KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System. Installation Guide

Transcription

1 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide

2 Notice Congratulations on your purchase of the KODAK 9000C and KODAK 9000C 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 Installation Guide for the KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System includes information on the cephalometric features. For the panoramic or the 3D features, see the KODAK 9000 and KODAK D Extraoral Imaging System (SM711) Installation Guide. 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 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 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide Part Number: SM714 Revision Number: 01 Print Date: 06/2008 The brand names and logos reproduced in this Guide are copyright. KODAK is a trademark of KODAK used under License. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System, complies with Directive 93/42/CEE relating to medical equipment. 0086

3 Contents 1 About This Guide Conventions in this Guide Note to the User Warning and Safety Instructions Marking and Labeling Symbols Responsibility and Warranty KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW General Overview Mobile Components General Functional Components Digital Sensor Locations Laser Locations Label Locations Control Panel Overview X-Ray Remote Control Overview KODAK 9000C AND KODAK 9000C 3D PACKAGING Standard Packaging SITE PREPARATION BEFORE INSTALLATION Standard Compliance Environmental Requirements Unit Dimensions Electrical Requirements X-Ray Room Requirement PC System Requirements INSTALLING THE CEPHALOSTAT Tool Requirements Technical Staff Requirements Opening the Box Installing the Cephalostat Unit Installing the Cephalostat Arm Installing the Cephalostat Head Wiring the Cephalostat Head Wiring the Cephalostat to the Unit Head Installing the Cephalometric Frankfort Positioning Laser (For Upgrade Only) Installing the Cephalostat Positioning Locker (For Upgrade Only) Post-Installation Control Adjusting the Cephalostat Head Adjusting the Inclination of the Cephalostat Head KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed 01 iii

4 Contents Adjusting the Height of the Cephalostat Head Adjusting the Ear Cones Alignment Adjusting the Nasion Support Selecting the Cephalometric Blade Collimator Parameters Calibrating the Cephalometic Blade Collimator Checking the Image Quality Fitting the Covers Fitting the KODAK 9000C and KODAK 9000C 3D Covers Fitting the Cephalostat Covers Maintenance Annual Maintenance TECHNICAL SPECIFICATIONS Compliance with International Standards Manufactured by: Compliance with International Regulations Compliance with European and International Standards Classification in Accordance with EN/IEC Classification in Accordance with EN/IEC Ambient Operating Conditions Storage Conditions Transport Conditions Cephalometric Unit Technical Specifications Unit Electronic Specifications X-Ray Generator Technical Specifications iv

5 Chapter 1 About This Guide Conventions in this Guide The following special messages emphasize information or indicate potential risk to persons 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. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

6 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 the frequency interferences of the 30MHz to 1GHz band to at least 12db. 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 9000C and KODAK 9000C 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 IEC :1993+A1:1997+A2:2001 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. 1 2 About This Guide

7 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. DO NOT hang from the cephalostat. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

8 Marking and Labeling Symbols Marking and Labeling Symbols Type B device symbol complying with the IEC 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 RADIATION DO NOT STARE INTO BEAM CLASS 2 LASER PRODUCT Maximum laser output:1mw,650nm IEC :1993+A1:1997+A2:2001 N L LASER WARNING Laser radiation. DO NOT stare into the beam. Class 2 laser product. Maximum output power: 1mW, 650 nm (IEC standard) This unit emits laser radiation. Connecting point to the neutral conductor Connecting point to the live conductor Protection ground (G) Functional ground 1 4 About This Guide

9 Responsibility and Warranty Responsibility and Warranty Only damage affecting products themselves will be considered. The client can in no case claim damage compensation if it does not purely concern the product itself and provided that this exclusion of responsibility does not infringe any legal measures. This warranty does not cover damages and faults due to accident, incorrect usage, improper use, negligence, or wear and tear due to normal use. Carestream Health, Inc. can not be held liable for the consequences resulting from the non-application of the instructions contained in the installation and user manuals, namely bodily harm, profit loss, operational interruptions, data loss, loss of a financial nature, or any direct or indirect damage. Carestream Health, Inc. reserves the right to examine any presumed defect. Clients are not entitled to delay the payment of their bills or any financial deductions by way of products reputed to be faulty. Due to the continuous development of its products, Carestream Health, Inc. reserves the right to amend at any time the manual and products mentioned therein, without justification or notification to the people involved. Our products are guaranteed in their original packaging. Carestream Health, Inc. cannot be held liable for damages resulting from transportation. Consumable spares, software and accessories are excluded from the warranty. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

