ALPHA-STIM M User manual

Electromedical Products International, Inc.
2201 Garrett Morris Parkway
Mineral Wells, TX 76067-9034 USA
Toll Free: 1-800-FOR-PAIN (367-7246)
Tel: [phone] Fax: [phone]
Email: [email protected]om
Web: www.alpha-stim.ca
LET NOTHING STOP YOU.™
Alpha-Stim®M
microcurrent & cranial
electrotherapy stimulator
Owner’s Manual

1
Alpha-Stim®M
Microcurrent and Cranial Electrotherapy Stimulator
For Control of Insomnia and Pain
OWNER'S MANUAL
Type BF Equipment. This stimulator is internally powered only.
See instructions for use. Read this manual thoroughly before using the
device. Do not plug lead wires into wall sockets or line cord receptacles
underanycircumstances. Doingso could resultin severe shock or burns
whether the lead wires are attached to the stimulator or not.
Medical Electrical Equipment classified by Underwriters Laboratories
Inc.®with respect to electric shock, fire, mechanical and other specified
hazards only in accordance with UL-60601-1 and CAN/CSA C22.2 No.
601.1.
Conformity Statement for Europe: Alpha-Stim®M is a Class IIa, Type BF
medical device. It has been independentlytested by outside agencies in
order to provide assurance of conformity to applicable standards for
medical equipment safety and electromagnetic compliance.
When the end-user wishes to discard this product, it must be sent to
separate collection facilities for recovery and recycling. By separating
this product from other household-type waste, the volume of waste sent
to incinerators or land-fills will be reduced and natural resources will thus
be conserved.
Caution Statement: Federal law (USA) restricts this device to sale by, or on the
order of a licensed health care practitioner.
© Copyright 2017 by Electromedical Products International, Inc. ALL RIGHTS
RESERVED. Alpha-Stim® is a registered trademark. Manufactured under U.S.
patents 8,612,008, 8,457,765, 8,463,406 and Worldwide Patents Pending.
Rev F Canada

2
Features .................................................................................................................................................. 3
A Note to Health Care Practitioners ............................................................................................ 4
Control Buttons.................................................................................................................................... 5
LCD Display ........................................................................................................................................... 6
Introduction. ......................................................................................................................................... 8
Description ............................................................................................................................................ 9
Electromedical Therapeutics. .........................................................................................................10
Using the Alpha-Stim®M for Pain Control: Clean Skin, Evaluate Your Pain...............13
Use the Alpha-Stim®M with Confidence.................................................................................14
Quick Guide.........................................................................................................................................14
Microcurrent Electrical Therapy (MET) To Treat Pain with Smart Probes ....................15
Smart Probe Treatment Strategy A ............................................................................................18
Smart Probe Treatment Strategy B ............................................................................................21
To Treat Pain with AS-Trode™ Electrodes ...............................................................................22
Cranial Electrotherapy Stimulation (CES) To Treat Insomnia with Earclip
Electrodes...................................................................................................................................24
What to Expect...................................................................................................................................26
Prescribing Information: EPI is ISO Certified, Electromagnetic Interference,
CE Conformity Statement for Europe, Caution Statement for United States and
Canada, Indications ................................................................................................................27
Prescribing Information Continued: Contraindications, Precautions, Adverse
Effects ..........................................................................................................................................28
Technical Specifications..................................................................................................................29
Storage and Cleaning......................................................................................................................30
Trouble Shooting ..............................................................................................................................30
Service...................................................................................................................................................31
5 Year Limited Warranty.................................................................................................................31

