Transcription

1 WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. ebiflabkq=s~êáç lééê~íáåö=fåëíêìåíáçåë===== = båöäáëü xposure times - with Cone 8 SS Temps d exposition - avec localisateur 8 FP Aufnahmezeiten - mit Tubus 8 FHA Tiempos de exposiciòn - con localizador 8 FP mA 70 kvp S igital X-RAY HLIONT Vario V3 (120V)

2 Sirona ental Systems GmbH Operating Instructions HLIONT s~êáç ear customer, Thank you for purchasing your ebiflabkq=s~êáç. Intraoral radiography can be performed with this unit. The technical documents supplied are a part of this product: Operating Instructions, Installation Instructions, Installation Report / Warranty Passport and On-site Installation. Keep these documents nearby for quick and easy reference at all times. In order to protect your warranty rights, please fill out the System Report / Warranty Passport provided together with the service technician. Read the Operating Instructions to familiarize yourself with the product before taking X-rays on the patient. Always be sure to observe the currently valid Radiation Protection Guidelines and the Safety Notes in these Operating Instructions. Your HLIONT team Maintenance To ensure the safety and health of patients, operators and third parties, inspections and maintenance calls must be carried out at the specified intervals in order to guarantee the operational safety and functional reliability of your product (IC / IN N etc). It is the responsibility of the operator to ensure that the required inspections and maintenance work are carried out. In the event that the operator fails to fulfill the obligation to carry out inspections and maintenance or ignores error messages, Sirona ental Systems GmbH and/or its authorized dealers can not assume liability for any damage attributable to this This product is provided with a C marking in accordance with the regulations stated in the irective 93/42/ C of June 14, 1993 concerning medical products

3 Sirona ental Systems GmbH HLIONT s~êáç Contents Contents 1 Warning and safety information Technical escription Controls and display elements Accessories Operating Preparing an exposure Switching the unit ON Selecting the radiographic technique Setting the exposure data Positioning the patient/x-ray tube unit Bite-wing exposure Releasing an exposure xposure times Recommended exposure times xposure times using tube with 8" source-skin distance (SS) - class film xposure times using tube with 12" SS - class film xposure times using tube with 8" source-skin distance (SS) - class film xposure times using tube with 12" SS - class film xposure times using tube with 8" SS - Sirona full-size/universal X-ray sensor xposure times using tube with 12" SS - Sirona full-size/universal X-ray sensor Care and maintenance of unit List of error codes Inspection and maintenance Annual inspection performed by the operator or other authorized personnel Maintenance performed by the service technician Checking image quality

4 1 Warning and safety information Sirona ental Systems GmbH HLIONT s~êáç 1 Warning and safety information Warning and safety information Symbols used Proper use General safety information Modifications to the system isturbance of electronic equipment worn by the patient. Radiation protection To prevent personal injury and damage to property, please observe the warning and safety information provided in these operating instructions. They are highlighted with a warning symbol and with the word "ATTNTION". Observe accompanying documents (on name plate) This unit has been designed for use in creating intraoral radiographic exposures. The unit must not be used in areas where there is a risk of explosion. Improper use or stress (e.g. hard contact of the tube assembly / support arm with another object, overextension of the support arm) may cause damage to the X-ray equipment or the support arm. In such cases, an inspection of the X-ray system must be performed by a service engineer. Patient X-ray exposures may be performed only when the unit is functioning flawlessly, this means, e.g. even, jolt-free and silent movement of the support arm. The patient must not be left unattended at the unit. Modifications to this system which could impair the safety of operators, patients or third persons are prohibited by law! For reasons of product safety, this product may be operated only with original Sirona accessories or thirdparty accessories expressly approved by Sirona. The user is responsible for dangers resulting from the use of non-approved accessories. To prevent the malfunction of electronic devices and loss of stored data in connection with radio controlled clocks, telephone cards, etc. all such items must be removed from the patient prior to the X-ray exposure. The applicable radiation protection regulations must be observed. The prescribed radiation protection accessories must be used. If the release button is connected with a cable, the operator must leave the vicintiy of the X-ray tube unit before releasing an exposure. No one except the patient may remain in the exposure room. In exceptional cases a third party who is not a member of the practice staff may assist the patient. Visual contact with the patient and the unit must be maintained during every X-ray exposure. In case of malfunction, interrupt the exposure immediately by letting go of the release button

