Physiotherapy PhysiothérapieRev1 1012P/N 861-7154252-in-1 Physiotherapy DeviceQuestions? Comments?1-800-363-2381 www.amgmedical.comInstructionsAMG Medical Inc.Montréal, QC H4T 1V5 1-800-363-2381Alpharetta, GA 30022 1-866-321-4846Please read this manual thoroughlybefore using this device for the first time.715-425 TENS instructions rev1 1012715-425861-71542524,811 cm x 18,81 cmFolded: 10,5 cm x 15 cm. Open: 21 cm x 15 cmTMThis is a double-sided, saddle-stitched instruction booklet.Isabelle Picard

TABLE OF CONTENTSINTRODUCTION. 3What is pain? How does TENS work?What is EMS and how does it work?SAFETY INFORMATION . 4Indication for use Contraindication WarningPrecautions Adverse reactionsDEVICE OVERVIEW . 6DISPLAY SYMBOLS. 7INSTRUCTIONS FOR USE . 8Insert the battery Connect electrodes to lead wiresConnect lead wires to the device Place electrodes on skinTurn the device on Select the therapy program (mode) and siteSet the pulse width and rate Set the treatment timeAdjust the intensity for each channel and begin treatmentAfter treatment is finished To consult the memoryTo turn off the device Low battery indicatorCLEANING AND MAINTENANCE . 12Cleaning the device and accessories MaintenanceTo replace the batteryTHERAPY PROGRAMS . 14TENS programs EMS programsSKIN CARE RECOMMANDATIONS. 15TROUBLESHOOTING . 16STORAGE . 17DISPOSAL . 17WARRANTY . 18TECHNICAL INFORMATION. 182

INTRODUCTIONThis device can be used for pain relief and muscle stimulation. Itprovides two independent, controllable output channels. A pair ofelectrodes which can be connected to each output channel and thecurrent's parameters and intensity level can be adjusted accordingto your needs.1. What is pain?Pain warns our body of injury to prevent additional damage. Thissensation is important because without it, vital parts of our bodiesmight be injured without our knowledge. However, long-lasting,persistent (chronic) pain, once diagnosed serves no apparentpurpose and reduces quality of life.2. How does TENS work?TENS (Transcutaneous Electrical Nerve Stimulation) refers tothe transmission of small electrical pulses through the skin to theunderlying peripheral nerves. The theory of TENS suggests twodifferent modes of operation:In conventional (high frequency) TENS, continuous mild electricalactivity may block the pain signal traveling to the brain. If the painsignal does not get through to the brain, the pain is not “felt”.In low frequency TENS, short bursts of electrical activity maystimulate the release of endorphins, the body's own pain-controlsubstance. Ask your physician or therapist for more details. Nomatter what pain theory is used, TENS has been proven useful in painmanagement for many patients in helping to make their lives better.3. What is EMS and how does it work?In normal muscular activity, the central and peripheral nervoussystems transmit electrical signals to the muscles, making themcontract. EMS (Electrical muscle stimulation) uses an externalsource (the stimulator, via wires and electrodes) to achieve thesame effect, creating involuntary muscle contractions. This canhelp improve and maintain muscle tone without actual physicalactivity and therefore prevent atrophy.3SAFETY INFORMATION1. This device is recommended for: Symptomatic relief ofchronic intractable pain, acute post traumatic pain or acute postsurgical pain Improving local blood circulation Relief frommuscle spasms2. Do not use in the following situations: Undiagnosed painsyndromes (until etiology is established). Cancerous lesions thatare present in the treatment area. Swollen, infected, inflamed areasor skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins,etc.). Demand type implanted pacemaker or defibrillator. Epilepsy Serious arterial circulatory problems in the lowerlimbs Abdominal or inguinal hernia Safety has not beenestablished for use during pregnancy. Electrical stimulation isnot effective on pain that is of central originWARNINGFor external use only. The long-term effects of frequent electricalstimulation are unknown. This device should be used only underthe continued supervision of a licensed medical practitioner.Do not apply stimulation over the thyroid or carotid sinus regions,as this could disrupt breathing, cardiac frequency or blood pressure.Do not use while connected to high-frequency surgical equipmentor near shortwave or microwave therapy equipment. Never use inenvironments with high humidity (ex.: bathroom). Never place theelectrodes anywhere on the front of the thorax or transthoracicallyas it can increase the risk of ventricular fibrillation, cause cardiacarrhythmia and lead to cardiac arrest. Never place the electrodesin a way that would cause the current to flow through the head.Never use near the eyes, the genitals, the heart or on areas whichlack normal sensation. This stimulator should never be used bypatients who are noncompliant or are emotionally, cognitively ormentally impaired. Keep the stimulator out of reach of children.4

