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IF 3WAVE - DJO Global

1. Caring for the IF 3wave System Clean the outside of the device and lead wires as needed with a damp cloth and mild soap Never immerse the device or lead wires in water alcohol or other fluids Do not use cleaning fluids or solvents to remove stains or dirt These liquids may damage the plastic case and lead wires Store all the operating components in the carrying case Understanding Special Display Messages COLLE __ ee Time Remain 39 min Battery Indicator Chi AMP me 50 Ch2 AMP 42 ry A Hold to unlock A New Battery The battery indicator appears on most screens in the upper right corner When the battery is fully charged the indicator is completely shaded black As the device is used the shaded area of the indicator becomes smaller NOTE The approximate battery life of the IF Swave is 10 hours to half intensity amplitude and 3 hours at full intensity 42 IF Swave User s Manual 926940_IF3Wave_Guts Fr indd 42 2 27 14 8 57 PM PR Operation programme LE ow Battery Time Remain 39 Chi AMP 50 Indicator Ch2 AMP 50 Battery Low Battery Low Message When the Battery Low message appears use the device until it automatically shuts off When the battery is completely depleted a message appears on the screen informing you that the device will shut down When the device automatically shuts off the program must be restarted when a charged battery is installed The device returns to
2. Limited Warranty e Empi warrants all of their manufactured products to be free from defects in workmanship and materials for three years e Battery charger bases rechargeable batteries carry cases lead wires electrodes and other accessories are warranted to be free from defects in workmanship and materials at the time of delivery e Empi will repair or replace at its facility any product found to be defective within the warranty period This warranty does not apply to any product damaged by misuse or repaired or altered by anyone other that Empi Inc e This warranty is in lieu of any or all other warranties expressed or implied No person is authorized to bind Empi to any representation of warranty other than those specifically set forth herein NOTE The warranty period begins with the date of purchase from the manufacturer A F u Empi Empi Inc 205 Highway 22 East Clear Lake SD 57226 For more information call 1 800 328 2536 or visit www empi com All Rights Reserved 926940 Rev F Empi 02 14 Caution Federal law restricts this device to sale by or on the order of a physician SEmpi a better prescription for pain IF 3wave IF 3wave USER S MANUAL Edema Reduction Read This Manual Carefully Before Operating Your IF 3wave SEmpi Empi Inc ISO Certified 13485 12 96 Empi 2 14 All Rights Reserved lit nee 18 Te Ul ON esseni cououwucwoseunavouns 5 How the IF 3wave
3. Enable Disable Sound Setup Selection Screen e Select Stim Type This option allows the clinician to select the type of stimulation program he or she wants to set up e Select Language English The default language is English This option allows the clinician to change the language to English Spanish USA or French Canada e Edit Programs This option allows the clinician to delete existing programs from a list or edit existing ones The IF Swave stores up to ten programs in the Program List e System Sound This option allows the clinician to enable or disable units sound 52 IF Swave User s Manual Clinician Setup Stimulation Modalities The IF 3wave system offers four stimulation modalities gt e F QO e NMES m e Combination IF NMES ct e PDC ct O Each modality offers a variety of programs such as preset continuous sweep and manual Each program offers treatments for conditions such as low back pain neck pain spasm reduction and quadriceps re education Selecting the Stimulation Modality The Select Stimulation Type screen displays the four stimulation modalities To access the desired modality use the Scroll button to highlight it and press the Select button Select Stim Type Er IF NMES COMBO IF NMES PDC W Select Select Stimulation Type Screen IF 3wave User s Manual 53 926940_IF3Wave_Guts_Fr indd 53 2 27 14 8 57 PM TIAA Clinic
