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GE Healthcare

BRIVO CT Series
Technical Reference Manual

GE Hangwei Medical Systems does business as GE Healthcare

This Manual Supports the Following Product Names:

BRIVO CT 315
BRIVO CT 325

BRIVO CT Series
Technical Reference Manual, English
5314180-1EN
Revision: 10
© 2012 General Electric Company
All rights reserved.
Revision History

REV DATE REASON FOR CHANGE


1 January, 2010 Initial release for BRIVO CT
2 January, 2010 Initial release for BRIVO CT
3 January, 2010 Initial release for BRIVO CT
4 January, 2010 Initial release for BRIVO CT
5 June, 2010 Update Information
6 November, 2010 Update Information
7 December, 2010 Update Information
8 January, 2011 Update Information
9 July, 2011 Update Information
10 February, 2012 Update Information

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© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

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© 2012 General Electric Company. All rights reserved.
Table of Contents
Revision History .......................................................................................................................................i-i

Chapter 1: BEFORE YOU START


User Information Description ................................................................................................1-2
Applications Help.........................................................................................................................1-3

Chapter 2: X-RAY PROTECTION

Chapter 3: SAFETY
Warning Labels and Symbols................................................................................................3-2
Equipment Warning Labels (Reference 21CFR 1040.10 (h)) ....................................3-4
Radio Wave Safety......................................................................................................................3-9
General Safety Guidelines .................................................................................................... 3-10
Implantable Device Safety........................................................................................... 3-11
Radiation Safety (Reference 21CFR 1020.30 (h) (1) (i)).............................................. 3-12
Authorized Users .............................................................................................................. 3-12
General Radiation Safety.............................................................................................. 3-12
Scans Acquired at the Same Tomographic Plane ............................................ 3-13
CTDIvol .................................................................................................................................. 3-14
Pediatric and Small Patient Imaging....................................................................... 3-14
X-Ray Tubes........................................................................................................................ 3-14
Electrical Safety ................................................................................................... 3-15
Mechanical Safety.................................................................................................................... 3-16
General Mechanical Safety ......................................................................................... 3-16
Patient Positioning ................................................................................................................... 3-17
Laser Safety (Reference 21CFR 1040.10 (h))................................................................. 3-19
Reconstructed Image Orientation.................................................................................... 3-20
Data Safety.................................................................................................................................. 3-21
Application Specific Safety Topics.................................................................................... 3-24
Advanced Applications Safety............................................................................................ 3-24
IMPORTANT SAFETY INFORMATION.................................................................................. 3-25
Operator Console Ergonomics........................................................................................... 3-25
Posture .................................................................................................................................. 3-25
Equipment Adjustments................................................................................................ 3-26
Accessories.................................................................................................................................. 3-27
Emergency Stop and Emergency Egress ...................................................................... 3-27
Emergency Stop................................................................................................................ 3-27
Emergency Stop Button Symbols............................................................................. 3-29
Emergency Egress ........................................................................................................... 3-29
Maintenance and Cleaning.................................................................................................. 3-29
Cleaning Equipment (Bio Hazard) ..................................................................................... 3-31

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BRIVO CT Series

Environmental Concerns ...................................................................................................... 3-31


Explanation of Pollution Control Label................................................................... 3-31
Precautions ................................................................................................................................. 3-33

Chapter 4: TUBE WARMUP

Chapter 5: DAILY CALIBRATION


Daily Calibration...........................................................................................................................5-1

Chapter 6: SCANNER UTILITIES PROCEDURE

Chapter 7: PREPARE THE SYSTEM

Chapter 8: CHECK DISK SPACE


Check Image Space ...................................................................................................................8-1

Chapter 9: RESET THE SYSTEM


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

Chapter 10: STOP/START THE OPERATING SYSTEM


To turn off switches at Gantry lower left side, Shutdown the system............. 10-1
To turn on the switches at Gantry lower left side, start up the System.......... 10-2

Chapter 11: GENERAL INFORMATION


System components:...................................................................................................... 11-1
Emergency Stop: .............................................................................................................. 11-1
Intended Use...................................................................................................................... 11-1
Indications for Use................................................................................................................... 11-1
CT Description............................................................................................................................ 11-2
CT Operation Theory............................................................................................................... 11-2
DICOM Print................................................................................................................................. 11-3
X-Ray.............................................................................................................................................. 11-3
Tube Warmup ........................................................................................................................... 11-4
BRIVO CT Theory of Operation ........................................................................................... 11-4
System Characteristics.................................................................................................. 11-4
Network ........................................................................................................................................ 11-6
DICOM IEC Network Form .................................................................................................... 11-8
Purpose of Brivo scanner connection to network ............................................ 11-8
Network interface technical specifications .......................................................11-10
Network information flows specifications .........................................................11-10
Required characteristics and configuration of network
for support of Brivo Scanner specifications ......................................................11-14

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X-ray Generation and Detection Details .................................................................... 11-15
System Operational Modes .............................................................................................. 11-17
System Image Quality Features ..................................................................................... 11-18
Current X-Ray Tube Capacity Effects Prescriptions and Interscan Delays 11-19
Data Collection ....................................................................................................................... 11-19
Reconstruction ....................................................................................................................... 11-20
Calibration Scans ................................................................................................................. 11-21
Warm-up Required............................................................................................................... 11-21
Data Storage ........................................................................................................................... 11-21
Image Display ......................................................................................................................... 11-21
Gray Scale................................................................................................................................. 11-22
CT Number................................................................................................................................ 11-23
Variables You Cannot Control ........................................................................................ 11-24
Pixels............................................................................................................................................ 11-24
Pixel Coordinates .................................................................................................................. 11-24
RAS Coordinates .................................................................................................................... 11-25
Pixels and CT Numbers ...................................................................................................... 11-27
Window Width ........................................................................................................................ 11-28
Window Level.......................................................................................................................... 11-28
Principle of Digital Tilt (DT) ................................................................................................. 11-28
What is Tilt Image ......................................................................................................... 11-28
Digital Tilt .......................................................................................................................... 11-30

Chapter 12: QUALITY ASSURANCE


Overview....................................................................................................................................... 12-1
Phantom Description.............................................................................................................. 12-1
QA Schedule (Reference 21CFR 1020.33 (d)(2)) ........................................................... 12-2
Phantom Setup.......................................................................................................................... 12-2
System Performance (Reference 21CFR 1020.33 (d)(2)).......................................... 12-3
Maintain Image Quality................................................................................................. 12-3
Scan the QA Phantom............................................................................................................ 12-4
Test and Analysis of the Phantom Images........................................................... 12-4
Contrast Scale ................................................................................................................... 12-4
High Contrast Spatial Resolution ...................................................................................... 12-5
Slice Thickness........................................................................................................................... 12-7
Positioning Light Accuracy (optional).............................................................................. 12-8
Low Contrast Detectability .................................................................................................. 12-9
Noise and Uniformity (Reference 21CFR 1020.33 (j))............................................. 12-10
Typical Results and Allowable Variations................................................................... 12-10
Contrast Scale ................................................................................................................ 12-11
High Contrast Spatial Resolution........................................................................... 12-11

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BRIVO CT Series

Nominal Slice Thickness .............................................................................................12-11


Low Contrast Detectability ........................................................................................12-11
Noise and CT Number of Water ..............................................................................12-11
DOSIMETRY................................................................................................................................12-12
CTDIw (Reference IEC 60601-2-44 and 21 CFR 1020.33(c))........................12-12
CTDI...............................................................................................................................................12-12
Peak Skin Dose ........................................................................................................................12-18
Deterministic effect (refer to IEC60601-2-44:2009 Clause 203.5.2.4.5) ........12-21
Other Dosimetry Information ...........................................................................................12-22
Dose Length Product (DLP) .......................................................................................12-22
Dose Efficiency (Reference IEC 60601-2-44) ....................................................12-22
Dose and Sensitivity Profile at Phantom Center......................................................12-22
Image Performance (Reference 21CFR 1020.33 (c) (3) (v))...................................12-31
Deviations (Reference 21CFR 1020.33 (c)) ..........................................................12-33

Chapter 13: TUBE SPECIFICATIONS


X-Ray Tube Assembly Information................................................................................... 13-1
Diagnostic Source Assembly .............................................................................................. 13-1
X-Ray Tube IEC Information ................................................................................................ 13-3
X-ray Tube Housing ........................................................................................................ 13-3
X-ray Tube Insert.............................................................................................................. 13-3
X-ray Tube Assembly...................................................................................................... 13-3
X-ray Tube Insert Information.................................................................................... 13-3
Nominal Anode Input Power (Reference IEC 60613) ....................................... 13-3
Maximum Anode Heat Capacity............................................................................... 13-3
Maximum Anode Heat Dissipation (Reference IEC 60613)........................... 13-3
Anode Heating and Cooling Curves ................................................................................ 13-4
Single Load Rating (Reference IEC 60613)............................................................ 13-4
Serial Load Ratings (Reference IEC 60613) .......................................................... 13-4
Rotating Anode Supply.................................................................................................. 13-4
Tube Assembly Information ................................................................................................ 13-4
Tube Assembly Heating and Cooling Curves ............................................................. 13-6
Leakage Radiation - Loading Factors .................................................................... 13-6
Half Value Layer ............................................................................................................... 13-6
CT Scan Ratings ................................................................................................................ 13-6
Classification (Reference IEC 60601-1) .................................................................. 13-7
Transportation and Storage ....................................................................................... 13-7
Transport Packaging ...................................................................................................... 13-7
Thermal Characteristics of X-Ray Tube Assembly
(Reference IEC 60613) .................................................................................................... 13-7
Generator Specifications ...................................................................................................... 13-8
Main Power Supply (Reference IEC60601-2-44)................................................ 13-8
Generator Rating and Duty Cycle ............................................................................ 13-8
Measurement Basis ........................................................................................................ 13-9

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The Attenuation Equivalent ................................................................................................. 13-9
Environmental Specifications .......................................................................................... 13-10
Non-Operating Environment (Reference IEC 60601-1) ............................... 13-10
Operating Environment.............................................................................................. 13-10

Chapter 14: Regulatory Information


Applicable Regulations and Standards:......................................................................... 14-1

Chapter 15: Electromagnetic Compatibility


EMC Performance .................................................................................................................... 15-1
Notice upon Installation of the Product......................................................................... 15-4
General Notice................................................................................................................... 15-4
Countermeasures against EMC-related Issues.......................................................... 15-4
General countermeasures........................................................................................... 15-4
Notice on Service...................................................................................................................... 15-8

Chapter 16: SYSTEM SPECIFICATIONS


........................................................................................................................................................... 16-1
BRIVO CT Rating Plate (Reference 21CFR 1020.30 (h) (1) (i)) .................................. 16-8
Image Performance ................................................................................................................ 16-9
According with IEC61223-3-5 description ........................................................... 16-9
Consistent with the description of YY0310 ....................................................... 16-14
Basic Parameters .................................................................................................................. 16-16
Detector............................................................................................................................. 16-16
Scan Mode........................................................................................................................ 16-16
Scan FOV........................................................................................................................... 16-16
Image Reconstruction and Display ...................................................................... 16-17
Helical scan pitch factor ............................................................................................ 16-17
Exposure Time Accuracy ........................................................................................... 16-17
Scan exposure Time Variance................................................................................. 16-17
X-ray High-Voltage Generator Parameters...................................................... 16-17
Gantry Basic parameters .......................................................................................... 16-18
Patient Support Basic Parameters........................................................................ 16-18
Laser Alignment Lights .............................................................................................. 16-19
Alignment Light Accuracy (Refer to IEC 61223-3-5 for test method).... 16-19
Scout Basic Parameters............................................................................................. 16-19
Symbols and Classification............................................................................................... 16-20
Class 1 Equipment ........................................................................................................ 16-23
Type B Equipment......................................................................................................... 16-23
Ordinary Equipment..................................................................................................... 16-23
Operation Of Equipment............................................................................................ 16-23
Environmental Specifications.................................................................................. 16-23
System Cooling Requirements ............................................................................... 16-23
Subsystem Minimum Allowance (Watts / BTU/Hr) ........................................ 16-24

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BRIVO CT Series

Cleaning..............................................................................................................................16-24

Chapter 17: PLANNED MAINTENANCE


Maintenance by CT Users..................................................................................................... 17-5

Chapter 18: Product Manufacturer

Chapter 19: PREINSTALLATION


System Introduction................................................................................................................ 19-1
The Standard System consists of the following major components. ...... 19-1
Room Sizes .................................................................................................................................. 19-2
Minimum Room Dimensions....................................................................................... 19-2
Component Dimensions ............................................................................................... 19-2
Radiation Protection ............................................................................................................... 19-3
Radiation Considerations............................................................................................. 19-3
Scatter Radiation ............................................................................................................. 19-3
Construction Materials .......................................................................................................... 19-8
Floor ....................................................................................................................................... 19-8
Cabling Considerations ......................................................................................................... 19-8
Temperature And Humidity................................................................................................. 19-8
Gantry/Scan Room:......................................................................................................... 19-8
Operator’s Control/Equipment Room:.................................................................... 19-8
Altitude.................................................................................................................................. 19-9
Installation Insite ...................................................................................................................... 19-9
Phone Line........................................................................................................................... 19-9
Unique IP Address............................................................................................................ 19-9
Power Requirement ................................................................................................................ 19-9
System Interconnects ..........................................................................................................19-10
System Interconnect Diagram.........................................................................................19-11
Storage Requirement ...........................................................................................................19-11

Chapter 20: INSTALLATION


Gantry Installation ................................................................................................................... 20-1
Table Installation ...................................................................................................................... 20-1
System with Template Installation................................................................................... 20-2
Operator Control....................................................................................................................... 20-2
System Power, Ground And Signal Cable Connection............................................ 20-2
Cable Inter-Connection ......................................................................................................... 20-2
Indication Light/Switch Connection ................................................................................ 20-2
Ground Continuity Check...................................................................................................... 20-2
System Power ............................................................................................................................ 20-3
Scan Test...................................................................................................................................... 20-3

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Calibration ................................................................................................................................... 20-3
CT Number Adjustment ......................................................................................................... 20-3
System Verification.................................................................................................................. 20-3
Language Selection................................................................................................................. 20-3
Back-up System State Data ................................................................................................ 20-3
System And Room Cleaning ................................................................................................ 20-4

Chapter 21: Abbreviations

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BEFORE YOU START

Chapter 1
BEFORE YOU START

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

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

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

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

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BRIVO CT Series

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 four 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.
• Quick Step Guide: The Quick Step Guide contains general instructions required to
operate the scanner. It provides users with a step-by-step guide for a set of listed
procedures.
How to read this guide in the system
1. Insert the CD-ROM of this guide into the DVD-RAM drive of the Operator Console.
2. Select the [Service] icon. Click on [Operator Manual] of the menu on the upper right
corner of the screen, the system shows electronic documents of this guide.

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BEFORE YOU START

Applications Help
Although we try to make this guide complete and accurate, undocumented changes or
unexpected results do occur.
If you can't find the answer to your application question, you may call the Customer Center.
Use this phone number for non emergency purposes only, because you may not receive an
immediate response.
800-810-8188

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 and the
Technical Reference Manual.

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.

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X-RAY PROTECTION

Chapter 2
X-RAY PROTECTION

CAUTION: Improperly used X-Ray equipment may cause injury. Read and understand
the instructions in this book before you attempt to operate this equipment.
The General Electric Company, 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 local related law on Radiation Protection and
Measurements, and the International Commission on Radiation Protection.

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.

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SAFETY

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.

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.
This manual should be kept near the console for easy access.
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 (21CFR 801.109).
The system is classified as a Class I, IPX0 equipment, not suitable for use in the
presence of a flammable anaesthetic 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.

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BRIVO CT Series

Warning Labels and Symbols


This chapter addresses three safety classifications:

DANGER: 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.

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

Warning, Caution - consult accompanying documents

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SAFETY

Symbol Description

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)

General Warning Sign (may be accompanied with text)

Refer to instruction manual/ booklet

Pushing prohibited

Manufacturer (responsible design owner)

Model Number

Serial Number

Date of Manufacture

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BRIVO CT Series

Symbol Definition (Continued)

X-Ray Filtration (Al Equivalent Filtration)

Minimum Filtration

Radiation of Laser Apparatus

Large Focal Spot

Equipment Warning Labels (Reference 21CFR 1040.10 (h))


The following Warning Labels are used on the equipment:
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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SAFETY

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

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BRIVO CT Series

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 Table Caution Label

CAUTION: Do not grasp the side of the cradle.


Figure 3-6 Keyboard Warning Label

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.
The following Warning Labels are used on the equipment per IEC60601-1:2005:

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SAFETY

Figure 3-7 Caution 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 3-8 The Pushing prohibited label is used on Power Distribution Unit

! 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 3-9 The Weight Maximum caution label is used on table

! CAUTION
AVOID INJURY.
Do Not Exceed Table
>180kg Maximum Capacity
of 180 kg (397 lb).

CAUTION: AVOID INJURY. Do Not Exceed Table Maximum Capacity of 180 kg (397lb).

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BRIVO CT Series

Figure 3-10 Load Limit Caution

CAUTION: Excessive weight can break accessory and cause injury. Do not load more than
34kg or 75 pounds.
Figure 3-11 Accessory Caution

CAUTION: Do not hit the accessory against the gantry. Patient injury or equipment
damage could result.
Figure 3-12 Accessory Load Limit

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

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SAFETY

Figure 3-13 The following label is attached to the operator console.

CAUTION: Do not use the following devices near this equipment. Cellular phone, radio
transceiver, mobile radio transmitter, radio controlled toy, etc. Use of these
devices near this equipment could cause this equipment to perform outside
the published specifications. Keep power to these devices turned off when
near this equipment.

WARNING: DO NOT put this computer at high levels, to avoid the risk of falling!

Radio Wave Safety


Never use the following devices near this equipment.
Use of these devices near this equipment may induce erratic function of the equipment.
Devices not to be used near this equipment
Devices which intrinsically transmit radio waves such as;
cellular phone, transceiver, mobile radio transmitter and radio-controlled toy, etc.
Keep those devices power-off near this equipment.

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BRIVO CT Series

NOTE: Medical staff in charge of this equipment is required to instruct technicians, patients
and other people who may be around the equipment to fully comply with the above
regulation.
NOTE: Your system also has a warning label on a console that warns of the above hazard.

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 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. 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.
• Unauthorized personnel should not be allowed access to the system.
• 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 scanner if it appears damaged or fails. Wait for qualified
personnel to correct the problem.
• 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 and then 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.

