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coDiagnostiX

Implant Planning Software

Instructions for Use


Original
Important! Keep this document for future reference.
CONTENTS

1. About this guide 5


1.1 Disclaimer 5
1.2 License, trademarks and other rights 8

2. Introduction and overview 10


2.1 Intended use 10
2.2 Device description and features 10
2.3 Accessories and products used in combination 15
2.4 Indications 16
2.5 Contraindications 17
2.6 Precautions 17
2.7 Compatibility information 20
2.8 Data protection 21
2.9 Further information 23
2.10 Installation 24
2.11 Disposal 26

3. Basic principles 27
3.1 Getting acquainted 27
3.2 coDiagnostiX start screen 28
3.3 DICOM import 30

4. EASY mode 32
4.1 User interface 32
4.2 Case planning 36

5. EXPERT mode: User interface and basic functions 44


5.1 Toolbar 45
5.2 Views 46
5.3 Object tree 48
5.4 Plans 50

6. EXPERT mode: Step by step case planning 51


6.1 Align patient coordinate system 51
6.2 Panoramic curve 52
6.3 Detect nerve canal 53
6.4 Import and match model scan data 55
6.5 Plan implants 58
6.6 Plan sleeves 60
6.7 Design the surgical guide 61
6.8 Print protocols 64

7. Optional and supporting functionalities 65


7.1 DWOS Synergy 65
7.2 Measurement functions 67
7.3 AI Assistant 68

8. Safety check 71

9. Maintenance 74

10. Distributors and service 75

11. Technical data 76


11.1 Ambient conditions 76
11.2 Hardware and software requirements 76
11.2 Label 80
11.3 Supporting information for CBCT or CT scans 81
11.3 Licensing Matrix 82

12. Symbols on the product and/or packaging 83


1. About this guide

Caution

The provided instructions contain important information on the safe and appropriate use of
the software. Make sure to have read and understood this document prior to installing and
operating the software.

These Instructions for Use are valid for the Product life cycle (p. 7) of coDiagnostiX 9.

In case of questions, contact your local distributor (see chapter Distributors and service (p. 75) ).
Please keep this document for future reference.

Electronic Instructions for Use

coDiagnostiX 9 Instructions for Use are provided in electronic form. If a paper version is
required, the user may print these instructions himself/herself or request a paper version from
the manufacturer. For further information and contact details see:
http://www.ifu.dentalwings.com

1.1 Disclaimer
coDiagnostiX software is designed for use by persons who have appropriate knowledge in
implantology and surgical dentistry. To run the software, users must also have basic skills in
operating a computer.

coDiagnostiX 9 Instructions for Use 5


The user of coDiagnostiX is solely responsible for determining whether or not any product or
treatment is suitable for a particular patient and circumstances. The user of coDiagnostiX is
solely responsible for the correctness, completeness and adequacy of all data entered into
coDiagnostiX software. The user has to check the correctness and accuracy of planning with
coDiagnostiX software and to assess each individual case.

Correct dimensioning of the surgical guide and the selection of an appropriately validated guide
material lies within the sole responsibility of the user.

The user is responsible to provide necessary hard- and software to run it. Refer to chapter Data
protection (p. 21) and Hardware and software requirements (p. 76) for further details.
coDiagnostiX is not intended to be used in direct contact with the patient or with life-sustaining
devices.

Dental Wings products must be used in accordance with their accompanying instructions for
use. Improper use or handling of Dental Wings products will void the warranty, if any, given for
Dental Wings products. If you require additional information on the proper use of Dental Wings
products, contact your local distributor. The user is not allowed to modify Dental Wings
products.

DENTAL WINGS GMBH, ITS AFFILIATES OR DISTRIBUTORS DISCLAIM REPRESENTATIONS AND


WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, WITH
RESPECT TO THE PRODUCTS, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, ERROR-FREE OPERATION OR NON-INFRINGEMENT, AND THE
PRODUCTS ARE SOLD “AS IS”.

Our maximum liability arising out of the products or their use, whether based upon warranty,
contract, tort or otherwise, shall not exceed the actual payments received by us in respect of
the purchase price thereof. In no event shall we be liable for special, incidental or
consequential damages, including, but not limited to, loss of profits, loss of data or loss of use
damages, arising hereunder or from the sale of the products.

Updates to hardware and software components are made regularly. Therefore, some of the
instructions, specifications and pictures contained in these Instructions for Use may differ
slightly from your particular situation. Dental Wings reserves the right to revise or make
changes or improvements to this product or documentation at any time without obligation to
notify any person of such revisions or improvements. The user is obliged to study the latest
developments of coDiagnostiX regularly.

6 coDiagnostiX 9 Instructions for Use


Product life cycle

The product life cycle of coDiagnostiX software is 3 years. After expiration of this time, the
software may continue to function properly as long as configuration or hardware are not
modified and a valid license maintained. However, as cybersecurity vulnerabilities, legal and
regulatory requirements change at regular intervals, the legal manufacturer does not ensure
cybersecurity and compliance with the regulatory framework beyond the product life cycle
period of 3 years. To maintain regulatory compliance, update your software regularly. Please
note, that the actual use of coDiagnostiX is subject to your compliance with our license
framework.

Input data

The software supports a wide range of image sources, including Cone-Beam Computed
Tomography (CBCT) and, optionally, surface scanners, as well as model scans from different
sources. It is also possible to work with other sliced image data or volume data.

The performance of coDiagnostiX depends on the quality and accuracy of the CBCT or CT and
model scans that have been imported in the software. The user is solely responsible to ensure
that the quality of the data imported in the software is sufficient for proper performance of
coDiagnostiX. The DICOM data from CBCT or CT devices should have a resolution of at least
512x512 and a slice width of ≦ 1 mm. There shall be no artifacts and distortions in the regions
of interest, so that relevant anatomical structures are visible in the scans.

CBCT or CT devices must comply with the recommendations of ICRP97 (International


Commission on Radiological Protection). Such devices are required to be calibrated at regular
intervals to assure the data reflects the patient situation most accurately. In case the CBCT or
CT device is not calibrated, the intensity of the radiological absorption (visualized in Hounsfield
Units (HU) does not accordingly correspond to the bone density. Supporting information to assist
in the provision of suitable input data for coDiagnostiX can be found in chapter Supporting
information for CBCT or CT scans (p. 81).

coDiagnostiX 9 Instructions for Use 7


Third party products and product data

When planning patient cases with coDiagnostiX and during the practical implementation of such
planning the user may work with third party products and/or product data. Dental Wings GmbH,
its subsidiaries, or distribution partners disclaim any liability for damages in connection with or
arising from such third party product data or products being used within this scope.

1.2 License, trademarks and other rights

coDiagnostiX license

coDiagnostiX software is protected by a License Agreement and may be used or copied only in
accordance with the terms of this agreement. It is illegal to copy or use coDiagnostiX software
on any medium except those permitted in the License Agreement.

Some of the features offered by coDiagnostiX may require an additional license on your dongle.
Contact your local distributor for more information.

Availability

Some of the products mentioned in this guide may not be available in all countries.

Third-party software

coDiagnostiX software contains code from third-parties which is provided under specific
licenses:
– Open Source Computer Vision Library (3-Clause BSD License)
– Omni Thread Library (3-Clause BSD License)
– Eigen (Mozilla Public License 2.0)

License conditions are available within coDiagnostiX. Open the Help (?) menu and select About >
Trademarks and 3rd party licenses to display them.

8 coDiagnostiX 9 Instructions for Use


Trade names and trademarks

DENTAL WINGS and/or other trademarks and registered trademarks from Dental Wings
mentioned herein are the trademarks or registered trademarks of Dental Wings. All other
trademarks are the property of their respective owners.

