ENDOS DC - Ritter Dental Australia
Contents
1. 0434 Y User s Manual Release 16 April 2003 Rev 0 USER S MANUAL Contents mad Contents 1 INTRODUCTION 1 1 4 Icons n the manual ioter ica 1 2 SAFETY ASPECTS 2 21 War inesu y RO M M naL ua cus 3 2 2 Protection X TAY Sos s ga PO OUS aa OH IRR E 4 2 9 Environmental risks and disposal 5 244 Symbols A UG ORI MO LU ORE A AN METERS 6 3 CLEANING AND DISINFECTION 7 4 DESCRIPTION 8 4 1 Identification labels dl 8 4 2 HUN CHONS eerte a a a a a ad 10 4 2 1 ENDOS DO Iveco AA y O ERE Eee 10 4 2 2 High frequency generator or HF 11 qi 3 GOLD pultattOTiSo A ya o RO a aa 12 4 3 1 Standard configuration 12 4 3 2 Mobile stand configuration 13 4 3 3 Remote keyboard configuration 14 5 TECHNICAL FEATURES 15 5 1 Method of measuring technical factors 18 5 2 Qurves t be features tos ta PO E V Tri dea sheds 20 53 Standard and regulations etienne CV run 22 5 4 Overall dimension uuu u a a ida dt lid daa 23 6 GENERAL USE INSTRUCTIONS 24 6 L Equipment start up itc a a ee eon eet eee 24 6 2 Special keyboard TICS ii a ta 25 6 2 1 Change from Focus Film Distance2. a Maintenance Dates ars Technical Cause O A A A A ds Maintenance isa TIM ses CAUSES Goin a WAN A A o eid Maintenance Date Technician A MEN EL EAU darias ai tossed whee a S Maintenance Date a RR tS Cause iade A sd ise Maintenance Date a Technde39B m duh ward when ad CAUSES he SU eS ede ie ead ea eee ES Maintenance Date Suis vole Technvzcran Z Bath eel eos SES CAUS www ant UI AS T eS DA BE SC TRUE ENDOS DC CE 50 Rev 0 Cod 6961900203 Rev O 0434 VILLA SISTEMI MEDICALI S p a Via Delle Azalee 3 20090 Buccinasco MI ITALY Tel 39 02 48859 1 Fax 39 02 4881844 DEL Medical Systems Group
3. 1 ENDOS DC CE USER S MANUAL Safety aspects 2 SAFETY ASPECTS w WARNING Read this chapter very carefully Villa Sistemi Medicali design and make their equipment according to safety requirements moreover they supply all necessary information for appropriate use and warnings relating to dangers connected with X ray generators The manufacturer does not accept any responsibility for e use of ENDOS DC equipment for purposes other than those for which it has been designed e damages to the equipment the operator the patient caused both by wrong installations and maintenance that do not follow the procedures contained in the User s and Service Manuals provided with the equipment and by wrong operating techniques e mechanical and or electrical changes made during and after installation that differ from the ones in the Service Manual Only personnel authorised by the manufacturer may carry out technical work on the equipment Only authorised personnel can remove the tubehead from its support and or gain access to live parts ENDOS DC CE 2 Rev 0 USER S MANUAL LLA Safety aspects SISTEM 2 1 Warnings The equipment must be used according to the procedures in this manual and never for different purposes from the ones for which it has been designed Before carrying out any maintenance disconnect the equipment from the power line using the circuit breaker provided ENDOS DC
4. Check and correction MEDICAL e Partially exposed X rays Possible causes e X rays directed far from the medial section of the film e Low fluid level with subsequent partial development of the film e Two or more films one close to the other in the developer e Darkened X rays Possible causes e The film has been in the warehouse for too long check expiry date e Accidental exposure of the film to X ray Accidental exposure of the film to other sources of natural or artificial light e Dark line on X rays This line appears when the film is excessively folded e X rays with marks of electrostatic electricity When the film is excessively compressed and the air is dry electrostatic electricity can be released so it can run down to compression points where black marks form e X rays with chemical spots The scattering of developing or fixing fluid on the film before development and fixing procedures causes spots on the X rays these spots are e Dark if caused by the developing fluid e Light if caused by the fixing bath e X rays with emulsion loss If the film is kept in a warm water bath too long for instance all night the emulsion can soften and partially come off the base of the film After development the film will be scratched Rev O 47 ENDOS DC CE USER S MANUAL Check and correction 8 2 Typical faults caused by wrong positioning X rays with extended or shortened images The X ray beam i
5. 601 1 e EN 60601 1 1 IEC 601 1 1 EN 60601 1 2 IEC 601 1 2 EN 60601 1 3 IEC 601 1 3 EN 60601 2 28 IEC 601 2 7 EN 60601 27 IEC 601 2 7 e CFR 21 Subchaper J for version operating at rated line voltage 99 132 V C CE symbol certifies the compliance of ENDOS DC to 93 42 CEE legal directives ENDOS DC CE 22 Rev 0 USER S MANUAL L Technical features MEDICALI 5 4 Overall dimensions VPE FRONI VIEW 120 4 38 PE WA UU Z 7 22 22222 AIDA IEEE Figure 4 Wall uersion ouerall dimensions Figure 5 Mobile Stand uersion ouerall dimensions Rev 0 23 ENDOS DC CE USER S MANUAL General use instructions 6 GENERAL USE INSTRUCTIONS 6 1 Equipment start up a b Press the main switch located on the bottom part of the generator cover to start the CHECK function which begins when the keyboard and display LED come on After the CHECK function the machine sets itself by default in the configuration corresponding to the last selection executed From this moment the apparatus is in the waiting condition NOTE e The ready for X rays condition is signalled when the corresponding green LED 21 comes on the condition is achieved by pressing one of the anatomic or manual selection keys The ready for X rays condition is active for about 15 s If no exposure is taken during this period the equipment retu
