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Air Techniques ProVecta 3D Prime Installation Instructions Manual

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ProVecta 3D Prime
EN-
US
Installation instructions
2210200497L41
*2210200497L41*
A7767

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Summary of Contents for Air Techniques ProVecta 3D Prime

  • Page 1 ProVecta 3D Prime Installation instructions 2210200497L41 *2210200497L41* A7767...

  • Page 3: Table Of Contents

    Contents Contents Exposure button ... . . Memory card slot ... . Sensor window ....Important information About this document .

  • Page 4: Important Information

    These installation instructions are an integral part of the unit. – CAUTION Risk of minor injuries Air Techniques shall not be held liable and – NOTICE offers no guarantees of the safe and Risk of extensive material/property damage smooth operation of this unit if you fail to...

  • Page 5: Copyright Information

    Printing or copying these Installation and Operat- ing Instructions, including excerpts thereof, may only be carried out with the written approval of Lower and upper temperature limits Air Techniques. Lower and upper humidity limits no condensation Stacking limits Recycling...

  • Page 6: Safety

    Intended use and indication licensed medical practitioner. Caution: Federal law restricts this device ProVecta 3D Prime is computed tomography x- to sale by or on the order of a Doctor. ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and pediatric patients.

  • Page 7: Specialist Personnel

    All installation, resetting, alteration, expansion, ❯ reduced electromagnetic immunity, and repair work must be carried out either by leading to an erroneous operation Air Techniques personnel or by a suitably quali- mode. fied person approved by Air Techniques. NOTICE Protection from electric...

  • Page 8: Only Use Genuine Parts

    2.11 Only use genuine parts 2.14 Protection from cybersecurity threats Only Air Techniques accessories and special ❯ accessories or those approved by Air Techni- The unit is to be connected to a computer that ques may be used. can be connected to the Internet. Therefore, the Only use original spare and replacement parts.

  • Page 9: Product Description

    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...

  • Page 10: Scope Of Delivery

    ......A7395 ProVecta 3D Prime ....A7750 Silicone pads for head support Plus .

  • Page 11: Technical Data

    Maximum power Fuses* (2 pcs.) T 10.0 AH / 250 V~ (IEC 60127-2, Sheet * The fuses may only be replaced by Air Techniques or by a body authorized by Air Techniques. Classification Medical device of class FDA classification (CFR Title 21)

  • Page 12: X-Ray Tube Performance Data

    Product description X-ray emitter Nominal voltage, high-voltage generator 50 - 99 (±10 %) Nominal current, high voltage generator 4 - 16 (± 10%, max. 75 kV 16 mA, max. 99 kV 10 mA) Cooling, high-voltage generator Automatic monitoring Shut-off at ≥ 60°C Additional filtering at 50 kV 2.0 + 3.0 (added automatically for CBCT) mm Al...
  • Page 13 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 14 Product description Anode Thermal Characteristics 175 W COOLING HEATING TIME (min) Detector Pano/CBCT Brand Xmaru1404CF Type CMOS photodiode array Pixel size μm 49.5 99 (2x2 binning) 198 (4x4 binning) 0.001949 0.003898 (2x2 binning) 0.007795 (4x4 binning) Sensor size 230 x 160 x 26 9.06 x 6.30 x 1.02 Active surface area 135.8 x 36.4...
  • Page 15 Product description Electromagnetic compatibility (EMC) Interference emission measurements High-frequency emissions in accordance with CISPR 11 Group 1 Interference voltage at the power supply connection Class A CISPR 11:2009+A1:2010 Electromagnetic interference radiation Class A CISPR 11:2009+A1:2010 Emission of harmonics Class A IEC 61000-3-2:2005+A1:2008+A2:2009 Voltage changes, voltage fluctuations, and emission of Conforms...
  • Page 16 Product description Immunity to interference levels by near fields of wireless HF communication devices Radio service Frequency band Test level GSM 1800 CDMA 1900 GSM 1900 1700 - 1990 DECT LTE bands 1, 3, 4, 25 UMTS Bluetooth WLAN 802.11 b/g/n 2400 - 2570 RFID 2450 LTE band 7...

  • Page 17: Dimensions

    Product description Dimensions 572,5 mm 22,54 in 1212 mm 47,72 in 2210200497L41 1911V004...

  • Page 18: Model Identification Plate

    Product description Model identification plate Type plate of the unit Type plate of the X-ray tube 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 19: Function

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

  • Page 20: Status Led

    Product description 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 (e.g. bite block and mounting for bite block, chin support for edentulous patients) Description of the positioning aids...

  • Page 21: Exposure Button

    Product description Exposure button The unit has a slot for a memory card. The slot is needed for service purposes only. Exposure switch Sensor window The exposure switch is used to trigger the pre- pared image acquisition and start the X-ray expo- The active sensor surface is indicated by the sure.

  • Page 22: Requirements

    Only qualified specialists or persons Children and pregnant women must consult a ❯ trained by Air Techniques may install, doctor before recording an X-ray image. connect, and commission the unit. No person other than the patient is permitted ❯...

  • Page 23: 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.

  • Page 24: Installation

    Installation Check to see if the Tiltwatch display has been ❯ Installation 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 25 Installation Take out the accessories carton and the carton ❯ The column can be lifted more easily off with cross-member and C-shaped arm and the pallet if the lowest outer carton is place to one side. folded to the outside. Take out the column with column slide and ❯...

