Etkon GmbH Lochhamer Schlag 6 DE-82166 Gräfelfing Germany AUTHORIZED SERVICE PARTNERS Straumann’s authorized service partners cover all service needs for the entire device life cycle. Please contact your local Straumann representative to redirect you to the authorized service partner. ORDERING COMPONENTS Only use original accessories and spare parts.
The Marker for Straumann Falcon™ Impression Tray for Straumann Falcon™ Edentulous Tray for Straumann Falcon™ 5.10 Calibration Tool for Straumann Falcon™ 6. UNPACKING AND SETTING UP STRAUMANN® FALCON Unpacking all components Connecting the system Attaching the camera to the handpiece motor First start 7.
Page 4
11.2 Connection error between the camera and the computer 12. APPENDIX 12.1 Reference numbers 12.2 Specifications 12.3 Instrument dimensions 12.4 Transport and storage conditions 12.5 EMC Manufacturer’s Declaration for Straumann Falcon™ 12.6 FCC Notice 12.7 Radio Equipment Directive 12.8 Open-source licenses overview...
STRAUMANN® FALCON The intended use of Straumann Falcon™ is to aid clinicians with the visualization of a digital protocol during dental procedures. Straumann Falcon™ is indicated for locating and displaying the position of a dental instrument. The device is indicated for use in the oral cavity.
ѹ For information about your local authorized service partner, see Authorized service partners on page 2. 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.
2.2 NAMES, SYMBOLS, AND ABBREVIATIONS Component names Component name Description Straumann Falcon™ Device Camera for Straumann Falcon™ Camera All in one Computer for Straumann Falcon™ Computer Software for Straumann Falcon™ Software Falcon-compatible motor & adapter Adapter Registration Tool for Straumann Falcon™ Registration tool Marker for Straumann Falcon™...
Page 8
Symbol Symbol Description Symbol Source Do not use more than 10 times Institut Straumann AG Do not use more than 20 times Institut Straumann AG Non-sterile ISO 15223-1 Sterilized using irradiation ISO 15223-1 Sterilized using ethylene oxide ISO 15223-1 Sterilized using aseptic processing techniques...
Page 9
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 e.g.: 90 %...
3.2 REPAIR As a manufacturer 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.
ѹ Before operating the device, it is mandatory to read the IFU/Manual and the warning messages carefully. ѹ Straumann Falcon™ practitioners must have knowledge of dental implantology and instruction in the handling of the Straumann product described herein (“Straumann Product”) to use the Straumann Product safely and properly in accor- dance with these instructions for use.
Page 12
Я Do not use components that are not intended for use with the device. Я The USB storage device must be compatible with the Straumann Falcon™ Я The USB storage device must be formatted in the exFAT or FAT32 file system (NTFS is not fully compatible).
Page 13
Я If the tray is broken, please use a new tray and restart the entire workflow. Я In the event of component failure or if the Straumann Falcon™ is not working appropriately, the user can decide, at any time, to stop the procedure and either restart a new workflow or continue with completely freehand surgery.
Я A large metallic object Я 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. 4.3 NOTICES Attention: Failure to observe the notices may result in damage to the device.
For reference numbers, see Reference numbers on page 72. For technical specifications, see Specifications on page 72. 5.2 THE CAMERA FOR STRAUMANN FALCON™ The camera contains the optical device (stereo camera) that captures the pattern of the marker. In addition, two LED lights are integrated into the housing.
Note: 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 (708097) Note: The Micromotor and adapter is an NSK device. Please strictly follow the IFU provided by NSK.
5.4 THE ALL-IN-ONE COMPUTER FOR STRAUMANN FALCON™ The medical-grade computer is dedicated to the Straumann Falcon™ and uses a LINUX operating system. The Software for Straumann Falcon™ is pre-installed. The screen displays the user interface and is equipped with a touch-sensitive panel. It can be operated with gloves.
5.5 THE REGISTRATION TOOL FOR STRAUMANN FALCON™ The registration tool is used to calibrate the handpiece and to register the drills. It consists of the following: ѹ A ceramic plate with a laser-marked marker ѹ Three tapered slots for different drill lengths ѹ...
