NewTom VG Series User Manual
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NewTom VG Series User Manual

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0051
97050869
Rev. 3
28.04.2017
EN

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Summary of Contents for NewTom VG Series

  • Page 1 0051 97050869 Rev. 3 28.04.2017...
  • Page 2 The original version of this manual is in Italian. NEWTOM™ VG is a trade mark of CEFLA s.c. All other products and trade names mentioned in this document are registered marks of the relevant manufacturers. INFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES The medical device referred to in this manual consists of a scanner and a control, display and calculation unit (Main Workstation).

  • Page 3: Table Of Contents

    Contents 1. INTRODUCTION TO THE MANUAL ......................... 5 1.1. CONTENTS ................................5 1.2. STRUCTURE ............................... 5 1.3. STYLISTIC CONVENTIONS ..........................5 2. SAFETY-RELATED INFORMATION ........................6 2.1. APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION ............6 2.2. SYMBOLS ON THE DEVICE ..........................7 2.3.
  • Page 4 5. PRELIMINARY OPERATIONS ..........................30 5.1. DAILY CHECK ..............................30 5.2. BLANK ACQUISITION ............................31 5.2.1. BLANK ACQUISITION INVALIDATION ...................... 32 5.3. BEAM LIMITER TEST ............................32 5.4. LOWERING THE ROTATING ARM COMPLETELY ..................33 6. SCANNING ................................34 6.1. SCANNING A PATIENT ............................. 35 6.1.1.

  • Page 5: Introduction To The Manual

    The routine software operation set for this device (scanning, data processing, reporting and document management) and the use instructions for the operator are dealt with in the “Acquisition Operations with NewTom VGi evo” annex to the "NNT User Manual" document.

  • Page 6: Safety-Related Information

    2. SAFETY-RELATED INFORMATION This chapter provides safety-related information the operator must become familiar with before using the device. To ensure the patient and the operator safety, always follow the instructions provided herein, especially as far as functional tests, electric and mechanic safety and X-ray emission protection are concerned. In this regard, refer to chap.

  • Page 7: Symbols On The Device

    2.2. SYMBOLS ON THE DEVICE The table below provides a description of the symbols on the device labels: Symbol Standard Description IEC 60417-5010 On / Off (pressure-pressure) IEC 60417-5032 Alternating current ISO 7000-0434A Warning ISO 7010-W001 General warning signal IEC 60878 Warning: hazardous voltage.

  • Page 8: Device Switching On And Off

    Symbol Standard Description IEC 60417-5638 Emergency stop. Head collision hazard. Original symbol required To avoid any collision, refer to par. 6.1.2 - "Positioning the patient and by IEC 60601-1 par. 9 starting the scanning" to position the patient in the correct way. 2.3.

  • Page 9: Safety Of Patient And Operator

    2.5. SAFETY OF PATIENT AND OPERATOR Work following the correct procedures and position the patient correctly to avoid risks for the patient and the involved operators. Pay special care in case of debilitated people or with traumas. 2.5.1. PATIENT POSITIONING Make sure the patient is correctly positioned in the scanning area, with the head on the chinrest and that no other part of the body can touch the device or risk to be squeezed during the positioning and the examination.

  • Page 10: Protection Against Ionizing Radiations

    2.7. PROTECTION AGAINST IONIZING RADIATIONS WARNING: NewTom VGi evo is an X-ray device and as such it exposes patients and operators to the risk deriving from ionizing radiations. It must be used in compliance with the safety standards set forth by the radiological protection standard in force in the country of use.

  • Page 11: Protection Against Laser Radiations

    2. A signal on operator console as shown below. Such signal is displayed on the operator console only after the X- ray emission is started by pressing START on the keyboard or using a mouse (refer to chap. 6 ”Scanning”) and remain visible for the entire scanning and/or emission duration.

  • Page 12: Devices Connected To The Control Console

    2.9. DEVICES CONNECTED TO THE CONTROL CONSOLE Any computer, monitor, printer, mouse, keyboard and any other device connected to the device control workstation MUST be compliant with the ISO and/or IEC and/or EN and/or local standards. Moreover, the workstation must be compliant with the IEC 60950-1 standard. For further information contact the Manufacturer.

  • Page 13: Device Safety And Maintenance

    3. DEVICE SAFETY AND MAINTENANCE This includes information on device and environment safety. It also provides general information and procedures concerning the system maintenance. The user is responsible for a correct use of the system, in compliance with the instructions and procedures provided in this manual.