10 Responsibility and Warranty 1 6 About This Guide

11 Chapter 2 KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW The KODAK 9000C and KODAK 9000C 3D digital imaging unit is compliant with the requirements of the EEC and international medical standards. The KODAK 9000C and KODAK 9000C 3D unit has been designed to carry out the following radiological examinations: Lateral Frontal (PA or AP) Oblique Submento-vertex Carpus General Overview The KODAK 9000C 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 cephalostat arm The cephalostat head The head clamps and ear cones The nasion support The acquisition software (see Imaging Software Overview ) The KODAK 9000C 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 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

12 General Overview 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 The hand grips The cephalostat arm The cephalostat head The head clamps and ear cones The nasion support The acquisition software (see Imaging Software Overview ) The following figures illustrate the general overview of the KODAK 9000C and KODAK 9000C 3D unit. Mobile Components Figure 2-1 illustrates the up and down movement of the KODAK 9000C and KODAK 9000C 3D mobile component and the 180 rotation of the rotative arm. Figure 2 1 KODAK 9000C and KODAK 9000C 3D Unit Mobile Components 2 2 KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW

13 General Overview General Functional Components Figure 2-2 illustrates the general functional components of the KODAK 9000C and KODAK 9000C 3D. Figure 2 2 KODAK 9000C and KODAK 9000C 3D Unit Functional Components b a RJ45/1 10 RJ45/ Unit fixed arm 16 Unit rotative arm 2 Control panel 17 Under the head front cover 3 Hand grips 18 Under the head back cover 4 Temple supports 19 Head cover 5 Chin rest base 20 Column side cover 5 a Panoramic chin rest 21 Column inside cover 5 b 3D chin rest and forehead support 22 ON/OFF button 6 Unit mains connecting terminal 23 Wall mounting brackets 7 Green warning lamp (ready state indicator) 24 Wall mounting brackets cover KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

14 General Overview 8 Column connecting terminals 25 Column upper cover 9 X-Ray remote control 26 Cephalostat arm 10 Door safety switch 27 Cephalostat end of the arm cover 11 PC hosting the imaging and acquisition software 28 Cephalostat head top cover 12 Ethernet outlet RJ45/1 29 Cephalostat head side cover 13 LAN RJ45/2 30 Carbon fiber screen 14 Sensor 31 Head clamps and ear cones 15 X-ray source assembly 32 Nasion support 2 4 KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW

15 General Overview Digital Sensor Locations Figure 2-3 illustrates the locations of the panoramic, 3D and cephalometric digital sensors of the KODAK 9000C and KODAK 9000C 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 9000C and KODAK 9000C 3D Unit Panoramic, 3D and Cephalometric Digital Sensor Locations Digital 3D * KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

16 General Overview Laser Locations Figure 2-4 illustrates the location of the lasers of the KODAK 9000C and KODAK 9000C 3D. Figure 2 4 KODAK 9000C and KODAK 9000C 3D Unit Laser Positions B 5 A 1 B A D central positioning laser beam 2 Mid-sagittal positioning laser beam 3 Horizontal positioning laser beam 4 3D Field of View (FoV) positioning laser beam 5 Cephalometric Frankfurt positioning laser beam 2 6 KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW

17 General Overview Label Locations Figure 2-5 illustrates the location of all the labels of the KODAK 9000C and KODAK 9000C 3D. The label locations of the KODAK 9000C are represented with *. IMPORTANT The labels presented are ONLY for the KODAK D option. The *Panoramic presents the labels and their locations for the KODAK Figure 2 5 KODAK 9000C and KODAK 9000C 3D Unit Label Locations 2008/04/23 K9000 C 3D XPNK004 * 0.90A 2008/04/23 X-Ray Source Assembly :CU ,5 mm AI 2,5 mmai CEI OPX * Type : CG932 * Panoramic 2008/04/23 K9000 C XPNK A KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

18 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 6 Unit Control Panel kv ma S mem Height Adjustment button: Adjusts the height of the unit to the height of the patient. 2 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: 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. 2 8 KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW

19 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 Exposure button: launches image acquisition. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

