WARNINGS AND CAUTIONS

General Warnings

The "Compex Sport' is intended for use on healthy muscles. It is to be used by adults only. KEEP OUT OF THE REACH OF CHILDREN.

Never use the "Compex® Sport" on:

• painful muscles
• atrophied muscles
• muscles with spasms
• muscles associated with a limb with a painful or afflicted joint

The "Compex® Sport" is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind.

None of the "Compex® Sport' stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the "Compex® Sport' programs is definitely not suitable for rehabilitation and physiotherapy.

Do not use the "Compex® Sport":

• for muscle reeducation
• to prevent or retard disuse atrophy
• to prevent venous thrombosis
• to maintain or increase range of motion
• for muscle spasms
• for blood flow deficiencies

Contraindications

Do not use the "Compex® Sport" if you have one or more of the following medical conditions:

1. This device must not be used on persons with cardiac pacemakers, defibrillators, or other implanted metallic or electronic devices.
2. Cardiac demand pacemakers.
3. Epilepsy.
4. Following acute trauma or fracture.
5. Following recent surgical procedures.
6. Critical ischemia of lower limbs.
7. Abdominal or inguinal hernia.
8. Cancerous lesions.

Warnings

1. The long-term effects of prolonged use of electrical stimulation are unknown.
2. Stimulation should not be applied on the neck. Severe spasm of the muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. Stimulation on the neck could also have adverse effects on the heart rhythm or blood pressure.
3. Electrodes used for electrical stimulation should not be applied across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart.
4. The effects of stimulation of the brain are unknown. Therefore, stimulation should not be applied across the head and electrodes should not be placed on opposite sides of the head.
5. Safety of powered muscle stimulators for use during pregnancy has not been established.
6. The "Compex® Sport' should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at risk of injury.
7. Caution should be used for patients with suspected or diagnosed heart problems.
8. Caution should be used when operating the device over the abdominal region during menstruation periods.
9. Caution should be used when applying the device over areas of the skin that lack normal sensation.
10. Stimulation should not be applied when in the bath or shower.
11. Do not use the device in a humid atmosphere (sauna, hydrotherapy, etc.).
12. Electrodes should be applied only to normal, intact, clean skin. Electrodes should not be applied over open wounds or over swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.),
13. Electrodes should not be shared with other persons. Each person should have their own set of electrodes; otherwise, undesirable skin reactions may occur.
14. Self-adhesive electrodes should be replaced if they no longer stick firmly to the skin.

Precautions

1. Some persons may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).
2. This device should be kept out of the reach of children.
3. This device should be used only with the leads, electrodes, and accessories recommended for use by the manufacturer.

Adverse Reactions

1. Skin irritation and burns beneath the electrodes have been reported with the use of stimulation electrodes applied to the skin.
2. Headache and other painful sensations have been reported during or following the application of electrical stimulation applied to the head, face, and near the eyes.