3
The Alpha-Stim®M (Part No. 400) comes complete and ready to use with 1 set
of Earclip electrodes (Part No. 401), 1 15-ml bottle of Alpha Conducting
Solution™ (Part No. ACS, 250-ml refill bottles available, Part No. ACSR), 2 sets
of lead wires for 4 electrodes (Part No. 403), 2 Smart Probes (Part No. 402),
4 silver AS-Trode™ brand single person multiple use self-adhesive electrodes
(Part No. AT, good for approximately 2 weeks to 1 month of use), 100 Probe
Electrode Pads (Part No. PEP), 256 Earclip Electrode Pads (Part No. EEP),
Illustrated Owner’s Manual, Lanyard, Storage Case, and 2 AA batteries. This is
everything you need to begin using your new Alpha-Stim®M. Replace Alpha
Conducting Solution™, AS-Trode™ brand electrodes, Probe Electrode Pads
(PEPS™) and Earclip Electrode Pads (EEPS) only with authorized Alpha-Stim®
and AS-Trode™ brand products. For best performance, we recommend using
lithium batteries.
Alpha-Stim®M features include:
1. Full digital control for precision, consistency and reliability.
2. Choice of Earclip electrodes, Smart Probes, or AS-Trode™ electrodes.
3. Back lighting when any button is pressed.
4. Continuous circuit checks when electrodes are in contact with skin.
5. 3 frequency selections (0.5 Hz recommended).
6. 10 second Smart Probe cycle begins on contact with skin.
7. 10, 20, 40 or 60 minutes countdown cycles to auto-off.
8. Continuous time elapsed timer.
9. Large timer display.
10. 2 independent channel controls providing 0 - 600 microamperes (µA) of
current.
11. Frequency, current and treatment time may be locked to preset values
throughout entire treatment session.
12. Mute option for all functions (except Smart Probe).
13. Cumulative timer.

4
14. Choice of belt clip or lanyard so the Alpha-Stim®M can be worn around
the neck.
15. 30 minute auto-off when not in use.
16. Able to withstand electrostatic discharges of up to 6,000 volts.
17. Automatically and permanently disables itself should a single fault
develop within the device causing the current to exceed 700 µA.
18. Uses 2 AA 1.5 volt batteries (included).
19. Battery strength indicator.
20. Probe Electrode Pads (PEPS™) and Earclip Electrode Pads (EEPS) requires
Alpha Conducting Solution™ (included).
21. 5 year limited warranty.
Thank you for recommending the Alpha-Stim®M. This manual is written for the
person who will use the Alpha-Stim®M, but your input will be invaluable to
your patient. One way to help is to explain to your patient exactly where his or
her problem is located. You might also suggest specific electrode locations
where a particular pain may be originating from. Electromedical Products
International, Inc. is available to help serve the needs of your patients. New
research is often available that may have a direct bearing on a patient's specific
disorder. Feel free to write, call, fax, or email EPI for any reason at all. Also, check
the website regularly for new information. We welcome your input in the form
of testimonial letters or emails and participation in the forums on our website.
Electromedical Products International, Inc.
2201 Garrett Morris Parkway
Mineral Wells, TX 76067-9034 USA
Phone 1.800.FOR.PAIN or
940.328.0788
Fax [phone]
Email [email protected]
Web www.alpha-stim.ca

5
1. On - Off
2. Frequency. 0.5
Hz is the strongest
frequency setting and
the one most people
will achieve the best
results with for all
applications (Earclips,
Smart Probes and
AS-Trode™ electrodes).
3. Timer. Smart
Probe 10 second
waveform cycle starts
when electrodes touch
skin. Countdown timers:
select 10, 20, 40 or 60 minutes.
Continuous time elapsed timer.
4. Lock. Press 2 times within 5 seconds to lock or unlock settings
during treatment if desired.
5. or Current. Increases or decreases current for each channel.
Increases at 50 microamperes (µA) per second when held down.
Decreases at 100 µA per second. When the device is turned on, the
current defaults to 100 µA except on Smart Probe setting
which defaults to current setting from previous use.

6
1. Light Sensor lights LCD screen for 10 seconds in a dark room when any
button is pushed.
2. Test Circuit symbol and an audio warning indicates device is not
treating for one or both channels (the number of the Channel that is not
working will appear). The timer will stop and shut down in 30 minutes if
nothing else is done. Current must be set above 0 µA and moistened
electrodes must be in contact with skin for Alpha-Stim®M to work. An
audible signal and resumption of the timer occurs the instant the integrity
check circuit determines everything is working properly.
3. Battery Charge indicator. Replace battery when only 1 bar remains at
which time the device shall give out an audible low battery warning and
repeat the warning every 10 minutes (unless the mute function is on).

