Minicat xoran User Manual

USER MANUAL

Table of Contents

1.0 READ THIS FIRST

................................................................................................................................... 11.1 Safety Guidelines

................................................................................................................................... 41.2 Table of Symbols

................................................................................................................................... 81.3 Electromagnetic Interference

................................................................................................................................... 101.4 Cleaning and Service

................................................................................................................................... 111.5 Data Backup

................................................................................................................................... 121.6 Regulatory Compliance

2.0 INTRODUCTION

................................................................................................................................... 142.1 Welcome

................................................................................................................................... 142.2 MiniCAT™ Overview

................................................................................................................................... 152.3 Online User Manual

................................................................................................................................... 152.4 System Hardware

................................................................................................................................... 162.5 Other Components

................................................................................................................................... 192.6 Quick Reference Guide

3.0 STARTUP AND SHUTDOWN

................................................................................................................................... 223.1 Emergency Shutdown

................................................................................................................................... 233.2 System Startup

................................................................................................................................... 273.3 User Management

................................................................................................................................... 283.4 System Shutdown

................................................................................................................................... 293.5 Uninterruptible Power Supply (UPS)

4.0 PATIENT DATABASE

................................................................................................................................... 314.1 Patient Database

................................................................................................................................... 314.2 Enter New Patient

................................................................................................................................... 324.3 Find Existing Patient

................................................................................................................................... 344.4 Advanced Search

................................................................................................................................... 364.5 Delete Patient Record

................................................................................................................................... 364.6 Purge Files

5.0 DAILY CALIBRATION

6.0 ACQUIRING IMAGES

................................................................................................................................... 396.1 Select Imaging Protocol

................................................................................................................................... 406.2 Prepare the Patient

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................................................................................................................................... 416.3 Seat and Position Patient

................................................................................................................................... 446.4 Dry Run and Scout

................................................................................................................................... 486.5 Start Acquisition

7.0 VIEWING IMAGES

................................................................................................................................... 507.1 Open Study

................................................................................................................................... 517.2 Viewing Options

................................................................................................................................... 527.3 Select Slices

................................................................................................................................... 557.4 Viewing Tools

................................................................................................................................... 627.5 Annotation Tools

................................................................................................................................... 677.6 Oblique and TMJ Tools

................................................................................................................................... 757.7 3D Viewing Window

................................................................................................................................... 777.8 Comparison Tool

8.0 MODALITY WORKLIST CLIENT

9.0 OUTPUT IMAGES

10.0 TECHNICAL SPECIFICATIONS

................................................................................................................................... 8210.1 General Information

................................................................................................................................... 8410.2 Imaging Properties

................................................................................................................................... 9510.3 X-Ray Specifications

................................................................................................................................... 9710.4 Scatter Map

................................................................................................................................... 10010.5 Dose Information

................................................................................................................................... 10410.6 Installation Requirements

................................................................................................................................... 10910.7 IGS Compatibility

79 81 82

11.0 QUALITY CONTROL TESTS

................................................................................................................................... 11411.1 Laser Accuracy

................................................................................................................................... 11511.2 CT Number of Reference Materials

................................................................................................................................... 11611.3 Spatial Resolution

................................................................................................................................... 11811.4 CT Number and Standard Deviation of Water

................................................................................................................................... 11911.5 Artifact Test

................................................................................................................................... 12011.6 Uniformity Test

................................................................................................................................... 12111.7 Contrast Scale

................................................................................................................................... 12711.8 Image Noise

................................................................................................................................... 12811.9 Nominal Tomographic Section Thickness and Slice Sensitivity Profile

INDEX

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1.0 READ THIS FIRST

Patient E-Stop

Operator E-Stop

This section contains important safety information about using your MiniCAT™.

1.1 Safety Guidelines

Although several safety considerations were made in the design, no amount of safety features can completely eliminate the risk associated with X-ray radiation. Improper use may result in injury.

Emergency Stop:

In the event of an emergency (i.e. any moving component collides with any parts of the equipment, items in the environment, or that could cause physical injury to the patient), the operator should utilize the Emergency Stop (E-Stop) button to turn off the power to all moving parts in order for the patient to be safely removed from the machine.

All persons operating or occupying the area around the scanner must be properly trained on the principles of radiation safety. The persons authorized to operate the equipment will be properly trained by Xoran Technologies on the principles of operation. Operators of the equipment must ascertain the regulatory requirements and the risks associated with the application of X-ray radiation to patients.

The use of protective devices, such as radiation barriers and protective aprons, are always recommended. Consult with a health physicist or other radiation protection expert to determine the

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appropriate radiation protection devices and practices.

Caution: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. Xoran Technologies LLC is released of all responsibility and

indemnity for injury that may result from X-ray radiation or the improper use of the device.

Radiation Safety

The gantry is self-shielded to an extent. However, no design can guarantee that all X-ray radiation is shielded. Therefore, we recommend that additional radiation protection devices are utilized when operating the equipment. A health physicist, or other radiation protection expert, should evaluate the proposed areas in which the MiniCAT™ will be used to determine the radiation protection measures that must be taken.

The MiniCAT™ is equipped with an operator control box that allows for the initiation of a scan while the operator is at a safe distance behind a protective barrier. The operator control box also contains an emergency stop button to terminate X-ray radiation and all powered motion of the

equipment in the case of an emergency.

Testing or calibration should never be performed while a patient is positioned in or near the scanner. The operator should utilize the appropriate radiation protection devices while testing or calibrating the equipment.

No attempt should be made to move, adjust or manipulate the scanner or patient during image acquisition. This could result in unnecessary radiation exposure, injury to the patient and/or damage to the equipment.

It is the responsibility of the user to learn about X-ray radiation health risks and to adopt and follow proper X-ray radiation safety policies and procedures before operating the

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MiniCAT™. All federal and state regulations pertaining to radiation safety must be observed. Please refer to your state radiation safety regulations for specific requirements about the

safe and proper use of the scanner. Stand behind the operator's barrier when using X-ray. Lead-shielded aprons and dose monitoring badges may be required.

ALARA

The principle of As Low As Reasonably Achievable (ALARA) has been implemented into the imaging protocols of the MiniCAT™ and this principle shall be exercised by the user at all times. In this way, unnecessary exposure to radiation can be avoided. ALARA principles shall be exercised by the user at all times. Only required personnel should be in the room when the scanner is in use.

Personal Dosimetry

The purpose of a radiation dosimetry program is to measure the radiation dose equivalent from occupationally exposed radiation workers. You must check with your state radiation safety program to ascertain your state's specific radiation dosimetry requirements.

X-Ray Warning System

When the MiniCAT™ is in use and X-rays are being emitted, you will see a yellow flashing light (located on top of the operator's console) complemented with an audible chirping sound. In addition, it is possible to install external warning lights and/or audible alarms when the X-ray source is enabled in ready state. Call Xoran Customer Service to learn more about these options if required in your area.

Door Interlock System

The MiniCAT™ is equipped with provisions for an optional door interlock circuit. This type of circuit shuts off power to the X-ray source when the door is opened. Call Xoran Customer Service to learn more about these options if required in your area.

Extension Cords / Cables:

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Do not use any extension cords which have not been provided with the MiniCAT™. Use only the

Note: Health Canada does not permit the use of the MiniCAT CT scanner for imaging pregnant or pediatric patients.

Note: The best practice is to consult with a qualified medical physicist to ensure safety and compliance. Feel free to contact Xoran Customer Service for assistance in locating an appropriate medical physics professional in your area. 1-800-70-XORAN (800-709-6726)

interface cables provided with the MiniCAT™. Do not alter the cabling configuration.

Additional Software and Accessories:

Do not connect any items or equipment to the MiniCAT™ which are not part of the system or install any additional software. Either of these actions can cause the system to malfunction and will result in voiding your warranty.

Disposal

Follow local regulations on disposal of waste parts. The X-ray source assembly, image sensor and all electronic circuits should be regarded as non-environmental friendly waste product and should be disposed of in such a way as to minimize the hazard to the health of personnel and the value of property and the community.

Instructions, Training, Use

The MiniCAT™ shall be used, supervised or directed by an individual who is competently aware of the potential hazards involved from ionizing radiation and who is capable of minimizing these hazards. Xoran provides comprehensive training and support for MiniCAT™ users. Xoran accepts no responsibility for the misuse of a MiniCAT™. The user is responsible for compliance with their state's regulation for owning and operating a CT scanner.

1.2 Table of Symbols

The following symbols can be found in this manual and on the equipment.

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Symbol

Description

Type B Applied Part

Electric Shock, High Voltage: This

symbol alerts you to the presence of uninsulated dangerous voltage inside the enclosure -- voltage that may be sufficient to constitute a risk of shock.

Protective Earth, Ground: Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked "Hospital Only" or "Hospital Grade."

Attention: Consult accompanying notices and/or warnings.

