an emergency.
Press the System Emergency OFF button (red, circular button located on the wall) in the
event of a catastrophic emergency, such as fire or earthquake.

Reset the Emergency OFF Button

1. Press the Start button on the Main Disconnect Control.
 Power to the Power Distribution Unit (PDU), operator console and system electronics
will be restored.
2. Press the Reset gantry key on the gantry panel.
 Power to the gantry drives, X-ray system and table drive will be restored.

Emergency Patient Care During X-Ray ON:

• Press STOP SCAN to abort x-ray and stop gantry/table movement.
• Press PAUSE SCAN to pause scanning after the current scan completes.

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• During an exam, the system pauses between scans if you Press any button on the
control panel other than the alignment lights. It stops X-Ray if you Press the same
button(s) during a scan.
• Select Resume on the screen to continue the exam.

Emergency Egress
System operation may be stopped due to power failure or a safety event (something coming
into contact with the collision sensors), or the system may be halted by the operator in
response to emergency conditions.
The Cradle unlatch button should only be used in two situations.
1. In Emergency Egress situations.
2. When using the SmartStep scan type.

To safely remove the patient:

1. Press the Cradle Release gantry key or the Emergency Stop button (Figure 3-26) to
disengage the clutch
2. Pull the cradle to its out position, using the Cradle Lip or Cradle Handle (Figure 3-26).
3. Assist the patient off the table.

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Maintenance and Cleaning

 To guarantee safe, reliable equipment performance, the site must be prepared
according to GE Medical Systems requirements, as specified in the Pre-Installation
Manual.
 There are no user serviceable parts in this system. The product should be installed,
maintained and serviced by qualified service personnel according to procedures laid
down in the product service manuals.
 The system in whole or in part should not be modified in any way without prior
written approval by GE Medical Systems.
 Keep the equipment clean. Remove body fluids and/or IV spills to prevent a health
risk and damage to internal parts. Clean the equipment with any of the following
Approved Cleaning Agents:
– Warm water and soap or a mild antiseptic
– Common household bleach, diluted 10:1
– Sani-cloth HB
– Perasafe
– Incidin Plus
– TriGene
 Also, use dry cleaning for electro components.
 Do not clean the connectors on the cables for ECG, Respiratory equipment etc. If you
need to clean them contact GE Service.
 Planned maintenance must be carried out regularly to ensure safe operation of the
equipment.
 For user maintenance of the system and performance tests, refer to the
maintenance and calibration information in the Technical Reference Manual.

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Cleaning Equipment (Bio Hazard)

CAUTION: Blood Bourne Pathogens Procedure - Before any equipment is serviced or

returned to GE Medical Systems, the following criteria must be met:
 Equipment used in a clinical setting must be cleaned and free of any blood and other
infectious substances.
 Customers are responsible for the sanitary condition of the equipment. The
suggested equipment clean-up procedure for cleaning any fluids or matter
discovered in accessible areas or inside under direction of service are as follows:
– Wear personal protective equipment.
– Wear proper Nitrile gloves.
– Before cleanup take note of sharp corners or objects that could cut the gloves. If
gloves tear, remove, wash hands thoroughly and re-glove.
– Use cloth or paper towels along with cleaner, taking care not to splash.
– Sanitize the area using common bleach diluted 10:1 or an Approved Cleaning
Agent listed in the Maintenance and Cleaning section. Clean any tools that come
in contact with body fluid.
– Since viruses require moisture to remain active, dry the entire area.
– When confident the area is clean and dry, place cleaning materials in a red
biohazard bag.
– Remove gloves, turning them inside out, and put gloves in the biohazard plastic
bag. Seal and give the bag to appropriate personnel for disposal.

Environmental Concerns
This symbol indicates that the waste of electrical and electronic 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.

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Name and Concentration of Hazardous Substances

Explanation of Pollution Control Label

This symbol indicates the product contains hazardous materials in excess
of the limits established by the Chinese standard SJ/T11363-2006
Requirements for Concentration Limits for Certain Hazardous Substances in
Electronic Information Products. The number in the symbol is the
Environment-friendly Use Period (EFUP), which indicates the period during
which the toxic or hazardous substances or elements contained in
electronic information products will not leak or mutate under normal operating conditions
so that the use of such electronic information products will not result in any severe
environmental pollution, any bodily injury or damage to any assets. The unit of the period is
"Year".
In order to maintain the declared EFUP, the product shall be operated normally according to
the instructions and environmental conditions as defined in the product manual, and
periodic maintenance schedules specified in Product Maintenance Procedures shall be
followed strictly.
Consumables or certain parts may have their own label with an EFUP value less than the
product. Periodic replacement of those consumables or parts to maintain the declared EFUP
shall be done in accordance with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected
separately and handled properly after decommissioning.

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Table 3-4 Table of hazardous substances' name and concentration

Hazardous substances' name

Component Name
(Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE)
Operator Console X O O X O O
Gantry X O X X X X
LCD Monitor O X O O O O
ECG Cardiac Trigger X O O X X X
Power Distribution Unit X O X X X X
Patient Table X O X X X X
• O: Indicates that this toxic or hazardous substance contained in all of the
homogeneous materials for this part is below the limit requirement in SJ/T11363-2006.
• X: Indicates that this toxic or hazardous substance contained in at least one of the
homogeneous materials used for this part is above the limit requirement in
SJ/T11363-2006.
– Data listed in the table represents best information available at the time of
publication
– Applications of hazardous substances in this medical device are required to
achieve its intended clinical uses, and/or to provide better protection to human
beings and/or to environment, due to lack of reasonably (economically or
technically) available substitutes.

This product consists of devices that may contain mercury, which must be recycled or
disposed of in accordance with local, state, or country laws. (Within this system, the
backlight lamps in the monitor display contain mercury.)
The X-Ray Collimator contains the following potentially hazardous materials:
 Lead: Lead salts are toxic and their ingestion may cause serious problems. The
manipulation/ handling of lead is subject to regulations.

WARNING: Do not discard the X-Ray Tube Assembly among industrial waste or domestic
garbage.

WARNING: A damaged X-ray Tube Assembly should not be dispatched through the
national postal service.

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The X-Ray Tube Assembly contains the following potentially hazardous materials:
 Lead: Lead salts are toxic and their ingestion may cause serious problems. The
manipulation/ handling of lead is subject to regulations.
 Oil: Univolt 54 and Crosstrans 206 mineral oil are not toxic, but the prevailing
environmental regulations should be observed for their disposal or recuperation. For
example, it is forbidden to dispose of these oils in the wastewater or sewage system
or in the natural environment.
Your local GEMS field service will advise you on the suitable means of disposal of equipment.
 The X-Ray Tube Assembly to be discarded should be forwarded to the GEMS Service
network, and it will be disposed of in a GEMS recycling center.

Precautions
Take all the necessary precautions for the personnel handling the recovery or destruction of
X-Ray Tube Assemblies, and in particular against the risks due to lead.
These personnel must be informed of the danger involved and of the necessity to observe
the safety measures.

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Chapter 4
Accessing the Learning and
Reference Guide

The Learning and Reference Guide is designed to get you up and running your system. It is
recommended that each system operator review the complete Learning and Reference
Guide.
To start the Learning and Reference Guide:
• Select the [Learning Solutions] icon.
• Select the language you wish to review in.

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Chapter 5
Tube Warmup

To maintain image quality and long tube life, complete the Warmup procedure.
• Display the Scan Monitor screen.
• Select Daily Prep and Tube Warmup to display the Warmup screen.
– When you haven't used the X-Ray tube for more than three hours
– Fastcal - Tube warmup runs automatically when Fastcal is selected.
– Before Calcheck
– Before system calibration
GE suggests you warm up the tube after every three hours of non-use.
• The system displays the following message on the Scan Monitor screen:
More than 2 hours have elapsed since the last scan. Tube needs warming.
NOTE: Tube warmup will run in Autoscan mode.
• Read the compatibility Warning.
• Position the gantry to 0 tilt.
• Click [Accept] when you understand the implications.
• Tube warmup runs a set of tube heating scans.
• When finished, the system display returns to the daily prep screen.
A message that tube warm-up has been completed will also be in the system message log.

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Figure 5-1 Pop-up warning message during tube warm up

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Chapter 6
Daily Fast Cal Procedure

To maintain image quality, complete the Fast Cal procedure once a day.
1. Display the Scan Monitor screen.
– Clear the gantry opening.
– Raise the table above the patient loading level.
2. Select [Daily Prep] and [Fast Cal] to display the screen.
– Before the start of every scan day
– Before Cal check
– Before system calibration
3. The system automatically selects the Auto Scan function.
– The system automatically selects the following sequence of scans:
a) Mylar Window Check
b) Cold Warmup
c) Warmup 1
d) Warmup 2
e) Collimator Cal
f) FPA Check Scans
g) Clever Gain Calibration
h) Fast Calibration
NOTE: Some of the warmup scans may not run if tube is sufficently warm before fast cal.
– Follow system instructions to initiate the first scan, and the system acquires the rest
of the scan set.
– Remain near the console during auto scan acquisition, so you can stop X-Ray if
someone enters the scanner room.

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Figure 6-1 Pop-up warning message during fast cal

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Chapter 7
Prepare the System

• Clean the Accessories and check for damage.

• Check and remove dried contrast agent from:
– Mylar ring (around the gantry opening)
– Detector window
– Table extension and cradle surfaces — especially the Patient Restraint plastic
channels on the table
– Accessories (Head holders, pads and cushions, etc.)
• Check supplies.

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Chapter 8
Check Disk Space

Maintain Image and Scan file space on the disk, because the system refuses to scan when it
runs out of file space.

Check Image Space

• Check the daily schedule, and multiply the list of patients by the estimated number of
images each study requires.
• Compare your estimate to the remaining 5122 images listed in the Feature Status Date
and Time area.
• If your estimate exceeds the available Image Space:
– Film any previously unfilmed studies. (Optional)
– Transfer designated images to another suite or console.
– Archive and remove the oldest images from the system disk.
Always follow the filming and archive routines established for your facility.

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Chapter 9
Reset the System

System Shutdown/Reset Procedures

To prevent system software problems, restart your system once every 24 hours.
(Recommended: Shutdown and restart at the end of the last shift.) If the system has a
persistent problem, record the time, circumstances, and error messages, then call service.

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Chapter 10
Stop/Start the Operating System

Shutdown System.
To turn off main disconnect control (MDC) or A1, Shutdown the system.
1. On Display Monitor, select the [Shutdown] icon.
 A pop-up attention box appears.

2. Select Shutdown and click OK.

• Shutdown check 1:

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If there are open/active patient scan/tube warmup/fastcal or service tool menus, the
attention window below will be seen.

ATTENTION:System shutdown cannot be accomplished when scan acquisition hardware

is in use. End Exam, exit Daily Prep menu or close any open Service Tool before
attempting shutdown.
Click Confirm in the pop-up. End patient exam/tube warmup/fastcal or dismiss the service
tool. Then start from step 1 to select the [Shutdown] icon.
• Shutdown Check 2:
For system with Performix Plus Tube, make sure the gantry is in zero tilt before shutdown,
otherwise the attention message below will be displayed.

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ATTENTION:Gantry tilt is not zero. Move gantry to zero tilt to enable Shutdown of the
system.
Click Confirm in the pop-up and return the gantry to zero tilt. Then start from step 1 to
select the [Shutdown] icon.
3. If shutdown check 1 and 2 are passed, pop-ups below will be displayed sequentially.
NOTE: The Dialog1 and Dialog2 below will be posted for only the system with Performix Plus
Tube. Click Confirm in the pop-ups to continue shutdown process.
Dialog1

WARNING: System is preparing for shutdown. The gantry will rotate immediately after
Confirm is pressed.

5478900-2-1EN Rev. 3 (October 2016) 10-3

Dialog2

ATTENTION:System is waiting for tube rotor to stop.

Dialog3

ATTENTION:System shutting down. Please wait...

• When the system is fully shutdown, the message System Halted is posted.

10-4 5478900-2-1EN Rev. 3 (October 2016)

4. Press the STOP button on the MDC or A1 connector panel or power off the console with
power switch at the front of the console (if no MDC or A1 Control Panel).

If You Turn OFF the MDC at the End of the Scan Day:
To start the system if main disconnect has been powered off:
1. Press the START button on the main disconnect control (A1) to restore power to the PDU,
console(s) and subsystem electronics.
2. Press the RESET button to turn on the Gantry Control panel to restore power to the
Gantry drives, X-Ray system, and Table drive.
• When this dialog disappears and “System Reset Successful“ message is seen in the
feature status area, the system is ready to use.
– Attention
OC is initializing please wait...

For Systems with UPS (Uninterrupted Power Supply)

Follow the manufacturer's recommended advice for operating and servicing the UPS
system.

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10-6 5478900-2-1EN Rev. 3 (October 2016)

Chapter 11
General Information

This section provides a simple introduction to CT, or Computed Tomography, for people with
no detailed physics or medical diagnostic education.

System components:
• The system components are explained in the Learning and Reference Guide.
GE Healthcare products are designed to provide optimum performance with GE-supplied
parts. Accordingly, GE can make no assurances that Equipment performance will not be
affected by the use of non-GE-supplied parts. In some instances use of non-GE-supplied
parts may affect Equipment performance or functionality.
To enhance user awareness when non-GE-supplied tube are in use, the Equipment has been
designed to recognize GE-supplied tubes and report to the user the presence of a
non-GE-supplied tube. This will permit the user to make any adjustments to Equipment use
that the user deems appropriate. Use of the Equipment with non-GE-supplied parts is
always at the user’s discretion. GE assumes no liability for the use of non-GE-supplied parts
and disclaims any responsibility for any affect such parts may have on Equipment
performance.

Emergency Stop:
• Emergency Stop procedures are described in the CT Safety tab.

CT Description
In conventional radiography, X-Rays pass through the patient to a film, which records
anatomic “shadows.” The X-Rays create a planar image, called a radiograph.
In computed tomography, electronic circuits detect and measure the X-Rays, and send
these measurements to a computer system that converts the information to a pixel value
matrix. These pixel values appear as a two dimensional image on a monitor. Even though
CT creates X-Ray exposures, we normally refer to them as images.

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Additional computer software permits you to manipulate, shade, rotate, correlate, and
measure the images to derive even more information. The system also provides the means
to store the images on permanent or temporary media.
Conventional radiography can discern tissue density differences of 5%. CT can distinguish
density differences of 1% or less.
Traditional CT systems collect 1 row of data at a time. The LightSpeed Series CT scanner
system may improve customer productivity and open the door for new applications and
unparalleled scan speeds via a revolutionary 16-row data acquisition system.

