ALPHA-STIM AID User manual

0
Alpha-Stim® AID
Cranial electrotherapy stimulator
Owner’s Manual
LET NOTHING STOP YOU™


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2
Alpha-Stim® AID Owner’s Manual
Cranial Electrotherapy Stimulator for the
Treatment of Anxiety, Insomnia and Depression
© Copyright 2022 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.
IFU-CUS-002 REV G
Type BF Equipment. Internally
powered.
Consult operating instructions.
Read manual thoroughly
before using the device.
Text consists of a warning or
precaution relating to safety.
Read the text carefully and
use the equipment as
instructed to ensure safety.
Reference Number.
Serial Number.
CAUTION: Federal law
restricts this device to sale by
or on the order of a physician.
CE marking certifies that a
product has met consumer
safety, health or environmental
requirements.
Date of Manufacture.
Manufacturer.
Medical device.
Non-sterile.
Authorized Representative in
the European Community.
IP22
Protection against ingress of
solid foreign objects >12.5
mm and dripping water when
tilted at 15 degrees.
Single patient- multiple use.
Use-by-date.
Keep away from sunlight.
Do not use if package is
opened or damaged.
Waste electrical and electronic
equipment should not be
discarded together with
unseparated household
waste, but must be
collected separately.
Lot Number.
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.
Unique Device Identifier.
ONLY
USA

3
Features .................................................................................................................................. 4
Installation of Batteries ..................................................................................................... 6
A Note to Health Care Practitioners ............................................................................ 7
Control Buttons ................................................................................................................... 8
LCD Display ........................................................................................................................... 9
Introduction ........................................................................................................................10
Description ..........................................................................................................................11
Electromedical Therapeutics. .........................................................................................12
Use the Alpha-Stim® AID with Confidence .............................................................13
Quick Guide ........................................................................................................................13
Cranial Electrotherapy Stimulation (CES) to Treat Anxiety, Insomnia
and/or Depression with Earclip Electrodes .......................................................14
What to Expect ..................................................................................................................16
Prescribing Information ..................................................................................................17
Technical Specifications .................................................................................................19
Storage and Cleaning .....................................................................................................20
Trouble Shooting ..............................................................................................................21
Service ..................................................................................................................................22
Notes on Disposal ............................................................................................................22
5 Year Limited Warranty ................................................................................................23
CONTENTS

4
The Alpha-Stim® AID Device Package Contains:
- 1 set of Earclip Electrodes
- 1 50 ml bottle of Alpha-Stim® Conducting Solution
- 1 empty bottle for use with Alpha-Stim® Conducting Solution
- 256 Earclip Electrode Pads (EEPS™)
- Owner’s Manual
- Lanyard
- Storage case
- 2 AAA 1.5 volt lithium batteries
The Alpha-Stim® AID Kit Comes Complete and Ready to use with:
Alpha-Stim® AID device – The Alpha-Stim® AID device is a battery powered
electrical device that produces low level electrical current to treat
anxiety, insomnia and depression. Device accessories connect to the
Alpha-Stim® AID to facilitate treatment. Part# 500
Earclip Electrodes – Earclip Electrodes are accessories to the Alpha-Stim®
AID. The Earclip Electrodes transfer the current from the Alpha-Stim® AID
device to the patient through the earlobes. Part# 501
Alpha-Stim® Conducting Solution is an accessory to the Alpha-Stim® AID
device. It is supplied as a liquid in a separate bottle. It is a proprietary mineral
salt solution that facilitates an efficient transfer of the Alpha-Stim® AID
current from the device to the electrodes and finally to the patient.
Alpha-Stim® Conducting Solution is applied to the Electrode Pads to ensure
the current is conducted properly. Part# SL50
Electrode Pads – Earclip Electrode Pads (EEPS™) are also accessories for the
Alpha-Stim® AID device. They are felt-like pads made from polyester that
allow Alpha-Stim® Conducting Solution absorption to facilitate transfer of
current. The pads have an adhesive backing allowing them to stick to the
Earclip Electrodes. The adhesive does not contact the patient’s skin. The pads
are saturated with Alpha-Stim® Conducting Solution to ensure proper
current flow from the Alpha-Stim® device through to the Earclip Electrodes
and to the patient. Part# EEP
FEATURES

