VistaIntra DC. Installation and Operating Instructions L V010

Transcription

1 VistaIntra DC Installation and Operating Instructions L V010

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3 Contents Important information 1 Documentation Warnings and symbols Notes on copyright 2 2 Safety Intended use Incorrect use General safety notes Radiation protection Qualified personnel Protection against electrical current Only use original parts Transport Disposal 4 Product description 3 Overview Delivery Contents Special accessories Disposable materials 6 4 Technical data X-ray tube performance data Dimensions Model identification plate Note on Conformity 11 5 Function Control panel Exposure switch Radiation field collimation Wall mounting plate Adapter plate 14 Mounting 6 Prerequisites Area of installation Notes on electrical connections 15 7 Installation Attaching the appliance with the wall mounting bracket Secure unit with wall mounting plate Mount radiation field collimation Safety for the electrical connection Connecting the appliance to the power supply 17 8 Operation Acceptance test Electrical safety check Switch unit on Service menu settings 18 Usage 9 Instructions for use Standard settings on switch-on Positioning patient, X-ray unit and detector Activate exposure Cleaning and disinfecting 25 Trouble-shooting 11 Tips for Operators and Technicians 26 Annex 12 Information on EMC according to General notes Abbreviations Guidelines and manufacturer's information Table of calculation L V010 1

4 Important information 1 Documentation These Installation and Operating Instructions form an integral part of the unit. They conform to the relevant version of the equipment and the status of technology valid at the time of first operation. Dürr Dental cannot guarantee smooth operation and safe function of the unit and will not accept any liability where the instructions and notes contained in these installation and operating instructions are not strictly observed. This translation has been carried out in all good faith. The original German version is decisive. Dürr Dental accepts no liability for incorrect translation. 1.1 Warnings and symbols Warnings The warnings in this document are there to point out possible injury to persons or damage to machinery. The following warning symbols are used: General warning symbol Warning - dangerous electrical voltage Warning - X-rays The warnings are structured as follows: SIGNAL WORD Description of type and source of danger Possible consequences of ignoring the safety warning here Measures to be taken to avoid any possible danger. The signal word differentiates between different levels of danger: DANGER High risk of danger of serious injury or death WARNING Possible risk of danger of serious injury or death CAUTION Risk of danger of minor injuries NOTICE Risk of serious damage Further symbols These symbols are used within the documentation and on the unit itself: Notes, e.g. special instructions concerning economical use of the unit. Observe the accompanying documentation. CE mark UL Classification Manufacturer Date of manufacture Dispose of product correctly and in accordance with EU directive (2002/96/ EG-WEEE). Part type B EC REP Authorised EU representative Wear protective gloves Switch off the appliance (i. e. unplug and disconnect from mains). 1.2 Notes on copyright All circuits, processes, names, software and appliances quoted are protected under industrial property rights. Any reprinting of the technical documentation, in whole or in part, is subject to prior approval of Dürr Dental being given in writing L V010

5 2 Safety This unit has been so designed and developed that under normal and proper usage any possibility of damage or injury can be virtually ruled out. However, there is always a small margin of risk. Please observe the following instructions carefully. 2.1 Intended use This unit is designed solely for using intraoral x- rays in the examination and diagnosis of diseases and illnesses of teeth, jaw and the oral cavitiy. 2.2 Incorrect use Any use of this appliance above and beyond that specifically described in these instructions will be deemed to be as not according to the intended use. The manufacturer cannot be held liable for any damage resulting from incorrect usage. The user bears all risks. 2.3 General safety notes Before using the appliance observe any and all guidelines, laws, regulations and other restrictions which may apply to the appliance. Before each use check the function and condition of the appliance. Do not convert or change the appliance in any way. Observe the Installation and Operating Instructions precisely. Keep the Installation and Operating Instructions in an accessible place so that the operator has instant access to them. 2.4 Radiation protection Observe all mandatory current X-ray protection rules and take all necessary X-ray protection measures. Use the proscribed X-ray protection equipment. In order to reduce the amount of X-ray exposure, we recommend the use of bismuth, lead shielding or protective aprons, especially for children and teenagers. Any operative personnel must keep away from the X-ray unit when taking an exposure. The legally specified minimum distance must be maintained (e. g. Germany 1.5 m, Austria 2.0 m). Important information Children and pregnant women must consult a doctor prior to any X-ray. As well as the patient, any other person present in the X-ray room must wear X-ray protection. In exceptional circumstances a third party may be present to give assistance, but this must not be a member of the surgery personnel. Ensure visual contact with the patient and the unit during exposure. In the case of any interruption when taking an exposure, stop the procedure immediately by letting go of the release switch. 2.5 Qualified personnel Instructions for use Persons who operate the appliance must, on the basis of their training and knowledge, ensure safe and correct handling of the appliance. Ensure personnel are trained in the correct usage of the appliance. Installation and repair Installation, resetting, alterations, extensions and repairs must be carried out by Dürr Dental or by qualified personnel specifically approved and authorized by Dürr Dental. 2.6 Protection against electrical current When working on and with the appliance always observe the local electrical safety procedures. Never come into contact with patients and open plug-in connections on the appliance at the same time. Damaged supply lines and connections must be replaced immediately. 2.7 Only use original parts Only use accessories and special accessories stipulated or approved by Dürr Dental. Only use original working parts and spare parts. 2.8 Transport The original packaging offers the optimum protection for the appliance during transport. If required, the original packaging for the unit can be ordered at Dürr Dental L V010 3