X-ray Caution: These symbols indicate the presence of X-ray radiation. This X-ray device may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.

Pinch Point: This symbol alerts you to the potential for injury due to moving mechanical parts. Keep hands clear during operation.

X-Ray Focal Spot: This symbol appears on the X-ray tube head, showing the approximate location of the X-ray focal spot.

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Symbol

Description

Class II Laser: This symbol alerts you to the presence of Class II laser light. Do not stare into the beam.

Laser Alignment Symbol:

Electrostatic Sensitive Symbol:

Circuit Breaker Symbol:

Patient Chair Symbol:

Emergency Stop Symbol:

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Symbol

Description

Chair Elevation Symbol (Up / Down): Patient Symbol:

AC Power Symbol:

Power Symbol (OFF):

Power Symbol (ON): DC Power Symbol:

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Symbol

Description

Medical Grade Power Cord Symbol:

Non-Ionizing Electromagnetic Radiation Symbol:

Serial Connection Symbol:

EC REP

RMS UK, Ltd., Somerset, BS48 4NU United Kingdom

Immunity / Test

Electrostatic Environment Guidance

Electrostatic Discharge

Compliant to +4 kV. Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%.

1.3 Electromagnetic Interference

The MiniCAT™ has been tested and found to comply with the limits for Class A equipment pursuant to IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a commercial environment. The MiniCAT™ generates, uses and can radiate electromagnetic energy. If the MiniCAT™ is not installed and used in accordance with these instructions, it may cause harmful interference to surrounding equipment.

MiniCAT™ is intended for use in an electromagnetic environment specified below. The user of the MiniCAT™ should ensure that it is used in such an environment.

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Immunity / Test

Electrostatic Environment Guidance

EFT and Surge

Electrical power quality should be that of a typical commercial or hospital environment. See Electrical Power Requirements in section

10.6.

Voltage Dips/Dropout

Mains power quality should be that of a typical commercial or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the equipment be plugged into an uninterruptible power supply (included). See Electrical Power Requirements and Apparent Resistance of Supply Mains in section 10.6.

Conducted RF

Portable and mobile communication equipment should be separated from the MiniCAT™ by no less than 19 feet (6 meters).

Radiated RF

The MiniCAT™ is intended for use in an electromagnetic environment in which radiated disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the MiniCAT™ as recommended below, according to the maximum output power of the communications equipment.

Maximum Output Power

(Watts)

Separation (150 kHz to 800

MHz)

Separation (800 MHz to 2.5

GHz)

0.01

15 in (38 cm)

30 in (76 cm)

0.1

15 in (38 cm)

30 in (76 cm)

46 in (117 cm)

8 ft (2.4 m)

12 ft (3.7 m)

24 ft (7.3 m)

100

38 ft (11.7 m)

77 ft (23.4 m)

Note: Field strengths from transmitters, as determined by an electromagnetic site survey, should be less than the compliance level of 3 V/m.

If the MiniCAT™ is suspected of causing harmful interference to other surrounding equipment, the

user is encouraged to try to correct the interference by one or more of the following methods:

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Turn the MiniCAT™ off and on to verify that the interference is coming from the MiniCAT™.

Move the other equipment further away from the MiniCAT™. Connect the other equipment into an outlet on a circuit different from that to which the

MiniCAT™ is connected. Contact Xoran Customer Service for additional assistance.

1.4 Cleaning and Service

Cleaning Schedule

It is recommended that the equipment be cleaned and disinfected in the following manner: Between Patients:

Clean patient head holder with alcohol. Do not spray.

Daily:

Clean dust from surfaces by wiping with a dry or slightly damp cloth. Do not use any

chemicals on any part of the MiniCAT™.

Monthly:

Check for defective X-ray indicator lights and sounds. Gently vacuum dust from fans behind acquisition workstation and server (if applicable). Open server front panel and gently vacuum dust accumulation (if applicable).

Service and Maintenance

It is recommended that the equipment be inspected and serviced annually. Inspection and service must be performed by Xoran Technologies LLC or other technician licensed and qualified to service this equipment. Circuit diagrams, component parts lists, descriptions and calibration instructions can be made available upon request.

Service/preventative maintenance for the first year of equipment operation is covered by Xoran Technologies under the equipment warranty. Ongoing service and preventative maintenance can be purchased under a service agreement with Xoran Technologies.

It is the responsibility of the user to ensure that the equipment is maintained in compliance with the manufacturer recommended maintenance schedule. The manufacturer and the assembler/installer cannot be held responsible for the failure of the owner/user to have the manufacturer's recommended

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maintenance performed.

Computer Maintenance

Remove dust and inspect (Annually) Replace Video Card (Every 4 years)

UPS Maintenance

Remove dust and inspect (Annually) Replace batteries (Every 3 years)

MiniCAT™ Maintenance

Clean and inspect (Annually) Replace Head Select IM483 fan (Annually) Replace DC Power Supply (Every 5 years) Replace Receptor Cooling Fan (Every 5 years) Chair and laser alignment (Annually)

Electromechanical Safety Test

Line Voltage Test (Annually) Chassis to Ground Test (Annually) Leakage Current Test (Annually)

Source Maintenance

Perform Source check and recalibrate as needed (Annually)

Application Maintenance

Geometric Calibration (Annually) Shutter Calibration (Annually) Water Attenuation Calibration (Annually)

Quality Control Tests

CT Number of Reference Materials (Annually) Spatial Resolution (Annually) CT Number and Standard Deviation of Water (Annually) Artifact Test (Annually) Uniformity Test (Annually) Contrast Scale (Annually) Image Noise (Annually) Nominal Tomographic Section Thickness and Slice Sensitivity Profile (Annually)

Maintenance Schedule:

1.5 Data Backup

Every effort has been made to ensure that patient data is stored safely on the MiniCAT™. However, it is recommended that periodic backup is performed to prevent data loss in the event of catastrophe or system failure. It is the user's responsibility to ensure adequate data backup is performed.

Call Xoran Customer Service for recommendations on how to perform data backup most effectively.

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1.6 Regulatory Compliance

MiniCAT™ has been tested and/or evaluated against and found to be compliant with the following standards/requirements:

IEC 60601-1:2003-04-25 (ED.1) with Revisions up to 2003/06/30: IEC 60601-1-1:2000 Collateral Standard-General Requirements for Radiation Protection

for Diagnostic X-ray Equipment

IEC 60601-1-2: 2001 + A1: 2004 Class A for Emissions, Immunity for Non LifeSupporting Equipment

IEC 60601-1-3 1994 Particular Requirements for Safety of X-ray Equipment

IEC 60601-1-4 General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems

IEC 60601-2-32: 1994 Particular Requirements For the Safety of X-ray Equipment for Computed Tomography

IEC 60601-2-44: 2001 Particular Requirements For the Safety of X-ray Equipment for Computed Tomography

CAN/CSA C22.2 No.:601.1-M90 Collateral Standard-Safety Requirements for Medical Electrical Systems

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Equipment Class:

Protection against electric shock: Class I Applied part has degree of protection against electric shock: Type B Applied Part Class of equipment against ingress of liquids: Ordinary Equipment, IPX0 Radiated emissions: Class A FDA: Class 2 Mode of Operation: Continuous operation with intermittent loading

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2.0 INTRODUCTION

2.1 Welcome

Dear Valued Xoran Customer,

Thank you for purchasing the MiniCAT™ scanner. We designed the MiniCAT™ scanner and the User Manual to be easy to use. This User Manual

gives you chronological, step-by-step instructions for operating the scanner. It also provides you with technical specifications of the MiniCAT™ scanner.

To ensure the safe and proper use of your new scanner, please make sure that you read and understand this User Manual before operating the scanner and follow the User Manual’s operating and safety instructions when using the scanner. The instructions in this User Manual are meant to supplement your Xoran on-site training, your radiation safety training as required by your State’s Radiation Safety Regulations, and your own professional training and expertise.

Customer Service and Support is our first priority. We want to do everything we can to help you use your new MiniCAT™ scanner in a safe and efficient manner.

If you have any questions, please call us at: 800-70-XORAN (800-709-6726). Our Customer Service Engineers will be happy to help you.

Sincerely, Xoran Technologies LLC

www.xorantech.com

2.2 MiniCAT™ Overview

MiniCAT™ is a compact, upright volume computed tomography system designed for highresolution, bone window imaging of the sinuses, temporal bones and skull base. MiniCAT™

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provides immediate access to images at the patient’s point-of-care resulting in a faster diagnosis and treatment.

MiniCAT Intended Use:

The MiniCAT is an X-ray imaging device that constructs a three-dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses.

2.3 Online User Manual

The most up-to-date version of this manual can always be viewed online at http://

help.xorantech.com/MiniCAT_5.2. Navigate the online manual by clicking chapter headings in the table

of contents (on the left). For a PDF copy, click the convert to PDF button in the top right-hand corner of the online manual.