7
4. Frequency setting indicator. 0.5, 1.5, or 100 Hz for both Channels.
5. Timer setting indicator. Select Smart Probe 10
second cycle begins on contact with skin, 10, 20, 40 or 60 minutes
countdown to auto-off or Continuous count forward timer.
6. Time remaining on all settings except Continuous which shows time
elapsed.
7. 0 - 600 microamperes (µA) of
current for Channel 1.
8. 0 - 600 microamperes (µA) of
current for Channel 2.
9. Lock is on when display is lit.
10. Mute feature for all settings except Smart Probe. To turn on or off
press the key sequence: Lock-Timer-Lock.
11. ΣCumulative Timer records total hours and minutes Alpha-Stim®M has
been in use.

8
Congratulations on your selection of the Alpha-Stim®M Microcurrent Electrical
Therapy (MET) and Cranial Electrotherapy Stimulation (CES) device. You have
purchased a quality medical device. In so doing, you have already taken the first step
to a more comfortable and rewarding life.
Electromedical Products International, Inc. (EPI) is a leading innovator of the finest
state-of-the-art medical technology available to improve the quality of your life. EPI and
its distributors are dedicated to helping those who use our products. We have technical
experts available to assure you receive the best possible results from treatment.
Telephone consultations in English may be scheduled with you or your doctor Monday
through Friday, 9 AM until 5 PM, Central Time (Texas, USA). You may also communicate
with us by mail, fax, or email. The company stands behind all our medical devices with
a 5 year limited warranty.
The Alpha-Stim®M is a precision medical device used for the management of
insomnia and pain. Alpha-Stim®M provides a safe, effective and proven alternative
to drugs especially in disorders that require long-term management. Potential side
effects of drugs are avoided. After treatment, there are usually no physical
limitations imposed so you can resume normal activities. The treatment is simple
and easily self-administered at any time. People using the Alpha-Stim®M usually
report a pleasant, relaxed feeling of well-being accompanied by an alert mind.
The current is applied by hand-held Smart Probes or self-adhesive AS-Trode™
electrodes for pain control, or by Earclip electrodes for insomnia. During a treatment
you may experience a mild tingling sensation at the electrode sites. If the current is
too high, you might experience dizziness and nausea which can be alleviated by
reducing the current.
The Alpha-Stim®M is often the only means required to relieve insomnia and
pain. However, it may also be added to other therapy. The Alpha-Stim®M will not
interfere with most other treatments except that it may rapidly reduce the
requirements for some medications by approximately one third to one half. Only a
physician is qualified to adjust medication dosages so keep your doctor informed of
your progress.
Once you understand the basic product features and procedures,you will find
the Alpha-Stim®M is easy to use. Please read this entire manual
thoroughly before using it. Be sure to follow the general instructions given herein
and any specific directions from your health care practitioner.

9
Results in electromedicine are based on the design of the waveform, the
amount of current, the location of the electrodes, and the amount of time it is
used. The Alpha-Stim®M is a microcomputer incorporating the latest advances
in solid state electronics. All components are of the highest quality available to
assure the user reliable and trouble-free performance. The design assures
electrical safety by the use of readily available 1.5 volt AA batteries.
The Alpha-Stim®M was developed through original research by
Electromedical Products International, Inc. It is a precision technology which
generates a modified square, bipolar waveform of 0.5, 1.5, or 100 Hz (pulses per
second), at 50 to 600 microamperes (1 µA is one-millionth of an ampere), in a
50% duty cycle.
The Alpha-Stim®M is small, compact and light-weight. It was designed to
be versatile. It can be used in a health care practitioner's office, clinic or hospital,
for portable and quick response needs such as emergency medical or military
applications, as well as for self-administered treatment at home on a scheduled
or as-needed basis.
The controls are fully digital for precision, consistency and reliability and at
the same time simple and easy to operate. An adjustable timer and a locking
option that freezes the treatment time, frequency and current assures the
prescribed treatment waveform and dosage even if you are distracted or fall
asleep. The amount of current can easily be decreased to assure comfort or
increased to reduce treatment time.
The Alpha-Stim®M may be categorized into two general categories.
Microcurrent Electrical Therapy, or MET, is a generic term used to describe low
level current used for pain control typically applied for 2 to 5 minutes through
probes, or self-adhesive electrodes for longer applications. The second
category, represented by the application using the Earclip electrodes to treat
the brain for insomnia is known as Cranial Electrotherapy Stimulation, or CES.
One important feature of the Alpha-Stim®M is an electronic circuit which
operates to maintain a nearly constant current flow to the electrodes
minimizing the effects of electrode resistance variations. The Alpha-Stim®M
continuously performs self-diagnostics to assure that all aspects of the circuitry
are always working properly and the electrodes are making adequate contact

