Indications for Use and Safety Information

Indications for Use

The OnePacs System is an image management system designed to store and transmit DICOM compliant data between locations such as hospitals, imaging centers, and other health care institutions, and interpretation sites. The OnePacs system archives, distributes, retrieves, and displays such data from all standard DICOM modalities. The OnePacs system allows users to store reports and other information associated with such DICOM compliant data. The OnePacs system may be deployed for educational and research use only, or for clinical use/patient care.

Notice for users within the United States:

Safety Information

All users of the OnePacs system who will be involved in the treatment or diagnosis of patients should fully read and understand the OnePacs documentation, including these Safety Instructions. Failure to read and follow these instructions and other OnePacs documentation could result in incorrect usage of the software, which could ultimately affect patient outcome.

Before using any data within the OnePacs system, users should first ascertain whether or not the data presented are complete and correct. For example, it is possible that a study within the OnePacs system has only been partially transmitted from a sending facility, and the DICOM standard provides no inherent means of determining examination completeness. If there is any uncertainly as to whether or not the information available through the OnePacs system is complete and correct, the user must take appropriate steps to ensure that it is before continuing. Such measures may include establishing means for confirming that the correct number of images have transmitted for studies on the OnePacs system, and contacting PACS or other IT administrators to resolve any uncertainties or discrepancies.

Hardware and Software

Please ensure that all hardware utilized meets or exceeds the minimum OnePacs System Requirements, and that all software installations follow the provided installation instructions. Display devices such as monitors must be clinical quality and must undergo regular calibration, maintenance, and any other necessary evaluation at regular intervals. The device should be re-evaluated following any changes being made to the display configuration.

Image archiving

The OnePacs system may be used for archiving DICOM and related patient data. The OnePacs system uses multiple and redundant methods of storing and backing up archived data to minimize the possibility of data loss. Users should however bear in mind that, despite such measures, the possibility for data loss such as due to natural disasters, software error, operator error, and other factors does exist. Users should bear in mind that the possibility of such data loss does exist when planning their integration of the OnePacs system into their care environment. Users may additionally store their own archival copies of their information off-line from the OnePacs system, or engage other data archival services as desired, to achieve their required level of redundancy and data security.

Incorporation into Clinical Systems

Please note that the OnePacs system does not exist in isolation but rather, offers components for the management of DICOM and related data that exist within the context of a health care delivery system. Therefore the data available within and results apparent from data within the OnePacs system are dependent on the integrity and reliability both of upstream and downstream components and manipulations. The fact that data exists within or is presented by the OnePacs system does not confirm that such data were acquired accurately by properly maintained and calibrated imaging modalities, nor that such data have not been subject to upstream or downstream corruption. Users and administrators should engage in rigorous end to end quality control and testing to ensure all components of their health care delivery system are appropriately maintained and correctly functioning.

Exclusions from Diagnostic Use

In this section certain use cases will be discussed for which components of the OnePacs system should not be used for diagnostic purposes. This is not intended to be a complete list of potential scenarios in which a professional user might judge that the OnePacs system is not an appropriate choice for their intended use case. It is up to the user to assess the appropriateness of their entire diagnostic environment for their intended clinical applications, including OnePacs system components. This includes professional judgments made by medical practitioners in the course of providing patient care.

Mammography

The OnePacs system may be used to store, transfer and view mammography images.  Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.  Mammographic images should only be viewed with a monitor approved by FDA for viewing Mammographic images. It is the user’s responsibility to ensure monitor quality, ambient light conditions and that image compression ratios are consistent with clinical application.

Users may also use an approved 3rd party mammography viewing system in association with approved mammography display devices in conjunction with the OnePacs system for interpreting mammographic studies.

Lossy Compressed Images

Lossy compressed images displayed by the software will show the text "*LOSSY*" in yellow on the text overlay region. Images may be compressed in an irreversible (lossy) format either at the acquiring modality, or by components of the information pipeline through which studies travel, including local PACS systems or the OnePacs Gateway.

According to US FDA guidelines, the determination as to whether images are diagnostically adequate for interpretation is up to the professional judgment of the interpreting physician, including whether or not any degree of lossy compression is appropriate (excepting mammographic images, for which only lossless compression may be used). The OnePacs system by default transmits Mammography and Conventional Radiograph images in lossless format, and other images at a conservative 1:8 level of lossless compression. At this level of compression, it is generally accepted that there is no perceptible change in image quality attributable to lossy versus lossless-compressed images. However, individual users of the OnePacs system may adjust compression parameters to suit their professional preferences and opinion, including utilizing only lossless compression if preferred.

Enhanced Multiframe MR/CT Images

OnePacs viewers should not be used for primary diagnosis on Enhanced Multiframe MR and CT images. While such images can be displayed, certain information presented by the software will be incomplete, such as per-frame data in multi-frame functional groups, or text overlay information.

