INSPECTrOⅣ RβPORT

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SYSTEM SERIAL ttER 二 WO■ 36

2. REFERENCE DOCUMENTS

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4. CHANGE OF TEST PROCEDURE

Signatture

AuthoF

T.ヽEM理 0

Date

CT oA Section Manager 10A Manager

|五 .ONO

Design Manager

Y

承 i俸府WiOγAK=

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SIpria2M‐ OT―電 P.2

5. ACCEPTANCE TESTS AND MEASUREMENT DATA

5。 1. MECHANICAL TESTS― STATIC

5。 1.1. COVER FIT AND COVER MOVEMENT (P〓 PaSS, F〓 Fai■ )

Cover lnterfaces Para■ ■e■

Space Betveen Corn Cover and co■ ■imator B■ ade 〉 5.Omm

5,2. MECHANICAL TESTS― DYNAMIC

5.2.1. TABLE MOTIONS

5.2.1.1. TYPE CT― WT-20

・HEIGHT (UP― DOWN〕

(Pr F)

(Pr F)

P

P

・VERTICAL SPEED :

e180kg■ Oad

equa■■y distributed

LONGITUDINAL STROKE :

e180kg■oad

equa■■y distributed

LONGITUDINAL SPEED :

e180kg■Oad

equa■■y distributed

372 mm+/-5 to 922mm -5/+4 11Lll士

372 11Lli t0 924 11ull

士MeaSur■ng height : between f■ oor and top

surface of end cover

From 372 mm to 922 mm

e 23.9s ～ 34.3s

UP 31.O s

DOWN 29.7 s

From

From

From 1570 to

From 1570 mm

High Speed e

High Speed e

Low Speed

Low Speed

O to 1570 11咀 ll+3/― Omm

O mm to 1570

O llLll -3/+Omm

to 1570

Hl【R

【rlln

mm/S

IIL::/S

Hl【n/S

mm/S

150 ± 3.OHlm/s

FORWARD 150.0

BACKWARD 150.0

e 5 ± 1.OllLl1/s

FORWARD

BACKWARD

5.0

5.0

C

Supria2M― OT― E P。 3

TABLE INCREMENT ACCURACY l (IEC61223-3-5:2004 c■ .5。 1)

・180kg■ Oad equa■ ■y distributed for CT― WT-20.

。Set the tab■e top 500mm from back of the tab■ e.

°(A)Move the tab■ e top-300mm′ After that 30011Lll by pressing MOVE button

from Operator Conso■ e.

°(B)Norma■ Scan without X― ray, Image Mode 10mm× li

(CO■■imation30.625mm× 16), 30 times. Forward and Backward.

BACKWARD 300.O mm

The distance between start and return position

shou■d be ■ess than or equa■ to l.OHlrn.

工NDEXING

(A)

INDEXING

(A)

: 30011Lli卜 1.OllLli

FORWARD 300.O mm

: 300il■ l:卜 1.Olluli

BACKWARD 300.0

(B) FORWARD

BACKWARD

(B) BACKWARD

FORWARD

300.O mm

300.O mm

(A)

(B)

0.00 mm

0.■O mm

300。 O mm

300.O mm

0.00 mm

0.00 mm

TABLE INCREMENT ACCURACY 2 (IEC61223-3-5:2004 c■ .5.1)

・180kg■ Oad equa■■y distributed.

・Set the tab■ e top 500mm to inward■ imit.

・(A)Move the tab■ e top 30011Lll, After that -300mm by pressing MOvE button

from Operator Conso■ e.

°(B)No■ llla■ SCan without X― ray, Image Mode 10mm× li

(CO■■imation: O.62 511Lll× 16), 30 times. Backward and Forward.

剛　　ｍFORWARD 300.0

The distance between start and return position

shou■d be ■ess than or equa■ to l.Omm.

