Differences

This shows you the differences between two versions of the page.

--- decimal3d:instructions_for_use:instructions_for_use [2019/09/03 19:31] – [User Responsibilities] kmobile
+++ decimal3d:instructions_for_use:instructions_for_use [2019/09/03 20:16] – [User Profile] kmobile
@@ Line 12: / Line 12: @@
 ===== Clinical Safety =====
-It is the responsibility that the user performs end-to-end testing prior to the clinical implementation of Astroid. 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.
+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.
-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 clinical treatment plans. This includes, but is not limited to, the application training provided by Astroid staff.
+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 to, the application training provided by .decimal staff.
-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:
+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:
-  - Geometric relationships of the hardware machine models
+  - Data access and storage
-  - The dose algorithm
+  - Accuracy of 3D scanning
-  - Data access and storage
+  - Accuracy of the digitizing
-  - Accuracy of the planning dose systems.
+  - Accuracy of the ordering.
 ==== Warning ====
@@ Line 27: / Line 27: @@
 <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 dose distribution. Since users are responsible for testing the acceptability of the delivered dose before treatment, Astroid, 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 the system.
 </WRAP>
@@ Line 34: / Line 34: @@
 ===== 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, optimization, and many other purposes, for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans.
+The decimal3D App is an interactive end user application that leverages advanced optical scanning technology to capture a three dimensional, full color, dimensionally accurate rendering of a patient. This rendering can be used for multiple applications including but not limited to digitizing the shape of a physician drawn treatment area and design of the electron aperture to treat this area. The decimal3D includes functionality for the electron aperture to be ordered.
 ===== User Profile =====
-The Astroid Planning App is a tool to develop radiotherapy treatment plans for delivery using a proton therapy system. Such plans are generally developed to meet the directives of a physician through a formal documented prescription. As such, the users of this application are expected to be supervised by an attending physician and should themselves be experienced in the physics and dosimetric characteristics of proton radiotherapy. Additionally, users are expected to have formal training in general radiotherapy techniques and best practices, proton therapy specific planning techniques, and general principles of patient safety and care. Most users will have college-level training or degrees, as well as licensure for their particular roles and responsibilities through their state, nation, or professional association. Users should also be well versed in regulations regarding protection of patient health information and have a basic understanding of standard practices regarding computer usage and security.
+The decimal3D should be used the guidance of a physician by authorized users such as physicists, certified medical dosimetrists, radiations therapists, radiologic technologists, nurses and those who have been trained by the .decimal staff or by the clinical staff.
 ===== Product Features =====