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en:specification [2021/02/04 21:20] onyxadminen:specification [2024/03/21 16:16] (current) – [Medical Purpose] onyxadmin
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-\\ 
 ====== Specification ====== ====== Specification ======
-[[http://www.onyxceph.com/index.php?option=com_content&view=article&id=75&Itemid=68&lang=de|{{:start.png?200|}}]]+[[https://onyxceph.eu/en/|{{:start.png?200|}}]]
 ---- ----
  
-===== Medical Purpose =====+===== Product Description =====
  
-Software OnyxCeph³™, developed, placed on the marked and put into service by Image Instruments is intended to be used for the medical purpose of managing and diagnostically evaluating two-dimensional and three-dimensional images in the framework of dental applications by qualified staff only.\\ +The standalone Windows™ software OnyxCeph³™ provides software tools to digitally perform analog image-based in-house workflows in orthodontic facilities. To the extent that these workflows output measurement informationtheir accuracy shall at least match the accuracy of the corresponding analog workflows.\\  
-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 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.\\  
-The intended medical purpose requires a correct registration and activation of the software by the user.\\ +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.\\ 
-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.\\+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 purposethe measured values provided within the scope of clinical use can only be used to back up independently made treatment decisions.\\
 \\ \\
  
-===== 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, as well as to have received a dedicated training in the use of the software.\\ 
 +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}}]]\\ 
 +\\
  
-Software OnyxCeph³™ running on Windows™ Operational Systems reperesents client/server network application with integrated  SQL database NexusDB for the purpose of +=====Medical Purpose===== 
-  +OnyxCeph³™ is 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.\\ 
-  * 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 measures or the manufacture of orthodontic appliances, even if these take into account the calculation results of the software. [[indication_for_use|{{:link.png|read more}}]]\\ 
-  * Image-based treatment planning  +\\ 
-  * Patient education+===== Performance Data =====
  
-using two-dimensional and three-dimansional image data in orthodonticsgeneral 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://www.image-instruments.de/OnyxFAQs_en/|manual]]]\\+The availability of a new program version is displayed by a release update button top right in the program main window if online connected. Alternativelythe 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 userNon-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]]      | Available program versions     | | [[programversions|Program Versions]]      | Available program versions     |
 | [[versionfeatures|Version Featurelist]]   | Program version comparison | | [[versionfeatures|Version Featurelist]]   | Program version comparison |
-| [[modules_000|Module Windows]]              | Module Overview+| [[modules_000|Module List]]               | Module List
-| [[modulelib_2d|Module Windows 2D]]        | Overview Modules 2D| +| [[modulelib_32|Module Windows]]           | Module Windows|
-| [[modulelib_3d|Module Windows 3D]]        | Overview Modules 3D|+
 \\ \\
  
 ===== Release Information ===== ===== Release Information =====
  
-[[http://www.onyxceph.com/index.php?option=com_content&view=article&id=96&Itemid=98&lang=en|Release history]]\\ +[[release_info|Release history]]\\
-[[release_notes|New in current Release]]\\+
 \\ \\
  
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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|}} [[getting_started|Getting Started]] +{{:link.png?nolink|}} [[getting_started|Getting Started]] 
 \\ \\
en/specification.1612470059.txt.gz · Last modified: 2021/02/04 21:20 by onyxadmin