(A)

(B)

Supria2M― OT― E P.4

5.2.2. GANTRY MOTIONS(IEC 60601-2-44:2009 c■ .203.107 a))

・Axia■ Rotation : o.55s e O・ 539≦ (operating time)≦ 0.56■

(SCan Time) 0.549 s

0.80s e O・ 784≦ (operating time)≦ 0.816

0.804 s

1.00s e O・ 980≦ (operating time)≦ 1.020

■.007 s

l.50s e l・ 470≦ (operating time)≦ 1.530

1.515 s

2.00s e l.960≦ (operating time)≦ 2.040

2.013 s

Scanogram

CT―WT-20 c

Length

INWARD

Length

INWARD

Length

INWARD

Length

INWARD

Length

INWARD

Length

INWARD

Length

INWARD

Length

INWARD

Gantry Ti■ t

180kg■ Oad

1501[Lll e

■.81 s

250ilLll e

2.82

350mm e

3.82

50011ull e

5.32

7501:Lli c

7.83

100011Lll e

10.34

125011Lll e

12.85

15001:L:l e

15.35

-30°

1.52s≦ (strOk time)≦ 2.10s

OUTWARD l.81 s

2.36s≦ (strOk time)≦ 3.26s

s OUTWARD 2.82 s

3.20s≦ (strOk time)≦ 4.42s

s OUTWARD 3.82 s

4。 46s≦ (strOk time)≦ 6.16s

s OUTWARD 5.32 S

6.56s≦ (strOk time)≦ 9.o6s

s OUTWARD 7.83 s

8.68s≦ (strOk time)≦ 11.96s

s OUTWARD 10.34 S

10.76s≦ (strOk time)≦ 14.86s

s OUTWARD ■2.80 s

12.86s≦ (strOk time)≦ 17.76s

s OUTWARD 15.35 S

+30° + 0。 25°

30.00 + 30.00

Supria2M― OT―E P.5

5.2.3. SAFETY TESTS

Leakage Radiation from the Source Assemb■ y

Technique:130kVr 50mA′ 2s, Image Mode l.25mm× li (Co■■imation: 0.625mm× 2)f

■argeP stationary scan moderWith■ ead on the pre― co■■imator b■ ade

Specification Measured Va■ ue

Less than O.88mGy/h廻 lm O.03 mGy/h

・Resistance to ground from any touchab■ e surface

R ≦ 100 m Ohm (IEC 60601-■ :2005 c■ .8.6.4 a):

・Leakage current at the system earth te■ ll:■na■

I ≦ 5 mA (IEC 60601-1:2005 c■ .8.7.4.5): 1.5 HIA

・Die■ ectr■ c strength test

AC 1500 V for lmin. between the earth primary circuit and body of the equip

―ment of scannerr tab■ ef and Operator conso■ e :

(Pass , Fai■ ) PaSS

AC 2500 V for imin. between the earth primary circuit and body of the equip

―ment of inverter and converter :

(Pass , Fai■ ) PaSS

Location

Scanner Gantry Un■ t

Patient Tab■ e

Operations for safety :

Emergency Stop

X― ray ExpOsure On Light

CPU Power Sw■ tch

Gantry Power switch

Audib■ eX― ray ExpOsure

Door Switch

Res■ stance

■5 mΩ ′

35 mΩ ,

Location

Operator Conso■ e

Res■stance

40 mΩ

Pass

Pass

Pass

Pass

Pass

Pass

(PaSS=

(PaSS,

(PaSS,

(PaSS,

(PaSS,

(PaSS,

Fai■ )

Fai■ )

Fai■ )

Fai■ )

Fai■ )

Fa■■)

Supria2Mい OT― E P。 6

5.2.4. CONTROLS AND LEG工 NDS (P=PaSS『 F=Fa■■〕

(P, F) P , MouSe

(PP F) P

Position (P, F) P

T土ユt (P′ F) P

Breath Navi(OptiOn)(P▼ F)N.A.

Ganttry / Tab■e Buttons :

Emergency

Ti■ t +

Up

ForTara

PRESET■

PRIISE■ 2

Options Buttons :

HOME (Foot Switch)

PRESET (F00t Switch)

(P,F)N.A.

(Pr F)N.A.