6. Vertical angle To get a real image of the tooth the X ray must be perpendicular to the bisecting line 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 according to these criteria it is possible to apply an average vertical incidence for each area The incidence angle of the X ray beam can be correctly measured by the graded scale applied to the tubehead Figure 10 Legend Figure 10 A Tooth longitudinal axis B Bisecting line C Film level D Occlusal level RC X ray beam Rev 0 35 ENDOS DC CE USER S MANUAL MI General use instructions X ray beam incidence Horizontal direction The K ray beam must be set horizontally in particular in the ortho radial direction regarding inter proximal spaces see Figure 11 in order to avoid a superimposition of the structures see Figure 12 RC OC X O Figure 11 Figure 12 Correct position Wrong position Legend Figure 11 and Figure 12 RC X rau beam ENDOS DC CE 36 Rev 0 USER S MANUAL General use instructions MED 6 6 2 Parallel technique Using this technique the film level is placed parallel to the tooth axis Owing to anatomic factors the film is generally kept away from the lingual surface of the tooth except for molars When it is introduced into the patient s oral cavity the film is fixed on a support to prevent distortion The
7. according IEC 336 X ray emission ENDOS DC CE 6 Rev 0 USER S MANUAL cae T Cleaning and disinfection SISTEMI 3 CLEANING AND DISINFECTION The following procedures should be observed carefully in order to guarantee accurate hygiene and cleaning e Before cleaning the equipment disconnect it from the line using the cut out switch which must be provided when setting up This operation is necessary as some internal parts remain live even after it has been switched off from the on board switch e careful not to let water or other fluids enter the equipment in order not to cause a short circuit and corrosions e Never use solvents alcohol petrol Trichloroethylene corrosive or abrasive substances when cleaning External surfaces Use a soft cloth and for a stronger action a neutral soap to prevent damaging painted surfaces During cleaning operations prevent surplus detergent and or fluids entering the equipment or staying on painted surfaces Parts that come into contact with the patient s skin These parts should be disinfected at regular intervals with a 2 Glutaraldeide solution to guarantee hygiene Rev 0 7 ENDOS DC CE USER S MANUAL MEDICALI Description 4 DESCRIPTION 4 1 Identification labels ENDOS DC CE 8 Rev 0 USER S MANUAL Description la ENDOS DC label 230V version SISTEMI MEDICALI ENDOS DC Line 230 V
8. automatic cooling pause of the tubehead This pause is equal by default to 15 times the exposure time during this period it is not possible to perform a new exposure or to re set new data NOTE The cooling time may vary according to the workload of the equipment Refer to the information given in the notes in chapter 5 ENDOS DC CE 38 Rev 0 USER S MANUAL L General use instructions MEDICAL WARNING e The exposure button is a dead man control so it must be held pressed during the whole exposure If the patient should move during the examination the button must be released immediately interrupting the emission of X rays The message 2 will appear on the remote control alphanumeric display e The message 2 identifies that the exposure procedure has been interrupted when the exposure has already started in this case the film must be replaced before proceeding with a new exposure and you must wait until the automatic pause has finished e Ifa further exposure is performed without replacing the film you would obtain non diagnostic results due to a double exposure e Message AOS refers to an interruption in the exposure during preheating no dose has been delivered e Ifan error message appears on the screen at the end of the exposure indicating the letter E followed by a number and the buzzer persists switch off the system immediately since you may be in the presence of undesi
9. is an electro medical device and for this reason can be used only under the supervision of highly qualified medical staff in possession of all the necessary knowledge about X ray protection The user is responsible for fulfilling all the legal requirements connected with the possession installation and use of the equipment itself ENDOS DC is built for continuous running with intermittent load for this reason the planned duty cycle must be observed Appropriate accessories such as lead aprons must be used where necessary to protect the patient from radiation Although the equipment is designed to provide a reasonable degree of protection from electromagnetic interference according to IEC International regulations it must be installed at an adequate distance from electricity transformer rooms static continuity units two way amateur radios and cellular phones The latter can be used only at a minimum distance of 1 5m from any part of the equipment Any instrumentation or equipment for professional use located near ENDOS DC must conform to Electromagnetic Compatibility regulations Non conforming equipment with known poor immunity to electromagnetic fields must be installed at a distance of at least 3m from ENDOS DC and supplied by a dedicated electric line ENDOS DC must be turned off when using electro cautery or similar equipment in the vicinity of the equipment itself The equipment is not designed to be used in the presence o
10. of equipment and detachable parts Gross weight including packing 35 kg Net weight of equipment in standard 22 kg configuration 60 cm extension arm standard 2 9 kg 80 cm extension arm 3 5 kg 30 cm extension arm NOTE ABOUT COOLING TIME d ENDOS DC equipment is designed to guarantee the best efficiency of use for the operator this feature also includes a low tube cooling time in order to limit the waiting time between one exposure and the next even when the equipment is being used intensively In order to guarantee the useful life of the equipment cooling time varies according to the conditions in which the equipment is used and it can assume even 1 30 values 30 s waiting every 1 s exposure or 1 45 45 s waiting every 1 s exposure The calculation algorithm preset in the equipment takes into account the usage conditions and applies the correct value for the pause between two consecutive exposures Considering all this you are advised not to switch the ENDOS DC off immediately after an exposure Rev 17 ENDOS DC CE USER S MANUAL Technical features Method of measuring technical factors NOTE The best way to measure technical factors is by taking a direct measurement of radiological parameters This is also called the invasive method This method requires access to live parts so it can be performed by personnel authorised by the Manufacturer only The measurement method using non invasive
