Chapter Specifications i Chapter Contents 8.1 Environmental Conditions of EMC (Electromagnetic Compatibility) ..........0..e0.c0ece2 +2 oe eee 8-2 8.2. Specifications 02. J .t\. t/a sae era 8-8 8.3 Dimensional Drawings .............++--2-- +++ 8-15 8.4 X-Ray Tube Unit Reference Axis and Focal Spot Position 8-16 8-17 8.5. Radiography Parameters 86 Anatomical Program cists ci 87 Labels...8.1 Environmental Conditions of EMC (EI Cable List | : Cable Name ae Shield Note (Manufacturer/Part | Power Cable 40m No | Shimadzu Corporation / $03-75758 Hand Switch Cable 45m No ‘Shimadzu Corporation / S11-64136 Luminous Hand Switch Cable 45m No ‘Shimadzu Corporation / S11-64129 ‘Additional Protective Grounding Wire | 4.2m No | Shimadzu Corporation / 501-90150-02 (@]_note The cables listed above are the parts specified to be compliant with the standards. These parts are not provided to the system. HH Option List Option Type Note (Manufacturer) Remote Controller Shimadzu Corporation ‘Dose Area Product Meter Dose Calculation Unit Shimadzu Corporation Distance Indicator ideas ll i - 4 SEE be CeaeaE fe 5 —— - ‘Luminous Hand Switeh ‘Additional Hand8.1 Environmental Conditions of EMC (Electromagnetic Ii Guidance and Manufacturer's Declaration - Electromagnetic Immunity Guidance and Manufacturer's Declaration - Electromagnetic Immunity ‘The MobileArt Evolution is intended for use in the electromagnetic environment specified below. The Customer or the user of the MobileArt Evolutionshould assure that it is used in such an environment. Immunity Test EN/IEC 60601 Test Level Compliance Level, Electromagnetic Environment - Guidance Electrostatic discharge (ESD) £6 KV contact 46 KV contact Floors should be wood, cconerete or ceramic tile Ifthe floors are covered with EN 61000-42/ E8KV air 48 KV air synthetic material, the relative IEC 61000-4.2 humidity shouldbe atleast 30% Electrical fast transient [22 kV BW = saa Mains power quality should be burst for power supply lines | for power supply tines | Mains , that ofa typical commercial or FY §1000-4-4 seLRY uy hospital environment. IEC 61000-4-4 for inpuvoutput lines for inpuvoutput tines ae : +1 KV lin() fines) | +1 KV tints) to tines | Mains See ae EN 61000-4-5/ sown’ [eres at oF atypical commercial TEC 6100-45 sy pnts fo earth | 22 KY Hoes) feat | spre creme Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11/ TEC 61000-4-11 S%Up (©95.% dip in Ut) for 05 cycle 40% Ur (60 % dip in Us) for 5 cycles 70% Up (30% dip in Uy) for 25 cycles: 5 % Uy (95 % dip in Up) for 05 cycle 40% Ur (60% dip in Uz) for S cycles 10% Uy G30 % dip in Up) Mains power quality should be that of typical commercial or hospital environment Ifthe user of the MobileArt Evolutionrequires continued ‘operation during power mains interruptions, itis recommended that the MobileArt Evolutionshould be powered from an uninterruptible power supply or— eee 8.2 Specifications Three types of the equipment are available each with different column heights. a Column Height Type T 1930 mm Type S 1780 mn Type SH 1780 mm 8.2.1 Operating Environment item ‘Specification Atmosphere 'No explosive or crtosive gases “Ambient Temperature 10 1040°C Relative Humidity 30 10 85% (with no condensation) Atmosphere Pressure 800 hPa to 1060 hPa Environment Luminosity 150 10 500 Ix 8.2.2 