Villa-Endograph-DC-users-manual
Contents
1. Figure 6 Dimensions of the wall version lt 430 16 7 8 _ SUN NI DA 290 gt 1070 54 270 10 5 8 948 37 5 16 540 21 1 4 1090 43 130 5 1 8 Rev O D Es 80 3 1 8 LARG 20 3 4 743 29 1 4 63 2 1 2 Figure 7 Dimensions of the mobile stand version 29 ENDOGRAPH DC USER S MANUAL General instructions for use 6 GENERAL INSTRUCTIONS FOR USE 6 1 Control panel Description and functions The Endograph DC control panel is divided into function areas plus a display to view the operative messages and error signals The following figure shows a general view of the control panel while details on each functional area are provided in the following pages LCD messages display Select Size key Function key Decrease key Increase key X rays in progress Ready for X rays luminous selection luminous selection Tooth anatomic selection key Figure 8 Endograph DC control keypad ENDOGRAPH DC 30 Rev 0 USER S MANUAL General instructions for use The following figure shows the LCD display details of every function area are shown on the f2. Method for measuring the technical factors The measuring method with non invasive instruments for example kV t meter is accepted even if it generally provides less accuracy In fact the measurement of the high voltage at the tube with non invasive instruments is closely correlated to the method selected by the instrument manufacturer in general this method is more inaccurate than the direct method and may also require two subsequent exposures In the same way the method of measuring the anodic current with the indirect method is affected by systematic errors as they are often based on the measurement of the current time product dividing the measurement by the time measured with the said method e High voltage value at the tube kVp The kVp value is defined as the stationary value of the high voltage applied at the tube that is stabilised under load after the pre heating time Measure the value of the kVp with a non invasive instrument with 2 accuracy setting the exposure time to 1 second e Measuring the exposure time The exposure time must be measured using a non invasive instrument In compliance with standard IEC 60601 2 7 the exposure time is measured as the interval of time between the moment in which the high voltage has reached for the first time a value equal to 75 of the peak value and the moment in which it goes down below this value 25 ENDOGRAPH DC USER S MANUAL Technical data 5 2 Tube ch
3. User s Manual Version December 21 2012 Rev 0 USER S MANUAL Revision history Revision history Manual code 6959900203 ev ue me Dein hg NN 21 12 2012 Oo a y j Document approval Rev 0 ENDOGRAPH DC USER S MANUAL Revision history THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOGRAPH DC Rev 0 USER S MANUAL Contents Contents 1 INTRODUCTION 1 1 1 Icons appearing in the manual 1 2 SAFETY INFORMATION 2 Dil ire eh a Grohe ee ee St 3 211 MICCEOMaACNELIC EMISSIONS US means rein etes ele here diet 4 Dili Elceromasniea e EE 5 2 1 3 Recommended separation distances to portable and mobile ect SEITEN A A ni T 2 2 Protection against E e e israel 8 2 3 Environmental risks and displacement Li 9 2 4 Oy MDOIS USEC ates ER id 10 CLEANING AND DISINFECTION 11 4 DESCRIPTION 12 e d Identification E aideront eee 12 4 2 Functions models and Version iii adidas 14 4 2 1 High Frequency HF Generatori albi 15 42 2 Extension arm and SCISSOrS ari gpl 15 O hee RS lens 16 Pigott EE 16 453 COMMEUTATIONS A Ne NA A RARE A ea NA ane 17 4 3 1 Standard CONSUMIR 17 4 5 2 Remote Mer COMMOUTAUIOIL A na 18 40 0 Mobilestand iconisurationi silla alari 19 4 3 4 Configuration with remote X ray button 20 4 3 5 Configuration with wireless X ray button 21 5 TECHNICAL DATA 22 5 1 Method for measuring the technical factors 25 5 2 TUDSCHaraCteH SHE CU VE Snellire 26 Dro IRelerencessiandards enel 28 SA
4. Maximum rated m output POSE of from 150kHz to from 8OMHz to from 800MHZz to the transmitter W 80MHz 800MHz 2 5GHz d 12xvP d 1 2xVP d 23xVP For transmitters maximum rated output not shown in the table the recommended separation distance d in meters m can be calculated using the equation applicable to the frequency of the transmitter where P is the highest rated output of the transmitter in watts W according to the manufacturer of the transmitter Note 1 at 80 MHz and 800 MHz apply the separation distance for the higher frequency interval Note 2 these guidelines may not apply to all situations Electromagnetic propagation depends on the absorption and reflection of structures objects and people Rev 0 7 ENDOGRAPH DC USER S MANUAL Safety injormation 2 2 Protection against radiation Although the dose supplied by modern X ray units is quite low the operator must adopt the precautions and or suitable protection for the patient and himself according to current regulations during the execution of radiography WARNING Protection against radiation is regulated according to law The equipment may only be used by specialised personnel a b c d e ENDOGRAPH DC The film or the digital sensor must be placed in the patient s mouth either manually or using the specific supports and must be held in position by the patient if necessary During exposure to the rays the operator must not
5. USER S MANUAL System use 7 7 1 Indication of the battery charge status and replacement The wireless X ray button diagnoses the status of battery If the battery level is lower than 2 7V the remote control informs the user by flashing the green LED 5 times quickly NOTE ER this situation a few exposures can be made but the batteries should be replaced as soon as possible Proceed as follows to replace the batteries e unscrew the two screws located on the back of the button e open the two half shells keeping the green button facing upwards and paying attention to the electronics located inside e replace the batteries respecting the indicated polarities e reclose the two half shells and tighten the screws If the charge level is lower than 2 4V the LED on the remote control will flash quickly 10 times and exposures cannot be made 7 7 2 Combination procedure between the remote control and timer The wireless X ray button will only work with the timer with which it was combined If for some reason the two devices must be combined again proceed as described in the Service Manual Rev 0 51 ENDOGRAPH DC USER S MANUAL System use 7 8 Display of the number of exposures made With the ready for X ray status the user is able to view the number of exposures made by pressing the Increase and Tooth automatic selection keys at the same time The number will be shown on the display for approx 3s EN