11. seriousness of the anomaly found and the possible effect on the operators safety and or the equipment 7 1 Fatal alarms during start up These alarms do NOT allow any exam to be performed It is possible to try to switch the equipment on and off but if the alarm is repeated you must call the technical assistance service Displayed ANOMALY type ACOUSTIC Message signaling Checksum error of memories EEPROM EPROM C H 1 Configuration writing error on memory EEPROM Absent EPROM R a N a Rev 0 43 ENDOS DC CE USER S MANUAL L MEDICAL Error messages on the screen 7 2 Alarms during exposure Any anomalies that occur during exposure always stop the exposure itself The acoustic signal present or absent depends on the time the breakdown occurred and the success of the exposure interruption These errors cannot be removed without turning off the equipment and in most cases indicate a failure or deterioration of the equipment requiring technical assistance Displayed ANOMALY type ACOUSTIC Message signaling Emission even after the end of exposure Present until RX ON is active Back up timer intervention Present until RX ON is active PFC overvoltage safety intervention Present until RX ON is active PFC undervoltage safety intervention Present until RX ON is active E1 7 Feedback kV beyond upper limit Present until RX ON is active Feedback mA under lower limit Present until RX ON is active Feedb
12. 225A 50 Hz Duty cycle 1 16 Max exposure time 25 Manufactured MMMMYYYY X RAY CONTROL Model 8361300000 S N 25XXYYYY 20090 Buccinasco 0434 MILANO ITALIA 2 WARNING label only for 120V version COMPLIES WITH DHHS PERFORMANCE STANDARD 21 CFR SUBCHAPTER J WARNING THIS X RAY UNIT MAY BE DANGEROUS TO THE PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED ELECTRICAL SHOCK HAZARD DO NOT REMOVE PANELS RISK OF EXPLOSION DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS FOR CONTINUED PROTECTION AGAINST RISK OF FIRE REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE DANGER RISQUE D ESPLOSION NE PAS EMPLOYER EN PRESENCE D ANESTHESIQUES INFLAMMABLES POUR ASSURER UNE PROTECTION CONTINUE CONTRE LE RISQUE D INCENDIE UTILISER UNIQUEMENT UN FUSIBLE DE RECHANGE DE MEME TYPE ET DE MEMES CARACTERISTIQUES NOMINALES 5a Tubehead label 230V version DIAGNOSTIC SOURCE ASSEMBLY Model ENDOS DC 8461400002 S N 35XXYYYY Output max 65kVp 5mA 2 sec m 0 7 IEC 336 Total filtration 22 mm Al X ray beam lt 6 at FFD 20 cm X RAY TUBE Model OCX 70 G CEI Bologna Italy Xe Manufactured VILLA SISTEMI MEDICALI 20090 BUCCINASCO MILANO Manufacturer 6a Collimator 30cm label optional 230V version SISTEMI MEDICALI BEAM LIMITING DEVICE Model 61614050 Diameter lt 6 cm at FFD 30 cm
13. 4 Arms continuous continuous 2 25 Arms 5 7 Arms impulsive impulsive 230 V Power consumption 50 VA continuous 50 VA continuous 0 55 kVA impulsive 0 55 kVA impulsive 230 V Automatic selection 60 pre set times Circuit type constant potential The unit can be operated with the line voltage 100 V 10 96 under the condition that line resistance is lower than 0 4 complies with IEC 601 1 Max line current absorption at 100 V 10 96 is 6 A High voltage value 65 kVp Rev 0 15 ENDOS DC CE USER S MANUAL Technical features Tubehead features Manufacturer VILLA SISTEMI MEDICALI Buccinasco MI Italia Rated voltage 65 kVp Tubehead power 325 W max Total filtration 22 mm AI 65 kV HVL Half Value Layer gt 1 5 mm Al eq Transformer insulation Oil bath Interval between exposures duty cycle 1 15 adaptive Minimum focus to skin distance Radiation leakage at 1 m 0 25 mGy h Technical factors for radiation leakage Anode cooling capacity max 90W ENDOS DC CE 16 Rev 0 USER S MANUAL L Technical features MEDICAL Environmental conditions Operating temperature range 10 C 40 C Operating relative humidity range 3096 75 Temperature range for transport and 20 C 70 C storage Max relative humidity for transport and lt 95 non condensing storage Min atmospheric pressure for storage 630hPa and transport Weight
14. FFD 20 cm to FFD 30 cm 25 6 2 2 Change from FFD 30 cm to FFD 20 25 6 3 Preset Manual Gx posure dia 26 6 3 1 Selection of receptor type for anatomic exposure mode 26 6 3 2 Anatomical preset exposure 27 0233 Manual exposure are QUERN ERA aX deos RA e ax a eo E ERA DA Exe un 29 6 4 Modification of customisable table 30 Rev 0 i ENDOS DC CE USER S MANUAL ex Contents 6 5 Preparation of the tubehead 6 6 Exposure TECHNIQUES Oe 6 6 1 Bis cting technique isi see RUN Reit 6 6 2 Parallel technique eese i 5 7 Exec tion of Exposure sss A ee UI Ss UT PI Ub ee 6 8 Command kevbDOSEQ ou oco qu c pota NI deoa eU dod ap m hd ope did Ded 7 ERROR MESSAGES ON THE SCREEN 7 1 Fatal alarms during Startup e ee code hi eren Maa ARS S D 1 2 Alarms dutihe expOSUE euo o e EHI NONE EUR UR VC 7 3 Alarms not affecting further exposures 8 CHECK AND CORRECTION OF POSSIBLE ERRORS IN DENTAL X RAYS 8 1 Typical faults in intraoral X EaySs s ce ine terree i Deu deba 8 2 Typical faults caused by wrong positioning eee 9 MAINTENANCE This publication can only be reproduced transmitted transcribed or translated into any human or computer langu
