2019-04ceflasupport.com/data/media/product_documentation/myray/... · 2019. 8. 23. · of standards...

97050997 Rev. 03 2019-04

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SUMMARY 1 APPLICABILITY 3

2 IEC ACCEPTANCE TEST 3 2.1 Positioning of the patient support [IEC 61223-3-5 par. 5.1] 3 2.2 Patient positioning accuracy [IEC 61223-3-5 par. 5.2] 3

2.2.1 Axial patient positioning accuracy [IEC 61223-3-5 par. 5.2.1] 3

2.2.2 Sagittal and coronal patient positioning light [IEC 61223-3-5 par. 5.2.2] 3

2.3 Tomographic section thickness [IEC 61223-3-5 par. 5.3] 4

2.3.1 Tomographic section thickness for axial scanning [IEC 61223-3-5 par. 5.3.1] 4

2.3.2 Tomographic section thickness for helical scanning [IEC 61223-3-5 par. 5.3.2] 4

2.4 Dose [IEC 61223-3-5 par. 5.4] 4 2.5 Noise, mean CT number and uniformity [IEC 61223-3-5 par. 5.5] 4 2.6 Spatial resolution [IEC 61223-3-5 par. 5.6] 4 2.7 IEC 61223-3-5: reference values 4

3 DOSE MEASUREMENTS 7 3.1 Loading factors for dose measurements in 3D operating modes 7 3.2 Table of CTDI100 declared for 3D operating modes of the device 9 3.3 Table of CTDIW, CTDIfree air, CTDIvol, DLP declared for 3D operating modes of the device 13 3.4 Air Kerma and DAP declared for 3D operating modes of the device 17 3.5 Air Kerma and DAP declared for 2D operating modes of the device 19

EN DOSE DECLARATION AND ACCEPTANCE TEST 3

1 Applicability

Values and measures contained in this document refer to the panoramic, cephalometric and tomographic

systems identified with serial numbers starting with one of the following combinations of characters:

70A1_____

70A2_____

70A3_____

70A4_____

70A5_____

70A6_____

70A7_____

The serial number with eight alphanumeric characters is visible on the identification plate of the device,

which is positioned at the base of the mobile column.

2 IEC Acceptance Test The description of software utilities used to carry out acceptance tests is contained in the Software Manual. Please find below the specific instructions of the equipment to carry out such tests (as per the requirements

of standards IEC 61223-3-4, IEC 61223-3-5 and DIN 6868-161).

For each test, the relevant paragraph of the reference standard is specified.

At the end of the chapter a table containing the reference values is available.

2.1 Positioning of the patient support [IEC 61223-3-5 par. 5.1]

Not applicable.

2.2 Patient positioning accuracy [IEC 61223-3-5 par. 5.2]

The device is equipped with four laser targeting systems to facilitate patient positioning.

The upper horizontal positioning is used for CBCT, PAN, DENT, SIN and TMJ examinations for the correct

positioning of the patient, and in particular in PAN and DENT examinations to ensure that the patient’s

Frankfurt plane is horizontal.

The sagittal vertical trace ensures the symmetry of the patient head with respect to the sagittal midline.

The vertical focusing trace is used in PAN, DENT, SIN and TMJ examinations and indicates the exact

position of the focal point for the positioning of the upper canin cusp or the condylar head.

The lower horizontal trace is used in CBCT examinations for tracing the lower limit of the field of view, and in

CEPH examinations in order to ensure that the patient’s Frankfurt plane is horizontal.

No pointer is provided for the coronal plane detection.

2.2.1 Axial patient positioning accuracy [IEC 61223-3-5 par. 5.2.1]

Position an object along the axial plane indicated by the horizontal line and scan. For data analysis, see the

Software Manual.

2.2.2 Sagittal and coronal patient positioning light [IEC 61223-3-5 par. 5.2.2]

Position an object along the sagittal plane indicated by the vertical line and scan. For data analysis, see the

Software Manual.


2.3 Tomographic section thickness [IEC 61223-3-5 par. 5.3]

2.3.1 Tomographic section thickness for axial scanning [IEC 61223-3-5 par. 5.3.1]

Refer to the Software Manual.

2.3.2 Tomographic section thickness for helical scanning [IEC 61223-3-5 par. 5.3.2]

Not applicable.

2.4 Dose [IEC 61223-3-5 par. 5.4]

Perform scans for each mode as required by standard IEC 60601-2-44. The machine automatically

calculates the x-ray load according to the object acquired. No system is in place to manually select the x-ray

load for a scan.

2.5 Noise, mean CT number and uniformity [IEC 61223-3-5 par. 5.5]


2.6 Spatial resolution [IEC 61223-3-5 par. 5.6]


2.7 IEC 61223-3-5: reference values

The following table contains reference values and operating conditions to be used for 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

Refer to Section 3.


5.5 Noise, mean CT

number and uniformity

Loading factors: automatically selected by the software.

