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1. AMG Medical Inc warrants the stimulator to be free from defects in material and workmanship for a period of one 1 year to be proven by means of the sales receipt or invoice This warranty is valid for the original purchaser only Any alterations abuse misuse or accidental damage voids this warranty Repairs under warranty do not extend the warranty period For service under warranty call us at 1 800 363 2381 between 8 AM and 5 PM EST e 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 customer or unauthorized third parities C Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre D Accessories which are subject to normal wear and tear e Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim TECHNICAL INFORMATION e Channel Two isolated channels e Power supply 1 x 9V battery type 6F22 e Waveform Single square pulse e Pulse duration adjustable from 30 to 350us e Pulse frequency adjustable from 1 to 150Hz e Treatment time 5 to 6Omin e Amplitude 0 40V Vpp Large output 40V 10 at 500ohm load e Operating conditions O C to 40 C with a relative humidity of 30 75 Atmospheric pressure from 700 hpa to 1060
2. e Epilepsy Serious arterial circulatory problems in the lower limbs e Abdominal or inguinal hernia Safety has not been established for use during pregnancy Electrical stimulation is not effective on pain that is of central origin WARNING For external use only The long term effects of frequent electrical stimulation are unknown This device should be used only under the 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 equipment or near shortwave or microwave therapy equipment Never use in environments with high humidity ex bathroom Never place the electrodes anywhere on the front of the thorax or transthoracically as it can increase the risk of ventricular fibrillation cause cardiac arrhythmia and lead to cardiac arrest Never place the electrodes in a way that would cause the current to flow through the head Never use near the eyes the genitals the heart or on areas which lack normal sensation This stimulator should never be used by patients who are noncompliant or are emotionally cognitively or mentally impaired Keep the stimulator out of reach of children 4 Precautions e Do not adjust controls while operating machinery or vehicles Never use the stimulator during any activity in which involontary movement would repre
3. 13 THERAPY PROGRAMS Program Time Rate Width Wave description TENS Burst 30 100Hz 200us 9 pulses burst 2 bursts sec Normal 30 100Hz 200us Continuous Mod 30 100Hz 200us First 0 5 sec pulse width at 50 setting Next 0 5 sec pulse rate at 50 setting and width at 100 setting SD1 30 100Hz 120 Set intensity goes from 100 to 200us 60 then back to 100 while set pulse goes from 60 to 100 and back to 60 over 10 second cycles SD2 30 100Hz 60 Setintensity goes from 100 to 200us 30 then back to 100 while set pulse goes from 30 to 100 and back to 30 over 10 second cycles Shoulder 30 2 60 12 second cycles span 50 125Hz 200us_ Rate stays in the 2 10Hz range for 1 3 of the cycle time as it modulates down to 2Hz and back up again Lower 30 100Hz 300 1 second cycles span 60 back 200us Modulated amplitude via pulse width 0 5 sec at 100 of set intensity and 0 5 sec at 50 Elbow 30 2 100 12 second cycles span 50 125Hz 200us_ Rate stays in the 2 10Hz range for 1 3 of the cycle time as it modulates down to 2Hz and back up again Knee 30 50Hz 200us_ 6 second cycles 1 sec up 1 sec down then 6 seconds rest EMS A 30 50Hz 200us 6 second cycles 1 sec up 1 sec down then 6 seconds rest S 30 50Hz 200us 8 second cycles 2 sec up 2 sec down then 4 seconds rest D 30 40Hz 200us 11 second cycles 4 sec up 2 sec down then 15 sec rest 1 sec delay 14 THERAPY P
4. hpa e Storage conditions 10 C to 55 C with a relative humidity of 10 90 atmospheric pressure from 700 hpa to 1060 hpa e Dimensions 110 x 65 x 30 2 mm e Weight 139 g with battery 18
5. NSTRUCTIONS FOR USE 1 Insert the battery Slide the belt clip off then the battery compartment cover Insert a 9V battery included matching the positive and negative ends of the battery A to the markings then close the compartment ha 2 Connect electrodes to lead wires Insert the lead wire connector into the electrodes connector ensuring that no bare metal remains exposed This device has 2 output channels which can be used simultaneously with 2 electrode pairs or individually 1 channel with 1 electrode pair After making sure that the device is turned off insert the wire plugs into the sockets at the top of the unit Caution Always use the lead wires supplied with this unit 4 Place electrodes on skin Ensure that the skin surface where the electrodes will be placed is clean and dry Apply electrodes to the exact site indicated by your physician The electrodes should be placed firmly and evenly on the skin to ensure good contact Caution e Always wash and dry the treatment area before applying the electrodes e Do not turn the device on when the electrodes are not applied to the treatment area Never adjust reposition or remove the electrodes while the device is still on e Always use this device with 4cm x 4cm self adhesive square electrodes or larger If they seem to have lost their adhesive properties replace with new ProActive electrodes Important note Electrode po