6 Important information Dürr Dental cannot accept any liability for damage caused during transport by the use of unsuitable packaging, this is also valid during the warranty term. Only transport the appliance in its original packaging whenever possible. Keep the packing materials out of the reach of children. 2.9 Disposal Appliance Dispose of the appliance correctly. Within the European Union dispose of the appliance according to EU directive 2002/96/EG (WEEE). If you have any questions concerning correct disposal, please contact Dürr Dental or your usual dental supplier. X-ray unit The x-ray unit contains a tube which may implode, lead sheathing and mineral oil L V010

7 Product description 3 Overview Supporting arm 2 Scissor arm 3 Adapter plate (optional) 4 Wall mounting plate (optional) 5 Sundries 6 Exposure switch 7 Control panel 8 Control unit including wall mounting plate 9 Main power switch 10 Horizontal arm 11 Radiation field collimation 12 X-ray emitter L V010 5

8 Product description 3.1 Delivery Contents The following articles are included in the scope of delivery. Possible variations due to countryspecific requirements and/or import regulations are possible.: VistaIntra DC X-ray unit with short extension arm VistaIntra DC X-ray unit with medium extension arm VistaIntra DC X-ray unit with long extension arm X-ray emitter Scissor arm Horizontal arm Control unit with control panel Exposure switch and holder X-ray field collimation 3 x 4 Sundries Ferrite core Installation and operating instructions Installation instructions Drill template 3.2 Special accessories The following items can be optionally used with the unit: Image plate and film holder system set, colour Image plate and film holder system conversion set for endo-exposures, colour Wall mounting plate X-ray field collimation 2 x Tube extension 300 mm Covering plate for external control panel mounting Commissioning and intraoral constancy checks Test specimen Intra / Extra Digital Adapter plate Sirona Heliodent MD Sirona Heliodent DS Trophy Irix/CCX Planmeca Intra Trophy Elitys Disposable materials Cleaning and disinfecting FD 350 Classic disinfection wipes CDF35CA0140 FD 333 surface disinfectant CDF333C6150 FD 322 surface disinfectant CDF322C L V010

9 Product description 4 Technical data Electrical data for the appliance Nominal voltage V AC Max. voltage fluctuation % ±10 Frequency Hz 50/60 Rated power W 500 Maximum power VA 1200 Classification Medical products class IIb Manufacturer: VATECH Co., Ltd. for Dürr Dental 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea Authorised EU representative: Vatech Dental Manufacturing Ltd., Suite 3, Ground Floor, Chancery House, St. Nicholas Way, Sutton, SM1 1JB UK Electromagnetic compatibility (EMC)* HF emissions in accordance with CISPR 11 Group 1 Class A Harmonic oscillations in accordance with IEC Class A Voltage fluctuations/flicker in accordance with IEC Matches Conducted HF interference V 1 in accordance with IEC V/m 3 Radiated HF interference E 1 in accordance with IEC V eff 3 *See also "12 Information on EMC according to " Technical data for X-ray unit Toshiba D-041SB (stationary anode type) Model DG-10A05T3 Generator 140 x 150 x kg Tube length mm 200 (300 optional) Generator power kw 0,5 Nominal voltage kvp Nominal current ma 4-7 X-ray tube cooling Automatically controlled 50 C Air cooling: Optional Inherent filtration 1.0 mm Al Total filtration Min. 2.0 mm Al Focal spot size as per IEC mm 0, L V010 7

10 Product description Technical data for X-ray unit Radiation field collimation mm 60/30 x 40 (20 x 30 optional) Exposure time sec. 0,04-2 Total filtering mm Al 2,0 Anode material Tungsten Anode angle 12,5 Pulse to pause ratio 1:60 or greater 4.1 X-ray tube performance data L V010

11 Product description General technical data Arm length mm Total length mm Weight kg 24,4 26,4 28,4 Ambient conditions during operation Temperature C Relative humidity % Air pressure hpa Ambient conditions for storage and transport Temperature C -10 to +60 Relative humidity % Air pressure hpa Dimensions 450 (600, 900) L V010 9