5 Sirona ental Systems GmbH HLIONT s~êáç 1 Warning and safety information lectromagnetic compatibility (MC) isposal The HLIONT s~êáç complies with the requirements of IC :2001. Medical electrical devices are subject to special precautionary measures regarding MC. They must be installed and operated as specified in the document "Installation Requirements". Portable and mobile HF communication devices can influence medical electrical equipment. The use of mobile telephones in the practice or hospital area therefore must be prohibited. It applies generally that the national regulations have to be complied with when disposing of this product. Please observe the regulations applying in your country. Within the uropean conomic Community the directive 2002/96/C (W) for electrical and electronic devices requires environmentally compatible recycling / disposal. Your product is marked with the adjacent symbol. With the goal of environmentally compatible recycling / disposal, your product must not be disposed of with the domestic refuse. The black bar under the "refuse bin" symbol means that it has been put onto the market after (See N 50419:2005) Please note that this product is subject to the directive 2002/96/C (W) and laws applicable in your country and must be sent for environmentally compatible recycling / disposal. The X-ray tube assembly of this product contains a tube with a potential implosion hazard, a lead lining and mineral oil. Please contact your dealer if your product should be finally disposed of. ismantling and reassembly When dismantling and reassembling the unit, always proceed as outlined in the instructions for reassembly. This is necessary to ensure correct unit function and stability

6 2 Technical escription Sirona ental Systems GmbH HLIONT s~êáç 2 Technical escription Technical ata Nominal voltage: Permissible line voltage fluctuations: Nominal current: Rated line frequency: Power line resistance: House wiring fuse: Power requirement: Tube voltage: Tube current: High-voltage curve: 220V / 230V / 240V or 100V / 110V / 120V + 6% 10% (230V), ± 10% (100, 110, 120, 220, 240V) at 230V: 6A at 100V: 9.5A 50Hz / 60Hz at 220V - 240V: 0.95 Ohm at 100V - 120V: 0.3 Ohm 16A < 1.5kW 70kV 7mA Monopulse X-ray tube Radiation times: 30ms 3.2s Mark-to-space ratio: 1:30 (radiation-time-dependent overheating protection) Total filtration in X-ray tube unit: > 2mm Al / 70 kv IC /1999 Focal spot size acc. to IC 336: Focal spot mark: 0.8mm SS 8 (203mm) or 12 (305mm) = source-skin distance iameter of radiation field at tube end: Type of protection against electric shock: egree of protection against electric shock: < 60 mm Protection class I Type B egree of protection against penetration of water: Conventional unit (w/o protection against penetration of water) Year of manufacture: (on the rating plate) Operating mode: Continuous power rating: Rating (70kV, 7mA) Continuous operation 17W max 490W max

7 Sirona ental Systems GmbH HLIONT s~êáç 2 Technical escription Technical ata Anode material: xposure data to determine leakage radiation: Leakage radiation Operating conditions (compliant with IC 601-1) Transport and storage conditions (compliant with IC 601-1) Tungsten ma/70kv < mgy/h Ambient temperature: 10 C 40 C (50 F 104 F) Relative humidity: 30% 75% Temperature: -40 C +70 C (-40 F 158 F) Relative humidity: 10% 95% HLIONT s~êáç has been inspected by the V Testing and Certification Institute for compliance with: IC IC / 1993 IC / 1994 IC / 1998 HLIONT s~êáç has been found to comply with these regulations. Original language of Operating Instructions: German Cool-down curve for X-ray tube housing Joule x t (min)

8 2 Technical escription Sirona ental Systems GmbH HLIONT s~êáç Cool-down curve for X-ray tube Joule t(min) Warm-up curve for X-ray tube housing Joule x t (min) Illumination Focal spot mark Central ray Anode angle

