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Dental Wings 100 Instructions For Use Manual

Intraoral scanner
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Intraoral Scanner
Instructions for Use
Original
Model 100
Model 001
dental wings

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  • Page 1 Intraoral Scanner Instructions for Use Original Model 100 Model 001 dental wings...

  • Page 3: Table Of Contents

    CONTENTS 1.    About this guide 1.1    Disclaimer 1.2    License, trademarks and other rights 2.    Introduction and overview 2.1    Intended use 2.2    Device description and features 2.3    Accessories and products used in combination 2.4    Indications 2.5    Precautions 2.6    Compatibility information 2.7    Data protection 2.8    Further information 2.9    Disposal 3.

  • Page 4: About This Guide

    Dental Wings products must be used in accordance with their accompanying instructions for use. Improper use or handling of Dental Wings products will void the warranty, if any, given for Dental Wings products. If you require additional information on the proper use of Dental Wings products, contact your local distributor.

  • Page 5: License, Trademarks And Other Rights

    Instructions for Use may differ slightly from your particular situation. Dental Wings reserves the right to revise or make changes or improvements to this product or documentation at any time without obligation to notify any person of such revisions or improvements.
  • Page 6 Dental Wings. All other trademarks are the property of their respective owners. Copyright Dental Wings documents may not be reprinted or published, in whole or in part, without the written authorization of Dental Wings. CHAPTER 1 | Intraoral Scanner Instructions for Use...

  • Page 7: Introduction And Overview

    With the distributor logo and color   With a distributor-specific set of accessories   With a distributor-specific software configuration   With a country-specific power cord Note The laptop (scanner unit of Model 100) can be replaced by the scanner unit of Model 010 (portable).

  • Page 8: Accessories And Products Used In Combination

    Moreover, it can be used in combination with other products (e.g. CAD/CAM software). Dental Wings has validated the specific products given in chapter Technical data and label (see Accessory parts, p. 47), in Appendix A - Reprocessing of the handpiece sleeve (p. 51) and in Appendix B - Reprocessing of the Intraoral Scanner (without handpiece sleeve) (p.

  • Page 9: Indications

    Further use of 3D scans 3D scans from the Intraoral Scanner may be used with other software products. It is required that such products can handle open STL files. Dental Wings has validated the use of: DWOS: 3D dental restorations design software Straumann®...
  • Page 10 Model 001 (cart): Installing additional software may compromise system integrity, slow down performance, and create compatibility issues. Model 100 (laptop): Install only software validated to be used in combination with the scanner. Always handle the handpiece with great care as it contains fragile components. Dropping the handpiece and its sleeves on the floor may damage it permanently.

  • Page 11: Compatibility Information

    Never put any load on the scanner. Make sure to comply with all applicable standards and technical regulations for any computer hardware used. Computer hardware is not intended to be used in close proximity (within a distance of 1.5 meters) to the patient.

  • Page 12: Further Information

      - Backup your data regularly to avoid loss of data.   - Use the anonymization function to protect patient personal data if required. 2.8    Further information Dental Wings and its products are registered in the main markets. If you have any questions please contact your local distributor. Radiation information The handpiece contains LEDs.
  • Page 13 Caution     Usage, control, adjustment or execution of the infrared laser projector other than specified below may result in hazardous exposure to radiation. Usage of the gesture recognition module is specified in Gesture control - Model 001 (cart) (p. 26). The gesture recognition module (SR300) contains an infrared laser projector and shall not be repaired, modified or disassembled.

  • Page 14: Disposal

    Caution     The use of accessories other than those specified in Technical data and label (see Accessory parts, p. 47) may result in increased emission or decreased immunity of the Intraoral Scanner.   The Intraoral Scanner allows for wireless network connection. However, it may be interfered with radio frequency (RF) sources in the vicinity of the device (e.g, electromagnetic security systems, cellular telephones, radio frequency identification (RFID) or other in-band transmitters), even if that other equipment complies with the International Special Committee on Radio Interference (CISPR)
  • Page 15 For details on how to dispose of your device and its packaging, please contact your local distributor.