CT Operation Theory
The PDU (power distribution unit) distributes system power. Power travels from the PDU to
the gantry. The components that produce X-Rays reside inside the gantry. The generator
produces high voltage to the X-Ray tube. High voltage propels electrons from the X-Ray
tube filament to its anode. Heat and x-radiation result.
The X-Ray tube's heat capacity and dissipation determine the frequency and length of CT
exposures. A Helical and Cine exposure can last up to 120 seconds and Axial exposures last
from 0.5 to 4 seconds.
The scintillator material in the detector absorbs the X-Ray that passes through the patient,
and generates a corresponding level of light. The detector converts the light levels into a
corresponding electric current. The DAS (Data Acquisition System) samples each detector
cell in all 16-row detector about 1000 times per rotation, amplifies and quantifies the
existing current, then sends the resulting data to the IG (Image Generator).
Each complete sample by the DAS is called a view. The recon engine converts all the views
into a single matrix of pixel values, called an image. The display processor takes a copy of
the digital matrix data, and converts it into television shades of gray, and sends the image to
the monitor for display. The OC (operator console) contains the monitor and controls the
computer, X-Ray, and cradle drives.

DICOM Print
The LightSpeed Series can send a camera request to a camera that has DICOM print
capabilities.

X-Ray
The X-Ray tube contains filaments, a cathode and an anode. The filament provides the
electrons that create X-Rays. The X-Ray system generates a current that heats the filament
until electrons start to “boil off” and break away from the filament. We refer to the filament
current as “mA.” Increasing the mA increases the number of electrons that become
available to make X-Ray. Higher concentrations of electrons improve image resolution.

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The X-Ray system creates a high voltage, or kV, potential between the cathode and anode.
The negative charge on the cathode repels the electrons that boil off the filament. The
positive are grounded and attracts the negatively charged electrons. The electrons strike
the rotating anode target and displace electrons in the target material. This interaction
creates heat and X-Ray photons. The target rotates to help spread the heat over a larger
area. Increasing the kV increases the electron strike speed, which in turn increases the
intensity or “hardness” of the X-Ray photon beam.

X-ray must reach the detector reference X-Ray Tube

cells at the edges of the selected SFOV.

Centered Patient

Gantry Opening

Detector
DAS

Tube Warmup
Warmup provides an automated group of low technique exposures designed to safely bring
the X-Ray tube to operating temperature before you start to scan for the day. Warmups
increase tube life and help produce more consistent, quality images.

LightSpeed Series Theory of Operation

System Overview
The LightSpeed Series CT scanner is a premium-tier, 3rd generation CT scanner. It will
support all clinical applications currently supported by the LightSpeed product line.

System Characteristics
• New Gantry ID with 4/8/16 slice CT scanner and 16-row (4/8 slice) or 24-row (16 slice)
detector.
• LightSpeed Series optional variable rotation scan speeds (0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 2.0,
3.0, 4.0).
• Helical acquisitions at significantly faster table speeds.
• Potential for new applications due to faster coverage and fewer tube cooling delays.

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• The ability to generate 4/8/16 axial images per gantry revolution.

• Every system EMC compliant with improved reliability and uptime.

Tube
Performix Ultra, Performix Plus, MAXIRay CT ULTRA

Detector for 4/8

• 16 rows in Z axis = 16 physically separated cells in Z
• Detector cell segregation in Z provides post-patient collimation.
• 1.25mm effective cell size in Z at ISO center
• up to 8 data rows output.
• Cells summable in Z by FET array to provide various slice thickness.
• Cell summation combinations include:
– 1 x 1.25mm
– 2 x 0.625mm
– 4 x 1.25mm
– 4 x 2.5mm
– 4 x 3.75mm
– 4 x 5.00mm
– 8 x 1.25mm
– 8 x 2.5mm
• Integrated, permanently bonded flex connectors.
Scalable Data Acquisition Sub-System (GDAS)
• 8 (or 4) rows input from detector.
• 8 (or 4) rows output to console.
• Supported by 48 (or 24) interchangeable converter (CNVT) cards.
• 128 input channels/converter card GDAS.
• 31-gain, integrating, front-end pre-amp.
• Supports 1968 Hz sampling.
• Forward error correction applied to output data.
• Control functions:
– Detector FET array and heater control.
– Error detection and reporting.

Detector for 16
• 24 rows in Z axis = 24 physically separated cells in Z 
(HighSpeed CT/i = single cell).
• Detector cell segregation in Z provides post-patient collimation.

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• 2.19mm actual detector cell size in Z.

• 1.25mm effective cell size in Z at ISO center — Outer 8 rows
• 0.625mm effective cell size in Z at ISO center — Inner 16 rows.
• 16 data rows output.
• Cells summable in Z by FET array to provide various slice thickness.
• Cell summation combinations include:
– 1 x 1.25mm
– 2 x 0.625mm
– 4 x 1.25mm
– 4 x 2.5mm
– 4 x 3.75mm
– 4 x 5.00mm
– 8 x 1.25mm
– 8 x 2.5mm
– 16 x 0.625mm
– 16 x 1.25mm
• Integrated, permanently bonded flex connectors.

Scalable Data Acquisition Sub-System (GDAS)

• 16 rows input from detector.
• 16 rows output to console.
• 31-gain, integrating, front-end pre-amp.
• Supports 1968 Hz sampling.
• Forward error correction applied to output data.
• Control functions:
– Detector FET array and heater control.
– Error detection and reporting.

Scalable Data Acquisition Sub-System (MDAS)

• 16 rows input from detector.
• 16 rows output to console.
• Supported by 96 interchangeable converter (CNVT) cards.
• 128 input channels/converter card MDAS.
• 31-gain, integrating, front-end pre-amp.
• Supports 1640 Hz sampling.
• Forward error correction applied to output data.

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• Control functions:
– Detector FET array and heater control.
– Error detection and reporting.

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Patient Scanning

Parameter LightSpeed Series

ISO Height 1015 mm
Focal spot to ISO 541 mm
Focal spot to det 949 mm
SFOV 496.9 mm
Bore 700 mm

EMI/EMC
All systems built to global regulatory emissions (EMC) and immunity (EMI) compliance
standards to improve reliability, uptime and performance in its intended environment.

Network
Remote Host Parameters
The LightSpeed Series Network function has new enhancements to support DICOM
networking. When adding or updating a remote list, there are some new parameters
needed. All of the following information, except for Comments, needs to be provided in order
to set up a remote host:
• The Host name to be entered is the name of the device. If the device is DICOM, the name
must match exactly to the name given to the device.
• The Network address of the device is provided by the institution's network administrator.
• The Network protocol is DICOM. If the LightSpeed Series will be sending to this device,
the device must be DICOM and the DICOM network protocol must be selected.
• DICOM protocol has a "dialect" which may cause some troubles like disappearances of
some portion of image annotation when connecting to the situation where data transfer
is not confirmed.
• The Port number is unique to the device. If the device is an Advantage Windows
workstation or another LightSpeed system, the number will be 4006.
• The AE Title is unique to the device. If the device is an Advantage Windows workstation
or another GE Healthcare system, the AE Title will be the same as the Host name.
• The Comment field allows you to input a comment.

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• The Archive Node refers to the archiving responsibility of the device:

– If Auto is selected, the CT system will automatically check to see if the device is a
Storage Commitment Provider.
– If Yes is selected, the device will be responsible for archiving images. When the
device has received and saved the images, a notification message will be displayed
on the scanner console and the Archive status for the exam will be “A” for archived.
– If No is selected, the device will not be responsible for archiving.
NOTE: The device must be a Storage Commitment Provider in order for remote archive node
to function.
• Access to the local host refers to the device's ability to access the LightSpeed Series.
Select Yes if you want the device to be able to send to and/or query the LightSpeed
Series.
• The Custom search feature enables the Custom search dialog box to be automatically
displayed when you select receive from the remote browser. If Yes is selected, the
feature is enabled. If No is selected, the Custom search dialog box will not automatically
be displayed. You can, however, get to the search feature once the remote browser is
displayed, by simply selecting Search, on the remote browser.

Network Compatibility
The LightSpeed image format is DICOM. This image format may only be transferred between
systems using a DICOM network protocol. The receiving station must support DICOM receive
for LightSpeed images to be transferred (send or receive) to it.
Use the following table for network compatibility. The table lists the network protocol to use
and the features available for that system. The far left column lists the system the user is at
(from).
Table 11-1 Network Compatibility

From To
LightSpeed/ HiSpeed HiSpeed CT IC HiSpeed 3rd Party
BrightSpeedTM CT/i Advantage NX/i, X/i, or DICOM
QX/i Station
LightSpeed/ DICOM Query DICOM Advantage*** Advantage*** DICOM DICOM*
Send Query Query Query Query Query**
BrightSpeedTM Receive Send Receive Receive Send Send
Receive Receive Receive**
HiSpeed CT/i DICOM DICOM Advantage Advantage DICOM DICOM*
Query Query Query Query Query Query**
Send Send Send Send Send Send
Receive Receive Receive Receive Receive Receive**
HiSpeed DICOM Advantage Advantage Advantage Advantage DICOM
Advantage Send Query Query Query Send Send
Send Send Send
Receive Receive Receive

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From To
LightSpeed/ HiSpeed HiSpeed CT IC HiSpeed 3rd Party
BrightSpeedTM CT/i Advantage NX/i, X/i, or DICOM
QX/i Station
CT IC DICOM Advantage Advantage Advantage Advantage DICOM
Send Query Query Query Send Send
Send Send Send
Receive Receive Receive
HiSpeed DICOM DICOM Advantage Advantage DICOM DICOM*
FX/i, DX/I, LX/i Query Query Query Query Query Query**
Send Send Receive Receive Send Send
Receive Receive Receive Receive**
3rd Party DICOM DICOM DICOM DICOM DICOM DICOM*
DICOM  Query Query Query Query Query Query**
Send Send Receive Receive Send Send
Station Receive Receive Receive Receive**

* Some 3rd party stations use the ODINA network protocol. In this case use DICOM protocol
and port number 104.
** Query capability is only available only if station is a query retrieve provider.
*** Advantage Net is not available on PC Base Systems.
NOTE: BrightSpeedTM Elite/Edge/Excel, LightSpeed16, Ultra, Plus, QX/i, or HiSpeed QX/i PC
based systems do not support Advantage Network Protocol.
Table 11-2 Advantage Windows Network Compatibility

From
AW 1.X AW 2.X AW 3.X AW4.X LightSpeed or
BrightSpeedTM
LightSpeed or DICOM DICOM DICOM DICOM DICOM
HiSpeed QX/i Send Send Send Query Query
Send Send
Receive Receive
AW 1.X SdC Net SdC Net SdC Net SdC Net DICOM
Query Query Query Query Query
Send Send Send Send Send
Receive Receive Receive Receive Receive
AW 2.X SdC Net SdC Net SdC Net SdC Net DICOM
Query Query Query Query Query
Send Send Send Send Send
Receive Receive Receive Receive Receive
AW 3.X SdC Net V1 SdC Net V2 SdC Net V3 SdC Net DICOM
Query Query Query Query Query
Send Send Send Send Send
Receive Receive Receive Receive Receive
AW 4.X SdC Net SdC Net SdC Net SdC Net DICOM
Query Query Query Query Query
Send Send Send Send Send
Receive Receive Receive Receive Receive

5478900-2-1EN Rev. 3 (October 2016) 11-9

NOTE: BrightSpeedTM Elite/Edge/Excel, LightSpeed16, Ultra, Plus, QX/i, or HiSpeed QX/i PC

based systems do not support Advantage Network Protocol.

DICOM IEC Network Form

Purpose of LightSpeed scanner connection to network

The LightSpeed Scanner is intended to be connected to a network in order to support the
following functionality:
• DICOM services to retrieve images from other DICOM-compliant machines
• DICOM services to push images to other DICOM-compliant machines
• DICOM services to query for images on other DICOM-compliant machines
• DICOM services to print images on DICOM complaint printers
• DICOM services to confirm that images have been permanently stored on a
DICOM-compliant machine
• DICOM services to get DICOM modality worklist information from a remote hospital or
radiology department information system computer
• DICOM services to allows a Modality Performed Procedure Step to be communicated to
the Hospital/Radiology information system
• DICOM services to verify the remote DICOM system is connected properly to the HD
scanner device
• Services to provide authentication and authorization against Enterprise directory
servers
All of the above features are optional on the LightSpeed Scanner.

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Network interface technical specifications

Connection Name: Hospital network port
Physical network connection type: IEEE 802.3-1998 1000/100/10 BaseT Ethernet
Speeds and duplex modes supported: 10Mbps, 100Mbps, and 1Gbps half and full
duplex
Auto-negotiate
Default IP Address (from factory): IP Address – 192.9.101.1
Subnet Mask – 255.255.255.0
Gateway – empty
IP addressing: IPv4 static
QoS Support: n/a

Network information flows specifications

Flow Name DICOM image retrieve
Network Connection on device Hospital network port
Usage Type/Function/Purpose Get a DICOM image or set of image from a
network device
Licensed/optional/required optional
Communication Any network device supporting the DICOM
Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and CT Image Storage
Encoding MR Image Storage
Enhanced SR
X-Ray Radiation Dose SR – CT Radiation Dose
RT Structure Set Storage
Positron Emission Tomography Image Storage
Ports (default) 4006
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name DICOM image push

Network Connection on device Hospital network port
Usage Type/Function/Purpose Send a DICOM image or a set of images to a
network device
Licensed/optional/required optional

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Communication Any network device supporting the DICOM

Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and CT Image Storage
Encoding MR Image Storage
Grayscale Softcopy Presentation Sate Storage
Enhanced SR
X-Ray Radiation Dose SR – CT Radiation Dose
RT Structure Set Storage
Positron Emission Tomography Image Storage
Ports (default) 4006
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name DICOM image query

Network Connection on device Hospital network port
Usage Type/Function/Purpose Find a list of DICOM images from a network
device
Licensed/optional/required optional
Communication Any network device supporting the DICOM
Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and Study Root Query/Retrieve Information Model -
Encoding FIND
Study Root Query/Retrieve Information Model -
MOVE
Ports (default) 4006
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name DICOM Storage Commit

Network Connection on device Hospital network port
Usage Type/Function/Purpose Used to confirm that local DICOM images have
been permanently stored on a remote DICOM
device
Licensed/optional/required optional

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Communication Any network device supporting the DICOM

Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and Storage Commitment Push Model SOP Class
Encoding
Ports (default) 4006
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name DICOM modality worklist information

Network Connection on device Hospital network port
Usage Type/Function/Purpose Transfer patient information for HIS/RIS system
to CT scanner
Licensed/optional/required optional
Communication Any network device supporting the DICOM
Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and Basic Modality Worklist Information Model –
Encoding FIND SOP Class
Ports (default) 4006
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name Modality Performed Procedure Step

Network Connection on device Hospital network port
Usage Type/Function/Purpose Send a report about a performed patient exam
to the HIS/RIS system
Licensed/optional/required optional
Communication Any network device supporting the DICOM
Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and Modality Performed Procedure Step SOP Class
Encoding

5478900-2-1EN Rev. 3 (October 2016) 11-13

Ports (default) 4006

Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name DICOM Print

Network Connection on device Hospital network port
Usage Type/Function/Purpose Send a DICOM image to a DICOM printer
Licensed/optional/required optional
Communication Any network device supporting the DICOM
Partner application layer protocol(s) listed below
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and Basic Grayscale Print Management Meta SOP
Encoding Class
Basic Color Print Management Meta SOP Class
Print Job SOP Class
Pinter SOP Class
Ports (default) 4006
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

Flow Name Enterprise Authentication / Authorization

Network Connection on device Hospital network port
Usage Type/Function/Purpose Authenticate local user against Enterprise Server
Licensed/optional/required optional
Communication Any network device supporting the enterprise
Partner directory servers supported by the CT Scanner
Device/IP Address/Network
Middle Layer Protocols TCP/IP
Application Layer Protocol and Microsoft Active Directory / Novell eDirectroy
Encoding
Ports (default) 3002, 3003, 3004, 6386
Traffic characterization and Bandwidth On demand, local user initiated. The bandwidth
Requirements is dependent on the local site.
Latency max n/a

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Flow Name DNS

Network Connection on device Hospital network port
Usage Type/Function/Purpose Network services
Licensed/optional/required optional
Communication Hospital DNS Server
Partner
Device/IP Address/Network
Middle Layer Protocols UDP
Application Layer Protocol and DNS
Encoding
Ports (default) 53
Traffic characterization and Bandwidth Initiated by scanner network software
Requirements sporadically as required to translate a remote
host name into an IP address
Latency max n/a

Required characteristics and configuration of network for support of

LightSpeed Scanner specifications
The network must meet the specific requirements above for all traffic flows associated with
the subset of features, use cases and workflow required by the responsible organization’s
users.
In addition, the network must be “flat” (i.e. limited to a single IP broadcast domain).

