an overview of alpha-stim technology for anxiety,...

An Overview of Alpha-Stim® Technology for Anxiety, Insomnia, Depression

and Pain Management for the Healthcare Professional

Overview Guide AID+M_Layout 1 7/10/12 8:16 PM

Alpha-Stim® is a medical device used worldwideby physicians, healthcare professionals, morethan 70 American Veterans Affairs Medical Centers and in many Military Medical Centersworldwide as an effective, non-pharmacologicalchoice for the treatment of anxiety, insomnia, depression and pain management. Alpha-Stim®

is a stand-alone therapy and may also be used in conjunction with medications, behavioral thera-pies and other treatment modalities. Alpha-Stim®

can be used in a clinical setting or ordered forhome use.

Alpha-Stim® is regulated in the USA by the Foodand Drug Administration (FDA) and is approved

in many other countries worldwide, including having a CE Mark for Europe. Doctor and patientsurveys reveal it has helped 90% of the patientswho tried it, and it is supported by over 55 completed independent research studies andpublished reports.

Alpha-Stim® treats patients with microcurrenttechnology using two protocols: Cranial Elec-trotherapy Stimulation (CES) and MicrocurrentElectrical Therapy (MET).

CES is the process of using a microcurrent of lessthan one-half milliampere, delivered directly into the brain via earclip electrodes for 20 to 60minute sessions in order to treat anxiety, insom-nia and depression. MET is the process of direct-ing a microcurrent of less than one millampere,through the body via Alpha-Stim® Smart Probesor self-adhesive AS-Trodes™ with a 2 to 5 minute protocol for the treatment of peripheral pain.

How Alpha-Stim® WorksEvidence from published research and ongoingstudies shows that the Alpha-Stim® waveform activates particular groups of nerve cells that arelocated at the brainstem (Figure 1). These groupsof nerve cells produce the chemicals serotoninand acetylcholine which can affect the chemicalactivity of nerve cells that are both nearby and at more distant sites in the nervous system. Thesecells are situated to control the activity of affer-ent nerve pathways into the brain and efferentnerves that course down into the spinal cord. Bychanging the electrical and chemical activity ofcertain nerve cells in the brainstem, Alpha-Stim®

technology appears to amplify activity in someneurological systems, and deactivate activity inothers. This neurological ‘fine tuning’ is calledneuromodulation, and occurs either as a result of,or together with the production of a certain typeof electrical activity pattern in the brain known asan alpha state which can be measured on an EEG.

An Overview of Alpha-Stim® Technology for Anxiety, Insomnia, Depression and Pain Management for the Healthcare Professional

Figure 1.

Putative Mechanism


Such alpha rhythms are accompanied by feelingsof calm, relaxation and increased mental focus.The neurological mechanisms that are occurringduring the alpha state appear to decrease stress-effects, reduce agitation, stabilize mood, andregulate both sensations and perceptions of particular types of pain.

These effects can be produced after a singletreatment as evidenced by fMRI, LORETA and EEG mechanistic studies and clinical double-blind randomly controlled trials in medicine, psychology and dentistry (available atwww.alpha-stim.com). Repeated treatments have been shown to increase the relativestrength and duration of these effects. In somecases, effects have been stable and permanent,suggesting that the electrical and chemicalchanges evoked by Alpha-Stim® technology have led to a durable re-tuning of aspects of the nervous system back to normal function.

What Makes Alpha-Stim® Unique?It’s the waveform (Figure 2). Alpha-Stim® gener-ates a unique and proprietary waveform that no other device can replicate. The waveform in a therapeutic device is analogous to the precisechemical compound that differentiates one drug

from another. Alpha-Stim’s® waveform is distinctive in its proven safety and efficacy.

The waveform uses microcurrents (millionths ofan ampere) delivered in a precise configurationvia earclip electrodes which direct the current tothe brain. The waveform is specifically designedto increase alpha brainwaves (associated with increased relaxation) and decrease delta waves(associated with increased alertness) as seen onquantitative electroencephalogram (QEEG) brainmaps (Figure 3).