20 X-Ray Remote Control Overview 2 10 KODAK 9000C AND KODAK 9000C 3D UNIT OVERVIEW

21 Chapter 3 KODAK 9000C AND KODAK 9000C 3D PACKAGING Standard Packaging Table 3 1 Cephalometric Assembly Components Box Components Dimension (mm) Weight Cephalostat head Cephalostat arm Cephalostat covers Cephalometric Frankfurt positioning laser assembly* Cephalostat positioning locker* Documentation (User Guide and Installation Guide) 1200mm (L) x 800mm (D) x 1100mm (H) 78 kg * The listed components will be in your packaging only if you have to install the Cephalostat option at a later date than the KODAK 9000 or KODAK D. Table 3 2 Components Product Description Quantity Cephalostat head 1 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

22 Standard Packaging Table 3 2 Components (Continued) Product Description Quantity Cephalostat arm End of the arm cover 1 Head top cover 1 Head side cover 1 Cephalometric Frankfurt* positioning laser assembly 1 Cephalostat positioning locker* 1 * The listed components will be in your packaging only if you have to install the Cephalostat option at a later date than the KODAK 9000 or KODAK D. 3 2 KODAK 9000C AND KODAK 9000C 3D PACKAGING

23 Chapter 4 SITE PREPARATION BEFORE INSTALLATION IMPORTANT Prior to placing the order and before installation, carefully check the following requirements for the x-ray room. Standard Compliance Install the unit in an x-ray room compliant with all official regulations applicable to protection against radiation. This room must reduce the frequency interferences of the 30MHz to 1GHz band to at least 12db. Environmental Requirements Check the following ambient operating condition requirements of the x-ray room before installing the unit: Temperatures: 5 ~35 C Relative humidity: 30 ~ 85% Atmospheric pressure: 700 ~ 1060 hpa KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

24 Unit Dimensions Unit Dimensions MAXI 1595 mm (62 3 ") mm (54 3 ") mm (15 63 ") mm (12 3 ") mm ( 25 ") mm (22 51 ") mm (61 27 ") 32 The unit dimensions illustrated in the above figure are as follows: Maximum height of the unit (2378mm) Minimum (1016mm) and maximum (1693mm) height of the chin rest Minimum (1030mm) and maximum (1706mm) height of the ear cones Width (2150mm) and depth (1595mm) of the unit WARNING If you need to add a base plate you must add 15mm to the height of the unit SITE PREPARATION BEFORE INSTALLATION

25 Electrical Requirements Electrical Requirements WARNING* You MUST select the operating voltage when placing an order. The operating voltage CANNOT be modified on site. The unit can operate at: 100/110/130 V 50/60 Hz 230/240 V 50/60 Hz Table 4 1 Optional Operating Voltages of the Unit Nominal voltage * (no load) Minimum Maximum Maximum line current 100 V V 90 V 143 V 20 A 230 V V 207 V 264 V 10 A CAUTION The power supply line must be equipped with a connection box that ensures a constant connection. It must not be possible to connect the unit to the power supply without using a tool. The unit must be protected against any accidental disconnection. If other units are installed on the same line, interference and voltage fluctuations can cause the radiological unit to operate abnormally. We strongly recommend that a separate electrical line be dedicated to supply power to the KODAK 9000 and KODAK D unit. This line should be protected by a circuit breaker with a maximum current of: 16 A at 230/240 V 20 A at 110/130 V A differential circuit breaker of 30 ma KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

26 Electrical Requirements Figure 4 1 Electrical Diagram of the X-ray Room and Connections G L N L 1A 5 N RJ45 K9000C 8 L N bis 9 L N General mains 7bis X-ray warning lamp connecting terminal 2 Differential circuit breaker 8 Column connecting terminals 3 Red color actuator emergency stop push-button 9 X-ray remote control 4 Red color actuator emergency stop push-button 10 Door safety switch 5 Red warning lamp, power ON indicator 11 Mains outlet (for electric tools) 6 Unit mains connecting terminal 12 Ethernet outlet (RJ45/1) 7 Green warning lamp, ready state indicator 13 Contactor 4 4 SITE PREPARATION BEFORE INSTALLATION