Values are calculated as Arbitrary Units (a.u.) because the machine is not designed to

provide HUs. Measurements carried out on Catphan 500 phantom.

FOV Mode Axial

Thickness Stand. Dev Mean CT N. Uniformity

6 x 6

8 x 6

8 x 8

10 x 6

10 x 8

10 x 10

13 x 8

15 x 6

13 x 10

16 x 10

13 x 14e

13 x 16e

16 x 18e

9 x 16e

Low Dose

Regular

Best Quality

500 µm ≤ 300 1050 ± 150 ≤ 120

4 x 4

9 x 9

7 x 6

Low Dose

Regular

Best Quality

500 µm ≤ 220 1050 ± 150 ≤ 80


5.6 Spatial resolution Loading factors: automatically selected by the software.

FOV Mode MTF10 (lp/cm) MTF50 (lp/cm)

6 x 6

8 x 6

8 x 8

10 x 6

10 x 8

10 x 10

13 x 8

15 x 6

Low Dose ≥ 11 ≥ 6

Regular ≥ 12 ≥ 6

Best Quality ≥ 16 ≥ 6

13 x 10

16 x 10

13 x 14e

13 x 16e

16 x 18e

9 x 16e

Low Dose ≥ 11 ≥ 6



4 x 4

9 x 9

7 x 6

Low Dose ≥ 11 ≥ 11




3 Dose measurements

3.1 Loading factors for dose measurements in 3D operating modes

Loading factors automatically set by the software using a head phantom compliant with IEC 60601-2-44 Par.

203.108 positioned at FOV centre.

Table 1 – Typical Loading Factors using “Adult Head Phantom” and “Pediatric Head Phantom” for 3D operating modes

FOV Dose

Tube

Voltage

Total

Shots

Number

Single

Shot

Time

Exposure

Time

Adult Head Phantom Pediatric Head

Phantom

Radiologic

Load

Anodic

Current

Radiologic

Load

Anodic

Current

kV shots ms s mAs mA mAs mA

6 x 6

Low dose 90 160 10 1.6 7.26 4.54 4.80 3.00

Regular 90 360 10 3.6 19.88 5.52 11.20 3.00

Best quality 90 400 20 8.0 80.00 10.00 32.00 4.00

8 x 6

Low dose 90 160 10 1.6 4.80 3.00 4.80 3.00

Regular 90 360 10 3.6 14.40 4.00 10.80 3.00

Best quality 90 400 20 8.0 84.00 10.50 32.00 4.00

8 x 8

Low dose 90 160 10 1.6 4.80 3.00 4.80 3.00

Regular 90 360 10 3.6 12.60 3.50 10.80 3.00

Best quality 90 400 20 8.0 52.20 6.52 32.00 4.00

10 x 6

Low dose 90 160 10 1.6 5.66 3.54 4.80 3.00

Regular 90 360 10 3.6 16.24 4.51 10.80 3.00

Best quality 90 400 20 8.0 48.00 6.00 32.00 4.00

10 x 8

Low dose 90 160 10 1.6 4.80 3.00 4.80 3.00

Regular 90 360 10 3.6 13.86 3.85 11.88 3.30

Best quality 90 400 20 8.0 32.00 4.00 32.00 4.00

10 x 10

Low dose 90 160 10 1.6 4.80 3.00 4.80 3.00

Regular 90 360 10 3.6 11.88 3.30 11.88 3.30

Best quality 90 400 20 8.0 32.00 4.00 32.00 4.00

13 x 8

Low dose 90 240 10 2.4 7.20 3.00 7.20 3.00

Regular 90 360 10 3.6 16.24 4.51 10.80 3.00

Best quality 90 400 20 8.0 68.00 8.50 32.00 4.00

13 x 10

Low dose 90 240 10 2.4 7.20 3.00 7.20 3.00

Regular 90 360 10 3.6 13.86 3.85 11.88 3.30

Best quality 90 400 13 5.2 41.60 8.00 20.80 4.00

13 x 14e

Low dose 90 480 10 4.8 14.40 3.00 14.40 3.00

Regular 90 720 10 7.2 32.48 4.51 21.60 3.00

Best quality 90 800 13 10.3 82.20 8.00 41.60 4.00


Table 1 – Typical Loading Factors using “Adult Head Phantom” and “Pediatric Head Phantom” for 3D operating modes