6. ROGRAMS CONTINUED Program Time Rate EMS Neck 30 20Hz Abdomen 30 65Hz Hip 30 50Hz Leg 30 40Hz Foot 30 65Hz Width 180us 250us 250us 200us 200s Wave description Continuous 10 second cycles 2 sec up 2 sec down then 8 seconds rest 13 second cycles 1 sec up 2 sec down then 10 sec rest 13 second cycles 1 sec up 2 sec down then 10 sec rest 10 second cycles 2 sec up 2 sec down then 8 seconds rest SKIN CARE RECOMMANDATIONS e Always clean the treatment area using a mild soap rince skin thoroughly and dry well before applying the electrodes and after removing them e Clip excess hair with scissors do not shave the treatment area e Your doctor or therapist may recommend the use of a skin prep solution Let it dry thoroughly before applying the electrodes e Avoid stretching the electrode over the skin as this could cause pulling stress Apply the electrode from the center outward to prevent this from happening e When removing the electrodes pull in the direction of hair growth e It may be helpful to apply a skin lotion over the treatment area when not using the electrodes e Never apply the electrodes over irritated or broken skin 15 TROUBLESHOOTING If your device does not seem to be operating correctly refer to the chart below to determine what may be wrong Should none of these measures correct the problem the device should be serviced Problem Po
7. Rev1 1012 P N 861 715425 Questions Comments 1 800 363 2381 www amgmedical com AMG Medical Inc Montr al QC H4T 1V5 1 800 363 2381 Alpharetta GA 30022 1 866 321 4846 roactWwe Physiotherapy Physioth rapie allevia 2 in 1 Physiotherapy Device Instructions Please read this manual thoroughly before using this device for the first time TM TABLE OF CONTENTS INTRODUCTION noii edee a an eaa aaa eea 3 What is pain e How does TENS work What is EMS and how does it work SAFETY INFORMATION cc ccccsccsssecesseecsseeesseeceseeeeseeeesseeesseees 4 Indication for use Contraindication e Warning Precautions Adverse reactions DEVICE OVERVIEW 0 0 ccccssccscccssevseccssarenceceetenectettensagaesie cteneestenicecenssnes 6 DISPLAY SYMBOLS esaiar R senate 7 INSTRUCTIONS FOR USE 000 cece seen ene enee nena 8 Insert the battery e Connect electrodes to lead wires Connect lead wires to the device Place electrodes on skin Turn the device on Select the therapy program mode and site Set the pulse width and rate Set the treatment time Adjust the intensity for each channel and begin treatment After treatment is finished To consult the memory To turn off the device e Low battery indicator CLEANING AND MAINTENANCE sssccssseccssseeesseeesseeessseeenseeenseees 12 Cleaning the device and accessories e Maintenance To replace the battery THERAPY PROGRAMS ss ssssss
8. ay block the pain signal traveling to the brain If the pain signal does not get through to the brain the pain is not felt In low frequency TENS short bursts of electrical activity may stimulate the release of endorphins the body s own pain control substance Ask your physician or therapist for more details No matter what pain theory is used TENS has been proven useful in pain management for many patients in helping to make their lives better What is EMS and how does it work In normal muscular activity the central and peripheral nervous systems transmit electrical signals to the muscles making them contract EMS Electrical muscle stimulation uses an external source the stimulator via wires and electrodes to achieve the same effect creating involuntary muscle contractions This can help improve and maintain muscle tone without actual physical activity and therefore prevent atrophy SAFETY INFORMATION 1 This device is recommended for e Symptomatic relief of chronic intractable pain acute post traumatic pain or acute post surgical pain Improving local blood circulation Relief from muscle spasms 2 Do not use in the following situations Undiagnosed pain syndromes until etiology is established e Cancerous lesions that are present in the treatment area Swollen infected inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Demand type implanted pacemaker or defibrillator
