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Rev. 2
28.04.2017
ATTACHMENT to the USER MANUAL
New
Tom
5G
XL –
Dose d
ecla
ration a
nd a
scce
pta
nce t
est
EN
NOTES
This document is provided as a consultation manual intended for the device users.
CEFLA s.c. follows a policy based on the constant development and update of the product. For this reason, it
reserves the right to change the content of this manual without prior notice.
This document can not be modified, copied, reproduced, distributed, saved on magnetic or optical supports, or
published on websites and other on-line services, in full or in part, without the prior written authorisation of CEFLA
s.c.
The original version of this manual is in Italian.
NEWTOM™ 5G is a trademark of CEFLA s.c.
All other products and trade names mentioned in this document are registered marks of the relevant
manufacturers.
INFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES
The medical device referred to in this manual consists of a scanner and a control, display and calculation
unit (Main Workstation). Such device, as delivered and configured by the production and assistance
technical personnel, is an X-ray device compliant with the safety requirements set forth by the Italian
Legislative Decree of 19 September 1994, no. 626 implementing Directives 89/391/EEC, 89/654/EEC,
89/655/EEC, 89/656/EEC, 90/269/EEC, 90/270/EEC, 90/394/EEC and 90/679/EEC concerning the
improvement of the health and safety of workers in the workplace, and with the essential requirements set
forth by the Italian Legislative Decree 24 February 1997, no. 46 implementing Directive 93/42/EEC as
amended, on the medical 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 electronic equipment.
Any tampering with, modification, updating or other change both of hardware1 and software2 of the device as
supplied and installed by the company (and in the conditions specified in the attached documentation) may
partially or totally compromise the device expected operation. This may also alter the safety features with
consequent hazard increase for patients, operators and surrounding environment.
For this reason, should the user need to modify the device, he/she must request a written authorisation by
CEFLA s.c.
Failure to comply with what is specified in this informative note will null and void the device warranty and the
civil and/or penal responsibility for any consequent damage and/or accident and/or worsening of the patient,
operator or other people health (including the surrounding environment) will be borne by the person who
tampered with the device or his/her legal representative.
1 Adding of a new memory expansion, a new hardware on the connection bus, a printer, the replacement of the graphic display interface represents an important modification.
2 Including the operative system and the applications already installed upon medical device delivery.
Automatic updates of the operative system, changes to network connection parameters, modification and/or addition and/or removal of interface software with hardware (device driver) and/or services (e.g. file and printer sharing service) and/or applications represent an important modification.
SUMMARY
1 IEC Acceptance Test .......................................................................................................................................... 1
1.1 Positioning of the patient support [paragraph 5.1] .............................................................................................. 1 1.2 Patient positioning accuracy [paragraph 5.2] ...................................................................................................... 1
1.2.1 Axial patient positioning accuracy [paragraph 5.2.1] ................................................................................... 1 1.2.2 Sagittal and coronal patient positioning light [paragraph 5.2.2] ................................................................. 1
1.3 Tomographic section thickness [paragraph 5.3] ................................................................................................... 1 1.3.1 Tomographic section thickness for axial scanning [paragraph 5.3.1] ........................................................... 1 1.3.2 Tomographic section thickness for helical scanning [paragraph 5.3.2] ........................................................ 1
1.4 Dose [paragraph 5.4] ............................................................................................................................................. 2 1.5 Noise, mean CT number and uniformity [paragraph 5.5] ..................................................................................... 2 1.6 Spatial resolution [paragraph 5.6] ........................................................................................................................ 2 1.7 IEC 61223-3-5: reference values ........................................................................................................................... 3
EN DOSE DECLARATION AND ACCEPTANCE TEST 1
1 IEC Acceptance Test The description of the software utilities for execution of the acceptance tests is given in the "NNT User Manual" document. Below are the specific instructions for conducting these tests on the device (as required by IEC 61223-3-4, IEC 61223-3-5, DIN 6868-161). For each test the relative paragraph of the standard to which it refers is indicated. A table indicating the reference values is given at the end of this chapter.
1.1 Positioning of the patient support [paragraph 5.1] Not applicable.
1.2 Patient positioning accuracy [paragraph 5.2] NewTom 5G XL is equipped with two laser pointing systems to facilitate patient positioning. The laser beam is cross-shaped where the horizontal line identifies the axial plane and the vertical line the central sagittal plane of the volume examined. There is no pointer to identify the coronal plane.
1.2.1 Axial patient positioning accuracy [paragraph 5.2.1] Place an object along the axial plane identified by the horizontal line and do a scan. See “Data analysis software” in the "NNT User Manual" document.
1.2.2 Sagittal and coronal patient positioning light [paragraph 5.2.2] Place an object along the sagittal plane identified by the vertical line and do a scan. See “Data analysis software” in the "NNT User Manual" document.
1.3 Tomographic section thickness [paragraph 5.3]
1.3.1 Tomographic section thickness for axial scanning [paragraph 5.3.1] Refer to the "NNT User Manual" document.
1.3.2 Tomographic section thickness for helical scanning [paragraph 5.3.2] Not applicable.
FWHM value
EN DOSE DECLARATION AND ACCEPTANCE TEST 2
1.4 Dose [paragraph 5.4] Perform the scans for each modality as requested by Standard IEC 60601-2-44. The device automatically calculates the radiologic loading factors based on the scanned object. There is no way to manually select the radiological load for a scan.
