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User's Manual 

Visitor T30 C-DR 

 

Page 8/74 

[File: 218899-01-01-B.docx] 

2

 

SAFETY 

2.1

 

Warnings and precautions 

 

Maintenance and defects

 

Do not use the equipment for any application before the user correctly performs all regular checks 
and updates the periodical equipment maintenance. If it is sure ( or probable) that any part of the 
equipment is defective or wrong adjusted, don't use it before performing all reparations.

 

The use of an equipment with defective parts or adjusted in a wrong way, can expose the user or the 
patient to ionizing radiations or to other dangers concerning safety. This can cause serious or mortal 
physical injuries, or wrong diagnosis or therapies.  

Importance of safety

 

Do not use the equipment for any application before reading, understanding and assimilating all 
information about safety, safety and emergency procedures specified in the current chapter about 
Safety, The use of the equipment without a proper knowledge of safety rules can cause serious or 
mortal physical injuries, or wrong diagnosis or therapies. 

Proper

 

training

 

Do not use the equipment for any application unless you have a proper and adequate training to a 
safe and efficient use. 

If you aren't sure to be able to use this equipment in a safe and efficient way, don't use it. The use of 
this equipment without proper and adequate training can cause serious or mortal physical injuries or 
wrong diagnosis or therapies. 

Do not use the equipment with the patients if there is no adequate understanding of its capabilities 
and functions. Using the equipment without an adequate knowledge of its functioning can 
compromise the efficacy and/or reduce the safety of the patient, the user and other people nearby. 

Safety systems

 

Never try to remove, modify, exclude or obstruct any safety device on the equipment. An 
intervention on safety devices can cause serious physical injuries or even death. 

Expected use and compatibility

 

Do not use the equipment for purpose other than those for which it is intended. Do not use the 
equipment with other  products than the ones whose compatibility has been recognized by the 
Manufacturer. The use of the equipment for purposes other than the ones expected or with an 
incompatible product, can cause serious or mortal physical injuries or wrong diagnosis or therapies. 

This equipment must be used only in compliance with the safety instructions specified in this User's 
Manual and exclusively for intended purposes. 

 

It is user's responsibility to ensure that effective norms concerning installation and use of medical equipment 
are respected. 

 

 

 

Содержание Visitor T30 C-DR

Страница 1: ...User s Manual System Visitor T30 C DR Revision B Version OEM Date 05 2018 Language ENG File 218899 01 01 B...

Страница 2: ...File 218899 01 01 B docx Page intentionally left blank...

Страница 3: ...n against ionizing radiations 15 2 9 Laser light source 15 2 10 FPD warnings and precautions 16 2 11 Labeling 17 3 MAINTENANCE CLEANLINESS AND DISPOSAL 20 3 1 Periodic maintenance 20 3 2 Regular check...

Страница 4: ...ions 49 8 3 Total filtration of the equipment 49 8 4 Mechanical data 50 8 5 Operation data 52 8 6 Radiological data 53 8 6 1 kV mAs relationship 53 8 7 X ray group 54 8 7 1 Monobloc 54 8 7 2 X ray tub...

Страница 5: ...02 48 859 1 Fax 39 02 48 81 844 e mail vsmservice villasm com 1 4 Publishing details Published by the Manufacturer The Manufacturer reserves the right to modify this User s Manual and the equipment he...

Страница 6: ...caution message can cause slight or moderate personal injuries damages to the equipment or to other goods and expose to a possible remote risk of more serious injury and or environmental pollution Thi...

Страница 7: ...rformed by not qualified people and or by people who use not approved spare parts can cause serious damages to the equipment and personal injuries risks 1 8 Training Equipment users must be properly t...

Страница 8: ...aren t sure to be able to use this equipment in a safe and efficient way don t use it The use of this equipment without proper and adequate training can cause serious or mortal physical injuries or wr...

Страница 9: ...ven this medical device must be used properly and subject to regular maintenance and care as described in Maintenance cleaning and disposal paragraph The Manufacturer can t be considered responsible f...

Страница 10: ...ronments suitable for medical activities Besides IEC 60601 1 norm provides instructions about the equipotential earth connection point Additional equipotential earth connection An additional equipoten...

