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12 APPENDIX C - Labels

✔

X-RAY SOURCE LABEL

Position:

On the X-ray source tube head.

✔

INVERTER LABEL

Position:

On the inverter chassis.

✔

USA FEDERAL LAW LABEL

Position:

Rear plastic cover on the bottom left side on top of the main switch and input fuse label

NewTom 5G

– User Manual

12-7

CAUTION

Federal law restricts this device to sale by
or on the order of a practitioner licensed by
the law of the State in which he practices to
use or order the use of x-ray imaging
systems.

21CFR801.109(b)

Содержание NewTom 5G

Страница 1: ...NewTom 5G User Manual 0051 97050196 Rev 5 28 04 2017 EN...

Страница 2: ...dical devices The medical device referred to in this manual is an X ray device compliant with Directive 2011 65 EU on the restriction of the use of certain hazardous substances in electrical and elect...

Страница 3: ...g radiation 2 7 2 8 Protection from laser exposure 2 9 2 9 Devices connected to the NewTom 5G console 2 10 2 10 Maintenance time lag 2 11 3 SAFETY AND MAINTENANCE OF THE DEVICE 3 1 3 1 Installation re...

Страница 4: ...and starting a new scan 6 4 6 1 2 1 Patient positioning with patient table 6 6 6 1 2 2 Patient positioning with patient table with stretcher 6 9 6 2 Scanning a denture 6 13 6 2 1 Preliminary operation...

Страница 5: ...claration 10 14 10 8 Stray radiation diagram 10 22 10 9 Laser 10 23 10 10 Other data 10 23 10 11 Electromagnetic compatibility 10 24 10 11 1 Essential performance 10 28 11 APPENDIX B SECURITY STANDARD...

Страница 6: ...ith any other documentation and to use it whenever a new staff member has to be trained for using the device 1 2 Structure This manual is divided in the following chapters Chapter 1 Introduction to th...

Страница 7: ...ution Chapter 9 IEC61223 Acceptance Test Provides procedures for testing as required by IEC61223 standard APPENDIX A Technical references Provides the technical reference of the device APPENDIX B Secu...

Страница 8: ...o the device and or the user s and or the patient s safety IMPORTANT Instructions that you MUST follow to complete a task 1 3 1 Text conventions Bold text Indicates a menu or an item to select Italics...

Страница 9: ...r these guidelines please refer to the current chapter to Chapter 3 Safety and maintenance of the device and to Chapter 6 Scanning WARNING All the operators must be familiar with the operating and env...

Страница 10: ...dangerous voltage IEC 60417 5019 Protective earth ground IEC 60417 5017 Earth ground N IEC 60445 Connection point for the neutral conductor on permanently installed equipment L IEC 60445 Connection p...

Страница 11: ...to the procedures described in Chap 4 5 System start up and 4 6 System shut down 2 4 Emergency stop The device is supplied with 4 emergency buttons The first button is installed close to the operator...

Страница 12: ...positioning Be sure that a patient is properly placed inside the scan area with his her head on the head support and that no part of his her body may impact the device or be pressed during the positi...

Страница 13: ...e patient can be extracted from the scan area and can walk away from the scanner 2 5 4 Patient s exit during fault malfunctioning of the patient s table In case of patient table malfunctioning act on...

Страница 14: ...ng and bending the legs transversely or longitudinally depending on the direction of the movement Get close to patient as much as possible Ensure a good hand grid on the patient before starting any mo...

Страница 15: ...tion Protection Expert Operator An operator must oversee the examination process from his her control position according to the laws in force NO ONE SHOULD BE BY THE PATIENT DURING THE EXAMINATION PRO...

Страница 16: ...g the emission The x ray emission status is identified by 1 A signal on the workstation screen such as the one reported below It appears on video just after the START command has been selected via key...

Страница 17: ...OFF and contact technical assistance 2 8 Protection from laser exposure The device is equipped with a double laser in order to aid the operator during the patient positioning The vertical line identi...

