Complementary
Medical Products Ltd.
225
East 36th Street #15C
New York, NY 10016
Tel: (212) 779-2342
Complementary
Medical Products Ltd.
may be reached by e-mail
at:
Info@Reiddds.com
Caution: In some countries
including the U.S.A.,
the Alpha-Stim 100 may
only be used with a prescription
from a licensed health
care practitioner.
- Copyright
1992 by Electromedical
Products International,
Inc. ALL RIGHTS RESERVED
- Alpha-Stim
is a registered trademark
of Electromedical Products
International, Inc.
CONTENTS
INTRODUCTION
Congratulations on your
selection of the Alpha-Stim
100 microcurrent stimulator
(an advanced form of transcutaneous
electrical nerve stimulation,
or "TENS"). You have purchased
a quality medical instrument.
In so doing, you have
already taken the first
step to a more comfortable
and rewarding life.
Electromedical
Products International,
Inc. (EPII) is a leading
innovator of the finest
state-of-the-art medical
technology available to
improve the quality of
your life. EPII is dedicated
to helping those who use
our products. We have
technical experts available
to assure you receive
the best possible care.
Consultations with you
or your doctor may be
scheduled Monday through
Friday, 10 AM until 3
PM, Pacific Time. The
company also stands behind
all our products with
a five year warranty.
The Alpha-Stim
100 is a precision medical
instrument used for the
management of pain. This
treatment is non-invasive
and drug-free. The Alpha-Stim
100 provides a welcome
alternative to drugs,
especially in painful
disorders that require
long-term management.
Unlike drugs, the Alpha-Stim
100 leaves the mind alert.
Any danger of accidental,
intentional, and/or suicidal
overdose of drugs is avoided.
After treatment, there
are no physical limitations
imposed so you can resume
normal activities. The
treatment is simple and
can easily be self-administered
at any time. People using
the Alpha-Stim 100 will
often report a pleasant
relaxed feeling of well
being along with their
pain relief.
The current
is applied by easy-to-use
self-adhesive electrodes
or hand-held probes. During
a treatment you may experience
a mild tingling sensation
as a result of the stimulating
current flow.
The Alpha-Stim
100 is often the only
means required to relieve
pain. However, it may
also be added to other
therapy prescribed by
your doctor. The Alpha-Stim
100 will not interfere
with most other treatments,
including most drugs.
You will
find the Alpha-Stim 100
is very easy to use. Please
read this entire booklet
thoroughly before using
it. Be sure to follow
the general instructions
given herein, and the
specific directions from
your doctor.
A
NOTE TO DOCTORS
Thank
you for prescribing the
Alpha-Stim 100. This manual
is written for the end-user,
but your input will be
invaluable to your patient.
One way to help is to
explain to the patient
using this device exactly
where his or her problem
is located, and any specific
electrode locations that
might work best.
PAIN
Have you ever wondered
what pain really is?
The ancient
Greeks called pain an
emotion, the opposite
of pleasure. This "definition"
was the most widely accepted
theory for pain until
the 17th century when
Rene Descartes noted that
there are specific cells
throughout our bodies
which receive pain stimuli.
These "receptors" convert
the stimuli into electrical
messages which travel
along specific nerve pathways
to the brain where the
message is recognized
as pain.
In the
1800's physiologists recognized
patterns in people who
suffered from pain. They
concluded that seemingly
unrelated and often non-painful
events add up over a period
of time until even a minor
disturbance can trigger
pain.
Today,
pain is understood to
be a complex event occurring
throughout our nervous
system. A delicate balance
is maintained between
nerves that carry pain
messages. The brain also
produces chemicals called
endorphins that help to
block pain.
Pain
is the symptom which most
often causes us to seek
out medical care. Acute
pain is pain caused by
a recent injury or illness.
It helps to alert us when
something is wrong. This
type of pain usually lasts
a few days to months,
until the problem which
first caused it is solved.
Chronic
pain is pain that persists
or recurs for a prolonged
period of time. This is
the type of pain which
stems from ailments such
as arthritis and other
joint problems, certain
back conditions, injuries
and accidents, and many
other problems concerning
the nerves, muscles, and
bones.
