9000 and 9000 3D User Guide Rev 03 June 2009

Notice Congratulations on your purchase of the KODAK 9000 and KODAK 9000 3D 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 and 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. KODAK 9000 and KODAK 9000 3D Extraoral Imaging System is intended to be used at the direction of dentists, oral surgeons and orthodontists for panoramic extraoral x-ray imaging of the dento-maxillo-facial area. In addition, the 3D systems include a digital volumetric tomography mode which is intended to produce three-dimensional x-ray images of the dento-maxillo-facial region. 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 US Federal law restricts this device to sale by or on the order of a physician. This document is originally written in English. Manual Name: KODAK 9000 and KODAK 9000 3D Extraoral Imaging System User Guide Part Number: SM710 Revision Number: 03 Print Date: 06/2009 The brand names and logos reproduced in this Guide are copyright. KODAK is a trademark of KODAK used under License. KODAK 9000 and 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 AND KODAK 9000 3D UNIT OVERVIEW General Overview... 2–1 Mobile Components... 2–2 General Functional Components... 2–3 Digital Sensor Locations... 2–4 Laser Locations... 2–5 Label Locations... 2–6 Control Panel... 2–7 X-Ray Remote Control Overview... 2–8 Positioning Accessories and Replacement Parts... 2–9 Panoramic Positioning Accessories... 2–9 Patient Positioning Indicators... 2–10 3D Positioning Accessories... 2–10 3-IMAGING SOFTWARE OVERVIEW PC System Requirements... 3–1 General Software Overview... 3–2 KODAK Dental Imaging Software... 3–2 Acquisition Interface Module... 3–3 Acquisition Interface Module... 3–4 Panoramic Acquisition Window Overview... 3–4 Panoramic Program Pane... 3–6 Panoramic Patient Pane... 3–7 Panoramic Parameter Pane... 3–8 3D Acquisition Window Overview... 3–9 3D Program Pane... 3–11 3D Patient Pane... 3–12 3D Parameter Pane... 3–13 4-GETTING STARTED Switching on the Unit... 4–1 Starting the Imaging Software... 4–2 Creating a Patient Record... 4–2 Accessing the Acquisition Windows... 4–3 5-ACQUIRING IMAGES Acquiring a Panoramic, TMJ x2 or Sinus Image... 5–1 KODAK 9000 and KODAK 9000 3D Extraoral Imaging System User Guide (SM710)_Ed 03

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Contents

Preparing the Unit and Setting the Acquisition Parameters...5–1 Preparing and Positioning the Patient...5–2 Launching the X-ray...5–5 Acquiring a TMJ x4 Image...5–6 Acquiring a 3D Single-Volume Image...5–7 Preparing the Unit and Setting the Acquisition Parameters...5–7 Preparing and Positioning the Patient...5–8 Launching the x-ray...5–11 Manually Pre-Setting the Single-Volume Position of the Patient...5–12 Acquiring a 3D Multi-Volume Image...5–13 Preparing the Unit and Setting the Acquisition Parameters...5–13 Preparing and Positioning the Patient...5–15 Launching the x-ray...5–17 X-Ray Dose Emission Information...5–19 6-TROUBLESHOOTING Quick Troubleshooting...6–1 7-MAINTENANCE Daily...7–1 Monthly...7–1 Annually...7–2 8-TECHNICAL SPECIFICATIONS Compliance with International Standards...8–1 Manufactured by:...8–1 Compliance with International Regulations...8–1 Compliance with European and International Standards...8–1 Classification in Accordance with EN/IEC 60601-1...8–2 Classification in Accordance with EN/IEC 60601-1-2...8–2 Ambient Operating Conditions...8–2 Storage Conditions...8–2 Transport Conditions...8–2 Unit Technical Specifications...8–3 Unit Electronic Specifications...8–5 X-Ray Generator Technical Specifications...8–6

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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 as low as reasonably achievable 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 and 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 eyes of the patient.

