No.

2A201-474E

INSPECTION SPECIFICATIONS/TEST RECORD

FOR WHOLE-BODY X-RAY CT SCANNER

MODEL TSX-101A
(MULTISLICE CT SCAN SYSTEM)
SYSTEM S/N_________
(2A201-474E)

 TOSHIBA MEDICAL SYSTEMS CORPORATION 2004

ALL RIGHTS RESERVED
 No. 2A201-474E

IMPORTANT!

1. No part of this manual may be copied or reprinted, in whole or in part,

without written permission.

2. The contents of this manual are subject to change without prior notice
and without our legal obligation.

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REVISION RECORD

REV. DATE REASON PAGE SER. DOC.

(MM/YY) /AUTHOR CHANGED No. PRODUCT.

INI. 03/'04 Mr. Soejima ------- KD-WPX

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THIS PAGE IS LEFT BLANK INTENTIONALLY.

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RECORD OF INSPECTION

System serial No. :

Power frequency : (Hz)

Slice number at the end of inspection : (SLICE)

Date at the end of inspection :

1. General safety test

(1) Enclosure leakage current (0.1 mA or less) :

(2) Contact resistance (Max 0.2 Ω) : (Ω)

(3) Withstand-voltage test (for 1 minute) :

2. Function test

(1) Gantry :

(2) Patient couch :

(3) System console :

(4) X-ray generation system :

(5) Positioning projector :

(6) Interlock :

(7) Emergency :

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3. Image quality

(1) Image noise, CT number in water

Scan the following phantoms. For each of the two reconstructed images, perform ROI
calculation on the center area of 250 × 250 pixels.

Slice thickness Scan

No. Phantom kV/mA Scan time Stack mode FC
for scanning field
1 φ400 polypropylene 120/500 1 sec 4 mm × 4 2-stack L FC70
2 φ320 water 120/500 1 sec 4 mm × 4 2-stack M FC70
3 φ240 water 120/500 1 sec 4 mm × 4 2-stack S FC70
4 φ180 water 120/400 1 sec 4 mm × 4 2-stack SS FC70
5 Q/A* 120/320 1 sec 4 mm × 4 2-stack S FC41

* For the Q/A phantom, scan the image noise module and perform measurements using the
Q/A software.

Standard Measured value Measured value

No. SD reference
uniformity 1st image 2nd image 1st image 2nd image
1 -115 ∼ -95 9.6 ∼ 14.4
2 -3.0 ∼ 3.0 8.0 ∼ 12.0
3 -3.0 ∼ 3.0 3.6 ∼ 5.4
4 -3.0 ∼ 3.0 2.1 ∼ 3.1
5 85 ∼ 105 1.0 ∼ 2.6

(2) CT number accuracy

Scan the following phantom.

For each of the two reconstructed images, measure the CT number of each material using the
Q/A software.

Phantom : Q/A phantom (slice thickness module)

Scan conditions : 120 kV/1 sec/300 mA/S/4 mm × 4/2-stack/FC70

Measured value
Position Material Reference value
1st image 2nd image
(a) Air -1030 ∼ -990
(b) Low-density polyethylene -115 ∼ -95
(c) Delrin 350 ∼ 370
(d) Teflon 960 ∼ 1000

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(3) Uniformity

Scan the following phantom.

For each of the two reconstructed images, measure CT number difference at the center of the
image using the Q/A software.

Phantom : Q/A phantom (image noise module)

Scan conditions : 120 kV/1.0 sec/320 mA/S/4 mm × 4/2-stack/FC41

Measured value
Reference value
1st image 2nd image
≤4

(4) Spatial resolution

Scan the following phantom.

For each of the two reconstructed images, measure the 2%MTF using the Q/A software.

Phantom : Q/A phantom (MTF module)

Scan conditions : 120 kV/1 sec/200 mA/S/1 mm × 4/2-stack/FC30, FC90

Measured value
Reconstruction function Reference value
1st image 2nd image
FC 30 ≥ 9 lp/cm
FC 90 ≥ 14.5 lp/cm

(5) Density resolution

Scan the following phantom.

For each of the two reconstructed images, measure the contrast diameter (%*mm) using the
Q/A software.

Phantom : Q/A phantom (image noise module, low-contrast module)

Scan conditions 1 : 120 kV/1.0 sec/320 mA/S/4 mm × 4/2-stack/FC41

Measured value
Reference value
1st image 2nd image
≤ 0.6

Scan conditions 2 : 120 kV/1.0 sec/190 mA/S/4 mm × 4/2-stack/FC41

Measured value
Reference value
1st image 2nd image
≤ 1.2

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(6) Slice thickness

Scan the following phantom.

For each of the four reconstructed images, measure the slice thickness using the Q/A software.

Phantom : Q/A phantom (slice thickness module)

Scan conditions : 120 kV/1 sec/300 mA/S/8 mm, 6 mm, 4 mm, 3 mm, 2 mm, 1mm,
0.5 mm × 4/No-stack/FC70

Measured value
Slice thickness Reference value
1st image 2nd image 3rd image 4th image
8 mm × 4 7.2 ∼ 8.8 mm
6 mm × 4 5.4 ∼ 6.6 mm
4 mm × 4 3.6 ∼ 4.4 mm
3 mm × 4 2.7 ∼ 3.5 mm
2 mm × 4 1.8 ∼ 2.5 mm
1 mm × 4 0.8 ∼ 1.5 mm
0.5 mm × 4 0.4 ∼ 0.8 mm

(7) CT number of TOS phantom

Scan the 320 mm dia. TOS phantom and measure the CT number for an area of 25 x 25 pixels
at <a> to <f> for each of the two reconstructed images (see figure below).

Test conditions Spec. Test result

Scan conditions The difference between 1st image
Tube voltage/current : 120 kV/300 mA the CT numbers
<a>:
Scan speed : 1 sec obtained scanning the
Slice width : 4 mm × 4/2-stack attached TOS phantom <b>:
Reconstruction at the time of <c>:
Algorithm : FC70 installation, and those <d>:
Scan field : M shown in the right
column should be <e>:
<c> within ±5 or less. <f>:
<d>
<b>
<e> 2nd image
<a>
<a>:
<b>:
<c>:
<f> <d>:
<e>:
Measure at six points, <a> to <f>, shown <f>:
above.

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4. System composition

(1) Incorporated type of system

No. Unit name Model Serial No.

1 Scanner system TSX-101A
2 Gantry CGGT-018A
3 X-ray tube CXB-750D
4 Detector & data acquisition system CDAS-033A
5 Patient couch CBTB-016A
CBTB-016B
6 Console CKCN-012C
7 X-ray high-voltage generator CXXG-008A

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5. Inspection judgement

(1) Appearance (Flaws, stains, rust) :

(2) Accessories (according to the packing list) :

This is to certify that all the descriptions given above are correct.

Date

Tested by: Approved by:

Quality
Assurance Group

10 E
1385,SHIMOISHIGAMI,OTAWARA-SHI,TOCHIGI-KEN 324-8550,JAPAN