6. the value of kV applied to the tube 1 Press the Function Key the receptor icon will start to flash 2 Use the Increase and Decrease Keys to select the type of receptor from among Phosphor Digital 3 Confirm the selection by pressing the Function key the icon indicating the presence of the long cone will start to flash SID 30 cm 4 Use the Increase and Decrease keys to select the presence or absence of the cone 5 Confirm the selection by pressing the Function key NOTE If the cone is not present the relative icon will not appear on the display 6 The value of kV applied to the tube will start to flash 7 Use the Increase and Decrease keys to select the required value 60 kV 65 kV 70 KV ENDOGRAPH DC 34 Rev 0 USER S MANUAL General instructions for use 8 Confirm the selection by pressing the Function key NOTE As the setting menu is cyclic it will return to point 1 receptor type selection 9 To exit the setting menu hold down the Function key for approx 2s The system will return to the ready for X ray state Rev 0 35 ENDOGRAPH DC USER S MANUAL System use T SYSTEM USE 7 1 Switching on the device Press the power switch located on the right side of the timer cover This will start the CHECK function which is indicated by an acoustic signal and the turning on of the LEDS and the display When the CHECK functio
7. USER S MANUAL Description Functions models and versions The Endograph DC intra oral X ray unit makes it possible to obtain consistently high quality X rays thanks to the reproducibility of the unit parameters with very short exposure times and a very small focus spot The Endograph DC intra oral X ray unit is compatible for being combined with digital image acquisition systems thereby obtaining the maximum benefits of today s digital intra oral radiologic technology If you do not currently have a digital system the use of high speed film or film in the EKTRASPEED Kodak category is recommended in order to limit the dose absorbed by the patient A button on the control keypad is used to select the operating mode and it is possible to select films with different speeds sensitivity the phosphor sensor the digital sensor or a customised user mode Custom mode The Endograph DC X ray unit has an LCD display with dimensions of 84mm x 45mm 240x128 pixel which makes it easier for the operator to perform all operations guaranteeing the immediate and complete display of the exposure parameters The Endograph DC system can use the optional 30 cm collimator cone to be ordered separately with code 61XXXXXX The long cone inserted selection is signalled by the specific symbol on the display In this configuration the exposure times that were pre set in the anatomic selection are automatically increased by a multiplicative factor of 2
8. 4 11 Magnetic field at the main frequency 50 60 Hz IEC 61000 4 8 2 kV for power supply lines 1 kV for input output lines 1 kV between phases 2 kV between phase and earth O Ut for 0 5 cycles 40 Ut for 5 cycles 70 Ut for 25 cycles O U for 5 s 2 KV for power supply lines 1 KV for input output lines 1 kV between phases 2 KV between phase and earth O Ut for 0 5 cycles 40 Ut for 5 cycles 70 Ut for 25 cycles 0 U for 5 s or ceramic tile If the flooring is covered with synthetic material the relative humidity must be at least 30 The quality of the mains voltage must be the same as a typical commercial or hospital environment The quality of the mains voltage must be the same as a typical commercial or hospital environment The quality of the mains voltage must be the same as a typical commercial or hospital environment If the Endograph DC user requires continuous operation during interruptions in the mains voltage it is recommended to power the Endograph DC with an uninterrupted power supply or batteries The levels of the magnetic fields at mains frequency must be the same as a typical commercial or hospital environment Note U is the a c mains voltage prior to the application of the test level Rev 0 ENDOGRAPH DC Radiated RF IEC 61000 4 3 Conducted RF IEC 61000 4 6 ENDOGRAPH DC from 80 MHz to 2 5 GHz 3 V fr
9. The Endograph DC system includes the following generator tube head complete with collimator CPU or logic card that controls the system functions keypad extension arm and scissors arm WARNING The Endograph DC system does not automatically detect the presence of a cone or other item the operator is responsible for checking the congruity between the indication on the display and the actual situation of use ENDOGRAPH DC 14 Rev 0 USER S MANUAL Description 4 2 1 High Frequency HF Generator The remote controlled HF generator together with the tube head uses state of the art microelectronic technology to obtain optimal quality X rays while reducing the patient dose of rays Conventional systems generally use the intrinsic capacity of the RX generator tube to conduct the electric current in one direction only This generates a train of RX impulses The Endograph DC unit instead uses constant voltage technology that generates continuous and stable emission of X rays This reduces the emission of soft rays guaranteeing the constancy of the emission parameters kVp and mA The microprocessor based control ensures constant and repeatable exposure times by simply pressing a button it is possible to automatically select the exposure times based on the size of the patient and the selected tooth 4 2 2 Extension arm and scissors arm This consists of an arm with a double joint which permits horizontal and upward extensio
10. elongated Probably caused by the excessive folding of the film in the patient s mouth ENDOGRAPH DC 58 Rev 0 USER S MANUAL Maintenance 10 MAINTENANCE This unit like all other electrical appliances must be used correctly and also serviced and controlled at regular intervals This precaution ensures a safe and efficient performance The periodical maintenance consists in checks performed by the operator himself and or by a qualified Technician The operator can control the following items check that the plates are complete and well fixed check that there are no traces of oil on the tube head check that the remote control cable does not show signs of breaking or wear check that the unit is not damaged externally as to compromise the safety of protection from radiation check the balancing of the scissors arm WARNING If the operator detects irregularities or failures he must immediately call the Technical Service Rev O 59 ENDOGRAPH DC Installation Maintenance Maintenance Maintenance Maintenance Maintenance Maintenance Maintenance ENDOGRAPH DC USER S MANUAL Maintenance MAINTENANCE LOGBOOK Date turcas oul es Tecni tan ies ette dm De DARO sites ss TG ae Ta Lans aurais ns eS RS D Me e A esd es oes ee Bie tos ee Ge tai E ERO Date shoei esse ata Technica ghe nit Ae oe Bare E he ak te Sees ac eh EE Date ts ve ts TeCnnkeral sissi ee ee CSST RE E Rd cee