Alpha-Stim® Provides Proof Alpha-Stim’s® proven results are due to its propri-etary, patented technology and protocols. Whilethere are other CES devices on the market, noother device has the clinical results and researchto support its technology. Just as every 5 mgwhite pill is not the same, Alpha-Stim’s® uniquewaveform produces results vastly different fromits competitors. None provide as much proof ofsafety and efficacy as Alpha-Stim®, if they provideany proof at all.

Why You Should Prescribe Alpha-Stim®

Through extensive research and surveys, EPI has identified five major reasons a licensedhealthcare professional would recommend anAlpha-Stim® device for their patients:1. Safety 2. Proven Efficacy3. Research3. Cost Effectiveness5. Customer Service and Support

Alpha-Stim® can easily be incorporated into your practice, providing you with an effectivetreatment choice for your patients.

Safety Alpha-Stim® provides therapeutic, lasting results without the risks of dangerous side effects, tolerance and addiction, and may also beused as an adjunct to medication. Alpha-Stim®

allows your patients to resume normal, daily activities after treatment, and is suitable for clinical or home use.

Patients are becoming increasingly concernedabout the dangers and potential side effects ofmost medications. Many patients are looking fora safer and more effective alternative to pharma-ceuticals. Alpha-Stim® is supported by over 55 research studies, published reports and ongoingresearch, as well as surveys of doctors, patientsand professional endorsements.

Figure 2.

The Patented Alpha-Stim® Waveform

Time in Seconds

Cu

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Figure 3. This quantitative EEG brain map shows the changes in brain activity by traditional EEG groupings in 30 university student volunteers after a single 20 minute treatment with Alpha-Stim® at 0.5 Hz. Blue shows a decrease in activity of sleepy delta brainwaves while red shows an increase in activity of relaxing alpha brainwaves.

Xanax (N=2238)

Ativan (N=838)

Alpha-Stim (N=114)

Alpha-Stim (N=358)

Zoloft (N=2028)

Wellbutrin (N=1168)

Alpha-Stim (N=89)

Alpha-Stim (N=311)

Vicodin (N=1163)

Oxycontin (N=1171)

Alpha-Stim (N=73)

Alpha-Stim (N=428)

Lunesta (N=462)

Sonata (N=62)

Alpha-Stim (N=98)

Alpha-Stim (N=163)

Insomnia

Anxiety

Depression

Pain

0% 20% 40% 60% 80% 100%

Percent Improvement

84%

80%90%

85%

56%

Service Member

Civilian

68%

81%

84%

70%

67%

78%

83%

77%

74%

65%

82%

Patient Self Reports: Alpha-Stim vs. Drugs

Figure 4. Patients who reported a positive response according to: WebMD Drug Surveys, and Alpha-Stim Service Member and civilian surveys. Alpha-Stim Data from 2011 Military Service Member Survey (N=152) and Alpha-Stim Patient Survey (N=1,745). Conducted by Larry Price, PhD, Associate Dean of Research and Professor of Psychometrics and Statiistics, Texas State University. Pharmaceutical Survey Data from: www.WebMD.com/drugs. Accessed on October 28, 2011.


In over three decades of studies involving approx-imately 8,800 people in active treatment groups,only minor, self-limiting side effects have been reported. The two most common side effectswere headaches (0.10%) and skin irritation at theelectrode sites (0.07%) only seen in people withvery light skin.

Proven EfficacyAlpha-Stim® is used extensively with military personnel by more than 200 practitioners withinthe Department of Defense (DOD) and over 70Veterans Administration (VA) hospitals to treatpost-traumatic stress disorder (PTSD), anxiety, insomnia, depression and pain.

In an August 2011 survey, 99.9% of 1,745 Alpha-Stim® users consider it effective!

Figure 4 presents results of the October 2011 Military Service Member Survey and Alpha-Stim®

Patient Survey. Alpha-Stim®

users – civilians and Service Mem-bers - consistently reported morepositive responses than those thatuse pharmaceuticals.

