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Straumann Falcon User Manual

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USER MANUAL
Straumann® Falcon
Technical handling information

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Summary of Contents for Straumann Falcon

  • Page 1 USER MANUAL Straumann® Falcon Technical handling information...

  • Page 3: Contact Information

    Please contact your local Straumann representative to redirect you with authorized service partner. ifu.straumann.com Ordering components Only use original accessories and spare parts. Order Straumann® Falcon components from an authorized Straumann service partner. For order information, see "Reference numbers" on page 76...

  • Page 5: Table Of Contents

    Intended use of Straumann® Falcon ........

  • Page 6: Intended Use Of Straumann® Falcon

    CONTRAINDICATIONS Do not use Straumann® Falcon on fully edentulous patients. Patients must have a minimum of 3 adjacent teeth to support marker positioning and another tooth for accuracy check (distant of a minimum of 30 mm from the marker position).

  • Page 7: Notes On The User Manual

    For information about your local authorized service partner, see "Authorized service partners" on page 3  Equipment options This document describes the full version of the Straumann® Falcon device. It may therefore cover components that are not included in the package you purchased.

  • Page 8: Names, Symbols, And Abbreviations

    Please refer to the packaging label for the applicable symbols related to the product. Symbol Symbol Description Symbol Source Consult instructions for use ISO 15223-1 Follow the link to the eIFU: ifu.straumann.com Manufacturer ISO 15223-1 Date of manufacture ISO 15223-1 CE marking is the manufacturer's declaration that the product meets the MDR (EU) 2017/745 requirements of the applicable EC legislation.
  • Page 9 Qty.: Quantity Institut Straumann AG Patent Marking Institut Straumann AG Pat.: Follow the link to the patent information: pat.straumann.com Use-by date ISO 15223-1 Temperature limit (e.g.: min 5 °C / max. 20 °C) ISO 15223-1 e.g.: Upper limit of temperature (e.g.: max. 20 °C) ISO 15223-1 e.g.:...
  • Page 10 Symbol Symbol Description Symbol Source Keep dry ISO 15223-1 Caution ISO 15223-1 Contains hazardous substances ISO 7000 Contains biological material of animal origin ISO 7000 Custom-made device MDR (EU) 2017/745 custom-made device Humidity limits (e.g. min 10% / max. 90%) ISO 15223-1 90 % e.g.:...

  • Page 11: Warranty And Liability

    The user is responsible for making sure that all care and cleaning activities are performed. Repair As manufacturers of medical electrical equipment, Straumann can assume responsibility for the safety properties of the device only if repairs on the device are performed by authorized service partners, and if components of the device are replaced only by original spare parts in case of failure.

  • Page 13: Safety Information

    SAFETY INFORMATION General................... 14 Safety messages .

  • Page 14: General

    GENERAL General attention To avoid serious or fatal injury, read this User Manual thoroughly before you use the device and its components. Pay particular attention to all safety precautions. • Always follow the instructions in this User Manual. • Do not use the device in a way that is not described in this User Manual. •...

  • Page 15: Safety Messages

    If the user needs to dismantle the DENADAPT from the motor for reprocessing purposes, a re-calibration of • Straumann® Falcon is necessary and shall be performed by an authorized Straumann service partner. For information about your local authorized service partner, see "Authorized service partners" on page 3.
  • Page 16 The USB storage device shall be formatted in exFAT or FAT32 file system (NTFS is not fully compatible). The Software for Straumann® Falcon can only access the highest level on a USB storage device, i.e. the root directory and cannot access folders.

  • Page 17: Warning Messages

    A metallic unit casing A larger metallic object Any other metal part grounded with the protective earth Straumann recommends that all persons working with this device are made aware of the significance of the ESD warning. WARNING MESSAGES List of warning messages Failure to observe warning messages may result in death or serious injury.

  • Page 18: Caution Messages

    • Do not use components that passed their service interval. • For a list of supported materials, see "Overview of Straumann® Falcon components" on page 23  Injury to the patient due to not specified temperature conditions of the components Distortion of camera housing in case of heating by built-in parts (e.g.
  • Page 19 Damage to the components due to mechanical stress Shock, vibration, or pressure can damage the components of the device. Keep sources of vibration away from the components. • Do not place objects on the components. • Infection by biohazardous waste Treat the device as biohazardous waste.

  • Page 21: Straumann® Falcon Overview

    Overview of Straumann® Falcon components........

  • Page 22: Straumann® Falcon Workflow

    STRAUMANN® FALCON WORKFLOW Preoperative* Before surgery During surgery After surgery Case preparation Treatment planning Surgical preparation Starting up device Loading case Placing tray with Registering marker instrument Viewing 3D-scan Selecting instrument Performing accuracy check test Guided surgery Exporting case report...

