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--- decimal3d:instructions_for_use:instructions_for_use [2019/09/03 19:42] – [Clinical Safety] kmobile
+++ decimal3d:instructions_for_use:instructions_for_use [2023/04/17 16:34] (current) – [Known Limitations] 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 radiation therapy beam-shaping block devices through the use of optical scanning technology. This device will serve as a direct replacement to the current processes for designing such radiotherapy devices in cases where a “clinical patient set up” is used (i.e. cases where the treatment field is determined by direct physician examination, not by internal imaging technology). 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 of the user to perform 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 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 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 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.
 ===== 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 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 =====
-In the most common, primary 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 via Thinknode®), user interface controls, and visualization tools.
+decimal3D is a medical software accessed on an iPad and managed through the Apple App Store® (users must create an account with Apple to manage their iPad software installations). 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 delivery by .decimal. Ordered Treatment Devices can also be exported to R&V and other software systems via the built in DICOM file sender. Additional patient data, such as Patient Setup photos, can be exported via the patient's profile screen.
- The Astroid Planning App software communicates with other treatment planning systems generally by sending & receiving files in various DICOM RT formats, although the extensive Application Programming Interface (API) of Thinknode® allows users to easily build their own export and import conversion applications. 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. It is this area that provides opportunity for the most likely incorrect use of the software, which would be poor or inadequate commissioning of the application (note many other cases of potential misuse have be designed out of the system by limiting allowed user interactions, providing warnings, and preventing unsafe or incompatible operations). This main misuse is mitigated by requiring that users understand that it is their responsibility to perform appropriate quality assurance measurements for every patient plan prior to treatment, which should independently confirm that the treatment plan information displayed within the Astroid Planning App adequately matches the actual, to be delivered, plan. Please note that such testing is a safety and regulatory requirement in most territories.
+{{page>decimal3d:userguide:userguide#application_features}}
 ==== System Availability and Data Integrity ====
-As with any cloud based application there is always concern with system availability and uptime. Astroid makes use of caching at various system levels to improve performance and mitigate some of these concerns, however, this can never provide 100% assurance and reliability. Since customer has unique needs, specific business agreements will be entered into with each customer as appropriate to detail the reliability guarantees and assurances. Data integrity is generally a less variable concern, as Astroid's cloud storage providers strong guarantee the highest commercially available data redundancy and integrity limits (approaching 99.999999% per year). Data is transferred to and from the cloud services using secure transfer protocols, that guarantee error-free of transfer using common industry standard techniques (for more details please see the [[https://developers.thinknode.com/guides/ipc|Thinknode IPC article]]). While Astroid has been designed with security in mind, users should understand that it is still their responsibility to ensure the system is accessed and controlled properly. Following international standards for IT risk management, such as IEC 80001-1, is therefore highly recommended.
+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 to ensure continuous support and service for all components of the decimal3D system. All system data is stored locally on the iPad using secure encryption technology. As this application stores patient protected 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 the iPad data can be locked, deleted, and recovered in the event an iPad is lost or stolen.
-Since data integrity is such a critical feature for application such as this, the Astroid Planning App automatically saves both the state of the application and the working record data on a timer (triggering every minute or less) as well as on exit of any create or edit event in the application. Additionally, each "save" event creates a new entry in the record's history log in Thinknode, which provides a log file for editing of all records and a ensures that patient records are saved securely on an independent medium so they are not lost in the event of a local system failure or crash.
+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, if necessary, in the event of local data loss. As such, users should take care to digitize and place orders in a timely fashion and transfer ordered treatment device data from decimal3D to the appropriate patient record database via our DICOM export feature on a regular basis.