  • Page 26: Setting Up The Unit

    Installation Setting up the unit Installation variants Standard Default Default Walls not with addi- Without With under- able to take tional wall underfloor floor heating the load bracket at heating the bottom 240 (529) Weight in kg (lbs) 180 (397) 180 (397) 180 (397) (with stand)
  • Page 27 Installation As an alternative to the supplied wall Requirements mounting bracket, it is also possible to – Easily accessible electrical connections use a short wall mounting bracket (see – The electrical connections comply with the "3.2 Optional items"). This will move the requirements (see "4 Technical data") unit closer to the wall.
  • Page 28 Installation Set up the column with the aid of the transport Secure the wall mounting bracket to the retain- ❯ ❯ grips. ing plate. Here, the wall mounting bracket can be Remove the foam parts. ❯ attached in several different mounting posi- Remove the lower transport grip.
  • Page 29 Installation Roughly align the column. Drill the anchor holes for the floor plate. ❯ ❯ Fine adjustment is performed later on once the It is possible to drill through the holes in the cross-member has been installed. floor plate (max. drill bit diameter 10 mm). This step is omitted if the column cannot be screwed to the floor.
  • Page 30 Installation Installing the cross-member with rotating unit Check to make sure that the mounting faces ❯ on the cross-member and on the column slide Place the carton with cross-member and C- ❯ are clean and free of damage. shaped arm in front of the column. Remove the carton.
  • Page 31 Installation One or two persons secure the cross-member ❯ During the following steps, maintain the with C-shaped arm, while another person correct sequence when tightening the attaches the cross-member to the column slide screws. with the two bushings and screws. Use the transport grips to lift the cross-mem- ❯...
  • Page 32 Installation Position the assembly aid for the locating Tighten the locating screw by hand. To do this, ❯ ❯ screw and carefully tap in the locating screw it may be necessary to exert some pressure on with a hammer until it reaches the stop. the screw.
  • Page 33 Installation Check the alignment of the cross-member with Fit the cover plate. ❯ ❯ 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.
  • Page 34 Installation Connecting the cross-member Connect the wiring connections from the col- ❯ umn slide to the cables and sockets on the Route the cables from the column slide ❯ cross-member. through the cable attachments. Connection T01 Protective ground connection PCB A01 Export C LIMIT A01-CN1706...
  • Page 35 Installation Attach the ferrite core of cable A01-CN1706 Remove the screw and threaded pin from the ❯ ❯ close to PCBA01. cross-member securing the C-shaped arm. Using cable ties, tie together all cables that run ❯ from the cross-member to the column slide and secure them.
  • Page 36 Installation Loosen the four screws of the mounted covers, Secure the cover with a screw and washer. ❯ ❯ but do not remove them completely. Position the cover on the rotating unit and slide ❯ it to the rear. 2210200497L41 1911V004...
  • Page 37 Installation Attach the sensor cover and retightened the Mount the lower covers on the left and right of ❯ ❯ loosened screws. the cross-member. In the process, make sure that the four mount- ings on the sensor cover are plugged in between the cast bracket and cover.
  • Page 38 Installation Check to make sure that the covers are seated Tighten the lower covers on the left and right. ❯ ❯ 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 designated mounting of the housing.
  • Page 39 Installation Mount the lower cover to the front of the cross- Mount the upper cover of the cross-member. ❯ ❯ member. For the installation use screws with washers (max. ∅ of the washer: 20 mm). 2210200497L41 1911V004...

  • Page 40: Preparation Of The Reconstruction Computer

    Do not yet fit the silicone covers for the screw ❯ holes in case any parts of the housing need to be taken off again. Preparation of the recon- struction computer The unit supports the following imaging pro- grams: – VisionX made by Air Techniques 2210200497L41 1911V004...

  • Page 41: Connecting The Unit

    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 ❯ installation wizard. Installing the frame grabber card and USB...
  • Page 42 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 43 Installation Connect the cable to the PCB A07. Remove the cable bridge from slot X6 DOOR ❯ ❯ Slot X2: EXP SW Route the cable of the door contact switch ❯ Installing the door contact switch (optional) through the cable bushing to the front into the A door contact switch can be connected to the column.
  • Page 44 Installation for connections, this connection can be made via Remove the protective cap from the connector ❯ the connection on the rear of the unit. of the fiber optic cable and from the plug Connect the equipotential bonding cable (not socket on the PCB and plug the fiber optic ❯...
  • Page 45 Installation Insert the plug connector 1 into the outer Combining devices safely ❯ OPTIC1 port. Take care when connecting units together or to parts of other systems as there is always an ele- O P T I C 2 O P T I C 1 ment of risk (e.g.

  • Page 46: Limiting The Height Adjustment

    Installation Layout as 2/PE AC 200–240 V (US) Check for correct alignment when fasten- Connect the wires of the mains connection ❯ ing the adjustment cam. The beveled side cable to the mains. must face downwards. Remove the adjustment cam and screw it back ❯...

  • Page 47: Commissioning And First Start-Up

    Installation Commissioning and first Use the main power switch to switch 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.

  • Page 48: Electrical Safety Checks

    Installation Move the unit to the minimum height level of ❯ The USB stick contains device-specific the unit. calibration data. We recommend storing Are there any suspicious noises? the stick with the documents of the Is there a sufficient distance between the top device (e.

  • Page 49: Performing An Acceptance Test

    Installation Performing a pano functional test Positioning the test body Remove the mounting for bite block, chin sup- ❯ ports etc. Insert the holder for the pano test body. ❯ Insert the pano test body in the holder. ❯ Taking the X-ray image Take a test image.

  • Page 50: Appendix

    Appendix Appendix Handover record This document confirms that a qualified handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN)
  • Page 52 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 excel- lent 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 deal- ers.

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