Drugs
are often effective in
blocking acute pain. We
certainly would not be
able to go through surgery
without them. But drugs
also have side effects
which may require us to
limit such necessary activities
as driving a car. For
the chronic pain sufferer
drugs are often not effective
enough. This is why, in
this age of microelectronics,
electrical stimulation
has been re-discovered
and is being found to
be an effective means
of managing pain with
the least side effects.
ELECTROMEDICAL
THERAPEUTICS
The application of electromedical
currents is not a new
concept. Ancients recognized
the therapeutic value
of naturally occurring
electrical phenomena long
before William Gilbert
defined electricity in
1600. Both Aristotle and
Plato refer to the Black
Torpedo (electric ray
fish) prescribed in 46
A.D. by the physician
Scribonius Largus for
the relief of a variety
of medical conditions
from headaches to gout.
In the 1800's dentists
reported excellent results
using crude electrical
devices for pain control.
By the turn of this century,
electrical devices were
in widespread use to manage
pain and "cure" everything
from cancer to impotency.
Because of the unrefined
early electrical technologies
and strength of the pharmaceutical
lobbies, this form of
therapy fell into disrepute
by the medical profession.
As a result, medical colleges
stopped teaching electrotherapeutics.
Biophysics was virtually
eliminated from medical
practice leaving chemistry
as the master science
and with it the burden
of responsibility for
curing all of mankind's
ills. Now that we are
approaching the turn of
another century it is
clear that the sole explanatory
chemical model has not
lived up to its promise
causing modern medicine
to re-examine the role
of biophysics.
In 1965
Drs. Ronald Melzack of
Canada and Patrick Wall
of the U.K. published
a paper explaining a new
comprehensive theory of
how pain is processed
by our nervous systems.
This theory also explained
how electrical stimulation
can influence the physiology
of pain. By 1967 electrical
devices were surgically
implanted to control severe
low back pain. Shortly
thereafter, surface electrical
units were used to test
the person's response
as a means of screening
suitable surgical candidates.
It was soon discovered
that these surface electrical
stimulators were also
effective and they could
be used for the relief
of pain without the surgery.
Since then, these devices,
known as transcutaneous
electrical nerve stimulators
(TENS), have become widely
accepted by doctors and
dentists to control most
forms of pain.
Medical
science has established
that there are extensive
electrical fields at work
in the body. The nervous
system, for example, has
long been known to work
through both electrochemical
and purely electrical
signals. In fact, all
molecules are held together
by electrical bonding
at the atomic level. This
knowledge has led medical
scientists such as Dr.
Robert Becker of the U.S.A.
and Dr. Björn Nordenström
of Sweden (who served
as Chairman of the Nobel
Assembly) to propose new
theories of physiology
based on bioelectrical
control systems.
Over
the past decade, technology
has surpassed chemical
analysis for the diagnostic
side of medicine. With
Alpha-Stim technology,
therapeutic intervention
based on the new
biophysics is finally
emerging as a viable alternative
to pharmacological management
and surgery. The original
Alpha-Stim Model 2000
weighed 40 pounds and
cost $5,850 when it was
first introduced in 1981.
The Alpha-Stim 100 microcurrent
stimulator utilizes the
most advanced technology
available today. We hope
it will help to control
your pain and improve
the quality of your life.
HOW
TO USE THE ALPHA-STIM
100
1.
Check battery
Be sure you are
using a good, fresh alkaline
battery such as the one
provided with the unit.
Replace the battery when
the display indicates
BATT LOW. Once the display
indicates BATT FLAT the
Alpha-Stim 100 will discontinue
stimulation until a new
battery is installed.
2. Connect electrode wires
to Alpha-Stim
Plug L-shaped jack into
the output receptacle
on the Alpha-Stim. The
top receptacle is for
channel 1, the bottom
is for channel 2.
3. Attach electrodes to
wires
Insert the pin jacks into
the wire coming off the
self-adhesive electrodes.
