User`s Manual - Frank`s Hospital Workshop
Contents
1. MET Or LO Mm M D i x T 091 26 61 42 62 0001 Bre Ez co N K m OO N r 3 no CN MN N UP LO DO Nod S L6 41 997 59 ce See Gr 6 8102 0698 8622 E Figure 15 Pag 26 32 1 File M 30010E00 doc Villa Sistemi Medicali Visitor T152. Figure pos 1 deactivated brake File M_30010E00 doc Figure 8 pos 2 activated brake Villa Sistemi Medicali Visitor T15 User s Manual 4 2 Positioning For positioning the unit the following instructions should be considered Don t move the unit when the brakes are activated For the movements use the proper handles e the safety knob and turn it till it is taken out see Figure 5 e For adjusting and positioning the arm height use the handle on the monobloc see Figure 8 Position the monobloc collimator assembly over the relevant area of the patient see Figure 10 Figure 11 e the unit ON see the paragraph 4 4 Start up and checks at the ignition e the collimator lamp ON the lamp will stay on for about 305 e Collimate the x ray beam to the dimension of the cassette see the next paragraph If necessary release the brake to perform this operation don t forget to set it againl e When the positioning has been completed lock all the movements braking handles and the parking brake TO 9 Figure 9 Figure 10 Figure 11 File M 30010E00 doc 1 Pag 13 32 Users Manual Visitor T15 Villa Sistemi Medicali 4 3
3. Energia Accumulata Stored Energy Energie Emmaga iB 0 98 in g 16 mm N 270mm 0 63 in 7 2761n LA 64 mm ee CN 2 52 n 3 a ai ES N i J 15 D m 216 mm 8 50 912 in l 0 5 10 15 Tempo Time Temps min Figure 16 Figure 17 Single load curves Single load curves 0 8 3 3000min 1 3 3 3000min Anodic current mA Exposure Time s Anodic current mA Exposure Time s 350 00 5 E g 600 lt 5 E 5 5 sokv 500 50 n 2 60 kV 70 kV 80 kV 5 oy 80 kV 2 52 F 90 kV 3 100kv 100 E 8 120 1 m Prud 5 1 lt 5 L 2 100 8 0 01 0 1 1 10 0 01 0 1 1 10 Tempo di esposizione Time Temps sec Tempo di esposizione Time Temps sec Figure 18 Figure 19 Pag 28 32 Rev 1 File M 30010E00 doc Villa Sistemi Medicali Monobloc Visitor T15 User s Manual MHF 2015 320x140x255mm 12 60x5 51x10 04in 19 Kg 41 891b X22 0 8 1 3 Large focus not used Rotating 2850rpm at 50Hz 3400rpm at 60Hz External thermostat 57 Max continuous thermal dissipation of monobloc 2 mm Al
4. MEDICAL MOBILE Revision 2 Version March 26 2004 File M 30010E00R02 doc Liser s IVI nual WARNING The information that is printed within this manual is vital for the correct use of the equipment please read it carefully before use Users Manual Visitor T15 Villa Sistemi Medicali This page is intentionally left blank File 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual TABLE OF CONTENTS Ee SAFETY AND CO MPLANG Eense 2 Lr 6 See ue UII DEAD tL MU COME D UL LI PME OTe 2 1 2 eeann sod oa eh cette get atl auto cael each ats Rehan Rieder 2 1 3 Electromagnetic compatibility EMC accede ror ste tree b e tpe eee eee tust e be muse 3 1 4 PROLECHON CO soe toseoek wrest den ck stance tes monk ute chk ales e cedit 3 135 CSS SRG tn etd Me LAG eo ce et Mik ecl LC atid oe 3 16 AP OIIEGHOM ecd dxeshbiellOpi ee stores em ub emu nase MM MM MEE 4 A WinME a a 4 kos SuSE 4 Spp MI M LM PS M ME 5 PRU T 5 2 COMPONENT IDENTIFICATION E N E 6 2 e dee ERR 6 22 SOMA OM seater to CUM EM ELM UM ECL M pM MM E MMC 6 249 Lu ret EM MA A M MA ed E 7 2 POC NOISE SS ACH EARR AA RG AE 8 Die anderr ME
5. Max protection against leaked radiation 125kV 4mA EN60601 1 3 par 29 204 3 Indicator accuracy It corresponds to the x ray fields with tolerance lower than EN60601 1 3 par 29 202 8 2 ot used FFD Inherent filtration 2 0mmAl EN60601 1 3 par 29 201 2 29 201 6 1 3 pr EN60601 1 3 29 202 9 2 ot the used FFD Classification EN60601 1 par 5 Protection against electrical hazards Class Protection against direct and indirect contacts Unit with applied part Type B Protection against water penetration Common protection IPXO 6 6 4 meter dose area product meter optional This device is installed only on request Type brand and model Dosimeter with ionization chamber PTW Freiburg Pre endende TIG 6 7 Accessories and options Description __ X ray handswitch with extendible cable lonization chamber dosimeter mod DIAMENTOR PX 6 8 Compliance with Directives and Technical Standards Medical devices safety l Pag 30 32 Rev 1 File M 30010E00 doc Villa Sistemi Medicali 6 9 Labels and symbols 6 9 1 Labels of the unit Model VISITOR T15 Code XXXXXXXXXX Serial Number Date mfg XX XX Supply 115 230V iss Frequency 50 60Hz POWER Standby 2A AN Radiography 9A AN Classification I RK IEC 60601 1 C 0051 lonizing radiation max 125 kV
6. User s Manual 6 6 Components specifications 6 6 1 Generator Description Inverter HF 2015 Working frequency 20kHz max Max inverter frquency in high voltage Power supply Max absorbed current Technology Safeties overcurrent overvoltage IGBT driver fault Generator power in constant DC current IEC 601 1 15kW 150mA per 0 13 Max voltage to the tube Max ripple at Rise time at 100kVp Max current in radiography File M 30010E00 doc 1 Pag 27 32 Users Manual Visitor T15 Villa Sistemi Medicali 6 6 2 Tube Housing Assembly X Ray Tube Nominal anode power IEC 613 EN 60613 Nominal foci size IEC 336 EN 60336 64mm 2 52in Min inherent filtration IEC 522 80kJ 107kHU 22kI min 29 5kHU min Nominal high voltage Tube seasonin After a long idle period 3 months or more it is necessary to proceed to the X RAY TUBE SEASONING The procedure and the tube seasoning modes are described in the Service Manual Dimensions Heating and cooling curves of anode Stored energy kJ Time min i 50 cm 19 69 in 36 cm 14 17 in 70 cm 27 56in 100 cm 39 37 in 122 mm 4 80 in 0 75 1 p e 046 mm 80 mm if 0 03 0 04 i X 1 81 in 8 3 15 in mE ap i VR d Scy 25mm
