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--- dosimetry:instructions_for_use:instructions_for_use [2018/11/05 17:35] – [Testing Responsibilities] kerhart
+++ dosimetry:instructions_for_use:instructions_for_use [2021/07/29 18:23] (current) – external edit 127.0.0.1
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 The intended use for this application is to aid software developers in implementing programs that contain functionality similar to radiation treatment planning systems (TPS), including programs designed to provide independent secondary checks of other TPS results. Therefore typical indications for use are for planning or analyzing proton radiation therapy treatments for cancer patients with a wide range of disease locations. This is the context in which this application was developed and it was within this scope of use that the system was tested and cleared for sale by the FDA.
-===== Warning =====
-Since this application is intended to be used primarily by other software developers in a possible wide range of TPS-like applications, the foreseeable misuses are difficult to predict. However, the most likely source of misuse will be simply due to misunderstanding by developers of the input and output data values and formats of the various exposed functions. Therefore it is critical that all developers read these Instructions for Use carefully and completely and consult the provided User Guides and other training materials to ensure proper use of the application and proper interpretation of results.
-<wrap em>Caution: Federal law restricts this device to sale by or on the order of a physician.</wrap>
 ===== User Profile =====
-As stated, this application is not intended to be a direct end-user facing program; therefore it will not be used by the average medical dosimetrist for day-to-day planning needs. Rather, the application will be used by experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes. Within the clinical setting it is expected that these types of users will develop in-house systems or other commercial applications that utilize the functions provided by this product. While the DCF and DTF have been cleared for clinical use, this does not remove the need for these experienced and educated users to provide final testing and approval of their derived programs before releasing to clinical staff. Since the results from any calculation performed by this product are only as good as the provided inputs, special care must be taken by developers to ensure proper inputs are designed, constructed, and verified for their particular application and clinical setup. This burden can never be removed from the user of the astroid dosimetry app and this is a primary reason why a strong working knowledge of proton radiation therapy and computer programming are required to utilize this product within a clinical setting. The [[commissioning_guide:commissioning_guide|astroid Proton Dosimetry Commissioning Guide]] is provided to help guide developers along the right path for developing inputs, commissioning their machines, and adequately testing any derived applications. With this resource and a solid understanding of treatment planning system use, commissioning, and QA, developers will be able to create stable and accurate programs that meet their unique clinical and/or research needs.
+As stated, this application is not intended to be a direct end-user facing program; therefore it will not be used by the average medical dosimetrist for day-to-day planning needs. Rather, the application will be used by experienced computer programmers, researchers, and physicists that contain a strong working knowledge of proton radiation therapy and general treatment planning processes. Within the clinical setting it is expected that these types of users will develop in-house systems or other commercial applications that utilize the functions provided by this product. While the DCF and DTF have been cleared for clinical use, this does not remove the need for these experienced and educated users to provide final testing and approval of their derived programs before releasing to clinical staff. Since the results from any calculation performed by this product are only as good as the provided inputs, special care must be taken by developers to ensure proper inputs are designed, constructed, and verified for their particular application and clinical setup. This burden can never be removed from the user of the astroid dosimetry app and this is a primary reason why a strong working knowledge of proton radiation therapy and computer programming are required to utilize this product within a clinical setting. The [[dosimetry:commissioning_guide:commissioning_guide|Astroid Doismetry App Commissioning Guide]] is provided to help guide developers along the right path for developing inputs, commissioning their machines, and adequately testing any derived applications. With this resource and a solid understanding of treatment planning system use, commissioning, and QA, developers will be able to create stable and accurate programs that meet their unique clinical and/or research needs.
 ===== User Testing Responsibilities =====
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   - Accuracy of the planning dose systems.
-==== Warning ====
+===== Warning =====
-It is critical that all users read these Instructions for Use and the User Guide material carefully and completely and consult the provided User Guides and other training materials to ensure proper use of the application and proper interpretation of results.
+It is critical that all users read these Instructions for Use and the User Guide material carefully and completely and consult the provided User Guides and other training materials to ensure proper use of the application and proper interpretation of results. Additionally, since this application is intended to be used primarily by other software developers in a possible wide range of TPS-like applications, the foreseeable misuses are difficult to predict. However, the most likely source of misuse will be simply due to misunderstanding by developers of the input and output data values and formats of the various exposed functions. Therefore it is critical that all developers read these Instructions for Use carefully and completely and consult the provided User Guides and other training materials to ensure proper use of the application and proper interpretation of results. Users and developers must also understand their responsibilities and liabilities when using this product for patient treatment.
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 ==== Proton Treatment Delivery Machine Model ====
-The current state of proton delivery machines is such that two major modes of delivery are utilized: spread-out Bragg peak (SOBP) and pencil-beam scanning (PBS). Each such mode requires various machine parameters to be defined which facilitate the proper modeling of the dose delivered by a beam. Providing a means for users to specify the parameters necessary to configure their system is therefore an important concern so that the dose calculation algorithms can provide proper results for users of a variety of proton machine vendors. The proton treatment machine model provides user configurable parameters that allow dose calculation results to be commissioned to a variety of proton machine types, especially IBA and Mevion machines.
+The current state of proton delivery machines is such that two major modes of delivery are utilized: spread-out Bragg peak (SOBP) and pencil-beam scanning (PBS). Each such mode requires various machine parameters to be defined which facilitate the proper modeling of the dose delivered by a beam. Providing a means for users to specify the parameters necessary to configure their system is therefore an important concern so that the dose calculation algorithms can provide proper results for users of a variety of proton machine vendors. The proton treatment machine model provides user configurable parameters that allow dose calculation results to be commissioned to a variety of proton machine types, however only IBA machines have been commissioned for clinical use with Astroid at this time.
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-<WRAP center 40%>.decimal LLC, 121 Central Park Place, Sanford, FL. 32771</WRAP>
+<WRAP center 50%>.decimal LLC, 121 Central Park Place, Sanford, FL. 32771</WRAP>