Final Inspection Report "Prepared (8) | Approved (#2!) | (HA OAON Ber Aled) 22tol ALA OF 71BOL s#EeHOE BCL 7 ls | (ABANSAA) | Zar Date Inspector ] ] | ol Ake Zo fo .t Sat to can [22-4 | am | o% | In| off Model (248)] RCT700 Se Serial No. wiz¥e)| RAN A554 = (Joloob6 ) | Reference (2AI2) + A1SBAIIIEEA (ROI-700- 848 31-01/001-700-M 01 818-01/A0I-700-21-7 218-01) (Ra1=720-H.8cR) | T No. (e)] Test Items (@4H88) | Inspection criterion (R7HIAHIE) Results (Aba 2 Check the Visual Tests. Visual Tests (S12) |ayzjoy ovgaisp 71801 J#ete}0r BCH. | | | t | Electrical - Mechanical Check the Electrical - Mechanical Safety Safety test ie 2 Ler ores oreggy |B B71 2098 ere sesa f aa iia) rieol Br6Ior BEC. | 3 | Radiation Safety Tests (Check the Radiation Safety Tests p Performance Tests (S01 Bet Ale) Check the Performance Tests SSAA 7G FEHOF BCH. Opinion (siz) = Ray, Co, Ltd. Rev. (4) a «VIPROMED ®, SERVICE) Kes,4. Visual Tests (212) (1) Check the exterior ofthe product (A 212 41 Hel) vion (MR BY A7F2AI71B | orae Loeenee | Test Method and Criterion ( we p@ Tee) em Check he extemal conditions ofthe assembled predicts 1 (Hol 2a NBS HE Ow saw SOR elec) Check te conto of val ? (ia 85, Nae RgOe HEI) L A ssl 7 Check the asembly satus and canditon of gap P examination (212 Case SRV 2 Cased ZI BOL BEA WeIsICL | ea = heck tre condton ofthe touch panel p | (23 #8 vel eset gatetch) [= Gheekthe condition of panting (iat SANSA SIRE ? (2) Check the chinrest assembly module (#01 S26 Sie) — nesits | Dedsion 8) | Remark Test Method and Criterion (AR! BL AEE aura ra ray ei) | Check the osserbied product by mounting the headrest on i | the chines assembly module, i (BUOl ARE MBS! YwO] SOF Headrest Beebo BAI) e ein Check the turning load of chinrest. (WO] 2BO1 SIS 8} #301) P (aeaay Check the headrest movement Heedren2l SIPGI8 B52) Sl) P (3) Remote control operation (212 $8) - Resuts | Decision (2) | Remark Test Method and Criterion (HAMM 51 XIHR1AZ1E) euaen lpm ren Os Che foun freon oem onal IE Wa) Re os (4) Movement test of lift column (212818) S21) Resuts | Decision @B) Remark | ethod and Criterion (GAY AHAB) ‘Test Method and criterion (HA BI AIRIAZIE) aan trem [roo : o Ween Gack ten ment econ ficken aaa on sone] P =e {5)Label ate! | Decision (2 Test Method and Criterion (AH 81 A7RIA7IE) a oe tenet aaah pam [Fe lm) Check the nba. ~ Product Lasec Tube Tank, Detector Ceph (ise aus wee AE BSL v a3 BY & Ags Yee ae ae ae Ze) r BBY 2 COM Bz ae BB Pp eee e Weg a w fea ae P | a aaa ae p ose E RQI700-3}5(g)ubi set i Results Remark ! ion i | “Test Method and Criterion (Ab SL LAE) ava Trea] cm | ary | | (UDI SIA), MRE Bet aialsiex geleIcty v vol Azza aa D 4a ae r oY see z RQI700-815/ 2, Electrical « Mechanical Safety Tests (@21.210% HBO Be Ae) ‘# Measuring Device Information of the Electrical - Mechanical Safety Tests (71.7/M% CHSO ME Alt) AR7 B= No. Test tems (HAS) Measuring Device (#8 41471) G (RAY-T-07) SERA / CO (RAY-T-106) FEA 1. | Leakage of current (electricity) (FEA) | (RAY-T-06) Sidacs 1B (RAY-T-09) Digital Multimeter / [) (RAY-T-48) Digital Multimeter 2 | Ground Resistance Test (HAIMA) | ( (RAY-T-06) Earth Continuity Tester 3_| Power input Test (#21 8A) Ch (RAY-1-03) Digital