Страница 18: ...cted to the NewTom 5G console Workstations displays printers keyboards and other devices which may be connected to the NewTom 5G console MUST comply with ISO and or IEC and or EN standards and or loca...

Страница 19: ...2 About safety 2 10 Maintenance time lag Please be sure that the maintenance controls that are described in Par 3 4 Device maintenance are performed NewTom 5G User Manual 2 11...

Страница 20: ...ng to a Qualified Expert recommendations A device may not be exposed to acids corrosive substances saltiness and wet Operating temperature from 10 to 35 Celsius Operating humidity condition min 10 max...

Страница 21: ...y measures against the risk of fire in the place in which the device has been installed Electrostatic discharges Electrostatic discharge may damage electrical parts in the device Consequently the floo...

Страница 22: ...ectly authorized by the manufacturer or distributor Replace parts were not approved by the manufacturer or distributor Environmental conditions were not conform according to the requirements of the la...

Страница 23: ...le and to the device See Par 3 5 Cleaning and disinfection Preventive maintenance Please periodically check the workstation scanner workstation control box and control box power supply cables Also ver...

Страница 24: ...nctioning Check 12 months Mechanical functioning Check 12 months Other test depending of local regulations Radioprotection expert or other qualified person depending on local regulations Global system...

Страница 25: ...protections whenever possible The aggressive effects of chemical products also depend on the time they stay in contact with the surfaces It is therefore important not to leave the product on the surfa...

Страница 26: ...are classified as Class I medical device and may not be replaced with others in a lower class The single use protections must be in compliance with the ISO 10993 1 standards on biocompatibility and ap...

Страница 27: ...mal use of the device 3 6 Transport and storage During transport and storage the following conditions must be observed Transport and storage temperature from 20 to 70 Celsius Transport and storage hum...

Страница 28: ...is recycled in a manner that protects human health and the environment In case of unauthorized disposal of the device there are sanctions that vary according to the local and or regional regulations...

Страница 29: ...both two and three dimensional images The device is operated and used by physicians dentists x ray technologists and other legally qualified professionals WARNING NewTom 5G is able to produce panorami...

Страница 30: ...is higher and so unnecessary radiation exposure is of particular concern for pediatric patients 4 1 3 Improper Use The NewTom 5G device has not been designed for the following uses and or application...

Страница 31: ...comment etc Finally new images can be saved inside the study The study images can be used to compile a report that can be then printed and or saved on a physical support To study in deep these themes...

Страница 32: ...822 and main workstation installed out of the patient area It is also possible to add more workstations for data processing and storage For additional informational about this matter please refer to t...

Страница 33: ...rief description of each button and sign Emergency button to be used only during danger situations To restore the default condition after pressing the button rotate it in the direction indicated by th...

Страница 34: ...ent is positioned inside the gantry to adjust the position along the x and y axis of the table P1 button to be used after the patient is sitting in the table to move him her inside the gantry P2 butto...

Страница 35: ...XRAY EMISSION FAULT indicators A green LED turns on once the connection between patient table and NNT software is active A yellow LED turns on during x ray emission A red LED turns on in case of pati...

Страница 36: ...ovement Transversal table movement is not allowed in case of facilitated uphill position The minimum maximum excursions of the movements are limited to defaults values by active collision controls P1...

Страница 37: ...EADY 5G PC connection Led A green LED is on when the connection between 5G and PC is active X RAY EMITTION X ray emission Led A yellow LED is on when an x ray emission is active FAULT Fault Led A red...

Страница 38: ...workstation console and the cable glands for the power supply cable and for the cable of the remote emergency button 4 4 Standard accessories The device is supplied with a few standard accessories QA...

Страница 39: ...d The manufacturer also provides the power supply cable with an end connected to the scanner unit it is in charge of the user to connect it to the mains during installation WARNING Accessories transdu...