  • Page 14: Safety Guidelines

    3.2. SAFETY GUIDELINES The device is not protected against liquid and spray penetration. The penetration of liquids can damage the electric and electronic components and generate hazardous situations for the patient, the operator and the environment. The device safety systems do not reduce the fire-fighting protections installed in the room where the device is used. •...
  • Page 15 The device must be exclusively repaired and maintained by personnel authorised directly by the manufacturer or the distributor. All components of the system must be checked and, if necessary, replaced by qualified personnel. WARNING: If the NewTom VGi evo unit has not been used to scan patients for longer than three months, please proceed with x-ray source forming process (see “Acquisition Operations with...
  • Page 16 Manager Component Activity Time interval Routing testing User Global system QA Phantom check Weekly Local Support Service Error log Check 12 months Every external part Damage check 12 months Emergency buttons Emergency test 12 months Electrical functioning Check 12 months Mechanical functioning Check 12 months...

  • Page 17: Cleaning And Disinfection

    3.5. CLEANING AND DISINFECTION WARNING: Always turn off the device before performing any cleaning operation WARNING: Cleaning is the first step of any disinfecting process. Physically scrubbing with detergents and surface-active substances and rinsing with water removes a considerable amount of micro- organisms.

  • Page 18: Hygiene Procedures For Patient Protection

    3.5.1. HYGIENE PROCEDURES FOR PATIENT PROTECTION Disposable hygienic protections are the main protection means against cross contamination between patients. In order to prevent the transmission of infectious diseases between patients, it is essential to always use disposable protections. Disposable protections are class I medical equipment and cannot be replaced with other protections having lower specifications.

  • Page 19: Device Disposal

    3.7. DEVICE DISPOSAL 3.7.1. INFORMATION FOR DEVICE OWNER This symbol on the device indicates that it must not be disposed of together with other urban waste but it is necessary to collect it separately. The separate collection of this equipment is organised and managed by the manufacturer. When it is necessary to dispose of this equipment, contact the manufacturer and follow the system that the manufacturer has adopted to allow the equipment separate collection.

  • Page 20: Starting Procedures

    4.1. INTRODUCTION TO THE SYSTEM 4.1.1. INTENDED USE The device NewTom VGi evo is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area.

  • Page 21: Improper Use

    Gently (www.imagegently.org) website or in FDA website for "Pediatric X-ray imaging". 4.1.3. IMPROPER USE The NewTom VGi evo device has not been designed for the following uses and/or applications (reasonably foreseeable improper use): – use with patients that cannot stand still during the entire scanning cycle (30 seconds max.);...

  • Page 22: Operation Principle

    The examination images can be used to write a report that can be printed and/or saved on electronic support. For further information, refer to the "NNT User Manual". 4.2. OPERATION PRINCIPLE In the "Cone-Beam" technology, the detector-tube system (conical X-ray beam and bidimensional detector) performs one rotation around the patient and acquires data necessary for the volumetric reconstruction.

  • Page 23: Scanner

    4.4. SCANNER 4.4.1. OPERATOR CONSOLE AND CONTROLS The scanner is the core part of the system. On the lateral supports (on the right or left side, as required) there is the operator console that allows moving the device and turning on the warning lamp that indicates the device switching on and the X-ray emission in progress. Following is a short description of each button on the device remote control: S Scanner movement selection button: it enables the button operation for the vertical movement and the arm rotation of the scanner.

  • Page 24: Scanner Movement

    4.4.2. SCANNER MOVEMENT After pressing the S button (Scanner movement selection button) the console screen will display the scanner image. Press the F1 / F2 arrows to move the unit up/down or F3 / F4 arrows to rotate the arm clockwise or counter- clockwise.

  • Page 25: Service Menu

    4.4.5. SERVICE MENU After pressing the M button (Menu selection button) the console screen will show the selection image of the information or service menu. By pressing the F3 / F4 arrows it is possible to position the selection red cursor under the service menu (marked by a spanner) and confirm with button E (Confirmation button).

  • Page 26: X-Ray Emission

    4.4.7. X-RAY EMISSION During the scanning process (when the system emits X-rays), the screen will show a page with a grey background and a yellow emission symbol. At the end of the emission, this page will automatically disappear. 4.5. CONTROL BOX 4.5.1.