27 Electrical Requirements A single-phase alternating current power supply is required. The electrical installation specifications should be as follows: Table 4 2 Electrical Installation Specifications Supply Voltage 230V/240V 100V/110V/ 130V Frequency 50/60 Hz 50/60 Hz Electrical supply 6 kw 6 kw Line current required Cable cross-section according to length 16A For 30 m: 2.5 mm2 20A For 10 m: 2.5 mm2 Max. line impedance Differential circuit breaker (2) Maximum current to trip circuit breaker 30 ma 30 ma 16A 20A Protect the power supply line with a differential circuit breaker that trips at maximum current. Specifications of 2 red color actuator emergency stop push-button (3) and (4) 250V 6A UL listed 250V 6A UL listed Install these stop push-buttons to simultaneously, switch off the current to the active conductors of the radiological installation and exclude any other electric equipment. Locate (3) inside the x-ray room, near the unit, for the operator to quickly cut the power supply if necessary. Locate (4) outside the x-ray room, near the x-ray remote control for the operator to quickly cut the power supply if necessary. Maintain them in OFF (open) position until a deliberate action is performed. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

28 Electrical Requirements Table 4 2 Electrical Installation Specifications (Continued) Specifications of the warning lamps (5) and (7) 60 W 60 W Locate the red warning lamp (5) outside the x-ray room to indicate the unit is active (1 lamp at each access point). Locate the green warning lamp (7) outside the x-ray room to indicate the ready state of the unit for acquisition. Contactor (13) 16A-250V UL listed 20A-250V UL listed Door Safety Switch (9) 1A / 250V 1A / 130V Optionally, connect the door safety switch (9) that deactivates the x-ray remote control if the door remains open. Use the following switches: Emergency Stop Switch: Manufacturer: Cutler-Hammer Ref: E22AT111 E22AT112 Contactor: Manufacturer: Telemecanique Ref: LC1 D4011 F6 (110/130 V - 60 Hz) P5 (230/240 V - 50 Hz) U6 (230/240 V - 60 Hz) IMPORTANT If you cannot use the above manufacturer devices, use an equivalent emergency switch and contactor in the UL list with the same specifications. For more information, see UL clause SITE PREPARATION BEFORE INSTALLATION

29 X-Ray Room Requirement X-Ray Room Requirement IMPORTANT Use an appropriate wall fixing system suitable for the type of wall construction. See the examples below. The following illustrations provide examples of wall types and fixations. 2 x 2 x 16 mm 16 mm 2 x 2 x 16 mm 16 mm Table 4 3 X-Ray Room Requirements Room Components Minimum Requirement Comments Width of the door 75 cm (30") Height of the ceiling 240 cm (95") If needed, a shorter column is possible by special order. Strength of the wall Withstanding an extraction force of 150 kpa at each point of attachment. It is the responsibility of the installer to choose an appropriate fixing system that withstands the extraction force. Load-bearing capacity of the floor 500 kg/m2 The floor must be solid and flat. Required space for the KODAK 9000C and KODAK 9000C 3D unit 1500 (L) x 2000 (D) x 2400 (H) mm IMPORTANT Install the unit where a minimum amount of space is provided to allow easy access for the patient or the maintenance technician (see Figure 4-2). KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

30 X-Ray Room Requirement Figure 4 2 Minimum X-Ray Room Space Configuration for K9000C and K9000C 3D MINI 630 mm (24 103") 128 MINI 2230 mm (87 51 ") 64 RJ45/1 RJ45/ bis Red color actuator emergency stop push-button 9 X-ray remote control 4 Red color actuator emergency stop push-button 10 Door safety switch 5 Red warning lamp, power ON indicator 11 Mains outlet (for electrical tools) 6 Unit mains connecting terminal 12 Ethernet outlet (RJ45/1) 7 Green warning lamp, ready state indicator 13 Local Area Network (LAN), (RJ45/2) 7bis X-Ray warning lamp connecting terminal WARNING You MUST prepare the appropriate electrical requirements and configurations of the x-ray room before installing the unit. You MUST locate separately the following low voltage and high voltage connections: - Low Voltage: (12), (9), (10) - High Voltage: (6), (5), (7bis) 4 8 SITE PREPARATION BEFORE INSTALLATION

