Intended Purpose: NeuroNode is an Augmentative and Alternative Communication (AAC) device intended
to provide noninvasive, electromyographic (EMG)-mediated computer access, communication, and environ-
mental control capability for users with impaired speech and/or motor function. Other user actions and
gestures (e.g. touch, visual, movement) can complement this EMG-based computer control.
NeuroNode is non-sterile and reusable, and is intended to be used continuously for up to 24 hours in contact
with the user’s intact muscle-contacting skin surface.
It is intended that either users themselves (depending upon the extent of their communication or mobility
limitations) or their caregivers fit the NeuroNode to the user and place the electrode sensors on the user’s skin.
It is intended that during routine use, the NeuroNode electrode sensors are placed over target muscles that
meet two criteria:
• The target muscle responds, at least minimally, to a command for contraction; and
• The target muscle returns to a resting state in order to differentiate one activation from another.
Indications: NeuroNode uses the body’s bioelectrical EMG signals to control a computer and/or
generate speech.
NeuroNode is comprised of AAC technology that is easy to use and is indicated for users suffering from
diseases or conditions which limit their motor functions and communication abilities such as ALS (Amyotrophic
Lateral Sclerosis, also known as Lou Gehrig’s Disease), MND (Motor Neuron Disease), SCI (Spinal Cord Injury),
or cerebral palsy.
Contraindications: NeuroNode is not indicated to be a life-supporting device or the user’s sole means of
communication. An alternative communication method should be available at all times. The NeuroNode is not
indicated to be the user's sole means of environmental control or computer-controlled mobility. Use of the
NeuroNode for these purposes must be performed under supervision.
Warnings and Precautions
Battery Handling: When the NeuroNode battery is nearing the end of its useful charge, the NeuroNode will
pulse yellow. The NeuroNode should be placed on the charger and recharged at this point.
Unless the NeuroNode is already charged within 10% of its capacity, the red charger light should illuminate
when the NeuroNode is placed on the charger. The red charger light will turn off once the NeuroNode is fully
charged.
Environment: Do not allow a conductive object to touch the battery contacts on the bottom of the
NeuroNode.
Warnings in this document are indicated with this symbol:
Adherence to the noted warnings will promote safe and efficacious use of the NeuroNode.
Precautions in this document are indicated with this symbol:
An understanding of the noted precautions will enhance the usefulness of the NeuroNode.