Страница 11: ...be taken is to separate the equipment from other electric power sources and from all other sources in order to reduce the risk of electrical shocks 2 6 Electrostatic discharge ESD Always resort to sta...

Страница 12: ...n unusual situations affect on the equipment working Electromedical products request special precautions referring to electromagnetic compatibility EMC and must be installed and started up in complian...

Страница 13: ...lines Exclusive use of the listed accessory or line with the exception of internal original spare part components Electric medical units are subject to special precautionary measures with regard to E...

Страница 14: ...electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and...

Страница 15: ...area if it isn t possible please protect yourself Wear gloves for protection against radiations Always use the lowest collimation of the x ray area Check that interested area is completely exposed Th...

Страница 16: ...omponent Observe the limitations on the max weight concentrated on a small area of the FPD surface Observe the limitations on the max weight divided uniformly on the whole FPD surface The limitations...

Страница 17: ...itch for exposures D Magnetothermic switch A Label for the monobloc rotation lock By rotating the knob clockwise the rotation stops A Label for the parking brake lock By moving the lever of the brake...

Страница 18: ...r the movement position of the equipment B Label for the exposure hand switch A Laser openings B Warning labels Avoid the exposure Radiations are emitted from this opening A Laser radiation symbol B W...

Страница 19: ...isitor T30 C DR User s Manual File 218899 01 01 B docx Page 19 74 A Laser radiation symbol B Warning label Laser Radiation Do not stare into beam Class 2 LASER product IEC 60825 1 2007 Po 1mW 645 10nm...

Страница 20: ...e user of the equipment must ensure that all checks and their actions are performed satisfactorily before using the equipment for its intended purpose Interval Object Method Daily Defective lights com...

Страница 21: ...ecome opaque or can break Disinfection The disinfection method used must be in compliance with all laws and norms in force for disinfection and protection against explosions in force in the country wh...

Страница 22: ...o that it is no longer usable for the intended purposes The return proper disposal or recovery of this medical equipment must be done in compliance with the European WEEE Waste Electrical and Electron...

Страница 23: ...d anatomic area In fact the number of programmed anatomics and radiological data can be customized typically during installation according to requests and operation modes of the hospital The display o...

Страница 24: ...F Power supply cable G Circuit breaker Equipotential node H Exposure control hand switch I Lock of the arm movement during transport A Monobloc support arm B Monobloc rotation movement lock C Control...

Страница 25: ...f the circuit breaker in I position 4 4 Collimator A Longitudinal collimation B Lamp ignition pushbutton and laser pushbutton optional C Guides for accessories positioning filters or DAP meter D Tape...

Страница 26: ...ator lamp switching ON The switching ON is timed for about 30s SMALL FOCUS Small focus selection The led ON indicates the performed selection LARGE FOCUS Large focus selection The led ON indicates the...

Страница 27: ...released to the patient on a printer available as accessory 4 7 Display Alphanumeric display with four lines of 20 characters for the display of the equipment status the x ray parameters and the warni...

Страница 28: ...Commands Area contains all functions applicable to the frames Inside this area there are several sections INFORMATION PROCESSING OPTIMIZATION A INFORMATION Information concerning the patient data and...

Страница 29: ...ress the RESET key to go on W INI APR APR checksum error Press the RESET key to go on W ERROR IN APR An APR error is out of scale Set differently the parameters W TUBE SEASONING After a long idle peri...

Страница 30: ...ched 75 of the value set within the first 10mS of exposure or lackage of kV Press the RESET key to go on repeat x rays F MAX TIME The max exposure time has been reached Press the RESET key to go on re...

Страница 31: ...ication A the status and alarm messages concerning the equipment working are displayed FPD panel status Wi Fi signal status quality X ray generator status Battery charge status of FPD panel In case of...

Страница 32: ...called transportation and with all the blocks of the movements activated 1 Monobloc collimator group arm A lowered up to the click of the safety lock B To be sure that the lock of the movement is act...

Страница 33: ...yboard leds light up 5 At the end of the test on the display the name of the equipment and the software version appear 6 If present the DAP meter the writing DAP XXXXXXXX appears XXXXXXXX can have the...

Страница 34: ...phase of the capacitors group The display indicates BUSY The phase of equipment start up changes from a few seconds to two minutes according to the residual charge of the capacitors 8 The writing BUS...

