decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/09/03 21:04] – [Product Features] kmobile | 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 primary purpose of this product | + | The primary purpose |
- | 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 test each device ordered through decimal3D | + | It is the user's responsibility to test each device ordered through decimal3D |
===== 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 decimal3D have had training on the decimal3D App and possess the appropriate clinical education, experience. This includes, but is not limited | + | It is the responsibility of the facility to ensure that all users of the decimal3D have had training on the decimal3D App and possess the appropriate clinical education |
- | + | ||
- | It is recommended that users follow acceptable global standards during the commissioning of the decimal3D. During the clinical set up, the following should be tested to ensure clinical safety prior to treatment: | + | |
- | - Data access and storage | + | |
- | - Accuracy of 3D scanning | + | |
- | - Accuracy of the digitizing | + | |
- | - Accuracy of the ordering. | + | |
==== 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 treatment on a patient, users are responsible for performing patient specific QA to ensure clinical acceptability of the delivered treatment device. Since users are responsible for testing the acceptability of the delivered dose before treatment, .decimal, its staff, and representatives shall not be liable for any mis-treatments that may result from use of the system. | + | Prior to the delivery of any treatment on a patient, users are responsible for performing patient specific QA to ensure clinical acceptability of the delivered treatment device. Since users are responsible for testing the acceptability of the delivered dose before treatment, .decimal, its staff, and representatives shall not be liable for any mis-treatments that may result from use of its software or devices. |
</ | </ | ||
<wrap em> | <wrap em> | ||
- | ===== Intended Use ===== | ||
- | |||
- | The decimal3D App is an interactive end user application that leverages advanced optical scanning technology to capture a three dimensional, | ||
===== User Profile ===== | ===== User Profile ===== | ||
- | The decimal3D should be used the guidance of a physician by authorized users such as physicists, certified medical dosimetrists, | + | The decimal3D |
===== Product Features ===== | ===== Product Features ===== | ||
- | decimal3D | + | decimal3D |
==== 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 ==== | ||
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FIXME- should we delete this for the first go round? | FIXME- should we delete this for the first go round? | ||
- | ==== Data Validation | + | ==== 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 ==== | ||
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==== 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: | ||
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=== 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