Durr Dental VistaPano S 2.0 Installation Instructions Manual
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Durr Dental VistaPano S 2.0 Installation Instructions Manual

Durr Dental VistaPano S 2.0 Installation Instructions Manual

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VistaPano S 2.0
VistaPano S Ceph 2.0
EN-US Installation instructions

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Summary of Contents for Durr Dental VistaPano S 2.0

  • Page 1 VistaPano S 2.0 VistaPano S Ceph 2.0 EN-US Installation instructions...
  • Page 2 The latest version of the instructions is available in this page: https://bit.ly/m/air-techniques-imaging-manuals...

  • Page 3: Panoramic X-Ray Device

    Contents Contents Operating elements ... Status LED ....Positioning aids panoramic Important information image ..... About this document .

  • Page 4: Table Of Contents

    Contents 10 Panoramic program parameters ..10.1 Large built patient ... . 10.2 Average built patient ..10.3 Small patient .

  • Page 5: About This Document

    Direct danger of severe injury or death About this document – WARNING Possible danger of severe injury or death These installation instructions apply to: – CAUTION VistaPano S 2.0 Risk of minor injuries REF: A9350 – NOTICE VistaPano S Ceph 2.0 Risk of extensive material/property damage...

  • Page 6: Indications For Use

    Important information Safety Type B Applied Part The unit has been developed and designed appropriately such that hazards are largely excluded if the unit is used in accordance with its Do not reuse Normal Use. Despite this, the following residual risks can remain: Sterilize with steam at 134 °C –...

  • Page 7: General Safety Information

    Important information General safety information Radiation protection – Always comply with the specifications of all – Comply with all applicable X-ray protection guidelines, laws, and other rules and regula- regulations and X-ray protection measures. tions applicable at the site of operation for the –...

  • Page 8: Protection From Electric Shock

    Important information Language understanding – Electromagnetic disruptions can lead to a loss of system performance. Therefore it may be Understands English or other languages provided necessary to remove devices that generate in the manual. static electricity in the surrounding area, or to Experience remove the user’s static electricity before use.

  • Page 9: Exposure Switch

    Important information Protection from cybersecurity NOTICE threats Erroneous operation mode due to use The unit is to be connected to a computer that immediately adjacent to other devices can be connected to the Internet. Therefore, the or with other stacked devices system needs to be protected from threats from Do not stack the unit together with the Internet.
  • Page 10 Important information If required, original packaging for the unit can be ordered. Manufacturer and distributor shall not accept any responsibility or liability for damage occurring during transport due to the use of faulty packaging, even where the unit is still under guarantee. –...

  • Page 11: Product Description

    Product description Product description Overview Fig. 1: VistaPano S 2.0 Panoramic X-ray device Comfort bite block* Wall bracket Bite block* Installation mounting hardware Holder for bite block* Test phantom holder for ProVecta S-Pan Chin support for maxillary joint image* Exposure switch...

  • Page 12: Temple Support Plus

    Product description Fig. 2: VistaPano S Ceph 2.0 X-ray system Bite block* Installation mounting hardware Holder for bite block* Test phantom holder for ProVecta S-Pan Chin support for maxillary joint image* Temple support plus* Chin holder for edentulous jaws* Exposure switch Chin support for sinus image* Protective bite block covers* Carpus plate*...

  • Page 13: Scope Of Delivery

    Protective bite block covers (100 pieces) . . A7395 VistaPano S 2.0 ....A9350 Test phantom holder for ProVecta S-Pan –...

  • Page 14: Technical Data

    Product description Technical data Electrical data of the device Nominal Voltage V AC 200 - 240 Max. mains voltage fluctuation ±10 Frequency 50/60 Maximum power Type of protection IP X0 Operating mode height adjustment max 2 min ON / 18 min OFF (Ratio 1:9 switch-on/switch-off time) Operating mode Non-continuous operation (NFPA 70: long...
  • Page 15 Product description General technical data VistaPano S 2.0 VistaPano S Ceph 2.0 Height 1587 - 2287 Height incl. stand (optional) 62.48 - 90.04 1615 - 2315 63.58 - 91.14 Dimensions (W x D) 990 x 1160 1900 x (1145 - 1160) 38.97 x 45.67...

