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INDICATIONS AND WARNINGS

Intended Use

Compex® is intended
to stimulate healthy muscles
in order to improve or facilitate
muscle performance.

The Compex employs programs for neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS).

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA 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 Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy.

The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The Compex Wireless USA may therefore be considered a technique of muscle training.

How to Use Compex®

For your first use you will want to use Compex® in a comfortable position, depending on the muscle group being activated, sitting or laying down. As you become comfortable with the sensation of the muscle contractions, you can begin to progress into movement with your device. Before use read the manual carefully to understand how the programs work. Turning the device up can intensify the muscle contractions, so it is important to work with in your limit as this can cause elevated levels of muscle soreness.

In order to use the Compex® safely and effectively, the following essential matters must be considered:

  1. the choice of the appropriate muscle work program
  2. the planning of stimulation sessions
  3. the placement of the electrodes
  4. the setting of the electrical current intensity

WARNINGS AND CAUTIONS

GENERAL WARNINGS

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

Never use the Compex® on:

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

The Compex® is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind.
None of the Compex® 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® programs is definitely not suitable for rehabilitation and physiotherapy.

Do not use the Compex®:

  • 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® 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. Stimulation should not be applied 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.

WHERE NEVER TO APPLY THE ELECTRODES

  • On the head or any area of the face.
  • On the neck or any area of the throat.
  • On both sides of the thorax simultaneously (front and back sides, or lateral sides).
  • On, or in the vicinity of skin lesions or eruptions of any kind.
  • Over the abdominal region during menstruation periods.
  • On skin areas lacking of normal sensation.
  • Only use the electrodes supplied by Compex. Other electrodes may present a risk of unsuitable electrical characteristics with your stimulator.
  • Other electrodes may present a risk of unsuitable electrical characteristics with your stimulator.
  • Do not use the same electrodes on different people. Each user must have his or her own electrode set. Otherwise, skin reaction or cross contamination may occur.
  • Do not use a set of electrodes for more than fifteen sessions.
  • Do not plunge the electrodes into water.
  • Do not apply a solvent of any kind onto the electrodes.
  • Always stop the stimulator before removing or moving the electrodes.
  • Wash skin thoroughly, and then dry it before applying the electrodes.
  • Apply the whole surface of the electrodes firmly to the skin.
  • Do not use electrodes that do not stick properly, i.e. that do not stick to the skin or that only partially stick to the skin.