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