decimal3d:instructions_for_use:instructions_for_use
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decimal3d:instructions_for_use:instructions_for_use [2019/09/03 21:35] – [Access Control] kmobile | decimal3d:instructions_for_use:instructions_for_use [2021/08/19 12:48] – [Known Limitations] dpatenaude | ||
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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 | + | It is the responsibility |
- | 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 |
+ | |||
+ | {{page> | ||
==== 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 Mark II 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- | + | The following is a list of several important items that users should |
+ | |||
+ | * All linear dimensions are shown in centimeters (cm) | ||
+ | * 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 (note: decimal3D will display in am/pm format, while iOS may display in 24 hr format depending on local settings) | ||
==== Data Validation ==== | ==== Data Validation ==== | ||
- | Users are responsible for confirming machine data input into decimal' | + | Users are responsible for confirming |
- | ==== Data Displays and Interpretation ==== | + | |
- | decimal3D contains many displays throughout the scanning, digitizing | + | ==== Unauthorized Use and Access Control ==== |
- | ==== Unauthorized Use ==== | + | decimal3D will contain sensitive patient information that is protected under various governmental regulations, |
- | The decimal3D will contain sensitive patient information that is protected under various governmental regulations, | + | ==== System Calibration ==== |
- | ==== Access Control ==== | + | The decimal3D application relies on both the Structure Sensor Mark II and built-in iPad color camera. Proper operation of the decimal3D App requires that these two components be properly calibrated to ensure accurate alignment of scanned image colorization. A calibrator app has been provided with your iPad and the system is shipped pre-calibrated. However, part of the regular maintenance of the decimal3D application is for users to verify and adjust the calibration every 6 months OR anytime the Mark II Sensor is removed from the iPad OR anytime the system is subjected to an impact (e.g. fall or drop) that may have jarred or shifted the Sensor. The calibration procedure is simple and the provided calibrator app walks users through adjusting and testing the system' |
- | FIXME - this can be deleted? | + | ==== Patient Data Export ==== |
- | ==== Known Limitations ==== | + | The decimal3D application provides multiple ways to export patient data for other systems. Ordered treatment devices may be exported to R&V as well as other external software using the DICOM share functionality on a selected scan. This functionality requires a hostname and port to be provided in the Advanced Settings screen of the application. |
- | For a list of known system issues | + | Additionally, |
- | [[planning: | + | In both cases, caution should be taken that proper destinations are selected to protect patient data. |
- | [[dosimetry: | + | ===== Known Limitations |
+ | Below are listed the known application limitations, | ||
+ | - 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, | ||
+ | - Scans are able to be deleted even if they contain contours and beams, so care should be exercised whenever deleting scans as all data associated with that scan will also be deleted | ||
+ | - Very bright indoor lighting can interfere with scanning, especially on dark or shiny surfaces; if you experience difficulty with the scanner recognizing a surface, try scanning in a lower light condition | ||
+ | - Long term application use without an application restart can produce errors where scans fail to render in the display; the app should be closed fully and restarted to correct the issue | ||
+ | - Any unsaved changes will be lost if the application logs out the user due to 10 minutes of inactivity (however, changes may appear saved if the application is not fully restarted). | ||
+ | - Existing patients created in older versions of the application may not show patient name in all UI fields (data is not lost, but is not visible on all screens). | ||
- | === Release Notes === | ||
- | For the release notes for each version of the Planning | + | For the release notes for each version of the decimal3D |
---- | ---- | ||
- | <WRAP center 60%> | + | <WRAP center 60%> |
decimal3d/instructions_for_use/instructions_for_use.txt · Last modified: 2023/04/17 16:34 by kerhart