15. MED e Exposure time measurement Use a memory oscilloscope connecting the hot point of the sound to and the mass to TPGND Set the oscilloscope to wave form storage with the trigger on the positive side Select the required exposure time and make an exposure The exposure time is defined as the interval between the moment when Kv value goes above 75 of the stationary value and the fall under this value exposure time accuracy must be 5 or 2 ms if bigger When using non invasive tool such as a kVp time meter there may be a bigger error depending on the measurement tool used Rev 0 19 ENDOS DC CE USER S MANUAL Technical features 5 2 Curves tube features OCX 70 G Emission feature anodic current 1 5 2 0 2 5 3 0 3 5 filament voltage V Load anodic current 0 01 0 1 1 10 sec 100 exposure time ENDOS DC CE 20 Rev 0 USER S MANUAL VLL Technical features ME Curve anode cooling 150 W 120 W 6 90 W kJ 70W Curve tubehead cooling 80 60 40 ul 20 0 0 100 200 300 400 time min Rev 0 21 ENDOS DC CE USER S MANUAL L MEDICAL Technical features 5 3 Standard and regulations ENDOS DC equipment complies with the following regulations EN 60601 1 IEC
16. Model 61614050 Diameter lt 6cm at FFD 30 cm S N 40XXYYYY Manufactured MMMM YYYY PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J sco IN EFFECT AT DATE OF MANUFACTURE LIA THIS PRODUCT COMPLIES WITH FDA RADIATION Rev ENDOS DC CE USER S MANUAL Description 4 2 1 Functions ENDOS DC ENDOS DC 15 able to produce excellent quality X rays thanks to parameters repeatability and has very short exposure times and a very small focal spot ENDOS DC X ray equipment is compatible with VDEORADIOGRAPHY equipment systems Digital image acquisition equipment and incorporates the latest digital X ray intraoral technology If you do not possess VIDEORADIOGRAPHY equipment you are recommended to use high speed films or EKTASPEED films Kodak in order to limit the dosage absorbed by the patient The working mode can be selected using the control keyboard with the possibility of choosing between two films of a different speed sensibility the digital sensor or a mode that can be customised by the user called Custom ENDOS DC equipment can use the optional 30cm collimator cone to be ordered separately with 6161405000 code the change from standard cone 20 cm to 30 cm cone or vice versa is possible using a special key the long cone inserted selection is displayed by the LED 23 start up The change from standard cone 20 cm to long cone 30 cm is made by touching keys film speed 13 and increase 2
17. S MANUAL L General use instructions MEDICAL 6 3 2 Anatomical preset exposure When the previous exam was performed in manual exposure to go to preset exposure just press one of the anatomic selection keys In preset mode it is possible to vary the size key 3 and the type of tooth key 7 By pressing the size key 3 which emits an acoustic signal you can change the patient size selection Large patient 4 Normal patient 5 Small patient 6 Use key 7 to vary the selection of the tooth type Each time this key is pressed the type of tooth selected is displayed visually by the LEDs 8 to 12 Based on the selected film type preset exposure time are given in Table 1 emer mme LED14 LED15 Size Large Normal Small Large Normal Small Table 1 NOTE d m values reported above concern type D film film selection 1 LED 14 and type E film selection 2 LED 15 The above selection automatically chooses a 5mA anode current shown by the start up of LED 18 which guarantees good quality images with reduced exposure times ENDOS DC equipment is designed also to use ultra sensitive films speed F The possibility to select this film type can be configured by the Service Engineer at installation If you want to change the combination of films in use you must call the Technical Service to set up the proper configuration Rev 27 ENDOS DC CE USER S MANUAL General use instruct
18. S N 40XXYYYY Manufactured YYYY 20090 Buccinasco MILANO ITALIA 1b ENDOS DC label 120V version SISTEMI MEDICALI 20090 Buccina ENDOS DC Line 120 V Duty cycle 1 16 Manufactured MMMMYYYY 5 7 A 99 V 60 Hz Max exposure time 2 s X RAY CONTROL Model 8361300100 S N 25XXYYYY THIS PRODUCT COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J sco 0434 IN EFFECT AT DATE OF MANUFACTURE MILANO ITALIA DP arm label Manufactured by VILLA SISTEMI MEDICALI S p A 20090 Buccinasco MILANO ITALY Model 8161200702 Serial number 13XXYYYY Settled for ENDOS DC 4 Extension arm label Manufactured by VILLA SISTEMI MEDICALI S p A 20090 Buccinasco MILANO ITALY Model 8161200X02 Serial number 10XXYYYY 5b Tubehead label 120V version SISTEMI MEDICALI 20090 Buccina MILANO ITAI X ray beam 6 X RAY TUBE Manufacturer DIAGNOSTIC SOURCE ASSEMBLY Model ENDOS DC 8461400002 S N 35XXYYYY Output max 65kVp 5mA 2 sec m 0 7 IEC 336 Total filtration 22 mm Al at FFD 20 Model OCX 70 G Bologna Italy S N Manufactured THIS PRODUCT COMPLIES WITH FDA RADIATION PERFORMANCE STANDARDS 21 CFR SUBCHAPTER J IN EFFECT AT DATE OF MANUFACTURE VILLA SISTEMI MEDICALI 20090 BUCCINASCO MILANO 6b Collimator 30cm label optional 120V version BEAM LIMITING DEVICE
19. ack mA over upper limit Present until RX ON is active Current overload of filament Present until RX ON is active Anode overload Present until RX ON is active kV overvoltage signal Present until RX ON is active E 23 Found undesired emission RX ON present Present until RX ON is active RX ON drop before exposure end Present until RX ON is active WARNING Always switch the equipment off when an alarm appears and the buzzer is active In any case the back up timer will stop exposure ENDOS DC CE 44 Rev 0 USER S MANUAL L Error messages on the screen MEDICAL 7 3 Alarms not affecting further exposures Situations which do not directly affect the safety of the operator patient or equipment are considered as re settable anomalies The situation which caused the alert condition is always displayed by a flashing green LED and the corresponding error message which in these cases has the syntax The error condition prevents further exposures until it is reset by pressing any key in this case the display on the screen and keyboard reflects the last selection made Displayed ANOMALY type ACOUSTIC Message YP signaling A01 X ray button already pressed at the touch of any key Absent exiting IDLE ON status A02 X ray button release during exposure Present until RX ON is active A03 X ray button release during pre heating phase Absent 2 time not present yet WARNING In the event of an 2 si