31 PC System Requirements PC System Requirements This section specifies the minimum PC system requirements for KODAK 9000C and KODAK 9000C 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 and KODAK D software. If necessary you MUST update your PC system configuration. KODAK 9000C and KODAK 9000C 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 standard. IMPORTANT For KODAK 9000C, you can use the Viewing graphic board configuration for acquisition. Table 4 4 Minimum PC System Requirements Item Viewing Acquisition * Comments CPU 2 GHz Intel Duo Core 3 GHz Intel Pentium 4 RAM 2 GB 2GB RAM has a major impact on system performance. Hard disk drive 1.2 GB for software installation 1.2 GB for software installation Graphic board 80 GB free space to use the software Nvidia / ATI based board supporting Open Glide 1.2 with 256 MB of video RAM on AGP x8 video bus (example: Nvidia GeForce 6800 GT) Nvidia board on PCI Express video bus, minimum GeForce 8800 GT 512 MB of video RAM, or Quadro FX MB of video RAM The video RAM has major impact on system performance. Monitor 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 Windows Vista 32 bits 1 monitor 17" 1280 x 880 minimum screen resolution Windows XP Home / Pro edition SP2 Your monitor is a vital component in displaying quality images. Low-quality screens will prevent you from proper diagnoses and treatment. Ethernet interface 1 Ethernet interface 2 Ethernet interfaces (100Mbits) CD/DVD drive A CD-ROM drive is required to install the product. A CD-ROM drive is required to install the product. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

32 PC System Requirements Table 4 4 Minimum PC System Requirements (Continued) Item Viewing Acquisition * Comments Backup Media Removable/portable, external hard disk drive Removable/portable, external hard disk drive. We strongly recommend a daily backup of x-ray images and patient records. * For the KODAK 9000 (panoramic) acquisition, you need only the Viewing graphic board configuration SITE PREPARATION BEFORE INSTALLATION

33 Chapter 5- INSTALLING THE CEPHALOSTAT Tool Requirements The installer must supply the following tools: Power drill Screws and heavy duty fixings Spirit level Measuring tape Cutter Metric Allen keys Metric spanners IMPORTANT The tool references mentioned in this manual are ISO tool references. Technical Staff Requirements The installation requires the following number of technicians: Unit Component Technicians Arm 2 Head 2 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

34 Opening the Box Opening the Box Before opening the cephalostat assembly box make sure that you have the required tool. To open the cephalostat assembly box, follow these steps: 1. Remove the upper cardboard from the packaging. DO NOT cut through the cardboard. 2. Remove the cephalostat arm. 3. Remove gently and set aside the cephalostat head cover. 4. Remove the protection elements. Lift off the packaging carton. 5. Remove gently the cephalostat head from the transport support and place it on the ground. 6. Remove the other accessories. 5 2 INSTALLING THE CEPHALOSTAT

35 Installing the Cephalostat Unit Installing the Cephalostat Unit WARNING You MUST comply with the standards currently in force while installing and using the radiological unit. Whenever necessary, you MUST use a shield or wear a lead-lined apron. ONLY an approved Trophy technician is qualified to inspect or maintain the unit while it is switched on and while the covers are removed. In this case, NO unqualified person must approach the unit. Before installing the cephalostat unit, make sure that: The unit is switched off. All the unit covers are removed. You have the required tools. IMPORTANT If you install the cephalostat at a later date than the KODAK 9000 and KODAK D, then you need to install the cephalostat Frankfort positioning laster and the cephalostat positioning locker. To install the cephalostat unit, follow these steps: Installing the Cephalostat Arm 1. With the help of 1 person, position the cephalostat arm on the rear of the mobile component of the column. To attach the arm, insert and then tighten the fixing screws (A) and (B). A B 13 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

36 Installing the Cephalostat Unit 2. Turn and lift the elbow tube (A) to the height adjustment sign (B). Tighten the fixing screws of the elbow tube (A). B A 4 mm 3. Bind together the cables (B) emerging from the elbow tube (A) with adhesive tape and slide them inside the tube to avoid any damage while installing the cephalostat head. A A A B B B 5 4 INSTALLING THE CEPHALOSTAT

37 Installing the Cephalostat Unit Installing the Cephalostat Head 4. With the help of 1 person, lift the cephalostat head and insert the elbow tube (A) inside the elbow tube clamps (B). 5. Insert the elbow tube (A) as far as the height adjustment sign (C). Screw the fixing screws but do not tighten them. 6. Correctly position the cephalostat head using a spirit level (D) placed on the side of the cephalostat head. Tighten the fixing screws. A C B D 6 mm KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