  • Page 27: Standard Accessories

    4.6. STANDARD ACCESSORIES The device is provided with some standard accessories. The main accessories are listed below. Refer to the local distributor for the complete list of available accessories. Craniostat: Fixed to the scanner mechanical structure, it allows the correct positioning of the patient and avoids excessive movements of the patient during the examination.

  • Page 28: X-Ray Emission Remote Control

    4.6.1. X-RAY EMISSION REMOTE CONTROL The system is provided with a remote control to enable the X-ray emission, in compliance with the IEC60601-2-63 standard requirements. For its use, refer to the safety standards set forth by the radiological protection standards in force in the country of use.

  • Page 29: Cables

    4.7. CABLES The device is provided with cables for the connection of workstation/scanner and workstation/control box. I.e.: • Ethernet cable (4 pairs/26 AWG-FTP-Category 6) (Workstation / Scanner) • CAN bus cable (2 pairs/24 AWG shielded) (Workstation / Control box) In addition, there is a cable branch for the control of the scanner at the control box outlet. The manufacturer provides the supply cable with an end directly connected to the device.

  • Page 30: Preliminary Operations

    5. PRELIMINARY OPERATIONS • "Daily check"; • Blank image acquisition ("Blank acquisition"); This chapter describes the required and/or useful functions: • Beam limiter test • Rotary arm complete lowering The blank image must be acquired every 13 weeks, whereas it is compulsory to start the Daily check every day before starting patients' examinations.

  • Page 31: Blank Acquisition

    5.2. BLANK ACQUISITION The Blank Acquisition allows optimising the scanning performance through the acquisition of a background image. This procedure is automatically performed by the software whenever necessary. Before starting the procedure, make sure that the scanning area is completely empty. For this purpose, if not previously carried out, remove the chinrest structure.

  • Page 32: Blank Acquisition Invalidation

    5.2.1. BLANK ACQUISITION INVALIDATION This function is only available for the main workstations. To invalidate the blank acquisition, follow the instructions below: → From the NNT software, select “Scan” “Invalidate Blank”. Upon next selection of the acquisition FOV, the NNT software will request the next Blank acquisition.

  • Page 33: Lowering The Rotating Arm Completely

    5.4. LOWERING THE ROTATING ARM COMPLETELY This function is useful to fully lower the rotary arm. For instance, in case of mobile application, during the transport it is recommended to position the arm completely lowered. WARNING: Before using this function make sure that nothing obstacles the arm downward movement! To lower the rotary arm, follow the instruction below: →...

  • Page 34: Scanning

    The description of the scanning procedure is provided in the specific chapter of the document "Acquisition operations with NewTom VGi evo" attached to the "NNT User Manual". We also recommend referring to chapters 2-“Safety-related information" and 3 - "Device safety and maintenance"...

  • Page 35: Scanning A Patient

    To choose one of these modes, select the desired scanning mode (FOV) from the "Scan Manager" panel located at the bottom right of the NNT software main window: "Scan Manager" panel of the NNT software 6.1. SCANNING A PATIENT 6.1.1. PREPARING THE PATIENT The preparation of a patient for an examination is an important process that can contribute to the correct execution of the scanning and to obtain high-quality images.

  • Page 36: Craniostat Use

    6.1.2. CRANIOSTAT USE Craniostat components: 1 – Base 2 – Rods 3 – Chinrest 4 – Bite piece 5 – Bite piece block lever 6 – Cross member 7 – Front support 8 – Arms 9 – Anatomic arches 10 – Arms block levers 11 –...
  • Page 37 Please remember that, in order to remove it, it is necessary to take lever (5) to the unlocking position and to slide it out of its seat. The upper part consists of a cross member (6) that can slide vertically along the carbon rods (2).

  • Page 38: Positioning The Patient And Starting The Scanning

    Perform these operations when prompted by the software. The guidelines for patient positioning during examination of the different anatomic regions are outlined in the attached document “General guidelines for use of the protocols of NewTom VGi evo”. WARNING: The scanning area where the patient is positioned must be free of objects since they could injure the patient and/or invalidate the examination results.
  • Page 39 Adjust the scanner height through the suitable buttons on the console to reach the area to be scanned with the laser lines. Adjust the chinrest system height so as to bring it to the patient's chin height. Adjust the craniostat height (as indicated in par. 6.1.2 - “Craniostat use”). Tell the patient to position in the craniostat recommending him/her to: grab with his/her hands the handles on the chinrest structure;...