4. On the device press the a button to display the Program screen The last program used will be highlighted If no change is desired wait 10 seconds and the highlighted program will operate 5 Use the Ch1 and Ch2 and or V buttons to set the amplitude for each channel as directed by your clinician 6 When the therapy program ends the device shuts off automatically Otherwise press the a button twice quickly within two seconds to shut the device off Changing a Therapy Session 1 Follow steps 1 through 4 in Running a Therapy Session above 2 To select anew program press the Ch1 Aor V button to highlight the desired therapy program 3 Press the Ch2 Aor V button to select a program 4 Use the Ch1 and or Ch2 Aand V buttons to set the amplitude for each channel as directed by your clinician 5 When the therapy program ends the device shuts off automatically Otherwise press the button twice quickly within two seconds to shut the device off IF 3wave User s Manual 13 926940_IF3Wave_Guts_Fr indd 13 2 27 14 8 57 PM NN Quick Reference Ending a Session Prior to the End of Therapy 1 Press the button twice quickly within two seconds to shut the device off Unclip the belt clip from your clothing Disconnect the lead wire s from the device Disconnect the lead wire s from the electrodes oe oe Pf Remove the electrodes from your skin Follow the instructions on the electrod
5. s Manual 926940_IF3Wave_Guts_Fr indd 24 2 27 14 8 57 PM Operation Overview United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner This section includes the following instructions for performing a therapy session Perform these instructions in the order they are presented e Installing the IF Swave s Battery e Connecting the Lead Wires to the Electrodes e Connecting the Lead Wires to the Device e Preparing the Skin for a Therapy Session e Applying the Electrodes to the Skin e Using the Device for a Therapy Session e Ending a Therapy Session This section also includes the following instructions e Charging the Battery e Storing the Battery e Caring for the IF 3wave System e Understanding Special Display Messages e Finding the Software Revision and Serial Number e Using the Belt Clip Before operating the IF 3wave System read the previous sections of this manual that describe the system and Its features To gain the maximum benefit from your IF Swave System carefully follow your clinician s instructions and use the system for only the specific symptoms detailed by your clinician If you have any questions or problems or experience any new symptoms or painful areas contact your physician therapist or clinician for appropriate diagnosis and treatment They are most familiar with your specific situation and are the best source of additional gui
6. 1 year 72 926940_IF3Wave_Guts_Fr indd 72 Device Specifications 3 09 X 6 33 X 1 42 in 07 X 16 0 X3 6 Cm 12 oz 350 gm with battery 3 6 Vdc rechargeable Lithium ion battery 3000 mAh Type BF equipment battery operated Complies with 21 CRF Part 898 performance standards for electrode lead wires Temperature 4 to 104 F 20 to 40 C Relative Humidity 65 20 Atmospheric Pressure 700 to 1060 hPa 0 69 to 1 05 atm Temperature 4 to 95 F 20 to 35 C Relative Humidity 65 20 Atmospheric Pressure 700 to 1060 hPa 0 69 to 1 05 atm IF Swave User s Manual 2 27 14 8 57 PM QE Specifications IF Mode Specification Ci O Parameters Device Specifications Waveform Biphasic square wave zero DC 125 us IF Waveform Output Frequency Channel 1 Fundamental frequency 4000 Hz fixed Channel 2 Selectable frequency 4001 to 4150 Hz Interference frequency 1 to 150 Hz Pulse Width 125 us at 4000 Hz 120 5 ms at 4150 Hz Maximum Charge 12 5 u Coulombs sum of two channels Per Pulse Output Current O to 50 mA constant voltage into 500 Q load selectable in 1 mA increments Output Voltage O to 25 V into 500 Q load O to peak IF Swave User s Manual 73 926940_IF3Wave_Guts_Fr indd 73 2 27 14 8 57 PM TIAA Specifications IF Preset Program Preset Treatment Treatment OC ued ee Sweep Ramp Range 1 Hz s Treatment Time Segment Time Increment Low Back Ami st 20 min 60
7. 15 min 50 Hz 300 us 3 SEC 10 sec 3 sec 10 sec Strengthening Quadriceps 15 min 90 Hz 300 us 3 SEC 10 sec 3 Sec 30 sec Re eductation PDC Mode Specification Parameters Device Specifications Waveform Biphasic square wave net zero DC Triphasic square wave time average DC component 300 UA maximum Le Cycle Time gt 60 us lt 1800s 4 1800s PDC Biphasic Waveform IF 3wave User s Manual 77 926940_IF3Wave_Guts_Fr indd 77 2 27 14 8 57 PM TN Specifications LT Cycle Time gt 900ns gt 60 us 1800us gt e 1800Us gt PDC Triphasic Waveform Output Frequency Biphasic 278 Hz Triphasic 222 Hz Pulse Width 60 us Maximum Charge 6 u Coulombs Per Pulse Output Current O to 100 mA constant current into 1000 Q load selectable in 1 mA increments Output Voltage O to 100 V into 1000 Q load O to peak Ramp Up Time O to 90 maximum of set output at a rate of 10 MA per seconds 95 to 100 maximum of set output in next 5 minutes On Time 18 to 48 minutes selectable at 5 minute increments Ramp Down Time Maximum to O for last 7 minutes Treatment Time 30 to 60 minutes selectable at 5 minute increments 78 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 78 2 27 14 8 57 PM EN Specifications IF NMES Combination Mode Specification IF NMES Combination Preset Treatments Preset Total Treatment Time First 20 Minutes Second 20 Minutes