  • Page 16: Installation

    3.    Installation Caution     Keep the original box and packaging material for safe transportation of the device in case of service, repair and disposal. Unpack and pack your scanner following the instructions. For instructions on how to pack the scanner, see Packing the scanner (p. 40). 3.1    Unpacking the scanner Store the shipping box in a safe place in case you need to transport or ship the scanner in the future.

  • Page 17: Setting Up The Scanner

    Model 100 (laptop)   Figure 3:  Steps for unpacking the scanner — Model 100 3.2    Setting up the scanner Caution     Make sure you have read and understood these instructions for use before installing and operating the scanner. Comply with all precautions and safety information.
  • Page 18  14. USB cable  15. Handpiece connector (with holder) Figure 4:  Identification of the scanner parts Note The laptop (scanner unit of Model 100) can be replaced by the scanner unit of Model 010 (portable). CHAPTER 3 | Intraoral Scanner Instructions for Use...
  • Page 19 Figure 5:  Plugging the handpiece to the back of the screen — Model   Figure 6:  Plugging the handpiece to the handpiece connector — Model 001 (cart) 100 (laptop) Caution     Make sure that the handpiece/handpiece connector is plugged in the scanner unit before the handpiece comes into contact with patients.
  • Page 20 Assemble the handpiece sleeve Glide the sleeve on the handpiece (without sleeve) and rotate it clockwise to lock Disassemble the handpiece sleeve Rotate the sleeve counter-clockwise to unlock it from the handpiece. Glide the sleeve off. Figure 7:  Assembling and disassembling the handpiece sleeve Caution  ...
  • Page 21 Model 100 (laptop)  1. Plug the power cord in the back of the laptop.  2. Plug the power cord into the power outlet.  3. Press the power button (see Scanner controls, p. 23) Refer to instructions for using the device (see Basic principles and user interface, p. 23).
  • Page 22 To confirm correct installation of your device, proceed as follows:  1. Disassemble the handpiece sleeve (see Figure 7:  Assembling and disassembling the handpiece sleeve, p. 20).  2. Clean the optics on the handpiece sleeve using a foam tip applicator soaked with alcohol (see Figure 8:  Cleaning the optics of handpiece and sleeve, p. 22).

  • Page 23: Basic Principles And User Interface

    Power button: used to start up the scanner unit Status Scanner status Light on Turned on Light off Turned off Model 100 (laptop) Model 001 (cart)     Light ring: provides the user with a feedback of handpiece's status Color Handpiece status...
  • Page 24  1. Press the power switch in the power on position.  2. Press the power button.  3. Select your user icon and type in your PIN. Model 100 (laptop)  1. Press the power button.  2. Select your user icon and type in your PIN.
  • Page 25  1. Starting outside of the screen, swipe you finger from the left side to the center of the screen.  2. You now have access to the menu of the operating system (OS).  3. Follow OS instructions to connect to wireless networks. Model 100 (laptop) Follow OS instructions to connect to wireless networks. Shutting down the scanner Caution  ...
  • Page 26 Gesture control - Model 001 (cart) The cart model is equipped with a gesture recognition module. It works with an infrared laser sensor [for safety information, refer to Further information (p. 12)] which is located above the screen as shown on Figure 4:  Identification of the scanner parts (p. 18).
  • Page 27 io pause Pauses the current scan (re-launch with the start command). io next Switches to the next step. io reset Erases the current data. io undo Removes surface data in a chronological fashion. io redo Restores surface data in a chronological fashion. io lock Protects the current scan against modification.