5.7 THE MARKER FOR STRAUMANN FALCON™ Mounted on the trays, the marker serves as a reference point for the navigation system in the patient’s lower or upper jaw. ѹ It has a pattern that is captured by the camera. ѹ The marker possesses a star-shaped groove that is used to fix it to the trays.
5.9 EDENTULOUS TRAY FOR STRAUMANN FALCON™ The edentulous tray holds the marker and is fixed to the lower or upper jawbone by means of 2 or 3 bone fixation screws. ѹ It has 3 holes dedicated to the bone fixation screws, 2 on the side lip and one transversely.
6. UNPACKING AND SETTING UP STRAUMANN® FALCON The main tasks for unpacking and setting up the system: 1. Unpacking all components 2. Connecting the system 3. First start 4. Calibration Prerequisites Correct transport and storage of the components. For more information about the transport and storage conditions, see Transport and storage conditions on page 75.
6.2 CONNECTING THE SYSTEM 1. Mount the stand on the computer using the screws. 2. Remove the lid on the computer to expose the cable ports. 3. Connect the DC adapter to the main connection on the computer. 4. Connect the female end of the power cord to the DC adapter. 5.
6.3 ATTACHING THE CAMERA TO THE HANDPIECE MOTOR The camera is attached to the handpiece motor using the adapter. To attach the camera to the adapter: 1. Connect the handpiece to the motor/adapter/cable as described by the manufacturer IFUs. 2. Move the camera over the adapter. 3.
Page 24
Next, the admin user must be created The password must have at least 12 characters (letters and numbers) and all fields must be filled in. Note: If the administrator password is lost, the system must be sent back to the manufacturer to be reset. Once the admin user is created, the system can be connected to the wifi.
Page 25
3. Choose the desired connection from the available options and enter the password. 4. Click Connect to confirm. Note: the software periodically checks whether an update is available. The system must be connected to a valid internet connection to ensure that the updates are installed.
Page 26
In both cases, the registration dialogue opens if a CaseXchange™ account has not been connected yet. A new CaseXchange™ account can be created by in- serting the requested information. In alternative, an existing CaseXchange™ account can be restored by clicking the restore button. If registration is successful, either the CaseXchange Settings menu (if opened from Settings) or the Part- ner menu (if opened from Import) will open.
Page 27
Connect with cDX. First create a connection number in cDX. Enter the number in the system and press “Connect”. If the connection number is incorrect, a Wrong num- ber message appears. If the number is correct, you are shown the informa- tion and prompted to confirm or decline.
Page 28
If you confirm, a waiting dialogue appears, the can- cellation of which (cancel or cross) leads to a decline: Meanwhile, the cDX side receives the information, which must be confirmed or rejected. Technical handling information...
Page 29
If confirmed, both sides show a corresponding notice. In the partner dialogue, the cDx partner is displayed. By clicking on the partner name, it is possible to read more information about that person, or to edit or delete him/her. Technical handling information...
Page 30
If the case has been shared, it appears in the list in the import dialogue: Once the case has been selected, it can be imported (download and import take place one after the other without any influence from the user). If the marker was planned on the software and was selected by the planner incorrectly, an error message appears stating that no marker was found.
7. STRAUMANN FALCON™ OPERATION STEPS Surgery planning 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 check test Guided surgery Exporting case report...
Together with data from case planning and the information on the exact implant position, the angle and depth of the instru- ment for preparing the implant bed and placing the implant are displayed in real time on the Screen for Straumann Falcon™.
Page 34
ѹ Backup and Restore ѹ Factory Reset ѹ Choose the Export Log files button to export the Straumann Falcon™ log files to a USB storage device ѹ Choose the Instrument database button to import/export datasets of instruments, delete, edit, or add single instru- ments.
Page 35
To set up the user data: 1. On the menu bar, choose the button. The con- figuration overlay is displayed. 2. To access the user data, choose the button on the configuration overlay. The user data overlay is displayed. 3. Edit the user data and password. A virtual keyboard is displayed when you place the cursor in an editable field.
Page 36
To update the system: 1. Choose the Service Screen button to access the service screen overlay 2. Click on software update 3. Click Update from cloud 4. Register the device following the indications 5. If an update is present, it will be possible to perform it. To export the log files: 1.
