FLAT Ill TECHNICAL MANUAL (MTFLATII-U03) Via della Pisana, 431 - 00163 Rome - Italy Phone: +39-6- 66160206 (10 lines) Fax: +39-6-66160357 E-MAIL general @ metaltronica.comPLAT II TECHNICAL MANUAL DOCUMENT STATUS SHEET Title of Document: FLAT III TECHNICAL MANUAL (MTFLATIII-U03) Version Release Date Reason of change ENGLISH o1 25/01/01 | First dedicated release (93/42) General Revision ENGLISH 02 15/04/02 Double Deata plus Dosemeter Small field Digital system New CPU 01-170-1 ENGLISH 03 16/07/03 Mii@nUrl Ag od Minimum kV to 20 New Potter- Bucky Automatic collimator FOR HIGH SPEED STARTER OPTION REFER TO DEDICATED MANUAL DECLARATION ACCORDING TO IEC 601-1 STANDARD EDITION 1992 Metaltronica declares its responsibility concerning safety, reliability end equipment features enclosed in this manual only if the following items are fully satisfied: 1)-installation; - updates; ~ recalibration; repairs and/or modifications ‘carried out by technical personnel officially authorized from Metaltronica S.r.1. Rome Italy. 2) Electrical preinstallation performed in the site where he system has to be put into operation, carried ‘out according to prescription given by IEC rules concerning Medical Application, 3) Use of the equipment performed following instructions given in this manual, WARNING Using and keeping X-Ray equipment and device must follow the local Regulations and ni concerning Medical X-Ray handling, jonal laws) Note According to CE 93/42 Directive for Medical Devices concerning product traceability, Metaltronica as manufacturer, must be informed of any owner or installation address change. MDD traceability is prerequisite to assure their safety and reliability over the time. METALTRONICA Tndex iFLAT JI TECHNICAL MANUAL INDEX Document status sheet pag. II CHAPTER 1- UNITS DESCRIPTION Unit description .. General specification of mammographic unit Flat It Environment protection and waste disposal Main parts ... se Flat Ill dimensional drawings Standard and optional device ... Standard accessories and optional a i Control panel Display plan with Deata plus.. General accessories ..... CHAPTER 2 - INSTALLATION Device classification. pag. 2-2 Identification label seneeee AQ. 2-3 Precaution for installation pag. 2-5 Flat Ill dimensions and weight sonnennannnerseens PQ: 2-5 Unpacking pag. 2-6 Installation check list .-pag.2-7 Ambient storage conditions. Ambient operating conditions. Sine rsaanre aseorinaseersoaeeermooeeooeteesaaneeneoa| ig -=: pag. 2-8 pag. 2-9 Backside view main internal components location. Power line connection. ae sevnnsnnnne@Q. 214 pag. 243 Voltage selector METALTRONICA indexFLAT III TECHNICAL MANUAL Emergency cut off.. LCD contrast adjustment... Data and time setting... Pag. 2-14 song. 215 pag. 2-16 pag. 2-17 Door safety switch.. External lamp... pag. 218 Exposure counter...... sens PAQ. 2-18, Service menu. ee pag. 219 Dip Switch and correlated functions... PQ. 2-20 Calibration... pag 2-21 Unit cleaning... Instruction for use. Packing instructions (UNI 9151)... CHAPTER 3 - THEORY AND CALIBRATION ROTATING ANODE STARTER. Calibration of safety circuit... Control led ... Function configuration .... Enabling braking. Braking tim Disabling safety circuit Changing main tension.. Trouble shooting... FILAMENT. Filament power suppl Anode current calibration. Calibration of ampere meter protection... Voltmeter protection calibration .. Anode current check by external device... Check led. Trouble shooting . HIGH TENSION POWER SUPPLY METALTRONICAFLAT IN TECHNICAL MANUAL Deseription....... Checking internal kV. Checking external KV... ‘Checking and adjustment points.. nn PQ. 3-21 pag. 3-22 pag. 3.22 pag. 3-22 pag. 3-23, Exposure time control.... Adjustment max output current, Control led Trouble shooting... AUTOMATIC EXPOSURE METER ... Introduction Mammographic system ... Selecting film/screen combination. Control test Offset [0] calibration .. detector [r] gain calibration Procedure preparation Developer... X-ray cassette for test....... Film pack for test... Test dummy.ccsi O.D. reference x-ray.. Time for carrying out procedure Anode Filter combination... Software installation Starting Deata plus procedure... Calibration file Film Screen combination ..srcee Anode Filter combination. Main Menon Environmental condition Sensitometric curves . Operating techniques Linear Calibration of optical densit Selection of test layers, ‘“METALTRONICAFLAT