  • Page 23: Overview Of Straumann® Falcon Components

    OVERVIEW OF STRAUMANN® FALCON COMPONENTS Touchscreen Computer Registration Tool Camera DENADAPT adapter + cable DENADAPT adapter + cable Digital tray and Marker Device components For reference numbers, see "Reference numbers" on page 76  For technical specifications, see "Specifications" on page 77...

  • Page 24: The Camera For Straumann® Falcon

    The adapter is mainly made of stainless steel and fiber- reinforced plastic. Not all handpiece motors are compatible with the adapter. For information about compatible handpiece motors, see Falcon IFU (707343)  The adapter is cleaned and sterilized together with the handpiece motor.

  • Page 25: The Computer For Straumann® Falcon

    THE COMPUTER FOR STRAUMANN® FALCON The computer is specially designed for Straumann® Falcon using a LINUX operating device. The Software for Straumann® Falcon is pre-installed. The computer is switched on by the power button and switched off by the software.

  • Page 26: The Registration Tool (Denareg)

    In the basic version, the touchscreen is placed on a stand. Alternatively, it can be mounted on the swivel arm of the Cart (DENACART) from Mininavident AG. The surfaces of the touchscreen are made of plastic, glass, and silicone rubber. Apply a 15.6" sterile touch screen to cover to monitor.

  • Page 27: The Digital Tray

    THE DIGITAL TRAY The Digital tray holds the marker and is snapped on the teeth of the lower or upper jaw. For information about handling the digital tray and the marker, see "Positioning, the digital tray with the marker" on page 38 ...

  • Page 28: The Cart (Denacart) (Optional)

    THE CART (DENACART) (OPTIONAL) The device cart is an accessory that can be ordered optionally. It offers the following possibilities for working with Straumann® Falcon: A swivel arm for holding the touchscreen • Storage space for the computer • Four drawers for extra storage space •...

  • Page 29: Overview Of The Software

    OVERVIEW OF THE SOFTWARE The Straumann® Falcon software can be fully operated by the touchscreen. No mouse or keyboard is necessary. For working with Straumann® Falcon, the user interface guides the user through the four main menu entries Patient, Overview, Navigation, and Export.

  • Page 30: Device And User Information

    Together with data from case planning and the information on the exact implant position, the angle and depth of the instrument for preparing the implant bed and placing the implant are displayed in real time on the Screen for Straumann®...
  • Page 31 Choose the Shut down device button to shut down the device • Choose the Log file export button to export the Straumann® Falcon log files to an USB storage device • Choose the Service screen button to access the service screen overlay (the service screen is only for technician service, •...
  • Page 32 To set up the user data To start up the device, press the power switch on the computer. A password is required for the user to access the system. Wait until the Patient screen is displayed. On the menu bar, choose the button.
  • Page 33 To export the log files On the menu bar, choose the button. The configuration overlay is displayed. On the front of the computer, insert the USB storage device with adequate storage capacity. To export log files, choose the Log file export button.

  • Page 35: Operation

    OPERATION Preoperative phase ................36 Positioning, the digital tray with the marker.

  • Page 36: Preoperative Phase

    Smile in a Box service) Assembling the tray and marker (performed by the Smile in a Box service) Attach the designed tray with the marker in the patient’s mouth Importing the case planning data into Straumann® Falcon Dental implant surgery Workflows for marker capturing...
  • Page 37 Prerequisites • Registration tool (DENAREG) and adapter for handpiece motor (DENADAPT) are available - from Mininavident AG For more information about the device and the components, see "Straumann® Falcon overview" on page 21  A printed digital tray is available.

  • Page 38: Positioning, The Digital Tray With The Marker

    POSITIONING, THE DIGITAL TRAY WITH THE MARKER Tray 2: Palatally positioned Tray 2: Buccally positioned Tray 1: Lingually positioned Tray 1: Buccally positioned Positioning of the digital tray and the marker Fixated to the jaw where one or more implants have to be placed, the marker serves as a reference point for the navigation device in the patient’s mouth.

  • Page 39: Importing The Case Planning Data

    IMPORTING THE CASE PLANNING DATA USB storage device indicator Selected case Status symbol Importing the case planning data - Patient screen To import the case planning data To start up the device, press the power switch on the computer. User needs to enter password to access system. Wait until the Patient screen is displayed.
  • Page 40 Insert the USB storage device containing the case planning data for the planned surgery. The USB storage device indicator lights up in blue when a valid USB device is connected ( The import starts automatically. Wait until the import is finished. The import is finished when the patient name is listed on the Patient screen and the status symbol of the imported case planning data is green ( If the marker cannot be evaluated by the software, the status symbol of the imported case planning data becomes red...