5
Owner’s manual – Describes what items come with the device and how to
use it. Includes a symbol table along with precautions, warnings and
contraindications. Device use is the same for the healthcare provider as it is
for use directly by the patient. Part# 503CUS
Lanyard – The lanyard is an optional accessory for the Alpha-Stim® AID
device. It is a cloth cord to hold the Alpha-Stim® AID device around the neck
when in use, if desired. Part# 502
Storage Case(s) – Alpha-Stim® AID comes in a hard case. An optional soft
case can be purchased separately. Part#s 504 & 505
2 AAA batteries – The Alpha-Stim® AID is powered by lithium batteries which
are supplied in the initial order. They provide the energy source and are
placed inside the Alpha-Stim® AID before use. Batteries can be replaced with
off the shelf lithium batteries as needed. Part# 5300
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 15,000 volts.
15. Automatically and permanently disables itself should a single fault
develop within the device causing the current to exceed 700 µA.

6
16. Battery strength indicator.
17. Earclip Electrode Pads (EEPS™) requires Alpha-Stim® Conducting
Solution (included).
18. 5 year limited warranty.
19. Protection against ingress of solid foreign objects >12.5 mm and
dripping water when tilted at 15 degrees.
20. Uses 2 AAA 1.5 volt batteries (included in the package but
not installed).
Inserting batteries
Slide the cover of the battery case on the back
side of the device in the arrow direction.
Insert the enclosed batteries according to
the symbols (+/-) into the base of the
battery case.
Close the battery case again and push the
cover towards the device until it snaps
into position.
When changing the batteries, only use 2 AAA
1.5-volt lithium batteries.
Danger of chemical burns! Leaking
battery acid may lead to chemical burns.
Avoid contact between battery acid and skin,
eyes and mucous membranes.
If battery acid comes in contact with any of these parts, rinse the
affected area with copious amounts of plain water immediately
and seek medical attention if necessary. Keep batteries out of
children’s reach. If a battery has been swallowed seek medical
attention immediately.
INSTALLATION OF BATTERIES

7
Do not disassemble, recharge, short circuit batteries or dispose of
them in fire. There is a risk of explosion.
Remove batteries from the device if you do not use it for a
prolonged period.
Do not dispose of used batteries in the household garbage, instead
dispose of them as special waste or at a battery collection point in a
specialist outlet.
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.
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 940-328-0888
Email [email protected]
Web www.alpha-stim.com
A NOTE TO HEALTH CARE PRACTITIONERS

8
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.
CONTROL BUTTONS

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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. Σ Cumulative Timer records total hours and minutes Alpha-Stim® AID
has been in use.
LCD DISPLAY

10
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, email,
Facebook, Instagram or Twitter. 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 treatment
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 thor-
oughly before using it. Be sure to follow the general instructions given herein
and any specific directions from your health care practitioner.
The Alpha-Stim
®
AID was developed by Dr. Daniel L. Kirsch, a neuroscientist,
and Raymond Chan, an engineer. 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 where he was elected
President in 2012. He was also the only American Member of InterPain, the
organization for pain specialists in Germany and Switzerland. He was the
Electromedical Department Editor of the journal, Practical Pain Management and
Editor-in-Chief of Contentment and Combat Stress Magazines. 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
INTRODUCTION

11
Group in Santa Monica, California. He also served as an expert research and
practice consultant to Veterans Affairs Medical Centers and the United States
Army and Navy. He is an author of books and articles and lectured frequently to
physicians and psychologists worldwide on pain and stress until his retirement
in 2020.
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.
DESCRIPTION

12
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 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 anxiety, insomnia and depression began in Russia during the 1950s
and first came to the USA in the 1960s.
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 USA
1
and Dr. Björn Nordenström of Sweden
2
(who served as
Chairman of the Nobel Assembly) to propose completely new theories of
physiology based on our latest understanding of biophysics.
1
Becker, Robert O. The Body Electric. New York: William Morrow and Co. 1985.
2
Nordenström, Bjorn E.W. Biologically Closed Electric Circuits. Stockholm: Nordic Medical
Publications, 1983.
ELECTROMEDICAL THERAPEUTICS