12 Product description (600, 900) L V010

13 4.3 Model identification plate Appliance The model identification plate is located on the outside of the control unit housing. Product description 4.4 Note on Conformity This appliance has been tested according to the relevant directive of the European Union and the required conformity acceptance procedure. This appliance meets all the necessary requirements. The VistaIntra DC has been developed and manufactured according to the following provisions: Protection against the penetration of water: Not protected: IPX0 Protection against electric shock: Appliance of protection class I, application part of Type B The CE mark declares that the product satisfies the applicable requirements according to Directive 93/42/EU for medical products. X-ray unit The model identification plate is located on the housing of the X-ray unit. REF SN SN Order number Serial number Year Parts code Product serial number X XXXX XXXXX L V010 11

14 WARNING: THIS X-RAY UNIT MAY BE DANGEROUS TO PATIT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS AND MAINTANCE. SCHEDULES ARE OBSERVED. Product description 5 Function VistaIntra DC is an extraoral x-ray unit and is factory set at the correct x-ray dosage for each dental area required using Dürr Dental image plates and sensors. It consists of a control unit, the arm system and an X-ray unit. The handle on the X-ray head allows precise positioning of the X-ray unit. 5.1 Control panel VistaIntra 1 Display μgycm 2, kv, ma, sec, error 2 Selection of tooth symbol 3 Selection of X-ray parameter 4 Menu Adult/Child 5 Control lamp X-ray irradiation 6 Release key 7 Stand-by display 8 Save key 9 Menu image plate/sensor Selection of tooth symbol Front tooth Molar Premolar Bite wing exposure L V010

15 Product description Selection of X-ray parameter kv -> ma -> sec To input the following parameters, press the button kv: 60-70, (optional) ma: 4-7 sec: or Menu Adult/Child Adult Child Menu image plate/sensor Image plate Sensor L V010 13

16 Product description 5.2 Exposure switch Exposure switch can be used as alternative to using the control panel to activate irradiation. 5.3 Radiation field collimation The radiation field collimitation reduces the useful x-ray field to the required dimensions. This reduces the x-ray exposure to the patient. Observe any national regulations. 5.4 Wall mounting plate The wall mounting plate can be installed if required in order to ensure the holding forces of the fittings. The unit should be fixed to the wall mounting plate using the four screws provided. 5.5 Adapter plate The adapter plate is mounted if necessary. The already available drill holes of products from other manufacturers are used for attaching. The unit should be fixed to the adapter plate using the four screws provided L V010

17 Mounting Only fully-qualified or from Dürr Dental trained personnel may set-up, install or operate this appliance. 6 Prerequisites 6.1 Area of installation The room chosen for set up should fulfil the following requirements: Closed, dry room Should not be a purpose-made room (e. g. boiler room or wet cell) Take environmental conditions into consideration "4 Technical data". 6.2 Notes on electrical connections Ensure that electrical connections to the mains power supply are carried out according to current valid national and local regulations and standards governing the installation of low voltage units in medical facilities. Insert an all pole disconnect switch (all-pole switch) with >3 mm contact opening width into the electrical connection to the mains power supply. Observe the current consumption of the units to be installed. The diameter of the connections will depend on the current consumption, length of line and the ambient temperature of the suction unit. Information concerning current consumption of the units to be installed can be found in the relevant Technical Data. The following table lists the minimum diameters of the connections in relation to the current consumption: Current consumption of unit [A] Cross-section [mm 2 ] > 10 and < > 16 and < > 25 and < 32 4 > 32 and < 40 6 > 40 and < Type of layout Line properties (minimum requirements) fixed Light plastic sheathed cable (e.g. NYM J) flexible PVC-flexible line (e.g. H05 VV F) or rubber connection (e.g. H05 RN F or H05 RR F L V010 15

18 Mounting 7 Installation 7.1 Attaching the appliance with the wall mounting bracket Use appropriate fixing materials for the floor area. The load bearing properties of the fixtures must guarantee sufficient security. Fix the wall mounting plate to the wall using four screws and rawplugs. Fix the wall mounting plate to the wall using four screws and rawlplugs Ø100 M8 Ø12 (8x) 159, ,5 495 Ø ,4 406, , ,1 The unit should be fixed to the wall mounting plate using four M8 screws. 2-Ø Mount radiation field collimation 210,4 5 Slide the radiation field collimitation piece onto the tube and adjust according to the image plate or the sensor. 7.2 Secure unit with wall mounting plate 1 Use appropriate fixing materials for the floor area. The load bearing properties of the fixtures must guarantee sufficient security. 2 2 x 3 or 3 x Safety for the electrical connection Create a permanent electrical connection to the mains power supply in accordance with DIN L V010

