Compex Sport Elite 2.0, EDGE 2.0 User Manual

SPORT ELITE 2.0
MUSCLE STIM + TENS
i
TABLE OF CONTENTS
FOREWORD...................................................... 1
GLOSSARY OF MEDICAL TERMINOLOGY ......................... 2
INDICATIONS FOR USE........................................... 4
PRECAUTIONARY INSTRUCTIONS ..................................................5
CONTRAINDICATION ..............................................................6
WARNINGS....................................................................610
CAUTIONS ...................................................................1114
ADVERSE REACTIONS ...........................................................14
WHOE SHOULD USE THE COMPEX? ..............................................15
INTRODUCTION .............................................1617
HOW DOES ELECTROSTIMULATION WORK?........................................ 16
MOTOR NERVE STIMULATION (EMS)............................................... 16
BENEFITS OF ELECTROSTIMULATION ............................................17
DEVICE DESCRIPTION .......................................1822
COMPEX SPORT ELITE ...........................................................18
ACCESSORIES ................................................................... 19
PROGRAMS ..................................................................2123
MUSCLE STIMULATION TRAINING PROGRAMS ............................2021
ENDURANCE ........................................................... 20
RESISTANCE............................................................ 20
STRENGTH ............................................................. 21
EXPLOSIVE STRENGTH.................................................. 21
SPECIALIZED MUSCLE TRAINING PROGRAMS .............................2122
POTENTIATION ......................................................... 21
TRAINING RECOVERY ..................................................22
PREWARMUP .......................................................... 22
COMPETITION RECOVERY............................................... 22
MUSCLE RELAXATION .................................................. 22
PAIN RELIEF TENS ...........................................................22
DEVICE SET UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2325
USAGE GUIDELINES .............................................................23
CHOOSING THE APPROPRIATE MUSCLE WORK PROGRAM ........................23
PLANNING STIMULATION SESSION ..............................................23
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TABLE OF CONTENTS
ADJUSTING STIMULATION ENERGIES........................................23
PROGRESSION IN THE LEVELS............................................... 23
ELECTRODE POSITIONS AND TIPS........................................2425
CONNECTING THE CABLES TO THE STIMULATOR.............................25
DEVICE OPERATION ........................................2632
PRELIMINARY SETTINGS .................................................... 26
SELECTING A PROGRAM.....................................................28
PERSONALIZING A PROGRAM ............................................... 28
DURING THE STIMULATION SESSION..........................................2931
ADJUSTING STIMULATION ENERGIES ........................................29
PROGRAM PROGRESSION ................................................... 30
END OF PROGRAM ..........................................................31
RECHARGING THE DEVICE....................................................3132
ELECTRICITY CONSUMPTION ................................................ 32
RECHARGING ...............................................................32
SPECIFICATIONS .............................................3337
CLEANING THE UNIT............................................................. 33
MAINTENANCE..................................................................33
STORAGE AND TRANSPORTATION CONDITIONS .................................. 33
PATENTS ........................................................................33
DISPOSAL.......................................................................34
STANDARDS ....................................................................34
HOW TO GET HELP ..............................................................34
DESCRIPTION OF DEVICE MARKINGS.............................................35
OUTPUT WAVEFORM ............................................................36
UNIT CHARACTERISTICS ......................................................... 36
POWER SUPPLY .................................................................36
OUTPUT SPECIFICATIONS .......................................................36
DESCRIPTION OF ACCESSORIES..................................................36
ELECTRO MAGNETIC CAPABILITY TABLES ................... 3740
TROUBLESHOOTING......................................... 4142
WARRANTY.....................................................43
INDEX .......................................................4445
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This manual has been written for the owners and operators of the Compex® Sport Elite. It contains general instructions for operation, precautionary instructions, and maintenance recommendations. In order to obtain maximum life and efficiency from your Compex Sport Elite, and to assist in the proper operation of the unit, read and understand this manual thoroughly.
The specifications put forth in this manual were in effect at the time of the publication. However, changes to these specifications may be made at any time without obligation on the part of DJO, LLC.
Before starting any program, you should become
acquainted with the compexusa.com website to establish
an appropriate training plan.
The compexusa.com website helps you take your first
steps with the device.
FOREWORD
Glossary of Medical Terminology
Abdominal or Inguinal Hernia: Occurs when a portion of the abdomen (usu­ally fat or small intestine) bulge through a weak area of the abdominal wall.
Acute Trauma: An injury resulting from a single event.
Aerobic Metabolism: When the body is able to use oxygen to generate energy
for the body. This is usually seen in long distance events.
Afflicted Joint: A joint that has been impaired or has pain.
Anaerobic Metabolism: When the body can no longer use oxygen to produce
energy it begins to use carbohydrates that are stored in the body. This is gener­ally used for short burst of energy.
Arterial Circulation: This is blood circulating from the heart out to the body through the arterials
Atrophied Muscle: when muscle wastes away due to disease, injury, or lack of physical activity.