When provided with a choice ofcomplementary and alternativemedicine therapies, veteranschose Alpha-Stim® 3 out of 4times (73%) over other availabletherapies.

Figure 5 highlights the amount of improvement reported duringthat veteran study. Even in treat-ment resistant cases, most patientsreceive significant improvementfrom Alpha-Stim® therapy. (Table 1).

In another survey conducted from 2006 – 2011, respondentswere also asked to report their

perceived improvement, in the form of a Likertrating scale, since beginning treatment. Figure 6reveals that the effects are robust, with 60% improving 50% or more.

ResearchAlpha-Stim’s® effectiveness is supported by 55completed studies and many more studies thatare currently in progress. There is more researchsupporting Alpha-Stim® technology than there is for most drugs. It is important to note thatAlpha-Stim® research is funded independently.Funding sources include the National Institutes of Health, National Cancer Institute, Departmentof Defense and the US Department of VeteransAffairs.

In addition to current research, EPI has collectedsurvey data from both doctors and patients thatuse Alpha-Stim®. Forty-seven doctors reportedtheir results on 500 patients in 22 diagnostic categories resulting in a 50-page analysis published in the book The Science Behind CranialElectrotherapy Stimulation by Dr. Daniel L. Kirsch(2nd Ed. Medical Scope Publishing, Edmonton, Alberta 2002).

That data correlates well with a published, peer-reviewed outcome study of 2,500 patients’self-reports (Table 2) where Alpha-Stim® was used for at least 3 weeks. In most diagnostic subcate-gories, both doctors and patients reported that 9 out of 10 people had significant results basedon the survey standard of a minimum of 25% improvement. Effect sizes were robust with

Figure 5. Tan, Gabriel, Dao, Tam K., Smith, Donna L., Robinson, Andrew and Jensen, Mark P. Incorporating Complementary and Alternative Medicine(CAM) Therapies to Expand Psychological Services to Veterans Suffering From Chronic Pain. Psychological Services, 7(3):148–161, 2010.

Percent Inprovement in 32 VeteransAcross 158 Treatment Sessions

40

35

30

25

20

15

10

5

0Worse No Change 1 to 24% 25 to 49% 50 to 74% 75 to 99% Complete

RecoveryAmount of Improvement

% o

f A

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a-St

im S

urv

ey R

esp

on

der

s

0.1% 1.0%

15.9%

22.6%

32.6%

26.8%

1.0%

60% of Patients Improved at Least 50%

Figure 6. Results of a 2011 Alpha-Stim CES Patient Survey.


most Alpha-Stim® patients reporting at least 50% improvement in their symptoms. Combiningthe outcomes of both double-blind randomizedclinical trials and comprehensive survey data assists in predicting treatment outcomes. Thereare hundreds of endorsements on www.alpha-stim.com, from physicians and other licensedhealthcare professionals, sports teams and Alpha-Stim® users, which fill in the personaldetails about the Alpha-Stim® experience that scientific research reports omit.

For an in-depth list of research conducted foranxiety, insomnia, depression and pain manage-ment, see the research section of our website atwww.alpha-stim.com.

Cost EffectivenessOver a five year period, Alpha-Stim® can saveyour patients thousands of dollars in comparisonto drugs commonly prescribed for anxiety, insomnia, depression and pain (Figure 7).

Customer Service and SupportEPI’s outstanding customer service team is avail-able to help you with any questions or concernsranging from clinical and technical support to insurance billing or financing options for your patients. Over the years, EPI has developed a variety of resources to assist you and your patients at no additional cost. We pride ourselveson providing the best ongoing support of anymedical device company.

EPI provides the following resources: • Patient brochures• Illustrated Owner’s Manuals• Animated treatment procedures and

protocols on DVD• Our award winning, comprehensive

website: www.alpha-stim.com • Educational videos and articles

Electromedical Products International, Inc. andour well trained distributors are dedicated tohelping you seamlessly integrate Alpha-Stim®

into your treatment plans. Try Alpha-Stim® onyour treatment-resistant and drug-adverse patients first. You will be impressed with thechanges you see.

