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INSPECTrOⅣ RβPORT
■
SYSTEM SERIAL ttER 二 WO■ 36
2. REFERENCE DOCUMENTS
フ
Tosted by :
Checked by 弓
ヽ
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SupFia2M― OT― E P。 ■
pato
17.IMaF.
2-0■4
De誠卵
Mqr
N,OZAKI
Approved―
by
■.ONO
Checked
by
イ,コ軸ぬZハKI
Prepared
by
T.呻
Contentsi
IFiFat re■ eaoo.
ItemlRev
0
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=
/
,.
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
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