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mininavident DENACAM User Manual

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USER MANUAL
VERSION 2.5

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  • Page 1 USER MANUAL VERSION 2.5...
  • Page 2 All dental implantations are indications for using this DENACAM components from an authorized mininavident navigation system. service partner.  For order information, see "Reference numbers" on page 106 www.mininavident.com/faq DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 3 Local contraindications: Inadequate bone volume or quality, local root remnants. Navigation system contraindications Heavy artefacts in region of marker, preventing unambiguous detection. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 4 Minor content changes. 1.2.0 May 2021 Address of EC representative added. EC representative symbol added in table “Symbols used on the components”. Open-source licenses information added in appendix. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 5 System cart replaced with new version. Care and cleaning procedures added and updated. Adjustments to the cleaning agents used. Illustrations updated. Applicable standards updated. Minor content changes and additions. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 6 If you continue to have difficulties despite having thoroughly studied the User Manual, please contact an authorized service partner.  For information about your local authorized service partner, see "Authorized service partners" on page 2 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 7 UDI Electrical security. Applied part type B EC representative Batch code or Lot number Date of manufacture Do not dispose of with domestic waste DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 8 Frequently asked questions HDMI High-definition multimedia interface High frequency International Electrotechnical Commission Instructions for use International Organization for Standardization Light emitting diode Radio frequency Unique device identification Universal serial bus DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 9 Duration mininavident grants a product warranty of 24 months from the date of purchase. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 10 Hospital / practice / departement (incl. address): Signature of user: The signature confirms that the user has been successfully trained on the DENACAM system, accordance with the legal regulations (medical devices marketing regulation, medical devices act) and has understood the content of this manual. Particular attention has been paid to the chapter of safety notes, operation, care, and cleaning.

  • Page 11: Table Of Contents

    SAFETY INFORMATION General ........12 Safety classifications ....12 Safety messages.

  • Page 12: General

    Notice components. Important information that is not safety relevant is indicated with the following icon: Note Indicates additional information on correct use or useful tips. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 13: Safety Messages

    For a list of supported materials, see "Overview of the system transmitters. If it is necessary to operate the product components" on page 21 close to other devices or in a stack with other DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 14: Warning Messages

    Any other metal part grounded with the protective earth mininavident recommends that all persons working with this system are made aware of the significance of the ESD warning label. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 15: Caution Messages

    For information about cooling down the system, see "To cool down unplugged in case of an emergency. the system" on page 102  For more information about the installation, see "Installation and setup" on page 33 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 16: Notices

    Decontamination (cleaning, disinfection, and sterilization) is required before reuse, recycling, or disposal of the system. • Dispose of the system according to the local regulations. For more information, contact your Service representative. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 17: Safety Labels On The Components

    Marker / Tray The component must only be used with one patient and must not be reprocessed Adapter - Bien-Air ventilated with cable Electrical security. Applied part type B. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 18 SAFETY INFORMATION SAFETY LABELS ON THE COMPONENTS DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 19 SYSTEM OVERVIEW DENACAM workflow ......20 Overview of the system components ... . . 21 The DENAOPT camera.

  • Page 20: Denacam Workflow

    Selecting instrument Performing accuracy check test Guided surgery Exporting case report Shutting down system Picture 1 DENACAM workflow  For more information about operation, see "Operation" on page 47 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 21: Overview Of The System Components

    "Installation and setup" on page 33  For reference numbers, see "Reference numbers" on page 106  For technical specifications, see "Specifications" on page 106 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 22: The Denaopt Camera

    Only wipe disinfection is allowed. The camera must not handpiece motor. be sterilized.  For information about cleaning, see "Individual cleaning  For information about cleaning, see "Individual cleaning instructions" on page 81 instructions" on page 81 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 23: The Denacomp Computer

    DisplayPort for the touchscreen  For information about connecting the computer to other components, see "Connecting the system" on page 37 The surfaces of the computer are made of aluminum. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 24: The Denascreen Touchscreen

    For information about mounting the touchscreen to the system cart, see"Installing the system cart (optional)" on page 35 The surfaces of the touchscreen are made of plastic, glass, and silicone rubber. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 25: The Denareg Registration Tool

    • A centrally positioned marker REGISTRATION TOOL M1800 REGISTRATION TOOL M1801 WITH EMBEDDED SECOND MARKER The registration tool is made of stainless steel and zirconia. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 26: The Denatray Tray

