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Indications for Use

The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

Caution: The OnePacs system as deployed for clinical use is a registered/licensed medical device. Educational and Research versions of the OnePacs system are neither intended nor licensed for clinical use, and should only be used as permitted by applicable and governing regulations.

Notice for users within the United States:

Caution: The OnePacs system as deployed for clinical use is For Prescription Use Only (US Regulation 21 CFR 801.109). Federal law restricts this device to sale by or on the order of a physician.


OnePacs Workstation for macOS is a software device intended for the viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. 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.

Introduction

The goal of OnePacs Workstation for macOS is to deliver the best possible viewer for images produced by radiology equipment. Its key features are displaying, reviewing, interpreting and post-processing images. OnePacs Workstation for macOS is an image processing software primarily dedicated to DICOM images.

OnePacs Workstation for macOS is based on Horos, which is based on OsiriXOsiriX was originally an open-source project, distributed under the LGPL license. However, the project has recently evolved into a closed-source format. This has given other communities the opportunity to inherit the original project with its original philosophy, thus creating the Horos project. OnePacs Workstation for macOS is a declination of Horos that specializes it for usage with the other OnePacs components.

OnePacs Workstation for macOS fully supports the DICOM standard for an easy integration in your workflow environment. It offers advanced post-processing techniques in 2D and 3D, and offers a complete integration with any PACS. OnePacs Workstation for macOS supports 64-bit computing and multithreading for the best performances on the most modern processors.

User documentation pages are available for the following subjects:

 

System Requirements

  • OnePacs Workstation for macOS can only be installed on an Apple computer running macOS version 10.11 (El Capitan) or newer. It cannot be installed on a Windows or Linux based PC. A configuration including at least 8 GB of RAM, a solid state drive and an Intel Core i7 processor is recommended, but you should be able to use OnePacs Workstation for macOS with more basic configurations. We also recommend that you use macOS version 10.13 (High Sierra).
  • Anti-Virus: It is recommended to exclude OnePacs Workstation for macOS from your anti-virus scans.

Other Requirements

  • For diagnostic image viewing, appropriate diagnostic-quality and regulation-compliant monitors should be used. For accuracy, it is recommended that screen configurations are periodically checked on all monitors where OnePacs Workstation for macOS is being used.
  • The OnePacs license agreement requires physical access restrictions limiting physical access to the workstation to authorized personnel with a legitimate need to access the equipment and/or the use of whole hard disk encryption (e.g. FileVault on macOS).
  • It is required to select correct region where OnePacs Workstation for macOS is being used due to local regulations.
  • All users should read/understand OnePacs Workstation User's Manual and take proper training prior to using OnePacs Workstation for macOS.
  • See the Security Considerations page for other requirements and best practice recommendations on using OnePacs securely.

Troubleshooting

Should you encounter any issues with the use of OnePacs Workstation for macOS, please feel free to use any of the usual contact methods for reaching OnePacs support. We offer free and open public forums for generic discussion and troubleshooting, and direct contact with support personnel is available to subscribers of OnePacs according to terms established with each subscribing group. Please contact your radiology group's technical support personnel for further details. 

Reporting a Problem

OnePacs fully tests each release of OnePacs Workstation for macOS, but some problems can remain unknown, only discovered within a specific situation or when connected to another software environment. When problems occur with OnePacs Workstation for macOS, users should communicate them to OnePacs, allowing us to correct these problems within a short timeframe and to let other users know about them, if necessary. Each problem will be evaluated to determine how serious it is and a workaround or a patch will be provided.

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