38 Installing the Cephalostat Unit Wiring the Cephalostat Head 7. Pull the cables out of the elbow tube (A). Remove the adhesive tape. Connect the following wiring in the following order: Cable... On the... To... (B) 967/CJ653/J10 Power supply board CN1 (C) Green and yellow cable Next to power supply box Ground screw (D) Ethernet Pano (with ferrite) Control box Pano (E) Ethernet Workstation (with ferrite) Control box Workstation (F) 964/CJ732/J29 (with ferrite) Control box Synchro B C D A F E 2.5 mm 5 6 INSTALLING THE CEPHALOSTAT

39 Installing the Cephalostat Unit Wiring the Cephalostat to the Unit Head 8. Pull the cables out of the cephalostat arm. Pass the cables through the opening in the column and attach them with a cable tie to avoid cable wear due to usage as shown in the figure below. Connect the wiring in the following order: Cable... On the... To... (A) 967/CJ653/J10 CJ653 J10 (B) Ethernet Pano Ethernet Pano (C) Ethernet Workstation Ethernet Workstation (D) 964/CJ732/J29 CJ732 J29 B CJ699 CJ653 J4 LF440 J6 J10 A J5 CJ653 C CJ732 J15 J28 J29 D CJ732 J14 J21 J18 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

40 Installing the Cephalometric Frankfort Positioning Laser (For Upgrade Only) Installing the Cephalometric Frankfort Positioning Laser (For Upgrade Only) To install the cephalometric Frankfort positioning laser, follow these steps: 1. Unscrew and remove the generator front cover. 2. Position correctly the cephalometric Frankfurt positioning laser and screw the fixing screws. 3. Connect the cable LASER CEPH on the CJ732 board to the J28 LASER CEPH connector. Attach the cable with a cable tie. 4. Turn on the unit. On the control panel, click to turn on the positioning laser beams. Make sure that the cephalometric Frankfurt positioning laser beam is projected in the middle of the ear cone. If needed, adjust the laser using the fixing screw of the laser. x2 2.5 mm x2 5 8 INSTALLING THE CEPHALOSTAT

41 Installing the Cephalostat Positioning Locker (For Upgrade Only) Installing the Cephalostat Positioning Locker (For Upgrade Only) To install the cephalostat positioning locker, follow these steps: 1. Position correctly the cephalostat positioning locker and screw the fixing screws. 2. Insert the inductive sensor s tip of the cable 982/CJ822 in the hole (A). Connect the cable connector 982/CJ822 on J3 (B). IMPORTANT When the installation of the unit is complete and the unit is turned on, the LED on the inductive tip must lit. If the LED is not lit you must insert more the tip to create the necessary electric contact. 3. From the CJ804 collimator board, solder the power supply cable 981/CJ804/J2 to the cephalostat positioning locker, with cables: Brown to - (C) Red to + (D) 4. From the CJ804 collimator board, connect cable 980/CJ804/J1 to 980/CJ732/J23 on J23 (E). B CJ699 LF440 D CJ653 C A CJ732 E KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

42 Post-Installation Control Post-Installation Control Before the post-installation control, check that: The installation of the unit is complete. The installation of the KODAK dental imaging software is complete. You have the test tool. The unit is on. WARNING You MUST correctly calibrate the rotative arm of KODAK 9000 or KODAK D. If the arm calibration is not correctly executed the cephalometric mode will not be operational. (see KODAK 9000 and KODAK D Service Guide (SM712) Ed02, Using the Technical Menu, Calibration procedures, Arm Calibration ) Adjusting the Cephalostat Head Adjusting the Inclination of the Cephalostat Head To adjust the cephalostat head inclination, follow these steps: 1. Position the head clamps in a frontal AP position. 2. Access the Cephalometric Acquisition Window. In the Program pane: Click. Click for a 30 x 30 format INSTALLING THE CEPHALOSTAT

43 Post-Installation Control 3. Launch an x-ray using the x-ray remote control. The head clamps must be correctly and vertically positioned on the acquired x-ray image. Check that the blade is parallel to the image border. 4. If needed, adjust the cephalostat head mechanically using the elbow tube for horizontal inclination of the cepahlostat head. Untighten the fixing screws (A) slightly. Use the fixing screws (B) to adjust the horizontal inclination. Tighten the fixing screws (A) when you have reached the desired adjustment. IMPORTANT DO NOT adjust using the blade collimator. If necessary, adjust using the cephalometric head. 2.5 mm 4 mm x4 A B x1 A B x1 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