Power Supply e Specification [posse [soc led lead storage battery (12 V x 20 cells) ‘Phase 100, 110, 120, 200, 220, 230, 240 V AC. 100, 110, 120 V AC: 1.00 max. , 220, 230, 240 V AC: a ese BaeHB High Power Type (32 kW) tem, Specification Max. Electric Power 32. kW (100 KV, 320 mA, 20 ms / 80 kV, 400 mA, 20 ms) 16 kW (LOO KY, 160 mA, 0.1 s) Nomunal Electric Power: (product of max current flow possible for 0.1 seconds and tube voltage, at 100 kV nominal tube voltaze) Nominal maximum tube voltage and 133 kV, 200 mA, maximum tube current where nominal ‘maximum tube voltage output is possible: Maximum tube current and maximum tube 400 mA, 80 kV voltage where maximum tube current ‘output is possible Ratings Combination of tube voltage and tube 100 KV, 320 mA / | current that outputs maximum electrical 80 KV, 400 mA power Minimum current-time product 0.32 mas Maximum current-time product 320 mAs Nominal minimum irradiation time: 1 msee Large Current-Time Product | Focus: Settings Possible at 401090 KV: 0.32 0 320 mAs 101 to HOKY: 0.3210 250 mAs 121 to 133 KV: 0.32 0 200 mAs 91 t0 100kV- 0.32 to 280 mAs 111 to 120 kV: 0,32 to 220 mAs Given Cassette Radiography Voltage’! | Small 4010 90KV: 0.3210 320 mAs 101 to OY: 0.32 t0 250 mAs 121 to 133 kV. 0.32 10200 mas 91 t0 100KV: 0.32 to 280 mAs 111 to 120 KV: 0,32 t0 220 masem CE ‘The various cond tions area follows ibe voltage (within +10 mAs within = (10% +0 (tim 1st " »). Tube current (within + 20%) i, 2 mh Tne wns 0% a) 8.2.4 X-ray Tube Unit Hl High Power Type (32 kw) Item Specification Model 0.71 3U63C-36 Nominal Focal Spot Size 07/13 mam Target Angle 16 degrees ‘Nominal Max, TibeVoltage | Radiography 1B3kV Max. Heat Content | 750 ki (1060 KU Xray Tube Unit (tu Max. Continuous: pena) Heat Dissipation | 120 W070 HUA) Rate Max. Anode Heat Conch 210 kd (00 KHU) aay tine MEEATAHA | 99 a sony (tube only) i Max. Continuous Heat Dissipation | 210 W G00 HUIS) Rate ‘Maximum 60°C Surface Temperature on Touchable (Compliant 12C60601-2-28 for painted X-ray tube unit surf Surface of X-ray Tube Unit Mass 128kg.jen ‘Specification Max. Anode Heat) 910 300 kHU) Content Xray Tube Os Anode Heat | 90 W (130 HU) (tube ont) | Dasipation Rate Max. Continuous Heat Dissipation | 210 W G00 UIs) Rate ‘Surface Temperature on Touehable | Maximum 60°C Surface of X-ray Tube Unit (Compliant to TEC60601-2-28 for painted X-ray tube unit surface) Mass ke 8.2.5 Collimator item Specification Model RNC Shape Rectangular Field Max Tiel 4430 mm > 430 mm at SID Im Min. Field ‘Omm x O mim (eaves closed) a Average Illumination } 160 Ix min, q Tuminanee Ratio 3 min 5 — 34 7 2% of SID map UMI2 V 100 W 101) of LED lamp8.2.6 X-ray Tube Unit Holder 8.2.7 Item Focal Spot Height Specification Type T: 600 mm to 2010 mm Type 8: 600 min to 1860 mm Type SH: 750 mm to 2010 mm. Amn Length 635 mm to 1200 mm Column Rotation Range 4270 degrees X-ray Tube Rotation Angle +180 degrees X-ray Tube Axial Rotation Forward 90 degrees, backward 20 degrees Minimum Inherent Filtration Item ‘Specification Total 2.5 mm Alat 70kV X-ray Tube Unit 1.5 mm Al equivalent at 70 kV. Collimator‘Specification Disposable Wipes Holder Cylindrical wet tissue containers can be held, witha radius between 120 mm to 150 mm and a height between 190 mm to 230 mm. Remote Controller ‘Using the infrared