User Guide
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KODAK 9000 3D Extraoral Imaging System
User Guide
Notice Congratulations on your purchase of the KODAK 9000 Extraoral Imaging System. Thank you for your confidence in our products and we will do all in our power to ensure your complete satisfaction. The User Guide for the KODAK 9000 3D Extraoral Imaging System includes information both on the Panoramic features as well as the 3D features. If you have purchase only the KODAK 9000 Panoramic system, information relevant to 3D does not apply to your radiological system. We recommend that you thoroughly familiarize yourself with this Guide in order to make the most effective use of your system. The information contained in this Guide may be subject to modification without notice, justification or notification to the persons concerned. No part of this Guide may be reproduced without the express permission of Carestream Health, Inc.
This document is originally written in English. Manual Name: KODAK 9000 3D Extraoral Imaging System User Guide Part Number: SM710 Revision Number: Edition 01 Print Date: 11/2007 The brand names and logos reproduced in this Guide are copyright. KODAK is a trademark of KODAK used under License. KODAK 9000 3D Extraoral Imaging System, complies with Directive 93/42/CEE relating to medical equipment.
Contents 1-About This Guide Conventions in this Guide... 1–1 Note to the User... 1–2 Warning and Safety Instructions... 1–2 Marking and Labeling Symbols... 1–4 2-KODAK 9000 3D DIGITAL IMAGING UNIT OVERVIEW Functional Overview... 2–1 Control Panel Overview... 2–4 X-Ray Remote Control Overview... 2–5 Positioning Accessories and Replacement Parts... 2–6 3-IMAGING SOFTWARE OVERVIEW PC System Requirements... 3–1 General Software Overview... 3–2 Kodak Dental Imaging Software... 3–2 Acquisition Interface Module... 3–2 Kodak Dental Imaging Software Overview... 3–3 Patient Window Overview... 3–3 Imaging Window Overview... 3–5 3D Imaging Windows Overview... 3–8 Acquisition Interface Module... 3–14 Panoramic Acquisition Window Overview... 3–14 Panoramic Program Pane... 3–16 Panoramic Patient Pane... 3–17 Panoramic Parameter Pane... 3–18 3D Acquisition Window Overview... 3–19 3D Program Pane... 3–21 3D Patient Pane... 3–22 3D Parameter Pane... 3–23 4-GETTING STARTED Starting the Imaging Software... 4–1 Creating a Patient Record... 4–1 Accessing the Acquisition Windows... 4–2 Switching On the Unit... 4–2 5-ACQUIRING IMAGES Acquiring a Panoramic, TMJ x2 or Sinus Image... 5–1 Preparing the Unit and Setting the Acquisition Parameters... 5–1 Preparing and Positioning the Patient... 5–2 Launching the X-ray... 5–4
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Contents
Acquiring a TMJ x4 Image...5–6 Acquiring a 3D Image...5–7 Preparing the Unit and Setting the Acquisition Parameters...5–7 Preparing and Positioning the Patient...5–7 Launching the x-ray...5–10 Manually Pre-Setting the Patient Positioning...5–11 6-MAINTENANCE Daily...6–1 Monthly...6–1 Annually...6–2 7-TECHNICAL SPECIFICATIONS Compliance with International Standards...7–1 Manufacturer...7–1 Model...7–1 Compliance with International Regulations...7–1 Compliance with International Standards...7–1 Ambient Operating Conditions...7–1 Storage Conditions...7–1 Transport Conditions...7–1 Unit Technical Specifications...7–2 Unit Electronic Specifications...7–4 X-Ray Generator Technical Specifications...7–5
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Chapter 1
About This Guide Conventions in this Guide The following special messages emphasize information or indicate potential risk to personnel or equipment:
WARNING Warns you to avoid injury to yourself or others by following the safety instructions precisely.
CAUTION Alerts you to a condition that might cause serious damage.
IMPORTANT Alerts you to a condition that might cause problems.
NOTE Emphasizes important information.
TIP Provides extra information and hints.
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Note to the User
Note to the User WARNING X-rays can be harmful and dangerous if not used properly. The instructions and warnings contained in this guide must be therefore carefully followed. As a manufacturer of radiology units that conform to stringent radiological protection standards in force throughout the world, we guarantee a maximum degree of protection against radiation hazards. Nonetheless, you are handling a radiology unit specially designed to emit x-ray doses in order to carry out a medical diagnosis. The room in which your radiology Unit is to be installed must comply with all official regulations applicable to protection against radiation. You must install your radiology unit in a room protected against x-ray emission. This room must reduce to at least 12db the frequency interferences of the 30MHz to 1GHz band. Your local representative will assist you in the initial use of your radiology Unit and will supply any relevant information you may require. To use and operate your panoramic unit and your digital imaging software you must follow the instructions contained in this guide.