FOV Dose

Tube

Voltage

Total

Shots

Number

Single

Shot

Time

Exposure

Time

Adult Head Phantom Pediatric Head

Phantom

Radiologic

Load

Anodic

Current

Radiologic

Load

Anodic

Current

kV shots ms s mAs mA mAs mA

13 x 16e

Low dose 90 480 10 4.8 14.40 3.00 14.40 3.00

Regular 90 720 10 7.2 27.72 3.85 23.76 3.30

Best quality 90 800 13 10.3 82.20 8.00 41.60 4.00

15 x 6

Low dose 90 240 10 2.4 7.20 3.00 7.20 3.00

Regular 90 360 10 3.6 12.60 3.50 10.80 3.00

Best quality 90 400 20 8.0 72.00 9.00 32.00 4.00

16 x 10

Low dose 90 240 10 2.4 7.20 3.00 7.20 3.00

Regular 90 360 10 3.6 11.77 3.27 11.77 3.27

Best quality 90 400 13 5.2 36.40 7.00 20.80 4.00

16 x 18e

Low dose 90 480 10 4.8 14.40 3.00 14.40 3.00

Regular 90 720 10 7.2 27.47 3.82 23.54 3.27

Best quality 90 800 13 10.4 83.20 8.00 41.60 4.00

4 x 4

Low dose 90 90 10 0.9 3.54 3.93 3.54 3.93

Regular 90 360 10 3.6 18.00 5.00 10.80 3.00

Best quality 90 400 20 8.0 84.00 10.50 32.00 4.00

9 x 9

Low dose 90 160 10 1.6 4.80 3.00 4.80 3.00

Regular 90 360 10 3.6 11.88 3.30 11.88 3.30

Best quality 90 400 20 8.0 32.00 4.00 32.00 4.00

7 x 6

Low dose 90 160 10 1.6 4.80 3.00 4.80 3.00

Regular 90 360 10 3.6 16.24 4.51 10.80 3.00

Best quality 90 400 20 8.0 60.20 7.52 32.00 4.00

9 x 16e

Low dose 90 480 10 4.8 14.40 3.00 14.40 3.00

Regular 90 720 12 8.9 29.26 3.30 23.76 3.30

Best quality 90 800 13 10.4 88.40 8.50 41.60 4.00


3.2 Table of CTDI100 declared for 3D operating modes of the device

Values expressed in mGy. Tolerance is ± 30%. CTDI100 values measured in accordance with IEC 60601-2-

44 Par. 203.109.1. Loading factors as per reference Table 1.

Table 2A: CTDI100 – Measures with “Adult Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI100

Center

CTDI100

North

CTDI100

West

CTDI100

South

CTDI100

East

CTDI100

Peripheral

mGy mGy mGy mGy mGy mGy

6 x 6

Low dose 0.8 0.7 2.3 0.5 1.6 1.3

Regular 2.1 1.3 1.7 1.1 2.4 1.6

Best quality 8.6 5.2 7.0 4.5 9.7 6.6

8 x 6

Low dose 0.5 0.4 1.4 0.3 1.0 0.8

Regular 1.4 0.9 1.2 0.7 1.6 1.1

Best quality 9.5 5.8 7.7 5.0 10.8 7.3

8 x 8

Low dose 0.5 0.4 1.3 0.3 1.0 0.8

Regular 1.4 0.9 1.2 0.7 1.6 1.1

Best quality 6.0 3.6 4.8 3.1 6.8 4.6

10 x 6

Low dose 0.7 0.5 1.8 0.4 1.3 1.0

Regular 1.8 1.1 1.5 0.9 2.0 1.4

Best quality 5.2 3.1 4.2 2.7 5.8 4.0

10 x 8

Low dose 0.5 0.4 1.3 0.3 1.0 0.8

Regular 1.6 1.0 1.3 0.8 1.8 1.2

Best quality 3.4 2.1 2.7 1.8 3.8 2.6

10 x 10

Low dose 0.5 0.4 1.3 0.3 0.9 0.7

Regular 1.1 0.7 0.9 0.6 1.3 0.9

Best quality 3.3 2.0 2.7 1.7 3.8 2.6

13 x 8

Low dose 0.7 0.6 0.4 0.6 0.8 0.6

Regular 1.8 1.4 0.9 1.6 2.0 1.5

Best quality 5.8 6.3 4.0 6.9 8.7 6.5

13 x 10

Low dose 0.7 0.6 0.4 0.6 0.8 0.6

Regular 1.5 1.3 0.8 1.4 1.7 1.3

Best quality 4.2 3.4 2.2 3.7 4.7 3.5

13 x 14e

Low dose 1.4 1.2 0.7 1.3 1.6 1.2

Regular 3.5 2.9 1.8 3.2 4.0 3.0

Best quality 15.4 12.7 8.1 13.8 17.4 13.0

13 x 16e

Low dose 1.4 1.2 0.7 1.3 1.6 1.2

Regular 3.4 2.8 1.8 3.1 3.9 2.9

Best quality 11.5 9.4 6.0 10.3 13.0 9.7


Table 2A: CTDI100 – Measures with “Adult Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI100