Push gently, but firmly
into place for a good
connection. Note that
the electrode wires are
only split a few inches
apart. They may be pulled
apart further to allow
more distance between
the electrodes.
4.
Clean skin
Clean skin thoroughly
around the treatment area
and allow it to dry thoroughly
before applying electrodes.
Use mild soap and water
or 70% isopropyl alcohol.
5.
Evaluate your pain
It is a good idea to evaluate
your pain before and after
each treatment. Your doctor
can give you guidelines
to help you do a quick,
simple evaluation. This
may consist of simply
noting the level of pain
you are experiencing at
the beginning and end
of the treatment, or moving
the affected body part
through a range of motion
and noting the increased
range along with the decreased
pain after treatment.
Keeping a daily (or even
as often as hourly) chart
of changes in your pain
levels on a 0 (no pain)
to 10 (maximum pain) scale
will assist your doctor
in giving you the best
possible advise. To help
you understand this system,
a description of pain
levels follows (use odd
numbers for half values):
| PAIN LEVEL |
DESCRIPTION |
10
EXCRUCIATING, often
debilitating.
8
INTOLERABLE, concentration
difficult, able to
perform certain tasks
of an undemanding
nature.
6
DISTRESSING, but able
to continue tasks.
4
DISCOMFORTING, may
be ignored at times.
2
MILD, only aware of
it when attention
is brought to it.
0
NO PAIN. |
It
is also helpful to keep
a record of the Alpha-Stim
treatment times with the
intensity and frequency
(Hz) settings, along with
the electrode locations
you use.
Some
questions that will help
you and your doctor understand
your pain are:
When
did it start?
Is there a position that
lessens or increases it?
Is there anything you can
do to lessen or increase
it?
Does it feel deep under
the skin or superficial?
Are there any particularly
sensitive spots you can
point to with one finger?
Is it always in the same
place or does it move around?
Are you having other symptoms
which may be associated
with your pain?
How does it change throughout
the day or week?
What words describe it?
6. Place electrodes
Where you place the electrodes
is the most important
variable for optimum results.
You must always use electrodes
in pairs (one pair for
each channel). Peel the
self-adhesive electrodes
off of the protective
backing and save the backing
to store the electrodes
after use. If the adhesive
is drying out and the
electrodes do not stick
well, you may wet the
electrodes by wetting
your finger with water
and lightly rubbing it
over the electrode for
just one second (more
time will saturate them
and actually shorten their
life). Discard and
replace electrodes when
adhesive has split or
worn through to the conductive
backing. Only use EPII
electrodes available through
your authorized Alpha-Stim
dealer. Some electrodes
are as much as 20 times
less conductive and will
not allow the Alpha-Stim
current to penetrate the
skin resistance.
Follow your physician's
recommendations or use
the following electrode
placement guidelines:
Visualize where your
pain is or where your
doctor has determined
your pain is originating
from. If possible, place
one electrode directly
over the area of pain,
and the other where an
imaginary line drawn between
the two electrodes would
go directly through the
area of pain to the opposite
side of that part of the
body. If it is not possible
to place one directly
over the painful area,
or if that does not produce
the best results, then
still place the two electrodes
in such a way that a line
drawn between them would
go through the area of
pain. Keep in mind that
the body is three dimensional
and many different lines
can be drawn through your
pain. One of these
lines should work better
than the others. Therefore
the best electrode location
for you is the one that
works best for you. Several
attempts to find the best
electrode locations are
usually necessary. The
results are often better
when both pairs (channel
1 and 2) of electrodes
are used together. When
using both pairs, place
the electrodes in a "X"
pattern so that they cross
where the pain is. After
treatment the pain may
move around. This will
require moving the electrodes
to "follow" the pain.
Do not
place the electrodes too
close together. For example,
one right next to each
side of the spine is not
a good placement for back
pain. In this example
the current will travel
just under the surface
of the skin to the other
electrode and not penetrate
to the area requiring
treatment. Here it would
be better to put one electrode
next to the spine and
the other on the opposite
side of the body, on the
side, near the front.
