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--- decimal3d:instructions_for_use:instructions_for_use [2019/08/19 13:12] – [Planning App Instructions for Use] dpatenaude
+++ decimal3d:instructions_for_use:instructions_for_use [2019/09/03 20:16] – [User Profile] kmobile
@@ Line 3: / Line 3: @@
 ===== Overview and Indications for Use =====
-The Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans. This Astroid Planning App leverages the existing .decimal Astroid Dosimetry App [FDA 510(k) K150547], which is a library of treatment planning functions accessed through the Thinknode® cloud services framework, for device creation, dose calculation, optimization, and all other dosimetry and processing calculations. Since the Astroid Dosimetry App is responsible for performing the calculations, the scope of this Astroid Planning App is to be the interface for end users to input treatment planning data and review the results. Typical indications for use of this application are for the treatment of persons with cancer, over a wide range of potential disease locations. In the most common use case of the software, users will import patient data from existing imaging and contouring software programs, manage physician prescription and intent information, develop a proton treatment plan, and analyze the plan to determine how well it meets the physician’s goals. Since the critical treatment planning functions and calculations are handled outside this software application, by a software of known quality and pedigree, the primary and most frequently used functions of this software are the record keeping service (for patient data storage), user interface controls, and visualization tools.
+The primary purpose of this product is to provide an advanced optical scanning technology using an iPad App that enables the user to capture a three dimensional, full color, dimensionally accurate of the patient and the treatment area drawn by the physician. The user is then able to digitize the treatment area, design the electron aperture as well as place the beam utilizing decimal3D. The decimal3D app also allows the user to order through an interface with the decimal Direct API.
-Furthermore, since the accuracy of information computed and displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software over the full range of expected treatment conditions before the system is utilized for patient treatment.
+Furthermore, since the accuracy of information displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software before the system is utilized for patient treatment.
 ===== User Responsibilities =====
-It is the user's responsibility to commission and test the dose accuracy prior to patient treatment. This general liability on the end users should be understood and communicated to all users and a representative with signatory authority from each facility using Astroid must sign a //User Agreement// stating their understanding and acceptance of this responsibility.
+It is the user's responsibility to test each device ordered through decimal3D prior to use on a patient. The user must also agree to the //Terms and Conditions// as well as the //Processing Agreement// prior to ordering a device for patient use.
-Additionally, a site administrator with signatory authority will be required to sign an //End User License Agreement// on behalf of the facility indicating understanding of the responsibilities for quality, accuracy, and security described herein.
 ===== 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 ====
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 <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>
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 ===== 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 =====