Differences

This shows you the differences between two versions of the page.

--- dosimetry:instructions_for_use:instructions_for_use [2015/07/02 15:32] – created dpatenaude
+++ dosimetry:instructions_for_use:instructions_for_use [2021/07/29 18:23] (current) – external edit 127.0.0.1
@@ Line 7: / Line 7: @@
 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 =====
+It is the user's responsibility to commission and test the dose accuracy prior to patient treatment. This general liability on the end users should be understood and communicated to all users and a representative with signatory authority from each facility using Astroid must sign a //User Agreement// stating their understanding and acceptance of this responsibility.
+Additionally, a site administrator with signatory authority will be required to sign an //End User License Agreement// on behalf of the facility indicating understanding of the responsibilities for quality, accuracy, and security described herein.
+===== Clinical Safety =====
+It is the responsibility of the user to perform end-to-end testing prior to the clinical implementation of Astroid. The user should follow accepted industry guideline (such as AAPM TG244) for the end-to-end testing. This testing should be performed by qualified personnel.
+It is the responsibility of the facility to ensure that all users of the Astroid treatment planning system have had training on the Astroid product and possess the appropriate clinical education, experience, and (where applicable) licensure to develop clinical treatment plans. This includes, but is not limited to, the application training provided by Astroid staff.
+It is recommended that users follow acceptable global standards during the commissioning of the Astroid product. During the clinical set up, the following should be tested to ensure clinical safety prior to treatment:
+  - Geometric relationships of the hardware machine models
+  - The dose algorithm
+  - Data access and storage
+  - Accuracy of the planning dose systems.
+===== 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. 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.
+<WRAP center round important 60%>
+Prior to the delivery of any plan on a patient, users are responsible for performing patient specific QA to ensure clinical acceptability of the delivered dose distribution. Since users are responsible for testing the acceptability of the delivered dose before treatment, Astroid, its staff, and representatives shall not be liable for any mis-treatments that may result from use of the system.
+</WRAP>
-===== Testing Responsibilities =====
+<wrap em>Caution: Federal law restricts this device to sale by or on the order of a physician.</wrap>
-Refer to the [[commissioning_guide:commissioning_guide#testing_responsibilities|Commissioning Guide]] for a full detailed description of the user testing requirements for using the astroid Dosimetry App.
 ==== Derived Applications ====
@@ Line 49: / Line 70: @@
 ==== 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.
 ----
 <WRAP center 10%>//USR-004//</WRAP>
-<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>