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USER MANUAL

VERSION 1.2

Summary of Contents for DENACAM

Page 1: ...USER MANUAL VERSION 1 2 ...

Page 2: ...eal time computerized navigational system intended to provide assistance in the intra operative surgical phases of dental implantation surgery The system provides precise navigational guidance of surgical instruments according to the preoperative planning in the dental implantation procedure Patient population Partially edentulous and edentulous adult and geriatric patients who require dental impl...

Page 3: ...anatomic bone conditions tobacco abuse uncontrolled periodontitis temporomandibular joint disorders treatable pathologic diseases of the jaw and changes in the oral mucosa pregnancy inadequate oral hygiene Local contraindications Inadequate bone volume or quality local root remnants Navigation system contraindications Heavy artefacts in region of marker preventing unambiguous detection Electromagn...

Page 4: ...nual is included with it either as a hard copy or on an electronic storage device so that the new owner can familiarize himself with its functions and the specified warning and safety information Online portal for technical documents mininavident has set up an online portal for the technical documents at http www mininavident com manuals From there you can download this User Manual along with othe...

Page 5: ...CE mark with identification number of the notified body Consult instructions for use Consult User Manual Data matrix code for product information including UDI Date of manufacture Do not dispose of with domestic waste Federal law restricts this system to sale by or on the order of a dentist physician or any other practitioner licensed by the law of the state in which he or she practices to use or ...

Page 6: ...to perform care and cleaning activities or ignores error messages mininavident and its authorized dealers cannot assume liability for any damage thus incurred Duration mininavident grants a product warranty of 24 months from the date of purchase Non sterile Not for re use Reference number Serial number Abbreviation Definition 3D Three dimensional AC Alternating current ANSI American National Stand...

Page 7: ...ddress Signature of user The signature conﬁrms that the user has been successfully trained on the DENACAM system in 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 The signature conﬁrms the hand over of the the fu...

Page 8: ...ACCEPTANCE PROTOCOL TRAINING DENACAM System User Manual REF M1000 1001 I Version 1 2 8 ...

Page 9: ...SAFETY INFORMATION General 10 Safety classifications 10 Safety messages 11 Safety precautions 11 Warning messages 12 Caution messages 13 Notices 14 Safety labels on the components 15 ...

Page 10: ...to the ANSI Z535 6 2011 standard Familiarize yourself with the following meanings and icons Safety alert The safety alert symbol is used to alert you to potential physical injury hazards Comply with all safety messages that follow this symbol to avoid possible damage to the system injury or death These symbols and signal words are used for specific hazards Important information that is not safety ...

Page 11: ...ers UNAUTHORIZED ACCESS Unauthorized access to the components of the system can result in data loss system damage or system unavailability Only authorized persons may access system components TOUCHSCREEN The touchscreen is equipped with touch sensitive control technology Operating with pointed objects such as ballpoint pens pencils etc could damage or scratch its surface Always operate the touchsc...

Page 12: ...unit casing A larger metallic object 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 Warning messages List of warning messages Failure to observe warning messages may result in death or serious injury Before operating the system read the warning messages carefully O...

Page 13: ...n emergency For more information about the installation see Installation and setup on page 29 INJURY TO THE PATIENT DUE TO USE OF NON FUNCTIONAL OR NON CONFORM COMPONENTS Use of damaged contaminated or not correctly working components may lead to inaccurate navigation procedure Do not use USB storage devices with a separate power supply USB storage devices with a separate power supply may seriousl...

Page 14: ...E TO MECHANICAL STRESS Shock vibration or pressure can damage the components of the system Keep sources of vibration away from the components Do not place objects on the components INFECTION BY BIOHAZARDOUS WASTE Treat the system as biohazardous waste Decontamination cleaning disinfection and sterilization is required before reuse recycling or disposal of the system Dispose of the system according...

Page 15: ...plains the meanings of the labels at the locations where you find the labels Table 2 Safety labels on the components Label Where to find Meaning Computer Consult User Manual Computer Do not dispose of with domestic waste Non sterile 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 us...

Page 16: ...SAFETY INFORMATION SAFETY LABELS ON THE COMPONENTS DENACAM System User Manual REF M1000 1001 I Version 1 2 16 ...

