tionsceflasupport.com/data/media/product_documentation/newtom/... · 2019. 8. 23. · IEC 60601-1-3 (2008 2nd Ed.). radiological safety for dental extra-oral X-ray equipment, according

97050960 Rev. 01

17.11

Technic

al a

nd D

osim

etr

ic S

pecific

ations

EN

EN TECHNICAL AND DOSIMETRIC SPECIFICATIONS 2

TABLE OF CONTENTS

1 PURPOSE ............................................................................................................................................................ 3

2 INTRODUCTION .................................................................................................................................................. 3

2.1 INFORMATION ON X-RAY PROTECTION ........................................................................................................................ 3 2.2 DESCRIPTION OF THE DEVICE ..................................................................................................................................... 4

3 DOSIMETRIC TABLES .......................................................................................................................................... 5

4 POSITIONING OF X-RAY BEAM METER FOR DOSIMETRIC MEASUREMENTS ........................................................ 5

5 MEASUREMENTS OF ANODE VOLTAGE (KV) ....................................................................................................... 7

5.1 STANDARD PAN EXAMINATION ......................................................................................................................... 7 5.2 BITEWING EXAMINATION .................................................................................................................................. 7 5.3 MAXILLARY SINUSES EXAMINATION ................................................................................................................. 7 5.4 SUGGESTIONS TO USE THE DOSIMETER (E.G. UNFORS XI / RAYSAFE) ............................................................... 8

6 CARRYING OUT EXPOSURES IN MANUAL MODE ................................................................................................ 9

7 ENABLING OF NON-EXPOSED AREAS ON PANORAMIC EDGES DISPLAYING .......................................................12

8 CHECK OF PRIMARY RAY BEAM SIZE..................................................................................................................14

9 CARRYING OUT PANORAMIC X-RAYS IN LOW DOSE MODE ...............................................................................17

10 LIMITS CONCERNING LEAKAGE CURRENT MEASUREMENT ................................................................................19

11 ACCEPTANCE TEST ACCORDING TO STANDARD IEC 61223-3-5:2005 ..................................................................20

11.1 INSTRUCTIONS ................................................................................................................................................ 20 11.2 ACCEPTANCE LIMITS ........................................................................................................................................ 21

12 APPENDIX A: TECHNICAL FEATURES ..................................................................................................................22

12.1 ELECTRICAL FEATURES ..................................................................................................................................... 22 12.2 ENVIRONMENTAL FEATURES........................................................................................................................... 22 12.3 X-RAY PERFORMANCE - KV, MA, EXPOSURE TIME ........................................................................................... 23 12.4 X-RAY FIELD, FILTRATION, GEOMETRY, DOSE .................................................................................................. 24

12.4.1 X-RAY TUBE: TOSHIBA D-067SB .............................................................................................................. 27 12.4.2 X-RAY TUBE: TOSHIBA D-054SB .............................................................................................................. 29 12.4.3 X-RAY TUBE: CEI OPX/105 ....................................................................................................................... 31 12.4.4 X-RAY TUBE: KAILONG KL5 ..................................................................................................................... 34

12.5 PAN SENSOR FEATURES ................................................................................................................................... 37 12.6 3D PANEL FEATURES ........................................................................................................................................ 37 12.7 LASER FEATURES.............................................................................................................................................. 37

13 APPENDIX B: SIZE SPECIFICATIONS FOR "QA PHANTOM" ..................................................................................38

14 APPENDIX C: PROCEDURE FOR DAP CALCULATION STARTING FROM THE MEASURED AIR KERMA ...................40

15 APPENDIX D: TABLE OF DEFAULT VALUES FOR 2D PROJECTIONS.......................................................................44


1 PURPOSE

This document provides technical information and instructions intended for qualified service technicians. The use of this manual by unauthorised personnel is forbidden. Information provided in this manual refers to the following devices:

Panoramic 2D systems identified by codes REF 708G – 708J – 708M

Panoramic and tomographic 2D/3D systems identified by codes REF 708H - 708K - 708N

The REF code is visible on the identification plate of the device.

2 INTRODUCTION

2.1 INFORMATION ON X-RAY PROTECTION The equipment has been designed and manufactured paying special attention to the safety issue both for the patient and for the operator in charge of its use. It complies with EC regulation on safety, according to the provisions of Directive 93/42/EEC transposed into Italian legislation by Legislative Decree no.46 of 24/02/1997 and subsequent amendments. In particular, the equipment complies with the following requirements:

general safety, according to the provisions of standard IEC 60601-1 (2005 and subsequent amendments and additions, 3rd Ed.)

radiological safety in diagnostic X-ray equipment according to the provisions of collateral standards IEC 60601-1-3 (2008 2nd Ed.).

radiological safety for dental extra-oral X-ray equipment, according to the provisions of special standard IEC 60601-2-63 (2012 2nd Ed.) and of standard on X-ray equipment for Computed Tomography IEC 60601-2-44 (2009 3rd Ed.) (where applicable).

general requirements for software life cycle processes, according to the provisions of standard IEC 62304 (2006 1st Ed.).

