K9000 3D User Guide
K9000 3D User Guide
K9000 3D User Guide
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.
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
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
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
iv
Chapter 1
About 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.
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.
LASER WARNING
For maximum safety, advise the patient not to look at the beam.
Before turning on the beams, lower the Frankfurt plane beam to
LASER RADIATION
DO NOT STARE INTO BEAM the lowest level. While making adjustments, ensure that the beam is
CLASS 2 LASER PRODUCT
Maximum laser output:1mW,650nm
IEC60825-1:1993+A1:1997+A2:2001 not directed into the patient's eyes.
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.
LASER WARNING
Laser radiation. DO NOT stare into the beam.
Class 2 laser product.
LASER RADIATION Maximum output power: 1mW, 650 nm (IEC 60825-1
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
Maximum laser output:1mW,650nm
standard)
IEC60825-1:1993+A1:1997+A2:2001
This Unit emits laser radiation.
The KODAK 9000 3D Unit has been designed to carry out the following radiological
examinations:
• Panoramic
• Maxillary Sinus
• Temporomandibular Joints (TMJ)
• 3D images
• 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
5b
1 10
9
2
6 7
8 11
5a
3 2
1 2 3
1 2
8 1 2 3
kV mA S
mem
9 10 11 4 5 6 7
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.
Accessory Description
Accessory Description
3D bite block
3D chin rest
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.
* 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.
NOTE
If you access the Imaging Window directly from your own patient
management software, you will not see the Patient Window.
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.
2 Menu Bar: Provides access to the following functions: 3 Toolbar: Provides quick
access to the following
menu functions:
Menu Submenu Description
File New panoramic Accesses the Panoramic
image Acquisition Window for a
panoramic image
New 3D image Accesses the 3D Acquisition
Window for a 3D image
4 Dental Arch Pane: Displays the existing teeth images of the patient dental arch. To open different
history types to access patient images:
• Click P for a display of all Panoramic images.
• Click F for a reduced history with the FMS displayed.
• Click C for a reduced history with the Cephalometric images displayed.
5 Control Panel: Adjusts and enhances certain zones of the image for a clearer display.
6 Image Windows: Depending on the image type, the title bar displays different information.
7 Contextual Toolbar: The toolbar type depends on the image type context. You can reposition the
toolbar.
NOTE
For information and procedures on how to use these functions, from
the menu bar click ? to access the online help.
To access the 4 View Window, from the Home Page click the 4 View Window tab.
Figure 3–4 4 View Window
Measurements
Click to show or hide measurements.
To access the Curved Slicing Window, from the Home Page click the Curved Slicing Window
tab.
Figure 3–5 Curved Slicing Window
To access the Oblique Slicing Window, from the Home Page click the Oblique Slicing Window
tab.
Figure 3–6 Oblique Slicing Window
NOTE
NOTE
The above list of exam types are only a sample of exam options of the
Program pane.
1 Fine-tuning buttons:
Kilovolt
milliampere
3 Exposure time:
seconds
3D Program Pane
The 3D Program pane enables you to choose different radiological exams. The diagram in
the Program pane represents the jaw.
Figure 3–12 3D Program Pane
3D Patient Pane
The 3D Patient pane enables you to choose different patient parameters. The selection of the
patient parameters influences the quality of the image. The selected parameters must be based
on the patient age and morphology.
Figure 3–13 Panoramic Patient Pane
3D Parameter Pane
The 3D Parameter pane enables you to choose exposure parameters for the radiological
image acquisition. You must adapt the parameter settings to the patient type.
Figure 3–14 3D Parameter Pane.
1 Fine-tuning buttons:
Kilovolt
milliampere
• All the connections between the Unit and the PC are properly connected.
• The PC is turned ON.
OR
From your PC, click Start > All Programs > Kodak > Kodak Dental Software.
OR
2. Enter the required patient information. The Last name, the First name and the Date of
birth fields are required.
3. From the menu bar, select Picture > Insert Picture to add a *.tif or *.bmp picture of the
patient to the record. Select the picture from your directory and click Open.
4. Click OK to save. The patient record is automatically assigned a 7-digit number starting
with a letter (for example, M0000001).
1. In the Imaging Window, from the toolbar, click to access the Panoramic
1. On the Unit column, press the ON button. The name of the patient appears in the Display
Screen of the Control Panel.
IMPORTANT
To increase the operating life of the x-ray tube, if the Unit has not been used
for a month, you must follow these following procedures before use.