1.5 Noise, mean CT number and uniformity [paragraph 5.5] Refer to the "NNT User Manual" document.
1.6 Spatial resolution [paragraph 5.6] Refer to the "NNT User Manual" document.
EN DOSE DECLARATION AND ACCEPTANCE TEST 3
1.7 IEC 61223-3-5: reference values The following table contains the reference values and the operating conditions to be applied in the various tests.
5.1 Positioning of the patient
support
N.A.
5.2 Patient positioning
accuracy
5.2.1 Axial patient positioning
accuracy
10mm from isocenter
5.2.2 Sagittal and coronal patient
positioning light accuracy
10mm from isocenter
5.3 Tomographic section
thickness
5.3.1 Tomographic section
thickness 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 helical scanning
N.A.
5.4 Dose
Loading factors: automatically selected by the
software with Head Phantom
See Appendix A.
5.5 Noise, mean CT number
and uniformity
Loading factors: automatically selected by the
software.
Values are calculated as Arbitrary Unit (a.u.)
because of the machine is not designed to give HU.
Measured with Catphan 500.
EN DOSE DECLARATION AND ACCEPTANCE TEST 4
FOV Mode Voxel Dim. Stand. Dev Mean CT N. Uniformity
[21 x 19]
[18 x 16]
[15 x 22e] *
[15 x 12]
[15 x 5]
* Voxel size
only 300um
– Only Eco
Scan and
Regular
Scan
- Eco Scan -
300 um < 65 675 ÷ 1300 < 200
250 um < 100 675 ÷ 1300 < 175
200 um < 110 675 ÷ 1300 < 150
- Regular
Scan
Standard
Dose
300 um < 45 675 ÷ 1300 < 200
250 um < 70 675 ÷ 1300 < 175
200 um < 75 675 ÷ 1300 < 150
- Regular
Scan
Boosted
Dose
300 um < 30 675 ÷ 1300 < 200
250 um < 40 675 ÷ 1300 < 175
200 um < 45 675 ÷ 1300 < 150
- Enhanced
Scan
Standard
Dose
300 um < 35 675 ÷ 1300 < 125
250 um < 70 675 ÷ 1300 < 100
200 um < 80 675 ÷ 1300 < 75
- Enhanced
Scan
Boosted
Dose
300 um < 35 675 ÷ 1300 < 125
250 um < 70 675 ÷ 1300 < 100
200 um < 80 675 ÷ 1300 < 75
[15 x 5]
HiRes Eco Scan -
150 um < 80 675 ÷ 1300 < 125
125 um < 170 675 ÷ 1300 < 125
100 um < 190 675 ÷ 1300 < 125
HiRes Regular
Scan
Standard
Dose
150 um < 70 675 ÷ 1300 < 125
125 um < 150 675 ÷ 1300 < 125
100 um < 160 675 ÷ 1300 < 125
HiRes Regular
Scan
Boosted
Dose
150 um < 60 675 ÷ 1300 < 125
125 um < 115 675 ÷ 1300 < 125
100 um < 130 675 ÷ 1300 < 125
HiRes Enhanced
Scan
Standard
Dose
150 um < 60 675 ÷ 1300 < 125
125 um < 100 675 ÷ 1300 < 100
100 um < 110 675 ÷ 1300 < 75
HiRes Enhanced
Scan
Boosted
Dose
150 um < 60 675 ÷ 1300 < 125
125 um < 100 675 ÷ 1300 < 100
100 um < 110 675 ÷ 1300 < 75
[12 x 8]
[10 x 10]
[10 x 5]
[8 x 8]
[8 x 5]
- Eco Scan -
300 um < 35 675 ÷ 1300 < 75
250 um < 70 675 ÷ 1300 < 75
200 um < 80 675 ÷ 1300 < 75
- Regular
Scan
Standard
Dose
300 um < 30 675 ÷ 1300 < 75
250 um < 60 675 ÷ 1300 < 75
200 um < 65 675 ÷ 1300 < 75
EN DOSE DECLARATION AND ACCEPTANCE TEST 5
- Regular
Scan
Boosted
Dose
300 um < 25 675 ÷ 1300 < 75
250 um < 45 675 ÷ 1300 < 75
200 um < 50 675 ÷ 1300 < 75
- Enhanced
Scan
Standard
Dose
300 um < 35 675 ÷ 1300 < 75
250 um < 70 675 ÷ 1300 < 75
200 um < 80 675 ÷ 1300 < 75
- Enhanced
Scan
Boosted
Dose
300 um < 35 675 ÷ 1300 < 75
250 um < 70 675 ÷ 1300 < 75
200 um < 80 675 ÷ 1300 < 75
HiRes Eco Scan -
150 um < 80 675 ÷ 1300 < 45
125 um < 170 675 ÷ 1300 < 45
100 um < 190 675 ÷ 1300 < 45
HiRes Regular
Scan
Standard
Dose
150 um < 70 675 ÷ 1300 < 45
125 um < 150 675 ÷ 1300 < 45
100 um < 160 675 ÷ 1300 < 45
HiRes Regular
Scan
Boosted
Dose
150 um < 60 675 ÷ 1300 < 45
125 um < 115 675 ÷ 1300 < 45
100 um < 130 675 ÷ 1300 < 45
HiRes Enhanced
