KODAK 8000 Digital Panoramic System User Guide Rev 01 Nov 2008

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 8000 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 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 Acquisition Interface Module... 3–3 Panoramic Acquisition Window Overview... 3–3 Panoramic Program Pane... 3–5 Panoramic Patient Pane... 3–6 Panoramic Parameter Pane... 3–7 4-GETTING STARTED Switching on the Unit... 4–1 Starting the Imaging Software... 4–2 Creating a Patient Record... 4–2 Accessing the Acquisition Window... 4–3 5-ACQUIRING PANORAMIC IMAGES Acquiring a Panoramic 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 Acquiring a Sinus Image... 5–5 Preparing the Unit and Setting the Acquisition Parameters... 5–5 Preparing and Positioning the Patient... 5–5 Launching the X-ray... 5–6 KODAK 8000 Digital Panoramic User Guide (SM722)_Ed 01

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Contents

Acquiring a TMJ x2 and x4 Image...5–8 Preparing the Unit and Setting the Acquisition Parameters...5–8 Preparing and Positioning the Patient...5–8 Launching the X-ray...5–9 X-Ray Dose Emission Information...5–11 6-MAINTENANCE Daily...6–1 Annually...6–1 7-TROUBLESHOOTING Information Messages...7–1 Quick Troubleshooting...7–3 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...8–4 X-Ray Generator Technical Specifications...8–5

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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 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 8000 Digital Panoramic System 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. 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. To avoid the risk of electric shock, this equipment must ONLY be connected to a mains supply with protective earth. 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. DO NOT rotate the rotative arm manually.

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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 8000 UNIT OVERVIEW The KODAK 8000 digital panoramic unit is compliant with the requirements of the EEC and international medical standards. The KODAK 8000 digital panoramic unit is designed to carry out the following radiological examinations: • • •

Panoramic Maxillary Sinus Temporomandibular Joints (TMJ)

General Overview The KODAK 8000 digital panoramic unit is composed of the following functional components: • • • • • • • • • •

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

The following figures illustrate the general overview of the KODAK 8000 digital panoramic unit.

IMPORTANT The patient entry can be positioned either on the right or the left side of the KODAK 8000 unit.

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General Overview

Mobile Components Figure 2-1 illustrates the up and down movement of the KODAK 8000 digital panoramic unit mobile component and the rotation of the rotative arm. The patient entry can be positioned either on the right or the left side of the KODAK 8000 unit

Figure 2–1

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KODAK 8000 UNIT OVERVIEW

KODAK 8000 Unit Mobile Components

General Overview

General Functional Components Figure 2-2 illustrates the general functional components of the KODAK 8000 digital panoramic unit. The patient entry can be positioned either on the right or the left side of the KODAK 8000 unit

Figure 2–2

KODAK 8000 Unit Functional Components

1

11

12

8 3

9

10

7 6

13

4 2 5

1

ON/OFF button

7

Height adjustment buttons

2

Chin rest and bite block

8

Panoramic digital sensor

3

Temple supports

9

X-Ray source assembly

4

Temple supports control knob

10

Collimator selector

5

Hand Grips

11

Unit rotative arm

6

Control panel

12

X-Ray remote control

13

PC hosting the imaging and the acquisition software

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General Overview

Digital Sensor Locations Figure 2-3 illustrates the location of the digital panoramic sensor of the KODAK 8000 digital panoramic unit. The patient entry can be positioned either on the right or the left side of the KODAK 8000 unit

Figure 2–3

KODAK 8000 Digital Sensor Locations

system

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KODAK 8000 UNIT OVERVIEW

General Overview

Laser Locations Figure 2-4 illustrates the location of the lasers of the KODAK 8000 digital panoramic unit. The patient entry can be positioned either on the right or the left side of the KODAK 8000 unit

Figure 2–4

KODAK 8000 Unit Laser Beam Locations

3

2

1

1

Mid-sagittal plane positioning laser beam

2

Frankfort plane positioning laser beam

3

Canine plane positioning laser beam

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General Overview

Label Locations Figure 2-5 illustrates the location of all the labels of the KODAK 8000 digital panoramic unit. The patient entry can be positioned either on the right or the left side of the KODAK 8000 unit

Figure 2–5

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KODAK 8000 UNIT OVERVIEW

KODAK 8000 Unit Label Locations

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

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Digital Panoramic System

kV

1

mA

S

2

3

4

1

X-Ray emission LED: Yellow, indicates the x-rays are being emitted.

