OWNER`S MANUAL - Bio-Medical Instruments, Inc.
Contents
1. 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 refer 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 1800 s dentists reported excellent results using crude electrical devices for pain control 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 depression and insomnia began in the Soviet Union during the 1950s and continues through this day One hundred years ago electrical devices were in widespread use to manage pain and claimed to cure a variety of medical disorders Because of the unrefined early electrical technologies and political clout of the pharmaceutical lobbies this form of therapy fell 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 i2. during the early part of treatment If this occurs treatment should be continued until at least 2 minutes after this feeling lifts and a lighter feeling is experienced even if it takes more than 60 minutes 7 Check battery Be sure you are using a good fresh battery n FA such as the one provided with the unit Replace the battery 19 59 A coy ew cytes apara when the display indicates battery low as illustrated Once the display indicates battery flat as illustrated the Alpha DAM I AABAA MAA Stim SCS will discontinue stimulation until a new battery is installed Do not use a rechargeable battery 8 Relax Sit or lie down and let the Alpha Stim SCS relax you 9 Automatic Power off At the end of the timed cycle the power will turn off automatically 10 Disconnect and remove ear clip electrodes Use daily for the first 2 weeks then 3 times per week or as directed by your physician SKIN CARE 1 Apply electrodes on dry clean unbroken skin only 2 Before applying and after removing electrodes wash skin with mild soap and water or clean with baby wet wipes Rinse and allow to dry completely 3 Excess hair at the electrode site should be clipped but not shaved 4 If skin irritation develops discontinue use and consult your physician WHAT TO EXPECT Anxiety reduction is usually experienced during a treatment but may be felt hours later or as late as 1 day after treatment Depression and or insom
3. Alpha Stim SCS may affect the operation of cardiac pacemakers particularly demand type pacemakers Precautions For external use only Do not allow children to use or handle this device without adult supervision Do not operate potentially dangerous machinery or vehicles during and in some cases for several hours after treatment Safety of stimulation has not been established during pregnancy There have been isolated reports of blood pressure being lowered by CES so care should be taken while using the Alpha Stim SCS with high blood pressure medication Adverse Effects Adverse effects are usually mild and self limiting Adverse effects seen in approximately 4 541 patients in controlled open uncontrolled conditions and by physician survey and reasonably associated with the use of CES are dizziness 6 cases 0 13 skin irritation electrode burns 5 cases 0 11 and headaches 9 cases 0 20 Prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last for hours to days Treatment immediately prior to going to sleep may cause difficulty sleeping due to increased alertness It is recommended that CES be used at least 3 hours before going to sleep Paradoxical reactions such as hyper excited states increased anxiety and sleep disturbances may occur If the Alpha Stim SCS does not control your anxiety depression and or insomnia within 3 weeks consult your physician TECHNICAL SPECIFICATIONS El
4. Control 5 Sk Oc ne en ee eee ee ee ee ee nee ee eee PEPE 6 WA CO EXPEC airinn AA EE A E EA eos EPERE 6 Prescribing Information Indications Contraindications Precautions Adverse Effects 7 TECHNICA DOCCHICANONS earan E AEE EAEE E RA 7 Storage and Cleaning snnusnnnnnnsnnnnnnnnnnnrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 8 TOUDI SIO QUIN G isara EE E EER 8 OC acess este EE E A E T EEEa 8 5 Year Limited Warranty annnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nenne 8 A NOTE TO DOCTORS Thank you for recommending the Alpha Stim SCS This manual is written for the person who will be using the Alpha Stim SCS but your input will be invaluable to your patient Alpha Med is available to serve the needs of your patients and to support you in doing so New research is constantly available that may have a direct bearing on one of your patient s specific disorders Feel free to write call fax or email Alpha Med for any reason at all INTRODUCTION Congratulations on your selection of the Alpha Stim SCS cranial electrotherapy stimulator CES You have purchased a quality medical instrument In so doing you have already taken the first step to a more comfortable and rewarding life Alpha Med was established with the aim of improving the quality of our Clients lives and we are dedicated to help those who use our products We have
5. relief with as little as only a few minutes of treatment every other day When used properly we trust your new Alpha Stim SCS will help to control your anxiety depression and or insomnia and improve the quality of your life HOW TO USE THE ALPHA STIM SCS FOR ANXIETY DEPRESSION AND OR INSOMNIA CONTROL 1 Clean skin Clean the skin of your ear lobes ONE BUTTON OPERATION thoroughly and allow them to dry before applying electrodes Use mild soap and water or baby wet wipes Read the following instructions carefully Then you may simply moisten and place the clip electrodes on your ear lobes and turn the POWER button on for 20 or 60 minutes That s all there is to it If necessary adjust the current up or down to a vm t lip electrodes to Alpha Stim SCS Oe ne comfortable level at any time during treatment Insert L shaped plug from the ear clip electrodes into the output receptacle on the Alpha Stim SCS 3 Attach earclip electrode pads to ear clips First clean and dry the ends of the ear clips then peel 4 self adhesive earclip electrode pads off of their protective backing and attach them to the inside of each ear clip electrode as originally packed Replace earclip electrode pads after each treatment If using the Alpha Stim SCS in a clinical setting clean the clips thoroughly with alcohol prior to replacing the earclip electrode pads between patients 4 Wet electrodes Wet each of the 4 earclip
