1. Manuals
  2. Brands
  3. NewTom Manuals
  4. Medical Equipment
  5. VG
  6. User manual

NewTom VG User Manual

Cone beam 3d
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Cone Beam 3D
VG User Manual
Rev. 4.4 - January, 13 2011

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the VG and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for NewTom VG

Summary of Contents for NewTom VG

  • Page 1 Cone Beam 3D VG User Manual Rev. 4.4 - January, 13 2011...
  • Page 2 QR s.r.l. The original version of this manual has been written in English language. NEWTOM™ VG is a commercial trademark of QR s.r.l. All other products and brand names are registered trademarks or trademarks of their respective companies.
  • Page 3 MANUFACTURER’S NOTICE ABOUT MEDICAL DEVICES: The medical device described in this manual, composed by Scan Unit (gantry), patient support (patient table) and Control, display and computation unit (Main Workstation) as delivered and configured by the manufacturing and servicing personnel, is a medical radiological device subject to the safety requirement stated by both international standards and local regulation.

  • Page 4: Table Of Contents

    Index INDEX INTRODUCTION TO THIS MANUAL ......................5 1.1 C ..............................5 ONTENTS 1.2 S ............................... 5 TRUCTURE 1.3 S ..........................7 TYLE CONVENTIONS 1.4 A ......................... 7 BOUT USING THIS MANUAL ABOUT SAFETY ............................8 2.1 G ..........................8 ENERAL SAFETY RULES 2.2 T ...........................
  • Page 5 Index 6.1.2 Positioning the patient and starting a new scan ................33 6.2 S ..........................35 CANNING A DENTURE 6.2.1 Preliminary operations........................35 6.2.2 Denture positioning ......................... 35 QUALITY ASSURANCE .......................... 36 7.1 P ..........................36 HANTOM POSITIONING 7.2 S ............................

  • Page 6: Introduction To This Manual

    Scanning 1 Introduction to this manual 1.1 Contents This manual was created as a mean to provide information and instructions about using a NewTom VG device. Dedicated software routines (scan, data processing, reporting, document management) and their user instructions are described in the attached Software Manual.
  • Page 7 Introduction to this manual  Scanning): describes the process for patient's positioning and scanning.  Chapter 7 (Quality assurance): gives instructions about executing the Quality Assurance process.  Chapter 8 (Troubleshooting): a list of faults and suggestions about their resolution. ...

  • Page 8: Style Conventions

    Introduction to this manual 1.3 Style conventions Primary information about safety and possible notes are included in this manual in the following form: DANGER: It alerts for a potential danger which may cause injury or death of a person. WARNING: It signals the presence of a potential danger which may damage the device.

  • Page 9: About Safety

    This chapter includes information about safety that must be learnt by the user before using the device. For a proper use of a NewTom VG device, the operator needs to have in-depth knowledge of the mode of operation and of the related controls.

  • Page 10: Turning The Device Off

    Scanning  Scanning" Local laws Carefully follow every requirements about installation and maintenance of the device. Please refer to the local laws whenever these may be more strict than the instructions inside this manual. Switching on and off of the device Turning the device on and off must be performed according to the procedures described inside this manual (see 2.2 "Turning the device off"...

  • Page 11: Emergency Shutdown

    Scanning WARNING: Turn off the device when it has not been used for longer than 3 hours. WARNING: Always turn the device off at the end of the working time. 2.3 Emergency shutdown The device is supplied with two emergency buttons. A first button is placed on the user's table (see figure), whereas the second one is by the main switch, on the control box.

  • Page 12: Patient's And User's Safety Guidelines

    2.4.3 Protection from ionizing radiation WARNING: NewTom VG is a radiological device and therefore it exposes operators and patients to the risks consequent to the exposure to ionizing radiation. It must be used according to safety rules that are contemplated by the local laws regarding this matter.
  • Page 13 Scanning Devices displaying the emission The x-ray emission is signalled by: 1. A signal on the workstation screen such as the one reported below. It appears on video just after the START command been sent keyboard mouse (see Chapter " Rev.4.4 - January, 13 2011 Page 12 of 75...
  • Page 14 Scanning 2. Scanning"). It is displayed all along the scan process. 3. Light indicators (LEDs) inside the control panels. They can be found on the sides of the Scanner Unit. They light on just after the START command has been sent via keyboard or mouse (see Chapter 1 " Rev.4.4 - January, 13 2011 Page 13 of 75...

