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--- decimal3d:instructions_for_use:instructions_for_use [2019/09/03 21:20] – [Data Validation and Limits] kmobile
+++ decimal3d:instructions_for_use:instructions_for_use [2019/09/04 12:15] – [Overview and Indications for Use] kerhart
@@ Line 3: / Line 3: @@
 ===== Overview and Indications for Use =====
-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.
+The primary purpose and intended use of this device is to improve the efficiency of designing patient specific radiotherapy devices through the use of optical (laser) scanning technology. This device will serve as a direct replacement to the current processes for designing such patient-specific radiotherapy devices. One such common current process is for electron therapy clinical setups, which involves hand drawing of the patient-specific aperture shape onto a semi-transparent “template” block, using the treatment light field to verify accuracy against the treatment area that has been outlined directly on a patient by the treating physician. This now flattened and projected aperture shape can then be scanned and digitized allowing for computer controlled fabrication. This new decimal3D device will replace this process by providing a means to accurately scan and digitize the treatment area.  After the surface scan is obtained, this device also provides a means for designing and ordering the required devices (e.g. digitization of the field for electron apertures), analogous to the current digitization process in the existing clinical workflow.
-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.
+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 of a “clinical set up” approach, independent of any information provided by this application. In other words, the role of this product is to simply ensure efficient and accurate ordering of a patient-specific device from our company, in cases where a licensed radiation oncologist has predetermined that such a device and treatment approach is appropriate for the patient at hand. Thus this device’s indications for use include patients with a variety of cancer and disease conditions, under the direct supervision and guidance of a radiation oncologist that has prescribed a desired dose of radiation to be delivered to the patient.
 ===== User Responsibilities =====
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 ==== Unauthorized Use ====
-The Astroid Planning Application will contain sensitive patient information that is protected under various governmental regulations, therefore users must ensure they adequately follow all appropriate and applicable rules regarding how, where, and when their staff may access the application and its data. In order to facilitate proper usage and protections, Astroid has a robust user permissioning scheme, as well as industry standard options for configuring password requirements, as explained at the [[https://developers.thinknode.com/services/ams/settings|Thinknode Account Management Settings page]]. Since all application and data access requires user login credentials, it is important that site administrators implement a strong password policy and that all users understand the importance of maintaining secrecy of their password (i.e. passwords should never be shared among more than one user). It is these user credentials that protect the system and its data from unauthorized access and replication.
+The decimal3D will contain sensitive patient information that is protected under various governmental regulations, therefore users must ensure they adequately follow all appropriate and applicable rules regarding how, where, and when their staff may access the application and its data. Since all application and data access requires user login credentials, it is important that site administrators implement a strong password policy and that all users understand the importance of maintaining secrecy of their password (i.e. passwords should never be shared among more than one user). It is these user credentials that protect the system and its data from unauthorized access and replication.
 ==== Access Control ====
-Astroid (Thinknode) administrators have the ability to manage user access, passwords, and "lock" data records to prevent unwanted and unintended modification. Several features have specific access rights that can be configured, including the ability to lock data records, unlock data records, and delete data. By configuring these options, administrators can lock critical data records, such as beam models, equipment information, and other machine/site level data, such that only expressly authorized users can edit these fields. All critical site records such as these should be kept "locked" at all times, and should be unlocked by only be authorized users when expliciting desiring to edit said records (and locking them again after modification is complete). In addition to the practice of locking site data records, users are expected to establish a review process whereby a minimum of two authorized individuals will review all proposed site data changes (including beam models and equipment data) prior to updating the records in Thinknode (please note that at this time, all such records are downloaded, reviewed, and updated through the Thinknode Desktop Client, which is available for download [[https://desktop.thinknode.com/|here]]).
+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 and permission settings please refer to [[https://developers.thinknode.com/services/iam|Thinknode IAM Services]]. The Thinknode services provide two important considerations regarding your clinical data, first, the permission schemes and access control, provide effective control against unintentional and malicious data manipulation and the inherent storage redundancy of the cloud resources provides exception protection against data loss.
+For a list of known system issues and limitations please refer to the following.
-==== 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:userguide:userguide#known_application_limitations|Planning App Known Limitations]]
-[[dosimetry:userguide:userguide#known_application_limitations|Dosimetry App Known Limitations]]
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 === Release Notes ===
-For the release notes for each version of the Planning Application, please refer to the [[https://dotdecimal.freshdesk.com/support/discussions/forums/9000203024|.decimal Freshdesk Forum]].
+For the release notes for each version of the Planning Application, please refer to the FIXME we need to come up with where this is.