6. technical experts available to assure that you receive the best Possible support Telephone consultations can be scheduled with you and your doctor Sunday through Thursday 10 a m to 5 p m You may also communicate with us by mail fax or email We stand behind all our Alpha Stim Stimulators with the manufacturer s 5 year warranty as indicated in this manual The Alpha Stim SCS is a precision medical instrument used for the management of anxiety depression and or insomnia This treatment is non invasive and drug free The Alpha Stim SCS provides a welcome alternative to drugs especially in disorders that require long term management Unlike some drugs the Alpha Stim SCS leaves the mind alert The dangerous side effects of drugs are avoided including accidental intentional and or suicidal overdosing After treatment there are usually no physical limitations imposed so you can resume normal activities The treatment is simple and can easily be self administered at any time People using the Alpha Stim SCS usually report a pleasant relaxed feeling of well being The current is applied by ear clip electrodes During a treatment you may experience a mild tingling sensation as a result of the stimulating current flow The Alpha Stim SCS is often the only means required to relieve anxiety depression and or insomnia However it may also be added to other therapy prescribed by your doctor The Alpha Stim SCS will not interfere with most othe
7. wiping the surface with a damp cloth when dirty Use mild soap and water Use of other cleaning solutions may damage the case Never spray cleaners directly on to the device 70 isopropyl alcohol may be used on the clip electrodes to disinfect them between treatments TROUBLE SHOOTING PROBLEM POSSIBLE SOLUTIONS There is no sensation of current Note This is normal for some people Try turning up the current or wetting electrodes There is no OULD Ul ies enaadw suas cues vcinaxcedenwixads Change the battery if the battery low or battery flat icon appears in the display Try turning up the current Check electrodes make sure electrode connection is firmly in place Earclip electrode pads do not stick well Replace ear clip electrode pads Apply to a clean dry surface SERVICE The Alpha Stim SCS is not user serviceable To obtain service first contact Alpha Med your authorized Alpha Stim distributor for advice or a return authorization number RAN Upon authorization by Alpha Med you may send the entire unit with all accessories and packed in the original carrying case to Alpha Med by registered mail or delivery insured and freight prepaid Please include a copy of your invoice and a note describing the problem Please do not forget to include your return address your phone number and if available your fax number and email address 5 YEAR LIMITED WARRANTY While in the opinion of Electromedical Products
8. 01 Garrett Morris Parkway Mineral Wells Texas 76067 9034 USA Tel 1 800 367 7246 in the USA and CANADA Tel 940 328 0788 Fax 940 328 0888 E Mail alpha stim epli com None of the materials provided on this manual may be used reproduced or transmitted in whole or in part in any form or by any means electronic or mechanical including photocopying recording or by any information storage and retrieval system without permission in writing from the publisher Requests for permission to reproduce or translate materials in whole or in part whether for sale or for non commercial distribution should be addressed to Alpha Med All rights reserved
9. International Inc EPI the manufacturer of Alpha Stim devices the Alpha Stim SCS product is generally effective in relieving anxiety depression and or insomnia health care is not an exact science and individual results will vary Accordingly EPI makes no warranties as to the effectiveness of its products for a given individual Electromedical Products International Inc warrants to the original purchaser and no one else that each new Alpha Stim SCS is free of defects in workmanship and materials under normal use for a period of 5 years from original purchase date except for accessories The warranty registration card must be completed and returned to Alpha Med in order to validate the warranty Accessories such as batteries and electrodes are excluded from the warranty and are sold as is because they may be easily damaged before or during use During the warranty period EPI s sole obligation shall be at EPI s option to replace or repair the Alpha Stim SCS without charge In order to recover under this warranty purchaser must first contact Alpha Med your authorized Alpha Stim distributor by phone mail fax or email for a return authorization number RAN Purchaser must have an original copy of the invoice to prove that the product is still covered by warranty The authorized return may then be shipped to Alpha Med safely packaged with all accessories packed in the original carrying case by registered