  • Page 28: Scanning

    5.    Scanning 5.1    Accuracy This scanner performs highly accurate scans. For scanning accuracy as measured according to Dental Wings testing standard, see Technical data and label (p. 43). Caution     To achieve scanning accuracy, comply with all given instructions. Considering that the final accuracy and fit of the restoration highly depend upon the preciseness of the user's manipulations and judgment, the clinical outcome is easily influenced by the following factors  ...
  • Page 29   Select a User or a Dentist.   Enter security PIN.   Select New case.   Enter case description, including tooth number, restoration type, material and shade.   Set Appointment Date for the preparation.   Set Due Date, as the target delivery for the restoration at your clinic.  ...
  • Page 30 Alignment Caution     Verify that upper and lower arches are identified as such.   Align upper and lower scans onto the bite scan, following on-screen instructions.   If needed, invert upper and lower arches by selecting Swap Arches.   If needed, switch quadrant by selecting Switch Sides.
  • Page 31 Export to STL   Click the Case database icon from the taskbar.   On the case to export, swipe your fingers towards the right side of the screen.   Select Export STL.   Select the destination folder.

  • Page 32: Maintenance

      Model 001 (cart): Installing additional software may compromise system integrity, slow down performance, and create compatibility issues.   Model 100 (laptop): Install only software validated to be used in combination with the scanner. CHAPTER 6 | Intraoral Scanner Instructions for Use...

  • Page 33: Reprocessing

    Move the device while holding it by the handle (see Identification of the scanner parts, p. 18).   When arrived at destination lock each wheel by pushing down the tab. Model 100 (laptop)   Shut down according to instructions (see Shutting down the scanner, p. 25)  ...

  • Page 34: Data Backup

    Scanner (without handpiece sleeve) contain further details on how to reprocess the device. The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner for re-use. It remains the responsibility of the user to ensure that the reprocessing as actually performed using equipment, material and personnel in the dental or reprocessing facility achieves the desired result.

  • Page 35: Changing Fine Fuses

    The Intraoral Scanner performs automatic backups of the database, as long as you define a destination for it:  1. Log in as Administrator.  2. Select the Settings icon from the taskbar, then the System Settings submenu.  3. In the field Backup target directory, type in a location or click the folder icon to browse to the desired destination for storing the files created by the automatic backup feature.
  • Page 36 Do not replace components of the scanner without the prior authorization from your distributor. Refer servicing to authorized service personnel. Servicing is required when the device has been damaged in any way, has been exposed to rain or moisture, does not operate normally, or has been dropped. Contact your local distributor. The Intraoral Scanner does not require regular service.

  • Page 37: Troubleshooting

    7.    Troubleshooting Find below a list of messages (some are abbreviated) that could appear while using the Intraoral Scanner, and the actions that should be taken to solve the problem. On-screen message Required action Start up and log in   Cannot start setup...
  • Page 38 On-screen message Required action Database   Case creation failed..could not be computed/imported... Restart the device and try again. Unable to save... Patient/Dentist update/deletion failed. Database backup execution failed. Try to export in a different folder and/or a different file name. Implant kit / ipflib file errors.
  • Page 39 On-screen message Required action The scan has been interrupted to prevent Wait one minute to let the handpiece cool down and then resume overheating... scanning. DWOS Connect   No internet connection... Check internet connection. Server not found/not reachable... Authentication to DWOS Connect failed. Try again later.

  • Page 40: Packing The Scanner

    8.    Packing the scanner Model 001 (cart) Packing the scanner for transportation must be done as follows:   Shut down the scanner unit.   Flip the power switch in the power off position.   Unplug the power cord, wind it carefully and place it inside one of the packaging inserts.  ...
  • Page 41 Model 100 (laptop)      Figure 13:  Steps for packing the scanner - Model 100 (laptop)

  • Page 42: Distributors And Service

    9.    Distributors and service Refer servicing to authorized service personnel. Contact your local distributor if your scanner needs to be repaired or if you need technical support for the scanner software. Alternatively, contact support@dental-wings.com (in English, French or German). CHAPTER 9 | Intraoral Scanner Instructions for Use...

