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Air Techniques ProVecta 3D Prime Installation Instructions Manual

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ProVecta 3D Prime
Installation instructions
EN
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Manufactured in Germany for
2210200497L41

A7767

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Summary of Contents for Air Techniques ProVecta 3D Prime

  • Page 1 ProVecta 3D Prime Installation instructions Manufactured in Germany for 2210200497L41  A7767...

  • Page 3: Table Of Contents

    Contents Important information Installation 1 About this document                2 6 Requirements                     18 Warnings and symbols           2 Installation/setup room          18 Copyright information            3...

  • Page 4: Important Information

    Note, eg specific instructions regarding Air Techniques shall not be held liable the efficient use of the unit and offers no guarantees of the safe and smooth operation of this unit if you fail to...

  • Page 5: Copyright Information

    Therefore, please note the following Keep away from sunlight during storage 2.1 Intended use and indication Comply with the Operating Instructions ProVecta 3D Prime is computed tomography x- ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and Wear hand protection...

  • Page 6: Radiation Protection

    The sale or prescription of this device by a med- Air Techniques personnel or by a suitably ical practitioner is subject to the restrictions of qualified person approved by Air Techniques...

  • Page 7: Istics

    IEC60601-1-2:2014 mineral oil 2.10 Only use genuine parts 2.13 Protection from cybersecurity Only Air Techniques accessories and special threats accessories or those approved by Air Tech- niques may be used The unit is to be connected to a computer that...

  • Page 8: Product Description

    Product description Overview 14 13 3D and panoramic X-ray unit Head supports with cushion Wall bracket Hygienic protective covers for bite block Frame grabber card 10 Bite block USB dongle 11 Adapter for bite block USB stick with device-specific calibration 12 Chin holder for maxillary joint image data 13 Chin holder for edentulous jaws Small parts set (eg screws, nuts)

  • Page 9: Scope Of Delivery

    Bottom wall bracket set, 16 inch, ProVecta 3D Prime                  A7750 short (wall/wall installation)            A7754 –...

  • Page 10: Technical Data

    Fuses* (2 pcs) T 100 AH / 250 V~ (IEC 60127-2, Sheet 5) * The fuses may only be replaced by Air Techniques or by a body authorized by Air Techniques Classification Medical device of class Medical Devices Directive 93/42/EEC...

  • Page 11: X-Ray Tube Performance Data

    Product description X-ray emitter Nominal current, high voltage generator 4-16 (± 10%, max 75kV16mA, max99kV10mA) Cooling, high-voltage generator Automatic monitoring Shut-off at ≥ 60°C Additional filtration at 50 kV mmAl 20 + 30 (autom added for CBCT) inAl 008 + 012 (autom added for CBCT) Integrated filtration at 50 kV mmAl inAl...
  • Page 12 Product description Emission and Filament Characteristics Constant potential high-voltage generator Nominal Focus Spot Value: 0.5 80kV 100kV 50kV FILAMENT CURRENT [A] Anode Thermal Characteristics 175 W COOLING HEATING TIME (min) Detector Pano/CBCT Brand Xmaru1404CF Type CMOS photodiode array Pixel size 495 99 (2x2 binning) μm 198 (4x4 binning)
  • Page 13 Product description Detector Pano/CBCT Frame rate 535 107 (2x2 binning) 308 (4x4 binning) Greyscale Image capture scale Acquisition mode (magnification factor) 4777 1223 Panoramic 126 2362 1881 481 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 Electromagnetic compatibility (EMC) Interference emission measurements...
  • Page 14 Product description Immunity to interference levels by near fields of wireless HF communication devices Radio service Frequency band Test level TETRA 400 380 - 390 GMRS 460 430 - 470 FRS 460 LTE band 13, 17 704 - 787 GSM 800/900 TETRA 800 iDEN 820 800 - 960 CDMA 850 LTE band 5 GSM 1800 CDMA 1900 GSM 1900 1700 - 1990...

  • Page 15: Dimensions

    Product description 4.2 Dimensions 1212 mm 47,72 in 2210200497L41 1812V002...

  • Page 16: Model Identification Plate

    Product description 4.3 Model identification plate Type plate for the complete system X-ray tube type plate 4.4 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 2210200497L41 1812V002...