Warning and Safety Instructions When operating the Kodak 9000 3D unit, observe the following warning and safety instructions:
DANGER OF ELECTRIC SHOCK This is an electrical Unit. DO NOT expose it to water spray. Such action may cause an electric shock or a malfunction of the Unit.
LASER WARNING
LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT Maximum laser output:1mW,650nm IEC60825-1:1993+A1:1997+A2:2001
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About This Guide
For maximum safety, advise the patient not to look at the beam. Before turning on the beams, lower the Frankfurt plane beam to the lowest level. While making adjustments, ensure that the beam is not directed into the patient's eyes.
Warning and Safety Instructions
WARNINGS:
•
•
•
•
• •
• • • • • • • • • • •
You are responsible for the operation and maintenance of this unit. Only legally qualified persons can operate this unit. DO NOT open the cover of the unit.When necessary, have a trained authorized service technician carry out inspection and maintenance operations. Install this Unit in an x-ray room that complies with current installation standards. From this location, you must be able to maintain visual or audio communication with the patient and be able to access the Acquisition interface module during exposure. This Unit must be permanently connected to the ground with a fixed power supply cable. DO NOT place the PC and the peripheral equipment connected to it in the immediate vicinity of the patient in the Unit. Leave at least 1.5 m distance between the patient and the Unit. The PC and the peripheral equipment must conform to the IEC60950 standard. See your computer installation guide for details of the data processing system, PC and screen. Leave a sufficient amount of clear space around the CPU to ensure that it is properly ventilated. To obtain maximum image quality and visual comfort, position the screen to avoid direct light reflections from internal or external lighting. DO NOT operate the Unit if there is the threat of an earthquake. Following an earthquake, ensure that the Unit is operating satisfactorily before using it again. Failure to observe this precaution may expose patients to hazards. X-ray equipment is hazardous to patients and the operator if you do not observe the exposure safety factors and operating instructions. DO NOT place objects within the field of operation of the Unit. The patient should wear a protective lead-lined shoulder apron, unless other Radiation Protection Protocols apply locally. Disinfect any parts of the Unit that come into contact with the patient and the operator after each patient has been exposed to x-rays. While adjusting the height of the Unit, ensure that the patient is kept clear of the mechanism. When the Unit is not in use, ensure that the ON/OFF switch is set to OFF (O). If the Unit develops a fault, switch it to off (O), display an “Unserviceable” notice and contact a service technician. To dispose of the Unit or its components, contact a service technician. Ask the patient to refrain from moving during the entire period of exposure. Ask the patient to remain still until the Unit arm has stopped moving and the RESET movement has completed. DO NOT use this Unit in conjunction with oxygen-rich environments. This Unit is not intended for use with flammable anesthetics or flammable agents.
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Marking and Labeling Symbols
Marking and Labeling Symbols
Type B device symbol complying with the IEC 60601-1 standard
In the EEC, this symbol indicates: DO NOT discard this product in a trash receptacle; use an appropriate recovery and recycling facility. Contact your local sales representative for additional information on the collection and recovery programs available for this product WARNING and IONIZING RADIATION symbols warn you about radiation dangers.
LASER WARNING
LASER RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT Maximum laser output:1mW,650nm IEC60825-1:1993+A1:1997+A2:2001
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About This Guide
Laser radiation. DO NOT stare into the beam. Class 2 laser product. Maximum output power: 1mW, 650 nm (IEC 60825-1 standard) This Unit emits laser radiation.
Chapter 2
KODAK 9000 3D DIGITAL IMAGING UNIT OVERVIEW The KODAK 9000 3D digital imaging unit is compliant with the requirements of the EEC and international medical standards. The KODAK 9000 3D Unit has been designed to carry out the following radiological examinations: • • • •
Panoramic Maxillary Sinus Temporomandibular Joints (TMJ) 3D images
The KODAK 9000 3D Unit is composed of the following functional components: • •
Control Panel Remote Control
Functional Overview The following figures illustrate the components of the KODAK 9000 3D Unit. Figure 2-1 illustrates the up and down movement of the Unit mobile component and the 180° rotation of the rotative arm. Figure 2–1
KODAK 9000 3D Unit mobile components
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Functional Overview
Figure 2–2
KODAK 9000 3D Unit functional components
5b
5 10
1
9 2 7
6 8
11 5a 5 3 4
2–2
1
ON/OFF button
6
Temple supports
2
Unit fixed arm
7
Sensor
3
Control panel
8
Generator
4
Hand Grips
9
Unit rotative arm
5
Chin rest base
10
X-Ray remote control
5a
Panoramic chin rest
11
PC hosting the imaging and the acquisition software
5b
3D chin rest and bite block
KODAK 9000 3D D IGITAL IMAGING UNIT OVERVIEW
Functional Overview
Figure 2–3
KODAK 9000 3D Unit Positioning Laser Beam components
A
3
2
4
3
2
1
B
4
A 1 B
1
2
1
3D central positioning laser beam
2
Mid-sagittal positioning laser beam
3
Horizontal positioning laser beam
4
3D Field of View (FoV) positioning laser beam
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Control Panel Overview
Control Panel Overview The control panel is an alphanumeric, digital soft touch console. It allows the operator to control certain Unit functions. It also displays the operating parameters and error messages.