    Therefore, mininavident recommends to reprocess the marker no more than 50 times.  For information about cleaning and inspecting, see "Individual cleaning instructions" on page 81 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 27: The Denacart System Cart

    The surfaces of the system cart are made of plastic, steel, and aluminum. Only wipe disinfection is allowed. The system cart must not be sterilized.  For information about cleaning, see "Individual cleaning instructions" on page 81 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 28: Overview Of The Software

    Drill selection overlay entries Patient, Overview, Navigation, and Export. Navigation screen Each main menu entry has its own screen, and if Export screen necessary, additional overlays. • Case report viewing overlay DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 29 DENASCREEN touchscreen. The necessary dimensions of instruments are stored in the integrated instrument database.  For information about setting up the software, see "Service tasks" on page 40 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 30: System And User Information

    For information about logging in to the service screen, see • Language "Service tasks" on page 40 • Date and time • Choose the button to edit the user data DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 31 Choose the MARKER check button to perform a marker visibility check.  For more information about the marker visibility check, see "To perform a marker visibility check" on page 83 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 32 Choose the button to exit. translation position and the angulation. Choose the Save button. If you don’t want to save, choose the Cancel button DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 33 INSTALLATION AND SETUP Unpacking and setting up the system ... . 34 Unpacking all components ....34 Contents of the packages .

  • Page 34: Unpacking And Setting Up The System

    4 Tray 2 emergency. DENAMARK MARKER  For more information about safety, see "Safety information" • 2 Markers (reusable M1500) page 11 • 4 Markers (single-use M1501) DENACAM QUICK START GUIDE DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 35: Installing The System Cart (Optional)

    13 mm Socket (Swivel joint with fixing plate/ Identify the pre-installed cables and connect the Swivel arm) system.  For information about connecting the system, see "Connecting the system" on page 37 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 36 INSTALLATION AND SETUP UNPACKING AND SETTING UP THE SYSTEM Slide the computer into the intended compartment inside the system cart. Close the back door of the system cart. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 37: Connecting The System

    Connect the DC power cable. Connect the USB cable of the camera to the USB camera port on the computer. Connect the AC power cable to the mains connection on the computer. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 38: Attaching The Camera To The Handpiece Motor

    Screw the adapter to the motor. Visually inspect the fixed adapter. Check that the adapter is firmly connected and no gap is visible between the adapter and the motor. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 39 Bring the camera and the adapter together. The camera is automatically fixed and adjusted to the plate by magnets. Visually inspect the fixed camera. Check that the camera is firmly connected to the adapter. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 40: Service Tasks

    Choose the Service screen button. the computer. A keyboard is displayed. Wait until the Patient screen is displayed. On the menu bar, choose the button. The configuration overlay is displayed. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 41 On the service screen overlay, select a LED timeout value. Choose the button to exit. To check the software label Patient screen > button > Service screen button. The software label is displayed. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 42: Calibrating The Handpiece

    Register the handpiece in the software prior drilling • The handpieces and motors used must have a rotational play around the motor axis of <=1.2 degree (stop to stop) DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 43 90° position relative to start the calibrating process again. to the handpiece motor. Remove the handpiece from the calibration pin. Choose the button to exit. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 44: Setting Up The Instrument Database

    The USB storage device indicator lights up in blue are replaced. when a valid USB device is connected ( Choose Patient screen > button > Instrument database button. On the Instrument database overlay, choose the Import/Export button. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 45 The dataset is saved on the USB storage device. dimensions of the new instrument.  For information about the dimensions, see "Instrument dimensions" on page 108 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 46 Choose the Delete button to delete the instrument. • Choose the Duplicate button to duplicate the instrument.  For information about the dimensions, see "Instrument dimensions" on page 108 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 47 OPERATION Preoperative phase ......48 Assembling, positioning, and attaching the tray with the marker ......50 Planning the dental implant surgery .