Proven Efficacy: Results at a Glance

No Slight Fair Moderate Marked Complete SignificantCondition N Worse Change <24% 25-49% 50-74% 75-99% 100% >25%

Anxiety 349 0% 2.29% 4.01% 11.17% 25.50% 51.86% 5.16% 93.70%

Insomnia 135 0% 11.85% 8.89% 12.59% 25.19% 33.33% 8.15% 79.26%

Depression 184 0% 4.35% 5.89% 16.85% 20.65% 44.57% 7.61% 89.67%

Pain 286 .35% 1.75% 6.99% 16.78% 26.92% 37.76% 9.44% 90.91%

Table 1. Physician surveys showing percent improvement in 500 Alpha-Stim® patients where 25% or greater is considered significant.

Figure 7. Drug prices are from www.drugpriceinfo.com

Insomnia

$10,000

$8,000

$6,000

$4,000

$2,000

0

Alpha-

Stim

® AID

Ambie

n™Lu

nesta

™Res

toril

™

Sonat

a™

Anxiety

$5,000

$4,000

$3,000

$2,000

$1,000

0

Alpha-

Stim

® AID

Ativan

™

Buspar

™Klo

nopin™

Xanax

™

Pain

$16,000

$14,000

$12,000

$10,000

$8,000

$6,000

$4,000

$2,000

0

Alpha-

Stim

® MOxy

Contin™

Imitr

ex™

Topam

ax™

Som

a™

Depression

$12,000

$10,000

$8,000

$6,000

$4,000

$2,000

0

Alpha-

Stim

® AID

Cekex

a™Le

xapro

™

Paxi

l™

Proza

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5 Year Cost Comparisons


Alpha-Stim® and Your Practice

Try it RISK FREE!

Ask about our Practitioner Loan Program to tryAlpha-Stim® free for 60 days (available in mostareas).

To speak directly with a dedicated member of our customer service team and enroll in the Practitioner Loan Program call: (800) FOR-PAIN if you are in the US or Canada. All other callersdial (940) 328-0788. You may also email us at:[email protected]

Training Attend a complimentary webinar hosted by amember of our clinical support staff and learnvaluable insights to effectively integrate Alpha-Stim® into your practice, as well as treatment protocols for the various indications of Alpha-Stim®. On-site training is available in some places,depending on your location and needs.

Select the Alpha-Stim®

Alpha-Stim® technology is available in two user-friendly models, the M and the AID. Both are appropriate for clinical and home use.

Alpha-Stim® M is a com-bined Microcurrent Electri-cal Therapy (MET) and Cranial ElectrotherapyStimulator (CES) that treatspain, sleep and mood disorders like anxiety and depression. Alpha-Stim® Mis the most complete andversatile model, and theonly choice for those whowant to treat pain. Alpha-Stim® M comes complete with Smart Probes andself-adhesive AS-Trodes™ for treating pain, andEarclips for administering CES.

Results of Using Alpha-Stim® Technology for CES and MET

Slight Fair Moderate Marked SignificantCondition N <24% 25-49% 50-74% 75-100% >25%

61 175 237 250 662Psychological (all cases) 723 8.44% 24.20% 32.78% 34.58% 91.56%

13 29 42 44 115Anxiety (alone) 128 10.16% 22.66% 32.81% 34.38% 89.84%

33 85 122 130 337Anxiety (with other) 370 8.92% 22.97% 32.97% 35.14% 91.08%

3 19 19 17 55Anxiety/Depression 58 5.17% 32.76% 32.76% 29.31% 94.83%

11 23 1 2 46Depression (alone) 537 13.21% 20.75% 43.40% 22.64% 86.79%

29 61 93 82 236Depression (with other) 265 10.94% 23.02% 35.09% 30.94% 89.06%

6 30 39 48 117Stress 123 4.88% 24.39% 31.71% 39.02% 95.12%

10 47 47 59 153Insomnia 163 6.13% 28.83% 28.83% 36.20% 93.87%

136 623 741 449 1,813 Pain 1,949 6.98% 31.97% 38.02% 23.04% 93.02%

Table 2. Patient Self Reports table represents results of using Alpha-Stim® technology for at least 3 weeks.


