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

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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

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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.

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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.

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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 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).

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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.

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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.

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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®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