Page 17: ...s 19 The DENAOPT camera 20 The DENADAPT adapter 20 The DENACOMP computer 21 The DENASCREEN touchscreen 21 The DENAREG registration tool 22 The DENATRAY tray 22 The DENAMARK marker 23 The DENACART system cart 23 Overview of the software 24 System and user information 26 ...

Page 18: ...low Preoperative Before surgery During surgery After surgery 1 Preparing and positioning tray and marker 2 Performing CBCT scan Case planning 3 Importing case 4 Starting up system Loading case 5 Placing tray with marker Viewing 3D scan 6 Registering round bur or drill 7 Selecting round bur or drill 8 Performing tray position test 9 Guided drilling 10 Exporting case report Shutting down system ...

Page 19: ...unpacking the components and setting up the system see Installation and setup on page 29 For reference numbers see Reference numbers on page 90 For technical specifications see Specifications on page 90 Picture 2 System components DENATOUCH touchscreen DENACOMP computer DENAREG registration tool DENADAPT adapter DENATRAY tray 1 and 2 with DENAMARK marker DENAOPT camera ...

Page 20: ...r handpiece motor and cleaned individually Only wipe disinfection is allowed The camera must not be sterilized For information about cleaning see Individual cleaning instructions on page 69 The DENADAPT adapter The adapter connects the camera to the handpiece motor with a magnetic quick release fastener It is screwed to the handpiece motor permanently For information about mounting the adapter to ...

Page 21: ...leaning the computer must be switched off Only wipe disinfection is allowed The computer must not be sterilized For information about cleaning see Individual cleaning instructions on page 69 The DENASCREEN touchscreen The touchscreen displays the user interface and is equipped with a touch sensitive panel It can be used with gloves The software can be fully operated by the touchscreen No mouse or ...

Page 22: ...e of stainless steel and zirconia The marker on the registration tool has a pattern that is captured by the camera The pattern may lose the contrast after several reprocessings 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 The DENATRAY tray The tray holds the D...

Page 23: ...r no more than 50 times For information about cleaning and inspecting see Individual cleaning instructions on page 69 The DENACART system cart The system cart is an accessory that can be ordered optionally It offers the following possibilities for working with the DENACAM System A swivel arm for holding the touchscreen Storage space for the computer Four drawers for extra storage space Equipment f...

Page 24: ...verview Drilling and Export Each main menu entry has its own screen and if necessary additional overlays 1 Patient screen 2 Overview screen Drill registration overlay Drill selection overlay 3 Drilling screen 4 Export screen Case report viewing overlay Picture 3 Overview user interface 1 Patient screen Searching cases Importing and loading cases Deleting cases 2 Overview screen Viewing the case Ch...

Page 25: ...onal position and angle of the handpiece in relation to the DENAMARK marker in the mouth On the basis of the data from the case planning this position and case information on the exact implant position drill angle and drilling depth are displayed in real time on the DENASCREEN touchscreen For information about setting up the software see Service tasks on page 35 ...

Page 26: ...data Surgeon s name Surgeon s address Language Date and time Choose the button to edit the user data For information about how to set up the user data see To set up the user data on page 27 System monitor DENACOMP CPU temperature DENAOPT temperature Choose the Shut down system button to shut down the system Choose the Show user manual button to view the User Manual pdf file Choose the Service scre...

Page 27: ...ntil the Patient screen is displayed 2 On the menu bar choose the button The configuration overlay is displayed 3 To access the user data choose the button on the configuration overlay The user data overlay is displayed 4 Edit the user data A virtual keyboard is displayed when you place the cursor in an editable field 5 Choose the Save button If you don t want to save choose the Cancel button ...

Page 28: ...SYSTEM OVERVIEW OVERVIEW OF THE SOFTWARE DENACAM System User Manual REF M1000 1001 I Version 1 2 28 ...

Page 29: ...d setting up the system 30 Unpacking all components 30 Contents of the packages 30 Installing the system cart optional 31 Connecting the system 32 Attaching the camera to the handpiece motor 33 Service tasks 35 Teaching the handpiece 38 ...

Page 30: ...l the parts are in the package and in good condition Contents of the packages For reference numbers see Reference numbers on page 90 DENACART SYSTEM CART OPTIONAL 1 System cart 1 Swivel arm inclusive screw for mounting the touchscreen DENACOMP COMPUTER 1 Computer 1 AC power cable DENASCREEN TOUCHSCREEN 1 Touchscreen including stand 1 DC power cable 1 USB cable 1 DisplayPort cable DENAOPT CAMERA 1 ...