44 Post-Installation Control Adjusting the Height of the Cephalostat Head To adjust the height of the cephalostat head, follow these steps: 1. Position the head clamps in a lateral position. 2. Access the Cephalometric Acquisition Window. In the Program pane: Click. Click for a 30 x 30 format. 3. Launch an x-ray using the x-ray remote control. 4. In the Imaging Window, on the drawing toolbar, click. On the acquired image, draw a line from the bottom of the image to the center of the ball (ear cone). The resulting value must be: Height: between 800 and 900 pixels (between mm and 114.5mm if calibrated at the nasion support reference plane). Length: between 800 and 900 pixels (between mm and 114.5mm if calibrated at the nasion support reference plane). 800 L 900 pixels 800 H 900 pixels 5 12 INSTALLING THE CEPHALOSTAT

45 Post-Installation Control 5. If needed, adjust the height, using the cephalostat arm screws (A). Untighten slightly the screws (A) and lift the cephalostat head to the correct height. Tighten the cephalostat arm screws (A). x4 A KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

46 Post-Installation Control Adjusting the Ear Cones Alignment To adjust the ear cones alignment, follow these steps: 1. Position the head clamps in a lateral position. 2. Access the Cephalometric Acquisition Window. In the Program pane: Click. Click for a 30 x 30 format. 3. Launch an x-ray using the x-ray remote control. The ear cone ball (A) must be at the center of the head clamps circle (B). 4. In the Imaging Window, on the drawing toolbar, click. On the acquired image, draw a line from the center of the ball (A) to the center of the circle (B). The resulting value must be ±10 pixels. B +10 pixels A 5 14 INSTALLING THE CEPHALOSTAT

47 Post-Installation Control 5. If needed, adjust the cephalostat head mechanically: For a horizontal adjustment, use the cephalostat arm screws (A) and (B) For a vertical adjustment, use the elbow tube clamps screws (C). C C x4 A x1 B A B x1 2.5 mm 4 mm 4 mm Adjusting the Nasion Support To adjust the nasion support, follow these steps: 1. Lower the nasion support to a vertical position. 2. Access the Cephalometric Acquisition Window. In the Program pane: Click. Click for a 30 x 30 format. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

48 Post-Installation Control 3. Launch an x-ray using the x-ray remote control. The nasion support must be perpendicular to the ear cones. 4. In the Imaging Window, on the drawing toolbar, click. On the acquired image, draw a perpendicular line between the center of the ear cones and the nasion support holes to check that the nasion support is positioned vertically. 5. If needed, adjust the nasion support, using the nasion support fixing screws (A). A 2 mm 5 16 INSTALLING THE CEPHALOSTAT

49 Post-Installation Control Selecting the Cephalometric Blade Collimator Parameters To select the cephalometric blade collimator parameters, follow these steps 1. From the fixed arm, on the control panel, on press and hold and at the same time, until you see Collimator Calibration Parameters displayed on the Display Screen of the control panel. 2. Press to enter the sub-menus. The following sub-menus are displayed: Pano: Panoramic parameters Ceph: Cephalometric parameters 3D: 3D parameters 3. Press to select Ceph. The following parameters are displayed: ORG: ORG X and ORG Y DIM: DIM X and DIM Y Facing the digital sensor: A is the left blade B is the right balde C is the top blade D is the bottom balde + Dim Y C A B + Org Y Org X + + Dim X D KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

50 Post-Installation Control 4. On : Press to decrease the parameters. Press to increase the parameters. Press to modify the parameters. 5. When the parameter selection is finished, press to save the selection. 6. Press until you see Collimator Calibration Parameters menu. 7. Press to see the Exit menu. The following sub-menus are displayed: Exit and save Exit without saving 8. Press to select Exit and save. Press to save and exit INSTALLING THE CEPHALOSTAT

51 Post-Installation Control Calibrating the Cephalometic Blade Collimator To calibrate the cephalometric blade collimator, follow these steps: 1. Access the Cephalometric Acquisition Window. In the Program pane: Click. Click for a 30 x 30 format. 2. Launch an x-ray using the x-ray remote control. A white margin must be displayed on all sides of the acquired image. The acquired image must be correctly centered. 3. If needed, reselect the cephalometric blade collimator parameters and relaunch the x-ray until you obtain the correct margins (see Selecting the Cephalometric Blade Collimator Parameters). NOTE This calibration is for all image formats. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