9 WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. Sirona ental Systems GmbH 3 Controls and display elements 3 Controls and display elements 8 12 xposure times - with Cone 8 SS Temps d exposition - avec localisateur 8 FP Aufnahmezeiten - mit Tubus 8 FHA Tiempos de exposiciòn - con localizador 8 FP mA 70 kvp S igital X-RAY HLIONT Vario * Power switch 2. Standby (ready) indicator lamp (L) 3. X-radiation indicator lamp (L) 4. igital exposure time display 5. Time selector with integrated digital mode button, control switch for canceled exposures. 6. igital mode indicator lamp 7. Release button 7* optional left-hand or right-hand release button; may also be combined as release button with 2nd safety button located on the other side 8. Timer box 9. Scale for setting angle of inclination 10. X-ray field limitation device, rotatable (Option) 11. X-ray tube unit 12. xposure time table

10 4 Accessories Sirona ental Systems GmbH 4 Accessories 1 1. Test specimen for constancy test for conventional radiographic technique Order no Test specimen for constancy test for universal and full-size sensors Order no mA 70 kvp S xposure times - with Cone8 SS Aufnahmezeiten - mit Tubus 8 FHA Tempsd exposition - avec localisateur 8 FP Tiempos de exposiciòn -conlocalizador 8 FP igital X-RAY WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited Tube extension to 12" SS Order no X-ray field limitation blue with twist grip for Full Size sensor and for conventional radiographic technique 3x4 cm Order no X-ray field limitation black with twist grip for Universal sensor and for conventional radiographic technique 2x3 cm Order no Sensor holder set with sighting rings and guide rods manufactured by NTSPLY RINN Sirona order no.: i NOT Not all of the accessories shown here are included in the scope of delivery

11 Sirona ental Systems GmbH 5 Operating 5 Operating 5.1 Preparing an exposure 7mA 70 kvp igital 4 X-RAY 2 S xposure times - with Cone 8 SS Aufnahmezeiten -mit Tubus 8 FHA Temps d exposition - avec localisateur 8 FP Tiempos de exposiciòn - con localizador 8 FP WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. 5 6 ON OFF Switching the unit ON Set the main power switch to position I. When doing so, be sure not to turn or press the release button (7) or the time selector (5). After the power is switched on, a self-test executes for approx. 5 seconds and the software status is displayed. The exposure time set prior to the last exposure is then displayed. At the same time the standby indicator lamp (2) lights up. When the igital mode indicator (6) also lights up, the digital radiographic technique is selected (see next page). The unit is ready for operation. i NOT If an error is detected during the self-test, this will be indicated on the digital exposure time display (4) (see chapter entitled "List of error codes"). If the standby L (2) does not light up, the unit is not ready for operation! Switch the unit OFF and ON again. ATTNTION If the same error occurs again, please contact your service technician

12 5 Operating Sirona ental Systems GmbH Selecting the radiographic technique igital 6 7mA 70 kvp igital X-RAY WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure S xposure times - Aufnahmezeiten - 5 You can switch back and forth between the conventional and the digital radiographic technique by briefly holding down the time selector (5). The resulting reduction in the exposure time will then be displayed. If you are working with a digital radiographic system (e.g. SIXIS), the igital mode indicator lamp (6) on the unit must be illuminated. Use an X-ray field limitation for the digital radiographic technique. i NOT The recommended exposure times apply to full-size and universal SIXIS intraoral radiographic sensors. Other values apply when using radiographic sensors from other manufacturers. Conventional 7mA 70 kvp igital X-RAY S xposure times - Aufnahmezeiten If you want to take conventional (film) exposures, the igital mode indicator (6) must not be illuminated. You can switch back and forth between the conventional and digital radiographic technique by briefly holding down the time selector (5). The igital mode indicator (6) then switches off. The exposure time for conventional exposures is then displayed. WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure

13 Sirona ental Systems GmbH 5 Operating a b c d Setting the exposure data xposure times Set the determined exposure time according to the table printed on the label or turn the time selector (5) manually. 14 / 16 different steps, each of which is digitally displayed, can be selected with the time selector. Turn the selector knob clockwise to increase and counter-clockwise to decrease the exposure time. a Values displayed for the conventional (film) radiographic technique using a 50 Hz unit. b Values displayed for the digital radiographic technique with SIXIS Intraoral and a 50 Hz unit. c Values displayed for the conventional (film) radiographic technique using a 60 Hz unit. d Values displayed for the digital radiographic technique with SIXIS Intraoral and a 60 Hz unit. Recommended setting values mpfohlene Recommended Aufnahmezeiten exposure times bei with 8 Tubus 8" tube xposure times - with Cone 8 SS Aufnahmezeiten -mit Tubus 8 FHA Temps d exposition - avec localisateur 8 FP Tiempos de exposiciòn - con localizador 8 FP 0.63 The table printed on the label next to the display field contains the values recommended for X-ray exposures of different teeth using the digital and conventional radiographic techniques for adults and children. Legend ient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. mpfohlene Recommended Aufnahmezeiten exposure times beiwith 12 Tubus 12" tube xposure times - with Cone 12 SS Aufnahmezeiten -mit Tubus 12 FHA Temps d exposition - avec localisateur 12 FP Tiempos de exposiciòn - con localizador 12 FP igital radiographic technique for SIXIS Intraoral (digital radiography) Conventional radiographic technique ( and films) = film sensitivity class = film sensitivity class Adult Child Mandibular front tooth ent and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. Mandibular bicuspid / canine tooth Maxillary front tooth Maxillary bicuspid / canine tooth and mandibular molar Maxillary molar

14 5 Operating Sirona ental Systems GmbH xample: Conventional (film ) radiographic technique with 8" tube Adult patient Maxillary molar xposure time: seconds 7mA 70 kvp igital xposure times -with Cone 8 SS Aufnahmezeiten -mit Tubus 8 FHA X-RAY S Temps d exposition - avec localisateur 8 FP Tiempos de exposiciòn - con localizador 8 FP 1.63 i NOT The exposure times of the digital and conventional exposures are separately programmed. The factory installed IGITAL programming is set for SIXIS. Conventional The recommended exposure data applies to Class film types such as Kodak kta Speed, Agfa-entus M2. For films of sensitivity class such as Kodak Ultra Speed. Film holder When using a film holder, set all values 1-2 steps higher. Conditions of film and processing Varying film and processing conditions may make it necessary to increase or decrease the setting by one step. See also Page 18 xposure time table T and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. xample: igital radiographic technique (SIXIS) with 8" tube Child Mandibular front tooth xposure time: 0.06 seconds 7mA 70 kvp igital xposure times - with Cone 8 SS Aufnahmezeiten -mit Tubus 8 FHA X-RAY Temps d exposition - avec localisateur 8 FP Tiempos de exposiciòn - con localizador 8 FP T and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited. S 0.63 igital The recommended exposure times apply to SIXIS intraoral X-ray sensors: Full-size and universal If other X-ray sensors, e.g. from other manufacturers, are used, it may be necessary to increase or decrease these settings. Make sure to comply with the manufacturer s recommendations. i NOT Line voltage compensation: specially with very short exposure times (e.g. with digital operation), line voltage fluctuations may lead to fluctuations in image density / quality. In order to remedy this problem, the service engineer (see Service Manual) can set a line voltage compensation in the timer box. This will prolong the preselected exposure time correspondingly in case of line voltage fluctuations, thus furnishing the desired image density. ose will remain constant in this case. The actual exposure time will be displayed for approx. 8 seconds. After that, the exposure time display will automatically return to the originally selected exposure time. Positioning the patient/x-ray tube unit

15 Sirona ental Systems GmbH 5 Operating 5.2 Positioning the patient/x-ray tube unit Adjust the X-ray tube unit Have the patient sit down on the chair. Right-angle technique (with X-ray field limitation) Position the film or X-ray sensor using a holding system. When employing the right-angle technique, the X-ray sensor should be used only with holders designed for use with our sensor holder. Always follow the Operating Instructions for intraoral radiography supplied with SIXIS. 45 angle technique (without X-ray field limitation) The film or X-ray sensor must be held by the patient. i NOT The sensor should be placed in a new hygienic protective cover prior to each application on a new patient! The protective sanitary covering is not shown in the illustrations for the sake of clarity. Angle of inclination xposure tube for the occlusal plane HLIONT Vario Supramaxillary teeth Molars 35 Bicuspids and canine teeth 45 Front teeth 55 Bite-block exposure 80 Bite-block exposure -90 Front teeth -20 Bicuspids and canine teeth -10 Molars -5 Submaxillary teeth