  • Page 16: X-Ray Tube Performance Data

    Product description *The reference axis is the perpendicular of the X-ray exit window at the level of the side marker for the focal point on the cover of the X-ray emitter **Tube voltage/current range and exposure time depend on the type of exposure: –...
  • Page 17 Product description – Maximum deviation of the voltage peak from the displayed value ±10 % – Maximum deviation of the tube current from the displayed value ±20 % – Maximum deviation of the exposure time from the displayed value ± (5 %+ 50 ms) –...

  • Page 18: Electromagnetic Compatibility (Emc)

    Product description Anode Heating/Cooling Characteristics 315 W 225 W 175 W COOLING HEATING TIME [min] X-ray Housing Assembly Tube Characteristics TIME [min] Electromagnetic compatibility (EMC) Phenomenon Mode of Tested con- Test voltage Test cate- Basic EMC standard or test proce- operation nector gory /...
  • Page 19 Product description Phenomenon Mode of Tested con- Test voltage Test cate- Basic EMC standard or test proce- operation nector gory / dure requirement Voltage changes, voltage fluctuations – Mode of Voltage sup- 230 V AC, Pst: 1 operation ply unit AC 50 Hz Plt: 0.65 emission of flicker...
  • Page 20 Product description Phenomenon Mode of Tested con- Test voltage Test cate- Basic EMC standard or test proce- operation nector gory / dure requirement Immunity to interference by voltage – Mode of Voltage sup- – 220 V AC, 0 % U dips operation ply unit AC...
  • Page 21 Product description Dimensions 990 mm 38,98 in Fig. 3: VistaPano S 2.0 2208100052L01 A9302 2504V001 EN-US...
  • Page 22 Product description 990 mm 38,98 in Fig. 4: VistaPano S 2.0 with floor stand EN-US 2208100052L01 A9302 2504V001...
  • Page 23 Product description 1900 mm 74,80 in 1378 mm 54,25 in 990 mm 38,98 in Fig. 5: VistaPano S Ceph 2.0 2208100052L01 A9302 2504V001 EN-US...
  • Page 24 Product description 1900 mm 74,80 in 1378 mm 54,25 in 990 mm 38,98 in Fig. 6: VistaPano S Ceph 2.0 with floor stand EN-US 2208100052L01 A9302 2504V001...

  • Page 25: Model Identification Plate

    Product description Model identification plate The identification plates are located on the X-ray emitter and on the telescopic column. Conformity assessment This device has been subjected to conformity acceptance testing in accordance with the cur- rent relevant guidelines of the European Union. This equipment conforms to all relevant require- ments.

  • Page 26: Operating Elements

    Product description Function Cephalometric X-ray unit Panoramic X-ray device 1 Sensor (Ceph) 2 Nose support 3 Ear rods with holder 4 On/off switch 5 EMERGENCY OFF button The cephalometric unit digitally records the anat- omy of the cranium. Status LED The X-ray task is started via the imaging software C-shaped arm and activated via the touch screen.

  • Page 27: Status Led

    Product description Positioning aids panoramic image Fig. 7: Monitor, unit ready to acquire image 1 Logged-in patient 2 Selected X-ray image 3 Display of the X-ray parameters (duration, DAP value, voltage and current) 4 Selected parameters 1 Head support with cushion The Messages button can be used to recall cur- 2 Frankfurt plane of the X-ray positioning beam rent messages.

  • Page 28: Exposure Button

    Product description Panorama Cephalometric pro- jections Ear rods with holder Chin holder for maxillary joint image Chin holder for sinus image Nose support Head supports with cushion Carpus plate Positioning aids for cephalo- metric projections The applied parts in accordance with IEC 60601-1 are: –...

