decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/09/03 21:07] – [System Availability and Data Integrity] kmobile | decimal3d:instructions_for_use:instructions_for_use [2019/09/13 01:38] – [Known Limitations] 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 ===== | ===== Clinical Safety ===== | ||
- | It is the responsibility that the user performs end-to-end testing prior to the clinical | + | It is the responsibility that the user performs end-to-end testing prior to the clinical |
- | 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 | + | 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 |
- | + | ||
- | 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 ==== | ==== 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. These off-the-shelf hardware components are covered by manufacture warranties, which can be extended |
+ | |||
+ | It should be noted however, that decimal3D nor its host iPad should be used as the sole location to store critical patient treatment record information. As a mobile device, iPads can be prone to potential loss or damage. Once an order has been placed however, .decimal securely stores the treatment device information on its servers for the time period required by the US FDA and users may request this information, | ||
==== Coordinates and Units of Measure ==== | ==== Coordinates and Units of Measure ==== | ||
- | FIXME- should we delete this for the first go round? | + | The following is a list of several important items that users should understand |
- | + | ||
- | ==== Data Validation and Limits ==== | + | |
- | + | ||
- | Users are responsible for inputting | + | |
- | + | ||
- | ==== Data Displays and Interpretation ==== | + | |
- | + | ||
- | decimal3D contains many displays throughout the scanning, digitizing and beam placement process. Please refer to FIXME. | + | |
- | + | ||
- | ==== Unauthorized Use ==== | + | |
- | The Astroid Planning Application will contain sensitive patient information that is protected under various governmental regulations, | + | * All linear dimensions are shown in millimeters (mm) |
+ | * All angular dimensions are shown in degrees (deg) | ||
+ | * All date/time values are provided in a // mm/dd/yyyy h:m:s am/pm // format using local time | ||
+ | * All date and time information should match current iOS date and time, including proper use of daylight savings time where appropriate | ||
- | ==== Access Control ==== | ||
- | Astroid (Thinknode) administrators have the ability to manage user access, passwords, and " | + | ==== Data Validation ==== |
- | As Astroid is a cloud based application the site administrator will be responsible for the installation | + | Users are responsible for confirming |
- | For further information on access management | + | ==== Unauthorized Use and Access Control ==== |
- | ==== Known Limitations ==== | + | decimal3D will contain sensitive patient information that is protected under various governmental regulations, |
- | For a list of known system issues and limitations please refer to the following articles for the Planning App and Dosimetry App, respectively. | + | ==== System Calibration ==== |
- | [[planning: | + | The decimal3D application relies on both the Structure Sensor and built-in iPad color camera. Proper operation of the decimal3D |
+ | ===== Known Limitations | ||
- | [[dosimetry: | + | Below are listed the known application limitations, |
+ | - Treatment position information (e.g. isocenter, gantry angle, couch angle, collimator angle) is not available at this time as there is no sufficient link between the scanner coordinate and treatment machine coordinate systems | ||
+ | - Site information including Machine and Address Settings cannot be edited from decimal3D (these can be edited using .decimal' | ||
+ | - User passwords cannot be changed within the decimal3D App (please log in to direct.dotdecimal.com to change your password or contact .decimal customer service to request a password reset) | ||
+ | - Patient Databases are stored locally on each iPad, so facilities with more than one iPad will not be able to access all patient records from each iPad (note: once an Order is place however, the order information is available via direct.dotdecimal.com, | ||
+ | - Once a scan has been created its name cannot be edited (scan names are for convenience only and are used elsewhere in the application) | ||
+ | - Once a beam has been created its name cannot be edited (beam names are used within the cutout engraving, therefore if an appropriate name was used, we recommend that you create a new beam with the desired name, using the same parameters, and then delete the wrongly named beam) | ||
- | === 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