  • Page 15: Laser Exposure (Applies To Devices With Positioning Laser Beam)

    About safety 4. Scanning"). They stay on all along the scan process. WARNING: If the x-ray emission signals are on when the specific command has not been sent or if they are off after a START emission command or if the x-ray emission does not stop after the supposed time, IMMEDIATELY TURN THE DEVICE OFF and contact technical assistance.

  • Page 16: Safety Notes

    2.6 Safety notes Workstations, displays, printers, keyboards and other devices which may be connected to the main NewTom VG workstation must comply with ISO and/or IEC and/or EN standards and/or local laws in force. QR srl is available for further information.

  • Page 17: Safety And Maintenance Of The Device

    Safety and maintenance of the device 3 Safety and maintenance of the device This chapter includes information about environmental safety and care for the device. General information and procedures regarding the device maintenance are also provided. The user is responsible for a proper use of the system, according to the instructions and procedures which are described inside this manual.

  • Page 18: Guidelines For Safety

    Safety and maintenance of the device 3.2 Guidelines for safety The device is not protected against liquid or gas infiltration. Liquid intrusion may damage the electrical parts and put the patient, the user and the environment in danger. Safety systems of the device do not decrease safety measures against the risk of fire in the place in which the device has been installed.

  • Page 19: Device Maintenance

    Safety and maintenance of the device 3.4 Device maintenance WARNING: Always turn the power off the device before any maintenance act. WARNING: The device has no repairable part inside. Never remove the device covers. WARNING: The only part that can be repaired by the user is the input fuse. It is placed in the input panel, on the control box side.

  • Page 20: Cleaning And Disinfection

    Safety and maintenance of the device Maintenance agreement The device should be periodically checked: please contact the manufacturer or distributor to discuss for a maintenance contract. System testing check list The following check list specifies the suggested time spaces for the system controls. For further information please contact Your local distributor.

  • Page 21: Disinfection

    Safety and maintenance of the device WARNING: Do not apply cleaning solutions directly on the device surface. 3.5.2.2 Workstation and peripherals Follow the manufacturer's instructions for cleaning the workstation and its peripheral units. If these are missing, please refer to the previous paragraph. To clean the display use a wet cloth with alcohol or a solution made up of 1/3 to 2/3 distilled water and alcohol.

  • Page 22: Device Disposal

    Safety and maintenance of the device 3.7 Device disposal 3.7.1 Information for the device owner This symbol, on a device label, shows that the product can not be disposed along with other urban garbage. The separate collection of this equipment at the time of disposal is managed by the dealer. When disposing the equipment the user should contact the dealer and follow the suggested procedure to allow the separate collection and recycling of this equipment at the time of disposal.

  • Page 23: Getting Started

    Getting started… 4 Getting started… This chapter provides a brief introduction for the NewTom VG system, its power on and off routines and control devices. 4.1 An introduction to the system The device NewTom VG is a panoramic 3D system, dedicated to dento-maxillo-facial area imaging. It performs the so called "cone-beam"...

  • Page 24: Overall View

    Getting started… 4.3 Overall view The system is made up of three main parts: scanner unit, control box and main workstation. It is also possible to add more workstations for data processing and storage. This subject is discussed in the Software Manual.

  • Page 25: Scanner Unit

    Getting started… 4.4 Scanner unit 4.4.1 Controls placed on the scanner unit The scanner unit is the main part of the system, it performs the scan. Two control panels are placed on the columns side. They have the same appearance and function: the control of the positioning movements, the light display of the x-ray source emitting state and the control of the positioning laser beam.

  • Page 26: Control Box

    Getting started… 4.5 Control box The control box contains the electronics devices that manage the functioning of the system. 4.5.1 Main switch On the external surface of the control box You can find the main switch to turn the system on/off and the fuse support.

  • Page 27: Standard Accessories

    Getting started… 4.6 Standard accessories Along with the device some standard accessories are supplied. They are: Head support: it is fixed to the scanner unit. It makes possible for correct patient's positioning and prevents excessive movement of the patient during the scan. QA phantom: used for the execution of the quality assurance procedure.