  • Page 29: Sensor Window

    Product description Cephalometric X-ray unit 1 Line sensor housing 2 Active sensor surface 1 Indicator lamp (LED) 2 Exposure button Sensor window The active sensor surface is indicated by the markers in the corners of the sensor window. The cross indicates the geometric mid-point of the active sensor surface.

  • Page 30: Installation/Setup Room

    Installation Radiation protection Installation – Comply with all applicable X-ray protection regulations and X-ray protection measures. – Use the prescribed X-ray protection equip- Only qualified specialists or persons ment. trained by Air Techniques may install, – In order to reduce the level of X-ray exposure, connect, and commission the unit.
  • Page 31 Installation – Ensure that the electrical connections to the Installation type Line layout (minimum mains power supply are established in accord- requirements) ance with current valid national and local regu- lations and standards governing the installation – Rubber connection of low voltage units in medical facilities. (e.g., H05 RN‑F or –...
  • Page 32 Installation Installation Check to see if the Tiltwatch display has been activated. NOTICE Danger to components due to electro- static discharge (ESD) Establish equipotential bonding Tiltwatch between the person carrying out the work and the surroundings, e.g. via a wrist strap that is connected to the basic unit.
  • Page 33 Installation Place the panoramic unit upright at the If the column with the column slide cannot installation site on the wall. A distance of be screwed to the floor (e.g. in the case of 70 cm (27.56 in) to the wall on the right is underfloor heating) or of the wall lacks the recommended for patient access and the appropriate strength, then the lower wall...
  • Page 34 Installation Mark four holes for drilling on the wall. Screw in the corresponding threaded pins as required to align the unit. Tighten all screws. Use the aligning plate to mark four holes on Fit the screw covers. the floor. Drill four holes in the wall and four holes in the floor.
  • Page 35 Installation Align the cephalometric unit. If necessary, Attach the cephalometric unit with four loosen the 4 bolts to balance the cephalo- M8x25 screws. metric arm. Attach the ambient light and connect the electricity. Attach the cephalometric unit with two M6x20 screws. When making ambient light electrical con- nection make sure that the nearby optical cable and other cables of the unit are not...
  • Page 36 Installation Connect cable H003537A with “Ceph” on Screw two M10 x 30 screws into the floor the MCU board. stand. 1 Ambient light cable 2 E-grabber card 3 MCU board Attach the upper panel. Floor stand mounting (optional) Mount the floor stand on the two screws. When installing the floor stand make sure that the mains cable and the other cables of the unit are not damaged.
  • Page 37 Installation Tighten the floor stand using two M10 x 20 Remove the two screws that act as trans- screws. port locks to secure the C-shaped arm and put them in a safe place. Tighten the two screws under the floor stand.
  • Page 38 Installation Use a spirit level to align the unit crossways. Attach the floor stand cover with three M5 x 8 screws. Align the cephalometric unit. If necessary, loosen the 4 bolts to balance the cephalo- metric arm. Screw in the corresponding screws as required to align the unit.
  • Page 39 Installation Attach the cephalometric unit with four Connect cable H003537A with “Ceph” on M8x25 screws. the MCU board. 1 Ambient light cable 2 E-grabber card 3 MCU board Attach the upper panel. Attach the ambient light and connect the Limiting the height adjust- electricity.
  • Page 40 – Connection manager is installed with the VistaPano install package – Runs automatically when the PC is started – Establishes the connection between the PC and VistaPano S 2.0 – Connection state – gray : Unit off or not connected –...

  • Page 41: Connecting The Unit

    The voltage connected to the door contact switches and exposure switches must not exceed 24 V. 1 CN101 Exposure switch 2 CN103 Door contact switch 3 Ethernet connection for VistaPano S 2.0 Acquisi- tion PC CN100 CN104 CN101 EXPO_SW2 DOOR Switch 1 VistaPano S 2.0...

