9
6) The indications for use are listed above. Use for any other purpose may be
dangerous.
7) Do not use this device for undiagnosed pain syndromes until you have consulted a
physician.
8) Patients with an implanted electronic device, such as a cardiac pacemaker,
implanted defibrillator, or any other metallic or electronic device should not use this
device without first consulting a doctor.
9) Stimulation delivered by this device may be sufficient to cause electrocution.
Electrical current of this magnitude must not flow through the thorax or across the chest
because it may cause a cardiac arrhythmia.
10) Do not place electrodes on the front of the throat as spasm of the Laryngeal and
Pharyngeal muscle may occur. Stimulation over the carotid sinus (neck region) may
close the airways, make breathing difficult, and may have adverse effects on the heart
rhythm or blood pressure.
11) Do not place electrodes on your head or at any sites that may cause the electrical
current to flow transcerebrally (through the head).
12) Patients with heart disease, epilepsy, cancer or any other health condition should
not use this device without first consulting a physician.
13) Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or silicone rubber. If a rash develops or pain persists, discontinue use and
consult a doctor.
14) Electrode placement and stimulation settings should be based on the guidance of
prescribing practitioner.
IS) Effectiveness is highly dependent upon patient selection by a person qualified in the
management of pain afflicted patients.
16) Isolated cases of skin irritation may occur at the site of the electrode placement
following long-term application. If this occurs, discontinue use and consult your
physician.
17) The electrodes are only to be placed on healthy skin. Avoid skin irritation by
ensuring that good contact is achieved between electrodes and skin.
18) If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation Intensity to a comfortable level and contact your physician if problems
persist.