16 5 Operating Sirona ental Systems GmbH 5.3 Bite-wing exposure Bite-wing exposure settings are the same as for submaxillary exposures. xample with 8" SS tube for a conventional (film) exposure: 7mA 70 kvp igital X-RAY S Adult, tooth in bicuspid region, exposure time: s. xposure times - with Cone 8 SS Aufnahmezeiten -mit Tubus 8 FHA Temps d exposition - avec localisateur 8 FP Tiempos de exposiciòn - con localizador 8 FP T and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited

17 Sirona ental Systems GmbH 5 Operating 5.4 Releasing an exposure 7mA 70 kvp igital X-RAY S xposure times - with Cone 8 SS Aufnahmezeiten -mit Tubus 8 FHA Temps d exposition - avec localisateur 8 FP Tiempos de exposiciòn - con localizador 8 FP WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed. Unauthorized use is prohibited Not removable in USA/CAN 0.63 ATTNTION Observe radiation protection regulations, see page 4. Check for correct exposure data. The standby indicator lamp (2) is illuminated. Release exposure by holding down the release button (7). The X-RAY L (3) remains lit up during the entire exposure. The exposure time is also indicated by an acoustic signal. uring operation by remote control, the L (3) on the remote control is also lit up. The exposure is finished when the radiation automatically switches off. The Ready L (3) remains switched off until the automatic tube cooling delay has expired (automatic exposure interlock). xample: For s exposure time and a pulse-topause ratio of 1 : s automatic exposure blocking results. Interrupting an exposure The exposure can be interrupted by simply letting go of the release button. The elapsed exposure time will then flash together with the Ready L. If you then press the time selector (5), the elapsed exposure time will stop flashing and the previously set exposure time will reappear on the display. The unit is again ready for operation following the automatic tube cooling delay. Repeat the exposure. Insert a new film cassette before taking another film exposure. The unit may remain switched on until you have finished working. Remote control rror message If an error or fault is detected during an exposure, the exposure will be automatically interrupted. The error code will then appear on the digital display and the Ready L will simultaneously switch off

18 xposure times 6.1 Recommended exposure times 0,04 0,06 0,07 0,09 0,11 0,13 0,16 0,20 0,25 0,32 0,40 0,50 0,63 0,80 1,00 1,25 1,60 2,00 2,50 3, xposure times using tube with 8" source-skin distance (SS) - class film Seconds ,16 0,20 0,25 0,20 0,25 0,32 0,20 0,25 0,32 0,20 0,25 0,32 0,25 0,32 0,40 0,32 0,40 0,50 Supramaxillary Submaxillary 6.3 xposure times using tube with 12" SS - class film For films of sensitivity class F: set one step lower. xample: select s instead of s. Set 1-2 steps higher when using a film holder. Supramaxillary Submaxillary Seconds 0,32 0,40 0,50 0,32 0,40 0,50 0,40 0,50 0,63 0,40 0,50 0,63 0,40 0,50 0,63 0,50 0,63 0,80 0,63 0,80 1,00 Supramaxillary Submaxillary Supramaxillary Submaxillary 6 xposure times Sirona ental Systems GmbH

19 xposure times using tube with 8" source-skin distance (SS) - class film Seconds 0,25 0,32 0,40 0,32 0,40 0,50 0,32 0,40 0,50 0,32 0,40 0,50 0,40 0,50 0,63 0,50 0,63 0,80 Supramaxillary Submaxillary Supramaxillary Submaxillary 6.5 xposure times using tube with 12" SS - class film Seconds 0,50 0,63 0,80 0,50 0,63 0,80 0,63 0,80 1,00 0,63 0,80 1,00 0,63 0,80 1,00 1,00 1,25 1,60 1,25 1,60 2,00 Supramaxillary Submaxillary Supramaxillary Submaxillary Sirona ental Systems GmbH 6 xposure times

