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Summary of Contents for Durr Dental VistaPano S
- Page 1 VistaPano S Operating Instructions 9000-618-256/02 ...
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Page 3: Table Of Contents
Contents Important information Installation 1 About this document 3 6 Requirements 16 Warnings and symbols 3 Installation/setup room 16 Copyright information 3... - Page 4 Contents 115 Manual cleaning, intermediate rinsing, disinfection, final rinse, drying 36 116 Automatic cleaning, intermediate rinsing, disinfection, final rinse, drying 37 117 Check for function 37 118 Steam sterilising 37 119 Issue clearance for the parts for...
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Page 5: Important Information
Important information About this document Other symbols These symbols are used in the document and These installation and operating instructions on or in the unit: form part of the unit Note, eg specific instructions regarding If the instructions and information in efficient and cost-effective use of the unit these installation and operating instruc- tions are not followed, Dürr Dental will Comply with the Operating Instructions... -
Page 6: Safety
Important information Safety shielding or protective aprons, especially for children and teenagers The unit has been developed and designed in The persons operating the equipment must such a way that dangers are effectively ruled out keep away from the X-ray unit while the expo- if used in accordance with the proper, intended sure is being taken The minimum distance re- use Nevertheless, residual risks can remain... -
Page 7: Only Use Genuine Parts
Important information 2.7 Only use genuine parts Only use Dürr Dental parts or accessories and special accessories specifically approved by Dürr Dental Only use only genuine working parts and spare parts 2.8 Transport The original packaging provides optimum pro- tection for the device during transport If required, original packaging for the unit can be ordered from Dürr Dental Dürr Dental does not accept any respon-... -
Page 8: Product Description
Product description Overview 13 12 Panoramic X-ray unit Small parts DBSWIN imaging software DVD VistaSoft imaging software DVD Test body holder Exposure switch Head support with cushion* Hygienic protective covers for bite block* Bite block* 10 Adapter bite block* 11 Chin holder for maxillary joint image* 12 Chin holder for edentulous jaws* 13 Chin holder for sinus image* *These are parts that the patient will come into contact with... -
Page 9: Scope Of Delivery
(100 pieces) 2207-010-50 FD 322 rapid surface Test body holder for VistaPano S (can disinfectant CDF322C6150... -
Page 10: Technical Data
Product description Technical data Electrical data for the unit Nominal voltage V AC 200 - 240 Max mains voltage fluctuation ±10 Frequency 50/60 Rated power Maximum power Classification Medical product class 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... - Page 11 Product description Maximum Rating Charts DC (Center Grounded) Constant potential high-voltage generator Nominal Focus Spot Value: 0.5 70kV 80kV 60kV 90kV 50kV 100kV EXPOSURE TIME [s] Emission and Filament Characteristics Constant potential high-voltage generator Nominal Focus Spot Value: 0.5 80kV 100kV 50kV FILAMENT CURRENT [A]...
- Page 12 Product description Anode Thermal Characteristics 175 W COOLING HEATING TIME (min) Monoblock Cooling Curve TIME (min) Detector Brand Xmaru 1501CF-HS Type CMOS photodiode array Pixel size μm Active surface area 6 x 1504 Frame rate Greyscale General technical data Height 1580 - 2280 Dimensions (W x D) 990 x 1130 Vertical radius...
- Page 13 Product description Image capture scale Acquisition mode (magnification factor) Panoramic 4902 3750 1152 FDD: distance from focal spot to detector FOD: distance from focal spot to object ODD: distance from object to detector (ODD = FDD - FOD) Image capture scale = FDD/FOD Ambient conditions during operation Temperature °C...