11. of the acoustic signal depends on the moment in which the problem occurred and on the success of the procedure for stopping the rays These errors cannot always be removed without turning off the device and in most cases indicate situations of system faults or deterioration that require the intervention of technical assistance Displayed Type of ABNORMALITY AC OUS ate message signal e Dm WARNING If an error message appears and the buzzer sounds always turn off the system In any case the intervention of the back up timer always stops X ray emission ENDOGRAPH DC 54 Rev 0 USER S MANUAL Messages on display 8 3 NON fatal errors Situations that do not directly involve the safety of the operator the patient or the system are considered as resettable anomalies The error condition prevents additional exposures until it is reset by pressing the Increase key EE Type of ABNORMALITY ACOUELIO message signal CHO Memory checksum error EEPROM None Release of X ray button during emission None Release of button during the pre heating None phase WARNING If E12 is displayed the X ray button was released with the emission in progress therefore the film must be replaced or the image receptor must be restarted to obtain the diagnostic results X ray button active after the cooling phase If E11 is displayed release the X ray button if this has not been pressed this indicates a fault therefore call the
12. support service Rev 0 55 ENDOGRAPH DC USER S MANUAL Control and correction 9 CONTROL AND CORRECTION OF ANY ERRORS IN THE DENTAL X RAYS 9 1 Typical defects of intra oral X rays e X rays too light Possible causes e Insufficient X ray exposure short time e Insufficient development time e Film processor damaged e Film processor temperature lower than the recommended value e Incorrect dilution of the developing liquids e X rays too dark Possible causes e Excessive X ray exposure e Excessive development time e Film processor temperature higher than the recommended value e Incorrect dilution of the developing liquids e X rays out of focus impossible to see the details Possible causes e The patient moved e The tube head moved e X rays with herringbone shaped marks Some intra oral films have a thin layer of lead in the package that engraves a few herringbone shaped marks in the lower part These films can only be exposed to radiation on one side If the film is exposed from the wrong side the layer of lead will absorb a large quantity of radiation during exposure The result will be a lighter X ray and the film will show herringbone shaped marks ENDOGRAPH DC 56 Rev 0 USER S MANUAL Control and correction e X rays partially exposed Possible causes e Rays directed far from the median section of the film e Level of the developing liquids is too low resulting in the partial devel
13. to the bisector of the angle formed by the longitudinal axis of the tooth and by the film After positioning the X ray beam and the patient s head based on these criteria an average vertical incidence can be applied for each area The incidence angle of the X ray beam can be correctly measured using the graduated scale located on the tube head Figure 14 Legend Figure 14 A Longitudinal axis of the tooth B Bisector C Film surface D Occlusal surface RC X ray beam ENDOGRAPH DC 46 Rev 0 USER S MANUAL System use Incidence of the X ray beam horizontal direction The X ray beam must be adjusted horizontally in particular in the orthoradial direction relative to the interproximal spaces see Figure 15 to prevent an overlapping of structures see Figure 16 RC RC Figure 15 Figure 16 Correct position Incorrect position Legend Figure 15 and Figure 16 RC X ray beam Rev 0 47 ENDOGRAPH DC USER S MANUAL System use 7 5 2 Parallel technique With this technique the surface of the film is positioned parallel to the tooth s axis Due to anatomic factors the film is kept far from the lingual surface of the tooth in general with the exception of molars When the film is introduced into the patient s mouth it is fixed ona support to prevent distortion The patient holds the support with his teeth Various types of supports are available on the market that can be adapted to different t
14. ASS ee ah CINETICA RU RENDRA eat e Date wis eee See eh ds ECTS Tas eii aa CSS Sas ts OP Mra RS Sith cas AA Sw a Ce ee Date ant ale eee So came TSI Te ia ee ee rare MS eg exe A O a dee E SE Hee A E Eee gt E e Date siennes is F CAMICLAM 4 4 2 A a a dede Cd de dd di CS cds DO dd E ei E A a ee ae Bee Date sociali gi TOC Gy Ca ali a Re Ge eo Sse a oa HS Aa ae ac dee Sd wt Geeta cs Yoh os Hatten Ee ed ID oA ea NA 60 Rev O Cod 6959900203_Rev 0 C 0051 VILLA SISTEMI MEDICALI S p a Via Delle Azalee 3 20090 Buccinasco MI ITALY Tel 39 02 48859 1 Fax 39 02 4881844
15. DOGRAPH DC 52 Rev 0 USER S MANUAL Messages on display 8 ERROR MESSAGES ON THE DISPLAY Endograph DC is fully controlled by a microprocessor which controls the programming of the emission parameters and signals the various conditions of the machine the possible abnormalities and errors via displayed messages The following tables show the various messages that can appear on the display their meaning and their cause The error messages are separated into three different categories classified based on the severity of the abnormality discovered and their possible effect on the safety of the operators and or the system 8 1 Fatal errors upon power up and in the ready idle and cooling statuses These signals do NOT permit an examination to be performed It is possible to try to turn the equipment off and on but if the signal is repeated technical assistance must be contacted ed ec Type of ABNORMALITY AC ONSE message signal X ray button pressed at power up A key pressed at power up None other than the X ray button Unwanted X ray emission Present as long as RX ON is active WARNING If EO1 is displayed release the X ray button if this has not been pressed this indicates a fault therefore call the support service Rev 0 53 ENDOGRAPH DC USER S MANUAL Messages on display 8 2 Fatal errors during X ray emission Any abnormalities during the X ray beam always stop the emission The presence or absence