7. 14 Control panel 15 Arm safety lock for transport 16 Monobloc support arm 17 Safety lock for monobloc rotation Figure Collimator Tu 2 Longitudinal collimation Extensible meter for focus skin distance check Transversal collimation 4 Lamp switching ON for the luminous irradiation tield indication 5 Guides for the accessories positioning filters or DAP dosimeter Figure 2 File M 30010EO00 doc Villa Sistemi Medicali 2 3 Control panel ___ Ready Visitor T15 User s Manual FK Reset Here is a brief description of the keys function in standard use and the signals meaning POTTER COLLIMATOR POWER MENU Figure 3 Unit OFF Unit ON the green led indicates that the unit is connected to the mains and supplied External potter selection only if the potter is inserted in the proper connector Collimator lamp ON the lighting is timed for about 305 HIGH or LOW POWER selection The led ON indicates the HIGH POWER selection Allows scrolling through pages in systems with more than one page File M_30010E00 doc 1 Pag 7 32 Users Manual Visitor T15 Villa Sistemi Medicali kV kV To modify KV value To modify mAs value Return to the main menu Function keys F1 F2 F3 F4 They
8. Collimator adjustment 1 the frontal panel of the collimator there are two knobs for the beam adjustment width and length as well as the push button to turn ON the collimator lamp see Figure 12 It is possible to turn the lamp ON by pressing the COLLIMATOR push button placed on the control panel Figure 12 The extensible meter allows to measure with accuracy the focus film distance FFD 2 necessary rotate the collimator see Figure 13 Figure 13 Pag 14 32 Rev 1 File M 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual 4 4 Start up and checks at the ignition l Connect the unit to the mains Voltage presence is indicated by the lightening ON of the yellow led placed aside the ON button If while it is plugged the red light is off check that the automatic switch lever placed aside the unit is up ON position 2 Turn the unit ON pressing the ON button follow step by step the Start up phase and verity 15 performance by the following comparison e check of the display every digit is completely ON every pixel is dark e check of leds and beepers all the leds of the keyboard turn ON and the beeper emits prolonged sound e software version without dosimeter UNIT NAME VER X XX XX with dosimeter DAP XXXXXXXX UNIT NAME VER X XX XX gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt XXXXXXXX can have
9. Total filtration Leakage radiation lt mGy h according to IEC 601 1 3 Thermal monobloc capacity 600kJ 800kHU Loading heating and cooling curves H V transformer insulation Dimensions 290 11 42 See the enclosed diagrams Oil bath 965 2 56 230 1 18 d H I THERMIC SAFETY S SSSSSSSSS D m 4 R3 D qr Cea es ci VES 024 125 4 92 170 6 69 55 2 177 233 9 17 Figure 20 Heating and cooling curves of monobloc Stored energy kJ Time min 180min Figure 21 File M 30010E00 doc Rev Pag 29 32 Users Manual Visitor T15 Villa Sistemi Medicali 6 6 3 Collimator Type brand and mode Manual with internal light source Ralco R221 Square field multilayers Light source Halogen Lamp 12V 100W with timed switching on at approx 30s 43x43cm 169316 93 at Tm 89 37in DFF Prearrangement to insert the dosimeter
10. V3 V3 DEFECT V3 DEFEKT FALLO V3 APR DATEN RESET APR INLAPR INLAPR e INLAPR bed ERRORE IN APR APRDEFECT APR WERT FALSCH FALLO APR STARTER STARTER BLOCAGE BLOQUEO INTERLOOK BLOCCATO DEMARREUR ANLAUF FEHLER CEBADOR CHOPPER HACHEUR CHOPPER FAULT isa CHOPPER FEHLER FALLO PULSADOR TIME OUT TEMPO SCADUTO TEMPS EXPIRE PREP ZU LANG FUERA TIEMPO READY PRONTO PRET BEREIT LISTO BUSY ATTESA ATTENDRE WARTEN ESPERA KEINE LACK OF X RAY ERRORE RAGGI FAUTE RAYON STRAHLUNG SIN RADIACION MAX TIME TEMPO MAX TEMPS MAX MAX EXP ERREICHT TIEMPO MAX DATA ERR ERR DATI FAULE DE VALEUR DATEN FEHLER FALLO DATO EXP INTERRUP MAN STOP RX STOP MANUALE STOP MANUAL UNDERBROCHEN MANUAL TRANSF KV WANDLER KV INVERTER KV ERR ERR KV INVERTER DEFECT FEHLER FALLO KV TRANSF INVERTER SOVRACCARICO TRANSF SURCHAR WANDLER SOBRECARGA OVERLOAD INV GE UBERLAST TRANSF INVERTER FAULT ERRORE INVERTER e WANDLER FEHLER FALLO TRANSF ERR TUBE CALIBR ERR CALIB TUBO CALIB DEFECT ROHRE FALLO CALIB l l l l l l KALIBRIEREN l MANUAL MANUALE MANUAL MANUELL MANUAL HAND SWITCH ERR PULSANTE RX BOUTON DEFECT HANDSCHALT DEF FALLO MANDO File M_30010E00 doc Pag 11 32 Users Manual Visitor T15 4 4 1 Pag 12 32 1 FUNCTIONING Transport For the transport of the unit consider the following instructions Villa Sistemi Medicali e The unit must be OFF the supply plug must be removed from the socket outlet and the cabl
11. and the emission phases It is not possible to activate the emission phase rad without preparation however it is possible to perform preparation without activating the emission The most frequent alarms during the use of the x ray handswitch are the following 1 TIME OUT The x ray handswitch has been pressed at the 1 step preparation for more than 15s In order to perform radiography it is necessary to release the handswitch and repeat the procedure 2 MAN STOP RX The x ray handswitch has been released before the end of exposure In this case the display will show the radiological data obtained In order to repeat the exposure it is necessary to press RESET 4 5 4 Useful information Only if the display shows the writing READY and the READY led is ON it is possible to perform an exposure e The 1 line of the display shows the use messages and the error signals e 4 line of the display shows the radiological parameters After every exposure the 4 line shows the radiological parameters and in the middle the exposure time e While shifting trom APR MODE Anatomical programming to the MANUAL MODE radiological parameters do not change Pag 18 32 Rev 1 File M 30010E00 doc Villa Sistemi M edicali Visitor T15 User s Manual 4 5 5 O ptional dosimeter DAPmeter The unit can be supplied on request with a ionizing chamber dosimeter dose area product meter DAP meter installed The DAPme