(P, F) P ,

(P,F)P ,

(P,F)P ,

(P,F)P ,

(P′ F)P ,

(P,F, P ′

RESET

Ti■t ―

Down

Backvard

HOME

Door Switch

P

P

P

P

P

Supria2単 -OT― E P,7

5.3. PERFORMANCE TESTS

5。 3.1. SPATIAL RESOLUTION mF for IEC61223-3-5:2004 c■ .5.6)

Technique

(No■ illa■ )

Technique

(Hi― Reso)

C― Phantom Spatia■ Reso■ ution lnsert 16.5cm

■20kV, 200mA, 2.Os,Larger FOV:210 for Scan, Head Mode, Co■ ■i

mation o.625× 8i, Image Mode〓 5.00× li『 Fi■ter=14

FOV:50 for Post Reconstruction, BHC S BCC : OFF

0。 6011ull e100を contrast 0.60 mm

:C― Phantom Spatia■ Reso■ution lnsert 16.5cm

120kV, 200mAf 2.OsfLarge, FOV:210 for Scan, Head Moder Co■ ■i

mation O。 625× 8i, Image Mode〓 5.00× lif Fi■ter=60H

FOV:50 for Post Reconstruction, BHC &BGC : OFF

0.35mm e10oを contrast 0.35 mm

MTF Technique: C― Phantom MTF w■ re section

(Norma■ ′Head)■ 20kV, 150mA, 2.Os=Large, FOV:210 for Scan, Head Moder Co■ ■i

mation O.625x16, Image Mode=■ Omm x li『 Fi■ ter〓 12『

FOV:50 for Post Reconstructionf BHC &BGC : OFF

50を MTF 3。 7 ± 0.5■P/cm

10を MTF 6.5 ± 0.6■p/cm

3.8 ■p/Cm

■p/Cm6.7

MTF Technique: C― Phantom MttF wire section

(No■ ima■ ,Body)120kV, 200mA, 1.Os,Large, FOV:210 for Scan, Body Mode, Co■ ■i

mation O.625 x 16『 Image Mode=10mm x l■ , Fi■ ter=32,

FOV:50 for Post Reconstruction, BHC &BGC : OFF

50を MTF 3.8 ± 0.5■p/cm 3。 7 ■p/cm

10を MTF 6.7 ± 0.6■p/cm 6.7 ■p/cm

MTF Technique: C― Phantom MTF wire section

(Hi―reso) ■20kV′ 200mA, 2.OsfLarge, FOV:210 for Scan= Head Mode, Co■ ■i

mation O。 625 x 16, Image Mode=10mm x li, Fi■ ter〓 60H,

FOV:50 for Post Reconstruction′ BHC & BGC : OFF

50を MTF 12.2 ± 1.2■p/cm

10名 MTF 14.7 ± 1.5■p/cm

12.0 ■p/Cm

14.7 ■p/Cm

Supria2М―OT―E P.8

5。 3.2. LOW CONTRAST

Technique : C― Phantom Low ContFaSt Reso■ ution lnsert ■6.5cm

120kV「 200mA, 2.Os, ■nFge, FOV:160,

Image MOde ■Omm× ユif Fi■ ter=■ 1, wW〓■6～ 32, Scan No,〓 ■0,

BHC S BCC t OFF『 Note. C× D: ContFaSt(を )× Diameter(HHl)

Specifioation Reference MeasuF6d Va■ ue

C× D≦0.90o (50を っrObabi■ity,

(0.30者 x3.QHlm)

(■ )0.24 暑

(2)o。 23 亀・

(3)0.24 を

(4)0.21 を

(5)0,24 を

(6)0.22 を

(7)0.24 暑

(3)0.24 暑

(9)0.22 を

(10)0.2■ 暑

× 3.5 mm =

× 3.5 HIn =

× 3.O mm =

× 4.O HIn 署

× 4.O HIIn 〓

× 3.5 H【 n 〓

× 4a5 rrn 〓

× 3,5 πln 〓

× 3心 O HIn 〓

× 4.O HEn 〓

Supr■ a2M― OT― E P.9

(IEC6■ 223-3-5:2004 c■ .5.5)

