KaVo ProXam iP Instructions For Use Manual
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KaVo ProXam iP Instructions For Use Manual

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Instructions for use

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Summary of Contents for KaVo ProXam iP

  • Page 1 KaVo ProXam iP Instructions for use...
  • Page 2 The manufacturer, assembler and importer are responsible for the safety, reliability and performance of the unit only if: - installation, calibration, modification and repairs are carried out by qualified authorised personnel - electrical installations are carried out according to the appropriate requirements such as IEC 60364 - equipment is used according to the operating instructions.

  • Page 3: Table Of Contents

    2.3.2 Operating elements......................19 2.3.3 Connections......................... 20 2.3.4 Cartridges (S0-S2)....................... 20 2.3.5 Imaging plate........................21 Light protection cover........................21 Assembly..............................22 Requirements..........................22 3.1.1 Installation/setup room....................22 3.1.2 System requirements....................22 3.1.3 Monitor......................... 22 Installation............................ 22 Instructions for use KaVo ProXam iP...
  • Page 4 Network connections....................28 Commissioning..........................30 3.3.1 Network configuration....................30 3.3.2 Network protocols and ports..................30 3.3.3 Configuring unit in KaVo Device Tool for ProXam iP........... 30 3.3.4 X-ray unit settings......................31 3.3.5 Acceptance tests......................32 Usage............................... 34 Correct use of imaging plates.......................34 Operation............................36...

  • Page 5: Important Information

    This Instructions for use represents a part of the unit. If the instructions and information in this Instructions for use are not followed, KaVo will not be able to offer any warranty or assume any liability for the safe operation and the safe functioning of the unit.
  • Page 6 Switch off and de-energise the unit (e.g. unplug from mains) Do not reuse Health Industry Bar Code (HIBC) Direct current (DC) Non-ionizing electromagnetic radiation This way up / store and transport in an upright position Keep dry Stacking limits KaVo ProXam iP Instructions for use...

  • Page 7: Copyright Information

    • Personal injury due to lack of hygiene, e.g. infection. 1.2.1 Intended purpose KaVo ProXam iP The unit is intended exclusively for use in dental applications for the scanning and processing of image data on an image plate. Instructions for use...

  • Page 8: Intended Use

    • to protect against cross-contamination 1.2.2 Intended use KaVo ProXam iP The unit may only be operated using accessories and optional articles manufactured by or branded with Dürr Dental. The unit may only be cleaned using the disinfectants and cleaning agents approved by and specified by the manufacturer.

  • Page 9: Qualified Personnel

    Instruct or have every user instructed in handling the unit. Installation and repairs Installation, readjustments, alterations, upgrades and repairs must be carried out by KaVo or by qualified personnel specifically approved and authorised by KaVo. 1.2.6 Electrical safety •...

  • Page 10: Essential Performance Characteristics

    1 Important information 1.2.7 Essential performance characteristics The KaVo ProXam iP unit does not possess any significant performance characteristics as set out in IEC 60601-1 (EN 60601-1) section 4.3. The unit complies with the requirements according to IEC 60601-1-2:2014. 1.2.8 Notification requirement of serious incidents...

  • Page 11: Protection From Threats From The Internet

    Restrict access to units to trustworthy users, e.g. via a user name and password • Make sure that only trustworthy content is downloaded • Only install software and firmware updates that have been authenticated by the manufacturer Instructions for use KaVo ProXam iP...

  • Page 12: Product Description

    2.1.1 Scope of delivery The following items are included in the scope of delivery (possible variations due to country-specific requirements and/or import regulations): • KaVo ProXam iP Imaging Plate Scanner • 2x KaVo imaging plate Size 0 • 2x KaVo imaging plate Size 1 •...

  • Page 13: Accessories

    Imaging plates and light protection covers • KaVo Imaging Plate and Light Protection Cover, Size 0 (Imaging plates 2 pcs, Light protection covers 1000 pcs) • KaVo Imaging Plate and Light Protection Cover, Size 1 (Imaging plates 2 pcs, Light protection covers 1000 pcs) •...

  • Page 14: Wear Parts And Replacement Parts

    Line pairs / mm (Lp/mm) approx. 16.7 Noise level during scanning dB(A) approx. 45 Network connection LAN technology Ethernet Standard IEEE 802.3u Data rate Mbit/s Connector RJ45 Type of connection Auto MDI-X Cable type ≥ CAT5 KaVo ProXam iP Instructions for use...
  • Page 15 Electromagnetic compatibility (EMC) interference immunity measurements cover Immunity to interference, discharge of static Compliant electricity IEC 61000-4-2:2008 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Instructions for use KaVo ProXam iP...
  • Page 16 GSM 1800 1700 - 1990 CDMA 1900 GSM 1900 DECT LTE band 1, 3, 4, 25 UMTS Bluetooth 2400 - 2570 WLAN 802.11 b/g/n RFID 2450 LTE band 7 WLAN 802.11 a/n 5100 - 5800 KaVo ProXam iP Instructions for use...
  • Page 17 ± 8 kV contact ± 2kV, ± 4 kV, ± 8 kV, ± 15 kV air Immunity to interference, rapid transient bursts – Compliant I/O, SIP/SOP ports IEC 61000-4-4:2012 ± 1 kV 100 kHz repetition frequency Instructions for use KaVo ProXam iP...