DEVICE OVERVIEW4. Precautions Do not adjust controls while operating machinery or vehicles.Never use the stimulator during any activity in which involontarymovement would represent a risk of injury. Turn the stimulator off before applying or removing electrodes. Only use with ProActiveTM lead wires and electrodes. Long-term stimulation at the same electrode site may causeskin irritation. Use only as prescribed by a physician. Never use in rooms where aerosols (sprays) are usedor pure oxygen is being administered. Do not use it nearhighly flammable substances, gases or explosives. Apply the electrodes to clean, dry, and unbroken skin only. Keep electrodes separate during treatment. Electrodes comingin contact with each other could result in improper stimulationor skin burns.5. Possible adverse reactionsSkin irritation or electrode burn under the electrodes. Allergic skinreaction to electrode gel may also occur.BackTopBelt clipChannel 1lead wiresocketBattery coverChannel 1intensitycontrolFrontChannel 2intensitycontrolDisplayscreen(LCD)Therapy sitequick selectParameterincreaseParametersetting5Channel 2lead wiresocketMode selectParameterdecrease6

DISPLAY SYMBOLSINSTRUCTIONS FOR USETreatment lsewidthMemoryTimerChannel 1outputintensityTherapysiteselectorChannel 2outputintensity1. Insert the batterySlide the belt clip off, then the batterycompartment cover. Insert a 9V battery(included), matching the positiveand negative ends of the batteryto the markings, then close the compartment.2. Connect electrodes to lead wiresInsert the lead wire connector intothe electrodes connector, ensuringthat no bare metal remains exposed.3. Connect lead wires to the deviceThis device has 2 output channels,which can be used simultaneously(with 2 electrode pairs) or individually(1 channel with 1 electrode pair). Aftermaking sure that the device is turnedoff, insert the wire plugs into the socketsat the top of the unit.Caution: Always use the lead wiressupplied with this unit.4. Place electrodes on skinEnsure that the skin surface where the electrodes will be placed isclean and dry. Apply electrodes to the exact site indicated by yourphysician. The electrodes should be placed firmly and evenly on theskin to ensure good contact.78