12. normal operation The unit is suitable to be used for x ray examinations and diagnosis dedicated to Operating theater Sport medicine Plaster room First aid Pediatrics Orthopaedics This x ray unit must not be used in areas where danger of explosion exists 1 7 Interfaceability The device does not foresee any interaction with medicines instead it s possible to apply to the unit the ionization chamber dosimeter as optional mod DIAMENTOR PX It complies with the safety requirements foreseen by the 93 42 EEC Directive However the liability of the interface if it has not been evaluated and authorized by Villa Sistemi Medicali in writing is of the operator and or the person who has performed the interface 1 8 Classification Protection against electrical hazards Class Protection against direct and indirect contact Unit Type B with Type B applied part Protection against water penetration Common protection IPXO Use condition protection essere teet ite tete be aut Continuous use with intermittent load Pag 4 32 Rev File M 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual 1 9 1 10 Compliance 0051 This x ray unit is in compliance with the electromedical devices Directive 93 42 EEC and with the other national and international standards in force The distributor according to the European Directive 93 42 EEC of
13. refer to the display line number 4 lines display ON when the unit is ready for radiography When this led is ON there is x ray emission 2 4 Audible signals Here is the list of the most important audible signals A LONG BEEP Alarm malfunction Pag 8 32 1 File M 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual 2 9 Signals and error messages The unit foresees three types of alarm that can appear on the display e Warnings WARN e Errors ERR Fatal Errors FERR Warnings WARN When this alarm appears after taking the proper precautions it is enough to press RESET on the control panel to go on to work with the same modes set In order to interpret the alarm refer to the tables indicated successively Errors ERR When this alarm appears after taking the proper precautions it is enough to press RESET on the control panel to go on to work with the same modes set In order to interpret the alarm refer to the tables indicated successively This type of alarm always leaves a trace in fact the unit stores information about the error date time kV and mAs so that the service intervention is made easier Fatal Error FERR This alarm does not allow operations to continue on the unit It s necessary to switch the unit OFF This type of alarm always leaves a trace in fact the unit stores information about the error date time kV and mAs so that the service intervention is m
14. the following values READY the reading of the chamber is enabled and it works properly ERROR the reading of the chamber is enabled but it does not work properly it is not present or it is not connected INACTIVE status displayed after ERROR signal and after pressing the key RESET If the DAP is accepted to the test the writing READY appears and the system goes If it is not accepted the writing ERROR appears and the audible error alarm is activated At this point it is necessary that the operator intervenes by pressing the key RESET it is possible to go on with the start up of the unit by indicating DAP INACTIVE e phase of capacitors battery charge Start Up on the unit it is possible to set the radiological data including the APR but it is not possible to perform an exposure till the writing READY appears on the display USE If it does not occur it is probable that the unit is faulty or that there are some malfunctions contact the authorized service personnel File M_30010E00 doc Rev 2 Pag 15 32 Users Manual Visitor T15 4 5 Exposures 4 5 1 Operative procedure Villa Sistemi Medicali Set the exposure data by following the operative procedure here below IGNITION amp START UP MANUAL MODE Upon ignition the unit is in MANUAL MODE Adjust the radiological parameters by pressing kV and mAs keys Press the key DOSE to disable the reduction dose function PRESS X R
15. the system and its safety would not be guaranteed any longer damages possibly affecting electrical and electromechanical parts formation of flammable air mixtures and vapor solutions In cases where there is a danger that disinfection products may form inflammable or explosive gaseous mixtures always ensure that such gases have dispersed before re using the equipment Pag 22 32 Rev File M 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual 6 TECHNICAL DATA 6 1 Electrical data Voltage 115 230Vac 10 standard monophase with automatic unit prearrangement in function of the mains plug amp play 50 60Hz standard Absorbed current Values of current absorbed by the unit in the different operative conditions and in the two power supply values 115 Vac 50Hz 230 Vac 50Hz 0 58A LSA 3 0A 3 8A 5 5A 7 3A 3A Line compensation Line resistance Standard socket outlet Class with applied parts type B Isolation class Class with applied parts type B Use conditions Continuous tunctioning with intermitting load The unit is not suitable to the use where danger of inflammable mixtures with air or nitrous oxide exists 6 2 Functioning features User s interface Keyboard with LCD alphanumeric display 4 lines X 20 characters for all the operative parameters and messages of possible taulty status Service program for faults finding Microprocessor management Set