20. age with the written consent of the Manufacturer This Manual is the English translation of the Italian original version ENDOS DC CE ii Rev O USER S MANUAL L Introduction MEDICAL 1 INTRODUCTION NOTA d manual is updated to the product status it is sold with to guarantee the user an adequate reference when using the equipment and for everything connected with its use safety The manual may not reflect product variations without any impacts on operative mode and safety The intraoral radiographic ENDOS DC produces high quality intraoral X rays thanks to the exam repetitiveness combined with reduced exposure times and the small dimensions of the focal spot ENDOS DC is designed exclusively for performing intraoral X rays The equipment has the following features e very good quality X rays pictures e user friendly e ergonomic design The purpose of this manual is to provide the user with instructions that will allow him to run the equipment safely and efficiently The equipment must be used according to the procedures in the manual and never for different purposes from the ones for which it has been designed 1 4 Icons in the manual Indicates a NOTE we recommend particular attention in reading the d subjects identified with this icon Indicates a WARNING subjects identified with this icon concern v safety aspects regarding the patient and or the operator Rev
21. aph 6 6 c Move the tubehead cone towards the patient and focus it exactly towards the tooth to X ray referring to the following Figures NOTE If you want to use the cone with rectangular collimator 35x45mm assemble it by clicking it onto the end of the present cone positioning it as requested Rev 31 ENDOS DC CE USER S MANUAL General use instructions LOWER JAW MANDIBLE INCISIVI incisors incisives PREMOLARI premolars pr molaires CANINI canines canines MOLARI molars molaires Figure 6 ENDOS DC CE 32 Rev O USER S MANUAL General use instructions MED UPPER JAW INCISIVI CANINI incisors canines incisives canines 20 PREMOLARI MOLARI premolars molars pr molaires molaires Figure 7 Rev 33 ENDOS DC CE USER S MANUAL General use instructions OCCLUSAL 65 0 HO HO MASCELLA MANDIBOLA upper jaw lower jaw machoire mandibule Figure 8 BITE WING RAGGIO CENTRALE main beam rayon central Figure 9 ENDOS DC CE 34 Rev 0 USER S MANUAL General use instructions MED 6 6 Exposure techniques This paragraph describes the different techniques generally used for intraoral exposure 6 6 1 Bisecting technique Incidence X ray beam
22. at the same time and it is indicated by the LED 23 In this selection pre set exposure times in anatomic selection are automatically increased by a multiplication factor equal to 2 Vice versa the change from long cone to standard cone is achieved by touching keys film speed 13 and decrease 1 at the same time WARNING ENDOS DC equipment does not automatically detect the presence of the type of cone it is the operator s responsibility to check that the luminous sign does actually indicate the true situation ENDOS DC CE 10 Rev 0 USER S MANUAL Description 4 2 2 High frequency generator or HF ENDOS DC is composed of a generator a tubehead including a collimator a CPU card or logic which controls the equipment functions and a keyboard used to select exposure parameters The standard configuration provides a keyboard directly connected to the CPU card while an optional configuration allows the keyboard to be set up in remote control in this case instead of the X ray button you can use the key provided directly on the keyboard itself The HF generator driven by remote control linked with the tubehead uses microcontroller technology know how to get very good quality X rays and at the same time reducing the X ray dose to the patient Conventional equipment generally uses the intrinsic skill of the RX generator tube to conduct electric current in only one way In this way you get the genera
23. f anaesthetic mixtures inflammable with air oxygen or nitrous oxide Equipment parts which may come into contact with the patient must be cleaned regularly according to the instructions given later in this document WARNING For safety reasons it is forbidden to overload the extension arm or the scissors arm in an anomalous way for example by leaning on them Rev 0 3 ENDOS DC CE USER S MANUAL Safety aspects 2 2 Protection from X rays Although dosage given by modern X ray equipment is low on average during the execution of the exposure the operator must take all precautions to protect the patient and himself in compliance with the regulations in force WARNING Protection from X ray radiation is regulated by law The equipment must be used by specialised personnel only a b 4 The film or the digital sensor must be put into the patient s mouth manually or using the appropriate supports If possible it must be held by the patient himself During X ray exposure the operator must not come into contact with the tubehead or the collimator cone During exposure the operator must be at a certain distance from the X ray source at least 2 metres in the opposite direction to X ray beam During exposure the operator and the patient are the only people allowed in the room The lead aprons should be used to reduce the undesirable effect of secondary radiation on the patie
24. gnal the X ray button has been released with considerable emission so the film must be replaced in order to obtain diagnostic images In the event of an AO1 signal you must release the X ray button if this is not pressed it identifies a breakdown so call the Technical Assistance service Rev 45 ENDOS DC USER S MANUAL Check and correction 8 1 CHECK AND CORRECTION OF POSSIBLE ERRORS IN DENTAL X RAYS Typical faults in intraoral X rays Too pale X rays Possible causes e Inadequate exposure to X rays short time e Inadequate development time e Damaged developer e Developer temperature lower than the requested value e Wrong dilutions of developing fluids e Too dark X rays Possible causes e Excessive exposure to X rays e Excessive development time e Developer temperature over the requested value e Wrong dilution of developing fluids e Out of focus X rays impossibility to see details Possible causes e The patient moved e The tubehead moved e X rays with fishbone marks Some intraoral films have a thin lead layer in the box with some fishbone marks engraved in the lower part These films can be exposed to radiation only on one side If the film is exposed to the wrong side the lead layer will absorb a large amount of radiation during exposure The result will be a lighter X ray and the film will show fishbone marks ENDOS DC CE 46 Rev USER S MANUAL A