Caution: Always wash and dry the treatment area before applying theelectrodes. Do not turn the device on when the electrodes are notapplied to the treatment area. Never adjust, reposition orremove the electrodes while the device is still on. Always use this device with 4cm x 4cm self-adhesive squareelectrodes, or larger. If they seem to have lost their adhesiveproperties, replace with new ProActiveTM electrodes.Important note: Electrode positioning can be one of the mostimportant parameters in achieving success with TENS therapy.Of utmost importance is the willingness of the health carepractitioner to try the various styles of electrode placement tofind which method best fits the needs of each individual patient.Everyone responds to electrical stimulation differently and,accordingly, their needs may vary from the conventional settingssuggested here. If the inital results are not positive, feel free toexperiment. Once an effective positioning has been achieved,mark down the electrodes sites and the settings at the end of thismanual so that it can easily be replicated at home.5. Turn the device onCarefully read the contraindications and safety information in thismanual before using for the first time. Turn the intensity control foreither channel 1 or 2 clockwise. The device will beep. Continue asdescribed below before increasing output intensity.6. Select the therapy program (mode) and sitePress M until the required mode (EMS or TENS) and body part areselected. The selected therapy mode will then flash on screen.97. Set the pulse width and ratePress S to enter parametersetting mode, then use the arrowbuttons to adjust the pulse widthto the value prescribed by yourdoctor or therapist. Then, pressS again and use the arrowbuttons to adjust the pulse rateto the value prescribed by yourdoctor or therapist.8. Set the treatment timePress S, then use the arrow buttons to adjust the treatment time.9. Adjust the intensity for each channel and begin treatmentSlowly turn the intensity control dials clockwise until you reach theprescribed setting. To further increase the intensity, turn the dialsclockwise. To decrease the intensity or turn the device off, rotatethe dials counter-clockwise to the desired setting or to the "OFF"position. If treatment becomes uncomfortable, decrease theintensity to your comfort level and contact your doctor or therapist ifthe problem persists.10

CLEANING AND MAINTENANCE10. After treatment is finishedOnce the treatment time has elapsed, turn the intensitycontrol dials counter-clockwise to the "OFF" position.Unplug the lead wires from the device.To remove the electrodes, lift one edge and gently peel(do not pull on the lead wires because this maydamage the electrodes). Place theelectrodes on the liner and removethe lead wire by twisting andpulling at the same time.11. To consult the memoryWith the unit shut off, press and hold Mand turn one intensity control knobs to entermemory mode. A M will be displayed onthe screen.NOTE: The maximum number ofrecords is 30, after which the oldest recordwill be deleted.1. StimulatorRemove the battery before cleaning. Wipe the stimulator with asoft, slightly moistened cloth. If a more thorough cleaning isneeded, you can also moisten the cloth with mild soapy water.Do not submerge the stimulator or expose it to a large amountof water. Do not use any chemical cleaners or abrasive agents toclean this device. After use, store the stimulator in its foam-paddedcarrying case to protect it from shock and dust. If you plan not touse it for a prolonged period, remove the battery from the unit andstore in a cool, dry place.2. Electrodes Use the device only with the leads and electrodes providedwith this device or sold under the ProActive brand, followingthe placements and settings prescribed by your practitioner. It is recommended to use at minimum 4cm x 4cm self-adhesive,square electrodes. Inspect your electrodes before every use and replace as needed.Reusing electrodes too many times may cause slight skin irritation,low adhesion or ineffective stimulation. Between uses, store the electrodes in the resealed bag in a cooldry place. It may be helpful, between applications, to moistentheir adhesive surface with a few drops of water (be careful not toover-saturate) and then let them air-dry to help them last longer.Use the arrow keys to navigate between records and S to switchbetween data withing one record. To clear the memory, pressthe quick select button.12. To turn off the deviceRotate both intensity controls to "0".13. Low battery indicatorWhen the indicator flashes, replace the batteries as soon aspossible. However, the stimulator will continue to operate forseveral hours. If stimulation seems weaker than usual, replacethe battery.11Reusable, self-adhesive electrodes12