16. these instructions l connect the Potter Bucky grid or the table for the examination to the socket outlet placed on the frontal unit part 2 press the push button for the Potter Bucky selection if the potter works properly the led of the key turns on place monobloc and collimator set the exposure field as shown previously lock the parking brake select manually the values of kV and mAs or in APR mode by choosing the data about the examination that you need to perform pick up the x ray handswitch keep away at least 2m from the x ray tube press and hold down the handswitch in prep position for the preparation about 1 25 press the x ray handswitch in rad position O hold down the x ray handswitch till the exposure time is finished The end of the exposure is indicated by three Beeps emitted by the audible signal of the unit E x REEL Note occasionally when the potter grid has been selected non consent to proceed may appear in this case check the connection Note it is possible to press the x ray handswitch fully rad position from the beginning In this case the x ray exposure will be performed automatically after the preparation 4 6 Shutdown procedure Ensure unit is switched off before removing the connector from the mains outlet When finished the examination do the following 1 Turn the unit off by acting on the dedicated button OFF placed on the control console 2 Disconnect the cabl
17. 0 film screen system SC 400 can cover a sensitivity range of Sminz 320 DIN to Smax 560 DIN From the derived dose value Ks the tolerance for S will be approx 30 2 The filter combination of 1 mmAl 0 1 mmCu is also permissible File M 30010E00 doc Rev 2 Pag 17 32 Users Manual Visitor T15 Villa Sistemi Medicali 4 5 3 Perform an exposure Before performing an exposure make sure that all the necessary precautions against radiation have been taken After a long idle period 3 months or more it is very important to proceed with the X RAY TUBE SEASONING It is necessary to avoid high voltage discharges that could be destructive for the X ray tube The seasoning procedure is described in the Service Manual e Keep away as much as possible from the x ray source If on the display READY appears and the READY led is ON the exposure can be controlled e The emission control is made up of a two steps switch 1 step preparation about 1 s 2 step exposure control 4 H e ltis possible to press the exposure control at once 1 step prep 2 step rad second step Then there is a delay of about 1 2 Figure 14 s before the real exposure e the x ray control down till the exposure has been performed properly 3 beeps The x ray handswitch activates both the x ray preparation phase prep and the emission phase rad The Figure 14 shows how to operate the handswitch to activate the preparation
18. 40 C From 25 C to 70 C Relative humidity Visitor T15 User s Manual From 30 to 75 non condensing From 10 to 90 non condensing From 700 to 1060hPa From 500 to 1060hPa 6 5 Mechanical data Description Weight Max width Length in transport position Max height in transport position Max height with the arm at the max extension Control panel height Focus floor distance Arm rotation around the vertical axis Monobloc rotation around the arm axis Monobloc rotation around its axis Max height of the front unit leg Cassette holder Movement Wheels diameter File M 30010E00 doc Data approx 185 Kg 408 Lb 700mm 27 56in 1 338mm 52 68in 1458mm 57 40in 2258mm 88 90in 1000mm 39 37in 456 2018mm 17 95 79 45in n a 180 151 133 18 in respect of the vertical axis 105mm 4 1 3in 5 cassettes format 35 x 43cm 12x15in Manual Double tront swiveling wheel Parking brake Handle for tilting obstacles overcoming Rear wheel 0250mm 9 84in width 50mm 1 97in Front double wheel 80mm 3 15in width 22mm 0 87in 1 Pag 25 32 Users Manual Visitor T15 Villa Sistemi Medicali 6 5 1 Unit sizes
19. AY HANDSWITCH TO PERFORM EXPOSURES Pag 16 32 Rev 1 Press RESET to return to MANUAL MODE Press MENU to proceed to APR MODE ANATOMIC PROGRAMMED MODE APR L Z IAIBIDIOIMI E IN v 5 The first line shows the name of the exams group the others show the 1 page of the exams of that group Every group is composed by 6 exams press MENU to shift to the 2 page SKULL ABDOMEN 11 14 Ljumbja r Sipli nie Abdomen ap 15 Press F1 to shift to the next group 2 4 5 Hiulmle riu si le l blolw Press F2 F3 or FA to Press F2 to return to select the proper APR menu program PROGRAM DISPLAY 11 15 60 0 4 1 line reserved to messages 278 selected group 3 line program name 4 line radiological parameters kV amp mAs The modification of some x ray parameters in respect of the stored values is indicated by i asterisk placed near the program name 34 line To store new values it is necessary to press F3 and MENU the same time File 30010E00 doc Villa Sistemi M edicali Visitor T15 User s Manual 4 5 2 X Programs for the Anatomical programming mode APR MO DE Here is a table with the APR default values Consider that they are valid by plac
20. Cleaning Please take the following information into consideration before choosing a detergent To clean plastic surfaces simply use water and soap and nothing else If other detergents are used e g with a high alcoholic content or corrosive solvents or abrasive detergents the material will tend to break or opacily To clean enameled parts and aluminium surfaces simply rub them with a wet cloth and a delicate detergent after that rub them with a dry wool cloth e 5 regards chromium plated surfaces only rub them using dry wool clothes do not use any detergent clean the other surfaces of the equipment never use highly alcoholic products corrosive or abrasive detergents and solvents Before cleaning the unit please take the following actions e Turn off the unit and unplug the mains power supply cable Ensure that no liquid seeps into the unit so as to avoid short circuiting or corroding the electrical and electromechanical parts 5 4 Disinfection To disinfect the equipment it s advisable to use a common liquid solution featuring an aldehyde base or disinfectants featuring an ampholytic surface active agent base e g Tego 103 Korsolin Substitute disinfectants releasing chlorine or based on phenols are likely to weaken the materials hence they are much to be avoided The same limitations apply to undiluted solutions featuring a high alcoholic content Do not use disinfectant spray it might penetrate