Page 31: ...m cart 4 Attach the magnetic multiple socket to the intended holder inside the system cart 5 Identify the pre installed cables and connect the system For information about connecting the system see Connecting the system on page 32 6 Slide the computer into the intended compartment inside the system cart 7 Close the back door of the system cart Picture 5 Installing the system cart Touchscreen Swive...

Page 32: ...Connect the touchscreen to the computer Connect the DisplayPort cable Connect the USB cable Connect the DC power cable 2 Connect the USB cable of the camera to the USB camera port on the computer 3 Connect the AC power cable to the mains connection on the computer Picture 6 Connecting the system USB camera connection Touchscreen Mains connection Computer DisplayPort monitor connection USB monitor ...

Page 33: ... adapter 3 Align the connection tubes of the motor with the connection openings of the hose 4 Screw the adapter to the motor 5 Visually inspect the fixed adapter Check that the adapter is firmly connected and no gap is visible between the adapter and the motor 6 Before first use the handpiece must be taught together with the adapter For information about teaching the handpiece see To teach the han...

Page 34: ...ALLATION AND SETUP UNPACKING AND SETTING UP THE SYSTEM DENACAM System User Manual REF M1000 1001 I Version 1 2 34 3 Visually inspect the fixed camera Check that the camera is firmly connected to the adapter ...

Page 35: ...e handpiece see Teaching the handpiece on page 38 To access the service screen 1 To start up the system press the power switch on the computer Wait until the Patient screen is displayed 2 On the menu bar choose the button The configuration overlay is displayed 3 Choose the Service screen button A keyboard is displayed Picture 8 Service tasks Service screen overlay ...

Page 36: ...storage device containing the software update file The USB storage device indicator lights up in blue when a valid USB device is connected 4 On the service screen overlay choose the Software update button If a valid update file is available the Software update overlay is displayed 5 Choose the Start update button and wait until the update is finished 6 Remove the USB storage device 7 Choose the bu...

Page 37: ...r insert the USB storage device with adequate storage capacity 3 On the service screen overlay choose th Log file export button The Export log files overlay is displayed The USB storage device indicator lights up in blue when a valid USB device is connected 4 Choose the Export log files button and wait until the log files are saved on the USB storage device 5 Remove the USB storage device 6 Choose...

Page 38: ...pin Button for LED light Caution Injury to the patient due to incorrect camera handpiece motor handling Incorrect handling of the camera and handpiece motor may lead to inaccurate shifted navigation procedure Assemble the adapter and the handpiece motor correctly Attach the camera correctly on the adapter Make sure the adapter is always fully locked in position Register the handpiece in the softwa...

Page 39: ... over the handpiece motor by means of the adapter and rotate the camera counterclockwise to a 90 position relative to the handpiece motor Move the camera forwards over the handpiece motor into the secured position For information about rotating the camera see To rotate the camera on the handpiece motor on page 50 5 On the teaching overlay choose the Teach position button Make sure the handpiece st...

Page 40: ...INSTALLATION AND SETUP UNPACKING AND SETTING UP THE SYSTEM DENACAM System User Manual REF M1000 1001 I Version 1 2 40 ...

Page 41: ...case planning data 47 Before surgery 48 Setting up the workspace 49 Loading the case and place the tray with the marker 51 During surgery Guided Drilling 53 Registering the round bur or the drill 54 Performing the guided drilling 58 After surgery 61 Viewing and exporting a case report 62 Deleting a case if desired 64 Completing the guided drilling 64 ...

Page 42: ...nformation and procedures contained in this User Manual Do not carry out operation care and cleaning unless you have read and understood the information provided in the user documentation Follow best practices especially when you work with biohazardous material Caution Injury to the patient due to incorrect tray marker or CBCT scanner handling Incorrect tray or marker handling may lead to bad CBCT...

Page 43: ...ailable Tray 1 holds the marker on the right side Tray 2 holds the marker on the left side 2 Identify the appropriate position on the jaw to place the tray with the marker Taking into account the patient s situation place the marker either buccally lingually or palatally Place the tray close to the implant site More distance leads to more inaccuracy Make sure to leave enough space for working with...