Scan
Standard
Dose
150 um < 60 675 ÷ 1300 < 45
125 um < 115 675 ÷ 1300 < 45
100 um < 130 675 ÷ 1300 < 45
HiRes Enhanced
Scan
Boosted
Dose
150 um < 60 675 ÷ 1300 < 45
125 um < 115 675 ÷ 1300 < 45
100 um < 130 675 ÷ 1300 < 45
[6 x 6]
- Eco Scan -
300 um < 300 800 ÷ 1300 < 75
250 um < 400 800 ÷ 1300 < 75
200 um < 500 800 ÷ 1300 < 80
- Regular
Scan
Standard
Dose
300 um < 30 800 ÷ 1300 < 75
250 um < 60 800 ÷ 1300 < 75
200 um < 65 800 ÷ 1300 < 75
- Regular
Scan
Boosted
Dose
300 um < 25 800 ÷ 1300 < 75
250 um < 45 800 ÷ 1300 < 75
200 um < 50 800 ÷ 1300 < 75
-
Enhanced
Scan
Standard
Dose
300 um < 35 800 ÷ 1300 < 75
250 um < 70 800 ÷ 1300 < 75
200 um < 80 800 ÷ 1300 < 75
- Enhanced
Scan
Boosted
Dose
300 um < 35 800 ÷ 1300 < 75
250 um < 70 800 ÷ 1300 < 75
200 um < 80 800 ÷ 1300 < 75
EN DOSE DECLARATION AND ACCEPTANCE TEST 6
HiRes Eco Scan -
150 um < 80 800 ÷ 1300 < 45
125 um < 170 800 ÷ 1300 < 45
100 um < 190 800 ÷ 1300 < 45
HiRes Regular
Scan
Standard
Dose
150 um < 70 800 ÷ 1300 < 45
125 um < 150 800 ÷ 1300 < 45
100 um < 160 800 ÷ 1300 < 45
HiRes Regular
Scan
Boosted
Dose
150 um < 60 800 ÷ 1300 < 45
125 um < 115 800 ÷ 1300 < 45
100 um < 130 800 ÷ 1300 < 45
HiRes Enhanced
Scan
Standard
Dose
150 um < 60 800 ÷ 1300 < 45
125 um < 115 800 ÷ 1300 < 45
100 um < 130 800 ÷ 1300 < 45
HiRes Enhanced
Scan
Boosted
Dose
150 um < 60 800 ÷ 1300 < 45
125 um < 115 800 ÷ 1300 < 45
100 um < 130 800 ÷ 1300 < 45
5.6 Spatial resolution
Loading factors: automatically selected by the software.
Scan mode: MTF50 (lp/cm) MTF10 (lp/cm)
Only [6x6] Eco Scan
[all FOVs] Eco / Regular Scan non-HiRes
[all FOVs] Eco / Regular Scan HiRes
[all FOVs] Enhanced Scan non-HiRes
[all FOVs] Enhanced Scan HiRes
> 7
> 8
> 9
> 6
> 8
> 13
> 15
> 18
> 12
> 15
EN DOSE DECLARATION AND ACCEPTANCE TEST 7
APPENDIX A: Dose declaration (5.4)
All measures are calculated at the center of the FOV.
Declared typical loading factors1
FOV Scan protocol Dose
protocol
Tube
voltage Scan time
Shot
time
Number
of shots FPS
Radio-logic
load
Anodic
current
cm x cm // // KV sec msec # Hz mAs mA
21x19
Eco Standard 110 18,0 5 270 15,00 10,29 7,62
Regular Standard 110 18,0 9 400 22,22 21,29 5,91
Regular Boosted 110 18,0 9 400 22,22 39,96 11,10
Enhanced Standard 110 25,8 9 600 23,26 37,35 6,92
Enhanced Boosted 110 25,8 9 600 23,26 62,51 11,58
18x16
Eco Standard 110 18,0 5 270 15,00 9,90 7,34
Regular Standard 110 18,0 9 400 22,22 21,06 5,85
Regular Boosted 110 18,0 9 400 22,22 37,50 10,42
Enhanced Standard 110 25,8 9 600 23,26 38,37 7,11
Enhanced Boosted 110 25,8 9 600 23,26 65,48 12,13
15 x 12
Eco Standard 110 18,0 5 270 15,00 11,56 8,57
Regular Standard 110 18,0 9 400 22,22 24,14 6,71
Regular Boosted 110 18,0 9 400 22,22 41,05 11,41
Enhanced Standard 110 25,8 9 600 23,26 44,13 8,17
Enhanced Boosted 110 25,8 9 600 23,26 74,93 13,88
15 x 5
Eco Standard 110 18,0 5 270 15,00 17,08 12,65
Regular Standard 110 18,0 9 400 22,22 34,36 9,54
Regular Boosted 110 18,0 9 400 22,22 56,44 15,68
Enhanced Standard 110 25,8 9 600 23,26 61,59 11,41
Enhanced Boosted 110 25,8 9 600 23,26 100,11 18,54
12 x 8
Eco Standard 110 18,0 5 270 15,00 16,78 12,43
Regular Standard 110 18,0 9 400 22,22 34,37 9,55
Regular Boosted 110 18,0 9 400 22,22 56,85 15,79
Enhanced Standard 110 25,8 9 600 23,26 59,89 11,09
1 Loading factors automatically set by the software using a “Head Phantom” in compliance with IEC 60601-2-44: 2009 Par. 203.108
positioned in the centre of the FOV.