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SAFETY

• 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.
• Always follow the exam procedures provided in the operator manual. Verify correct
entry of identification, patient positioning, and other patient data before proceeding
with the exam. Incorrect procedures or patient data entry could cause misinterpretation
of the exam results.
• 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.
• Use only GE approved equipment with this system.
• Do not load any non GE approved software onto the computer.

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 implantable devices such as


pacemakers or neuro stimulators and could cause operational changes to the
device. Consult with the Technical Service assistance/Hot line of the
Implantable manufacturer prior to scanning. The Operator Warnings and
instructions from the implantable device manufacturer may provide further
assistance.

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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.

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 local law on Radiation Protection
and Measurements and the International Commission on Radiation Protection.

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 Healthcare 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.

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WARNING: Never calibrate, test the scanner, or warm the tube with patients or personnel
present in the scan room.
– 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.

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:
– Use proper techniques according to anatomy location and clinic application you are
scanning.
A warning message Figure 3-14 is posted when [Confirm] is selected for the following scan
types:
– SmartPrep Baseline and Monitor scans
– Cine scans
– Axial scans with zero table increment (Interval)
Figure 3-14

After reading the message, if you wish to continue with the scan, click [Continue].

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CTDIvol
The CTDIvol is a weighted average measurement in a reference phantom. This dose is
expressed in milliGrays.
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/.

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

X-Ray Tubes
The scanner 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 overheat and explode if the cooling delays do not meet its design
requirements.
• The images could exhibit artifacts if your X-Ray tube fails to conform with GE tube
performance specifications
• Radiation leakage may exceed GE specifications when a non GE X-Ray tube is installed
in the scanner.

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• The reported dose information may be inaccuracy for any configurations that include
tubes other than GE tubes.

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 scanner.

CAUTION: we cannot assure the accuracy of reported dose information for any
configurations that include tubes other than GE tubes because reported dose
information is calculated based on empirical observations of systems with GE
tubes.

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 supply mains with a protective earth. 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.

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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 Healthcare requirements. If you have any questions about
these requirements, contact GE Healthcare.
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.

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.
• 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 at the base
areas, such as individually in a figure eight at the base of stationary equipment. This
discourages signal interference and protect cables from damage due to traffic.
• 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 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.

Mechanical Safety

General Mechanical Safety


• Check for any obstruction around the equipment before attempting to move the table.
When performing table motions, always monitor the progress of the motion.

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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.

Patient Positioning

DANGER: DO NOT PLACE A PATIENT ON THE TABLE WEIGHING MORE THAN THE UPPER
LIMIT OF 180 KG. THIS COULD CAUSE THE TABLE TO FAIL AND THE PATIENT
COULD FALL.

Table capacity:
– Less than 180 kg with ±0.25 mm positional accuracy guaranteed.

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

CAUTION: When using accessories, make sure all accessories are CT imaging
accessories. 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 movement cradle and may cause an injury.
• The concentrated weight of short, heavy patients can cause the cradle to make contact
with the gantry.
– Make sure you do not drive the cradle into the gantry cover.
– Make sure you do not pinch the patient's skin or extremities between the cradle and
the gantry.
• Avoid any patient contact with the gantry during cradle movement (manual or software
driven).
• Latch the cradleduring the patient loading and unloading.
• Latch the cradle before you load or unload the patient.

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

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: When the patient is in the scanning position before scanning, make sure that
the space needed for the patient and patient's attachments is smaller than
the Gantry opening. When the required space is close to the Gantry opening,
it's necessary for the operator in the scan room to operate the cradle to do
reciprocating motion within the scan range to make sure that there would not
be interference between the Gantry opening and the patient and patient's
attachments.

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.
• Check the accessory attachment plate fixed to the end of the move cradle. Repair or
replace if loose or damaged.
• Use the move cradle extender to support the patient's head or feet during a scan.

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.
Cradle extender is only designed to support 75 pounds (34kg). Ask the patient
to move up into the head holder or manually help the patient into position.
To move the patient out of the gantry in an emergency, the cradle can be manually
withdrawn.

WARNING: Security strap should be used to fix the patient's head and body. This is to
prevent the patient from injury of Gantry.

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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 the
patient has been positioned on the cradle and an exam started.

CAUTION: The Head Holder or the move cradle 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 the move cradle
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 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.

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.

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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: 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 3-15 Patient Orientation
A P

R L L R

P A
Head First Supine Head First Prone
A P

R
L R L

P A
Feet First Supine Feet First Prone

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SAFETY

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.

Data Safety

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.
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.

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


misdiagnosis.

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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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SAFETY

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: The manual cradle release feature is intended for emergency egress and
small movements. In rare instances, if the cradle release is used to move a
patient out of the gantry, instead of using the table control buttons as
specified in the operator manual, a discrepancy of up to 6 mm between the
numerical display on the gantry and the actual position of the table can be
introduced.

Application Specific Safety Topics

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. 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

WARNING: For helical scans, the Segment Recon Mode in Retrospective Recon may be
used to assess if there is an artifact or not. If questions still arise, then re-scan
the area with a 2 second Axial scan.

Advanced Applications Safety

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.

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SAFETY

IMPORTANT SAFETY INFORMATION


As a manufacturer of CT systems, we would like to take a moment to remind all
Technologists and Radiologists that clinical interpretation errors can be made due to motion
artifacts in large vessels, i.e. Thoracic Aorta. These motion artifacts may emulate a vessel
dissection. Interpretation errors may cause misdiagnosis or unnecessary surgery. Vessel
motion artifacts have been documented in Radiology literature for some time.

Motion artifacts in large vessels may be caused when using any manufacturer’s CT scanner
capable of scanning with 1 second or less rotation times. The pulsation of the vessel creates
a double margin of the vessel emulating a dissection. The motion artifact is an interaction
between the pulsation of the vessel and the rotation time of the scan.

As an aide, we have updated the CT system with the following information to help rule out
artifact or real pathology in clinical situations where a vessel dissection may be apparent.

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 1.0 second scans. This can occur in axial or helical scans. If you have
scanned axially or helically with a 1.0 second rotation time and observe this
phenomenon, rescan the area with a 2 second axial scan to verify if it is artifact or
patient pathology.

Please ensure that the appropriate personnel in your CT Department are made aware of this
notice. If you have any questions regarding this notice, please contact your local GE
representative.

If you would like to review additional information in the clinical literature please review the
following publication: Gotway, Michael: Helical CT evaluation of the thoracic aorta.
Applied Radiology: Sept. 2000, 7-28.

Operator Console Ergonomics


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

Posture
Correct posture is very important. To ensure correct posture while sitting at your operator
console, follow these basic steps:
1. Face the monitors and keyboard without twisting your body.
2. Sit comfortably erect with the small of your back well supported.
3. Position your forearms parallel to the floor, with your wrists straight.

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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
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.

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:
Keep the patient in view at all times.
– Never leave the patient unattended.
– 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.

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

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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.

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

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.

Emergency Stop and Emergency Egress


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

Emergency Stop
• In the event of a hardware failure that could cause serious damage, such as smoke, fire
or unintentional cradle movement, press one of the red [Emergency Stop]
switches located on the operator console or at the gantry control panels. Low power to
the electronic components in the computer and data acquisition system remains ON.
• When Emergency Stop is applied, the moving cradle may overrun by less than 10 mm.

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GE provides training support. Contact your local GE sales representative to arrange training
sessions to meet your needs.
The system has five Emergency Stop buttons:
• One on each side of control panel on the front of the gantry. (Figure 3-16)
Figure 3-16 Front of Gantry Emergency Stop Buttons

Emergency Stop Buttons

• Two on the rear cover of the gantry.


• One on the Acquisition control (Figure 3-17)
Figure 3-17 Emergency Stop Button on the Keyboard

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SAFETY

Emergency Stop Button Symbols


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

Emergency Egress
System operation may be stopped due to power failure or the system may be halted by the
operator in response to emergency conditions.
The Cradle unlatch button should only be used in Emergency Egress situations.

To safely remove the patient:


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

Maintenance and Cleaning


• To guarantee safe, reliable equipment performance, the site must be prepared
according to GE Healthcare 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 Healthcare.

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• 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 up 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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SAFETY

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 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.

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

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

Component Hazardous substances' name


Name (Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE)
Operator
X O O X X X
Console
Gantry X O X X X X
LCD Monitor O X O O O O
Power
X O X X X X
Distribution Unit
Scan Table X O X X O O
• 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 federal laws. (Within this system, the backlight
lamps in the monitor display contain mercury.)

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SAFETY

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.
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 GEHC field service will advise you on the suitable means of disposal.
The X-Ray Tube Assembly to be discarded should be forwarded to the GEHC Service
network, and it will be disposed of in a GEHC 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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TUBE WARMUP

Chapter 4
TUBE WARMUP

To maintain image quality and long tube life, complete the Warmup procedure.
• Open the scan monitor screen. As shown in Figure 1

Figure 1

• Select [Tube Warmup] key to display the Warmup screen. As shown in Figure 2 below.
– When you haven't used the X-Ray tube for more than two hours
– Daily Calibration: Tube warmup runs automatically when Daily Calibration is
selected.

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BRIVO CT Series

Before system calibration

Figure 2

Figure 3

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TUBE WARMUP

GE suggests you warm up the tube after every two hours of non-use.
• The system displays the following message on the Scan Monitor screen:
Warming up the tube as recommended will provide the high quality image and extend the
life of the tube.
Make sure that no one is in the scan room and the gantry aperture is clean during warmup.
NOTE: Tube warmup will run in Autoscan mode.
• Read the compatibility Warning.
• Click [Confirm] when you understand the implications.
• Tube warmup runs a series of tube heating scans. As shown in Figure 3
• When finished, the system display returns to the Tube Warmup screen.
A message that tube warm-up has been completed will also be in the system message log.

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DAILY CALIBRATION

Chapter 5
DAILY CALIBRATION

Daily Calibration
To maintain image quality, complete the daily Calibration procedure once a day.
1. Display the Scan Monitor screen.
– Make sure there is no obstruction in the Gantry opening.

Figure 1

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BRIVO CT Series

2. Select [Tube Warmup] and [Daily Calibration] to display the screen. As shown in
Figure1 and Figure2.
– Before the start of every scan day.
– Before calibration check
– Before system calibration

Figure 2

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DAILY CALIBRATION

3. The system automatically selects the Auto Scan function. As shown in Figure3.
– The system automatically selects sequence of scans

Figure3

NOTE: Some of the warmup scans may not run if tube is sufficently warm before daily
calibration.
– Following system instructions to initiate the first scan, and the system acquires the
rest of the scan set.
Remain near the console during auto scan acquistition, so you can stop X-Ray if someone
enters the scanner room.

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SCANNER UTILITIES PROCEDURE

Chapter 6
SCANNER UTILITIES PROCEDURE

IIn order to maintain image quality, in every 1 to 3 months to complete once the user
calibration procedure
1. Open the scan monitor screen.
- Clear the gantry opening.
2. Select [Scanner Utilities] --> [User Calibration]--> [Air
Calibration] to open the screen. As shown in Figure 1 and
Figure 2.
- Every 1 to 3 months to complete once.
- The system automatically selects the series of scan。

Figure 1

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BRIVO CT Series

Figure 2

3. Select [Air&Phantom Calibration] key to open the screen. As shown in Figure3.

Figure 3

• Because the air-calibration does not improve the image quality.


• Complete once every one to three months.
• System automatically selects the series of scan.
– Warm up
– Air Scan
– 20cm of water phantom scanning, with the center offset 40mm.
– 20cm of water phantom scanning, with the center offset 70mm.
NOTE: Some of the warmup scans may not run if tube is sufficently warm before the fast
calibration.
– According to system instruction to start the first scan, the system requirements for
the rest of scanned Series.
– 20cm of water Phantom in different locations need to be scan.
– Remain near the console during auto scan acquisition, so you can stop X-ray if
someone enters the scanner room.

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PREPARE THE SYSTEM

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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CHECK DISK SPACE

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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RESET THE SYSTEM

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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STOP/START THE OPERATING SYSTEM

Chapter 10
STOP/START THE OPERATING
SYSTEM

To turn off switches at Gantry lower left side, Shutdown the


system.
• On Display Monitor, select the [Shutdown] icon. 
Dialog is posted

• Select Shutdown and click OK. Dialog will be posted


– Attention
System shutting down please wait...
• When the system is down a message is posted
– System Halted
• Press “Power” button of OC
• Turn off Gantry/Table, Rotate, XG switches.

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BRIVO CT Series

To turn on the switches at Gantry lower left side, start up the


System.
• Turn on Gantry/Table, Rotate, XG switches on Gantry
• Press “Power” button on OC.
• Dialog is posted on the display monitor
– System starting up please wait...
• When this dialog disappears the system is ready to use.
• If your system has the HIPAA login enabled, you are required to login to the system.

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GENERAL INFORMATION

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.

Intended Use
The system is intended to be used for head and whole body computed tomography.

Indications for Use


The BRIVO CT Series scanner is a series of general purpose CT scanner, with 2 types of
products in the family, single and dual slice detector. This series of systems are indicated for
head and whole body CT scanning and applications.

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BRIVO CT Series

BRIVO CT may be used in following areas:


• Neuro CT Angiography studies
• CT head and neck and orthopedic studies
• CT pulmonary imaging studies
• Abdomen,
• Pelvis
• Extremity
Patient Population: Patient at all age, who is suspected with disease.
Operator Profile: Operator including different level of CT technologists, who must be trained
in CT system operation and has sufficient knowledge of radiation.
Intended Use Environment: The CT system intended to be used in Radiology, Oncology,
Clinic, Emergency Room, etc.

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 LCD. Even though CT
creates X-Ray exposures, we normally refer to them as images.
Additional computer software can 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.

CT Operation Theory
The PDU (power distribution unit) which is located inside the Gantry is responsible for
distributing system power. Power travels from the PDU to the components which generate
X-Rays. 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 (optional)/ 30 (standard) seconds
and Axial exposures last from 1 to 5 seconds.

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GENERAL INFORMATION

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 of the single or dual Slice detector about 972 times per second, amplifies and quantifies
the existing current, then sends the resulting data to the DARC (Data Acquisiton and Recon
Center).
Each complete sample by the DAS is called a view. The reconstruct 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 LCD for display. The OC (operator console) contains the LCD and controls the
computer, X-Ray, and cradle drives.

DICOM Print
The BRIVO CT 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.
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.

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BRIVO CT Series

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.

BRIVO CT Theory of Operation


System Overview
BRIVO CT scanner is a 3rd generation CT scanner. It will support all clinical applications
currently supported by the CT/e Series System.
BRIVO CT system is a new series of Computed tomography system, and it has two types of
detector ad DAS (Data Acquisition System) configuration, single-slice and dual-slice.

System Characteristics
• New single and dual slice CT scanner with new gantry, new ID, and simplified and
connection and simplified workflow for clinical routine scan.
• Optional variable rotation scan speeds (1.0, 1.5, 2.0, 3.0, 5.0) .
• Helical acquisitions at significantly faster table speeds.
• Every system EMC compliant with improved reliability and uptime.

X-ray Tube - CTe X-ray Tube


Venus x-ray tube, develop from the X-ray tube on HiSpeed.

Detector and Data Acquisition Sub-system for single slice


• Up to 10mm coverage (at ISO center).

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GENERAL INFORMATION

• Support 1.0mm, 2.0mm, 3.0mm, 5.0mm, 7.0mm, 10.0mm slice thickness.


• 100% detector geometry dose efficiency.
• 128 channel convert cards GDAS.
• Automatic detector heater control.
• Error detection and reporting.

Detector and Data Acquisition Sub-system for dual slice


• Up to 20mm coverage (at ISO center).l
• Dual rows in Z axis, two rows input from detector.
• Support 0.6mm, 1.0mm, 1.2mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm, 6.0mm, 7.0mm,
10.0mm slice thickness.
• 100% detector geometry dose efficiency.
• 128 channel convert cards GDAS.
• Automatic detector heater control.
• Error detection and reporting.

Patient Scanning
BRIVO CT uses a “shorter” geometry than HiSpeed CT/i. Since X-Ray intensity varies as the
square of the distance, the benefit of BRIVO CT geometry, measured at ISO center, is:
(630/541)2 = 1.36 = 36% better X-Ray flux utilization. It also reduces the centrifugal force on
the tube which will allow for future faster rotational speeds.

Parameter BRIVO CT Series


ISO Height 900 mm
Focal spot to ISO 541 mm
Focal spot to det 949 mm
SFOV 430 mm
Bore 650 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.

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BRIVO CT Series

Network
Remote Host Parameters
BRIVO CT 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 network protocol.
• The Port number is unique to the device. If the device is an Advantage Windows
workstation or another BRIVO CT 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.
• 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 BRIVO CT. Select Yes if
you want the device to be able to send to and/or query the BRIVO CT 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.

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GENERAL INFORMATION

Network Compatibility
BRIVO CT 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 BRIVO CT 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/Bri HiSpeed HiSpeed CT IC HiSpeed 3rd Party
ghtSpeed/ CT/i Advantage NX/i, X/i, or DICOM
/BRIVO CT QX/i Station
LightSpeed/ DICOM Query DICOM Advantage*** Advantage*** DICOM DICOM*
BrightSpeed/ Send Query Query Query Query Query**
Receive Send Receive Receive Send Send
BRIVO CT 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
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: BRIVO CT/BrightSpeed Elite/Edge/Excel Select, LightSpeed16, Ultra, Plus, QX/i, or
HiSpeed QX/i PC based systems do not support Advantage Network Protocol.

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BRIVO CT Series

Table 11-2 Advantage Windows Network Compatibility

From
AW 1.2 AW 2.0 AW 3.10 AW4.0 LightSpeed/
BrightSpeed/
BRIVO CT
LightSpeed/ DICOM DICOM DICOM DICOM DICOM
BrightSpeed/ Send Send Send Query Query
BRIVO CT Send Send
Receive Receive
AW 1.2 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 2.0 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 3.1 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 4.0 SdC Net SdC Net SdC Net SdC Net DICOM
Query Query Query Query Query
Send Send Send Send Send
Receive Receive Receive Receive Receive

NOTE: Advantage Windows systems do not support Query Retrieve provider. Send images
from the Advantage Windows to the BrightSpeed Elite/Edge/Excel Select, LightSpeed
QX/i, LightSpeed Plus, or LightSpeed Ultra.