Tip: From the MiniCAT™ software, press the F1/HELP key at any time to launch the online

manual.

2.4 System Hardware

The following diagram shows the MiniCAT™ system hardware with the main components identified.

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These components will be referred to throughout this manual.

Part Number

Description

15234

Phantom Holder

20008

Seat Cushion

20011

Workstation with Keyboard and Mouse

20132

Mouse Pad

15239

Carbon Fiber Head Holder

2.5 Other Components

The following is a list of other components that accompany the MiniCAT™. Call Xoran Customer Service for replacements as needed.

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Part Number

Description

27276

Head Pads (wedges)

30022

Head Pads (head strap)

30824-01

Broadband Router

30006

Foot Stool

30010

HP 6940 Printer

30013

Pregnancy Sign

30015

Caution Sign

30600

SmartOnline Uninterruptible Power Supply

30231-00

Operator's Desk

30019

Booster Seat

30233-02

Samsung 21.5" LCD Monitor

40025 V5.0

MiniCAT™ Quick Reference Guide v5.0

40026 CD V5.1

MiniCAT™ User Manual v5.1

60038

Phantom Set

Additional MiniCAT Software 'Viewing Stations':

A MiniCAT 'Viewing Station' is a computer that has MiniCAT software installed and is used as an additional client workstation within a Practice or Hospital environment. Viewing Stations can be used for viewing Xoran studies and generating image outputs. Viewing stations are connected to a Xoran server and they retrieve patient data and studies from the Xoran server over local area network.

The following features are available to users on Viewing Stations:

Search and display patient information View Study Files Modify window/level, image selection, annotations and perform other available image

modification operations

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Perform image output actions including exporting and printing images and DICOM push

Note: Only use original components provided with the MiniCAT™. Do not use any other parts or accessories.

Note: The Xoran server supports up to 5 concurrent connections and up to 20 client connections. The following features will not be available to users on a Viewing Station:

Acquisition and daily calibration Reconstruction of raw Study File data (CPU and GPU) Modality Worklist support Patient Record Management (creating, modifying and deleting patients) Modifying Study Header Deleting Study File Importing Study Files

Study File Purge User Management

NOTE:

1. The '3D View' functionality will be assured to function with a Xoran Specified Computer System.

Note: A Xoran Specified Computer System will require the user to limit the installation of miscellaneous third party software. Additional software programs installed on your workstation could impact the efficient function of the Xoran 3D View.

2. The '3D View' option may not work with standard computer systems - minimum computer hardware and software specifications for Viewing Stations are supplied in section 10.6 of this User Manual (Installation Requirements).

3. Xoran does NOT assure that 3D Viewing will work, as intended to, on a NON-Xoran Supplied Computer System.

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2.6 Quick Reference Guide

Note: This page is a brief overview of the MiniCAT™. Please attend MiniCAT™ training with a qualified instructor, and read the complete MiniCAT™ User Manual before operating the equipment.

Note: Refer to Section 3.2 for System Startup instructions.

Caution: X-ray radiation emitted. Follow radiation safety protocols.

Caution: Laser light emitted. Do not stare into the beam.

PREPARATION

1. Perform a Daily Calibration

For best results, scanner should be powered on for at least one hour before calibration

Click Daily Calibration from the Tools menu (or press the F9/CAL key)

2. Enter Patient Information

Enter patient information and click Save

SCANNING

1. Select Patient

From the Patient Database, locate and highlight the patient record Click Acquire New and follow the on-screen prompts

2. Select Procedure

Create a study title, select the procedure and choose the ordering physician

3. Seat and Position Patient

Have patient remove jewelry, glasses, hair accessories, etc. from patient's head Adjust height of patient chair until ear is positioned as shown Use alignment light to position patient based on imaging protocol (see below)

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Align top of ear just below wing of head holder

Sinus Scan

Align with high cheekbone

Temporal Bone Scan

Align with tragus

Sinus Scan for GE IGS

Align with corner of eye

Insert temple wedges squarely and

securely on sides of patient's head

Secure patient's head

with forehead strap

Caution: X-ray radiation emitted. Follow radiation safety protocols.

No Scout Needed

Sinus Scan Scout

Temporal Bone Scout

Sinus Scan Scout with

GE Headset

4. Scan Patient

Scout confirms patient position

Click Start Acquisition to initiate the scanning process and follow the on-screen prompts When the scan is complete, the gantry will rewind and reconstruction will start

automatically

5. View and Export Images

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The study will open in the Multi-planar Reconstruction (MPR) window. This is the

Note: Press the F1/HELP key to access the online user manual.

default setting for viewing and manipulating reconstructed images. Axial, coronal, sagittal, and 3D views are all visible at once.

Click Image Output from any image viewing window to export images (if applicable)

6. Initiate Scan Transfer to XoranConnect®

After the acquisition and reconstruction are complete, click Exit in the viewer window to initiate scan transfer and allow it to be available on XoranConnect®

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3.0 STARTUP AND SHUTDOWN

Patient E-Stop

Operator E-Stop

3.1 Emergency Shutdown

In the case of an emergency, the system rotation can be stopped and X-ray emission can be halted by pressing the Emergency Stop (E-Stop) button. The operator E-Stop is located on the Operator Control Box on the operator’s desk. The Patient E-Stop is located on the Patient Controller which can be held by the patient during the scan.

When activated, the E-Stop control immediately shuts down the scanner, cutting power to all moving parts and ceasing the emission of X-rays. The operator or patient should press the E-Stop in case of emergency or system malfunction where the safety of the patient or operator is at risk, such as:

Extreme patient motion during acquisition (i.e. standing up). Software malfunction (i.e. frames do not appear during image acquisition). A person or object enters the gantry path during acquisition

After pressing the E-Stop:

Have the patient exit the scanner Rotate the E-Stop button clockwise to reset the MiniCAT Contact Xoran Customer Service if additional support is required.

After pushing the E-Stop, the overhead gantry can be manually rotated so that the patient can safely

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system.

exit the scanner.

Caution: Turn E-Stop clockwise to reset. It is also recommended to restart MiniCAT™ software after resetting the E-Stop.

Caution: It is recommend that the scanner remain on at all times. If the scanner has been shut down for any reason, please allow one hour for the scanner to warm up before scanning patients to ensure the best quality images.

3.2 System Startup

Both the MiniCAT™ scanner hardware and the workstation must be turned on for the system to function properly.

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Turn on MiniCAT™ Hardware

POWER:

The system is turned on.

READY:

The system is ready to perform a scan.

To turn on the system, push the green ON button on the Operator Control Box.

Turn on the Workstation

The workstation computer controls the MiniCAT™ system hardware and software. Press the power button to start the workstation.

Also, turn on peripheral devices such as the workstation monitor, printer and server (if applicable) at this time.

The Operator Control Box should be located on the operator’s desk. The lights on the Operator Control Box represent the following:

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X-RAY ON:

The X-ray source is on (emitting radiation).

FAULT:

When lit, this light indicates that the X-ray has timed out. Please contact Xoran Customer Service for assistance.

FAULT:

(flashing)

When rapidly flashing, this light indicates a hardware initialization problem. Please follow the system shutdown procedure, followed by the system startup procedure. If the problem persists, please contact Xoran Customer Service for assistance.

Note: The same light configuration is on the front overhead cover of the machine (except the fault light). The Yellow OFF button on the Operator Control Box can be used to turn off the MiniCAT™ scanner hardware. It is recommended that the system be left on at all times.

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Launch MiniCAT™ Software

1. Double click on the MiniCAT™ icon on the desktop if your system allows access to the Windows desktop. If not, proceed to step 2 below.

2. Enter username and password.

If system has exited to Windows login, type "ct" as your user name and "ct" as the password to return to MiniCAT application.

Upon login, Patient Database window will open.

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3.3 User Management

Any person operating the MiniCAT™ system is called a user. User information can be managed in the User Management window. To launch, select the User Management option from the Tools menu in the application.

The most common User Management actions are listed below:

New User: From the User menu select New User. Fill in the user information into the fields.

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Edit User: Users of the MiniCAT™ system are classified as either an “Ordering

Note: It is recommended that the scanner remain on at all times. If the scanner has been shut

down for any reason, please allow one hour for the scanner to warm up before scanning patients to ensure the best quality images.

Note: All users should Log Out or shut down the workstation when it is not in use due to security of patient data and for best workstation performance.

Physician” or “Technologist”. Each patient study should be assigned to an ordering physician.

Delete User: A user account can be deleted from the system by selecting the selecting a user name and clicking Delete User. All information about that user is removed from the system.

Active: Active users have the ability to log onto the system and use the MiniCAT™ software. Clearing the Active check box deactivates the user. This prevents this user from using the scanner but preserves the user data for record-keeping and/or future reactivation purposes.