  • Page 28: Cables

    Accessories, transducer and cables different from the ones here specified may change the electromagnetic compatibility characteristics of the device. 4.7 Optional accessories At the present time there are no optional accessories for a NewTom VG system. Rev.4.4 - January, 13 2011 Page 27 of 75...

  • Page 29: System Startup

    Getting started… 4.8 System startup To properly turn the device on: 1. Power the scanner unit on with the main switch (on the control box). 2. Turn on the workstation. (Please refer to its manual). 3. Wait for the workstation operating system to startup. 4.

  • Page 30: Preliminary Procedures

    Scanning 5 Preliminary procedures This chapter describes the procedures to perform compulsorily before starting scanning patients. These procedures are three:  X-Ray source conditioning;  Daily check;  Blank acquisition; This chapter describes also some required and/or useful functions:  Beam limiter test ...

  • Page 31: Blank Acquisition

    Scanning 5.3 Blank acquisition Blank acquisition allows to optimize the scan performance acquiring a background image. This procedure is request by the software every two weeks. REMOVE Before starting the procedure, please verify that the scan area is completely free from objects. Remove the head support.

  • Page 32: Beam Limiter Test

    Scanning 5.4 Beam limiter test NOTE: This procedure applies only to devices with multiple FOV.  From the NNT software main toolbar select Tools Scanner Test. The service window will appear.  From the service window toolbar select the Tools Beam Limiter Test.

  • Page 33: Scanning

    Scanning 6 Scanning This chapter describes the procedures to follow for a proper patient's or denture positioning and examination. The exact procedure to perform a scan on a patient or on a denture can be found in the corresponding chapter inside the Software Manual. Please also refer to: Chapter 2 "About safety";...

  • Page 34: Positioning The Patient And Starting A New Scan

    Scanning Relaxation Ask the patient to keep the mouth closed without grinding the teeth together. Avoiding delays Good examination times can be obtained also by carrying out all the preliminary procedures before starting the scan itself. Voice instructions Introduce the patient possible voice instructions that the operator may give during the scan. 6.1.2 Positioning the patient and starting a new scan Hereafter is a description of how to position and center a patient inside the scan area.
  • Page 35 Scanning Rotate the arm by mean of the side panels buttons, making sure that the detector does not collide with the patient's shoulders, chair back (seated patient) or occiput. Using the vertical movement buttons move the device in till the patient feels fully comfortable in a natural posture.

  • Page 36: Scanning A Denture

    Scanning Adjusting the position The position of the patient can be verified through the use of the LL (lateral - lateral) and AP (anterior - posterior) scout views. 6.2 Scanning a denture 6.2.1 Preliminary operations Data about the denture are to be inserted, if they are not already in the software database. For details refer to the Software Manual.

  • Page 37: Quality Assurance

    Quality assurance 7 Quality assurance The quality assurance process consists in performing a routine scan on the specific phantom, through an automated procedure. It is recommended to perform such a test at least once a week, in order to assure the proper functioning of the device and the validity of a scan results.
  • Page 38 Quality assurance Place the QA phantom on its base in a central position. The first displayed scout view represents the phantom as seen by the scanner in the start position. Using this reference one can center the phantom in the direction perpendicular to the rotating arm. Repeat this step as many times as necessary (the aluminium cylinder should appear between the vertical sketched red lines, also see the Software...

  • Page 39: Sample Images

    Quality assurance 7.2 Sample Images Hereafter some sample images from a QA phantom analysis. Side view. Axial view. Panoramic view. 7.3 Storage of QA data The software automatically stores each phantom analysis report. The reports can be opened by selecting ...

  • Page 40: Troubleshooting

    Troubleshooting 8 Troubleshooting The following tables list problems that may occur and quick instructions to follow to solve them. If the "What to do…" column lists more than a solution, please try with the first one and so on till the problem full resolution.

  • Page 41: Iec61223: Acceptance Test

    Not applicable. 9.2 Patient positioning accuracy [paragraph 5.2] The NewTom VG (version Zoom/HiRes) is equipped with cross-shaped laser pointer aimed to help the patient positioning. The horizontal line locates the scanned volume central axial plane, the vertical line locates the scanned volume central sagittal plane. No location pointer has been provided for coronal plane location.