In addition to the provisions of individual standards, special attention has been paid, on one hand, to the overall assessment of situations of risk typical of complex equipment (in line with what set forth by point 4) and, on the other hand, to a calibration of the machine strongly oriented according to the principle of optimisation, i.e. using the minimum dose compatible with the informational level provided for the specific application. With regard to the first aspect, it is necessary to mention all hardware and software safety devices used to stop the machine operation, and in particular the X-ray tube, in case of malfunction of any component of the system control chain. With regard, instead, to the radiological optimisation, the following elements must be mentioned:

use of a X-beam detector provided with high quantum efficiency;

use of an optimisation technique of the X-ray beam intensity according to the size of the patient's head;

selection of a minimum dose-noise ratio consistent with obtaining the required diagnostic information quality.


2.2 DESCRIPTION OF THE DEVICE The device is able to produce 2D images, such as:

standard or paediatric panoramic views (PAN);

full or partial dentition views, selected by the user (DENT);

front or side views of maxillary sinuses (SIN);

side or postero-anterior views of temporomandibular joints (TMJ), from multiple angles. With the suitable machine configuration, the device can also acquire volume images through the Cone-Beam technique. This technique allows acquiring all data required for volume reconstruction of the examined area through a single full rotation of the generator-detector system around the patient (sequence of X-ray images). The device is composed of a rotary arm connected to a support column. The rotary arm is able to turn and translate, allowing the X-ray emission and detection system to be moved around the patient; the motor-driven support column can move vertically upwards or downwards. In 2D mode, the device uses a high and narrow area of the sensor (linear area) able to detect a fan-shaped X-ray beam. In 3D mode, an X-ray cone-beam is collimated on a rectangular panel with 180° opening circular movement, allowing the volume reconstruction through the CBCT technique. The device is available in two versions, 2D only or 2D/3D:

2D version 2D/3D version

Device suitable for 2D images and examinations Device suitable for 2D images and examinations

and for CBCT tomographic reconstruction


3 DOSIMETRIC TABLES

For dosimetric data of the device, refer to the annex "Dose declaration and acceptance test"code 97050961.

4 POSITIONING OF X-RAY BEAM METER FOR DOSIMETRIC MEASUREMENTS

To perform dosimetric measurements, position the dosimeter in the central part of the sensor inside the rectangle. The perfect alignment between dosimeter and beam is essential in order to ensure accurate measurement values. If “Unfors” / “Raysafe” type dosimeters are used, it could be necessary to switch between “LOW / HIGH” sensitivity according to technical factors and exposure time used. Position the dosimeter on the sensor in the lower beam area. In this position, the dosimeter cable should be faced upwards. In case of 2D sensor, the dosimeter positioning is very critical, because of the limited beam opening (4mm), which can lead to measurement errors even with the slightest positioning error. Pay special attention to position the sensitive part of the meter at the centre of the low bottom of the 2D sensor central area, as shown in the figure below.

2D sensor: position the sensitive area of the dosimeter at the centre of the low bottom of the sensor central area, with cable facing upwards.


2D/3D sensor: position the dosimeter in the low area of the beam, with cable facing upwards.


5 MEASUREMENTS OF ANODE VOLTAGE (KV)

WARNING: The following instructions are intended only for radiology technicians, qualified for dose measurement.

During a Standard Pan examination, the anode voltage is modulated during the trajectory in order to obtain the maximum value, corresponding to the value set through the control panel, in the central area of the trajectory near the area in which X-rays have to cross the spinal column.

5.1 STANDARD PAN EXAMINATION The kV value set though the control panel represents the maximum value reached at the centre, along the spinal column. Al the beginning and at the end of the trajectory kV values are lower. The kV measurement carried out at the beginning of the trajectory will necessarily provide lower values with respect to the set ones, therefore the Standard Pan examination is not recommended to carry out kV measurement.

5.2 BITEWING EXAMINATION During the whole examination, mA values are constant and correspond to the set ones. The kV values have a variable profile.

5.3 MAXILLARY SINUSES EXAMINATION During maxillary sinuses examination, kV values are kept constant for the whole ray emission duration. Also mA values are constant during the whole examination and correspond to the ones set before the examination. Since kV value is constant for the whole duration of the examination, this protocol is recommended for kV measurements.