Center

CTDI100

North

CTDI100

West

CTDI100

South

CTDI100

East

CTDI100

Peripheral


15 x 6

Low dose 0.7 0.6 0.4 0.7 0.8 0.6

Regular 1.4 1.2 0.8 1.3 1.6 1.2

Best quality 7.8 6.5 4.1 7.0 8.9 6.6

16 x 10

Low dose 0.7 0.6 0.4 0.6 0.8 0.6

Regular 1.1 0.9 0.6 1.0 1.3 1.0

Best quality 3.6 3.0 1.9 3.3 4.1 3.1

16 x 18e

Low dose 1.4 1.1 0.7 1.3 1.6 1.2

Regular 2.2 1.9 1.2 2.0 2.5 1.9

Best quality 7.3 6.0 3.8 6.5 8.2 6.2

4 x 4

Low dose 0.4 0.1 0.4 0.1 0.1 0.2

Regular 2.2 0.6 0.9 0.7 0.8 0.8

Best quality 9.5 6.0 5.0 4.7 4.6 5.1

9 x 9

Low dose 0.6 0.4 1.4 0.4 1.0 0.8

Regular 1.4 0.8 1.1 0.8 1.4 1.0

Best quality 4.1 2.4 3.1 2.3 4.1 3.0

7 x 6

Low dose 0.6 0.4 1.4 0.4 1.0 0.8

Regular 2.2 1.2 1.6 1.2 2.2 1.5

Best quality 8.4 4.8 6.2 4.6 8.4 6.0

9 x 16e

Low dose 1.2 0.7 0.9 0.6 1.2 0.8

Regular 2.9 1.6 2.1 1.6 2.9 2.0

Best quality 8.2 4.7 6.1 4.5 8.3 5.9


Table 2B: CTDI100 – Measures with “Pediatric Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI100

Center

CTDI100

North

CTDI100

West

CTDI100

South

CTDI100

East

CTDI100

Peripheral


6 x 6

Low dose 0.7 0.8 0.4 0.8 1.3 0.8

Regular 1.6 1.7 1.8 1.8 1.8 1.8

Best quality 5.0 5.6 5.9 5.7 5.9 5.8

8 x 6

Low dose 0.7 0.8 0.4 0.9 1.3 0.8

Regular 1.6 1.7 1.8 1.8 1.8 1.8

Best quality 5.0 5.6 5.9 5.7 5.9 5.8

8 x 8

Low dose 0.7 0.8 0.4 0.9 1.3 0.9

Regular 1.6 1.8 1.9 1.8 1.9 1.9

Best quality 5.1 5.7 6.1 5.8 6.0 5.9

10 x 6

Low dose 0.7 0.8 0.4 0.9 1.3 0.9

Regular 1.6 1.8 1.9 1.8 1.9 1.8

Best quality 5.0 5.6 5.9 5.7 5.9 5.8

10 x 8

Low dose 0.7 0.8 0.4 0.9 1.3 0.9

Regular 1.8 2.0 2.1 2.0 2.1 2.1

Best quality 5.1 5.8 6.1 5.9 6.1 6.0

10 x 10

Low dose 0.7 0.8 0.4 0.9 1.3 0.9

Regular 1.8 2.0 2.1 2.0 2.1 2.0

Best quality 5.0 5.7 6.0 5.8 6.0 5.8

13 x 8

Low dose 1.1 0.9 0.8 0.9 1.0 0.9

Regular 1.6 1.4 1.2 1.4 1.5 1.4

Best quality 3.9 4.4 3.9 4.4 4.7 4.4

13 x 10

Low dose 1.0 0.9 0.8 0.9 1.0 0.9

Regular 1.7 1.5 1.3 1.5 1.6 1.5

Best quality 3.0 2.7 2.4 2.7 2.9 2.7

13 x 14e

Low dose 2.1 1.9 1.7 1.9 2.0 1.9

Regular 3.1 2.8 2.5 2.8 3.0 2.8

Best quality 10.0 8.8 7.8 8.9 9.5 8.7

13 x 16e

Low dose 2.1 1.8 1.6 1.9 2.0 1.8

Regular 3.4 3.0 2.7 3.0 3.2 3.0

Best quality 7.8 6.9 6.1 6.9 7.4 6.8

15 x 6

Low dose 1.1 0.9 0.8 0.9 1.0 0.9

Regular 1.6 1.4 1.2 1.4 1.5 1.4

Best quality 4.9 4.3 3.8 4.3 4.6 4.3


Table 2B: CTDI100 – Measures with “Pediatric Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI100