8.2 CALIBRATION The calibration must be performed once after the handpiece is installed on the motor. 1. Patient screen > button > Service Screen but- ton. 2. On the service screen overlay, choose the Calibra- tions Management button. The calibration management overlay is displayed. 3.
Page 38
7. The system is now ready for calibration. 8. Insert the pin of the calibration tool in the drill chuck of the handpiece until it comes to a stop. 9. Rotate the camera counterclockwise to a 0° po- sition relative to the central marker on the cali- bration tool.
Page 39
13. A blue dot under the angle indicates the calibra- tion of this position is finished. 14. Rotate the calibration tool along the pin axis so that the camera can see the other side of the cali- bration tool. 15. Push laterally the housing of the calibration tool on one side until the new marker is visible and hold still.
If the patient has at least 2 Register the marker position on marker according to the adjacent teeth, fix the impression the Falcon software by touching 3 planning tray on the patient’s teeth. If the non-adjacent teeth patient has less than 2 adjacent teeth, fix the edentulous tray on the patient’s jawbone.
Я Requires an impression tray, DMG O-Bite and one marker ѹ Surgical dental motor compatible with Straumann Falcon™, e.g. NSK ѹ Straumann recommends using a CBCT scan with a minimum resolution of < 0.3 mm, preferably 0.2 mm, that is no older than 6 months.
9.4 PLANNING THE DENTAL IMPLANT SURGERY ACCORDING TO THE CHOSEN WORKFLOW Case planning - Planning-based marker localization (available only with Smile in a Box®) workflow 1. Perform a CBCT scan with a suitable scanner. Note: The CBCT needs a resolution of <0.3 mm, preferably 0.2 mm. 2.
9.5 IMPORTING THE CASE PLANNING DATA To import the case planning data: ѹ To start up the device, press the power switch on the computer. Select user and enter the password to access system. Wait until the Patient screen is displayed. The user can choose between 2 options to import a case: 1.
3. Placing the tray with the marker in the patient’s mouth. Prerequisites ѹ Straumann Falcon™ is available and ready to use. ѹ Components have been cleaned and disinfected following cleaning and disinfection instructions (see page 68). ѹ A case planning was carried out in advance and the valid data is available on the device.
9.7 SETTING UP THE WORKSPACE Touchscreen Assistant’s position Patient’s mouth Registration tool Dentist’s position Cable from camera to the computer 9.7.1 To set up the workspace 1. Position the touchscreen so that the patient‘s mouth as well as the touchscreen are simultaneously in view during sur- gery.
Page 46
3. Bring together the registration tool components. 4. Place the registration tool on a stable and level surface. Make sure that the registration tool is easy to reach with the handpiece. 5. Optional: Apply 15.6" sterile touchscreen cover to monitor if wanted. For information about the sterile touchscreen cover please read the IFU from the manufacturer.
Page 47
9.7.4 To rotate the camera on the handpiece motor You can rotate the camera in a position that you prefer for surgery. 1. Slide and hold the camera backwards over the handpiece motor (by means of the adapter) and rotate the camera to the required angle relative to the handpiece motor.
9.8 LOADING THE CASE INTO STRAUMANN FALCON™ Buttons for posterior or anterior view Information about the implants Case information Screenshot button Accuracy check button Technical handling information...
Page 49
9.8.1 To load the case 1. On the Patient screen, select the case. If the case is not displayed, scroll through the list. 2. Choose the Start case button. Wait until loading is finished. The case loading is finished when the Select motor Overlay screen with the calibrated components is displayed on top of the Overview screen.
9.9 PLACING THE TRAY WITH THE MARKER IN THE PATIENT’S MOUTH To perform a surgery with Straumann Falcon™, 3 trays are available: ѹ Digital Tray ѹ Impression Tray ѹ Edentulous Tray 9.9.1 Digital Tray (only through Smile in a Box®) The digital tray is manufactured by the Smile in a Box®...
Page 51
9.9.2 Impression Tray The impression tray is needed when the chosen work- flow requires the localization of the marker with screws and/or teeth. The tray is fixed on the teeth of the patient. The ma- terial DMG O-Bite is needed to fix the tray. Before applying the O-Bite, remove one or both wing- lets from the tray to reduce the length of the tray, if the available space in the patient’s mouth is limited...