19 Make sure the connection lines to the appliance are not subject to any mechanical tension. Before initial start-up, check the supply voltage with the voltage information on the model identification plate (see also "4. Technical Data"). 7.5 Connecting the appliance to the power supply Prerequisites: 99 Correctly installed mains cable available at the height of the wall mounting plate. 99 Rated current to conform with information on the model identification plate of the power unit. Then connect up the lines. 8 Operation Mounting NOTICE Short circuit due to build up of condensation The appliance can only be put into operation once it has warmed up to room temperature and it is dry. The necessary tests (e. g. acceptance test) are regulated by the locally applicable national law. Find out which tests are to be made. Carry out tests in accordance with national law. 8.1 Acceptance test When carrying out the commissioning tests where the image plate and sensor are used as receivers, the Intra / Extra Digital test body is required and possibly the appropriate test body holder. Before commissioning, carry out the acceptance test of the X-ray system according to national regulations. The tests of constancy, that must be carried out at regular intervals by the surgery personnel, are based on the results of the acceptance test. 8.2 Electrical safety check Carry out an electrical safety check according to all national regulations (e.g. patient conductivity, conductivity of housing). Document the results. 8.3 Switch unit on The display will show the standard values for x- ray exposures or the setting values used for the last exposure carried out. Operational display lamps, LED for menu tooth symbol, LED for menu Adult/Child and LED for menu image plate/sensor all light up L V010 17

20 Mounting 8.4 Service menu settings All settings are saved after the first triggering. While the button is pressed, also press the button longer in order to switch to the service menu. Browse in the menu with or. Use to select the respective menu option. Under menu option 1. Cone Type, browse with and confirm with. Use to go back to the Service menu. Under menu option 2. DAP Setting, browse with and confirm with. Go back to the Service menu with. Under menu option 3. Default Value Reset, confirm the resetting with. Under menu option 4. kv Option, browse with and confirm with ; kv are only permitted for countries without restrictions of the German X-ray Act. Under menu option 5. X-ray Count, browse with and confirm with. Under menu option 6. Exposure Set, make the respective selection with and confirm with. Under menu option 6. Version the current firmware version can be called up. Acknowledge with. Under menu option 7. Demo the demo version can be started by pressing the button. Leave the service menu after inputting all values with the button L V010

21 Usage 9 Instructions for use NOTICE Exerting force on the unit can lead to it becoming damaged Do not lean against or support yourself using the unit. 9.1 Standard settings on switch-on The tube length can be preset in the Service-Menu "8.4 Service menu settings". An extension of the tube influences the image quality and the dose area product displayed. Standard settings on switch-on Last detector used Premolar Adult 60 kv 7 ma The following table shows the standard values for the exposure time and the dose area product of an image plate of an adult patient. Without X-ray field collimation DC radiator, 7 ma Tube length 20 cm X-ray field collimation 2x3 X-ray field collimation 3x4 60 kv mgycm 2 60 kv mgycm 2 60 kv mgycm 2 Incisor 0.08 s 14, s 3, s 6,2 Premolar 0.12 s 21, s 4, s 9,3 Molar 0.17 s 31, s 6, s 13,2 Bite wings 0.18 s 32, s 7, s 14 Without X-ray field collimation DC radiator, 6 ma Tube length 30 cm X-ray field collimation 2x3 X-ray field collimation 3x4 70 kv mgycm 2 70 kv mgycm 2 70 kv mgycm 2 Incisor 0.13 s 11, s 2, s 5,0 Premolar 0.18 s 16, s 3, s 6,9 Molar 0.25 s 22, s 4, s 9,6 Bite wings 0.27 s 24, s 5, s 10, L V010 19

