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1. 4mA depending on con trols settings Max current consumption 43 4 mA max current and pulse width settings output into a 1K Ohm 100nF load Battery Standard 9V alkaline Battery life 2 to 3 weeks of average use for an alkaline battery depending on usage Operating temperature range 5 27 C 41 0 80 6 F Operating relative humidity range 35 50 Storage temperature range 0 40 C 82 104 F Storage relative humidity range 35 50 Recommended electrodes The ODFS has been tested and approved for use with the fol lowing electrodes No other electrodes are recommended e PALS Platinum Blue 50 x 50 mm self adhesive electrodes Axelgaard Model 901220 e PALS Platinum Neurostimulation Electrodes 1 5 x 2 5 oval 4 x 6 4cm Axelgaard Model 896230 14 0 ODFS COMPONENTS AND ACCESSORIES Table 2 lists the components of this ODFS system and their part numbers These components may be ordered by faxing order form to 216 379 9116 or visiting the NDI Medical web site at www odfs com ODFS Dropped Foot Stinulator User Manual 22 TABLE 2 System Components Patient Components Catalog Number ODFSIII V6 2 Stimulator 9025 1 set of electrode leads 1m 9035 2 packages of 4 PALS neurostimulation 5cm x 5cm square platinum blue electrodes 9026 1 elastic stocking tubigrip size F 9027 1 alkaline battery 9V 9028 1 pair of cork insoles 9029 Foot switch extension lead 1 2m 9040 Foot switch 2 9030 Carrying case 9031 User
2. Stimulating a nerve in the side of your leg will activate the muscles that lift the foot The stimulation is timed by using a foot switch that is worn inside your shoe under the heel of your foot The ODFS System is made up of several parts connected together and worn on your body The stimulator allows you to turn the system on and off and to make some adjust ments as instructed by your therapist The stimulator is an elec tronic device about the size of a pack of playing cards It may be worn on a belt clip or in your pocket The electrode leads are cables worn under your clothing that connect the stimulator to self sticking skin surface electrodes on the side of your leg Asmall foot switch is placed in your shoe under the heel The foot switch is connected to the stimulator by a separate lead The foot switch turns the stimu lation on and off in time with your walking pattern The cork insole keeps the foot switch in the correct position in your shoe The elastic tubing helps keep the electrodes and cables in the proper position ODFS Dropped Foot StinUator User Manual 6 8 2 PATIENT SYSTEM COMPONENTS 8 2 1 Stimulator The stimulator generates the electrical stimulation It is light weight wearable and battery operated The stimulator is pro grammed by your therapist specifically for you Figure 1 dis plays the front panel of the stimulator Output Electrode Pause Test Foot Switch Jack Button Buton Jack 8 4
3. vL 7 6 5 NODESIII On Off7 Level Belt Clip Figure 1 Stimulator Front Panel Electrode Jack jack for the electrode lead Pause Button temporarily turns stimulator off Test Button checks the electrode position and output level Foot Switch Jack jack for foot switch On Off Level turns stimulator on off and increases stimulus Belt Clip clip for attaching to belt clothing Battery Indicator flickers yellow showing output flickers red showing low battery 7 ODFS Dropped Foot Stimulator User Manual 8 2 2 Electrode Leads The Electrode Lead is a cable that connects your stimulator to your electrodes see Figure 2 Pause Button Connections Stinulator Figure 2 Electrode Leads and Electrodes 8 2 3 Electrodes Electrodes are reusable and self sticking to the skin see Fig ure 2 Electrodes conduct the stimulation through the skin into the nerve and muscle of your lower leg The usual electrode size is 5 cm x 5cm At times your therapist may choose to use a different size based on your size and comfort Your electrodes should be reused for a period of time It is important to replace your electrodes when they become worn or loose their stick A pair of electrodes usually last about one month of daily use ODFS Dropped Foot StinUator User Manual 8 8 2 4 Elastic Tubing Elastic tubing Tubigrip Size F aids in securing your elec trodes and leads around your leg Caution This product con tains natura