EN DOSE DECLARATION AND ACCEPTANCE TEST 8
Declared typical loading factors1
FOV Scan protocol Dose
protocol
Tube
voltage Scan time
Shot
time
Number
of shots FPS
Radio-logic
load
Anodic
current
cm x cm // // KV sec msec # Hz mAs mA
Enhanced Boosted 110 25,8 9 600 23,26 98,38 18,22
10 x 10
Eco Standard 110 18,0 5 270 15,00 16,55 12,26
Regular Standard 110 18,0 9 400 22,22 34,21 9,50
Regular Boosted 110 18,0 9 400 22,22 56,60 15,75
Enhanced Standard 110 25,8 9 600 23,26 59,82 11,08
Enhanced Boosted 110 25,8 9 600 23,26 96,47 17,87
10 x 5
Eco Standard 110 18,0 5 270 15,00 21,00 15,56
Regular Standard 110 18,0 9 400 22,22 42,36 11,77
Regular Boosted 110 18,0 9 400 22,22 69,82 19,40
Enhanced Standard 110 25,8 9 600 23,26 71,31 13,21
Enhanced Boosted 110 25,8 9 600 23,26 115,17 21,33
8x8
Eco Standard 110 18,0 5 270 15,00 18,77 13,92
Regular Standard 110 18,0 9 400 22,22 37,71 10,48
Regular Boosted 110 18,0 9 400 22,22 61,94 17,22
Enhanced Standard 110 25,8 9 600 23,26 68,83 12,75
Enhanced Boosted 110 25,8 9 600 23,26 107,10 19,84
8x5
Eco Standard 110 18,0 5 270 15,00 20,51 15,20
Regular Standard 110 18,0 9 400 22,22 41,27 11,46
Regular Boosted 110 18,0 9 400 22,22 66,91 18,60
Enhanced Standard 110 25,8 9 600 23,26 73,28 13,57
Enhanced Boosted 110 25,8 9 600 23,26 129,15 23,93
6x6
Eco Standard 110 18,0 5 180 10,00 2,70 3,00
Regular Standard 110 18,0 9 400 22,22 41,40 11,93
Regular Boosted 110 18,0 9 400 22,22 67,71 19,51
Enhanced Standard 110 25,8 9 600 23,26 76,76 14,22
Enhanced Boosted 110 25,8 9 600 23,26 131,88 24,42
15x5 HiRes
Eco Standard 110 18,0 9 360 20,00 52,16 16,10
Regular Standard 110 20,2 15 360 17,82 111,90 20,72
Regular Boosted 110 20,2 15 360 17,82 172,79 32,00
EN DOSE DECLARATION AND ACCEPTANCE TEST 9
Declared typical loading factors1
FOV Scan protocol Dose
protocol
Tube
voltage Scan time
Shot
time
Number
of shots FPS
Radio-logic
load
Anodic
current
cm x cm // // KV sec msec # Hz mAs mA
Enhanced Standard 110 36,0 15 600 16,67 165,64 18,40
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
12x8 HiRes
Eco Standard 110 18,0 9 360 20,00 47,59 14,69
Regular Standard 110 20,2 15 360 17,82 102,01 18,89
Regular Boosted 110 20,2 15 360 17,82 170,29 31,54
Enhanced Standard 110 36,0 15 600 16,67 163,62 18,18
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
10x10
HiRes
Eco Standard 110 18,0 9 360 20,00 45,29 13,97
Regular Standard 110 20,2 15 360 17,82 100,29 18,57
Regular Boosted 110 20,2 15 360 17,82 168,53 31,21
Enhanced Standard 110 36,0 15 600 16,67 148,13 16,46
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
10x5 HiRes
Eco Standard 110 18,0 9 360 20,00 59,17 18,27
Regular Standard 110 20,2 15 360 17,82 125,37 23,23
Regular Boosted 110 20,2 15 360 17,82 172,79 32,00
Enhanced Standard 110 36,0 15 600 16,67 193,89 21,55
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
8x8 HiRes
Eco Standard 110 18,0 9 360 20,00 55,62 17,18
Regular Standard 110 20,2 15 360 17,82 119,24 22,09
Regular Boosted 110 20,2 15 360 17,82 172,79 32,00
Enhanced Standard 110 36,0 15 600 16,67 182,30 20,26
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
8x5 HiRes
Eco Standard 110 18,0 9 360 20,00 63,02 19,47
Regular Standard 110 20,2 15 360 17,82 135,56 25,13
Regular Boosted 110 20,2 15 360 17,82 172,79 32,00
Enhanced Standard 110 36,0 15 600 16,67 194,23 21,59