3.4 System Shutdown

User Logoff

To log out, click Log Out.

Turn Off Workstation

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"Turn Off" directly from the Login screen.

Note: The MiniCAT™ workstation will automatically reset every eight hours of inactivity.

Turn Off Scanner

To turn off the scanner, push the yellow OFF button on the Operator Control Box. It is safe to leave the scanner on continuously.

3.5 Uninterruptible Power Supply (UPS)

The MiniCAT™ system is equipped with an Uninterruptible Power Supply (UPS) which contains a backup battery with enough capacity to complete one scan with reconstruction. If the facility power

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goes out while a scan is in progress:

Note: When the scan is complete, it is recommended that the system be shut down and the main circuit breaker turned off until continuous power is restored. A new scan should not be initiated on battery power.

The system will continue to be powered by the UPS battery. The scan in progress will complete as usual. No information will be lost. The UPS will beep indicating that the battery is being consumed.

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4.0 PATIENT DATABASE

Note: The Patient Database window will close and revert back to the login screen after two hours of inactivity.

The Patient Database is the user interface to patient records and studies.

4.1 Patient Database

The Patient Database window is automatically opened when the MiniCAT™ software application is launched.

4.2 Enter New Patient

1. To enter a new patient, click Start Over in the lower-left portion of the Patient Database

window.

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2. Enter patient data in the fields.

3. After entering the information in the required fields, click Save on the bottom left of the screen.

4.3 Find Existing Patient

1. To find an existing patient, click Start Over. The Find button will be enabled and the patient data fields will become blank.

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2. Patient records can be searched by name, patient ID, or birthdate. Enter any known information in the patient data fields. For example, type the first few letters of the patient's last name.

3. After you enter your search criteria, click Find. A list of matching patients will be displayed.

4. Click on the [+] to view studies listed under this patient's name.

There are three types of study files. They are described below.

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Study File Type

Description

Scout

A Scout is the single X-ray image that is used to ensure that the patient is properly positioned for the scan.

Raw

Raw data is a sequence of images collected by the MiniCAT™ system during an acquisition. This raw data is reconstructed using a tomographic algorithm to create 3D imagery.

Recon.

The final result is known as the Reconstruction. This 3D volume imagery can be viewed as a series of coronal, sagittal or axial slices, as well as in many other ways.

5. To open a study for viewing, double-click on its title.

Note: Refer to Chapter 7 for more information on viewing patient studies.

4.4 Advanced Search

Patient studies may also be searched by ordering physician, imaging protocol, or a range of dates when the studies were acquired.

1. Click Start Over in the Patient Database window.

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2. Select the Advanced Search option from the main menu.

Note: Refer to Chapter 7 for more information on viewing patient studies.

3. Enter search criteria into the Advanced Search window and click Search. A list of matching patients will be displayed.

3. Click on the [+] to view studies listed under this patient's name in the Patient Database.

4. To open a study for viewing, double-click on its title.

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4.5 Delete Patient Record

Caution: This action permanently deletes files from your system. Be sure to follow any required procedures for record retention and data backup before deleting patient records.

You can delete a patient record by right-clicking on the patient’s name and choosing Delete Patient from the drop-down menu.

4.6 Purge Files

To purge unneeded patients and studies in your system, follow these steps:

1. Select the Purge option from the Tools menu.

2. Specify date interval to purge.

3. Select study type(s) to purge.

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4. Press OK to remove the files permanently from your system.

Caution: This action permanently deletes files from your system. Be sure to follow any

required procedures for record retention and data backup before purging files.

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5.0 DAILY CALIBRATION

Caution: A patient must not be in the scanner during Daily Calibration. X-rays will be emitted during Daily Calibration.

Caution: It is the user's responsibility to ensure that proper radiation safety procedures are followed before X-rays are emitted.

For best image quality, the MiniCAT™ system must be calibrated daily. Calibration should be performed after the system has been powered on for at least one hour. It is recommended to leave the MiniCAT™ system on overnight and calibrate each morning.

Daily Calibration Procedure

1. The area between the X-ray source and detector must be free of all objects. Remove

the head holder, phantom holder and any phantom that might be present before continuing.

2a. Select the Daily Calibration option from the Tools menu.

2b. Alternatively, you can push the F9/CAL key.

3. A message will appear to confirm that all objects have been removed from the field of view.

Click OK to proceed.

4. A message will appear to start the calibration process. Click Calibrate to begin.

5. A message will appear asking you if it is OK to turn on the X-ray source. Ensure that you are

behind the radiation barrier and click OK.

6. Remain behind the radiation barrier until a message appears indicating the calibration is complete.

The calibration procedure will take approximately 5 minutes to complete.

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6.0 ACQUIRING IMAGES

Caution: When protocol is selected, the gantry may move. Select protocol before positioning the patient in the scanner.

Protocol

Description

Sinus 20s (600)

20-second imaging protocol with 600 frames (i.e. adult sinus scans).

Sinus 10s (300)

10-second imaging protocol with 300 frames. Scan is faster and lower dose, but image quality will be somewhat reduced compared to Sinus 20s (600) (i.e. adult follow-up sinus scans and/or pediatric scans).

Sinus 10s (150)

10-second imaging protocol with 150 frames is a very low-dose sinus scan (i.e. adult follow-up sinus scans and/or pediatric scans).

T Bone 20s (600)

20-second temporal bone imaging protocol with 600 frames provides higher spatial resolution than the Sinus 20s protocol, and field of view is somewhat smaller.

Water QC

To be used only for specified quality control tests.

Resolution QC

To be used only for specified quality control tests.

6.1 Select Imaging Protocol

1. After entering new patient information or selecting an existing patient, click Acquire New.

2. The Patient Confirmation window will appear. Confirm that the patient selected from the

Patient Database is the one you want to scan. Click Acquire New to proceed.

3. The Acquisition window will appear.

4. Select the appropriate protocol from the Protocol menu. The standard protocol options are as

follows:

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Note: Additional protocols are available for creating images compatible with various image-guided surgery systems. If you have need for a protocol compatible with a specific IGS system, please call 800-70-XORAN (800-709-6726). A Xoran Customer Service representative will be happy to assist you.

5. Select the ordering physician.

Note: The Acquisition window will close and revert back to the Patient Database after 30 minutes of inactivity.

Note: It is advisable to ask female patients of childbearing age if they are or may be pregnant.

To add a new ordering physician, click the Add Physician icon to the right of the Ordering Physician.

To change the ordering physician on a study, right-click a patient's name in the Patient Database and select Ordering Physician.

6.2 Prepare the Patient

Prior to the scan:

Instruct the patient to remove jewelry, hair accessories and glasses. Instruct the patient to sit upright, relax and face straight ahead. The patient can hold the Patient E-Stop control in lap or hands. Small lasers will be used for positioning. Remind the patient to close eyes. A Scout may be taken to verify position. A Dry Run can demonstrate scanner movement without emitting X-rays.

During the scan:

Instruct the patient to sit as still as possible for best image quality. Instruct the patient to avoid talking, chewing, yawning, swallowing, coughing or slouching. Instruct the patient to breathe naturally, moving head as little as possible. The scan will be completed in 20 seconds or less. The overhead gantry will rotate. The patient should close their eyes to avoid following this

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motion with the head.

Caution: Select protocol BEFORE positioning the patient in the scanner.

The scanner makes a chirping sound as it performs the scan. In case of any problem, the patient can stop the scan by pressing the Patient E-Stop

button on the Patient Control Box.

After the scan:

The overhead gantry will rewind when the scan is complete.

6.3 Seat and Position Patient

1. After selecting the protocol and educating the patient, seat the patient in the scanner. Adjust the

chair so that the patient's head is positioned in the scanner as shown below.

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2. The neck pad is positioned in the bottom bracket for adults and the top bracket for pediatric

patients. See example below.

3. Use the Patient Align arrows on the controller to move the chair up and down.

4. Seat the patient so the neck pad fits comfortably at the curve of their neck. The patient's ears

should be approximately 0.5 inches (1 cm) below the sides of the head holder.

5. Instruct the patient to close their eyes.

6. Press the Alignment Light button on the controller to turn on the alignment lasers.

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Caution: Laser light emitted. Do not stare into the beam.

Press button once to turn on the laser for a few seconds. Press and hold for three seconds to turn on the laser for five minutes. For a Sinus scan, the laser should project the crosshairs on the patient's high cheekbone as

shown below.

For a Temporal Bone scan, the laser should project the crosshairs on the patient's tragus as shown below.

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7. Insert temple wedges squarely and securely on sides of head. Included with each head holder

are three pairs of different-sized temple wedges to fit patients of varying head sizes.

