Bioness BITS, Clinicians Manual

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5 Chapter 2 - Safety Information
• 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 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.
Incident Reporting
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established if within
the European Union.