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Summary of Contents for mininavident DENACAM
- Page 1 USER MANUAL VERSION 1.2...
- Page 2 For order information, see "Reference numbers" on page 90 sight of the marker. Intended medical indication www.mininavident.com/faq All dental implantations are indications for using this navigation system. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- 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 1.2...
- Page 4 Online portal for technical documents mininavident has set up an online portal for the technical documents at http://www.mininavident.com/manuals. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 5 Limited protection against dust ingress (no harmful deposit). Protected against low pressure water jets from any direction. Limited ingress permitted. Keep dry Manufacturer DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 6 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 1.2...
- Page 7 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 8 ACCEPTANCE PROTOCOL / TRAINING DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 9: Table Of Contents
SAFETY INFORMATION General ........10 Safety classifications ....10 Safety messages. -
Page 10: 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 1.2... -
Page 11: Safety Messages
30 cm away from any part of the system. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 12: Warning Messages
Any other metal part grounded with the instructions for operation and maintenance. 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 1.2... -
Page 13: Caution Messages
For information about cooling down the system, see "To cool down unplugged in case of an emergency. the system" on page 87 For more information about the installation, see "Installation and setup" on page 29 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 14: 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 1.2... -
Page 15: Safety Labels On The Components
The component has not been sterilized or treated with a process during manufacturing to eliminate potential microorganisms Not for re-use The component must only be used with one patient and must not be reprocessed DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 16 SAFETY INFORMATION SAFETY LABELS ON THE COMPONENTS DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 17 SYSTEM OVERVIEW DENACAM workflow ......18 Overview of the system components ... . . 19 The DENAOPT camera.
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Page 18: Denacam Workflow
Performing tray position test Guided drilling Exporting case report Shutting down system Picture 1 DENACAM workflow For more information about operation, see "Operation" on page 41 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 19: Overview Of The System Components
"Installation and setup" on page 29 For reference numbers, see "Reference numbers" on page 90 For technical specifications, see "Specifications" on page 90 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 20: 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 69 instructions" on page 69 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 21: The Denacomp Computer
The surfaces of the touchscreen are made of plastic, Only wipe disinfection is allowed. The computer must not glass, and silicone rubber. be sterilized. For information about cleaning, see "Individual cleaning instructions" on page 69 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 22: The Denareg Registration Tool
Therefore, mininavident recommends to reprocess the registration tool no more than 50 times. For information about cleaning and inspecting, see "Individual cleaning instructions" on page 69 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 23: The Denamark Marker
69 and aluminum. Only wipe disinfection is allowed. The system cart must not be sterilized. For information about cleaning, see "Individual cleaning instructions" on page 69 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 24: Overview Of The Software
Drill selection overlay entries Patient, Overview, Drilling, and Export. Drilling 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 1.2... - Page 25 DENASCREEN touchscreen. For information about setting up the software, see "Service tasks" on page 35 DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 26: System And User Information
• Date and time For information about logging in to the service screen, see • Choose the button to edit the user data "Service tasks" on page 35 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 27 Edit the user data. A virtual keyboard is displayed when you place the cursor in an editable field. Choose the Save button. If you don’t want to save, choose the Cancel button DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 28 SYSTEM OVERVIEW OVERVIEW OF THE SOFTWARE DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 29 INSTALLATION AND SETUP Unpacking and setting up the system ... . 30 Unpacking all components ....30 Contents of the packages .
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Page 30: Unpacking And Setting Up The System
DENATRAY TRAY 2 emergency. • 4 Tray 2 For more information about safety, see "Safety information" DENAMARK MARKER page 9 • 2 Markers DENACAM QUICK START GUIDE DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 31: Installing The System Cart (Optional)
For information about connecting the system, see "Connecting the system" on page 32 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 1.2... -
Page 32: 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 1.2... -
Page 33: Attaching The Camera To The Handpiece Motor
The camera is automatically fixed and adjusted to Before first use, the handpiece must be taught the plate by magnets. together with the adapter. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 34 INSTALLATION AND SETUP UNPACKING AND SETTING UP THE SYSTEM Visually inspect the fixed camera. Check that the camera is firmly connected to the adapter. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 35: 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 1.2... - Page 36 The USB storage device indicator lights up in blue when a valid USB device is connected ( On the service screen overlay, select a LED timeout value. Choose the button to exit. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 37 Choose the Export log files button and wait until the log files are saved on the USB storage device. Remove the USB storage device. Choose the button to exit. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 38: Teaching The Handpiece
• Attach the camera correctly on the adapter • Make sure the adapter is always fully locked in position • Register the handpiece in the software prior drilling DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 39 90° position relative Remove the handpiece from the teaching pin. to the handpiece motor. Choose the button to exit. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 40 INSTALLATION AND SETUP UNPACKING AND SETTING UP THE SYSTEM DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 41 OPERATION Preoperative phase ......42 Assembling, positioning, and attaching the tray with the marker ......43 Planning the dental implant surgery .
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Page 42: Preoperative Phase
"Safety information" cleaning unless you have read and page 9 understood the information provided in the user documentation. • Follow best practices, especially when you work with biohazardous material. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 43: 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 1.2... - Page 44 / palatinally. For information about recommended impression material, see www.mininavident.com/faq Press the impression material from both sides so that it flows more towards buccolingual than mesiodistal. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 45 • To check the correct fit of the tray, cut the impression material mesially and distally. • Remove interfering impression material buccally and lingually / palatinally. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 46: Planning The Dental Implant Surgery
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 47 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 47: Importing The Case Planning Data
CBCT scan. Perform a new CBCT scan. For information about performing a CBCT scan, see "Planning the dental implant surgery" on page 46 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 48: Before Surgery
• Follow best practices, especially when you work with biohazardous material. For more information about safety, see "Safety information" page 9 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 49: 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 1.2... - Page 50 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 1.2...