16. ER S MANUAL Technical data 9 TECHNICAL DATA Technical characteristics Equipment Endograph DC Manufacturer VILLA SISTEMI MEDICALI Buccinasco MI Italia Class I with type B applied parts A Class according to EN 60601 1 classification IPXO standard device 99 264 V 110 240 V 50 60 Hz Protection degree Line voltage Rated voltage Line frequency Maximum line current 2 5 Arms impulsive 230 V 70kV 6mA 5 2 Arms impulsive 115 V Technical factors for maximum line current Absorbed power 583W 584VA 566W 570VA Maximum apparent line resistance 0 4 Q 99 132 V 0 8 Q 198 264 V 6 3 AT from 0 01 to 2 00 s in 36 steps Mains fuse Selectable times Automatic selection 882 pre programmed times 7 anatomic 3 sizes 3kV 2 SID 3 receptors t5o t2 ms 60 65 70 kVp selectable 6 mA 8 rated voltage 10 rated voltage 2 08 284x253x123 3 mm High voltage values Tubehead current kV accuracy Tubehead anodic current accuracy Maximum exposure time e z 5 L O 7 pul e O o k Q O lt ENDOGRAPH DC 2 N Rev O USER S MANUAL Technical data Tube head characteristics Manufacturer CEI Bologna Italy 60 65 70 kV selectable 420 W gt 2 5 mm Al eq 70 kV Tubehead power Total filtration 7 O ct O Qi lt O D da O an lt Half value Layers gt 2 mm Al eq Transformer insulation Oil bath Interva
17. ZE 29 6 GENERAL INSTRUCTIONS FOR USE 30 6 1 Control panel Description and functions 30 6 1 1 Keen enee er NEE 32 OLA Increase Decrease ENEE 32 OGL Scelectoize EOS 33 6 1 4 Function key selection of receptor cone presence and kV value 34 Rev 0 i ENDOGRAPH DC USER S MANUAL Contents 7 SYSTEM USE 36 Tak SWITCHING On Che EE 36 7 2 Programmed Manual exposure uni 37 1 2 1 Performing a programmed exposUrEriiain il 38 Tidedo Perorminea manual ExXpPOSUITEup sia 40 Too DONNE CUSFOMISEC MES dias 41 TAs Preparing the tabe Aea is 42 Tio Exposure Ee 46 7 9 1 Bisector tec EE 46 10 2 Parallel techinGue ASAS 48 7 6 Exposure with the supplied X ray button 49 7 7 Exposure with the wireless X ray button optional 50 7 7 1 Indication of the battery charge status and replacement o1 L 1 2 Combination procedure between the remote control and timer o1 7 8 Display of the number of exposures made 92 8 ERROR MESSAGES ON THE DISPLAY 53 8 1 Fatal errors upon power up and in the ready idle and COONSE SIA USES eebe bebe 93 3 2 Fatal errors durin X ray MISSION ne dites 94 Sid NON SEENEN Ee dE 55 9 CONTROL AND CORRECTION OF ANY ERRORS IN THE DENTAL X RAYS 56 Y dl Typical detectsotintra oral X Tayo ossi E AS a ai 56 9 2 Typical defects caused by incorrect positioning ooccoccnccnncnnonncnnonannnonos 58 10 MAINTENANCE 59 No part of this pub
18. aracteristic curves OX 70 5 Emission characteristics Filament characteristics anode current mA pas O filament current A o Oo o QD 22 24 26 28 30 32 34 18 20 22 24 26 26 30 32 34 filament voltage V filament voltage V anode currentmA exposure time sec ENDOGRAPH DC 26 Rev 0 USER S MANUAL Technical data Anode cooling curve kJ Tube head cooling curve E kJ 0 100 200 300 400 Time min Rev 0 27 ENDOGRAPH DC USER S MANUAL Technical data Reference standards Endograph DC complies with the following standards IEC 60601 1 1988 A1 1991 A2 1995 Medical Electrical Equipment Part 1 General requirements for safety IEC 60601 1 6 2004 Medical electrical equipment Part 1 General requirements for safety collateral standard Usability IEC 60601 1 2 2001 Al Electromagnetic Compatibility Requirements and Tests IEC 60601 1 3 1994 Gen Requirements for Radiation Protection in Diagnostic X ray Equipment IEC 60601 2 7 1998 Particular requirements for the safety of high voltage generators of diagnostic X ray generators IEC 60601 2 28 1993 Particular requirements for the safety of X ray source assemblies and X ray tube assemblies for medical diagnosis IEC 62304 2006 Ac 2008 Medical device software Software life cycl
19. at the end of its life The separate collection of the present equipment that has reached the end of its life is organised and managed by the manufacturer The user who wishes to dispose of this equipment must contact the manufacturer and follow their system to enable the separate collection of the equipment at the end of its life Suitable separate waste collection for the subsequent start of the equipment discarded for recycling for treatment and for environmentally friendly disposal contributes in preventing possible adverse effects on the environment and health and promotes the reuse and or recycling of materials of which the equipment is comprised Illegal disposal of the product by the holder implies the application of administrative sanctions provided by law Rev 0 9 ENDOGRAPH DC USER S MANUAL Safety injormation Symbols used In this manual and on the Endograph DC itself apart from the symbols indicated on the keypad also the following icons are used see Chapter 6 Symbol Description e Device with type B applied parts In some of its parts the device contains materials and liquids that at the end of the lifespan of the unit must be disposed of at the a appropriate disposal centres Alternating Current N Connection point to the neutral conductor L Connection point to the line conductor Operation earthing Me OFF device not connected to the mains ON device connected to the mains z Exposure ena
20. be in contact with the tube head or the collimator cone During exposure the operator must maintain a certain distance from the source of the rays at least 2 metres in the opposite direction of the emission During exposure only the operator and the patient may be present in the room Use the specific leaded aprons to reduce the undesired effect of secondary radiations for the patient 8 Rev 0 USER S MANUAL Safety injormation 2 3 Environmental risks and displacement Some of the device s components contain material and liquids that at the end of the equipment life cycle must be disposed of at the recycling centres appointed by the local health units In particular the device contains the following materials and or components e Tube head non biodegradable plastic materials glass dielectric oil lead tungsten aluminium copper e Other parts of the device non biodegradable plastic materials metal materials printed circuits iron plastic materials INFORMATION TO USERS IN THE EUROPEAN COMMUNITY according to art 13 of Legislative Decree 25th July 2005 nr 151 Implementation of Directives 2002 95 EC 2002 96 EC and 2003 108 EC regulating the reduction of the use of hazardous substances in electrical and electronic equipment as well as the waste disposal The symbol with the waste bin crossed on the equipment or its packaging indicates that the product must be separately collected from other waste
