decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/08/19 13:12] – [Release Management (Launcher)] dpatenaude | decimal3d:instructions_for_use:instructions_for_use [2020/01/27 16:15] – 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 |
- | 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 | + | It is the responsibility |
- | It is the responsibility of the facility to ensure that all users of the Astroid treatment planning system | + | It is the responsibility of the facility to ensure that all users of the decimal3D |
- | + | ||
- | 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 ==== | ==== 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 Mark II 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 | + | It should be noted however, that decimal3D nor its host iPad should be used as the sole location to store critical patient treatment record information. As a mobile device, iPads can be prone to potential loss or damage. Once an order has been placed however, .decimal securely stores |
==== 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 |
- | | + | * All linear dimensions are shown in centimeters |
- | | + | |
* 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 Displays and Interpretation ==== | + | |
- | + | ||
- | Astroid contains many displays throughout the plan creation process. Please refer to [[http:// | + | |
- | + | ||
- | ==== Unauthorized Use ==== | + | |
- | + | ||
- | 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 " | + | ==== Data Validation ==== |
- | As Astroid is a cloud based application the site administrator will be responsible for the installation | + | Users are responsible for confirming |
- | For further information on access management | + | ==== Unauthorized Use and Access Control ==== |
- | ==== Known Limitations ==== | + | decimal3D will contain sensitive patient information that is protected under various governmental regulations, |
- | For a list of known system issues and limitations please refer to the following articles for the Planning App and Dosimetry App, respectively. | + | ==== System Calibration ==== |
- | [[planning: | + | The decimal3D application relies on both the Structure Sensor Mark II and built-in iPad color camera. Proper operation of the decimal3D |
- | [[dosimetry: | + | ===== Known Limitations |
+ | Below are listed the known application limitations, | ||
+ | - 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 the scanner coordinate and treatment machine coordinate systems | ||
+ | - Site information including Machine and Address Settings cannot be edited from decimal3D (these can be edited using .decimal' | ||
+ | - User passwords cannot be changed within the decimal3D App (please log in to direct.dotdecimal.com to change your password or contact .decimal customer service to request a password reset) | ||
+ | - Patient Databases are stored locally on each iPad, so facilities with more than one iPad will not be able to access all patient records from each iPad (note: once an Order is place however, the order information is available via direct.dotdecimal.com, | ||
+ | - Once a scan has been created its name cannot be edited (scan names are for convenience only and are used only for convenience in the application) | ||
+ | - Once a beam has been created its name cannot be edited (beam names are used as part of the cutout engraving text, therefore if an appropriate name was used, we recommend that you create a new beam with the desired name, using the same parameters, and then delete the wrongly named beam) | ||
- | === Release Notes === | + | ===== Release Notes ===== |
- | For the release notes for each version of the Planning | + | For the release notes for each version of the decimal3D |
decimal3d/instructions_for_use/instructions_for_use.txt · Last modified: 2023/04/17 16:34 by kerhart