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--- decimal3d:instructions_for_use:instructions_for_use [2019/09/03 21:40] – [Release Notes] kmobile
+++ decimal3d:instructions_for_use:instructions_for_use [2019/09/04 12:44] – kerhart
@@ Line 1: / Line 1: @@
 ====== decimal3D Instructions for Use ======
-===== Overview and Indications for Use =====
+===== Overview, Indications for Use, and Intended 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, which will be treated 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 =====
-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.
+It is the user's responsibility to test each device ordered through decimal3D for proper function, fit, and clinical acceptability **__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.
 ===== 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.
+It is the responsibility that the user performs end-to-end testing prior to the clinical use of decimal3D. The user should follow accepted industry guideline and clinical experience for the end-to-end testing. This testing should be performed by qualified personnel and should ensure (at a minimum) that users are able to scan, digitize, and order an electron block that meets or exceeds the clinical accuracy as compared to the clinic's current process for clinical electron set ups.
-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 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 and experience to properly use the application.
-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 ====
-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 and proper interpretation of results.
+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%>
-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>
 <wrap em>Caution: Federal law restricts this device to sale by or on the order of a physician.</wrap>
-===== Intended Use =====
-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 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.
+The decimal3D App should be used under the guidance of a physician by authorized users such as physicists, certified medical dosimetrists, radiation therapists, and other licensed clinical staff who have been trained by the .decimal staff or by the clinical staff.
 ===== Product Features =====
-decimal3D will handle patient data entry. The user will be able to take a three dimensional scan of the area where the physician has outlined the area to be treated. This scan will be in full color and dimensonally accurate. From this the user can digitize the treatment area, design the electron aperture as well as place the beam. The decimal3D App also allows the user to order the aperture through and interface with the decimal Direct API.
+decimal3D is a medical software accessed on an iPad and managed through the Apple App Store®. decimal3D allows users to enter standard patient information, capture a three dimensional scan of the physician drawn treatment area, digitize the exact shape of the treatment field, and place a beam to complete the design of a patient-specific electron aperture. The decimal3D App also allows the user to order the aperture for fabrication and deliver by .decimal.
 ==== System Availability and Data Integrity ====
-FIXME - We need to discuss this
+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 ====