CEFLA NewTom GO Manual Download Page 1

Page: 1 / 76

97050801

Rev. 09

2018-07

New

Tom

Summary of Contents for NewTom GO

Page 1: ...97050801 Rev 09 2018 07 NewTom GO EN...

Page 2: ...3 4 1 CONSOLE ONBOARD THE MACHINE 23 4 2 X RAY EMISSION REMOTE CONTROL 23 4 3 PERFORM A SIMULATION DUMMY RUN 24 5 PERFORMING A 2D X RAY EXAMINATION 25 5 1 STARTING THE SYSTEM 25 5 2 SELECTING THE EXAM...

Page 3: ...ONS 60 9 5 PANORAMIC SENSOR CHARACTERISTICS PAN 61 9 6 3D PANEL FEATURES 61 9 7 LASER CHARACTERISTICS 61 9 8 DIMENSIONAL CHARACTERISTICS 62 9 9 ENVIRONMENT CHARACTERISTICS 65 9 10 PC REQUIREMENTS 66 9...

Page 4: ...instructions included in this manual apply to all models of the NewTom GO family hereinafter referred to as NewTom GO In the following part of this manual instructions that only apply to the device m...

Page 5: ...equency generator The image is then transmitted to a computer in real time USA federal law restricts this device to sale by or on the order of a licensed healthcare practitioner NewTom GO allows the f...

Page 6: ...rs ru Website www zenith rs ru For technical service it is possible to contact the local distributor 1 1 DESCRIPTION OF THE MANUAL This manual is an essential consultation tool and contains important...

Page 7: ...on technical specifications and illustrations contained in this publication are not binding The Manufacturer reserves the right to make technical modifications and improvements without modifying these...

Page 8: ...ve 93 42 EEC and subsequent amendments and integrations Dir 2007 47 EC Medical Device Directive Directive 2006 42 EC Machinery Directive Technical standards IEC 60601 1 2005 IEC 60601 1 2 2007 IEC 606...

Page 9: ...t identification code Product serial number Manufacturer Date of manufacture month year Consult the enclosed documentation before using the relevant part of the equipment It is necessary to read the u...

Page 10: ...ystem is installed must exclusively be for medical use and designed by an expert in protection against the risks associated with exposure to radiation in accordance with the regulations in force in th...

Page 11: ...she must wear a leaded apron with thyroid collar f Inform the patient about the risks associated with the exam acquire his her informed consent and archive the document In case of claims or need of te...

Page 12: ...evice or its parts to the Manufacturer or a Technical Service centre disinfect all the external parts of the device using a specific product see the paragraph Cleaning and disinfection and preferably...

Page 13: ...ed to use the specific medium level disinfectant STER 1 PLUS CEFLA S C which is compatible with the painted surfaces plastic parts and unpainted metal surfaces Alternatively it is recommended to use p...

Page 14: ...V rays The bite piece and the chinrest can be disinfected by immersing them in a cold sterilising liquid For sterilisation of these parts follow the instructions of the supplier of the sterilising pro...

Page 15: ...s not approved by itself not complying with the regulations and not installed by qualified technical personnel acknowledged by the Manufacturer Do not use electronic equipment not compliant with IEC 6...

Page 16: ...mission is immediately interrupted and all the movements of the patient support and the rotary arm are stopped all the linear motors run a distance of less than 10 mm and the rotary movements a distan...

Page 17: ...environment The customer or the user of NewTom GO must ensure its use in an electromagnetic environment with the following features Immunity test IEC 60601 1 2 Test level Level of conformity Electroma...

Page 18: ...ol interferences can be caused Recommended distance between the RF portable and mobile communication devices and NewTom GO NewTom GO is intended for use in electromagnetic environment where RF irradia...

Page 19: ...rs must remain closed Authorised personnel must always be present outside the room until the projection is completed Pay attention not to release the emission button too soon Please note that during a...

Page 20: ...t the current average usage percentage or based on 4 examinations per hour Distance between rotation axis and measurement point Circular measurement points Stray radiation 0 5 m 12 Gy h 1 0 m 3 Gy h 2...

Page 21: ...tem and the image detector around the patient according to complex orbits following the morphological profile The rotating arm is attached to a column support capable of moving vertically through a mo...

Page 22: ...3D 2D panel for panoramic tomographic images only for 3D machines Craniostat Craniostat only for 3D machines Optional standard stand Remote ray button optional USB Pen Drive containing the Instructio...

Page 23: ...the LED is blue If the X ray device is in standby the LED is blue and flashing If the machine is in error the LED is red The yellow LED on the right comes on when X ray emission is in progress 4 2 X R...

Page 24: ...TION DUMMY RUN The unit moves when the following operations are performed The operator must Closely monitor the patient and immediately let go of the button to stop movement if there is a risk of the...

Page 25: ...side the console lights up and an acoustic signal is emitted If the X ray device is in standby multicolour flashing LED press the CONFIRM button to reset the functions Before starting exposure wait fo...