Page 44: ...argin Use only recommended impression material For information about recommended impression material see www mininavident com faq 2 Press the impression material from both sides so that it flows more towards buccolingual than mesiodistal 3 Slowly position the loaded tray in the patient s mouth parallel to the vertical axes of the teeth Once the tray is seated hold it in place without applying pres...

Page 45: ...Use only recommended impression material For information about recommended impression material see www mininavident com faq 10 Slowly position the loaded tray in the patient s mouth Once the tray is seated hold it in place without applying pressure Avoid to contact the teeth with the tray 11 Wait until the light body impression material is hardened 12 Remove the tray from the patient s mouth Remov...

Page 46: ... at least 5 mm distance between the marker and the edge of the CBCT scan field Not fully scanned marker will lead to inaccuracy For information about the suitable CBCT scanner see www mininavident com faq 3 Remove the tray from the patient s mouth and store it Do not remove the marker from the tray anymore until the implant surgery is completed 4 Plan the dental implant surgery with a suitable pla...

Page 47: ...d 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 3 If the marker cannot be evaluated by the software the status symbol of the imported case planning data remains orange In this case the marker was not detected correctly during the CBCT sc...

Page 48: ...gery on page 46 The tray with the marker for the case is available and ready to use For more information about the tray and marker see Assembling positioning and attaching the tray with the marker on page 43 SAFETY For more information about safety see Safety information on page 9 Warning Serious injury to the patient due to incorrect handling As an operator ensure that you know the relevant safet...

Page 49: ...our fingers 2 Route the cable from the camera to the computer outside of the operating area over the patient 3 Place the registration tool on a stable and level surface Make sure that the registration tool is easy to reach with the handpiece To start up the system 1 On the computer press the power switch Wait until the Patient screen is displayed Picture 12 Setting up the workspace Touchscreen Den...

Page 50: ... the attached camera The camera must be firmly connected to the adapter To separate the camera from the adapter pull the two components apart To rotate the camera on the handpiece motor You can rotate the camera in a position which you prefer for surgery 1 Slide and hold the camera backwards over the handpiece motor by means of the adapter and rotate the camera into the required angle relative to ...

Page 51: ...plants Tray check button Caution Injury to the patient due to incorrect tray or marker handling Incorrect handling of the tray or marker may lead to inaccurate or shifted navigation procedure Make sure that the tray is attached correctly in the patient s mouth Make sure that the marker is not soiled Check if the retention of the tray is sufficient Make sure that the patient does not shift the tray...

Page 52: ...either the button or the button Rotate the 3D model by moving it with your finger on the touchscreen Take a screenshot by choosing the button 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 To place the tray with the marker in the patient s mouth 1 On the Overview s...

Page 53: ... and ready to use The patient and the implant site is prepared for a dental implant surgery SAFETY For more information about safety see Safety information on page 9 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 Do not carry ...

Page 54: ...f the registration tool Caution Injury to the patient due to incorrect drill or registration tool handling Incorrect handling of drills or the registration tool may lead to inaccurate or shifted navigation procedure Always verify the chosen round bur or drill prior drilling Follow the Surgical Procedure Protocols of the dental implant system Register each round bur or drill you want to use in the ...

Page 55: ... to the diameter of the round bur The LEDs of the camera light up automatically when the registration tool is in the field of view of the camera 5 On the touchscreen the round bur registration overlay is displayed The registration starts automatically as soon as the round bur is in a valid position Make sure that the round bur stays in the valid position while the registration is running 6 Wait un...

Page 56: ... Surgical Protocol of the dental implant system 3 Insert the drill into the drill chuck 4 Guide the drill entirely in one of the three slots of the registration tool 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 5 Insert the drill at an angle into the slot so that the drill bit fac...

Page 57: ...ystem is now ready for drilling To check the tray position You can check the correct position of the tray with the marker in the patient s mouth using the tray check function 1 Register a round bur or drill For information about registering a round bur or drill see To register the round bur on page 55 2 On the Overview screen choose the button 3 Follow the instruction on the screen The round bur o...

Page 58: ...e 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 Picture 15 Guided drilling Drilling screen Screenshot button Buttons for posterior or anterior view Projection panel Target panel Axis from the handpiece Buttons for different projection modes Caution Injury to the patient due to incorrect drill or reg...