Figure 2–4
Unit Control Panel
8
kV
mA
2
1
3
S
mem
9
2–4
10
11
4
5
6
1
Height Adjustment button: Adjusts the height of the unit to the height of the patient.
2
3D Head Adjustment button: Adjusts the patient head to the x-ray beams.
3
3D Adjustment button: Adjusts the Unit arm movements to correctly position the patient for 3D acquisition.
4
Laser Beam button: Activates the beams to correctly position the patient.
5
3D Position Verification button: Verifies the correct 3D positioning.
6
Reset button: Resets the Unit arm to the initial position to enable the patient to enter and exit the Unit.
7
3D Memorization button: Memorizes the 3D current positioning parameter settings that override the default parameters.
8
Display Screen: Displays the current acquisition parameters and the error messages.
9
Ready Indicator LED: Green indicates the Unit is ready for acquisition.
10
X-Ray Emission LED: Yellow indicates x-rays are being emitted.
11
System Status LED: Red indicates error alerts.
KODAK 9000 3D D IGITAL IMAGING UNIT OVERVIEW
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X-Ray Remote Control Overview
X-Ray Remote Control Overview The x- ray remote control enables you to launch a radiological image acquisition via the exposure button from outside the x-ray room. You must press and hold the exposure button until the end of acquisition. Premature release of the exposure button interrupts the acquisition.
Figure 2–5
X-Ray Remote Control
1
1
Exposure button: launches image acquisition.
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Positioning Accessories and Replacement Parts
Positioning Accessories and Replacement Parts The following accessories are used when positioning a patient. They are delivered with the KODAK 9000 3D digital imaging unit.
Table 2–1
Panoramic Positioning Accessories and Replacement Parts Accessory
Description • • •
Panoramic chin rest TMJ x2 Sinus
TMJ x4 nose rest
Panoramic standard bite block
Bite block for edentulous patients
Single use sheaths for bite blocks (500 pcs box)
Table 2–2
3D Positioning Accessories and Replacement Parts Accessory
Description
3D bite block
3D chin rest
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KODAK 9000 3D D IGITAL IMAGING UNIT OVERVIEW
Chapter 3
IMAGING SOFTWARE OVERVIEW PC System Requirements This section specifies the minimum PC system requirements for Kodak 9000 3D extraoral imaging system software. IMPORTANT It is MANDATORY to check that the PC system configuration is compatible with the PC system requirements for the Kodak 9000 3D software. If necessary you MUST update your PC system configuration. Kodak 9000 3D MUST be connected to the PC via a point-to-point Ethernet link and not via a LAN. DO NOT place the PC and the peripheral equipment connected to it in the immediate vicinity of the patient in the Unit. Leave at least 1.5 m distance from the Unit. The PC and the peripheral equipment must conform to the IEC 60950 standard.
Table 3–1
Minimum PC System Requirements Minimum Workstation Image Viewing Requirements
Minimum Workstation Acquisition Requirements
CPU
2 GHz Intel Duo Core
3 GHz Intel Pentium 4
RAM
2 GB
2GB
Item
Hard disk drive
• •
1.2 GB for software installation
Comments
RAM has a major impact on system performance.
1.2 GB for software installation
80 GB free space to use the software
Graphic board
Nvidia / ATI based board supporting Nvidia board on PCI Express video The video RAM has major impact Open Glide 1.2 with 256 MB of video bus, minimum GeForce 8800 GTS on system performance. RAM on AGP x8 video bus (example: 640 MB of video RAM, or Quadro Nvidia GeForce 6800 GT) FX 4600 768 MB of video RAM
Monitor
• • •
Operating system
• • •
Ethernet interface CD/DVD drive
1 monitor 17" or larger 1024 x 768 minimum screen resolution - 32 bits color mode Windows 2000 SP4 Windows XP Home / Pro edition SP2 Windows Vista 32 bits 1 Ethernet interface
• • •
1 monitor 17" 1024 x 768 minimum screen resolution
• •
Windows 2000 SP4*
•
Windows Vista 32 bits*
Your monitor is a vital component in displaying quality images. Low-quality screens will prevent you from proper diagnoses and treatment.