  • Page 48: Preoperative Phase

    Importing the case planning data Importing the case planning data into the DENACAM System into the DENACAM System Dental implant surgery Picture 10 Workflows for marker capturing DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 49 If you are using for the different workflows software/ products/ materials from other manufacturer refer to their IFU.  For more information about safety, see "Safety information" page 11 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 50: Assembling, Positioning, And Attaching The Tray

    Make sure to leave enough space for working with dental instruments between the tray and the implant site. Make sure that the marker can always be seen from the camera. Take into account the implant position DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 51 To check the correct fit of the tray, cut the that it flows more towards buccolingual than impression material mesially and distally. mesiodistal. • Remove interfering impression material buccally and lingually / palatinally. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 52 Make sure there is no gap visible between the impression material and the teeth. Remove the tray from the patient’s mouth. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 53: Planning The Dental Implant Surgery

    Perform a CBCT scan with a suitable scanner.  For information about the suitable CBCT scanner, see www.mininavident.com/faq Position the prepared tray with the marker in the patient’s mouth. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 54 Import the case planning data into the DENACAM System to validate the data.  For more information about importing the case planning data, "Importing the case planning data" on page 55 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 55: Importing The Case Planning Data

    Perform a new CBCT scan or change to case planning option B or C.  For information about performing a CBCT scan, see "Planning the dental implant surgery" on page 53 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 56 If a newer version of the planning exists, the case won't import and give a message. • If an older version with treatment data exists, the case won't be imported and give a message. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 57: Before Surgery

    • Follow best practices, especially when you work with biohazardous material.  For more information about safety, see "Safety information" page 11 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 58: Setting Up The Workspace

    Place the registration tool on a stable and level surface. Make sure that the registration tool is easy to reach with the handpiece. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 59 Release the camera over the handpiece motor into To separate the camera from the adapter, pull the the secured position. two components apart. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 60: Loading The Case And Place The Tray

    Check if the retention of the tray is sufficient. • Make sure that the patient does not shift the tray with the tongue or the cheek. • Perform an accuracy check. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 61 The screenshot is added to the case report. It is labeled with the current date and time.  For more information about the case report, see "Viewing and exporting a case report" on page 73 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 62: Handling Of Cases With Multiple Markers

    (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. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 63: During Surgery - Guided Surgery

    Procedure Protocol of the implant system, are to the motor. available and ready to use. • The patient and the implant site or cavity is prepared for a treatment. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 64 The sequence of the instruments may differ depending on the implant system. • The procedures in this User Manual do not replace the Surgical Procedure Protocols of the dental implant system. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 65: Registering The Instrument

    Follow the Surgical Procedure Protocols of the dental implant system. • Register each instrument you want to use in the software prior surgery. • Re-register the drill once you have rotated the camera. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 66 Turn the instrument if the registration does not start automatically. Wait until the registration is finished and the instrument selection overlay is displayed. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 67 If the positions are identical, you can choose the button and proceed with centering or drilling. If the positions are not identical, reposition the tray with the marker and perform the test again. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 68 For information about repositioning the tray with the marker, see "To place the tray with the marker in the patient’s mouth" page 61 Choose the button again to stop the accuracy check. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 69: Performing The Guided Surgery

    The screenshot is added to the case report. It is labeled with the current date and time.  For more information about the case report, see "Viewing and exporting a case report" on page 73 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 70 Make sure the camera has a clear view on the marker. 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. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 71 While working, make sure the instrument remains in displayed. the best position and angle (cross-hair and angle Pay particular attention to the situation around the display remain green). nerve channel. Register the subsequent instruments if necessary. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 72: After Surgery

    • Follow best practices, especially when you work with biohazardous material.  For more information about safety, see "Safety information" page 11 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 73: Viewing And Exporting A Case Report

    This offset is part of the accuracy value in implant direction in the case report. Minus value means the hole is shorter, plus value means it is deeper than planned. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 74 The case report is saved on the USB storage device. To view the case report on the touchscreen, choose Remove the USB storage device. button. The case report is displayed. Choose the button to close the case report. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 75: Deleting A Case If Desired

    To confirm the deletion, choose the button. If you do not want to delete the case, choose the button. Choose the Shut down system button. A confirmation message is displayed. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 76 This can take a bit, so there is a loading screen. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 77 CARE AND CLEANING Basic principles......78 Cleaning, disinfecting, and sterilizing About the reuse of components... . . 78 the single-patient use marker M1501 .