Страница 40: ...first If You try to use the NNT software before the appliance has done its initialization successfully an error will occur see Chap 8 Troubleshooting 4 6 System shut down Next is the procedure for a...

Страница 41: ...two weeks 14 days while Daily check is mandatory every day before patients acquisitions If these procedures are not performed the software will disable the scan functions Operating modes are described...

Страница 42: ...please verify that the scan area is completely free from objects At the end of conditioning process the software will automatically run the Daily Check and Blank acquisition procedures 5 2 NewTom 5G...

Страница 43: ...ystem verifies that each part of itself properly works WARNING Before launching the procedure please verify that the scan area is completely free from objects To that end take out the patient table Ne...

Страница 44: ...rformed by the software every two weeks The resulting blank acquisition image should look like shown in the figure Please carefully verify that no artifacts or objects appear WARNING Before launching...

Страница 45: ...alidate the blank acquisition and repeat the operation To invalidate the blank acquisition select Scan Invalidate Blank from the main toolbar At the next detector field selection the NNT software will...

Страница 46: ...FOV 3 Set the radiological parameters depending on the selected FOV Standard SFS 1 mA 10 msec KV 110 HiRes standard SFS 6 mA 10 msec KV 110 4 Perform an acquisition 5 Verify the acquired image is corr...

Страница 47: ...HiRes 8x8 HiRes 6x6 HiRes WARNING Use the smallest field of view required based on the clinical requirements In general for small size and pediatric patients it is recommended to use the smallest FOVs...

Страница 48: ...ition already performed Preparing the patient Ask the patient to remove if present any jewelry earrings necklaces glasses and removable metallic prothesis Accommodating the patient After accommodating...

Страница 49: ...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 to possibl...

Страница 50: ...nd medical field WARNING The scan area the place in which a patient is positioned during the scan must be free from any objects except from the head support They may damage the patient or invalidate t...

Страница 51: ...to the gantry Zone A 35 Kg 77 lbs Zone B 90 Kg 198 lbs Zone C 175 Kg 385 lbs 2 Sitting areas for adult patient maximum weight 160Kg 3 Distribution of maximum rated load 175kg 160kg 15Kg accessories Ne...

Страница 52: ...tient s table position should be reset default position for patient accommodation This task can be accomplished by pressing the P2 button on the table console 2 Help the patient to sit down on the tab...

Страница 53: ...e positioning process 4 Finely adjust the patient position by using the table console buttons UP DOWN LEFT RIGHT FORWARD BACK In order to help the operator during the positioning of the patient the la...

Страница 54: ...included in the Acquisition Operations with NewTom VGi 5G document annex to the NNT User Manual document 6 Once the scan process is finished press the P2 button in order to slide out the table from t...

Страница 55: ...re details about this acquisition mode please refer to the Acquisition Operations with NewTom VGi 5G document annex to the NNT User Manual document 1 After the device has been turned ON the patient s...

Страница 56: ...ress P1 button on the console by moving the patient table to exam preparation position Figure 13 Patient table in exam preparation position 4 Unlock the stretcher and slide it into the gantry Then rel...

Страница 57: ...t the laser can be turned on by pressing the LASER button on the scanner control panels or on the table console required the NNT software to be open 7 For the patient scan please refer to Par Patient...

Страница 58: ...5 Patient table with stretcher out of the gantry Press P2 button in order to reset the patient table to the default position facilitated uphill position and allow the patient to leave the room 6 12 Ne...

Страница 59: ...le carbon fiber board as shown in the following picture Pay attention to do not reverse the denture must be in the same position as in the patient mouth 4 Finely adjust the denture position by using t...

Страница 60: ...acilitated uphill position 3 Remove the head support and press P1 button on the console by moving the patient table to exam preparation position 4 Unlock the stretcher and slide it into the gantry The...