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
6x6 HiRes Eco Standard 110 18,0 9 360 20,00 64,21 19,82
Regular Standard 110 20,2 15 360 17,82 135,63 25,15
EN DOSE DECLARATION AND ACCEPTANCE TEST 10
Declared typical loading factors1
FOV Scan protocol Dose
protocol
Tube
voltage Scan time
Shot
time
Number
of shots FPS
Radio-logic
load
Anodic
current
cm x cm // // KV sec msec # Hz mAs mA
Regular Boosted 110 20,2 15 360 17,82 172,79 32,00
Enhanced Standard 110 36,0 15 600 16,67 205,50 22,84
Enhanced Boosted 110 36,0 15 600 16,67 269,98 30,00
15x22e
Eco Standard 110 36,0 5 540 15,00 24,11 8,93
Regular Standard 110 36,0 9 800 22,22 50,97 7,08
Regular Boosted 110 36,0 9 800 22,22 86,03 11,95
CineX [18x19] Scan time ≤20s 110 0,2÷4,0 10 20÷400 20,00 12,00 3,00
[18x19] Scan time ≥20s 110 3,15÷5,40 10 315÷540 15,00 16,20 3,00
Ray2D [18x19] 75 0,01÷0,5 10 1÷50 15,63 1,5÷35,0 3÷70
EN DOSE DECLARATION AND ACCEPTANCE TEST 11
Declared Dose: CTDI (CTDI100 2, CTDIperh
3, CTDIw 4, CTDIvol
5, CTDIfreeair 6)
and DLP7 using typical loading factors8
FOV Scan
protocol
Dose
protocol
CTDI 100
Center
CTDI 100
North
CTDI 100
West
CTDI 100
South
CTDI 100
East CTDI perh CTDI w CTDI vol DLP
CTDI
free air
cm x cm // // mGy mGy mGy mGy mGy mGy mGy mGy mGy*cm mGy
21x19
Eco Standard 1,6 2,0 1,8 1,6 1,7 1,8 1,7 1,7 35 2,1
Regular Standard 3,0 3,8 3,5 3,2 3,4 3,5 3,3 3,3 68 4,2
Regular Boosted 4,9 6,1 5,9 5,0 5,6 5,6 5,4 5,4 109 6,7
Enhanced Standard 5,7 7,1 6,7 6,2 6,8 6,7 6,4 6,4 129 7,1
Enhanced Boosted 8,6 10,7 9,9 9,1 10,1 10,0 9,5 9,5 193 10,5
18x16
Eco Standard 1,4 1,9 1,7 1,5 1,7 1,7 1,6 1,6 28 2,1
Regular Standard 2,9 3,7 3,4 3,1 3,4 3,4 3,2 3,2 57 4,1
Regular Boosted 4,5 5,6 5,2 4,8 5,2 5,2 5,0 5,0 87 6,4
Enhanced Standard 5,7 7,1 6,6 6,0 6,6 6,6 6,3 6,3 110 7,2
Enhanced Boosted 8,8 10,8 10,0 9,3 10,0 10,0 9,6 9,6 169 10,9
15 x 12
Eco Standard 1,5 2,0 1,7 1,6 1,8 1,8 1,7 1,7 23 2,4
Regular Standard 3,0 3,9 3,4 3,2 3,5 3,5 3,3 3,3 45 4,3
Regular Boosted 4,5 5,8 5,2 4,8 5,3 5,2 5,0 5,0 67 6,8
Enhanced Standard 5,9 7,5 6,9 6,3 6,9 6,9 6,5 6,5 88 7,8
Enhanced Boosted 9,1 11,6 10,6 9,7 10,6 10,6 10,1 10,1 136 11,8
15 x 5 Eco Standard 2,2 2,8 2,6 2,4 2,6 2,6 2,5 2,5 16 3,4
Regular Standard 4,4 5,6 5,2 4,7 5,2 5,2 4,9 4,9 31 6,8
2 CTDI100 Values expressed in mGy. The tolerance is ± 30%. CTDI100 values measured according to IEC 60601-2-44: 2009 Par.
203.109.1.
3 CTDIperh (CTDI peripheral) Values expressed in mGy. The tolerance is ± 30%. CTDIw and CTDIvol values calculated according to IEC
60601-2-44: 2009 Par. 201.3.211 and 201.3.212 c).
4 CTDIW (CTDI weighted)Values expressed in mGy. The tolerance is ± 30%. CTDIw and CTDIvol values calculated according to IEC
60601-2-44: 2009 Par. 201.3.211 and 201.3.212 c).
5 CTDIvol (CTDI volumetric)Values expressed in mGy. The tolerance is ± 30%. CTDIw and CTDIvol values calculated according to IEC
60601-2-44: 2009 Par. 201.3.211 and 201.3.212 c).
6 CTDIfree air Values expressed in mGy. The tolerance is ± 30%. CTDIfree air values calculated according to IEC 60601-2-44: 2009 Par.
203.109.2.
7 DLP Values expressed in mGy*cm. The tolerance is ± 30%. DLP values as defined in IEC 60601-2-44:2009 par. 201.3.214.
8 Loading factors automatically set by the software using a “Head Phantom” in compliance with IEC 60601-2-44: 2009 Par. 203.108
positioned in the centre of the FOV.