  • Page 42: Network Connection

    Installation Connect the cable to Slot CN101. Established ethernet connection. Installing the door contact switch (optional) Network connection Route the cable of the door contact switch Purpose of the network connection through the cable bushing to the front into The network connection is used to exchange the column.

  • Page 43: Commissioning And First Start-Up

    Installation Commissioning and first One time Pano (SD) acquisition. start-up Installing and configuring the unit Electrical safety checks Device report Carry out the electrical safety check accord- ing to national law (e. g. in accordance with Call up the device report to check or contact the IEC 62353).

  • Page 44: Calibrating The Unit

    Installation Creating an X-ray station If the image acquisition type is to be dis- played in the menu bar, tick the check box Click Automatic search. next to Favorite. The wizard will open. Result: Select an X-ray station from the list. The configuration is active for the next image If the X-ray station is not in the list, this acquisition with this image acquisition type.
  • Page 45 Installation First adjust the adult collimator. If the radiation field does not strike the sensor at PressImage Calibration > Collimator Align- right angles, the collimator will need to be man- ment (Adult) > Go. ually corrected on the unit. Press Initialize > AutoAlign. The current position of the adult collimator is displayed.
  • Page 46 Installation Realign the collimator with the AISU tool. Check the calibration of the collimators with the RAW viewer. The collimator adjustment has been suc- cessful if the radiation field strikes the sensor End the calibration. To do so, press Close. at right angles.
  • Page 47 Installation Collimator too far left or right Remove the collimator cover. If the collimator is too far to the left or right, adjust the value for the collimator. Press Capture. An X-ray image is captured with the current collimator position. Slightly loosen the four screws on the colli- mator.
  • Page 48 Installation Determine position of the copper filter. Start the X-ray image acquisition. Press Pano > Copper filter position > GO. Stop the X-ray image acquisition when the message Release X-ray button is displayed. Click Initialize. Confirm the message Bright capture. Press RawViewer.
  • Page 49 Installation Press Auto calibration and follow the pro- Press Image calibration > Ceph > Sensor gram. Calibration > GO. Click Initialize. After calibrating the sensor upload the data to the unit. Click Auto calibration. Start AISU Service > Upload. After calibrating the sensor upload the data Press Select File >...
  • Page 50 Installation Calibrate the ear rods Press Image calibration > Pano > Phantom Alignment (Lat) > GO. Set the ear rods for lateral mode. Click Initialize. Remove the ear cushion. Press Capture. An X-ray image is captured with the current collimator position. The X-ray image can be viewed in RAW Viewer.
  • Page 51 Installation Loosen the screws lightly to set the ear rod Adjust the angle a little. bracket in the Y direction. Set the X-ray image in the AISU tool again. If both ear rods are identical, the calibration Slide the ear rod bracket in the Y direction. was a success.

  • Page 52: Acceptance Check

    Installation Upload CAL files. Monitoring the unit via the Press Service > Bright File Upload. network Combining devices safely – Safety and essential performance features are independent of the network. The device is designed appropriately for operation inde- pendent of a network. However, some of the functions are not available in this case.

  • Page 53: Default Values

    Appendix Appendix Default values Pano Scan and exposure times Program Arch Exposure time Scan time Exposure time Scan time Standard pan- Wide 13.5 14.0 oramic Normal 13.5 14.0 Narrow 13.5 14.0 Child 11.5 12.3 Right, Left Wide 14.0 Normal 14.0 Narrow 14.0 Child...
  • Page 54 Appendix Program Arch Exposure time Scan time Exposure time Scan time Maxillary joint Wide 11.6 11.6 Normal 11.6 11.6 Narrow 11.6 11.6 Child 11.6 11.6 Scan time: The actual time that the equipment shoots the patient except for the initial acceleration and late deceleration stages.
  • Page 55 Appendix Mode Patient Voltage Current Voltage Current Maxillary joint, Large 10.0 10.0 lateral Average 10.0 10.0 Small 10.0 10.0 Child Maxillary joint Large 10.0 10.0 Average 10.0 10.0 Small 10.0 10.0 Child Ceph Scan and exposure times Program Exposure time Scan time Exposure time Scan time...