System Data and Control Flow

F
Table
Generator
Controller
Data Flow
D E
Stationary On Rotation
Control Flow Controller Processor Tube

Real-time Control Flow

H Cam
Collimator
G

Slip Ring

UIF Monitor Detector

Host
Computer DAS

Keyboard

5478900-2-1EN Rev. 3 (October 2016) 11-15

Component Functions Data and Control Flows

Host User interface, image display 1 Scan and recon prescription from
Computer operator
TGP Stationary base real-time 2 Scan parameters distributed
control and “master” a. table position
controller b. rotating parameters
ORP (On Rotating base real-time c. kV and mA selections
Rotation control d. X-Ray beam collimation and filter
Processor) selections
Table Patient table real-time control e. detector slice thickness and DAS gain
Controller selections
Slip-ring Signal and power transfer 3 Real-time control signals during scanning
between stationary and
rotating components
Generator High voltage generation 4 High voltage
Tube X-ray generation 5 Un-collimated X-Ray beam
Cam Formation of the X-Ray beam 6 Collimated X-Ray beam
Collimator
Detector Conversion of X-Ray to analog 7 Analog scan data
signal data
DAS Conversion of analog signal 8 Digital scan data
data to digital data

X-ray Generation and Detection Details

Overview
The distinguishing feature of LightSpeed Series is the capability to simultaneously collect
multiple rows of scan data.
Gantry Coordinate System
X, Y, Z: Scanner gantry coordinate system:
• X = Tangent to circle of rotation.
• Y = Radial (from ISO toward tube focal spot).
• Z = Longitudinal (in/out of the scan plane).

11-16 5478900-2-1EN Rev. 3 (October 2016)

X X-Ray Tube Focal Spot

ISO
Scan Plane
Z
Patient Table

Components
Figure 11-1 X-ray generation and detection components viewed from side of gantry

Anode/Target
Tube

Cathode
Bowtie
Cam Collimator Uncollimated X-Ray Beam
Tungsten Cams

Front of Gantry Collimated X-Ray Beam

LightSpeed 5.X Detector=

Continuous Collimator +
57×16 Row Detector Modules

Detector Collimator
16 Individual Lumex Cells
FET Array

Integrated Flex:
16 Columns x
2 Macro Rows=
Z 32 Signals/flex

CAM Collimator
The pre-patient collimation of the X-Ray beam is accomplished via 2 independently
controlled tungsten cams (refer to Illustration 11-2).

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Figure 11-2 CAM collimator examples

Focal Spot
Offset

Cam Offset
Beam Offset
Wide Beam Narrow Beam Narrow Beam
Centered Centered Cams Offset in Z
e.g. 4x5mm Slices e.g. 4x1.25mm Slices e.g. 4x1.25mm Slices
or
8x2.5mm Slices Offset used to compensate for
Z axis beam offset.

Z-Axis Cell Summation

The LightSpeed Series detector is segmented into cells in the Z dimension, providing
post-patient collimation of the X-Ray beam. This post-patient collimation is provided by the
segmentation of the detector cells, and not by a separate post-patient collimator as some
CT systems use.
The post-patient collimation, along with summation of cells in the Z direction by the detector
FET array, determines the Z-axis slice thickness of the scan data.
The Z dimension extent of each cell are 0.625mm at ISO center for the center 16 rows and
1.25mm for the outer 8 rows.
1, 2, 3 or 4 cells are summed in Z to produce a “macro cell.” All macro cells in the same Z
plane form a “macro row.” A macro row consisting of a single cell in each column produces
scan data with thickness of either 0.625mm or 1.25mm at ISO center (see Illustration 11-3). A
macro row consisting of summed cells in each column produces scan data with varied
thickness at ISO center (see Illustration 11-3). The 16 macro rows are labeled 8A, 7A, 6A, 5A,
4A, 3A, 2A, 1A, 1B, 2B, 3B, 4B, 5B, 6B, 7B, and 8B. 8A is closest to the patient table. Each flex
transmits 8 macro cells to the DAS per column x 16 columns per detector module = 128 data
channels per flex (Figure 11-3).

11-18 5478900-2-1EN Rev. 3 (October 2016)

Figure 11-3 Channel summation in Z — Examples

Tungsten Cams
Patient Table Tungsten Cams Patient Table 20mm Collimation
10mm Collimation

16x0.625 16x1.25

8A, 7A, 6A
, 5A, 4A, 3A, 2A, 1A 1B, 2B, 3B, 4B, 5B, 6B, 7B, 8B 8A, 7A, 6A
, 5A, 4A, 3A, 2A, 1A 1B, 2B, 3B, 4B, 5B, 6B, 7B, 8B

Tungsten Cams
Tungsten Cams Patient Table
Patient Table 10mm Collimation
20mm Collimation

8x1.25 8x2.5

4A, 3A, 2A
, 1A 1B, 2B, 3B, 4B 4A, 3A, 2A
, 1A 1B, 2B, 3B, 4B

Collimator Theory
The purpose of tracking is to follow the focal spot so that we can keep the uniform X-ray of
the narrowest possible beam on the detector to reduce dose and still avoid artifacts.
The focal spot moves in Z due to thermal changes in the tube and a mechanical forces
during gantry rotation and tilt angle.
Each cam is basically an independent system.

5478900-2-1EN Rev. 3 (October 2016) 11-19

What does tracking do?

focal Closed loop repositions collimator

spot to hold the beam steady
Collimator Control 1 measure position of X-ray beam
Board (CCB)
2 compute new collimator position
Stepper motor 3 move collimator to follow the focal spot
repositions cams

Data channels that make

the image stay in flat X-ray
DAS Control Board
(DCB) Z axis module operates partly
Compute new cam position in the X-ray shadow
from z cell signal ratio
Position of X-ray shadow on Z
cells determines the signal ratio

With Fast response to keep beam centered on the detector

In the Hi Res mode (1i x 1.25 mode) the collimator

projects an X-ray beam on a single 1.25 mm detector row.
Only 1 image per rotation is generated at the lowest
possible single slice dose.

System Operational Modes

Overview
• Scout
• Axial
• Helical
• Cardiac Helical
• Cine

Scout
Scout imaging is used for anatomical location in conjunction with scan and recon
prescription, to provide an anatomical cross-reference for axial images, and to provide quick
feedback to the user as to the anatomy scanned. Scout supports the following features:
• Less than 10 second reconstruction.
• All kV and mA stations available, dependant on generator and tube limitations.
• 1.25 mm resolution in Z.
• 100 mm/sec table speed.

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• Data collected in 4 x 1.25 mm mode. Reconstruction algorithms “combine” data to

maintain 1.25 mm resolution in Z.

Pediatric Imaging
Adult techniques and protocols should not be used on pediatric patients (under 2 years of
age.)

Axial and Cine

For radiation oncology imaging, Axial and Cine scan modes continues to be commonly
practiced mode of acquisition. Especially for Respiratory Gating.
Axial and Cine imaging features include:
• All kV and mA stations available, dependant on generator and tube limitations.
• Scan speeds: 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 2.0, 3.0, 4.0 seconds.
• Cine: 0.5, 0.6, 0.7, 0.8, 0.9, 1.0 seconds.
• Variable image thickness.
• Sample rates: 984 Hz, 1090Hz, 1230Hz, 1400Hz, 1640Hz, 1968Hz support 0.5 seconds
scanning.
• Segmented reconstruction option for cine scans.
LightSpeed Series can acquire 16 axial slices in a single rotation. These slices can be
reconstructed independently to produce 16 images. These images may be combined to
produce composite images. For example:
Data collected in 16 x 1.25 mode
(16i) 16 x 1.25 mm images
(4i) 4 x 5.00 mm images
(2i) 2 x 10.00 mm images
Helical

Helical Overview
The 24-row detector and 16-row DAS provide the greatest benefits when used in the helical
mode. In the helical mode, data from 16 detector rows is selectively combined and weighted
during reconstruction in order to achieve the optimal balance between image z-axis
resolution, noise, and helical artifacts.
Helical imaging features include:
• All kV and mA stations available, dependant on generator and tube limitations.
• 120 second maximum helical scan time.
• Pitches:

5478900-2-1EN Rev. 3 (October 2016) 11-21

NOTE: Beginning with the LightSpeed Series M3.1 release, the user interface has changed
the scan mode names. These new names indicate pitch as expressed by the ratio of
table travel per rotation to beam collimation. The new scan mode name designation
will be indicated on image annotation.

Previous Scan Mode

Scan Mode
Designator

HQ 1:1
HQ 0.75:1
HS 1.5:1
UQ 0.625:1
UM 0.875:1
UF 1.35:1
US 1.675:1

• Variable image thickness (recon parameter).

• Sample Rates: 984 Hz, 1090Hz, 1230Hz, 1400Hz, 1640Hz
• Segmented reconstruction option.
• 0.1mm minimum incremental retrospective recon image spacing.
Once the LightSpeed Series helical data is collected, it can be reconstructed at image
thickness greater than or equal to 1x the detector macro-row size. Premium image quality
(near axial image quality) is achieved at 2x the detector macro-row size. The thinnest image
thickness possible, which has image quality slightly degraded from 1.5:1 pitch on HiSpeed
CT/i, is 1x the detector macro-row size.

Premium Image Quality Helical Example

Premium image quality (near axial image quality) is achieved as follows:
• Detector macro-row size = 50% of the desired image slice thickness.
• Pitch (table travel over beam collimation) = 0.625:1.
LightSpeed Series “Premium” IQ example for 8 slice mode:
• 5mm image
• 8x 2.5 mm detector mode
• Table speed of 6.25 mm/rotation (0.5625:1)
LightSpeed Series “Premium” IQ example for 16slice mode:
• 0.5625:1 mode
• 5mm image

11-22 5478900-2-1EN Rev. 3 (October 2016)

• 16x 0.625mm detector mode

• 5.625 mm/rotation

Cardiac Helical Overview

A lower pitch helical scan is available for cardiac applications in conjunction with the CardIQ
SnapShot option. In this scanning mode, heart rate monitoring is performed during the
helical acquisition and the associated ECG gating information is stored with the scan data
such that a cardiac gated SnapShot reconstruction algorithm can be applied for prospective
and retrospective images. SnapShot reconstruction is used to minimize the motion of the
heart in the resultant images. The pitch factor for the cardiac helical scan is determined by
the system and is a function of the patient heart rate.
Cardiac Helical imaging features include:
• All kV and mA stations available, dependent on generator and tube limitations.
• 120 second maximum cardiac helical scan time.
• Pitches: determined by system, ranging from 0.25 to 0.35, based on patient heart rate. A
higher heart rate will use a higher pitch factor.
• Variable image thickness via acquisition slice thickness parameter only (0.625, 1.25, 2.5,
3.75, and 5.0mm). No image thickness recon parameter is available.
• SnapShot Segment Burst and Burst+ and Segmented (non-gated) reconstruction
options.
• Cardiac phase location parameter of 0 to 99% of R-to-R cycle.
• 0.1mm minimum incremental retrospective recon image spacing.
Once the cardiac helical data has been collected, it can be reconstructed at one or more
arbitrary heart cycle phase locations. Segmented reconstruction is also available
retrospectively if non-gated images are desired.

Calibration Modes
LightSpeed Series calibrations include:
• Z-axis gain calibration - new for LightSpeed Series
• Tube warm-up
• Air calibration*
• Phantom calibration*, upgrades for 50cm SFOV
• Water Cal
• IQ Cal check
* = similar to HiSpeed, upgraded for 16 row data collection

5478900-2-1EN Rev. 3 (October 2016) 11-23

Current X-Ray Tube Capacity Effects Prescriptions and

Interscan Delays
The system provides prescription alternatives when:
• Current prescription requires excessive prep, interscan, or intergroup delay.
• Technique requirements exceed the prescribed delays.
Although the rotating anode increases the tube's heat tolerance, it still has a physical limit.
The anode transfers its heat to the oil filled tube housing. The housing, in turn, dissipates
heat into the surrounding air.
The system keeps a running total of estimated tube heat. When you request scans during
Scan Prescription, the system estimates the number of heat units these scans will produce,
and compares this value with the running total.
If the prescription estimate exceeds the current capacity, the system displays a series of
prescription Optimize screens that recommend increased delays, alternative Scan Technic
settings, or offer to split the current scan group into smaller groups.

Focal Spot
The X-Ray tube contains a small filament and a large filament. The small filament
concentrates the focal spot size, which improves spatial resolution but cannot tolerate high
technique. The large filament tolerates high technique but loses some of the small
filament’s spatial resolution.
The system automatically selects the small filament:
• When the technique equals 24kW, or less.
The system automatically selects the large filament:
• When the technique exceeds 24kW.
Example: Reduce mA setting from 210mA to 200mA (120kV) to enable Small Filament.

Filament Selection
On traditional single-slice CT systems, such as HiSpeed CT/i, the filament selection effects
the slice thickness for thin slices scanning, with a larger filament producing a larger effective
slice thickness. The LightSpeed Series has eliminated this effect, and true thin slice imaging
can be achieved using both the small and large filament.