Copyright

Dental Wings documents may not be reprinted or published, in whole or in part, without the
written authorization of Dental Wings.

coDiagnostiX 9 Instructions for Use 9


2. Introduction and overview

2.1 Intended use


coDiagnostiX is intended to be used as preoperative planning software for dental implant
placement.

2.2 Device description and features


coDiagnostiX is a planning software for virtual positioning of dental implants taking into account
the patient's anatomical structures and future prosthetic needs. coDiagnostiX can import and
process 3D CBCT or CT scan data (DICOM standard) and model scan data and export planning
and design data for the production of surgical guides.

Device variants and configuration

coDiagnostiX is available in a producer and a client version.

The client can export digital surgical guide and virtual planning data only through a coDiagnostiX
producer version.

coDiagnostiX is an open software system. The library contains implant, abutment and sleeve
systems from a large number of manufacturers.

10 coDiagnostiX 9 Instructions for Use


Caution

Please be aware that the user of coDiagnostiX software is solely responsible for the
correctness, accuracy and completeness of all data entered into the coDiagnostiX software.

To be able to use the library (master database), the user has to accept the following terms
and conditions.

1. The master database may contain implants and surgical instruments that are not
registered in the country of the user. The user has to make sure to use only those items
which have been properly registered.

2. The user is obligated to always check that the data from the master database are similar
equivalent with both the catalog values provided by the manufacturer and the information on
the elements received.

Principles of operation

Implant planning with coDiagnostiX is based on a patient’s medical image data such as CBCT or
CT that are processed by coDiagnostiX after being transferred via CD/DVD, network or various
other storage media. Planning is performed by the calculation of several views (such as virtual
OPG or a three-dimensional reconstruction of the image dataset), by the analysis of the image
data and the placement of implants, abutments and sleeves. Planning data are used for
designing surgical guides which can be exported as manufacturing information. The surgical
guide which directs the implant and the instruments during implant insertion transfers the
virtual implant position from the computer to the patient's anatomy.

Implant planning with coDiagnostiX is part of a guided surgery workflow. There are two principal
workflows that can be realized with coDiagnostiX:

n A digital workflow using 3D manufacturing systems:


This workflow is state of the art. All the instructions contained and the planning steps
described in this document are based on such digital workflow.

coDiagnostiX 9 Instructions for Use 11


n An old analog workflow using gonyX and its accessories:
For the specifics of an analog workflow see coDiagnostiX Instructions for Use, version 11.1
(issued 2016-12-02), which is available through our eIFU website
(http://www.ifu.dentalwings.com). Important information and instructions for the analog
workflow can be found in chapters:

2.2 Device description and features


2.3 Accessories and products used in combination
2.7 Precautions
2.10 Further information
3.1 Toolbar
4.6 Detect gonyX reference pins
4.10 Print Protocols
5. Safety check
7.3 Supporting information for (CB)CT scans

12 coDiagnostiX 9 Instructions for Use


The following chart outlines the positioning of coDiagnostiX within a guided surgery workflow.

coDiagnostiX 9 Instructions for Use 13


This chart outlines the standard work steps within coDiagnostiX. For further details see chapter
EXPERT mode: Step by step case planning (p. 51).

14 coDiagnostiX 9 Instructions for Use


2.3 Accessories and products used in combination

3D manufacturing systems

There are many ways to produce surgical guides with 3D manufacturing systems (e.g. 3D
printing system), provided the manufacturing system can read open STL format files and
process biocompatible material.

The coDiagnostiX workflow has been validated with the following materials and 3D
manufacturing systems (examples):

– Objet Eden260V printer and Med610 material (Stratasys)


– Rapid prototyping machine D30N2 SN3 with FotoDentLED.Aimplant as material
(Dreve/InnovationMediTech)
– FORMIGA P110 laser sintering system with synthetic powder material PA 2200 (EOS)
– Solflex 350 3D printer with Solflex med printing material (Zircado being the German
way2production distributor)
– Varseo 26435 3D printer with VarseoWax Surgical Guide printing material (Bego)

For a complete list of validated materials and systems, contact Dental Wings.

Each 3D manufacturing system which fulfills the requirements above may, in principle, be
suitable. The user needs to ensure that the surgical guide can be produced with sufficient
accuracy and that the material used for fabrication is suitable for the use as a surgical guide in
patients.

Caution

Patients dental anatomy is subject to change. It is the user's responsibility to adhere to good
dental practice in respect of time delays between data collection, treatment planning and
surgery. In addition, the shelf life of fabricated guides shall be considered.

coDiagnostiX 9 Instructions for Use 15


Software products

Software products that may be used in combination with coDiagnostiX are:

– Dental Wings DWOS®


Dental CAD software for prosthetic design
– Straumann® CARES® Visual
Dental CAD software for prosthetic design
– Dental Wings Intraoral Scanner Software Application
Software running on the Dental Wings Intraoral Scanner
– DWOS Connect
Service used to share scan files from Dental Wings/Straumann scanner devices

For details on compatibility see Compatibility information (p. 20).

Other open dental CAD software systems which can read and output open STL format files may
be suitable as well for use in combination with coDiagnostiX. However, the suitability of such
products has to be validated by the user.

3D navigation systems

coDiagnostiX users may transfer treatment plans to 3D navigation systems in proprietary


format.

The correct specification of coDiagnostiX proprietary file format has been verified by
mininavident AG for the DENACAM system.

2.4 Indications
coDiagnostiX is an implant planning software tool intended for use by dental professionals who
have appropriate knowledge in implantology and surgical dentistry.

16 coDiagnostiX 9 Instructions for Use


This software reads imaging information output from medical scanners such as CBCT or CT
scanners. It allows preoperative simulation and evaluation of patient anatomy and dental
implant placement.

For automated manufacturing of surgical guides in the dental laboratory environment,


coDiagnostiX allows for export of data to 3D manufacturing systems.

2.5 Contraindications
coDiagnostiX is not intended to be used in direct contact with the patient nor is it intended to be
used with life-sustaining devices.

coDiagnostiX must only be applied if additional radiation dose from 3D radiology (compared to
conventional x-ray) can be justified. Contraindications applying to other medical devices used
within the scope of a guided surgery workflow have to be taken into consideration.

2.6 Precautions
The provided instructions contain important information on the safe and appropriate use of the
software. Make sure to have read and understood this document prior to installing and
operating the software.

Please be aware that the user of coDiagnostiX software is solely responsible for the
correctness, accuracy and completeness of all data entered into the coDiagnostiX software.

Do not use datasets which can be created in spite of warning messages unless you fully
understand the consequences of those warnings and are sure that there will be no unacceptable
risk for the correctness and accuracy of your planning.

Automatic nerve detection does not guarantee exact and accurate nerve canal display. Make
sure to always verify the correct position of the nerve canal manually.

Always verify the correctness and accuracy of nerve canal display.

coDiagnostiX 9 Instructions for Use 17


If nerve definition is not clear due to poor image quality, the dataset must not be used.

Always maintain an appropriate safety distance to the nerve canal.

Always maintain an appropriate distance around the implant.

Printouts containing images of the dataset are not intended for diagnostic purposes.

Patient data presented on the iPad are intended for presentation purposes only. Do not use such
data for diagnostic purposes.

Correct dimensioning of the surgical guide and the selection of an appropriately validated guide
material lies within the sole responsibility of the user.

Make sure that the inspection windows placed in the surgical guide do not affect the stability of
the final guide. Otherwise there is the risk of inaccurate drilling results which may compromise
patient safety.

Never drill directly through the guide. Always use appropriate metal guidance to avoid chipping.