remote controler allows performing radiography and switching the collimator lamp ON or OFF remot Protective Screen (folding) ‘Operator exposure can be reduced by using the protective sereen Dose Area Product Meter Indicates the dose-area product (cannot be installed together with the dose calculation unit or the distance indicator) Dose Caleulation Unit Calculates and displays the radiation dosage of the X-ray applied to surface of the patient (cannot be installed together with dose area product meter) Distance Indicator ‘Shows the distance measured by the dose calculation unit (cannot be installed together with dose area product meter). Keyless Entry ‘The system can be managed using a password instead of a key switch, ‘Changing the Grip Bar Height ‘The grip bar height can be changed to 950 mm, 970 mm, or 1000 1mm from the floor surface. Select the desired height during installation (default bar height is 910 mm). Luminous Hand Switch ‘The hand switch is illuminated to indicate when the radiography ‘preparation is finished, or that radiography is in progress. ‘Additional Hand Switeh Allows adding an illuminated hand switch to front of system. ues | BY allaching the grid case, 2 shects of grid holder can be stored. ‘box stores 15 light weight 14 x 17 inches-J Dimensional Drawings .3.1 General Dimensions aa Item Specification Total Width 580mm Total Length. 1145 mm Type T: 1930 mm Height of Column Type S: 1780 mm Type SH: 1780 mm Mass High Power Type (32 kW): 435 kg Standard Type (12.5 kW): 400 kg Maximum Travel Speed Approx. 5 kin/h (Maximum instantaneous travel speed: 6 km/h, may vary depending on condition) Maximum Storage Capacity of Cassettes 10 We : <38.5 Radiography Parameters 8.5.1 High Power Type (32 kW) Wi Normal Use Large Focus Tube Tube Voltage (kV) Current- Time Product 133 125 100 80 60 40 (mAs) 032 0.0016 0.0012 0.0010 0.0010 0.0010 0.0012 os 0.0025 0.0020 0.0016 0.0012 0.0016 0.0020 1 0.0050 0.0040 0.0032 ‘0.0025 0.0032 0.0040 2 0.0100 0.0080 0.0063 0.0050 0.0063 0.0080) 5 0.040 0.020 0016 0012 0.016 0.020 8 0.080 0.063 0.040 0.020 0.025 0032‘Current Bote 133 125 100 ed 80 (mAs) 0.32 0.0032 0.0025 0.0020 0.0016 0.0016 0.0020 05 0.0050 00040 0.0032 00025 0.0025 0.0032 1 0.0100 0.0080 0.0063 0.0050 0.0050 0.0063 2 0.0200 0.0160 0.0120 0.0100 0.0100 0.0120 5 0.063 0.050 0.040 0.032 0.025 0.032 8 0.100 0.100 0.063 0.050 0.050 0.050 10 0.125 0.125 0.080 0.063 0.063 0.063 16 0.320 0.200 0.125 0.100 0.100 0.100 20 0.400 0.250 0.200 0.125 0.125 0.125 50, 100 0.63 0.50 0.40 032 032 100 2.00 1.60 1.00 0.80 0.63 063 | 200 4.00 3.20 250 2.00 125 125 ee ‘i : 3.20 2:50 2.00 iB (Unit see) i 2i Low-Battery Mode Large Focus Tube Cert Tube Voltage (kV) Time ee | Pees (ress 125 400 80 60 40 0.32 0.0016 0.0012 0.0010 0.0010 0.0010 0.0012 05 0.0025 0.0020, 0.0016, 0.0012. 0,0016 0.0020 1 0.0050 0.0040 0.0032 0.0025, 0.0032 0.0040, 2 0.0100 0.0080 0.0063 0.0050 0.0063 0.0080 5 0.040 0.020 0.016 0.012 0.016 0.020 8 0.160 0.080 0.040 0,020 0.025 0.032 ra 0200 0.160 0.080 0.040 0.032 0.040 16 0.320 0320 0.200 0.160 0.100 oo | es 20 0.400 0.400 0.250 ced i ne L 0.080 = 1.00 1.00 0.63 a i 00 page 400 2.00 2.00 ed 200 70) es |e ~ so |‘Small Focus Tube Tube Voltage (kV) ae Product 133. 