  • Page 41: Before Surgery

    Loading the case into Straumann® Falcon. Placing the digital tray with the marker in the patient’s mouth. Prerequisites Straumann® Falcon is available and ready to use. • A case planning was carried out in advance and the valid data is available on the device.

  • Page 42: Setting Up The Workspace

    SETTING UP THE WORKSPACE Touchscreen Assistance’s position Patient’s mouth Registration tool Cable from camera to the computer Dentist’s position Setting up the workspace To set up the workspace Position the touchscreen so that the patient's mouth as well as the touchscreen are simultaneously in view during surgery.
  • Page 43 To start up the device On the computer, press the power switch and enter your password. Wait until the Patient screen is displayed. To attach the camera to the adapter Place the camera over the adapter. Bring the camera and the adapter together. The camera is automatically fixed and adjusted to the plate by magnets.
  • Page 44 Release the camera over the handpiece motor into the secured position. Injury to the patient due to incorrect instrument or registration tool handling Incorrect handling of instruments or the registration tool may lead to inaccurate or shifted navigation procedure. • Re-register the instrument once you have rotated the camera.

  • Page 45: Loading The Case And Place The Digital Tray With The Marker

    LOADING THE CASE AND PLACE THE DIGITAL TRAY WITH THE MARKER Buttons for posterior or anterior view Case information Screenshot button Accuracy check button Information about the implants Overview screen Injury to the patient due to incorrect tray or marker handling Incorrect handling of the digital tray or marker may lead to inaccurate or shifted navigation procedure.

  • Page 46: Handling Of Cases With Multiple Markers

    Choose the button. Wait until loading is finished. The case loading is finished when the Overview screen with the 3D model is displayed. On Overview screen, you have the following possibilities: View the 3D model either from posterior or anterior direction by choosing either the button or the button.
  • Page 47 When doing a long press on an inactive marker, this marker is selected as the active marker (transparency changes to opaque, the previous active marker turns transparent). • After a marker change, an accuracy check is mandatory, to ensure that the correct marker is active. In the report it is noted which marker was active.

  • Page 48: During Surgery - Guided Surgery

    CBCT data is imported directly into Straumann® Falcon without using planning software. • Guiding mode: Straumann® Falcon guides the instrument using the planning data with the correct angle to the correct position and depth.The software guides you through the process.

  • Page 49: Registering The Instrument

    REGISTERING THE INSTRUMENT Registration spots Marker of the registration tool Camera Registration tool Registration slots for cylinder drills Button for LED light Registering the instrument Injury to the patient due to incorrect drill or registration tool handling Incorrect handling of instruments or the registration tool may lead to inaccurate or shifted navigation procedure. •...
  • Page 50 Select the instrument Insert the instrument into the drill chuck. Guide the instrument to the registration tool. The LEDs of the camera light up automatically when the registration tool is in the field of view of the camera. Depending on the instrument do one of the following: For a cylindrical drill, insert the drill at an angle into one of the slot so that the drill bit faces forward.
  • Page 51 On the instrument selection overlay, select the correct instrument. If you want to use another instrument, or to re-register the instrument, guide the instrument again to the registration tool and choose the Retry button. Accuracy check will automatically start after the registration of the first instrument after having loaded a case. This will confirm the correct position of the digital tray with the marker in the patient's mouth using the accuracy check function.
  • Page 52 • If the positions are not identical (more than 1mm difference), reposition the digital tray with the marker and perform the test again. For information about repositioning the digital tray with the marker, see "To place the digital tray with the marker in the patient’s ...

  • Page 53: Performing The Guided Surgery

    PERFORMING THE GUIDED SURGERY Buttons for different projection modes Projection panel Axis from the handpiece Screenshot button Cross section focus button Buttons for flipping the view Target panel Guided surgery - Navigation screen Injury to the patient due to incorrect instrument or registration tool handling Incorrect handling of instruments or the registration tool may lead to inaccurate or shifted navigation procedure.
  • Page 54 On the touchscreen, the Overview screen changes to the Navigation screen as soon as you move the handpiece to the patient’s mouth. On the Navigation screen, you have the following possibilities: • View the 3D model either from different directions by choosing a button. •...
  • Page 55 Depending on the instrument, do one of the following: For centering the entry point of the implant site, place the round bur on the bone. • While centering, make sure the round bur remains in this position (cross-hair remain dark blue). For all other instruments, place the instrument on the planned position and change the angle of the instrument until •...
  • Page 56 Observe the situation on the projection panel. The planning and the current instrument position is displayed. Pay particular attention to the situation around the nerve channel. Register the subsequent instruments if necessary.