25. in until you get the requested value A buzzer sounds every time a time variation is made it is also possible to make a quick variation of exposure times 4 units a second by keeping either keys 13 or 14 pressed for more than 2 seconds NOTE Exposure times can vary from a minimum of 0 01 seconds to a maximum of 2 seconds 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 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 5 Manual exposure times NOTE For exposure times lower than 0 04 s the lt 25 limit between the value of different selections is not observed EN60601 2 7 regulation Values lower than 0 10 s are generally used with digital sensors Rev 0 29 ENDOS DC CE USER S MANUAL General use instructions Modification of customisable table ENDOS DC has the possibility of customising anatomical exposure times to adapt them to the user s actual usage conditions This is possible by using a customisable table or custom shown on the keyboard of the corresponding symbol and LED 17 At the beginning the custom table is set to the same values as the digital table to access the table itself and modify it use the following procedure a b 4 Press the film selection key 13 to b
26. ions Exposure times for type F film are Film type F Large Normal Smali Premolars 0 12 0 09 006 Incisors canines Table 2 Exposure times for digital radiography LED 16 are given in Table 3 Digital sensor Size Large Normal Small Upper molars 0 15 006 premolars 009 006 006 Table 3 This selection automatically sets a value of 4 mA anode current signalled by the corresponding LED 19 NOTE This selection is designed for the use with a CCD type sensor if a sensor with a different sensitivity is in use for instance permanent phosphorus sensor this can be configured by the Service Engineer at installation or during a service call Phosphorous sensor times are given in Table 4 Phosphorous sensor nage Normal Table 4 ENDOS DC CE 28 Rev USER S MANUAL General use instructions MED 6 3 3 Manual exposure ENDOS DC makes it possible to work not only in the anatomic mode already described above but also in the manual mode To access the manual mode just press one of the two keys increase 2 or decrease 1 In this way the system exits the automatic exposure times selection mode by switching off the LED corresponding to the type of tooth and size The alphanumeric display 22 will show the last automatic selected time mode to vary it just press the decrease or increase keys aga
27. nt ENDOS DC CE 4 Rev 0 USER S MANUAL Safety aspects ME 2 3 Environmental risks and disposal Some parts of the equipment contain material and fluids which must be disposed of in special areas designated by the local health authorities at the end of the equipment s life cycle In particular the equipment contains the following materials and or components e Tubehead external packages in non biodegradable plastic dielectric oil lead copper brass aluminium resin tungsten beryllium e Power supply and remote control external packages in non biodegradable plastic iron copper plastic reinforced by fibre glass e Tubehead extension iron aluminium copper NOTE 8 me Manufacturer and the Distributor do not accept any responsibility for the disposal of equipment or parts discarded by the user and the related costs Rev 0 5 ENDOS DC CE USER S MANUAL Safety aspects 2 4 Symbols in use The following symbols are used in this manual and on ENDOS DC Equipment with Type B applied parts aa Alternate current Connecting point to the neutral conductor Connecting point to the live conductor Protection ground Functional ground OFF equipment not connected to the electric line EE NK ON equipment connected to the electric line Permission key to exposure the permitted exposure status is displayed by switching on the corresponding green symbol Focal spot
28. nt Normal patient Thin patient Large patient selection LED Normal patient selection LED Small patient selection LED Automatic tooth selection key Automatic Bite wing selection LED Upper molars automatic selection LED Lower molars automatic selection LED Pre molars automatic selection LED Incisor canine automatic selection LED 13 14 15 16 17 18 19 20 21 22 23 24 Film type selection key Type 1 film selection key Type 2 film selection key Digit radiovideography selection LED Customisable selection LED Custom 5 mA anodic current selection LED 4 mA anodic current selection LED Emission underway warning LED Ready for X rays warning LED to indicate that you can the emission procedure by pressing the appropriate button 3 digit exposure time display Long cone inserted warning LED X rays key Rev 0 41 ENDOS DC CE USER S MANUAL L Error messages on the screen MEDICAL 7 ERROR MESSAGES ON THE SCREEN ENDOS DC is completely controlled by a microprocessor which not only controls the programming of emission parameters but also identifies the different machine statuses and possible anomalies and errors on the screen by means of coded messages The following tables illustrate the meaning of the various messages which might appear on the screen and also explains their cause and remedies Error messages are divided into three different groups classified according to the