Center

CTDI100

North

CTDI100

West

CTDI100

South

CTDI100

East

CTDI100

Peripheral


16 x 10

Low dose 1.0 0.9 0.8 0.9 1.0 0.9

Regular 1.7 1.5 1.3 1.5 1.6 1.5

Best quality 3.1 2.7 2.4 2.7 2.9 2.7

16 x 18e

Low dose 2.1 1.8 1.6 1.8 2.0 1.8

Regular 3.4 3.0 2.6 3.0 3.2 2.9

Best quality 6.2 5.4 4.8 5.5 5.9 5.4

4 x 4

Low dose 0.6 0.3 0.7 0.2 0.2 0.4

Regular 2.5 1.2 1.2 1.1 1.0 1.1

Best quality 7.6 4.0 3.5 3.5 3.5 3.6

9 x 9

Low dose 0.9 1.0 0.5 1.1 1.7 1.1

Regular 2.3 2.4 2.6 2.5 2.6 2.5

Best quality 6.5 7.1 7.5 7.2 7.6 7.3

7 x 6

Low dose 0.9 1.0 0.5 1.1 1.6 1.1

Regular 2.0 2.2 2.3 2.3 2.4 2.3

Best quality 6.4 6.9 7.3 7.0 7.4 7.1

9 x 16e

Low dose 1.8 2.0 2.1 2.0 2.1 2.1

Regular 4.5 4.9 5.1 5.0 5.2 5.1

Best quality 13.1 14.2 14.9 14.4 15.1 14.7


3.3 Table of CTDIW, CTDIfree air, CTDIvol, DLP declared for 3D operating modes of the device

CTDIW, CTDIfree air, CTDIvol values expressed in mGy. DLP values expressed in mGy*cm.

Tolerance is ± 30%. For this application, CTDIW values correspond to CTDIvol.

CTDIW values are calculated in compliance with IEC 60601-2-44 Par. 201.3.211 and 201.3.212 c). CTDIfree air

values are calculated in compliance with IEC 60601-2-44 Par. 203.109.2. DLP values are calculated in

compliance with IEC 60601-2-44 Par. 201.3.214.

Loading factors as per reference Table 1.

Table 3A: CTDIFree Air, CTDIw, CTDIvol, DLP – Measures with “Adult Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI

Free Air

CTDI

Weighted

CTDI

Volumetric DLP

mGy mGy mGy mGy *cm

6 x 6

Low dose 0.9 1.1 1.1 6.8

Regular 2.5 1.8 1.8 10.9

Best quality 10.0 7.2 7.2 43.5

8 x 6

Low dose 0.6 0.7 0.7 4.1

Regular 1.7 1.2 1.2 7.2

Best quality 11.1 8.0 8.0 48.2

8 x 8

Low dose 0.7 0.7 0.7 5.3

Regular 2.2 1.2 1.2 9.6

Best quality 9.3 5.0 5.0 40.4

10 x 6

Low dose 0.7 0.9 0.9 5.4

Regular 2.1 1.5 1.5 9.1

Best quality 6.0 4.4 4.4 26.2

10 x 8

Low dose 0.7 0.7 0.7 5.3

Regular 2.4 1.3 1.3 10.6

Best quality 5.3 2.9 2.9 22.9

10 x 10

Low dose 0.9 0.7 0.7 6.5

Regular 2.2 1.0 1.0 9.6

Best quality 6.5 2.8 2.8 28.2

13 x 8

Low dose 1.0 0.6 0.6 5.1

Regular 2.5 1.6 1.6 12.6

Best quality 10.9 6.3 6.3 50.2

13 x 10

Low dose 1.2 0.6 0.6 6.2

Regular 2.7 1.4 1.4 13.7

Best quality 7.3 3.7 3.7 37.2

13 x 14e

Low dose 2.0 1.3 1.5 23.4

Regular 5.0 3.2 3.6 57.6

Best quality 21.8 13.8 15.8 252.6


Table 3A: CTDIFree Air, CTDIw, CTDIvol, DLP – Measures with “Adult Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI

Free Air

CTDI

Weighted

CTDI

Volumetric DLP

mGy mGy mGy mGy *cm

13 x 16e

Low dose 2.2 1.3 1.4 25.4

Regular 5.4 3.1 3.4 61.9

Best quality 18.2 10.3 11.6 208.1

15 x 6

Low dose 0.8 0.7 0.7 4.0

Regular 1.5 1.3 1.3 7.8

Best quality 8.3 7.0 7.0 42.2

16 x 10

Low dose 1.2 0.6 0.6 6.2

Regular 2.0 1.0 1.0 10.1

Best quality 6.4 3.3 3.3 32.6

16 x 18e

Low dose 2.5 1.2 1.4 27.7

Regular 4.0 2.0 2.2 44.8

Best quality 12.9 6.5 7.3 145.1

4 x 4

Low dose 0.4 0.3 0.3 1.1

Regular 1.8 1.2 1.2 5.1

Best quality 9.0 6.5 6.5 26.3

9 x 9

Low dose 1.1 0.7 0.7 6.4

Regular 2.6 1.2 1.2 10.4

Best quality 7.6 3.3 3.3 30.1

7 x 6

Low dose 0.7 0.7 0.7 4.3

Regular 2.7 1.8 1.8 10.5

Best quality 10.3 6.8 6.8 40.7

9 x 16e

Low dose 2.1 0.9 1.0 18.9

Regular 5.3 2.3 2.6 46.9

Best quality 15.3 6.7 7.5 135.5


Table 3B: CTDIFree Air, CTDIW, CTDIvol, DLP – Measures with “Pediatric Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI

Free Air

CTDI

Weighted

CTDI

Volumetric DLP

mGy mGy mGy mGy *cm

6 x 6

Low dose 0.5 0.8 0.8 4.7

Regular 1.2 1.7 1.7 10.3

Best quality 3.9 5.5 5.5 32.9

8 x 6

Low dose 0.6 0.8 0.8 4.8

Regular 1.2 1.7 1.7 10.3

Best quality 3.9 5.5 5.5 33.1

8 x 8

Low dose 0.7 0.8 0.8 6.5

Regular 1.7 1.8 1.8 14.2

Best quality 5.4 5.6 5.6 45.2

10 x 6

Low dose 0.6 0.8 0.8 4.8

Regular 1.2 1.7 1.7 10.5

Best quality 3.9 5.5 5.5 33.2

10 x 8

Low dose 0.8 0.8 0.8 6.5

Regular 1.9 2.0 2.0 15.8

Best quality 5.4 5.7 5.7 45.6

10 x 10

Low dose 0.9 0.8 0.8 8.0

Regular 2.3 1.9 1.9 19.5

Best quality 6.6 5.6 5.6 55.7

13 x 8

Low dose 1.1 1.0 1.0 7.8

Regular 1.6 1.4 1.4 11.5

Best quality 4.9 4.2 4.2 33.6

13 x 10

Low dose 1.3 0.9 0.9 9.5

Regular 2.1 1.6 1.6 15.5

Best quality 3.8 2.8 2.8 28.0

13 x 14e

Low dose 2.1 1.9 4.4 71.1

Regular 3.1 2.9 3.3 52.7

Best quality 9.9 9.1 10.4 167.2

13 x 16e

Low dose 2.3 1.9 2.2 38.9

Regular 3.8 3.1 3.5 63.4

Best quality 8.7 7.2 8.1 145.2

15 x 6

Low dose 0.8 1.0 1.0 5.8

Regular 1.2 1.4 1.4 8.6

Best quality 3.6 4.5 4.5 26.8


Table 3B: CTDIFree Air, CTDIW, CTDIvol, DLP – Measures with “Pediatric Head Phantom” for 3D operating modes

Tolerance: ± 30%

FOV Dose

CTDI

Free Air

CTDI

Weighted

CTDI

Volumetric DLP

mGy mGy mGy mGy *cm

16 x 10

Low dose 1.3 1.0 1.0 9.5

Regular 2.1 1.5 1.5 15.4

Best quality 3.8 2.8 2.8 28.3

16 x 18e

Low dose 2.6 1.9 2.1 42.4

Regular 4.2 3.1 3.4 68.6

Best quality 7.6 5.7 6.3 125.6

4 x 4

Low dose 0.4 0.5 0.5 1.8

Regular 1.1 1.6 1.6 6.3

Best quality 3.4 4.9 4.9 19.8

9 x 9

Low dose 1.1 1.0 1.0 9.2

Regular 2.7 2.4 2.4 21.9

Best quality 7.8 7.1 7.1 63.6

7 x 6

Low dose 0.7 1.0 1.0 6.0

Regular 1.6 2.2 2.2 13.3

Best quality 5.0 6.9 6.9 41.3

9 x 16e

Low dose 2.2 2.0 2.2 40.4

Regular 5.3 4.9 5.5 98.6

Best quality 15.5 14.1 15.9 286.1


3.4 Air Kerma and DAP declared for 3D operating modes of the device

Values of Air Kerma as per IEC 60601-1-3:2008 + A1:2013 par. 3.4 calculated according to IEC 60601-2-

63:2012 + A1:2017 par. 203.6.4.5. Values expressed in mGy. Tolerance is ± 30%.

The ionisation chamber of the tool has been positioned on the rotation axis. To obtain the Air Kerma values

on the panel, multiply the values in the table by a factor equal to 0.35 for FOVs [4 x 4], [9 x 9], [7 x 6], [9 x

16e], or equal to 0.42 for the other FOVs,

DAP values as per IEC 60601-2-63:2012 + A1:2017 par. 201.3.204 calculated according to IEC 60601-2-

63:2012 + A1:2017 par. 203.6.4.5. Values expressed in mGy*cm2. Tolerance is ± 30%.

Loading factors as per reference Table 1.

Table 4: Air Kerma, DAP – Measures with “Adult Head Phantom” and “Pediatric Head Phantom” for 3D