THERAPY PROGRAMS3. Cleaning the electrode cordsClean the electrode cords by wiping them with a damp cloth.Coating them lightly with talcum powder will reduce tanglesand help them last longer.4. Maintenance Do not attempt any repairs to the device or any of its accessories.Contact us at 1-800-363-2381 for repair information. The manufacturer will not be held responsible for the resultsof maintenance or repairs by unauthorized persons. Check the device before each use for signs of wear and/ordamage. Replace worn items (electrodes, lead wires) as required.5. To replace the batteryTo ensure safe and adequate functionning of this device, it isnecessary to periodically change the battery. To do so, slide the beltclip off, then the battery compartment cover. Remove the oldbattery and insert a new one, matching the positive and negativeends of the battery to the markings, then close the compartment.Caution: If a battery has leaked, avoid any contact with skin, eyesand mucous membranes. Flush anyaffected skin with water and contacta medical professional right away.Do not attempt to rechargethe battery supplied with thisdevice. If you plan not to usethe device for a long time,remove the battery and storeappropriately, away from heat.13ProgramTENS BurstTime Rate30Width100Hz 200µsWave description9 pulses/burst, 2 bursts/sec.Normal30100Hz 200µsContinuousMod.30100Hz 200µsFirst 0.5 sec.: pulse width at 50%setting. Next 0.5 sec.: pulse rateat 50% setting and width at 100%setting.SD130100Hz120 200µsSet intensity goes from 100% to60% then back to 100% while setpulse goes from 60% to 100% andback to 60%, over 10-second cycles.SD230100Hz60 200µsSet intensity goes from 100% to30% then back to 100% while setpulse goes from 30% to 100% andback to 30%, over 10-second cycles.Shoulder 302 60 125Hz 200µs12-second cycles, span: 50%.Rate stays in the 2-10Hz range for1/3 of the cycle time as itmodulates down to 2Hz and backup again.Lowerback30100Hz1-second cycles, span: 60%.Modulated amplitude via pulse width0.5 sec. at 100% of set intensity and0.5 sec. at 50%.Elbow302 100/125Hz 200µs12-second cycles, span: 50%Rate stays in the 2-10Hz range for1/3 of the cycle time as itmodulates down to 2Hz and backup again.Knee3050Hz200µs6-second cycles (1 sec. up / 1 sec.down) then 6 seconds rest.EMS A3050Hz200µs6-second cycles (1 sec. up / 1 sec.down) then 6 seconds rest.S3050Hz200µs8-second cycles(2 sec. up / 2 sec.down) then 4 seconds rest.D3040Hz200µs11-second cycles (4 sec. up / 2 sec.down) then 15 sec. rest (1 sec. delay).300/200µs14

THERAPY PROGRAMS (CONTINUED)ProgramEMS NeckTime RateWidthWave description3020Hz180µsContinuousAbdomen 3065Hz250µs10-second cycles (2 sec. up / 2 sec.down) then 8 seconds rest.Hip3050Hz250µs13-second cycles (1 sec. up / 2 sec.down) then 10 sec. rest.Leg3040Hz200µs13-second cycles (1 sec. up / 2 sec.down) then 10 sec. rest.Foot3065Hz200µs10-second cycles (2 sec. up / 2 sec.down) then 8 seconds rest.SKIN CARE RECOMMANDATIONS Always clean the treatment area using a mild soap, rince skinthoroughly and dry well before applying the electrodes and afterremoving them. Clip excess hair with scissors – do not shave the treatment area. Your doctor or therapist may recommend the use of a skin prepsolution. Let it dry thoroughly before applying the electrodes. Avoid stretching the electrode over the skin as this could cause"pulling stress". Apply the electrode from the center outward toprevent this from happening. When removing the electrodes, pull in the direction of hair growth. It may be helpful to apply a skin lotion over the treatment area whennot using the electrodes. Never apply the electrodes over irritated or broken skin.TROUBLESHOOTINGIf your device does not seem to be operating correctly, refer to thechart below to determine what may be wrong. Should none of thesemeasures correct the problem, the device should be serviced.ProblemDisplay failsto light upPossible causeBattery contact failureElectrodes are driedout or dirtyElectrodes areimproperly positionedOld / worn / damagedlead wiresStimulation is Intensity is too highuncomfortable Electrodes are tooclose togetherDamaged or wornelectrodes or lead wiresElectrode active areais too smallWeak or nostimulationThe user instructions arenot being followedIntermittentoutputSolution1) Install new batteries2) Ensure that the battery is insertedcorrectly, respecting the polarities,and that battery contacts are inplace and in good conditionReplace and re-connect the electrodesReposition and re-connectthe electrodesReplace the lead wiresDecrease intensityReposition the electrodesReplace the lead wiresReplace electrodes with ones that are16 cm2 (4 cm x 4 cm or 1.5” x 1.5”)or largerPlease check the manual before useProgram option in useSome programs will seem intermittent.This is expected.Lead wires1) Verify connection is secureand firmly in place2) Turn down the intensity. Rotate leadwires in socket 90 . If the problempersists, replace lead wire.3) If replacing the lead wire does notsolve this problem, contact us at:1-800-363-23811516

