Compex EDGE 2.0 User manual


EDGE 2.0
MUSCLE STIM + TENS

i
TABLE OF CONTENTS
FOREWORD ...................................................1
GLOSSARY OF MEDICAL TERMINOLOGY.........................2
INDICATIONS FOR USE .........................................4
SAFETY INFORMATION ...............................................517
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 ..................................................................2021
MUSCLE STIMULATION TRAINING PROGRAMS ............................2021
ENDURANCE ........................................................... 20
RESISTANCE............................................................ 20
SPECIALIZED MUSCLE TRAINING PROGRAMS ................................ 21
TRAINING RECOVERY................................................... 21
PAIN RELIEF TENS ...................................................... 21
DEVICE SET UP ........................................... 2224
USAGE GUIDELINES ............................................................. 22
CHOOSING THE APPROPRIATE MUSCLE WORK PROGRAM ........................ 22
PLANNING STIMULATION SESSION .............................................. 22
ADJUSTING STIMULATION ENERGIES ............................................ 22
PROGRESSION IN THE LEVELS ............................................... 22
ELECTRODE POSITIONS AND TIPS........................................... 23
CONNECTING THE CABLES TO THE STIMULATOR............................. 24

ii
TABLE OF CONTENTS
DEVICE OPERATION ..................................... 2531
PRELIMINARY SETTINGS .................................................... 25
SELECTING A PROGRAM..................................................... 26
PERSONALIZING A PROGRAM ............................................... 26
DURING THE STIMULATION SESSION..........................................2830
ADJUSTING STIMULATION ENERGIES ........................................ 28
PROGRAM PROGRESSION ................................................... 29
END OF PROGRAM .......................................................... 30
RECHARGING THE DEVICE....................................................3031
ELECTRICITY CONSUMPTION ................................................ 31
RECHARGING ............................................................... 31
SPECIFICATIONS.......................................... 3235
CLEANING THE UNIT............................................................. 32
MAINTENANCE.................................................................. 32
STORAGE AND TRANSPORTATION CONDITIONS .................................. 32
PATENTS ........................................................................ 32
DISPOSAL....................................................................... 33
STANDARDS .................................................................... 33
HOW TO GET HELP .............................................................. 33
DESCRIPTION OF DEVICE MARKINGS............................................. 34
OUTPUT WAVEFORM ............................................................ 35
UNIT CHARACTERISTICS ......................................................... 35
POWER SUPPLY ................................................................. 35
OUTPUT SPECIFICATIONS ....................................................... 35
DESCRIPTION OF ACCESSORIES.................................................. 35
ELECTRO MAGNETIC CAPABILITY TABLES .................. 3740
TROUBLESHOOTING ...................................... 4142
WARRANTY ................................................. 43
INDEX.................................................... 4445


This manual has been written for the owners and operators
of the Compex® Edge. It contains general instructions for
operation, precautionary instructions, and maintenance
recommendations. In order to obtain maximum life and
efficiency from your Compex Edge, 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 (usu-
ally 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 gener-
ally 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 through-
out 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.


ABOUT COMPEX EDGE
INDICATIONS FOR USE
The Compex Edge EMS is used for:
The Compex Edge is intended to stimulate healthy muscles in order to improve or
facilitate muscle performance.
The work imposed on the muscles by the Compex Edge programs is definitely not
suitable for rehabilitation and physiotherapy.
The Compex Edge 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 Edge 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 anesthetics.
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 Edge on atrophied muscles, muscles with spasms, or muscles
associated with a limb with a painful or afflicted joint
Do not use the Compex Edge 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 Edge if you have one or more of the following medical
conditions:
• The Edge 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 Edge if you have been diagnosed with epilepsy before consulting your
physician
• Do not use the Edge following acute trauma or fracture, or following recent surgical
procedures
• Do not use the Edge if you have critical ischemia of lower limbs, or other serious arterial
circulation problems in lower limbs
• Do not use the Edge if you have abdominal or inguinal hernia
• Do not use the Edge if you have cancerous lesions
• Do not use the Edge over the abdominal region during pregnancy
• Do not use the Edge 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 Edge.
• Physician Care: If you have had medical or physical treatment
for your pain, consult with your physician before using the
Edge.
• Physician Care: If your pain does not improve, becomes more
than mild, or continues for more than five days, stop using the
Edge and consult yoru physician.
• Physician Care: Consult with your physician before using the
Edge, 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
Edge 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 Edge over, or in
proximity to, cancerous lesions.
Safety Information