9. ensity controls to O Low battery indicator When the indicator flashes replace the batteries as soon as possible However the stimulator will continue to operate for several hours If stimulation seems weaker than usual replace the battery 11 CLEANING AND MAINTENANCE 1 Stimulator Remove the battery before cleaning Wipe the stimulator with a soft slightly moistened cloth If a more thorough cleaning is needed you can also moisten the cloth with mild soapy water Do not submerge the stimulator or expose it to a large amount of water Do not use any chemical cleaners or abrasive agents to clean this device After use store the stimulator in its foam padded carrying case to protect it from shock and dust If you plan not to use it for a prolonged period remove the battery from the unit and store in a cool dry place 2 Electrodes e Use the device only with the leads and electrodes provided with this device or sold under the ProActive brand following the placements and settings prescribed by your practitioner e It is recommended to use at minimum 4cm x 4cm self adhesive square electrodes e 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 e Between uses store the electrodes in the resealed bag in a cool dry place It may be helpful between applications to moisten their adhesive surface with a f
10. ew drops of water be careful not to over saturate and then let them air dry to help them last longer Connector for Lead Wire Pin ff Adhesive Pad Reusable self adhesive electrodes 12 3 Cleaning the electrode cords Clean the electrode cords by wiping them with a damp cloth Coating them lightly with talcum powder will reduce tangles and help them last longer 4 Maintenance e Do not attempt any repairs to the device or any of its accessories Contact us at 1 800 363 2381 for repair information e The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons e Check the device before each use for signs of wear and or damage Replace worn items electrodes lead wires as required To replace the battery To ensure safe and adequate functionning of this device it is necessary to periodically change the battery To do so slide the belt clip off then the battery compartment cover Remove the old battery and insert a new one matching the positive and negative ends of the battery to the markings then close the compartment Caution If a battery has leaked avoid any contact with skin eyes and mucous membranes Flush any affected skin with water and contact a medical professional right away Do not attempt to recharge the battery supplied with this device If you plan not to use the device for a long time remove the battery and store appropriately away from heat
11. sent a risk of injury e Turn the stimulator off before applying or removing electrodes e Only use with ProActive lead wires and electrodes e Long term stimulation at the same electrode site may cause skin irritation Use only as prescribed by a physician e Never use in rooms where aerosols Sprays are used or pure oxygen is being administered Do not use it near highly flammable substances gases or explosives e Apply the electrodes to clean dry and unbroken skin only e Keep electrodes separate during treatment Electrodes coming in contact with each other could result in improper stimulation or skin burns 5 Possible adverse reactions Skin irritation or electrode burn under the electrodes Allergic skin reaction to electrode gel may also occur Front Parameter increase Parameter setting DEVICE OVERVIEW Back Belt clip Battery cover II Display screen LCD Channel 1 lead wire socket Channel 2 lead wire socket Channel1 Channel 2 intensity intensity control control Therapy site quick select m Mode select Parameter decrease DISPLAY SYMBOLS Treatment mode Low battery SD2 Pulse rate P Pulse width Memory Time remaining Hr Min uS Hz TA Timer Channel1 Therapy Channel 2 output site output intensity selector intensity 3 Connect lead wires to the device I
12. sition the electrodes If at any becomes electrodes on the time you feel pain or discomfort stop red and or same site use immediately you feel a Electrodes aren t Ensure the electrodes are attached stabbing pain applied on the skin properly securely to the skin The electrodes are dirty Clean the electrode pads with a damp lint free cloth or replace with new electrodes Clean the electrode cord according to the description in the user manual The surface of the electrode is scratched Replace with a new electrode Output current The electrode pads stops during come off the skin therapy A cable is disconnected Turn off the device and attach the electrode firmly to the skin Turn off the device and connect the cable Batteries are low Replace with new batteries STORAGE e Remove the battery if the device is not in use for long periods of time e Store the device in a dry place and protect it against heat sunshine and moisture e Never place any heavy objects on the device DISPOSAL Used fully discharged batteries must be disposed of in a specially labeled collection container at toxic waste collection points or through an electrical retailer Please dispose of the device in accordance with the directive 2002 96 EC WEEE Waste Electrical and Electronic Equipment a Contact your local distributor for information regarding disposal of the unit and accessories 17 LIMITED WARRANTY