3. Select the following parameter settings; then, for each setting, from the Remote Control,
press and hold the button to launch the x-ray:
• 70 kV - 6.3 mA
• 80 kV - 10 mA
• 85 kV - 10 mA
• Reset the Unit rotative arm to start position for patient entry
• Selected the patient record
• Accessed the Imaging Window
• Accessed the Panoramic Acquisition Window
1. In the Panoramic Acquisition Window, click the Program button to access the Program
pane. Click on the section of the jaw to select the anatomical zone for the x-ray image,
such as panoramic, TMJ x2 or sinus.
• Corpulence
• Dental arch morphology
• Incisors orientation
3. If needed, click the Parameter button to access the Parameter pane and select the
appropriate parameters.
4. Position the appropriate chin rest on the chin rest support and cover the bite block with a
hygienic barrier. If needed, use the edentulous bite block. Press and hold to raise
the chin rest to the maximum height.
2. Ask the patient to wear a lead apron. Ensure that the apron lays flat across the patient
shoulders.
3. Ask the patient to enter the Unit. On the Control Panel, press and hold to adjust the
Unit to the patient height.
NOTE
If the patient is too tall, ask the patient to sit on a stool.
• Stand up straight.
• Grip the lower handle on each side.
• Rest the chin on the chin rest support and
bite into the bite block.
• Position the feet slightly forward.
• Relax the shoulders for full motion of the
Unit rotative arm.
NOTE
Correct posture reduces the shadow of the spinal column transferred
to the image.
5. On the Control Panel click to turn ON the positioning laser beams. Press and hold
NOTE
You can re-activate the laser positioning beams as needed. You can
press the same button to turn OFF the laser beams, or wait 60 seconds
for the beams to turn OFF automatically.
1 1
2 2
IMPORTANT
The spinal column and the nose of the patient must be aligned in a
straight line (1).
7. Ask the patient to close the eyes, to remain still, to swallow, to place the tongue in contact
with the palate and to breath through the nose.
1. Leave the x-ray room and close the door. You must keep eye contact with the patient
during acquisition.
IMPORTANT
To stop the acquisition, if any problem, release the exposure
button of the remote control or press the red emergency stop
button.
2. Launch the x-ray with the remote control. Press and hold the exposure button until the end
of acquisition. The turns yellow indicating x-ray emission. The image appears on the
Preview Screen of the Panoramic Acquisition Window. When the acquisition ends, the
Panoramic Acquisition Window disappears and the acquired image is automatically
transferred to the Imaging Window.
• Reset the Unit rotative arm to start position for patient entry
• Selected the patient record
• Accessed the Imaging Window
• Accessed the Panoramic Acquisition Window
1. From the Panoramic Acquisition Window, in the Program pane, select the TMJ and
click .
2. Remove , place on the chin rest support and cover it with a hygienic barrier.
3. Press and hold to raise the chin rest to the maximum height.
5. Ask the patient to remain still and close the eyes. Acquire an image with the mouth closed.
6. To acquire an image with open mouth, on the Control Panel click to reset the Unit
rotative arm.
7. Ask the patient to stay in the same position and open the mouth. Acquire an image with
the mouth open.
Acquiring a 3D Image
Before acquiring a 3D image, check that you have:
• Reset the Unit rotative arm in start position for patient entry
• Selected the patient record
• Accessed the Imaging Window
• Accessed the 3D Acquisition Window
1. In the 3D Acquisition Window, click the Program button to access the Program pane.
Select the region of interest and click to validate the selection, or click to
cancel the modifications.
• Corpulence
• Dental arch morphology (optional)
• Incisors orientation (optional)
3. Click the Parameter button to access the Parameter pane. Select the appropriate
parameters.
4. Position the 3D head rest and 3D standard bite block and cover the bite block with a
hygienic barrier.
2. Ask the patient to wear a lead apron. Ensure that the apron lays flat across the patient
shoulders.
3. Ask the patient to enter the Unit. On the Control Panel, press and hold to adjust the
Unit to the patient height.
NOTE
If the patient is too tall, ask the patient to sit on a stool.
6. Click on the Control Panel to turn ON the positioning laser beams. Adjust the
patient using the following 2 positioning laser beams:
NOTE
You can re-activate the laser positioning beams as needed. You can
press the same button to turn OFF the laser beams, or wait 60 seconds
for the beams to turn OFF automatically.
7. Press and hold to align the upper or lower jaw with the 3D FoV (2) positioning
laser beam. Tighten the temple supports (3).
8. Ask the patient to close the eyes, to remains still and to breath through the nose.
1. Leave the x-ray room and close the door. You must keep eye contact with the patient
during acquisition.
IMPORTANT
To stop the acquisition, if any problem, release the exposure
button of the remote control or press the red emergency stop
button.