Page 26: ...ondent to an average 4 year old child he shall not be exposed to NewTom GO In order to ensure a safe use of the device specifically in the radiography of children it is suggested to consult the genera...

Page 27: ...t hand teeth only for 3D machines Patient positioning is very important in order to obtain the best focusing of the anterior teeth Please follow the recommendations of paragraph 5 4 Patient Positionin...

Page 28: ...m in lateral view at the level of the left hand maxillary sinuses Temporomandibular joints examinations TMJ Preview Name Description TMJ Both R L Lateral and frontal exam of both the right and left jo...

Page 29: ...llowing pages will show the button bar of the 3D version Unless otherwise specified the console functions in case of 2D version of the machine are completely equivalent For 3D machine only Every scree...

Page 30: ...options of the relevant sizes small medium big each of them with its own default kV mA and time parameters The kiloVolt kV and milliAmpere mA values that appear are the default Voltage and Current va...

Page 31: ...her as described in paragraph 5 4 Patient positioning In addition to the console present on the device it is possible to use the control console on PC iPAD or its limited version for other mobile plat...

Page 32: ...estores the image to its original status On the right hand side instead there are 2 icons the first sends the image via e mail if the relevant option is enabled and the second is used to save the imag...

Page 33: ...X rays For a panoramic pediatric projection or panoramic dentition select PAN and then select the purple dots for PAN CHILD or PAN DENTITION The figure appears as blue and changes to white Click on t...

Page 34: ...G Having the patient correctly positioned for a panoramic X ray is extremely important for the quality of the image The size and shape of the most sharply defined area on the image depends on the corr...

Page 35: ...presented by an imaginary line running from the upper edge of the auditory meatus to the lower edge of the orbit Sagittal vertical trace 2 it ensures the symmetry of the patient head with respect to t...

Page 36: ...ts upper side with anatomic arches that once the patient is positioned can be adjusted and automatically locked by simply pressing point A with your fingers The arches perform synchronous movements wi...

Page 37: ...tient to the unit so that he she is in front of the bite and can grasp the large handles Ask the patient to rest his or her chin on the chinrest 4 Ask the patient to take one step forward while still...

Page 38: ...LATERAL TMJ 1 Remove the chin rest and the bite and insert the under nose support 2 Adjust the unit height in order to facilitate the patient s access using the keys to move the column upward or down...

Page 39: ...d inclination just raise or lower the unit using the height adjustment buttons 5 4 5 SIN EXAMINATION 1 Remove the chin rest and the bite and insert the under nose special support for sinuses 2 Adjust...

Page 40: ...control is steady on Ask the patient not to move during the examination and to breathe slowly and regularly For panoramic PAN projections ask the patient to swallow just before X ray radiation exposur...

Page 41: ...mic child PAN CHILD produce an automatically reduced and optimized exposure that with a reduction in trajectory time dose still allows the evaluation of the overall oral health of the patient The imag...

Page 42: ...nterior X ray image The image on the left shows a typical image with SIN exposure 5 6 5 DENTITION BITEWING EXAMINATIONS The program of dentition panoramic exposure enables an analysis with optimised o...

Page 43: ...used for protection against radiation make sure the patient s neck is not covered If it is an area will not be X rayed 6 1 SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE The 3D exam can only be pe...

Page 44: ...ressing the icon In both cases the screen shown on the left will be displayed containing the correctly selected CBCT program 1 Selection of the field of view FOV In order to display the list of the av...

Page 45: ...chine and on the diameter of the selected field of view the following options will be available Lower arch protocol Upper arch protocol Two arches protocol Maxillary sinuses protocol 3 Mode selection...

Page 46: ...end of the patient positioning the final selection of the anatomical region for the 3D exam will be realised via a guided procedure on the PC workstation Changing the factors of the X ray exposure tec...

Page 47: ...wait for the device to complete the automatic reset procedure 6 Support selection and patient positioning Once the reset is completed follow the instructions displayed in the left hand box and if nec...

Page 48: ...are 8 Scanning mode selection In the following screen select the Eco Scan or the Regular Scan option in order to start the CBCT acquisition process Follow the instructions for the acquisition operatio...

Page 49: ...n the desired direction A position detector on the chinrest will indicate whether the chosen position is correct for the selected examination If it is incorrect the software will not allow to continue...

Page 50: ...ed CT studies on children unless they are essential to reach a diagnosis Before carrying out an X ray examination all indications and the medical history of the patient must be carefully examined It i...

Page 51: ...acquisition of tomographic examinations because it includes the volumetric image reconstruction technology only for 3D machines If you need to send the X ray examination to the patient or another ope...

Page 52: ...intenance 8 1 PERIODIC INSPECTIONS TO CHECK THE IMAGE 8 1 1 X RAY EMISSION QUALITY CONTROL In order to assure adequate X ray emission efficiency the following parameters should be measured and checked...

Page 53: ...gins the green rectangle must be completely inside the acquired grey area the grey rectangle sides must pass through the red line pairs where these are drawn 8 1 3 2D IMAGE QUALITY CONTROLS BY MEANS O...

