Minicat xoran User manual

USER MANUAL

MiniCAT™ User Manual v5.2
Part: 40026 CD V5.2 Rev 06 DCO 1889 10/27/2014
© 2014 Xoran Technologies LLC
Table of Contents
1.0 READ THIS FIRST 1
................................................................................................................................... 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 14
................................................................................................................................... 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 22
................................................................................................................................... 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 31
................................................................................................................................... 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 38
6.0 ACQUIRING IMAGES 39
................................................................................................................................... 396.1 Select Imaging Protocol
................................................................................................................................... 406.2 Prepare the Patient

MiniCAT™ User Manual v5.2
Part: 40026 CD V5.2 Rev 06 DCO 1889 10/27/2014
© 2014 Xoran Technologies LLC
................................................................................................................................... 416.3 Seat and Position Patient
................................................................................................................................... 446.4 Dry Run and Scout
................................................................................................................................... 486.5 Start Acquisition
7.0 VIEWING IMAGES 50
................................................................................................................................... 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 79
9.0 OUTPUT IMAGES 81
10.0 TECHNICAL SPECIFICATIONS 82
................................................................................................................................... 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
11.0 QUALITY CONTROL TESTS 111
................................................................................................................................... 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 Thicknessand Slice Sensitivity Profile
INDEX 130

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MiniCAT™ User Manual v5.2 © 2014 Xoran Technologies LLC
1.0 READ THIS FIRST
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 fromthe machine.
Patient E-Stop
OperatorE-Stop
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 withthe 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.
Radiation Safety
The gantry is self-shielded to an extent. However, no design can guarantee that allX-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.
Caution: This X-ray unit maybe dangerous to patient and operator unless safe
exposure factors and operating instructions are observed. Unauthorized use is
prohibited. Xoran Technologies LLC is released of allresponsibility and
indemnity for injury that may result fromX-ray radiation or the improper use of
the device.
It is the responsibility ofthe 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™.
Allfederal 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 ofthe 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 shallbe 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 alltimes. Only required personnel should be in the roomwhen 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 offpower to the X-ray source whenthe door is opened. Call Xoran Customer Service
to learn more about these options ifrequired 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
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 ofthe systemor install
any additionalsoftware. Either of these actions can cause the systemto malfunction and will result in
voiding your warranty.
Disposal
Follow localregulations ondisposalof waste parts. The X-ray source assembly, image sensor and
allelectronic circuits should be regarded as non-environmentalfriendlywaste 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™ shallbe used, supervised or directed by an individual who is competently aware of
the potentialhazards involved fromionizing radiation and who is capable ofminimizing 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.
Note: Health Canada does not permit the use ofthe 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. Feelfree to contact Xoran Customer Service for assistance in locating an appropriate
medicalphysics professionalin your area. 1-800-70-XORAN (800-709-6726)
1.2 Table of Symbols
The following symbols can be found in this manualand 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 ofshock.
Protective Earth, Ground: Grounding
reliability can only be achieved when the
equipment is connected to an equivalent
receptacle marked "Hospital Only" or
"HospitalGrade."
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
potentialfor 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 BreakerSymbol:
Patient ChairSymbol:
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
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
harmfulinterference ina commercialenvironment. 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 harmfulinterference to surrounding equipment.
MiniCAT™ is intended for use inan electromagnetic environment specified below. The user of the
MiniCAT™ should ensure that it is used in such an environment.
Immunity / Test
Electrostatic Environment Guidance
Electrostatic Discharge
Compliant to +4 kV. Floors should be wood, concrete or ceramic tile.
Iffloors are synthetic, the relative humidityshould be at least 30%.

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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 inan 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)
1
46 in (117 cm)
8 ft (2.4 m)
10
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 ofthe following methods:

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MiniCAT™ User Manual v5.2 © 2014 Xoran Technologies LLC
Turn the MiniCAT™ off and on to verify that the interference is coming from the
MiniCAT™.
Move the other equipment further away fromthe 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 additionalassistance.
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 vacuumdust fromfans behind acquisition workstation and server (ifapplicable).
Open server front paneland gently vacuumdust 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 ofthe owner/user to have the manufacturer's recommended

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maintenance performed.
Maintenance Schedule:
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)
ElectromechanicalSafety Test
Line Voltage Test (Annually)
Chassis to Ground Test (Annually)
Leakage Current Test (Annually)
Source Maintenance
PerformSource check and recalibrate as needed (Annually)
Application Maintenance
Geometric Calibration (Annually)
Shutter Calibration (Annually)
Water Attenuation Calibration (Annually)
Quality ControlTests
CT Number of Reference Materials (Annually)
SpatialResolution (Annually)
CT Number and Standard Deviation ofWater (Annually)
Artifact Test (Annually)
Uniformity Test (Annually)
Contrast Scale (Annually)
Image Noise (Annually)
NominalTomographic Section Thickness and Slice Sensitivity
Profile (Annually)
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) withRevisions up to 2003/06/30:
IEC 60601-1-1:2000 CollateralStandard-General Requirements for Radiation Protection
for Diagnostic X-ray Equipment
IEC 60601-1-2:2001 + A1:2004 Class A for Emissions, Immunity for Non Life-
Supporting Equipment
IEC 60601-1-3 1994 Particular Requirements for Safety of X-ray Equipment
IEC 60601-1-4 GeneralRequirements for Safety-CollateralStandard:Programmable
ElectricalMedicalSystems
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 CollateralStandard-SafetyRequirements for Medical
ElectricalSystems

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

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MiniCAT™ User Manual v5.2 © 2014 Xoran Technologies LLC
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 technicalspecifications 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 professionaltraining 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 ina safe and efficient manner.
If you have any questions, please call us at: 800-70-XORAN (800-709-6726). Our Customer
Service Engineers willbe happyto help you.
Sincerely,
Xoran Technologies LLC
www.xorantech.com
2.2 MiniCAT™ Overview
MiniCAT™ is a compact, upright volume computed tomographysystemdesigned for high-
resolution, bone window imaging ofthe sinuses, temporalbones and skullbase. MiniCAT™

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MiniCAT™ User Manual v5.2 © 2014 Xoran Technologies LLC
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-dimensionalmodelof the head and
neck fromimages taken during a rotationalX-ray sequence. The
MiniCAT is optimized for the imaging ofthe maxillofacialcomplex, temporalbone, 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 manualby clickingchapter 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 ofthe 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 diagramshows the MiniCAT™ systemhardware withthe main components identified.

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These components willbe referred to throughout this manual.
2.5 Other Components
The following is a list of other components that accompany the MiniCAT™. Call Xoran Customer
Service for replacements as needed.
Part Number
Description
15234
PhantomHolder
20008
Seat Cushion
20011
Workstation with Keyboard and Mouse
20132
Mouse Pad
15239
Carbon Fiber Head Holder

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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 Manualv5.1
60038
PhantomSet
Additional MiniCAT Software 'Viewing Stations':
A MiniCAT 'Viewing Station' is a computer that has MiniCAT software installed and is used as an
additionalclient workstation within a Practice or Hospitalenvironment. 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 fromthe Xoran server over localarea
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 performother available image
modification operations