Modality Calibration

Measurements performed on images in the OnePacs system are calculated according to calibration data provided by the acquisition modalities. If a there is uncertainly as to whether a modality has been calibrated correctly or maintained properly with appropriate quality control measures, neither the images it produces nor measurements derived from those images should be used for diagnostic purposes. Note that size measurements for projectional modalities such as mammography and computed radiography are generally obtained at the detector plane and additionally may be subject to correction based on assumptions regarding the depth of the anatomy of interest and/or fiducial markers, and may differ significantly from actual anatomic measurements of regions of interest. Calibration of images for other modalities is a complex process performed by the modalities based on factors such as the size of detector elements or fiducial markers. Users should be aware of the calibration methods used for images they interpret and ensure that such calibration methods have been appropriately employed before using measurements for diagnostic purposes.

Manually Calibrated Images

Components of the OnePacs system may be configured to use custom pixel sizing, that is, manual size measurement calibration. Such manual calibrations are subject to a degree of intrinsic inaccuracy and operator error. The reported values thus should be interpreted bearing in mind a large degree of intrinsic inaccuracy and imprecision, and should not be used for applications where precise measurements are needed. Additionally, values such as Region of Interest (ROI) measurements may have dependencies on pixel size, and users must bear in mind similar limitations when using ROIs created on manually calibrated images. Within a given series or display set, each image requires individual calibration. Manually calibrated values are not stored permanently either on the user's individual Workstation or within the OnePacs system. If manually calibrated values are to be used, they must be individually generated within each session.

Nuclear Medicine/PET

Components of the OnePacs system are capable of storing and transmitting nuclear medicine images, though certain tools such as Standard Uptake Value (SUV) measurements, Image Fusion, and maximum or minimum intensity projections, may not be available. The professional judgment of the interpreting physician must be used in determining whether the facilities available in the OnePacs system are sufficient for their diagnostic needs. Users may of course utilize alternative DICOM viewers with specialized functionality for Nuclear Medicine/PET to take advantage of such advanced imaging tools as needed.

Key Images

The OnePacs system may be used to produce "key images" to summarize examination findings for communication or presentation, which may include hard-coded annotations and measurements. These are not intended for primary diagnosis and are created subject to potential operator error. For diagnostic purposes, only the original images should be reviewed and all analysis or measurement required for diagnosis should be based solely on the original source images.

Image Storage and Retrieval Functionality

The OnePacs system contains components designed for the transmission and storage of DICOM images. Users should always bear in mind that operations to store images or transmit images over networks are subject to potential failure. The success or failure of any storage or transmission operation upon which patient care diagnosis or treatment decisions will depend should be confirmed by the user prior to utilization of the data.

DICOM Query/Retrieve

The DICOM standard does not provide an inherent means of determining when an examination is complete, that is, whether or not all images for a particular study are present or have been received. Therefore, when a study is sent to the OnePacs system from a PACS or modality, or retrieved to a viewer from the OnePacs system, neither the OnePacs system nor the viewer have the capability of informing the user whether or not the study is complete. Users should coordinate study transmission activities and confirmation of success or failure of transmissions accordingly.

When a user relies upon the transmission or retrieval of data between a DICOM device and a OnePacs system component, the user should check for appropriate success or error messages to ensure successful operation completion. In the OnePacs study retriever, the retrieval status for both automatically initiated as well as manually initiated transfers will indicate whether or not all images were retriever from the server, as well as whether or not all images were successfully stored to the user's chosen viewer. The OnePacs Workstation for Windows contains an "Import Activity Monitor" which sorts images into the categories of "Received", "Failed", and "Available".  Only images in the "Available" status are available for review.

Study Files

It is possible to attach PDF documents or other files to studies within the OnePacs system. Please note that patient safety or confidentiality could be at risk if a document is attached to the incorrect study. The OnePacs system can not evaluate the appropriateness of any documents or other attachments made to any particular case. If it turns out that an incorrect attachment has been made to particular study, please contact your local PACS administrator to ensure that all copies of any such incorrect data have been purged.

Prior/Additional Studies

When reviewing a given study for a given patient through the OnePacs system, there may exist, both within the OnePacs system, and external to the OnePacs system, one or more additional studies for the patient in question which may be useful to refer to in the course of interpreting the current examination. The OnePacs system will list to the user in the worklist interface those studies which appear to be matching studies for the patient in question based on demographic criteria, namely, patient ID, issuer of patient ID, last name, and date of birth. If some but not all of these data match, the system will flag the study as a "possible prior examination." In such a case, the user must review the details of the study to determine whether or not it is in fact an additional study for the patient in question.

Users should bear in mind that not all additional or prior studies available for a patient may necessarily have been loaded into the OnePacs system, and if such studies have been entered into OnePacs, operator error such as mistakes in medical record number entry at the modality could result in the studies not being recognized as alternative/prior studies within OnePacs. Users should be aware of the history of any patient being treated and should use all available resources to ensure that all required studies or other information are available and complete.

Advanced Viewer Functions

Advanced visualizations funtions such as Multi-planar Reconstructions (MPR), Volume Rendering, and other derived images are available in components of the OnePacs system in certain regulatory regions. For non-clinical use, or in appropriate regulatory regions, derived images may be created and reviewed within the OnePacs system, such as Multiplanar Reconstructed images (MPR), Volume Rendered images (VR), and other image types. These derived image types involve displaying the source data not in the originally acquired form, but in ways more accessible to human visual interpretation, and may involve rounding errors, volume averaging artifacts, and other sources of error. Such images should be used only as tools accompanying the original source data for interpretation.