Alpha-Stim® AID treats anxiety, insomnia and de-pression. It cannot be usedto treat a specific pain siteon the body, but may stillbe useful for people whosuffer from pain relatedmood and sleep problems.See Table 3 for a summaryof product features.

5 Year Limited WarrantyAlpha-Stim® M and AID are warranted to be free from defects in materials and workman-ship under normal use for a period of five yearsfrom the date of purchase (not including bat-teries and accessories). See the Owner’s Manualfor complete details.

About EPIElectromedical Products International, Inc. (EPI)was founded in 1981 by Dr. Daniel L. Kirsch, whodeveloped Alpha-Stim® technology. Alpha-Stim®

is a safe and effective solution for the treatmentof pain, mood, and sleep disorders. In 2009 EPI

was a recipient of the Best of Business Award inthe Surgical and Medical Instruments category bythe Small Business Commerce Association (SBCA).

In 2011 EPI earned the American Institute of Stress Award for Distinction and Innovation basedon the growing list of publicationsin peer reviewed journals demon-strating safety and efficacy ofAlpha-Stim® products. EPI and itsstaff are dedicated to the pursuit ofexcellence in the treatment of medical andhealthcare related issues.

EPI today is a global enterprise with representa-tives throughout the world. EPI is an FDA regis-tered establishment with operations certified byUnderwriters Laboratories (UL) and the Interna-tional Standards Organization (ISO) 13485:2003standards for quality in medical devices. Alpha-Stim® products maintain the CE mark signifyingcompliance with the European Medical Device Directive, and are licensed by Health Canada.

Alpha-Stim® M Alpha-Stim® AIDFor treating multiple pain areas, and anxiety,insomnia and depression.

For treating anxiety,insomnia and depression without pain.

Alpha-Stim® Product Features

Primary Indications

Treatment Methods

PainAnxietyInsomniaDepression

Smart Probes for PainElectrodes for PainEarclips for CESPlusFive (5) Year WarrantyFree access to clinical and technical support

44 4

44

4

44

44

444

44

Table 3


Alpha-Stim® Inventor-Daniel L. Kirsch, PhD, DAAPM, FAIS

Dr. Kirsch is a world renownedneuroscientist with over threedecades of experience in the elec-tromedical field, including exten-sive clinical practice experience.Throughout his career Dr. Kirschhas designed medical instrumen-tation and their applications and

developed clinical systems for implementing pain,anxiety, insomnia, depression and stress control

technologies. Dr. Kirsch was board-certified bythe American Academy of Pain Management in1990 and the 2008 Recipient of the prestigiousAAPM Richard Weiner Educator of the YearAward in Pain Management, and was named aFellow of the American Institute of Stress in 1997.He is also a Member of the International Societyfor Neurotherapy and Research and a Member of Inter-Pain (association for pain specialists inSwitzerland and Germany).

Illustrated owner’s manuals.

Animated treatment proceduresand protocols on DVD.

Our award-winning, comprehensive website: www.Alpha-Stim.com.


Technical Specifications

Electrical Alpha-Stim® M: 2 AA 1.5 volt, Batteries and Alpha-Stim® AID: 2 AAA 1.5 volt (included).

Timer Alpha-Stim® M: 10 second Smart Probe activated by skin contact, 10, 20, 40, and 60 minute count down timers to auto-off, and continuous time elapsed timer on M, and Alpha-Stim® AID: 20, 40 or 60 minute countdown timers to auto-off.

Current 0 to 600 microamperes (µA) for the M and 0 to 500 µA for the AID adjustable in 50 µA increments.