10
with the skin. Ergonomic and user-friendly features (such as the Smart Probe,
lock, auto-off timers and alarm that warns you if an electrode falls off) make the
Alpha-Stim®M reliable, easy, quick, and fun to use.
The Alpha-Stim®M was developed by neurobiologist, Dr. Daniel L. Kirsch
and engineer, Raymond Chan. Dr. Kirsch has been a leading pioneer in the field
of electromedicine since 1972. He was board-certified in pain management by
the American Academy of Pain Management from 1990 - 2015, and awarded
the Richard S. Weiner Pain Educator of the Year Award by AAPM in 2008. He
became a Fellow of the American Institute of Stress in 1997. He is also a Member
of Inter-Pain, the organization for pain physicians in Germany and Switzerland.
He is the Electromedical Department Editor of the journal, Practical Pain
Management and a Consulting Editor for the Journal of Neurotherapy. Dr. Kirsch
has served as Clinical Director of the Center for Pain and Stress-Related
Disorders at Columbia-Presbyterian Medical Center in New York City and the
Sports Medicine Group in Santa Monica, California. He is an author of books
and articles and lectures frequently to physicians and psychologists worldwide
on pain and stress management and is an expert research and practice
consultant to Veterans Affairs Medical Centers and the United States Army.
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
referred to the Black Torpedo (electric ray fish) prescribed in 46 AD by the
physician Scribonius Largus for the relief of a variety of medical conditions from
headaches to gout (head to foot). In the 1800s dentists reported pain reduction
using early and somewhat crude electromedical devices.
By the late 1800s electrical devices were in widespread use to manage pain
and claimed to cure a variety of medical disorders. The exuberant claims of early
electrical technologies facilitated by the political clout of the pharmaceutical
lobbies caused this form of therapy to fall into disrepute by the medical
profession in the early part of the 20th century. 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

11
of responsibility for curing all disease. Now, in the 21st century it is clear that
chemistry as the sole therapeutic model for medicine has not lived up to its
promise, causing modern medicine to re-examine the potential of biophysics.
Experimentation with low intensity electrical stimulation of the brain was
first reported by Drs. Leduc and Rouxeau of France in 1902. Initially, this method
was called electrosleep as it was thought to be able to induce sleep. Research
on using what is now referred to as Cranial Electrotherapy Stimulation (CES) for
treatment of insomnia began in Russia during the 1950s and first came to the
USA in the 1960s.
In 1965 Drs. Ronald Melzack of Canada and Patrick Wall of the United
Kingdom published a paper explaining a new comprehensive theory of how
pain is processed by the nervous system. Their Gate Control theory also
explained how electrical stimulation can influence the physiology of pain
pathways. By 1967 electrical devices were surgically implanted to control severe
low back pain. Surface electrical stimulation devices were used to test the
person's response as a means of screening surgical candidates and to
determine the most effective electrode site for implantation. It was soon
discovered that electromedical treatment through the skin (transcutaneous)
was equally effective and could be used for pain relief alone, avoiding surgery.
Since then, these devices, known as transcutaneous electrical nerve stimulators
(TENS), have become widely accepted by health care practitioners to control
many forms of pain.
All life is of an electrochemical nature. There are extensive electrical fields
at work throughout the universe and 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. Basic science research into the nature of
bioelectrical control systems in humans and animals led medical scientists such
as Dr. Robert O. Becker of the USA1and Dr. Björn Nordenström of Sweden2
(who served as Chairman of the Nobel Assembly) to propose completely new
theories of physiology based on our latest understanding of biophysics.
1Becker, Robert O. The Body Electric. New York: William Morrow and Co. 1985.
2Nordenström, Bjorn E.W. Biologically Closed Electric Circuits. Stockholm: Nordic
Medical Publications, 1983.