  • Page 56: Child

    Appendix Mode Patient Voltage Current Voltage Current Average 14.0 15.0 Small 14.0 15.0 Child 14.0 15.0 Carpus Large Average Small Child EN-US 2208100052L01 A9302 2504V001...

  • Page 57: Panoramic Program Parameters

    Appendix 10 Panoramic program parameters X-rays generated from the X-ray focal spot pass through the X-ray beam limiting device for each patient position to create an image reception area. DAP is calculated by a combination of air kerma that measured in the image receptor and the reception area .

  • Page 58: Average Built Patient

    Appendix Image qual- Program Arch Voltage Current Exposure time mGycm Bitewing Wide 87.4 Child 87.4 Bitewing Wide 43.8 Right, Left Child 43.8 Bitewing Wide 22.2 Front Child 22.2 Orthogonal Wide 160.1 13.5 Child 123.4 13.5 SD/HD Sinus Lat Wide 70.3 Child 54.1 Sinus PA...

  • Page 59: Small Patient

    Appendix Image qual- Program Arch Voltage Current Exposure time mGycm Bitewing Wide 85.2 Child 85.2 Bitewing Wide 42.7 Right, Left Child 42.7 Bitewing Wide 21.4 Front Child 21.4 Orthogonal Wide 157.0 13.5 Child 121.0 13.5 SD/HD Sinus Lat Wide 68.6 Child 52.8 Sinus PA...

  • Page 60: Child (<12 Years)

    Appendix Image qual- Program Arch Voltage Current Exposure time mGycm Bitewing Wide 83.1 Child 83.1 Bitewing Wide 41.6 Right, Left Child 41.6 Bitewing Wide 20.8 Front Child 20.8 Orthogonal Wide 153.9 13.5 Child 118.6 13.5 SD/HD Sinus Lat Wide 66.9 Child 51.5 Sinus PA...
  • Page 61 Appendix Image qual- Program Arch Voltage Current Exposure time mGycm Bitewing Wide 58.4 Child 58.4 Bitewing Wide 29.2 Right, Left Child 29.2 Bitewing Wide 14.6 Front Child 14.6 Orthogonal Wide 109.4 13.5 Child 84.3 13.5 SD/HD Sinus Lat Wide 47.0 Child 36.2 Sinus PA...

  • Page 62: Ceph Program Parameters

    Appendix 11 Ceph program parameters The extraoral dental X-ray system meets the requirements set out in standard IEC 60601-2-63. The dosage information complies with the requirements of the standard and is stated in mGy. Radiation accuracy: Information about the overall uncertainty of the stated values for air kerma and dose area product shall be noted in the accompanying document and must not exceed 50%.

  • Page 63: Small Patient

    Appendix Image quality Program Voltage Current Exposure time mGycm Head, lateral 90.9 Head PA 87.4 87.4 Waters View 87.4 Carpus 38.2 11.3 Small patient Image quality Program Voltage Current Exposure time mGycm Head, lateral 22.5 Head lateral full 37.9 format Head PA 26.2 26.2...
  • Page 64 Appendix Image quality Program Voltage Current Exposure time mGycm Head, lateral 84.0 Head PA 81.5 81.5 Waters View 81.5 Carpus 35.6 EN-US 2208100052L01 A9302 2504V001...

  • Page 65: Information On Scattered Radiation

    Appendix 12 Information on scattered radiation 12.1 Measuring conditions 180° 90° 270° 0° 12.2 Pano, adult Test conditions standard Pano, adult Distance from focal point 1 m, 1.5 m, 2 m Generator voltage 90 kVp Current 14 mA Exposure time 13.5 s HD, 13.5 s 1.5 m...