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Page 14: Dimensions
Product description 4.2 Dimensions 9000-618-256/02 1712V015... -
Page 15: Type Plate
European Union guidelines This equipment conforms to all relevant require- ments The VistaPano S has been developed and man- ufactured in accordance with the following regu- lations: – Installation of X-ray units: [DG-10A05T3] IEC 60601-2-28 (1993) –... -
Page 16: Operation
Product description Operation 5.1 Touch screen Activate/deactivate all positioning beams Test circulation, keep the button pressed Return Display language 5.2 Exposure button Exposure switch EMERGENCY OFF button The exposure switch is used to trigger the pre- pared image acquisition and start the X-ray ex- On/off switch posure The LED indicates the unit status, as X-ray tube... -
Page 17: Positioning Aids
Product description 5.3 Positioning aids 5.4 Manual switch for height adjustment (optional) The positioning aids are used to correctly posi- tion the patient in the unit The suitable position- The manual switch can be used as an alterna- ing aid is selected according to the selected im- tive to the buttons on the touch screen for the age The head supports gently keep the head of height adjustment of the unit... -
Page 18: Installation
Installation 6.3 System requirements Only qualified specialists or employees trained by Dürr Dental are permitted to The system requirements for the compu- install, connect and start using the unit ter systems can be found in the down- Requirements load area at wwwduerrdentalcom (doc- ument no 9000-618-148) 6.1 Installation/setup room 6.4 Monitor... -
Page 19: Installation
Installation Installation A copy of the system manufacturer‘s declaration in accordance with Article 12 7.1 Electrical safety when making of Directive 93/42/EEC can be found in connections our download section at wwwduerrden- talcom (document no 9000-461-264) Make sure that none of the electrical cables leading to the unit are under any mechanical tension Before initial start-up check that the mains... -
Page 20: Commissioning And First Start-Up
Installation Commissioning and first 8.2 Electrical safety checks start-up Carry out the electrical safety check according to the national law (e g in accordance with IEC 62353) NOTICE Document the results Short circuit due to the build up of condensation 8.3 Switch on the unit Do not switch on the unit until it has warmed up to room temperature and CAUTION it is dry Danger of injury due to movement of... - Page 21 Installation Configuring the network Configuring the unit in VistaSoft Data transmission between the unit and PC is Select > X-ray stations > Automatic carried out over a separate network connection search The required network cable and the Ethernet Select the X-ray unit from the list card are included in the scope of delivery of the Enter the name and address of the operator unit Click OK to close the wizard...
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Page 22: Operation
Operation Operation 9.1 Switch on the unit CAUTION Danger of injury due to movement of the the C-shaped angle connector piece After switching on the unit and confirm- ing the parameters on the touch screen, the C-shaped angle connector piece is positioned Persons can be injured dur- ing this Nobody must remain in the area of the C-shaped angle connector piece while the unit is being switched on Switch on the device... -
Page 23: Adjusting The Imaging Software
Operation 9.2 Adjusting the imaging software The settings are described using the example of the DBSWIN imaging software For further information on using the imaging software, refer to the relevant manual Parameter overview in DBSWIN Patient type Selection of patient type will depend on the patient's size or their head circumference This means that the preset patient type may need to be changed if necessary The X-ray parameters are preset using the patient type (see "Appendix") If a child is selected then the x-ray parameters are different:... - Page 24 Operation Arch The selected jaw form influences the rotational behaviour of the C-shaped angle connector piece dur- ing image acquisition This enables an image with an ideal layer position to be captured even on a particularly narrow or wide jaw Normal arch Narrow arch Wide arch...
- Page 25 Operation Panoramic images Orthogonal The image shows the complete dental area and is generated perpendicular to the maxillary arch This prevents overlapping crowns Bite wing The image shows the lateral dental area with a size limited to the bite wings Bite wing front The image shows the anterior area with a size limited to the bite wings Bite wing right The image shows the right posterior region with...
- Page 26 Operation Sinus images Sinus, lateral The image shows the lateral sinuses Sinus, PA The image shows the posterior-anterior sinuses 9000-618-256/02 1712V015...
- Page 27 Operation Preparing an X-ray image in DBSWIN – DBSWIN has been started Select the patient Select the X-ray tab The configuration window opens The patient type, maxillary arch and imaging program parameters are preselected according to the patient Check the parameters If the preselected parameters are correct, continue to work directly on the unit 9000-618-256/02 1712V015...
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Page 28: Setting Up The Unit
Operation 9.3 Setting up the unit WARNING There is a danger of cross contami- nation if hygienic protective covers are not used or they are used more than once. Do not use the bite block without the hygienic protective cover Do not use the hygienic protective cover more than once (disposable item) Disinfect the positioning aids, see "10 Clean- ing and disinfection" Fit the bite block with a hygienic protective cover and insert Frankfurt plane of the X-ray positioning... - Page 29 Operation Preparing panoramic imaging CAUTION Danger of injury due to movement of WARNING the the C-shaped angle connector There is a danger of cross contami- piece nation if hygienic protective covers After switching on the unit and confirm- are not used or they are used more ing the parameters on the touch screen, than once. the C-shaped angle connector piece is Do not use the bite block without the positioned Persons can be injured dur- hygienic protective cover ing this Do not use the hygienic protective...
- Page 30 Operation toothless in the case of patients who do not The patient opens or closes their mouth have any teeth) If necessary, correct the height of the unit again Preparing the maxillary joint image For the maxillary joint image, one image is required with the mouth closed and one with the mount open Insert the chin support for the maxillary joint image...
- Page 31 Operation Preparing a sinus image Adjusting the position with the positioning beams Insert the chin support for a sinus image Insert the chin support and position the WARNING patient Danger – risk of dazzling from laser beam Do not allow the laser beam to shine directly into the eyes of the patient Only activate the X-ray positioning beam when the patient has closed his/her eyes The alignment of the upper canine X-ray...