Страница 61: ...refer to Par Denture scan and Remote patient position adjustment included in the Acquisition Operations with NewTom VGi 5G document annex to the NNT User Manual document 8 Once the scan process is fi...

Страница 62: ...these actions exactly when the software signal them For more details about use of the patient table please refer to the Patient Table User Procedures document 1 Press the P2 button on the table conso...

Страница 63: ...n by pressing the LASER button on the scanner control panels or on the table console required the NNT software to be open Position the phantom in such a way the laser will match with the reference lin...

Страница 64: ...osition PATIENT TABLE WITH STRETCHER ONLY Once the scan process is finished remove the phantom and the support from the table unlock the stretcher and slide completely out of the gantry relock the str...

Страница 65: ...7 Quality assurance 7 2 Images samples Hereafter some sample images from a QA phantom analysis Lateral view Axial view Panoramic view 7 4 NewTom 5G User Manual...

Страница 66: ...s can be opened by selecting from the main menu View QA Report To move among the reports list use the PAGE DOWN PAGE UP keyboard button It is possible to save a copy of the QA report analysis in PDF f...

Страница 67: ...8 Troubleshooting 8 Troubleshooting For the troubleshooting of the device please refer to the NNT Error Guide document NewTom 5G User Manual 8 1...

Страница 68: ...osition an object along the axial plane identified by the horizontal line and scan it by using the 6x6 HiRes FOV refer to the NNT User Manual for data analysis Sagittal and coronal patient positioning...

Страница 69: ...ckness for axial scanning Loading factors automatically selected by the software Thickness Recommended criteria 5 0 mm 1 0 mm 1 0 mm 0 5 mm 0 5 mm 0 0 5 mm 5 3 2 Tomographic section thickness for heli...

Страница 70: ...TDIFREE AIR CTDIvol 15x22e other FOVs CTDI100w 18x16 15x22e 15x12 12x8 8x8 N A 10 9 mGy 30 Equal to CTDI100w 8 8 mGy 30 10 0 mGy 30 9 2 mGy 30 6 2 mGy 30 5 3 mGy 30 Loading factors automatically selec...

Страница 71: ...tra small voxel 15x5 HiRes standard voxel 15x5 HiRes ultra small voxel 12x8 HiRes standard voxel 12x8 HiRes ultra small voxel 6x6 HiRes standard voxel 6x6 HiRes ultra small voxel 65 110 35 80 80 190 8...

Страница 72: ...oxel 15x5 HiRes ultra small voxel 12x8 HiRes standard voxel 12x8 HiRes ultra small voxel 6x6 HiRes standard voxel 6x6 HiRes ultra small voxel 1000 10 1000 10 1150 10 1150 10 1120 10 1120 10 1050 10 10...

Страница 73: ...8x8 standard voxel 15x5 HiRes standard voxel 12x8 HiRes standard voxel 6x6 HiRes standard voxel 8 7 8 10 10 10 MTF10 lp cm 18x16 standard voxel 15x22e standard voxel 8x8 standard voxel 15x5 HiRes stan...

Страница 74: ...natomical analyzed volume Cylinder Standard Resolution max x H max 18x16 cm 15x22cm 15x12cm 12x8cm 8x8cm High Resolution max x H max 15x5cm 12x8cm 8x8cm 6x6cm Weight and dimensions Scanner unit Width...

Страница 75: ...38 lbs Feet Rest 30 Kg 66 lbs Patient table with stretcher Width max 3600 mm 141 7 Depth max 840 mm 33 Height max 900 mm 35 4 Weight without package 300 Kg 661 3 lbs Maximum load 175Kg 385 8 lbs 160Kg...

Страница 76: ...pth 14 n Pixel Size 0 254 x 0 254 mm 12x8 Image pixels 570 x 500 Pixels Pixel depth 14 n Pixel Size 0 254 x 0 254 mm 8x8 Image pixels 453 x 494 Pixels Pixel depth 14 n Pixel Size 0 254 x 0 254 mm 15x5...