  • Page 78: Basic Principles

    Components with limited life cycles mininavident defines a maximum number of reuses for certain reusable components (for example the markers). Inspect these components carefully before and after each use. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 79: About Appropriate Cleaning Solutions And

    It must be approved by VAH / DGHM or FDA, or marked with a CE mark. • The cleaning solutions must be suitable and compatible for use with the components. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 80: About Preparing For Cleaning

    Preliminary cleaning should be done with lint-free disposable paper wipes. To ensure that components undergoing cleaning can be properly assembled / re-assembled, pay attention to the individual assembly / re-assembly instructions. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 81: Individual Cleaning Instructions

    FD 333 quick disinfectant (DÜRR DENTAL) It is recommended to clean the components as soon as • Isopropanol 70% possible, but within 2 hours after each use. • Lint-free, disposable paper wipes DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 82: Cleaning The Camera

    Visually inspect the computer, touchscreen, and the computer. system cart for: • Damaged surfaces • Contamination If the components are still contaminated, repeat the steps. In case of damage, replace the components. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 83: Cleaning, Disinfecting, And Sterilizing

    • Cold tap water of at least drinking water quality or Store the camera. deionized water • Soft brush • Sterile 20 mL syringe • Lint-free, disposable paper wipes DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 84 Clean the adapter either manually or automatically. To clean and disinfect the adapter automatically  For information about automatic cleaning, see "Automatic cleaning with a washer-disinfector for adapter" on page 95 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 85 Damaged surfaces • Fissures • Chipping • Other abrasion • Contamination • Functionality If the adapter is still contaminated, then repeat the steps. In case of damage, replace the adapter. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 86: Cleaning, Disinfecting, And Sterilizing The

    Run the automatic cleaning program based on the parameters in table 4. Visually inspect the parts of the registration tool using a magnifying glass for: • Damaged surfaces • Fissures • Chipping DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 87 ® (131 °F) e.g. Neodisher Medizym 0.2% (2 ml/L) Rinse Cold deionized water 3 minutes Rinse Cold deionized water 2 minutes Thermal disinfection 90 °C (194 °F) 5 minutes DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 88 Conditions for Steam Sterilization - Moist Heat (Autoclave), Fractionated vacuum Variable Europe Preconditioning Pulses Temperature 134 °C (273 °F) 132 °C (270 °F) Full cycle exposure time 3-18 minutes 4 minutes Drying time 30 minutes 30 minutes DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 89: Cleaning, Disinfecting, And Sterilizing

    Fill a 20 mL syringe with tap water and flush the rinse under running cold tap water for 1 minute. cavities and all hard-to-reach and accessible areas of the component. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 90 97 • Functionality To perform a marker visibility check To start up the system, press the power switch on the computer. Wait until the Patient screen is displayed. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 91: The Single-Patient Use Marker M1501

    If not, • Deionized water use a new marker. ® • Cidex • Disposable syringe, 20 ml • Basin, stainless steel DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 92: Cleaning And Disinfecting, Or Disposing

    10 minutes. During soaking mechanically clean the tray with a soft bristled brush for 15 seconds. Remove the tray from the detergent solution. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 93 Visually inspect the tray for: • Damaged surfaces • Fissures • Chipping • Other abrasion • Contamination • Functionality To store the tray  For information about storing, see "Storing" on page 97 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 94 CARE AND CLEANING INDIVIDUAL CLEANING INSTRUCTIONS To dispose the tray after use Detach the marker from the tray. Dispose the tray according to the local regulations. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 95: Basic Instructions

    Drying process ® ® The information provided is based on the use of „Sekumatic MultiClean" by ECOLAB . Times and temperatures may vary if a different cleaning solution is used. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 96 Position components with hidden cavities facing downwards to support the rinsing process. • Carefully place components to avoid damages. • Follow all manufacturer‘s instructions for the use of the washer-disinfector. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 97: Sterilization And Storing

    Start the program. Remove the components from the sterilizer after the program ends. Check that the seal of the package is closed and the package is dry. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 98: Servicing

