Roscoe Medical INTENSITY 10, Instruction Manual

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6. The instruction of use was listed; any improper use may be
dangerous.
7. Do no use this device for undiagnosed pain syndromes until
consulting 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
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 trans-cerebrally (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 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.
15. Effectiveness is highly dependent upon the patient and the
selection of therapy by a person qualified in the management
of pain.
16. Isolated cases of skin irritation have occurred 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.