125 100 80 ae 40 (mAs) 0.32 0.0032 0.0025 0.0020 0.0016 0.0016 0.0020 0s 0.0050 0.0040 0.0032 0.0025 0.0025 0.0032 fl 0.0100 0.0080 0.0063 0.0050 0.0050 0.0063 3 0.0200 0.0160 0.0120 0.0100 0.0100 0.0120 5 0.100 0.100 0.063, 0.040 0.025 0.032, 8 0.160 0.160 0.100 0.080 0.063 0.050 10 0.200 0.200 0.125 0.100 0.080 0.063 16 0.320 0.320 0.200 0.160 0.125 0.100 20 0.400 0.400 0.250 0.200 0.160 0.125 50 1.00 1,00 0.63 0.50 0.40 0.32 2.00 2.00 1.25 1.00 0.80 0.63 2.00 1.608.5.2 Standard Type (12.5 kw) Hi Normal Use ji ae Tube Voltage (kV) (mAs) 125 100 80 60 0.32 0.0064 0.0064 0.0051 0.0032, 0.0032 05 0.0063 0.0063 0.0050 0.0040 0.0032, 4 0.0100 0.0080, 0.0063 0.0063, 0.0063 n4 0.0200 0.0160 0.0125 0.0125 0.0125, 5 “0.063 0.040 0.032 0.032 0.032 8 0.100 0.063 0.050 0.050 0.050 10 0.125 0.080 0.063 0.063 0.063 16 0.200 0.125 0.100 0.100 0.100 Bi 0250 0200 0.125 0.125 01125Hi Low-Battery Mode mmcnae Tube Voltage (KV) Time Product 80 60 ao | (mAs) 125 100 r 032 0.0004 0.0064 0.0051 0.0032 0.0032 05 0.0100 0.0063 0050 | 0.0040 0.0032 1 0.0200, 0.0125 0.0100 0.0080 0.0063 2 0.0400 0.0250, 0.0200 0.0160 0.0120 5 0.100 0.063 0.050 0.040, 0,032 8 0.160 0.100 0,080 0.063 0.050 10 0.200 0.125 0.100 0.080 0.063 16 0320 0.200 0.160 0.125 0.100 20 0.400 0.250 0.200 0.160 0.125 50 1.00 0.63 0.50 0.40 0.32 100 2.00 1.25 1.00 080 068 2.50 2.00 1.60 3.20 2.50The factory-set anatomical program numbers (APR numbers) and their radiography parameters are indicated below. High Power Type (32 kW) APR for Chest 6 Anatomical Program id leg are set 32 kw electric power, using the large focus, to minimize image blur from body movement. Exposure time may be extended and tube current decreases in some radiography settings when choosing the small focus, Electric power* of High mAs settings like APR for Abdomen and Waist have no difference between the large and small focus. * Electric power mean kV times mAs, APR Imaging | Projection | _ Body ba ee Number | Region | Direction | Thickness 1 Head Frontal Thin ot 4 Sima 2 Head Frontal | Normal a 4 Small 5 Head Frontal Thick 66 16 Small 4 Head Lateral, Thin 56 14 ‘Small 3 Head Lateral ‘Normal 58 4 ‘Small 6 Head: Lateral Thick 6 14 ‘Small 7 Head Oblique Thin 56 18 Small 8 Head Oblique 8 Small 9 Head Oblique 18 Sina 10 Chest Frontal | Large i Chest 67 jaan aie 12 Chest : | B a 4 hs 1s f 14) he is: Oblique Normal 59 18 9 Head Oblique ‘Thick a 18 0 Chest Frontal Thin 79 28 u Chest Frontal Nonna 9 32 R Chest Frontal Thick 2) 32 13 Chest Lateral Thin 88 32 W Chest Lateral Nomnal 91 36 15 Chest Lateral Thick 95 4 6 Chest Oblique Thin 87 32 v Chest ‘Oblique Noma 90 32 Is Chest Oblique Thick B 32 ir) Abdomen Frontal Thin 4 56 20 Abslomen Frontal Normal 7 6 2 Abdomen Frontal Thick 80 m 2 ‘Abdomen Lateral Thin 86 @ B ‘Abdomen Lateral Normal 0 @ Ey Abdomen Lateral Thick 95 3 25 ‘Abdomen Oblique Thin 8 80 26 Abdomen Obligu Nonna a 30 2 ‘Abdomen Oblique hick 89 80 28 Waist Frontal Thin Pa a a ii et Frontal ‘Normal 68 25 a : Thick 71 5 | tin 2 2 __ Nonna 84 3 =a i leeH) Leg Lateral Normal 8 mM / 2 Leg Lateral Thick 1 7 ! a Leg Oblique Thin 65 8 4“ Leg Oblique Nonmal 65 9 45 Leg Oblique Thick 65 19 46 Foot Frontal Thin 38 22 47 Foot Frontal Normal 58 25 48 Foot Frontal Thick él 25 49 Foot Lateral ‘Thin ST a 50 Foot Lateral Normal 58 2 SI Foot Lateral thick a 2 2 Foot Oblique Thin 55 25 3 Foot Oblique Normal 38 25 54 Foot Oblique Thick