21. bling key the exposure enabled status is indicated by C the switching on of the corresponding green symbol Ray Emission D Focus spot according to IEC 336 Warning see the accompanying documentation Product identification code Serial number Date of manufacture year and month Manufacturer s name and address Filtration Tube head C Conformity to the EC 93 42 Directive and subsequent amendments 0051 and additions subsequent amendments and additions ENDOGRAPH DC 10 Rev 0 USER S MANUAL Cleaning and disinfection 3 Rev 0 CLEANING AND DISINFECTION In order to guarantee a good level of hygiene and cleaning it is necessary to respect the following procedures e Before starting any cleaning operation disconnect the unit from the mains using the main line switch that must be foreseen during the installation phase This manoeuvre is necessary because some parts inside the unit are still live even after it was turned off using the power switch e Make sure water or other liquids do not penetrate inside the unit in order to prevent short circuits or corrosion e Never use corrosive or abrasive substances alcohol petrol trichloro ethylene to clean the unit External surfaces Use a soft cloth and for more effective cleaning use neutral soap and be careful not to damage the painted surfaces During cleaning operations make sure that the detergent and or liquids do not enter inside the unit or re
22. e processes ETSI EN 300 220 2 v 2 3 1 ETSI EN 301 489 3 v 1 4 1 Electromagnetic Compatibility and Radio Spectrum matters ERM ISO 14971 2007 Medical Devices Application of Risk Management to Medical Devices C 0051 Guarantees Endograph DC compliance with Directive 93 42 and as amended subsequent amendments and additions CAN CSA C22 2 No 601 1 M90 2nd edition A1 A2 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance UL 60601 1 1st edition Medical Electrical Equipment Part 1 General Requirements for Safety ENDOGRAPH DC 28 Rev 0 USER S MANUAL Technical data 5 4 Ce Elo FRONT VIEW p ax I Sy 4 L oS i SH KO et PA e J NG 2 E J S 7 SL 2900 7 dos 123 Se 5 E 4 13 16 O id i 300 600 800 F Ss 11 3 4 23 5 8 31 1 2 S S D bk 683 983 1183 d i 785 1085 1285 3 ot H 26 7 8 38 11 16 46 9 16 31 42 3 4 50 5 8 N T leg kel seat i 1430 1730 1930 270 lt a of 56 5 16 68 1 8 76 10 5 8 DR ES 2110 83 120 4 3 4 ZN 1370 54
23. ect the unit from the power supply using the provided circuit breaker Endograph DC is an electro medical device and therefore it can be used only under the supervision of suitably qualified medical personnel with the necessary knowledge on X ray protection The user is responsible for the fulfilment of the legal requirements regulating the ownership installation and use of the equipment itself Endograph DC has been built to support continuous operation at intermittent load therefore please follow the described use cycles Wherever necessary use the appropriate accessories such as the leaded aprons to protect the patient from radiation Endograph DC must be turned off when using electrosurgical devices or similar equipment near the unit This device has not been designed to be used in environments where anaesthetic mixtures flammable with air oxygen or nitrous oxide can be detected In order to prevent risks of short circuit and corrosion avoid the entry of water or other liquids in the equipment The parts of the unit that can come into contact with the patient must be cleaned regularly according to the instructions provided below in this document WARNING For safety reasons it is prohibited to abnormally overload the extension arm or the scissors arm for example by leaning on it Rev 0 3 ENDOGRAPH DC USER S MANUAL Safety injormation 2 1 1 Electromagnetic emissions In accordance with the IEC 60601 1 2
24. ked by this icon refer to the safety aspects of the patient and or the operator Rev 0 1 ENDOGRAPH DC USER S MANUAL Safety injormation SAFETY INFORMATION WARNING Please read this chapter thoroughly VILLA SISTEMI MEDICALI designs and builds the devices in compliance with the safety requirements furthermore it supplies all information necessary for correct use and the warnings related to danger associated with X ray generating units The manufacturer cannot be held responsible for e use of Endograph DC equipment different from the purpose for which it was originally designed e damage to the unit the operator or the patient caused both by incorrect installation and maintenance procedures different from those described in this user and service manuals supplied with the unit and by wrong operations e mechanical and or electrical modifications performed during and after the installation different from those described in the service manual Only personnel authorised by the manufacturer may carry out technical operations on the unit Only authorised personnel can remove the tube head from its support and or access the components under tension ENDOGRAPH DC 2 Rev 0 USER S MANUAL Safety injormation 2 1 Warnings The device must be used in compliance with the procedures described and never be used for purposes different from those herewith indicated Before performing any maintenance operation disconn
25. l between the exposures 60 times the X ray time 1 60 0 5 IEC 336 Es EG CG Is a 10 ch Minimum focus to skin distance 20 cm optional 30 cm cone X ray diameter 20cm focus lt 6 cm 35x45 mm 25x35 mm 20x30 mm optional Convection Leakage radiation at 1 metre lt 0 25 mGy h Technical factors for leakage radiation 70 kV 6 mA 1 s duty cycle 1 exposure every 60 seconds O oF 5 va X ray tube characteristics Manufacturer CEI Bologna Italy OX 70 5 Inherent filtration 0 5 mm Al equivalent to 70 kV Pa O O Anode tilt angle Tungsten Rated voltage 60 65 70 kV selectable Filament max voltage 3 1 V Filament max current Anode thermal capacity 7 kJ JABE O O O O O ct O a CH N gt Anode cooling capacity max 110W Rev 0 23 ENDOGRAPH DC USER S MANUAL Technical data Environmental conditions Operating temperature range 10 C 40 C Relative working humidity RH range 30 75 Temperature range for transport and 20 C 70 C storing Humidity range for transport and lt 95 non condensing storing Minimum atmospheric pressure for 630hPa storing and transport Weight of the unit and the removable parts Gross weight including packaging 30 kg Net weight of the unit in the standard configuration Extension arm 60 cm standard Scissors arm with tube head support ENDOGRAPH DC 24 Rev 0 USER S MANUAL Technical data 5 1 Rev 0