21. ET APR APR checksum error Press RESET to proceed W APROUT OF RANGE An APR value is out of range Set differently the parameters After a long idle period 3 months or more it is necessary to proceed with the x ray Press RESET to proceed call Service tube seasoning in order to avoid severe for the tube seasoning damages Turn off wait for some minutes turn F FILAMENT Absence of filament current on and if the error appears again call Service W HOT TUBE wn ME Wait for the monobloc cooling the max allowed value Turn off wait for some minutes turn F V2 FAULT pe EME u a if the error appears again and kV circuit call Service STARTER INTERLOCK Error during the start time DOGS ed ino F CHOPPER FAULT Chopper error Press RESET to proceed repeat x rays The x ray handswitch has been pressed Release the handswitch and repeat W TIMEOUT the 1 step for more than 15 secs radiography kV don t reach the 75 of the set value Pacs RESET AA nd ebed F LACK OF X RAY within the first 10ms of exposure or lack of P P xrays exposure MAX TIME The max exposure time has been achieved Press RESET to proceed and repeat 25 Turn off wait for some minutes turn F DATA ERR Memory error data checksum error on and if the error appears again call Service W MAN STO P RX The xray handswitch has been released Press RESET to pro
22. N I Mee 24 6 4 GIG ROTE sane So veseneiawestntars 25 Gos Mechanical Odid 25 Orok UTSES RE TU Um TM 26 6 6 IS SSSI CCT OFS qaot uas c wt tud 2 COs Cole glo 6 10 NET TD OU ES PON ERE PIER 27 04525 Tupe FOUMI ASOM N M PU T MM Ed LI 28 Gl CODI quss RM M MM IM CMM DM M ML E 30 6 6 4 meter dose area product meter optional cssseeesee ee 30 Gals Accesos Cine Op _______ _ 30 6 8 Compliance with Directives and Technical Standards c cccccceccseeceeceueceueceueeeeseeeeeaeeeneees 30 Oros _ 5 SHC ecu MeL Fu LR M M EM LEM UE res 3 PREMIO Cre m NUR EE OU 3l Ou Wales et Siar cea a ete metu em ae aat ii das cattolica 32 Sah wed assis de uf saa ds pet duse 32 NC EMEN OGIO OS CO DL T DEEP dz DOCUMENT STAIUS DM eic oa eco ea o ue ta trios la dao MEN ed resti File M_30010E00 doc 1 Pag 1 32 Users Manual Visitor T15 Villa Sistemi Medicali 1 SAFETY AND COMPLIANCE The purpose of this user s manual is to provide a set of easy to use instructions for the proper use of the system All of the intormation contained herein is based on the current version of the system Villa Sistemi Medicali reser
23. SS Suspe dioe testeen cu ems 9 d MESSAGES ON THE DISPLAY ERU e NAR ERU DOM Se EXPE P UPS Deae ser EVANS USA 10 LEE Spenge c 12 Zu DEGUISBO resutve sim mundani sra teen _ __ __ _ 2 4 2 POST INC 13 elus lera 14 AAs Ond CHECKS Gis 15 4 5 ESOS e ba aee tuc M EI 16 515 procedu EE OO OE TEE 16 4 5 2 Programs for the Anatomical programming mode APR MODE 7 18 dur dr A SET NON TOMI obse UA M s NL ited 18 45a dosimeter as d 19 4 5 6 Optional Radiography with examination table and Potter Bucky grid 20 A5 DOC CONC uda aene nodis ta etd E Mee tM p M uM aa MEE 20 Gn 21 Suy Ceno MORD etu dei Odette eret semp redondo ota 21 9 25 Tte USBIF 21 Clean ER TNT 22 5 4 yet cee eee 22 6 TEGRINIGAL tei o EC u Omer tradimus 23 Se NOR ccc ETENIM NS 23 0325 iBORCHORINO Te alU BS Seed OA re tat 23 po NC ONE CNET SUEY A ELM EUN ole Dnt TT Gt ei ELM LIO
24. ade easier For the unit operator Every signal is displayed and appears in the language according to the unit configuration ITA ENG GER SPA WARNING SIGNAL FATAL ERROR SIGNAL FATAL ERROR The display shows error or warning messages on The display shows the error message on the first the first line whilst the other lines show the unit line whilst the other lines are blank status In this condition it is necessary to turn the unit off In this condition press RESET on the keyboard wait for some minutes turn the unit on again and see Figure 3 to go on to work with the same set repeat the operations performed previously modes the same error appears again it is necessary to stop the unit use and call Service In order to interpret the unit messages refer to the following pages File M_30010E00 doc Rev 1 Pag 9 32 User s Manual Visitor T15 Villa Sistemi M edicali 3 MESSAGES ON THE DISPLAY F fatal error W alarm S unit status potion The unit is ready to perform an exposure Preparation phase Wait for READY message et System clock error Turn off wait for some minutes turn F POWER FAULT 9 ope on and if the error appears again Energy not available call Service Turn off wait for some minutes turn V3 FAULT Absence of V3 power supply on and if the error appears again call Service W RES
25. ansmitters such as mobile phones or similar mobile radio devices These and other transmitting devices including those in compliance with the EMC standards may intluence the proper functioning of medical apparatus when used in proximity and with a relatively high transmitting power Therefore the use of radio equipment proximity to electronically controlled systems must be avoided in order to eliminate any interference risk Explanation The electronic apparatus that meets the EMC standards has been designed so that under normal conditions any malfunctioning risk caused by electromagnetic interferences is avoided However if radio signals coming from high frequency transmitters with a relatively high transmitting power are used near the electronic apparatus the risk of electromagnetic incompatibility cannot be completely controlled Any transmissions by mobile radio equipment must be avoided Mobile phones must be switched off in zones close to the unit These rules must be applied when the unit is switched on that is to say connected to the mains and ready for use 1 4 Protection against ionizing radiation Before any x ray exposure ensure that all the necessary protective precautions have been taken During the use of x rays personnel present in the room must comply with the following rules concerning protection against ionizing radiation e When necessary use protective shielding against radiation in addition to
