Chattanooga Continuum - Contraindications; Warnings

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PRODUCT DESCRIPTION
As a functional electrical stimulation (FES) device, the
indications for the following condition:
• Stimulation of the leg and ankle muscles of
partially paralyzed patients to provide flexation
of the foot, thus improving the patient’s gait
CAUTION: Federal Law (USA) restricts this device to sale
by or on the order of a physician (or licensed practitioner).
CONTRAINDICATIONS
Chattanooga Continuum should not be used for the
following situations or patients with:
• Demand type implanted pacemaker of
defibrillator
• Any transcerebral electrode placement
• Any electrode placement that applies current to
the carotid sinus region
Specific to use of Chattanooga Continuum as a TENS
device:
• Whenever pain syndromes are undiagnosed,
until etiology is established
Specific to use of Chattanooga Continuum as an FES
device:
• Assisting paraplegic patients into the standing
position
WARNINGS
Supervised Use – This device should only be operated
under the prescription and supervision of a physician
(or licensed practitioner) that is familiar with the
precautionary measures and operational functions
associated with the unit being used.
Long Term Eects – The long term eects of chronic
use of electrical stimulation are unknown. Electrical
stimulation devices do not have any curative value.
Symptomatic Treatment – This device is a symptomatic
treatment and, as such, suppresses the sensation of pain,
which would otherwise serve as a protective mechanism.
Central Origin Pain – Electrical Stimulation is not eective
for central origin pain such as headaches.
Pregnancy – The safety of using electrical stimulation
during pregnancy or birth has not been established.
Throat Stimulation – Severe spasm of the laryngeal and
pharyngeal muscles may occur when the electrodes are
placed across the throat or mouth.
This may be strong enough to close o the airway or
cause breathing diculty.
Transthoracic Stimulation – Do not apply electrical
stimulation transthoracically (through the chest area) in
that the introduction of electrical current into the heart
may cause cardiac arrhythmias.
Skin & Vascular Problems – Do not use this device over
swollen, inflamed or infected areas, skin eruptions, or areas
of decreased sensation.
Heart Disease – Precaution should be taken prior to using
electrical stimulation on patients suspected of having heart
disease.
MRI Scans – Do not wear electrode or controller during
Magnetic Resonance Imaging (MRI) scans as this may
result in metal overheating and causing skin burns in the
area of the patch.
Tripping – Care should be used to avoid tripping on lead
wires, especially when the foot switch is utilized.
High Frequency Surgical Devices – Simultaneous
connection of a patient to a high frequency surgical
device may result in burns at the site of the electrodes and
possible damage to the device.
Damage From Liquids – Do not immerse the device in
water or other liquids.
Water or liquids could cause malfunction of internal
components of the system, causing a risk of injury to the
patient.
Electrical Shock – To prevent electrical shock, disconnect
the unit from the power source before attempting any
maintenance procedures.
Uncomfortable Stimulation – If the stimulation levels are
uncomfortable or become uncomfortable, reduce the
intensity to a comfortable level.
Contact your clinician if the problem persists.