26. lication may be reproduced transmitted transcribed or translated without the prior written consent of the manufacturer This manual is the English translation of the original Italian manual version ENDOGRAPH DC Rev 0 USER S MANUAL Introduction 1 INTRODUCTION NOTE gli his manual is updated for the product it is sold with in order to guarantee an adequate reference to use the product properly and safely The manual may not reflect changes to the product that do not affect operating modes or safety The Endograph DC intra oral X ray unit takes high quality intra oral X rays thanks to reduced exposure times and the small dimensions of the focus spot Endograph DC is intended exclusively for intra oral X rays System operation is managed by a microprocessor which permits high reproducibility of the exposure times The system consists of the following parts e timer Endograph DC complete with the wall support e extension arm 30cm 60 cm or 80cm for the wall version e Scissors arm DP e Tube head 60 65 70 KV 6 mA The aim of this manual is to instruct the user on the safe and effective use of the device The device must be used in compliance with the procedures described and never be used for purposes different from those herewith indicated 1 1 Icons appearing in the manual This icon indicates a NOTE please read the items marked by this icon d thoroughly This icon indicates a WARNING the items mar
27. main on the painted surfaces Parts in contact with the patient s skin To ensure the hygiene of these parts they should be periodically disinfected with a 2 glutaraldehyde solution 11 ENDOGRAPH DC USER S MANUAL Description 4 DESCRIPTION 4 1 Identification plates ENDOGRAPH DC 12 Rev 0 USER S MANUAL Description 1 Endograph DC plate ENDOGRAPH DC 110 240V 5 2A 115V gt Duty cycle 1 60 8359000XXX Line 2 5A 230V 50 60Hz MEDICALI Max exposure time 2 S N SN 29Y Y XXXX m YYYY M via delle Azalee 3 20090 BUCCINASCO MILANO ITALY CE 2 3 Tube head DP arm plate plate 8459400000 S i YYYY MM 6mA 25 KES ll CEI Italy Q MREOS SN IIVYZZZZ Output max 70 kVp VILLA SISTEMI MEDICALI 8159200000 SN 18YYZZZZ M o5siec 336 REF oxo SN LIL ETE Villa Sistemi Medicali S p A Via Delle Azalee 3 20090 Buccinasco Milano Italy 22 mm Al 5 Collimator 30 cm optional plate Wireless VILLA SISTEMI MEDICA LI BEAM LIMITING DEVICE lt 6cm at FFD 30cm EI Si via delle Azalee 3 20080 BUCCINASCO MILANO ITALY 42YY 2222 Via delle Azalee 3 MI Italy YYYY MM A Rev 0 13 20090 Buccinasco 4 Extension arm plate 8161200X02 SN 10YY 2222 6 RX button optional plate Wireless switch for Endograph DC 30YYXXXX C E0051 ENDOGRAPH DC
28. mmed exposure mode In programmed mode it is possible to change the size type of tooth and kV value Each time the Size selection key is pressed indicated acoustically the Large patient Normal patient Small patient selection changes To change the selection of the type of tooth use the Tooth anatomic selection key Each time this key is pressed the selection of the type of tooth changes in rotation This is signalled acoustically and shown on the display Based on the type of film that is selected the pre set times are provided in Table 1 Size Small Normal Large incisor oos 012 ois Table 1 NOTES gl hese values are related to film type F The Endograph DC system can be programmed to use film with different sensitivity levels the programmed times vary depending on the film s multiplicative factor It is possible to request this setting from the technician during installation ENDOGRAPH DC 38 Rev 0 USER S MANUAL System use If digital radiography is selected the exposure times are indicated in Table 2 Digital sensor size Small Normal Large ie Premolar Dip 0 06 BA Table 2 The times for permanent phosphor sensors are provided in Table 3 Permanent phosphors Size small Normal Large Table 3 NOTE EE he times indicated in the tables are relative to the selection 65kV The times for the 60kV selection are obtained by multiplying the
29. n The tube head remains balanced in all positions NOTE EN he scissors arm was designed to work correctly with a maximum opening angle of 160 therefore an opening angle of less than 160 is required for its use A horizontal extension arm can also be added which is available in different sizes 30 60 80 cm to satisfy all requirements Rev 0 15 ENDOGRAPH DC USER S MANUAL Description 4 2 3 Tube head The tube head makes it possible to select one of three different high voltage values 60 65 70 kVp The radiogenic unit is equipped with a collimator with a focus skin distance of 20 cm and a ray emission diameter of 6 cm at the cone exit The tube head is connected to the arm by a guide which permits 390 horizontal rotation and 290 vertical rotation 4 2 4 Timer The timer consists of an LCD display 240x128 pixel two LEDs yellow X rays in progress green ready for X rays and 5 buttons that are used to select from among 3 different patient sizes 3 types of sensors film phosphor or digital and 7 different pre set anatomical structures incisor canine premolar lower molar upper molar front bite wing and rear bite wing There are 36 fixed times available for manual selection which vary from a minimum of 0 01 seconds up to a maximum of 2 seconds The timing is managed in order to guarantee exact precision of the exposure times NOTE EE he configuration can be set using the remote X ray con
30. n is complete the machine will position itself by default in the configuration corresponding to the last selection made The unit is now ready for X rays NOTE e The ready for X rays condition is signalled by the switching on of the relative green LED e The ready for X rays condition remains for a set period of time variable during the installation phase default 2 minutes after this period of time has passed this status will be disabled and pressing the exposure button will not emit rays The brightness of the display will also be reduced e To return to the ready for X rays status the device must be woken up by pressing any key except for the X ray button ENDOGRAPH DC 36 Rev 0 USER S MANUAL System use 7 2 Programmed Manual exposure The operator can select between working with a programmed anatomic selection that is with values set by the manufacturer based on the size and type of tooth or perform an examination in manual mode where it is possible to change the set times With the programmed anatomic selection it is possible to select the type of receptor used different types of film phosphor and digital sensors the size of the patient and the kV value Rev 0 37 ENDOGRAPH DC USER S MANUAL System use 7 2 1 Performing a programmed exposure If the previous examination was carried out in manual exposure mode press one of the size selection or anatomic selection keys to switch to progra