Filament Selection Table

In order to provide the best image quality, and maximize patient throughput, the LightSpeed
Series system bases the automatic filament selection upon the following table:

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Data Collection
The detector and DAS assembly mounts opposite the X-Ray tube on the rotating base. The
X-Ray beam leaves the X-Ray tube, passes through the gantry opening, and enters the
detector. Any material (patient or phantom) positioned within the gantry opening absorbs or
deflects the weaker X-Ray photons. The numbers of photons that enter the detector
depends upon the intensity of the X-Ray beam and the density of the material in the gantry
opening. An increase in density causes a decrease in the number of photons that enter the
detector.
The revolutionary new LightSpeed detector allows 16 rows of data to be collected at a time
for both axial and helical imaging. This allows 4 axial images to be generated in a single
gantry rotation in the axial mode. This allows helical images to be taken at faster speeds,
and with lower power, than single slice scanners.
The DAS measures the detected X-Ray at regular time intervals, called views, and transmits
the information to the image reconstructor for reconstruction into a display image. The
total degrees of gantry rotation and the scan time determine the number of raw views per
image.
For scans greater than 1 second, the raw views are summed together before image
reconstruction. This allows the system to maintain constant image reconstruction times and
spatial resolution/aliasing for all scan speeds. (Note that image reconstruction of more raw
views reduces aliasing at the expense of reconstruction time.)
Example: A 1-second and a 4-second scan both gather data over 360 degrees, so both
scans reconstruct the same number of views per image. A segmented reconstruction uses
data acquired over 235 degrees, so it reconstructs fewer views per image.

5478900-2-1EN Rev. 3 (October 2016) 11-25

Scan Parameters

Scan Choice Determines:

kV X-Ray energy intensity and calibration data used
mA X-Ray dose
Scan Time and Length of scan rotation in seconds; length of delay in
Interscan Delay seconds between exposures
Scan Rotation Degrees of scan rotation during data collection
(normal scan, partial scan) (X-Ray on)
Gantry Tilt Angle X-Ray travels through patient
Spacing Z-Axis distance between scan centers
Thickness Width of image
Azimuth X-Ray tube location during scout scan
Centimeters of data available, and any special
SFOV — Scan Field of View processing applied or available, for image
reconstruction.

Reconstruction
The scanner compares the collected data with the calibration data then converts the
detector channel views into a two dimensional matrix. The system converts each matrix
element (pixel) into a CT number. The system displays a scout image as it acquires the data,
but an axial image will be displayed after reconstruction is completed. The axial and scout
images take approximately one second to reconstruct.
Reconstruction Algorithm: Soft, Std, Detail, Bone, Lung, Edge, Bone Plus.
Your choices control the image outcome. Choose parameters to enhance or tailor the
acquisition and processing to the anatomy of interest. Select scan technique and image
parameters that provide optimum resolution.
The system has disk space for 1500 scan files or 2400 (16 slice) scan rotations. The system
stores the most recent scan data in the oldest scan file with an unreserved status. The
system continually overwrites the scan files with data.

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CAUTION: If you plan to reconstruct images, you must use files that reside in the disk.
Either reserve the scan files you plan to retrospectively reconstruct, or
reconstruct unsaved scan files before the system overwrites the files with
new scan data. The system refuses to overwrite reserved scan files.
Remember to release the reserved scan files when you finish retrospective
reconstruction.

Helical Scan Data Usage

In general, every data channel will contribute to at least one image during helical image
reconstruction. Some data channels are not used at the very beginning and end of the
helical scan due to to the physics of multi-slice scanning and helical view weighting
algorithms.
During helical image reconstruction, some data channels in the middle of the helical scan
are not used if the image interval prescribed is GREATER THAN the values listed in the table
below.
For example, all data channels will be used for 1.25 mm images, 0.562 pitch, if the image
interval is less than or equal to 1.24 mm.

Channel Utilization Table-Full Modes

Scan Mode Image Thickness
Table Detector
Helical Speed row 0.625m 1.25mm 2.5mm 3.75mm 5.0mm 7.5mm 10mm
Pitch (mm/rot) collimation m
(mm)
0.562:1 5.625 0.625 0.68 2.18 4.76 4.98 5.36
11.25 1.25 1.25 4.52 6.96 9.32 10.71 10.84
0.938:1 9.375 0.625 0.93 2.34 4.98 5.31 5.74
18.75 1.25 1.87 4.82 7.34 9.22 9.97 11.85
1.375:1 13.75 0.625 1.24 2.65 5.28 5.60 6.04
27.5 1.25 2.49 5.42 7.94 10.01 10.56 11.93
1.75:1 17.5 0.625 1.24 2.65 5.28 5.60 6.05
35.0 1.25 2.49 5.44 7.93 9.99 10.56 11.95
0.625:1 6.25 1.25 1.24 4.45 6.80 5.74 8.10 10.60
12.5 2.5 2.49 6.78 10.77 15.70 16.72
0.875:1 8.75 1.25 1.24 4.38 6.94 5.74 8.11 10.61
17.5 2.5 2.49 6.79 11.04 15.70 16.72
1.35:1 13.5 1.25 2.50 6.24 7.18 7.23 9.60 11.98
27.0 2.5 4.99 9.47 11.69 14.98 14.02
1.675:1 16.75 1.25 2.49 4.97 6.33 7.81 9.57 11.92
33.5 2.5 4.97 9.60 10.18 15.15 13.96

5478900-2-1EN Rev. 3 (October 2016) 11-27

Channel Utilization Table-Plus Modes

Scan Mode Image Thickness
Table Detector
Helical Speed row 0.625m 1.25mm 2.5mm 3.75mm 5.0mm 7.5mm 10mm
Pitch (mm/rot) collimation m
(mm)
0.562:1 5.625 0.625 1.20 2.72 4.66 5.29 6.41
11.25 1.25 2.49 6.16 8.96 9.32 10.71 12.98
0.938:1 9.375 0.625 1.51 2.93 5.30 5.61 6.70
18.75 1.25 3.11 6.29 9.22 9.36 10.84 13.34
1.375:1 13.75 0.625 1.82 3.24 5.39 5.90 7.08
27.5 1.25 3.97 6.88 9.31 11.07 11.43 13.92
1.75:1 17.5 0.625 1.82 3.24 5.39 5.90 7.08
35.0 1.25 3.98 6.90 9.32 11.06 11.45 13.94
0.625:1 6.25 1.25 2.24 6.17 8.24 10.23 10.79 12.72
12.5 2.5 4.67 8.35 11.22 15.46 22.21
0.875:1 8.75 1.25 2.36 4.72 8.47 10.24 10.80 12.73
17.5 2.5 4.84 8.48 11.22 16.22 20.22
1.35:1 13.5 1.25 3.87 4.65 9.25 10.61 12.98 13.86
27.0 2.5 7.74 9.99 13.47 15.83 16.60
1.675:1 16.75 1.25 3.97 6.42 9.29 10.67 13.04 13.91
33.5 2.5 7.93 10.18 13.65 16.00 16.75

Nominal Helical Slice Thickness

Because the data for a helical image is weighted over more than one rotation, to provide the
best possible image quality the nominal image slice may differ slightly from the user
selection, dependent on table speed, pitch and slice selection. The nominal FWHM slice
widths are given in the following table.

Slice Thickness Full Mode

Selected Slice
Scan Table
Mode Speed 0.625mm 1.25mm 2.5mm 3.75mm 5.0mm 7.5mm 10mm
(mm/rot)
Axial N/A 0.60 1.09 2.34 3.75 4.84 7.35 9.84
Helical 5.625 0.63 1.25 2.50 3.75 5.00
0.562:1 11.25 1.25 2.50 3.75 5.00 7.50 10.00
Helical 9.375 0.85 1.25 2.50 3.75 5.00
0.938:1 18.75 1.6 2.50 3.75 5.00 7.50 10.00
Helical 13.75 0.80 1.25 2.50 3.75 5.00
1.375:1 27.5 1.60 2.50 3.75 5.00 7.50 10.00
Helical 17.5 0.85 1.25 2.50 3.75 5.00
1.75:1 35.0 1.60 2.50 3.75 5.00 7.50 10.00

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Selected Slice
Scan Table
Mode Speed 0.625mm 1.25mm 2.5mm 3.75mm 5.0mm 7.5mm 10mm
(mm/rot)
Helical 6.25 1.25 2.50 3.75 5.00 7.50 10.00
0.625:1 12.5 2.50 3.75 5.00 7.50 10.00
Helical 8.75 1.25 2.50 3.75 5.00 7.50 10.00
0.875:1 17.5 2.50 3.75 5.00 7.50 10.00
Helical 13.5 1.60 2.50 3.75 5.00 7.50 10.00
1.35:1 27.0 3.20 3.75 5.00 7.50 10.00
Helical 16.75 1.70 2.50 3.75 5.00 7.50 10.00
1.675:1 33.5 3.20 3.75 5.00 7.50 10.00

Slice Thickness Plus Mode

Selected Slice
Scan Table
Mode Speed 0.625mm 1.25mm 2.5mm 3.75mm 5.0mm 7.5mm 10mm
(mm/rot)
Helical 5.625 0.75* 1.50 3.00 4.50 6.00
0.562:1 11.25 1.50 3.00 4.50 6.00 9.00 12.00
Helical 9.375 0.92** 1.50 3.00 4.50 6.00
0.938:1 18.75 1.90 3.00 4.50 6.00 9.00 12.00
Helical 13.75 1.0 1.50 3.00 4.50 6.00
1.375:1 27.5 1.90 3.00 4.50 6.00 9.00 12.00
Helical 17.5 1.0 1.50 3.00 4.50 6.00
1.75:1 35.0 1.90 3.00 4.50 6.00 9.00 12.00
Helical 6.25 1.50 3.00 4.50 6.00 9.00 12.00
0.625:1 12.5 3.00 4.50 6.00 9.00 12.00
Helical 8.75 1.50 3.00 4.50 6.00 9.00 12.00
0.875:1 17.5 3.00 4.50 6.00 9.00 12.00
Helical 13.5 2.00 3.00 4.50 6.00 9.00 12.00
1.35:1 27.0 3.00 4.50 6.00 9.00 12.00
Helical 16.75 2.00 3.00 4.50 6.00 9.00 12.00
1.675:1 33.5 3.00 4.50 6.00 9.00 12.00

Note: * Head SFOV 0.95 mm

Note: ** Head SFOV 1.0 mm

Cardiac Helical Slice Profiles

Slice profile measurements for Cardiac helical scans are complicated by the fact that a
variable helical pitch is chosen based on the patient’s heart rate. For helical pitches greater
than 0.125, the full width half max of a slice collimated at 0.625 is approximately 0.8mm
(16x0.625 mode), 1.25 is approximately 1.6mm (16x1.25, 8x1.25, 4x1.25 mode) and 2.5 is
approximately 3.2mm (8x2.5, 4x2.5 mode).

5478900-2-1EN Rev. 3 (October 2016) 11-29

When a pitch value significantly below 0.125 is chosen, the slice profile may vary
significantly from image to image in a single helical scan. The profile will depend on the
location of the prescribed image with respect to the detector locations. The variation in the
slice profiles can be understood by thinking of an axial scan. In an axial scan, an arbitrary
image location is not permitted. However, an attempt to create an image at an intermediate
location could be performed by using data from adjacent detector rows. This would result in
an increased slice profile. As the pitch becomes much less than 2.0, the helical scan data
becomes more and more like axial scan data.
At a pitch of 1.4, for example, which is the prescribed pitch for a Cardiac Segment scan with
a patient heartrate of 60 bpm and gantry period of 0.5 sec, a 35% variation in the nominal
FWHM is possible.

Calibration Scans
Calibrations scans of air, and uniform objects called phantoms, provide the baseline
information the system needs to produce patient images. The system needs calibration
data for every possible combination of kV, detector row thickness, focal spot size, and scan
field of view.

Warm-up Required
Warm-up the tube:
• Immediately before Cal Check.
• Immediately before Calibration.
• When the tube has cooled to the point that a warm-up is required to ensure optimal
image quality.

Data Storage

NIO16 console
The Console/Computer contains 292 gigabytes (Gb) of magnetic disk that records and
retains 1500 scan files or 9600 (16slice) scan rotations, a Reconstruction Processor that
processes scan data into image data, and a magnetic disk that stores CT specific scan
software.
The computer contains 146 gigabytes (Gb) of system disk that hold about 250,000
uncompressed 5122 image files, along with software.
Despite storage space, the system eventually runs out of disk space. If your facility plans to
preserve image data, you must periodically transfer images and scan information to the
designated archive media.

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GOC4 console
The Console/Computer contains 36 gigabytes (Gb) of magnetic disk that records and retains
2900 1-second scan rotation files, a Reconstruction Processor that processes scan data into
image data, and a magnetic disk that stores CT specific scan software.
The computer contains 73 gigabytes (Gb) of system disk that hold about 130,000
uncompressed 5122 image files, along with software.
Despite storage space, the system eventually runs out of disk space. If your facility plans to
preserve image data, you must periodically transfer images and scan information to the
designated archive media.

Image Display
Requested images pass through the IP (image processor) on their way to the screen. The
Image Processor uses a bulk memory to store images selected for Auto View, MID, paging,
magnification, rotation, reformat or 3D (3D optional).
The images appear on the image monitor. The screen contains a display matrix of 1024 x
1024 picture elements, or 1,048,576 pixels. The 1024 display can be further divided into
viewports. The number of viewports displayed determine the number of pixels within a
viewport. Each pixel displays one of the 256 available shades of gray.
The LightSpeed Series system reconstructs axial and continuous images of 5122 pixels.
Images from other scanners may display 64, 128, 320, or 1024 pixel image matrices.
The amount of anatomy represented by each pixel equals the Display Field of View diameter
in mm divided by the matrix width/height.
The system assigns a unique CT number value, originally called a Hounsfield Unit, to each
pixel. The two dimensional pixel represents a three dimensional portion of patient tissue.
The pixel value represents the proportional amount of X-Ray beam that passed through
anatomy and entered the detector.

Gray Scale
The monitor translates the computed pixel value into a shade of gray. Your window Width
and Level choices control which range of CT values receive emphasis. The window Width
assigns the quantity of pixel values to the gray scale. The window Level determines the
center pixel value in the gray scale.

Possible range of pixel values

Width

Level

5478900-2-1EN Rev. 3 (October 2016) 11-31

• Window Width = selected range of pixel values

• Window Level = middle value
The system displays every pixel value that falls outside the gray scale as either black or
white. It assigns a gray value to every pixel that falls within the selected window. IF enabled,
the filmed image displays a gray scale icon along the left border of the image.
The system displays the currently selected window Width and window Level along the
bottom of the screen: W = xxxxx and L = xxxxx. To determine the pixel values currently
represented by the gray scale: Divide the window Width by 2; add and subtract this number
to/from the window Level.
Example: W=320; L= -1500; 320 P 2 = 160 
-1500 + 160 = -1340; -1500 - 160 = -1660
The gray scale represents values from -1340 to -1660
To find the best gray scale for an image, decrease the window width to 2. Increase or
decrease levels until the tissue of interest turns gray. Now increase the window width until it
includes the rest of the image.

CT Number
Nominal CT numbers range from -1024 to +3071 and extended CT numbers range from
-31743 to +31743. The LightSpeed Series is defaulted to the extended CT number range.
This system references CT number zero to water and CT number -1000 to Air.
Lung and fat have negative pixel values and normally appear black (nominal CT numbers
range). A CT number over 200 represents dense material like contrast agent, calcium, bone,
and normally appears white (nominal CT numbers range).
Inverse Video reverses video white to black, but pixel values remain the same.