EN DOSE DECLARATION AND ACCEPTANCE TEST 12
Declared Dose: CTDI (CTDI100 2, CTDIperh
3, CTDIw 4, CTDIvol
5, CTDIfreeair 6)
and DLP7 using typical loading factors8
FOV Scan
protocol
Dose
protocol
CTDI 100
Center
CTDI 100
North
CTDI 100
West
CTDI 100
South
CTDI 100
East CTDI perh CTDI w CTDI vol DLP
CTDI
free air
cm x cm // // mGy mGy mGy mGy mGy mGy mGy mGy mGy*cm mGy
Regular Boosted 6,4 8,3 7,7 6,9 7,7 7,7 7,3 7,3 47 10,2
Enhanced Standard 8,6 11,2 10,1 9,2 10,1 10,1 9,6 9,6 62 11,8
Enhanced Boosted 12,7 16,5 14,9 13,6 14,9 15,0 14,2 14,2 91 17,5
12 x 8
Eco Standard 1,7 2,1 1,8 1,6 1,8 1,8 1,8 1,8 16 2,7
Regular Standard 3,6 4,1 3,6 3,2 3,6 3,6 3,6 3,6 33 6,3
Regular Boosted 5,3 6,3 5,4 4,8 5,4 5,5 5,4 5,4 50 12,5
Enhanced Standard 7,0 8,1 7,1 6,1 6,8 7,0 7,0 7,0 65 10,5
Enhanced Boosted 10,5 12,3 10,8 9,2 10,2 10,6 10,6 10,6 98 15,7
10 x 10
Eco Standard 1,5 1,6 1,3 1,2 1,3 1,4 1,4 1,4 16 2,8
Regular Standard 3,0 3,1 2,7 3,5 2,7 3,0 3,0 3,0 34 5,7
Regular Boosted 4,5 4,6 4,1 3,7 4,1 4,1 4,2 4,2 49 8,6
Enhanced Standard 6,4 6,5 5,4 5,4 5,4 5,7 5,9 5,9 68 9,7
Enhanced Boosted 9,5 9,6 8,0 8,0 8,0 8,4 8,7 8,7 100 14,1
10 x 5
Eco Standard 2,0 2,1 1,8 1,6 1,7 1,8 1,9 1,9 12 4,0
Regular Standard 4,1 4,1 3,6 3,2 3,5 3,6 3,8 3,8 24 8,0
Regular Boosted 6,1 6,1 5,4 4,8 5,2 5,4 5,6 5,6 36 12,1
Enhanced Standard 9,2 9,3 7,9 6,9 7,9 8,0 8,4 8,4 54 13,2
Enhanced Boosted 13,6 13,7 11,7 10,2 11,7 11,8 12,4 12,4 80 19,6
8x8
Eco Standard 1,8 1,6 1,3 1,2 1,3 1,4 1,5 1,5 14 3,3
Regular Standard 3,7 3,3 2,7 2,4 2,6 2,7 3,1 3,1 28 6,7
Regular Boosted 5,4 4,8 3,9 3,6 3,8 4,0 4,5 4,5 42 9,9
Enhanced Standard 7,5 6,4 5,2 4,7 5,2 5,4 6,1 6,1 56 11,8
Enhanced Boosted 10,8 9,2 7,5 6,7 7,5 7,7 8,7 8,7 81 16,8
8x5
Eco Standard 2,1 1,9 1,5 1,4 1,5 1,6 1,8 1,8 11 3,9
Regular Standard 4,4 3,8 3,1 2,9 3,1 3,2 3,6 3,6 23 7,9
Regular Boosted 6,3 5,6 4,6 4,2 4,5 4,8 5,3 5,3 34 11,6
Enhanced Standard 8,5 7,5 5,8 5,3 5,8 6,1 6,9 6,9 44 13,4
Enhanced Boosted 13,6 12,1 9,3 8,5 9,3 9,8 11,0 11,0 71 21,3
EN DOSE DECLARATION AND ACCEPTANCE TEST 13
Declared Dose: CTDI (CTDI100 2, CTDIperh
3, CTDIw 4, CTDIvol
5, CTDIfreeair 6)
and DLP7 using typical loading factors8
FOV Scan
protocol
Dose
protocol
CTDI 100
Center
CTDI 100
North
CTDI 100
West
CTDI 100
South
CTDI 100
East CTDI perh CTDI w CTDI vol DLP
CTDI
free air
cm x cm // // mGy mGy mGy mGy mGy mGy mGy mGy mGy*cm mGy
6x6
Eco Standard 0,5 0,4 0,3 0,3 0,3 0,3 0,4 0,4 3 0,9
Regular Standard 3,8 2,9 2,3 2,1 2,2 2,4 2,8 2,8 21 7,4
Regular Boosted 5,6 4,2 3,4 3,1 3,3 3,5 4,2 4,2 31 11,2
Enhanced Standard 7,5 5,7 4,4 4,0 4,3 4,6 5,6 5,6 41 13,2
Enhanced Boosted 11,7 8,9 6,8 6,1 6,7 7,1 8,6 8,6 63 20,2
15x5
HiRes
Eco Standard 5,5 7,2 6,9 6,0 6,7 6,7 6,3 6,3 40 9,6
Regular Standard 11,2 14,7 13,8 12,1 13,6 13,6 12,8 12,8 82 19,1
Regular Boosted 16,1 21,2 20,0 17,6 19,5 19,6 18,4 18,4 118 27,4
Enhanced Standard 21,7 27,5 25,2 23,1 25,8 25,4 24,2 24,2 155 29,1
Enhanced Boosted 32,7 41,5 37,9 34,8 38,9 38,3 36,4 36,4 233 43,2
12x8
HiRes
Eco Standard 4,8 5,9 5,2 4,3 4,9 5,1 5,0 5,0 46 7,9
Regular Standard 9,6 11,8 10,5 8,7 9,8 10,2 10,0 10,0 92 16,1
Regular Boosted 14,9 17,9 16,2 13,3 15,2 15,7 15,4 15,4 142 24,5
Enhanced Standard 17,3 19,8 17,5 14,9 16,7 17,2 17,2 17,2 159 26,0