31. nstant and equal to 10s 6 Ifthe X ray button was already pressed at the end of the cooling pause the exposure will be inhibited and the error E11 will be displayed NOTE di the system statuses are shown on the display during the exposure preheating X ray emission and the cooling pause Rev 0 49 ENDOGRAPH DC USER S MANUAL System use 7 7 Exposure with the wireless X ray button optional It is possible to make an exposure using the wireless X ray button Proceed as follows ke The and Press and release the wireless X ray button The green LED will turn on indicating that the communication with the timer was successful Move away the desired distance no greater than 5m in the opposite direction of the X ray beam Press the X ray emission button and hold it down during the entire exposure procedure continues as described in paragraph 7 6 points 4 5 6 NOTE d V the green LED flashes the first time the wireless X ray button is pressed one of the following situations may have occurred ENDOGRAPH DC The device is not ready for X rays signalled by the green LED switching on Make sure it is not switched off in sleep mode or in any other error mode The transceiver in the remote control and the one in the timer are not correctly combined Follow the combination procedure described in paragraph 7 7 1 The transceiver in the timer is faulty contact the technical support 50 Rev 0
32. ollowing pages Tooth anatomic structure indication kV values indication 0 00 s Patient size i Type of receptor indication indication Exposure time Dose indication indication Figure 9 LCD display Rev 0 31 ENDOGRAPH DC USER S MANUAL General instructions for use 6 1 1 Tooth anatomic selection key Press the Tooth anatomic selection key to select in rotation from among the exposure times pre set for the various teeth It is possible to select from among seven different anatomic structures and the selection is shown on the display Incisor F Canine 7 Ba d g 6 1 2 Increase Decrease key The Increase or Decrease keys are used to scroll the different selections in the menus or to manually change the exposure times ENDOGRAPH DC 32 Rev 0 USER S MANUAL General instructions for use 6 1 3 Select Size key Press the Select size key to select in rotation from among the the different patient sizes small medium and large Also in this case the exposure times will change An acoustic signal is emitted each time a key is pressed and the selected size will be displayed Rev 0 33 ENDOGRAPH DC USER S MANUAL General instructions for use 6 1 4 Function key selection of receptor cone presence and kV value Using the Function key it is possible to select an image receptor the presence of the long cone SID 30 cm
33. om 150 kHz to USER S MANUAL Safety information The RF portable and mobile communications units should not be used closer to any part of the Endograph DC including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2xVP from 80 MHz to 800 MHz d 2 3xVP from 800 MHz to 2 5 GHz d 12xvP where P is the maximum rated output of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m The field strength of the fixed RF transmitters determined by an on site electromagnetic survey should be lower than the compliance level in each frequency range Interference may be verified near devices marked with the following symbol o Rev O USER S MANUAL Safety injormation 2 1 3 Recommended separation distances to portable and mobile radio equipment Endograph DC is designed to operate in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the system can help prevent electromagnetic interference by ensuring a minimum distance between mobile and portable RF communication devices transmitters and Endograph DC as recommended in the following table in relation to the maximum output power of the radio devices Separation distance according to the frequency of the transmitter
34. opment of the film e Two or more films placed next to each other in the film processor e Obscured X rays Possible causes e Film stored for too long check expiration date e Accidental exposure of the film to rays e Accidental exposure of the film to other sources of natural or artificial light e Dark line on the X rays This line appears when the film is folded excessively e X rays with traces of electrostatic electricity When the film is compressed excessively and the air is dry electrostatic electricity may be released which is discharged in the compression points on which black branching marks will appear e X rays with chemical spots Scattering the developing fluid or fixer on the film before development and the fixing procedures will create spots on the X ray these spots are e Dark if caused by the developing liquid e Light if caused by the fixer e X rays with loss of emulsion If the film is left in a hot water bath for too long for example overnight the emulsion may soften and detach partially from the base of the film After development the film will appear scratched Rev 0 57 ENDOGRAPH DC USER S MANUAL Control and correction 9 2 Typical defects caused by incorrect positioning e X rays with elongated or shortened images The X ray beam is not perpendicular to the bisector of the angle formed by the longitudinal axis of the tooth and by the film e X rays with the top of the tooth
35. ss one of the Size selection or Tooth automatic selection keys ENDOGRAPH DC 40 Rev 0 USER S MANUAL System use 7 3 Storing customised times Endograph DC makes it possible to customise the programmed exposure times in order to adapt them to the user s actual conditions of use Proceed as follows to store the customised times 1 Use the Increase and Decrease keys to select the required value 2 Hold down the Function key until an acoustic signal is emitted a screen with the request to confirm or cancel the change will appear 3 Press the Increase key to confirm or the Decrease key to cancel the change NOTE dh he stored time is related to the size the tooth the type of receptor and the kV value shown on the display at that moment If the long cone is selected some time values may be approximate Rev 0 41 ENDOGRAPH DC USER S MANUAL System use 7 4 Preparing the tube head 1 Position the tube head with an angle suitable for the exposure and positioning required see Figure 10 Figure 11 Figure 12 Figure 13 2 Introduce the image receptor in the patient s mouth according to the selected technique bisector or parallel In this regard see paragraph 7 5 3 Move the tube head cone towards the patient and direct it exactly towards the tooth to be X rayed referring to the following figures NOTE If you want to use the rectangular collimator apply it to the end of