12
Alpha-Stim®technology incorporates these theories and is proven more
efficacious than most other treatments for the conditions it treats. It is a viable
alternative or complementary treatment with pharmacological management,
surgery and other interventions. The original Alpha-Stim®Model 2000 weighed
40 pounds and cost $5,850 when it was first introduced in 1981. The Alpha-
Stim®M microcurrent stimulator utilizes the most advanced technology
available today. It is now possible, in most cases, to alleviate insomnia and pain
with far less current than used in previous technologies, and experience long
term and cumulative relief with as little as only a few minutes of treatment every
other day. When used properly, we trust your new Alpha-Stim®M will improve
the quality of your life.

13
Clean Skin
Clean the skin around the treatment area before applying electrodes. Use mild soap
and water, alcohol pads or antibacterial wipes and allow skin to dry. Areas where
skin oils or dirt have accumulated, or where cosmetics or hair spray have been used,
must be thoroughly cleaned to ensure adequate conductivity. Monitor skin
condition prior to and post treatment. Skin irritation may develop in light skin. If skin
burns are noted following treatment, discontinue use and apply an appropriate skin
cream. Varying electrode locations may minimize irritation.
Evaluate Your Pain
Evaluate your pain before and from time-to-time during and after each treatment.
Your health care practitioner can give you guidelines to help you do a quick, simple
evaluation. This may consist of simply moving into a position that causes you to be
more aware of your pain, then noting the level of pain you are experiencing on a 0
(no pain) to 10 (maximum pain) scale at the beginning and end of each treatment.
Moving the affected body part through its range-of-motion and observing the
increased range along with the decreased pain after treatment are good indicators
of progress. Because Alpha-Stim®works quickly for most people it is helpful to use
these reference parameters to determine effectiveness throughout a single
treatment session. Keeping a daily (or even as often as hourly) chart of changes in
your pain locations and levels on a 0 to 10 scale will help track progress and may be
useful in determining the best areas to treat. To help you understand this system, a
description of pain levels follows (use odd numbers for between values, e.g., Level 1
would indicate a very slight pain that does not interfere with activities):
Pain Level Description
0 No pain.
2 Mild pain; only aware of pain when focused on it. Considered
nagging and annoying but only slightly interferes with activities
of daily living (ADL).
4 Tolerable pain; can be ignored somewhat.
6 Distressful pain; interferes significantly with ADL.
8 Severe pain; can not concentrate or do anything but simple tasks.
10 Disabling pain; unable to perform ADL.
It may also be helpful to keep a diary of Alpha-Stim®treatment times, duration of
each treatment, frequency (Hz) and current (µA) settings along with the electrode
locations you use.

14
Because the Alpha-Stim®M uses such a low level of current, many people do
not feel anything at all, even at the maximum current level. Do not be concerned
if you can not feel the current; this is perfectly normal and your perception of
the current will not affect the results. The Alpha-Stim®M is working unless the
Test Circuit symbol appears displaying the number 1 or 2 for the Channel
you are using or the low battery indicator is down to the last bar. Some people
only achieve maximum relief when using the Alpha-Stim®M for hours every
day, or even all the time. While this is rarely necessary it is also not harmful −
so use the Alpha-Stim®M with confidence knowing you have a safe and
effective tool and LET NOTHING STOP YOU™.
Quick Guide
Read the following instructions carefully. Then, after you
have used the Alpha-Stim®M once you simply press the
Power button, place the electrodes or Earclips in the
appropriate place(s) and adjust the current to a
comfortable level. The time and frequency parameters
default to the previous settings until changed. That's all
there is to it! Readjust the current up or down to a
comfortable level at anytime during treatment, if
necessary.