Technique t 120kV, ■50mAr 2。 Os, LArge, Co■ ■imation ■.25mmX■ 6P Image Mod

e ■Omm× 2i′ FOV32■ 0, Fi■ ter〓■27 ■6っ 5cm Water Phantom,

BHC&BGC = OFF

Specification

CT Noけ Center O ± 4

1mage ■ -1.1

・ UNIFORM工TY Specification

iCT No.(Cも nter)一CT No.(edge)|≦ 4.0

UP SIDE Image l o.8

DOWN SIDE Image l ■.o

RIGHT SIDE Image ■ 0.7

LEFT SIDE Image l o.7

Measllred va■ ue

Image 2 -■ .0

Measured va■ ue

工mage 2 0.7

1mage 2 0.8

Image 2 0,7

1mage 2 0,8

Measllred Va■ ue

を Image 2 0.2■5 を

■20kVr 40mA, 2,Os, C01■ ■mation 560mm× 4■ , Large, S工 ice

Mode=1.25mm× 16if FOV=2■ 0, Head Moder F■ ■ter=■ 2, Air′

BHC&BGC t OFF

Specification

CT No. Center ―■000 ± 25

Measured Va■ ue

Image l -999。 4 1mage 2 -999.4 1mage 3

Supria2M― OT― E P.■ 0

5.3.4. LINEARITY′ UNIFORMITY, NOISE(30511Lll) (IEC61223-3-5:2004 c■ .5.5)

Technique 120kV′ 200mA, 1.Os, Large, Co■ ■imation l.251:Щ ::× 16i『

Image Mode 1011L::× 2iJFOV:350, Body Mode, Fi■ ter=32′

30.5cm Water Phantom′ BHC & BGC : OFF

・ LINEARITY Specification Measured Va■ ue

CT No. Center 0± 8

1mage l 6 Image 2 0.0

・ UNIFORMITY Specification Measured va■ ue

ICT No.(Center)~CT No。 (edge)|≦8.0

UP SIDE Image 1 5.4

DOWN SIDE Image 1 5.5

RIGHT SIDE Image 1 5.4

LEFT SIDE Image 1 5。 7

・ NOISE Spec■ fication Measured Va■ ue

SD No 0.875 士o.175を

Image 1 0.880 を Image 2 0.889 を

5。 3.5。 TOMOGRAPHIC PLANE LOCATION (IEC61223-3-5:2004 c■ .5.2)

・The distance between the position of scan p■ ane and that of

■ight ■oca■ izer shou■d be ■ess than or equa■ to 2mm.

0.■ O mm

+O

Image 2

1mage 2

1mage 2

1mage 2

4.5

4.3

4.5

4。 2

・The distance between the position of scan p■ ane and the position of

se■ect s■ ice ■n scanogam shou■d be ■ess than or equa■ to 2mm.

0.06 Hlm

Supria2M― OT― E P.11

5.3.6. SLICE THICKNESS (IEC61223-3-5:2004 c■ .5.3)

Technique : 120kV, 150mA, 2.Os, FOV:210, Head Mode= Fi■ ter〓 12r C― Phantom

lmage Mode 10.OHlm× 2■ , 5.Omm× 2i, 3.75mm× 4i, ■.2 511ull× 16i,

0.625mm× 16ir O・ 625mm× 8i, 1.2511阻 ll× li

Specification(FWHM) Measured Va■ue(FWHM)

10.00mm 士 ュ.omm (Zoom Fov=80)

Image l 9.74 mm lmage 2 9.76 mm

5.0011Lll 」Ll.ollLll(ZOOm Fov=80)

Image l

3.751:Щ li 」Ll・ OllLll(ZOOm Fov=80)

Image l

lmage 3

1.25Hl【 n ± 0.6 2 5Hl【■ (ZOOm Fov=80)

Image l

lmage 8

1mage 15

0.625mm(■ 6■ )± 0.50mm (ZOOm Fov=80)