- Page 32 Operation For a sinus image: If necessary, correct the X-ray positioning beam manually Patient over-extends the cervical vertebral column by approx 10° to 15° Check the X-ray positioning beam for the mid- sagittal plane and correct if necessary The patient is correctly positioned using the Have the patient smile so the upper canine is X-ray positioning beam visible...
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Page 33: Taking The X-Ray
Operation 9.5 Taking the X-ray While the image is being taken, the LED on the exposure switch and on the unit lights CAUTION up yellow An acoustic signal sounds Injuries through x-rays While an X-ray is being taken, this is indicat- X-rays can cause tissue damage ed on the touch screen with: Comply with the radiation protection regulations... -
Page 34: 96 Transmitting And Saving The Image
Operation 9.6 Transmitting and saving the image While the image is being triggered, DBSWIN displays a preview of the image While the image preview is active, it is possible to select or deselect the S-PAN technology after tak- ing the image Without an image preview, the image is copied directly to the database of the soft- ware For further information on the software, refer to the "DBSWIN manual" Check the image and optimise it if necessary... -
Page 35: Restoring The Last Image
Operation 9.7 Restoring the last image Releasing the EMERGENCY OFF button You need to release the EMERGENCY OFF but- If required, the last image can be restored by ton before you can restart the unit selecting the tool button Pull the EMERGENCY OFF button down to re- lease it 9.8 EMERGENCY OFF The EMERGENCY OFF button stops the unit... -
Page 36: Cleaning And Disinfection
Operation 10 Cleaning and disinfection 10.2 Positioning aids The positioning aids must be cleaned and dis- infected if they are contaminated or soiled Use NOTICE the following cleaning and disinfectant agents: The use of unsuitable agents and methods can damage the unit and – FD 322 Quick-acting surface disinfection accessories. – FD 333 Quick-acting surface disinfection Only use the disinfectants and clean- –... -
Page 37: Reprocessing
Operation 11 Reprocessing Important information! The reprocessing notes in accordance The following accessories need to be reproc- with EN 17664 have been independently essed: tested by Dürr Dental for the preparation – Bite block: of the device and its components and - Manual cleaning their reuse - Manual disinfection The person conducing the reprocessing... -
Page 38: 114 Preparation At The Operating
Operation 11.5 Manual cleaning, intermediate Comply with the specifications in "115 Manu- al cleaning, intermediate rinsing, disinfection, rinsing, disinfection, final rinse, final rinse, drying" and "116 Automatic clean- drying ing, intermediate rinsing, disinfection, final A combined cleaning and disinfectant agent is rinse, drying" when selecting the cleaning and required for manual cleaning and disinfection It disinfectant agents to be used must have the following properties:... -
Page 39: Disinfection, Final Rinse, Drying
Operation 11.6 Automatic cleaning, – Standards DIN EN ISO 11607-1/2 – The applicable sections of the standard series intermediate rinsing, DIN EN 868 disinfection, final rinse, drying The sterilisation packaging must be sufficiently Selection of the washer-disinfector large Once it is loaded, the sterilisation packag- ing may not be under any strain Automatic cleaning and disinfection requires a CD with the following properties and validated Steam sterilising... -
Page 40: 10 Storing Parts For Sterilisation
Operation 11.10 Storing parts for sterilisation Comply with the stated storage conditions: – Store the parts protected against contami- nation – Dust-protected, eg in a locked cabinet – Protected against moisture – Protected against excessive temperature fluctuations – Protected against damage Packaging for a sterile medical device can suffer damage as a result of a particular inci- dent and the passage of time Potential ex- ternal contamination of the sterile barrier... -
Page 41: Maintenance
Operation 12 Maintenance 12.1 Recommended maintenance schedule Please contact the Service department if there are discrepancies in the DAP values The following must be noted when performing maintenance work The unit and the accessories required for its use must only be set up in a dry room It must be ensured for the long term that the equipment remains in good condition The operation of the device can be influenced by factors such as temperature, light, ventilation, dust, salt etc... - Page 42 Operation Inspection in- Inspection work terval Every 3 years Functional test of the display Are all symbols displayed? Functional test of the exposure button Do the various status LEDs light up? Check that the head supports mechanism functions correctly Are the head supports easy to detach and put back on? Functional test of the EMERGENCY OFF button Is the EMERGENCY OFF button easy to operate mechanically, and does it light up when pressed?