Inadequate surgical guides may result in damage to vital anatomy at the time of surgical
procedure.

Thoroughly check the congruency of the contours of the merged 3D objects in all views to
ensure correct and accurate alignment of both objects upon import. Matching of model scan
data is a prerequisite for surgical guide design. Matching accuracy directly influences the
accuracy of the designed surgical guide.

Make sure to comply with all applicable standards and technical regulations for any computer
hardware used. Computer hardware is not intended to be used in close proximity (within a
distance of 1.5 meters) to the patient. Do not use multiple-socket extension cords to plug the
hardware.

Before placing the scan template or surgical guide into the patient's mouth, make sure to
prepare such template or guide according to standard operating procedures in dentistry and the
instructions for use provided for your material.

Patients dental anatomy is subject to change. It is the user's responsibility to adhere to good
dental practice in respect of time delays between data collection, treatment planning and
surgery. In addition, the shelf life of fabricated guides shall be considered.

18 coDiagnostiX 9 Instructions for Use


It is the sole responsibility of the user to make sure that accessories and products used in
combination with coDiagnostiX are intended to be used for such purpose. Follow their
instructions for use.

Protect your data against loss, unauthorized access and unauthorized use.
– Secure your computer system by installing a malware scanner or firewall.
– Use a strong password to protect your computer system, storage media and presentation
devices.
– Use data encryption to secure data on your computer system and storage media.
– Backup your data regularly to avoid loss of data.
– Use the anonymization function to protect patient personal data if required.

Archiving and restoring datasets in different versions of coDiagnostiX can cause compatibility
problems.

Do not dispose of this device as unsorted municipal waste. Collect separately.

The user is responsible to assure health data de-identification, data backup and disaster
recovery, and health data authenticity.

Online updates are also used to solve safety and/or information security issues. Such updates
are mandatory. Such will be clarified by the information provided with the online update.

The user is responsible to install and configure - as required by its IT Policy - the operational
system and SQL server when using network database. This includes the installation and setup of
automatic logoff, audit controls, authorizations, configuration of security features, emergency
access, malware detection/protection, node authentication, personal authentication, integration
of coDiagnostiX in the product lifecycle roadmap, system and application hardening, health data
storage confidentiality.

Certain coDiagnostiX functionalities and services require data transfer. Access to data, storage
and transfer shall comply to national regulations on information security.

For further details on encryption methods, type of data transferred, location of hosts, and
storage refer to https://dentalwings.com/data-protection-faqs/.

coDiagnostiX 9 Instructions for Use 19


2.7 Compatibility information

Caution

Archiving and restoring datasets in different versions of coDiagnostiX can cause


compatibility problems.

Avoid using different versions of coDiagnostiX. If you have any problems, contact your local
distributor (see Distributors and service (p. 75))
In general, patient datasets from older versions of coDiagnostiX can be opened with
coDiagnostiX (backward compatibility). Check your dataset carefully to avoid minor
incompatibilities which might lead to failures in the planning of dental implants and/or the
production of surgical guides. Older versions of coDiagnostiX, however, cannot work with
datasets from current coDiagnostiX versions.

The current released version of the master database may not be compatible with previous
versions of coDiagnostiX.

caseXchange

caseXchange is a platform for coDiagnostiX users to exchange coDiagnostiX datasets. For the
compatibility of the users' coDiagnostiX software versions see the information above.

20 coDiagnostiX 9 Instructions for Use


DWOS Connect

coDiagnostiX offers an interface to DWOS Connect to import files provided by compatible Dental
Wings/Straumann scanner devices. coDiagnostiX is compatible with the latest version of DWOS
Connect. Make sure to always work with the latest software versions on such scanner devices.
For the compatibility of the software version contact your local distributor (see Distributors and
service (p. 75).

DWOS Synergy

DWOS Synergy allows for online case sharing between coDiagnostiX and Dental Wings
DWOS/Straumann CARES Visual. For the compatibility of the software version contact your local
distributor see Distributors and service (p. 75).

2.8 Data protection


Access to the software is restricted by the licensing system.

To protect data against loss or unauthorized use, several security mechanisms have been
implemented in coDiagnostiX:
– Data encryption during storage and transfer through the internet
– An archiving system to backup patient and planning data
– An on-demand anonymization function for privacy protection

coDiagnostiX 9 Instructions for Use 21


Caution

The user is responsible to install and configure - as required by its IT Policy - the operational
system and SQL server when using network database. This includes the installation and
setup of automatic logoff, audit controls, authorizations, configuration of security features,
emergency access, malware detection/protection, node authentication, personal
authentication, integration of coDiagnostiX in the product lifecycle roadmap, system and
application hardening, health data storage confidentiality.

The user is responsible to assure health data de-identification, data backup and disaster
recovery, and health data authenticity.
Protect your data against loss, unauthorized access and unauthorized use.
– Secure your computer system by installing a malware scanner or firewall.
– Use a strong password to protect your computer system, storage media and presentation
devices.
– Use data encryption to secure data on your computer system and storage media.
– Backup your data regularly to avoid loss of data.
– Use the anonymization function to protect patient personal data if required.

Bear in mind that the user is responsible for data protection on user side. Make sure to
adequately protect such data.

Caution

Certain coDiagnostiX functionalities and services require data transfer. Access to data,
storage and transfer shall comply to national regulations on information security.For further
details on encryption methods, type of data transferred, location of hosts, and storage refer
to https://dentalwings.com/data-protection-faqs/.

22 coDiagnostiX 9 Instructions for Use


2.9 Further information
There is no physical, chemical, electrical, mechanical, biological, electromagnetic or radiation
hazard related to the software. Nevertheless, the software has several integrated warning
functions designed to alert and remind the user of his/her legal responsibility to plan precisely
and verify all planning results.

Please be aware that any serious incident that has occurred in relation to coDiagnostiX should
be reported to your local distributor and the competent authority responsible for medical
devices or data protection in your country. If you have any questions, please contact your local
distributor. (see Distributors and service (p. 75)).

Dental Wings and its products are registered in the main markets. The Declaration of
Conformity for coDiagnostiX is available through our eIFU website at:
https://ifu.dentalwings.com/.

For further questions, please contact your local distributor (see Distributors and service (p. 75)).

For further information on products used in combination, please refer to the following
documents or sources of information:

DWOS and DWOS Connect:


– DWOS Instructions for Use
– DWOS User Help

Straumann® CARES® Visual:


– Straumann® CARES® Visual Instructions for Use
– Straumann® CARES® Visual User Help

Dental Wings Intraoral Scanner:


– Intraoral Scanner Instructions for Use

coDiagnostiX 9 Instructions for Use 23


2.10 Installation

Caution

Make sure to comply with all applicable standards and technical regulations for any
computer hardware used. Computer hardware is not intended to be used in close proximity
(within a distance 1.5 meters) to the patient. Do not use multiple-socket extension cords to
plug the hardware.

Steps for installation

1. Check that your hardware and software meet the specifications (see Hardware and software
requirements (p. 76)).
2. Insert the installation medium into the computer.
3. If the installation process does not start automatically, start the program manually by
executing the setup.exe file on your installation medium.
4. Follow the instructions on the screen.
5. The installation is successful as soon as the coDiagnostiX start screen appears.

In case of any questions or if you need further assistance during installation, contact your local
distributor (see chapter Distributors and service (p. 75)).

Note

Do not plug the dongle into the computer until you are prompted to do so by the installation
program.

24 coDiagnostiX 9 Instructions for Use


Installing optional software and configuring the network

Document reader: Choose an application that can read PDF files and is compatible with your
operating system. Install in line with the routines of your operating system and as instructed by
the document reader manufacturer.

