User's Manual

Keep out of Reach of Children

The StimRouter components should be kept out of the reach of children.

Skin Abnormalities

Do not adhere the StimRouter electrode to sites that are swollen, infected or inflamed, or that

have skin eruptions such as phlebitis, thrombophlebitis and varicose veins. Do not adhere the

StimRouter electrode to skin that is breached.

Skin Irritation

It is normal for the skin under the StimRouter electrode to become red. The redness should

disappear in approximately one hour once the user patch is removed. However, some patients

may experience skin irritation, an allergic reaction, or

hypersensitivity

to the electrical stimulation

or the gel electrodes. Persistent redness, lesions or blisters are signs of irritation. Use of the

StimRouter components should be temporarily halted until the irritation is resolved. In some

cases, irritation can be avoided by removing the StimRouter electrode periodically to allow the

skin to breathe and changing the stimulation parameters. Patients should consult their clinician

if irritation persists.

Known or Suspected Heart Problems

Use caution when treating patients with suspected or diagnosed heart problems.

StimRouter Electrode Placement and Stimulation

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Electrical stimulation should not be applied trans-thoracically or at the heart such that

current may travel into or through the cardiac tissue, as such introduction of electrical

current may cause heart rhythm disturbances.

Turn off stimulation before adhering, removing or handling the StimRouter electrode.

StimRouter electrode placement and stimulation settings should be determined by the

implanting physician and/or treating clinician.

Do not apply the StimRouter electrode over any obstruction that would reduce

the designated electrode surface area (for example, an adhesive bandage). A smaller

electrode surface area could result in serious injury to the patient.

Do not apply the StimRouter electrode over skin folds, scarred tissue, irritated skin,

uneven skin surfaces or broken skin.

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Clinician’s Guide