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Page 43: Troubleshooting
Troubleshooting 13 Tips for operators and service technicians Any repairs above and beyond routine maintenance must only be carried out by suitably quali- fied personnel or by one of our service technicians 13.1 Error messages No connection to the unit Switch the unit off and back on Inform a service technician Unable to acquire an X-ray image Switch the unit off and back on... -
Page 44: Appendix
HF emissions in accord- Class A The VistaPano S unit is suitable for use in installations ance with CISPR 11 other than buildings used for residential purposes and in buildings that are directly connected to the PUBLIC... - Page 45 Appendix Resistance to electromagnetic interference (immunity) for all devices and systems The device is designed for use in electromagnetic environments specified below The customer or op- erator of the device should ensure that the device is operated such an environment Interference im- IEC 60601 - test Compliance level Electromagnetic environment munity tests level - guidelines ±6 kV contact dis- ±6 kV contact dis- Electrostatic dis- Floors should be made of wood...
- Page 46 Appendix Electromagnetic interference immunity for devices or systems that are not life-sustaining Portable and mobile communication devices should not be used any closer to the unit (including ca- bles) than the recommended safety distance, which is calculated based on the applicable formula for the transmission frequency Interference im- IEC 60601 - test Compliance Recommended safety distance munity tests level level...
- Page 47 Appendix Recommended safety distance between portable and mobile HF communication devices and the unit The device is designed for use in the electromagnetic environments specified below, in which the HF disturbance variables are controlled The customer or the operator of the device can help to prevent electromagnetic interference by maintaining the minimum distances between mobile HF communica- tion equipment (transmitters) and the device as recommended below in accordance with the maxi- mum output line of the communication equipment Rated power of the...
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Page 48: 144 Calculation Table
Appendix 14.4 Calculation table If the measured values deviate from the standard, the values are specified in chapter "4 Technical data" The safety distances can then be calculated in the tables shown below Rated power of the transmitter in Watts (W) in accordance with the specifications of the transmitter manufacturer Compliance level for the test in acc with IEC61000-4-6 Compliance level for the test in acc with IEC61000-4-3... -
Page 49: Program Parameters
Appendix 15 Program parameters The extraoral dental X-ray system meets the requirements set out in the standard IEC 60601-2-63 The dosage information complies with the requirements of the standard and is stated in mGycm 15.1 Tall, well-built patient, S-Pan Image quality Program Voltage Current Scanning time mGycm Standard pan- oramic Right, left... -
Page 50: 153 Small Patient, S-Pan
Appendix Image quality Program Voltage Current Scanning time mGycm Standard pan- 1394 135 oramic Right, left 692 Front 1145 111 Bite wing 991 Bite wing, 495 right, left Bite wing, front 259 Orthogonal 1394 135 Maxillary joint, 2x 629 lateral, open and closed Maxillary joint, 2x 722... -
Page 51: 154 Child, S-Pan
Appendix Image quality Program Voltage Current Scanning time mGycm Maxillary joint, 2x 703 PA, open and closed Sinus, lateral 604 Sinus, PA 1036 103 15.4 Child, S-Pan Image quality Program Voltage Current Scanning time mGycm Standard pan- 489 oramic Right, left 204 Front 330 Image quality Program Voltage... -
Page 52: 156 Child Arch, Average Patient
Appendix Image quality Program Voltage Current Scanning time mGycm Standard pan- 914 115 oramic Right, left 452 Front 730 Bite wing 1017 Bite wing, 508 right, left Bite wing, front 266 Orthogonal 914 115 Maxillary joint, 2x 646 lateral, open and closed Maxillary joint, 2x 74 PA, open and... -
Page 53: 157 Child Arch, Small Patient
Appendix Image quality Program Voltage Current Scanning time mGycm Sinus, lateral 620 Sinus, PA 1063 103 15.7 Child arch, small patient Image quality Program Voltage Current Scanning time mGycm Standard pan- 612 oramic Right, left 255 Front 412 Image quality Program Voltage Current Scanning time mGycm Standard pan- 868 115 oramic... -
Page 54: Information On Scattered Radiation
Appendix 16 Information on scattered radiation Test equipment: Dosemeter Victoreen 660 Test conditions Program parameters HD / Adult / Standard Pano Distance to the focal spot Voltage 80 kVp Current 16 mA HD, 13.5 s 1.5 m ° 984 mR/h 378 mR/h 198 mR/h 347 mR/h 176 mR/h 93 mR/h 154 mR/h 62 mR/h... -
Page 55: 17 Information On The Leakage Rate 53
Appendix 17 Information on the Direction HD, Adult, HD, Child, leakage rate 13.5 s 11.5 s ° Test equipment: Dosimeter Victoreen 660 192 mR/h 202 mR/h Test conditions 88 mR/h 94 mR/h Program parameters HD / Adult, child / 71 mR/h 86 mR/h Standard Pano 6 mR/h 74 mR/h Distance to the focal 63 mR/h 63 mR/h... - Page 60 Hersteller/Manufacturer: VATECH Co. Ltd. 13, Samsung 1-ro 2-gil Hwaseong-si, Gyeonggi-do, 18449 Korea Fon: +82 31 323 8639 www.vatech.co.kr Vertreiber/Distributor: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
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