Whole-body X-ray CT System

Model ECLOS

DOSE AND SAFETY INFORMATION GUIDE

Tokyo, Japan

Copyright © Hitachi Medical Corporation. 2007. All rights reserved.

QS4 45456 E1E-BW1020-1

QS4 45456
This guide was originally drafted, approved and supplied by Hitachi Medical Corporation in the
English language.

CONTENTS
Page
1. X-ray tube assembly ···························································································· 1
2. Accuracy of radiation output ················································································· 1
3. Loading factors in CT system ················································································ 1
4. Radiation quality ································································································ 2
5. Computed Tomography Dose Index 100 ·································································· 2
6. Sensitivity profile and dose profile ········································································· 6
7. Stray radiation ··································································································· 9
8. Emergency stop ································································································ 10

E1E-BW1020-1
QS4 45456 i
QS4 45456
1. X-ray tube assembly
For information of X-ray tube assemblies, refer to the following instruction manuals
attached with X-ray tube assembly.
“GS3070 Rotating Anode X-ray tube”
“GS4570 Rotating Anode X-ray tube”
“Information for Users”
“Information for Assemblers”
“Information for Assembly and installation”

2. Accuracy of radiation output (IEC60601-2-44 cl. 50.101)

2.1 Accuracy of X-ray tube voltage and current
X-ray tube voltage: PAE = Display value +/- 5%
Cv = 0.05
X-ray tube current: PAE = Display value +/- 10% (in case of 10~25mA)
PAE = Display value +/- 8% (in case of over 50mA)
Cv = 0.05
PAE means the Percent Average Error. Cv means Coefficient of Variation

2.2 Linearity of Radiation Output

The quotients of the measured values of air kerma divided by the indicated values of
current time product (mAs), obtained at any two settings at above loading factors, do
not differ by more than 0.2 times the mean value of these quotients.
K1 K 2
+
K1 K 2 Q1 Q2
− ≤ 0.2 ×
Q1 Q2 2
where
K 1 , K 2 are the measured values of air kerma;
Q1 ,Q2 are the indicated current time product(mAs).

3. Loading factors in CT system (IEC60601-2-44 cl. 6.8.2)

Nominal X-ray tube voltage 130 kV @ 300 mA, large focus
130 kV @ 175 mA, small focus
Highest X-ray tube current 350 mA @ 120 kV, large focus
225mA @ 100 kV, small focus
Nominal electric power 42 kW @ 120 kV, 350 mA and 4s*
(* 4s is available loading time in volume scan only.)

Loading factor for leakage radiation 130 kV, 50 mA, large focus

E1E-BW1020-1
QS4 45456 1
4. Radiation quality
4.1 First half-value layer in CT(IEC60601-2-44 cl. 29.201.5)
100 kV: 3.0 mm Al minimum
120 kV: 3.8 mm Al minimum
130 kV: 4.2 mm Al minimum

4.2 Filtration (IEC60601-1-3 cl.29.201.3, cl. 29.201.4)

Inherent filtration in X-ray tube assembly: 1.0 mm Al minimum
Fixed wedge filter: 2.0 mm Al minimum
Total filtration in CT: 3.0 mm Al minimum

5. Computed Tomography Dose Index 100 (IEC60601-2-44 cl. 29.1.102)

The integral of the dose profile along a line perpendicular to the tomographic plane from –50
mm to +50 mm, divided by the product of number of tomographic sections N produced in a
single scan and the nominal tomographic section thickness T

+50 mm
D( z )
CTDI 100 = ∫
−50 mm
N ×T
dz

Where
CTDI100 is Computed Tomography Dose Index;
D(z) is the dose profile along a line Z perpendicular to the tomographic plane, where dose is
measured in air kerma;
N is the number of tomographic sections produced in a single rotation of the radiation source;
T is the nominal tomographic section thickness.

5.1 Dosimetry phantom

The dosimetry phantom shall consist of PMMA (polymethyl-methacrylate) cylinders of
diameter 160 mm for HEAD techniques and 320 mm for BODY techniques. The length
of the phantom shall be at least 140 mm.