8. Secure forehead strap as shown below.

9. Remind the patient to remain still and relax while positioned in the scanner.

6.4 Dry Run and Scout

Perform Dry Run

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The Dry Run function rotates the overhead gantry without activating the X-ray source. This

Caution: Distances in Scout image are not to scale. Scout should not be used for any

purpose other than positioning patient.

function allows the patient to become more familiar and comfortable with the system. This can help to reduce patient motion during the actual CT scan.

1. Check the Dry Run box, and the Acquisition button will change to Dummy Acquisition.

2. A caution will appear. Make sure that nothing is in the path of the rotating overhead gantry.

3. Click OK, and the gantry will rotate and rewind without firing the X-ray source.

Acquire Scout

A Scout is a single lateral X-ray taken to verify that the patient is positioned properly.

1. In the Acquisition window, click Scout.

2. The following dialogue box will appear:

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Caution: Make sure that all required radiation safety procedures are complied with before proceeding.

3. Remain behind the barrier, and click OK. The Scout image will be acquired.

4. Check the Scout image to make sure that the following criteria are met. If the Scout image does not meet these criteria, the patient should be re-positioned.

For sinus scans:

The sinuses are within the window. Patient head appears facing sideways. Head is upright - not tilting forward or backward. Space exists between the tip of nose and edge of the scout image. The top part of the upper lip is included.

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An example of a good sinus Scout View is shown below:

Note: For temporal bone imaging, a Scout may not be the best method to assess a patient's positioning. Xoran recommends using only the laser alignment lights.

An example of a poor sinus Scout View is shown below. Improper patient positioning is indicated by the visibility of the maxilla and upper teeth, and no space in front of the nose.

For temporal bone scans:

The temporal bone area is centered in the Scout View image.

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6.5 Start Acquisition

1. After confirming that your patient is properly positioned, you are ready to acquire the CT scan.

2. Stand behind the operator's barrier.

3. Click Start Acquisition.

4. Confirm that the scanner has been powered on for at least 60 minutes. Click OK to continue, if

a confirmation dialogue appears.

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The following message will appear:

Caution: Make sure that all required radiation safety procedures are complied with before proceeding.

Warning: To stop the scanner in case of an emergency, press the Emergency Stop (E- Stop) button.

Note: A timer will inform the user when the next acquisition can be performed. Sequential

acquisitions must be at least 10 minutes apart.

5. Remind the patient not to move.

6. Click OK. The scan acquisition will begin.

The acquisition will take 20 seconds or less. The overhead gantry will rotate around the patient and a series of X-ray images will be

acquired. While the X-ray source is turned on, the system will make a chirping sound. When the scan is complete, the overhead gantry will rewind to its original position.

7. Reconstruction will begin automatically. This takes approximately one minute.

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7.0 VIEWING IMAGES

Note: If the 3D window is not in view, refer to Section 7.7 to enable the 3D view.

This chapter explains how to open a study, view images using various viewing options and tools, make annotations and select images for output.

7.1 Open Study

1. To open the study from the Patient Database, click the [+] next to the patient's name to view records listed under that patient.

2. Double click on the Recon study you wish to view.

3. The study will open in the Multi-planar Reconstruction (MPR) window. This is the default setting for viewing and manipulating reconstructed images. Axial, coronal, sagittal, and 3D views are all visible at once.

Tip: An overlay containing patient's name and other information appears in the upper left corner. Press <Ctrl-O> to toggle this text on and off.

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7.2 Viewing Options

Image Viewing Option

Description

MPR

Four views are displayed at once. This is a powerful way to navigate the 3D scan volume.

Axial

A series of axial slices are displayed. Coronal

A series of coronal slices are displayed. Sagittal

A series of sagittal slices are displayed. 3D

A 3D viewer is displayed.

The Navigation menu is located in the upper right corner. This menu contains several image viewing options. They are described below.

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Image Viewing Option

Description

Selected Slices

User-selected slices are displayed (see next section on how to select slices).

To change the view, click on the desired view option in the navigation menu. For example, clicking Coronal will present the coronal series of slices as shown below.

7.3 Select Slices

The Selected Slices view option allows you to view slices which have been selected by the user. Slices can be selected in order to be printed or exported.

1. Select a view option in the navigation menu (Axial, Coronal, Sagittal, or MPR).

2. Click SELECT in the lower-right corner of any image to select the image.

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3. When an image is selected, the label will change to the word SELECTED.

4. Thumbnail views of Selected Images will appear in the Selected Images window.

5. Right-clicking on the Selected Image thumbnail will provide a menu of the following options:

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Slice Option

Description

Copy

Copy Selected Image

Remove Selected

Removes a single image from the Selected Images series. Remove All

Removes all images in the Selected Images window.

Go To

Displays the selected slice in MPR view.

Autosort

Orders your selected slices from anterior to posterior.

Change Selection

Allows the user to obtain pre-selected sets of images which are customized by Xoran to fit your imaging needs.

Tip: Hold down the SHIFT key to operate on multiple selected images at once.

Range Indicator

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The Range Indicator is a convenient way to select a series of slices. It appears as a colored bar with tick marks representing the locations of selected slices. The spacing between tick marks represents the pitch.

Click on the Range Indicator and drag it side to side to move the entire selected series all at once.

7.4 Viewing Tools

Zoom

1. Select the Pan/Zoom tool from the toolbar.

2. Place the cursor anywhere in the image (except over the colored lines).

Left-click to zoom in. Right-click to zoom out.

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Pan

1. Select the Pan/Zoom tool from the toolbar.

2. Place the cursor anywhere in the image (except over the colored lines).

Click and hold down the left mouse button. Move the mouse to pan the image until desired position is achieved.

Scroll

There are three ways to scroll through the axial, coronal and sagittal slices:

1. The mouse wheel

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2. The slider

3. The cut-plane lines

Each viewing window has colored vertical and horizontal lines called cut-plane lines. The lines represent the location of the other two views shown in the MPR window.

For example, in the Sagittal view shown below:

The green line represents the Axial slice plane. The orange line represents the Coronal slice plane.

Cut-plane lines can be moved by clicking and dragging. This causes the images in the other view windows to change.

Two cut-plane lines may be moved together simultaneously by grabbing the lines at their intersection.

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Slice Thickness

The slice thickness is displayed in the upper-right corner of each image in MPR view in a box labeled ST.

Slice thickness can be changed by clicking on the ST box and selecting from the list.

Minimum Slice Thickness (ST) for Sinus: 0.4 mm

Columns

The number of slice images displayed on the screen in Axial, Coronal, or Sagittal views can be

altered using the Columns pull-down menu. The following examples show 3 columns (top) versus 5 columns (bottom) in Coronal view.

3 columns

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5 columns

Window/Level

The Window/Level values determine the brightness and contrast of the displayed image. To adjust:

1. Click on the Window/Level icon in the toolbar:

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2. The cursor will change to show that you are using the W/L tool. Now click and drag anywhere

Note: 2D and 3D window/level values are independent of each other.

in the image.

Window value increases as the mouse is moved to the right of the image and decreases to the left.

Level value increases as the mouse is moved towards the top of the image and decreases towards the bottom.

2b. Alternatively, you can manually input the desired window/level values or adjust the sliders in the

Window/Level pane.

3. The window/level values appear in the patient information overlay, labeled W/L.

4. Preset options for window/level can be applied. Click on the down arrow next to the brightness/ contrast icon, and a drop-down menu will appear.

Select Bone to restore the window and level values to their default values.

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Select Set Window/Level to manually adjust the window and level values for an image and save adjusted values as a new preset.

Rotate

The Rotate tool allows images to be rotated in MPR view.

Find the double-ended arrow on the right side of the image.

Click and drag the arrow up and down to rotate the image. Rotation angle adjustments are recorded in the patient information overlay, listed as alpha,

beta and gamma angles (values in degrees).

Images can be restored to their original non-rotated orientations by selecting the Restore Original Tilt option from the Toolbox menu, or by pressing Ctrl + T.

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7.5 Annotation Tools

The tools below allow you to make distance measurements and create comment overlays on images. All measurement and annotation tools can be used in any window where images are displayed. To view annotations within a scan, click the appropriate annotation within the Regions area.

Distance Tool

In the MPR viewer, the Distance Tool measures the distance between two points on an image (in millimeters).

1. Click on the Distance Tool icon in the toolbar to activate the tool.

. Left-click on the starting point of your desired measurement.

Click once on each endpoint. Do not hold mouse button down.

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. Move the cursor to the end point of your desired measurement and left-click. A distance

Note: The distance values are millimeters.

Line Options

Description

Change Name

Changes the name of the line.

Change Color

Changes the line color.

Set current color as default

Sets the current color of the line as the default color for subsequent lines.

value will appear.

Line objects can be moved by left-clicking the line and dragging it to the desired location. Line objects can be modified by right-clicking the line. A drop-down menu will appear

with the following options:

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Line Options

Description

Visible

De-selecting this option makes the line disappear from view. Bring the object back to view by right-clicking the corresponding object from the Regions menu and selecting Visible.