  • Page 17: Function

    Product description Function 5.2 Operating elements Emergency stop switch Touch screen On/off switch Button for opening/closing the head sup- X-ray tube ports C-shaped elbow Button for positioning beams on/off Status LED Buttons for height adjustment Operating elements The touch screen can be used to operate the Memory card slot unit Information can be entered on the touch screen with the tip of a finger...

  • Page 18: Status Led

    Product description 5.3 Status LED Lever for positioning the upper canine posi- tioning beam Mid-sagittal positioning beam Grips The applied parts in accordance with IEC 60601-1 are: – Grips – Head supports with cushion – Positioning aids (egbite block and mounting for bite block, chin support for edentulous patients) Description of the positioning aids...

  • Page 19: Exposure Button

    Product description 5.5 Exposure button 5.7 Sensor window The active sensor surface is indicated by the Exposure switch markers in the corners of the sensor window The exposure switch is used to trigger the pre- The cross indicates the geometric mid-point of pared image acquisition and start the X-ray ex- the active sensor surface posure The LED indicates the status of the unit, as does the LED on the unit...

  • Page 20: Installation En

    Installation Radiation protection Only qualified specialists or persons Comply with all applicable X-ray protection trained by Air Techniques may install, regulations and X-ray protection measures connect, and commission the unit Use the prescribed X-ray protection equip- Requirements ment 6.1 Installation/setup room In order to reduce the level of X-ray exposure,...

  • Page 21: System Requirements For The Reconstruction Computer

    PC and the unit The processor and graphics board must meet the specifications and system requirements to ensure a faultless reconstruction Should these requirements not be met, Air Techniques does not provide any guarantee for faultless reconstruction CPU: ≥...

  • Page 22: Installation

    Installation Installation Check to see if the Tiltwatch display has been activated NOTICE Danger to components due to elec- trostatic discharge (ESD) Always switch off the operating volt- Tiltwatch age before carrying out any assembly or installation work on the device Before and during the installation or assembly work on the device, make sure that the person carrying out the work is earthed...

  • Page 23: Setting Up The Unit

    Installation 7.3 Setting up the unit Remove the foam packaging from the patient arm Requirements: Take out the cartons with the trim parts and – Easily accessible electrical connections covers and place to one side – The electrical connections comply with the The cartons marked Components inside requirements (see "4 Technical data") contain parts or accessories Requirements for wall/floor installation:...
  • Page 24 Installation Installing the column with column slide Attach the upper wall mounting bracket (refer to the accessories carton) to the column Keep the column in the foam parts and lay it down in front of the wall to position it CAUTION The unit could tip over and cause injuries. Position the unit or secure it appropri- ately such that it cannot tip over Place some foam from the packaging under the upper part of the column This will make it...
  • Page 25 Installation Attach the retaining plate to the column Figure 2: Possible mounting position for the lower wall mounting bracket Secure the wall mounting bracket to the re- taining plate Roughly align the column Here, the wall mounting bracket can be at- Fine adjustment is performed later on once tached in several different mounting positions the cross-member has been installed...
  • Page 26 Installation Roughly align the column again Detach the cable from the column slide in front of the mounting face and reroute it to the rear Check to make sure that the mounting faces on the cross-member and on the column slide are clean and free of damage Drill the anchor holes for the floor plate It is possible to drill through the holes in the...
  • Page 27 Installation Use the transport grips to lift the cross-mem- One or two persons secure the cross-member ber with C-shaped arm out the foam parts with C-shaped arm, while another person at- and place the cross-member on the column taches the cross-member to the column slide slide with the two bushings and screws Here, the pins serve as centering aids/guides...
  • Page 28 Installation Position the assembly aid for the locating Tighten the locating screw by hand To do screw and carefully tap in the locating screw this, it may be necessary to exert some pres- with a hammer until it reaches the stop sure on the screw Failure to use the assembly aid may lead to damage to the screw thread...
  • Page 29 Installation Check the alignment of the cross-member Fit the cover plate with a spirit level Correct its position with the adjustable feet on the floor plate To do this, it may be necessary to loosen the screws on the floor plate and on the wall mounting brackets Remove the transport grips Pull off the protective film from the column...
  • Page 30 Installation C LIMIT Export A01-CN1706 A01-CN1300 Connect the wiring connections from the col- umn slide to the cables and sockets on the cross-member Attach the ferrite core of cable A01-CN1706 close to PCBA01 Using cable ties, tie together all cables that run from the cross-member to the column slide and secure them This will prevent any cables from being...
  • Page 31 Installation Removing the transport locks and secure them with adhesive tape if re- quired The screws may be difficult to remove as they are fitted with screw locks Do not dispose of the screws from the transport locks Remove the screws from the X-slide and Y- slide Installing the housing parts Throughout the entire installation pro-...
  • Page 32 Installation Position the cover on the C-shaped arm and Attach the sensor cover and retightened the slide it to the rear loosened screws In the process, make sure that the four mountings on the sensor cover are plugged in between the cast bracket and cover Secure the cover with a screw and washer 2210200497L41 1812V002...
  • Page 33 Installation Mount the lower covers on the left and right of Check to make sure that the covers are seat- the cross-member ed correctly The Y-cover (white plastic panel) must lie between the housing and the cast part of the cross-member The notch in the Y-cover must face forwards and be located in the desig- nated mounting of the housing...
  • Page 34 Installation Tighten the lower covers on the left and right Left-hand cover: three screws with washers screwed in from above Left-hand cover: one screw with washer screwed in from below Right-hand cover: three screws with wash- Mount the upper cover of the cross-member ers screwed in from above Right-hand cover: one screw with washer screwed in from below...