Страница 35: ...it indicates the charging After some seconds the login screen appears Fill out the User and Password fields with your data Click on the icon down on the left in order to see the keyboard on the screen...

Страница 36: ...e push button to switch ON the collimator lamp B and the tape measure C to measure with accuracy the focus film distance DFF If necessary rotate the collimator The collimator can rotate around its axi...

Страница 37: ...al system C After choosing a patient the acquisition window opens It is possible to modify the parameters kV mAs Focus choose the patient size turn ON the collimator lamp pass to CR mode The pushbutto...

Страница 38: ...data of the exams already present with the intervention of qualified and trained service 7 6 1 DeLuxe Click on the key Add Study A to add a new exam In the window Add Study it is possible to choose a...

Страница 39: ...examination table or Potter Bucky grid 7 7 2 Free exposure After the initial tests the display shows the initial screen The initial parameters of the equipment are displayed as they have been stored...

Страница 40: ...ect organ and the associated exposure parameters kV mAs focus appear 1 line reserved to messages 2 line selected group 3 line name of examination 4 line x ray parameters kV and mAs The modification of...

Страница 41: ...on the patient and performed with the x ray tube with a SID Source Image receptor Distance of 100 cm without grid The dose measurement has been performed according to IEC 60601 1 3 5 2 4 2 with dosime...

Страница 42: ...Name Focus kV mAs Gym Thorax 0 5 kg SF 60 0 1 0 14 Thorax 1 0 kg SF 60 0 2 0 24 Thorax 2 0 kg SF 60 0 32 0 37 Thorax 3 0 kg SF 62 0 4 0 54 Thorax 4 0 kg SF 65 0 4 0 63 Thorax 5 0 kg SF 68 0 4 0 75 CH...

Страница 43: ...diations Take the proper measures in order to avoid exposing any part of the body to direct or indirect radiations Completely extend the extensible cable of the x ray control and keep at least two met...

Страница 44: ...preparation cycle stops automatically and the stand by condition returns if the exposure is not controlled within 15sec from its activation At the end of the exposure the equipment returns in stand by...

Страница 45: ...click preparation phase for more than fifteen seconds without pressing the 2 click X ray releasing phase the message OVERTIME is displayed Release the pushbutton press the key RESET and repeat the ex...

Страница 46: ...ding to requirements 2 Connect the examination table or the Potter Bucky grid to the connector A placed on the front part of the equipment If the connection with the examination table or with the Pott...

Страница 47: ...e preparation or in a following phase The function of the DAP meter is to measure the dose area product Gym2 that is going out towards the patient n is the number of exposures performed after the last...

Страница 48: ...able place for the parking For short movements between a bed and the other one or between a room and the other one and however for movements lower than ten minutes the Digital Imaging System can be ke...

Страница 49: ...king with intermittent load Classification according to the liquids seepage IPx0 Safety in presence of anaesthetic inflammable gases The equipment is not type AP or APG 8 2 Environmental conditions En...

Страница 50: ...ht in transport position 1483 mm Height of the transport handle 949 mm Description Data Focus floor distance Z axis 417 mm 2092 mm Max height 2333 mm Rotation of the monobloc around the arm axis swive...

Страница 51: ...Visitor T30 C DR User s Manual File 218899 01 01 B docx Page 51 74 All dimensions are in mm Linear tolerances 5 mm angular 1...

Страница 52: ...an English French German Spanish Portuguese Russian through the configuration program X ray handswitch Local pushbutton control with extensible cable Remote control without wires optional Safeties Bre...

Страница 53: ...220 mAs mAs accuracy 10 IEC 60601 2 54 Exposure times 115 230Vac 0 001 2 2 s according to mAs Time accuracy 10 IEC 60601 2 54 In DR the mAs and the exposure times are limited respectively at 110 mAs...

Страница 54: ...e max power 1 Rise time to the max power 2 ms Monobloc performance According to the load curves of the x ray tube Housing description Min inherent filtration 75 kV 1 1 mmAl Dimensions L x P x H 320 x...

Страница 55: ...ominal focus dim IEC 60336 0 8 mm small focus 1 3 mm large focus Nominal anodic power IEC 60613 16 kW small focus 32 kW large focus Anodic material RT Focus track Tungsten Rhenium TZM Anode mass molyb...