Delete

Deletes the line object.

Circle and Rectangle Tools

Note: The units of the mean and standard deviation values are in Hounsfield units

The Circle and Rectangle Tools allow a region of any image to be selected and report statistics of the image region within the shape outline.

1. Click on the Circle Tool icon or the Rectangle Tool icon in the toolbar to activate the tool.

2. Left-click on the center of the target region.

Click once. Do not hold mouse button down.

3. Left-click again on the edge of the target region, and a shape object will appear. The mean, standard deviation and surface area values will appear inside the ellipse.

Shape objects can be moved by left-clicking the line and dragging it to the desired location.

Shape objects can be modified by right-clicking the line. A drop-down menu will appear with the following options:

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Shape Options

Description

Change Name

Changes the name of the shape.

Change Color

Changes the color of the shape.

Set current color as default

Sets the current color of the shape as the default color for subsequent shapes.

Visible

De-selecting this option makes the line disappear from view. Bring the object back to view by right-clicking the corresponding object from the Regions menu and selecting Visible.

Shape

Changes the shape to a rectangle, ellipse, circle or square.

Delete

Deletes the shape object.

Text Tool

Text can be added to an image. This simple but flexible tool can be useful for labeling anatomical features or making notes.

1. Click on the Text Tool icon or the Label Tool icon from the toolbar.

2. Left-click and drag the cursor diagonally on an area of the image where the text box will be located. Click again to release. Double-click on the word Text or Label, and begin typing.

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Text and Label Options

Description

Edit

Edits the content of the text box.

Change Name

Changes the name of the text box.

Change Color

Changes the color of the font.

Set current color as default

Set the current color of the font as the default font color for subsequent text boxes.

Visible

De-selecting this option makes the line disappear from view. Bring the object back to view by right-clicking the corresponding object from the Regions menu and selecting Visible.

Text and Label objects can be moved by left-clicking inside the box and dragging it to the desired location.

Text and Label objects can be modified by either double-clicking inside the box or by right-clicking inside the box. A drop-down menu will appear with the following options:

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Text and Label Options

Description

Global

Text will be visible on all the other slices in the dataset (within the same viewing window).

Delete

Deletes the text box.

7.6 Oblique and TMJ Tools

The Oblique and Two Points Oblique tools can be used in any plane.

Oblique Tool

1. Click on the Oblique icon . When this icon is active, you have the ability to flatten oblique and curved objects into a two-dimensional view.

2. Left-click to deposit points along the desired pathway, and double-click on the last point to end the line. An example is shown below.

3. The following screen will appear:

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A new entry appears in the Regions menu as "Oblique 1". You can toggle between this view and others by selecting the desired view in the navigation menu (top right corner), or clicking on the view in the Regions menu.

The image on the left side shows the oblique pathway. The image at the top right shows the cut along the oblique pathway. The slice thickness is 0.4 mm and can be changed by left-clicking on the Slice Thickness

(ST) value in the top right corner of the image and selecting a new value. The thumbnail images in the bottom right frame are cuts that are perpendicular to the

oblique pathway. These are equally spaced along the length of the oblique pathway. The highlighted thumbnail image indicates the location within the oblique pathway, as

represented by the perforated line on the left image and the top right image.

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Move the oblique line by hovering over it with the cursor until it is active (it will change

Oblique Options

Description

Change Name

Changes the name of the object.

color), grabbing it by holding down the left mouse button and dragging it to the desired location.

Make changes to the oblique line by moving the cursor over it until the oblique line changes color and then right-clicking the mouse. A drop-down menu will appear with options. Make similar changes by right-clicking the corresponding oblique line in the Navigation menu and choosing from the menu options.

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Oblique Options

Description

Change Color

Changes the color.

Set current color as default

Sets the current color of the oblique object as the default color for subsequent oblique objects.

Visible

De-selecting this option makes the line disappear from view. Bring the object back to view by right-clicking the corresponding object from the Regions menu and selecting Visible.

Go To

Opens the Oblique window (the new screen that appears after you define an oblique line).

Delete

Deletes the oblique line.

Insert Point

Inserts an additional point to the oblique object.

Delete Point

Deletes the selected point from the oblique object.

Two Points Oblique Tool

1. Click on the Two Points Oblique icon . When this icon is active, you have the ability to flatten oblique and curved objects into a two-dimensional view.

2. Left-click to deposit two points along the desired pathway. An example is shown below (a yellow line with cross hairs representing the click points).

3. The following window will appear:

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A new entry appears in the navigation menu as "Two Points Oblique 1". You can toggle between this view and others by selecting the desired view in the navigation menu (top right corner), or clicking on the view in the Regions menu.

The image on the left side shows the oblique pathway. The image on the lower right shows the cut along the oblique pathway. The slice thickness is 0.4 mm and can be changed by left-clicking on the Slice Thickness

(ST) value in the top right corner of the image and selecting a new value. Move the oblique line by hovering over it with the cursor until it is active (it will change

color), grabbing it by holding down the left mouse button, and dragging it to the desired location.

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Two Points Oblique Options

Description

Change Name

Changes the name of the object.

Change Color

Changes the oblique line color.

Set current color as default

Sets the current color of the Two Points Oblique object as the default color for subsequent Two Points Oblique objects.

Visible

De-selecting this option makes the line disappear from view. Bring the object back to view by right-clicking the corresponding object from the Regions menu and selecting Visible.

Go To

Takes you to the Oblique window (the screen that appears after you define an oblique line).

Delete

Deletes the oblique line.

TMJ Tool

The TMJ (Temporomandibular Joint) tool can be used in the Axial plane.

1. Click on the TMJ icon . When this icon is active, you have the ability to look at the temporal mandibular joints in a two-dimensional view.

2. Left-click below and to the right of the patient's left condyle (this is a radiological view, so patient's left is the right side of the image). Alternatively, you could choose a point below and to the left of the patient's right condyle. The point chosen for this example is highlighted with the red arrow.

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3. Move the cursor up and to the right (patient's left) to deposit the second point. The line that connects these two points should cross over the center of the joint. The second point chosen for this example is highlighted with the red arrow.

As soon as this point is selected, the letter "L" appears over this line, indicating the patient's left. A second line appears on the patient's right side that may or may not be over the right condyle. You can move this line so that it is positioned properly.

4. The following screen will appear:

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A new entry appears in the Navigation menu as "TMJ 1". You can toggle between this view and others by selecting the desired view in the navigation menu (top right corner), or clicking on the view in the Regions menu.

The two images in the upper right portion of the screen are the right and left image cuts along the TMJ lines.

The default slice thickness is 5.2 mm and can be changed by left-clicking on the Slice Thickness (ST) value in the top right corner of each image and selecting a new value.

The two panes of small images are cuts that are perpendicular to the TMJ lines. These are equally spaced along the length of each TMJ line.

Move the TMJ lines by hovering over them with the cursor until they are active (they will change color), grabbing them by holding down the left mouse button, and dragging them to the desired location.

Make changes to the TMJ lines by moving the cursor over them until the TMJ lines change color and then right-clicking with the mouse. A drop-down menu will appear with options. Make similar changes by right-clicking the corresponding TMJ lines in the Navigation menu and choosing from the following menu options:

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TMJ Options

Description

Change Name

Changes the name of the TMJ object.

Change Color

Changes the TMJ line color.

Set current color as default

Sets the current color of the TMJ object as the default color for subsequent TMJ objects.

Visible

De-selecting this option makes the line disappear from view. Bring the object back to view by right-clicking the corresponding object from the Regions menu and selecting Visible.

Go To

Takes you to the TMJ window (the screen that appears after you define a pair of TMJ lines).

Delete

Deletes the pair of TMJ lines.

7.7 3D Viewing Window

To enable the 3D viewing window, click the Tools menu from the Patient Database and select Show 3D.

To reconstruct the 3D window after an acquisition, click Show in the bottom-right corner of the 3D plane in the MPR window.

Zoom

1. Select the Pan/Zoom tool from the toolbar.

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2. Place the cursor anywhere in the image (except over the colored lines).

Left-click to zoom in. Right-click to zoom out.

Rotate

1. Click and hold anywhere on the screen.

Drag the cursor in the direction you want to rotate the view.

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Cross-sectional Views

1. Click the edge of one of the planes and move it towards the other parallel plane.

7.8 Comparison Tool

1. To enable the comparison tool, select any two reconstructed studies.

To select multiple studies, click on two studies while holding Ctrl.

2. Right-click and select Compare.

When reconstructed studies from different patients are compared, a confirmation window will appear asking to proceed.

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3. Side-by-side single-planar views will appear. You can switch between the coronal view (shown

below), sagittal, and axial.