Blood Flow Deficiency: The body is not able to properly move blood through­out the body. Can be caused by a number of different conditions.
Capilary fragility: Capilaries deliver blood to between the arterires and veins. Sometimes these can become weak and break down and not transfer blood effectively.
Capilary damage: When there is damage to the capilaries it can cause them to break down and can even leak into the body.
Cardiac Arrhythmia: An irregular heartbeat. This can mean that the heart is beating too fast, too slow, or not in a normal rhythm.
Disuse Atrophy: This is caused when the muscles are no longer active and begin to shrink
Fracture: A break in the bone
Glossary of Medical Terminology
Ischemia: a lack of blood supply to an organ or other part of the body. Usually affects the heart muscles
Lactic Acid: Waste left in the muscle after working at a high level of exercise for an extended period of time. Lactic Acid has been known to cause fatigue in the muscle and is related to muscle soreness
Muscle Re-education: the use of physical exercises to restore muscle tone and strength after an injury or disease
Muscle Spasm: an involuntary contraction of a muscle that can cause a great deal of pain.
Muscle Twitch Response: this is a contraction of the muscle that can be felt or seen, or a movement of the muscle and skin as the muscle fibers contract and relax.
Venous Thrombosis: a blood clot that forms within a vein.
INDICATIONS FOR USE
INDICATIONS FOR USE
The Compex Sport Elite EMS is intended for:
The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The work imposed on the muscles by the Compex Sport Elite programs is definitely not suitable for rehabilitation and physiotherapy.
The Compex Sport Elite TENS is intended for:
Temporary relief of pain associated with sore and aching muscles due to strain
from exercise or normal household and work activities
The symptomatic relief and management of chronic, intractable pain and relief of
pain associated with arthritis.
The Compex Sport Elite is an Over-the-Counter device to be used by adults only.
Safety Information
Some instructions found in this section and throughout this manual
are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definitions of these symbols are as follows:
PRECAUTION
PRECAUTION
Text with “PRECAUTION” indicates a situation which, if not avoided,
may result in minor or moderate injury to the user or patient or damage to
the equipment of other property.
WARNING
Text with “WARNING” indicates a situation which, if not avoided, could result in death or serious injury
PRECAUTIONARY INSTRUCTIONS
NON-IONIZING ELECTROMAGNETIC RADIATION
Text with a “Non-Ionizing Electromagnetic Radiation” indicator informs the user of possible hazards resulting from elevated, potentially dangerous levels of non-ionizing radiation.
NOTE: Throughout this manual,
“NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.
EXPLOSION HAZARD
Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable
DANGEROUS VOLTAGE
Text with a “Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered in certain program configurations of waveforms.
BIOHAZARDOUS MATERIALS
Text with a “Biohazard” indicator serves to inform the user of possible hazards resulting in improper handling of components and accessories that have come in contact with bodily fluids.
Contraindications
Text with a "CONTRAINDICATION"
indicates a situation in which the device should not be used.
Safety Information
Never use the Compex Sport Elite on atrophied muscles, muscles with spasms, or muscles associated with a limb with a painful or afflicted joint
Do not use the Compex Sport Elite for muscle reeducation, to prevent or retard disuse atrophy, to prevent venous thrombosis, to maintain or increase range of
motion, or for blood flow deficiencies
Do not use the Compex Sport Elite if you have one or more of the following medical conditions:
• The Sport Elite must not be used on persons with cardiac pacemakers, defibrillators, or other implanted metallic or electronic devices. Such use could cause shock, burns, electrical interference, or death.
• Do not use the sport elite if you have been diagnosed with epilepsy before consulting your physician
• Do not use the Sport Elite following acute trauma or fracture, or following recent surgical procedures
• Do not use the Sport Elite if you have critical ischemia of lower limbs, or other serious arterial circulation problems in lower limbs
• Do not use the Sport Elite if you have abdominal or inguinal hernia
• Do not use the Sport Elite if you have cancerous lesions
• Do not use the Sport Elite over the abdominal region during pregnancy
• Do not use the Sport Elite if you have sensitivity problems or unable to express yourself
Physician Care: If you are in the care of a physician, consult
with your physician before using the Sport Elite.
Physician Care: If you have had medical or physical treatment
for your pain, consult with your physician before using the Sport Elite.
Physician Care: If your pain does not improve, becomes more
than mild, or continues for more than five days, stop using the Sport Elite and consult yoru physician.
Physician Care: Consult with your physician before using
the Sport Elite, becuase the device may cause lethal rhythm disturbances to the heart in susceptible individuals.
Long Term: The long term effects of electrical stimulation are
unknown.
First Use: Never carry out an initial stimulation Do not use the
Sport Elite for the first session on a person who is standing. The first five minutes of stimulation must always be performed on a person who is sitting or lying down. In rare instances, people who are nervous experience a vasovagal reaction. This is of psychological origin and is connected with a fear of the muscle stimulation as well as surprise at seeing one of their muscles contract without having intentionally contracted it themselves. A vasovagal reaction causes heart to slow down and blood pressure to drop, which can make you feel weak and faint. If this does occur, all that is required is to stop the stimulation and lie down with the legs raised until the feeling of weakness disappears (5 to 10 minutes).