• Head: Since the effects of stimulation of the
brain are unknown, stimulation from the Edge
should not be applied across your head and
electrodes should not be placed on the opposite
sides of the head.
• Chest: The Edge 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 Edge 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 Edge 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 Edge
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 Edge 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
Edge during a session while the stimulator is switched on. Switch the
stimulator off first.
• Medical Equipment: Do not use the Compex Edge 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 Edge is used in the
presence of flammable anesthetics mixture with air, oxygen, or
nitrous oxide.
• Medical Equipment: The Compex Edge 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


• Charging: Never use the Compex Edge 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 Edge
“bleeps”continuously, if there is abnormal heating or smell, or if smoke
comes from the charger or the Compex Edge.
• 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


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


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


PRECAUTION
• TENS: TENS is a symptomatic treatment and, as such, suppresses the
sensation of pain that would otherwise serve as a protective mechanism.
• TENS: Effectiveness is highly dependent upon patient selection by a
practitioner qualified in the management of pain patients.
• Bleeding: Use caution if you have a tendency to bleed internally, such as
following an injury or fracture.
• Physician Care: Consult with your physician prior to using the device after
a recent surgical procedure, becuase stimulation may disrupt the healing
process.
• Children: Keep this device out of the reach of children.
• Skin Care: Use caution if stimulation is applied over areas of skin that lack
normal sensation.
PRECAUTIONS WHEN USING ELECTRODES
• Only use electrodes supplied by DJO, LLC. Other electrodes may have
electrical properties that are unsuitable for the Compex Edge stimulator.
• Do not use electrodes with a surface < 19 cm (2.94 in), as there will be a risk
of suffering a burn injury. Caution should always be exercised with current
densities > 2mA/cm (12.9mA/in).
• Always turn off the stimulator before moving or removing any electrodes
during a session.
• Do not place the electrodes in water.
• Do not apply solvents of any kind to the electrodes.
• For best results, wash and clean the skin of any oil and dry it before attaching
the electrodes.
• Attach the electrodes in such a way that their entire surface is in contact with
the skin.
• For obvious reasons of hygiene,
each user must have his/her own
electrode set. Do not use the same
electrodes on different people.
Safety Information


SAFETY GUIDE
PRECAUTIONS WHEN USING ELECTRODES CONT.
• Self-adhesive electrodes should be replaced if they no longer
stick firmly to the skin.
• Some people with very sensitive skin may experience redness
under the electrodes after a session. Generally, this redness is
completely harmless and disappears after 10 to 20 minutes. Never
start another stimulation session in the same area, however, if the
redness is still visible.
• Do not apply electrodes on, or in the vicinity of skin lesions
or eruptions of any kind (wounds, swelling, burns, irritation,
eczema, etc.)
• You may experience skin irritation and burns beneath the stimulation
electrodes applied to your skin.
• You may experience headache and other painful sensations during or
following the application of electrical stimulation applied to your head, face,
and near your eyes.
• You Should stop using the device and should consult with your physician if
you experience adverse reactions from the device
ADVERSE REACTIONS
PRECAUTION


SAFETY GUIDE
WHO SHOULD NOT USE THE COMPEX EDGE
Check the following list of 17 questions:
If you answer “Yes”, or “Maybe” , or “I don’t know” to one or more questions, do not
use the device and contact DJO, LLC for more information.
If you have 15 “No” answers, you can use the Compex Edge.
Questions Yes/No
1 Do you have a cardiac pacemaker, debrillator, or other im-
planted metallic or electronic device?
2 Have you ever been diagnosed or suspected of having
Epilepsy?
3 Have you recently been victim of an acute trauma
(less than 6 months)?
4 Have you recently been subject to a surgical procedure
(less than 6 months)?
5 Do you have blood ow deciency in your lower limbs?
6 Do you have an abdominal or inguinal hernia?
7 Do you suer from cancer?
8 Are you pregnant?
9 Have you ever suered from or been diagnosed with cardiac
problems or diseases?
10 Do you have painful or aicted joints?
11 Do you have muscle spasms?
12 Do you have atrophied muscles?
13 Do you have a tendency to bleed internally, such as fol-
lowing an injury or fracture?
14 Do you need muscle reeducation?
15 Do you have any joint showing a decrease in its range
of motion?
16 Are you in the presence of electrical monitorying equip-
ment (e.g., cardiac monitors, ECG alarms)?
17 Are you under the age of 22 yrs old?
DJO, LLC
Toll free: 1-877-266-7398 (877-COMPEX8)