IIT TECHNICAL MANUAL. Test x-rays and calibration data collection. mAs and O.D. data interpolation Building the ZERO POINT calibration curve, Storing data in the uni Linearity chec! ZERO POINT curve for the other operating modes... RHODIUM filter management... Modification of the reference -density after calibratio Maximum breast density li Disabling Operating Technique and/or Film Screen Manual density correction. ONE POINT mode calibration. Calibration forms Reduced calibration procedure Density linearization vows Storage of last 1300 exposure Statistical data DoseMETER .. Introduction Management Software .. PQ. 3-54 Configuration eae nag. 3-57 Tube position. a seen AQ. 3-58 Distance between focus and skin.. Reference doses KV operative interval for dose measurement... Verification of calibration. Periodical calibration... Data collection forms .. COMPRESSION SYSTEN ... Introduction ......0. Adjustment of the compress Manual Compression. Motorized Compression .. Safety release, METALTRONICAFLAT Ill TECHNICAL MANUAL ‘Adjustment of maximum compression power . Mechanical adjustment of the clutch... XCRAYS/LIGHT FIELD ALIGNMENT PROCEDURE ... Assembly / disassembly of the same tube.... Replacement of the tube. Rays collimation Light / rays coincidence....... SWITCHING ON CIRCUIT. Power supply ... On/off sequences... Functional variations... Trouble shooting Fi.TROMaNM Mo/RH AUTOMATIC FILTER Description. PAG. 3-77 soe PAQ. 3-78 pag. 3-79 Electrical components. Installation.. DiciraL miacine sysTEM Description... ‘Modification of the unit.... Connection... Instruction fOr USE essere 7 FLAT/EASYLABEL COMMUNICATION INTERFACE PAG. 3-84 CHAPTER 4 ~ PERIODICAL MAINTENANCE TROUBLE SHOOTINGPeriodical inspections Pag. 4-2 Check list ..... Trouble shooting... METALTRONICA Index VILPLAT Il TECHNICAL MANUAL, CHAPTER 5 — ELECTRIC DIAGRAMS LIST OF FUSES. FLAT : GENERAL DIAGRAM 92-082-5 CPU Mother board... 92-072-4 CPU board.... 92-076-3 RAM+COM1+COM2 92-077-RA Analog input. 92-078-2 Exposure control interface pag. 5-2 pag. 5-5 pag. 5-13 pag. 5-15 pag. 5-19 pag. 5-23 92-079-1 Inverter ~ filament- rotating anode interface... }. 5-27 92-080-5 Control panel Interface - Digital YO 5-31 93-107-2 Potter Bucky driver + COMB... . 5-35 93-083-6 Keyboard/ control panel. |. 5-39 93-073-4 Filament power supply... 1. 5-43 92-074-3 Rotating anode starter ). 5-45, 96-153-0 Mirror motor driver... . 5-49 FLAT Fuses... 552 Transformer protection |. 553 Cables, CHAPTER 6 - SPARE PARTS LIST Standard maintenance spare part lst... Special maintenance spare part list. Exceptional maintenance spare part list “METALTRONICA Index VILFLAT Ill TECHNICAL MANUAL ‘METALTRONICAFLAT III TECHNICAL MANUAL FLAT III The mammographic unit FLAT ll represents the basic of Metaltronica’s design, a model used to give the Clients worldwide, the possibility of purchasing one with moderate prices, without changing the auality. Itis a unit technologically advanced, in which, the application of industrial production concepts, which are on appropriate scales, including the essential accessories, have permitted to present it in the market using a low price range for this type of product. The FLAT lil is equipped with characteristics that makes the whole system particularly light and easy to use, also for unexperienced operators. It is suggested that when a cheap price unit is requested, the quality features of the top configuration model remains unchanged. The FLAT IIl is equipped with an automatic exposure device (AEC), based on an extremely advanced concept that allows, through the use of special phantoms and PC (software), to store in the mammographic unit's memory, during installation, the typical calibration curve for the available film Process that is essential in order to obtain constant iconographic results for all the breasts examined independent to their intrinsic density This unit, manufactured entirely in Italy, is extremely reliable, and allows for high quality diagnostic exams to be carried out with iow costs and, without any retakes. ‘The FLAT Ill is particularly suitable for mammographic “screening” programs. The FLAT Ill, is a complete independent radiological system, with exposure control checked by appropriate safety devices; made from H.F. generator, incorporated with an x-ray tube dual focus, Potter-bucky with mobile carbon fibre grid, an efficient magnification device, and a complete