  • Page 18: Imaging Plate

    Relative humidity % < 80 Dimensions of intraoral imaging plates Size 0: 22 x 35 mm Size 1: 24 x 40 mm Size 2: 31 x 41 mm 2.2.3 Light protection cover Classification Medical Device Class (MDR) I KaVo ProXam iP Instructions for use...

  • Page 19: Type Plate

    European Union guidelines. This equipment conforms to all relevant requirements. Dürr Dental hereby declares that the radio system type "KaVo ProXam iP" conforms to directive 2014/53/EU. The full text of the EU Declaration of Conformity is available at www.duerrdental.com.

  • Page 20: Operation

    After scanning, the imaging plate runs through the erasure unit. Image data still held on the imaging plate is erased with the aid of bright light. The imaging plate is then ejected for re-use. KaVo ProXam iP Instructions for use...
  • Page 21 The status LEDs display the following status messages: Device starts Communication display Standby Ready to scan Imaging plate currently being processed Cartridge for imaging plate missing Error A message is displayed in the software Instructions for use KaVo ProXam iP...
  • Page 22 S2 cartridge for S2 imaging plate is in the device Status LED flashing 2.3.1.2 Connections The connections are located on the rear of the unit, underneath the cover. 1 Network connection 2 Reset button 3 Connection for power supply unit KaVo ProXam iP Instructions for use...

  • Page 23: Operating Elements

    The status LEDs display the following status messages: Device starts Communication display Standby Ready to scan Imaging plate currently being processed Cartridge for imaging plate missing Error A message is displayed in the software Instructions for use KaVo ProXam iP...

  • Page 24: Connections

    According to the imaging plate used, the cartridge corresponding to the size of the imaging plate must be inserted in the device. The cartridge that is currently in the device is indicated via the LEDs on the device. KaVo ProXam iP Instructions for use...

  • Page 25: Imaging Plate

    Use only distributor's imaging plates with the unit. The unit is unable to read any other types of imaging plates. 2.4 Light protection cover The light protection cover protects the imaging plate against light. Instructions for use KaVo ProXam iP...

  • Page 26: Assembly

    3 Assembly 3 Assembly NOTE Only qualified specialists or employees trained by KaVo are permitted to install, connect and start using the unit. 3.1 Requirements 3.1.1 Installation/setup room The room chosen for set up must fulfil the following requirements: •...
  • Page 27 About this task The unit can be mounted on a wall with the wall mounting bracket (optional article Wall Mounting Plate for KaVo ProXam iP). The following information is supplementary to the device Instructions for use. As a general rule, the Instructions for use for the device must also be observed.
  • Page 28 2. Remove rear rubber feet and the screws under them. 3. Remove the unit's rear side cover. Remove the cover plugs and the attachment screws under the edge of the rear side cover. KaVo ProXam iP Instructions for use...
  • Page 29 6. Mount cover by slotting the top edge into place (1), then closing the cover (2) and securing with screws. Make sure the cables are correctly fed through the bottom edge of the cover. NOTE When operating the device, the rear side cover must be mounted. Instructions for use KaVo ProXam iP...

  • Page 30: Electrical Connections

    The unit has no main power switch. For this reason it is important that the unit is be set up in such a way that the plug can be easily accessed and unplugged if required. KaVo ProXam iP Instructions for use...
  • Page 31 1. Attach the matching country-specific adapter to the power supply unit. 2. Remove the screw covers and screws from the bottom of the device. 3. Pull the cover back (1) and remove downwards from the rear of the device (2). Instructions for use KaVo ProXam iP...

  • Page 32: Network Connections

    • "Update" of devices that are connected to the IT network • "Upgrade" of devices that are connected to the IT network • The data connection utilises part of the bandwidth of the network KaVo ProXam iP Instructions for use...
  • Page 33 2. Connect the supplied network cable to the network connection of the device. NOTE The cover on the rear must be correctly fitted when the device is operated within the patient environment. 3. Refit the cover. Instructions for use KaVo ProXam iP...

