decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/08/19 13:12] – [Planning App Instructions for Use] dpatenaude | decimal3d:instructions_for_use:instructions_for_use [2019/09/04 12:44] – kerhart | ||
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====== decimal3D Instructions for Use ====== | ====== decimal3D Instructions for Use ====== | ||
- | ===== 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. All system data is stored locally on the iPad using secure |
- | + | ||
- | 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 | + | FIXME- |
- | * The Astroid Planning exclusively uses DICOM coordinate systems for display information (machine based coordinates are NOT available) | + | ==== Data Validation ==== |
- | * All linear dimensions are shown in millimeters (mm) | + | |
- | * All angular dimensions are shown in degrees (deg) | + | |
- | * All radiation dose quantities will be shown with their corresponding units within the application (e.g. Gy(RBE) or %) | + | |
- | * All date/time values are provided in a // dd/mm/yyyy h:m:s // format using local time on a 24 hour clock | + | |
- | * All date and time notifications in Astroid should match current Windows OS date and time, including proper use of daylight savings time where appropriate (note: Astroid will display in 24 hour format, while Windows may display in am/pm depending on local settings) | + | |
- | + | ||
- | ==== Data Validation | + | |
- | + | ||
- | 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, | + | |
+ | Users are responsible for confirming machine data input into decimal' | ||
==== Data Displays and Interpretation ==== | ==== Data Displays and Interpretation ==== | ||
- | Astroid | + | decimal3D |
==== Unauthorized Use ==== | ==== Unauthorized Use ==== | ||
- | The Astroid Planning Application | + | The decimal3D |
==== Access Control ==== | ==== Access Control ==== | ||
- | Astroid (Thinknode) administrators have the ability to manage user access, passwords, and " | + | FIXME - this can be deleted? |
- | 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. | + | ==== Known Limitations ==== |
- | For further information on access management | + | For a list of known system issues |
- | + | ||
- | ==== 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. | ||
- | [[planning: | ||
- | [[dosimetry: | ||
Line 98: | Line 69: | ||
=== 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