26. ceed before the end of exposure During x ray emission kV decrease under 1596 or increase over 11096 of the set IN VERTER KV ERRO R toV unbalanced Press RESET and repeat exposure during exposure F INVERTER OVERLOAD Inverter power out of range Press RESET and proceed INVERTER FAULT IG BT drivers error Press RESET and proceed ERR TUBE CALIB X ray tube calibration error Call Service Check the x ray handswitch integrity turn off and on again the unit then W TUBE SEASO NING Chopperemor TI TI HAND SWITCH ERR Faulty x ray handswitch try again If the error appears again call Service W ti IN ACTIVE The dosimeter is not connected __ ____________ DOSE The doses meter has reached 5 614 RESET to reset the value max value that can be displayed BR O DAP READY The dosimeter is ready DAP ERROR The dosimeter is connected but in fault Press RESET and call Service DAP RESET The sum of the product area doses have been reset Dosimeter Pag 10 32 Rev 1 File M_30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual The table below shows all the messages and signals in the five languages that can be set NI 216 ii ii mmn English CB Italian I French F German D Spanish ES CLOCK OFF ERR OROLOGIO CHRONO DEF lo FALLO RELOJ POWER FAULT POTENZA GUASTA BAT DEFECT STU FALLO ACUMUL V3 FAULT ERRORE
27. e wound See Par 4 6 Shutdown procedure e Place the monobloc collimator group vertically and activate its rotation satety lock see Figure 4 e the safety knob and rotate it till it is taken out see Figure 5 e Move downwards the arm by using the handles and by keeping in vertical position the monobloc collimator group when the parking position is reached see Figure 6 rotate and engage the safety lock Release the parking brake see Figure 7 and Figure 8 e Move the unit by using only the proper handles for the transport e Don t move the unit on surfaces with inclination higher than 10 e In order to overtake obstacles it is possible to use the handle placed on the column ug i Figure 5 Safety knob Figure 4 Movements of the monobloc collimator group Figure 6 Parking position
28. e and must be regarded as hazardous waste For additional information contact Villa Sistemi Medicali File M 30010E00 doc 1 Pag 3 32 Users Manual Visitor T15 Villa Sistemi Medicali 1 6 Application amp final destination This unit is a portable x ray system aimed to fulfil a wide range of clinical applications it must be operated exclusively by qualified trained personnel who have been informed of the risks linked to the use of ionizing radiation The compactness and maneuverability of the unit enables the operator to navigate through obstacles such as doors small rooms narrow aisles and lifts with ease and allows accurate positioning between patient beds The ergonomic design of the unit allows the operator excellent visibility during operation and movement The perfectly balanced monobloc arm allows free movement and positioning even in the more awkward positions The shape of the base allows easy positioning and handling under the patient beds The position and shape of the four antistatic wheels make the system easy to move even on coarse surfaces The system does not belong to the category of equipment designed for continuous operation The system is not used in direct contact with the patient however accidental contact of some unit parts with the patient and operator is possible Contact with the patient is non invasive Contact with the operator is strictly for reasons linked to the use of the equipment
29. e and wrap it on the wire wrap 3 Place the unit in parking position lowered with activated mechanical brakes Pag 20 32 Rev 1 File M 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual 2 MAINTENANCE Villa Sistemi Medicali can supply on request a programmed maintenance plan to be performed on the unit M General Warnings As with any medical device this system requires e proper use e regular checks by the user e maintenance and repairs by the authorized personnel Operational reliability of the unit is kept by following these precautions Villa Sistemi Medicali can provide on request circuit drawings parts list adjustment instructions or further information for the unit repair As users of x ray units it is necessary to take these precautions in compliance with the prevention standards formulated by the laws concerning the medical equipment The unit needs regular checks and maintenances The purpose of the following warnings is to keep a good operating and safety level The unit includes mechanical parts that are subjected to wear during normal use of the equipment After a long period of use it is possible that the safety of the system may decrease due to the parts wear Regular checks and maintenance are necessary to protect the patient and the operator from damage as a result of the breakage of any mechanical parts The correct adjustment of the electro mechanical and electronic modules is e
30. es must for any reason be moved modified omitted Villa Sistemi Medicali cannot be held liable for any malfunction damage or danger resulting from improper use of the system or non compliance with the rules for proper maintenance 1 1 Electrical safety e Only trained service personnel authorized by Villa Sistemi Medicali may remove the unit covers and only in accordance with the instructions contained in the Service Manual e This X ray unit may only be used in environments or medical rooms in compliance with the applicable IEC standards e The X ray unit must not be used in areas where there exists a danger of explosion e Cleaning and disinfecting agents including those used on patients may create an explosive gaseous mixture Use only those products in compliance with the applicable rules 1 2 Mechanical safety e After positioning the unit engage the parking brakes e Only use the proper handles to move the unit e Avoid collision with obstacles Pag 2 32 Rev File M 30010E00 doc Villa Sistemi Medicali Visitor T15 User s Manual L3 Electromagnetic compatibility EMC This apparatus is in compliance with the applicable rule regarding EMC Directive 89 336 that defines the max allowed emission levels from electronic devices and the required immunity from interference caused by externally generated electromagnetic fields It is not however possible to exclude radio signals coming from tr