13
Alpha-Stim
®
technology incorporates these theories and is proven more
efficacious than most other treatments for the conditions it treats. The original
Alpha-Stim
®
Model 2000 weighed 40 pounds and cost $5,850 when it was first
introduced in 1981. The Alpha-Stim
®
AID utilizes the most advanced technology
available today. It is now possible, in most cases, to alleviate anxiety, insomnia,
and depression with far less current than used in previous technologies, and
experience long-term and cumulative relief with as little as only 20 minutes of
treatment every other day. When used properly, we trust your new
Alpha-Stim
®
AID will improve the quality of your life.
Because the Alpha-Stim
®
AID 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
®
AID is working unless the
Test Circuit symbol appears, or the low battery indicator is down to the last
bar. Some people only achieve maximum benefits when using the Alpha-Stim
®
AID for hours every day. While this is rarely necessary it is also not harmful so
use the Alpha-Stim
®
AID 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
®
AID once you simply
press the Power button, wet the Earclip Electrode Pads
(EEPS™) on the Earclip Electrodes, place them on both
ear lobes and adjust the current to a comfortable level.
That's all there is to it! Adjust the current up or down
to a comfortable level at any time during treatment if
necessary.
USE THE ALPHA-STIM
®
AID WITH CONFIDENCE

14
1. Clean ear lobes with 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 after treatment. Skin irritation may develop in
light skin. If skin burns are noted following treatment, discontinue use
and apply an appropriate skin cream. Varying Earclip Electrode
locations around the ear lobe may minimize irritation.
2. Plug dual connector end of Earclip Electrode wires into jack on left
side of the Alpha-Stim® AID. Figure 1.
3. Remove and discard old Earclip Electrode Pads (EEPS™) if present.
Remove old glue residue, clean and dry Earclip Electrodes and attach 4
new EEPS™. Note that EEP™ case opens
with label on bottom.
4. Saturate 4 new Earclip Electrode Pads
(EEPS™) thoroughly with several drops of
Alpha-Stim® Conducting Solution while
on Earclip Electrodes.
5. Press Power on.
6. Mute the audio, if desired, with the key
sequence: Lock-Timer-Lock. To reinstate
the audio alerts, press the same key
sequence again.
7. Set Timer. 20 minutes is usually enough
time if the current is set to at least 250
µA. 40 minutes to 1 hour is recommended if the
current is at or below 200 µA. Squeeze Earclip
Electrodes and apply one to each ear lobe. Figure 2.
8. Current defaults to 1 (100 µA) when the Alpha-Stim® AID is turned
on. Increase Current slowly (5 is the highest setting) until a slight
CRANIAL ELECTROTHERAPY STIMULATION (CES)
TO TREAT ANXIETY, INSOMNIA, AND/OR
DEPRESSION WITH EARCLIP ELECTRODES
Figure 1

15
vertigo is experienced (a dizzy feeling,
similar to the sensation of rocking on
a boat), then decrease immediately
until the dizziness stops. Also
decrease immediately if the normal
tapping sensation felt on the ear
lobes is uncomfortable. For people
who have a history of experiencing
vertigo such as motion sickness, treat
at a subsensory current setting of 1
(100 µA) for one hour or more to
prevent residual vertigo after treatment. The tolerable current level
will be determined by the subjective feeling of vertigo which should
subside immediately upon reducing the current. The current should
always be reduced just below the level that causes vertigo.
9. Press Lock twice to lock settings, if desired. Press Lock twice again to
unlock and change settings, if necessary.
10. Relax, if possible, during the treatment. It is best to sit quietly or lie
down although it is also possible to read, work at a desk or watch
television during treatment. Do not attempt to drive or operate any
dangerous tools or machinery during treatment.
11. Power will turn off automatically at the conclusion of the timed cycle.
12. Always complete a CES session. When the timed session ends, and a
“heavy” feeling is still experienced, resume treatment until at least 2
minutes after the heaviness lifts and a light feeling develops. Failure to
do this can result in disorientation that can last for hours to days.
Some people benefit the most from several hours of treatment in a
given treatment session.
13. Remove and discard EEPS™. Clean and dry Earclip Electrodes and
replace 4 EEPS™ for the next treatment, if desired. EEP™ case opens
with label on bottom.
14. Store Alpha-Stim® AID away from children.
15. CES may be used as often as necessary but for most people it is best
to treat between once a day and twice a week. Results usually
improve and last longer with additional treatments.
Figure 2

