ALPHA-STIM AID 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.com
Authorized Representative:
MediMark Europe
11, rue Émile Zola - BP 2332,
38033 Grenoble Cedex 2 - France
Tel: [phone],
Fax: [phone]
Email: [e-mail]
experience life...AGAIN™
Alpha-Stim®AID
cranial electrotherapy stimulator
Owner’s Manual

1
Alpha-Stim®AID
Cranial Electrotherapy Stimulator
For Control of Anxiety, Insomnia and Depression
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 under any circumstances. Doing so could result in
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. 34VF.
Conformity Statement for Europe: Alpha-Stim®AID is a Class IIa,
Type BF medical device. It has been independently tested 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 for United States: Federal law (USA only) restricts this device to
sale by, or on the order of a licensed health care practitioner. Outside the USA it is
available worldwide without a prescription but consultation with a qualified health
care professional is recommended for difficult and unresponsive problems or when
used with pharmaceuticals or other therapeutic intervention.
© Copyright 2016 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 and Worldwide Patents Pending.
REV: I

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Features..................................................................................................................................3
A Note to Health Care Practitioners............................................................................4
Control Buttons...................................................................................................................5
LCD Display...........................................................................................................................6
Introduction..........................................................................................................................7
Description............................................................................................................................8
Electromedical Therapeutics............................................................................................9
Use the Alpha-Stim®AID with Confidence .............................................................11
Quick Guide........................................................................................................................11
Cranial Electrotherapy Stimulation (CES) to Treat Anxiety, Insomnia
and/or Depression with Earclip Electrodes.......................................................12
What to Expect ..................................................................................................................14
Prescribing Information: EPI is ISO Certified, Electromagnetic Interference,
CE Conformity Statement for Europe, Caution Statement for the
United States...............................................................................................................15
Prescribing Information Continued: Indications, Contraindications,
Precautions, Adverse Effects..................................................................................16
Technical Specifications .................................................................................................17
Storage and Cleaning .....................................................................................................18
Trouble Shooting..............................................................................................................18
Service ..................................................................................................................................19
5 Year Limited Warranty ................................................................................................19

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The Alpha-Stim®AID (Part No. 500) comes complete and ready to use with
1 set of Earclip electrodes (Part No. 501), 1 15-ml bottle of Alpha
Conducting Solution™ (Part No. ACS, 250-ml refill bottles available, Part
No. ACSR), 256 Earclip Electrode Pads (Part No. EEP), Illustrated Owner’s
Manual, Lanyard, Storage Case, and 2 AAA batteries. This is everything you
need to begin to use your new Alpha-Stim®AID. Replace Alpha
Conducting Solution™ and Earclip Electrode Pads (EEPS) only with
authorized Alpha-Stim®brand products.
Alpha-Stim®AID features include:
1. Full digital control for precision, consistency and reliability.
2. Earclip electrodes.
3. Back lighting when any button is pressed.
4. Continuous circuit check when electrodes are in contact with skin.
5. Preset to 0.5 Hz.
6. 20, 40 or 60 minutes countdown cycles to auto-off.
7. Large timer display.
8. 0 – 500 microampere (µA) current control.
9. Current and treatment time may be locked to preset values
throughout entire treatment session.
10. Mute option.
11. Cumulative timer.
12. 30 minute auto-off when not in use.
13. Lanyard so AID can be worn around the neck.
14. Able to withstand electrostatic discharges of up to 6,000 volts.
15. Automatically and permanently disables itself should a single fault
develop within the device causing the current to exceed 700 µA.
16. Uses 2 AAA 1.5 volt batteries (included).
17. Battery strength indicator.
18. Earclip Electrode Pads (EEPS) requires Alpha Conducting Solution™
(included).
19. 5 year limited warranty.

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Thank you for recommending the Alpha-Stim®AID. This manual is written
for the person who will use the Alpha-Stim®AID, but your input will be
invaluable to your patient. 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
Toll Free 1.800.FOR.PAIN
Outside of the USA +940.328.0788
Fax [phone]
Email [email protected]
Web www.alpha-stim.com

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1. On - Off
2. Timer. Waveform cycle starts when electrodes touch skin.
Countdown timers: select 20, 40 or 60 minutes.
3. Lock. Press 2 times within 5 seconds to lock or unlock settings
during treatment if desired.
4. or Current. Increases or decreases current. 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.

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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. The timer will stop and the
device will turn off 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®AID to work.
An audible signal and resumption
of the timer occurs the instant the
integrity check circuitry 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 mute function is on).
4. Timer. Select 20, 40 or 60 minutes countdown to auto-off.
5. Time setting indicator. Displays time remaining.
6. 0 - 500 microamperes (µA) of current.
7. Mute feature. To turn on or off press the key sequence: Lock-
Timer-Lock.
8. Lock is on when display is lit.
9. ΣCumulative Timer records total hours and minutes Alpha-Stim®AID
has been in use.

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Congratulations on your selection of the Alpha-Stim
®
AID 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 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
®
AID is a precision medical device used for the
management of anxiety, insomnia and depression. After treatment, there
are usually no physical limitations imposed so you can resume normal
activities. The treatment is simple and easy to self-administer at any time.
People using the Alpha-Stim
®
AID usually report a pleasant, relaxed feeling
of well-being.
The current is applied by Earclip electrodes for anxiety, insomnia and
depression. 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 both be alleviated by reducing
the current.
Once you understand the basic product features and procedures you
will find the Alpha-Stim
®
AID 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.

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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
®
AID 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 AAA batteries.
The Alpha-Stim
®
AID 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 Hz (pulses per
second), at 50 to 500 microamperes (1 µA is one-millionth of an ampere), in
a 50% duty cycle.
The Alpha-Stim
®
AID 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 and current settings assures
the prescribed treatment waveform and dosage even if you are distracted
or fall asleep. The amount of current can easily be increased to reduce
treatment time or decreased when necessary to assure comfort.
One important feature of the Alpha-Stim
®
AID is an electronic circuit
which operates to maintain a nearly constant current flow to the electrodes
minimizing the effects of skin resistance variations. The Alpha-Stim
®
AID
continuously performs self-diagnostics to assure that all aspects of the
circuitry are always working properly and the electrodes are making
adequate contact with skin. Ergonomic and user-friendly features (such as
the lock, auto-off timers and alarm that warns you if an electrode falls off)
make the Alpha-Stim
®
AID reliable, easy, quick, and fun to use.

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The Alpha-Stim
®
AID 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 in
1990, 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 of responsibility for curing all disease. Now,
in the 21st century, it is clear that chemistry as the sole therapeutic model