Power Meter 4 | Withstand voltage test (ELA) | 1 (RAY-T-05) Puncture Tester (1) Leakage of current (electricity) (28) ‘Test Method (M8) 127171 N17 A BS7SAA 67 SHAR A MAGA MAS A evo oie Inspect by IEC 60601-1, 8.7 Leakage currents and Patient auxiliary currents | Results | Decision (EHS) | Remark Test criterion (#}7HEAH1@) meee @aaian Teh [Fab iz) + Earth leakage current 71-5162) 1) normal conditions: 5 mA or less (2/4:2HeH : § mA ol) (201 yma] 2) a single fault status: 10 mA or less (HRD: 10 mA o18t) |(aL5E mal + External leakage current 18-421 Using the 1) normal conditions: 0.1 mA or less Hartel 0.1 mA olst) —|ce0e{ ymal suring Device 2) a single fault status: 05 mA or less (HODES : 0.6 mA oft |(eeel yma ta way ~The patient leakage current Sra Vv 1) normal conditions: 0.1 mA or less (3AFSHEH : 0.1 mA ole#) —|¢ 6.0% yma 2) a single fault status: 05 mA or less (GIL DEHEH : 0.5 mA O18H) |( 0.c+{ mal RQI700-81S(2) Ground Resistance Test (18418) Test Method ASE) 27/7] AIAN HY SHISHA 8.6.4 ANGA DW AFUS SS Alero oie Inspect by 1EC 9601-1, 86.4 Impedance and current-cartying capability a Results | Decision (BB) | Remark —_| Test criterion @IHIA7I) am bale] ey | Uf the device has non-removable (fixed) the power card, the impedance between protection ground and all metal parts . wv ie the (with protected ground) will not exceed 0.10. (0,65 90) Measuring Device APMAY MEDI SP VOTNGNS veane Os 187] BA) [Fewolet QTAAS 0.19 AD gotot SICH) (3) Power Input Test (#2121 21421) Test Method (AP) | 9 S7/7| H77IAH KAY BH SHISHA 4.11 AUAS Alwareiot o} er | Inspect by IEC 60601-1, 4.11 Power Input i ar 2 —— Results | Decision #8) | Remark cama : exam Pale] em eds the rated 100W or 100VA 1 Ke Meno te fest eet OF TOOVA 10% oes 25WK 10K" 45) TL» yg] pesiee oa. " (AS7| BA) (4) Withstand voltage test (M2214) Test Method (Aha) IEC 60601-1 (33) 8.6.4 2] ABBE Ser Inspect by IEC 60601-1, 86.4 Impedance and current-carrying capability Re Decision (BH t Test criterion (H7HIA71E) nee eoutsel || erate sa Teer) aD Preliminary inspection. (1471 AFH 2) le Connecting the lead wire, Check the warning light and warring sound. | Pf ORB - 2015 4 ae ATBE Wane wo. | Live parts and accessible metal parts in contact with the protective earth. (Sao Betz Warts Bae) Cueof Cnet No. | a= ana Using th 7 | eae TS0OV 60 = S177 (OMA O18 Cina 4 ae Bers Live parts and Patient contactable part. ae (Sees) ast ga71eH) aa 6.3 yma No, aes Asa 2 | ae A000V 60 S17} (OMA OTe | RQI700-A1S Rev. (10)3. Radiation Safety Tests (AI! @r@Ol Bet Ale!) (1) Test on the display of operational status (HOH H4)) Resuts | Decision (8) Remark Test Method And Crt PRIA jest Method And Criterion (ZAR $1 X}7HIA}71) aisaco "pan fre) 4m Check the display of operational status. | 2 PHES Molaens select the display of operational status ‘Check Point (alotatet) aes) | | Display of * ready” status ‘Check the Green LED. P Asai (Bs| ae ae BAD (eat LED #2!) ‘examination Display of “exposuring x-ray’ status | Check the Yellow LED r uv | eon | (x Eat S BAI) (241 LED #2!) | Display of “termination” status Check the Sound ? (xe BA BB BAN) Oa BAgR dee Kel) Display of “danger” status Chock the Red LED ? (H® BAl) (S44 LED tel) | ‘4 