operating modes. Tolerance: ± 30%

FOV Dose

ADULT HEAD PHANTOM PEDIATRIC HEAD PHANTOM

Air Kerma DAP Air Kerma DAP

mGy mGy *cm2 mGy mGy *cm2

6 x 6

Low dose 1.3 56.3 0.9 37.2

Regular 3.5 152.4 2.0 85.8

Best quality 14.1 605.5 5.6 242.2

8 x 6

Low dose 0.8 44.1 0.8 44.1

Regular 2.4 133.1 1.8 99.8

Best quality 15.5 872.9 5.9 332.5

8 x 8

Low dose 0.9 63.4 0.9 63.4

Regular 2.6 191.7 2.2 164.3

Best quality 10.9 800.0 6.7 490.4

10 x 6

Low dose 1.1 76.2 0.9 64.6

Regular 3.0 214.0 2.0 142.3

Best quality 8.5 611.3 5.6 407.6

10 x 8

Low dose 0.9 81.4 0.9 81.4

Regular 2.9 271.4 2.2 211.4

Best quality 6.2 582.8 6.2 582.8

10 x 10

Low dose 0.9 105.7 0.9 105.7

Regular 2.2 262.8 2.0 238.9

Best quality 6.3 760.4 6.3 760.4

13 x 8

Low dose 1.2 94.6 1.2 94.6

Regular 3.0 234.3 2.0 155.8

Best quality 12.8 1006.3 6.0 473.5

13 x 10

Low dose 1.2 123.3 1.2 123.3

Regular 2.7 269.7 2.1 210.2

Best quality 7.2 726.5 3.6 363.2

13 x 14e

Low dose 2.4 378.4 2.4 378.4

Regular 5.9 937.0 3.9 623.1

Best quality 25.5 4025.0 12.9 2037.0


Table 4: Air Kerma, DAP – Measures with “Adult Head Phantom” and “Pediatric Head Phantom” for 3D

operating modes. Tolerance: ± 30%

FOV Dose

ADULT HEAD PHANTOM PEDIATRIC HEAD PHANTOM

Air Kerma DAP Air Kerma DAP

mGy mGy *cm2 mGy mGy *cm2

13 x 16e

Low dose 2.4 435.3 2.4 435.3

Regular 5.9 1067.5 4.6 831.8

Best quality 20.0 3585.5 10.1 1814.6

15 x 6

Low dose 1.1 74.8 1.1 74.8

Regular 2.2 148.4 1.9 127.2

Best quality 11.8 794.1 5.2 352.9

16 x 10

Low dose 1.2 146.3 1.2 146.3

Regular 2.0 236.8 1.8 217.2

Best quality 6.3 760.4 3.6 434.5

16 x 18e

Low dose 2.4 585.1 2.4 585.1

Regular 3.9 947.1 3.1 744.8

Best quality 12.7 3041.5 6.3 1520.8

4 x 4

Low dose 0.8 17.4 0.8 17.4

Regular 4.1 82.4 2.4 48.2

Best quality 20.0 402.0 7.9 158.8

9 x 9

Low dose 1.0 104.2 1.0 104.2

Regular 2.6 258.3 2.4 234.8

Best quality 7.5 747.5 7.5 747.5

7 x 6

Low dose 1.0 49.0 1.0 49.0

Regular 3.8 185.4 2.5 123.3

Best quality 14.4 710.3 7.7 377.6

9 x 16e

Low dose 2.1 416.6 2.1 416.6

Regular 5.2 1033.2 3.8 762.8

Best quality 15.0 2989.8 7.0 1407.0


3.5 Air Kerma and DAP declared for 2D operating modes of the device

Values of Air Kerma as per IEC 60601-1-3:2008 + A1:2013 par. 3.4 calculated according to IEC 60601-2-

63:2012 + A1:2017 par. 203.6.4.5. Values expressed in mGy. Tolerance is ± 30%.

DAP values as per IEC 60601-2-63:2012 + A1:2017 par. 201.3.204 calculated according to IEC 60601-2-

63:2012 + A1:2017 par. 203.6.4.5. Values expressed in mGy*cm2. Tolerance is ± 30%.

The ionisation chamber of the tool has been positioned on the panel.

Table 5: Air Kerma, DAP – Measures in 2D operating modes (PAN, TMJ, SIN, CEPH projections).

Tolerance: ± 30%

Family Projection

Loading Factors AIR KERMA DAP

Exp

time Tube Voltage

Anodic

current Small Typical Large Small Typical Large

s kV

(small)

kV

(typical)