Windows XP Home / Pro edition SP2
2 Ethernet interfaces (100Mbits)
A CD-ROM drive is required to install A CD-ROM drive is required to the product. install the product.
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General Software Overview
Table 3–1
Minimum PC System Requirements Item
Backup Media
Minimum Workstation Image Viewing Requirements Removable/portable, external hard disk drive
Minimum Workstation Acquisition Requirements
Comments
Removable/portable, external hard disk drive.
We strongly recommend a daily backup of x-ray images and patient records.
* NOTE: The indicated operating systems considerably increase the 3D volume image reconstruction time. The normal duration of a few minutes is increased by more than an hour.
General Software Overview The Kodak 9000 3D extraoral imaging system operates with the following software: • •
Kodak dental imaging software Acquisition interface module
Kodak Dental Imaging Software The Kodak dental imaging software is a user-friendly working interface that was designed and developed specifically for radiological diagnosis. It is the common imaging platform for all our digital systems for dentistry. The Kodak dental imaging software has the following features: • • •
Patient record management via Patient Window features Extraoral and intraoral image management via Imaging Window features 3D image management via 3D Imaging Window features
NOTE If you access the Imaging Window directly from your own patient management software, you will not see the Patient Window.
Acquisition Interface Module The Acquisition interface module is a user-friendly working interface that was designed and developed specifically for Kodak 9000 3D extraoral imaging system. The Acquisition interface module has the following features:
3–2
•
Panoramic acquisition interface via Panoramic Acquisition Window
•
3D acquisition interface via 3D Acquisition Window
IMAGING SOFTWARE OVERVIEW
Kodak Dental Imaging Software Overview
Kodak Dental Imaging Software Overview Patient Window Overview The Patient Window is the first window that appears when you launch the Kodak dental imaging software. This window is the main patient record management interface that provides you with all the patient record functions. Figure 3–1
Patient Window
1 2 3
4
5
1 Title Bar: Displays: • Software name
• •
2
Software version Practitioner name
Menu Bar: Provides access to the following functions: Menu
Submenu
Description
Patient
New
Creates a new patient record
Find
Finds a patient file
Modify
Modifies a patient record
Delete
Deletes a patient file
Imaging
Leads to the Imaging window
3 Toolbar: Provides quick access to the following menu functions:
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Kodak Dental Imaging Software Overview
Picture
Utilities
Options
?
Exit
Exits the Patient window
Insert picture
Inserts the patient picture
Remove picture
Removes the patient picture
Reindex
Regenerates all the index table
Archival...
Archives images before the given date
Preferences...
Configures the language and the database location
Toolbar
Hides or shows the toolbar
Help topics
Displays the online contextual help
About...
Lists the following information: • Software version
•
Copyright
4 Patient photograph if available. 5 Patient Record Pane: Patient information that you must enter in each field.
NOTE For information and procedures on how to use these functions, from the menu bar click ? to access the online help.
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IMAGING SOFTWARE OVERVIEW
Kodak Dental Imaging Software Overview
Imaging Window Overview The Imaging Window is the main imaging interface that provides you with the panoramic imaging functions. Figure 3–2
Imaging Window
1 Title Bar: Displays: • Software name
• • •
Software version Practitioner name Patient name
2 Menu Bar: Provides access to the following functions:
Menu
Submenu
Description
File
New panoramic image
Accesses the Panoramic Acquisition Window for a panoramic image
New 3D image
Accesses the 3D Acquisition Window for a 3D image
History Open
Opens the patient history record with image files
Save
Saves the acquired image
Close
Closes the patient image
3 Toolbar: Provides quick access to the following menu functions:
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Kodak Dental Imaging Software Overview
Delete
Deletes selected image
Prints the patient image
Print Setup
Sets up the printing parameters
Slide Show
Displays a set of images in a particular sequence
Report
Creates customized letters
Word Report
Creates a report template
Import image file
Imports images from a selected folder
Import digital camera Imports images acquired with a digital camera
Context
TUV
DICOMDIR
Imports/Exports DICOM images
TWAIN
Scans images
Copy
Copies selected image to clipboard
Paste
Pastes selected image
Send to
Sends the selected image either via e-mail or to a selected folder
Exit
Exits the Imaging Window
Save context
Saves the current images and screen display
Open context
Opens the saved images and screen display
Print context
Prints the selected images
Panoramic certification
Creates one series of quality reference images at installation (by installer)
Panoramic constancy Generates monthly images to test compare with reference images Options
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IMAGING SOFTWARE OVERVIEW
Preferences
Customizes specific preferences, such as, interface and online help languages, practitioner name, image preferences and so on.
Advanced options
Enters acquisition location data information
Customized
Customizes contextual toolbars