ol 28 35 ‘Ann Frontal Thin 58 28 56 ‘Ann Frontal ‘Nona 38 aid 37 Arm Frontal Thick ol 32 38 ‘Arm Tateral Thin 6 28 B Ta Lateral ‘Normal 6 32 a am Lateral Thick | 65 36 < ai ique i 22 a @ Hs? Sil layImaging Region Projection Body kV Direction Thickness R Hand | Oblique Thick 37rT Labels Locations where the labels are attached are shown as follows. ® a® Qo : (h. oo agswe : eo)i Name Plates @Name plate of MobileArt Evolution @Name plate of collimator R-20C @ldentification label of Xray control ‘unit MUX-200D:x¢ (For ve a i ae ee a ee RAE ean IVEAAX GDH RM One ten wo ert. evalut on Eben abaxeidad Hot (eArt eval utlon ERREO: A Sh Tot / SA far Fey oir Ib aes TAH 2072307200 he VA 50/60, 1k INTERIAL POWER Y E PROTECTION PE B , NANUFACT Nade in vaven sean 3s sox A ERE etios saan | Ore IAD2ZU Nah Inokyo-turaseraono,Nakeoyo-Hu, oto 80 TION, whee t- 8TH) XEPRERIX— a MATOR 2 BRE BFE oy sree 20cisiie ne ty Se wbcTIBE hyo me si AL au Type ca PROTECTION MANUFACTURED god) RERABTGS 2601400009 Mh me Aa w® ERRBYEPT Woivice nace: shinehvB-Cavebar sano, layers tee RAO HERE VIE BENFe Warning Labels | @caution Label F “——_ & CAUTION } TN ST TS BSE ret so oe sue leeuevege, nt 7a0xeMuu Creu, Se oeetteMRURHRE S EMER TINS P| @Caution Label G (Only for Grid Case) TEPER nance A NOTE vee [Oo N07 PUT Th CASSETTE THE GRID CASE ‘Caution Label A amie eeeae Doky-REREy7eARgOT CHU Gicaenvesnsnure. — @Caution Label H Bei pemenare (Only for Large-Sized Cassette Box) — me A CAUTION coca Tk OST UT ET ASETE 8 IY PEIN 3 HSS OF AaPeRPALTCEM, | Ae yzORRT BUG WORBERALUNETEELCCEW. samy Warning Label A 4 WARNING X-RADIATION, is Kay ecucrer oy be canes pent nt perils sale eps aco an peri ecto a ered ‘@Waming Label B | ZX WARNING SSS Le Operating instructions and ‘maintenance Saltese cbse 2 8 @Caution Label of Breaker DO NOT TURN ‘OFF? qt Ae ecula BREAKERS eoR RUNNING. see | DRIATAMMREE, 445° L -eoFFcueneceaan: | Indication Labels @small Movement Switch Label D> @Additional Earthing Wire Label OREM ADDITIONAL GROUNDING WIRE Wi Other Labels @UL Label ASSY CERTIFICATION COMPLIES WITH FDA RADIATION PERFORMANCE ‘STANDARDS, 21 CFR SUBCHARTERing For X-Ray Tube Unit ee oo a= \i 2 i Name Plates @Name plate of X-ray tube assembly (High Power Type (32 kW)) NNER XRPSE MODEL xsayubo assemdy O. 7/1, 3U1630-36 RS X #0. 7/1. 1630-36 ERO TERR we PN SN 52-24780 [Ba] -——— Xs Fou faa / 0.7/1.8 PERUANENT FILTRATION at at TORY cy POTEET ON nT Asc! PMA at 7 vuleactunen of] OA ado in Japan ZN, AGERE 220aBBzx00228000 3 692-24760 OMB RYE Poe nes sanm al SHIMADZU CORPORATION |LNichinokyorKunabaracho, Nakagyorku, Kyoto 804-8511, Japan Name plate of X-ray tube assembly (High Power Type (32 kW),For UL)Xm ee woneL WR HAL 3U1630-36 2M 0.7/1 m Raation Fea nee i Wax Se2°24180. [Bi] 2xv0099660 sort A eat TY d SHIMADZU CORPORATION _1-Niahinokvo-Kunabaracho,Nakagyo-ku, Kyoto 604-8511, Jasan Name plate of Xray tube assembly (Standard Type (12.5 kW), For UL) yaa pains lo7nauie0 36 rama max. [133K INSERT TYPE orasuec ‘| INSERT SERIALNO. Focus (73mm. PERMANENT FILTRATION | 1.5mm AL at 70kV_ MANUFACTURED KYOTO: IADZ! IRPORATION Rete ina aan Neato en i Warning Labels @label around a radiation gate @Warning Label (High Voltage)er Labels @UL Label ASSY CERTIFICATION COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS, 21 CFR SUBCHARTER J