20 IMPORTANT: The following two tables list examples for exposure times based on Sirona full-size and universal X-ray sensors. When using other X-ray sensors, please take the exposure times from the applicable operating instructions for these sensors. 6.6 xposure times using tube with 8" SS - Sirona full-size/universal X-ray sensor Seconds 0,04 0,06 0,07 0,04 0,06 0,07 0,06 0,07 0,09 0,06 0,07 0,09 0,06 0,07 0,09 0,07 0,09 0,11 0,09 0,11 0,13 Supramaxillary Submaxillary 6.7 xposure times using tube with 12" SS - Sirona full-size/universal X-ray sensor NOT: ifferent density intervals apply to radiation times < 0.07! Supramaxillary Submaxillary Seconds 0,09 0,11 0,13 0,09 0,11 0,13 0,11 0,13 0,16 0,11 0,13 0,16 0,11 0,13 0,16 0,13 0,16 0,20 0,16 0,20 0,25 Supramaxillary Submaxillary Supramaxillary Submaxillary 6 xposure times Sirona ental Systems GmbH

21 Sirona ental Systems GmbH 7 Care and maintenance of unit 7 Care and maintenance of unit Cleaning Remove dirt, grime and disinfectant residue with mild, household detergent. o not allow fluids to enter the ventilation slits! Any medicinal agents accidentally spilled onto surfaces should be wiped off immediately. isinfecting isinfect using either spray-on or wipe-on surface disinfectants. Be sure to observe all instructions and restrictions specified by the manufacturer. Use only tested and approved agents! Never use: agents containing active ingredients or additives such as carbolic acid, peracetic acid, peroxide or other oxygen-cleavng agents, sodium hypochlorite or any iodine-cleaving agents. Caring for the film holder Please observe the hygiene instructions of the film holder manufacturer. Caring for the SIXIS sensor holder system Please observe the disinfection and sterilization instructions of NTSPLY RINN

22 8 List of error codes Sirona ental Systems GmbH 8 List of error codes rror code escription Corrective action.01 Release button was pressed during switch-on phase..02 Time switch was pressed during switchon phase. Switch unit OFF and ON again. Switch unit OFF and ON again..03 Line voltage outside permissible range. Switch unit OFF and ON again..05 Power frequency outside permissible range. Switch unit OFF and ON again..09 Internal alarm circuit tripped. Switch unit OFF and ON again. ATTNTION If an error is displayed again after switching the unit off and then on again, please contact your service technician

23 Sirona ental Systems GmbH 9 Inspection and maintenance 9 Inspection and maintenance Inspection and maintenance work must be performed at regular intervals to protect the safety and health of patients, users and third parties. 9.1 Annual inspection performed by the operator or other authorized personnel As the operator, you should ensure the safety and reliability of your system by performing maintenance on it at regular intervals (at least once annually) or having this work performed by your dental dealership. The information in the document Inspection and maintenance supplied will be of help to you here. 9.2 Maintenance performed by the service technician In addition to the scheduled annual inspection by the user or persons contracted to perform this, a maintenance inspection must be performed after 4, 7 10 and then every two years. The information in the document Inspection and maintenance supplied will be of help to the service technician here. 9.3 Checking image quality At regular intervals, however at least once a year, the user must evaluate the image quality. With the use of digital image receptors, the increase in image post-processing effort making use of the brightness or contrast control (e.g. for SIXIS) can be taken as an evaluation criterion. For X-rays requiring developing of films, an increase in the exposure time serves as the evaluation criterion. If these evaluation criteria are fulfilled independently of the patient anatomy and of possible sources of error, such as developing of film or patient positioning, contact a service technician immediately in order to eliminate possible unit faults. In addition it is necessary to observe country-specific requirements. Furthermore, we would like to call your attention to the brochures of film manufacturers and also to our Quality Image Service. For this, please contact your dental dealer or the manufacturer directly

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