  • Page 40: Special Considerations For Children And Small Patients

    NewTom VGi evo is equipped with laser pointers and a special system that reads the 3D coordinates for the patient's support position, which helps the user to identify the best position for patients of different sizes before any radiation emission.

  • Page 41: Scanning A Prosthesis

    6.2.1. PRELIMINARY OPERATIONS Enter the patient's prosthesis data (if not already present in the software database). For further information, refer to the “Acquisition Operations with NewTom VGi evo” annex to the “NNT User Manual” document. 6.2.2. POSITIONING THE PROSTHESIS Following is a description of the operations to be performed to position and centre the prosthesis inside the scanning area.

  • Page 42: Quality Control

    Before starting scanning the phantom it is necessary to select the acquisition field. The test execution procedure is described in the “Acquisition Operations with NewTom VGi evo” annex to the “NNT User Manual” document. 7.1. PHANTOM POSITIONING Following is a description of the operations to be performed to position and centre the phantom inside the scanning area.

  • Page 43: Image Examples

    To centre the QA phantom from the front side use the second "scout view" obtained with the arm at 90 degrees. It is therefore possible to scan the phantom. For further details, refer to the “Acquisition Operations with NewTom VGi evo” annex to the “NNT User Manual” document. scout view.

  • Page 44: Troubleshooting

    8. TROUBLESHOOTING To solve device problems, refer to the “NNT – Error Guide” document. USER MANUAL...

  • Page 45: Appendix A: Technical Specifications

    9. APPENDIX A: TECHNICAL SPECIFICATIONS Scanner Scanning system (cone beam Single rotation and volumetric acquisition technology) Mode: Time / X-ray emission [24x19]: 15 s / 1.8 s [16x16]: 15 s / 1.8 s [15x12] 15 s / 1.8 s [15 x 5]: 15 s / 1.8 s [12x8]: 15 s / 1.8 s...
  • Page 46 [24x19]: Ø max 24 cm, h max 19 cm [16 x 16]: Ø max 16 cm, h max 16 cm [15x12]: Ø max 15 cm, h max 12 cm [15 x 5]: Ø max 15 cm, h max 5 cm [12 x 8]: Ø...
  • Page 47 X-ray image scout view [24x19] Image pixels 720 x 780 dots Pixel depth Pixel size 0.368 x 0.368 [16x16] Image pixels 540 x 678 dots Pixel depth Pixel size 0.368 x 0.368 [15x12] Image pixels 518 x 512 dots Pixel depth Pixel size 0.368 x 0.368 [15x5]...
  • Page 48 [10x5] HiRes Image pixels 820 x 432 dots Pixel depth Pixel size 0.184 x 0.184 [8x8] HiRes Image pixels 680 x 684 dots Pixel depth Pixel size 0.184 x 0.184 [8x5] HiRes Image pixels 680 x 432 dots Pixel depth Pixel size 0.184 x 0.184 [5x5] HiRes...
  • Page 49 [10x10] Shape Cylinder Reconstructed volume size Ø10 x H10 (max) Voxel size 0.300 0.250 0.200 Image pixels 344 x 344 412 x 412 516 x 516 dots Pixel depth [10x5] Shape Cylinder Reconstructed volume size Ø10 x H5 (max) Voxel size 0.300 0.250 0.200...
  • Page 50 [10x10] HiRes Shape Cylinder Reconstructed volume size Ø10 x H10 (max) Voxel size 0.150 0.125 0.100 Image pixels 688 x 688 672 x 672 672 x 672 dots Pixel depth [10x5] HiRes Shape Cylinder Reconstructed volume size Ø10 x H5 (max) Voxel size 0.150...
  • Page 51 X-ray Parameters IAE X-RAY TUBE mod. RTM 30 HS 0.3/0.6 (rotary anode) USER MANUAL...
  • Page 52 USER MANUAL...
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  • Page 58 MONO-BLOCK Make IMD s.r.l. Model HF1 R X-ray tube IAE RTM 30 HS 0.3/0.6 (part no. XRM.11.X51.001 / IRM.11.280.001) Classification (IEC 60-601) Class I Type B PHYSICAL DATA Sheath material Aluminium Heat capacity 550 kJ Maximum continuous thermal dissipation 60 W at 110kV, 3.6 mA, 10 ms, 15 FPS Maximum temperature 60°...
  • Page 59 X-ray generator-tube-sheath assembly Mono-block Model HF1 R X-ray tube IAE RTM 30 HS 0.3/0.6 Source-detector distance 721 mm Source-skin distance (minimum) 150 mm Total filtration 1.4 mm Al (Inherent filtration) + 10.6 mm Al (Supplementary filtration) Beam maximum dimension 238 mm x 179 mm (detector area) Voltage accuracy at the tube <...
  • Page 60 Stray Radiation Map Stray radiation (uGy/mAs) according to IEC 60601-2-44:2009 Par. 203.13. Measured using “head phantom” according to IEC 60601-2-44:2009 Par. 203.108. Laser Output power 0.9 mW Wave length 635 nm Beam divergence 70º Pulse length Continuous wave Classification Class 1 USER MANUAL...
  • Page 61 TABLE: Guidance and manufacturer's declaration - electromagnetic emissions The NewTom VGi evo device is designed to operate in the electromagnetic environment specified below. The customer or user of the NewTom VGi evo device must ensure that it is used in such environment. Emission test...
  • Page 62 TABLE: Guidance and manufacturer's declaration - electromagnetic emissions The NewTom VGi evo device is designed to operate in the electromagnetic environment specified below. The customer or user of the NewTom VGi evo device must ensure that it is used in such environment. Test level IEC...
  • Page 63 TABLE: Guidance and manufacturer's declaration - electromagnetic emissions The NewTom VGi evo device is designed to operate in the electromagnetic environment specified below. The customer or user of the NewTom VGi evo device must ensure that it is used in such environment. Test level IEC...
  • Page 64 The customer or the operator of the NewTom VGi evo device could help in preventing electromagnetic interferences ensuring a minimum distance between the RF mobile and portable communication devices and the NewTom VGi evo device as indicated below, in relation to the maximum output power of the radio-communication equipment.