Cancer: Do not apply stimulation from the Sport Elite over, or in
proximity to, cancerous lesions.
Safety Information
Head: Since the effects of stimulation of the
brain are unknown, stimulation from the Sport Elite should not be applied across your head and electrodes should not be placed on the opposite sides of the head.
Chest: The Sport Elite stimulus is delivered by
the waveforms of this device, in certain configurations, will deliver a charge of 25 microcoulombs (µC) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the chest because it may cause a cardiac arrhythmia.
Chest: Do not apply stimulation from the Sport Elite across your
chest becuase the introduction of electrical current into the chest may cuase rhythm disturbances to your hear, which could be lethal
Neck: Do not apply stimulation from the Sport Elite
over your neck becuase this could cause severe muscle spasms resulting in closure of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.
Wounds: Do not apply stimulation from the Sport
Elite over open wounds or rashes or over swollen, red, infected, and inflamed areas or skin eruptions, (e.g., phlebitis, thrombophlebitis, varicose veins)
Healthy Skin: Apply stimulation from the Sport
Elite only to normal, intact, healthy skin.
Children: Do not use the device on children, if it has
not been evaluatd for pediatric use.
Safety Information
During Use: Do not disconnect any stimulation cables from the
Sport Elite during a session while the stimulator is switched on. Switch the stimulator off first.
Medical Equipment: Do not use the Compex Sport Elite if you
are connected to a high-frequency surgical instrument as this could cause skin irritation or burns under the electrodes.
Cables: Never connect stimulation cables to an external power
supply. There is a risk of electric shock.
Biohazard: Handle, clean and dispose of components and
accessories that have come in contact with bodily fluids according to National, Local and Facility rules, regulations and procedures.
Hazard: Explosion hazard if the Compex Sport Elite is used in
the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide.
Medical Equipment: The Compex Sport Elite should not be used
adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the unit should be observed to verify normal operation in the configuration in which it will be used.
Medical Equipment: Do not apply stimulation in the presence
of electronic monoitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when the electrical stimulation device is in use.
Safety Information
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Charging: Never use the Compex Sport Elite or the charger if it is
damaged (case, cables, etc.) or if the battery compartment is open. There is a risk of electric shock.
Charging: Disconnect the charger immediately if the Compex Sport Elite
“bleeps” continuously, if there is abnormal heating or smell, or if smoke comes from the charger or the Compex Sport Elite.
Charging: Do not recharge the battery in a confined space (carrying
case, etc.). There is a risk of fire or electric shock.
Charging: Never recharge the stimulator without first disconnecting the
stimulation cables.
Bath or Shower: Do not apply stimulation when in the bath or shower
Sleeping: Do not apply stimulation while sleeping
Driving: Do not apply stimulation while driving, operating machinery, or
during any activity in which involuntary muscle contractions from electrical stimulation can put you at risk of injury.
Altitude: Do not use the stimulator at altitudes of over 9,842 feet (3,000
meters)
Safety Information
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PRECAUTION
Read, understand, and practice the precautionary and
operating instructions found in this manual. Know the limitations and hazards associated with the treatment table. Observe any and all precautionary and operational decals placed on the unit.
Medical Equipment: DO NOT operate this unit in an
environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
Radio Frequency: This unit generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this unit on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the equipment, connect the unit to an outlet on a different circuit from that which the other device(s) are connected, and consult DJO, LLC for help.
Irritation: You may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical conductive medium (gel). The irritation can usually be reduced by using an alternative conductive medium or alternative electrode placement.
Heart Disease: If you have suspected or diagnosed heart
disease, you should follow the precautions recommended by your physician.
Safety Information
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PRECAUTION
EPILEPSY: If you have suspected or diagnosed epilepsy, you
should follow the precautions recommended by your physican.
Accessories: Use only accessories that are specially designed for
the Compex Wireless USA. Do not use accessories manufactured by other companies on the Wireless USA. DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories or cables may result in increased emissions or decreased immunity of the Wireless USA.
Cleaning: Do not allow any foreign bodies (soil, water, metal,
etc.) to penetrate the device, the battery compartment and the charger.
Pregnancy: The safety of electrical stimulation during pregnancy
has not been estabilished.
Humidity: Do not use the device in water of in a humid
atmosphere (sauna, hydrotherapy, etc.).
Temperature: This unit should be operated in temperatures
between 32 °F and 104 °F (0 °C and 40 °C), atmospheric pressures between 700 and 1060 hPa and Relative Humidity ranging from 30%-75%.
Condensation: Sudden temperature changes can cause
condensation to build up inside the stimulator. To prevent this, allow it to reach ambient temperature before use.
TENS: TENS is not effective for pain of central origin, including
Headache.
TENS: TENS is not a substitute for pain medications and other
pain management therapies.
TENS: TENS devices have no curative value
Safety Information
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