  • Page 42: Iec 61223-3-5 Reference Table

    IEC61223: Acceptance Test 9.7 IEC 61223-3-5 reference table This table supplies reference values and reference conditions to be used when applying the IEC 61223-3-5 as acceptance test, when specified by contractual agreements. For 95kV and 110kV configuration: 5.1 Positioning of the patient N.A.
  • Page 43 IEC61223: Acceptance Test Loading factors: automatically selected by the software. 5.5 Noise, mean CT number and uniformity Values are calculated as Arbitrary Unit (a.u.) because of the machine is not designed to give HU. Measured with Catphan 500. Dose Mode: Standard Dose, Standard Voxel Full <...
  • Page 44 IEC61223: Acceptance Test For 95kV configuration: 5.4 Dose Loading factors: automatically selected by the software. CTDI N.A. FREE AIR CTDIvol Equal to CTDI 2.7 mGy 30% Full Mode CTDI 5.5 Noise, mean CT number Loading factors: automatically selected by the software. and uniformity Values are calculated like Arbitrary Unit (a.u.) as the machine are not planned in order to supply the Hounsfield Values (HU).

  • Page 45: Appendix A: Technical Reference

    APPENDIX A: Technical Reference APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 44 of 75...
  • Page 46 APPENDIX A: Technical Reference Scanner unit Scanning system (cone beam Single rotation and volumetric acquisition. technology) Mode: Time / X-Ray emission time: Scan parameters Full: 18 s / 3.6 s HiRes Zoom: 26.7 s / 5.4 s Zoom: 18 s / 3.6 s Sampling angle 360°...
  • Page 47 APPENDIX A: Technical Reference Detector Pixels 1920 x 1536 m Pixel size 127 x 127 Pixel depth Frame rate Max Scout view radiological images Full mode: Image pixels 960 x 768 Pixels Pixel depth Pixel Size 0.254 x 0.254 HiRes Zoom mode: Image pixels 1536 x 960 Pixels...
  • Page 48 APPENDIX A: Technical Reference Reconstructed volume Full mode: Shape Cylinder Reconstructed Volume Size Ø15 x H10 Voxel Size 0.300 0.250 Image pixels 512 x 512 614 x 614 Pixels Pixel depth HiRes Zoom mode: Shape Cylinder Reconstructed Volume Size Ø12 x H6 Ø11.5 x H6 Voxel Size 0.150...
  • Page 49 APPENDIX A: Technical Reference Radiological parameters TUBE IAE mod. x22 0.3/0.6 Rev.4.4 - January, 13 2011 Page 48 of 75...
  • Page 50 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 49 of 75...
  • Page 51 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 50 of 75...
  • Page 52 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 51 of 75...
  • Page 53 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 52 of 75...
  • Page 54 APPENDIX A: Technical Reference X-Ray tube CEI model OX110/15 Rev.4.4 - January, 13 2011 Page 53 of 75...
  • Page 55 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 54 of 75...
  • Page 56 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 55 of 75...
  • Page 57 APPENDIX A: Technical Reference Rev.4.4 - January, 13 2011 Page 56 of 75...
  • Page 58 APPENDIX A: Technical Reference X-ray tube head Brand P.S.M. s.r.l. Modello HF1R HF1F X-ray tube IAE X22 0.3/0.6 CEI OX-110/15 Classification (IEC 601-1) Class I Type B Mechanical data Head material Aluminum Heat storage capacity 550 kJ Maximum continuos heat dissipation 60 W @ 110kV, 3.6 mA, 10 ms, 15 FPS Maximum temperature 3 60...
  • Page 59 APPENDIX A: Technical Reference Rotor HF1R HF1F Startup 230Vac / 0.8s / 10A n.a. Running 60Vac / 2A X-ray source assembly X-ray tube head HF1R HF1F X-ray tube IAE X22 0.3/0.6 CEI OX-110/15 Focal spot to image detector distance 630 mm 650 mm Focal spot to skin distance (minimum) 150 mm...
  • Page 60 APPENDIX A: Technical Reference Peak voltage 350 Vpk Maximum peak current 120 Apk Max. Wave form Sinusoidal 20 kHz MECHANICAL DATA Dimensions 160 x 280 x 235 mm Weight 7 kg Dose declaration CTDIw values declared for operative modalities of the device Values are expressed in mGy/scan.
  • Page 61 APPENDIX A: Technical Reference Measured in head phantom according to IEC 60601-2-44 par.29.1.102.2 Rev.4.4 - January, 13 2011 Page 60 of 75...
  • Page 62 APPENDIX A: Technical Reference Laser Note: Applies to devices with positioning laser beam Laser diode output power 0.9 mW Wavelength 635 nm Beam divergence 70º Pulse length Continuous wave Classification Class 1 Other data 200 V  ( 10%) / 215 V  ( 10%) / 230 V  ( 10%) / 240 V  ( 10%) Absorbed power 50/60 Hz (...
  • Page 63 Guidance and manufacturer's declaration - electromagnetic emissions The device NewTom VG is intended for use in the electromagnetic environment specified below. The customer or the user of the device NewTom VG should assure that is used in such an environment. Electromagnetic environment – guidance...
  • Page 64 TABLE: Guidance and manufacturer’s declaration – electromagnetic immunity The equipment NewTom VG is intended for use in the electromagnetic environment specified below. The customer or the user of the device NewTom VG should assure that is used in such an environment. Electromagnetic Environment –...
  • Page 65 RF transmitters, an electromagnetic site survey should be performed. If the measured field strength in the location in which the NewTom VG is used exceeds the RF compliance level above, the NewTom VG should be observed to verify normal operation. If abnormal...
  • Page 66 TABLE: Recommended separation distances between portable and mobile RF communications equipment and the equipment The device NewTom VG is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device NewTom VG can help prevent...
  • Page 67 CAUTION! NEWTOM VG should not be stacked directly on top of other equipment, and other equipment should not be stacked on top of NEWTOM VG. If stacking is necessary, observe NEWTOM VG to verify normal operation in the stacked configuration in...