range of accessories that help the operator to do his job. The control panel and the anti-X protection screen can be placed either on the right or on the lelt side or on the both sides. ‘The FLAT II! with option AMFLC-XX (C-Arm with variable F.F.D.) allows to make all mammographic projections without moving the patient or having to fix the “C”-arm's height. For Flat Ill a large optional accessory selection is available in order to expand its features to the maximum levels achievable today. Isocentric rotation C-ARM with variable F.F.D. allows easy and fast operation for every projection of the breast without moving the patient and without changing C-ARM vertical position. Dual mode Film and Digital stereo biopsy. Dosemeter for skin dose measurement. Easylabel daylight or darkroom film ID system with auxiliary display close to the unit for enhanced Patient comfort and check of personal data before printing on Film. ‘MBTALTRONICA CAP 1 Page 2 of 36FLAT III'TECHNICAL MANUAL GENERAL SPECIFICATIONS OF MAMMOGRAPHIC UNIT FLAT II é '220/230/240Vac +10% 50/60Hz 6.6 KVA (0.5 kVA stand-by) |Current absorption 30 A peak [Line voltage compensation ‘AUTOMATIC IH.V. generator with kV closed loop and line Feed forward compensation linverter Technology ‘urrent fed, Mosfet bridge with output urrent limit capability and short circuit rotection Inverter Frequency 25 kHz (50 kHz optional) ‘ipple Frequency/Amplitude 50 kHz (100 kHz optional) < 2% Nominal Power 3500 W 35 kVx100 mA (4600W 33kV 140mA optional) kV range 207 35 kV .V resolution (Man & Auto mode) 0,5 kV kv precision 41% |kv repeatability. £0/1% V risetime 1.5 ms from 0 to100% kV dispiay_ XXX KV (3 di lanode current max 100 mA (140mA optional) ImAs range ‘Small focus: 1/200 mAs (from 21 to 30 KV) 1/180 mAs (from 31 to 35 kV) Large focus 1/640 mAs (from 21 to 30 kV) 1/500 mAs (from 34 to 35 kV) mAs resolution (Automatic) 0,1 mAs mAs display XXX mAs (4 digits) Exposure Time ‘Automatically selected in function of selected mAs METALTRONICA CAP I Page 3 0f 36FLAT III TECHNICAL MANUAL lAnode rotation speed —_——— X-RAY TUBE ASSEMBLY . VARIAN M147 ‘2800 rpm 50 Hz [Target material Molybdenum [Maximum Anode Heat Content 222k3 (300 KHU) [Maximum Anode Cooling rate 740 W (60 KHU/Min) Maximum X-Ray Tube Assembly Heat content 370K) (500 KHU) jousing continuous Heat Dissipation 100 W (435 HU/Sec) sooling method free air convection lanode Disc Target Angle 10° lanode Disc Diameter 7imm [Power 3600 W large 800W small. Focal spots 2 Focal spot size according to IEC 336 0,1 small 0,3 large -RAY Window 0,75mm Beryllium [Inherent filtration 0,0mm Al IEC 522/1976 IFix Filter (standard) 30um Molybdenum |Automatic Filter Filtromamm ‘30um Molybdenum 30um Rhodium IHVL measured at 28kV >0,3 mm Al equiv. (TOTAL FILTRATION >0.5mm Al X-RAY TUBE ASSEMBLY (L.A.E. XM12i) lanode rotation speed ‘3000 rpm 50 Hz Target material Molybdenum um Anode Heat Content 225k3 (300 kHU) Maximum Anode Cooling rate 500 W Maximum X-Ray Tube Assembly Heat content 320K3 (440 KHU) [Housing continuous Heat Dissipation ‘830 W (108 HU/s) cooling method free air convection lanode Disc Target Angle 12.5° JAnode Disc Diameter somm. Power 4800 W large _1150W small Focal spots 2 Focal spot size according to TEC 336, 0,4 small 0,3 large x-RAY Window. 0,5mm Beryllium. {Inherent filtration 0,0mm Al IEC 522/1976 IFix Filter_(standard) 30um Molybdenum lAutomatic Filter Filtromamm 30;m Molybdenum 30pm Rhodium IHVL measured at 28kV. >0,3 mm Al equiv. ‘OTAL FILTRATION >0.5mm Al main CPU control 'UBE ASSEMBLY THERMAL OVERLOAD PROTECTION. ith active temperature sensor under Upper limit temperature 65° outside tube assembly. U and °C display available in technical enu. METALTRONICA CAP 1 Page 4 of 36FLAT III TECHNICAL MANUAL, controlled parameters auto parameters selection criteria \UTOMATIC EXPOSURE CONTROL (DEATA PLUS’ wuto KV / Auto mAs (ZERO POINT) Manual kv / Auto mAs (ONE POINT) elected in function of effective BREAST DENSITY evaluated by preexposure x- ray pulse < 10msec [Auto kV range Function of the selected technique (standard-extended-high contrast-low \dose), the Anode/Filter coupling and the| precise regulation + 0.5/+ 1/+ 1.5kV janual density control 1isteps 0:5 Programmable from PC independently for all the operative techniques available| iFilm Screen combinations with Deata [plus 16 film/screen programmable for 768 independent calibration Film Screen