4. the ON OFF LEVEL dial counter clockwise until it clicks and the pointer is pointing upwards to the number zero 0 Peel your electrode away from your skin by lifting it at the edge Do not pull the electrode by the connector Return the electrodes to the plastic sheet and remove the electrode lead by pulling the plug from the connector Do not pull on the electrode lead After removing the electrodes inspect your underlying skin for any irritations Wash and dry the area to remove any remaining gel Remove the foot switch cork insole from your shoe Store all parts in the bag provided ODFS Dropped Foot Stimulator User Manual 16 9 7 CLEANING AND MAINTENANCE Stimulator and Leads e Donotimmerse in water e Clean using a damp cloth e Do not use alcohol based cleaners Electrode After repeated use your electrodes will lose their stickiness Dampen the surface of the electrodes with water and leave for afew minutes to dry If this is not successful replace the elec trodes Electrodes should last four to six weeks See Table 2 for re ordering information Leads and Foot Switch The condition of the leads and foot switch should be inspected from time totime Ifthe leads become worn or if the plastic covering becomes stiff or brittle replace the item 17 ODFS Dropped Foot Stimulator User Manual 10 0 TROUBLESHOOTING TABLE 1 BASIC TROUBLESHOOTING TIPS Problem Stimulation weak Stimulation weak with new bat
5. your skin under the electrodes as follows 1 Wash your electrode sites with mild soap and water Rinse and dry thoroughly 2 Trim excess body hair from the electrode sites with scis sors DO NOT shave the site Shaving may cause increased sensitivity ODFS Dropped Foot Stinulator User Manual 10 NOTES 9 2 Do not place your electrode on cut broken or irritated skin Do not use skin creams near the electrode sites If skin irritation develops remove your electrodes and discon tinue using the stimulator Consult your therapist or clinician ELECTRODE PLACEMENT Position yourself comfortably in a straight backed chair When finding the electrode position and testing the device it is best to have your leg straight 1 2 Be sure the stimulator is turned off Connect the electrodes to the leads by inserting the pin on into the connector on the end of the electrode Push the pin all the way in so no bare metal is seen Repeat this step for your second electrode Remove any oil or lotion from your skin before applying elec trodes See section on Preparing the Skin Check your skin for cuts abrasions or reddened areas Do not apply electrodes over these areas Contact your therapist for instructions Peel the electrode away from the plastic sheet by lifting at the electrode edge Do not pull the electrode by the connection Place the electrode connected to the black plug on your leg as instructed by your therapist Pla
6. 001 MAN 000 1 ODFS DROPPED FOOT STIMULATOR Caution USER MANUAL Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the state in which he she practices to use or order the use of the device CONTACT INFORMATION Please contact your Clinician or Therapist if you are experiencing any difficulties Clinicians Name Phone Therapists Name Phone NDI Medical One Chagrin Highlands 2000 Auburn Drive Suite 320 Cleveland OH 44122 216 378 9106 www odfs com 001 MAN 000 1 TABLE OF CONTENTS COC HOW saceccrizarexccsxraxncatncisaciousiaiisisiicsionenancion 1 Indications for USE sacaccccnssisissisicisnisnninisinnainieneieseaauan 1 Contraindications neissicarcnsiiswsnionsvinnivinnsiinninvinnstuananencnaxaian 1 Warning Sas deccects cenatesdecsaccececcedeeuicanecceacsoecanneeercepeteces 2 PRE CANNONS iccatcrarmarcrerassrarsrorivcacnadcccsusasccisendanesencion 3 Adverse Reactions ssssssssssssssssssssssssssaeeeeees 4 Contents of Standard Package eeeeeeeees 5 Description of System Component 000 6 Device Description cccceeeeeeeeeeeeeeeeeeeeeeeeeee 6 Patient System Components cccceeeeeeeeees 7 SUITING secsi tite aaia 7 Electrode Leads iainxtascerasicescsasissamscucsasisistuacdeagerctene 8 BISCO COS iccistentiasarciarasarintasnnincsnscccsunasiccancdsr esas ria 8 Elastic TUBING ac eeexcieve
7. ENT IS NDI MEDICAL RESPONSIBLE FOR ANY SPECIAL INDIRECT PUNITIVE INCIDENTAL OR CONSE QUENTIAL DAMAGES RELATED TO THE ODFS SYSTEM COMPONENTS WHETHER OR NOT THE SAME WERE FORESEEABLE OR NDI MEDICAL WAS ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES NOTE Warranty period begins from the date of shipment ODFS Dropped Foot Stinulator User Manual 24 16 0 ODFS DROPPED FOOT STIMULATOR ELECTRODE POSITION WORKSHEET Patient Name Therapist Name Therapist Contact Info Electrode Position Top of the fibula bone Apagar Clinician therapist Please mark on this diagram the location and polarity of the electrodes Electrode Electrode lead length Type and 25 ODFS Dropped Foot Stimulator User Manual