Printer: Install in line with the instructions given by the printer manufacturer.

3D mouse: Follow the instructions given in the coDiagnostiX User Help (coDiagnostiX EXPERT
Mode > General tools > 3D mouse).

Microsoft® SQL Server®: Follow the instructions given in the coDiagnostiX User Help
(Advanced functionalities > Network Database SQL).

DWOS Synergy: For installation and configuration see DWOS Synergy (p. 65).

Network configuration: Configure your system as described in chapter Hardware and software
requirements (p. 76)

Languages

coDiagnostiX user interface is available in several languages. The language can be set in the
coDiagnostiX Management (see section Management in chapter Management (p. 28)).

Getting acquainted with the software

To learn how to work with coDiagnostiX and get acquainted with its functions, see Getting
acquainted (p. 27).

Uninstallation

If you need to uninstall your coDiagnostiX software for any reason, use the tools and procedures
provided by your operating system (refer to chapter Hardware and software requirements (p.
76)).

coDiagnostiX 9 Instructions for Use 25


2.11 Disposal
Electrical and electronic devices must be disposed of separately from normal household waste
in order to promote reuse, recycling and other forms of recovery, to avoid adverse effects on the
environment and human health as a result of the presence of hazardous substances in some of
their components and to reduce the quantity of waste to be eliminated with a view to reducing
landfill. This includes accessories such as remote controls, power cords, etc.

Caution

Do not dispose of this device as unsorted municipal waste.


Collect separately.

For details on how to dispose of your device and its packaging, please contact your local
distributor.

26 coDiagnostiX 9 Instructions for Use


3. Basic principles
The software user interface is based on the Microsoft® Windows® standard allowing you to
control the system easily by mouse. To become familiar with the system and the control
elements such as buttons, check boxes and edit controls, consult the user manual of your
operating system.

3.1 Getting acquainted


To learn how to work with coDiagnostiX and get acquainted with its functions and related
workflows, the following instructions, training sessions and media are offered:
n coDiagnostiX Instructions for Use (this document)
n Regular online training courses which are open for all users with a valid coDiagnostiX license.
Users can register for these webinars on our website at https://codiagnostix.com/training.
n Training videos which are available from within coDiagnostiX (see Support and help in chapter
coDiagnostiX start screen (p. 28)).
n Context-sensitive coDiagnostiX User Help providing detailed explanations and additional
information on advanced functions (see Support and help in chapter coDiagnostiX start
screen (p. 28)).

coDiagnostiX 9 Instructions for Use 27


3.2 coDiagnostiX start screen

Basic functionalities of the coDiagnostiX start screen

ΠCreate New dataset


Opens a dialog box to import DICOM data (e.g. from a CD) and to create a patient
dataset.

 Open dataset
Opens the Patient Database (DICOM already imported).

Ž caseXchange
Provides direct access to the communication platform caseXchange. For users with
enabled Order Management feature, access is provided to the Order Management
instead.

 Management
The coDiagnostiX Management section provides access to administrative functions
such as backup or language setting.
Archiving and restoring datasets in different versions of coDiagnostiX can cause
compatibility problems. (See Compatibility information (p. 20))

28 coDiagnostiX 9 Instructions for Use


 Support and help
The Support and Help Center provides centralized access for help, support and
training. Here, you can start a remote support session, if necessary (active internet
connection required). For information on how to get acquainted with the software,
see chapters Distributors and service (p. 75) and Getting acquainted (p. 27).

‘ Work Mode

Select EXPERT or EASY to launch coDiagnostiX in your preferred work mode. EXPERT
offers the full set of planning tools to support standard as well as advanced
treatment workflows. EASY mode is a streamlined user interface with step-by-step
guidance for users, who plan standard treatment cases, or outsource to a laboratory
or planning center.

’ Main menu
Provides access to database-related functions, other modules and the License
Management.

“ License and version numbers


Your license number and the coDiagnostiX version number are shown both in the
status bar on the start screen and in the About box (access from the main menu >
Help (?) > About).

Updates
If updates are available, an information bar pops up to inform the user about pending updates
(see Maintenance (p. 74))).

coDiagnostiX 9 Instructions for Use 29


3.3 DICOM import

Starting coDiagnostiX and loading a DICOM case


n Start the coDiagnostiX software; ensure that the dongle is connected.
n Transfer the DICOM data that you received from the CBCT or CT scanner to your computer
(e.g. insert CD/DVD into your computer's disc drive).

Caution

Please be aware that the user of coDiagnostiX software is solely responsible for the
correctness, accuracy and completeness of all data entered into the coDiagnostiX software.

n Click New on the start screen.

n Select Import data from CD/DVD and click


Import.
n In case of any problems (error messages,
warnings, etc.), contact customer service.
n Choose if you would like to plan a case for
maxilla or mandible. To plan both maxilla
and mandible you need to create two
separate plans.

coDiagnostiX switches to the standard planning screen.

30 coDiagnostiX 9 Instructions for Use


Caution

Do not use datasets which can be created in spite of warning messages unless you fully
understand the consequences of those warnings and are sure that there will be no
unacceptable risk for the correctness and accuracy of your planning.

coDiagnostiX 9 Instructions for Use 31


4. EASY mode

4.1 User interface

coDiagnostiX EASY planning screen

ΠObject tree: All planning steps in order of workflow; current step highlighted, object
overview.

 Help: Collapsible inline help panel with instructions for current step.

Ž Views: Tools and view manipulation for current step.

 Navigation and help tools: Access to help and navigation between steps.

32 coDiagnostiX 9 Instructions for Use


The object tree in coDiagnostiX EASY mode:

n Clear step-by-step overview of current case


planning with collapsible sub-steps
n Call up any step at any time with one mouse click
n At-a-glance object data
n Quick access to plan management and help

coDiagnostiX 9 Instructions for Use 33


Navigation and help tools in coDiagnostiX EASY mode:

Description Symbol

Returns to start screen. The current case planning will be


saved automatically.

The Navigation buttons allow you to move back and forth


between individual steps of the case planning.

Opens help dialog. A pop-up column with user instructions


describing the current step appears.

Launches the plan management dialog box.

34 coDiagnostiX 9 Instructions for Use


Managing plans in coDiagnostiX EASY mode

Planning data are managed in plans. You may create several plans for one patient, delete plans
or copy plans.

n Access planning functions via the Plan


Management Button ( ) in the object tree.
n Protect plans against changes, by selecting
the Plan Management Button ( ) ð
Properties and ticking Protect this plan
against changes.
n Finalize plans by selecting the Plan
Management Button ( ) ðProperties and
ticking Mark this plan as final.

coDiagnostiX 9 Instructions for Use 35


4.2 Case planning
The coDiagnostiX EASY mode is fully guided by the software in the order of workflow steps. The
four main steps are Prepare data, Place implants, design Surgical guide and Finish the guide.

Step 1: Prepare data

Align patient coordinate system:

n Click Prepare data ð sub-step Jaw


Selection & Alignment in the object tree.

n Align as described on the screen. To move


the patient coordinate system, click, hold,
and drag with the left mouse button.
n To rotate the coordinate system, click, hold
and, drag with the right mouse button.

36 coDiagnostiX 9 Instructions for Use


Define the panoramic curve:

n Click Prepare data ð sub-step Panoramic


curve in the object tree.

n Move points to create panoramic curve.


n A pop-up window in the upper right corner
indicates the current axial position in the
3D view for better orientation.

Import and match a model scan:

n Navigate to Surgical guide ð sub step


Model scan in the object tree.

coDiagnostiX 9 Instructions for Use 37


n Click Add model scan at the bottom of the
Add model scan
planning screen.
n Follow instructions as described in the
wizard.