  • Page 35: Computer

    Installation Mount the upper column cover Mount the lower column cover Do not yet fit the silicone covers for the screw holes in case any parts of the housing need to be taken off again 2210200497L41 1812V002...

  • Page 36: Preparation Of The Reconstruction

    If the Start menu does not open automatically, run the file Start.exe Select the installation language you require Accept the Licence Agreement Select the required components Select the ProVecta 3D Prime unit Follow the further instructions given by the in- stallation wizard Installing the frame grabber card and USB dongle...
  • Page 37 Installation Removing the housing cover In order to be able to connect the unit, the front cover on the column needs to be removed Remove the screw X01 Optic Pano: Connection to the recon- struction computer X02 Optic Ceph: Connection to the Ceph unit (no function) PCB A07: Connection to the exposure Remove the cover...
  • Page 38 Installation Installing the exposure switch Remove the cable bridge from slot X6 DOOR Route the cable of the exposure switch though the cable bushing to the front into the column Connect the cable to the PCB A07 Slot X2: EXP SW Route the cable of the door contact switch through the cable bushing to the front into the column When using slot X4 (RJ45), connect the signal...
  • Page 39 Installation Connecting the equipotential bonding If equipotential bonding is required in order to comply with local regulations and requirements for connections, this connection can be made via the connection on the rear of the unit Connect the equipotential bonding cable (not included in the scope of delivery) to the con- nection on the unit The connection complies with DIN 42801 The connection for the equipotential bonding...

  • Page 40: Limiting The Height Adjustment

    Installation in accordance with current valid national and Layout as 2/PE AC 200–240 V (US) local regulations and standards governing the Connect the wires of the mains connection installation of low voltage units in medical fa- cable to the mains cilities Note the current consumption of the devices that are to be connected...

  • Page 41: Commissioning And First Start-Up

    Installation Commissioning and first Remove the adjustment cam and screw it back on in the required position of the unit start-up NOTICE Short circuit due to the build-up of condensation Do not switch on the unit until it has warmed up to room temperature and is dry The required tests (egacceptance test) must be done in accordance with local rules and reg- ulations Find out which tests are required...

  • Page 42: Electrical Safety Checks

    Installation Configuring the unit The main power switch lights up green after The configuration is done in the settings of the it is switched on The status LED lights up imaging software blue Start the imaging software Click  Click Devices Check to make sure that the checkmark is placed in the column Connected This shows that the unit is connected to the imaging software and that it has been...

  • Page 43: Carrying Out A Functional Test

    Installation 8.5 Carrying out a functional test At least 25LP/mm and two contrast bores must be visible In countries, in which the acceptance and con- sistency checks are a legal requirement, the The image must be uniform and free of arti- functional test can be omitted facts The functional test must be performed to ensure Since this image is a processed X-ray...
  • Page 44 For over 50 years, Air Techniques has been a leading innovator and manufacturer of dental products. Our priority is ensuring complete satisfaction by manufacturing reliable products and providing excellent customer and technical support. Whether the need is digital imaging, utility room equipment or merchandise, Air Techniques can provide the solution via our network of authorized professional dealers.

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