CAUTION: CT Numbers are NOT absolute; misdiagnosis is possible. System and patient
variables may effect CT Number accuracy. If you rely solely upon CT numbers
without taking the following variables into consideration you could
misdiagnosis an image.
The following variables effect CT Number accuracy:
• Partial volume effects of anatomy
• Scans acquired with IV or oral contrast agents
• X-Ray tube deterioration
• Improperly calibrated system (poorly centered phantom, used wrong phantom,
replaced current calibration files with extremely old Cal files)
• Beam hardening due to patient anatomy, especially bone.

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To reduce CT Number variations:

• Warm-up the X-Ray tube whenever the system recommends it; make sure the tube
design matches the software configuration parameters
• Center the patient anatomy of interest in the gantry opening. Select an SFOV that
encompasses the patient.
• Acquire comparable images with similar scan and reconstruction choices.
• Maintain consistent table height throughout the exam.
• Test image quality on a regular basis to provide the numerical data to track system
performance over time.
To decrease the potential for misdiagnosis:
• Use ROI to compare pathology to surrounding tissue
• Scan structures with slice thicknesses about one-half the thickness of the lesion or less.
Example: Prescribe scan thickness of 5mm or less to scan a Lesion with a 10mm thickness.
(Display an axial image and use the Measure Distance and ROI functions to determine the
size of the pathology.
Center ROI measurements over the midpoint of the pathology to minimize partial volume
effects.

Variables You Cannot Control

The mixture of tissue types, such as fat with tissue within the same voxel (a pixel with depth),
varying patient sizes, differences between CT machines and X-Ray tubes, all lead to CT
number variance. In a well calibrated scanner, water has a CT number that ranges from -3
to +3. The CT number remains uniform across all kV settings. However, as the X-Ray tube
ages, kV decreases and pixel values become less dependable.

Pixels
The anatomic image consists of rows and columns of small, square, picture elements called
pixels. The screen displays 1,048,576 pixels in a matrix of 1024 horizontal rows of 1024
pixels. Add number of viewports selected for viewing to determine the number of pixels used
for display in each viewport. The screen pixel size remains the same, but the amount of
anatomy the pixels represent varies with the scan and display field of view (SFOV & DFOV). A
pixel also represents a specific anatomic area. The system identifies each two dimensional
pixel by its location, area and value.

Pixel Coordinates
Describe pixel location two ways.

5478900-2-1EN Rev. 3 (October 2016) 11-33

• Matrix Coordinates: Upper left pixel = (0,0);

lower right pixel = (511,511);
pixel in center of matrix = (255,255);
pixel ten columns to the right = (10,0)

axial image

NOTE: The illustration above represents a 512 x 512 matrix viewport.

• RAS: Anatomic distance from the center of the landmark slice
Target the image; decrease the DFOV diameter. Center the reconstruction on coordinates
other than the SFOV center.
Magnifying and targeting can displace the central SFOV pixel from the central pixel. Look at
the DFOV coordinates and magnification annotation to find the SFOV center, or display the
grid. The grid always appears over the pixel in the center of the DFOV Matrix (coordinate
255,255).

RAS Coordinates
These three distances in millimeters appear on the upper left of the viewport on which the
mouse cursor is on, when Continuous Report Cursor is selected.
• The pixel with the R/L and A/P coordinates closest to zero, represents the SFOV center.
The S/I coordinate always equals the table location at isocenter.

axial plane
axial image

11-34 5478900-2-1EN Rev. 3 (October 2016)

Coordinates transition from R to L, A to P, and S to I, to show relationships between current

location, landmark location, and isocenter.

Coordinate location falls to the patient's right of the

Right:
mid-sagittal plane (right of isocenter)
Coordinate location falls to the patient's left of the
Left:
mid-sagittal plane (left of isocenter)
Coordinate location falls above the mid-coronal plane
Anterior
(above isocenter)
Coordinate location falls below the mid-coronal plane
Posterior:
(below isocenter)
Scan location falls between the selected landmark and
Inferior:
patient's feet
Scan location falls between the selected landmark and
Superior:
patient's head

The DFOV and matrix determine pixel size.

A reconstructed pixel represents an area determined by dividing the DFOV (in mm) by the
reconstruction matrix, squared. You may magnify pixels up to eight times the reconstructed
size, or minify them to one half size. The anatomic area represented by each pixel decreases
as the magnification factor increases; anatomic area/pixel increases as the magnification
factor decreases.

Pixel Size in millimeters

DFOV in cm 512 x 512
10 0.20
15 0.29
20 0.39
22 0.43
25 0.49
30 0.59
35 0.68
40 0.78
45 0.88
50 0.98

The DFOV determines the anatomic area imaged by a single reconstruction.

• Area equals r2 (Area =3.14 x radius x radius)

5478900-2-1EN Rev. 3 (October 2016) 11-35

• The 50cm FOV has a 25cm radius, so its area equals 1963cm2.
• The ROI or magnification factor determines the anatomic area covered by a magnified
image.
Example: A pixel represents 0.5 by 0.5mm. Magnify pixel size by 2. Each pixel now represents
0.25 by 0.25mm of anatomy.

Pixel Size equals DFOV P Matrix size

Pixel area
equals
pixel size
pixel size squared
(width)
in mm
512
Matrix

DFOV in mm

Pixels and CT Numbers

Besides anatomic location and area, each CT pixel also represents a CT number, which in
turn indicates tissue density.
• An ROI averages the values of the enclosed pixels, and displays the resulting Mean
value.
• Standard Deviation describes the difference between the minimum and maximum ROI
value.
• A large ROI provides a larger, more accurate statistical sample than a small ROI.
An image pixel represents a three dimensional volume, or voxel. It represents anatomy
with a location, an area, and a pixel (density) value. The system flattens the 1.25, 2.5, 3.75, 5,
7.5, 10mm scan thickness into a two-dimensional screen image. If a pixel represents a
variety of tissues, the system averages the contents to produce an averaged, rather than
accurate, pixel value. Uniform tissues (within the voxel) produce fairly accurate pixel values.
CT pixel shading shows relative density. Denser materials weaken X-Ray and produce
whiter pixels. (Assumes Inverse Video OFF)
MR pixel shading reflects relative physiology. Whiter pixels represent molecules that
relaxed earlier after magnetic alignment than the darker areas.

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Reformat displays non axial planes created from contiguous pixels extracted from
multiple images. 3D locates similar pixel values within contiguous images, and generates a
mathematical model to produce images that appear three dimensional. BMD samples pixel
values to estimate bone or tissue density.
Reconstruction assigns one value to every image pixel. CT uses pixel values of -1024
to +3071 (nominal range) or -31743 to +31743 (extended range). MR uses pixel values of
+16,000. The screen pixel translates the assigned value into one of the 256 shades of gray.
Vary the gray scale window width and level to select anatomy for display. Window Width
determines the quantity of gray pixel values. Window Level selects the center Window
Width pixel value.
Example: Two windows may contain identical widths of 100 values, but display completely
different anatomy, because one has a level of -100 and the other has a level of 150

Window Width
The system uses 256 gray shades to display 4000 CT pixel values (nominal range). The
Window Width selection determines the number of CT values represented by each shade of
gray. A narrow window assigns fewer pixels to each gray level than a wide window.
Example: WW = 256 System assigns one pixel value to each gray shade WW = 2560 System
assigns ten pixel values to each gray shade.
Enlarge the window to display anatomy that includes air, tissue, and bone, and subtle
differences in the tissue vanish, because the system assigns too many pixel values to each
shade of gray.
Narrow the window, then adjust the level to display only soft tissue. Subtle differences in
tissue density appear, because the system assigns fewer pixel values to each shade of gray.
Adjust the window whenever the display anatomy changes. Large window widths display a
range of anatomic structures and densities, while narrow windows enable subtle density
discrimination within the anatomy of interest.

Window Level
The Level equals the CT number value of pixel in the center of the Window Width range. The
Level value receives the middle shade of gray. The system displays pixel values that fall
between the center and upper window level as gray to off white. It displays pixel values that
fall between the center and lower window values as gray to charcoal. When you change the
level, the window width moves up and down the CT number line. The CT values change with
Window Level, but the Window Width and number of pixels per gray level don’t change.
Inverse Video reverses display conventions. Dense or high numbers are portrayed as black
rather than white.

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11-38 5478900-2-1EN Rev. 3 (October 2016)

Chapter 12
Quality Assurance

In order to assure consistent image quality over the system's lifetime, establish and
maintain a regular Quality Assurance (QA) program.
Constancy testing of the system should be performed in accordance with IEC 61223-2-6
or per your facility's specific QA program.
Scan a known material (usually a phantom) under a prescribed set of conditions.
• Compare the results to previous or optimum values.
• Repeat these tests on a regular basis to detect changes in image quality values before
the problem becomes visible.
– If you notice a degradation in image quality, or a change in QA values, you can
schedule a site visit and let the service person or imaging physicist run more detailed
tests.
– Early intervention could prevent a major breakdown.
Quality Assurance begins with baseline performance data acquired during system
installation, or after the repair or replacement of an X-Ray tube, collimator, detector, DAS, or
PDU circuitry.
• Compare subsequent QA results against the baseline.
• You can save baseline images for a visual comparison with your daily QA checks, but the
measurement values provide a more objective way to monitor quality.
NOTE: Copy the QA Data Form found at the end of this section. Use the form to record
baseline data and subsequent QA data.

QA Phantom (Reference 21CFR 1020.33 (d)(1))

Use the Quality Assurance Phantom to assess system performance and establish an
ongoing Quality Assurance program.
The phantom design provides maximum performance information with minimum effort.
This phantom measures six aspects of image quality.

5478900-2-1EN Rev. 3 (October 2016) 12-1

• Contrast Scale
• High Contrast Spatial Resolution
• Low Contrast Detectability
• Noise and Uniformity
• Slice Thickness
• Laser Light Accuracy
The QA phantom contains three sections, each corresponding to a single scan plane.
• Section 1: Resolution block S0mm scan location
• Section 2: Contrast membrane S40mm scan location
• Section 3: Water bath S60mm scan location
The following illustration contains a list of the sections and corresponding tests.

12-2 5478900-2-1EN Rev. 3 (October 2016)

Figure 12-1 QA Phantom

Section 1

High contrast resolution

Contrast scale
Slice thickness
Laser accuracy

Location: S0mm

Section 2

Low contrast detectability

Location: S40mm

Section 3

Noise and Uniformity

Location: S60mm

QA Schedule (Reference 21CFR 1020.33 (d)(2))

Each facility determines QA and phantom calibration schedule.
GE recommends that you acquire scans of Sections 1, 2 and 3 of the QA Phantom each day.
Create a Scan Protocol file for these QA scans.

5478900-2-1EN Rev. 3 (October 2016) 12-3

Figure 12-2 QA Phantom Alignment

4
5

Table 12-1 QA Phantom Alignment

Number Description
1 Circumferential Reference Line
2 Vertical Reference Line
3 Horizontal Reference Line
4 Horizontal Reference Line
5 Phantom Bracket
6 Phantom Holder
NOTE: Reference Lines are etched into the plastic and are unpainted.

Handling the QA Phantom

Adhere to the following guidelines when handling or positioning the QA Phantom.
• Visually inspect the QA Phantom and Phantom Holder for damage before each use. If
damaged, do not use the broken piece. Have it replaced immediately.
• The Phantom Bracket on the QA Phantom, used to support it on the Phantom Holder, is
not a handle. It should not be used to hold or carry the phantom. While transporting the
QA Phantom, carry it securely with both hands to avoid dropping it. A damaged QA
Phantom can potentially cause injury.
• The Phantom Bracket is meant to have a snug fit on the Phantom Holder. This minimizes
motion during scanning, which could lead to false failures in the QA images. The snug fit
requires the user to take care when positioning or removing the QA Phantom from the
Phantom Holder.

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• When positioning or removing the QA Phantom from the Phantom Holder, the patient
cradle should be moved out of the gantry fully (home position) and lowered enough so
the user can lift it straight up and off the holder. If the table is not moved to this position,
and the user reaches into the bore to adjust the QA Phantom, stress can cause the
bracket to break.
• If the QA Phantom is broken, cracked or leaking, it should be discarded immediately and
replaced with a new QA Phantom. Care should be taken to avoid any sharp edges which
may develop on the broken pieces, which can potentially cause injury. If the QA
Phantom is leaking water onto the floor, there is a potential slip and fall hazard. If the QA
Phantom is leaking while on or near the scanner, it is possible for water to get under the
table or gantry covers and cause damage.

System Performance (Reference 21CFR 1020.33 (d)(2))

Maintain Image Quality
Many factors affect Image Quality:
• Proper alignment of X-Ray tube, DAS, detector, and table
• KV and mA adjustments within specifications
• Current Calibration files
• Tube Warmup every time the system recommends it
• Daily Fastcals
• Appropriate pixel size, slice thickness, reconstruction algorithm, and special processing
selections during Scan Rx
• Patient remains motionless during scan acquisition
At least three people must cooperate to produce optimum images:
• Service representative aligns the system and adjusts kV and mA
• Operator follows facility guidelines to maintain daily image quality, prescribe the exams,
and update the calibration files
• Patient follows operator (and autovoice) instructions during exam
A QA program helps locate the source of image quality problems:
• Replaces patient with phantom
• Provides standard Scan Rx parameters
• Provides System Performance tests and comparisons

Position the QA Phantom

Place the QA phantom on the phantom holder, and level it.
Turn the knob facing the cradle CW to tilt the top of the phantom AWAY from the gantry.
Use the laser alignment lights to position the phantom:

5478900-2-1EN Rev. 3 (October 2016) 12-5

1. Align the axial light to the circumferential line marking Section 1.

2. Align the coronal light to the horizontal lines on either side of the phantom.
3. Align the sagittal light (where it strikes the top of the phantom) to the vertical line on the
top of the phantom.
4. Position the phantom and select .

Prescribe the QA Series for the Resolution, Low Contrastability, and Noise and
Uniformity Tests
1. Click [New Patient] to display the Patient/Exam Parameters screen.
 Use the same ID for all related QA tests so you can store the exams together.
2. Enter any additional information in the corresponding data field(s). (Optional)
3. Exam Description: Enter up to 22 characters to describe the test. (Recommended)
4. Select a protocol from the anatomical selector to select a QA protocol. (If available)
If your facility hasn't created a QA protocol, use the following parameters to finish the QA
series prescription:
On the Helical View Edit screen select the following parameters:
Table 12-2 Parameters for QA

Interface Input
Entry Head First
Position Supine
Anatomical Reference QA
Landmark Location 0 on resolution phantom at circumferential line/cross hatch.
Scan Type Helical 0.562:1
Scan Range I0 - S60
Thickness 10
Table Speed 11.25
Recon Interval 10
Tilt 0 degrees
SFOV Small
kV 120
mA 135
Rotation Speed 1 second

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Interface Input
DFOV 25cm (phantom diameter:approximately 21.5cm)
Standard and Bone to test high contrast resolution.
Algorithm Standard to test low contrast detectability
Standard for pixel value noise and uniformity
Matrix 512
Contrast None
Special Processing None

Analyze the QA Images

1. Display the first QA image, which is section #1 at scan location S0.
2. Copy the QA Data Form at the end of this section.
3. Record the data from the tests that follow in the corresponding area of the form.
4. Compare the current values to previously recorded values.
 If you notice a significant change in values, check the Small SFOV calibration status.
5. Calibrate the Small SFOV if the most recent calibration date falls outside the guidelines
established by your facility.
6. Report significant changes, or values that fall outside suggested windows, to your
supervisor or imaging physicist.
7. Follow facility procedures to notify service personnel.
8. Perform the following:
a) Contrast Scale test at scan location S0 of the helical scan.
b) High Contrast Spatial Resolution test at scan location S0 of the helical scan.
c) Low Contrast Detectability test at scan location S40 of the helical scan.
d) Noise and Uniformity test at scan location S60 of the helical scan.
e) Slice Thickness test at scan location S0 of the axial slice thickness scans.
f) Alignment Light Accuracy test at scan location S0 of the Alignment Light test scan.
Contrast Scale
Section 1 of the Phantom Tests the Contrast Scale
CT assigns CT numbers, also called (HU) Hounsfield Units, to the attenuation values of X-Ray
passing through a variety of material densities.
Software makes the attenuation visible by assigning shades of gray to groups of numbers
selected with the Window Width/ Level functions during image Display.