DICOM IEC Network Form

Purpose of Brivo scanner connection to network


The Brivo 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

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GENERAL INFORMATION

• 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 device
• Services to provide authentication and authorization against Enterprise directory
servers
All of the above features are optional on the Brivo Scanner.

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BRIVO CT Series

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

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GENERAL INFORMATION

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
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

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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 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

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GENERAL INFORMATION

Application Layer Protocol and Modality Performed Procedure Step 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 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.

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Latency max n/a

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 Brivo


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
Control Flow Stationary On-Board
Controller Controller ;UD\7XEH
Real-Time Control Flow 

H

G &ROOLPDWRU
+ 
Slip Ring

UIF Monitor Detector


Host '7%
Computer GDAS
 

Keyboard

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GENERAL INFORMATION

Component Functions Data and Control Flows


Host Computer User interface, image display 1 Scan and recon prescription from
operator
scan recon control, and prescription from user to master controller
image generation
Stationary Stationary base real time 2 Scan parameters
controller controller and “master” distributed
controller
Table controller patient table real-time 2. a Table Position
control
On-Board Rotating base real-time 2.b Rotating parameters
controller control 2.c KV and mA selections
2.d X-Ray beam collimation and filter
selections.
2.e Detector slice thickness and DAS gain
selections
3 Real-Time scan control signals during
scanning.
Generator High voltage generation 4 High voltage
Tube X-ray generation 5 X ray without collimation
Collimator Formation of the X-Ray 6 Collimated X-Ray beam
beam
Detector Conversion of X-Ray to 7 Analog scan data
analog signal signal
GDAS Conversion of analog signal 8 Digital scan data
data to digital data
Slip Ring Signal and Power transfer
between stationary and
rotating components.
DTB Covert digital data to 9 Network data with TCP/IP protocol
network data with TCP/IP
protocol and send to host
computer

X-ray Generation and Detection Details


Overview
The distinguishing feature of BRIVO CT 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.

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• Y = Radial (from ISO toward X-ray tube focal spot).


• Z = Longitudinal (in/out of the scan plane).

X X-Ray Tube Focal Spot

ISO
Scan Plane
Z
Patient Table

Components
Figure 11-1 X-ray generation and detection devices side viewed

X-Ray Tube

Cathode Anode
Uncollimated Bowtie
X-Ray Beam
Collimator Tungsten Bar

Collimated
X-Ray Beam

Row Detector Detector Collimator


Modules

Flexcable

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GENERAL INFORMATION

Collimator Theory
BRIVO CT325 collimator is capable of beam tracking. 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.

System Operational Modes


Overview
• Scout
• Axial
• 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, dependent on generator and tube limitations.
• 0.9 mm resolution in Z.
• 75 mm/sec table speed.
• Data collected in 1 mm mode. Reconstruction algorithms “combine” data to maintain
0.9 mm resolution in Z.

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

Axial
Axial and Cine imaging features include:
• All kV and mA stations available, dependent on generator and tube limitations.
• Scan speeds: 1.0, 1.5, 2.0, 3.0, 5.0 seconds.
• Cine: 1.0 seconds.
• Variable image thickness.
• Segmented reconstruction option for cine scans.

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BRIVO CT Series

Dual slice system can acquire 2 axial slices in a single rotation. These slices can be either
reconstructed independently to produce 2 images, or combined together to produce a
single image.

Helical

Helical Overview
In the helical mode, data from 1 or 2 (Dual Slice system) 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, dependent on generator and tube limitations.
• 120 second maximum helical scan time (Option), (60,90 Optional) Standard is 30
seconds.
• Pitches: 0.1 ~ 3.0:1 (Single slice), 0.75:1, or 1.5:1 (Dual slice).
• Variable image thickness (recon parameter).
• Segmented reconstruction option.
• 0.1mm minimum incremental retrospective recon image
spacing.

Image Quality Helical Example


Image quality of Helical Scan mode images is slightly degrade from Axial Scan images.
Thinner collimation and slower table speed will bring higher image quality, but scan speed
will be slow down too.

Calibration Modes
BRIVO CT calibrations include:
• X-ray Tube warm-up
• Air calibration*
• Phantom Cal
• CT# adjustment

System Image Quality Features


“BRIVO CT” Geometry
The “BRIVO CT” geometry is same as the BrightSpeed Series, LightSpeed QX/i and HiSpeed
Series.
Benefits include:

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GENERAL INFORMATION

• Produces (630/541)2 = 36% better X-Ray flux utilization than HiSpeed CT/i due to the fact
that the focal spot is moved closer to the patient. For axial scanning, images can be
generated with the same noise as HiSpeed CT/i using only 74% of the mAs.
• Reduce centrifugal force on the tube.

Scan and Recon Prescription User Interface (UIF)


All scan and recon options are clearly explained to the user.
Axial scan prescription describes various detector configuration, scan speeds, etc. Axial
recon prescription describe various recon slice thickness combinations and how these are
restricted by scan parameters.

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.

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 GDAS 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.

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For scans greater than 1 second, the raw views are summed together before transfering to
OC 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 5-second scan both gather data over 360 degrees, so both
scans reconstruct the same number of views per image.
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)
Digital Tilt Angle Tomographic section through patient
Spacing Z-Axis distance between scan centers
Thickness Width of image
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 0.5 second to reconstruct.
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 5000 1-second 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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GENERAL INFORMATION

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.

Calibration Scans
Calibrations scans of airand phantoms (uniform objects) , 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 Calibration.
• When the tube has cooled to the point that a warm-up is required to ensure optimal
image quality.

Data Storage
The Console/Computer contains 320GByte capacity HDD that records and retains at least
5000 1-second scan rotation files, processes scan data into image data.
The computer contains 320GByte capacity system disk that hold more than 150,000
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 LCD screen.
The Image Processor uses a bulk memory to store images selected for Auto View, MID,
paging, magnification, rotation, reformat or 3D.

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The images appear on the image monitor or LCD. The LCD 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 BRIVO CT 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 LCD 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
• 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; 320/2 = 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.

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GENERAL INFORMATION

CT Number
CT numbers on BRIVO CT System range from -31743 to +31743. The minimum CT number
was limited to -1024, because of air CT number is -1000, and no tissues in human body will
have lower CT# than air.
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.
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.
• 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.

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BRIVO CT Series

• 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 monitor 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 monitor 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.
• 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)

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


• RAS: Anatomic distance from the center of the landmark slice

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GENERAL INFORMATION

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 monitor 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.

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.

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BRIVO CT Series

A reconstructed pixel represents an area determined by dividing the Display FOV 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 monitor pixel
decreases as the magnification factor increases; anatomic area/monitor 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
43 0.84

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


• Area equals r2 (Area =3.14 x radius x radius)
• The 43cm FOV has a 21.5cm radius, so its area equals 1452cm2.
• The ROI or magnification factor determines the anatomic area covered by a magnified
image.
Example: A monitor pixel represents 0.5 by 0.5mm. Magnify pixel size by 2. Each monitor
pixel now represents 0.25 by 0.25mm of anatomy.

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GENERAL INFORMATION

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 0.6, 1.0, 2.0, 3.0,
5.0, 7.0, 10.0mm 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)
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.

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BRIVO CT Series

Reconstruction assigns one value to every image pixel. CT uses pixel values of -31743 to
+31743. 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 monitor gray shades to display 4000 CT pixel values (nominal range).
The Window Width selection determines the number of CT values represented by each
monitor 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.

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.

Principle of Digital Tilt (DT)

What is Tilt Image


Tilt image means the image slice has an angle with the Axial plane, and is not perpendicular
to the patient motion direction. Generally a Tilt image is acquired during a scan by tilting the
Gantry in the Y-Z plane, meanwhile the rotor direction of the Gantry is no longer in parallel
with the patient motion direction. Tilt images are often used in the scan of Lumbar spine,
cervical spine or head.
There is a vertical line in front of the Axial plane of a 90 degree scout image. The projection
of the tilt image is a line at an angle with the vertical line. This angle is called tilt angle.

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GENERAL INFORMATION

Figure 11-2 The location of a tilt image in the coordinates

y’
y

Figure 11-3 The location of a tilt image in the 90 degree scout image

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BRIVO CT Series

Digital Tilt
Meaning of the Digital Tilt
Digital tilt is to acquire a tilt image by utilizing a non-tilt image plus digital image processing
method. It has the below three meanings:
1. Provide graphical user interface for customer to select the scan parameters of the tilt
images.
2.The system optimizes the scan parameters of the non-tilt images according to the user’s
input thereby to acquire the images that meet the requirement of clinical diagnostic with as
low as possible dose.
3.Reconstruct the non-tilt images acquired according to the scan parameters automatically
optimized by the system. Provide tilt images needed by the user.

Procedure Principle and User Operation


The operation procedure of Digital Tilt is the same as Gantry tilt in the user side. All the
operation of optimization and reconstruction are automatically completed by the computer.
The below chart explains the procedure of producing Digital image:
Figure 11-4 Digital tilt operation flow chart
 
90  degrees  Localizer and scan  Display the 
scout image  parameter setting  DT Images 

 
Scan Parameter  Non‐Tilt  Tilt Image 
 
Optimization of  Image  reconstruction
 
non‐Tilt Scan    Scan 
 
   
Automatically completed by the system 

1. 90 degree scout image


The first step of tilt scan is the 90 degrees scout scan. This step is the same as other non-tilt
scans. The user needs to position the target scan locations according to the laser light and
estimate the scope of the scout scan.
2. Set the localizer
After getting the scout image, click on [Next Series] or [Create New Series] to enter the
Axial/Helical scan screen. The user can set the parameters of kV, mA, SFOV, Recon center
etc. When enter an angle in the area of [Tilt], or drag the localizer by mouse, the Digital Tilt
mode would be activated.

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GENERAL INFORMATION

When the system could not optimize the scan to acquire tilt image according to the
parameters input by the user, the impacted parameters would be displayed in red. This is to
inform the user to revise the parameter to enable the scan.
3. Optimization of non-tilt Scan Parameters
Optimization of non-tilt Scan Parameters include:
1) Calculate and optimize the scan range;
2) Optimize the slice thickness and slice interval of non-tilt scan
The Calculation and optimization of the scan range are performed as shown in below
illustration, in which the start/end location of the tilt images are input through user interface
by the user. It could be done either by editing related parameters, or by dragging the
localizer. The goal of optimization is to make the non-tilt scan range exactly covers the tilt
scan range. The non-tilt scan range is always larger than the tilt scan range because there is
an angle between the tilt image and the rotor plane. Moreover, since the scan range is
related to the FOV required by the tilt scan, it’s strongly recommended that the user use as
small the FOV as possible to perform the scan. Thus the scan range would be the smallest.
Figure 11-5 Digital Tilt Operation Process

Required
  tilt image

AP Gantry
  rotation axis
  z 

Non-tilt image scan range
 
Start location
  of tilt image End location of tilt image

WARNING: The user should pay extra attention to the sensitive organs to know if those
organs have already been covered by X-ray. Since Digital Tilt utilizes the
non-tilt image to reconstruct tilt image by digital image processing, all
non-tilt images are necessary which can cover all the area of tilt image. This
means that the two triangle area in the upper left corner and lower right
corner of the above illustration must be covered by X-ray though they look
like unscanned area in the user interface.

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4. Non-tilt image scan


After the system finishes optimization of the scan parameters, the user can click the
[Confirm] button. The system will automatically scan the required non-tilt images. The scan
process is the same as the non-tilt series.
NOTE: In the beginning of the scan, the user will not see the tilt image to be displayed until
the reconstruction of the first tilt image is finished. This is because the required tilt
image needs multiple frames of non-tilt image to reconstruct.
5. Reconstruction of the Tilt Image
The pixels on the image are acquired by interpolation algorithm. The pixel interpolation is
shown as below:
Figure 11-6 Pixel Interpolation of Tilt Image

Non‐tilt image pixels, acquired by scan

Tilt image pixels, acquired by 
Interpolation Algorithm 
Rotation Axis
z

The image quality is assured because the system optimizes the parameters (location, slice
thickness, slice interval etc.) of the non-tilt image. Tilt image has the same specifications as
non-tilt image except that the image resolution is a little lower compared with non-tilt image
(about one line pair).

WARNING: When reconstructing the tilt images, with the restriction of sampling density,
it’s possible to have periodical strip artifact in the positions with very
dramatic change along the z-direction. Should you have any concern about
such artifacts, you need to refer to the non-tilt image to confirm it. The
artifact image for reference is shown in below illustration (arrow pointed
area).

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GENERAL INFORMATION

Figure 11-7 Possible Artifact in the Tilt Image (different WW/WL of the same image)

   

6. Display of Tilt Image


Tilt images will be displayed in the user interface after reconstruction. Upon the completion
of the scan, the user may browse the tilt image through the browser. The user may also
browse the non-tilt image through the browser.
Post Processing of the Tilt Image
Tilt image could be used in 3D post processing such as Reformat. Since the system also
reserves the non-tilt image during the Digital Tilt operation and the non-tilt image contains
more detail information with larger scope, it’s strongly recommended that the user perform
3D reconstruction with the non-tilt images.

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QUALITY ASSURANCE

Chapter 12
QUALITY ASSURANCE

Overview
In order to assure consistent image quality over the lifetime of the diagnostic radiology
equipment, users must establish and actively maintain a regular Quality Assurance (QA)
program. If the constancy testing is needed, please refer to IEC 61223-2-6. These
procedures ask you to scan a known material (usually a phantom) under a prescribed set of
conditions, and then compare your results to predicted or optimum values. Because you
repeat these tests frequently, if not daily, you notice changes in image quality values before
the problem becomes visible. If you do 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 sophisticated tests. Their early intervention could prevent a major breakdown.
User QA begins with baseline performance data obtained by performing the QA tests as
soon as the system meets operating system specifications. Take the first set of baseline
performance data right after installation and update it any time the system undergoes an
upgrade or a major repair that affects image quality. Such as replacement of x-ray tube .
Compare your daily QA checks against these baselines. The Quality Assurance program
documents any change in image quality over time.
Although you can save baseline images to visually compare with your daily QA checks, you
don't have to. The numerical data supplied during the actual testing provides the necessary
objective data for comparison. This section contains a sheet titled QA DATA FORM that you
can copy and use to record this numerical data.

Phantom Description
Use the Quality Assurance and Performance Phantom provided with your CT scanner to
assess system performance and establish an ongoing Quality Assurance program. The
phantom's design provides maximum performance information with minimum effort. This

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phantom measures six aspects of image quality. It contains three sections, each
corresponding to a single scan plane. The following illustration contains a list of the sections
and corresponding tests.

Section 1 Section 2 Section 3


High Contrast Resolution Low Contrast Detectability Noise and Uniformity
Contrast Scale
Slice Thickness
Positioning Light Accuracy

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


The most effective Quality Assurance program involves obtaining basic performance data
once a day, or at least 2-3 times per week. You must obtain data frequently and on a regular
basis in order to detect any changes in system performance that might occur before it
effects clinical image quality. At minimum, acquire a single 10mm scan of Sections 1 and 3
of the Performance Phantom each day.

Phantom Setup
Place the performance phantom on the phantom holder and level it. (Tape a small piece of
cardboard or a washer to the phantom, if necessary to accomplish this.) Position the
phantom using the laser alignment lights as follows:
1. Align the axial light to the circumferential line marking Section 1.
2. Align the sagittal light (where it strikes the top of the phantom) to the vertical line on the
face of the phantom.
3. Position the phantom and press the Internal Land button on the gantry.

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QUALITY ASSURANCE

The performance phantom contains three sections. When you correctly follow the
positioning instructions listed above, Section 1 corresponds to 0.0 mm table position,
Section 2 (Low Contrast Detectability) to the 40.0 mm location and Section 3 (Noise and
Uniformity) corresponds to the 70.0 mm location.
Vertical Reference Line
Circumferential
Reference Line
Horizontal
Reference Line

Horizontal
Reference Line

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

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• 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 Request parameters
• Provides System Performance tests and comparisons

Scan the QA Phantom


Follow the normal Single Scan protocol. Scan three locations, one for each QA phantom
section. If you set up the phantom as described on the previous page, prescribe scan
location 0.0 for section 1 of the phantom, 40.0 for section 2 and 70.0 for section 3. Use the
scan parameters suggested in Table 12-1. You can use other parameters, but the
performance results won't match the data in this manual.
Table 12-1

SOFTKEY PROMPT SCAN VALUE ECONSTRUCTION


[NEW PATIENT] kV - 120 CAL FOV - 25cm
[HEAD FIRST] mA - 100 Recon FOV - 25cm
Time - 3 sec centered
[HEAD] Thickness - 10mm*
Scan Mode
[SINGLE SCAN] - 1i (BRIVO CT325) Recon Mode - Standard
- Single (BRIVO CT315)

*Check image thickness and positioning light accuracy by acquiring a number of images
and varying the slice thickness between scans.

Test and Analysis of the Phantom Images


Begin the analysis as soon as the Section 1 image display appears. Make copies of the form
at the end of the chapter and record the QA results there. Keep previously recorded QA
results and compare them to the most recent analysis for consistency.

Contrast Scale
Section 1 of the phantom tests the contrast scale. CT assigns CT numbers, also called (HU)
Houndsfield Units, to the attenuation values of X-Ray passing through a variety of material
densities. The software makes the attenuation visible by assigning shades of gray to groups

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QUALITY ASSURANCE

of numbers you select with Window Width/ Level functions during image Display. For test
purposes, the CT values of water and acrylic in the phantom represent the standard against
which you track your system's contrast scale over time. The test for contrast scale follows:
1. Display a circle cursor (approximately 1 cm in diameter) from [Ellipse ROI] on the image
as shown in Figure 1. For consistency, use the same size cursor and location each time
you perform this test.
2. Position the cursor on the Plexiglass block and click the left mouse button once to
calculate the ROI. Record the mean CT number on the QA Data Form. (Standard
deviation record optional.)
3. Position the cursor over the water section and click the left mouse button once to
calculate the ROI. Record the mean CT number for water on the QA Data form. (Standard
deviation record optional.)
4. Subtract water's CT number from Plexiglass' CT number and record the difference on the
QA Data form.

Position 1cm ROI over water

Position 1cm ROI over Plexiglas

FIGURE 1

High Contrast Spatial Resolution


Section 1 of the phantom contains six sets of bar patterns in a Plexiglass block that you use
to test high contrast spatial resolution. Each pattern consists of sets of equally sized bars
and spaces, in the following sizes: 1.6 mm, 1.3 mm, 1.0 mm, 0.8 mm, 0.6 mm, and 0.5 mm.
Water fills the spaces and provides about 12% (120 HU) contrast. Examine the bar patterns
to determine the limiting resolution, defined here as the smallest bar pattern in which you
see all five bars.