Frequency Alpha-Stim® M: 0.5, 1.5, or 100 Hz (pulses per second) combined with a constant 0.4 Hz. The average pulse repetition rate is 0.8 Hz at the most widely used setting of 0.5 Hz. Alpha-Stim® AID is preset at 0.5 Hz.

Pulse Varying between 0.25, 0.5, 0.75, andWidths 1 second at 0.5 Hz.

Charge At 600 µA and 0.5 Hz the charge per pulse varies between 150, 300, 450 and 600 micro-coulombs (C). Every 10 seconds the total charge is 1.5 millicoulombs (mC) in each direction.

Waveform The impedance range within which the waveform parameters remain valid are from 100 Ωto 10 K Ω. The waveform is composed of bipolar asymmetric rectangular waves at a 50% duty cycle repeating periodically. At 0.5 Hz it repeats at 10 second intervals. The wave-form is balanced to achieve 0 net current in either direction (see below).

Mechanical

Alpha-Stim® MHeight 11.0 cmWidth 7.2 cmDepth 2.1 cm without belt clipWeight 152 gm with batteries

Alpha-Stim® AIDHeight 9.8 cmWidth 6.3 cmDepth 2.0 cm

Weight 101 gm with batteries

Alpha-Stim® MThe Alpha-Stim® AID comes complete and ready to usewith 1 set of Earclip electrodes, 1 15-ml bottle of AlphaConducting Solution™ (250 ml refill bottles available), 256 Earclip Electrode Pads (EEPS), Illustrated Owner’s Manual, Instructional DVD, Lanyard, Storage Case, and 2 AAA Batteries.

Alpha-Stim® AIDThe Alpha-Stim® M comes complete and ready to use with 1 set of Earclip electrodes, 1 15-ml bottle of AlphaConducting Solution™ (250 ml refill bottles available), 2 sets of lead wires for 4 electrodes, 2 Smart Probes, 4 silverAS-Trode™ brand single person multiple use self-adhesiveelectrodes (good for approxi mately 2 weeks to 1 month of use), 100 Probe Electrode Pads (PEPS™), 256 Earclip Electrode Pads (EEPS), Illustrated Owner’s Manual, Instructional DVD, Lanyard, Storage Case, and 2 AA Batteries.

The Patented Alpha-Stim® Waveform

Time in Seconds

Cu

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t in

Mic

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Prescribing Information

What to ExpectWhen used correctly, Alpha-Stim® technology is signifi-cantly effective for 9 out of 10 people. Patients sufferingfrom pain, anxiety or insomnia may see noticeable resultsfollowing a single treatment. Patients with depression typically require at least three weeks of daily treatment before experiencing significant improvement. Once thecondition is under control, use of the Alpha-Stim® can bedecreased. If desired results are not achieved, please contact EPI or your local distributor for clinical support.

Alpha-Stim® may be used as an adjunct to medication, psychotherapy or other treatments. Some medications may need to be reduced as CES may augment the effectsof prescribed medication.

Following treatment, most physical activities may be resumed immediately. However, some patients may experience a euphoric feeling, or deep relaxation, thatmay temporarily impair their mental and/or physical abilities for the performance of potentially hazardous tasksfor up to several hours after treatment. Care should betaken when operating a motor vehicle or heavy machinery,until you know how Alpha-Stim® might affect you.

No significant lasting side effects have been reported. Occasional headache, discomfort or skin irritation underthe electrodes or lightheadedness may occur. When treat-ing on the head, some patients will see flashing lights dueto stimulation of the optic nerve during treatment. Theseare all mild, self-limiting reactions.

EPI is ISO CertifiedElectromedical Products International, Inc. is an Interna-tional Standards Organization (ISO) certified establish-ment. ISO is an International organization working withsome140 countries and the United Nations to maintainstandards for all applications of technology for global industry. Requirements for the medical device industry relate to design controls, risk management, environmentalcontrols, special processes (e.g., software validation), traceability, record retention, and regulatory actions suchas vigilance.