2

Display Screen: Displays the current acquisition parameters and the error messages.

3

Reset button: Resets the unit arm to the initial position to enable the patient to enter and exit the unit.

4

Laser beam button: Activates the laser positioning beams to correctly position the patient.

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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

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Exposure button: launches image acquisition.

KODAK 8000 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 8000 digital panoramic unit. Table 2-1 lists the panoramic positioning accessories.

Table 2–1

Panoramic Positioning Accessories and Replacement Parts Accessory

Description

Panoramic chin rest and TMJ x2

Maxillary sinus chin rest

TMJ x2 and TMJ x4 nose rest

Standard bite block

Bite block for edentulous patients

A set of right and left temple supports x2

Single use sheaths for bite blocks (500 pcs box)

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Positioning Accessories and Replacement Parts

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KODAK 8000 UNIT OVERVIEW

Chapter 3

IMAGING SOFTWARE OVERVIEW PC System Requirements This section specifies the minimum PC system requirements for KODAK 8000 digital panoramic system software. IMPORTANT It is MANDATORY to check that the PC system configuration is compatible with the PC system requirements for the KODAK 8000 software. If necessary you MUST update your PC system configuration. KODAK 8000 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 Item

System Requirements

Comments

CPU

1 GHz, 32 bits processor (Pentium or equivalent - Intel chipset)

RAM

256 MB (512 MB recommended)

The RAM has a major impact on system performance.

Hard disk drive

40 GB (80 GB recommended)

The Video RAM has major impact on system performance. KDIS requires a minimum disk space of 1.2 GB for installation

Ethernet interface

•

1 Ethernet interface (100 Mbits) • 1 Ethernet interface (100 Mbits) if the PC is connected to a LAN and/or a WAN

There must be 2 Ethernet interfaces if the PC is connected to a LAN and/or a WAN.

Monitor

•

Your monitor is a vital component in displaying quality images. Low-quality screens will prevent you from proper diagnoses and treatment.

1 monitor 17" or larger • 1024 x 768 minimum screen resolution - 32 bits color mode •

Operating system

•

Windows 2000 SP4 Windows XP Home / Pro edition SP2 with DirectX 9.0c or higher • Server 2003 or Windows Vista 32 bits •

CD/DVD drive

A CD-ROM drive is required to install the product.

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General Software Overview

Table 3–1

Minimum PC System Requirements (Continued) Item

Backup Media

System Requirements Removable/portable, external hard disk drive

Comments We strongly recommend a daily backup of x-ray images and patient records.

General Software Overview The KODAK 8000 digital panoramic systems 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 using Patient Window features Extraoral and intraoral image management using Imaging Window features. NOTE For a complete information on the KODAK Dental Imaging Software, see the “KODAK Dental Imaging Software, Quick Start Guide”.

Acquisition Interface Module The Panoramic Acquisition Window is the acquisition user-friendly interface that was designed and developed specifically for KODAK 8000 digital panoramic systems.

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IMAGING SOFTWARE OVERVIEW

Acquisition Interface Module

Acquisition Interface Module Panoramic Acquisition Window Overview The Panoramic Acquisition Window is the main panoramic interface with the KODAK 8000 digital panoramic system that provides you with imaging acquisition functions. Figure 3–1

1

Panoramic Acquisition Window

Information button: • About: Identifies the Software and the Firmware versions

•

Reset of the Values: Resets to the manufacturing parameter settings

2

Preview Screen: Displays the acquired image in real time.

3

Selected Parameter Display: Displays the current acquisition parameter settings.

4

System Status Screen: Displays various alert or warning messages originating from the unit.

5

X-Rays ON / OFF button: Turns off the x-ray emissions to demonstrate the acquisition process for the patient.

6

Generator Cooling indicator: Indicates the automatic cooling time (mm:ss) required for the generator to reach 0 for a new acquisition.

7

Positioning laser button: Activates the laser positioning beams to correctly position the

patient. 8

Reset button: Resets the rotative arm in the start position.

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