Measuring Device information of Test on limitation of X-ray Leakage (rid X M21 AB) ABZ Bt No. Test items (AAS) Measuring Device (8 4&7) Test on limitation of X-ray Leakage © feed xual ah treav-7-43)Radcal Accu-Dose~ (2) Test on limitation of X-ray Leakage (HHS St TEM YASS KES! AA (rat XM Het) ‘Test Method (AHH) [AMI SI1INSAAs WHS x MBA 9.7.11 XHR SAI TAMAS Inspect by 9.7.1.1 leakage radiation test in 8. Diagnostic x-ray equipment of MFDS directive Results | Decision (EHS) Remark aa Tralee] ela Test criterion (AI7HAA71E) ray tube devices, leak goodness X-ray tube device, the action leakage measurement conditions when the goodness of X ray tube device, the X ray tube leakage dose 100 cr the distance from | the device everywhere, in an hour, hitting the sum vy Using the 258 * 10°C / kg h (1OOmR/tx) under should be, 4389 sme, Measuring Device Kee BR) ree RAL BAH SHUG S83 FACE SHANE OH XMM ee eERe XG SBSEEE AE 100m HAM ADE Be BE 2.58%10-5C/kg HOOMAUHS ATE OF IL) RQI700-2154, Performance Tests (0 @E! Alg!) (1) Tolerance Test of x-ray exposure condition (XK ZAZA! GBA Ale) Test Method (Are) Inspect by 103.1 Tube voltage test in 8 Diagnostic x-ray equipment of MFOS directive (@ae Me] SRASIINEAA 8. HES XMAS 109.1 aaaAe we AEC | ial Results | Decision (8) | Remark est criterion (I7HBA : | Test criterion (AFB AI) (mares Tear ‘i ea) fever pn sre oe fe onal age ott rw a oe rosy is kot constant szodng 10 the citer spate in the Inpor ie (ome = | ee EA ‘Begna : 2 Quade Fae SAN SUNN SAO! AE 71 ee | Igoe QBN RUAN SANE VEC. Test Method (BAPE! t) Jnspect by 1032 Tube current test in 8, Diagnostic x-ay equipment of MFDS directive Baw AS] SRIGIIVNEAA 6 GIG XGRSAA WI2ATRAN TEE AT ] Results: Test criterion (R}7HAAP7IE) qarum Decision (8) | Remark em ira) ey Check the report to see ifthe current output value foreach modaiy is kepd onstant according to the criteria listed in the import inspection report. AUAAG : YS BAR Seizlol HAL BAAlOL ZIG! 71 r 222 UNA RASIBE| SIN BSAC hero cans bapecion te 4 “S2as CaM ree Test Method (APE) Inspect by 103.3 Exposure time in 8. Diagnostic x-ray equipment of MFOS directive [EAN AB ] SNABINNEAA 6 ALSXKHASA 109.9 88S AIH A setOn eICH. 7 Results | Decision (HB) | Remark Test criterion (R7HIA7IE) aa [pa tran any ‘Check the report to see i the exporute time output ofeach modality & kept 1 ewe ecigto nected inbemeattapein met. |p| fen cen EMAL A : 7 SHCIEIM ZAIZ waztol HOA SAMO 71 poses amie BIBSe WHOA SIseN SAE Bee. ete i (2) The dose reproducibility test (W@&4 Al8!) Test Method (3488) SRISVVIERA 8. IRBXKAAVA 1OAMBIABBL INC Inspect by 104 Dose repraducibilty test in 8 Diagnostic ay equipment of MFDS directive sores ae Results | Decision (28) terion (RFRA) ena tran ran ithe dose reproducibility test Selected X-ray survey of the condition when taking a regular dose of combination study the behavior aiuedbycotcechtnin tudtetssemors, | f | U BS A] MAE XY BAUS UB Soe sal7] Yee AHIES] MEALS 0.05 Oletololor etch RQI700-NE4 Measuring Device Information of the Quality Control Picture Quality Dose Phantom Test (SMe NE BEAR a1g7| Be No. Test Items (ZAHER) Measuring Device (8 Aa7) 1) Noise (8) AB 2)CT Number 21 B48 ANB 1. | 3) Spatial Resolution (DERE