Страница 56: ...x 0 cm max 43 x 43 cm Lighting source Clusters of high brightness LED power Lamp lighting time 30 s Light intensity IEC 60601 2 54 160 lux Minimum contrast ratio IEC 60601 2 54 4 1 Focal distance mea...

Страница 57: ...mensions 383 5 x 459 5 x 15 mm Applied weight limitations evened out on the whole surface 150 kg concentrated on a central area of diameter 80 mm 100 kg Wired communication technology Ethernet connect...

Страница 58: ...xternal dimensions 383 5 x 459 5 x 15 mm W x D x H Applied weight limitations uniformely distributed on the whole surface 150 kg concentrated on a central area of diameter 40 mm 100 kg Wired communica...

Страница 59: ...out on the whole surface 150 kg concentrated on a central area of diameter 40 mm 100 kg Wired communication technology Ethernet connection cable for backup Wireless communication technology 802 11a b...

Страница 60: ...tations evened out on the whole surface 150 kg concentrated on a central area of diameter 40 mm 100 kg Wired communication technology Ethernet connection cable for backup Wireless communication techno...

Страница 61: ...84 Pixel dimension 143 m Max resolution 3 7 lp mm MTF 2 lp mm beam RQA5 36 tip DQE 0 lp mm beam RQA5 70 Fill factor x kV Range 40 150 kVp A D conversion 16 bit Image preview x Final image 6 s Power su...

Страница 62: ...nal dimensions 328 5 x 268 5 x 16 mm Applied weight limitations evened out on the whole surface 150 kg concentrated on a central area of diameter 80 mm 100 kg Wired communication technology Ethernet c...

Страница 63: ...0 Electronic collimators rectangular and circular Grey scale inversion Multi image displaying Electronic image enlargement variable from 1 to 3 Optic zoom with variable enlargement from 1 to 3 2 Brigh...

Страница 64: ...ss memory 2 5 320GB SATA HDD Operating system Windows 7 PRO Display Description Size 19 TN LCDPanel 19 TFT Active Matrix Resolution 1280 x 1024 SXGA 16 2M color Luminance cd m2 350 cd m2 Contrast 1000...

Страница 65: ...gnostics according to IEC 60580 standard Principle of measurement Radiation measure with ionization chamber Measured quantity Area dose product Digital resolution 0 01 Gym2 Max linearity error 2 5 Nom...

Страница 66: ...rs Power supply 2 alkaline AA batteries LR6 1 5 V 2500mAh Autonomy 25 000 exposures Operative distance 10 mt 33 feet Operative angle 180 Remote anti loss research Repetition of a series of beeps if th...

Страница 67: ...serial number E Manufacturing date F Electrical data G Consult the attached documentation H Equipment classification I Ionizing radiation J Warning symbol K WEEE L CE certification A Monobloc type B M...

Страница 68: ...fully charged battery from the Battery Charger the full recharge is indicated by the switching ON of all green leds 3 Insert the battery into the proper seat of the panel so that the contacts on the e...

Страница 69: ...and rotate clockwise the closing device A 4 Put the discharged battery back in the Battery Charger The Battery Charger has some leds a green one on the back of the Battery Charger indicates the presen...

Страница 70: ...ger C Signal Led OFF disconnected from the mains or not in charge red fast recharge mode up to 90 green standard recharge from 90 to100 blue error In case during the battery charge the signal led is b...

Страница 71: ...ess FPD can be provided with a protection box for a better protection against shocks The panel and its box can be stored together or separated in the proper unit housing 1 Insert the panel towards the...

Страница 72: ...ion X ray emission control with extensible cable Standard Interface for examination table or Potter Bucky Standard Remote control for x ray emission Optional DAP meter with ionizing chamber Optional P...

Страница 73: ...Visitor T30 C DR User s Manual File 218899 01 01 B docx Page 73 74 Page intentionally left blank...

Страница 74: ...T30 C DR Page 74 74 File 218899 01 01 B docx 11 DOCUMENT STATUS Rev Date Description 0 10 2016 Document approval A 03 2017 New X Ray remote control switch and updating of equipment dimensions B 05 20...

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