combinations with Reduced Deata 3 film/screen with manual programmable optical density ity over 2 to 6 cm of £0,1 of O.D. eference O.D. Programmable during installation .E.C, short time stability measured <3% lever 10 exposures taken at 28kV ‘SomAs Detector PHTM 9000 SOLID STATE (9 active sensors) Detector Positions 3 Electronically selected positions Detector saturation protection ffective protection against erratic sponse due to detector saturation Test Phantom Bx2cm + 1cm + 0,5cm of Plexiglas for [calibration and daily self test procedure Exposition Break For breast density higher max value programmed during calibration with a dose< imAs \A.E.C. Self Test Procedure lincluded in control panel functions CR method: 4,5 cm phantom of 50% jlandular tissue and 50% adipose issue exposure taken with 28 kV Aer glandular dose measured in < 3mGy IMAGE QUALITY Measured by ARCADE, Marseilles France, With RMI phantom model 156 Maximum SCORE = 54 obtained from lunit FLAT S/N 139, (23/09/1996) Spatial resolution >14ip/mm in both directions DIGITAL IMAGING SYSTEM imaging receptor igital cassette with standard jimension; compatible with standard otter and cassette holder tector {CD 50x50 mm 2048x2048 pixel (24 um) [Dynamics 16000:1 14 bits METALTRONICA CAP I Page 5 0f 36FLAT III TECHNICAL MANUAL [Imaging tranfer time to 70 cm variable with motorized lmovement BYM C-ARM jotation Manual #180° with disc brake ertical movement with respect to [65cm F.F.D. C-ARM reast support (C-ARM in vertical —_[55cm min to 130 cm max sition) \s0/70 ble F.F.D. C-ARM [88 to 154 cm F.F.D. 60 cm 78 to 144 cm F.F.D. 70 cm Patient protection ith lexan screen for patient's face rotection out MATOR gS : e ht beam ith automatic switch ON when |g compression and electronic [Light intensity 2150 tux [Light BEAM collimation accuracy ‘according to IEC 601-1-3 Mirror with automatic OUT of FIELD function {collimation plates [Interchangeable collimation plate for 24x30 film size (FFD 65cm) + [214 (18x24 and 24x30 optional) [COMPRESSION SYSTEM ompression Paddle movement Manual or motor driven mpression Paddles (standard) 16x22 shifted, 12x8 straight compression Paddles 10x22 shifted, 24x30 shifted, 10x8 [shifted, 12X22 straight Free space available between ompression Paddle and image receptor |Compression Thickness Display INot necessary with available A.E.C. s optional, graduated scale for standard | ind BYM C-ARM are available. Digital isplay only for 65cm F.F.D. C-ARM. fee Paddle Release after lectable from control panel, Automatic | xposure yr Manual for 2D Biopsy MAGNIFICATION c | [Magnification ratio 1,5 / x2 (standard) with potter bucky || ‘1.8 with automatic focal spot selection, | [cassette holder without grid and ca: METALTRONICA CAP I Page 6 of.FLAT IM TECHNICAL MANUAL [detector ‘METALTRONICA CAP 1 Page 7 of 36ee ‘FLAT II TECHNICAL MANUAL [POTTER BUCKY GILARDONI jucky factor (grid) 1,96 [Ratio S1 lLines/cm 36 \Contrast factor 1,47 (Cassette size 18x24 standard 24x30 [Cassette compati ity ll the most diffused models with \Cassette detector switch \dow as: Agfa,Dupont, Fuji,Kodak,3M | | tout alarm in 5 languages to ave louble exposure or exposure without ssette [Top Cover ‘Carbon fibre Film marker Integrated with 9 brass labels ‘est with NORMI Phantom Typical 3,5 balls lother features interchangeable with other accessories without tools rid movement synchronized with X- RAY beam IDOSEMETER | Measured dose [Dose at skin level [Data visualization jon display, label printer and data memory with average dose value on {1300 exposition to evaluate released \dose according D.L. 187 [CONTROL TABLE Microprocessor controlled with unique | Technology [safety features exceeding IEC 601-1~ jall functions under active operator contro! Display GRAPHIC LCD Display 240x128 dots lalarm messages In 5 languages Serial port exposition data for Easylabel edicated for Film Labelling device asylabel (200 characters printed), IA.E.C. / tube calibration and last 100 exposures memory download. | (Calibration and service Serial port Digital imaging system interface [Exposition memory METALTRONICA st 1300 exposure memory; i ube Thermal Unit display and active _ | lprotection. | ‘echnical display for self-test and jefective block identification, firmware elease, exposure counter and last xposure time/date. verage dose, amount of exposure for" very kV value, amount of exposure in very test technique CAP I Page 8 of %