16
While the Alpha-Stim® AID is significantly effective when it is used correctly
for 9 out of 10 people who use it, it will not work for everyone. If the
Alpha-Stim® AID is not working well for you contact your health care
practitioner, your local authorized Alpha-Stim® distributor or EPI for
technical support.
Anxiety reduction is usually experienced during a single treatment but
may be experienced hours after treatment.
Insomnia is usually improved after the initial treatment but may take 3
weeks. Most people can use it at bedtime and when awakened during the
night. However, some people find they must conduct their 20 - 60 minute
Alpha-Stim® CES treatment at least 3 hours before going to bed because a
CES treatment may interfere with sleep. It may also be used in the morning
to promote better sleeping at night.
Depression typically takes 3 weeks or more of daily treatment to
experience significant improvement but may take considerably longer. After
the condition is under control, use of Alpha-Stim® 2 - 3 times per week or
less is usually sufficient to maintain good results.
Following treatment, there are usually no physical limitations imposed
so most users can resume normal activities immediately.
At present, there are over 100 research studies on using Cranial
Electrotherapy Stimulation in humans and more than 30 animal studies.
No significant lasting side effects have been reported. If a heavy feeling
occurs, continue treatment until at least 2 minutes after it gives way to a
light feeling. Any side effects which have occurred have all been mild,
self-limiting reactions.
WHAT TO EXPECT

17
EPI is ISO Certified
Electromedical Products International, Inc. is an International Standards
Organization (ISO) certified establishment. ISO is an International
organization working with some 140 countries and the United Nations to
maintain standards for all applications of technology for global industry.
Requirements for the medical device industry relate to design controls, risk
management, environmental controls, special processes (e.g. software
validation), traceability, record retention, and regulatory actions such
as vigilance.
Electromagnetic Interference
This equipment has been independently tested by outside agencies and
found to comply with the limits of Comité International Spécial des
Perturbations Radioélectriques (CISPR). These limits are designed to provide
reasonable protection against harmful interferences in a residential or
clinical environment. However, it is still possible that interference could
occur in a particular environment. In case interference does occur, increase
the distance between this device and the equipment it interferes with.
Consult Electromedical Products International, Inc. if the problem persists.
CE Conformity Statement for Europe
The Alpha-Stim
®
AID is a Class IIa, Type BF medical device. It has been
independently tested by outside agencies to provide assurance of
conformity to applicable standards for medical equipment safety and
electromagnetic compliance.
Indications
Alpha-Stim
®
AID is a precision medical device used for cranial electrotherapy
stimulation in adults 22 years and above for the treatment of anxiety,
insomnia, and depression.
Warnings and Precautions
-
Safety of stimulation has not been established during pregnancy.
-
Do not stimulate directly on the eyes or press the probes over the carotid
sinus (on the neck near the larynx). Application of the electrodes near
the thorax may increase the risk of cardiac fibrillation.
PRESCRIBING INFORMATION

18
- Potential hazard from simultaneous connection of a patient to a high
frequency surgical medical equipment and stimulator may result in
burns and possible damage to the stimulator.
- Operation in close proximity (e.g. 1m) to a shortwave or microwave
therapy medical equipment may produce instability in the
stimulator output.
- Modification of your Alpha-Stim® AID device or accessories is not
allowed, it could result in injury.
- Do not place Alpha-Stim
® in direct contact with lint, dust, light
(including sunlight).
- For external use only. Small parts, keep out of reach of children, avoid
inhalation or swallowing. Do not allow children to use or handle this
device without adult supervision.
- Do not operate potentially dangerous machinery or vehicles during
treatment, and in some cases for several hours after treatment.
- Do not plug leadwires into wall sockets or line cord receptacles under
any circumstances. Doing so could result in severe shock or burns
whether the leadwires are attached to the stimulator or not.
- 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.
Contraindications
Use of an Alpha-Stim® AID device is contraindicated with implanted
pacemakers or implanted or wearable defibrillators.
Adverse Effects
Adverse effects are usually rare (occurring less than 1% of the time), mild,
and self-limiting.
- dizziness
- skin irritation/electrode burns
- headaches
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