Use the other pair (channel
2) in the same manner
on the other side, or
move the first pair to
the other side after a
few minutes. Another possible
electrode placement for
back pain is to place
one on each side of the
body (between the shoulders
and the hips) and at the
level of pain. Finally,
back pain may respond
to one pair of electrodes
on the right shoulder
and left hip, with the
other pair on the left
shoulder and right hip.
You will have to experiment
until the best location
is found. Be sure to discuss
this with your doctor
initially, and again from
time-to-time.
Probes
A probe
is included to stimulate
through multiple electrode
sites for brief, 10 second
intervals at each location.
Use the same wires for
the probes as described
previously for the self-adhesive
electrodes. One probe
may be used with a self-adhesive
electrode, or two probes
may be used to maximize
the angles of approach.
A few minutes of probe
treatment is equivalent
to 20 minutes with the
self-adhesive electrodes
because the current is
more concentrated through
a smaller area. The electrodes
for the probes are self-adhesive
felts that must be saturated
with tap water to work.
When using the probes,
first attach the felt
to the probe, then dip
the felt in tap water
frequently, and replace
the felt when it becomes
worn. It is the minerals
in the water that conduct
the electricity. Distilled
water will not work.
A pinch of salt may be
added to improve the conductivity,
but in most areas tap
water works fine.
7.
Set the timer
The amount of time needed
to effectively manage your
pain depends on the cause
and severity of your pain,
your overall health, and
any ongoing physical or
psychological stress that
might make your condition
worse. Ten or twenty minutes
are the recommended treatment
times when using the self-adhesive
electrodes unless otherwise
specified by your doctor.
Additional treatment time
is usually not necessary,
but will not do any harm.
The exception to this
is that some patients have
reported a return of their
pain with excessive treatment.
If this occurs wait a day
or more (up to one week)
before resuming treatment.
When using the Alpha-Stim
100 to manage pain more
treatment time is not better!
If the pain is fully
relieved, it is usually
best to stop treatment at
that time and then repeat
the treatment as necessary.
To prevent the reoccurrence
of pain, the Alpha-Stim
100 used every other day
is actually more effective
for most people than when
used daily. However, some
people will require initial
and possibly ongoing daily
treatments for hours at
a time.
The results you
get determine what is best
for you.
The display
will count backwards with
all timers except CONT
(continuous). CONT counts
forward to 99 hours, 59
minutes and 59 seconds
before shutting the output
off. The PROBE timer counts
backwards for 10 seconds
then goes off for 2 seconds,
on for 10, etc. This allows
brief, 10 second treatments
of the problem through
many different angles
(lines) and is preferred
by most experienced Alpha-Stim
health care practitioners.
The LCD timer will display
the countdown. As an example,
when using the PROBE timer
the display will actually
read 9 seconds to 0 of
STIMULATION ACTIVE, then
1 to 0 of STIMULATION
INACTIVE.
8.
Set the frequency
Use 0.5 Hz unless otherwise
specified by your doctor.
Sometimes 100 Hz is best
for the initial treatment
(first 3 minutes of a session)
of certain types of pain
accompanied by inflammation.
1.5 Hz may be more effective
than 0.5 Hz in some people.
9. Turn power on and set
the intensity
First make sure the intensity
controls are set at a low
level (no more than 3).
Then turn the POWER on.
The LCD will read STIMULATION
ACTIVE and start to count
down for all settings except
CONT (continuous). Turn
INTENSITY (current control)
knob(s) up
very slowly.
Most people can take the
full amount of current,
but some people are more
sensitive and must use a
lower current. Immediately
decrease the intensity if
a tingling feeling under
the electrodes becomes uncomfortable,
or if dizziness or nausea
develops. This may happen
while you turn up the intensity,
or several minutes later.
Decreasing the intensity
will immediately relieve
any of these unpleasant
feelings and they are not
necessary for optimal effect.
Because the Alpha-Stim 100
uses such a low level of
current, many people do
not feel anything at all,
even with the INTENSITY
all the way up to the maximum
level of 6 (600 µA).
Do not be concerned if
this is the case with you.
It is perfectly normal and
your perception of the current
will not effect the results.