Страница 77: ...5x22e Shape Cylinder Reconstructed Volume Size 15 x H22 cm Voxel Size 0 300 0 250 0 200 0 150 mm Image pixels 610 x 610 Pixels Pixel depth 16 bit 15x12 Shape Cylinder Reconstructed Volume Size 15 x H1...

Страница 78: ...depth 16 bit 12x8 HiRes Shape Cylinder Reconstructed Volume Size 12 x H8 cm Voxel Size 0 150 0 125 0 100 0 075 mm Image pixels 820 x 820 700 x 700 672 x 672 672 x 672 Pixels Pixel depth 16 bit 8x8 HiR...

Страница 79: ...10 APPENDIX A Technical references 10 5 Radiological parameters 10 5 1 X Ray Tube IAE model X22 0 3 0 6 10 6 NewTom 5G User Manual...

Страница 80: ...10 APPENDIX A Technical references NewTom 5G User Manual 10 7...

Страница 81: ...10 APPENDIX A Technical references 10 8 NewTom 5G User Manual...

Страница 82: ...10 APPENDIX A Technical references NewTom 5G User Manual 10 9...

Страница 83: ...10 APPENDIX A Technical references 10 10 NewTom 5G User Manual...

Страница 84: ...minimum 70 kV 1 4 mm Al Oil volume compensation Rubber sack 410 cm Size 325 x 145 x 215 Weight 15 kg ELECTRICAL DATA Output voltage maximum 120 kV Cathode Earth 60 kV Anode Earth 60 kV Anode current m...

Страница 85: ...m detector area Reproducibility of the radiation output8 10 Tube voltage accuracy9 10 Tube current accuracy10 20 Radiation linearity11 20 Emission time accuracy12 10 1 ms mAs accuracy13 30 8 According...

Страница 86: ...NPUTS Maximum power 3 5 kW Supply voltage 230 V 10 Waveform Sinusoidal 50 60 Hz Maximum current 16 A Apparent supply resistance 0 14 ohm OUTPUTS Peak voltage 350 Vpk Peak current maximum 120 Apk Max W...

Страница 87: ...9 8x8 19 CTDI100 centre 3 3 5 2 8 2 6 9 11 0 CTDI100 0 3 1 4 7 7 7 6 4 9 6 CTDI100 90 2 8 4 2 6 8 5 7 9 0 CTDI100 180 2 2 3 3 5 4 4 5 7 6 CTDI100 270 2 5 4 0 6 3 5 2 8 7 CTDI100 periph 2 6 4 1 6 6 5...

Страница 88: ...5 12 8 21 3 CTDI100 0 8 7 10 7 17 6 CTDI100 90 7 5 9 1 15 1 CTDI100 180 6 3 7 7 12 8 CTDI100 270 7 4 9 1 15 1 CTDI100 periph 7 5 9 2 15 2 Date 2013 07 11 20 Loading factors automatically set by softwa...

Страница 89: ...10kV 48 84mAs Reg Scan Boosted Dose 110kV 97 63mAs 28 Loading factors automatically set by software Eco Scan Std Dose 110kV 19 07mAs Reg Scan Std Dose 110kV 28 37mAs Reg Scan Boosted Dose 110kV 71 89m...

Страница 90: ...201 3 212 c FOV Eco Scan Standard Dose Regular Scan Standard Dose Regular Scan Boosted Dose Enhanced Scan Standard Dose Enhanced Scan Boosted Dose 15x22e 35 4 6 7 0 10 9 35 Loading factors automaticam...

Страница 91: ...As 39 Loading factors automatically set by software Eco Scan Std Dose 110kV 19 07mAs Reg Scan Std Dose 110kV 28 37mAs Reg Scan Boosted Dose 110kV 71 89mAs Enh Scan Std Dose 110kV 38 14mAs Enh Scan Boo...

