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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:

Carter thermoformed back, lower left side, on the Main Fuse Input Switch Label.

Veterinary Application

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 Vet

Страница 1: ...0051 97050812 Rev 1 28 10 2016 ATTACHMENT to the User Manual Veterinary Application Attachment...

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: ...d Repetition Of A Scan 2 3 2 8 Protection From Laser Exposure 2 5 2 9 Devices Connected To The Command Console 2 5 2 10 Maintenance Time Lag 2 5 2 11 Built in Parts 2 6 3 SAFETY AND MAINTENANCE OF THE...

Страница 4: ...s 4 8 4 8 System Accessories 4 8 4 9 System Shut Down 4 8 5 PRELIMINARY PROCEDURES 5 1 5 1 Daily Check 5 1 5 2 Blank Acquisition 5 1 5 2 1 Invalidating The Blank Acquisition 5 1 5 3 Beam Limiter Test...

Страница 5: ...ing and managing documents and the user instructions are addressed in the NNT User Manual User Manual and NNT User Manual should be read and clearly understood in every part before starting using the...

Страница 6: ...The device is supplied with 4 emergency buttons The first button is installed close to the operator table The second button is located on the patient s table below the table control panel Two additio...

Страница 7: ...further details on positioning the animal please refer to par 6 1 2 Positioning the animal and starting a new scan 2 5 2 During the scan Please refer to the paragraph of the same name in the User Manu...

Страница 8: ...cording to safety rules that are contemplated by the local laws regarding this matter WARNING NewTom 5G Vet mustn t be used for routine examinations or screening For this purpose consider other diagno...

Страница 9: ...displayed all along the scan process 2 Light indicators LEDs inside the control panels They can be found on the sides of the scanner gantry They light on just after the START command has been sent vi...

Страница 10: ...re to the beam The beams can cause permanent eye damage WARNING Keep your eyes at least 40mm from the laser when the beam is on If necessary use appropriate protective glasses WARNING The use of contr...

Страница 11: ...2 About safety Non applied parts that may come into contact with the animal are external covers 2 6 Veterinary Application...

Страница 12: ...ons Please refer to the paragraph of the same name in the User Manual 3 3 1 Responsibility limits Please refer to the paragraph of the same name in the User Manual 3 4 Device maintenance Please refer...

Страница 13: ...to the paragraph of the same name in the User Manual 3 7 Device disposal 3 7 1 Information for the device owner Please refer to the paragraph of the same name in the User Manual 3 7 2 Information for...

Страница 14: ...of this volume displaying both two and three dimensional images The device is operated and used by x ray technologists and licensed veterinary professionals and other legally qualified professionals T...

Страница 15: ...device animals lying on the bed weighing over 160 kg animals whose body parts do not fit in the gantry diameter 580 mm use by staff that have not received training on the device use by staff that do...

Страница 16: ...00822 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...

Страница 17: ...nt positioning Next is a brief 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...

Страница 18: ...accessory used for the positioning of the animal Located on a special arm is the control button for moving the table and the lights indicating that the device is switched on that x rays are being emit...

Страница 19: ...ntrols FORWARD BACK Not available Not available Physically the stretcher can be moved only in manual mode LEFT RIGHT Transversal movement Transversal table movement is not allowed in case of facilitat...

Страница 20: ...vigation menu buttons F1 MODE F2 The function depends by the icon displayed on the screen in correspondence of the relevant key READY 5G PC connection Led A green LED is on when the connection between...

Страница 21: ...aragraph of the same name in the User Manual 4 7 1 Optional accessories Please refer to the paragraph of the same name in the User Manual 4 8 System accessories Please refer to the paragraph of the sa...

Страница 22: ...ragraph of the same name in the User Manual 5 2 Blank Acquisition Please refer to the paragraph of the same name in the User Manual 5 2 1 Invalidating the Blank acquisition Please refer to the paragra...

Страница 23: ...t in the scan area and adjust the table so as to frame the interested area and the neck bust of the animal assumes a correct position Avoiding delays Good examination times can be obtained also by car...

Страница 24: ...e A 35 Kg 77 lbs Zone B 175 Kg 385 lbs Zone C 175 Kg 385 lbs Stretcher into the gantry Zone A 35 Kg 77 lbs Zone B 90 Kg 198 lbs Zone C 175 Kg 385 lbsz 2 Sitting areas for adult patient maximum weight...

Страница 25: ...that the stretcher is completely out of the gantry and locked by the handle positioned at the side of the table console Then press P2 button on the table console Figure 5 Patient table in facilitated...

Страница 26: ...Figure 6 Patient table in exam preparation position 3 Unlock the stretcher and slide it into the gantry Then relock the stretcher Figure 7 Patient table with stretcher into the gantry 6 4 Veterinary A...

Страница 27: ...he scanner control panels or on the table console required the NNT software to be open 6 For the animal scan please refer to Par 4 1 Patient scan and 4 4 Remote patient position adjustment included in...

Страница 28: ...6 Scanning Press P2 button in order to reset the animal table to the default position facilitated uphill position and allow the patient to leave the room 6 6 Veterinary Application...

Страница 29: ...Manual 7 1 Phantom positioning Please refer to the paragraph of the same name in the User Manual 7 2 Images samples Please refer to the paragraph of the same name in the User Manual 7 3 Storage of QA...

Страница 30: ...8 Troubleshooting 8 Troubleshooting Please refer to the paragraph of the same name in the User Manual Veterinary Application 8 1...