22 Usage The following table shows the standard values for the exposure time and the dose area product of an image plate of a child patient. Without X-ray field collimation DC radiator, 7 ma Tube length 20 cm X-ray field collimation 2x3 X-ray field collimation 3x4 60 kv mgycm 2 60 kv mgycm 2 60 kv mgycm 2 Incisor 0.05 s 9, s 1, s 3,8 Premolar 0.07 s 12, s 2, s 5,4 Molar 0.11 s 20, s 4, s 8,5 Bite wings 0.11 s 20, s 4, s 8,5 Without X-ray field collimation DC radiator, 6 ma Tube length 30 cm X-ray field collimation 2x3 X-ray field collimation 3x4 70 kv mgycm 2 70 kv mgycm 2 70 kv mgycm 2 Incisor 0.08 s 7, s 1, s 3,1 Premolar 0.11 s 10, s 2, s 4,2 Molar 0.14 s 12, s 2, s 5,4 Bite wings 0.14 s 12, s 2, s 5,4 Check and adjust X-ray appliances in accordance with the following standard equipment-specific values. The following table shows the standard values for the exposure times and the dose area product of sensors for an adult patient. Without X-ray field collimation DC radiator, 7 ma Tube length 20 cm X-ray field collimation 2x3 X-ray field collimation 3x4 60 kv mgycm 2 60 kv mgycm 2 60 kv mgycm 2 Incisor 0.07 s 12, s 2, s 5,4 Premolar 0.10 s 18, s 3, s 7,7 Molar 0.13 s 23, s 5, s 10,1 Bite wings 0.14 s 25, s 5, s 10,8 Without X-ray field collimation DC radiator, 6 ma Tube length 30 cm X-ray field collimation 2x3 X-ray field collimation 3x4 70 kv mgycm 2 70 kv mgycm 2 70 kv mgycm 2 Incisor 0.11 s 10, s 2, s 4,2 Premolar 0.16 s 14, s 3, s 6, L V010

23 Usage Without X-ray field collimation DC radiator, 6 ma Tube length 30 cm X-ray field collimation 2x3 X-ray field collimation 3x4 70 kv mgycm 2 70 kv mgycm 2 70 kv mgycm 2 Molar 0.20 s 18, s 3, s 7,7 Bite wings 0.21 s 19, s 4, s 8,1 The following table shows the standard values for the exposure time and the dose area product of sensors of a child patient. Without X-ray field collimation DC radiator, 7 ma Tube length 20 cm X-ray field collimation 2x3 X-ray field collimation 3x4 60 kv mgycm 2 60 kv mgycm 2 60 kv mgycm 2 Incisor 0.04 s 7, s 1, s 3,0 Premolar 0.06 s 10, s 2, s 4,6 Molar 0.08 s 14, s 3, s 6,2 Bite wings 0.09 s 16, s 3, s 6,9 Without X-ray field collimation DC radiator, 6 ma Tube length 30 cm X-ray field collimation 2x3 X-ray field collimation 3x4 70 kv mgycm 2 70 kv mgycm 2 70 kv mgycm 2 Incisor 0.07 s 6, s 1, s 2,7 Premolar 0.10 s 9, s 1, s 3,8 Molar 0.13 s 11, s 2, s 5,0 Bite wings 0.14 s 12, s 2, s 5,4 Check and adjust X-ray appliances in accordance with the following standard equipment-specific values. Recommended exposure times for films with class E sensitivity on an adult patient. DC radiator, tube length 20 cm DC radiator, tube length 30 cm 7 ma 60 kv 6 ma 70 kv 7 ma 60 kv 6 ma 70 kv Incisor 0.16 s 0.08 s 0.32 s 0.16 s Premolar 0.20 s 0.10 s 0.40 s 0.20 s Molar 0.25 s 0.12 s 0.50 s 0.25 s Bite wings 0.32 s 0.16 s 0.64 s 0.32 s Recommended exposure times for films with class E sensitivity on a child patient L V010 21

24 Usage DC radiator, tube length 20 cm 7 ma 60 kv 6 ma 70 kv DC radiator, tube length 30 cm 7 ma 60 kv 6 ma 70 kv Incisor 0.10 s 0.05 s 0.20 s 0.10 s Premolar 0.12 s 0.06 s 0.25 s 0.12 s Molar 0.16 s 0.08 s 0.32 s 0.16 s Bite wings 0.20 s 0.10 s 0.40 s 0.20 s Check and adjust X-ray appliances in accordance with the following standard equipment-specific values L V010

25 Setting X-ray parameters Press selection key image plate/sensor. Press selection key tooth symbol. Press selection key Adult/Child patient. Press selection key imaging parameters kv, and to select other values Press selection key imaging parameters ma, and to select other values Press selection key imaging parameters secs, and to select other values Press key Save for 2 secs. Result: The individual settings have now been saved and can be read on the display. To reset the unit to the factory settings please contact your Service Technician. 9.2 Positioning patient, X-ray unit and detector CAUTION Injuries to the oral cavity Sharp-edged detectors can cause injuries to the oral cavity. Careful positioning of the detector into the patient's oral cavity. Allow the patient to sit down. Position the detector inside the oral cavity Position the x-ray unit. CAUTION Image quality insufficient If the x-ray unit is moved or if the patient moves during exposure then the images will not be usable. The patient should sit quite still during x-ray exposure. The x-ray unit must not be moved in any way during exposure. The detector can be any of the following: Film Sensor Image plate Ensure that the detector is placed within the x-ray field. Place the tube close to the skin. Usage Parallel techniques Position the detector using a holder system for parallel techniques (see leaflet "Image plates and film holder system" order number L4x, contained on accompanying DVD) Detector 2 Tooth axis Bisection angle technique The patient should hold the detector in the mouth in the correct position. The middle of the radiation ray is set at right angles to an (estimated) plane at half the angle between tooth axis and detector. 2 1 Detector 2 Tooth axis L V010 23