5.4 SUGGESTIONS TO USE THE DOSIMETER (E.G. UNFORS XI / RAYSAFE)

For proper execution of the tests and to prevent wrong measurements, refer to the instructions for use of the measurement tool used. In particular, it is always necessary to consider a suitable delay time for the measurement, i.e. a delay time with respect to the moment in which the meter detects the beginning of the emission to the moment in which the measurement is actually detected. For instance, the measurements carried out by “Unfors XI” consider a factory-set delay time of 5 ms and a kV measurement range of 160 ms (fixed). A delay time of 5 ms could be too short to carry out measurements on the X-ray device. Therefore it is recommended to set a delay time greater than 5 ms (for example, 50 ms).

To carry out kV measurement, use the “Maxillary sinus” protocol, which keeps the kV value constant for the whole duration of the exposure.


6 CARRYING OUT EXPOSURES IN MANUAL MODE

WARNING: exposures in manual mode can be carried out by qualified personnel only. Exposure with technical factors not permitted may damage the X-ray tube and the device.

Open Acquisition Server application and click on "Settings":


Activate "User Shot" procedure:

Use the arrows to set the desired loading factors. If no particular settings are required, use the default values. The exposure time is expressed in milliseconds. The "film speed" parameter is the sensor frame rate, expressed in frames per second. After having set the desired parameters, click on "SHOT" to carry out the acquisition.

The application will prompt the user to complete the command using X-ray button:


When this image is displayed, press X-ray button.

Keep the button pressed. Release X-ray button only when this image is displayed.

After a few seconds, the following notice is displayed, and the image acquired is shown on the left:


7 ENABLING OF NON-EXPOSED AREAS ON PANORAMIC EDGES DISPLAYING

The upper and lower edges of 2D images are usually faded because of the presence of collimation. Considering the poor information content of such areas, the device software crops the image by default to exclude them from displaying. To enable displaying of non-exposed areas on lower and upper edges of 2D images, carry out the following procedure.



Select “Show Margin” box:

2D images acquired at a later time feature non-exposed areas on the edges.

As a consequence of the activation of this function, a machine recalibration is not required.


8 CHECK OF PRIMARY RAY BEAM SIZE

WARNING: exposures in manual mode can be carried out by qualified personnel only. Exposure with technical factors not permitted may damage the X-ray tube and the device.

The procedure described in this paragraph can be used for 2D machines only (ref code: 708G, 708J, 708M). The same function, applied to a 2D/3D machine, does not provide valuable findings.



Activate "User Shot" procedure:

Check that default loading factors correspond to the following combination: 60 kV, 4 mA, 1000 ms, 100 Hz.

If this is not the case, use the arrows to change loading factors. The exposure time is expressed in milliseconds. The "film speed" parameter is the sensor frame rate, expressed in frames per second. After having set the required parameters, click on "SHOT" to carry out the acquisition.


The application will prompt the user to complete the command using X-ray button:

When this image is displayed, press X-ray button.

Keep the button pressed. Release X-ray button only when this image is displayed.

After a few seconds, the image acquired is shown on the left. If centring is correct, a white shade must be displayed along the entire profile of the rectangle, which indicates the edge of the sensitive area dimension.

The image displayed is compressed vertically to have a better view of the result, therefore it does not respect the height/width proportion.


9 CARRYING OUT PANORAMIC X-RAYS IN LOW DOSE MODE

If it is necessary to reduce the default dose administered to the patient, the device allows to manually change the exposure parameters of panoramic X-ray acquisitions.

To meet the applicable regulatory requirements, such function is activated by default for machines intended for UK market.


Select "Dose adjust" function:


Change manually the parameters of PAN Family and PAN Child acquisitions by entering the following recommended values:

Parameter PAN family (except PAN

Quick and PAN Child) PAN Child

kV medium size -9 -3

mA medium size -2 -3

kV small size -3 -3

mA small size -3 -3

After having set the values, click on "Apply".

The modification of "PAN Family" exposure values necessarily affects also DENT type acquisitions.


10 LIMITS CONCERNING LEAKAGE CURRENT MEASUREMENT

CEFLA X-ray equipment includes mains filters to minimise electromagnetic compatibility aspects that imply a typical and defined earth leakage current. The value of such current exceeds the limit prescribed for generic medical equipment, but is abundantly within the limit prescribed for fixed-installation radiological equipment. For the measurement of earth leakage current, international standards IEC 60601-1:2005 and subsequent amendments and additions (Ed. 3), and IEC 60601-2-63:2012 (Ed. 1) are considered applicable. Moreover, standards CEI 62-122 (2002-07) and CEI EN 62353 (2008-11) are applicable in Italy. Acceptable limits for leakage currents are provided for by general standard IEC 60601-1:2005, which in paragraph § 8.7.3 points out a value for earth leakage current, different from contact current, of 5 mA in normal conditions and of 10 mA in single fault conditions.