13. sitioning can be one of the most important parameters in achieving success with TENS therapy Of utmost importance is the willingness of the health care practitioner to try the various styles of electrode placement to find 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 settings suggested here If the inital results are not positive feel free to experiment Once an effective positioning has been achieved mark down the electrodes sites and the settings at the end of this manual so that it can easily be replicated at home Turn the device on Carefully read the contraindications and safety information in this manual before using for the first time Turn the intensity control for either channel 1 or 2 clockwise The device will beep Continue as described below before increasing output intensity Select the therapy program mode and site Press M until the required mode EMS or TENS and body part are selected The selected therapy mode will then flash on screen 7 Set the pulse width and rate Press S to enter parameter i setting mode then use the arrow buttons to adjust the pulse width to the value prescribed by your doctor or therapist Then press S again and use the arrow buttons to adjust the pulse rate to the value prescribed by your doctor or therapist Set the treatment time Pre
14. ss S then use the arrow buttons to adjust the treatment time Adjust the intensity for each channel and begin treatment Slowly turn the intensity control dials clockwise until you reach the prescribed setting To further increase the intensity turn the dials clockwise To decrease the intensity or turn the device off rotate the dials counter clockwise to the desired setting or to the OFF position If treatment becomes uncomfortable decrease the intensity to your comfort level and contact your doctor or therapist if the problem persists 10 10 11 12 13 After treatment is finished Once the treatment time has elapsed turn the intensity control 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 may damage the electrodes Place the electrodes on the liner and remove the lead wire by twisting and pulling at the same time To consult the memory With the unit shut off press and hold M and turn one intensity control knobs to enter memory mode A M will be displayed on the screen NOTE The maximum number of records is 30 after which the oldest record willbe deleted ln Use the arrow keys to navigate between records and S to switch between data withing one record To clear the memory press the quick select button To turn off the device Rotate both int
15. ssible cause Solution Display fails Battery contact failure 1 Install new batteries to light up 2 Ensure that the battery is inserted correctly respecting the polarities and that battery contacts are in place and in good condition Weak or no Electrodes are dried Replace and re connect the electrodes stimulation out or dirty Electrodes are Reposition and re connect improperly positioned the electrodes Old worn damaged Replace the lead wires lead wires Stimulationis Intensity is too high Decrease intensity uncomfortable Electrodes are too close together Reposition the electrodes Damaged or worn electrodes or lead wires Replace the lead wires Electrode active area is too small Replace electrodes with ones that are 16 cm 4 cm x 4 cm or 1 5 x 1 5 or larger The user instructions are not being followed Please check the manual before use Intermittent output Program option in use Some programs will seem intermittent This is expected Lead wires 16 1 Verify connection is secure and firmly in place 2 Turn down the intensity Rotate lead wires in socket 90 If the problem persists replace lead wire 3 If replacing the lead wire does not solve this problem contact us at 1 800 363 2381 Problem Possible cause Solution Stimulation Improper electrode Reposition electrode is ineffective placement Unknown Contact your doctor The skin Repetitive use of Repo
16. sssssssssssssssssssossssesseesnsesseesnsssseesnneess 14 TENS programs EMS programs SKIN CARE RECOMMANDATIONG secssesssecsssesseesseessenssnenenenes 15 TROUBLESHOOTING sssscssscstssscecsines sacseccesescaesccessnessaecencasecssncsscesscease 16 STORAGE ee 17 DISPOSAL ciciceeciscsscvesspnissaicasek ceetniesetted dancevctesVeactudestds raaraa rS 17 WARRANTY stessisiessccncsesctcstnas scestcesnctencesccvecscsaccsasascnteecssnaasesesnceastsanss 18 TECHNICAL INFORMATION 1 ssscssssssscsssesssesseesseessnssseessesssensneeess 18 INTRODUCTION This device can be used for pain relief and muscle stimulation It provides two independent controllable output channels A pair of electrodes which can be connected to each output channel and the current s parameters and intensity level can be adjusted according to your needs What is pain Pain warns our body of injury to prevent additional damage This sensation is important because without it vital parts of our bodies might be injured without our knowledge However long lasting persistent chronic pain once diagnosed serves no apparent purpose and reduces quality of life How does TENS work TENS Transcutaneous Electrical Nerve Stimulation refers to the transmission of small electrical pulses through the skin to the underlying peripheral nerves The theory of TENS suggests two different modes of operation In conventional high frequency TENS continuous mild electrical activity m
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