Bt w0¥'s) Alt 4) Uniformity (artifacts) ASL 5) Slice tekness AIR! 1D (RAY-T-41) QUART Phantom / © (RAY-T-42) QUART Phantom (2) Quality Control Picture Quality Dose Phantom Test B&H2| HU-M¥ BHAIG ‘BUN AMIS MBAS WA¥23,50.64,240WbackupWO2.8 23 ¥ 2SH¥01.QAWOL. Final Test ImageW02. RCT700 Test Method And Criterion (AMY BL AAAI) Results | Decision (8) | Remark wm Pelee! oD ‘Check each item after acquiring the phantom image. | (HU Bee USE ae Bee AEC 1) Noise) AI eh (ENR 2 20% 278 2) CT Number 21 S44 ANB | Refer to Appentix CT number (Appendix CT number BECO} 7 ZO} PMMA : -100HUsAreast00HU ‘ic -1100HUsAreas-900HU Ue 1 i P tower Shae =a left “Titer = ol, 495, v Right 5 ho = ie Results r P ; NA 23) Spatial Resolution-IAES Bt ¥Ats)AB MTF10% 2 1.0le/mm lee | 4) Uniformity (Artifacts) AB 2. There must be no clear Artifact. And it must be eligned with the center in, b. Homogeneity ® 25 a-Atectst180] OL SA EME Bal, SAM BHOl w sho} SUe7He RS Weletch. b. Of 7188 CIEEICH. Homogeneity > 25 Sl 5) Slice thickness ABE + Sice Thickness range : 40 mm & Ym / 20 mm + 1mm + Slice Thickness 891 : 40 mm + Imm /20 mm & trom Aaa Ws RQI700-AS4 Measuring Device Information of the CTDIw (CTOIw AIR) 2187] No. | Test items (AHR) Measuring Device (8 987} (2 (RAY-1-43) Radcal Accu-Dose+ / () (RAY-T-01) X-ray Multi Funtion meter Ute GYAN) CTO! BB BE Test Method GAPE) ] ‘6) CTDIw test \Measure the CTDI dose value in Tube voltage 85KY, tube current SmA, 14sec and CT scan mode. \ \st this tie, divide the measured value by the exposed area size 100mm (Z-axis) to determine the dose. fs caste tbe CTD ang the determined ae 4 crow AG [pret esky, BIH SmA, 14sec CTH BS C1DI dose 2 FBeHch. Plt SBE US BASF 37] 10ommeHyZ UH HBOS WBE AS Seto crow Uw ALEC Results | Decision (HE) | Remark | ure Pelee a the Phantom for CTDI Head then measure the dosage, calculate | ind record. (Evaluation Standard: less than 20mGy) laa y jaa ae ata “TDIS| Head Phantom# Alignment®! # dose BS SAH A A” data B¥ BE Latah 2iRebct. (B7t 71z + 20mGy O18) i | Test criterion (XI7HAAHIE) 1 yay “4 Measuring Device Information of the Quality Control Picture Quality Dose Phantom Test (BSBA LE WAR) ABT! Be No. Test Items (HBS) Measuring Device (@8. 71871) (4) Line Pair Resolution (M8 818144) 1 | (6) Contrast Resolution (HEE) 1D (RAV-T-41) QUART Phantom / (4 (RAY-T-42) QUART Phantom (6) X-RAY Field (EAFOH) “The condition for test of image quality (S4 4% B7t ZW): (Panorama - CU 1.8mm fer / Ceph - CU 0.6mm fter) (4) Line Pair Resolution (MB AVM) HSA WSS ABU’ ‘WW23,50.64.240WbackupW02.8 24 ¥ 23 W01.QAWO1. Final Test ImageWO2. RCT700 Test Method (2/A¥ eh) BHAEME FSG AAO] SAE SA ine pair resolution o] ANY EA AWAAS SVE Selec. Check the line pair resolution of each modality image by eyes. Results | Decision (28) aia [Pah | Fee Panorama (Standard) - (Line Pair Resolution) } v 25 Ip/mm or higher visual identification enabled 25 LP/mm O18 ROLE THs) RQIT00-AS Test criterion (#7 A71E)| Measuring Device Information of the CTDIw (CTDIw AE) 7] BAL no. | Test tems (24H) Measuring Device (8 ABZ) bo avr Radeal Accu-Doses / 3 (RAV-T-ON) Y-ray Mult Fution meter 7 ee Wrear-T-19) CTO! AS BS Test Method (HAS) ‘© CTO test \Measure the CTD! dose