  • Page 65: Appendix B: Compatibility

    10. APPENDIX B: COMPATIBILITY The NewTom VGi evo device has been manufactured in compliance with the IEC standards for the safety of medical electrical equipment, and particularly with the following standards: • IEC 60601-1: 2005 + AMEND. 1 (2006) + AMEND. 2 (2007) - General requirements for basic safety and essential performance.

  • Page 66: Appendix C: Device Labels

    11. APPENDIX C: DEVICE LABELS PLATE ON THE SCANNER Position: Right upright of the scanner, lower side CONTROL BOX PLATE Position: Left side of the control box USER MANUAL...
  • Page 67 APPLIED PART LABEL Position: on the motor-driven chinrest CONTROL BOX PLATE Ray source with rotary anode Position: On the X-ray source and inverter case USER MANUAL...
  • Page 68 PLATE WITH DEVICE COMMERCIAL NAME Position: On the scanner cover, in the lateral central area Position: On the detector case in the central area cMETus CERTIFICATION LABEL Position: Left side of the control box, under the laser label USER MANUAL...
  • Page 69 BEAM LIMITER LABELS BEAM LIMITER GLOBAL LABEL CEFLA s.c. – Italy P/N 96600870 (P/N 99934980) (P/N 99934903) S/N _____________ Position: Near the beam limiter assembly part no. 96600870 BRASS FILTER LABEL CEFLA s.c. – Italy P/N 99934979 – CuZn – 0.15 mm P/N 99935063 –...
  • Page 70 X-RAY BUTTON CONNECTOR INDICATION LABEL Position: Left side of the control box, at the bottom RJ45 ETHERNET BUTTON CONNECTOR INDICATION LABEL Position: Left side of the control box, at the bottom WARNING LABELS FOR LASER DEVICES Position: Left side of the control box, under the emergency button LABEL INDICATING TO REFER TO THE INSTRUCTION MANUAL Position: Left side of the control box, at the bottom LABEL INDICATING THE HEAD COLLISION HAZARD...
  • Page 71 STOP LABEL Position: On the emergency buttons CHINREST DEVICE LABELS Position: On the chinrest covers USER MANUAL...
  • Page 72 NEWTOM™ is a commercial trademark of CEFLA s.c. All other products and brand names are registered trademarks or trademarks of their respective companies. NEWTOM™ VG series is manufactured by: CEFLA s.c. Phone: +39 045 8202727 Fax +39 045 8203040 e-mail: info@newtom.it...

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