Warning and Safety Instructions

WARNINGS:

•

•

•

•

• •

• • • • • • • • • • •

You are responsible for the operation and maintenance of this unit. Only legally qualified persons can operate this unit. They MUST have training to use the radiological equipment. 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 AND KODAK 9000 3D UNIT OVERVIEW The KODAK 9000 and KODAK 9000 3D digital imaging unit is compliant with the requirements of the EEC and international medical standards. The KODAK 9000 and KODAK 9000 3D unit has been designed to carry out the following radiological examinations: • • • •

Panoramic Maxillary Sinus Temporomandibular Joints (TMJ) 3D images

General Overview The KODAK 9000 unit is composed of the following functional components: • • • • • • • • • •

The rotative arm The fixed arm with a control panel The panoramic digital sensor The x-ray source assembly The x-ray remote control The chin rest base The panoramic chin rest and bite block The temple supports The hand grips The acquisition software (see “Imaging Software Overview”)

The KODAK 9000 3D unit is composed of the following functional components: • • • • • • • • • •

The rotative arm The fixed arm with a control panel The panoramic digital sensor The 3D digital sensor The x-ray source assembly The x-ray remote control The chin rest base The panoramic chin rest and bite block The 3D chin rest and bite block The temple supports

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General Overview

• •

The hand grips The acquisition software (see “Imaging Software Overview”)

The following figures illustrate the general overview of the KODAK 9000 and KODAK 9000 3D unit.

Mobile Components Figure 2-1 illustrates the up and down movement of the KODAK 9000 and KODAK 9000 3D mobile component and the 180° rotation of the rotative arm.

Figure 2–1

2–2

KODAK 9000 and KODAK 9000 3D Unit Mobile Components

KODAK 9000 AND KODAK 9000 3D UNIT OVERVIEW

General Overview

General Functional Components Figure 2-2 illustrates the general functional components of the KODAK 9000 and KODAK 9000 3D. Figure 2–2

KODAK 9000 and KODAK 9000 3D Unit Functional Components

5b

5 10

1

9 2 7

6 8

11 5a 5 3 4

1

ON/OFF button

6

Temple supports

2

Unit fixed arm

7

Sensor

3

Control panel

8

X-Ray source assembly

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

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General Overview

Digital Sensor Locations Figure 2-3 illustrates the locations of the panoramic and the 3D digital sensor of the KODAK 9000 and KODAK 9000 3D.

IMPORTANT * When the unit is ONLY panoramic, the 3D option is not available. Therefore, the location of the digital sensor indicates that it is ready for the 3D option.

Figure 2–3

KODAK 9000 and KODAK 9000 3D Unit Panoramic and 3D Digital Sensor Locations

Digital 3D

*

2–4

KODAK 9000 AND KODAK 9000 3D UNIT OVERVIEW

General Overview

Laser Locations Figure 2-4 illustrates the location of the lasers of the KODAK 9000 and KODAK 9000 3D. Figure 2–4

KODAK 9000 and KODAK 9000 3D Unit Laser Beam Positions

A

3

2

4 1

2 3 4 B

A B

1

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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General Overview

Label Locations Figure 2-5 illustrates the location of all the labels of the KODAK 9000 3D. The label locations of the KODAK 9000 are presented with *.

IMPORTANT The labels presented are ONLY for the KODAK 9000 3D option. The “*Panoramic” presents the labels and their locations for the KODAK 9000.

Figure 2–5

KODAK 9000 and KODAK 9000 3D Unit Label Locations

* * X-Ray Source Assembly :CU 227 CEI OPX 105

* Panoramic

2–6

KODAK 9000 AND KODAK 9000 3D UNIT OVERVIEW

Control Panel

Control Panel 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 2–6

Unit Control Panel 8

kV

mA

2

1

3

S

mem

9

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 rotative 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: Positions the unit rotative arm at the selected or memorized 3D position.

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 the x-rays are being emitted.

11

System Status LED: Red, indicates the error alerts.

7

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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 2–7

X-Ray Remote Control

1

1

2–8

Exposure button: launches image acquisition.

KODAK 9000 AND KODAK 9000 3D UNIT OVERVIEW

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 and KODAK 9000 3D digital imaging unit.

Panoramic Positioning Accessories Table 2-1 lists the panoramic positioning accessories.

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)

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Positioning Accessories and Replacement Parts

3D Positioning Accessories Table 2-2 lists the 3D positioning accessories.

Table 2–2

3D Positioning Accessories and Replacement Parts Accessory

Description

3D bite block

3D bite block support

Single use sheaths for bite blocks (500 pcs box)

Patient Positioning Indicators Table 2-3 lists the patient positioning indicators represented on the chin rest base.

Table 2–3

Patient Positioning Indicators Positioning Indicators

Description

For sinus positioning

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KODAK 9000 AND KODAK 9000 3D UNIT OVERVIEW

Positioning Accessories and Replacement Parts

Table 2–3

Patient Positioning Indicators (Continued) Positioning Indicators

Description

• •

For TMJ x2 and TMJ x4 positioning For panoramic positioning

For 3D upper jaw positioning

For 3D lower jaw positioning

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Positioning Accessories and Replacement Parts

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KODAK 9000 AND KODAK 9000 3D UNIT OVERVIEW