29. patient holds the support itself near the teeth Various types of supports are available on the market to match the different types of teeth This technique enables you to get more accurate and more easily repeatable X rays compared with the bisecting technique see Figure 13 and Figure 14 HORIZONTAL SECTION Figure 13 VERTICAL SECTION Figure 14 Rev 37 ENDOS DC CE USER S MANUAL General use instructions 6 7 Execution of exposure WARNING In standard configuration i e with wall assembly the X ray button 24 on the keyboard is disabled for safety reasons In fact if enabled the user would not be able to move away from the equipment and to go outside the radius of the primary X ray beam In this configuration only the X ray button provided with extensible spiral cable can be used The keyboard X ray key can be used only for remote keyboard installations Only authorised personnel can enable the implementation of this feature a b c d e Set exposure time as described in paragraph 6 3 Move as far away as the X ray button cable will allow in the opposite direction to emission Press the X ray button holding it pressed for the whole exposure The start of the exposure is shown both visually by the X ray signal LED 20 and acoustically by an uninterrupted buzzer At the end of the exposure three horizontal segments appear on the screen representing the
30. play actually corresponds to the true conditions of the equipment 6 2 2 Change from FFD 30 cm to FFD 20 cm This is achieved by pressing the film speed 13 and decrease 1 keys The long cone selection LED 23 is switched off WARNING Ww The equipment does not automatically detect when a standard or long cone is being used so it is the user s responsibility to check that the visual display actually corresponds to the true conditions of the equipment Rev 0 25 ENDOS DC CE USER S MANUAL General use instructions 6 3 1 Preset Manual exposure It is possible to choose whether to work in pre set selection or anatomical i e with the values pre set by the manufacturer according to the size and the type of tooth or whether to perform an exposure manually i e with the possibility of varying the pre set times In anatomical selection it is possible to select the receptor type used different film types or digital radiography Selection of receptor type for anatomic exposure mode The device allows to select the type of receptor used 4 selections are possible through key 13 which toggles the selections among LED 14 15 16 and 17 Selections 14 and 15 are set for film types D and E Selection 16 is for digital radiography Selection 17 allows to use preselected exposure times configured directly by the customer see paragraph 6 4 ENDOS DC CE 26 Rev 0 USER
31. red emissions Accidental exposure is in any case interrupted by the generator s safety system this happens before a real hazard occurs for the patient and or operator The ENDOS DC system is designed to display the delivered dose in the last exposure This function can be switched on by configuring the system and can be modified by the service technician The value of the delivered dose is displayed at the end of the exposure and remains on the screen for a period of 5 seconds after this time the system returns to the controls waiting condition or tube cooling condition without any display WARNING The dose displayed on the screen expressed in mGy is calculated according to an empirical parameter calculated with type tests performed on some equipment representative of the normal production and is an approximate value that may vary even by 25 compared with the value of the dose actually delivered THE DELIVERED DOSE VALUE IS CALCULATED AT 20 cm FROM THE FOCAL POINT AND IS THEREFORE VALID ONLY FOR STANDARD 20 cm CONE Rev 0 39 ENDOS DC CE USER S MANUAL General use instructions THIS PAGE IS INTENTIONALLY LEFT BLANK ENDOS DC CE 40 Rev 0 USER S MANUAL General use instructions J O g 10 11 12 Command keyboard Figure 15 Command key Key for manually decreasing exposure times Key for manually increasing exposure times Anatomic selection key Large patie
32. ring the choice on custom 17 if not already selected press at the same time keys 13 and 7 to enter editing mode of the custom exposure times The editing condition is shown by the custom LED flashing 17 the time for the selected tooth size combination is displayed on the display in flashing mode the anode current LED in use is flashing Pressing the size selection key 3 or tooth selection key 7 will show the relevant exposure time blinking for the combination time is modified using increase 2 or decrease keys 1 Pressing at the same time the film selection key 13 and increase 2 or decrease key 1 changes the anodic current to be used for that size tooth combination as shown by the anodic current blinking Repeat the steps b and c to change other times in the table Confirm the set conditions by pressing the main X ray button or key When the display LED stops flashing this means that storage has been completed To exit the configuration of the customized table without storing data it is necessary to turn off the device ENDOS DC CE 30 Rev O USER S MANUAL General use instructions MED 6 5 Preparation of the tubehead a Set the tubehead with an angle suitable for the exposure and positioning requested see Figure 6 Figure 7 Figure 8 Figure 9 b Put the film into the patient s mouth according to the chosen way bisecting or parallel For this purpose see paragr
33. rns to the waiting condition In this case if you want to take an exposure press one of the anatomic selection key again Pressing one of the anatomic selection keys enables the toggle of the corresponding choices Exposure will be activated by keeping the X ray button pressed When setting up the remote keyboard optional exposure can be controlled by the key located on the keyboard itself ENDOS DC CE 24 Rev 0 USER S MANUAL L General use instructions MEDICAL NOTE procedures shown the following paragraphs refer to Figure 15 at the end of this chapter To look up this picture easily open the page to read it while reading the other pages of the manual 6 2 Special keyboard functions ENDOS DC keyboard is designed to facilitate selection operations so normally you must touch one single key to select a function on the other hand pressing a combination of two keys simultaneously gives access to special functions such as 6 2 1 Change from Focus Film Distance FFD 20 cm to FFD 30 cm This is achieved by pressing the Film speed and Increase keys at the same time When 30 cm FFD is selected the exposure time values selected are multiplied by the multiplication value 2 The long cone LED signal switches on 23 WARNING Ww The equipment does not automatically detect when a standard or long cone is being used so it is the user s responsibility to check that the visual dis
