Instructions for Use

IN THIS ARTICLE

ProKnow DS is a cloud-based RT-PACS (Radiation Therapy Picture/Patient Archiving and Communication System). This article describes how and when you should use ProKnow DS as well as the requirements for using the system within its defined operating conditions.

Indications for Use

ProKnow DS is a patient data archive, information management, and analytics software system with a focus on the data and images specific to radiation oncology patients. Users may upload digital patient data created by other devices to ProKnow DS to securely archive, display, and analyze the data. Users can view and navigate patient images, drawn anatomy, calculated dose, and plan details derived from the source files. Users can create or edit anatomy structures to be used either prospectively (e.g., as an input to treatment planning) or retrospectively (e.g., for data analysis, research, and outcomes studies). Users can extract metrics for any single patient, or across a collection of patients, then view results as tables or graphically. ProKnow DS is to be used as an accessory system to perform data archive, review, and analysis, and is not to be used for diagnosis, treatment, or as the sole form of plan approval.

Users of ProKnow DS should be trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicians. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).

CAUTION: Unites States federal law restricts this device to sale by or on the order of a physician.

Intended Uses

The specific intended uses of ProKnow DS are summarized below:

  1. ProKnow DS provides a scalable and secure data archive for binary digital imaging and communications in medicine (DICOM) data with a focus on radiotherapy (DICOM RT). The input data objects are created by other medical devices and uploaded to ProKnow DS for storage and processing. These input medical devices may include imaging systems, manual and auto-contouring systems, treatment planning systems, and other medical software/devices that output applicable data.
  2. ProKnow DS has an interactive viewer that can be used to display and analyze patient data such as images (e.g., CT and MR), contoured anatomical structures, treatment plan information, calculated radiation dose grids, and dose volume histograms (DVH).
  3. ProKnow DS provides anatomy contouring tools for the purpose of (1) creating new anatomy structure sets (i.e., a set of user-defined anatomy contours) and (2) editing structure sets created by another system and uploaded to ProKnow DS. The users’ new or edited structure sets can be downloaded in the industry standard DICOM RT Structure Set format to serve as an input to other software systems.
  4. ProKnow DS allows the user to create lists of user-defined metrics, and optionally per-metric performance objectives, which can be extracted and viewed per patient dataset. Metrics can be of two types: (1) derived, which are metrics extracted from the input DICOM objects or computed DVH data, and (2) custom, which are user-defined text or numeric fields and their user-supplied values. Tabulated results are displayed and can be used to facilitate and standardize tasks such as plan evaluation and peer review.
  5. ProKnow DS allows the user to define and track “collections” of patient datasets (i.e., cohorts) from which metrics from all patients in the collection can be extracted and analyzed as a population using interactive graphical tools such as histograms and scatterplots.

User Responsibilities

It is the responsibility of those utilizing this application to ensure all that all usages of this product relating to patient treatments are performed by trained and qualified personnel and that such personnel are aware that the quality of any generated patient data is highly dependent on the quality and correctness of the input data. If any questions or uncertainties exist regarding the quality, units, or identification of input data, they must be investigated and resolved before the data are used. It is the user's responsibility to validate the correctness of all patient data within the context of their normal treatment planning workflow. This general liability on the end users should be understood and communicated to all users, and a representative with signatory authority from each organization using ProKnow DS must sign an End User License Agreement on behalf of the organization indicating understanding of the responsibilities for quality, accuracy, and security described herein.

CAUTION: It is critical that all users read these Instructions for Use and the associated support material carefully and completely and consult the provided Online Help and other training materials to ensure proper use of the application and proper interpretation of results.

Additional Instructions for Use

The remainder of the instructions for use are separated into respective sections of the following document.

Support

For questions, comments, support requests, bug reporting, or to schedule a training session, please contact our customer support team at: support@proknow.com. We believe we can provide the most effective assistance via email versus the phone. The main reasons for this are as follows:

  • With email support we can thoroughly investigate an issue before replying without putting you on hold.
  • With email support we are able to join forces with other engineers to get to the bottom of a tricky issue or question. This is much harder with phone support and our 100% remote team.
  • With email support we can easily respond to an email sent outside of our business hours. Following up with voice messages can often become a game of phone tag.
  • With email support we have access to entire threads of conversation that we use to continuously improve our products and services. Generally with phone support, only a limited number of notes are available.

About

ProKnow DS is developed by Elekta.

manufacturer.svg

Elekta, Inc.
1450 Beale Street, Suite 205
St. Charles, Missouri 63303 USA

These Instructions for Use are available in English.

The MD symbol on the About ProKnow DS dialog in the ProKnow DS application indicates that the product is a Medical Device.

Product UDI: (01)00860000358705

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