Enhanced Boosted 26,4 30,3 26,8 22,7 25,5 26,3 26,4 26,4 243 39,3
10x10
HiRes
Eco Standard 4,2 4,8 3,9 3,4 3,8 4,0 4,0 4,0 46 7,1
Regular Standard 9,0 9,5 7,6 6,6 7,5 7,8 8,2 8,2 94 14,4
Regular Boosted 13,9 14,7 12,0 10,2 11,7 12,1 12,7 12,7 146 22,2
Enhanced Standard 14,8 15,2 12,7 11,2 12,7 12,9 13,6 13,6 155 21,7
Enhanced Boosted 24,3 24,8 20,8 18,4 20,8 21,2 22,2 22,2 255 35,7
10x5
HiRes
Eco Standard 6,3 6,8 5,5 4,6 5,0 5,5 5,8 5,8 37 10,5
Regular Standard 12,7 13,7 11,1 9,4 9,9 11,0 11,6 11,6 74 20,8
Regular Boosted 16,6 18,2 14,9 12,1 13,4 14,6 15,3 15,3 98 27,1
Enhanced Standard 23,7 24,8 19,7 17,5 19,7 20,4 21,5 21,5 138 32,6
Enhanced Boosted 30,7 32,1 25,5 22,6 25,5 26,4 27,9 27,9 179 42,6
8x8
HiRes
Eco Standard 5,0 4,6 3,6 3,1 3,5 3,7 4,2 4,2 38 9,1
Regular Standard 10,2 9,4 7,4 6,4 7,1 7,6 8,5 8,5 78 18,3
Regular Boosted 13,8 12,6 10,0 8,7 9,6 10,2 11,4 11,4 105 24,8
EN DOSE DECLARATION AND ACCEPTANCE TEST 14
Declared Dose: CTDI (CTDI100 2, CTDIperh
3, CTDIw 4, CTDIvol
5, CTDIfreeair 6)
and DLP7 using typical loading factors8
FOV Scan
protocol
Dose
protocol
CTDI 100
Center
CTDI 100
North
CTDI 100
West
CTDI 100
South
CTDI 100
East CTDI perh CTDI w CTDI vol DLP
CTDI
free air
cm x cm // // mGy mGy mGy mGy mGy mGy mGy mGy mGy*cm mGy
Enhanced Standard 18,3 15,8 12,6 11,4 12,6 13,1 14,8 14,8 137 28,3
Enhanced Boosted 25,0 21,6 17,2 15,7 17,2 17,9 20,3 20,3 187 39,0
8x5
HiRes
Eco Standard 6,1 5,7 4,1 3,8 4,1 4,4 5,0 5,0 32 10,9
Regular Standard 12,7 12,0 8,5 8,1 8,6 9,3 10,4 10,4 67 22,0
Regular Boosted 15,3 14,8 10,6 9,9 10,6 11,5 12,8 12,8 82 26,8
Enhanced Standard 20,7 17,6 14,7 12,6 14,7 14,9 16,8 16,8 108 32,4
Enhanced Boosted 27,5 23,4 19,5 16,7 19,6 19,8 22,4 22,4 143 42,2
6x6
HiRes
Eco Standard 5,3 4,0 3,1 2,9 3,1 3,3 4,0 4,0 29 11,3
Regular Standard 10,7 8,2 6,2 5,9 6,1 6,6 8,0 8,0 58 22,3
Regular Boosted 13,1 9,9 8,2 7,1 7,9 8,3 9,9 9,9 72 26,8
Enhanced Standard 18,0 13,4 10,9 9,4 10,9 11,1 13,4 13,4 98 34,4
Enhanced Boosted 22,7 16,8 13,7 11,8 13,7 14,0 16,9 16,9 123 43,0
15x22e
Eco Standard 2,0 2,5 2,3 2,1 2,3 2,3 2,2 2,4 65 4,7
Regular Standard 4,0 5,0 4,6 4,2 4,5 4,6 4,4 4,8 129 9,3
Regular Boosted 5,9 7,3 6,9 6,3 7,1 6,9 6,6 7,2 193 14,1
EN DOSE DECLARATION AND ACCEPTANCE TEST 15
Declared Dose: Air Kerma9 and DAP10 using typical loading factors11
FOV Scan protocol Dose protocol Air Kerma DAP
cm x cm // // mGy mGy*cm2
21x19
Eco Standard 2,0 786
Regular Standard 3,9 1.519
Regular Boosted 6,2 2.450
Enhanced Standard 6,6 2.587
Enhanced Boosted 9,6 3.791
18x16
Eco Standard 2,0 604
Regular Standard 3,8 1.184
Regular Boosted 5,9 1.824
Enhanced Standard 6,7 2.064
Enhanced Boosted 10,1 3.125
15 x 12
Eco Standard 2,1 458
Regular Standard 4,2 916
Regular Boosted 6,2 1.358
Enhanced Standard 7,3 1.580
Enhanced Boosted 11,0 2.388
15 x 5
Eco Standard 2,5 258
Regular Standard 5,0 516
Regular Boosted 7,5 767
Enhanced Standard 8,7 896
Enhanced Boosted 12,8 1.318
12 x 8
Eco Standard 2,6 316
Regular Standard 5,2 642
Regular Boosted 7,8 958
Enhanced Standard 8,9 1.090
9 Air Kerma Values expressed in mGy. The tolerance is ± 30%. Air Kerma values as defined in IEC 60601-1-3:2008 par. 3.4 calculated
according to IEC 60601-2-63:2012 par. 203.6.4.5.