HOW DOES ELECTROMUSCULAR STIMULATION EMS
WORK?
The principle of electrostimulation is to stimulate nerve fibers by means of electrical
impulses transmitted by electrodes. The electrical pulses generated by Compex Sport
Elite stimulator are high quality pulses - offering safety, comfort and efficiency.
The motor nerves, to stimulate a muscular response. The quantity and the benefits
obtained depend on the stimulation parameters and this is known as electro-
muscular stimulation (EMS).
ELECTROMUSCULAR STIMULATION EMS
In voluntary activity, the order for muscular work comes from the brain, which sends
a command to the nerve fibers in the form of an electrical signal. This signal is then
transmitted to the muscular fibers, which contract. The principle of electrostimulation
accurately reproduces the process observed during a voluntary contraction. The
stimulator sends an electrical current impulse to the nerve fibers, exciting them.
This excitation is then transmitted to the muscular fibers causing a basic mechanical
response (= muscular twitch). The latter constitutes the basic requirement for
muscular contraction. This muscular response is completely identical to muscular
work controlled by the brain. In other words, the muscle cannot distinguish whether
the command comes from the brain or from the stimulator. The parameters of the
Compex Sport Elite programs (number of impulses per second, contraction time, rest
time, total program time) subject the muscles to different types of work, according
to muscular fibers. In fact, different types of muscular fibers may be distinguished
according to their respective contraction speed: slow, intermediate and fast fibers.
Fast fibers will obviously predominate in a sprinter, while a marathon runner will
have more slow fibers. With a good knowledge of human physiology and a perfect
mastery of the stimulation parameters of the various programs, muscular work
can be directed very precisely towards the desired goal (muscular reinforcement,
increased blood flow, firming up, etc.).
INTRODUCTION
Electrical
pulse
Stimulated
muscle
Elementary mechanical response - Twitch
Transmission
of the excitation
Excitation
Motor
nerve


BENEFITS OF ELECTROMUSCULAR STIMULATION EMS
INTRODUCTION
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION TENS
Pain, whether chronic (long-term) or acute (short-term), can be relieved through
a variety of methods, including drugs, topical ointments, surgery, and electrical
stimulation. TENS devices deliver electrical pulses through the skin to the cutaneous
(surface) and afferent (deep) nerves to control pain. Unlike drugs and topical
ointments, TENS does not have any systemic side effects.
HOW DOES TENS CONTROL PAIN
TENS provides pain relief in two ways. One is the gate control mechanism. When the
body is injured, both pain and non-pain impulses are sent to the brain from the nervous
system. These pulses travel through nerves in your skin to deeper nerves, and then to the
spinal cord and brain. Along the path are many areas referred to as “gates”. These gates
determine which impulses are allowed to continue to the brain. The gates prevent the
brain from receiving too much information too quickly.
Since the same nerve cannot carry a pain and a non-pain impulse at the same time, the
stronger, non-pain impulse from the TENS device “controls the gate”.
The other mechanism of pain control is endorphin release. The TENS device can trigger
the body’s natural pain killers, called endorphins. These chemicals interact with receptors,
blocking the perception of pain. This is similar to the way the pharmaceutical drug,
morphine works, but without morphine’s side effects.
Electrostimulation is a very effective way to make your muscles work:
• with significant improvement of different muscular qualities
• without cardio-vascular or mental fatigue
• with limited stress on the joints and tendons. Electrostimulation thus allows a
greater quantity of work by the muscles compared with voluntary activity.
To be effective, this work must involve the greatest possible number of muscular
fibers. The number of fibers working depends on the stimulation energy. The
maximum tolerable energy should therefore be used. The user controls this aspect
of stimulation. The higher the stimulation energy, the greater the number of
muscular fibers that are working and, therefore, the more significant the progress
achieved. To maximize results, DJO, LLC recommends that you complement your
electrostimulation sessions with other efforts, such as:
• regular exercise
• proper and healthy nutrition