Safety Information

Indications for Use

The Bioness Integrated Therapy System (BITS) is intended to challenge and assess the physical, visual, auditory, and cognitive abilities of individuals, including those with deficits resulting from traumatic injuries and movement disorders as well as competitive athletes.

Examples of these abilities include:

• Visuomotor Coordination
• Reaction Time
• Visuospatial Perception
• Visual & Auditory Processing
• Working Memory
• Physical & Cognitive Endurance
• Balance Control
• Postural Stability

Precautions

• Unauthorized modifications to the Bioness Integrated Therapy System, such as installing or uninstalling software, will void the warranty.
• Accessing the internet or local intranet with the Bioness Integrated Therapy System will void the warranty.
• Do not alter the Windows 10 Operating System settings by adding Windows user accounts or adjusting the screen saver and sleep timer as this may interfere with the functioning of the software.
• Contact Bioness Product Support Department if any component of the system is malfunctioning. Attempts to modify the hardware will void the warranty.
• Make sure to follow the correct procedures when moving the portable stand, adjusting the height of the display screen, moving or adjusting the Balance Platform, using or storing the Sensor and using or storing the Chest Strap.
• Supervision and assistance for the patient should be provided during use of the Balance Platform.
• Ensure Balance Platform is on level ground prior to instructing clients to step on Platform.
• Keep area around the Balance Platform clear of other objects. Do not stack objects on the Balance Platform.
• Keep Balance Platform at a safe distance from portable stand and display screen when in use.
• Utilize Stabilizing Blocks to assist clients in getting on and off the Balance Platform.
• For clients with limited mobility, exercise precaution and remain within a safe distance when client is performing balance exercises.
• Always lock the wheel casters on the stand when the system is in a stationary position.
• Ensure the wheels on the portable stand are in the locked position before starting a therapy session with a client. Do not unlock wheel casters during therapy.
• Supervision should be provided during use of the system.
• Clients should not use an object that may damage, or is unsafe when interacting with the touchscreen.
• Use caution with clients diagnosed with, or suspected to have, epilepsy.
• Adhesive Patches provided are single use only and should not be transferred between patients.
• Do not use any chemical solvents that are acidic or alkaline cleaning agents.
• Always exercise universal precautions and wear gloves when cleaning any component of the system.

Warnings

• Do not move the Bioness Integrated Therapy System over obstacles on the floor or over uneven or soft surfaces. Doing so could cause the equipment to fall causing damage and/or injury.
• Ensure Sensors are charged prior to performing Balance Therapy.
• Do not charge the Sensors while it is in use by client or user.
• Sensors must be charged using the charging block and cable provided by Bioness.
• Do not use the Bioness Integrated Therapy System near strong electromagnetic fields (e.g. MRI).
• To avoid the potential of electrical shock do not use the Bioness Integrated Therapy System near water.
• Users of the Bioness Integrated Therapy System should exercise caution to prevent tripping hazards during the course of therapy. Sources of such tripping hazards include power cables and the legs of the Portable Stand. Please note that some additional falling hazards may result from use of the larger touchscreen display monitor, as clients may be required to stretch farther to complete exercises.
• Stored Energy Hazard: The lift mechanism in the Stand Tower is under tension and will move rapidly, on its own, as soon as attached equipment is removed. For this reason, do not remove equipment or make adjustments to lift tension unless the touchscreen display monitor has been moved to the highest position on the stand tower. Failure to follow these instructions may result in personal injury and/or equipment damage.
• The equipment must only be connected to an earthed MAINS socket-outlet (i.e. Only plug the Bioness Integrated Therapy System into 3 pronged grounded wall outlets.). Not doing so may result in an increased risk of electric shock.
• Misuse of the system could cause the unit to fall and result in injury and/or damage.
• Do not climb, sit, or lean on any part of the portable stand, doing so could cause the equipment to fall causing damage and/or injury.
• Remove the Sensor before undergoing any diagnostic or therapeutic medical procedure such as X-ray examination, ultrasound, MRI, etc.
• Users of the Balance Platform should exercise caution when stepping on or off the Balance Platform to prevent tipping hazards during the course of the therapy. Please note that some additional tipping hazards may result when performing Static Balance activities while on Platform as reaching could result in Platform tipping, loss of balance and subsequent fall hazard.
• The Bioness Integrated Therapy System software programs utilize moving and rotating graphics that may cause dizziness, vertigo, or nausea in sensitive patients. Individuals experiencing dizziness, vertigo, or nausea while using BITS should discontinue use immediately.
• The BITS Balance Adhesive Patch can be attached to patient's clothing or directly applied to the skin. It is normal for the skin under the Adhesive Patch to become red. The redness should disappear in approximately one hour once the patch is removed. However, some patients may experience skin irritation, an allergic reaction, or hypersensitivity to the gel pads on the back of the Adhesive Patch. Persistent redness, lesions or blisters are signs of irritation. Use of the Adhesive Patch should be temporarily halted until the irritation is resolved. Patients should consult their physician if irritation persists.
• Do not apply the Adhesive Patch over skin folds, scarred tissue, irritated skin, uneven skin surfaces, or broken skin.
• Always inspect the gel pads on the back of the Adhesive Patch before use. Do not apply the Adhesive Patch if the gel pads appear dried out, worn, dirty, or irregular.
• Make sure the Adhesive Patch liner is removed before adhering to the clothing or skin.
• Do not use the Adhesive Patch with an expired "Use by" date.
• Do not use unapproved devices/hardware with the Bioness Integrated Therapy System.
• Do not use unapproved accessories with the Bioness Integrated Therapy System.
• Improper shut-down of the BITS software may result in the loss of client data. Please follow proper instructions for the shut down process.
• Refer to the manufacturer's instructions provided with the touchscreen display for additional warnings and safety information.
• Bioness Integrated Therapy System is not intended to act as a diagnostic device and does not identify the presence or absence of clinical diagnoses.
• Make sure the computer is shut down and turned off before moving the stand.
• Make sure the Balance Platform is placed in a secured location when not in use to avoid tripping hazards.