Note

To import a DWOS Connect order, you need to log in to DWOS Connect first. Log-in
credentials are provided to you with the scanner device.

Caution

Thoroughly check the congruency of the contours of the merged 3D objects in all views to
ensure correct and accurate alignment of both objects upon import. Matching of model scan
data is a prerequisite for surgical guide design. Matching accuracy directly influences the
accuracy of the designed surgical guide.

Inadequate surgical guides may result in damage to vital anatomy at the time of surgical
procedure.

Define the nerve canal:

n In the object tree, navigate to Prepare data


ð sub-step Nerve canals.

38 coDiagnostiX 9 Instructions for Use


n Select the nerve canal position using the View Right Left
buttons at the top. Set the entry point at the
mental foramen and the exit point at the
mandibular foramen by clicking directly in
the views.

Automatic detection
Auto detect
n Click Auto detect at the bottom of the
screen. coDiagnostiX will automatically
detect the nerve canal.

Manual definition

n Define additional nerve canal points by clicking directly in the views.

For further information on safety distance to the nerve canal, see chapter Safety check (p. 71).

Caution

Always verify the correctness and accuracy of nerve canal display.

Automatic nerve detection does not guarantee exact and accurate nerve canal display. Make
sure to always verify the correct position of the nerve canal manually.

If nerve definition is not clear due to poor image quality, the dataset must not be used.

Always maintain an appropriate safety distance to the nerve canal.

coDiagnostiX 9 Instructions for Use 39


Step 2: Place implants

Plan implant:

n Navigate to step Place Implants in the


object tree.

n Click Add implant at the bottom of the


Add implant
screen. The Master Database opens.
n Select manufacturer, series and tooth
position.
n Move implant position via left mouse
Change selected implant
button; rotate implant via right mouse
button.
Remove selected implant
n Change or remove implants via buttons at
the screen bottom.

n Adjust implant length and diameter via


Implant length 12 mm
buttons in the next sub-step.
Implant
4.1 mm
diameter

Always verify the correct position of the implants.

For further information on the safety distance between implants, see chapter Safety check (p.
71).

Caution

Always maintain an appropriate distance around the implant.

40 coDiagnostiX 9 Instructions for Use


Add sleeves:

n Navigate to step Place implants.


n Select an implant in the object tree to add a
sleeve or abutment for this implant.

or

n select Overview in the object tree to add


sleeves or abutments to all implants at
once.

n Click on Select sleeve at the bottom of the


Select sleeve
screen to open the dialog box.
n Follow instructions in the dialog box.

Caution

Please be aware that the user of coDiagnostiX software is solely responsible for the
correctness, accuracy and completeness of all data entered into the coDiagnostiX software.

Step 3: Surgical guide

Design a surgical guide:

n Click Surgical guide ð sub-step Edit


design.

coDiagnostiX 9 Instructions for Use 41


n Select Create surgical guide at the
Create surgical guide
bottom of the screen. The design wizard
opens.
n Follow instructions as described in the
wizard.

For further information on accuracy of surgical guides, see chapter Safety check (p. 71).

Caution

Correct dimensioning of the surgical guide and the selection of an appropriately validated
guide material lies within the sole responsibility of the user.

Make sure that the inspection windows placed in the surgical guide do not affect the stability
of the final guide. Otherwise there is the risk of inaccurate drilling results which may
compromise patient safety.

Never drill directly through the guide. Always use appropriate metal guidance to avoid
chipping.

Step 4: Finish

Print protocols:

n Click Finish ð sub-step Print


protocol in the object tree.

42 coDiagnostiX 9 Instructions for Use


n Select the desired protocols
from the planning screen Selected protocols Material list Details Surgical protocol

menu.

Caution

Printouts containing images of the dataset are not intended for diagnostic purposes.

coDiagnostiX 9 Instructions for Use 43


5. EXPERT mode: User interface and basic
functions

coDiagnostiX planning screen (EXPERT mode) — user interface

ΠToolbar (for customizing, see Toolbar (p. 45))

 Views (for basic information and view manipulation, see Views (p. 46))

Ž Object tree (for tree functions and moving/manipulating objects, see Object tree (p. 48))

 Plan panel (for working with plans, see Plans (p. 50))

44 coDiagnostiX 9 Instructions for Use


5.1 Toolbar

ΠTools of the interactive planning workflow.

 Basic tools for view manipulation.

Ž Menu with complete set of functions.

Customizing the toolbar


Right-click on the toolbar and select Adjust to
open the dialog box.

– To add further icons, drag and drop the


icon from the box onto the toolbar.
– To remove icons from the toolbar, simply
drag them off the toolbar (with the dialog
box opened).

As the toolbar is customizable, any toolbar references made within these Instructions for Use
relate to the standard toolbar configuration comprising the standard planning workflow preset.

coDiagnostiX 9 Instructions for Use 45


5.2 Views

ΠViews are color-coded and can be displayed in other


views as reference line with the respective color.

 Enlarge a view by clicking the Full Screen button or


double-click the title bar.

Ž Move the Panoramic view inside and outside with


the right scroll bar.

Moving views

– Enable the Move and Turn tool from the


toolbar.
– Move the view with the left mouse button.
– Rotate the view with the right mouse
button (3D view only).

Manipulating the views: most important tools

Description Symbol

Enables/disables the Move and Turn tool.

46 coDiagnostiX 9 Instructions for Use


Description Symbol

Enables/disables the Localizer tool.

Enables/disables the Zoom tool.

Alternatively, press SHIFT and scroll the mouse wheel to


zoom in and out.

Resets all views and fits contents to the view box in all
views.

Toggles the visibility of the Reference lines in all 2D views.

Aligns the cross-sectional, tangential and axial views to the


axis of the currently selected implant (at least one implant
must have been planned).

Toggles full screen mode (maximizes view)

coDiagnostiX 9 Instructions for Use 47


5.3 Object tree

The object tree contains:

n Tree functions (e.g. add, delete)


n All the objects (e.g. implants, sleeves,
nerve canals, measurements, model scans,
surgical guides)
n Tooth position panel (currently selected
tooth position)
n Provides all the information about the
implant, abutment, sleeve and/or virtual
tooth for the given tooth position and
allows to edit them.
n Density statistics

Moving/rotating objects
– Select the object in the object tree.
– In the object tree, activate the
positioning mode.
– Move the object with the left mouse
button.
– Rotate the object with the right mouse
button (some objects only).

48 coDiagnostiX 9 Instructions for Use


Objects: most important tree functions

Description Symbol

Adds a new object (e.g. implant, measurement…).

Enables/disables the positioning mode.

As long as the positioning mode is not activated, the objects


cannot be “touched” with the mouse.

Deletes the selected object.

coDiagnostiX 9 Instructions for Use 49


5.4 Plans

Working with different plans


Planning data are managed in plans. You may
create several plans for one patient. Use the
combo box to browse your plans.

Plans can be:


n Newly created, deleted and copied (select
from the Plan menu)
n Protected against changes (select Plan >
Properties from the main menu and tick
Protect this plan against changes). Such
protection is reversible.
n Finalized (select Plan > Finalize from the
main menu). No further modifications will
be allowed. Create a copy of the plan if you
have to change something subsequently.