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Page 51: 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 a tray check if necessary. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 52 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 62 DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 53: During Surgery - Guided Drilling
The sequence of the drills 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 1.2... -
Page 54: Registering The Round Bur Or The Drill
• Register each round bur or drill you want to use in the software prior drilling. • Re-register the drill once you have rotated the camera. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 55 The LEDs of the camera light up automatically when choose the Retry button. the registration tool is in the field of view of the Re-register the round bur once you have rotated the camera. camera. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 56 Select the slot according to the length of the drill. The LEDs of the camera light up automatically when the registration tool is in the field of view of the camera. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 57 For information about repositioning the tray with the marker, see "To place the tray with the marker in the patient’s mouth" page 52 Choose the button again to stop the tray check. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 58: Performing The Guided Drilling
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 62 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 59 < 0.5 mm). Make sure the camera has a clear view on the marker. 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 1.2...
- Page 60 Pay particular attention to the situation around the nerve channel. Register the subsequent drills. Widen the implant bed to the final preparation diameter and depth with the subsequent drills. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 61: After Surgery
• Follow best practices, especially when you work with biohazardous material. For more information about safety, see "Safety information" page 9 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 62: 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 1.2... - Page 63 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 1.2...
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Page 64: Deleting A Case If Desired
• 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 1.2... - Page 65 CARE AND CLEANING Basic principles......66 Basic instructions......81 About the reuse of components.
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Page 66: 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 1.2... -
Page 67: About Appropriate Cleaning Solutions And Cleaning
The cleaning solutions must be suitable and compatible for use with the components. • The manufacturer’s instructions, such as those regarding concentration, exposure time, or temperature, must be followed. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 68: 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 1.2... -
Page 69: 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 1.2... -
Page 70: Cleaning The Camera
The camera does not need to be disconnected from system cart for: the computer. • 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 1.2... -
Page 71: Cleaning, Disinfecting, And Sterilizing
Cold tap water of at least drinking water quality or steps. In case of damage, replace the camera. deionized water Store the camera. • Soft brush • Sterile 20 mL syringe • Lint-free, disposable paper wipes DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 72 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" on page 81 DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 73 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 1.2...
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Page 74: Registration Tool
Prepare the cleaner and choose the exposure time in accordance with the manufacturer’s instructions. • Use only freshly prepared solutions. • Immerse parts ensuring all surfaces are completely wet. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 75 Repeat this step 5 times. Start ultrasonic. After 10 minutes exposure, stop ultrasonic and remove the parts of the registration tool from the ultrasonic bath. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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Page 76: Cleaning, Disinfecting, And Sterilizing The
• Cold tap water of at least drinking water quality or deionized water • Soft brush • Sterile 20 mL syringe • Magnifying glass • Lint-free, disposable paper wipes DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 77 Fill a 20 mL syringe with detergent solution and • Contamination flush the cavities and all hard-to-reach and accessible areas of the component. Repeat this • Functionality step 5 times. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 78 DIN 58953. Sterilize the packed marker. For information about sterilizing, see "Steam sterilization" page 83 Store the marker. For information about storing, see "Storing" on page 83 DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 79 Check the marker for cleanliness and repeat the steps if dirt is still visible. Leave the tray to dry on a single use, lint-free wipe or towel. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 80 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 1.2...
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Page 81: 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 1.2... - Page 82 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 1.2...
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Page 83: 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 1.2... -
Page 84: Servicing
For information about maintenance and repair protocol, see "Maintenance and repair protocol" on page 98 For information about your local authorized service partner, see "Authorized service partners" on page 2 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... - Page 85 TROUBLESHOOTING Software Messages/Warnings ....86 Hardware errors ......87 Temperature too high .
- Page 86 User is warned, that the system will shut down. • Warning Update warning Software could not be updated. • Some data are not valid or are missing. • Message can provide text for error cause. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 87 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 1.2...
- Page 88 52 Restart the guided drilling. For information about guided drilling, see "During surgery - Guided Drilling" on page 53 Reconnect the camera to the computer. DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
- Page 89 EMC manufacturer’s declaration for the DENACAM System ......94 Electromagnetic compatibility (EMC) ..94 Electromagnetic Emission .
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Page 90: Reference Numbers
Accessory Product name connecting the touchscreen REF number 1 DisplayPort port at the rear ® System cart DENACART for connecting the M2000 touchscreen ® Support for handpiece DENAOPTSTAND M1150 DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 91: 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 1.2... -
Page 92: 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 1.2... -
Page 93: Standards And Approvals
- Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:1995); German version EN ISO 13402:2000 ASTM F 1089 Standard Test Method for Corrosion of Surgical Instruments DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 94: 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 1.2... -
Page 95: Electromagnetic Emission
IEC 61000-4-8 environment. Note: U is the AC mains voltage prior to application of the test level. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 96: Electromagnetic Immunity Ii
RF compliance level above, the product should be observed, additional measures may be necessary, such as reorienting or relocating the product. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. DENACAM System | User Manual | REF M1000-1001 I Version 1.2... -
Page 97: 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 1.2... -
Page 98: 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 1.2... - Page 100 APPENDIX MAINTENANCE AND REPAIR PROTOCOL DENACAM System | User Manual | REF M1000-1001 I Version 1.2...
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