52 Post-Installation Control Checking the Image Quality To check the image quality, follow these steps: 1. Raise the nasion support. 2. Open the head clamps. 3. Position the image quality phantom (A) at the center of the digital sensor. A 4. Access the Cephalometric Acquisition Window. In the Program pane: Click. Click for a 30 x 30 format. 5. In the Parameter pane, select: 64 Kv 15 ma 0.4 s 6. Launch an x-ray to acquire an image INSTALLING THE CEPHALOSTAT

53 Post-Installation Control 7. In the Imaging Window, on the acquired image, zoom on the value grid (B) of the image quality phantom (A). The resulting value clearly visible must be minimum 2.5 (right, left, center and bottom). Check that there is no spliting lines of the grid of the image quality phantom. B B 8. Save the image. Use this image as reference for a later image quality verification. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

54 Fitting the Covers Fitting the Covers WARNING Before fitting the covers, you MUST switch off the unit. Fitting the KODAK 9000C and KODAK 9000C 3D Covers To fit the KODAK 9000C and KODAK 9000C 3D covers, follow these steps: 1. Fit the upper cover (A) on the column. Fit the cover on the wall-bracket (B). Fit the cover on the column connecting terminal (C) and tighten the fixing screws. L 4 x M5x mm 3 mm 1 x 1 x M5x20 M5x20 A 2 x M5x50 B 3x M4x8 J 1 x M5x20 1 x M5x20 D H 2 x M5x50 3x M4x8 E C 2 x M5x12 3 x M5x12 F K G 4 x M5x INSTALLING THE CEPHALOSTAT

55 Fitting the Covers 2. Switch ON the unit. To fit the protection plates (D) and (E), press and hold to position the rotative arm so that from above the unit head, you can see the 3 screw holes on each side of the rotation axe. 3x M4x8 3x M4x8 D E 2.5 mm IMPORTANT Make sure that you slide the protection plate side with the indention for the fixing screws towards the top. 3. Switch OFF the unit. From below the unit head, slide the protection plate (D) between the rotation axe and the unit head. From above the unit head, access and tighten the accessible fixing screws. Switch ON the unit. Press and hold to position the rotative arm so that you can access the inaccessible fixing screw. Switch OFF the unit. Access and tighten the fixing screw. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

56 Fitting the Covers 4. From below the unit head, slide the protection plate (D) between the rotation axe and the unit head. From above the unit head, access and tighten the accessible fixing screws. Switch ON the unit. Press and hold to position the rotative arm so that you can access the inaccessible fixing screw. Switch OFF the unit. Access and tighten the fixing screw. 5. Fit the 2 under the head covers (F) and (G) under the head and tighten the fixing screws. 6. Fit the right side column cover (H), position and attach the ON/OFF button to the cover securely with the fixing screws. 7. Fit the left side column cover (J) on the column and tighten the fixing screws. 8. Fit the inside column cover (K) to the column and tighten the fixing screws. 9. Fit the head cover (L) of the unit to the head chassis and tighten the fixing screws. You can switch on the unit now INSTALLING THE CEPHALOSTAT

57 Fitting the Covers Fitting the Cephalostat Covers To fit the cephalostat covers, follow these steps: 1. Fit the cephalostat end of the arm cover (A) and screw the fixing screws. 2. Fit the cephalostat head side covers (B) and screw the fixing screws. 3. Fit the cephalostat head top cover (C) and screw the fixing screws. C 4 x M5x12 A 2 x M5x16 B 5 x M5x12 KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed

58 Fitting the Covers 5 26 INSTALLING THE CEPHALOSTAT

59 Chapter 6 Maintenance Annual Maintenance We recommend that a general inspection of the unit should be carried out every year by an approved dental systems technician. The inspection should cover the following points: Check the attachment points to the floor and the wall. Check all the mobile components of the unit. Check the x-ray generator. Check the alignment of the x-ray. Make an image acquisition with the test tools and check the image. Check the focal trough and the symmetry. Check the degree of legibility of the labels. Check for damage to cables, covers, oil leaks, etc. If the results of any of these inspections are unsatisfactory, refer to the Service Manual in order to rectify any problems. If there is any doubt, do not operate the unit. KODAK 9000C and KODAK 9000C 3D Extraoral Imaging System Installation Guide (SM714)_Ed