decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/09/03 21:29] – [Unauthorized Use] 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 ===== | + | |
- | It is the responsibility that the user performs end-to-end testing prior to the clinical implementation of decimal3D. The user should follow accepted industry guideline (such as AAPM TG244) for the end-to-end testing. This testing should be performed by qualified personnel. | + | ===== Clinical Safety ===== |
- | It is the responsibility | + | It is the responsibility |
- | It is recommended | + | It is the responsibility of the facility to ensure |
- | - 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 ==== | ||
- | FIXME - We need to discuss | + | 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 encyption technology. As this application stores patient protect health information (PHI), clinics should secure the iPad following their internal Mobile Device protection policies to ensure protection of patient data and maintain HIPAA compliance. Remote tracking and lockout software is highly recommended to ensure data can be locked, deleted, and recovered in the event an iPad is lost or stolen. |
==== Coordinates and Units of Measure ==== | ==== Coordinates and Units of Measure ==== | ||
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==== 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