decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/08/19 13:11] – created dpatenaude | decimal3d:instructions_for_use:instructions_for_use [2019/09/04 13:34] – kerhart | ||
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- | ====== | + | ====== |
- | ===== Overview | + | ===== Overview, Indications for Use, and Intended |
- | The Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose | + | The primary purpose and intended use of this device is to improve the efficiency of designing patient specific |
- | Furthermore, | + | This product is not intended to replace CT imaging or other internal imaging modalities and should be used only in cases where a qualified Radiation Oncologist has made appropriate determination of the acceptability |
===== User Responsibilities ===== | ===== User Responsibilities ===== | ||
- | It is the user's responsibility to commission | + | It is the user's responsibility to test each device ordered through decimal3D for proper function, fit, and clinical acceptability **__prior |
- | + | ||
- | Additionally, | + | |
===== Clinical Safety ===== | ===== Clinical Safety ===== | ||
- | It is the responsibility that the user performs end-to-end testing prior to the clinical | + | It is the responsibility that the user performs end-to-end testing prior to the clinical |
- | + | ||
- | 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 | + | |
- | It is recommended | + | It is the responsibility of the facility to ensure |
- | - Geometric relationships of the hardware machine models | + | |
- | - The dose algorithm | + | |
- | - Data access and storage | + | |
- | - 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 | + | 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. |
<WRAP center round important 60%> | <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 | + | Prior to the delivery of any treatment |
</ | </ | ||
<wrap em> | <wrap em> | ||
- | |||
- | ===== Intended Use ===== | ||
- | |||
- | The Astroid Planning App is an interactive end user application that leverages the existing .decimal Astroid Dosimetry App library [FDA 510(k) K150547] of functions (accessed through the Thinknode® cloud services framework) for device creation, dose calculation, | ||
===== User Profile ===== | ===== User Profile ===== | ||
- | The Astroid Planning | + | The decimal3D |
===== Product Features ===== | ===== Product Features ===== | ||
- | In the most common, primary use case of the software, | + | decimal3D is a medical software accessed on an iPad and managed through |
- | The Astroid Planning App software communicates with other treatment | + | |
==== System Availability and Data Integrity ==== | ==== System Availability and Data Integrity ==== | ||
- | As with any cloud based application there is always concern with system availability | + | The decimal3D App is installed on a standard Apple iPad and uses the Structure Sensor by Occipital. These off-the-shelf hardware components are covered by manufacture warranties, which can be extended |
- | + | ||
- | Since data integrity is such a critical feature for application such as this, the Astroid Planning App automatically saves both the state of the application | + | |
==== Coordinates and Units of Measure ==== | ==== Coordinates and Units of Measure ==== | ||
- | The following is a list of several important items that users should understand in regards to the information displays in the Astroid Planning | + | The following is a list of several important items that users should understand in regards to the information displays in the decimal3D |
- | * The Astroid Planning exclusively uses DICOM coordinate systems for display information (machine based coordinates are NOT available) | ||
* All linear dimensions are shown in millimeters (mm) | * All linear dimensions are shown in millimeters (mm) | ||
* All angular dimensions are shown in degrees (deg) | * All angular dimensions are shown in degrees (deg) | ||
- | | + | * All date/time values are provided in a // mm/dd/yyyy h:m:s am/pm // format using local time |
- | | + | * All date and time information |
- | * All date and time notifications in Astroid | + | |
- | ==== Data Validation and Limits ==== | ||
- | Users are responsible for inputting a lot of data into the Astroid Planning App to develop clinical treatment plans. In the course of entering such data, there are opportunities for users to enter incorrect information. Although users are responsible for checking for such errors before clinical treatment, Astroid does provide some assistance in ensuring data limitations are met by a plan. Machine energy (range) limits, gantry angles, patient support (couch) angles, snout extensions, as well as shifter and aperture sizes and availability are all explicitly limited to user configured levels within the Astroid Planning App controls. Additionally, | + | ==== Data Validation ==== |
- | ==== Data Displays | + | Users are responsible for confirming the accuracy of machine data using decimal' |
- | Astroid contains many displays throughout the plan creation process. Please refer to [[http:// | + | ==== Unauthorized Use and Access Control ==== |
- | ==== Unauthorized Use ==== | + | decimal3D will contain sensitive patient information that is protected under various governmental regulations, |
- | The Astroid Planning Application will contain sensitive patient information that is protected under various governmental regulations, | ||
- | |||
- | ==== Access Control ==== | ||
- | |||
- | Astroid (Thinknode) administrators have the ability to manage user access, passwords, and " | ||
- | |||
- | As Astroid is a cloud based application the site administrator will be responsible for the installation of Astroid on to the appropriate workstations. Each user should have an individual log in and password to access the planning app that prevents unauthorized access. Best practices should be followed. | ||
- | |||
- | For further information on access management and permission settings please refer to [[https:// | ||
==== Known Limitations ==== | ==== Known Limitations ==== | ||
- | For a list of known system issues and limitations please refer to the following articles for the Planning App and Dosimetry App, respectively. | + | Below are listed |
- | + | ||
- | [[planning: | + | |
- | + | ||
- | [[dosimetry: | + | |
- | + | ||
- | + | ||
- | ==== Release Management (Launcher) ==== | + | |
- | + | ||
- | The astroid Planning App is installed and launched from the astroid Launcher. The Launcher program provides the following functionality in regards to the Planning App: | + | |
- | - Ensures that all users at a site are using the same version of the application | + | |
- | - Ensures that the local Planning App client stays in sync with the latest release version (as set via Thinknode) | + | |
- | - Provides user authentication and password management | + | |
- | + | ||
- | When an application update is available via the astroid Launcher, the users will be required to install the App in the Launcher. This is accomplished by selecting the //Install// button for the specific app. Within a few minutes, the app should be downloaded and installed locally for the current user account. The user will then be able to launch the released app version from the astroid Launcher. | + | |
- | + | ||
- | By using the astroid Launcher, users can log in to multiple realms with each realm using a different app version. This allows for scenarios of using non-clinical | + | |
- | + | ||
- | Details regarding the specific requirements for computers on which the Launcher and Planning App client applications will be installed can be found on the [[planning: | + | |
- | === Releasing a new App Version === | + | |
- | + | ||
- | In order to " | + | |
- | * **< | + | |
- | * **< | + | |
- | * References Immutable: < | + | |
- | " | + | |
- | " | + | |
- | } </ | + | |
- | * **< | + | |
- | * **< | + | |
- | * **< | + | |
- | For the launcher to register that an application should be installed for a realm, the //client// app with the // | + | - Treatment position information (e.g. isocenter, gantry angle, couch angle, collimator angle) is not available at this time as there is no sufficient link between |
+ | | ||
+ | | ||
- | For Example: from the above RKS hierarchy example, the application client named // | ||
=== Release Notes === | === Release Notes === | ||
- | For the release notes for each version of the Planning Application, | + | For the release notes for each version of the Planning Application, |
decimal3d/instructions_for_use/instructions_for_use.txt · Last modified: 2023/04/17 16:34 by kerhart