Страница 31: ...9 IEC61223 Acceptance Test 9 IEC61223 Acceptance Test Please refer to the paragraph of the same name in the User Manual Veterinary Application 9 1...

Страница 32: ...on Positioning lasers Anatomical analyzed volume Cylinder Standard Resolution max x H max 18x16cm 15x22cm 15x12cm 12x8cm 8x8cm High Resolution max x H max 15x5cm 12x8cm 8x8cm 6x6cm Weight and dimensio...

Страница 33: ...mm 15x22e Image pixels 2 x 672 x 768 Pixels Pixel depth 14 n Pixel Size 0 254 x 0 254 mm 15x12 Image pixels 672 x 768 Pixels Pixel depth 14 n Pixel Size 0 254 x 0 254 mm 12x8 Image pixels 570 x 500 Pi...

Страница 34: ...Shape Cylinder Reconstructed Volume Size 18 x H16 cm Voxel Size 0 300 0 250 0 200 0 150 mm Image pixels 610 x 610 732 x 732 680 x 680 672 x 672 Pixels Pixel depth 16 bit 15x22e Shape Cylinder Reconstr...

Страница 35: ...16 bit 15x5 HiRes Shape Cylinder Reconstructed Volume Size 15 x H5 cm Voxel Size 0 150 0 125 0 100 0 075 mm Image pixels 1020 x 1020 880 x 880 750 x 750 672 x 672 Pixels Pixel depth 16 bit 12x8 HiRes...

Страница 36: ...cal references 6x6 HiRes Shape Cylinder Reconstructed Volume Size 6 x H6 cm Voxel Size 0 150 0 125 0 100 0 075 mm Image pixels 410 x 410 492 x 492 614 x 614 672 x 672 Pixels Pixel depth 16 bit 10 6 Ve...

Страница 37: ...10 APPENDIX A Technical references Radiological parameters X Ray Tube IAE model X22 0 3 0 6 Veterinary Application 10 7...

Страница 38: ...10 APPENDIX A Technical references 10 8 Veterinary Application...

Страница 39: ...10 APPENDIX A Technical references Veterinary Application 10 9...

Страница 40: ...10 APPENDIX A Technical references 10 10 Veterinary Application...

Страница 41: ...10 APPENDIX A Technical references Veterinary Application 10 11...

Страница 42: ...um 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 maximu...

Страница 43: ...detector area Reproducibility of the radiation output6 10 Tube voltage accuracy7 10 Tube current accuracy8 20 Radiation linearity9 20 Emission time accuracy10 10 1 ms mAs accuracy11 30 6 According to...

Страница 44: ...TS 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 Wave...

Страница 45: ...00 180 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 4 8 7 15x5 HiRes18 CTDI100 centre 12 1 18 1 24 8 CTDI100 0 14 4 23 2 29 4 12 Measured by using head phantom acco...

Страница 46: ...7 7 11 7 15 8 6x6 HiRes21 CTDI100 centre 10 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 1...

Страница 47: ...48 84mAs Reg Scan Boosted Dose 110kV 97 63mAs 26 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 En...

Страница 48: ...and 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 18x22e 33 4 6 7 0 10 9 33 Loading factors automat...

Страница 49: ...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 Boosted...

Страница 50: ...o 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 47 Loading factors automatica...

Страница 51: ...ical 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 Regular scan Standard dose 1 96mAs 3 6s Veterinar...

Страница 52: ...10 APPENDIX A Technical references Regular scan Standard dose 2 94mAs 5 4s Date 2012 06 20 10 22 Veterinary Application...

Страница 53: ...chnical references Stray radiation diagram Stray radiation uGy mAs according to IEC 60601 2 44 2009 Par 203 13 Measured by using head phantom according to IEC 60601 2 44 2009 Par 203 108 Veterinary Ap...

Страница 54: ...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 42 A stand by Operating temperature 10 35 C Opera...

Страница 55: ...vironment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 The equipment NewTom 5G Vet uses RF energy only for its internal function Therefore its RF emission...

Страница 56: ...put 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 qualit...

Страница 57: ...cturer 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 58: ...mended 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...

Страница 59: ...tly on top of other equipment and other equipment should not be stacked on top of NewTom Vgi Vet If stacking is necessary observe NewTom Vgi Vet to verify normal operation in the stacked configuration...

Страница 60: ...62304 Edition 1 0b 2006 Medical device software Software life cycle processes IEC 62366 2007 1st Edition Medical devices Application of usability engineering to medical devices ANSI AAMI ES60601 1 20...

Страница 61: ...12 APPENDIX C Labels 12 APPENDIX C Labels PLATE ON SCANNER Position Rear plastic cover on the bottom left side Veterinary Application 12 1...

Страница 62: ...12 APPENDIX C Labels X RAY WARNING LABEL Position Front plastic cover on the bottom left side 12 2 Veterinary Application...

Страница 63: ...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 the...

Страница 64: ...odules 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 ETICHETTA GLOBALE BEAM LIMITER Position On LAMIERA...

Страница 65: ...FP 5G PLASTIC COVER EQUIVALENT FILTRATION LABEL Position On the internal plastic cover of the gantry cylinder CAN BUS CONNECTOR LABEL Position Rear plastic cover on the bottom left side next to the CA...

Страница 66: ...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 67: ...ERAL LAW LABEL Position Carter thermoformed back lower left side on the Main Fuse Input Switch Label Veterinary Application 12 7 CAUTION Federal law restricts this device to sale by or on the order of...

Страница 68: ...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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