Страница 92: ...re Eco Scan Std Dose 110kV 19 07mAs Reg Scan Std Dose 110kV 28 37mAs Reg Scan Boosted Dose 110kV 71 89mAs Enh Scan Std Dose 110kV 38 14mAs Enh Scan Boosted Dose 110kV 97 61mAs 49 Loading factors autom...

Страница 93: ...10 APPENDIX A Technical references Indication of the dose profiles Graphs calculated according to IEC 60601 2 44 2009 Par 203 110 Regular scan Standard dose 1 96mAs 3 6s 10 20 NewTom 5G User Manual...

Страница 94: ...10 APPENDIX A Technical references Regular scan Standard dose 1 96mAs 3 6s Regular scan Standard dose 2 94mAs 5 4s Date 2012 06 20 NewTom 5G User Manual 10 21...

Страница 95: ...m 55 Figure I Stray radiation uGy mAs according to IEC 60601 2 44 2009 Par 203 13 stray radiation on the vertical axis corresponds to the horizontal plane 55 Measured by using head phantom according t...

Страница 96: ...ing x ray emission 0 66 A stand by 200 V 10 50 60 Hz 1 6 3 A during x ray emission 0 72 A stand by 100 V 10 115 V 10 50 60 Hz 1 10 A during x ray emission 1 16 A stand by Operating temperature 10 35 C...

Страница 97: ...n environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 The equipment NewTom 5G uses RF energy only for its internal function Therefore its RF emission...

Страница 98: ...nput output lines 2 kV 1 kV Mains power quality should be that of a typical commercial and or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1kV 2kV Mains power quali...

Страница 99: ...acturer and d is the recommended separation distance in meters m Fields strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in...

Страница 100: ...below according to the maximum output power of the communication equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d...

Страница 101: ...tly on top of other equipment and other equipment should not be stacked on top of NewTom 5G If stacking is necessary observe NewTom 5G to verify normal operation in the stacked configuration in which...

Страница 102: ...ssification requirements and user s guide IEC 62304 Edition 1 0b 2006 Medical device software Software life cycle processes IEC 62366 2007 1st Edition Medical devices Application of usability engineer...

Страница 103: ...FP Plate only for chinese market Position Rear plastic cover on the bottom left side IDENTIFICATION LABEL FOR CHINESE MARKET only for devices intended for chinese market Position Rear plastic cover on...

Страница 104: ...ructions are observed AVVERTISSEMENT Cet appareil rayons X peut tre dangereux pour le patient et l op rateur si les param tres d exposition et instructions d utilisation ne sont pas respect es WARNING...

Страница 105: ...FUSE LABEL Position Rear plastic cover on the bottom left side next to the main switch WARNING LABEL FOR DEVICES WITH LASER NORMAL USE Position Rear plastic cover on the bottom left side on top of th...

Страница 106: ...er modules 1 couple for each side WARNING LABEL FOR LASER DEVICES DISTANCE 40MM Position On the laser brackets next to the laser modules 1 for each laser BEAM LIMITER GLOBAL LABEL Position On the beam...

Страница 107: ...collimator plate PLASTIC COVER EQUIVALENT FILTRATION LABEL Position On the internal plastic cover of the gantry CAN BUS CONNECTOR LABEL Position Rear plastic cover on the bottom left side next to the...

Страница 108: ...onnector HAND CRUSHING WARNING LABEL Position On the main structure next to the points with risk of hand crushing FOLLOW INSTRUCTIONS FOR USE LABEL Position Rear plastic cover on the bottom left side...

Страница 109: ...AW LABEL Position Rear plastic cover on the bottom left side on top of the main switch and input fuse label NewTom 5G User Manual 12 7 CAUTION Federal law restricts this device to sale by or on the or...

Страница 110: ...emark of CEFLA s c All other products and brand names are registered trademarks or trademarks of their respective companies NEWTOM 5G is manufactured by CEFLA s c Phone 39 045 8202727 Fax 39 045 82030...

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