2. Trigger the x-ray with the remote control. Press and hold the exposure button until the end
of acquisition. The turns yellow indicating x-ray emission. The image appears in the
Preview Screen. When the acquisition ends, the 3D Acquisition Window disappears.
3. Open the 3D head support and release the patient while waiting for the 3D image
reconstruction. Remove the hygiene barrier of the bite block.
4. Wait for the 3D image reconstruction. Open the Imaging Window and
in the pane, click to access the patient record and open the
acquired 3D image.
TIP
You can pre-set the acquisition parameters of the region of interest
manually using dental plaster imprint.
2. To pre-set the patient positioning, ask the patient to bite into a plate of dental plaster and
wait for the plaster imprint to harden.
3. Place the dental imprint on the bite block location. Press and hold to align the
Unit rotative arm to the region of interest using the 3D central positioning laser beam.
Press to save the manually selected parameter settings of the Unit rotative arm.
4. Remove the plaster imprint and position the patient in the Unit and follow the appropriate
steps to acquire the 3D image of the region of interest.
WARNING
Switch off the Unit, then, clean all accessible parts of the machine
with an alcohol-based non-corrosive product. Avoid using liquids
inside the Unit. Follow the alcohol-based product manufacturer
recommendations for safety precautions.
CAUTION
You can use the usual disinfectant products, but we recommend
that you protect the Unit from contamination by using barriers
available from dental distributors. Follow the disinfectant
product manufacturer recommendations for safety precautions.
Daily
Carry out the following maintenance tasks:
WARNING
Do not use detergents or solvents to clean the outer covers of the
Unit.
Monthly
Wipe the outer covers of the unit with a soft, dry cloth.
Annually
We recommend a general inspection of the Unit carried out by an authorized service
technician.
6–2 MAINTENANCE
Chapter 7
TECHNICAL SPECIFICATIONS
Compliance with International Standards
The KODAK 9000 3D digital imaging Unit is compliant with the International and EEC
standards.
Manufacturer
TROPHY
A subsidiary of Carestream Health, Inc.
4, Rue F. Pelloutier, Croissy-Beaubourg
77435 Marne la Vallée Cedex 2, France
Model
KODAK 9000 3D Unit, KODAK 9000 Unit.
Storage Conditions
• Temperatures: -10 ~ 60 °C
• Relative humidity: 10 ~ 95%
• Atmospheric pressure: 700 ~ 1060 hpa
Transport Conditions
• Temperatures: -10 ~ 60 °C
• Relative humidity: 10 ~ 95%
• Atmospheric pressure: 700 ~ 1060 hpa
Cooling Conditions
Maximum dissipation of heat from the x-ray 33 W
radiogenic assembly into the ambient air (for
utilization rate in continuous mode)
Measurement Conditions
kV Indirect on the peak kilovolt meter
mA Direct measurement in the circuit using an oscilloscope
Exposure time Measurement at 75% of the kV values with peak kilovolt meter
Standard Compliance
IEC 60601.1.3 Compliant
Nominal value of the inherent filtration at 70 kV 2.5 mm (0.10'') eq. Al
Nominal value of the supplementary filtration at 70 kV NA
Nominal value of the total filtration at 70 kV 2.5 mm (0.10'') eq. Al
Filtration value for the enclosure of the x-ray tube (at 100 kV) 0.2 mm (0.008")
Filtration value for the enclosure of the image receiver unit (at 100 0.2 mm (0.008")
kV)
Filtration value for the sensor case 0.8 mm (0.031") eq. Al
• A transformer and an x-ray tube and their associated electronic components immersed in oil
• An aluminum filter, which enhances the quality of the beam and reduces the dose received by the patient
• A lead collimator, which limits the size of the beam at the image receiver unit
• A thermal cutout, which trips at an operating temperature between 63 to 70° C ( ± 5° C)
Standard Compliance
IEC Standard 60601.2.28 Compliant
Manufacturer Trophy
Degree of protection against electric shock Class I
Degree of patient protection from the parts applied to the leakage current Type B
Maximum accumulated heat 110 kJ
Maximum continuous heat dissipation 33 W
Tolerances on the position of the focal spot +/- 2.5mm
Radiation leakage after one hour's operation (maximum utilization rate of < 1 mGy
93W, i.e. 90 kV, 10 mA, 13.9 sec. every 2 minutes 15 sec.)
Weight 8.2 kg
Dimensions 235 x 245 x 120 mm
100, 0
90, 0
80, 0
100 W
Accumulated heat in kJ
70, 0
66 W
60, 0
33 W
50, 0
15 W
40, 0 10 W
30, 0 Cooling
20, 0
10, 0
-
0 60 120 180 240 300 360 420 480 540 600 660 720
Time in minutes