26 WARNING: THIS X-RAY UNIT MAY BE DANGEROUS TO PATIT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS AND MAINTANCE. SCHEDULES ARE OBSERVED. Usage Upper jaw front tooth exposure X-ray is projected 45 downwards Bite wing technique During the bite wing exposure the patient needs to bite on a bite wing holder. X-ray is projected 5 to 8 upwards Lower jaw front tooth exposure X-ray is projected 25 upwards 9.3 Activate exposure Upper jaw molar and premolar exposure X-ray is projected 30 downwards CAUTION Injuries through x-rays X-rays can cause tissue damage. Observe the radiation protection regulations. Maintain minimum distance Lower jaw molar and premolar exposure X-ray is projected 5 upwards 3 4 VistaIntra 1 Display 2 Menu tooth symbol 3 Menu X-ray parameter 4 Menu Adult/Child 5 Control lamp X-ray irradiation 6 Release key L V010

27 NOTICE Unit damage due to switching frequency being too high If sufficient cooling of the x-ray unit is not ensured, this can lead to damage. Only activate the subsequent x-ray image after the displayed cooling time has elapsed. Check x-ray settings on control panel and change if necessary Change the tooth region using menu tooth symbol Change to adult or child using patient menu Check x-ray parameter and change if necessary Activate release The x-ray unit control lamp lights green -> unit is warming up The control lamp lights orange and an acoustic signal is heard -> unit is exposing Hold the activation key at least as long as the acoustic signal can be heard. Otherwise the exposure will be faulty and there will be an error message in the display. The image is ready as soon as the exposure time has passed. The X-ray unit control lamp goes out and the acoustic signal is no longer heard. The dose area product is shown on the display, when this function is enabled in the service menu. The unit cools down after every exposure. The cooling time is clearly displayed as it reduces. During this time the activation release can no longer be operated. The X-ray unit control lamp blinks. The unit is ready again. 10 Cleaning and disinfecting Usage NOTICE Unsuitable agents and methods can damage the appliance and accessories Only use the disinfection and cleaning agents specified or approved by Dürr Dental. Observe the instructions for use of the disinfection and cleaning agents. Wear protective gloves Prior to working on the appliance or in case of danger, disconnect it from the mains (e. g. pull the plug). The unit surface must be cleaned and disinfected of contamination or soiling. Use the following cleaning and disinfectant agents: 99 FD 322 Quick-acting disinfection 99 FD 333 Quick-acting disinfection 99 FD 350 Disinfection wipes NOTICE Liquid can cause damage to the appliance Do not spray the appliance with cleaning and disinfectant agents. Make sure that liquid does not get inside the appliance. Remove any soiling with a soft, wet, lint-free cloth. Disinfect the surfaces using a disinfectant wipe. Alternatively use a spray disinfectant on a soft, lint-free cloth. Observe the disinfectant instructions for use L V010 25

28 Trouble-shooting 11 Tips for Operators and Technicians Repairs above and beyond simple maintenance may only be carried out by a qualified technician or one of our service technicians. Problem Probable cause Solution E01 E02 E03 Electrical connection between the control panel and PCB (main board) is interrupted Electrical connection between the x-ray unit and PCB (main board) is interrupted Current strength exceeded maximum permitted value during exposure Switch the appliance off. Check the connection cable. Inform service technician. Switch the appliance off and on. Inform service technician. Switch the appliance off and on. Inform service technician. E08 X-ray unit temperature too high Switch off the x-ray unit until it has cooled down sufficiently. Switch the appliance on again. E09 E10 E11 E12 E13 E14 E15 Current strength outside permitted value during exposure X-ray exposure not activated despite key being pressed Exposure continues more than 0.5 secs, even though activation switch no longer pressed Displayed kv-value is lower than the value actually set Displayed kv-value is higher than the value actually set Displayed ma-value is lower than the value actually set Displayed ma-value is higher than the value actually set Switch the appliance off and on. Inform service technician. Wait 10 secs and try again If the fault repeats, inform your Service Technician. Switch the appliance off. Inform service technician. Switch the appliance off and on. If the fault continues to be displayed, inform your Service Technician. Switch the appliance off and on. If the fault continues to be displayed, inform your Service Technician. Switch the appliance off and on. If the fault continues to be displayed, inform your Service Technician. Switch the appliance off and on. If the fault continues to be displayed, inform your Service Technician L V010