  • Page 34: Commissioning

    1.3 or later: if no DHCP response, uses Auto-IP: 169.254/16 • Manual configuration (recommended) Configure the network settings of the unit using the KaVo Device Tool for ProXam iP. Check the firewall and release the ports, if applicable. 3.3.2 Network protocols and ports...

  • Page 35: X-Ray Unit Settings

    3 Assembly Steps 1. Start the KaVo Device Tool for ProXam iP. • Windows: Click the Start button and select the KaVo Device Tool for ProXam iP. • macOS: From the Applications, select KaVo Device Tool for ProXam 2. The unit can be searched and selected under the Unit tab.

  • Page 36: Acceptance Tests

    X-ray system must be carried out in accordance with national regulations. The constancy tests, which must be carried out at regular intervals by the surgery personnel, are based on the results of the acceptance test. KaVo ProXam iP Instructions for use...
  • Page 37 3 Assembly KaVo X-ray Intraoral Constancy test . For more information, see publication Electrical safety checks • Carry out the electrical safety check according to the national law (e. g. in accordance with IEC 62353) • Document the results •...

  • Page 38: Usage

    If the light protection cover has been damaged in the patient's mouth, rinse the mouth thoroughly with lots of water. Do not swallow the water in the process. • Imaging plates must only be read using an imaging plate scanner that is approved by the manufacturer. KaVo ProXam iP Instructions for use...
  • Page 39 If the imaging plate has been stored for longer than one week, erase the imaging plate prior to use. • Do not store imaging plates under hot or moist conditions. Observe the correct ambient conditions (see section "Technical data" on page 10). Instructions for use KaVo ProXam iP...

  • Page 40: Operation

    Loss of image information and equipment damage if an incorrect cartridge is used. Always use the correct size of cartridge for the imaging plate being used. Before each scanning process, compare the imaging plate size with the LED display on the control element. KaVo ProXam iP Instructions for use...
  • Page 41 1. Check that the correct cartridge has been inserted with the display (S0, S1, S2). If the incorrect cartridge has been inserted, it must be removed and the correct cartridge inserted. 2. Open the cover. Instructions for use KaVo ProXam iP...
  • Page 42 4 Usage 3. Remove cartridge. The green cartridge display extinguishes. When the device is ready to scan, the green status LED flashes in addition. KaVo ProXam iP Instructions for use...

  • Page 43: Capturing X-Ray Images

    Risk of cross contamination when not using the light protection cover or when using the light protection cover more than once Do not use an imaging plate without a light protection cover. Do not use the light protection cover more than once (disposable item). Instructions for use KaVo ProXam iP...
  • Page 44 1. If using it for the first time or if it has been stored for over a week: erase the imaging plate (see section "Erasing imaging plates" on page 46). 2. Completely slide the imaging plate into the light protection cover. The white (inactive) side of the imaging plate must be visible. KaVo ProXam iP Instructions for use...
  • Page 45 Damage to the imaging plate caused by a sharp-edged holding system. Only use holding systems that will not damage the light protection cover or the imaging plates in any way. Do not use holding systems with sharp edges. Wear protective gloves. Instructions for use KaVo ProXam iP...
  • Page 46 Clean and disinfect the light protection cover before removing the imaging plate. 2. In the event of heavy soiling, e.g. from blood, dry clean the light protection cover and protective gloves, e.g. wipe with a clean cellulose cloth. KaVo ProXam iP Instructions for use...

  • Page 47: Scanning Image Data

    2. Switch on the computer and monitor. 3. Start Romexis. 4. Select the patient. 5. Select the PSP capturing button. Recording starts directly. The green status LED lights up. 6. Scan the imaging plate at this point (and not before). Instructions for use KaVo ProXam iP...
  • Page 48 The imaging plate must not be pulled out of the light protection cover before placement on the input unit. There is the risk of image information being erased by ambient light (see section "Correct use of imaging plates" on page 34). KaVo ProXam iP Instructions for use...
  • Page 49 4. Remove the empty light protection cover. 5. Once the imaging plate has been inserted into the unit, close the cover and leave it closed throughout the entire scanning process. Instructions for use KaVo ProXam iP...

  • Page 50: Erasing Imaging Plates

    If, due to an error, the image data on the imaging plate has not been erased (software error message). Follow the steps below to erase imaging plates. Steps 1. Start Romexis. 2. Select a patient. 3. Click on the PSP capturing button. The capture window opens. KaVo ProXam iP Instructions for use...
  • Page 51 Ready for erasing. is ready for erasing, Romexis displays the message Please insert imaging plate into the scanner . 5. Open the scanner's cover. 6. Insert the imaging plate fully into the input unit. Instructions for use KaVo ProXam iP...