LIMITED WARRANTYProblemStimulationis ineffectiveThe skinbecomesred and / oryou feel astabbing painPossible causeImproper electrodeplacementUnknownRepetitive use ofelectrodes on thesame siteElectrodes aren’tapplied on the skin properlyThe electrodes are dirtyThe surface of theelectrode is scratchedOutput current The electrode padsstops duringcome off the skintherapyA cable is disconnectedBatteries are lowSolutionReposition electrodeContact your doctorReposition the electrodes. If at anytime you feel pain or discomfort, stopuse immediatelyEnsure the electrodes are attachedsecurely to the skinClean the electrode pads with a damp,lint-free cloth or replace with newelectrodes. Clean the electrode cordaccording to the description in theuser manualReplace with a new electrodeTurn off the device and attach theelectrode firmly to the skinTurn off the device and connect the cableReplace with new batteriesSTORAGE Remove the battery if the device is not in use for long periodsof time. Store the device in a dry place and protect it against heat,sunshine and moisture. Never place any heavy objects on the device.DISPOSALUsed fully discharged batteries must be disposed of in a speciallylabeled collection container, at toxic waste collection points or throughan electrical retailer.Please dispose of the device in accordance with the directive2002/96/EC WEEE (Waste Electrical and Electronic Equipment).Contact your local distributor for information regarding disposalof the unit and accessories.17AMG Medical Inc. warrants the stimulator to be free from defects inmaterial and workmanship for a period of one (1) year, to be proven bymeans of the sales receipt or invoice. This warranty is valid for theoriginal purchaser only. Any alterations, abuse, misuse or accidentaldamage voids this warranty. Repairs under warranty do not extend thewarranty period. For service under warranty, call us at:1-800-363-2381, between 8 AM and 5 PM EST. The following is excluded under the warranty:A) All damage which has arisen due to improper treatment,e.g. nonobservance of the user instructions.B) All damage which is due to repairs or tampering by the customeror unauthorized third parities.C) Damage which has arisen during transport from the manufacturerto the consumer or during transport to the service centre.D) Accessories which are subject to normal wear and tear. Liability for direct or indirect consequential losses caused by theunit are excluded even if the damage to the unit is accepted as awarranty claim.TECHNICAL INFORMATION Channel: Two isolated channels Power supply: 1 x 9V battery, type 6F22 Waveform: Single square pulse Pulse duration: adjustable, from 30 to 350μs. Pulse frequency: adjustable, from 1 to 150Hz Treatment time: 5 to 60min Amplitude: 0-40V(Vpp)(Large output 40V 10% at 500ohm load) Operating conditions: 0 C to 40 C with a relative humidityof 30% - 75%, Atmospheric pressure from 700 hpa to 1060 hpa Storage conditions: -10 C to 55 C with a relative humidityof 10% 90%, atmospheric pressure from 700 hpa to 1060 hpa Dimensions: 110 x 65 x 30.2 mm Weight: 139 g (with battery)18

Rev1 1012 P/N 861-715425 Please read this manual thoroughly before using this device for the first time. Physiotherapy Physiothérapie 2-in-1 Physiotherapy Device 715-425 TENS instructions rev1 1012 715-425 861-715425 24,811 cm x 18,81 cm Folded: 10,5 cm x 15 cm. Open: 21 cm x 15 cm This is a double-sided, saddle-stitched instruction booklet.