Page 52
9.9.3 Edentulous Tray The edentulous tray is needed when the chosen workflow requires the localization of the marker with screws and/or teeth. The tray is fixed directly on the jawbone where the implants are planned. To fix the tray it is possible to create an opening on the jaw’s gingiva, to reveal the bone.
2. Performing the guided surgery. 9.10.1 Prerequisites ѹ Straumann Falcon™ is available and ready to use. ѹ The case planning data is imported and loaded. For information about importing and loading the case planning data, see Importing the case planning data on page 41.
9.11 REGISTERING THE INSTRUMENT Registration spots Marker of the registration tool Camera Cylindric drill slots Caution: 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. ѹ...
Page 55
9.11.1 To register the instrument 1. Rotate the camera into position for a direct and frontal view of the marker. Make sure that the camera has a direct and frontal view of the marker. Deviations up to 45 ° are accept- able.
Page 56
ѹ For all other instruments, including the probe, place the instrument with the tip on the cross marking. 6. The registration starts automatically as soon as the instrument is in a valid position. On the touch- screen, the instrument registration overlay is dis- played.
9.12 CASE CHECK If the planning-based marker localization workflow is chosen, the case check will automatically start af- ter the registration of the probe. It is recommended to perform the case check after the localization of a new marker. It is possible to activate the case check function by clicking the button.
Page 58
Ensure that the position of the instrument in the patient‘s mouth and on the screen are the same (same teeth, same location) by rotating the model with the fingers. If the positions are identical, the software lets you press the OK button and proceed with navigation. ѹ...
9.13 LOCATION OF A NEW MARKER If the teeth surface/reference screw-based marker localization workflows are chosen, the software will request the user to touch a tooth/screw using the probe to start the localization. The system allows the location of one or more marker positions before and during surgery.
Page 60
4. Make sure the tray and the marker are fixed in the patient’s mouth. 5. Approach the selected landmark with the probe, making sure that the camera can detect the marker during the entire procedure of landmark detection. 6. If the landmark selected is a screw, touch the head of the screw with the probe until the position is validated on the software.
9.14 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 Caution: On the touchscreen, the Overview screen changes to the Navigation screen as soon as you move the handpiece to the patient’s mouth.
Page 62
To perform the guided surgery 1. On the Overview screen, check that the correct case is loaded. 2. Register the instrument. For information about registering the drill, see Registering the in- strument on page 52. 3. Check that the correct instrument is selected. 4.
Page 63
2.5 mm from the nerve. 9. Register the subsequent instruments if necessary. Warning: For Straumann implants, due to the func- tion and design of the drills, the drill tip is up to 0.5 mm longer than the insertion depth of the implant. For example, if you drill to the 10 mm marking, the actual implant bed has a depth of 10.5 mm.
9.15 AFTER SURGERY The main tasks after the surgery: 1. Viewing and exporting the case report. 2. Removing the case if desired. 3. Disposal of single-use components according to the instructions. Prerequisites The dental implant surgery is completed. Warning: 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.
9.16 VIEWING AND EXPORTING A CASE REPORT Name of active marker USB storage device indicator Buccal-Lingual view Anterior-Posterior view On the case report, the accuracy values show the de- Vestibular viation of the performed from the planned surgery in the buccal-lingual and anterior-posterior directions. Distal Apical Technical handling information...
Page 66
Note: For the drills integrated in the library there is an off- set between implant depth and drill depth, resulting from the offset indicated by the implant manufac- turer. This offset contributes to the accuracy value in the apical direction in implant direction in the case report.
Page 67
7. Remove the USB storage device. Notice: The FALCON computer should not be used as a storage system (no built-in backup). Data will be lost in the event of hardware failure or if the computer is sent to an authorized Straumann service partner (e.g. for repair).
9.17 DELETING A CASE IF DESIRED To delete the case: 1. On the Patient screen, select the case and patient. If the case is not displayed, scroll through the list. 2. Choose the button. A confirmation message is displayed. 3. To confirm the deletion, choose the Yes button. 4.