5478900-2-1EN Rev. 3 (October 2016) 12-7

For test purposes, the CT values of water and plexiglass in the phantom represent the
standard against which you track the system contrast scale over time.
The test for contrast scale follows:
Figure 12-3 Contrast Scale Phantom Section

Position 10mm box ROI

Position 10mm box ROI over water
over Plexiglass

1. Select Box ROI to position a 10mm box cursor on the image, as shown in Figure 12-3.
2. For consistency, use the same size cursor and location each time you perform this test.
3. Select Grid to provide a reference.
4. Select Box ROI to position a cursor over the Plexiglass resolution block (refer to Figure
12-3).
5. Record the mean CT number on the QA Data Form.
6. Optional: Record the Standard deviation
7. Select Box ROI to position a cursor over water (refer to Figure 12-3).
8. Record the mean CT number for water on the QA Data form.
9. Optional: Record the Standard deviation
10. Subtract the CT number of water from the CT number of Plexiglass
 Record the difference on the QA Data form.
 The difference should equal 120 ±12.

High Contrast Spatial Resolution

Section 1 (Figure 12-4) of the phantom contains six sets of bar patterns in a Plexiglass block
used to test high contrast spatial resolution.
Each pattern consists of sets of equally sized bars and spaces
Water fills the spaces and provides about 12% (120 HU) contrast.

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The resolution block contains the following bar sizes:1.6mm, 1.3mm, 1.0mm, 0.8mm, 0.6mm,
and 0.5mm.
1. Examine the bar patterns to determine the limiting resolution, defined as the smallest
bar pattern in which you see all five bars.
2. You should see all five 0.6mm bars in images reconstructed with the Bone algorithm
(15cm FOV).
3. Using the standard algorithm, measure the standard deviation of the pixel values in a
single or multiple bar pattern to provide a quantitative method for assessing changes in
system resolution.
4. ROI standard deviation provides a good indicator of system resolution and a sensitive
method to detect changes in system resolution.
The recommended procedure follows:
Figure 12-4 High Contrast Spatial Resolution Section

Position box cursor over largest

bar pattern, and size it until it
fits over the pattern.

Optional: repeat for 1.3mm,

1.0mm and 0.8mm patterns.

5. Select Erase to remove previous ROI data.

6. Position a box cursor over the largest (1.6mm) bar pattern, and size it to fit within the bar
pattern as shown in Figure 12-4.
7. Record the standard deviation on the QA data form.
 Standard deviation should equal 37 ± 4, if you used standard algorithm.
Optional: Repeat this procedure for the 1.3, 1.0, and 0.8mm bar patterns.
8. Record the standard deviation on the QA data form.

MTF (optional)
The Modulation Transfer Function (MTF) mathematically quantifies high contrast
resolution.
MTF measures the contrast preserved for a sine wave pattern as a function of frequency.

5478900-2-1EN Rev. 3 (October 2016) 12-9

An MTF curve begins at 1 for zero frequency, and decreases as frequency increases.
Example: An MTF of 1 equals total preservation of contrast
Example: An MTF of 0.5 equals 50% loss of contrast
The limiting resolution equals the frequency at which MTF falls to 0.
An MTF curve is shown in Figure 12-16.
Measure Frequency in line pairs per centimeter.
One line pair per centimeter equals one 5mm Plexiglass bar next to one water filled 5mm
space.
Optional: Consult the publication listed as Reference 1 in section for MTF measurement
instructions (Droege RT, Morin RL. “A Practical Method to Measure the MTF of CT Scanners,”
Medical Physics, Volume 9, No. 5, pp 758-760, 1982).

Low Contrast Detectability

Section 2 of the QA phantom tests low contrast detectability, defined here as the smallest
hole size visible for a given contrast level at a given dose.
This phantom section contains a doped polystyrene membrane suspended in water and
pierced by a series of holes in the following sizes: 10.0mm, 7.5mm, 5.0mm, 3.0mm, and
1.0mm.
• The difference in CT numbers between the water, and water plus plastic, equals the
contrast in Hounsfield Units (HU).
• Your first contrast measurement of the QA phantom establishes its baseline.
Subsequent measurements should fall within 0.1% of the baseline. (1HU)
• Divide the HU value by ten to obtain the contrast in percent.
• Measure the contrast between the plastic membrane and the surrounding water in the
following manner:
Figure 12-5 Low Contract Detectability Section
A.Position box ROI over polystyrene B.Position box ROI over
membrane above holes.
water above membrane.

Subtract B from A.
Count visible holes. Subtract D from C.

D.Position box ROI

C.Position box ROI over polystyrene over water below
membrane below holes. membrane.

1. Display an image of Section 2, which is at scan location S40.

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2. Select Erase to remove previous ROI data.

3. Select a Box ROI, and adjust the size to a rectangle about 5mm high and 50mm long.
4. First, position the ROI over the polystyrene membrane, just above the holes, as shown in
Figure 12-5.
5. Record this membrane CT number in the Top CT# column.
 QA data form (Figure ) at the end of this section.
6. Select Box ROI to position a cursor over the (100%) water section above the membrane,
as shown in Figure 12-5.
7. Record this water CT number in the Top CT# column.
8. Subtract the water's CT number from the membrane's CT number.
9. Record the difference.
10. Select Erase to remove previous ROI data.
11. Select Box ROI to position the cursor over the polystyrene membrane, just below the
holes, as shown in Figure 12-5.
12. Record this membrane CT number in the Bottom CT# column.
 QA data form (Figure ) is at the end of this section.
13. Select Box ROI to position the cursor over the (100%) water section below the
membrane, as shown in Figure 12-5.
14. Record this Water CT number in the Bottom CT# column.
15. Subtract the water's CT number from the membrane's CT number.
16. Record the difference.
17. Select Erase to remove previous ROI data.
18. Adjust the Window Width to 30 and the Window Level to the CT number you recorded
for water.
19. Count and record the number of visible holes.

Noise and Uniformity (Reference 21CFR 1020.33 (j))

Section 3 (Figure 12-6) of the phantom tests noise and uniformity, which is at scan location
S60.
Noise limits low contrast resolution, and masks anatomy with similar structure to
surrounding tissue.
QA phantom Section 3 provides a uniform image by which to assess image CT number noise
and uniformity.

5478900-2-1EN Rev. 3 (October 2016) 12-11

Use the Standard algorithm to reconstruct the image.

Figure 12-6 Noise and Uniformity Section

Optional: Take a box ROI

Position 2cm box ROI over
the center of the image. at the 12 o’clock position
75mm from center box.

Optional: Take a box ROI at

the 3 o’clock position
75mm from center box.

Image noise equals the standard deviation of CT numbers within a region of interest (ROI).
Noise results from electronic, mechanical, and mathematical differences in detected X-Ray
energy, electronic outputs, and reconstruction algorithms.
Tube Warmups, up to date calibration files, and daily Fastcals minimize noise and help
provide uniform images.
Refer to Figure 12-6.
1. Select Erase to remove previous ROI data.
2. Select Box ROI to position a 2 cm box ROI over the center of the image.
3. Record the mean CT number and standard deviation on the QA Data Form.
 QA data form (Figure ) is at end of this section.
4. Optional: Select Box ROI and move the cursor to the 12 o'clock position.
5. Record the mean CT number and standard deviation on the QA Data Form.
6. Optional: Select Box ROI to move the cursor to the 3 o'clock position.
7. Record the mean CT number and standard deviation on the QA Data Form.
 If the Image is reconstructed with Standard algorithm and Small SFOV, the Mean of
Center ROI should equal 0 ± 3.
 Standard deviation of the center ROI should less or equal 3.5 (nominal 3.2)
 The uniformity difference between the center ROI and the average of the edge ROIs
should be 0 ± 3.

Slice Thickness
Section 1 of the phantom also tests slice thickness.

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Both sides of the resolution block contain a pattern of air filled holes designed to
demonstrate slice thickness (refer to Figure 12-7).
Figure 12-7 Slice Thickness Section

Air filled
holes

The resolution block contains holes drilled 1mm apart and positioned to form a line at 45
degrees to the scan plane.
Each visible hole in the image represents 1mm of beam thickness.
The software assigns less negative CT numbers to partial hole images or holes located on
the edge of the slice profile.

5478900-2-1EN Rev. 3 (October 2016) 12-13

Prescribe the QA Series for the Slice Thickness Test - Phantom Section #1
1. Select a protocol from the anatomical selector to select a QA protocol (if available).
2. If your facility hasn't created a QA protocol, use the following parameters to finish the
QA series prescription:
3. On the Axial View Edit screen select the following parameters:
Table 12-3 QA Protocol for Slice Thickness

Interface Input
Entry Head First
Position Supine
Anatomical Reference QA
Landmark Location 0 on resolution phantom at circumferential line/cross hatch.
Scan Type Axial
Scan Range Prescribe 4 Groups
Thickness
Group Scan Range Spacing
(For 16 slices)
1 5mm/4I I7.5 - S7.5 0
2 3.75mm/4I I5.625 - S5.625 0
3 2.5mm/8I I8.75-S8.75 0
4 1.25mm/8l I4.375-S4.375 0
5 0.625mm/16I I4.688-S4.688 0
6 2.5mm/4I I3.75-S3.75 0
Tilt 0 degrees
SFOV Small
kV 120
mA 260
Rotation Speed 1 second
DFOV 25cm (phantom diameter:approximately 21.5cm)
Algorithm Standard
Matrix 512
Contrast None
Special Processing None

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Analyze the Slice Thickness in Images

To determine slice thickness, display the image at the recommended window level and
width, and count the visible holes.
 Black lines in the image represent a full millimeter of slice thickness.
 Gray lines count as fractions of a millimeter; two equally gray holes count as a single
1mm slice thickness.
 Refer to Figure 12-8.
Recommended window width: 250
Recommended window level:
• -100 for 1.25mm
• -25 for 2.5mm
• +25 for 3.75mm
• + 50 for 5.0mm
Figure 12-8 Slice Thickness Lines

Adjust the window width and level,

then count the lines, which
represent the air filled holes.

Note: The slice thickness bars are

less distinctive in helical scans.

Each black line represents one

millimeter of slice thickness. Gray
lines represent fractions of a
millimeter

You should see one line for each millimeter of scan thickness.
Figure 12-8 represents a 5mm image.

Alignment Light Accuracy (Reference 21CFR 1020.33(g)(2))

The manufacturers drilled deeper center holes on the reference to help identify them in the
image.
The center hole position corresponds precisely to the etched marker placed on the
circumference of the phantom.
When you use an accurate light, and align the phantom's circumferential etched marker to
the axial light, the resulting image should contain a symmetrical hole pattern around the
center (longer) hole in the slice thickness pattern.

5478900-2-1EN Rev. 3 (October 2016) 12-15

Refer to Figure 12-9.

For best results, use the 2.5mm/4i slice thickness.

Prescribe the QA Series for Alignment Light Accuracy - Phantom Section #1

Select a protocol from the anatomical selector to select a QA protocol. (If available) If your
facility hasn't created a QA protocol, use the following parameters to finish the QA series
prescription:
On the Axial View Edit screen select the following parameters:
Table 12-4 Parameters for Alignment Lights Check

Interface Input
Entry Head First
Position Supine
Type EX for the external alignment light test
Anatomical Reference
Type IN for the internal alignment light test.
Landmark Location 0 on resolution phantom at circumferential line/cross hatch.
Scan Type Axial
Scan Range I3.75 - S3.75
Thickness 2.5 mm/4i
Tilt 0 degrees
SFOV Small
kV 120
mA 260
Rotation Speed 1 second
DFOV 25cm (phantom diameter:approximately 21.5cm)
Algorithm Standard
Matrix 512
Contrast None
Special Processing None

Figure 12-9 Alignment Light Section

12-16 5478900-2-1EN Rev. 3 (October 2016)

Center hole position corresponds to

etched line around phantom
circumference.

Align etched line on phantom

to positioning light

1. Align the phantom to the Internal light and scan it.

 The actual scan plane should equal 0 ± 2.0mm.
2. Align the phantom to the External light and scan it.
 The actual scan plane should equal 0 ± 2.0mm.
Figure 12-9 and phantom positioning instructions.
3. Align the vertical, horizontal and circumferential lines on the phantom to the
corresponding laser lines.
 Azimuth 0 laser: Center phantom left and right within the FOV
 Azimuth 90 and 270 lasers: Center phantom up and down within the FOV.
4. Scan the phantom.
5. Display the resulting phantom image.
 Refer to Figure 12-9.
6. Select Grid to check sagittal and coronal light accuracy.
 Refer to Figure 12-10.
7. Center the phantom to isocenter, ±4.0mm, along the sagittal and coronal planes.
 Refer to Figure 12-9.

5478900-2-1EN Rev. 3 (October 2016) 12-17

Figure 12-10 Grid Check

A125.0 Hospital name
Patient name
a centered
Ex: 100 Console1
Ser: 1 Patient ID 5mm scan
date of scan
QA S0.0
matrix size
Img: 2
mag factor
DFOV 25.0cm
STND
L
R 1
1 2
2 5
.
.5 0
0 S0.0

kV 120
mA 260
Small
5.0mm
Tilt 0.0 R0.0
P125.0
W = 250 L = –50

QA phantom “Prone” or “Supine” A0.0

Typical Results and Allowable Variations

Because the human eye determines clinical image quality, it remains subjective and difficult
to define.
GE expects the standards of allowable variation in image quality parameters to vary with
the installation and image evaluator(s).
GE encourages you to establish and follow a Quality Assurance (QA) program so you can
discover any degradation of image quality before it effects clinical images.
Over time, institutions use the QA procedure to establish a correlation between acceptable
clinical image quality and acceptable variations in the image performance indices included
in the program.
Compare your images to the set of performance images that accompanied your system.
This section contains suggested allowable variations; don't mistake them for absolutes.
Compare any parameter variation to the maximum deviation specified in the next section
called, Dose and Performance.
Make sure you used the prescribed technique, then follow your facility guidelines to inform
service when the variations reach the specified maximum deviation.
Contrast Scale
The difference in CT numbers between the Plexiglass resolution block and water should
equal 120, with a suggested allowable variation of 10%.