  • Page 57: After Surgery

    AFTER SURGERY The main tasks after the surgery are: Viewing and exporting the case report. Removing the case if desired. Completing the guided surgery. Prerequisites The dental implant surgery is completed. Safety Serious injury to the patient due to incorrect handling As an operator, ensure that you know the relevant safety precaution guidelines and standards and the information and procedures contained in this User Manual.

  • Page 58: Viewing And Exporting A Case Report

    VIEWING AND EXPORTING A CASE REPORT Name of active marker USB storage device indicator Buccal-Lingual view Anterior-Posterior view Viewing and exporting the case report - Case report On the case report, the accuracy values show the deviation of the performed to the planned surgery in buccal-lingual and anterior-posterior direction.
  • Page 59 Minus value means the hole is shorter, plus value means it is deeper than planned (see page 78). Warning: For Straumann implants due to the function and design of the drills, the drill tip Is up to 0.5mm longer than the Insertion depth of the Implant For example, if you drill to the 10mm marking, the actual Implant bed has a depth of 10.5 mm.
  • Page 60 Choose the button. The Export screen is displayed. To view the case report on the touchscreen, choose the button. The case report is displayed. Choose the button to close the case report. To export the case report, insert a USB storage device with adequate storage capacity. The USB storage device indicator lights up in blue when a valid USB device is connected (...

  • Page 61: Deleting A Case If Desired

    Choose the Export to USB storage device button. The case report is saved on the USB storage device. Remove the USB storage device. DELETING A CASE IF DESIRED To delete the case On the Patient screen, select the case and patient. If the case is not displayed, scroll through the list.

  • Page 62: Completing The Guided Surgery

    COMPLETING THE GUIDED SURGERY Infection by biohazardous waste • Treat the device as biohazardous waste. Decontamination (cleaning, disinfection, and/or sterilization) is required before reuse, recycling, or disposal of the device. Notice • Dispose of the device according to the local regulations. For more information, contact your Service representative. To complete the guided surgery Remove the tray and marker from the patient’s mouth.
  • Page 63 Choose the button. Wait until the computer is shut down. If you do not want to shut down, choose the No button. When the device is shut down while a case is still open (or when there is a crash), recovery of the data, that hasn't been saved yet, is being started and the report of that case updated with the missing information.

  • Page 65: Cleaning And Disinfection

    CLEANING AND DISINFECTION Cleaning and disinfection ............... . 66 Individual cleaning instructions.

  • Page 66: Individual Cleaning Instructions

    CLEANING AND DISINFECTION INDIVIDUAL CLEANING INSTRUCTIONS The Straumann® Falcon is delivered non-disinfected and must be cleaned and disinfected prior to use. Prior to processing, remove the packaging system from the product: Component Preparing for cleaning Cleaning 1 - Computer Shut down computer & disconnect from wall socket...
  • Page 67 STORAGE Store the components in a dry, dust-free and humidity-free environment without direct solar irradiation. No specific packaging of disinfected devices is recommended. The user should define a maximum storage time for disinfected components. The components have to be used within this defined time or disinfected again directly before use. Temperature variations have to be avoided to prevent corrosive damage.
  • Page 68 Regular servicing is necessary for safe operation and should be carried out once a year. Straumann recommends that only an authorized service partner should undertake servicing and checking. For information about your local authorized service partner, see "Authorized service partners" on page 3...

  • Page 69: Troubleshooting

    TROUBLESHOOTING Software Messages/Warnings..............70 Hardware errors .

  • Page 70: Software Messages/Warnings

    The messages must be confirmed on the touchscreen either by choosing the OK, or No, or Yes button. Software messages Severity Message Troubleshooting information • Camera for Straumann® Falcon internal sensor > 55 °C (131 °F) Warning Temperature Camera • Measure: Cool down the device. ...
  • Page 71 Software messages Severity Message Troubleshooting information Warning Export failed • Is shown when export of instrument database was failed • Is shown when importing instrument database was failed Warning Import failed • Is shown when adding instruments to database from USB-drive Warning Include failed failed...

  • Page 72: Hardware Errors

    HARDWARE ERRORS If the device is not responding adequately consider the following points. TEMPERATURE TOO HIGH To cool down the device On the menu bar, choose the button. The configuration overlay with the Device monitor is displayed. Check the Computer CPU temperature and Camera temperature. Wait until the temperature drops to below 85 °C (185 °F) for the Computer CPU temperature, or 55 °C (131 °F) for the Camera temperature.
  • Page 73 Replace the defect fuse (T1.6 A H 250 V). Close the fuse compartment. Connect the power cable. To recover the device If the device is still powered on, shut down the device. For information about shutting down the device, see "To shut down the device" on page 62 ...