9.18 COMPLETING THE GUIDED SURGERY Notice: Infection by biohazardous waste ѹ Treat the device as biohazardous waste. Decontamination (cleaning, disinfection, and/or sterilization) is required before reuse, recycling, or disposal of the device. ѹ Dispose of the device according to the local regulations. For more information, contact your Service representative. To complete the guided surgery: 1.
10. PROCESSING (AND REPROCESSING) 10.1 INDIVIDUAL CLEANING INSTRUCTIONS 10.1.1 Active devices (FALCON computer and camera) 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...
7 - Calibration tool → Unpack → Inspect Note: Falcon Markers, impression trays and edentulous trays are invasive single use devices, as such they must be processed before use and must be disposed after use (single use devices). 10.2.2 Pre-treatment 1.
Regular servicing is necessary for safe operation and should be carried out once a year. Straumann recommends that only authorized service partners should undertake servicing and checking. For information about your local authorized service partner, see Authorized service partners on page 2.
11. TROUBLESHOOTING If the device is not responding adequately consider the following points. 11.1 TEMPERATURE TOO HIGH To cool down the device: 1. On the menu bar, choose the button. The configuration overlay with the Device monitor is displayed. 2. Check the Computer CPU temperature and Cam- era temperature.
Product name, REF number Camera Camera for Straumann Falcon™, FA1100 All-in-One computer for Straumann Falcon Computer for Straumann Falcon™, FA1300 Calibration tool Calibration tool for Straumann Falcon™, FA1200 Registration tool Registration Tool for Straumann Falcon™, FA1800 Consumables Product name, REF number Marker Marker for Straumann Falcon™, FA1500...
12.2.2 Accuracy The minimum theoretical optical accuracy of the Straumann Falcon™ is 0.75 mm (with a drill 60 mm 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 76
12.3.2 Dimensions for locator, round bur, and tap 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 12.3.3 Dimensions for implant adapter Dimension Implant adapter Total adapter length...
12.4 TRANSPORT AND STORAGE CONDITIONS The components can be moved and stored without damage in the associated transport packaging under the following conditions. Topic Specification Temperature range 0 °C to 50 °C (32 °F to 122 °F) Relative humidity 10–90% Vibration According to DIN EN 60068-2-6 Shape: Sinusoidal...
Portable RF communications equipment (including peripherals such as antenna cable and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Straumann Falcon™, including cables specified by the manufac- turer. Otherwise, degradation of the performance of this equipment could result.
Page 79
12.5.2 Electromagnetic immunity environment tested The Straumann Falcon™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Straumann Falcon™ should assure that it is used in such an environment. The Straumann Falcon™ was evaluated for Essential Performance which includes accuracy and latency. Testing showed that the Straumann Falcon™...
Page 80
Electromagnetic immunity II Straumann Falcon™ is intended for use in the electromagnetic environment specified below. The customer or the end user of Straumann Falcon™ should assure that it is used in such an environment. Immunity test standard IEC 60601 test level...
Page 81
Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment - guidance Proximity field from RF 27 V/m 27 V/m RF wireless equipment maximum output power and sepa- wireless communication 380-390 MHz 380-390 MHz ration distance tested (at 30 cm) : equipment 50 % PM 18 Hz 50 % PM 18 Hz...
Page 82
12.5.3 Recommended separation distances between portable and mobile RF communications equipment and the Straumann Falcon™ The Straumann Falcon™ is intended for use in the electromagnetic environment in which radiated RF disturbances are con- trolled. The customer or the user of the Straumann Falcon™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Straumann Falcon™...
12.6 FCC NOTICE The computer contains FCC marking and declaration under Advantech Co. Ltd which is as follows: FCC Class B This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
12.8 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 24.04 server https://ubuntu.com/ Contains packages of the main, restricted and universe groups.
Page 85
12.8.4 OpenSSL ѹ The OpenSSL toolkit stays under a double license, i.e. both the conditions of the OpenSSL License and the original SSLeay license apply to the toolkit. ѹ See the actual license text under https://www.openssl.org/source/license-openssl-ssleay.txt. ѹ Copyright (c) 1998-2019 The OpenSSL Project. All rights reserved. 12.8.5 Libdmtx ѹ...
Need help?
Do you have a question about the Falcon and is the answer not in the manual?
Questions and answers