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High Contrast Spatial Resolution

The standard deviation for an ROI in the 1.6mm bar pattern should equal 37 ± 4 for the
standard algorithm.

Axial Scan Slice Thickness

Slice thickness should not vary by more than ± 1mm from the expected value, when
evaluated according to instructions.
Relatively large tolerance due to size of markers in phantom.

Low Contrast Detectability

Because this test relies upon the perceptual judgment of the person counting visible and
well-defined holes, GE can't suggest an allowable variation. Rather, we suggest you choose
a single, barely visible hole and closely monitor that particular hole during subsequent
testing for degradation in this image parameter.

Noise & CT Number of Water

When you correctly image and analyze the water section of the phantom, you should see a
CT number for water of 0 ± 3 HU for the center ROI. The uniformity difference between the
Center ROI and the average of the edge ROIs should be 0 ± 3 for Small Body (0 ± 10
maximum deviation if Large Body is used).
Expect the noise in the center of the image to approximately less or equal 3.5 (nominal 3.2).
References
Droege RT, Morin RL. “A Practical Method to Measure the MTF of CT Scanners,” Medical Physics, Volume 9, No. 5,
pp 758-760, 1982.
Jacobson DR. “Quality Assurance for Computed Tomography — Correlation with System Performance,”
Application of Optical Instrumentation in Medicine XI, D. Fullerton, Editor, Proc. SPIE 419, pp 157-165, 1983.
AAPM, “Phantoms for Performance Evaluation and Quality Assurance of CT Scanners,” Report No. 1, American
Association of Physicists in Medicine, 1977.

DOSIMETRY
Dosimetry information is provided in terms of the CTDI and CTDIw dose indices. Optionally
CTDIvol and its associated DLP (dose length product) is automatically computed and
displayed on the patient Rx menu to assist in managing patient dose. This section provides a
brief description to help you better understand these dose reporting standards.

General Information
Dose is the amount of energy imparted by the X-ray beam at a given point in an exposed
material (patient tissue, phantom, air, etc. ) and is measured in units of mGy (milli Gray). (The
old unit was the Rad which equals 10 mGy.) Dose is dependent on the energy absorption
factors of the material and on the X-ray exposure. The X-ray exposure is measured in C/kg
(coulombs per kilogram) and is dependent on the technique factors used for the scan. The

5478900-2-1EN Rev. 3 (October 2016) 12-19

dose is generally proportional to the exposure which increases with increasing mA, kV and
scan time. The X-ray exposure to a point occurs from both direct X-ray from the tube and
from scattered X-ray due to adjacent material exposure.
Patient biological risk is related to dose but is also highly dependent on the specific organs
exposed. The effective dose is a way to characterize patient risk. The effective dose is the
sum of the doses weighted in accordance with the specific radio-sensitivity of the particular
organs or tissues exposed. Weighting values are published in ICRP 60 (International
Committee on Radiation Protection, Publication 60). Although we can accurately describe
the X-ray exposure potential to a patient for a CT scan, we can not easily determine the
patient dose or risk in terms of effective dose. This is because each patient is anatomically
unique and the specific details of his or her anatomy along with the source exposure must
be processed using time consuming monte-carlo computer programs to predict how
radiation will be scattered and accumulated within various patient organs.
Since it is not possible to characterize the specific dose given to individual patients, the CT
dose indices are provided to help make relative comparisons. These dose index values can
be used to compare CT systems and to help select appropriate operating conditions for
scanning. However, it is important to recognize that the dose reported by these indices is
inversely proportional to phantoms size (see Figure 12-11). This means that for the same
scan technique (protocol), smaller phantoms (patients) will produce a higher absorbed dose
than larger phantoms (patients) - see “Influence of phantom diameter, kVp and scan mode
upon computed tomography dose index”, Edward L. Nickoloff, Ajoy K. Dutta, and Zheng F. Lu,
Medical Physics 30, 395 (2003). Therefore, it is critical to remember that the body scan
FOV’s uses the 32cm CTDI phantom and all pediatric and head filter uses the 16cm CTDI
phantom for dose reporting purposes (CTDIVOL display on Scan Rx Menu). Table 12-6
indicates the phantom size used for each SFOV.
Figure 12-11 Relationship between dose and phantom size for head and body filters at
120kVp. Similar curves are obtained for the 80, 100, and 140 kVps.

1 2

12-20 5478900-2-1EN Rev. 3 (October 2016)

Table 12-5

Number Description
1 Head Filter
2 Body Filter
3 Relative Dose
4 Phantom Diameter (cm)

Table 12-6

SFOV type CTDI phantom

Ped Head
Small 16 cm Phantom
Head
Large 32 cm Phantom

CTDIw (Reference IEC 60601-2-44 and 21 CFR 1020.33 (c))

CTDIw or weighted CTDI100 is a dose index which consists of 2/3 of the CTDI100 peripheral dose plus
1/3 of the CTDI100 central dose. The CTDI100 dose is defined as the integral of the dose profile, Da(z),
produced in a single axial scan along a line perpendicular to the imaging plane from -50 mm to +50
mm, divided by the product of the number of slices, n, and the nominal tomographic section
thickness (row detection width), T.

Mathematical Definition of CTDI100 and CTDIw

n = number detector macro rows per scan

+50mm T = row detection width
1 Da(z) = dose profile in Z axis (absorbed in air)
CTDI100 = Da(z)dz
nT
-50mm

CTDIw =(2/3)xCTDI100 peripheral + (1/3)xCTDI 100cent

CTDIw is measured using either a 16 cm (for head scanning) or a 32 cm (for body scanning) PMMA
phantom of at least 14 cm in length. The measurements are taken at the center and peripheral (see
Figure 12-12 points A and B). The doses measured at these locations within the PMMA phantom, are
quoted as the dose absorbed in air rather than PMMA (absorption in air is about 11% higher than
absorption in PMMA).

5478900-2-1EN Rev. 3 (October 2016) 12-21

Figure 12-12 CTDI Dose Reference Phantom Description

1 Head phantom 16cm dia

B 2 Body phantom 32cm dia
3 Material PMMA(polymethyl methacrylate)
E A C 4 Thickness >14cm
5 A thru E pencil chamber openings
D 6A center
7 B thru E peripheral 1cm from surface

Table 12-7

Number Phantom Description

1 Head Phantom 16 cm diameter
2 Body Phantom 32 cm diameter
3 Material PMMA (polymethyl methacrylate)
4 Thickness > 14 cm thick
5 A Thru E Pencil chamber openings
6 A Center
7 B Thru E Peripheral 1 cm from surface

The dose at the four peripheral locations is very similar due to the geometry of the system
and phantom. CTDI values are reported only for peripheral location “B” as this conservatively
represents all-peripheral dose values.
CTDI100 and CTDIw dose tables and index factors are provided in the following section. To
determine the CTDI100 dose, select the appropriate standard technique dose (small or large
filters) and multiply by the factors for describing the technique used.

12-22 5478900-2-1EN Rev. 3 (October 2016)

CTDI100 Typical Technique

Typical Techniques for CTDI100 and CTDIw (For 16 slice)

HEAD-axial-cine BODY-axial-cine
25cm sfov 50 cm sfov
120kv 120kv
260 mA 260 mA
1 sec scan 1 sec scan
10mm, 2i mode 10mm, 2i mode

Typical Techniques for CTDI100 and CTDIw (For 4/8slice)

HEAD-axial-cine BODY-axial-cine
25cm sfov 50 cm sfov
120kv 120kv
260 mA 260 mA
1 sec scan 1 sec scan
5mm, 4i mode 5mm, 4i mode

(Typical techniques for CTDI100 and CTDIw are the same as for CTDI stated above)

Table of CTDI100 Dose Values (mGy) at Typical Technique (For 16 slice)

Head A Head B Body A Body B
46.41 48.59 14.09 29.07

Table of CTDI100 Dose Values (mGy) at Typical Technique (For 4/8 slice)
Head A Head B Body A Body B
46.75 47.71 14.35 29.33

Table of CTDI100, CTDIw, KV, SCAN MODE, and mAs ADJUSTMENT FACTORS
KV Adjustment Factor
KV Head A Head B Body A Body B
80 0.34 0.37 0.27 0.33
100 0.63 0.65 0.57 0.61
120 1 1 1 1
140 1.37 1.36 1.44 1.36
mAs ADJUSTMENT FACTOR = Rx mA * Rx single rotation time in seconds/ 260

5478900-2-1EN Rev. 3 (October 2016) 12-23

CTDI100 Aperture Adjustment Factors for Large Spot (>24kW) (For 16 slice)
Acquisition Mode Head A Head B Body A Body B
16 x 1.25 1.00 1.00 1.00 1.00
16 x 0.625 1.24 1.24 1.25 1.24
8 x 2.50 1.01 1.00 1.00 1.03
8 x 1.25 1.26 1.27 1.26 1.25
4 x 3.75 1.08 1.08 1.08 1.09
4 x 2.50 1.15 1.15 1.16 1.18
4 x 1.25 1.53 1.54 1.54 1.57
4 x 0.625 2.08 2.11 2.14 2.14
2 x 0.625, 1 x 1.25 2.55 2.60 2.58 2.60

CTDI100 Aperture Adjustment Factors for Small Spot (<24kW) (For 16 slices)
Acquisition Mode Head A Head B Body A Body B
16 x 1.25 1.01 1.01 1.01 1.01
16 x 0.625 1.13 1.14 1.13 1.13
8 x 2.50 0.96 0.96 0.97 0.96
8 x 1.25 1.16 1.17 1.16 1.15
4 x 3.75 1.08 1.08 1.08 1.09
4 x 2.50 1.11 1.10 1.11 1.13
4 x 1.25 1.41 1.43 1.46 1.49
4 x 0.625 1.95 1.98 2.00 2.03
2 x 0.625, 1 x 1.25 1.22 1.26 1.22 1.28

CTDI100 Aperture Adjustment Factors for Large Spot (>24kW) (For 4/8 slice)
Acquisition Mode Head A Head B Body A Body B
8 x 2.5 1.00 1.00 1.00 1.00
8 x 1.25 1.17 1.16 1.16 1.14
4 x 5.0 1.00 1.00 1.00 1.00
4 x 3.75 1.02 1.02 1.02 1.02

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CTDI100 Aperture Adjustment Factors for Large Spot (>24kW) (For 4/8 slice)
Acquisition Mode Head A Head B Body A Body B
4 x 2.50 1.10 1.09 1.09 1.08
4 x 1.25 1.47 1.46 1.46 1.45
1 x 1.25 3.37 3.37 3.50 3.50

CTDI100 Aperture Adjustment Factors for Small Spot (<24kW) (For 4/8 slices)
Acquisition Mode Head A Head B Body A Body B
8 x 2.5 0.92 0.92 0.91 0.90
8 x 1.25 1.09 1.09 1.09 1.08
4 x 5.0 0.92 0.92 0.91 0.90
4 x 3.75 1.02 1.01 1.01 1.00
4 x 2.50 1.03 1.03 1.02 1.02
4 x 1.25 1.29 1.29 1.29 1.29
2 x 0.63 1.46 1.50 1.47 1.49
1 x 1.25 2.95 2.95 2.95 2.95

Example 1 - The CTDI100 body peripheral dose for a 8.75mm/sec helical scan in 0.875:1 pitch,
8x1.25 slice mode, 250mA, 1.0s gantry speed and 120kV, is determined as follows:

29.07 mGy body peripheral dose (Body B) at typical technique

from CTDI100 table
x 1.00 120kV adjustment factor from kV Adjustment Factor
Table
x 1.25 8x1.25 aperture adjustment factor for Body B at
120kV, 250mA (i.e. 120 kV * 250 mA = 30 kW >24 kW,
so it is large spot) from CTDI100 Aperture Adjustment
Factors for Large Spot Table
x 250/260 mAs adjustment factor (250mAx1s)/(260mAx1s)
= 34.94 mGy CTDI100 Body peripheral dose

Example 2 - The CTDI100 body center dose for example 1 is determined as follows:

14.09 mGy body center dose (Body A) at typical technique

from CTDI100 table
x 1.00 120kV adjustment factor from kV Adjustment
Factor Table

5478900-2-1EN Rev. 3 (October 2016) 12-25

x 1.26 8x1.25 aperture adjustment factor for Body A at

120kV, 250mA (i.e. 120 kV * 250 mA = 30 kW >24
kW), so it is large spot) from CTDI100 Aperture
Adjustment Factors for Large Spot Table
x 250/260 mAs adjustment factor (250mAx1s)/(260mAx1s)
= 17.07 mGy CTDI100 Body center dose

Example 3 - The CTDIw body dose for example 1 and 2 is computed as:
CTDIw = (2/3)*34.94 + (1/3) *17.07 = 28.99 mGy

CTDIvol (Reference IEC 60601-2-44)

The volume CTDIw (CTDIvol) describes the average dose over the total volume scanned for
the selected CT conditions of operation. The system computes CTDIvol automatically. Note
that system computations may vary slightly from manual calculations due to differences in
round-off or truncation operations.The CTDIvol is defined as follows:
a) For axial scanning

N T
CTDIvol = d
CTDIw

where N is the number of slices produced in a single axial scan, T is the slice thickness (or
row detection width), and ∆d is the table travel in z-direction between consecutive scans.
b) For helical scanning

CTDIw
CTDIvol = Scan Mode Adjustment Factor (Pitch)

Reference IEC 60601-2-44.