10. OWNER S MANUAL Alpha Stim SCS cranial electrotherapy stimulator for control of anxiety depression and insomnia t Type B Equipment This stimulator is internally powered only See Instructions for use f Read this manual thoroughly before using 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 2601 1 and CAN CSA ens C22 2 No 601 1 34VF C US Conformity Statement for Europe The Alpha Stim SCS is a Class Ila Type B 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 Copyright 2002 by Electromedical Products International Inc ALL RIGHTS RESERVED Alpha Stim is registered in the US Patent and Trademark office and worldwide CONTENTS Iuligels Ue o ett ti ttt ten ht E et ies tts ee en ere ene ee oer A DSS CIID ON arrsa A EEE E EE EE ENA 4 Electromedical Therapeutics ccccccc ccc eeceee eee eee ene e eee e eee e eee e enn n nnn aeaaaeaeeeesensenees 5 How To Use The Alpha Stim SCS For Anxiety Depression and or Insomnia
11. ectrical Power Source One 9 volt battery included Replace with disposable batteries alkaline preferred Do not use rechargeable batteries Alpha Stinm SCS Waveform Timer Settings 20 or 60 minutes Current 10 to 500 pA continuously adjustable Frequency 0 5 Hz pulses per second p Waveform Bipolar asymmetric rectangular waves 50 g duty cycle 0 net current see graphic depiction below z a Mechanical 5 Height 10 0 cm Width 7 5 cm a ae Depth 2 3 cm Weight 106 gm with battery Accessories The Alpha Stim SCS is packaged complete with one set of ear clip electrodes 256 earclip electrode pads a 15 ml bottle of Alpha Conducting Solution a 9 volt battery carrying case and illustrated Owner s Manual This is everything necessary to begin to use the Alpha Stim SCS right away Replace the conducting solution and and earclip electrode pads only with authorized Alpha Stim brand products STORAGE AND CLEANING Remove the battery when storing the Alpha Stim SCS for an extended time more than 1 month Always use the carrying case to transport the Alpha Stim SCS When not in use the Alpha Stim SCS and all its accessories should be stored in the carrying case provided The Alpha Stim SCS and its accessories should be stored and used within a temperature range between 0 and 36 C with a relative humidity of 90 or less at an atmospheric pressure between 0 9 1 1 atm Clean the Alpha Stim SCS by periodically gently
12. electrode pads while attached to the ear clips with about 2 or 3 drops of Alpha Conducting Solution ACS Discard the ring around the ACS bottle after opening to seal it tightly and prevent leakage 5 Place electrodes on ears Clip electrodes on each ear lobe close to the jaw and as high on the lobe as possible You must always use both clip electrodes to complete the electrical circuit 6 Set the current turn power on and set the timer Be certain the current control wheel on side of device is all the way down to 0 The LCD will start counting down as soon as the Alpha Stim is turned on by depressing the power button on the left You adjust the timer between 20 and 60 minutes by pressing the button on the right while the Alpha Stim is on 20 to 60 minutes is recommended unless otherwise specified by your physician People who can only tolerate a current setting of 2 200 microamperes or less will generally need more than 20 minutes Turn the current up slowly until a comfortable tingling feeling is felt for some people it is normal not to feel anything Immediately e a siiaduainar hen 3S9 curent Knob decrease a aaa the current if the tingling feeling becomes uncomfortable or if Taala a y Current incicator dizziness or nausea develops Decreasing the current should immediately relieve any of these unpleasant feelings and they are not necessary for optimal effect Some people experience a feeling of heaviness
13. m The Alpha Stim SCS is actually a microcomputer incorporating the latest advances in solid state electronics All components are of the highest quality available to assure the user the ultimate in reliable and trouble free performance The output is accurate within 0 1 under all operating conditions The instrument s design assures electrical safety to the user by the use of readily available 9 volt batteries One battery will generally last for over 50 treatments One important feature incorporated into the Alpha Stim SCS is an electronic circuit which operates to maintain a nearly constant current flow to the electrodes minimizing the effects of electrode resistance variations due to poor electrode to skin contact Alpha Stim SCS was developed by neurobiologist Dr Daniel L Kirsch and consultant engineers Dr Kirsch has been a leading pioneer in the field of electromedicine since 1972 He is board certified in pain management by the American Academy of Pain Management and is a Fellow of the American Institute of Stress 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 lectures frequently to physicians worldwide on pain and stress management Only original Alpha Stim products meet Electromedical Products International Inc s exacting specifications ELECTROMEDICAL THERAPEUTICS
14. mail or delivery insured and freight prepaid Alpha Med and EPI will not be responsible for damage due to improper packaging or shipment If EPI determines there is a defect covered by this warranty the repaired or replaced product will be shipped back freight and insurance prepaid as soon as reasonably possible If EPI determines in its sole discretion that the product does not contain defective workmanship or materials EPI will return the product and the return freight and insurance charges shall be the purchaser s responsibility This warranty is voided immediately if the product has been subjected to abuse accidental damage damage in transit negligence acts of nature or damage resulting from failure to follow operating instructions or alteration disassembly by anyone other than by EPI Electromedical Products International Inc and Alpha Med shall not be liable for any direct indirect special incidental or consequential damages lost profits or medical expenses caused by any defect failure malfunction or otherwise of the product regardless of the form in which any legal or equitable action may be brought against EPI or Alpha med such as contract negligence or otherwise In no event shall EPI s or Alpha Med s liability under any cause of action relating to the product exceed the purchase price of the product Manufactured by ELECTROMEDIC AL Feoduacts International He Electromedical Products International Inc 22