50 coDiagnostiX 9 Instructions for Use


6. EXPERT mode: Step by step case
planning

6.1 Align patient coordinate system

n Click Align patient coordinate system in


the toolbar.

n Make the green plane coincide with the


patient's occlusal plane and the red plane
with the patient’s sagittal plane.
– Move the patient coordinate system
(PCS) with the left mouse button.
– Rotate the PCS with the right mouse
button.

n Click OK to save the alignment.

coDiagnostiX 9 Instructions for Use 51


6.2 Panoramic curve

n Click Panoramic Curve icon in the toolbar.

n Grab the points with the left mouse button


and move the curve according to the
patient’s anatomy.
n To create additional points, click outside
the existing five basic points.
n To delete additional points, right-click on
the point and select Delete Point from the
context menu. The five basic points cannot
be deleted.

52 coDiagnostiX 9 Instructions for Use


6.3 Detect nerve canal

n Click the Nerve Canal icon from the toolbar


to add the nerve canal objects. The
positioning mode is activated
automatically.

n In the object tree, select the nerve canal


which shall be detected. Set the entry point
at the mental foramen and the exit point at
the mandibular foramen by clicking
directly in the views.

Automatic detection
n Click Detect in the object tree.
coDiagnostiX will automatically detect the
nerve canal.

Manual definition
n Set additional nerve canal points by
clicking directly in the views and/or move
existing points as required. Sequence and
diameter of the nerve canal points may be
adjusted through the context menu.

For further information on safety distance to the nerve canal, see chapter Safety check (p. 71).

coDiagnostiX 9 Instructions for Use 53


Caution

Always verify the correctness and accuracy of nerve canal display.

Automatic nerve detection does not guarantee exact and accurate nerve canal display. Make
sure to always verify the correct position of the nerve canal manually.

If nerve definition is not clear due to poor image quality, the dataset must not be used.

Always maintain an appropriate safety distance to the nerve canal.

54 coDiagnostiX 9 Instructions for Use


6.4 Import and match model scan data

n Click Add model scan in the toolbar.

n Select the model scan source (CAD file,


segmentation, DWOS Connect order).
n Select the file and load it.

Note

To import a DWOS Connect order, you need to log in to DWOS Connect first. Log-in
credentials are provided to you with the scanner device.

n Select the method to align the model scan.


The standard method is alignment to
another object. For other possible
alignment options see the coDiagnostiX
User Help.

coDiagnostiX 9 Instructions for Use 55


n Select the registration object (segmentation of volume data or previously imported model
scan) that you want to use for matching. Model scan and registration object must cover
analogous anatomical regions.

n Define pairs of corresponding regions by


clicking the affected region both on the
model scan and on the registration object.
– For partially edentulous cases use the
remaining teeth.
– For edentulous cases use temporary
implants.

Pairs of corresponding regions should not lie on an (approximately) straight line and must be
set at anatomically significant positions and as far away from each other as possible.

n Click Next to perform automatic


registration.

56 coDiagnostiX 9 Instructions for Use


Caution

Thoroughly check the congruency of the contours of the merged 3D objects in all views to
ensure correct and accurate alignment of both objects upon import. Matching of model scan
data is a prerequisite for surgical guide design. Matching accuracy directly influences the
accuracy of the designed surgical guide.

Inadequate surgical guides may result in damage to vital anatomy at the time of surgical
procedure.

n If the result is not satisfying, align the


model scan manually in all 4 views. To do
so, move the scan contours with the mouse
or use the Fine Alignment function by
clicking the Fine Alignment icon in the
toolbar of the wizard.
n Click the Finish button to apply the scan
import to your case.

For more detailed information, consult the coDiagnostiX User Help.

coDiagnostiX 9 Instructions for Use 57


6.5 Plan implants

n Click the Add Implant icon from the


toolbar. The Master Database opens.

n Select the implant and the tooth position(s)


where the implant(s) shall be placed. Click
OK and the database closes.

Adjust the implant position. The positioning


mode is already activated.

Adjusting the implant


– Move the implant with the left mouse
button.
– Rotate the implant with the right mouse
button.

To support correct implant positioning, align


the views to the implant axis. This allows you
to rotate 360° around the implant in the
tangential view.

Always verify the correct position of the implants.

58 coDiagnostiX 9 Instructions for Use


Caution

Always maintain an appropriate distance around the implant.

coDiagnostiX 9 Instructions for Use 59


6.6 Plan sleeves

n Select your implant in the object tree and


click the Edit Sleeves icon in the toolbar.

n The dialog box opens.


n Select a sleeve system from the list.
n Adjust the parameters as desired.

Observe all instructions provided by the


sleeve system manufacturer.

Caution

Please be aware that the user of coDiagnostiX software is solely responsible for the
correctness, accuracy and completeness of all data entered into the coDiagnostiX software.

60 coDiagnostiX 9 Instructions for Use


6.7 Design the surgical guide

Preparation
n Complete your planning.
n Scan the master model and import this
scan. The model scan must not include any
wax-up or prosthetic setup.
n Match the model scan and the
corresponding segmentation.

Caution

Inadequate surgical guides may result in damage to vital anatomy at the time of surgical
procedure.

Design wizard
n Click the Surgical Guide icon in the toolbar
to open the wizard.
n Decide if you want to create a completely
new surgical guide or use an existing guide
as template.

coDiagnostiX 9 Instructions for Use 61


n Define the insertion direction for the
surgical guide. If you are working with the
dual scan method, tick Use bottom side of
dual scan.
n If required, define regions for bone
support.
n Define contact surfaces and adjust sleeve
mount settings. If required, draw contact
area for palatal support.
n Set offset, wall thickness and connector
thickness.
n Add inspection windows (optional).
n Add label text (optional).
n Finish your guide.

For further information on accuracy of surgical guides, see chapter Safety check (p. 71).

Export
n Export your surgical guide (producer
version only).
Make sure that the surgical guide you are
going to export represents the final
planning state.

For further information, see the coDiagnostiX User Help.

62 coDiagnostiX 9 Instructions for Use


Caution

Correct dimensioning of the surgical guide and the selection of an appropriately validated
guide material lies within the sole responsibility of the user.

Make sure that the inspection windows placed in the surgical guide do not affect the stability
of the final guide. Otherwise there is the risk of inaccurate drilling results which may
compromise patient safety.

Never drill directly through the guide. Always use appropriate metal guidance to avoid
chipping.

Please note that you are also responsible for the selection of an appropriate and calibrated 3D
manufacturing system and the correct fabrication of the surgical guide.

coDiagnostiX 9 Instructions for Use 63


6.8 Print protocols
Print protocols serve mainly as supporting information or means of documentation.

In the toolbar, click on the arrow of the Print


icon to open the menu.

Most important print protocols


n Details protocol: Available per implant
providing detailed implant, sleeve and
surgical protocol information together with
images of the planning views.
n Surgical protocol: Lists the sequence of
surgical instruments to be used as
specified by the selected guided surgery
system (selected manufacturers only).

Caution

Printouts containing images of the dataset are not intended for diagnostic purposes.

64 coDiagnostiX 9 Instructions for Use


7. Optional and supporting functionalities

7.1 DWOS Synergy


DWOS Synergy is an interface for communication between coDiagnostiX and Dental Wings DWOS
or coDiagnostiX and Straumann CARES Visual. It makes prosthetic design data from Dental
Wings DWOS or Straumann CARES Visual available in coDiagnostiX and, in turn, sends implant
planning information from coDiagnostiX to the DWOS or Straumann CARES Visual station.

Collaboration is possible:
– in local networks
– through the internet (with a DWOS Synergy account)

DWOS resp. Straumann CARES Visual side


n Create an order.
DWOS 4 & 5/CARES Visual 9 & 9.5:
Indication group: Others; Indication:
coDiagnostiX abutment
DWOS 6 & 7/CARES Visual 10 & 11:
Synergy order
n In the CAD Station, initiate the Synergy
session by opening the DWOS Synergy
dialog and specifying the local
server/online recipient.
n Inform the recipient (DWOS Synergy
partner) about the pending case.

coDiagnostiX 9 Instructions for Use 65


coDiagnostiX side
n Open the coDiagnostiX dataset for this
patient.
n In the planning view, click the Synergy icon
and connect with the shared dataset.
n Match the surface data with the patient's
DICOM data.