29 Trouble-shooting Problem Probable cause Solution E60 E61 Value over Activation switch is released while unit is being turned on Activation switch is released, before the set exposure time has been expired Operating error kv value or time entered is too high Switch the appliance off and on.take care that the activation key is not being pressed. Inform service technician. Quit by pressing key "Menu x- ray parameter" If the fault repeats, inform your Service Technician. Correct the value. Problem Probable cause Solution Unit does not start up No mains supply Check mains cable and sockets and change if necessary. Inform service technician. On / off switch is defect Check main fusing in building. Inform service technician. No x-ray irradiation X-ray unit temperature too high Wait until x-ray unit has cooled down sufficiently. X-ray image too bright X-ray image too dark Activation key on control panel is defect Activation key on exposure switch is defect The detector being used does not suit the unit settings X-ray unit incorrectly positioned X-ray parameters are not correctly set The detector is not correctly positioned in the mouth of the patient Detector being used not compatible with unit settings Inform service technician. Cable is defect or not connected to unit. Inform service technician. Wait until the X-ray unit has cooled down. Correct the position of the X-ray unit Check the X-ray parameters and change if necessary. Increase the exposure time. Notify the service technician. Correct the position of the detector Use different detector or change unit settings. X-ray parameters not set correctly Check x-ray parameters and, if necessary, set correctly. Reduce exposure time. Inform service technician L V010 27

30 Annex 12 Information on EMC according to General notes The information in this leaflet includes excerpts from the relevant European standards for electrical, medical appliances. The information reproduced here should be observed during the installation of individual appliances and when combining Dürr Dental appliances with products of other manufacturers. If there is any question of doubt, the complete standard must be checked Abbreviations EMC Electro-magnetic compatibility HF High frequency U T Voltage rating of appliance (supply voltage) V 1, V 2 Level of consistency for testing according to IEC E 1 Level of consistency for testing according to IEC P Rated power of transmitter in watts (W) according to manufacturer's information d Recommended safety distance in metres (m) 12.3 Guidelines and manufacturer's information Electromagnetic transmissions for all appliances and systems The appliance is designed for operation in one of the electromagnetic environments as outlined below. The customer/operator of such an appliance is obliged to ensure that the appliance is operated in such an environment. Interference measurements HF transmissions according to CISPR 11 HF transmissions according to CISPR 11 HF transmissions according to CISPR 11 Harmonic limits according to IEC Voltage fluctuations/flicker according to IEC According to Group 1 Group 2 Class [A or B] [Class A, B, C, D or Not Applicable] [Fully compatible or not applicable] Electro-magnetic environment guidelines The appliance employs HF energy exclusively for internal functions. Therefore, any HF transmissions are of extremely low nature and it is highly improbable that any other electronic components will receive any interference. The appliance must transmit electromagnetic energy in order to fulfil the functions for which it has been designed. Other electronic appliances in the vicinity could be affected. The appliance is designed for use in all types of environment including those in residential areas and other suitable areas which are connected directly to the local power supply serving residential buildings. Table 1: Electromagnetic transmissions for all appliances and systems L V010

31 Annex Electromagnetic resistance for all appliances and systems The appliance is designed for operation in one of the electromagnetic environments as outlined below. The customer/operator of such an appliance is obliged to ensure that the appliance is operated in such an environment. Resistance to interference checks Discharge of static electricity (ESD) according to IEC Rapid transient electrical bursts according to IEC Surges according to IEC Voltage drops, interruptions and fluctuations according to IEC Magnetic field under supply frequency (50/60 Hz) according to IEC IEC test levels ±6 kv contact discharge ±8 kv discharge to air ±2 kv for mains connections ±1 kv at input and output connections ±1 kv voltage external-external conductor ±2 kv voltage external-ground conductor < 5% U T (> 95% retardation of U T ) for 1/2 period 40% U T (60% retardation of U T ) for 5 periods 70% U T (30% retardation of U T ) for 25 periods < 5% U T (> 95% retardation of U T ) for 5 s Level of consistency ±6 kv contact discharge ±8 kv discharge to air ±2 kv for mains connections ±1 kv at input and output connections ±1 kv push-pull voltage ±2 kv push-pull voltage < 5% U T (> 95% retardation of U T ) for 1/2 period 40% U T (60% retardation of U T ) for 5 periods 70% U T (30% retardation of U T ) for 25 periods < 5% U T (> 95% retardation of U T ) for 5 s Electro-magnetic environment guidelines Floors should be of wood or concrete or be covered by ceramic tiles. If the floor is covered by synthetic material, the relative humidity must be at least 30%. The quality of the supply voltage should be that of a typical office building or of a hospital environment. The quality of the supply voltage should be that of a typical office building or of a hospital environment. The quality of the supply voltage should be that of a typical office building or of a hospital environment. Where the operator of the appliance requires continued function even during a power out, we recommend that the appliance is supplied by an uninterrupted power supply, e.g. battery power. 3 A/m 3 A/m Magnetic fields of the supply voltage should have the values found in a typical office building or of a hospital environment. Table 2: Electromagnetic resistance for all appliances and systems L V010 29