8. L to the level recommended by your therapist 4 Watch your foot move The ideal movement is the foot lifted dorsiflexion with a small amount of turning to the outside eversion Your therapist will advise you if your foot move ment is correct NOTE The test button will provide stimulation for a short pe riod of time and then stop You will need to press the test button again a If the correct movement is not produced Figure 5 Adjustment for Turning the Foot to the Outside 1 Increase the stimulation level a little 2 Press the test button again 9 4 CONNECTING THE FOOT SWITCH b lf the correct movement is not produced adjust the posi Once your electrodes are positioned correctly tion of the electrodes l l l 1 If your foot is turning outward too little bring the ac 1 Place your stimulator in the Pause mode by pressing the tive black plug electrode further back to increase Pause button once turning outward 2 Connect your foot switch to the foot switch lead 2 If your foot is turning outward too much bring the 3 Attach the sticky side of the foot switch to the heel of your active black plug electrode slightly further forward cork insole see Figure 6 If the therapist has already done to decrease turning outward this place the cork insole into your shoe 3 The position of the passive red plug electrode can also be adjusted to balance the lift of the foot in the same way Bring the electrode towards the shin bone to
9. Manual 9032 User Quick Reference Guide 9049 Optional accessories Electrode leads 0 5m 9034 Electrode leads 1 5m 9036 Foot switch extension leads 60cm 9037 Foot switch extension leads 75cm 9038 Foot switch extension leads 100cm 9039 PALS Neurostimulation 4cm x 6 4cm oval platinum blue electrodes 9043 NOTE Do not use any other accessories electrodes or leads other than the ones provided with your system or purchased from the manufacture ODFS Dropped Foot Stimulator User Manual 15 0 WARRANTY The ODFS stimulator is warranted against material defects in material and workmanship for a period of one year from date of delivery The exclusive remedy for breach of the foregoing war ranty is at purchaser s option either i the repair or replace ment of the defective stimulator or ii a refund of the purchase price paid for the defective stimulator Carrying cases lead wires electrodes and other accessories are warranted to be free from defects in workmanship and ma terials at the time of delivery The foregoing warranty shall be void with respect to any com ponent which following delivery has been subject to accident abuse misapplication improper repair or installation or alter ation THE FOREGOING WARRANTY IS THE SOLE AND EXCLU SIVE WARRANTY AND NDI MEDICAL DISCLAIMS ANY AND ALL OTHER WARRANTIES EXPRESSED OR IMPLIED IN CLUDING WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EV
10. Switch 9 Figure 4 Electrode Placement ccceeeeeeeeeeees 12 Figure 5 Adjustment for Turning the Foot to the Q SId Eei a eea 14 Figure 6 Foot Switch sseseessssseeeseseesreennnreneeerrrrrnnneee 15 LIST OF TABLES Table 1 Basic Troubleshooting Tips 006 18 19 Table 2 System Component cccceeeeeeeeeeeeeeees 22 ODFS Dropped Foot Stimulator User Manual 1 0 INTRODUCTION This manual is intended to provide information for the safe use of the ODFS Dropped Foot Stimulator for you and your car egiver Your therapist will train you to use the information in this manual Call your therapist if you need help in understanding how to use your ODFS 2 0 INDICATIONS FOR USE The ODFS is a device that uses low levels of electrical stimula tion to help those having a dropped foot lift their foot and im prove their walking Additional benefits may include e muscle re education retraining your muscles to act as they did before your injury e prevention retardation of disuse atrophy decrease bulk of muscle tissue when your muscles are not used maintained or increased joint range of motion increased local blood flow The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury 3 0 CONTRAINDICATIONS The ODFS should not be used on patients who have a car
11. ce the electrode connected to the red plug on your leg as instructed by your therapist The lead color is impor tant Typical electrode placement is described below and pictured in Figure 4 ODFS Dropped Foot Stimulator User Manual NOTE Your therapist may give you different electrode place ment instructions to get the best result for you Follow your therapist s home going instructions including the electrode po sition worksheet on page 25 of this manual The electrode connected to the black plug is placed over the common peroneal nerve just below the head top of the fibula bone To find your fibula locate the ankle bone on the outside of the ankle Run your fingers up this bone on the outside of your leg The top of the fibula bone will be the bony bump you feel before you get to your knee The electrode connected to the red plug is placed approxi mately 2 inches below and slightly forward of the black plug electrode Common peroneal nerve Top of fibula bone Figure 4 Electrode Placement ODFS Dropped Foot Stinulator User Manual 12 9 3 STIMULATOR SET UP Contact your therapist if you have problems getting the correct response you want from the stimulator 1 Connect the electrode lead to the socket labelled as OUTPUT p y on your stimulator 2 Turn the stimulator on until you hear a beep then press the TEST button 3 Adjust the level of stimulation by turning clockwise the black dial labelled ON OFF LEVE
12. cens cecueeeeecectcserssuscndncacetesdssceccetee 9 BAGI Y et E E EE 9 Cork INner SOl Esisi 9 Foot Switch Lead suicisivsviciensneneranscarsonnndocsmsuauanaianseune 9 POOL SWIC inssrctincniisrexersattosseosstiaminccrismeiauiihieneeese 10 Carrying Case avo tceeeteeeeeren encore eee ees 10 Additional Accessories sssssssecceeeeeeeeeeeeees 10 Operating the ODFS System cccccccecceceeeees 10 Preparing the Skin asad cic cidelcancicccweceeecncennicncecens dereasee 10 Electrode Placement cccceeeseeeesseceeeeeeeeee 11 Stimulator SSI since cecesecsccccrensccnsecceecetecncesiadees teas 13 Connecting the Foot Switch eee 14 Using Stimulation ide ecscsrenceecewecectcevennicenceceeexeeence 15 Removing the ODFS System ceeeeeeeeees 16 Cleaning and Maintenance cccecceeeceeeeees 17 Troubleshooting creiscacececesereerearccexcescvecertvecesxaedend 18 19 Travel or International Use ssessssseseeeeeeeees 19 GIOSS ANY nerne E EEEREN E 20 ODFS Dropped Foot Stimulator User Manual 13 0 SDS CIICANOING sssri EEEE 21 14 0 ODFS Components and Accessories 22 15 0 WRAY cate eed ote ernie E ERE 24 16 0 ODFS Dropped Foot Stimulator Electrode Position Worksheet ssccsssscminsrnessnniess 25 LIST OF FIGURES Figure 1 Stimulator Front Panel 0 eee 7 Figure 2 Electrode Leads and Electrodes 4 8 Figure 3 Foot Switch Lead and Foot
13. d burns beneath the electrodes have been reported with the use of electrical stimulators ap plied to the skin Headache Painful Sensations Headache and other painful sensations have been reported during or following the application of electrical stimulation near the eyes and to the head and face ODFS Dropped Foot Stimulator User Manual 4 Report any undesirable outcomes malfunctioning of the device mistakes in using the device or injury from the use of this de vice to your clinician Your clinician is responsible for reporting all of these events to the designated US distributor of the ODFS NDI Medical in writing e via email odfsinfo ndimedical com e or fax 216 378 9116 e or mailto NDI Medical 2000 Auburn Drive Suite 320 Cleve land OH 44122 7 0 CONTENTS OF STANDARD PACKAGE The ODFS System contains the following components e ODFSIII V6 2 Stimulator e 1 set of electrode leads 1m e 2 packages of PALS neurostimulation 5cm x 5cm square Platinum Blue electrodes e 1 elastic stocking Tubigrip size F Caution This prod uct contains natural Rubber Latex which may cause aller gic reactions 1 alkaline battery 9V 1 pair of cork insoles Size 10 5 foot switch lead 1 2m foot switches carrying case User Manual User Quick Reference Guide Ss wr ws Sw S 1 2 1 1 1 5 ODFS Dropped Foot Stimulator User Manual 8 0 DESCRIPTION OF SYSTEM COMPONENTS 8 1 DEVICE DESCRIPTION
14. decrease excessive outward turning of the foot Avoid stimulation directly over the shin bone It can be uncomfortable 13 ODFS Dropped Foot Stinulator User Manual ODFS Dropped Foot Stinulator User Manual 14 Black side against the insole Figure 6 Foot Switch Place your cork insole with foot switch attached into your shoe Connect your foot switch lead to the socket on the stimula tor labelled SWITCH Using Stimulation With the foot switch connected and the stimulator turned on the stimulation will start when you lift the heel of your foot off the floor and will stop when your heel is on the floor To stop the stimulation for a short time press the PAUSE button To restart the stimulation press the PAUSE button again ODFS Dropped Foot Stimulator User Manual NOTES When the stimulator is turned on or taken out of Pause mode a beep is heard When the ODFS is put into its pause mode a shorter and higher beep is hear The tubigrip sleeve can be placed over the electrodes and leads to help maintain their position CAUTION It is important to use the ODFS gradually over a period of two to three weeks This will allow your muscles to build strength Initially only wear the electrodes for the period the stimulator is used Gradually increase the time the elec trodes are worn as your skin becomes use to the electrodes 9 6 1 REMOVING THE ODFS SYSTEM After use turn your stimulator off by turning
