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.
- Dedicated hardware. The system used to view diagnostic images using OnePacs workstation should be devoted exclusively to this task. Other supporting software packages such as voice recognition systems can be installed, but the installation of software for other purposes is discouraged and could lead to conflicts with the OnePacs Desktop software.
- Operating System: OPW requires Windows Professional 10 64-bit.
Hard drive space: 100 GB or more free space is recommended. OnePacs Workstation is designed for use with a solid state hard drive (SSD). Performance will be degraded with spinning hard-drives.
- Memory: 16 GB or more of physical RAM is recommended. At least 8 GB is required.
Processor: A high-end modern CPU is recommended. As a general guide, a processor from the mid- to top of the list of high-end CPUs on the following website could be selected: https://www.cpubenchmark.net/high_end_cpus.html
As the OnePacs Workstation and Study Retriever software packages are heavily multi-threaded, at least four processor cores are recommended, and hyperthreading is useful.
- Bandwidth: Minimum bandwidth of 5mbps. 10 mbps or greater is recommended.
Anti-Virus: It is recommended to exclude the OnePacs working directory (C:\Program Files\onepacs by default) from your anti-virus scans.
Virtual EnvironmentVirtualized 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 Fusion version 10+ 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.
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 1680 x 1050 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.
- Installation Guide
- Accessing Studies
- Image Compression
- Workstation Troubleshooting Guide
- Multiple Monitor Usage