10 Values expressed in mGy*cm2. The tolerance is ± 30%. DAP values as defined in IEC 60601-2-63:2012 par. 201.3.204 calculated
according to IEC 60601-2-63:2012 par. 203.6.4.5.
11 Loading factors automatically set by the software using a “Head Phantom” in compliance with IEC 60601-2-44: 2009 Par. 203.108
positioned in the centre of the FOV.
EN DOSE DECLARATION AND ACCEPTANCE TEST 16
Declared Dose: Air Kerma9 and DAP10 using typical loading factors11
FOV Scan protocol Dose protocol Air Kerma DAP
cm x cm // // mGy mGy*cm2
Enhanced Boosted 13,1 1.613
10 x 10
Eco Standard 2,6 343
Regular Standard 5,4 696
Regular Boosted 8,0 1.044
Enhanced Standard 9,1 1.183
Enhanced Boosted 13,3 1.728
10 x 5
Eco Standard 2,9 213
Regular Standard 6,0 438
Regular Boosted 9,0 652
Enhanced Standard 9,9 718
Enhanced Boosted 14,6 1.054
8x8
Eco Standard 2,8 244
Regular Standard 5,7 493
Regular Boosted 8,5 732
Enhanced Standard 10,0 868
Enhanced Boosted 14,3 1.233
8x5
Eco Standard 2,9 173
Regular Standard 5,9 353
Regular Boosted 8,7 519
Enhanced Standard 10,2 606
Enhanced Boosted 15,9 949
6x6
Eco Standard 0,7 39
Regular Standard 6,1 321
Regular Boosted 8,3 435
Enhanced Standard 10,7 560
Enhanced Boosted 16,3 857
15x5 HiRes
Eco Standard 7,0 718
Regular Standard 13,9 1.429
Regular Boosted 19,8 2.029
Enhanced Standard 21,1 2.168
EN DOSE DECLARATION AND ACCEPTANCE TEST 17
Declared Dose: Air Kerma9 and DAP10 using typical loading factors11
FOV Scan protocol Dose protocol Air Kerma DAP
cm x cm // // mGy mGy*cm2
Enhanced Boosted 31,4 3.223
12x8 HiRes
Eco Standard 6,8 829
Regular Standard 13,3 1.631
Regular Boosted 20,4 2.501
Enhanced Standard 21,7 2.664
Enhanced Boosted 32,6 3.997
10x10 HiRes
Eco Standard 6,7 868
Regular Standard 13,6 1.766
Regular Boosted 20,8 2.701
Enhanced Standard 20,5 2.660
Enhanced Boosted 33,4 4.346
10x5 HiRes
Eco Standard 7,8 566
Regular Standard 15,4 1.111
Regular Boosted 19,9 1.442
Enhanced Standard 24,3 1.761
Enhanced Boosted 31,6 2.288
8x8 HiRes
Eco Standard 7,7 665
Regular Standard 15,2 1.318
Regular Boosted 20,7 1.788
Enhanced Standard 23,9 2.068
Enhanced Boosted 32,7 2.829
8x5 HiRes
Eco Standard 8,2 487
Regular Standard 16,4 975
Regular Boosted 20,0 1.191
Enhanced Standard 24,3 1.447
Enhanced Boosted 31,5 1.877
6x6 HiRes
Eco Standard 8,5 444
Regular Standard 16,7 874
Regular Boosted 20,2 1.062
Enhanced Standard 25,8 1.352
EN DOSE DECLARATION AND ACCEPTANCE TEST 18
Declared Dose: Air Kerma9 and DAP10 using typical loading factors11
FOV Scan protocol Dose protocol Air Kerma DAP
cm x cm // // mGy mGy*cm2
Enhanced Boosted 31,9 1.675
15x22e
Eco Standard 4,4 1.901
Regular Standard 8,7 3.779
Regular Boosted 13,0 5.647
FOV Scan Protocol shots Air Kerma DAP
mGy mGy*cm2
CineX
[18x19]
Scan time ≤20 sec 400 shots 2,80 1105
Full FOV
Scan time >20 sec 540 shots 3,79 1495
FOV Scan Protocol mA Air Kerma DAP
mGy mGy*cm2
Ray2D [18x19]
Exposure Time: 500ms
3 mA 0,092 37
6 mA 0,16 63
12 mA 0,29 114
24 mA 0,51 202
36 mA 0,74 290
48 mA 0,93 368
60 mA 1,11 438
70 mA 1,25 492