  • Page 52: Switching Off Unit

    The LEDs go out. 4.3 Cleaning and disinfection When cleaning and disinfecting the unit and its accessories, observe country-specific directives, standards and specifications for medical products as well as the specific specifications for dental practices and clinics. KaVo ProXam iP Instructions for use...

  • Page 53: Imaging Plate Scanner

    The manufacturer recommends ID 213, ID 212 or ID 212 forte instrument disinfectants for the cartridges if an immersion disinfection system is being used; these disinfectants have been subjected to material compatibility testing • Allow the cartridges to completely dry before using them Instructions for use KaVo ProXam iP...

  • Page 54: Light Protection Cover

    Disinfect the imaging plate storage tray using a disinfection wipe • Alternatively, the imaging plate storage tray can be treated in a thermal disinfector or steam steriliser Do not exceed a temperature of 134°C when doing this. KaVo ProXam iP Instructions for use...

  • Page 55: Maintenance

    Visually inspect the device. Check the imaging plates for signs of scratches and change if necessary. Remove dust and dirt from accessible parts. Carry out a system check. Every 3 years Exchange the cartridges. Instructions for use KaVo ProXam iP...

  • Page 56: Troubleshooting

    Always scan the image data of the imaging plate ambient light as quickly as possible. X-ray dose too low Check X-ray parameters. Incorrect brightness/contrast settings in the Adjust the brightness of the X-ray image in the software software. KaVo ProXam iP Instructions for use...
  • Page 57 Ghosting or double exposure on X-ray image Possible cause Remedy Imaging plate exposed twice Only expose the imaging plate once. Imaging plate not sufficiently erased Check the erasure unit is working correctly. Inform a service technician if the problem persists. Instructions for use KaVo ProXam iP...
  • Page 58 Shadow on X-ray image Possible cause Remedy Imaging plate removed from the light protection Do not handle imaging plates without a light cover before scanning protection cover. Store the imaging plate in a light protection cover. KaVo ProXam iP Instructions for use...
  • Page 59 X-ray tube and the patient. Check X-ray tube. Software unable to combine the data to make complete image Possible cause Remedy The X-ray dose on the imaging plate was Increase X-ray dose. insufficient Instructions for use KaVo ProXam iP...
  • Page 60 Turn the unit so that the light does not fall directly onto the input unit. X-ray image with small bright spots or clouding Possible cause Remedy Micro scratches on the imaging plate Replace the imaging plate. KaVo ProXam iP Instructions for use...
  • Page 61 Do not push out the imaging plate until the torn- off and before pushing into the input unit, off light protection cover has been placed on the the imaging plate is pushed out of the light input unit. protection cover Instructions for use KaVo ProXam iP...

  • Page 62: Software Errors

    Connection between PMII and CaptureUI has been interrupted. The connection may be recovered and the CaptureUI is usable without restarting. E20001 ProXam iP software Scanner software component Re-install the scanner software. error not found or cannot be started. If the problem continues, contact your service technician.

  • Page 63: Unit Faults

    E20003 Missing configuration Configuration file cannot be Reset the configuration with the read. KaVo Device Tool for ProXam If the problem continues, contact your service technician. E20004 Invalid configuration Configuration file has errors, the Reset the configuration with the...
  • Page 64 The ejected imaging plate can software. be imported on a suitable "Incorrect image plate type imaging plate scanner. Make E10025" sure that the imaging plate is protected against ambient light. KaVo ProXam iP Instructions for use...

  • Page 65: Terms And Conditions Of Warranty

    Claims from this warranty can only be asserted when the transfer form (copy) belonging to the product has been sent to KaVo, and the original can be presented by the operator or user. Exceptions to the standard warranty •...

  • Page 66: Appendix A: Resolution Data

    Intra Size 1 (2 x 4) 2.3 MB Intra Size 2 (3 x 4) 3.0 MB A.3 Contact information Distributor KaVo Dental GmbH, Bismarckring 39, 88400 Biberach, Germany Phone +49 7351 56-0, Fax +49 7351 56-1488 http://www.kavo.com Manufacturer DÜRR DENTAL SE Höpfigheimer Str. 17...

  • Page 67: Sample Handover Protocol Template

    Appendix A: Resolution data A.4 Sample handover protocol template Instructions for use KaVo ProXam iP...

  • Page 68: Appendix B: Country Representatives

    Appendix B: Country representatives Appendix B: Country representatives Country Address UK Responsible Person Duerr Dental (Products) UK Ltd. 14 Linnell Way Telford Way Industrial Estate Kettering, Northants NN 16 8PS KaVo ProXam iP Instructions for use...
  • Page 70 KaVo Dental GmbH | Bismarckring 39 | 88400 Biberach | Deutschland www.kavo.com...

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