32 Annex Electromagnetic resistance to interference for non life-supporting appliances or systems Portable and cordless radio appliances should not be used close to the appliance, including any electrical supply lines, as the recommended safety distance which has been calculated from the transmission frequency. Resistance to interference checks Conductive HF interference factor according to IEC Radiated HF interference factor according to IEC IEC test levels 3 V eff 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Level of consistency Recommended safety distance [V 1 ] V d = [3.5 / V 1 ] P d = 1.2 P [E 1 ] V/m d = [3.5 / E 1 ] P for 80 MHz to 800 MHz d = 1.2 P for 80 MHz to 800 MHz d = [7 / E 1 ] P for 800 MHz to 2.5 GHz d = 2.3 P for 800 MHz to 2.5 GHz Table 3: Electromagnetic resistance to interference for non life-supporting appliances or systems P Rated power of transmitter in watts (W) according to manufacturer's information d Recommended safety distance in metres (m) The field strength of stationary radio transmitters for all frequencies must be, according to investigation carried out on-site a lower than the consistency level. b Some interference is possible in environments surrounding appliances where the following symbol is present. Note 1 Note 2 Where 80 MHz and 800 MHz are present, the higher frequency range becomes valid. These guidelines are not applicable for all possible situations. The exact amount of electro-magnetic transmissions can be considerably influenced by the rate of absorption and reflection within the building, and the presence of objects and people. a The field strength of stationary transmitters, e.g. base station of radio telephones or cordless landline phones, amateur radio stations, on AM and FM radio or TV, cannot be theoretically exactly calculated in advance. In order to establish the electromagnetic environment taking these stationary transmitters into account, a study of the electromagnetic phenomena of the actual location must be undertaken. If the field strength measured at the location where the appliance is used exceeds the above level of consistency, the appliance should be observed in order to demonstrate the intended function. If any unusual behaviour of the appliance is observed, additional steps will be required, e.g. changing the orientation or location of the appliance. b The field strength is less than [V 1 ] V/m over the frequency range of 150 khz to 80 MHz L V010

33 Annex Recommended safety distances between portable and mobile HF communications devices and the appliance The appliance is designed for operation in one of the electromagnetic environments as outlined below in which the HF interference is controlled. The customer/operator of the appliance can help to prevent electromagnetic interference by maintaining minimum distances as recommended between portable and mobile HF communications devices (transmitters) and the appliance as outlined below according to the maximum output of the communications device. Rated power of transmitter (W) Safety distance dependent on transmission frequency (m) 150 khz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P MHz to 2.5 GHz d = 2.3 P Table 4: Recommended safety distances between portable and mobile HF communications devices and the appliance For transmitters whose maximum rated current is not included in the table above the recommended safety distance d in metres (m) can be calculated using the following mathematical formula and the appropriate column, where P is the maximum rated current of the transmitter in watts (W) according to the information of the manufacturer of the transmitter. Note 1 Where 80 MHz and 800 MHz are present, the higher frequency range becomes valid. Note 2 These guidelines are not applicable to all possible situations. The exact amount of electro-magnetic transmissions can be considerably influenced by the rate of absorption and reflection within the building and the presence of objects and people L V010 31

34 Annex 12.4 Table of calculation If the measured values deviate from the standard, the values in chapter "4 Technical data" are specified. The safety distances can then be calculated in the tables shown below. P :... V 1 :... E 1 :... P Rated power of transmitter in watts (W) according to manufacturer's information V 1 Level of consistency for testing according to IEC E 1 Level of consistency for testing according to IEC Resistance to interference checks Conductive HF interference factor according to IEC Radiated HF interference factor according to IEC IEC test levels 3 V eff 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz Level of consistency Recommended safety distances [V 1 ] V d = [3.5 / V 1 ] P [E 1 ] V/m d = [3.5 / E 1 ] P For 80 MHz to 800 MHz d = [7 / E 1 ] P For 800 MHz to 2.5 GHz Rated power of transmitter (W) 0.01 Safety distance dependent on transmission frequency (m) 150 khz to 80 MHz d = [3.5/V 1 ] P 80 MHz to 800 MHz d = [3.5/E 1 ] P 800 MHz to 2.5 GHz d = [7 / E 1 ] P L V010

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36 DÜRR DTAL AG Höpfigheimer Strasse Bietigheim-Bissingen Germany Fon: