4
ADVERSE REACTIONS
e
Use of the device may cause irritation to the skin beneath
the electrodes.
e
Burns beneath the electrodes have also been reported in
the literature.
e
Application of electrodes near the thorax may increase the risk of
cardiac fibrillation.
e
Allergic reactions to the gel adhesive may be possible.
e
Long-term stimulation of the same area may cause skin irritation.
WARNINGS
e
Do not place electrodes over the neck because this could cause severe
muscle spasms resulting in closure of the airway, difficulty breathing,
or adverse effects on heart rhythm or blood pressure.
e
Do not place electrodes across the chest because the introduction of
electrical current into the chest may cause rhythm disturbances to the
heart which could be lethal.
e
Do not place electrodes over open wounds, rashes, or over swollen,
red, infected, or inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, and varicose veins).
e
Do not place electrodes over, or in proximity to, cancerous lesions.
e
Do not place electrodes on the genitals.
e
Electrodes should be applied only to normal, intact, clean and
healthy skin.
e
Incorrect application of electrodes could result in discomfort or
burning of the skin.
e
Do not share electrodes with other persons because of the risks of
adverse skin reactions and disease transmission.
e
As Ellune is a TENS device, it is intended for symptomatic treatment
and has no curative effect.
e
Electronic devices (such as an ECG and others) may not operate
properly when TENS stimulation is in progress.
CAUTION:
e
Turn Ellune off before applying or removing the electrodes.
e
TENS is not recommended for patients with heart disease who have
not received a medical evaluation of possible adverse effects.
e
TENS should not be used to alleviate an undiagnosed pain syndrome
until the etiology has been well established.
e
Ellune should not be used for ovulation pain (mid-cycle pain).
e
Ellune should not be used while fertility problems are being evaluated,
diagnosed, or treated.