Once
the POWER is turned on
the timer setting will
determine the amount of
time the Alpha-Stim will
remain operational. If
a second set of electrodes
are added while the Alpha-Stim
is running, the second
channel will only provide
stimulation for the amount
of time remaining on the
LCD.
10.
Turn power off
At the end of the timed
cycle the display will read
STIMULATION INACTIVE and
the timer will read 0:00:00.
There will still continue
to be a slight drain on
the battery until the POWER
switch is turned off. To
save battery life,
do
not forget to turn the power
off.
11.
Remove electrodes
Carefully replace the electrodes
on their protective backing
and put them back in the
sealable bag they came in.
If you are keeping a log,
record your pain level now
and note the time interval
until the pain returns.
ONE
BUTTON OPERATION
After
you have used the Alpha-Stim
100 once, you may simply
place the electrodes and
turn the POWER button
on. That's all there
is to it! If necessary,
adjust the current up
or down to a comfortable
level at any time during
treatment.
SKIN
CARE
- Apply electrodes on
dry, clean unbroken
skin only.
- Before applying and
after removing electrodes,
wash skin with mild
soap and water or 70%
isopropyl rubbing alcohol.
Rinse and allow to dry
completely.
- Excess hair at the
electrode site should
be clipped but not shaved.
- If skin irritation
develops discontinue
use and consult your
physician.
WHAT
TO EXPECT
In most instances, the process
of change takes time. Although
some people will experience
results during or directly
following treatment, some
people will not achieve
an effect until as late
as the morning after the
treatment. Initially, you
may require five to seven
or more sessions before
the effects will be noticed.
If no change is noticed
after ten treatments, and
several electrode placement
sites have been tried, the
use of Alpha-Stim should
be reevaluated by the prescribing
doctor.
Although
a tingling sensation is
sometimes felt under the
electrodes, it is not
necessary to feel this
in order to achieve results.
The current should
never be kept at a level
that is uncomfortable.
The treatment
may leave you feeling
relaxed, but alert. Frequently,
people report an increase
in their energy level.
If you are having trouble
falling asleep, the treatment
should not be taken within
three hours of going to
bed or the increased alertness
may prevent sleep.
If anxious
or "hyper" feelings occur
during treatment, discontinue
use and consult your physician.
DESCRIPTION
The Alpha-Stim 100 is a
precision medical instrument
which generates low intensity
electrical current pulses
(up to 600 millionths of
an ampere) of controllable
intensity and frequency
of pulses (Hz). Results
in electromedicine are based
on the design of the wave
form, the amount of current
(intensity), the location
of the electrodes, and the
amount of time it is used.
The Alpha-Stim 100 actually
has three wave form generators;
one for each channel and
another common to both channels
that serves to add random
factors to avoid accommodation
by the nervous system. The
Alpha-Stim 100 is actually
a microcomputer, incorporating
the latest advances in solid
state electronics. All components
are of the highest quality
available to assure the
user the ultimate in reliable
and trouble-free performance.
The instrument's design
assures electrical safety
to the user by the use of
readily available 9 volt
batteries.
The Alpha-Stim
100 is small, compact
and light-weight. Its
design lends itself well
to treatment in a health
practitioner's office,
clinic or hospital as
well as self administered
treatment at home under
a doctor's direction.
The controls
are simple and easy to
operate. An adjustable
interval timer assures
the prescribed treatment
time even if you are distracted
or fall asleep. The amount
of current can be easily
modified for maximum comfort
and effectiveness. The
frequencies can be selected
at either the standard
0.5 Hz, or 1.5 Hz, or
100 Hz.
One important
feature incorporated into
the Alpha-Stim 100 is
an electronic circuit
which operates to maintain
a nearly constant current
flow to the electrodes,
minimizing the effects
of electrode resistance
variations due to poor
electrode-to-skin contact.
Indications
Electromedical therapy is
continuously being subjected
to rigorous study and evaluation
by the international medical
community. Findings to date
indicate that the Alpha-Stim
100 is an effective treatment
with broad applications
for a variety of syndromes
involving pain. It may be
sufficient, in many cases,
as the sole therapeutic
method required. Effective
results have been seen during
and/or subsequent to stimulation
over effected body parts,
adjacent areas, and areas
removed from those in pain.