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8.0 MODALITY WORKLIST CLIENT

The Modality Worklist Client software allows patient demographic information to be electronically transmitted to the MiniCAT™ scanner so that the operator does not need to enter the data manually. The imaging order is placed electronically (by an external information system) and a DICOM file is generated containing patient demographic information which is sent to the MiniCAT™. The scanner operator simply selects the patient name from a list of scans that have been ordered and performs the scan. The scan image data is attached to the demographic data and sent out to the facility PACS system. An active internet connection is required to use the Modality Worklist Client.

Query

A Query searches the hospital database for user-defined information.

1. Select a Worklist Server from the drop-down menu.

2. Enter as much patient-specific data as possible in the appropriate fields.

3. Click Query.

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4. Select a record to accept into the Patient Database. Click Accept. All applicable data is

automatically imported from the server into the Patient Database.

When a patient record in the server is similar (i.e. two records have the same patient name and same birthdate) to a patient record already in the Patient Database, you can either merge the records by checking the box next to the patient name, or create a new record if they are different patients.

If you choose to merge the records, inconsistent data will be highlighted in red. Click Yes to merge the data.

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9.0 OUTPUT IMAGES

Output Protocol

Description

Print Selected Images

Automatically prints the images in the Selected Images window. The default image layout is 3 rows by 2 columns.

Export Xoran Study

Exports Xoran study data to either a CD or USB flash drive.

Burn DICOM CD

Burns a Xoran image data onto a CD in DICOM format, which is compatible with most IGS systems.

Export to HTML

Exports a Xoran study in HTML format, viewable on any computer with a browser such as Internet Explorer.

Export to DICOM Axial

Exports the axial slices of a Xoran study onto a CD in DICOM format. Export to JPEG

Exports a Xoran study in JPEG picture format.

DICOM Push

Allows a study to be uploaded to a DICOM server such as a PACS system. Call Xoran Customer Service to help set this up.

The MiniCAT™ makes image output easy with preset protocols for printing, burning to CD/USB drive and transferring images over a network.

1. If printing, ensure that the desired slices appear under Selected Slices view.

2. Click the Image Output menu (along the main toolbar of the screen) to view all output protocols.

3. Left-click on the desired image output protocol. A sample list of Output Protocols are shown below. For additional protocols, please contact Xoran Customer Service.

MiniCAT™ User Manual v5.2

10.0 TECHNICAL SPECIFICATIONS

System Description

MiniCAT™ is a compact, upright, volume computed tomography (VCT) imaging system designed for high-resolution, low-radiation imaging of the sinuses, skull base and temporal bones.

System Dimensions

40" L x 36" W x 67" H (102 cm x 91 cm x 170 cm)

Weight

450 lbs

Overall Dimensions

28" L x 18" W x 50" H (71 cm x 46 cm x 127 cm)

Weight

115 lbs (52 kg)

Seat Height Adjustment

15.5" to 42" (39 cm to 107 cm)

Maximum Patient Weight

350 lbs (159 kg)

10.1 General Information

MiniCAT™ Scanner

Patient Support

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FRONT VIEW

TOP VIEW

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10.2 Imaging Properties

Imaging Properties

Slice Thickness

0.3 mm minimum for Temporal Bone (reconstructed)

0.4 mm minimum for Sinus (reconstructed)

Reconstruction Time

<30 s for 600 frames

Sinus Field of View, Axial

10.5 cm

Sinus Field of View, Cross-sectional

16.0 cm

Temporal Bone Field of View, Axial

6.0 cm

Temporal Bone Field of View, Crosssectional

16.0 cm

Number of Slices in a typical sinus scan

approximately 270 Axial slices

Number of Data Channels Used

744 (Sinus scans) 412 (Temporal bone scan)

Views

MPR/Axial/Coronal/Sagittal/Oblique/3D/TMJ/ Side-by-Side

Gray Scale Display

256 levels

Display Window

Adjustable level and width

Compatibility

DICOM 3.0

Acquisition Protocols (SourceRay Source)

Tube

Voltage

Tube

Current

Pulse

Length

Number

Frames

Exposure

Scan

Time

Default

Reconstruction

Protocol

Sinus 20s (600)

120 kVp

7 mA

11.5 ms

600

48.30 mAs

20 s

SMOOTH (400x400

0.4, 0.4, f1)

Sinus 10s (300)

120 kVp

7 mA

11.5 ms

300

24.15 mAs

10 s

SMOOTH (400x400

0.4, 0.4, f1)

Sinus 10s (150)

120 kVp

7 mA

11.5 ms

150

12.08 mAs

10 s

SMOOTH (400x400

0.4, 0.4, f1)

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T Bone 20s (600)

125 kVp

7 mA

14 ms

600

58.80 mAs

20 s

SHARP (536x536 0.3,

0.3, f0)

Resolution Calibration

120 kVp

7 mA

11.5 ms

600

48.30 mAs

40 s

SHARP (800x800 0.2,

0.2, f0)

Water Calibration

120 kVp

7 mA

11.5 ms

600

48.30 mAs

40 s

SMOOTH (400x400

0.4, 0.4, f1)

Legacy Acquisition Protocols (ISI Source)

Sinus 40s (600)

120 kVp

5 mA

16 ms

600

48 mAs

40 s

SMOOTH (400x400

0.4, 0.4, f1)

Sinus 20s (300)

120 kVp

5 mA

16 ms

300

24 mAs

20 s

SMOOTH (400x400

0.4, 0.4, f1)

Sinus 10s (150)

120 kVp

5 mA

16 ms

150

12 mAs

10 s

SMOOTH (400x400

0.4, 0.4, f1)

T Bone 40s (600)

125 kVp

7 mA

18 ms

600

75.6 mAs

40 s

SHARP (536x536 0.3,

0.3, f0)

Resolution Calibration

125 kVp

7 mA

18 ms

600

75.6 mAs

40 s

SHARP (800x800 0.2,

0.2, f0)

Water Calibration

120 kVp

5 mA

16 ms

600

48 mAs

40 s

SMOOTH (400x400

0.4, 0.4, f1)

Legacy Acquisition Protocols (SourceRay Source)

Sinus 40s (600)

120 kVp

7 mA

11.5 ms

600

48.30 mAs

40 s

SMOOTH (400x400

0.4, 0.4, f1)

Sinus 20s (300)

120 kVp

7 mA

11.5 ms

300

24.15 mAs

20 s

SMOOTH (400x400

0.4, 0.4, f1)

Sinus 10s (150)

120 kVp

7 mA

11.5 ms

150

12.08 mAs

10 s

SMOOTH (400x400

0.4, 0.4, f1)

T Bone 40s (600)

125 kVp

7 mA

14 ms

600

58.80 mAs

40 s

SHARP (536x536 0.3,

0.3, f0)

Resolution Calibration

125 kVp

7 mA

14 ms

600

58.80 mAs

40 s

SHARP (800x800 0.2,

0.2, f0)

Water Calibration

120 kVp

7 mA

11.5 ms

600

48.30 mAs

40 s

SMOOTH (400x400

0.4, 0.4, f1)

Note: If you are using legacy acquisition protocols and are unsure which source you have, please contact Xoran Customer Service.

MiniCAT™ User Manual v5.2

Reconstruction Protocols

Coronal

Slices

Sagittal

Slices

Voxel Width/

Depth

Voxel

Height

Filter Type

SMOOTH (400x400 0.4,

0.4, f1)

400

0.4

Hann

SHARP (536x536 0.3,

0.3, f0)

536

0.3

Ramp

SHARP (800x800 0.2,

0.2, f0)

800

0.2

Ramp

Filter Type

Description

Ramp

Provides sharp image detail with high-contrast

resolution.

Hann

Provides smooth image detail with low noise.