Page 54: ...d check the image does not present halos or black spots If the above mentioned spots are present check that the scan area is actually empty then click again on X ray Flash and repeat the acquisition p...

Page 55: ...he octagonal support Place the phantom on the octagonal support as shown in the figure Click on X ray Flash and press the rays button when prompted A side scout image is acquired to check positioning...

Page 56: ...ut Click Next to confirm correct positioning then Start Press the X rays button when prompted The system performs a complete scan of the QA phantom Once finished when the system prompts to continue th...

Page 57: ...e VDI Internal vertical diameter Internal diameter of the aluminium cylinder along the vertical axis in the central axial image H FWHM Horizontal Full Width Half Maximum Spatial resolution millimetres...

Page 58: ...A Anode current 4 15 mA automatically or manually selectable in steps of 1 mA Maximum continuous input anode power 42 W Leakage Technique Factor LTF 90kV 0 47mA Maximum peak input anode power 1080W e...

Page 59: ...mination type selected 3D mode 6 4s 16 8s pulsed mode Source distance primary collimator 100mm Output radiation intensity Output dose 0 20 mG mAs 70 kV 500 mm 0 30 mG mAs 90 kV 500 mm tolerance 30 Sou...

Page 60: ...60 OPERATOR S MANUAL EN 9 3 ISODOSE CURVES FOR 2D EXAMINATIONS 9 4 ISODOSE CURVES FOR CBCT EXAMINATIONS Only for 3D machines...

Page 61: ...pe Direct deposition CsI MTF 55 1 lp mm DQE 70 0 lp mm Sensor matrix dimensions 1152 x 48 pixels Gray level 16 bit Magnification PAN 1 25 5 Connection Gigabit Ethernet 9 6 3D PANEL FEATURES For 3D mac...

Page 62: ...CTERISTICS Suspended version Weight basic machine For 2D machine only 70 kg For 3D machine only 76 kg Maximum overall dimensions in diagram basic machine 972 x 872 mm Height Min 1626 mm Max 2226 mm Us...

Page 63: ...r column and wall mount Weight basic machine For 2D machine only 84 kg For 3D machine only 90 kg Maximum overall dimensions in diagram basic machine 1027 x 872 mm Height Min 1636 mm Max 2256 mm Use th...

Page 64: ...olumn and 45 wall mount Weight basic machine For 2D machine only 102 kg For 3D machine only 108 kg Maximum overall dimensions in diagram basic machine 1030 x 1213 mm Height Min 1636 mm Max 2256 mm Use...

Page 65: ...mensions in diagram basic machine 1030 x 872 mm Height Min 1661 mm Max 2281 mm 9 9 ENVIRONMENT CHARACTERISTICS Operating conditions Temperature 10 35 C Relative humidity 10 90 Pressure 710 1060 hPa Al...

Page 66: ...DDR3 8GB DDR3 1600 MHZ ECC OR HIGHER POWER SUPPLY UNIT 2 180 W 550 W 800 W 400 W 600 W VIDEO CARD 3 AMD Radeon HD 7450 PCI Express 2 0 128 Bit 1024 MB DDR3 706 MHz DirectX 11 AMD RADEON HD 7770 OC GHZ...

Page 67: ...D FIREPRO W7000 4GB GDDR5 400 W AMD SAPPHIRE RADEON R7 250 1GB RAM GDDR5 400 W AMD SAPPHIRE RADEON R7 260X RAM 1GB DDR5 500 W AMD SAPPHIRE RADEON R9 270 RAM 2GB DDR5 500 W Additional workstations For...

Page 68: ...s and laser hazard plates 2 Generator plate 3 WARNING and DHHS plate 4 Main plates and brand plates 5 Column plate These figures show the plates on all models of the NewTom GO family and they are for...

Page 69: ...nation in progress Close the door and if necessary repeat the examination W 0 8 Demo mode examination not loaded Demo started without loading the examination check connection with the PC Repeat the op...

Page 70: ...therefore expressly accepts that the Software may contain errors To this end the User agrees in his own interest to make back up copies of the files data and images regularly and diligently in order...

Page 71: ...lied in its original state and the Author does not offer and shall not acknowledge any guarantee for original defects or defects which might subsequently arise and shall not make any guarantee of qual...

Page 72: ...mains understood that should any inconsistencies arise regarding interpretation the Italian version shall prevail 11 1 9 SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE If the Author declares compli...

Page 73: ...ed User Manual Section X ray emission remote control 6 Check the control keyboard functionality functions must respond to interrogation User Manual Section Console onboard the machine 7 Check proper f...

Page 74: ...Dummy panoramic procedure making sure the axis movement rotation and translation simultaneously is smoothly and without noise See figure 1 next page User Manual Section Perform a simulation Dummy Run...

Page 75: ...EN OPERATOR S MANUAL 75 Figure 1 Figure 2...

Page 76: ......

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