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A more sensitive and quantitative method for assessing changes in system resolution
involves measuring the standard deviation of the pixel values in a single or multiple bar
pattern. ROI standard deviation provides a good indicator of system resolution and a
sensitive method to detect changes in system resolution. The recommended procedure
follows:
1. If necessary, click on [Erase] to remove previous ROI data.
2. Display and position a box cursor from [Box ROI] over the largest (1.6 mm) bar pattern.
The cursor should fit within the bar pattern as shown in Figure 2. Adjust the size and
position of the cursor as necessary.
3. Click the left mouse button once to calculate the ROI and record the standard deviation
on the QA data form.
4. (Optional) Repeat this procedure for the 1.3, 1.0, and 0.8 mm bar patterns.

Position box cursor


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

Optional: repeat for 1.3mm


pattern
Optional: repeat for 1.0mm
pattern

Optional: repeat for 0.8mm patternn

FIGURE 2

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QUALITY ASSURANCE

Slice Thickness
Section 1 of the phantom also tests slice thickness. Both sides of the resolution block contain
a pattern of air filled holes designed to demonstrate slice thickness. (See Figure 3.)

Air filled holes

FIGURE 3

The resolution block contains holes drilled 1 mm apart and aligned in the direction of slice
thickness (perpendicular to scan plane). Each visible hole in the image represents 1 mm of
beam thickness. The software assigns less negative CT numbers to partial hole images or
holes located on the edge of the slice profile. To determine slice thickness, display the
image at the recommended window level and width, and count the visible holes. Black
holes in the image represent a full millimeter of slice thickness. Gray holes count as fractions
of a millimeter; two equally gray holes count as a single 1 mm slice thickness.
Recommended window width : 300.
Recommended window level :
BRIVO CT325: -100 for 1.0 mm/2.0mm slices, -50 for 4.0 mm, -30 for 6.0mm slices, and +50
for 10.0 mm slices.
BRIVO CT315: -100 for 3.0 mm slices, 0 for 5.0 mm, and +50 for 10.0 mm slices.

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Your image may show less detail than this example.

Adjust the window width


and level, then count te
lines, which represent the
air filled holes.

Each black line represents one


millimeter of slice thickness. Gray
FIGURE 4 lines represent fractions of a
millimeter.

Positioning Light Accuracy (optional)


Refer to Figure 3 on the previous page: notice how the center hole in the hole patterns on
both sides of the resolution block appear longer than the others. The manufacturers drilled
the center holes deeper to help you identify them in the image. The center hole position
corresponds precisely to the black line scribed on the circumference of the phantom. When
you use an accurate Positioning light and align the phantom's circumferential line to the
axial light, you'll see a symmetrical hole pattern around the center (longer) hole in the slice
thickness pattern. See Figure 5. For best results, use the 1.0 mm slice thickness.

Center hole position


corresponds to black line
around circumference of
phantom

Align black line on


C. Position box cur- phantom to positioning
sor over polystyrene light
membrane below
holes, and take ROI.

FIGURE 5

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QUALITY ASSURANCE

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
0.75 mm thick polystyrene membrane suspended in water and pierced by a series of holes
in the following sizes: 10.0 mm, 7.5 mm, 5.0 mm, 3.0 mm, and 1.5 mm. The difference in CT
numbers between the water, and water plus plastic, equals the contrast in Houndsfield Units
(HU). 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:
1. If necessary, click on [Erase] to remove previous ROI data.
2. Display and position a box cursor from [Box ROI] over the image. Adjust the cursor to a
rectangle, approximately 1/2 cm high by 5 cm long, as shown in Figure 6.
3. First position the cursor over the polystyrene membrane above the holes. Click the left
mouse button once to calculate the ROI. Record the mean CT number in the Low
Contrast resolution box on the QA Data Form.
4. Next place the cursor in the water section above the membrane and click the left mouse
button once to calculate the ROI. Record the mean CT number.
5. Subtract the CT number of the water from the CT number of the membrane and record
the difference.
6. Click on [Erase] to remove previous ROI data.
7. Repeat steps 3, 4, and 5. This time position the cursor below the membrane holes, then
move it over the water area below the membrane.
8. Count and record the number of visible holes to determine contrast.

A. Position box cur- B. Position box cursor


sor over polystyrene over water above
membrane above membrane and, take
holes, and take ROI. ROI.
Subtract B from A

Count visible holes

D. Position box cursor


over water below
membrane, and take
FIGURE 6 ROI.
Subtract D from C

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


Section 3 of the phantom tests noise and uniformity. Take a water-only scan in Section 3 to
provide a uniform image by which to assess image CT number noise and uniformity. Enclose
a region of interest, click the left mouse button once to calculate the ROI, and the software
calculates and displays the standard deviation or noise of the pixels inside. The software
often divides the HU noise values by 1000 (representing the contrast scale between air and
water) and multiplies by 100 to convert HU to a percentage of water attenuation.
The procedure for noise and uniformity testing follows:
1. If necessary, click on [Erase] to remove previous ROI data.
2. Place a circle cursor approximately 2 cm in diameter on the center of the image as
shown in Figure 7. Adjust the size of the cursor as necessary.
3. Click the left mouse button once to calculate the ROI. Record the mean CT number and
standard deviation on the QA Data Form.
4. (Optional) Repeat the above instructions placing the cursor at the 12 o'clock position and
once again at the 3 o'clock position.
Optional: Take an ROI at the
Position circle cursor over 12 o’clock position.
the center of the image,
and take ROI.

Optional: Take an
ROI at the 3 o’clock
position.

FIGURE 7

Typical Results and Allowable Variations


Because people determine 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

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QUALITY ASSURANCE

correlation between acceptable clinical image quality and acceptable variations in the
image performance indices included in the program. This page 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 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 118, with a suggested allowable variation of 10%.

High Contrast Spatial Resolution


The standard deviation for an ROI in the 1.6 mm bar pattern should equal 36 HU, with a
suggested allowable variation of 20%.

Nominal Slice Thickness


Slice thickness should not vary from the expected value by more than 50% for thickness of
2.0mm or less and ± 1.0mm for thickness over 2.0mm, when evaluated according to
instructions. For slice thickness of less 1mm, slice thickness changes in the value of no more
than ± 0.5mm.

Low Contrast Detectability


Because this test relies upon the perceptual judgment of the person counting visible and
well-defined holes, we 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 and 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 ± 4 HU. Expect the noise in the center of the image to
approximately equal 3.1, with a suggested variation of 20%.

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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.

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.

NOTE: CTDI100 peripheral = average CTDI100 of B thru E


CTDI100 center = CTDI100 of A

CTDI
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).
Figure 12-1 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

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QUALITY ASSURANCE

Table 12-2

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.
VOLUME CTDIw (CTDIvol) (Reference IEC 60601-2-44)
For axial scanning:

CTDIvol = N  T CTDIw
d

D(z) — the DOSE PROFILE along a line z perpendicular to the TOMOGRAPHIC PLANE, where
dose is reported as ABSORBED DOSE in air.
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.

For helical scanning:

CTDIvol = CTDI w
CT螺距系数

For film scanning:

CTDIvol = n  CTDI w

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The measured CTDI100 are listed in the table, and the corresponding CTDIw, CTDIvol can be
calculated with above formulas via these values.
BRIVO CT325:
Statement of Typical Technique

HEAD BODY

25 cm Field of View (FOV) 43 cm FOV

120 kVp 120 kVp

150 mA 130 mA

1.5 sec scan time 1.5 sec scan time

10 mm slice thickness (2i Mode) 10 mm slice thickness (2i Mode)

10 mm interval 10 mm interval

CT Dose Index (CTDI) For Typical Technique At Various Positions On The Phantom Image.

HEAD±40% BODY±40%
B POSITION
(mGy) (mGy)

A 34 8
E A C
B 38 14

C 35 16
D
D 31 15

E 35 16

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QUALITY ASSURANCE

Normalized to a value of 1 for typical technique and position A. (All other technique settings
at typical value.)

POSITION HEAD BODY

10 mA A 0.07 0.08

200 mA A 1.33 1.54

1.0 sec A 0.5 0.67

5.0 sec A 2.50 3.33

7.0 mm A 0.99 0.99

5.0 mm A 1.00 1.00

3.0 mm A 1.01 1.00

2.0 mm A 1.00 1.01

1.0 mm A 1.04 1.00

0.6 mm A 0.98 0.99

140 kV A 1.43 1.50

Helical Dose For Typical Helical Technique

HEAD BODY

25 cm Field of View (FOV) 43 cm FOV

120 kVp 120 kVp

150 mA 130 mA

1.5 sec scan time 1.5 sec scan time

10 mm slice thickness 10 mm slice thickness

HQ Mode 10.5 mm/turn HQ Mode 10.5 mm/turn

If the Helical mAs, Slice Count and Interval selection equals the Axial mAs, Slice Count and
Interval selection, then Helical dose equals Axial dose.

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BRIVO CT315:
Statement of Typical Technique

HEAD BODY

25 cm Field of View (FOV) 43 cm FOV

120 kV 120 kV

150 mA 130 mA

1.5 sec scan time 1.5 sec scan time

10 mm slice thickness 10 mm slice thickness

10 mm interval 10 mm interval

CT Dose Index (CTDI) For Typical Technique At Various Positions On The Phantom Image.

HEAD±40% BODY±40%
B POSITION
(mGy) (mGy)

A 34 8
E A C
B 37 14

C 35 16
D
D 30 15

E 35 16

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Normalized to a value of 1 for typical technique and position A. (All other technique settings
at typical value.)

POSITION HEAD BODY

10 mA A 0.07 0.08

200 mA A 1.33 1.54

1.0 sec A 0.5 0.67

5.0 sec A 2.50 3.33

7.0 mm A 1.00 1.02

5.0 mm A 1.02 1.04

3.0 mm A 1.04 1.03

2.0 mm A 1.06 1.07

1.0 mm A 1.17 1.24

140 kV A 1.42 1.48

Helical Dose For Typical Helical Technique

HEAD BODY

25 cm Field of View (FOV) 43 cm FOV

120 kVp 120 kVp

150 mA 130 mA

1.5 sec scan time 1.5 sec scan time

10 mm slice thickness 10 mm slice thickness

10 mm interval 10 mm interval

If the Helical mAs, Slice Count and Interval selection equals the Axial mAs, Slice Count and
Interval selection, then Helical dose equals Axial dose.

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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 12-3 and Table 12-4 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.
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. These values are for
Brivo CT315 and Brivo CT325 product.

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.

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© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

Table 12-3 Peak Skin Dose Table for Brivo CT 315

SFOV /mAs/ Aperture (mm)


kV
/Focal Spot 1 2 3 5 7 10
Head/240mA
20.69 28.53 29.32 28.93 30.78 32.55
s/LargeFocal
120
Body/240mA
14.75 16.13 18.08 18.7 18.52 20.85
s/LargeFocal
Head/240mA
32.55 35.65 37.78 40.58 41.88 44.3
s/LargeFocal
140
Body/240mA
20.12 22.43 25.09 26.86 26.24 27.57
s/LargeFocal

Table 12-4 Peak Skin Dose Table for Brivo CT325

SFOV /mAs Aperture (mm)


kV
/Focal Spot 1.2 2 4 6 10 14 20
Head/240mA
14.02 24.47 28.55 30.26 32.82 35.16 37.61
s/LargeFocal
120
Body/240mA
12.71 16.48 17.85 19.05 20.47 22.53 24.27
s/LargeFocal
Head/240mA
20.83 35.7 39.18 41.48 45.41 48.58 52.74
s/LargeFocal
140
Body/240mA
19.06 22.56 24.79 26.96 29.76 31.57 33.98
s/LargeFocal

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%.)
Maximum peak of dose profile (max {Dperipheral (z)}) = Peak dose from Table 12-3 and 12-4*
(actual scan mA/240mA) * 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:

5314180-1EN Rev. 10 (February 2012) 12-19


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

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. (B thru E)

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:

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:

n Equal to the number of rotations.


The maximum value of the four dose profiles measured in the
max phantom periphery produced in a single axial rotation along lines z
perpendicular to the tomographic plane, where dose is reported as
{Dperipheral(z)} 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.

12-20 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

For Axial and Helical scanning involving table travel in two derections (“shuttle” mode):

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 mAs value of each operating condition at
which the CTDI100(peripheral) value will reach 1Gy and the deterministic effects may occur.
Table 12-5

Scan Duration (seconds) required to meet 1Gy CTDI100(peripheral)


at 130mA exposure (for Brivo CT325)

SFOV/Focal Aperture
kV
Spot 1.2 2 4 6 10 14 20
Head/Large
51 48 49 49 50 50 51
Focal
120
Body/Large
112 111 109 111 111 112 111
Focal
Head Large
36 34 34 35 35 35 36
Focal
140
Body Large
75 74 73 74 74 75 74
Focal

5314180-1EN Rev. 10 (February 2012) 12-21


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Table 12-6

Scan Duration (seconds) required to meet 1Gy CTDI100(peripheral)


at 130mA exposure (for Brivo CT315)
SFOV/Focal Aperture
kV
Spot 1 2 3 5 7 10
Head/Large
41 45 46 47 48 48
Focal
120
Body/Large
80 94 97 96 98 100
Focal
Head Large
31 34 35 35 36 36
Focal
140
Body Large
54 63 66 65 66 68
Focal

Other Dosimetry Information

Dose Length Product (DLP)


The dose length product (DLP) for the CTDIw can also be automatically computed by the
system if desired and displayed on the Scan Rx menu. The DLP is given in mGyCm (milliGray
Centimeters). The DLP is computed and displayed 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. The final
exam accumulated DLP provides a convenient measure for maintaining patient or
procedure dose management statistics. The DLP is computed given the CTDIw described
above as follows: axial scans: DLP =CTDIw x (Number of images) x (Image thickness in cm)/
(axial increment factor) cine, fluro, or 0 table increment axial scans: DLP = CTDIw x (Image
thickness in cm) Helical scans: DLP =CTDIw x (Exposure time) x (Table Speed)/(clustered
helical scan factor)

Dose Efficiency (Reference IEC 60601-2-44)


The dose efficiency, which is a function of focal spot size and beam collimation. Due to the
Brivo system Gantry geometry structure, the dose efficiency is 100%.

Dose and Sensitivity Profile at Phantom Center


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

12-22 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

For BRIVO CT325: Profile Curve for Body


1.0
Axial, Body, Center,
120 kV, 130 mA,
10 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Body, Center,
120 kV, 130 mA,
7 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

1.0
Axial, Body, Center,
120 kV, 130 mA,
5 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

5314180-1EN Rev. 10 (February 2012) 12-23


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Profile Curve for Body (Continued)


1.0
Axial, Body, Center,
120 kV, 130 mA,
3 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Body, Center,
120 kV, 130 mA,
2 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

1.0
Axial, Body, Center,
120 kV, 130 mA,
1mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

12-24 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

Profile Curve for Head


1.0
Axial, Head, Center,
120 kV, 150 mA,
10 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Head, Center,
120 kV, 150 mA,
7 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

1.0
Axial, Head, Center,
120 kV, 150 mA,
5 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

5314180-1EN Rev. 10 (February 2012) 12-25


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Profile Curve for Head (Continued)


1.0
Axial, Head, Center,
120 kV, 150 mA,
3 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Head, Center,
120 kV, 150 mA,
2 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

1.0
Axial, Head, Center,
120 kV, 150 mA,
1 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

12-26 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

FOR BRIVO CT315: Profile Curve for Body

1.0
Axial, Body, Center,
120 kV, 130 mA,
10 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Body, Center,
120 kV, 130 mA,
7 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

1.0
Axial, Body, Center,
120 kV, 130 mA,
5 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

5314180-1EN Rev. 10 (February 2012) 12-27


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Profile Curve for Body (Continued)


1.0
Axial, Body, Center,
120 kV, 130 mA,
3 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Body, Center,
120 kV, 130 mA,
2 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140
1.0
Axial, Body, Center,
120 kV, 130 mA,
1 mm, 1.5 sec.

0.5

0
0 Position (mm) 70 140

12-28 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

Profile Curve for Head

1.0
Axial, Head, Center,
120 kV, 150 mA,
10 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Head, Center,
120 kV, 150 mA,
7 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

1.0
Axial, Head, Center,
120 kV, 150 mA,
5 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

5314180-1EN Rev. 10 (February 2012) 12-29


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Profile Curve for Head (Continued)


1.0
Axial, Head, Center,
120 kV, 150 mA,
3 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140
Dose Profile Sensitivity Profile
1.0
Axial, Head, Center,
120 kV, 150 mA,
2 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140
1.0
Axial, Head, Center,
120 kV, 150 mA,
1 mm, 2.0 sec.

0.5

0
0 Position (mm) 70 140

12-30 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

Table 12-7 Dose Profile in Air FWHM for Brivo CT315

NO. Slice THK (mm) Aperture (mm) FWHM (mm)


1 1 1 0.84
2 2 2 1.72
3 3 3 3.22
4 5 5 5.25
5 7 7 7.13
6 10 10 10.13

Table 12-8 Dose Profile in Air FWHM for Brivo CT325

NO. Slice THK (mm) Aperture (mm) FWHM (mm)


1 0.6 1.2 0.88
2 1 2 2.04
3 2 4 4.23
4 3 6 6.14
5 5 10 10.11
6 7 14 14.01
7 10 20 20.17

Image Performance (Reference 21CFR 1020.33 (c) (3) (v))


Noise
At Typical Technique In Center Of Phantom Using Standard Algorithm

HEAD BODY

σ = 0.31 % σ = 0.47 %

MTF (Reference 21CFR 1020.33 (c)(3)(ii))

5314180-1EN Rev. 10 (February 2012) 12-31


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

(same conditions as above)


100 HEAD 100 BODY
M M
O 80 O 80
D D
U U
L 60 L 60
A A
T T
I 40 I 40
O O
N N
20 20
(%) (%)

0 2 4 6 8 10 0 2 4 6 8 10
Line pairs/cm Line pairs/cm

Nominal Tomographic Section Thickness

HEAD BODY

10.0 mm 10.0 mm

7.0 mm 7.0 mm

5.0 mm 5.0 mm

3.0 mm 3.0 mm

2.0 mm 2.0 mm

1.0 mm 1.0 mm

0.6 mm 0.6 mm

12-32 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
QUALITY ASSURANCE

Sensitivity Profile
See previous pages
Phantoms and Procedures
Dose
For best results, use the phantoms, dose profile and CTDI value calculation procedures
recommended in the CDRH final draft of "Routine Compliance Testing for Computed
Tomography X-Ray Systems" dated April 26, 1984.
Also, for best results, use the phantoms and CTDIw value calculation procedures
recommended in the IEC committee draft for vote of IEC60601-2-44, dated February,
1999.
Performance
Each test uses a 25 cm water-filled acrylic phantom
Noise
Noise equals the standard deviation of an array of pixels contained in 674 mm square
region of interest (ROI) for Head and 1994 mm square ROI for Body. The software divides the
standard deviation, expressed in Houndsfield Units, by 1000 (representing the contrast scale
between air and water), then multiplies by 100 to give a value in percent.
Modulation Transfer Function (MTF)
A point spread function (PSF) image is obtained by scanning the GE performance phantom
(2100614) wire section. Software performs a two dimensional Fourier Transform on the PSF
to obtain the MTF.
Slice
Use a wire ramp section of Catphan phantom, inclined 23 from the scan plane.
Sensitivity
23° from the scan plane to obtain sensitivity profiles.

Deviations (Reference 21CFR 1020.33 (c))


In order to come up with "the maximum deviation," manufacturers must imagine every
possible situation, however unlikely, that might occur within the entire user community. Our
statements of deviation include a maximum deviation to assure compliance with the
regulation, as well as a statement of expected deviations (2s) in the large majority of our
systems.
CTDI and CTDIW Typical Techniques (Reference 1020.33 (C) (2) i, ii and iii)
The anticipated "maximum deviation" for CTDI and CTDIw equals ± 40%. The expected
deviation equals ± 20%, except for the 40 mA or less and 1mm techniques, where variation
increases (up to a factor of two) due to the inherent deviation in small values.

5314180-1EN Rev. 10 (February 2012) 12-33


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Dose Profile (Reference 1020.33 (C) (2) iv)


Anticipate a "maximum deviation" of ± 30% or 2.0mm, whichever is larger, relating to dose
profiles (FWHM). This value includes variability inherent in the measurement of dose profile
with TLD chips.
Performance (Reference 1020.33 (C) (3))
Noise : The noise squared (σ2) in a CT image is inversely proportional to the x-ray dose used
to make the image. The maximum deviation anticipated for image noise equals ± 30%.
Expected deviation equals ± 10%.
MTF : Expect deviations within ± 10% for values on the MTF curve generated with data
gathered according protocol. Maximum deviations may reach ± 20% for other
methodologies.
Sensitivity Profile : Expect the full width slice half maximum sensitivity profiles to vary ±
20% or 1.0 mm, whichever is larger, when measured with a wire ramp section of Catphan
phantom, inclined 23° from the scan plane. If you use other methodologies, the maximum
deviation may reach 1.5 mm for all slice thicknesses, because these measurement errors
have the greatest effect on thin slices.

12-34 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Quality Assurance DA TA FORM
NOISE
CONTRAST ALIGN LOW CONTRAST RES-
HIGH SLICE

5314180-1EN Rev. 10 (February 2012)


DATE SCALE OLUTION
CONTRAST THICK
MEAN STD. SPATIAL NESS MEAN CT# MEAN STD
CT# DEV Y/N TOP BOTTOM CT# DEV

PLEXIGLAS 1.6mm WATER

© 2012 General Electric Company. All rights reserved.


1.3mm MEMBRANE
WATER
1.0mm DIFFERENCE
DIFFERENCE
0.8mm HOLES

PLEXIGLAS 1.6mm WATER

1.3mm MEMBRANE
WATER
1.0mm DIFFERENCE
DIFFERENCE HOLES
0.8mm

PLEXIGLAS 1.6mm WATER

1.3mm MEMBRANE
WATER
1.0mm DIFFERENCE
DIFFERENCE HOLES
0.8mm

PLEXIGLAS 1.6mm WATER


1.3mm MEMBRANE
WATER
1.0mm DIFFERENCE
DIFFERENCE
0.8mm HOLES
QUALITY ASSURANCE

12-35
BRIVO CT Series

12-36 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
TUBE SPEC IFICATIONS

Chapter 13
TUBE SPEC IFICATIONS

X-Ray Tube Assembly Information


Tube Unit Identification
System/Tube Description Housing Insert Insert
Catalog No. graphite anode Model Number Model Number Catalog No.
MX135 CT TH1.1 X-Ray tube 2232785-2 46-274891G1 D0095G
assembly

Improvements in the heat handling capabilities of this unit may result in new catalog and
Model number assignments

Diagnostic Source Assembly

Leakage Technique Factors (Reference 21CFR 1020.30 (h) (2) (i), 21CFR
1020.30 (h) (4) (i), IEC 60601-1-3, IEC 60601-2-28 and IEC 60601-2-44)
Tube Assembly Model No. 2232785-2, CT Collimator Model No. 2320783-2 (BRIVO CT325)
and 2259785-4 (BRIVO CT315), 140 kV, 24 mA

Minimum Inherent Filtration


Minimum inherent filtration of 6.0 mm aluminum equivalent at 70 kV:
• Tube Unit:
Tube Insert - 0.8 mm aluminum equivalent at 70 kV
Tube Housing - 0.2 mm aluminum equivalent at 70 kV
• Collimator (lower plate) - 4.5 mm aluminum equivalent at 70 kV
• Collimator (upper plate) - 0.5 mm aluminum

5314180-1EN Rev. 10 (February 2012) 13-1


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

TARGET LOADING in Kilowatts FOR EACH SCAN TECHNIQUE

mA 120kV 140kV
60 7.2 8.4
80 9.6 11.2
100 12.0 14.0
130 15.6 18.2
160 19.2 22.4
24.0
200
(4sec)

The following table lists cooling delay times (in seconds) used by the software before each
scan. These times assume maximum anode or tube unit heat loading and include cycling
the rotor for each scan.

COOLING DELAY TIME at 120kV

Scan Anode Cooling Delays


Technique 2.0 sec 3.0 sec
120kV and
60mA 70 70
80mA 70 70
100mA 73 73
130mA 73 73
160mA 73 73
200mA 88 108

COOLING DELAY TIME at 140 kV

Scan Anode Cooling Delays


Technique 2.0 sec 3.0 sec
140kV and
60mA 70 70
80mA 70 70
100mA 73 73
130mA 73 73
160mA 73 73

13-2 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
TUBE SPEC IFICATIONS

X-Ray Tube IEC Information

X-ray Tube Housing


Model 2232785-2

X-ray Tube Insert


Model 46-274891G1

X-ray Tube Assembly


In accordance with IEC 637/1979, the complete X-Ray tube assembly carries two
identification labels, one each for the housing and insert, marked with the model types and
numbers listed above.

X-ray Tube Insert Information


Type General Electric INSERT
Model 46-274891G1
Focal spot (Reference IEC 60336) 0.7mmW x 0.6mmL(IEC 336/1993)
0.8mmW x 0.6mmL(IEC 60336:2005)
Target Material Tungsten/Rhenium Alloy Focal Track on graphite base
Target Angle (Reference IEC 60601-2-28) 7°
Maximum Potential Difference (Reference IEC 60613) 140 kV
High Potential Generator : General Electric BRIVO CT System
High Potential Generator (2227720)
X-Ray Tube Filament Supply : Maximum voltage: 120KV (at maximum current of 200mA)
Maximum current: 160mA (at maximum voltage of 140KV)

Nominal Anode Input Power (Reference IEC 60613)


This tube accommodates GE BRIVO CT Series Products
with a nominal anode input power of 24 kW for 3 seconds.

Maximum Anode Heat Capacity


(Reference IEC 60613 and 21CFR 1020.30 (h) (2) (ii))
2.0 MHU

Maximum Anode Heat Dissipation (Reference IEC 60613)


500kHU/min

5314180-1EN Rev. 10 (February 2012) 13-3


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Anode Heating and Cooling Curves


(Reference IEC 60613 and 21CFR 1020.30 (h) (2) (ii))
Cooling Curve

Heating Curves
Stored Heat (KJ)

Time(sec) Time(min)

Single Load Rating (Reference IEC 60613)


24 kW for 3 seconds

Serial Load Ratings (Reference IEC 60613)


Controlled by the BRIVO CT system operating software

Rotating Anode Supply


Designed to operate on the BRIVO CT system (See accompanying system documentation.)

Tube Assembly Information


Labels: The X-Ray Tube Assembly carries two identification labels. One label identifies the
Model and serial numbers of components (X-Ray Tube and Housing), and provides the date
and location of assembly manufacture. The second label provides the name of the
manufacturer. A third label certifies compliance with USA Federal regulation 21 CFR Sub
chapter J, and lists the data and place of assembly manufacture.
Marking (Reference IEC 60601-2-28):
The X-Ray Tube Assembly carries markings required by IEC 60601-2-28 in the form of a
combined description. When applicable, the X-Ray Tube Assembly also carries labels to

13-4 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
TUBE SPEC IFICATIONS

certify compliance with regulation of addressee states (US Federal Regulation CFR
Sub-Chapter J, Nationally Recognized Testing Laboratory, CSA and CE Marking).
Reference Axis: Normal to the window center.
Target Angle : 70
Nominal Focal Spot Values : 0.7mmW x 0.6mmL(IEC 336/1993)
0.8mmW x 0.6mmL(IEC 60336:2005)
Focal Spot Modulation Transfer Functions : MTF for X-Ray Tube
Assembly Standard magnification = 1.3
Width Length

Frequency (lp/mm) Frequency (lp/mm)

Maximum Potential Difference (Reference IEC 60613): 140 kVp


Inherent Filtration
1.0 mm Al at 70 kV Tube 0.8 mm Al
IEC 522/1976 Housing 0.2 mm Al
Electrical Connections
See curves and diagrams
Emissions Characteristics
Connection stator, Thermal and Pressure overload switches
Principle Dimensions
Length 21.31 inches (54.1 cm)
Height 10.57 inches (26.8 cm)
Depth 28.20 inches (71.6 cm)
Weight 54.25 kg (±10%)
X-Ray Tube Conditioning
The BRIVO CT Series system software controls X-Ray tube conditioning. (See accompanying
system documentation.)
Maximum X-Ray Tube Assembly Heat Storage Capacity (Reference IEC 60613)
2.0 MHU
Continuous Heat Dissipation of X-Ray Tube Assembly (Reference IEC 60613)

5314180-1EN Rev. 10 (February 2012) 13-5


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

X-Ray Tube and Heat Exchanger 275kHU/min

Tube Assembly Heating and Cooling Curves


(Reference IEC 60613 and 21CFR 1020.30 (h) (2) (ii))

Tube Housing Heating Curves Tube Housing Cooling Curve


3000 2500

Stored Heat(KJ)
2500 2000
Storage (kJ)

2000 1500
1500 1kW
2 kW 1000
3.4 kW
1000
500
500
0
00 200 400 600 800 1000 1200 0 10 20 30 40 50 60

Time (s) Time(min)

NOTE: Cooling and heating curves reflect maximum tube performance. System software
monitors and controls tube operation.

Leakage Radiation - Loading Factors


(Reference 21CFR 1020.30 (h) (2) (i), 21CFR 1020.30 (h) (4) (i), IEC 60601-1-3, IEC 60601-2-28,
IEC 60601-2-44)
Specified values of the loading factors determining measures for protective shielding of
X-Ray Tube Assembly against leakage radiation according to IEC publication 407/1973 are
140 kV - 24 mA

Half Value Layer


(Reference 21CFR 1020.30 (m)(1), IEC 60601-2-44 and IEC 60601-1-3)
Minimum allowed Half Value layer:
120kV 4.3 mm Al
140kV 5.0 mm Al

CT Scan Ratings
These ratings apply to a system with computer controlled technique selection, scan mode,
and scan duration.
The system uses a math model to track tube temperature.
This tube cooling algorithm delays the start of a scan, if necessary, to avoid exceeding
temperatures that may damage the tube anode or unit.

13-6 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
TUBE SPEC IFICATIONS

Table 13-1 Tube Target Load in Kilowatts for Selected Scan Technique

mA 120 kV 140 kV
40 4.8 5.6
70 8.4 9.8
100 12.0 14.0
120 14.4 16.8
140 16.8 19.6
160 19.2 22.4
200 24.0 28.0

Classification (Reference IEC 60601-1)


IEC publication 536 /1978 and IEC Publication 601-1 Class 1

Transportation and Storage


-20° to +70° C, up to 95% Relative Humidity (non-condensing)
Commercial airlines accept X-Ray tube insert/housing shipments

Transport Packaging
Transport ONLY in packaging supplied by General Electric

Thermal Characteristics of X-Ray Tube Assembly (Reference IEC 60613)


• Heat storage capacity of X-Ray tube assembly: 2 MHU
• Maximum continuous heat dissipation of X-Ray tube assembly: 3.45 kW with heat
exchanger in operation.
Applicable operation condition of kV/mA is as below:

kV 120 140
mA 30 25

NOTE: The maximum continuous heat dissipation value represents anode input power only,
and does not include heat added by the anode stator or the oil pump.

5314180-1EN Rev. 10 (February 2012) 13-7


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Generator Specifications

Main Power Supply (Reference IEC60601-2-44)


• Line voltage (no-load) 380, 400, 415, 440, 460 or 480 VAC
• 3-phase, 50 or 60 Hz ±1.0 Hz
• Phase-to-phase balance within 3% of lowest phase-to-phase voltage.
• Line regulation 5% or less at maximum technique factor.
• Maximum line current demand, 100 Amps RMS (50/60 Hz) at 120 kV, 200 mA.

Generator Rating and Duty Cycle


• kV Range : 120, 140 kV
• mA Range : 10~200 mA
• Maximum Technique : 200mA(120kV),160mA(140kV)
• Maximum Output Rating : 120KV, 200mA, 4s, 24KW
• Generator Duty Cycle :

Maximum Technique Factor Max. Duty Cycle


120kV and 200mA 9%

kV, mA, and Timer Accuracy

Mode Condition Accuracy


Kilovoltage : Axial 120kV ±3%
Excluding initial 23 msec
Milliamperage : Axial 10 to 200mA ± 5 % (or ±1mA)
Excluding initial 100 msec

Scan Time: Axial

Choice of Scan time (Second) Actual Scan Time (Second)


5.0 5.0±10%
3.0 3.0±10%
2.0 2.0±10%
1.0 1.0±10%

kV : Subject to an additional ± 5% accuracy of instrumentation used for calibration and


measurement.

13-8 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
TUBE SPEC IFICATIONS

mA : Subject to an additional ± 5% accuracy of instrumentation used for calibration and


measurement.
Exposure : Subject to an additional ± 3% accuracy of instrumentation used
To comply with 21 CFR 1020. 30 requirements, accuracy of all the technical factors
combined with the optional operating parameters corresponding to the description of the
theoretical maximum deviation.
Time : for calibration and measurement.
Note : Accuracy subject to the following conditions :
1. Line regulation 5% or less.
2. Line voltages within this specified range : 380, 400, 415, 440, 460 or 480 VAC +6%
-5% (50 or 60Hz)
3. System powered for at least 30 minutes prior to measurements.
4. Line voltage variations caused by external loads should not exceed 1% or last
longer than 0.5 second while scanning.

Measurement Basis
X-ray Tube Potential : Precision voltage divider, Model No. 46-154966G1 reduces high
voltage generated across anode and cathode by 1000:1. Tube Potential equals the average
kilovoltage generated during the exposure, excluding transients at the beginning and end.
See Section 2 of the X-ray Alignment procedure in the Service documentation for the
complete measurement procedure.
X-ray Tube Current : X-ray Tube current equals the average milliamperage generated
during x-ray exposure. See Section 2 of the X-Ray Alignment procedure in the Service
documentation for the complete procedure.
Scan Time : Exposure time intervals equal the time during which the kilovoltage equals or
exceeds 75% of its peak value. Measure kilovoltage with a precision voltage divider and an
oscilloscope. Use the time base of the oscilloscope to measure exposure duration.

The Attenuation Equivalent


Cradle : 0.8 mm aluminum equivalent at 100 kV
Extender : 1.4 mm aluminum equivalent at 100 kV
NOTE: To obtain the optimum results, make sure nothing is left in the path of X-ray beam
that may have adverse effects on examinations.
Table 13-2 Tube Model and Catalog Numbers

Component Model Number Catalog No.


X-ray Tube Unit for BRIVO CT Systems D3161T MX135 CT TH1.1
X-ray Tube Housing Assembly 2232785-2 N/A
X-ray Tube Insert 46-274891G1 D0095G

5314180-1EN Rev. 10 (February 2012) 13-9


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

The X-ray tube assembly is classified as Class I, Type B electrical equipment per IEC
601-2-28.

Environmental Specifications

Non-Operating Environment (Reference IEC 60601-1)


Maintain a temperature range between 0°C and +30°C (relative humidity up to 70%
non-condensing) during storage and shipment of the tube unit.
Use GE Healthcare transport packaging during shipment.
You may ship via commercial airlines.

Operating Environment
Maintain an ambient temperature of less than 20-40°C and 30% to 60% (non-condensing)
relative humidity (50% nominal) during operation.

13-10 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Regulatory Information

Chapter 14
Regulatory Information

Applicable Regulations and Standards:


This product manufacturer which is GE Healthcare (General Electric Medical Systems) is ISO
9001 and ISO 13485 certified.
This product complies with the requirements of the following regulations and standards:
Council Directive 93/42/EEC concerning medical devices when it bears the following CE
marking of conformity:

Authorized representative for Europe/European registered place of business:


GE Medical Systems SCS
Quality Assurance Manager
283 rue de la Minière
78530 BUC France
Tel +33 130704040

• The People's Republic of China National Standard (GB) and the pharmaceutical industry
standards (YY) of the applicable standards.
• Applicable standards of Underwriters' Laboratories, Inc. (UL), an independent testing
laboratory.
• Applicable standards of the Canadian Standards Association (CSA).
• Applicable standards of the International Electrotechnical Commission (IEC):
The BRIVO CT scanner complies with IEC 60601-1: 1988 +A1:1991 +A2:1995, IEC
60601-1: 2005, UL 60601-1: 2003 (all configurations) and GB9706.1(all configurations).
The system is classified as a Class I, IPX0 equipment, not suitable for use in the
presence of a flammable anaesthetic mixture with oxygen or nitrous oxide. It is rated

5314180-1EN Rev. 10 (February 2012) 14-1


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

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.
The BRIVO CT scanner complies with IEC60601-1-1:2000, GB9706.15.
All portions of the BRIVO CT Series system are suitable for use in the patient
environment.
The system should be used only with GE approved equipment.
The BRIVO CT Series scanner complies with IEC 60601-1-2: 2001+A1: 2004 (ED2.1), IEC
60601-1-2: 2007 (ED3) (all configurations).
Detailed information concerning Electromagnetic Compatibility can be found in the
following section.
The BRIVO CT Series scanner complies with the applicable portions of IEC 60601-1-3:
1994, IEC 60601-1-3: 2008(all configurations), GB9706.12.
The BRIVO CT Series scanner complies with IEC 60601-2-28.

