BITS FR Support
Software Specifications
The BITS Functional Reality Software is currently intended to be used with the following general purpose computing platform which is a commercially available Head-Mounted Display (HMDs) that has been validated as compatible with the software application:
- HTC Vive Focus Vision: Release Version: 2.6
- BITS Functional Reality Software: Version 1.0.0
The BITS Functional Reality Clinician Software is currently intended to be used with the following general purpose computing platform which is an Android Tablet that has been validated as compatible with the software application:
- Android G10 Tablet: Android 14
- BITS Functional Reality Clinician Software: Version 1.0.0
BITS Functional Reality Software and BITS Functional Reality Clinician Software are available on closed general computing platforms: OTS Headset and Tablet. On both OTS hardware device platforms, the internet connectivity and auto-updates have been disabled to prevent inadvertent platform modifications. If any unexpected changes are observed notify Bioness Medical immediately.
If new software releases of OTS hardware are released by the manufacturer, Bioness Medical will complete verification and validation of the changes before release. All updates are reviewed and tested in accordance with FDA regulations to ensure continued safety, effectiveness, and compliance before being released.
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If you have questions or need technical support, contact the Bioness Product Support Department.
Indications for Use: The BITS Functional Reality (BITS FR) is a software-only device designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. BITS FR is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
Full prescribing information can be found in product labeling or at: https://bionessmedical.com/bitsfr/safety-information/
Instructions for Use / Clinician Guides can be made available upon request.
Contact [email protected] or 800-211-9136 to request an electronic copy.