    For information about maintenance and repair protocol, see "Maintenance and repair protocol" on page 121  For information about your local authorized service partner, see "Authorized service partners" on page 2 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 99 TROUBLESHOOTING Software Messages/Warnings ....100 Hardware errors ......102 Temperature too high .
  • Page 100 Some data are not valid or are missing. • Message can provide text for error cause. • Warning Leak-time warning User is warned that the system has too long leak-time DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 101 Marker centers have to have a distance of >8mm or the rotation of the markers have to have a difference of >30°. If these criteria aren't fulfilled, the case can't be imported. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 102 For a faster cool down, improve the cooling in the room. Replace the defect fuse (T1.6 A H 250 V). Choose the button to exit. Close the fuse compartment. Connect the power cable. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 103 61 Restart the guided surgery.  For information about guided surgery, see "During surgery - Guided surgery" on page 63 Reconnect the camera to the computer. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 104 TROUBLESHOOTING HARDWARE ERRORS DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 105 EMC manufacturer’s declaration for the DENACAM System ..... . . 114 Electromagnetic compatibility (EMC) ..114 Electromagnetic Emission .

  • Page 106: Reference Numbers

    1 DisplayPort port at the rear ® Registration tool with DENAREG for connecting the embedded second marker M1801 touchscreen Accessory Product name REF number ® System cart DENACART M2001 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 107: Precision Of The Optical System

    Implant lateral is the accuracy in a plane passing through the planned implant base and orthogonal to the planned implant axis. Implant depth is the accuracy in direction of the planned implant axis. Angular is the angle between the planned and drilled implant axis. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 108: Instrument Dimensions

    Cutting angle of the drill tip alpha_2 Cutting angle of the second step (large diameter) offset Difference between the drilling depth and the Difference between the drilling depth and the implant tip implant tip DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 109: Dimensions 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 DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 110: Dimensions For Implant Adapter

    Dimensions for implant adapter Picture 20 Dimension sheet for implant adapter Table 12 Dimensions for implant adapter Dimension Implant adapter Total adapter length offset Difference between the adapter and the implant base DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 111: Transport And Storage Conditions

    According to DIN EN 60068-2-30 25 °C ±3 °C (77 °F ±5.4 °F), 97.5% ±2.5% 40 °C ±3 °C (104 °F ±5.4 °F), 93.0% ±3.0% 7 cycles over 7 days DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 112: Standards And Approvals

    (IEC 62353:2014) EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012) DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 113 :2017. ANSI/AAMI ST15883- Washer-disinfectors — Part 1: 1:2009/(R)2014 General requirements, terms and definitions and tests (international standard FDA: 2002 Medical Washers and Medical Washer-Disinfectors - Class II Special Controls DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 114: The Denacam System

    The DENACAM System is suitable for use in a specific electromagnetic environment. The customer and the user of the system should make sure that it is used in an electromagnetic environment as described below. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 115: Electromagnetic Emission

    Warning: This DENACAM System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the DENACAM System should be observed to verify normal operation in the configuration in which it will be used.

  • Page 116: Electromagnetic Immunity I

    134.2 kHz, 65 A/m 134.2 kHz, 65 A/m 13.56 MHz, 7.5 A/m 13.56 MHz, 7.5 A/m Note: U is the AC mains voltage prior to application of the test level. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 117: Electromagnetic Immunity Ii

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DENACAM System is used exceeds the applicable RF compliance level above, the DENACAM System should be observed to verify normal operation.
  • Page 118 Warning: 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 the DENACAM System including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 119: Equipment And The Product

    Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance to decrease the likelihood that mobile/ portable communications equipment could cause interference if it is inadvertently brought into patient areas. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 120: Fcc Notice

    Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 121: Maintenance And Repair Protocol

    • Attach the adapter to the registration tool by the force of the magnets. • The magnetic force must be strong enough to lift the registration tool. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...
  • Page 122 Step 2: Step 3: Step 4: Repair: Software Upgrade to Remarks and observations: Check camera, version: software Check cabling Check adapter, New calibration computer, version: registration tool, system cart marker DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

  • Page 123: Open-Source Licenses Overview

    OPEN-SOURCE LICENSES OVERVIEW OPEN-SOURCE LICENSES OVERVIEW The following table lists the open-source tools employed in DENACAM system, the web site of the creator of the tool and the open-source license type for each tool. Table 20 List of open-source packages...

  • Page 124: Openssl

    OpenSSL License and the original SSLeay license apply to the toolkit. • See the actual license text under https:// www.openssl.org/source/license-openssl- ssleay.txt. • Copyright (c) 1998-2019 The OpenSSL Project. All rights reserved. DENACAM System | User Manual | REF M1000-1001 I Version 2.5...

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