X-ray source
Tube Unit Assembly IEC 60601-2-28 (1993)
assembly

The BRIVO CT Series scanner complies with the applicable portions of IEC 60601-2-32,
GB9706.14.

Associated
Patient Table IEC 60601-2-32: 1994
Equipment

The BRIVO CT Series scanner complies with IEC 60601-2-44.

IEC 60601-2-44: 2001


CT
BRIVO CT Series System +A1:2002 IEC 60601-2-44:
SCANNER...
2009(all configurations)

The BRIVO CT Series scanner laser alignment light complies with the applicable portions
of IEC 60825-1, GB7247.

14-2 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Electromagnetic Compatibility

Chapter 15
Electromagnetic Compatibility

EMC Performance
This CT system may characteristically cause electromagnetic interference with other
equipment, either through air or connecting cables. The term EMC ( ElectroMagnetic
Compatibility ) means the capability of the equipment, which curbs electromagnetic
influence from other equipment and at the same time does not affect other equipment with
similar electromagnetic radiation from itself. This product is designed to fully comply with
the group 1 IEC60601-1-2: 2001+A1: 2004 (ED2.1) and IEC 60601-1-2: 2007 (ED3) (all
configurations), Class A, in EMC regulations. In terms of EMC performance, limit value 12dB
relaxation in electromagnetic interference of permanently-installed medical system used in
a lead-shielded area, is applied to this product.
To provide reasonable protection against such interference, this product complies the
radiated emission as per CISPR11 Group1 Class A standard limits.
BRIVO CT system compliance below EMC Emissions and Immunity Declaration (See below
Table 15-1 and Table 15-2)

5314180-1EN Rev. 10 (February 2012) 15-1


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Table 15-1

EMC Emissions Declaration For BRIVO CT


The BRIVO CT is intended for use in the electromagnetic environment specified
below. The customer or the user of the BRIVO CT should assure that it is used in
such an environment.
Emissions Test Compliance Electromagnetic Environment Guide
RF emissions Group 1 The BRIVO CT uses RF energy only for its
CISPR 11 internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions Class A The BRIVO CT, when installed in such a
CISPR 11 shielded location, is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.

15-2 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Electromagnetic Compatibility

Table 15-2

EMC Immunity Declaration For BRIVO CT


The BRIVO CT is intended for use in the electromagnetic environment specified below.
The customer or the user of the BRIVO CT should assure that it is used in such an
environment.
Immunity Test IEC 60601-1-2 Compliance Electromagnetic Environment
Test Level Level Guidance
Electrostatic ± 6 KV contact ± 6 KV contact Floors should be wood, concrete, or
discharge (ESD) ± 8 KV air ± 8 KV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electrical fast ±2 KV for power ±2 KV for Mains power quality should be that
transient/burst supply lines power supply of a typical commercial or hospital
IEC 61000-4-4 ±1KV for lines environment
input/output ±1KV for
lines input/output
lines
Surge ± 1 KV line-line ± 1 KV line-line Mains power quality should be that
IEC 61000-4-5 ± 2KV ± 2KV of a typical commercial or hospital
line-ground line-ground environment
Voltage dips, Mains power quality should be that
short <5% UT of a typical commercial or hospital
interruptions environment. If the user of the BRIVO
and voltage (>95% dip in UT) CT requires continued operation
variations on for 5 sec during power mains interruptions, it
power supply is recommended that the BRIVO CT
input lines IEC be powered from an uninterruptible
61000-4-11 power supply or a battery.
Power
Power frequency magnetic fields
frequency 3 A/m 3 A/m should be at levels characteristic of a
(50/60Hz)
typical location in a typical
magnetic field
commercial or hospital environment.
IEC 61000-4-8
Note : UT is the a.c. mains voltage prior to application of the test level.

5314180-1EN Rev. 10 (February 2012) 15-3


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Notice upon Installation of the Product


• Locate the equipment as far as possible from other electronic equipment.
• Be sure to use either any cables provided by GEHC or ones designated by GEHC. Wire
these cables following these installation procedures.

General Notice
• Designation of Peripheral Equipment Connectable to this Product
Avoid using other equipment than designated. Failure to comply with this instruction
may result in poor EMC performance of the product.
• Notice against User Modification
Never modify this product. Unilateral user modification may cause degradation in EMC
performance. Modifications of product include ;
– Changes in cable ( length, material, wiring etc.)
– Changes in system installation/layout
– Changes in system configuration/components
– Changes in means of fixing the system/parts ( cover open/close, cover screwing )
• Operate the system with all covers closed. If you open any cover for some reason, be
sure to shut it before starting/resuming operation. Operating the system with any cover
open could affect EMC performance.

Countermeasures against EMC-related Issues


Generally it is pretty difficult to grapple with EMC-related issues. It may take much time and
cost.

General countermeasures
Electromagnetic interference with other equipment
• Electromagnetic interference may be alleviated by positioning other equipment far from
the system.
• Electromagnetic interference could be mitigated by changing the relative
location/installation angle between the system and other equipment.
• Electromagnetic interference may be eased by changing wiring locations of
power/signal cables of other equipment.
• Electromagnetic influence could be reduced by altering the path of power supply for
other equipment.
• Electromagnetic environment specified below Table14- 3 and Table 14-4.

15-4 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Electromagnetic Compatibility

Table 15-3

EMC Immunity Declaration For BRIVO CT


The BRIVO CT is intended for use in the electromagnetic environment specified below. The
customer or the user of the BRIVO CT should assure that it is used in such an environment.
Immunity IEC 60601-1-2 Compliance Electromagnetic Environment Guidance
Test Test Level Level
Protable and mobile RF communications
equipment should be used no closer to any
part of the BRIVO CT, including cables, than
the recommended separation distance
Conducted 3 Vrms 3V calculated from the equation appropriate for
RF 150 kHz to 80 the frequency of the transmitter.
IEC MHz Recommended Separation Distance
61000-4-6
3,5
d =[ ] P (see Table 15-4 )
3

3,5
d =[ ] P 80 MHz to 800 MHz (see Table 15-4 )
3
Radiated RF 3 Vrms
3 V/m
IEC 80 MHz to 2,5
61000-4-3 GHz 7
d = [ ] P 800 MHz to 2,5 GHz (see Table 15-4 )
(alternative 3
method: IEC
61000-4-21) Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey, a should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following symbol:

5314180-1EN Rev. 10 (February 2012) 15-5


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the BRIVO CT is used
exceeds the applicable RF compliance level above, the BRIVO CT should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the BRIVO CT.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
NOTE: These guidlines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

15-6 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Electromagnetic Compatibility

Table 15-4

Recommended separation distances between portable and mobile RF


communications equipment and the BRIVO CT
The BRIVO CT is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the BRIVO CT can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the BRIVO CT as recommended
below, according to the maximum output power of the communications equipment.
Rated Maximum Separation distance according to frequency of transmitter
Output Power (P) if m
Trabsnitter Watts (W)
150 kHz to 80 MHz to 800 MHz to
80 MHz 800 MHz 2,5 GHz
3,5 3,5 7
d =[ ] P d =[ ] P d =[ ] P
3 3 3
Separation Distance Separation Distance Separation Distance
meters meters meters
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the separation
distance can be estimated using the equation in the corresponding column, where P is the
maximum output power rating of the transmitters in watts (W) according to the transmitter
manufacturer.
Note : At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note : These guidlines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

5314180-1EN Rev. 10 (February 2012) 15-7


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Notice on Service
• Ensure all screws are tight after servicing. Loose screws may cause the degradation in
EMC performance.
• In case the high frequency gasket of this system is broken, replace it with a new one
immediately.

15-8 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

Chapter 16
SYSTEM SPECIFICATIONS

COMPONENT PART NUMBER RATING PLATE LOCATIONS


Operator Console 5325157 Console Rating Plates Example comply
with IEC60601-1:1988+A1+A2 and
IEC60601-1:2005

Scan Control Box 5337069 N/A


Film

5314180-1EN Rev. 10 (February 2012) 16-1


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

COMPONENT PART NUMBER RATING PLATE LOCATIONS


Fix Table 5322519
Rating Plate
WEEE Label

Cradle Tray_Rear

1105mm 5mm

16-2 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

COMPONENT PART NUMBER RATING PLATE LOCATIONS


Gantry 5323923 (BRIVO
CT315)
5324907 (BRIVO
CT325)
PDU 5324901 (380V)

Gantry Rating Plates Example comply with


IEC 60601-1: 1988+A1+A2
and IEC 60601-1: 2005

PDU Rating Plates Example comply with


IEC60601-1:1988+A1+A2
and IEC60601-1:2005

5314180-1EN Rev. 10 (February 2012) 16-3


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

COMPONENT PART NUMBER RATING PLATE LOCATIONS


X-ray Tube 2232785-2

Generator 2227720

Power Unit 2227721 N/A

16-4 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

COMPONENT PART NUMBER RATING PLATE LOCATIONS


HV Tank 2186730

Collimator 2259785-4 (BRIVO


CT315)
2320783-2 (BRIVO
CT325)

5314180-1EN Rev. 10 (February 2012) 16-5


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

COMPONENT PART NUMBER RATING PLATE LOCATIONS


Auxiliary unit 2213293 N/A
GDAS Assy 5142027-2 (BRIVO
CT315)
5142027 (BRIVO
CT325)

Detector 2245151 (BRIVO


CT315)
2321043 (BRIVO
CT325)

16-6 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

COMPONENT PART NUMBER RATING PLATE LOCATIONS


Cradle Extender 2137478
Assy

Head Holder 5334730 N/A


* 2115996-3

Phantom Holder 5395684 N/A


QA Phantom 2144715

NOTE: *Option, may not shopped with the system without this option.

5314180-1EN Rev. 10 (February 2012) 16-7


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

BRIVO CT Rating Plate (Reference 21CFR 1020.30 (h) (1) (i))


System Rating Plates Example comply with IEC 60601-1: 1988+A1+A2 and IEC 60601-1:
2005

GE HANGWEI MEDICAL SYSTEMS CO. LTD


NO.2 NORTH YONG CHANG STREET
ECONOMIC – TECHNOLOGICAL DEVELOPMENT ZONE
BEIJING, P.R.CHINA 100176

MODEL: BRIVO CT315


SOURCE: 3N~ 380V 50/60Hz
MOMENTARY POWER: 40KVA IPX0
CONTINUOUS POWER: 15KVA

GE HANGWEI MEDICAL SYSTEMS CO. LTD


NO.2 NORTH YONG CHANG STREET
ECONOMIC – TECHNOLOGICAL DEVELOPMENT ZONE
BEIJING, P.R.CHINA 100176

MODEL: BRIVO CT325


SOURCE: 3N~ 380V 50/60Hz
MOMENTARY POWER: 40KVA IPX0
CONTINUOUS POWER: 15KVA

RoHS logo size can not be less than 5 x 5, Unites mm, According to the size of the blank
recommend 9mm x 9mm.

16-8 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

Image Performance

According with IEC61223-3-5 description


Explained below is information that relates image performance, as required by IEC standard,
in compliance with the IEC 61223-3-5, First edition, August 2004. The measurement
procedure is described in IEC standard 61223-3-5.

Nominal Slice Thickness


Slice thickness should not vary from the expected value by more than 50% for thickness of
2.0mm or less and ±1.0mm for thickness over 2.0mm. (Regarding the optional slice
thickness less than 1.0mm, the deviation from the expected values should less than
±0.5mm.)

Dose
CTDIw Head Statement of Typical Technique:

BRIVO CT325
52mGy ±40% Axial,Head sFOV,25cm dFOV,120kV,150mA,2s,2ix10 mm
BRIVO CT315
49mGy±40% Axial,Head sFOV,25cm dFOV, 120kv, 150mA, 2s, 10mm
CTDIw Body Statement of Typical Technique:

BRIVO CT325
15mGy ±40% Axial,Large sFOV,43cm dFOV,120kV,130mA,1.5s, 2ix10mm
BRIVO CT315
13mGy±40% Axial,Large sFOV, 43cm dFOV, 120kv, 130mA, 1.5s, 10mm

5314180-1EN Rev. 10 (February 2012) 16-9


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

CTDlfree air
Table 16-1 CTDIfree air for Brivo CT315

Aperture Average Dose


Scan Tech SFOV mA
(mm) (mGy)
1i*10 Large 130 47.4
1i*7 Large 130 47.4
1i*5 Large 130 48.5
1i*3 Large 130 49.6
1i*2 Large 130 51.0

Free air/axial/ 1i*1 Large 130 57.2


120kV/1.5sec 1i*10 Head 150 55.5
1i*7 Head 150 55.1
1i*5 Head 150 56.1
1i*3 Head 150 57.3
1i*2 Head 150 59.0
1i*1 Head 150 66.2
1i*10 Large 130 65.5
1i*7 Large 130 65.8
1i*5 Large 130 66.9
1i*3 Large 130 68.1
1i*2 Large 130 70.3

Free air/axial/ 1i*1 Large 130 79.0


140kV/1.5sec 1i*10 Head 150 76.4
1i*7 Head 150 76.0
1i*5 Head 150 77.4
1i*3 Head 150 79.0
1i*2 Head 150 81.2
1i*1 Head 150 91.2

16-10 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

Table 16-2 CTDIfree air for Brivo CT325

Aperture Average Dose


Scan Tech SFOV mA
(mm) (mGy)
2i*10 Large 130 49.8
2i*7 Large 130 49.0
2i*5 Large 130 49.4
2i*3 Large 130 49.5
2i*2 Large 130 50.4
2i*1 Large 130 50.9

Free air/axial/ 2i*0.6 Large 130 47.2


120kV/1.5sec 2i*10 Head 150 58.0
2i*7 Head 150 57.0
2i*5 Head 150 57.3
2i*3 Head 150 57.5
2i*2 Head 150 58.4
2i*1 Head 150 55.2
2i*0.6 Head 150 54.6

5314180-1EN Rev. 10 (February 2012) 16-11


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Aperture Average Dose


Scan Tech SFOV mA
(mm) (mGy)
2i*10 Large 130 69.0
2i*7 Large 130 67.9
2i*5 Large 130 68.3
2i*3 Large 130 68.5
2i*2 Large 130 69.7
2i*1 Large 130 70.5

Free air/axial/ 2i*0.6 Large 130 65.5


140kV/1.5sec 2i*10 Head 150 80.2
2i*7 Head 150 78.9
2i*5 Head 150 79.3
2i*3 Head 150 79.6
2i*2 Head 150 80.8
2i*1 Head 150 81.5
2i*0.6 Head 150 75.7

CTDIfree air Reproducability: each CTDIfree air value shall be within ±10 % of the mean of a
set of 10 measurements.
Noise, Uniformity, Water CT number (Reference 21CFR 1020.33 (c) (3) (i) and YY0310)
Head
Noise: less than 0.35%
Uniformity: less than 3HU
Water Mean CT number: 0±3HU
Statement of Typical Technique:
BRIVO CT325:
Axial Head sFOV, 25cm dFOV, 120kV, 150mA, 2s, 2ix10mm, 200mm water phantom.
BRIVO CT315:
Axial Head sFOV, 25cm dFOV, 120kV, 150mA, 2s, 10mm, 200mm water phantom.

16-12 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

Body
Noise: less than 0.9%
Uniformity: less than 4HU
Water Mean CT number: 0±4HU
Statement of Typical Technique:
BRIVO CT325:
Axial, Large sFOV, 36cm dFOV, 120kV, 130mA, 1.5s, 2ix10mm, 300mm water phantom.
Axial, Large sFOV, 36cm dFOV, 120kV, 130mA, 1.5s, 10mm, 300mm water phantom.

Spatial Resolution
Head Statement of Typical Technique:
3.6lp/cm±20%lp/cm@50%MTF
6.4lp/cm±20%lp/cm@10%MTF
Statement of Typical Technique:
BRIVO CT325:
Axial/1.5S/10mm 2i/120kV/150mA/Head sFOV/25cm dFOV/STD
BRIVO CT315:
Axial/1.5s/10mm /120kV/150mA/Head sFOV/25cm dFOV/STD
High Resolution
11.2lp/cm±20%lp/cm@50%MTF
14.1lp/cm±20%lp/cm@10%MTF
Statement of Typical Technique:
BRIVO CT325:
Axial/1.5S/10mm 2i/120kV/150mA/Large sFOV/10cm dFOV/PFRM
BRIVO CT315:
Axial/1.5s/10mm/120kV/150mA/Large sFOV/10cm dFOV/PFRM
Body Statement of Typical Technique:
3.6lp/cm±20%lp/cm@50%MTF
6.4lp/cm±20%lp/cm@10%MTF

5314180-1EN Rev. 10 (February 2012) 16-13


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Statement of Typical Technique:


BRIVO CT325:
Axial/1.5S/10mm 2i/120kV/150mA/Large sFOV/25cm dFOV/STD
BRIVO CT315:
Axial/1.5s/10mm/120kV/150mA/Large sFOV/25cm dFOV/STD
High Resolution
11.2lp/cm±20%lp/cm@50%MTF
14.1lp/cm±20%lp/cm@10%MTF
Statement of Typical Technique:
BRIVO CT325:
Axial/1.5S/10mm 2i/120kV/150mA/Small sFOV/10cm dFOV/PFRM
BRIVO CT315:
Axial/1.5s/10mm/120kV/150mA/Small sFOV/10cm dFOV/PFRM

Low-Contrast Resolution
Be visible: 3mm/0.3%@ CTDI center < 40mGy
Statement of Typical Technique:
BRIVO CT325:
Axial/1.5S/10mm 2i/120kV/150mA/Small sFOV/19.2cm dFOV/STD/ Bowtie Filter
Helical//1.5S/10mm 2i /120kV/150mA/Small sFOV/19.2cm dFOV/STD/Bowtie Filter
BRIVO CT315:
Axial/1.5s/10mm/120kV/150mA/small sFOV/19.2cm dFOV/STD/Bowtie Filter
Helical/1.5s/10mm/120kV/150mA/small sFOV/19.2cm dFOV/STD/Bowtie Filter

Consistent with the description of YY0310


The following description is about image performance of information. Consistent with
YY0310, 2005 edition. Test steps described in the standard YY0310.