31. ing the x ray tube with a SID Source Image receptor Distance of 100 cm without grid In case of cassettes with grid it is necessary to increase the mAs values by four increments Folder PartofBody kV mAs SC DINT Cartella PartofBody kV mAs SC DINF Hiplremr 74 5 0 400 Skull 178150 400 Knee 66 4 0 200 Cenical Spine 66 6 3 400 lowerleg 60 40 200 lumbar Spineap 78 6 3 400 Anke 55 4 0 20 Abdomen 85 50 400 32 400 20 20 Shouiderap 96 160 200 gq 60 02 40 Ug Clavie 66 100 200 Thorax2 0kg 62 04 400 paremmes Pumens ebow 60 40 200 tienne Thorax4 okg 72 04 400 imme Thorax6 0kg 74 04 40 48 25 200 o2mmcu Thorax8 0kg 76 04 400 ap 46 25 200 Thorex 10Kg 76 063 400 Here is the list of the APR programs and groups names in the five settable languages APR G roups and programs AU AN English G B Italian I UPPER EXTREM IT ESTREMITA SUP EXTREMITES SUP O BERE EXTREMIT EXTREM SUPERIO R Handgelenk LO WER EXTREMIT ESTREM ITA IN F EXTREM ITES INF UNTERE EXTREMIT EXTREM IN FERIO R Hip Femur Hanche Femur Huefte O S Coxal Femur Rodilla pS US Foot Pied Fus 1 SC is the sensitivity class According to DIN 6867 10 a class 40
32. p Physiological effects Mechanical stability Operational modes VILLA SISTEMI MEDICAL 20090 ITALY MANUFACTURED ACCORDING TO THE MEDICAL DEVICE DIRECTIVE 93 42 EEC BY TECHNIX GRASSOBBIO BERGAMO ITALY A unit label 42 TECHNIX TECHNIX S p A Via E Fermi 26 24050 Grassobbio BG ITALY Inverter IHF 2015 Mode DC AC Serial N XXXXX Date mfg XX XX Supply 350 VDC Power 15kW Made in ITALY inverter label Figure 22 Visitor T15 User s Manual 20090 BUCCINASCO MILANO ITALY Tank unit MHF 2015 Serial Number XXXX X ray Tube X22 0 8 1 3 Seriol number XXXXX 0054 052 Focus Mos ME EA 2 7 100 U max 125 kVp max 200 mA VL MANUFACTURED ACCORDING TO THE MEDICAL DEVICE DIRECTIVE 93 43 EEC BY TECHNIX GRASSOBBIO BERGAMO ITALY A external monobloc label Via SCHIAPPARELLI 27 33 20035 LISSONE MI ITALY BEAM LIMITING DEVICE Min inherent filtation Al equiv type R 221 A 2mm Al 80 IEC 522 1976 s n X ray rating up to 125kVp Collimator Supply 12V AC DC 9A 50 60Hz Date of manufacture C N 0051 collimator label File M_30010E00 doc 1 Pag 31 32 Users Manual Visitor T15 Villa Sistemi Medicali 6 9 2 Internal symbols Protective ground clamp Dangerous voltage Precautionary warning 6 9 3 Variou
33. s symbols o Unit OFF 4 Unit Type B Unit ON lt gt Total filtration lonizing radiation NO Alternate voltage Large tocus 93 Equipotential node Small focus 6 9 4 Packing label It is stuck outside the packing with red writings on white background 7 Fragile Protect trom rain Upper edge of the packing Pag 32 32 Rev File M 30010E00 doc Document status Visitor T15 User s Manual DOCUMENT STATUS o ___ File M 30010E00R02 doc Pag 1 1
34. ssential as this has a direct influence on the unit operation the image quality the electrical safety and the exposure level of radiation to which the medical personnel and patients are subjected The maintenance plan includes checks and prevention measures to be done by expressly authorized personnel and at the unit owner s charge In the replacement of any parts that can affect the units safe operation use only original spare parts 5 2 Checks and inspection by the user The user must check the x ray unit as indicated in the table below In the event of operational faults or other deviations in respect of the standard operative behaviour the user must turn off the unit The unit may only be operated after repairs have been made If a faulty or malfunctioning unit is used risks to the operators and patients can increase Summary of the periodical checks Check the warning and danger labels integrity Weekly Check for oil leakage from the monobloc Check unusual noises in the monobloc during x ray emission Check the x ray tube and collimator centering Yearly Contact the technical after sale service to perform the constancy and reproducibility tests as indicated by IEC 1223 2 and IEC 1223 11 standards as well as the other operating tests of the unit as instructed in the programmed maintenance plan see Service Manual File M 30010E00 doc Pag 21 32 Users Manual Visitor T15 Villa Sistemi Medicali S
35. table languages Radiography control By handswitch with extendible cable It is proposed the use of the last kV value used in manual mode or APR Upon the ignition the unit is in manual mode with default values Safeties Filament current Monobloc temperature Overload Max kV or H V fault Stored data check Microcontroller auto test File M 30010E00 doc 1 Pag 23 32 Users Manual Visitor T15 Villa Sistemi Medicali 6 3 Radiological data APR anatomic program 24 exams memorization 4 programs each of 6 exams available in the 5 different selectable languages Constant kV and mA during the whole exposure It can be selected of L P 50 or H P 100 15kW 100kV 20kHz Max inverter frquency in high voltage AOkHz Max ripple lt 2 100kV Rise time lt 2ms 100kV 40 200 mA automatically associated to kV 0 2 200 mAs in 61 steps with increases of 12 5 0 002 2s in function of the set mAs and dose select kV Range 40 125kVp in step of 1kV mA Range 115 230Vac mA mAs gt 0 63 mAs lt 0 63 t lt 100ms t gt 100ms MODE MODE MODE 1 2 1 2 mAs value in function of kV 115 230Vac 0 2 200mAs in 61 steps with increases of 12 596 mAs kV 0 2 200 40 0 2 180 4 45 0 2 160 46 52 0 2 140 53 62 0 2 125 63 72 0 2 100 3 92 0 2 80 93 112 0 2 71 113 125 Pag 24 32 Rev 1 File M 30010E00 doc Villa Sistemi Medicali 6 4 Environmental data From 10 C to