15. diac pacemaker implanted defibrillator or other implanted metallic or electronic device Such use could cause electrical shock burns electrical interference or death 1 ODFS Dropped Foot Stimulator User Manual 4 0 WARNINGS Neck Stimulation Stimulation should not be applied over the patient s neck because severe spasm of the muscles may oc cur and the contractions may be strong enough to close the air way or cause difficulty in breathing Stimulation over the neck could also have adverse effects on the patient s heart rhythm or blood pressure Chest Stimulation Stimulation should not be applied across the patient s chest because the introduction of electrical current into the chest may cause rhythm disturbances to the patient s heart which could be lethal Open or Infected Wounds Stimulation should not be applied over open wounds or over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins Cancer Stimulation should not be applied over or in proximity to cancerous lesions Electronic Monitoring Equipment Stimulation should not be applied in the presence of electronic monitoring equipment such as cardiac monitors and ECG alarms Monitoring equipment may not operate properly when the electrical stimulation device is in use Bathing Showering Stimulation should not be applied when the patient is in the bath or shower Sleeping Stimulation should not be appli
16. ed when the patient is sleeping Machinery Operation Stimulation should not be applied when the patient is driving operating machinery or during any activ ity in which electrical stimulation can put the patient at risk of injury ODFS Dropped Foot StinUator User Manual 2 Consult with the patient s physician before using this device because the device may cause lethal rhythm disturbances to the heart in susceptible individuals Stimulation should only be applied to normal intact clean skin 5 0 PRECAUTIONS Long term Effects The long term effects of electrical stimu lation are unknown Transcerebral Stimulation The effects of stimulation of the brain are unknown Therefore stimulation should not be ap plied across the patient s head and electrodes should not be placed on opposite sides of the head Pregnancy The safety of using electrical stimulation during pregnancy has not been established Skin Irritation Some patients may experience skin irritation or hypersensitivity due to electrical stimulation or electrical conduc tive medium gel The irritation can usually be reduced by using an alternate electrode placement A slight reddening of the skin under the electrode is normal If stimulation causes long term mark ing of the skin discontinue use and consult your physical therapist Cardiac Patients with suspected or diagnosed heart disease should follow precautions recommended by their physicians Epileps
17. g Inversion Turning of the foot to the inside Peroneal nerve The nerve that controls dorsiflexion or lifting of the foot Spastic tone Spasticity Involuntary exaggerated muscle stiffness and spasm Swing phase Time during walking when the foot and leg are moving forward from the time the toe is off the ground until the heel strikes the ground ODFS Dropped Foot Stinulator User Manual 20 Therapeutic Diathermy High frequency electromagnetic ra diation electric currents orultrasonic waves used to heat body tissues for therapeutic purposes including but are not limited to bursitis synovitis muscle spasms and joint stiffness Warning the stimulation output has a physiological effect Read instructions before use Equipment type BF 13 0 SPECIFICATIONS Output asymmetrical or symmetrical bi phasic voltage driven waveform Output amplitude 20 4 to 100 10 mA into a 1k ohm in parallel with a 100nF load with an asymmetrical bi phasic out put 20 4 mA to 80 8 mA in symmetrical bi phasic mode Frequency 40 4 Hz Pulse width 7 4 to 365 20 microseconds Output time 0 2 0 02 to 6 0 6 seconds Extension time 0 to 1 2 0 02 seconds Rising edge ramp times 0 to 2 0 5 seconds Falling edge ramp times 0 to 2 0 5 seconds Low battery indication 7 0 0 2 V 21 ODFS Dropped Foot Stimulator User Manual Quiescent current consumption 1 5
18. kin with water NOTE Contact your therapist if you still have problems after following the troubleshooting tips 11 0 TRAVEL OR INTERNATIONAL USE In these days of increased security FES devices attract some interest from immigration and security staff at airports and ports For this reason it is advisable to take the following precautions e Check with your carrier to confirm that this device can be carried on the airplane e Unless use of the device is essential when traveling pack the device in your luggage 19 ODFS Dropped Foot Stimulator User Manual e Always take the instruction manual with the device so that you can demonstrate what the device is e The stimulator is safe to be put through both X Ray and metal detector machines e Like other electronic equipment the stimulator may affect navigation equipment on airplanes Make sure it is turned off while sitting down in the plane e Foreign power sources do not affect this battery powered device 12 0 GLOSSARY Dorsiflexion Lifting the foot or toes upward Dropped foot The inability to lift the foot or toes up while walk ing which results in the foot being dragged forward or swung out to the side frequently causing tripping Electrode The electrode is a self adhesive gel based pad that is used to pass the stimulation current into the body Elec trodes come in various shapes and sizes Eversion Turning of the foot to the outside Gait Pattern of walkin