Image■

Image 8

1mage 15

0.625mm(8■ )± 0.50mm (ZOOm Fov=50)

Image l

lmage 3

1mage 5

1mage 7

1.2 511ull ± 0.6 2 511LⅢ (ZOOm Fov=50)

Image l

4.86 mm lmage 2 4.90 mm

3.69 mm

3.66

1.25

1.29

1.37

0。 730

0。 710

0.750

0.660

0.690

0.690

0。 7■ 0

Image 2

1mage 4

3.66 mm

3.68 mm

0.740 mm

0.690 mm

0。 740 mm

ｍ　　　　　　　　ｍ　　ｍ　　ｍ

Image 2 1.34 11Ⅱ ll

Image 9 ■.29 11Lll

lmage 16 1.29 mm

ｍ　　ｍ　　ｍ

ｍ

ｍ

ｍ

　

　

ｍ

ｍ

ｍ

ｍ

　

　

ｍ

Image 2

1mage 9

1mage 16

Image 2

1mage 4

1mage 6

1mage 8

0.700 11ull

0.7■ 0

0。 710

0.700

1.10

Supria2M― OT― E P。 12

49.l mGy

54.9 mGy

56.9 mGy

93.6 mGy

16.2 mGy

44

9

6. CONFIGURATION

6.1.ユ . Hardware

Basic System S/N

CT―WS20-5M200 KA 1280340■

Rev

AScanner Gantry Un■ t

Centra■ Contro■ Conso■e CT― OC-20

X― ray Tube

Patient Tab■ e

Detector

Mag. Disk Drive(CT― OC-20:lMD)

Mag. Disk Drive(CT― OC-20:2MD)

DVD Drive(CT― OC-20)

Inverter(cT― WS20-5M200)

Accessories

Phantom

Phantom stand

Head Ho■ der

Patient Be■ t

Tab■ e Mattress

options

Footrest(wT-20)

Touch sw■tch

Footrest mat

Arrnrest(HF)

Headrest(HF)

Armrest(FF)

Headrest(FF)

Spacerl

Spacer2

Tr■ ang■e mat

Baby Support

Chinrest

I.V.drip pO■ e

Mat(FF)

PAT Light Loca■ izer

KA 12820401

ULM-5TA-01T(A)HQ20024714

CT― WT-20 KA 12811402

CT― DMS16-lB KA 12828401 A B

ST500NM0011 ZlMlP6P2

ST500NM001■ ZlMlP6Gl

iHAS124-04CU 2M82355000333743524434

CIMR―VA2A0012BAA J013YL744510024

(Y,N)

(Y′ N)

(Y,N〕

(Y,N)

(Y,N)

Y

Y

Y

CT― AC―FT20

CT― AC―TS20-3

CT― AC―FM20-2

CT― AC―AR20-HF

CT― AC― HR20-2

CT― AC―AR20-FF

CT― AC―HR20-3

CT― AC― SP20-1

CT― AC― SP20-2

CT― AC―NP20

CT― AC―BS20

CT― AC― CR20

CT― AC― P5

CT― AC―FM20-1

CT― PATLSR― SUPRIA

N.A

NoA

N.A.

N.A.

N.A.

N.A.

N.A.

N.A.

N.A.

N.A

N.A

N.A

N.A

N.A

Y

Y

N.A

Supria2M― OT― E P。 14

Breath― Navi disp■ ay CT― BRTH― SUPRIA

Foot Switch CrT― FSW― SUPRIA

uninterruptib■ e power supp■ y CT― UPS― ■

Step Down Transforr【ler CT―TR-9B

6.■ t2. SOftware

Basic Software

System lnsta■ ■

Inte■■ IP Option

Option Softwnre

Hyper o― Net R

fatPointer

riskPo■ nter

CT CO■ onoScopy

Perfus■ on

Lung Ana■ysis

Denta■ Ana■ysis

剛 M

MPPS

ouery Retrigve

N

SupFia2M― OT― E P。 15