  • Page 43: Technical Data And Label

    DW-IO-100 (laptop) 100 - 240 V~, 50 - 60 Hz, 72 VA Handpiece Connector input: Scanner unit input  100 - 240 V ~, 50 Hz - 60 Hz, 540 VA 5 V  , 15 W 5 mm x 20 mm, medium speed, 6 A, Fuse  ceramic (high breaking capacity),...
  • Page 44 Technical data Type/Model  DW-IO-001 (cart) DW-IO-100 (laptop) LED risk group (acc. IEC 62471)  Exempt   Laser class (acc. IEC 60825) Class 1 no laser Protection class (acc: IEC 60529)  IPXO (noncritical area - no protection)   Class 1 Equipment; Basic insulation, relies on an earth for protection.
  • Page 45 No restrictions apply LED light Optical technology High-speed measuring cameras Video cameras According to Dental Wings testing standard. For further details contact your local Scanning accuracy/time distributor (see Distributors and service, p. 42). Output format Open STL or cloud sharing through DWOS Connect...
  • Page 46 Figure 14:  Device label — Model 001   Figure 15:  Device label — Model 100 (bright background) Figure 16:  Device label — Model 100 (dark background) The label on the device shows its legal manufacturer. The country of origin of the legal manufacturer defines which certifications and declaration of conformity apply to your device.
  • Page 47 Accessory parts Standard Optional Part No. Image Intended use Model Model           6100-1 Replacement or additional (Connection Handpiece     handpiece for the Intraoral cable length Scanner. 2.54 m)       Replacement or additional     Handpiece Sleeve 6190-1 handpiece sleeve for the...
  • Page 48 Accessory parts Standard Optional Part No. Image Intended use Model Model           This box serves as Client Shipping     6092-1 (replacement) box for return Crate shipment. This box serves as Client Shipping     6392-1 (replacement) box for return shipment.

  • Page 49: Explanation Of Symbols

    11.    Explanation of symbols Indicates the device's legal manufacturer Indicates the date when the device was manufactured Indicates the serial number of the device Caution, consult Instructions for Use for important cautionary information. Laser radiation CLASS 1 Class 1 laser product acc. to IEC 60825-1 LASER PRODUCT Direct current  ...
  • Page 50 Caution: US Federal law restricts this device to sale by or on the order of a licensed health-care practitioner. Contents of the transport package are fragile. Handle with care. Indicates the correct upright position of the transport package Do not dispose of this device as unsorted municipal waste. Collect separately. Follow Instructions for Use Device includes a radio frequency transmitter;...

  • Page 51: Appendix A - Reprocessing Of The Handpiece Sleeve

    Appendix A - Reprocessing of the handpiece sleeve Manufacturer: Dental Wings Inc. Method: Sterilization and intermediate or low-level disinfection Device: Intraoral Scanner handpiece sleeve Figure 17:  Handpiece sleeve Precautions   Do not use abrasive cleaners.   Scratches on the optics cause damage to the handpiece sleeve. Be very careful in applying the soft, nylon-bristled toothbrush.
  • Page 52 Equipment and material   Steam sterilizer (CE marking; valid IQ/OQ/PQ)   Enzymatic detergent intended for cleaning of medical devices made of metal, glass and plastics   Intermediate or low-level disinfectant intended for surface disinfection of medical devices made of metal, glass and plastics;...
  • Page 53 Instructions Cleaning: Manual  1. Select specific enzymatic detergent so that they comply with the equipment description of this procedure. Follow their instruction for use in terms of storage, concentration, application, temperature and post-rinsing.  2. Immerse handpiece sleeve in enzymatic detergent and soak as described in its instructions for use.  3.
  • Page 54 CIDEZYME®/Enzol® (both ASP Johnson & Johnson) and ProSpray™ Wipes (Certol® International). In addition, it has been validated by Dental Wings using the aforementioned equipment and material, Bacillol® 30 Foam (Bode Chemie), Isopropanol 70% (Jedmon Products Ltd.), ProSpray C-60™...
  • Page 55 The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner handpiece sleeve for re-use. It remains the responsibility of the user to ensure that the reprocessing as actually performed using equipment, material and personnel in the dental or reprocessing facility achieves the desired result.