5.2 Typical values in the CT conditions of operation

Scan Parameter HEAD BODY
Tube voltage 120 kV 120 kV
Tube current 150 mA 250 mA
Scan time 2s 0.8 s
Current time product 300 mAs 200 mAs
Slice Thickness 5 mm x 4 images 5 mm x 4 images

E1E-BW1020-1
QS4 45456 2
 5.3 Dose at typical CT condition of operation

Position of CTDI100 HEAD BODY

CTDI100 (center) value 46.1 mGy 9.71 mGy

CTDI100 (peripheral, average) value 50.7 mGy 20.7 mGy
CTDI100 (peripheral, 0deg.) value 50.7 mGy 20.7 mGy
CTDI100 (peripheral, 90deg.) value 50.7 mGy 20.7 mGy
CTDI100 (peripheral, 180deg.) value 50.7 mGy 20.7 mGy
CTDI100 (peripheral, 270deg.) value 50.7 mGy 20.7 mGy
CTDIw value 49.2 mGy 17.0 mGy

The location of CTDI100(center) value is along the axis of rotation and the center of the
dosimetry phantom.

The CTDI100(peripheral) value is Average of the four value of CTDI100 located 10mm
interior to the surface at positions 0°, 90°, 180°, 270° along a line parallel to the axis of
rotation in the dosimetry phantom. The location of the maximum CTDI100 in
peripheral is 12 o’clock position in front of the gantry.

The weighted CTDI100 (CTDIw) is defined as

1 2
CTDI w = CTDI 100 (center ) + CTDI 100 ( peripheral ) .
3 3
(IEC60601-2-44 cl. 29.1.103.3)

E1E-BW1020-1
QS4 45456 3
 5.4 Normalized CTDI100
These below values are normalized CTDI100 by the typical dose in item 5.3.

Normalized CTDI100(center) value as a scan parameter varies from the typical CT

condition of operation.

Scan parameter HEAD BODY

100 kV 0.658 0.623

120 kV 1 1
130 kV 1.194 1.185
10 mA 0.067 0.040
150 mA 1 0.600
250 mA 1.667 1
350 mA 2.333 1.400
0.5 s 0.250 0.625
0.8 s 0.400 1
1s 0.500 1.250
1.5 s 0.750 1.875
2s 1 2.500
3s 1.500 3.750
1.25 mm thickness x 1 images
2.142 2.152
0.625 mm thickness x 2 images
2.5 mm thickness x 1 images
1.25 mm thickness x 2 images 1.583 1.598
0.625 mm thickness x 4 images
5 mm thickness x 1 images
2.5 mm thickness x 2 images
1.382 1.389
1.25 mm thickness x 4 images
0.625 mm thickness x 8 images
10 mm thickness x 1 images
5 mm thickness x 2 images 1.219 1.221
2.5 mm thickness x 4 images
7.5 mm thickness x 2 images
1.094 1.095
3.75 mm thickness x 4 images
10 mm thickness x 2 images
1 1
5 mm thickness x 4 images

E1E-BW1020-1
QS4 45456 4
 Normalized CTDI100(peripheral) value as a scan parameter varies from the typical CT
condition of operation.

Scan parameter HEAD BODY

100 kV 0.665 0.630

120 kV 1 1
130 kV 1.195 1.175

When a scan parameter varies from the typical conditions, you can estimate the dose
by multiplying the typical dose in item 5.3 by the Normalized CTDI100 listed above.

5.5 Maximum deviation

Deviation of CTDI100 shall not exceed limits below.
Limit is +/- 28% of CTDI100 value, except for the under 25mA conditions.
For the under 25mA condition, limit is +/- 33 % of CTDI100 values, it is greater than the
above due to the inherent deviation in small value.

E1E-BW1020-1
QS4 45456 5
6. Sensitivity Profile and Dose Profile (IEC60601-2-44 cl. 29.1.103)
The sensitivity profile is the relative response of a system for computed tomography as a
function of positioning along a line perpendicular to the tomographic plane at the location
corresponding to the center location of the dosimetry phantom. The dose profile is the
graphical representation of the dose as a function of position along a line perpendicular to
the tomographic plane is measured in the center location of the head-dosimetry phantom
and the body-dosimetry phantom.

