BITS FR Safety Information

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.

Warnings

• If a client complains of motion sickness, dizziness, headache, eye strain, or fatigue when using the device, stop use of device immediately.
• Patients may experience discomfort (e.g., visual strain, dizziness, nausea) during use of the device. At the discretion of the clinician, to reduce the risk of adverse effects, patients should be instructed to limit initial exposure duration and gradually increase session length as tolerated.
• Some patients may acclimate more effectively when initiating therapy with passthrough experiences prior to engagement in fully immersive environments.
• The time required for individual patients to acclimate to and obtain therapeutic benefit from extended reality (XR) interventions may vary. Clinicians should monitor patient response and adjust exposure parameters accordingly.
• For further information regarding regulatory considerations for augmented reality and virtual reality medical devices, refer to FDA guidance:
  https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-realityand-virtual-reality-medical-devices-questions-consider.
• Users of the system should exercise caution to prevent tripping hazards during therapy.
• The BITS FR system software programs utilize moving and rotating graphics that may cause dizziness, vertigo, or nausea in sensitive clients.
• Do not use unapproved devices with the BITS FR software system.
• Do not use unapproved accessories with the BITS FR software system.
• Refer to HTC Vive Focus Vision User Manual included with the Headset for warnings/precautions related to the Headset.
• Refer to Android G10 Tablet User Manual included with the Tablet for warnings/precautions related to the Tablet.=

Precautions

• Ensure a safe environment for the client while performing activities with the device (i.e. remove any surrounding obstacles and ensure that the client is unlikely to trip or fall).
• Ensure a medical professional is with the client at all times to prevent any injury.
• Improper shut-down of the BITS FR software may result in the loss of client data. Please follow proper instructions for the shutdown process.
• BITS FR software system is not intended to act as a diagnostic device and does not identify the presence or absence of clinical diagnoses.
• Do not attempt to modify the BITS FR software system (e.g., by installing or uninstalling software or changing system settings). Unauthorized modifications may compromise system security and increase the risk of cybersecurity threats.
• Do not connect the BITS FR software system to the internet or local intranet. Network access may expose the system to cybersecurity threats and is not required for normal operation.
• Make sure to follow the correct procedures from OTS Headset manufacturer when donning, doffing and calibrating the OTS Headset.
• System should only be used in a stationary environment (seated or standing).
• Be aware of the client’s limitations in range of motion and avoid program use that could lead to excessive gestures that could injure a client.
• Supervision and assistance for the client should be provided during use of the BITS FR software system.
• Keep area around the user clear of other objects.
• For clients with limited mobility, exercise precaution and remain within a safe distance when client is performing activities.
• Do not use any tool or object that could damage the system or pose a safety risk when operating the BITS FR software.
• Prolonged use of the BITS FR Software, OTS headset and OTS controllers can cause discomfort, eye fatigue, or strain.
• Disposable Face Masks provided are single use only and should not be transferred between clients.
• Do not use any chemical solvents that are acidic or alkaline cleaning agents. Follow manufacturer guidelines for cleaning procedures.
• Always exercise universal precautions and wear gloves when cleaning any component of the system.
• Only use OTS hardware that is compatible with BITS FR Software System (See Chapter 17 in the BITS FR Clinician’s Guide for more information).

Potential Adverse Events

Visual stimulation through head-mounted displays has a small possibility of provoking an adverse reaction. Possible complications include, but are not limited to, the following:

• Claustrophobia
• Discomfort or pain in the head or eyes
• Disorientation/vertigo/dizziness
• Drowsiness
• Eye strain
• Falls or fractures
• Headache/migraine
• Insomnia
• Light-headedness
• Motion sickness
• Nausea
• Pain
• Seizure
• Repetitive strain injury
• Vision problems

Should any of the above occur, stop using the device immediately. At the discretion of the clinician, to reduce the risk of adverse effects, patients should be instructed to limit initial exposure duration and gradually increase session length as tolerated.

Some patients may acclimate more effectively when initiating therapy with passthrough experiences prior to engagement in fully immersive environments.

The time required for individual patients to acclimate to and obtain therapeutic benefit from extended reality (XR) interventions may vary. Clinicians should monitor patient response and adjust exposure parameters accordingly.

For further information regarding regulatory considerations for augmented reality and virtual reality medical devices, refer to FDA guidance:
https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices-questions-consider.