Page 59: ...he target panel guide the round bur or drill over the target The lateral accuracy is within circle 2 at 2 mm within circle 1 at 1 mm The cross hair turns from white to green as soon as the round bur or drill is in best position lateral accuracy 0 5 mm Make sure the camera has a clear view on the marker 6 For centering the entry point of the implant site place the round bur on the bone While center...

Page 60: ...rill remains in the best position and angle cross hair and angle display remain green 9 Observe the implant site situation and the drilling on the projection panel The planned implant and the current drill position is displayed Pay particular attention to the situation around the nerve channel 10 Register the subsequent drills 11 Widen the implant bed to the final preparation diameter and depth wi...

Page 61: ...y information on page 9 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 Do not carry out operation care and cleaning unless you have read and understood the information provided in the user documentation Carefully follow the pr...

Page 62: ...irection Picture 16 Viewing and exporting the case report Case report USB storage device indicator Anterior Posterior view Buccal Lingual view L B A P Note At predefined drills there is an offset between implantdepth and drilldepth resulted from the recommended offset of the implant manufacturer This offset is part of the accuracy value in implant direction in the case report Minus value means the...

Page 63: ...en is displayed 3 To view the case report on the touchscreen choose the button The case report is displayed 4 Choose the button to close the case report 5 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 6 Choose the Export to USB storage device button The case report is save...

Page 64: ...nents for cleaning For information about the cleaning see Care and cleaning on page 65 To shut down the system 1 Remove the round bur or drill from the handpiece 2 On the menu bar choose the button The configuration overlay is displayed 3 Choose the Shut down system button A confirmation message is displayed 4 Choose the Yes button Wait until the computer is shut down If you do not want to shut do...

Page 65: ...Individual cleaning instructions 69 Cleaning the computer touchscreen and system cart 69 Cleaning the camera 70 Cleaning disinfecting and sterilizing the adapter 71 Cleaning disinfecting and sterilizing the registration tool 74 Cleaning disinfecting and sterilizing the marker 76 Cleaning and disinfecting or disposing the tray 78 Basic instructions 81 Manual and automatic cleaning 81 Manual cleanin...

Page 66: ...r used for another patient The manufacturer excludes any liability when single patient components are reused Reusable components Components that are not labeled for single patient use may be reused These reusable components have to be reprocessed before each use Frequent reprocessing has minor effects on the components The end of the product life is normally determined by wear and damage during us...

Page 67: ...e been validated by the medical device manufacturer as being capable of preparing non sterile mininavident medical devices It remains the responsibility of the user to ensure that the processing is actually performed using appropriate equipment materials and personnel in the reprocessing facility and achieves the desired result This requires validation and routine monitoring of the process Likewis...

Page 68: ...mponents as soon as possible but within 2 hours after each use It is recommended to transport contaminated components in a closed box or container 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 ...

Page 69: ...llow the basic principles for care and cleaning For more information see Basic principles on page 66 REQUIRED EQUIPMENT Surface disinfectant for example MinutenSpray Classic ALPRO MEDICAL GMBH PlastiSept eco ALPRO MEDICAL GMBH FD 333 quick disinfectant DÜRR DENTAL Isopropanol 70 Lint free disposable paper wipes Table 3 Individual cleaning instructions Overview Component Preparing for cleaning Clea...

Page 70: ... the camera as soon as possible but within 2 hours after each use Make sure always to follow the basic principles for care and cleaning For more information see Basic principles on page 66 REQUIRED EQUIPMENT Surface disinfectant for example MinutenSpray Classic ALPRO MEDICAL GMBH PlastiSept eco ALPRO MEDICAL GMBH FD 333 quick disinfectant DÜRR DENTAL Isopropanol 70 Lint free disposable paper wipes...

Page 71: ... the adapter It is recommended to clean and disinfect the adapter as soon as possible but within 2 hours after each use Make sure always to follow the basic principles for care and cleaning For more information see Basic principles on page 66 REQUIRED EQUIPMENT Multistage enzymatic cleaner detergent E g Sekusept MultiEnzyme P ECOLAB VAH listed disinfectant on peroxide basis E g Sekusept PLUS ECOLA...