value in Tube voltage 8SkY, tube current SmA, 14sec end CT scan mode, int this time, divide the measured value by the exposed area size 100mm (Z-axis) to determine the dose. ‘as, calculate the CTDIW value using the determined valve. crow AB pue BSKV, HUA SmA, 4sec® CTH BAO C1DI dose Bs SACL. [oi SUE US BYSA 27] 10ommeHe UO HBOS UV UH SH Cidw Us AEC Results | Decision (BS) | Remark Test criterion (XI7F#A7I) wren frieTras| ign the Phantom for CTD! Head then measure the dosage, calcula | land record (Evaluation Standard: less than 20mGy) L319 wo) 7 sal ae MA TDIS| Head & Phantom Alignmentt dose BS Se Hal” dota HY BE botot 21REICH. (B7E 718 : 20mGy OIsiy i 4 Measuring Device Information of the Quality Control Picture Quality Dose Phantom Test (BSBA HLM BEAM) A) Be No. Test Items (HAS) Measuring Device (@ 8 7171) (4) Line Pair Resolution (MF #4441) 1. | (6) Contrast Resolution (HES) 1D (RAV-T-41) QUART Phantom / CY (RAY-T-42) QUART Phantom (6) X-RAY Field (EAFOH +The condition for test of image quality (84 Ais 7} 222) = (Panorama - CU 1.8mm fiter/ Ceph - CU 0.6mm iter) (4) Line Pair Resolution (M8 MUM) “HSAA USS BYR WW23,50.64.240WbackupWO2.821d 92% W01.QAWOL, Final Test ImageW02. RCT700 ‘Test Method (WAP#) SRE SSH HAL HAIS|E Sw line pair resolution O] AW 7/EO AWEIF SHOE select CCheck the line pair resolution of each modality image by eyes Test criterion (47HIA7I) ha aun Pm re anorarma (Standard) - (Line Pair Resolution) U fs ine he ial eee aed ' 25 Le/mm O18 SAFE 7H) RQI700-415Resuts [Decsion (@@) | Remark Test criterion (AFH At1E) ae earn rae a2) (One Shot Type CEPH. (Lateral - HD) - (Line Pair Resolution) i A visual 25 tpvemm or higher vsval identification enabled vk | exarieation 25 LP/imm Ole SET Hs) | ez) a Results [Decision (BB) | Remark Test criterion (Y7FBA7I) aaa om lea | em bem Stor type EPFL ateral- HO) > (Une Pal Rasoltion) [Aa i cat fe ce exariration 25 Ip/mm or higher visual identification enabled | a 25 LP/mm Ole REESE 7H) | |e (6) Contrast Resolution (WEE) “AIBUA: Bales waa WW23.50.64.240WbackupW02.# a 392.8 W01.QAWO1, Final Test ImageWO2. RCT700 Test Method (Apa) BHAYSE SHG HAY BASIE SY Contrast Resolution O| AB 7IZH Aes SVS! Selelct. Check the contrast resolution ofeach modal image by eyes ita Tonite [Deskin @A)] Remark feet eet ne aura» [pelea | em Ta Pavoradrd) = ni Ren) p fe 2 2 step visual identification enabled @2 step ROEM 7H) eeen | fon (BE7FIAL1@) Results | Decision (2) | ‘Remark oan J uri» [pe [ray em Ine Shot Type CEPH. (Lateral - KD) - (Contrast Resolution) wih i esac 1 step visual identification enabled (1 step 27% 7H) es Results | Decision (23) Remark ‘on (HEAP Test criterion (HEAP) guam trea] ain Jan shape GP, ate Ho - aa Renn rie a 1 step visual identification enabled (1 step STH 7H) hada (0) X-RAY Field (EAH *#/SUAH TSS HSBSe WW23.50.64.240WbackupWO2. 