  • Page 74: Connection Error Between The Camera And The Computer

    CONNECTION ERROR BETWEEN THE CAMERA AND THE COMPUTER On the screen, a red symbol is displayed. Wait 30 seconds for an automatic reconnection of the camera and computer. Unplug the USB connector to separate the camera from the computer. Reconnect the camera to the computer.

  • Page 75: Appendix

    EMC manufacturer’s declaration for Straumann® Falcon ........

  • Page 76: Reference Numbers

    Camera for Straumann® Falcon M1100 Adapter DENADAPT M1204 Computer Computer for Straumann® Falcon M1300 Touchscreen Screen for Straumann® Falcon M1400 Cable Set Screen for Straumann® Falcon (USB/DisplayPort/Power) M1400-2000 Consumable Product name REF number Marker DENAMARK M1500 Registration tool DENAREG M1800...

  • Page 77: Specifications

    1 DisplayPort port at the rear for connecting the touchscreen ACCURACY Minimum theoretical optical accuracy of Straumann® Falcon is 0.75 mm (with a drill 60mm from the marker oriented 45° from the camera). The accuracy increases when the implant bed is closer to the marker (below 60 mm) and when the camera looks more even on the marker (angulation between marker &...

  • Page 78: Instrument Dimensions

    INSTRUMENT DIMENSIONS DIMENSIONS FOR CYLINDER AND STEP DRILL Dimension sheet for cylinder and step drill Dimensions for cylinder and step drill Dimension Cylinder drill/Tap Step drill and other shape Total drill length Total drill length Cutting length Cutting length (total of both steps) L_diff Cutting length of the first step (small diameter) Cutting diameter...

  • Page 79: Dimensions For Locator, Round Bur And Tab

    DIMENSIONS FOR LOCATOR, ROUND BUR AND TAB Dimension sheet for locator round bur and tab Dimensions for locator, round bur and tab Dimension Locator Round bur Total locator length Total round bur length from the cutting head center Tapered length Cutting length (total of both steps) Cutting head diameter...

  • Page 80: Dimensions For Implant Adapter

    DIMENSIONS FOR IMPLANT ADAPTER Dimension sheet for implant adapter Dimensions for implant adapter Dimension Implant adapter Total adapter length offset Difference between the adapter and the implant base...

  • Page 81: Transport And Storage Conditions

    TRANSPORT AND STORAGE CONDITIONS The components can be moved and stored without damage in the associated transport packaging under the following conditions. Transport and storage conditions Topic Specification Temperature range -10 °C to 55 °C (14 °F to 131 °F) Relative humidity 10–90% Vibration...

  • Page 82: Emc Manufacturer'sdeclaration For Straumann® Falcon

    30 cm away from any part of the device. Straumann® Falcon is suitable for use in a specific electromagnetic environment. The customer and the user of the device should make sure that it is used in an electromagnetic environment as described below.

  • Page 83: Electromagnetic Immunity I

    ELECTROMAGNETIC IMMUNITY I Straumann® Falcon is intended for use in the electromagnetic environment specified below. The customer or the user of Straumann® Falcon should assure that it is used in such an environment. Straumann® Falcon was tested for immunity to electromagnetic disturbances and passed using the following criteria: No visible change in the operation of Straumann®...

  • Page 84: Electromagnetic Immunity Ii

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Straumann® Falcon is used exceeds the applicable RF compliance level above, Straumann® Falcon should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Straumann®...

  • Page 85: Recommended Separation Distances Between Portable And Mobile Hf Communications

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Straumann® Falcon including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 86: Fcc Notice

    • Straumann® Falcon has been tested and found to comply with the limits for a Class B Digital Device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 87: Open-Source Licenses Overview

    OPEN-SOURCE LICENSES OVERVIEW The following table lists the open-source tools employed in Straumann® Falcon, the web site of the creator of the tool and the open-source license type for each tool. Tool Website License ubuntu 22.04 server https://ubuntu.com/ Contains packages of the main, restricted and universe group.

  • Page 88: Openssl

    THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHORS OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES;...
  • Page 90 Phone +41 (0)61 965 11 11 +41 (0)61 965 11 01 www.straumann.com © Institut Straumann AG, 2023. All rights reserved. Straumann® and/or other trademarks and logos from Straumann® mentioned herein are the trademarks or registered trademarks of Straumann Holding AG and/or its affiliates.