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.
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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.
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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.
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.
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 harmful interference in a commercial environment. The MiniCAT™ generates, uses and can radiate electromagnetic energy.
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.
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.
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 Life-...
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™...
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.
These components will be 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 Phantom Holder 20008 Seat Cushion...
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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.
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Perform image output actions including exporting and printing images and DICOM push 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:...
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. PREPARATION 1. Perform a Daily Calibration For best results, scanner should be powered on for at least one hour before calibration Note: Refer to Section 3.2 for System Startup instructions.
Both the MiniCAT™ scanner hardware and the workstation must be turned on for the system to function properly.
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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.
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X-RAY 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: When rapidly flashing, this light indicates a hardware initialization problem. Please follow the system shutdown procedure, followed by the system startup procedure. If (flashing) the problem persists, please contact Xoran Customer Service for assistance.
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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.
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.
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.
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. Note: The Patient Database window will close and revert back to the login screen after two hours of inactivity.
A Scout is the single X-ray image that is used to ensure that the patient is properly positioned for the scan. 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.
5.0 DAILY CALIBRATION 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.
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.
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™.
Exports a Xoran study in HTML format, viewable on any computer with a browser such as Internet Explorer. Export to DICOM Exports the axial slices of a Xoran study onto a CD in DICOM format. Axial Export to JPEG Exports a Xoran study in JPEG picture format.
10.0 TECHNICAL SPECIFICATIONS 10.1 General Information MiniCAT™ Scanner 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...
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Sinus Sinus 40s (600) protocol was found to be at approximately the 8 o’clock position when facing the MiniCAT and looking down on the CTDI phantom. CTDI at max periphery. The location of T Bone 20s (600) 7.1 mGy...
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Note: The operator of the MiniCAT™ must be able to make visual and audio contact with the patient being scanned while behind radiation barrier. Power Japan Japan Europe Requirement ~200V ~100V ~220-240V ~115V Line Voltage 50-60 Hz 50-60 Hz 50-60 Hz...
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MiniCAT™ scanner hardware or workstation/server. Installation/Relocation The MiniCAT™ cannot be installed or relocated by the user. Proper and safe setup requires specialized training and must be performed by a Xoran Technologies Customer Service Engineer. Call Xoran 1-800-70-XORAN (800-709-6726) for assistance.
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Administrative Station or a Physician's Office, where a laptop computer may be used, it is recommended that a minimum of additional 3rd Party Software be installed and that anti-virus software be utilized. Xoran cannot assure that the Minimum Requirements, outlined below, will allow 3D Viewing to run optimally as intended.
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OpenGL and 3D textures. Depending on the video card model and driver implementation, this General Minimum Specification might not be sufficient for 3D to work as intended. Xoran does not assure 3D Viewing will work, as intended to, even when the...
CD or DVD. Fast network card is required (100Mb/s or more). Network The computer should be able to reach Xoran dedicated router through local network. USB port An available USB port is required for HASP key provided by Xoran.
Xoran provides a quality control phantom to use for these quality control tests. Xoran has developed these procedures to scan only the sinuses and temporal bones, which are high- contrast or ‘bone window’ imaging tasks that require isotropic high spatial resolution and do not require the level of contrast resolution needed for other imaging tasks, such as brain or muscle tissue scanning, etc.
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Fig. 5. Top Left: the QC Phantom and the Custom QC and Uniformity Material modules in the MiniCAT. Top Right: Photo of the QC Module. Bottom Left: Simplified drawing of the QC Module. Bottom Right: Coronal and Axial images of an MiniCAT scan of the QC phantom.
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