24 @ 14W01.QAWOL. Final Test ImageWO2. RCT700 Test Method (2A) eld of each modality image by eves. TAS SAG HA RAE SI SNF AY SIO] AG 7S AVON RAS! SEC. check the xray Results | Decision (2%) Test criterion (AH7FBAHL®) er azn [ran [ra [Panorama (Standard) = Check the Xay fl iting arin he edge | = PHA AAO AG BAO] Moje x] Select) RQI700-AS| Resuts | Decision (BM)! Remark | Test criterion (A}7}HAt7IE) aaam bran lec | [eon a) {one shot Type CEPH. (Lateral - HD) | ‘Avsval . ‘Check the X-Ray field limiting area in the edge. wh | ‘exemination HSA AAPOF AIS BAO] O|tex| BelStch.) aeaan | | Test ian ATI) ro oa can Shot Type CEPH. (Lateral - HD) Aviat | Check the X-Ray field limiting area in the edge. t examination | PHBL ZAHOr Me SIO] MOLEX! weet (aeiaN «VIPROMED ) SERVICE RQI700-a1&(Field of View *3|SAAt ASS HBAS WA¥23.50.64.240WoackupW02. 3 Y 32H WO1.QAWOL. Final Test Image¥02. RCT700 4 Measuring Device Information of the Field of View ov) ABI ae No. Test items (488) hein (ea AB) 1 [orev TD (RAY-T-1) QUART Phantom / K&/(RAY-T-42) QUART Phantom a 1 Results | Decision (8) | __ Remark Ey | Tes Method And crteion AMY A APMIE) — acon ean Tray] ela) ‘checkitem after acquicng the phantom image. (ued See Uses Ete Beech 3) FOV diameter pas | © 0 160mm + Smm/(Max) Venn EM (@) Check the height of chinrest and laser beam ({Wo| #20] 5 BE! #2!) Test 7 ‘Measuring Device No. rest Items (ZAHER) (ea AN) 1) Check the height of chinrest {WO} $01) | C (RAV-T-41) QUART Phantom / CI (RAY-T-42) QUART Phantom 2) Check the height of laser beam (#88) | C (@AY-M-56) AOI BAI IG Results | Decision (BFS) Remark Test Method And Criterion (AW BL XPHIAPIE) —a < aoe gee aap pm trey] em fae en et ang eon ae Se A6e + HSS BAe 1) the height of chinrest (&{¥0] #01) 85mm ¢ 4mm [0.199 | * 2) the height of laser beam (84) i ve D 115mm og (2) Aton inspection Results [Decision 2) | Remark Test Method And Criterion (2LA}Hhe 52 3}7}214)7135) evan Pere] om heck the Aiga Inspection Result in the Log 144 Align inspection Result] BEB BIC) ) Align Inspection v “ogo Ain nipecon Ras) Waol assex| avon aac. | RQI700-4SData of CT patient Dose measurement (CT #4} M2t 33 Ba} Atz) Product Model [ay sysum, daprosc compute trophy, am Model (2.21) RCT700-SC ABS UVM SAMT STA ! {_Dete. (Bum 2020.10.19 Serial No. | RA720A5504 (2010066) | inspector (487) rg Measuring Device: [1] (RAY-T-01) X-ray Mult Funtion meter (PAY-T-43) Ragcal Accu-Dose+ 1, Measurement CTDI 100 (CTDI 100 4) Test conditions : Xay tube voltage : 85KV, tube Current : SmA, exposure time : 14s AVE BU : Xray BUS, DAF BA Bk, SA, 145 @ = Number of measurement: 3 times (9 SL 2t 2A ROL 38] 48S BRS ALE) = unit = mR (CIDI2| SBS mR HAS SBI} SAE) ® @ @ = Refer to 2. Calculation CTDIw (CTDI 100 late Ob@42] ASE TDI 100= [f X 100mm x 3 times average value]/(beam width=100mm ) ® {CTDI 100= [FX 100mm X 38] Be z/(beam width=100mm 02 100mm= LHECt.)) =0.0087mGy/mR, Converting factor in PMAA Phantom (f=0.0087mGy/mR, BHI) (2) 85kV-SmA al ‘Measured value (220) (mR) ia (98914) [rime camp] 2ime 250] 3time GED] average | COT yw center | 486.0 485.5 4869 486.13 4.23 AO} 47.1 4703 470.3 470.57 4,09 B(90°) 437.1 437.0 437.1 437.07 3.80 rs — cago") | 411.5 4113, 4118 41153 3.58 (270°) | 444.5 445.0 445.1 44487 3.87 2. Calculation CTDIw (CTDIw 714!) = CIDiw = 1/3CTDso0 + 2/3CTDig» (4 points average value, (4204 BAZ) Detal Calculation value (AAD 3:DVT-Acceptance Test Journal Controller: Device: Manufacturer: created on 2020-10-18 Test program: Sofware: OVTtee 12 Morutacurer: usa GmbH (ww quart iz) Detector sea: Depicted Volume: Entrance cose rata: Max scan tine: Test results {Image endtion approved according to category B Tube votege, tube curent. tube lead period, scan tm, focal spot nominal value, toll Rtraon are observable, ‘Bostoning aldes accorcing to manufacturer's dat are present and functioning. The dose-area products shown. “The positioning ofthe feld of primary beam with respect to the acive detector area is correct. ‘Aatelacs which would hamper the dlagnosis considerably ar not present. cose S:mGy Exposures: dose t:mGy dose Z:mGy Ulyes Pare Llves Pane Clyes Pare [ves Bre “The maximum aberration ofthe dose measurements fem the dose mean (7mGy) i 2%. Dose at theisocente: 2mGy Geometric dats: ‘modulation (9) Distance ofthe focal spot tothe conte cf rotation: ern Distance ofthe focal spot othe detector. en Horizontal diameter of scanned volume: om horizontal lameterofradiaton feld at detector: © om MTF (Column 1) line-pairsieam +DVT-Acceptance Test Journal created on 2020-10-18, Controller: Test program: Sofware: DVTiee 42 Manufacturer: Quan Geb (www quartz) Test phantom used: Seriatno: 333-444885 Prone: Fox: Emal: Device: on Manufacturer: Depicted Vokare: Type: RAT2OASS04 Entrance doce rte: ‘Serialno: RAT20ASS04 Max ecan time: Test results ir es Image rendton approved according to category 8 yes Pare “Tube voltage tube curet, ube loa period, scan te, focal spot nominal vaive, ttl iraion are observable, positioning aides according ta manufacturers data are present and funcioning. The dase-area products shown. Llyes Pane “The posting of the fies of primary beam wit respectto the active detector areal comect, Elves Bno ‘Aefacts which would hamper the agnosis considerably are rot present Elyes Pano Expoeures: ose t:mGy dose mGy dose S:mGy “The maximum aberration ofthe dose measurements fom the dose mean (Gy) is 7%. Dose atthe lsocente: my Geometicdata: _Distance.tthe focal spot tb the centro of rotation: om Distance ofthe focal spot othe detector en Horizontal damete of scanned volume em horizontal dlameter of radon teld at detector. © em MTF (Column 2) os | on 07 yy os. . ‘modulation (9) é ° os. 1 fine-palrsimmTUBE TANK Performance Test REPORT BS: PXD-200cT AawWas: 2010066, AAPA: 2020.10.19 Messuing Onice @ (UY-T-2t) agen GATOR) vaginim— @ WAT-TO1 WENO OO a 0 1 fosean crn onnoezn wan WE Tee O z 2 a * t 5 & & = 3 < = £ 3 = 8 a & iO T2APRIG KV: 45% / mA:420% / Secz4(5%+50ms) CSM Las [ears 6ORV-17mA-145, 1 $87] 1688] 1400) 77.44 2) 01m ano] Wwe STkY = eakv | mA 136mA = 204mA 0.001915 ony eral e $87] 1688] 1402] 7765 25) 07% WE Be: 220v-60Hz ae Foed TAT Wwe [| ma [sec [ méy [ temp | via [Seas] mass || 749) 1688] 902] 7427] 30] -am ayo] wv: 712sw = 7075 aoe | mas 136A ~ 204mA, Sec B5Sec ~ 955e 2| 750] 1688} 900] 7412 34] 07m Faee DOR amAS26 com] kn essey ~ 945i 80 | ma 32mA ~ 48mA Sec 409%Sec ~ 5515ec Foz soowamazoe | 1| 129] 407] 2000) S902 35) 17% | sev = tose ixoot mks 32mA ~ Ama 1001675 sec 1asssec~21058e¢} 1] 1029] 407] 2001] 916 35| un ‘ei He: 264v-SOHz EL Faee TAT we [oma [see [ey | temp. STRAT cam | lw: assty ~ sasey So iv tewccara | 1] 911] tesa] 031] 347 35 sez oxste Ose a AAAS BARE BZD Bq 2Z2) 2 ae oe gia vn «VIPROMED SERVICE Ke, tt Ral-Mlo} 21-05