15
1. Plug dual connector end of wires into
Channel 1 or Channel 2 jack and pin
plugs into Smart Probes. Figure 1.
2. Apply Probe Electrode Pads (PEPS™) to
Probes by placing clean Probe tip into
PEP™ in PEP™ case. PEP™ case opens
with label on bottom. Figure 2.
3. Press Power on.
4. Set Frequency to 0.5 Hz or desired setting. For joint problems (e.g.,
shoulders, elbows, wrists, fingers, hips, knees, ankles, toes) use 100 Hz for
10 - 20 seconds immediately followed by 0.5 Hz. Try 1.5 Hz if 0.5 Hz is not
effective.
5. Set Timer to Probe setting.
6. Set Current on Channel in use to 6 (600 µA). Decrease immediately if
uncomfortable. When used on or near the head, immediately decrease
the current if dizziness or nausea develops. This may happen initially or
several minutes into treatment. Decreasing the current will immediately
relieve these unpleasant feelings.
Figure 1
Figure 2

16
7. Saturate PEPS™ thoroughly with several drops of Alpha Conducting
Solution™ (ACS). Repeat as necessary throughout treatment. Figure 3.
8. Note level of pain for all areas being
treated and any limitations of movement
in joints before, during, and at conclusion
of treatment. It helps to keep a diary of
pain levels where 0 is no pain and 10 is
the worst the pain being treated has
been, along with time of day, duration of
treatment, frequency and current levels
used, and the most effective electrode
locations.
9. Apply Smart Probes to clean, dry skin.
Cycle will start with 2 beeps on contact
with skin and end with a single beep.
Hold Probes firmly against skin for the
entire 10 second cycle before moving to
next treatment location. Lift Probe off skin and replace to repeat
treatment at the same location. See Smart Probe Treatment Strategies
for guidelines for Probe placements. Figure 4.
Figure 4
Figure 3

17
10. Always place the Smart Probes to direct the current between them
through the area being treated. Two Smart Probes must always be used
together to complete the electric circuit. Figure 5.
Figure 5
11. Continue treatment until pain is completely gone or maximum relief is
achieved. There is usually an increased range of motion in treated areas.
Sometimes treated areas of the body feel stiff or tight after the pain is
gone. This will wear off over time.
12. Turn Power off.
13. Discard PEPS™.
14. Finish with Cranial Electrotherapy Stimulation (see directions on
page 24).
15. Repeat as necessary. Results usually improve and last longer with
additional treatments.
16. Store Alpha-Stim®M away from children.

18
1. First treat beyond the treatment area (e.g., the entire leg for knee pain) in
at least 2 places directing the current between the Probes through the
treatment area. Figure 6.1.
2. Treat closer in, around and through the area being treated for about 1
minute applying the Smart Probes at about 6 different angles of
approach with the Probes always placed on opposite sides of the body
(e.g., front to back or side to side). Figure 6.2.
3. Treat the same body part on the opposite side of the body in at least 2
places (such as other knee, wrist, other side of back, etc.). Figure 6.3.
4. Connect the two sides by placing one Probe below the treatment area and
the other in the same place on the opposite side of the body in a few
places. For example, follow “a line” under and around each knee placing
the Probes at intervals along the line. Figure 6.4. For back pain place
probes in at least 3 places on both sides of the body at the level being
treated and slightly above and below. This directs the current through the
nerves and spinal cord. Figure 7.
5. Repeat as necessary, varying Smart Probe positions but always directing
the current between the Probes through the area being treated.
6. Continue treatment until pain is completely gone or maximum relief is
achieved.

19
Figure 6.1 Figure 6.2
Figure 6.3 Figure 6.4