"The allowable values of the earth leakage current are 5 mA in normal condition and 10 mA in single fault condition. For a permanently installed ME equipment connected to a supply circuit that supplies only this ME equipment, a higher value of earth leakage current is allowed."

In case of permanently installed devices, as in the case in question, the general standard considers also higher leakage current values as acceptable. This point is also modified by particular standard IEC 60601-2-63:2012 for extra-oral X-ray equipment, whose limit is increased to 20 mA in paragraph § 201.8.7.3, both in normal conditions and in single fault conditions. The reference standard is CEI 62-122 (2002-07), but for fixed-installation equipment note 3 of paragraph § 7.5 is applicable, as earth connection is fixed and internal. Limits to be applied are indicated in line 3, and correspond to 5 mA in normal conditions and 10 mA in single fault conditions. Finally, Annex E of standard CEI EN 62353 (2008-11) specifies the same 5 mA and 10 mA limits for permanently installed equipment. Typically, CEFLA extra-oral X-ray machines have a rated leakage current, due to mains filters for immunity to EMC interferences, to the tune of 2.8mA in normal conditions and 5.5mA in single fault conditions.

Therefore, CEFLA extra-oral X-ray machines comply with a wide margin to harmonised IEC standards, respecting the restrictive limit of 5 mA in normal conditions and 10 mA in single fault conditions. Compliance in also valid with reference to standards CEI 62-122 and CEI EN 62353 (IEC 62353).


11 ACCEPTANCE TEST ACCORDING TO STANDARD IEC 61223-3-5:2005

11.1 INSTRUCTIONS

For instructions to carry out acceptance tests according to standard IEC 61223-3-5:2005 refer to Chapter “IEC61223 STANDARD: ACCEPTANCE TEST” of Software Manual. This document provides further technical details about the tests to be performed and the acceptance limits for the measured values. Phantom used for measurements: Catphan 500 (Phantom Laboratory) MTF10, MTF50: refer to the instruction manual of the phantom. Detect the landmark in the volumetric

datum and use the tool provided by the Software.

NSR% noise / signal ratio: detect 4 axial images in different positions in an area with uniform material, use

the software tool to calculate the CT number of the central ROI and the relevant standard deviation for

each axial image. Calculate the average of standard deviations for the 4 axial images and the average of CT

numbers in the central areas. The noise / signal ratio is the ratio between the 2 values.

UNIFORMITY (%): use the same 4 axial images used for NSR calculation. The following is defined: Mi = average of differences between CT numbers of peripheral ROIs and central ROI for each “i” axial image; CTiROI centr = CT number of central ROI for “i” axial image

UNIFORMITY (%) = max(Mi/ CTiROI centr)

The highest value (worst) of the 4 axial images is considered as the result.


11.2 ACCEPTANCE LIMITS

For the acceptance limits of the device, refer to the annex "Dose declaration and acceptance test"code 97050961.


12 APPENDIX A: TECHNICAL FEATURES This paragraph lists technical features of the device.

12.1 ELECTRICAL FEATURES

# Requirement Description

1. Supply voltage Nominal 115 – 240 VAC - Single phase (acceptable fluctuation +/-10%)

2. Supply frequency 50 / 60 Hz

3. Stand-by current 1A @ 115V; 0.5A @ 240V

4. Max working current 20A @ 115V; 12A @ 240V

5. Mains fuses Fuse F12A as default Fuse F20A is provided, to be used with mains supply voltage lower than 170 Vac

6. Column motor max ratio 25s ON, 400s OFF

7. Max apparent line resistance 0.5 Ω @ 240V 0.25 Ω @ 115V

8. Type of installation Fixed. No mains cord is supplied.

9. Mains terminal Terminal block is provided on the power board, for field wiring of external supply cable (2 poles and earth).

10. Emergency switch device An emergency stopping device is provided, in appropriate position to allow both the operator and the patient to actuate it; the actuator is a switch that interrupts the movements and X-ray emission, and is red.