  • Page 66: Pano, Pediatric

    Appendix 12.3 Pano, pediatric Test conditions standard Pano, child Distance from focal point 1 m, 1.5 m, 2 m Generator voltage 90 kVp Current 14 mA Exposure time 11.4 s HD, 11.5 s 1.5 m ° Nose 0,601 µGy 0,299 µGy 0,168 µGy 0,648 µGy 0,333 µGy...

  • Page 67: Ceph, Lat

    Appendix 12.4 Ceph, lat Test conditions Ceph, lat Distance from focal point 1 m, 1.5 m, 2 m Generator voltage 99 kVp Current 16 mA Exposure time 7.7 s 1.5 m ° Nose 0.342 µGy 0.229 µGy 0.148 µGy 0.472 µGy 0.144 µGy 0.08 µGy Right ear...
  • Page 68 Appendix EN-US 2208100052L01 A9302 2504V001...

  • Page 69: Information On The Leakage Rate

    Appendix 13 Information on the leakage rate 13.1 Measuring conditions 0° 90° 270° 180° 13.2 Standard Pano Test conditions standard Adult Child Pano, HD Distance from focal point 39.37 in Generator voltage 90 kVp Current 14 mA Exposure time 13.4 s 11.4 s Direction Adult, dose...
  • Page 70 Appendix Direction Adult, dose Child, dose ° mGy/h mGy/h 0.068 0.064 0.227 0.106 0.214 0.11 0.019 0.018 0.041 0.048 0.053 0.068 0.051 0.066 0.044 0.056 0.059 0.161 0.052 0.139 0.029 0.031 0.016 0.018 0.011 0.013 0.012 0.013 0.072 0.071 0.021 0.024 0.012 0.012...

  • Page 71: Ceph

    Appendix Erwachsener Kind Adult Child 13.3 Ceph Test conditions Ceph Distance from focal point 39.37 in Generator voltage 99 kVp Current 16 mA Exposure time 7.7 s Direction Adult, dose ° mGy/h 0.434 0.289 0.267 0.238 0.18 0.144 0.069 0.148 0.131 0.241 0.134...
  • Page 72 Appendix Direction Adult, dose ° mGy/h 0.092 0.086 0.096 0.075 0.051 0.031 0.035 0.184 0.047 0.027 0.021 0.018 0.019 0.021 0.025 0.039 0.038 0.029 0.03 0.069 0.069 0.34 0.272 EN-US 2208100052L01 A9302 2504V001...

  • Page 73: Quality Control Measures

    Appendix 14 Quality control measures Descriptions and instructions to assist in the repair of parts are provided specifically by Air Techniques approved and authorized service personnel. For technical assistance with quality control procedures, contact your local service representative. 14.1 Pano Test Frequency Testing tool...
  • Page 74 Appendix Test Frequency Testing tool Permissible criteria (Phantom/S Tube voltage Annually Voltage ≤ 10% of the specified value measure- ment device Collimator Min pixels Max pixels Left Right Threshold value 90% Limitation and align- Bottom VisionX ment of the Annually Inspect X-ray beam (4% slice)

  • Page 75: Warranty

    Appendix 15 Warranty Device is warranted to be free from defects in material and workmanship from the date of installation for a period of 2 years (24 months). Device is designed solely for use in a dental office environment and this warranty is not applicable to other applications.
  • Page 80 Distributed by: Air Techniques, Inc. 1295 Walt Whitman Road Melville, New York 11747-3062, USA Phone: +1 800-247-8324 Fax: +1 888-247-8481 www.airtechniques.com Hersteller/Manufacturer: VATECH Co. Ltd. 13, Samsung 1-ro 2-gil Hwaseong-si, Gyeonggi-do, 18449 Korea Fon: +82 1588-9510 www.vatech.com Australian Sponsor: Emergo Australia | Level 20 Tower II | Darling Park | 201 Sussex Street Sydney, NSW 2000 | Australia...

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