Slice Thickness
BRIVO CT315
a)Axial scan slice thickness
Slice thickness Parameter: 1mm, 2mm, 3mm, 5mm, 7mm, 10mm.

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SYSTEM SPECIFICATIONS

Slice thickness of 2mm and above: deviation of ± 1.0mm; the thickness of 1mm to 2mm;
deviation of ±50%; less than the thickness of 1mm; deviation of ±0.5mm.
b) Helical scan slice thickness
Slice thickness parameter: 1mm, 2mm, 3mm, 5mm, 7mm, 10mm.
Slice thickness of 2mm and above: deviation of ± 1.0mm; the thickness of 1mm to 2mm;
deviation of ±50%; less than the thickness of 1mm; deviation of ± 0.5mm.
BRIVO CT325
a)Axial tomography scan slice thickness
Slice thickness of mode parameter 1i: 1.2mm(option), 2mm, 4mm, 6mm, 10mm, 2i mode:
0.6mm(option), 1mm, 2mm, 3mm, 5mm, 7mm, 10mm.
Slice thickness of 2mm and above: deviation of ±1.0mm; the thickness of 1mm to 2mm;
deviation of ±50%; less than of the thickness of 1mm; deviation of ±0.5mm.
Helical tomography scan slice thickness
Slice thickness parameter: 0.6mm(option), 1mm, 2mm, 3mm, 5mm, 7mm, 10mm.
Slice thickness of 2mm and above: deviation of ±1.0mm;the thickness of 1mm to 2mm;
deviation of ±50%; less than the thickness of 1mm; deviation of ± 0.5mm.

Statement of Typical Technique (YY0310):


BRIVO CT325
Head: Axial, Head sFOV, 25cm dFOV, 120kV,160mA,1.5s, 2i x10mm,200mm water Phantom
Body: Axial, Small sFOV, 25cm dFOV, 120kV,160mA,1.5s, 2i x10mm,200mm water Phantom
BRIVO CT315
Head: Axial, Head sFOV, 25cm dFOV, 120kV,160mA,1.5s, 10mm,200mm water Phantom
Body: Axial, Small sFOV, 25cm dFOV, 120kV,160mA,1.5s, 10mm,200mm water Phantom
NOTE: Unless other explain, the following perfomance indicators in the above-mentioned
results under typical condition.
Center CT dose index (CTDIcent)
CTDIcent of typical values under typical head and body scan as follows:
BRIVO CT325: 37.6mGy
BRIVO CT315: 37.6mGy
Noise, Uniformity and Water CT number
Noise: less than 0.35%

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BRIVO CT Series

Uniformity: less than 4HU


Mean CT number: 0±4HU
Spatial resolution
Regular reconstruciton (typical head or body of scans): not more than 0.71mm(center dose
of not more than 40mGy.)
High resolution reconstruction: not more than 0.42mm(center dose of not more than
40mGy.)
Description of scan and reconstruciton technique:
BRIVO CT325: Axial/1.5s/3mm 2i/120kV/160mA/Head sFOV/10cm dFOV/PFRM
BRIVO CT315: Axial/1.5s/3mm/120kV/160mA/Head sFOV/10cm dFOV/PFRM
Low-Constract resolution
Not more than 3.0 mm (0.3% contrast, center dose not more than 40mGy), That is center
dose under the condition of not more than 40mGy able to distinguish between the
background contrast of 0.3% is not greater than 3mm goals.

Basic Parameters

Detector
BRIVO CT325: Double solid detector, detection of channel 685×2 posts (measure) +23×2
posts (reference)
BRIVO CT315: Single solid detector, detection of channel 685 posts (measure) +23 posts
(reference)
BRIVO CT series detector at the ISO center of the maximum effective detection range of
10mm (BRIVO CT315) and 20mm (BRIVO CT325), scan slice thickness by X-ray Collimator
control, detector geometric efficiency of 100%.

Scan Mode
BRIVO CT Series using slip-ring continuous scanning, fan-beam X-ray image methods.

Scan FOV
BRIVO CT Series of CT scans for the different parts of the human body offers variety of scan
FOV, Ped Head (180mm), Head (250mm), Small (250mm), Middle (350mm), Large (430mm).
One Ped Head and Head for head scans, Small, Middel, Large for the body scan .

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SYSTEM SPECIFICATIONS

Image Reconstruction and Display


BRIVO CT Series using filtered back-projection image reconstruction slices. In normal scan
mode, using 972 projection data to complete the reconstruction, the required data obtained
by scanning frame rotating week.
Image reconstruction matrix of 512x512 or 256x256. Display matrix of 512x512, 768x768
and 1024x1024.
User can adjust display FOV after the reconstruction process in order to arrive larger vision
of particular parts of purpose.
BRIVO CT Series offers the following reconstruction filtered function: Soft tissue function,
regular function, enhanced routine function, bone function, Chest function, fine function, the
edge of reconstruction function, high-resolution function. User can choose appropriate
reconstruction function to reconstruct according to require, and can be changed in the
post-reconstruction.

Helical scan pitch factor


BRIVO CT325: 0.75:1 and 1.5:1. 
BRIVO CT315: 0.1:1  to 3.0:1 continously adjustable, Adjust step size of 0.1 (Supported by the
patient with the smallest velocity impact in a smaller slice thickness can not be used when
the pitch of 0.1:1, and a similar coefficient of scan.

Exposure Time Accuracy


±10% of the prescribed exposure.

Scan exposure Time Variance


(Reference 21 CFR 1020.30 (h) (3) and YY0310)
Total Tolerance=±10% (includes Tool Variance of ±3%).

X-ray High-Voltage Generator Parameters


Power Input: 380~480V, Three-phase AC Input, 50Hz/60Hz ± 2%Hz, Phase imbalance is less
than 3%, line voltage adjstment is not more than 5%.
Generator Voltage: 80kV, 120kV, 140kV, which is not used for clinical scanning 80KV.
Generator Current: 10~200mA adjustable to 5mA step.
Generator maximum power: 24kW, Maximum technical factors 120kV/200mA.
Generator kV Accuracy: ±3%
Generator Current Accuracy: ±5% (or ± 1mA)

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BRIVO CT Series

Generator power and generator current of accuracy by the calibration and measuring
instruments of ± 5% impact of possible change.

X-ray High-Voltage Generator Parameters (constistent with YY0310


description)
Power Input: 380~480V, Three-phase AC Input, 50Hz/60Hz ± 2%Hz, Phase imbalance is less
than 3%, line power adjstment is not more than 5%.
Generator Power: 80kV, 120kV, 140kV, which is not used for clinical scanning 80KV.
Generator current: 10~200mA adjustable to 5mA step.
Generator maximum power: 24kW, maximum technical factor 120kV/200mA.
Generator kV accuracy: ±10%
Generator Current accuracy: ±10%

Gantry Basic parameters


The minimum diameter of opening part of the Gantry: 650 ±5mm
Alignment Light Accuracy (Refer to IEC 61223-3-5 for test method)
Axial alignment light: ± 1mm Sagital and Coronal alignment light: ± 3mm
Maximum Output Power <1.0 mW/laser beam
Power Supply 5 volt
Maintenance
• Laser alignment lights do not require user maintenance.
• Qualified service personnel must inspect the lights quarterly to assure proper
alignment.

CAUTION: The width of the LIGHT FIELD of Alignment Light is not exceed 3 mm, which is
not represent the actual width of TOMOGRAPHIC SECTION.

Patient Support Basic Parameters


Fix Table
Positioning Accuracy: ±1.0mm
Stepping Accuracy: ± 0.25mm
Moving Speed: 20mm/s (low speed), 100mm/s (high speed), error is not greater than ±3%

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SYSTEM SPECIFICATIONS

Design of load-bearing: 180kg


Horizontal range: not less than 1500mm
Over travel cradle in/out: less than 10mm

Laser Alignment Lights

Alignment Light Accuracy (Refer to IEC 61223-3-5 for test method)


Axial alignment light: ± 1mm Sagital
Coronal alignment light: ± 3mm
Maximum Output Power <1.0 mW/laser beam
Power Supply: 5 volt
Maintenance:
• Laser alignment lights do not require user maintenance.
• Qualified service personnel must inspect the lights quarterly to assure proper
alignment.

CAUTION: The width of the LIGHT FIELD of Alignment Light is not exceed 3 mm, which is
not represent the actual width of TOMOGRAPHIC SECTION.

Scout Basic Parameters


X-ray Tube Assembly location: 0~360°, to 5° as a stepping.
Scout Range: 50~700mm.
Scout Cradle Speed: 75mm/s ±3%.
Scout positioning Accuracy: ±1.0mm.

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BRIVO CT Series

Symbols and Classification

Symbol Publication Description

~ 417-5032 Alternating Current

~
3 335-1 Three-phase alternating current

~
3N 335-1
Three-phase alternating current
with neutral conductor

Direct Current

Dangerous voltage

Emergency Stop

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SYSTEM SPECIFICATIONS

Symbol Publication Description

417-5339 X-Ray source assembly Emitting

417-5009 Stand by

Start

Table Set

Abort

Intercom

(On Operator Console)


Power ON Light ON
Stand by Light OFF

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BRIVO CT Series

Symbol Description

Microphone (Mic)

Contrast

Brightness

o
50 CC
+30
System storage prior to installation:
Maintain storage temperature between 0°C and +30° C
0 oC

System storage prior to installation:


Maintain non-condensing storage humidity below 70%

Humidity 0-70%
Excluding DO NOT store system longer than 90 days
Condensation
Air Pressure System storage and shipment
700-1060hPa Maintain Air Pressure between 700 and 1060hPa

WEEE

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© 2012 General Electric Company. All rights reserved.
SYSTEM SPECIFICATIONS

Class 1 Equipment
Any permanently installed equipment containing operator or patient accessible surfaces
must provide backup protection against electric shock, in case the BASIC INSULATION fails.
In addition to BASIC INSULATION, Class 1 equipment contains a direct connection to a
PROTECTIVE (EARTH) CONDUCTOR which prevents shocks when a person touches a broken
piece of equipment or touches two different equipment surfaces simultaneously.

Type B Equipment
CLASS I, II, or III EQUIPMENT or EQUIPMENT with INTERNAL ELECTRICAL POWER SOURCES
provide an adequate degree of protection against electric shock arising from (allowable)
LEAKAGE CURRENTS or a breakdown in the reliability of the protective earth connection

Ordinary Equipment
Enclosed EQUIPMENT without protection against the ingress of water.

Operation Of Equipment
CONTINUOUS OPERATION WITH INTERMITTENT LOADING.
Operation in which EQUIPMENT is connected continuously to the SUPPLY MAINS. The stated
permissible loading time is so short that the long term on-load operating temperature is not
attained. The ensuing interval in loading is, however, not sufficiently long for cooling down
to the long term no-load operating temperature.
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE
WITH AIR or WITH OXYGEN or NITROUS OXIDE.

Environmental Specifications
Ratings and duty cycles of all subsystems apply if the site environment complies with the
following. The specified environment must be constantly maintained, weekends, holidays,
and throughout the night. Shutdown the CT system whenever the air conditioning fails.
Optional: Turn air conditioner OFF during CT shutdown for repair.

System Cooling Requirements


The cooling requirements do not include cooling for the room lighting, personnel, or non-CT
equipment present. Cooling requirements are listed by subsystem to allow planning for
each room of the CT suite. Cooling requirements are given for minimum, recommended, and
growth allowance scenarios. • The minimum cooling figures assume patient throughput of 3
patients per hour and 75 scan rotations per patient. • The recommended cooling
requirements assume patient throughput limited by the tube cooling algorithm. • The suite
cooling can be sized for future developments by using the growth allowance figures. This

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BRIVO CT Series

cooling will accommodate more patients per hour and/or potential future system
enhancements.

Subsystem Minimum Allowance (Watts / BTU/Hr)


Gantry Table PDU Operator Console TIO Optional Laser Camera 5500/18766** 200/682
1500/5118 2100/8200 800/2730 Recommended cooling values should not be used for
calculating system input power requirements. Recommended Allowance: 7150/24400
Growth Allowance: 9200/31400

Cleaning
The CT system is not waterproof. It is not designed to protect internal components against
the ingress of liquid.
Decontamination or cleanliness of the CT system (i.e. gantry, table, console and accessories)
is the sole responsibility of the health care provider owning and/or operating the CT system.
Caution :
Avoid chemical damage to surfaces. Some detergent or cleaning agent may damage the
surface.
Disclaimer :
GEHC bears no responsibility for sterilization of system surfaces.
GEHC shall not be held liable for any contagion which may have stemmed from
contaminated stains on the system surfaces.

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PLANNED MAINTENANCE

Chapter 17
PLANNED MAINTENANCE

The following chart shows the frequency of regular maintenance of the system,
Recommended frequency of BRIVO CT regular Maintenance is twice a year. The specific
maintenance cycles can be according to local custom, system usage and effectiveness of
the system to determine.
Priority Code
Priority Description
1 Safety and Regulatory
2 Image quality
3 Procedures that make the system unavailable for scanning
4 Procedures that can be performed while the customer is
scanning
Frequency Code
Frequency Description
S Once half a year
A Once a year
Regulation
and Safety

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BRIVO CT Series

Safety and Regulatory


ITEM SUB-SYSTEM DESCRIPTION Priority Frequence Annual PM Schedule
A B
PM0101 System Verify Emer- 1 S  

gency OFF but-


tons (Gantry /
Console / PDU)
PM0102 System Check X-ray ON 1 S  

lights or
buzzer/opera-
tion of scan
abort
PM0103 System Caution Label 1 S  

Check
PM0105 System Check Error Logs 1 S  
PM0111 System Phantom Check 1 A 
PM0201 O.C Verify Audio 1 S  

Function
PM0301 Gantry Check the num- 1 S  

ber of Gantry
revolutions
PM0501 Table Check Table 1 S  

Cover
PM0502 Table Gap between 1 S  

Table Cover and


Cradle
PM0503 Table Check Cradle Rail 1 S  
PM0504 Table Holder Stability 1 S  

Check
PM0505 Table Verify Unlatch 1 S  

Function
PM0607 XG Check Parts 1 S  

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PLANNED MAINTENANCE

Image Quality
ITEM SUB-SYSTEM DESCRIPTION Priority Frequence Annual PM Schedule
A B
PM0104 System Image Check 2 S  

(Image Perfor-
mance)
PM0302 Gantry Clean Mylar ring 2 S  

cover
PM0401 DAS Check/Clean 2 S  

Detector surface
Subtotal 1:15 1:20

System Performance
ITEM SUB-SYSTEM DESCRIPTION Priority Frequence Annual PM Schedule
A B
PM0106 System Perform Filter 3 A 0:15
Curve Test
PM0107 System Check Ground 3 A 0:05
Cable Terminals
PM0108 System Check DAS Count 3 A 0:15
PM0109 System Image Perfor- 2 A 0:50
mance
PM0110 System Tube Gas Bubble 2 A 0:40

Inspection
PM0202 O.C Inspect FANs 3 S 0:05 0:05
PM0203 O.C Verify Mouse for 3 S 0:05 0:05
smooth opera-
tion
PM0204 O.C Clean Display 4 S 0:10 0:10
monitor/Console
exterior
PM0205 O.C Check System 3 S 0:10 0.10
Clock
PM0206 O.C Check Cables / 3 S 0:05 0:05
Power Cables
PM0207 O.C Clean the Dust 3 S 0:10 0:10
Proof Filters
PM0303 Gantry Verify cables and 3 S 0:20 0:20
hardware are
tight

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BRIVO CT Series

ITEM SUB-SYSTEM DESCRIPTION Priority Frequence Annual PM Schedule


A B
PM0304 Gantry Gantry cover 4 S 0:10 0:10
cleaning
PM0305 Gantry Check Position- 3 S 0:10 0:10
ing lights
PM0306 Gantry Check Gantry 3 A 0:05
anchor
PM0307 Gantry Main bearing 3 A 0:20
grease-up
PM0308 Gantry Check drive belt 3 A 0:05
for wear
PM0402 DAS Verify Detector 3 S 0:05 0:05
Heater Control
PM0506 Table Clean Cradle tray 4 S 0:10 0:10
/ Table cover
PM0507 Table Check Table 3 A 0:05
anchors
PM0601 XG Check/Clean 3 S 0:10 0:10
Radiator FAN
PM0602 XG Check X-ray tube 3 S 0:20 0:20
oil and HV con-
nector
PM0603 XG Check HV Tank 3 S 0:20 0:20
and HV connec-
tor
PM0604 XG Check Power 3 S 0:05 0:05
cable connection
PM0605 XG Check X-ray 3 S 0:15 0:15
Tube overheat
safety
PM0606 XG Check KV and 3 A 1:00
mA
PM0701 PDU Check Power 3 A 0:05
Cable Terminals
PM0702 PDU Check Power 3 A 0:05
Line Voltage
Subtotal 2:50 6:35
Total 4:05 7:55

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PLANNED MAINTENANCE

Maintenance by CT Users
The following maintenance by CT users is highly recommended.
Check at least once a week if those items function properly.
• Emergency stop : Press the button to confirm the system stops.
• Cradle latch operation : Press the button to confirm the cradles latches.
• Clean covers
• System time accuracy: If the time is not accurate, adjust the time by using the below
method.
Method of date setting:
– Start the sytem. Wait when a window of ”You have 5 seconds to cancel Application
Startup” appears. Quickly click Cancel
– “Application Startup cancelled at user’s request. To manually start application type
’startup&’ on the console window.” appears. Click OK.
– Click [Data Setting] on the upright corner of the console window. The below window
appears:

– Adjust the system time and then click Set.

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© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

– On below popped up window, click Accept.

– The system will automatically reboot.


• The system must be cooled down for at least 2 hours after the date setting. Otherwise
the cooling curve will be changed. 