8. Hz to 150 Hz 24 sec up 24 Pain 2nd 20 min 5 Hz to 10 Hz sec down 1st 20 min SO m4 er 1 SON a Neck Pain 40 min ca Z 24sec up 24 2nd 20 min 1 HZ 1 O sec down 1st 20 min 60 Hz to 150 H Knee Pain 40 min 7 Z 24sec up 24 2nd 20 min 1 Hz to 10 Az sec down 1st 20 min OO Z UG 1 SOIR Shoulder Pain 40 min Z 24sec up 24 2nd 20 min J Fz te O sec down 1st 20 min 80 Hz to 150 H Wrist Pain 40 min i Z 24sec up 24 2nd 20 min 1 Hz to 10 Hz sec down 1st 20 min TOO Zen omz Ankle Pain 40 min 24 sec Up 24 2nd 20 min ate loi sec down 1st 20 min 100 Hz IC Pain 40 min 2nd 20 min 10 12 NOTE All electrical specifications are 10 into 500 Q load unless otherwise specified 74 IF Swave Users Manual 926940_IF3Wave_Guts_Fr indd 74 2 27 14 8 57 PM Specifications IF Continuous Program Parameters Device Specifications Interference Beat 1 to 150 Hz selectable in 1 Hz increments Frequency 4000 to 4150 Hz Treatment time 10 to 60 minutes selectable in 10 minute increments IF Sweep Program Sweep Do eee ble Treatment Time ange 6 sec up 6 sec down 1 1 to 150 Hz 12 sec up 12 sec down 24 sec up 24 sec down 6 sec up 6 sec down 2 Ito 10 z 12 sec up 12 sec down 24 sec up 24 sec down 6 sec up 6 sec down 3 2010 r0 Hz 12 sec up 12 sec down 24 sec Up 24 sec down 6 sec up 6 sec down 4 CONNUE 12 sec up 12 sec down 24 sec up 24 sec down 10 to 60 m
9. and French Canada If the operator cannot read these languages all instructions must be read and discussed in the operator s native language IMPORTANT Les crans IF 3wave sont traduits en anglais espagnol Am rique du sud et fran ais Canada Si l op rateur ne peut lire ces langues toutes les instructions doivent tre lues et discut es dans la langue maternelle de l op rateur IMPORTANTE Las pantallas de IF 3wave se proporcionan en ingl s espa ol EE UU y frances Canada Si el operador no puede leer ninguno de estos idiomas todas las instrucciones deberan leerse y comentarse en la lengua materna del operador IF 3wave User s Manual 7 926940_IF3Wave_Guts_Fr indd 7 2 27 14 8 57 PM 8 IF Swave User s Manual 926940 IF3Wave Guts Fr indd 8 2 27 14 8 57 PM Prescribing Information In general stimulation should be used under medical supervision for adjunctive therapy in the management of specific conditions The following information is contained in this section e Indications e Contraindications e Warnings e Precautions e Adverse Effects Indications Interferential IF stimulation can be used for the following applications e Relieve acute pain e Relieve and manage chronic pain e Relax muscle spasms e Maintain and increase range of motion e Increase local blood circulation Neuromuscular electrical stimulation NMES can be used for the following applications e Relax muscle
10. down Remove battery and call technical support Orange Battery is overheating Charger shuts down until battery is cool To charge the battery 1 Plug the power adapter into a standard 110 Vac outlet and the connector jack into the charger base 2 Slide the battery into the battery channel on the charger base until it clicks Make sure the Empi label on the battery is facing down 28 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 28 2 27 14 8 57 PM EX Operation Se 3 When the green LED shuts off remove the battery from the charger base 4 Unplug the power adapter Storing the Battery The battery should be removed from the device when it is stored for long periods of time more than two weeks All batteries should be stored in the carrying case Store all batteries in a dry location at 50 to 86 F 10 to 30 C and away from direct sunlight Rechargeable batteries slowly lose their charge in storage so they should be recharged every six months The batteries can loose their capacity to hold a charge when they are stored for long periods of time You can renew their capacity by charging and discharging them several times If your battery does not retain a charge during standard operation contact Customer Service at 1 800 328 2536 to purchase a new one Connecting the Lead Wires to the Electrodes To connect the lead wire s to the electrodes 1 Decide if you are using one lead wire two electrodes o
