Certifications and Registrations
US FDA: According to US Food and Drug Administration classification rules, the OnePacs system is a 'Medical Image Communication Device', or a class I medical device. OnePacs satisfies the requirements of the FDA for manufacturers of Class I devices, including Establishment Registration, Device Listing, U.S. Agent and Quality Systems (QS) regulation (21 CFR Part 820).
According to the guidelines stated in Directive 93/42/EEC of the European Community, the OnePacs system is a Class I Medical Device. OnePacs satisfies the requirements for bearing the CE mark on its labeling.
System Requirements
- Operating System: The preferred operating system is Windows 10 64-bit. The 64-bit versions of Windows 7, 8 and 8.1 are also supported.
- Additional software requirements: .NET 4.5 or later, Visual C++ 2010 runtime, Microsoft SQL server compact edition (installed automatically if needed).
- Memory: At least 4 GB RAM. 8 GB or more is recommended.
16GB of RAM or more is recommended if rendering large image sets and/or using third party applications like voice recognition software.
Hard drive space: 50 GB or more free space is recommended. Performance is best with a solid state hard drive (SSD).
Processor: An Intel i3, i5 or i7 processor (or similarly performing AMD processor) is recommended. Older dual core processors such as the Intel Core 2 Duo series will also work, though performance may be decreased. As the OnePacs Workstation and Study Retriever software packages are heavily multi-threaded, at least four processor cores are recommended, and hyperthreading is useful.
Anti-Virus: It is recommended to exclude the OnePacs working directory ("C:\onepacs" or "C:\Program Files\onepacs", by default) from your anti-virus scans.
Virtual Environment
Virtualized environments (such as VMware Fusion or Parallels on macOS) are not recommended or supported configurations for OnePacs Workstation. Per user feedback, OnePacs Workstation performance is inconsistent. If users wish to attempt to run OnePacs Workstation for Windows in virtualization on macOS, VMware version 8+ would likely be the preferred environment. However, OnePacs does not officially support or recommend virtualized environments, and would not be able to offer technical support specific to technical issues that occur with running OnePacs Workstation in virtualization.
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 is being used.
For worklist viewing and report editing, video resolution of at least 1024 x 800 is recommended.
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. BitLocker on Windows or FileVault on macOS).
- It is required to select correct region where OnePacs Workstation 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.
- See the Security Considerations page for other requirements and best practice recommendations on using OnePacs securely.