11. Overvoltage class II

12. Power supply system protection With limits for maximum current of 20 A and differential current of 30 mA

12.2 ENVIRONMENTAL FEATURES

Requirement Description

Operating conditions Temperature + 10 - +35 °C

Relative Humidity 10 – 90%

Pressure 700 – 1060 hPa

Altitude: max 3000 m

Transport and storage conditions Temperature -10 - +70 °C

Relative Humidity 10 – 90%

Pressure 700 – 1060 hPa


12.3 X-RAY PERFORMANCE - KV, MA, EXPOSURE TIME


1. kV - X-ray generator voltage 2D: 60-85 kV continuous mode (2D) with steps of 1 kV 3D: 90kV pulsed mode (3D mode) max 25% pulse

2. kV - X-ray generator frequency High frequency

3. kV - Indicated value The kV profile is part of the projection data set; the indicated kV value (on the unit keyboard) corresponds to the maximum value achieved during the exposure

4. kV - Real time modulation The kV pattern can be modulated during the x-ray exposure with resolution of 20 ms (mainly for compensation of the spine absorption)

5. kV - Accuracy Maximum declared deviation from nominal indicated value: 5% (10% IEC)

6. kV - Ripple ≤5% +-2% typical (measured @ 75kV)

7. kV - Ripple frequency 70-150KHz

8. mA - Anodic current 4-15mA; step 1 mA; (power out max 1080W in continuous mode)

9. mA - Indicated value The mA profile is part of the projection data set; the indicated mA value (on the virtual keyboard) corresponds to the maximum value achieved during the exposure

10. mA - Real time modulation The mA pattern can be modulated during the x-ray exposure with resolution of 20 ms (if required)

11. mA - Accuracy Maximum declared deviation from nominal indicated value: < 10% (20% IEC)

12. Linearity Error < 0.2

13. Variation Coefficient < 0.05

14. Current/voltage combination for the maximum output power

90kV - 12 mA 1080W 72 kV - 15 mA, 1080W continuous mode

15. Nominal power for an exposure time similar to conditions 100 kV and 0.1 s.

90kV, 12mA, 1080 W continuous mode

16. X-ray generator assembly - Maximum continuous power dissipation

42W

17. Leakage Technique Factor (LTF) 90 kV; 0.47 mA

18. Radiation leakage

<0.88mGy/h at 1 meter from the focal spot @90kV with maximum continuous anodic power

19. Exposure time - Range 2D: 1s - 15s continuous emission

3D: 4s - 36s pulsed mode with total effective X-ray emission time 9s (3D mode)

20. High Resolution mode (3D mode)

Pulsed emission: 180 frames; duty-cycle=25%; 100ms period, 25ms emission time, 18s total time; 4.5s x-ray time

21. Standard Resolution mode (3D mode)

Pulsed emission: 180 frames; duty-cycle=20%; 50ms period; 10ms emission time; 9s total time; 1.8s x-ray time

22. Exposure time. indicated value - Accuracy

Maximum declared deviation from nominal indicated value: ±(10%) The time period of exposure of selected projection is indicated on the virtual keyboard.

23. Exposure time - Backup timer Backup timer set at selected projection time +10% (power board / logic board)


12.4 X-RAY FIELD, FILTRATION, GEOMETRY, DOSE


1. Dose output 0.16 mGy/mAs @ 60 kV, 500mm

0.20 mGy/mAs @ 70 kV, 500mm

0.26 mGy/mAs @ 80 kV, 500mm

0.29 mGy/mAs @ 85 kV, 500mm

0.30 mGy/mAs @ 90 kV, 500mm

2. Declared value tolerance +/- 30%, including 10% tolerance of measuring chamber

3. Extra-focal radiation less than 2% of actual dose rate

4. EFFECTIVE DOSE in panoramic standard projection

5 µSv (estimated)

5. X-ray tube (alternatives) CEI OPX105

Kailong KL5

TOSHIBA D-054SB

TOSHIBA D-067SB

6. Maximum Anode Heat content 30kJ (CEI OPX105 – Kailong KL5)

35kJ (TOSHIBA D-054SB - TOSHIBA D-067SB)

7. Focal spot 2D: 0.5 mm (IEC 336)

3D: 0.6 mm (IEC 336) with TOSHIBA D-067SB

8. Target angle 2D: 5° with CEI OPX105 – Kailong KL5 - TOSHIBA D-054SB

3D: 12° with TOSHIBA D-067SB

9. Inherent filtration >2.5mm Al @85kV (2D mode)

6mm Al @85kV (3D mode) (+/-0.3mm)

10. HVL (Half Value Layer) 2D: HVL>=3.1mm @85kV (without added filter)

3D: HVL>=4.5mm @90kV (with automatic added filter)

11. Added filter In CBCT 3D mode there is 3.5mm Al filter added automatically

12. X ray equivalent attenuation between patient and CCD image receptor

< 1.2 mm Al equivalent

(due to sensor module parts interposed between patient and sensor surface)

13. X-ray shielding behind receptor (primary shield)

PAN 2D receptor

>0.5 Pb

14. Flat panel image receptor for 3D mode

>0.5 Pb

15. SID / FDD Source to Image Distance

500mm ± 5 mm (2D MODE)

500mm ± 5 mm (CBCT mode)

16. FOD (in CBCT mode) Focus to Object Distance of the volume acquired

356mm (CBCT mode)

17. Distance between x-ray source and skin (PAN & CBCT)

> 150 mm

18. X-ray field dimension at receptor side

2D version:

151x6 mm (Hamamatsu C10500D-43)

19. 3D version:

2D mode:146 x 6mm

3D mode: 146 x 146 cm (Varian 1515DXT)



20. Primary collimator - General 2D mode: All PAN projections (PAN, TMJ, SINUS, 3D) are obtained with one single primary collimator.