As with any therapeutic
intervention, not all patients
will respond to the Alpha-Stim
100. The degree of efficacy
will vary both with the
individual and the nature
of the problem being treated.
Accordingly, a trial evaluation
on each individual is recommended
to determine the best possible
electrode locations and
to ascertain whether or
not therapeutic benefit
can be derived from long-term
treatment.
The risk/reward
ratio for the Alpha-Stim
100 ranks exceedingly
high when compared to
pharmacological treatments
for the indicated disorders.
Typically,
one 10 to 20 minute treatment
session every other day
is sufficient to manage
the conditions for which
the Alpha-Stim 100 is
prescribed. However, some
people will find that
more (or less) treatment
is more effective for
their unique pain disorder.
Contraindications
Absolute contraindications
have not been established.
Precautions
For external use only. The
Alpha-Stim 100 may affect
the operation of cardiac
pacemakers (particularly
demand type pacemakers);
it is not recommended for
use by these patients. Do
not stimulate directly on
the eyes. Do not stimulate
over the carotid sinus (upper
side of neck). Do not allow
children to use or handle
this device without adult
supervision. Do not operate
potentially dangerous machinery
or vehicles during periods
of stimulation. Safety of
stimulation has not been
established during pregnancy.
Caution is advised in cases
where other forms of analgesia
would not be used; such
as to retain the beneficial
aspects of pain for diagnosis
or in cases where patients
may overuse pain-controlled
areas. Use only for the
purpose for which it is
prescribed.
Adverse
Effects
No clear documentation of
adverse effects exists to
date. No deaths or serious
injuries have been reported
following the use of any
TENS. The most common area
of concern in using electrical
devices is skin reactions
at the electrode sites.
To minimize this problem,
clean the skin prior to
use. Cleaning the skin will
also assure better electrode
contact. If skin irritation
occurs, consult your physician.
Caution
Federal Law (USA only)
restricts this device
to sale by or on the order
of a licensed health care
practitioner.
TECHNICAL
SPECIFICATIONS
Mechanical
- Alpha-Stim
100
- Height
5.31 inches
- Width
2.56 inches
- Depth
1.25 inches including
belt clip
- Weight
6.00 ounces
- Weight
with battery 13.50 ounces
- Carrying
Case
- Height
8.19 inches
- Width
10.63 inches
- Depth
1.81 inches
- Shipping
Weight With Unit 3.00
pounds
Electrical
- Power Source One 9
volt alkaline battery
(included)
- Timer Settings Probe:
10 seconds on alternating
with 2 seconds off;
10, 20, 60 minutes;
and continuous for 100
hours.
- Current (intensity)
10 to 600 microamperes
continuously adjustable
- Frequency 0.5, 1.5,
and 100 Hz (pulses per
second)
Accessories
The Alpha-Stim 100 is packaged
complete with one set of
self-adhesive electrodes
(good for up to one month
of use), electrode wires,
one probe, a 9 volt alkaline
battery and Owner's Manual.
Additional optional accessories
are available in most areas.
TROUBLE
SHOOTING
PROBLEM POSSIBLE SOLUTIONS
There is no sensation of This is normal for many people.
current. Turn up the INTENSITY.
There is no results. Try 5 to 10 treatments sessions.
Vary the electrode locations.
Try 1.5 Hz if 0.5 Hz is ineffective.
Treat more often or for longer
periods.
Consult your doctor.
There is no output. Change the battery if BATT FLAT.
Turn up the INTENSITY.
Check lead wires and electrodes:
make sure all connections are firmly
in place.
Electrodes do not stick well. Replace electrodes.
SERVICE:
To obtain service, first
call your authorized Alpha-Stim
distributor. If necessary,
send the entire unit with
the carrying case and
accessories, insured,
postage prepaid, and well
packaged, along with a
copy of your original
invoice and a note describing
the problem to Electromedical
Products International,
Inc. Please do not
forget to include your
return address and phone
number.