36. standard Endograph DC is suitable for use in the electromagnetic environment specified below The customer or user of the system must ensure that it is used in the said environment Emissions test Conformity EMC environment of use RF emissions Endograph DC is suitable for use in all domestic environments and in CISPR 11 environments directly connected to the mains power supply at low voltage that supplies buildings for domestic use Endograph DC uses RF power only for its internal functioning As a result its RF emissions are very low and most likely will not cause any interference in electronic devices located nearby celo O IEC 61000 3 2 fluctuation emissions compliance IEC 61000 3 3 ENDOGRAPH DC 4 Rev 0 USER S MANUAL Safety injormation 2 1 2 Electromagnetic immunity In accordance with the IEC 60601 1 2 standard Endograph DC is suitable for use in the electromagnetic environment described below The customer or user of the system must ensure that it is used in the said environment Immunity test Test level Compliance level EMC environment y IEC 60601 1 2 P of use Electrostatic 6 KV contact 6 KV contact The flooring must be discharges ESD 8 KV in air 8 kV in air must be wood concrete IEC 61000 4 2 Transients sequence of rapid electric impulses IEC 61000 4 4 Overvoltages IEC 61000 4 5 Voltage dips short breaks and voltage variations of the power supply feed line IEC 61000
37. the tube head cone positioning it as needed NOTE di If you want to use the 30 cm extension cone apply it to the end of the tube head s 20 cm cone WARNING If the 30 cm extension cone is applied the pre set exposure times will be automatically doubled in order to obtain the same radiographic result ENDOGRAPH DC 42 Rev 0 USER S MANUAL System use MANDIBLE INCISIVI CANINI incisors canines incisives canines PREMOLARI MOLARI premolars molars pr molaires molaires Figure 10 Rev 0 43 ENDOGRAPH DC USER S MANUAL System use MAXILLA d INCISIVI CANINI incisors canines incisives canines PREMOLARI MOLARI premolars molars pr molaires molaires Figure 11 ENDOGRAPH DC 44 Rev 0 USER S MANUAL System use OCCLUSAL 65 0 tl O HO MASCELLA MANDIBOLA upper jaw lower jaw machoire mandibule Figure 12 BITE WING O re RAGGIO CENTRALE main beam rayon central Figure 13 Rev 0 45 ENDOGRAPH DC 7 5 1 USER S MANUAL System use Exposure techniques This paragraph describes the various techniques used in general for intra oral exposure Bisector technique Incidence of the X ray beam vertical angle In order to obtain a real image of the tooth the ray must be perpendicular
38. trol outside the examination room This consists of a wall support onto which the X ray button is connected with an extendable cable NOTE EE he unit provides two separate contacts for the possible connection with external signalling devices One contact signals the status of the unit as operative and ready to be used the second emits the X rays The connection methods and the requirements necessary for the signalling devices are described in the Service Manual ENDOGRAPH DC 16 Rev 0 USER S MANUAL Description 4 3 4 3 1 Rev O Configurations Standard configuration Figure 1 Tube head Scissors arm Extension arm Timer OO Bb OO N m X ray button 17 ENDOGRAPH DC USER S MANUAL MEDIC Description 4 3 2 ENDOGRAPH DC ON arth QQ N PH Figure 2 Tube head Scissors arm Extension arm Wall support Remote timer X ray button 18 Rev 0 USER S MANUAL Description 4 3 3 Mobile stand configuration Figure 3 1 Tube head 2 Scissors arm 3 Stand 4 Timer 5 X ray button Rev 0 ENDOGRAPH DC pal Ko USER S MANUAL Description 4 3 4 Configuration with remote X ray button Figure 4 1 Remote X ray button optional ENDOGRAPH DC 20 Rev 0 USER S MANUAL Description 4 3 5 Configuration with wireless X ray button Figure 5 1 Wireless X ray button optional Rev 0 21 ENDOGRAPH DC US
39. values in the 65KV table by 1 45 they are multiplied by 0 7 for the 7OkV selection NOTE gli he times indicated in the tables are those set by the manufacturer These values can be changed as described in paragraph 7 3 A service technician is required to reset the default times Rev 0 39 ENDOGRAPH DC USER S MANUAL System use 7 2 2 Performing a manual exposure Endograph DC makes it possible to work not only using the programmed mode described above but also using the manual function To access the manual function press one of the two keys Increase or Decrease the size icon will flash The display will show the last time value selected in automatic mode to change it simply use the Decrease or Increase keys until reaching the desired value The single variation of the time is signalled by an acoustic message it is also possible to quickly change the exposure time 4 units per second by holding down one of the Increase or Decrease keys for more than 2 seconds NOTE EE here are 36 times that can be selected manually and range from a minimum of 0 01 s up to a maximum of 2 00 s according to the following table 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 10 0 11 0 12 0 14 0 16 0 18 0 20 0 22 0 25 0 28 0 32 0 36 0 40 0 45 0 50 0 56 0 63 0 71 0 80 0 90 1 00 1 10 1 25 1 40 1 60 1 80 2 00 Table 4 Manual exposure times To return to the automatic time selection pre
40. ypes of teeth This technique makes it easier to obtain more accurate and repeatable X rays than with the bisector technique see Figure 17 and Figure 18 HORIZONTAL SECTION Ni Keng FIS O Figure 17 VERTICAL SECTION Figure 18 ENDOGRAPH DC 48 Rev 0 USER S MANUAL System use 7 6 Exposure with the supplied X ray button 1 Using the main keypad select the exposure time as described in paragraph 7 4 based on the selected mode 2 Move away the distance permitted by the X ray button cable in the opposite direction of the X ray beam 3 Press the X ray emission button and hold it down during the exposure 4 A yellow light and an acoustic signal indicate the start of exposure WARNING e The X ray emission button is a dead man control therefore it must be held down during the entire exposure e Ifthe button is released before the end of the exposure the emission is automatically stopped this situation is shown on the display by the message E13 if the button was released during pre heating and E12 if the button was released during the emission of X rays This message will remain displayed until the Increase key is pressed 5 At the end of exposure the system starts the tube head cooling cycle 60 times the exposure time The time until the end of the pause is shown on the display NOTE d ke all exposure times shorter than 0 16s the cooling pause is co
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Villa Endograph DC users manual