15. nia control is generally felt after 1 to 3 weeks of daily treatment After the condition is under control use of Alpha Stim 3 times per week is usually sufficient to maintain good results The Alpha Stim SCS leaves the user alert while inducing a relaxed state One 20 minute session is usually all that is needed to effectively control anxiety depression and or insomnia for at least a day It may also be used as an adjunct to medication and or psychotherapy For people who have difficulty falling asleep Alpha Stim should be used at least 3 hours before going to bed or the increased alertness may interfere with sleep After treatment there are usually no physical limitations imposed so most people can resume normal activities immediately Some people may experience an euphoric feeling or relaxation that may temporarily impair their mental and or physical abilities for the performance of potentially hazardous tasks such as operating a motor vehicle or heavy machinery for up to several hours after treatment At present there are over 125 research studies on using cranial electrotherapy stimulation for anxiety depression and or insomnia related disorders in humans and 29 animal studies No significant lasting side effects have been reported Occasional self limiting headache discomfort or skin irritation under the electrodes or lightheadedness may occur If a heavy feeling occurs continue treatment until at least 2 minutes after it gives way t
16. o a light feeling Some people will see flashing lights due to stimulation of the optic nerve Some may experience the metallic taste of dental fillings Neither of these conditions are harmful PRESCRIBING INFORMATION CE Conformity Statement for Europe The Alpha Stim SCS is a Class lla Type B 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 Caution Statement Outside of the USA this device is available world wide without a prescription but consultation with a qualified health care professional is recommended for difficult and unresponsive problems or when used in conjunction with pharmaceuticals or other therapeutic intervention Indications Alpha Stim SCS cranial electrotherapy stimulation CES technology is continuously being subjected to rigorous study and evaluation by the international medical community Findings to date indicate that the Alpha Stim SCS is an effective treatment with broad applications for a variety of anxiety disorders or for the short term relief of the symptoms of anxiety depression and or insomnia In many cases it is the sole therapeutic method required As with any therapeutic intervention not all people will respond to the Alpha Stim SCS The degree of efficacy will vary with the nature of the problem being treated and the overall health of the person Contraindications
17. r treatments Once you understand the basic procedures You will find the Alpha Stim SCS very 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 doctor DESCRIPTION The Alpha Stim SCS was developed through original research by Electromedical Products International Inc in Texas USA Itis a precision technology which generates a modified square bipolar waveform of 0 5 pulses per second Hz 10 to 500 millionths of an ampere uA at a 50 duty cycle The Alpha Stim SCS is small compact and light weight Its design lends itself well to treatment in a health practitioner s office clinic or hospital as well as self administered treatment at home The controls are simple and easy to operate An automated timer assures the prescribed treatment time even if you are distracted or fall asleep The amount of current can be easily modified for maximum comfort and effectiveness The Alpha Stim SCS is categorized as cranial electrotherapy stimulation or CES represented by the application of using ear clip electrodes for the control of anxiety depression and or insomnia Results in electromedicine are based on the design of the waveform the amount of current intensity and the amount of time it is used The Alpha Stim SCS has 2 waveform generators that serve to add random factors to avoid accommodation by the nervous syste
18. t the burden of responsibility for curing all of mankind s ills Now at the start of the 21st century it is clear that chemistry as the sole explanatory model for medicine has not lived up to its promise causing modern medicine to re examine the role of biophysics Modern science has established that there are extensive electrical fields at work in 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 This knowledge has led medical scientists such as Dr Robert Becker of the U S A and Dr Bjorn Nordenstrom of Sweden who served as Chairman of the Nobel Assembly to propose completely new theories of physiology based on bioelectrical control systems Over the past few decades technology has surpassed chemical analysis for the diagnostic side of medicine With Alpha Stim technology therapeutic intervention based on the new biophysics is finally emerging as a viable alternative to pharmacological management and surgery The original Alpha Stim Model 2000 a sophisticated clinical device weighed 40 pounds and cost 5 850 U S when it was first introduced in 1981 The Alpha Stim SCS cranial electrotherapy stimulator utilizes the most advanced technology available today It is now possible in most cases to alleviate anxiety depression and or insomnia and experience long term and cumulative
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