Electromagnetic InterferenceThis equipment has been independently tested by outsideagencies and found to comply with the limits of Comité International Spécial des Perturbations Radioélectriques(CISPR). These limits are designed to provide reasonableprotection 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 theproblem persists.

CE Conformity Statement for EuropeThe Alpha-Stim® M and AID are Class IIa, Type BF medicaldevices. They have been independently tested by Under-writer Laboratories (UL) to provide assurance of conformityto applicable standards for medical equipment safety andelectromagnetic compliance.

Caution Statement for United StatesFederal law (USA only) restricts these devices to sale by or on the order of a licensed healthcare practitioner. Outsideof the USA they are available world wide without aprescription but consultation with a qualified healthcarepractitioner is recommended.

IndicationsAlpha-Stim® M is an effective treatment with broad appli-cations for a variety of syndromes involving pain, and boththe M and AID are used for the management of anxiety,insomnia and depression, or for the short term relief ofsymptoms associated with these indications. In many cases,Alpha-Stim® is the sole therapeutic method required. Effective results in pain management have been achievedduring and/or subsequent to stimulation over effectedbody parts, adjacent areas, and areas distant from those inpain. As with any therapeutic intervention, not all peoplewill respond to Alpha-Stim®. The degree of efficacy willvary with the nature of the problem being treated, theoverall health of the person, and with the method of treatment. As much as a one month initial trial may be required to see significant reductions in symptoms.

ContraindicationsAlpha-Stim® may affect the operation of implanted demand type cardiac pacemakers and implanted defibril-lators. Do not stimulate directly on the eyes, or press theAlpha- Stim® M probes over the carotid sinus (on the necknear the larynx).

PrecautionsFor external use only. Do not allow children to use or handle these devices without adult supervision. Do not operate potentially dangerous machinery or vehicles dur-ing treatment, and in some cases for several hours aftertreatment if the user experiences profound relaxation.Caution is advised in cases where other forms of analgesia(pain control) would not be used; such as to retain thebeneficial aspects of pain for diagnosis or in cases wherepeople may overuse pain controlled areas. Safety of stimulation has not been established during pregnancy.There have been reports of blood pressure being loweredin hypertensive patients by CES. Blood pressure should be monitored in people on blood pressure medications and the medication dosage should be lowered by the prescribing physician as necessary.

Adverse EffectsAdverse effects are usually mild and self- limiting. Adverse effects from data on approximately 8,800 patientsparticipating in 144 controlled studies, open clinical trials,and uncontrolled conditions, and by physician survey andreasonably associated with the use of CES are dizziness (6 cases, 0.07%), skin irritation/electrode burns (6 cases,0.07%), and headaches (9 cases, 0.10%). Prolonged CEStreatment at currents higher than necessary may causedizziness or nausea that can last for hours to days. Treatment immediately prior to going to sleep may cause difficulty sleeping due to increased alertness. Paradoxicalreactions such as hyperexcited states, increased anxiety,and sleep disturbances may occur in the initial stages oftreatment, but are rare.


Manufactured and marketed by:Electromedical Products International, Inc.2201 Garrett Morris Parkway / Mineral Wells,Texas 76067-9034 USATel: 1.800.367.7246 in the USA and CANADA, or 940.328.0788Fax: 940.328.0888 / Email: [email protected]

Authorized Representative for the European Union:MediMark Europe11, rue Émile Zola – BP 2332/38033 Grenoble Cedex2– FranceTél: +33 (0)4 76 86 43 22 / Fax: +33 (0)4 76 17 19 82E-Mail: [email protected]

Made in China to the exacting specifications of EPI, USA.

Type B Equipment.This stimulatoris internallypowered only.

See instructionsfor use. Read themanual thoroughlybefore using.

REV A

www.alpha-stim.com

© Copyright 2012 by Electromedical Products International, Inc. ALL RIGHTS RESERVED. Alpha-Stim® is registered in the U.S. Patent and Trademark Office and Worldwide Patents Pending.


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