See Scan Mode Adjustment Factors table for factor to use.
Table 12-8 Scan Mode Adjustment Factor

Scan Mode Adjustment Factor (For 16 slice)

16 Slice Scan Modes 8 Slice Scan Modes
Pitch 0.562:1 0.938:1 1.375:1 1.75:1 0.625:1 0.875:1 1.35:1 1.675:1
Factor 1.78 1.07 0.73 0.57 1.60 1.14 0.74 0.60

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Table 12-9 Helical Pitch Factor

Helical Pitch Factor Helical Pitch Factor Cardiac Helical Scan

GE Traditional Def. (IEC Definition) Mode Factor
4.4 0.275 3.64
4.8 0.30 3.33
5.2 0.325 3.08
5.6 0.35 2.86
6.0 0.375 2.67

Example 4 - The CTDIvol head dose for a 10mm 1i, 8x1.25 axial scan, at 150mA, 1.0s gantry
speed, 120kV and a 30mm table increment between consecutive scans, is determined by:

46.41 (head A),  center, peripheral dose from CTDI100 table

48.59 (head B)
x 1.00 120kV adjustment factor from kV Adjustment Factor Table
x 1.16 (head A), 1.17 (head B) 8x1.25 aperture adjustment factor for small spot (i.e. 120 kV *
150 mA = 18 kW <24 kW, so it is small spot) from CTDI100
Aperture Adjustment Factors for Small Spot Table
x 150/260 mAs adjustment factor (150mAx1s)/(260mAx1s)
=31.06mGy, 32.80mGy Center and peripheral CTDI100
= (1/3)x31.06 + (2/3) x 32.80 CTDIw
= 32.22mGy
x 1/3 Axial “pitch adjustment factor” = 10x1/30
10.74 mGy CTDIvol

Example 5 - The CTDIvol for a cardiac helical scan using the large SFOV, 16x0.625mm slice
mode, with helical pitch 6.0, 250mA, 0.5s gantry speed, and 140kV is determined as follows:

14.09 (body A), 29.07 (body Center, peripheral dose from CTDI100 Table
B)
x 1.44 (body A), 1.36 (body B) 140kV adjustment factor from Table
x 1.25 (body A), 1.24 (body B) 16x0.625 aperture adjustment factor for large spot from Table
(at 120kV, 250mA > 24 kW)
x 125/260 mAs adjustment factor (250mAx 0.5s)/(260mAx1s)
=12.19mGy, 23.57mGy Center and peripheral CTDI100
= (1/3)x12.19 + (2/3)x23.57 CTDIw
= 19.78 mGy
x 2.67 Cardiac helical “pitch factor” = 2.67 from Cardiac Helical Pitch
Factor Table

5478900-2-1EN Rev. 3 (October 2016) 12-27

52.80 mGy CTDIvol

Peak Skin Dose

This section provides information on the relationship between peak CT Skin Dose and CTDI
as standardized in IEC 60601-2-44, the most commonly used dose metric used to estimate
dose to the patient. The peak skin dose is actually a point dose and is of particular interest to
assess possible deterministic skin effects, especially in applications such as CT Perfusion
and interventional procedures where the same anatomical area is irradiated for relatively
long durations of time.
As CTDI100 is measured using a 10cm long pencil ionization chamber, at fixed locations
within a perfectly symmetrical and centered cylindrical phantom, the metric is not a direct
measure of patient dose given the non-uniform patient composition and natural differences
in patient sizes relative to the fixed sizes of the CTDI phantoms. In general terms, the dose to
the skin can be calculated only by estimating the amount of dose absorbed at surface of the
object. The peripheral CTDI100 measurement is measured at the surface (1cm inside the
surface of the phantom). However, for scans performed without table movement (such as CT
Perfusion and Fluoroscopy), the integrated-CTDI100 (peripheral) can be a significant
overestimation of the peak skin dose as much as a factor of two1.
As an informative description, a basic CT Skin Dose Index (CTSD) is provided below. While this
is not the peak skin dose (a point dose) for a patient, it is a metric that can be readily
calculated based on either the CTDI100 (peripheral) value and associated kV, mA, and aperature
adjustment factors found in Chapter 12 of the Technical Reference Manual or the peak of
the dose profile given in Table 12-9 below and the following adjustment equation. This
metric helps to address the overestimation of peak skin dose by use of CTDIvol values
especially for scanning without table movement such as found in CT perfusion and
interventional procedures.
Actual peak skin dose will vary due to a variety of factors that include actual patient size and
centering in the bore.
Table 12-10 Peak of dose profile in mGy for available apertures and kV and bowtie filter
combinations for a single one-second rotation at 260 mA. The head values are from the
peripheral locations of the 16cm CTDI phantom and the body values are from the peripheral
locations of the 32cm CTDI phantom.

1.The following article provides an explanation of the relationship between CTDIvol and peak skin
dose for helical and cine-mode exams: J. A. Bauhs, T. J. Vrieze, A. N. Primak, M. R. Bruesewitz, and
C. H. McCollough, 2008, "CT dosimetry: comparison of measurement techniques and devices," Ra-
diographies Vol. 28, pp. 245-253. Available at: http://radiographics.rsna.org/content/28/
I/245.full.pdf+html.

12-28 5478900-2-1EN Rev. 3 (October 2016)

SFOV / Aperture (mm)

kV
Focal Spot 20 15 10 5 1.25
Head
15.54 14.97 15.39 13.51 11.54
LargeFocal
Head
14.88 14.55 14.1 11.1 6.68
SmallFocal
80
Body
9.61 9.28 8.58 8.1 6.88
LargeFocal
Body
9.56 9.15 7.94 7.01 3.67
SmallFocal
Head
27.62 26.46 27.39 23.31 19.55
LargeFocal
Head
26.46 25.75 24.68 20.73 10.94
SmallFocal
100
Body
18.06 17.07 15.89 14.9 12.32
LargeFocal
Body
17.54 16.82 14.68 12.72 7.15
SmallFocal
Head
40.68 39.2 40.94 35.36 29.62
LargeFocal
Head
39.93 39.31 37.58 30.13 16.7
SmallFocal
120
Body
28.06 26.81 24.27 22.81 19.12
LargeFocal
Body
27.41 26.35 22.99 19.57 10.64
SmallFocal
Head
57.11 54.97 55.57 47.9 39.68
LargeFocal
Head
55.51 54.21 51.91 41.93 22.6
SmallFocal
140
Body
39.44 37.29 34.75 32.32 26.85
LargeFocal
Body
38.51 36.88 31.91 27.76 15.66
SmallFocal
Note: The values within this table have an expected variance of ± 40%.
(In the case of Segment Scanning, an expected variance would be
more than ± 40%.)

5478900-2-1EN Rev. 3 (October 2016) 12-29

Maximum peak of dose profile (max {Dperipheral (z)}) = Peak dose from Table 12-30* (actual
scan mA/260mA) * gantry rotation speed in seconds.
Computed Tomography Skin Dose Index (CTSD) is an indicator of the peak absorbed dose in
skin tissue located within the area of coverage of the radiation field.
For Axial scanning:

peripheral

N The number of tomographic sections produced in a single axial scan

of the X-ray source.
T The nominal tomographic section thickness.
d The patient support travel in z-direction between consecutive scans.
CTDI100 (peripheral) The average of the four values of CTDI100 measured around the dosim-
etry phantom periphery.

NOTE: For axial scanning with a total table travel of less than N x T, this definition may
overestimate the dose.
NOTE: For the selected CT condition of operation, but irrespective of any scanning length
that may be used clinically, the axial-scanning CTSD is an index of dose based on a
convention of 100 mm range of integration along the z-axis. For axial scanning, CTSD
corresponds to the dose averaged over the phantom central section peripheral holes.
For Helical scanning:

peripheral

CT pitch factor
NOTE: CT pitch factor will be a function of time when d or N x T are variable during the
exposure.
NOTE: For helical scanning with a small number of rotations and a table travel per rotation
of less than N x T, this definition may overestimate the dose.
NOTE: For the selected CT condition of operation, but irrespective of any scanning length
that may be used clinically, the helical-scanning CTSD is an index of dose based on
a convention of 100 mm range of integration along the z-axis. For helical scanning,
CTSD corresponds to the dose averaged over the phantom central section peripheral
holes.
For scanning without movement of the patient support:

max{Dperipheral(z)}

n Equal to the number of rotations.

12-30 5478900-2-1EN Rev. 3 (October 2016)

The maximum value of the four dose profiles measured in the

phantom periphery produced in a single axial rotation along lines z
max
{Dperipheral(z)} perpendicular to the tomographic plane, where dose is reported as
absorbed dose in air and is evaluated within a polymethyl
methacrylate (PMMA) dosimetry phantom.

NOTE: Includes situations where the patient support may be moved manually, for example,
during an interventional procedure.
For Axial and Helical scanning involving table travel in two derections (“shuttle” mode):

max{Dperipheral(z)}

n Equal to the number of rotations.

N The nominal tomographic section thickness.
R The range of table travel during the entire loading.
The maximum value of the four dose profiles measured in the phantom
periphery produced in a single axial rotation, with time weighted
max average CT conditions of operation, along lines z perpendicular to the
{Dperipheral(z)} tomographic plane, where dose is reported as absorbed dose in air and
is evaluated within a polymethyl methacrylate (PMMA) dosimetry
phantom.

Deterministic effect (refer to IEC60601-2-44:2009 Clause

203.5.2.4.5)
There is the possibility that in normal use the patient can be exposed to radiation dose levels
of 1Gy CTDI100(peripheral) or above, at which the deterministic effects may occur. Management
of the high radiation dose is critical to maintain the radiation safety.
The available settings concerning the radiation dose level including mA, kV, scan time,
Aperture, SFOV etc. The below table provides the Scan Duration(seconds) required to meet
1Gy CTDI100(peripheral) at 200mA exposure at same scan location.

Scan Duration(seconds) required to meet 1Gy CTDI100(peripheral) at 200mA exposure

Aperture

kV SFOV 2×0.62
16×1.2 16×0.6 4×0.62
8×2.50 8×1.25 4×3.75 4×2.50 4×1.25 5,1×1.2
5 25 5
5
Head 71 58 72 56 66 62 46 34 27
80
Body 134 109 131 108 124 114 86 63 52

5478900-2-1EN Rev. 3 (October 2016) 12-31

Scan Duration(seconds) required to meet 1Gy CTDI100(peripheral) at 200mA exposure

Aperture

kV SFOV 2×0.62
16×1.2 16×0.6 4×0.62
8×2.50 8×1.25 4×3.75 4×2.50 4×1.25 5,1×1.2
5 25 5
5
Head 40 33 41 32 38 35 26 19 15
100
Body 72 59 71 58 67 62 46 34 28
Head 26 21 26 21 24 23 17 12 10
120
Body 44 36 43 35 41 37 28 20 17
Head 19 15 19 15 18 17 12 9 7
140
Body 32 26 31 26 30 27 20 15 12

Other Dosimetry Information

Dose Length Product (DLP)

The dose length product (DLP) is a simple calculation and is given in milliGray-Centimeters
(mGy-cm). The DLP is computed and displayed on Scan Rx Menu for each group prior to the
scan as well as an accumulated DLP for all scans taken up to the current time during the
exam. Note that system computations may vary slightly from manual calculations due to
differences in round-off or truncation. The final exam accumulated DLP provides a
convenient measure for maintaining patient or procedure dose management statistics. The
DLP is computed given the CTDIvol described above as follows:
DLP = CTDIvol x (total scan coverage in cm).
The total scan coverage can be determined from the Scan Rx Menu as the product of the
table speed in cm/sec and the total exposure time in seconds. For helical scanning, the total
scan coverage (length) will be longer than the image length due to the having to obtain
additional scan views at both the beginning and end of a scan in order to have sufficient
data for reconstruction of the end images. - this is known as helical over beaming.
Differences between the displayed and manually calculated DLP value may occur if the total
coverage as a function of x-ray on-off time is not used.

Dose Efficiency (Reference IEC 60601-2-44)

The dose efficiency, which is a function of focal spot size and beam collimation, is also
automatically computed and displayed on the Scan Rx Menu. The dose efficiency is a
measure of how much of the Z-axis X-ray beam is used by the system.

LightSpeed16 Slice

12-32 5478900-2-1EN Rev. 3 (October 2016)

Collimation Dose_Efficiency_Large_Focal_Spot % Dose_Efficiency_Small_Focal_Spot %

2x0.625 41.87 78.31
4x0.625 47.90 53.06
4x1.25 63.44 72.50
4x2.5 86.75 90.96
8x1.25 78.41 85.19
16x0.625 78.80 85.70
4x3.75 92.04 90.87
8x2.5 96.99 99.82
16x1.25 97.40 98.66

LightSpeed 4/8 Slices

Collimation Dose_Efficiency_Large_Focal_Spot % Dose_Efficiency_Small_Focal_Spot %
2x0.625 N/A 100.00
1x1.25 30.96 36.34
4x1.25 65.93 73.86
4x2.5 87.43 90.58
8x1.25 81.11 87.10
4x3.75 92.92 90.78
8x2.5 96.97 99.82
4x5 96.97 99.82

Scout Dose
Generally, because of short scan times and low mA, the scout dose will be a small part of the
total patient exam dose, additionally a standardized scout dose calculation method has yet
to be developed for CT, therefore scout dose is not currently reported by the system.

Phantoms for Performance Testing (Reference 21CFR 1020.33

(c)(3)(v))
The results of this section conform to federal regulation 21CFR 1020.33 (c).
GE used the phantoms and procedures recommended in the CDRH final draft of “Routine
Compliance Testing for Computed Tomography X-Ray Systems” (dated April 26, 1984) to
measure dose and dose profile, and calculate CTDI.

5478900-2-1EN Rev. 3 (October 2016) 12-33

GE used a 21.5cm water filled acrylic phantom to measure all Head performance tests.
Testers placed a 30cm wide acrylic ring around the water phantom to measure Body
performance.

Noise
Statistically measure the CT numbers represented by an array of pixels contained in a 2 x
2cm central region of interest (ROI)
Noise equals the standard deviation expressed in Hounsfield units, divided by 1000 to
represent the contrast scale between air and water, then multiplied by 100 to give a value in
percent.

Noise
1020.33 (C) (3) i

The Standard Deviation In the Center scanned with Typical Technique and Standard 512
Recon at 5mm, 4i mode.

Head Body
0.5% 1.3% 260mAs 120 kVp

GE used the Small Body SFOV, rather than the Head SFOV.
Head: Use 25cm FOV
Body: Use 35cm FOV
Both SFOVs use similar resolution algorithms except the Small Body SFOV does not use the
bone/brain interface correction, which the phantom does not need.
The Small Body and Head SFOV produce negligible image performance differences.

12-34 5478900-2-1EN Rev. 3 (October 2016)

Representative Images (Reference 21CFR 1020.33 (d)(3)(i))

Figure 12-13 Representative Images
LightSpeed Series Axial Head (25cm FOV)

120kV, 260mA, 1sec, 5mm, 4i

LightSpeed Series Axial Body (35cm FOV)

120kV, 260mA, 1sec, 5mm, 4i

5478900-2-1EN Rev. 3 (October 2016) 12-35

For digital form of representative images, can refer to the following steps to find them on
the software UI.
1. On Display Monitor, select [Service] to show the Common Service Desktop. Then, click
the [Install 21CFR Images] under [Image Quality].

2. A message will pop up to show the installation success.

3. Go to [ImageWorks] to check the images. Image information: Exam: 320/ct99, Name:

Power Noise2.

12-36 5478900-2-1EN Rev. 3 (October 2016)

Nominal Slice Thickness (Reference 21CFR 1020.33 (c)(3)(iii))

Table 12-11 Nominal Slice Thickness

Head (For 16 slice) Body (For 16 slice)

5.0mm, 4i mode 5.0mm, 4i mode
3.75mm, 4i mode 3.75mm, 4i mode
2.5mm, 4i mode 2.5mm, 4i mode
1.25mm, 4i mode 1.25mm, 4i mode
1.25mm, 1i mode 1.25mm, 1i mode
0.625mm, 2i mode 0.625mm, 2i mode
2.5mm, 8i mode 2.5mm, 8i mode
1.25mm, 8i mode 1.25mm, 8i mode
1.25mm, 16i mode 1.25mm, 16i mode
0.625mm, 16i mode 0.625mm, 16i mode

Sensitivity Profile (Reference 21CFR 1020.33 (c)(3)(iv))

The sensitivity profile is a graph of the slice thickness. To recreate the original graphs, scan a
0.5mm tungsten wire in air that makes a 26.6° angle with scan plane. The wire is centered at
ISO center.
Refer to profile graphs in Figure 12-14 and Figure 12-15.