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Product Manufacturer

Chapter 18
Product Manufacturer

This chapter lists the manufacturer of the BRIVO CT Series product. The manufacturer listed
is authorized to CE mark the product listed
Table 18-1 BRIVO CT Series product manufacturer

Model Name Manufacturer Manufacturer Address


Manufacturing Site
BRIVO CT 315 GE Hangwei Medical Systems Co. Ltd* No. 2 North Yong Chang Street
BRIVO CT 325
Beijing Economic & Technological
Development Zone,
Beijing 100176, China

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BRIVO CT Series

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PREINSTALLATION

Chapter 19
PREINSTALLATION

System Introduction

The Standard System consists of the following major components.


• Scan Table
• Scanning Gantry containing X-ray tube, data acquisition system, X-ray generator,
detector and Table/Gantry processor.
• Operator’s Console mainly consisting of:
– Host PC
– 19” LCD Monitor
– Keyboard and Mouse
– Scan control box
NOTE: The OC does NOT contain the OC (Operator’s Console) table. A customer can order
the optional table or provide their own.

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BRIVO CT Series

Room Sizes
The following Table contains a list of necessary room dimensions for minimum service area
and patient/traffic concerns in a scan room.

Minimum Room Dimensions


Room Minimum Area m2 Typical Minimum Ceiling
Dimensions m
m×m
Gantry/Scan Room
11.4 4.555×2.5 2.4

Operator’s
Room/Control Room 2.7 1.45×1.86 2.4
(see Note below
The following Table provides main Component Dimensions.

Component Dimensions
COMPONENT LENGTH WIDTH HEIGHT
mm mm mm
Gantry 1784 967 1749
Table 2525 550 836

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PREINSTALLATION

Radiation Protection

Radiation Considerations
A qualified radiological health physicist should review Scan room shielding requirement
while taking into consideration equipment placement, weekly projected workloads, and
materials used for construction of walls, floors, ceiling, doors and windows.

Scatter Radiation
The following illustrations dispict measurable levels within the scanning room while
scanning a special phantom (PMMA for dose measurement) with the listed technique. Values
are in μGy/min and apply to both 60Hz and 50Hz operation.
NOTE: 1mR=8.76×10-6Gy (1Gy=114R)
Use correction factors of the following Table to adjust radiation levels to the usual scan
technique at your site.
Changed Parameter Multiplication Factor
mA New mA/160
Scan Time New Scan Time/1.5
Thickness Aperture Width/10 for CT315,
Aperture width/20 for CT325
Note: These factors are values with respect to “Typical scatter survey 140KV”.

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BRIVO CT Series

Horizontal
Figure 19-1 Brivo CT 325 head 140kv\160mA\2iX10mm, unit [µGy/min]

Figure 19-2 Brivo CT 325 body 140kv\160mA\2iX10mm, unit [µGy/min]

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PREINSTALLATION

Figure 19-3 Brivo CT 315 head 140kv\160mA\10mm, unit [µGy/min]

Figure 19-4 Brivo CT 315 body 140kv\160mA\10mm, unit [µGy/min]

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BRIVO CT Series

Vertical
Figure 19-5 Brivo CT 325 head 140kv\160mA\2iX10mm, unit [µGy/min]

Figure 19-6 Brivo CT 325 body 140kv\160mA\2iX10mm, unit [µGy/min]

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PREINSTALLATION

Figure 19-7 Brivo CT 315 head 140kv\160mA\10mm, unit [µGy/min]

Figure 19-8 Brivo CT 315 body 140kv\160mA\10mm, unit [µGy/min]

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BRIVO CT Series

Construction Materials

Floor
Gantry and patient Table support areas must rest on solid concrete or other basic flooring,
not resilient tile or carpeting which slowly yields over a period of time and distors table to
gantry alignment. Avoid to use them in other areas also, since it generates static electricity
and collects dust.
Other factors, including floor sag, must also be taken into condiseration while Searching for
potential causes of misalignment between gantry and table. The cradle can potentially
carry a 180kg (397lb) patient, and the center of gravity changes as the cradle cantilevers.

Cabling Considerations
Take care of protect interconnecting cables from physical damage (including water). Branch
circuit conductors that don’t terminate directly to a piece of equipment must be enclosed in
a metal raceway or metal wireway.
Regardless of the method chosen, make sure cable in the Gantry room, as well as
throughout the system, comply with local and national codes.

Temperature And Humidity


During the installation and start-up of the system you must take continuous temperature
checks to make sure the environment meets specifications listed as follows. Excessive
Temperature, coupled with reduced air flow from clogged filters, may overstress
components and cause failures.

Gantry/Scan Room:
• Temperature: 20 ℃ ~28 ℃ (at least 5 ℃ /Hr gradient)
• Relative Humidity: 30~70% RH

Operator’s Control/Equipment Room:


• Temperature: 15 ℃ ~30 ℃ (at least 5 ℃ /Hr gradient)
• Relative Humidity: 20~80% RH
• Air conditioning of the building may be sufficient
NOTE: 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.

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PREINSTALLATION

Altitude
• Minimum Altitude: sea level
• Maximum Altitude: less than 9,842 feet (3000 m) above sea level

Installation Insite

Phone Line
When installing the Insite, instruct the customer to have a Direct Inward/Outward Dial voice
grade line installed in the operator console room near the OC. The voice grade line interface
must use a RJ-11 type phone connector. It is the customer’s responsibility to have this
phone line properly installed and verified.

Unique IP Address
Obtain a unique IP address. If the customer has already obtained unique IP address or has
their own process to give you one, you may use the one they give you install InSite.
If the customer has not obtained a unique IP address or would like GE to get one for them,
contact your local technical support center.

Power Requirement
The system shall supply three-phase +Neutral line with full sized ground wire input power.
Phase to phase line voltage is 380V and phase to neutral line voltage is 220V. Normal rated
power is 50KVA.
The customer should supply the cables from distribution transformer to power distribution
box. It's recommended to select multi-strand copper cable which is easy to folder and
install. Cross-sectional area of phase line and ground line are 22~35mm2. Neutral line could
be thinner but larger than 16mm2.

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BRIVO CT Series

System Interconnects
The following illustrations contain information on all cable interconnections between basic
system components.

TO POWER SOURCE

PDB Primary System X-RAY ON DOOR SAFETY


Power Emergency LIGHT SWITCH
Disconnect OFF

Adapter (Option)

240VAC, 5A
24VDC, 200mA or MORE

Gantry TGP CN11 TABLE PS RL1 Table


PDU 24V TABLE RL2
Gantry and Table GND
PDU OC POWER
DTB J3
TGP CN5

Connector
To SCB J1 SCB J1 To TGP
OC POWER IN

HOST CON
OC NIC

OC SCB Fix Cable CONTRACTOR OR


USER SUPPLIED
NIC USB/COM

ETHERNET PHONE LINE


TRANCEIVER FOR INSITE

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PREINSTALLATION

System Interconnect Diagram


GANTRY OC
From PDB
or Adapter PDUBOX WORKSTATION
PDUBOX L1 OC POWER POWER IN
PDUBOX L2
PDUBOX L3
DTB J3 NIC
PDUBOX N
PDUBOX G1 SCB

SCB
TGP CN5 (FIX CABLE)

TABLE
GANTRY PS +24V/GND PS RL1
TGP CN11 RL2
REAR BASE GROUND FRAME GROUND

POWER CABLE PDUBOX N


GROUND CABLE SIGNAL CABLE

Storage Requirement
If the CT system goes into storage before installation, store it in a warehouse protected from
weather. Storage temperature should not exceed 0~+30ºC, and relative humidity should not
exceed 70%. Storage duration should not exceed 90 days.

30

700hPa - 1060hPa
0-70%

5314180-1EN Rev. 10 (February 2012) 19-11


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

19-12 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
INSTALLATION

Chapter 20
INSTALLATION

Gantry Installation
1. Remove all the transportation packing, then assemble the Dollies to the Gantry.
2. Deliver the Gantry with Dollies to the scan room.
3. Remove the dolly side protection rails from the front and the rear sides of the Gantry.
4. Place the channel steel on the floor. Use a pen to mark the location of the wholes on the
floor according to the wholes on the channel steel.
5. Anchoring according to the marked location of wholes.
6. Remove the channel steel.
7. Move the Gantry to the installation location and fix the Gantry to the floor by using the
anchoring bolts.
8. Remove the Gantry Dollies.
9. Adjust the level adjuster on the Gantry to make sure that the Gantry is leveled.

Table Installation
1. Remove all the transportation packaging from the Table.
2. Deliver the Table to the scan room.
3. Move the Table to be in front of the Gantry and perpendicular to the Gantry.
4. Fix the Table to the floor by using the anchoring bolts.
5. Remove the Table Dollies.
6. Adjust the level adjuster on the Table to make sure that the Table is leveled.

5314180-1EN Rev. 10 (February 2012) 20-1


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

System with Template Installation


1. Remove all the transportation packing, then assemble the Dollies to the Gantry.
2. Use the Template to determine the position of the Gantry and Table.
3. Move the Gantry into position, remove the Gantry Dollies, and level the Gantry.
4. Move the Table into position, Level the Table to the Gantry.
5. Make Table and Gantry alignment and anchor the system.

Operator Control
Prepare a proper operator desk in advance, put Host Computer, Monitor, Keyboard and
Mouse on it. Make sure Operator could see the patient on the Table from the operator
console.

System Power, Ground And Signal Cable Connection


Complete as much of the Contractor supplied wiring as possible before starting the system
cabling. Some Contractor supplied wiring, for example ground cables, must be pulled along
with the system cables. In addition, some raceway work, such as cutting and fitting covers
at equipment locations, must be finished after completing the cabling and placing the
equipment in position.
All system cables use a system component designator for identification. The end of each
system cable has a label near the connector that identifies the CABLE NUMBER and
CONNECTOR NUMBER.

Cable Inter-Connection

Indication Light/Switch Connection


The indication light or switch can be connected to this CT system.
• System Power-ON Light, Rotor-ON Light, and X-ray-ON Light
• Scan room door safety switch
• Simultaneous X-ray Exposure Interlock

Ground Continuity Check


Use an earth bonding test meter or equivalent device to measure the DC resistance
between the following components in the system, and verify that each is less than 0.1 ohm.

20-2 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
INSTALLATION

Ground Specification: less than 0.1Ω

System Power
Switch ON the main switch of the Operator Console. The system is started up, then the main
screen appears.

Scan Test
Make sure that functions of each sub-systems (including Operator Console, Gantry and
Table) are normal. Scan Process is successfully completed without error.

Calibration
The system provide the following functions to be adjusted: Hilight CALIBRATION, AIR
CALIBRATION, SPECTRAL CALIBRATION and CT NUMBER ADUSTMENT.

CT Number Adjustment
Adjust to make sure water has a CT number equal to zero and air has a CT number equal to
–1000.

System Verification
Click on Service to display the Service desktop, then select Configuration.

Language Selection
The system is shipped with English and Chinese language selected.

Back-up System State Data


The basic system data (System State Data) must be saved in advance in case the system
Hard Disk Drive in the OC is broken.

5314180-1EN Rev. 10 (February 2012) 20-3


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

System And Room Cleaning


1. Check Scanner, Equipment and control rooms whether comply to temperature and
humidity control requirement.
2. Clean rooms and exterior panels of components.
3. Vacuum clean all electronics cabinets and equipment dust filters. GE recommends a
weekly vacuuming of the dust filters at first since new installation sites experience
excessive dust and dirt. Lengthen the interval between maintenance over a period of
time, depending on the installation site environment.

20-4 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Abbreviations

Chapter 21
Abbreviations

Abbreviations Acronym

AW Advantage Workstation

CFR Code of Federal Regulations

CISPR International special committee on Radio Interference

CRT Cathode Ray Tube

CSA Canadian Standards Association

CT Computed Tomography

CTDI Computed Tomography Dose Index

CW Clockwise

DAS Data Acquisition System

DFOV Display Field of View

DICOM Digital Imaging and Communication in Medicine

DLP Dose Length Product

EFUP Environment-friendly Use Period

EHS Environmental Health and Safety

EMC Electro-magnetic Compatibility

EMI Electro-magnetic Immunity

FAQ Frequently Asked Questions

FBDIMM Fully Buffered Dual Inline Memory Module

FWHM Full Width Half Maximum

FWTM Full Width Tenth Maximum

HU Hounsfield Units

5314180-1EN Rev. 10 (February 2012) 21-1


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

Abbreviations Acronym

HV High Voltage

HVL Half Value Layer

IEC International Electro-technical Commission

IGD Inter-group Delay

IPD Inter-patient Delay

ISD Inter-scan Delay

IV Intra-venous

kV kilo-volts

kW kilo-watts

LCD Liquid Crystal Display

LCD Low Contrast Detectability

mA milli-amps (current)

mAs milli-amps X seconds (current x seconds)

MDC Main Disconnect Control

MTF Modulation Transfer Function

NCRP National Council on Radiation Protection and Measurements

OC Operator’s Console

PDU Power Distribution Unit

PM Planned Maintenance

PMMA Poly-methyl methacrylate

QA Quality Assurance

QEF Quality Equivalent Filtration

QSR Quality System Regulation

RAID Redundant Array of Independent Disks

RAM Random Access Memory

RAS Right/Left, Anterior/Posterior, Superior/Inferior

RF Radio Frequency

ROI Region of Interest

ROM Read Only Memory

SATA Serial Advance Technology Attachment

SCIM Scan Control Intercom Module

21-2 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Abbreviations

Abbreviations Acronym

Sec. or "s" Second

SFOV Scan Field of View

SSP Slice Sensitivity Profile

UL Underwriters’ Laboratories

WL Window Level

WW Window Width

5314180-1EN Rev. 10 (February 2012) 21-3


© 2012 General Electric Company. All rights reserved.
BRIVO CT Series

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21-4 5314180-1EN Rev. 10 (February 2012)


© 2012 General Electric Company. All rights reserved.
Numerics Accumulated Exam DLP 3-14
800 1-3 Dose Length Product 3-14
Projected Series DLP 3-14
A
Axial 11-17 E
Emergency Stop 11-1
C Environmental Specifications 13-10
Calibration
General information 11-21 F
Calibration Modes 11-18 Fastcal
Check Disk Space 8-1 Daily procedure 5-1
Image space 8-1 Filament Selection 11-19
Collimator Theory 11-17
CT G
General information 11-2 Gantry Coordinate System 11-15
Operation Theory 11-2 General Information 11-1
CT Description 11-2 Calibration Scans 11-21
CT Number 11-23 CT Description 11-2
General information 11-23 CT Number 11-23
Pixels and CT Numbers 11-27 CT Operation Theory 11-2
Window Width 11-28 Data Collection 11-19
CT Safety 3-10 Data Storage 11-21
CT/i Performix X-Ray Tube DFOV and Pixel Size 11-25
Tube Model and Catalog Numbers 13-9, Gray Scale 11-22
13-10 Image Display 11-21
CTDIw 3-14 Pixel Coordinates 11-24
Current X-Ray Tube Capacity Effects Prescrip- Pixels 11-24
tions and Interscan Delays 11-19 Pixels and CT Numbers 11-27
RAS coordinates 11-25
D Reconstruction 11-20
DAS Tube Warmup 11-4
Data Collection 11-19 Variables you cannot control 11-24
Data Collection 11-19 Window Width 11-28
General information 11-19 X-Ray 11-3
Data Storage 11-21 X-Ray Tube Capacity
General information 11-21 X-Ray Tube 11-19
Detector window 7-1 General information
DICOM Print 11-3 X-Ray 11-3
Disk Space 8-1 Gray Scale 11-22
Disk space 8-1 General information 11-22
Display
General information 11-21 H
Dose 3-14 Helical 11-18

5314180-1EN Rev. 10 (February 2012) Index-1


© 2012 General Electric Company. All rights reserved.
Helical Overview 11-18 Phantom Setup 12-2
Help 1-3 Scan the QA Phantom 12-4
Slice Thickness 12-7
I
Image Display 11-21 R
Image Quality RAS
Maintain image quality 4-1, 5-1 Annotation 11-25
Image Space 8-1 Coordinates 11-25
Image space 8-1 RAS Coordinates 11-25
Intended Use 11-1 Reconstruction 11-20
General information 11-20
M Reset 9-1
Matrix Reset Procedures 9-1
Pixel Coordinates 11-24
Mean 11-27 S
Mylar ring 7-1 Safety 14-1
Tube compatibility warning 4-3
P Scan and Recon Prescription User Interface
Pediatric Imaging 11-17 (UIF) 11-19
Periodic Maintenance 17-1, 18-1 Scan Parameters 11-20
Phone numbers 1-3 Scout 11-17
Pixel Coordinates 11-24 Space on Disks
Pixels 11-24 Maintain Image Space 8-1
DFOV and Pixel Size 11-25 Standard Deviation 11-27
General information 11-24 Start Up 7-1, 10-1
Pixel Coordinates 11-24 System components 11-1
Pixels and CT Numbers 11-27 System Image Quality Features 11-18
RAS Coordinates 11-25 System Operational Modes 11-17
Window Width 11-28 System Shutdown 9-1
Pixels and CT Numbers 11-27 System Specifications
Premium Image Quality Helical Example 11-18 Environment 13-10
Prepare the System System Warmup 4-1
Overview sheet 7-1
T
Q Tube Warmup 4-1, 11-4
QA 12-1 General information 11-4
QUALITY ASSURANCE Plasma screen warning 4-3
Dose and Performance 12-22 Two hours elapse between exams 4-1
High Contrast Spatial Resolution 12-5
Image Performance 12-31 V
Low Contrast Detectability 12-9 Variables You Cannot Control 11-24
Noise and Uniformity 12-10 Variables you cannot control 11-24
Phantom Description 12-1

5314180-1EN Rev. 10 (February 2012) Index-2


© 2012 General Electric Company. All rights reserved.
W
Warmup 4-1
Warm-up Required 11-21
Warmup Required 11-21
Window Level 11-28
Window Width 11-28
General information 11-28
Pixels and CT Numbers 11-28

X
X-Ray
General information 11-3
X-ray Generation and Detection Details 11-15
X-Ray Tube
X-Ray Tube Capacity 11-19

5314180-1EN Rev. 10 (February 2012) Index-3


© 2012 General Electric Company. All rights reserved.
5314180-1EN Rev. 10 (February 2012) Index-4
© 2012 General Electric Company. All rights reserved.
Manufacturer Address:

GE HANGWEI MEDICAL SYSTEMS CO., LTD.


NO. 2 NORTH YONG CHANG STREET
BEIJING ECONOMIC - TECHNOLOGICAL DEVELOPMENT ZONE
BEIJING, 100176, P. R. CHINA

www.gehealthcare.com

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