Page 72: ...UALLY 1 Place the adapter in the cleaning bath Prepare the cleaner and choose the exposure time in accordance with the manufacturer s instructions Use only freshly prepared solutions Immerse components ensuring all surfaces are completely wet 2 Clean the adapter in the cleaning bath Brush all hard to reach areas e g hinges threads sliding rings crevices holes and notches and accessible areas to re...

Page 73: ... 10 After 10 minutes exposure stop ultrasonic and remove the adapter from the ultrasonic bath 11 Rinse the adapter under running cold tap water for at least 1 minute 12 Repeat the rinsing step with deionized water 13 Wipe the adapter with a single use lint free wipe or towel or dry by an air gun with medical compressed air 14 Visually inspect the adapter for Damaged surfaces Fissures Chipping Othe...

Page 74: ...by a magnet 3 Rinse the parts of the registration tool under running cold tap water and remove dirt with a soft brush 4 Rinse the parts of the registration tool again and check visually the result 5 Clean the parts of the registration tool either manually or automatically To clean and disinfect the registration tool automatically For information about automatic cleaning see Automatic cleaning with...

Page 75: ...oose the exposure time in accordance with the manufacturer s instructions Use only freshly prepared solutions Follow all manufacturer s instructions for the use of the ultrasonic bath 7 Stop ultrasonic after 5 minutes exposure 8 Flush the parts of the registration tool in the ultrasonic bath Fill a 20 mL syringe with disinfection solution and flush the cavities and all hard to reach and accessible...

Page 76: ...se Make sure always to follow the basic principles for care and cleaning For more information see Basic principles on page 66 REQUIRED EQUIPMENT Multistage enzymatic cleaner detergent E g Sekusept MultiEnzyme P ECOLAB VAH listed disinfectant on peroxide basis E g Sekusept PLUS ECOLAB Detergent tank Cold tap water of at least drinking water quality or deionized water Soft brush Sterile 20 mL syring...

Page 77: ...omponent Repeat this step 5 times 3 Remove the marker from the cleaning bath and rinse under running cold tap water for 1 minute Fill a 20 mL syringe with tap water and flush the cavities and all hard to reach and accessible areas of the component 4 Check the marker for cleanliness and repeat the steps if dirt is still visible 5 Leave the marker to dry on a single use lint free wipe or towel DISIN...

Page 78: ... taking and after the CBCT scan Make sure always to follow the basic principles for care and cleaning For more information see Basic principles on page 66 REQUIRED EQUIPMENT Multistage enzymatic cleaner detergent E g Sekusept MultiEnzyme P ECOLAB VAH listed disinfectant E g MD 520 impression disinfectant DÜRR DENTAL Detergent tank Cold tap water of at least drinking water quality or deionized wate...

Page 79: ... 3 Remove the tray from the cleaning bath and rinse under running cold tap water for 1 minute Fill a 20 mL syringe with tap water and flush the cavities and all hard to reach and accessible areas of the component 4 Check the marker for cleanliness and repeat the steps if dirt is still visible 5 Leave the tray to dry on a single use lint free wipe or towel DISINFECTION MANUALLY 6 Place the tray in ...

Page 80: ...NING INDIVIDUAL CLEANING INSTRUCTIONS DENACAM System User Manual REF M1000 1001 I Version 1 2 80 To dispose the tray after use 1 Detach the marker from the tray 2 Dispose the tray according to the local regulations ...

Page 81: ...ons and cleaning equipment on page 67 Automatic cleaning with a washer disinfector Use the automatic cleaning procedure for Adapter mounted on the handpiece motor Registration tool Make sure always to follow the basic principles for care and cleaning For more information see Basic principles on page 66 When using the washer disinfector make sure that the cleaning process includes the following pha...

Page 82: ...ector Always load the components according to the manufacturer s instructions If necessary disassemble components as indicated in the individual cleaning procedures Do not overload the washer disinfector Place large components in a way that they do not cover other components and consequently impact the cleaning process Make sure that components with cavities are completely rinsed also from the ins...

Page 83: ...ter the program ends 4 Check that the seal of the package is closed and the package is dry Storing After sterilization the components must be stored in a dry dust and humidity free environment without direct solar irradiation Temperature variations have to be avoided to prevent corrosive damage The maximum storage time depends on various factors such as packaging method of storing environment and ...

Page 84: ...n and should be carried out once a year mininavident recommends that only an authorized service partner should undertake servicing and checking 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 ...