11. is set at zero for both channels Program Name amm Time Remain 39 min Chi AMP mm S50 Ch AMP 42 fi lt Hold to unlock A Selected Program Run Screen NOTES If you do nothing for 10 seconds the highlighted program runs If you choose the wrong program shut the device off and start over with step 1 Last Used Program Time Remain 39 min Chi AMPL_____ OO Ch2 AMPL __________ 0 Last Used Program Screen 36 IF 3wave User s Manual 926940_IF3Wave_Guts_Fr indd 36 2 27 14 8 57 PM EX Operation Se 4 To adjust the amplitude do one of the following a IF or PDC Treatments Use the Ch1 or Ch2 A and 7 buttons to set the amplitude for both channels as directed by your clinician b NMES Treatment Use the Ch1 and Ch2 A and V buttons to set the amplitude for each channel as directed by your clinician The amplitude for each channel can be different As you adjust the amplitude the bar on the screen changes to show the amplitude level The numeric value is also displayed The program starts 3 seconds after you stop making amplitude adjustments NOTES Adjust the amplitude until it is comfortable the stimulation should not cause discomfort 30 seconds after you adjust the amplitude the settings will lock to prevent accidental changes To make adjustments see Adjusting Amplitude During Treatment in this Operation section At the end of the session the screen displays a me
12. spasms e Prevent or retard disuse atrophy e Increase local blood circulation e Re educate muscles e Maintain or increase range of motion Pulsed direct current PDC stimulation can be used for the following applications e Reduce edema under negative electrode e Reduce muscle spasm e Increase local blood circulation under negative electrode e Retard or prevent disuse atrophy e Facilitate voluntary motor function e Maintain or increase range of motion IF 3wave User s Manual 9 926940 IF3Wave Guts Fr indd 9 2 27 14 8 57 PM lt Prescribing Information is Contraindications Cardiac pacemakers Do not use this device if the patient has a demand type cardiac pacemaker or any implanted defibrillator Transcerebral stimulation Do not apply electrical stimulation transcerebrally through the head Carotid sinus Do not use electrical stimulation over the carotid sinus neck nerves Unknown etiology Do not use this device when pain syndromes are undiagnosed Use only after origin of pain has been diagnosed Supervised use This device should be used under the continued supervision of a physician Long term effects he long term effects of chronic use of electrical stimulation are unknown Electrical stimulation devices do not have any curative value Symptomatic treatment This device is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve a
13. the Select button The program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction 4 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added 5 Do one of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen NOTES To return to the Setup screen press and release the 2 button twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section The large single electrode Dispersal Electrode is used for one channel and two channel PDC treatments The reverse splitter is connected to the lead wires when using two channel PDC The black pins from both Ch1 and Ch2 must be connected to the female connectors on the reverse splitter The pin connector on the reverse splitter should be connected to the large dispersive electrode for the device to work properly The reverse splitter is not used for one channel PDC treatments 66 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 66 2 27 14 8 57 PM Clinician Setup Selecting the Language English The default language is English The IF Swave can be used and programmed in English Spanish USA and French Canada When the desired language is selected all functi
14. A C22 2 No 601 1 M90 88 926940 IF3Wave Guts Fr indd 88 IF 3wave User s Manual 2 27 14 8 57 PM
15. Amplitude During Treatment When you start an IF NMES PDC or IF NMES Combination treatment you set the amplitude and the program starts the amplitude locks at the desired setting after 30 seconds If you wish to change the amplitude follow these steps To adjust the amplitude during treatment NOTE The auto lock feature may be disabled by the clinician 1 If the device is locked press and hold both Ch1 and Ch2 A buttons for 2 seconds 2 Adjust the amplitude as desired The setting will lock again after 30 seconds Program Name amm Time Remain 39 min Chi AMP SS Ch AMP 42 lt Hold to unlock A Key Unlock Screen After the therapy time expires the device shuts off automatically A message screen appears telling you the program is complete You can also end a treatment session before it is completed by pressing the amp button twice within 2 seconds To end a therapy session 1 Ensure that the unit is off 2 Disconnect the lead wire s from the device 3 Disconnect the lead wire s from the electrodes 40 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 40 2 27 14 8 57 PM EX Operation Se 4 Depending on the type of electrodes being used do one of the following to remove the electrodes from your skin e Reusable self adhering electrodes Remove the electrodes one at atime placing each one on the saved protective backing as you remove it adhesive side down DO NOT pul
