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US FDA: According to US Food and Drug Administrat= ion classification rules, the OnePacs system is a 'Medical Image Communicat= ion Device', or a class I medical device. OnePacs satisfies the requirement= s of the FDA for manufacturers of Class I devices, including Establishment = Registration, Device Listing, U.S. Agent and Quality Systems (QS) regulatio= n (21 CFR Part 820).
The OnePacs system is cleared for medical use in = Brazil under the ANVISA program.
Hard drive space: 100 GB or more free space is recommended. OnePacs Workstation is designed for use with a solid state h= ard drive (SSD). Performance will be degraded with spinning hard-drives.
Processor: A high-end modern CPU is recommended. As a general guide, a p= rocessor from the mid- to top of the list of high-end CPUs on the following= website could be selected: https://w= ww.cpubenchmark.net/high_end_cpus.html
As the OnePacs Workstation and Study Retriever= software packages are heavily multithreaded, performance will benefit from= the presence of multiple cores.
Anti-Virus: It is recommended to exclude the OnePacs<=
/span> working directory (C:\Program Files\onepacs by default) from your an=
tivirus scans.
Virtual Environment
For diagnostic image viewing, appropriate diagnostic-quality and reg= ulation-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 leas= t 1680 x 1050 is recommended.
The OnePacs license agreement require= s 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 File= Vault on macOS).
Note regarding derived/calculated images
Derived images, such as those resulting from multiplanar reformat (MPR) = tool or the "sharpen" tool, are based on calculations extrapolated from the= original imaging data. Accordingly they should be interpreted only in asso= ciation with and along with the source images.