 ==== Coordinates and Units of Measure ====
-The following is a list of several important items that users should understand in regards to the information displays in the Astroid Planning Application:
+The following is a list of several important items that users should understand in regards to the information displays in the decimal3D Application:
-  * The Astroid Planning exclusively uses DICOM coordinate systems for display information (machine based coordinates are NOT available)
+  * All linear dimensions are shown in centimeters (cm)
-  * All linear dimensions are shown in millimeters (mm)
   * All angular dimensions are shown in degrees (deg)
-  * All radiation dose quantities will be shown with their corresponding units within the application (e.g. Gy(RBE) or %)
+  * All date/time values are provided in a // mm/dd/yyyy h:m:s am/pm // format using local time
-  * All date/time values are provided in a // dd/mm/yyyy h:m:s // format using local time on a 24 hour clock
+  * 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)
-  * All date and time notifications in Astroid should match current Windows OS date and time, including proper use of daylight savings time where appropriate (note: Astroid will display in 24 hour format, while Windows may display in am/pm depending on local settings)
-==== Data Validation and Limits ====
-Users are responsible for inputting a lot of data into the Astroid Planning App to develop clinical treatment plans. In the course of entering such data, there are opportunities for users to enter incorrect information. Although users are responsible for checking for such errors before clinical treatment, Astroid does provide some assistance in ensuring data limitations are met by a plan. Machine energy (range) limits, gantry angles, patient support (couch) angles, snout extensions, as well as shifter and aperture sizes and availability are all explicitly limited to user configured levels within the Astroid Planning App controls. Additionally, certain incompatible settings, such as zero thickness rinds and overlapping structure min/max constraints are also explicitly prevented within the Astroid user interface. Despite these many data validation checks, some entries, such as min/max spot MU's are not validated within the Astroid user interface and users should include appropriate checks and warnings in their custom treatment plan reports to ensure such concerns are brought to the attention of all responsible parties before patient treatment begins. Such warnings should include a statement such as this (or similar): "CAUTION: SOME DATA ELEMENTS USED WERE OUTSIDE NORMAL RANGE".
-==== Data Displays and Interpretation ====
-Astroid contains many displays throughout the plan creation process. Please refer to [[http://apps.dotdecimal.com/doku.php?id=planning:userguide:tutorials:all_tutorials#astroid_optimization|the Astroid Tutorials]].
+==== Data Validation ====
-==== Unauthorized Use ====
+Users are responsible for confirming the accuracy of machine data using decimal's p.d App. This data will be used in decimal3D for determining available electron applicator sizes and tray locations. Users should complete a site survey found at [[https://dotdecimal.com/site-survey/]] if they do not have an account with .decimal. .decimal staff will aid users in setting up machines.
-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.
+==== Unauthorized Use and Access Control ====
-==== Access Control ====
+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. Please note that in addition to the iPad passcode or biometric access protections, decimal3D requires a separate user-specific login to ensure that all PHI is protected by non-shared access account credentials.
-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]]).
+==== System Calibration ====
-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.
+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's calibration.
-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.
+==== 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 and limitations please refer to the following articles for the Planning App and Dosimetry App, respectively.
+Additionally, Patient Setup photos may be taken, managed and exported via any patient detail screen. The gallery of images can be saved to external devices (ex: SD cards) using the Files application available on all iPads and a Lightning to SD Card or USB-C to SD Card adapter (for iPad pro devices).
-[[planning:userguide:userguide#known_application_limitations|Planning App Known Limitations]]
+In both cases, caution should be taken that proper destinations are selected to protect patient data.
-[[dosimetry:userguide:userguide#known_application_limitations|Dosimetry App Known Limitations]]
+===== Known Limitations =====
+Below are listed the known application limitations, defects, or inconsistencies.
+  - Site information including Machine and Address Settings cannot be edited from decimal3D (these can be edited using .decimal's p.d software available on Windows computers)
+  - 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, which can be accessed from any device or computer)
+  - 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).
+  - Scanners may lose connectivity to the iPad, giving a message stating "please connect structure sensor", even though the sensor is plugged in. Following the scanner manufacturers troubleshooting guide can help to resolve the issue: [[https://support.structure.io/article/409-why-does-my-new-mark-ii-or-structure-sensor-pro-say-please-connect-structure-sensor-it-is-connected|Structure Mark II Connectivity Help]]
-=== 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 decimal3D Application, please refer to [[decimal3d:app_versions|decimal3D Version History]].
 ----
-<WRAP center 60%>.decimal LLC, 121 Central Park Place Sanford, FL. 32771 1-800-255-1613</WRAP>
+<WRAP center 60%>.decimal LLC, 121 Central Park Place, Sanford, FL 32771. 1-800-255-1613</WRAP>