3D mode: Horizontal and vertical positions of the primary collimator are calibrated in factory and in field (by technical service personnel only).

21. Primary collimator – distance Focal spot to collimator distance

2D version: ~100mm

3D version: ~100mm

22. X-ray field

The boundary of the X-RAY FIELD is determined by the points where the AIR KERMA drops to 25% of the AIR KERMA at the centre of the X-RAY FIELD


Generator reference axis:

Geometry:


12.4.1 X-RAY TUBE: TOSHIBA D-067SB


Dimensional outline of D-067SB (mm)


12.4.2 X-RAY TUBE: TOSHIBA D-054SB


Dimensional outline of D-054SB (mm)


12.4.3 X-RAY TUBE: CEI OPX/105

Maximum ratings chart a

no

dic

cu

rren

t (m

A)

exposure time (s)

an

od

ic c

urr

ent

(mA

)

exposure time (s)

an

od

ic c

urr

ent

(mA

)

exposure time (s)


Emission characteristics DC

Filament & Emission characteristics


Anode heating / cooling curve

Dimensional outline CEI OPX/105


12.4.4 X-RAY TUBE: KAILONG KL5



Dimensional outline of KAILONG KL5


12.5 PAN SENSOR FEATURES For 2D machines only:

Sensitive area dimensions 6 x 151 mm

Resolution 5 lp/mm (PAN projection)

Primary screen > 0.5 mm Pb

Pixel size 100μm

Sensor technology CMOS

Scintillator material & type Direct deposition CsI

MTF 58% @ 1 lp/mm

DQE 70% @ 0 lp/mm

Sensor matrix dimensions 1512 x 60

Gray level 14 bits

Magnification (PAN) 1.25 ±5%

Connection Gigabit Ethernet

For 3D machines only (in 2D mode):

Sensitive area dimensions 6 x 146 mm

Resolution 5 lp/mm (PAN projection)

Pixel size 127 µm

Sensor technology Amorphous silicon


MTF 55% @ 1 lp/mm

DQE 70% @ 0 lp/mm

Sensor matrix dimensions 1152 x 48 pixels

Gray level 16 bits

Magnification (PAN) 1.25 ±5%


12.6 3D PANEL FEATURES For 3D machines only:

Sensitive area dimensions 146x146 mm

Resolution 3.94 lp/mm

Pixel size 127 x 127 µm

Sensor technology Amorphous silicon


MTF 57% @ 1 lp/mm (1x1)

DQE 70% @ 0 lp/mm (1x1)

Image pixels 1152 x 1152 pixels

Bit depth 16 bits


Voxel Size HiRes: 80-115-150µm

StdRes: 160-230-300µm

12.7 LASER FEATURES

Optical power Class 1 according to IEC 60825-1: 2003

Laser power Max 3mW

Diffractive optics Aspheric lens; Line shaped; 58 deg. openings

Wavelength 635-650 nm

Activation time Continuous wave; Timing limited to 30”


13 APPENDIX B: SIZE SPECIFICATIONS FOR "QA PHANTOM"


For the instructions concerning the procedures for acquisition and quality check through QA Phantom, refer to the User Manual.


14 APPENDIX C: PROCEDURE FOR DAP CALCULATION STARTING FROM THE MEASURED AIR KERMA

DAP is the absorbed dose multiplied by the radiated surface expressed in [Gy*cm2]. A 6x6 cm field with an input dose of 1mGy produces a DAP value of 36 mGy*cm2. When the field is increased to 10x10 cm with the same input dose, DAP increases to 100 mGy*cm2. DAP has the property of remaining constant when the ionisation chamber (detector) is moved closer or distanced from the X-ray source. After having measured Air Kerma, the following data are required to calculate DAP:

pixel dimension on flat panel

number of pixels on X and Y axes for each field of view whose DAP has to be calculated

collimator tolerances

distance of the flat panel from the source (SID)

distance of the ionisation chamber from the source (SOD)