19. l Rubber Latex which may cause allergic reactions 8 2 5 Battery Your stimulator is powered by one standard 9V alkaline battery 8 2 6 Cork Insole The foot switch is adhered to the underside of a cork insole to maintain the correct position of your foot switch within your shoe The insole transfers easily between your shoes 8 2 7 Foot Switch Lead The foot switch lead is a cable that connects your stimulator to your foot switch see Figure 3 Foot Switch Lead Foot Switch Figure 3 Foot Switch Lead and Foot Switch 9 ODFS Dropped Foot Stimulator User Manual 8 2 8 Foot Switch A small foot switch is placed in the shoe under your heel see Figure 3 The foot switch turns the stimulation on and off in time with your walking 8 2 9 Carrying Case A carrying case is included to help protect and keep the system clean Store your stimulator and lead wires in the case when they are not in use 8 3 ADDITIONAL ACCESSORIES Additional accessories such as alternate lead lengths are available from your therapist Your therapist will determine if you require any of these accessories 9 0 OPERATING THE ODFS SYSTEM 9 1 PREPARING THE SKIN Properly caring for your skin where the electrodes will be placed is important and may have the following benefits e Allows for more stimulation to reach the desired area e Prolongs the life of the electrodes e Reduces the risk of skin irritation e Could improve your comfort Prepare
20. tery Stimulation ineffective No stimulation or Low Battery Indicator Flickers in response to either test button or foot switch Possible Cause Old or dried out electrodes Dry Skin Battery Low Incorrect battery insertion Poor electrode contact Damaged or worn lead wire or electrode Improper placement of electrodes Stimulation in sleep mode Incorrect position of battery Battery low Faulty Stimulator ODFS Dropped Foot Stinulator User Manual Solution Moisten electrode with water or replace electrodes Moisten skin with water Replace battery Check battery placement Reapply electrodes secure firmly moisten skin and or electrodes with water Replace lead wire or electrodes Reposition electrodes Press Pause button Check battery placement Replace battery Contact your therapist for instructions TABLE 1 BASIC TROUBLESHOOTING TIPS CONT Problem Possible Cause Solution Low Battery Battery low Replace battery Indicator flicker changes from yellow to red No response to foot Faulty foot switch Replace switch but response to test button Faulty foot switch Replace lead Intermittent Foot switch position Relocate the foot stimulation while moved switch walking Faulty foot switch Replace Faulty electrode or Replace foot switch lead Incorrect Incorrect electrode Reposition movement placement electrodes produced by stimulation Poor electrode Moisten electrodes contact and s
21. y Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians Hemorrhage Caution should be used if the patient has a ten dency to bleed internally such as following an injury or fracture Recent Surgery Caution should be used following recent sur gical procedures when stimulation may disrupt the healing pro cess 3 ODFS Dropped Foot Stimulator User Manual Gynecology Caution should be used over the menstruating or pregnant uterus Sensory Loss Caution should be used over areas of skin that lack normal sensation Keep Out of Reach of Children Keep this device out of the reach of children Electrodes Leads Use this device only with the leads elec trodes and accessories recommended by the manufacturer Spasticity If stimulation causes increased spasticity involun tary exaggerated muscle stiffness and spasm discontinue use and consult your physical therapist Supervision of a Licensed Practitioner Use this device only under the continued supervision of a licensed practitioner Latex Allergies Caution The Tubigrip elastic stocking con tains natural Rubber Latex which may cause allergic reactions This item is provided as an accessory to the ODFS device If you are sensitive to products that contain latex your clinician will discuss possible alternatives to using this elastic stocking with you 6 0 ADVERSE REACTIONS Skin Irritation Skin irritation an
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