en:specification
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en:specification [2021/01/19 14:33] – [Program Versions] onyxadmin | en:specification [2024/04/09 12:35] (current) – [Product Description] onyxadmin | ||
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====== Specification ====== | ====== Specification ====== | ||
+ | [[https:// | ||
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- | ===== Functionality | + | ===== Device Description |
- | Software OnyxCeph³™ running on Windows™ | + | The standalone |
- | + | The tools developed for this purpose shall be flexibly configurable and combinable in order to digitally map a wide variety of orthodontic in-house workflows and thus generate a general benefit in the form of savings, facilitation and improvement.\\ | |
- | * Image archiving | + | In addition to this general benefit, the application of the software enables a clinical benefit exclusively in the form of deriving metric information from case-relevant 2D and 3D image data and is therefore classified as a medical device.\\ |
- | * Image-based diagnistics | + | The OnyxCeph³™ software does not make treatment decisions or provide treatment recommendations. The software itself and its outputs cannot be used directly on patients or for their treatment. According to the intended purpose, the measured values provided within the scope of clinical use can only be used to back up independently made treatment |
- | * Image-based treatment | + | \\ |
- | * Patient education | + | |
- | using two-dimensional and three-dimansional image data in orthodontics, general dentistry | + | =====Indications for Use===== |
- | [see also [[https:// | + | OnyxCeph³™ software is intended to be used for the medical purpose of managing and evaluating |
+ | The use of OnyxCeph³™ requires the user to have the necessary training | ||
+ | The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. [[indication_for_use|{{:link.png|read more}}]]\\ | ||
\\ | \\ | ||
- | ===== Program Versions ===== | + | =====Medical Purpose===== |
+ | OnyxCeph³™ is a software only device and is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only who have received dedicated training for use of the software.\\ | ||
+ | Clinical decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.\\ | ||
+ | The classification as a medical device cannot be transferred to treatment measures or the manufacture of orthodontic appliances, even if these take into account the calculation results of the software. [[indication_for_use|{{: | ||
+ | \\ | ||
+ | ===== Performance Data ===== | ||
+ | |||
+ | The correct function of the software requires the use of the most up to date program version (release). | ||
+ | The availability of a new program version is displayed by a release update button top right in the program main window if online connected. Alternatively, | ||
+ | The intended use of the software requires the proper registration and productive activation of the software by the user. Non-productively activated versions of the software only serve to familiarise the user with its use or for testing purposes.\\ | ||
+ | \\ | ||
+ | |||
+ | ===== Program Versions | ||
^ Topic ^ Content | ^ Topic ^ Content | ||
| [[programversions|Program Versions]] | | [[programversions|Program Versions]] | ||
| [[versionfeatures|Version Featurelist]] | | [[versionfeatures|Version Featurelist]] | ||
- | | [[modulelib_2d|Module | + | | [[modules_000|Module |
- | | [[modulelib_3d|Module Windows | + | | [[modulelib_32|Module Windows]] |
- | \\ | + | |
- | + | ||
- | ===== Release History ===== | + | |
- | [[http:// | + | |
\\ | \\ | ||
- | ===== Medical Purpose | + | ===== Release Information |
- | Software OnyxCeph³™, | + | [[release_info|Release history]]\\ |
- | Diagnostic and therapeutic decisions can not be motivated exclusively or even mainly on evaluation results provided by the software.\\ | + | |
- | The intended medical purpose requires a correct registration and activation of the software by the user.\\ | + | |
- | Unauthorized trial versions can only be used to become familiar with the application acc. to its user interface and functionality but do not represent a medical product so far.\\ | + | |
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- | ===== Image And Tracing Types ===== | + | ===== Image and Tracing Types ===== |
^ Topic ^ Content | ^ Topic ^ Content | ||
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=====Getting Started===== | =====Getting Started===== | ||
- | {{: | + | {{:link.png?nolink|}} [[getting_started|Getting Started]] |
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en/specification.txt · Last modified: 2024/04/09 12:35 by onyxadmin