Standard IEC 60601-2-63, par. 203.8.5.3 (correspondence between X-ray field and Reception Area), requires that the maximum tolerance is 3% of SID on each of the two X and Y axes, and 4% for the sum of X and Y axes. Therefore, for area assessment, it is necessary to apply a tolerance factor (overestimate) on both X and Y axes, representing the typical margin of deviation between the exact area acquired by the detector and the radiated area, determined by collimation setting. This tolerance value is 7 mm. For DAP calculation it is necessary to obtain an Area Factor (FA) to be multiplied by Air Kerma (AK) measured, the formula is: DAP = FA * AK For each field of view (FOV) there is a different DAP, therefore it is necessary to know the exact size of the field of view on the flat panel. To do so, it is necessary to know the number of pixels and the size of one pixel. The rated size (dp) of a single pixel is 0.127 x 0.127 mm for “HiRes” FOVs, 0.254 x 0.254 mm for the other FOVs. The number of pixels associated to each field of view is indicated in the table below.

FOV (cm x cm) Number of pixels (#p) on X axis Number of pixels (#p) on Y axis

[10 x 10] 576 576

[10 x 7] 576 400

[10 x 6] 576 380

[8 x 10] 456 576

[8 x 7] 456 400

[8 x 6] 456 380

[6 x 7] 342 400

[6 x 6] 342 380

[10 x 10] HiRes 1152 1152

[10 x 7] HiRes 1152 800

[10 x 6] HiRes 1152 760

[8 x 10] HiRes 912 1152

[8 x 7] HiRes 912 800

[8 x 6] HiRes 912 760

[6 x 7] HiRes 684 800

[6 x 6] HiRes 684 760


Multiplying these values by the pixel size the exact size of the field of view is obtained. LN = dp * #p

FOV (cm x cm) Rated length (LN) of X axis

on flat panel (mm) Rated length (LN) of Y axis

on flat panel (mm)

[10 x 10] 146,304 146,304

[10 x 7] 146,304 101.6

[10 x 6] 146,304 96.52

[8 x 10] 115,824 146,304

[8 x 7] 115,824 101.6

[8 x 6] 115,824 96.52

[6 x 7] 86,868 101.6

[6 x 6] 86,868 96.52

[10 x 10] HiRes 146,304 146,304

[10 x 7] HiRes 146,304 101.6

[10 x 6] HiRes 146,304 96.52

[8 x 10] HiRes 115,824 146,304

[8 x 7] HiRes 115,824 101.6

[8 x 6] HiRes 115,824 96.52

[6 x 7] HiRes 86,868 101.6

[6 x 6] HiRes 86,868 96.52

As mentioned above, tolerances must be applied to such measures. Therefore each rated length is increased by summing the margin of tolerance between acquired area and radiated area. Please note that, by increasing the length, the Area Factor for DAP calculation increases as well. LT = LN + Toll.

FOV (cm x cm) Length with tolerance (LT)

of X axis on flat panel (mm)

Length with tolerance (LT) of Y axis on flat panel

(mm)

[10 x 10] 153,304 153,304

[10 x 7] 153,304 108.6

[10 x 6] 153,304 103.52

[8 x 10] 122,824 153,304

[8 x 7] 122,824 108.6

[8 x 6] 122,824 103.52

[6 x 7] 93,868 108.6

[6 x 6] 93,868 103.52

[10 x 10] HiRes 153,304 153,304

[10 x 7] HiRes 153,304 108.6

[10 x 6] HiRes 153,304 103.52

[8 x 10] HiRes 122,824 153,304

[8 x 7] HiRes 122,824 108.6

[8 x 6] HiRes 122,824 103.52

[6 x 7] HiRes 93,868 108.6

[6 x 6] HiRes 93,868 103.52

The ionisation chamber positioned inside the field of view on the rotation axis is closer to the X-ray source with respect to the flat panel.


For the calculation of the area on the rotation axis the ratio between the distance of the chamber with respect to the source and the distance of the flat panel with respect to the source must be considered. In particular, the closer the ionisation chamber is to the source, the smaller the Area Factor is for which Air Kerma must be multiplied by to obtain DAP. Theoretically, the dose measured by the chamber is inversely proportional to the square of the distance of the ionisation chamber from the source, whereas the radiated area is directly proportional to the square of the distance itself, therefore DAP is expected to be constant when the distance of the chamber from the source varies. The distance between source and flat panel (SID) is 500 mm. If, for example, the ionisation chamber is positioned on the rotation axis, the distance of the chamber from the source (SOD) is 356 mm. To find the projected length (LP) of flat panel on ionisation chamber, for every single axis, the following formula is used: LP = LT * SOD / SID

FOV (cm x cm) Projected length* (LT) of X

axis on detector (mm) Projected length* (LT) of Y

axis on detector (mm)

[10 x 10] 109,152 109,152

[10 x 7] 109,152 77,323

[10 x 6] 109,152 73,706

[8 x 10] 87,451 109,152

[8 x 7] 87,451 77,323

[8 x 6] 87,451 73,706

[6 x 7] 66,834 77,323

[6 x 6] 66,834 73,706

[10 x 10] HiRes 109,152 109,152

[10 x 7] HiRes 109,152 77,323

[10 x 6] HiRes 109,152 73,706

[8 x 10] HiRes 87,451 109,152

[8 x 7] HiRes 87,451 77,323

[8 x 6] HiRes 87,451 73,706

[6 x 7] HiRes 66,834 77,323

[6 x 6] HiRes 66,834 73,706

*Values applicable in case of ionisation chamber positioned on the rotation axis of the device.