66 coDiagnostiX 9 Instructions for Use


7.2 Measurement functions
coDiagnostiX offers the following measurement functions. They can be accessed by selecting
Object > Add from the main menu.

Distance measurement: Distance between


two points in mm

Continuous distance: Distance between


several points in mm

Angle measurement: Angle in degrees (°)


spanned between two lines which are defined
by three points

Using the Zoom tool increases measurement accuracy (see Measurement functions (p. 67)

coDiagnostiX 9 Instructions for Use 67


7.3 AI Assistant
The AI assistant is an interface for communication to an AI service through the internet. A user
may request support solving routine and time-consuming tasks required in the coDiagnostiX
digital planning workflow. To use the AI service, it is required to provide CBCT and model scan
data to the AI assistant.

Start:

n In EXPERT mode, the AI assistant is


integrated with the DICOM Import.

It includes an option to decline and


can also be started by clicking the AI
button in the toolbar.

n If the AI assistant has been used for


preparing the DICOM data, you can
also use it for preparing the model
scan.

n Select Align using AI assistant from


the Model Scan dialogue. (see
chapter Import and match model
scan data (p. 55)

68 coDiagnostiX 9 Instructions for Use


Status:

While the AI data processing is done in


the background, you can continue
working with coDiagnostiX. Processing
duration relies on the bandwidth of the vvvvvvvvvvv
internet connection, workload of the AI
server and the size of the datasets. Work is progressing. vvvvvvvvvvvvvWork is done.

n Check the AI status anytime via the Click for further information . vvvvClick to get results
AI assistant symbol in the toolbar. vvvvvvvvvvvvvvvvvvvvvvvvvvvvvvvvvvvvv

n The AI status information also


appears in the list of datasets on the
coDiagnostiX Start screen (see
chapter coDiagnostiX start screen (p.
28) and chapter DICOM import (p.
30)).

Review the AI results:

After the AI assistant presents the


results, review them:

n The panel on the left shows which


objects the AI has detected and
allows you to select and switch
between them.

n Review and correct selected objects


as necessary. Follow the instructions
in chapter EXPERT mode: Step by
step case planning (p. 51), the AI
assistant and use available options.

coDiagnostiX 9 Instructions for Use 69


n Only selected objects (checkmarked) will be included in the planning. It is possible to
import only a subset of objects or reject all. In case of error, the object is presented
with a yellow warning symbol (see image) and cannot be selected.

n If you want to use the selected objects for treatment planning, click Import reviewed
data and continue planning with coDiagnostiX.

Notes
The AI is trained on pseudonymized data representative for adult patients with partial dentition
that have in the past been selected by coDiagnostiX users mainly in EU, USA and Japan as
suitable for dental surgery treatments. AI results are optimal for representative data trained. If
AI results are used for further planning, the user must diligently review and improve them as
necessary.

For optimal AI results, at least on tooth is required in each quadrant and a gap is needed
between the teeth in upper and lower jaw.

The AI service creates an error message for CBCT data with slice thickness > 0.8 mm.

AI tooth labeling may not be correct and cannot be corrected.

Caution

Please be aware that the user of coDiagnostiX software is solely responsible for the
correctness, accuracy and completeness of all data entered into the coDiagnostiX software.

70 coDiagnostiX 9 Instructions for Use


8. Safety check
ü Always align all 2D views to the implant
axis and rotate around the implant to
ensure correct positioning and to avoid any
collisions.

ü Always consult collision warning and critical nerve distance warning.

Distance warning

EXPERT mode

EASY mode

Distance/collision warnings will be displayed when an element is placed such that the distance
to other elements is less than a defined value. The user may still place the element where
desired to facilitate the surgical planning process. Final element placement must be consistent
with patient anatomy and the judgment of the clinician.

coDiagnostiX 9 Instructions for Use 71


Implant to implant Implant to nerve canal Sleeve to sleeve

Type Distance check Distance check Collision check

Adjustable by user Yes Yes No

Default value 3 mm 2 mm 0 mm

Range 0 - 10 mm 0 – 10 mm n/a

Caution

Always maintain an appropriate safety distance to the nerve canal.

Always maintain an appropriate distance around the implant.

ü Always verify automatic nerve canal


detection manually.
ü Always check that surface data (e.g. model
scan) have been correctly and precisely
aligned to the volume data (DICOM data).

Accuracy

ü Always give the information concerning CBCT and CT scans (accessible via the Help menu in
the software) to the radiologist before the first scan.
ü Control all automatic functions of the software.
ü After planning is completed, always finalize the plan (Plan > Finalize). Make sure that only
final plans are sent to production and/or used to export data (e.g. surgical guides) for
production.
ü Check all printouts to ensure that they belong to the corresponding finalized plan.
ü Backup your data at regular intervals to avoid loss of data due to system crash or hardware
failure.

72 coDiagnostiX 9 Instructions for Use


ü General prerequisite for accurate implant placement results is the compliance by the user
with all instructions given by the software manufacturer as well as an accurate planning with
coDiagnostiX on the part of the user.
ü After prior implant planning with coDiagnostiX, the accuracy of the surgical guides and the
location of the surgical site depend on the following factors:

– The quality of the CBCT and CT/model scan data


– The precision of aligning model scan data with CBCT and CT data by the user
– Errors in design of the surgical guide software model such as using incorrect sleeves or
inaccurate sleeve placement
– Errors in surgical guide manufacturing
– Failure to check fit of the surgical guide on the model prior to use
– Failure to check fit of the surgical guide on the patient prior to surgery
– Surgical guide incorrectly placed in the patient’s mouth, resulting in inaccurate fit and inter-
operative movement
– Inaccurate fit of the guided surgical instruments with the sleeves of the surgical guide;
instrument wear or incorrect sleeve selection can result in a loose fit and positional
inaccuracy.

coDiagnostiX 9 Instructions for Use 73


9. Maintenance
coDiagnostiX does not require any maintenance by the manufacturer during its product life cycle
(see Product life cycle (p. 7)).

However, the user is responsible to:


n Ensure that data are regularly backed up to prevent loss of data (see chapter Data protection
(p. 21) and section Management (p. 28) of chapter coDiagnostiX start screen (p. 28)).
n Update the software as indicated under Product life cycle (p. 7) to maintain regulatory
compliance beyond the original product life cycle. With an active internet connection, the user
is automatically notified about pending updates. To check for updates manually, open the
Help (?) menu and select Dental Wings Online > Check for New Updates.

Caution

Online updates are also used to solve safety and/or information security issues. Such
updates are mandatory. Such will be clarified by the information provided with the online
update.

74 coDiagnostiX 9 Instructions for Use


10. Distributors and service
In case of questions, please contact your local distributor.
Alternatively, contact [email protected] (in English or German).

coDiagnostiX 9 Instructions for Use 75


11. Technical data

11.1 Ambient conditions


To ensure intactness and operational readiness of hardware elements (dongle), data carriers
and other material provided for installation and use of coDiagnostiX, comply with the following
conditions:

Ambient conditions

Operating temperature 10°C to 40°C

Transportation temperature -29°C to 60°C

Storage conditions -20°C to 40°C, controlled moisture (no condensation)

Relative humidity 15 % to 85 %

Atmospheric pressure 12 kPa to 106 kPa

11.2 Hardware and software requirements


The user is solely responsible to provide hardware and software suitable to run coDiagnostiX. It
shall comply to national safety regulations and not impact the safety and performance of
coDiagnostiX. For mandatory requirements see the following table.

