en:specification
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en:specification [2021/01/28 21:17] – [Release-Notes current Version] onyxadmin | en:specification [2024/04/09 12:35] (current) – [Product Description] onyxadmin | ||
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====== Specification ====== | ====== Specification ====== | ||
+ | [[https:// | ||
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- | ===== Medical Purpose | + | ===== Device Description |
- | Software | + | The standalone Windows™ software |
- | Diagnostic and therapeutic decisions can not be motivated exclusively or even mainly on evaluation results provided by the software.\\ | + | The tools developed for this purpose |
- | The intended | + | In addition to this general benefit, the application of the software |
- | Unauthorized trial versions | + | 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 |
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- | ===== Functionality | + | =====Indications for Use===== |
+ | OnyxCeph³™ software 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.\\ | ||
+ | The use of OnyxCeph³™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, | ||
+ | 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|{{: | ||
+ | \\ | ||
- | Software | + | =====Medical Purpose===== |
- | + | OnyxCeph³™ | |
- | * Image archiving | + | Clinical decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.\\ |
- | * Image-based diagnistics | + | The classification as a medical device cannot be transferred to treatment |
- | * Image-based treatment | + | \\ |
- | * Patient education | + | ===== Performance Data ===== |
- | using two-dimensional and three-dimansional image data in orthodontics, general dentistry and oral-maxillofacial surgery.\\ | + | The correct function of the software requires the use of the most up to date program version (release). |
- | [see also [[https:// | + | 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 update information has to be checked on the product website www.onyxceph.com on a regular base.\\ |
+ | 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.\\ | ||
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| [[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 | + | ===== Release |
- | [[http:// | + | |
- | \\ | + | |
- | ===== Release Notes Current Version ===== | + | [[release_info|Release |
- | [[release_notes|New in current | + | |
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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.1611865064.txt.gz · Last modified: 2021/01/28 21:17 by onyxadmin