Therefore the Area Factor is the product between the projected length on X axis detector and the projected length on Y axis detector, reduced by a 100 factor to change the unit of measurement from [mm x mm] to [cm x cm] FA = LPx * LPy / 100

FOV (cm x cm) FA* (cm x cm)

[10 x 10] 119.14

[10 x 7] 84.40

[10 x 6] 80.45

[8 x 10] 95.45

[8 x 7] 67.62

[8 x 6] 64.46

[6 x 7] 51.68

[6 x 6] 49.26

[10 x 10] HiRes 119.14

[10 x 7] HiRes 84.40

[10 x 6] HiRes 80.45

[8 x 10] HiRes 95.45

[8 x 7] HiRes 67.62

[8 x 6] HiRes 64.46

[6 x 7] HiRes 51.68

[6 x 6] HiRes 49.26

*Values applicable in case of ionisation chamber positioned on the rotation axis of the device.

Therefore DAP can be calculated by multiplying the measured Air Kerma by the Area Factor of the relevant FOV. DAP = FA * AK Note: for DAP calculation procedures, the values are always expressed in millimetres except for Area Factor and DAP itself [mGy*cm2].


15 APPENDIX D: TABLE OF DEFAULT VALUES FOR 2D PROJECTIONS

The device has a default setting of exposure parameters for 2D projections, which can be manually selected through the control console settings. The tables below contain the default loading parameters proposed by the device when the type of patient (man, woman child) and the size (small, medium, large) vary.

Panoramic 2D Systems – REF: 708G – 708J – 708M

Projection Patient Size Voltage

(kV) Current

(mA) Time

(s)

PAN

Man

High 81 7 12.2

Medium 78 7 12.2

Low 76 7 12.2

Woman

High 80 7 12.2

Medium 77 7 12.2

Low 75 7 12.2

Child Low 72 7 12.2

SIN

Man

High 81 7 6.2

Medium 78 7 6.2

Low 76 7 6.2

Woman

High 80 7 6.2

Medium 77 7 6.2

Low 75 7 6.2

Child Low 72 7 6.2

TMJ (side)

Man

High 81 7 6.4

Medium 78 7 6.4

Low 76 7 6.4

Woman

High 80 7 6.4

Medium 77 7 6.4

Low 75 7 6.4

Child Low 72 7 6.4

PAN Child Child High 72 7 10.9

PAN Quick

Man

High 81 7 6.6

Medium 78 7 6.6

Low 76 7 6.6

Woman

High 80 7 6.6

Medium 77 7 6.6

Low 75 7 6.6

Child Low 72 7 6.6

PAN QUICK Child Child Low 72 7 6


Panoramic and Tomographic 2D/3D Systems – REF: 708H – 708K – 708N

Projection Patient Size Voltage

(kV) Current

(mA) Time

(s)

PAN

Man

High 81 8 12.2

Medium 78 8 12.2

Low 76 8 12.2

Woman

High 80 8 12.2

Medium 77 8 12.2

Low 75 8 12.2

Child Low 72 8 12.2

SIN

Man

High 81 8 6.2

Medium 78 8 6.2

Low 76 8 6.2

Woman

High 80 8 6.2

Medium 77 8 6.2

Low 75 8 6.2

Child Low 72 8 6.2

TMJ

Man

High 81 8 6.4

Medium 78 8 6.4

Low 76 8 6.4

Woman

High 80 8 6.4

Medium 77 8 6.4

Low 75 8 6.4

Child Low 72 8 6.4

PAN Child Child Low 72 7 10.9

PAN Quick

Man

High 81 8 6.6

Medium 78 8 6.6

Low 76 8 6.6

Woman

High 80 8 6.6

Medium 77 8 6.6

Low 75 8 6.6

Child Low 72 8 6.6

PAN QUICK Child Child Low 72 7 6

Documents

tionsceflasupport.com/data/media/product_documentation/newtom/... · 2019. 8. 23. · IEC 60601-1-3 (2008 2nd Ed.). radiological safety for dental extra-oral X-ray equipment, according