  • Page 56: Appendix B - Reprocessing Of The Intraoral Scanner (Without Handpiece Sleeve)

    Appendix B - Reprocessing of the Intraoral Scanner (without handpiece sleeve) Manufacturer: Dental Wings Inc. Method: Intermediate or low-level disinfection Device: Intraoral Scanner handpiece (without sleeve), scanner unit and accessories Figure 18:  Scanner (without sleeve) Precautions   Do not autoclave.
  • Page 57 Limitations on reprocessing Repeated reprocessing has minimal effect on the Intraoral Scanner (without handpiece sleeve). End of life is normally determined by damage and wear due to use. We strongly recommend that users regularly inspect the Intraoral Scanner (without handpiece sleeve). Users are solely responsible for issues arising from the use of damaged or worn Intraoral Scanner (without handpiece sleeve).
  • Page 58 Instructions Cleaning: Manual  1. Clean handpiece (without sleeve) with a soft, lint-free, non-abrasive cloth, moistened with potable tap water.  2. Clean the handpiece area that had been covered by the handpiece sleeve with a soft, lint-free, non-abrasive, disposable cloth moistened with enzymatic detergent.  3.
  • Page 59 ProSpray C-60™ (Certol® International), COEfect™ Minute Spray (GD AMERICA INC.), BioSonic® WIPE OUT (Coltène/Whaledent Inc.). The instructions given have been validated by Dental Wings as being capable of preparing the Intraoral Scanner handpiece for re-use. It remains the responsibility of the user to ensure that the reprocessing as actually performed using equipment, material and personnel in the dental or reprocessing facility achieves the desired result.

  • Page 60: Appendix C - Electromagnetic Compatibility Guideline

    (ESD) ± 2/4/8/15 kV air ± 2/4/8/15 kV air should be at least 30%. IEC 61000-4-2     DW-IO-100 power supply (21-0200) tested to comply at ±8 kV contact, ±2/4/8 kV air. Appendix C - Electromagnetic Compatibility Guideline...
  • Page 61 Electrical fast ± 2 kV ± 2 kV Mains power quality should be that of a transient/burst typical commercial or hospital 100 kHz repetition 100 kHz repetition environment. IEC 61000-4-4 frequency frequency ± 0.5/1 kV line to line ± 0.5/1 kV line to line...
  • Page 62 0.15 MHz - 80 MHz 0.15 MHz - 80 MHz Conducted disturbances inducted by RF fields d = 1.2 √ P 6 V in ISM bands between 6V in ISM bands between IEC 61000-4-6 0.15 MHz – 80 MHz 0.15 MHz – 80 MHz 80% AM at 1 kHz 80% AM at 1 kHz d = 1.2 √...
  • Page 63 IEC 60601-1-2:2014, Table 9 Band Service Max. power Distance Immunity test level (MHz) (V/m) 380-390 TETRA 400 430-470 GMRS 460; FRS 460 704-787 LTE Band 13, 17 GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE 800-960 Band 5 2400- Bluetooth;...
  • Page 64 Recommended separation distances between
 portable and mobile RF communications equipment and the Intraoral Scanner The Intraoral Scanner is intended to be use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Intraoral Scanner can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Intraoral Scanner as recommended below, according to the maximum output power of the communications equipment.
  • Page 65 Dental Wings Inc. Distr ibutor stamp 160 Rue St- Viateur E Montr eal QC H2T 1A8 CANADA +1 514 807- 8485 (Inter national) +1 888 856- 6997 (Nor th Amer ica) +1 514 223- 3981 Intraoral Scanner Instructions for...

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