  • Page 68: Appendix B: Standards Conformity

    APPENDIX B: Standards conformity APPENDIX B: Standards conformity Rev.4.4 - January, 13 2011 Page 67 of 75...
  • Page 69 APPENDIX B: Standards conformity The NewTom VG equipment has been built in conformity with IEC normative regarding safety of electric- medical devices of similar typology and, particularly, with the normative:  IEC 60601-1: 1988-12 Medical electrical equipment - Part 1: General requirements for safety ...

  • Page 70: Appendix C: Labels

    APPENDIX C: Labels APPENDIX C: Labels Rev.4.4 - January, 13 2011 Page 69 of 75...
  • Page 71 APPENDIX C: Labels PLATE ON THE DEVICE Location: lower part of the right side of the scanner unit. Rev.4.4 - January, 13 2011 Page 70 of 75...
  • Page 72 APPENDIX C: Labels PLATE ON THE CONTROL BOX QR s.r.l. – Via Silvestrini, 20 37135 Verona Italy +39 045 8202727 Model no: NewTom VG CONTROL BOX Serial Number : Manufactured : Power : 100 / 115 V ~ 10A 200 / 215 / 230 / 240 V ~...
  • Page 73 APPENDIX C: Labels LABEL ON X-RAY SOURCE X-Ray source with fixed anode X-Ray source with rotating anode Inverter Location: On the x-ray source and on the Inverter. Left side of the equipment near the Main Switch. Rev.4.4 - January, 13 2011 Page 72 of 75...
  • Page 74 APPENDIX C: Labels LABEL OF THE COMMERCIAL NAME OF THE DEVICE Location: centered frontally on the top cover of the scanner unit. Rev.4.4 - January, 13 2011 Page 73 of 75...
  • Page 75 APPENDIX C: Labels BEAM LIMITER BRASS PLATE (LARGE FIELD) QR s.r.l. – Italy P.N. 000114 S.N. ______________ 13 mm Al @ 70 kV Location: on the centre of the brass plate. SMALL FIELD BEAM LIMITER (applies to devices with multiple FOV) QR s.r.l.
  • Page 76 APPENDIX C: Labels WARNING LABELS ABOUT LASER (Applies to devices with positioning laser beam) CLASS 1 LASER PRODUCT Wavelenght:630-680 nm Max.Output<1mW CW IEC 60825-1:1993 + A1:1997 + A2:2001 APPARECCHIO LASER DI CLASSE 1 Lunghezza d’onda:630-680 nm Pot. Max.<1mW CW IEC 60825-1:1993 + A1:1997 + A2:2001 Location: Left side of the control box under the emergency button Rev.4.4 - January, 13 2011 Page 75 of 75...

Table of Contents