kV

(large) mA mGy mGy mGy mGy*cm2 mGy*cm2 mGy*cm2

PAN PAN

Standard 12.3 71 76 83 7 14.86 16.94 19.85 126.0 143.0 168.0

PAN Half PAN R 7.2 71 76 83 7 8.70 9.91 11.62 73.0 84.0 98.0

PAN Half PAN L 7.2 71 76 83 7 8.70 9.91 11.62 74.0 84.0 98.0

PAN Dentition 9.5 71 76 83 7 11.47 13.08 15.33 74.0 85.0 99.0

PAN Half R 6.1 71 76 83 7 7.37 8.40 9.85 47.7 54.0 64.0

PAN Half L 6.1 71 76 83 7 7.37 8.40 9.85 47.7 54.0 64.0

PAN Frontal

Dentition 4.2 71 76 83 7 5.07 5.78 6.80 32.8 37.4 44.8

PAN BiteWing 13.4 71 76 83 7 16.18 18.45 21.63 82.0 94.0 110.0

PAN BiteWing R 6.7 71 76 83 7 8.09 9.23 10.81 41.4 47.2 55.0

PAN BiteWing L 6.7 71 76 83 7 8.09 9.23 10.81 41.4 47.2 55.0

PAN PAN Child 11.2 65 69 73 7 11.25 12.77 14.29 83.0 95.0 106.0

PAN PAN Quick 6 71 76 83 7 7.25 8.26 9.68 61.0 70.0 82.0

PAN PAN Quick

Child 5.6 65 69 73 7 5.63 6.38 7.14 41.7 47.4 53.0

PAN Inferior 9.5 71 76 83 7 11.47 13.08 15.33 48.2 55.0 64.0

PAN Superior 9.5 71 76 83 7 11.47 13.08 15.33 55.0 63.0 74.0

PAN Half Inferior

R 6.1 71 76 83 7 7.37 8.40 9.85 30.9 35.3 41.0

PAN Half

Superior R 6.1 71 76 83 7 7.37 8.40 9.85 35.4 40.3 47.0

PAN Half Inferior

L 6.1 71 76 83 7 7.37 8.40 9.85 30.9 35.3 41.0



Tolerance: ± 30%

Family Projection


Exp

time Tube Voltage

Anodic


s kV

(small)

kV

(typical)

kV


PAN Half

Superior L 6.1 71 76 83 7 7.37 8.40 9.85 35.4 40.3 47.0

PAN Frontal Inferior

4.2 71 76 83 7 5.07 5.78 6.78 21.3 24.3 28.0

PAN Frontal

Superior 4.2 71 76 83 7 5.07 5.78 6.78 24.4 27.8 32.0

PAN PAN Ortho 16.5 71 76 83 7 19.93 22.72 26.63 169.0 192.0 225.0

PAN Half PAN Ortho R

10.2 71 76 83 7 12.32 14.05 16.46 104.0 119.0 139.0

PAN Half PAN Ortho L

10.2 71 76 83 7 12.32 14.05 16.46 104.0 119.0 139.0

PAN Half PAN Child R

6.7 65 69 83 7 6.73 7.64 8.55 49.9 57.0 63.0

PAN Half PAN Child L

6.7 65 69 83 7 6.73 7.64 8.55 49.9 57.0 63.0

TMJ TMJ PA R-

L 7.6 71 76 83 7 9.18 10.47 12.27 78.0 89.0 104.0

TMJ TMJ PA R

3X 11.4 71 76 83 7 13.77 15.70 18.40 117.0 133.0 156.0

TMJ TMJ PA L

3X 11.4 71 76 83 7 13.77 15.70 18.40 117.0 133.0 156.0

TMJ TMJ Lateral

R-L 7.8 71 76 83 7 9.42 10.74 12.59 80.0 91.0 107.0

TMJ TMJ Lateral

R 3X 11.7 71 76 83 7 14.13 16.11 18.88 120.0 136.0 160.0

TMJ TMJ Lateral

L 3X 11.7 71 76 83 7 14.13 16.11 18.88 120.0 136.0 160.0

SIN Maxillary SINUSES

6.5 71 76 83 7 7.85 8.95 10.49 66.0 76.0 89.0

SIN Maxillary SINUS R

5 71 76 83 7 6.04 6.89 8.07 51.0 58.0 68.0

SIN Maxillary SINUS L

5 71 76 83 7 6.04 6.89 8.07 51.0 58.0 68.0

CEPH CEPH Lat. short Quick

3.3 80 82 84 12 1.1 1.1 1.2 14.2 14.8 15.5

CEPH

CEPH Lat. short

reduced 9.0 80 82 84 12 2.9 3.1 3.2 33.3 34.8 36.3



Tolerance: ± 30%

Family Projection


Exp

time Tube Voltage

Anodic


s kV

(small)

kV

(typical)

kV


CEPH CEPH Lat. long Quick

4.5 80 82 84 12 1.5 1.5 1.6 19.4 20.2 21.1

CEPH

CEPH Lat.

long reduced

Quick 4.5 80 82 84 12 1.5 1.5 1.6 16.6 17.4 18.1

CEPH CEPH carpus

4.0 - 70 - 10 - 0.84 - - 11.08 -

CEPH CEPH Lat.

short 9.0 80 82 84 12 2.9 3.1 3.2 38.7 41.0 42.2

CEPH CEPH Lat.

long reduced 9.0 80 82 84 12 2.9 3.1 3.2 33.3 34.8 36.3

CEPH CEPH Lat.

long 9.0 80 82 84 12 2.9 3.1 3.2 38.7 41.0 42.2

CEPH CEPH AP-PA

9.0 80 82 84 12 2.9 3.1 3.2 38.7 40.4 42.2

CEPH

CEPH Lat.

short reduced

Quick

3.3 80 82 84 12 1.1 1.1 1.2 12.2 12.8 13.3

2019-04ceflasupport.com/data/media/product_documentation/myray/... · 2019. 8. 23. · of standards...

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