Here are Profile graphs. These sensitivity profiles are obtained from additional image of the
multi slice images at one scan. For example, using the image addition function, 4 multi
images of 5mm slice thickness become one image of 20mm slice thickness. These sensitivity
profiles include deviation of CT numbers. These dose profiles include variability inherent in
the measurement with TLD (thermoluminescence dosimeter) chips.

5mmx4 Sensitivity Profile 20mm Dose Profiles

1 1

0.8 0.8
Relative value
Relative value

0.6
0.6
0.4
0.4
0.2
0.2
0
0 -15 -10 -5 0 5 10 15
-15 -10 -5 0 5 10 15 Distance from scan center (mm)
Distance from scan center (mm)
Head Dose Profile
Sensitivity Profile Body Dose Profile

3.75mmx4 Sensitivity Profile 15mm Dose Profiles

1 1

0.8
0.8
Relative value
Relative value

0.6
0.6
0.4
0.4
0.2
0.2
0
0 -15 -10 -5 0 5 10 15
-15 -10 -5 0 5 10 15 Distance from scan center (mm)
Distance from scan center (mm)
Head Dose Profile
Sensitivity Profile Body Dose Profile
E1E-BW1020-1
QS4 45456 6
 2.5mmx4 Sensitivity Profile 10mm Dose Profiles

1 1

0.8 0.8

Relative value
Relative value

0.6
0.6
0.4
0.4
0.2
0.2
0
0 -15 -10 -5 0 5 10 15
-15 -10 -5 0 5 10 15 Distance from scan center (mm)
Distance from scan center (mm)
Head Dose Profile
Sensitivity Profile Body Dose Profile

1.25mmx4 Sensitivity Profile 5mm Dose Profiles

1 1

0.8 0.8
Relative value
Relative value

0.6
0.6
0.4
0.4
0.2
0.2
0
0 -15 -10 -5 0 5 10 15
-15 -10 -5 0 5 10 15 Distance from scan center (mm)
Distance from scan center (mm)
Head Dose Profile
Sensitivity Profile Body Dose Profile

E1E-BW1020-1
QS4 45456 7
 0.625mmx4 Sensitivity Profile 2.5mm Dose Profiles

1 1

0.8 0.8

Relative value
Relative value
0.6
0.6
0.4
0.4
0.2
0.2
0
0 -15 -10 -5 0 5 10 15
-15 -10 -5 0 5 10 15 Distance from scan center (mm)
Distance from scan center (mm)
Head Dose Profile
Sensitivity Profile Body Dose Profile

0.625mmx2 Sensitivity Profile 1.25mm Dose Profiles

1 1

0.8 0.8
Relative value
Relative value

0.6
0.6
0.4
0.4
0.2
0.2
0
0 -15 -10 -5 0 5 10 15
-15 -10 -5 0 5 10 15 Distance from scan center (mm)
Distance from scan center (mm)
Head Dose Profile
Sensitivity Profile Body Dose Profile

E1E-BW1020-1
QS4 45456 8
7. Stray radiation (IEC60601-2-44 cl. 29.208)
The stray radiation is measured in the horizontal plane(140cm hight). The body-dosimetry
phantom is positioned in the center of rotation of the CT scanner and centered on the
tomographic plane.
Loading factors: 130 kV, 200 mA , 2 s scan time, 5 mm thickness x 4 images
The unit of measurement is air kerma per mAs applied to the X-ray tube during normal use.
Here is the distribution of the stray radiation.

26
41

11
56
71
86
Scanner
Gantry

11
26
86
71
56

41
Patient Table

Div: 50cm Unit: nGy/mAs

Horizontal stray radiation

E1E-BW1020-1
QS4 45456 9
 8. Emergency stop (IEC60601-2-44 cl. 22.4.101)
The stopping distance of the patient support table movement: within 10 mm
The stopping angle of the gantry tilting: within 0.5 degree

E1E-BW1020-1
QS4 45456 10