Mandatory hardware/software

Memory Minimum: 8 GB RAM

Hard disk Minimum: 128 GB

76 coDiagnostiX 9 Instructions for Use


Mandatory hardware/software

Storage space n Installation: 5 GB of hard disk space required


n Free disk space for patient datasets and swap/chache files: Make
sure a minimum of 10 GB of free disk space is available prior to
each start of coDiagnostiX.
Note: If system and database are not located on the same drive,
10 GB of free disk space will be required on both the system and the
database drives.

CPU x86 compatible processor supported by the operating system (at least
Intel® Core™ 2 Duo processor P8600)

Peripheral devices n Monitor


n Keyboard
n 2-button mouse (mouse with scroll wheel recommended)
n One free USB port

Operating system n Microsoft® Windows® 10, 64-bit, Microsoft® Windows® 11, 64-bit

Additional requirements for running coDiagnostiX on Apple Mac OS X:

n Macintosh computer with Intel® processor


n Mac OS X 10.9 or newer
n ‘Parallels Desktop’ or 'VMWare Fusion' for Macintosh including
valid Windows® license (software to be purchased separately)

n Minimum: 1680 x 1050 pixels


Screen resolution
n Recommended: 1920 x 1080 pixels or higher

Minimum requirements have been specified to allow for smooth operation of coDiagnostiX. The
software might also run on configurations with higher performance. The suitability of such
configurations has to be validated by the user.

coDiagnostiX 9 Instructions for Use 77


Optional hardware/software

Peripheral devices n DVD drive


n DVD burner
n Printer
n 3D mouse: 3D mouse by 3Dconnexion

Document reader PDF viewer

Internet connection Required, for instance, for online updates, remote support, online
transfer and DWOS Synergy, AI Assistant, and 3Shape Communicate.

Network connection Required for using the optional Network Database SQL or Network
License

n WiFi: Transmission rate at least 11 MBit/s


or
n Network card: Transmission rate at least 10 MBit/s

Additional requirements for


the coDiagnostiX Network n Microsoft® SQL Server® required
Database SQL module

Additional requirements for n Additional computer with a free USB slot running Microsoft®
a coDiagnostiX Network Windows® which acts as a dongle server (a server running 24/7 is
License recommended, but not necessary)
n Permanent (W)LAN connection to the dongle server while running
coDiagnostiX on the client computer
n Optional: Shared network drive to store the database

Additional requirements for DWOS Synergy allows for case sharing between coDiagnostiX and
DWOS Synergy Dental Wings DWOS or Straumann CARES Visual stations. For
compatibility of coDiagnostiX and DWOS or CARES Visual versions, see
Compatibility information (p. 20).

78 coDiagnostiX 9 Instructions for Use


Network configuration

caseXchange, AI Assistant, n Client: port 443, outgoing


3Shape Communicate

Online Updater n Client: port 80, outgoing

Network Database SQL To configure your network for use with SQL Server®, see the
information provided by Microsoft or contact your Dental Wings
support.

Network dongle n Client: TCP port 54237, UDP port 21945, both outgoing
n Server: TCP port 54237, UDP port 21945, both incoming

DWOS Synergy

Install at least one Synergy server within your network. For information on where to download
the latest local Synergy server release, contact your local distributor (see Distributors and
service (p. 75)).

To be able to reach the Synergy server from other clients, the following ports need to be
activated (in most cases, this is done automatically by the installation program):

DWOS Synergy server

Port 15672 RabbitMQ server administration interface Incoming

Port 61613 STOMP protocol – communication with Incoming


coDiagnostiX

Port 5672 AMQP protocol – communication with Dental Incoming


Wings DWOS or Straumann CARES Visual

Port 61615 STOMP message queue dispatcher Incoming

Port 55555 (UDP) Broadcast query Outgoing

Port 55556 (UDP) Broadcast listener Incoming

coDiagnostiX 9 Instructions for Use 79


coDiagnostiX workstation

Port 80 HTTP protocol – Synergy over the internet. Not Outgoing


required for communication with local Synergy
server.

Port 443 SSL protocol – Synergy over the internet. Not Outgoing
required for communication with local Synergy
server.

Port 61613 STOMP protocol – communication with Outgoing


coDiagnostiX

Port 61615 STOMP message queue dispatcher Outgoing

Port 55555 (UDP) Broadcast query Outgoing

Port 55556 (UDP) Broadcast listener Incoming

11.2 Label

The product label is found in the software


About box.

On the start screen, select Help (?) > About


from the main menu to open the About box.

80 coDiagnostiX 9 Instructions for Use


11.3 Supporting information for CBCT or CT scans
The production of CBCT or CT scans lies within the full responsibility of the radiologist or
appropriately qualified personnel. However, the following requirements have to be observed to
support image data processing and implant planning with coDiagnostiX:

Preparation

n All metal parts which are not fixed must be removed from the patient’s mouth.
n Block the opposite jaw, for instance, with a wooden applicator or silicone.
n Insert dental cotton rolls to keep lips and cheeks away from the gingiva.
n Make sure the tongue does not touch the palate.

Positioning

n Align the occlusal plane to the scan plane as accurately as possible.

Important CT scanning parameters

n A gantry angle of 0° is recommended to achieve the best quality for image reconstruction.
n Do NOT vary reconstruction parameters within a series (constant value for X and Y axis).
n Set a high-resolution bone algorithm (actual setting depends on the device)
n Parameters for a complete dataset when using dynamic mode:
Slices: 0.5 mm to 1.0 mm (0.5 mm recommended)
n When using spiral mode, reconstruction to 1.0 mm slices or less (0.5 mm is recommended).
n KV: approx. 110 to 130
n mA: approx. 20 to 120

Storage of image data

n Only axial slices are required.


n DICOM III format, no raw data.

coDiagnostiX 9 Instructions for Use 81


11.3 Licensing Matrix

coDiagnostiX EASY EASY


PRODUCER CLIENT EASY
license features CHAIRSIDE PRINT*

Basic functionalities
Planning l l l l l
Safety l l l l
Data Import l l l l
Data Output l l l l l
Guide design l l l l
Export functionalities
Guide export l l l
Collaboration
Transfer cases via
l l l
caseXchange
Transfer cases via
l l
archive exchange
Other Functionalities
Advanced functions l l
AI Assistant* l l

For an exhaustive licensing matrix please contact your local distributor (see Distributors and
service (p. 75)). coDiagnostiX license features may be promoted in marketing material.

* Limited availability. Ask your Straumann partner.

82 coDiagnostiX 9 Instructions for Use


12. Symbols on the product and/or packaging

Caution, consult Instructions The CE sign indicates that the


for Use for important product complies with
cautionary information applicable EU regulations

Refer to Instructions for Use


Consult Instructions for Use (On medical devices: Follow
Instructions for Use)

Indicates the date when the


Indicates the medical device
medical device was
manufacturer
manufactured

Do not dispose of this device


Indicates the manufacturer's
as unsorted municipal waste.
catalog number
Collect separately.

Atmospheric pressure
Humidity limitation
limitation

Caution: Federal law restricts


Temperature limit for this device to sale by or on the
transport order of a licensed healthcare
practitioner

coDiagnostiX 9 Instructions for Use 83


www.dentalwings.com
www.codiagnostix.com

Dental Wings GmbH Distributor stamp


Düsseldorfer Platz 1
09111 Chemnitz
GERMANY

T +49 371 273903-70


F +49 371 273903-88

coDiagnostiX 9 Instructions for Use


P003.02 EN v. 12.6 2022-06-13

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