Page 85: ...TROUBLESHOOTING Software Messages Warnings 86 Hardware errors 87 Temperature too high 87 Power interruption 87 Connection error between the camera and the computer 88 ...

Page 86: ...To cool down the system on page 87 Warning Temperature DENACOMP DENACOMP CPU sensor 85 C 185 F System performance not optimal Possible damage to DENACOMP Measure Cool down the system For information about cooling down the system see To cool down the system on page 87 Warning Data import warning Error while reading the USB storage device Use another USB storage device or repair the device with a re...

Page 87: ...re drops to below 85 C 185 F for the DENACOMP CPU temperature or 55 C 131 F for the DENAOPT temperature For a faster cool down improve the cooling in the room 4 Choose the button to exit Power interruption A Power interruption can be triggered by the system fuse unintentional disconnection of the power cable or a power breakdown After a power interruption the system needs to be recovered To change...

Page 88: ...mport the case planning data again For information about importing case planning data see To import the case planning data on page 47 5 Reload the case planning data For information about loading case planning data see To load the case on page 52 6 Restart the guided drilling For information about guided drilling see During surgery Guided Drilling on page 53 Connection error between the camera and...

Page 89: ...ds and approvals 93 EMC manufacturer s declaration for the DENACAM System 94 Electromagnetic compatibility EMC 94 Electromagnetic Emission 95 Electromagnetic Immunity I 95 Electromagnetic Immunity II 96 Recommended separation distances between portable and mobile HF communications equipment and the product 97 Maintenance and repair protocol 98 ...

Page 90: ...NAOPTSTAND M1150 Topic Specification Model designation DENACAM System Power connection 90 240 V Nominal current 50 60 Hz Type of system earthing Protective earth Protection class Class I System fuse 2x T1 6A H 250 V Device class in accordance with Directive 93 42 EEC Class IIa Mode of operation Continuous operation with intermittent loading corresponding to the dental mode of working Operating con...

Page 91: ...including user influence was determined in an in vitro study using realistic clinic implant and related marker positions 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 Implant lateral...

Page 92: ...midity 5 95 Vibration According to DIN EN 60068 2 6 Shape Sinusoidal Frequency 7 200 Hz Acceleration 15 m s2 Frequency change 1 octave min Each 30 min in x y z direction Shock According to DIN EN 60608 2 27 Shape Half sinusoidal Acceleration 200 m s2 Duration 11 2 ms Repeat 100 x each in x y z direction Temperature cycling According to DIN EN 60068 2 14 T 20 C to 55 C 4 F to 131 F Repeat 10 cycles...

Page 93: ...7151 Surgical instruments non cutting articulated instruments general requirements and test methods DIN EN ISO 13402 Surgical and dental hand instruments 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 ASTM F 1744 Standard Guide for Care and Handling...

Page 94: ...tic interference or to reduced resistance to electromagnetic interference Operate the product in a place with a maximum distance to electrical and magnetic interfering transmitters If operation of the product close to other devices or together in a stack is necessary observe the correct function of the system HF surgical equipment can influence the operation of the system and may not be operated i...

Page 95: ...test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 8 kV contact 15 kV air Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line to li...

Page 96: ...ion distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromag...

Page 97: ...itter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2500 MHz d 2 3 P 0 01 0 12 m 0 12 m 0 23 m 0 1 0 38 m 0 38 m 0 73 m 1 1 2 m 1 2 m 2 3 m 10 3 8 m 3 8 m 7 3 m 100 12 m 12 m 23 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter wh...

Page 98: ...points The adapter must be firmly attached to the motor and meet the following requirements The adapter must engage in each possible position It must be free of a noticeable clearance The adapter is firmly connected and no gap is visible between the adapter and the motor Attach the adapter to the registration tool by the force of the magnets The magnetic force must be strong enough to lift the reg...

Page 99: ...001 I Version 1 2 99 Table 11 Maintenance and repair protocol Date Signature Step 1 Check cabling Step 2 Check camera computer system cart Step 3 Check adapter registration tool marker Step 4 New teaching Repair Software version Upgrade to software version Remarks and observations ...

Page 100: ...APPENDIX MAINTENANCE AND REPAIR PROTOCOL DENACAM System User Manual REF M1000 1001 I Version 1 2 100 ...

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