MiniCAT Scan Parameters

Maximum number of slices per acquisition

Cone Beam CT

Acquisition series

Volume

Reformat technique

Multi-planar reconstruction

kVp/mAs

600 Frame Sinus: 120 kVp / 48 mAs 300 Frame Sinus: 120 kVp / 24 mAs 150 Frame Sinus: 120 kVp / 12 mAs T Bone 20s (600): 125 kVp / 58 mAs T Bone 40s (600) (ISI): 125 kVp / 76 mAs T Bone 40s (600) (SourceRay) 125 kVp / 58 mAs

Dose length product

Sinus 20s (600): 97.0 mGy-cm Sinus 10s (300): 49.2 mGy-cm Sinus 10s (150): 24.6 mGy-cm T Bone 20s (600): 76.9 mGy-cm

ISI Source Sinus 40s (600): 85.2 mGy-cm Sinus 20s (300): 42.5 mGy-cm

MiniCAT™ User Manual v5.2

Sinus 10s (150): 20.6 mGy-cm T Bone 40s (600): 62.8 mGy-cm

SourceRay Source Sinus 40s (600): 97.0 mGy-cm Sinus 20s (300): 49.2 mGy-cm Sinus 10s (150): 24.6 mGy-cm T Bone 40s (600): 76.9 mGy-cm

Tube current modulation or dose reduction technique

Pulsed Beam, Limited mA, Collimation

Total effective dose estimate per acquisition

Sinus 20s (600): 0.17 mSv Sinus 10s (300): 0.09 mSv Sinus 10s (150: 0.04 mSv T Bone 20s (600): 0.14 mSv

Prescribed rotation time

Sinus 20s (600): 20 seconds Sinus 10s (300): 10 seconds Sinus 10s (150): 10 seconds T Bone 20s (600): 20 seconds

Sinus 40s (600): 40 seconds Sinus 20s (300): 20 seconds Sinus 10s (150): 10 seconds T Bone 40s (600): 40 seconds

Increment

N/A

Detector collimation (mm)

Sinus: 189 mm Temporal Bone: 105 mm

Slice thickness

Sinus: Selectable (0.4 mm minimum reconstructed) Temporal Bone: Selectable (0.3 mm minimum reconstructed)

Pitch or table feed

N/A

Scan FOV

Sinus: 16 x 10.5 cm Temporal Bone: 16 x 6 cm

Gantry tilt/angle

N/A

Kernel/filter

Sinus: Hann Temporal Bone: Ramp

MiniCAT™ User Manual v5.2

Geometry

Image Receptor Dimensions

Active area 241.3 x 192.5 mm

Source-to-Image Receptor Distance (CF Cover)

685.86 ± 1.37 mm

Source-to-Image Receptor Distance (Active Area)

700.86 ± 1.40 mm

Source-to-Isocenter Distance

480.34 ± 0.96 mm

Central Slice Location

Central Slice Laser ± 5 mm

Primary Beam Dimension at Isocenter for Sinus scans

167.2 ± 2.5 x 129.5 ± 1.9 mm

Superior of central slice

32.7 ± 1.6 mm

Inferior of central slice

96.8 ± 4.8 mm

Primary Beam Dimension at Isocenter for Temporal Bone scan

167.2 ± 2.5 x 71.9 ± 1.1 mm

Superior of central slice

32.8 ± 1.6 mm

Inferior of central slice

39.1 ± 1.9 mm

Number of detector elements

1536 x 1920

Element Spacing (dimensions)

0.127 x 0.127 mm

Protocol Name(s)

Noise Level (% of water

attenuation)

Sinus 20s (600), Sinus 40s (600)

2.88 ± 1.00

Sinus 10s (300), Sinus 20s (300)

4.86 ± 2.18

Sinus 10s (150)

7.09 ± 2.60

T Bone 20s (600), T Bone 40s (600)

5.72 ± 2.19

Image Noise

The following table gives the noise for each imaging protocol with maximum deviations.

MiniCAT™ User Manual v5.2

Tomographic Section Thickness

Protocol Name(s)

Tomographic Section

Thickness (mm)

Sinus 20s (600), Sinus 40s (600)

0.542 ± 0.048

Sinus 10s (300), Sinus 20s (300)

0.547 ± 0.071

Sinus 10s (150)

0.536 ± 0.130

T Bone 20s (600), T Bone 40s (600)

0.532 ± 0.043

The following table gives the tomographic section thickness for each imaging protocol with maximum deviations.

Measuring Nominal Tomographic Section Thickness is obtained by finding the full-width halfmaximum (FWHM) resolution of the Slice Sensitivity Profile (SSP). The SSP is obtained by scanning a small, sub-voxel bead in the QC module. However, the nominal tomographic section thickness is fixed for each protocol and is not selectable prior to acquisition.

Slice Sensitivity Profiles

MiniCAT™ User Manual v5.2

Sinus 20s (600), Sinus 40s (600)

Sinus 10s (300), Sinus 20s (300)

Sinus 10s (150)

MiniCAT™ User Manual v5.2

T Bone 20s (600), T Bone 40s (600)

MTF Profiles

The Modulation Transfer Function (MTF) is the amplitude frequency response of the imaging protocol and is a commonly used measure of system blur. The MTF profiles are given in the figures

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below.

Lower bounds on 50% and 10% contrast cut-off frequencies for MTFs of different protocols in units of oscillations per centimeter

Protocol

50% Contrast

10% Contrast

Sinus 20s (600), Sinus 40s (600)

3.33

6.00

Sinus 10s (300), Sinus 20s (300)

3.33

6.00

Sinus 10s (150)

3.33

6.00

T Bone 20s (600), T Bone 40s (600)

5.00

10.00

Maximum Deviation: The spatial frequency corresponding to the 50% and 10% contrast levels in the MTF graphs will have the guaranteed lower bounds listed in the table below.

Apparatus

The apparatus for MTF measurement consists of an acrylic cylinder phantom, 10 cm in diameter and

2.5 cm long axially, embedded with a tungsten wire filament. The tungsten wire filament is 50 microns in diameter.

Data Acquisition Methodology

An acquisition and reconstruction of the phantom is made in the desired imaging mode, with the tungsten filament centered horizontally in the field of view and vertically about the equatorial plane of the scanner (the plane of rotation of the focal spot). The vertical axis of the phantom should be aligned as closely as possible with the z-axis of the scanner. Note that, the vertical axis of the

phantom is NOT the axis parallel to the wire filament. Rather it is the axis around which the acrylic casing of the wire is circularly symmetric. The phantom was positioned to maximize the

view of the axial length of the phantom. More viewable slices translate into more data for estimation and improved MTF estimation accuracy.

MiniCAT™ User Manual v5.2

Sinus 20s (600), Sinus 40s (600)

Sinus 10s (300), Sinus 20s (300)

MiniCAT™ User Manual v5.2

Sinus 10s (150)

T Bone 20s (600), T Bone 40s (600)

MiniCAT™ User Manual v5.2

10.3 X-Ray Specifications

X-Ray Specifications

Source Block Manufacturers

Source-Ray, Inc., Imaging Sciences International, Inc. (ISI)

Source Block Model

SB-125-7K

Tube Manufacturer

Superior X-Ray Tube Co.

Tube Model Number

SXR-130-15-0.5

Tube Type

Stationary anode

Nominal Tube Potential Range

120 - 125 kVp ±5% tolerance

Nominal Tube Current Range r.m.s.

5 - 7 mA ±5% tolerance

Max. Tube Voltage

130 kVp (full wave rectified)

Max. Tube Current r.m.s.

8 mA

Target Material

Tungsten

Target Angle

15 degrees

Focal Spot Size

~0.5 mm (NEMA)

Minimum Inherent Filtration

2.0 mm Al @ 125 kVp

Rated Line Voltage

~120V AC, 50/60 Hz, 10A (r.m.s max line current) (integrated into diagnostic system)

Range of Line Voltage Regulation

Maximum line current r.m.s

10A

Technique Factors that Constitute the Maximum Line Current Condition

125 kVp, 58.8 mAs

X-ray Generator Duty Cycle

Pulsed: 50% duty cycle, 11-30 ms pulse on time Pulse Train: 30 pulses/sec (Hz) Pulse Train Time: 40 seconds on, 10 minutes off

Rise Time (X-Ray Output)

Less than 5 ms @ 125 kVp 7 mA measured @ 50% - 90 % of the voltage waveform.

MiniCAT™ User Manual v5.2

Leakage Radiation

Less than 100 mR/Hr

Leakage Technique Factors (SourceRay Source)

125 kV, 7 mA, 0.014 s pulse width, 30Hz, 8% duty cycle

Leakage Technique Factors (ISI Source)

125 kV, 7 mA, 0.018 s pulse width, 15Hz, 16% duty cycle

Beam Quality - half-value layer (HVL) (SourceRay Source)

9.4 mm equivalent Al @ 120 kVp

9.7 mm equivalent Al @ 125 kVp

Beam Quality - half-value layer (HVL) (ISI Source)

10.6 mm equivalent Al @ 120 kVp

10.9 mm equivalent Al @ 125 kVp

Minimum Permanent Filtration (SourceRay Source)

11.7 mm Al equivalent

Minimum Permanent Filtration (ISI Source)

10.6 mm Al equivalent

Measurement Criteria for Peak Voltage, Current, and Pulse Width

50% - 90 % of the voltage waveform, 125 kVp, 58.8 mAs

MiniCAT™ User Manual v5.2

10.4 Scatter Map

Secondary Radiation Measurements

Secondary scatter radiation was measured on the MiniCAT™ at 6 azimuthal locations A through F and at radii 1.0, 1.5, and 2.0 meters from isocenter and in the same plane as the central slice (i.e. level with the focal spot) which was approximately 120 centimeters above the floor (see diagram below).

The MiniCAT™ was operated at 120 kVp and 48.3 mAs per Sinus 20s (600) protocol for all secondary radiation measurements reported.

MiniCAT™ User Manual v5.2

Minicat xoran User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual