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 [2023/04/17 16:34] (current) – [Known Limitations] 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, users will import | + | decimal3D is a medical software accessed on an iPad and managed through |
- | The Astroid Planning | + | |
+ | {{page> | ||
==== 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 " | + | |
- | + | ||
- | 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 | + | ==== Data Validation |
- | For a list of known system issues and limitations please refer to the following articles | + | Users are responsible |
- | [[planning: | + | ==== Unauthorized Use and Access Control ==== |
- | [[dosimetry: | + | decimal3D will contain sensitive patient information that is protected under various governmental regulations, |
+ | ==== System Calibration ==== | ||
- | ==== Release Management | + | The decimal3D application relies on both the Structure Sensor Mark II and built-in iPad color camera. Proper operation of the decimal3D App requires that these two components be properly calibrated to ensure accurate alignment of scanned image colorization. A calibrator app has been provided with your iPad and the system is shipped pre-calibrated. However, part of the regular maintenance of the decimal3D application is for users to verify and adjust the calibration every 6 months OR anytime the Mark II Sensor is removed from the iPad OR anytime the system is subjected to an impact |
- | 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: | + | ==== Patient Data Export ==== |
- | - 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 | + | The decimal3D |
- | 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 or research | + | Additionally, |
- | 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: | + | In both cases, caution should |
- | === Releasing a new App Version === | + | |
- | In order to " | + | ===== Known Limitations ===== |
- | * **< | + | |
- | * **< | + | |
- | * References Immutable: < | + | |
- | " | + | |
- | " | + | |
- | } </ | + | |
- | * **< | + | |
- | * **< | + | |
- | * **< | + | |
- | For the launcher to register that an application | + | Below are listed |
- | For Example: | + | - Site information including Machine and Address Settings cannot be edited |
+ | - User passwords cannot be changed within | ||
+ | - Patient Databases are stored locally on each iPad, so facilities | ||
+ | | ||
+ | - Very bright indoor lighting can interfere with scanning, especially on dark or shiny surfaces; if you experience difficulty with the scanner recognizing a surface, try scanning in a lower light condition | ||
+ | - Long term application use without an application restart can produce errors | ||
+ | - Any unsaved changes | ||
+ | - Existing patients created in older versions of the application may not show patient name in all UI fields (data is not lost, but is not visible on all screens). | ||
+ | - Scanners may lose connectivity to the iPad, giving a message stating " | ||
- | === Release Notes === | ||
- | For the release notes for each version of the Planning | + | For the release notes for each version of the decimal3D |
---- | ---- | ||
- | <WRAP center 60%> | + | <WRAP center 60%> |
decimal3d/instructions_for_use/instructions_for_use.1566220314.txt.gz · Last modified: 2021/07/29 18:21 (external edit)