36. ter function is to measure dose area product cG gcm in output towards the patient The device that can be installed is type PTW Freiburg DIAM ENTO R PX T11020 00011 O nly authorized service personnel can perform the installation and the maintenance of the dosimeter If DAPmeter has been installed and it works properly the first line of the display shows alternatively the measures summation and the measurement unit cG ycm READY 00000 0 READY cGycm2 The measures summation is the sum of all the dose area products read by the chamber By pressing F1 RESET the value resets n dose area 1 1 n is the number of exposures performed after the last time that F1 RESET has been pressed In order to determine the correct Dose Area Product to which the patient has been exposed it is necessary to press 1 RESET before performing any exposures The possible measuring range is included between 00000 0cG 99999 9cG ycm When the measures summation exceeds 99999 9cG ycm the message MAXDO SE will appear The presence of this message does not exclude the possibility to perform exposures Users Manual Visitor T15 Villa Sistemi Medicali 4 5 6 Optional Radiography with examination table and Potter Bucky grid The examination table or the Potter Bucky that can be connected to the unit must be according to the Medical Devices Directive EEC 93 42 After positioning the cassette and the patient follow
37. the shielding already provided on the unit e Use protective aprons containing a material equivalent to 0 35mm of lead Material of this nature reduces radiation at 5OkV by 99 9596 and at by 94 596 The best protection against radiation is distance It is therefore recommended that you stay as far as possible from the x ray source and the exposure target For this purpose use all of the cable length provided for the foot switch e Avoid walking or standing directly the x ray beam Always use the smallest possible field of exposure by closing properly the collimator diaphragms The scatter dose produced depends principally on the volume of the irradiated object Never modify or disconnect the safety circuits or devices designed to prevent accidental exposures General disposal Villa Sistemi Medicali produces radiological systems that are advanced in terms of safety and environmental protection Assuming that the unit is properly used there is no risk to people or the environment In order to comply with applicable safety requirements it is necessary to use materials that may be harmful to the environment for example monobloc oil protective lead boards and electronic components Therefore where necessary proper disposal methods according to the regulations of the country where the unit is installed should be followed For this reason the unit may not be disposed of along with industrial or domestic wast
38. the unit Visitor T15 is Villa Sistemi Medicali Via delle Azalee 3 20090 Buccinasco MI Italia Tel 39 02 48 859 1 Fax 39 02 48 81 844 E mail vsmservice villasm com Information concerning the compliance can be required to Villa Sistemi Medicali The manufacturer according to the European Directive 93 42 EEC of the unit Visitor T15 is Technix S p A Via E Fermi 26 24050 Grassobbio BG ITALY Tel 4 39 035 33 56 78 Fax 39 035 33 56 75 Copyright The original release of this manual is in Italian language file AD30013IOORXX doc For further information please refer to the Italian version The software contained in the unit belongs to Technix S p A Upon receipt of the unit the user acquires the right to use the software in combination with the unit This right is neither exclusive nor transferable Written authorization to Technix S p A is mandatory prior to any modifications for the unit use with functions other than the ones foreseen File M 30010E00 doc 1 Pag 5 32 Users Manual Visitor T15 2 2 1 2 2 Pag 6 32 Rev Villa Sistemi Medicali COMPONENT IDENTIFICATION Overview NE M ER e Monobloc Goniometer Monobloc handle Collimator Supply cable winding Equipotential node Connector for Potter X ray handswitch Foot brake 10 Cassette holder 11 Magneto thermic switch 12 Supply cable 13 Handle for unit movement
39. ves the right to improve and implement changes to the intormation herein to retlect any changes necessitated by technological enhancements to the system e This x ray unit must be used in strict compliance with the safety instructions contained in this manual and must not be used for purposes other those tor which it was intended e The x ray unit may only be operated by skilled properly trained personnel with the required knowledge of x ray safety practices and the proper use of x ray equipment The operator is responsible for the use of the system in compliance with the applicable standards concerning installation and use e The unit must not be operated when electrical mechanical or radiological faults are present or when any of the indicators or alarm devices are malfunctioning When used in conjunction with other apparatus components or modules whose compatibility is uncertain it is necessary to ensure the absence of any danger to the patient or operator Consult Villa Sistemi Medicali for information e Villa Sistemi Medicali is responsible for the safety of its products only when maintenance repairs or modifications have been performed by Villa Sistemi Medicali or by personnel authorized by Villa Sistemi Medicali in writing e As with any technical apparatus this x ray unit must be used properly with periodic checks and maintenance as specified in the chapter Programmed maintenance e system safety circuits and devic
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