34. s not perpendicular to the bisecting line of the angle formed by the longitudinal axis of the tooth and by the film X rays with extended apex of the tooth Probably caused by excessive folding of the film in the patient s mouth ENDOS DC CE 48 Rev 0 USER S MANUAL Maintenance 9 MAINTENANCE Like all electrical equipment this unit requires not only correct use but also maintenance and checks at regular intervals This precaution will guarantee that the equipment works safely and efficiently Periodic maintenance consists in checks carried out directly by the operator and or by the Technical Service The operator can carry out the following checks himself check the labels are intact and well attached check there are no oil marks on the tubehead check the remote control cable is not broken or scratched check there are no external damages to the equipment which could make it unsafe in terms of protection from radiation check the scissors arm balance check that the X ray beam is centred check proper functioning of X ray exposure LED and exposure buzzer WARNING If you find irregularities or damages the operator must inform the Technical Service immediately Rev 0 49 ENDOS DC CE USER S MANUAL LL SISTEMI MEDICALI MAINTENANCE OPERATIONS RECORD Installation Date ot da eRe Maintenance Pater Las SAUS aaa
35. sion to mobile stand version is not provided Figure 2 Tubehead Scissors arm Mobile stand Timer with high frequency generator a A A OU Nme X ray button Rev 0 13 ENDOS DC CE USER S MANUAL ex Description 4 3 3 Remote keyboard configuration It is possible to get a remote keyboard configuration outside the exam room Moreover the apparatus provides two separate contacts for connection with external signaling devices One contact signals the equipment is ON and ready for use while the second one signals the presence of X rays The connection mode and the necessary signal device requirements are reported in the Service Manual NOTE In this configuration you are recommended to install the remote keyboard in a place that is reserved for the exclusive use of specialised technical personnel and not in a place that is accessible to unauthorised persons Figure 3 Tubehead Scissors arm Extension arm High frequency generator a AO N Remote timer ENDOS DC CE 14 Rev 0 USER S MANUAL L Technical features MEDICAL 5 TECHNICAL FEATURES Technical features Equipment ENDOS DC Manufacturer VILLA SISTEMI MEDICALI Buccinasco MI Italia Class Class P with type B applied EN 60601 1 classification Protection level Standard apparatus IP20 Line frequency 50 60 Hz Rated current 0 2 Arms 0
36. tion of a train of RX pulses Vice versa ENDOS DC apparatus uses the constant tension technology generating a continuous and steady exposure Moreover the emission of soft X rays is so small that it ensures that emission parameters kVp and mA are constant throughout exposure time The control microprocessor ensures that exposure times remain constant and that they can be repeated exposure voltage and exposure times depending on the patient s size and the selected tooth can be selected simply by pressing a key The HF tubehead is much smaller thanks to the back positioning of the X ray tube the length is only 27 cm while the focus skin distance remain at the standard 20 cm Because the tubehead is so light only 4 5 Kg the arm is remarkably easy to handle Rev 0 11 ENDOS DC CE USER S MANUAL Description 4 3 1 Configurations Standard configuration ENDOS DC is manufactured in standard configuration 9461000013 code composed of the parts defined in the following picture Figure 1 Tubehead Scissors arm Extension arm Timer with high frequency generator a BO N X ray button ENDOS DC CE 12 Rev 0 USER S MANUAL Description MEDICAL 4 3 2 Mobile stand configuration ENDOS DC can be assembled on a mobile stand this configuration gives greater flexibility of use NOTE d me mobile stand version must be requested when ordering The conversion from wall ver
37. tools for instance the kVp t meter is acceptable even though it usually gives a less accurate result In fact measuring the high tension tube value using non invasive tools is strictly correlated to the method chosen by the manufacturer of the tool himself generally this method is less accurate than the direct method and it may also require two consecutive exposures Similarly anode current measurement using the indirect method is affected by systematic errors as it is very often based on the current time product measurement dividing the measurement by the time measured by this method The logic card CPU has 3 test points TP kV TP mA and TP GND to which the tool used for the measurement is connected typically a digital multimeter with an entry resistance of more than 10 or memory oscilloscope High tension value to the tube Connect the positive prod on and the negative one on TPGND select a 1 s exposure time and read the value measured by DVM considering 1VDC 20 kV you must measure a 3 25 VDC 160 mV 3 09 3 41 value Anode current value Connect the positive prod on TPmA and the negative one TPGND select a 1 s exposure time and read the value measured by DVM considering 1VDC 2 mA you must measure a 2 5 VDC 125 mV 2 375 2 625 V value for 5 mA anode current while for 4 mA you must have 2 V DC 100 mV 1 9 2 1 V ENDOS DC CE 18 Rev 0 USER S MANUAL Technical features
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