16. F3Wave_Guts_Fr indd 33 2 27 14 8 57 PM ow Operation Using the Device for a Therapy Session After inserting the battery connecting the electrodes connecting the lead wires preparing the skin and applying the electrodes you are ready to begin your therapy session Refer to the following illustration for button identification as you read the instructions For more information about the buttons refer to Device Physical Features in the System Components section of this manual Ch1 Increase Ch2 Increase On Off Ch1 Decrease Ch2 Decrease Device Buttons NOTES e The clinician can set the language that is displayed on the screen If you need the device set up in another language ask your clinician The languages are English Spanish USA and French Canada e The following steps include selecting a program and setting the channel intensities Read through the steps before actually performing them 34 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 34 2 27 14 8 57 PM PR Operation e The device stores the last program used To start the last program used simply turn the device on and wait for the Programs screen to appear The program will start automatically e If you change the mode during a therapy session the amplitude returns to zero and must be reset See the appropriate instructions for your treatment e The IF 3wave has an auto locking feature that prevents accidental amplitude adju
17. IF3Wave_Guts_Fr indd 38 2 27 14 8 57 PM PR Operation NOTES If you do nothing for 10 seconds the highlighted program runs If you choose the wrong program shut the device off and start over with step 1 Last Used Program Time Remain 39 min Chi AMPL_____ s OO Ch2 AMPL __________ 0 Previously Used Program Screen 4 Use the Ch1 and 2 Increase and Decrease buttons to set the amplitude for each channel as directed by your clinician As you adjust the amplitude the bar on the screen indicates the set amplitude relative to the maximum available 100 The numeric value is also displayed NOTES Adjust the amplitude until it is comfortable it should not be uncomfortable 30 seconds after you adjust the amplitude the settings will lock to prevent accidental changes To make adjustments see Adjusting Amplitude During Treatment in this Operation section 5 At the end of the IF program 20 minutes the amplitude returns to zero Within two minutes you must set the amplitude for the NMES program which runs for 20 minutes 6 At the end of the NMES program the IF program repeats 20 minutes and its amplitude returns to the previous IF amplitude setting You do not have to reset it At the end of the session the screen displays a message Program Completed and the IF Swave will shut down in 15 seconds IF 3wave User s Manual 39 926940_IF3Wave_Guts_Fr indd 39 2 27 14 8 57 PM TN Operation Adjusting
18. Last 20 Minutes Low Back Neck IF Mode Sweep 60 to 120 Hz 60 min Ramp 6 sec up 6 sec down IF Mode Sweep 60 to 120 Hz 60 min Ramp 6 sec up 6 sec down IF 3wave User s Manual 926940_IF3Wave_Guts_Fr indd 79 NM Mode 80 Hz 300 us Pulse Width Ramp Up 2 sec On 8 sec Down 2 sec Off 2 sec NM Mode 80 Hz 300 us Pulse Width Ramp Up 3 sec On 6 sec Down 3 sec Off 2 sec IF Mode Sweep 5 to 10 Hz Ramp 12 sec up 12 sec down IF Mode Sweep 1 to 10 hz Ramp 12 sec up 12 sec down 79 2 27 14 8 57 PM Troubleshooting Problem Stimulation weak even at maximum intensity Stimulation weak with fresh batteries Stimulation stops Stimulation weakens within minutes after start Unintentional muscle contractions Stimulation uncomfortable Stimulation ineffective Open message displayed for one or both channels Battery Low message displayed Display won t come on when power is turned on 80 926940 IF3Wave Guts Fr indd 80 Possible Cause Old or dried out electrodes Poor electrode contact Worn electrodes Poor electrode contact Damaged or worn lead wires and or electrodes Batteries drained Therapy time complete Normal adaptation response Intensity too high Intensity too high Improper electrode placement Poor electrode contact Improper electrode placement Damaged worn or loose lead wires E
19. SR 54 lel ai sclc MONO ee ee 55 IF OAINTO SAS a AE EEE Eea 56 IF SWEED Teamen Rares EAA ma ose ie 58 cong EU em NME FTOIT cee enn mn nee nee ee ee een tee ae 59 NIMES Proso FOMOS ranie pE EE Ea a E aa 59 NIMES Manual TQM VSI sirisser eninin se ae E 60 2 IF 3wave User s Manual 926940_IF3Wave_Guts_Fr indd 2 2 27 14 8 57 PM ANDS Table of Contents NMES Simultaneous or Alternative Treatments cccccccseeeeseeeseeeeeeeeens 61 NMES LAG TEET a a 62 NMES Single Channel Treatment 63 setting uo Combination IF NMES Programs sariaren innin neinna 64 SELNI UD FOG POS a a a 65 selecting the Language English cccccsssecseeeeeeseeceeeeseueeseeeeseeeeeeeseseneeas 67 11011019 CNY ICA RE as 67 OO RSR EE S 68 EAL OAS UID a den ETETE EE 69 Enabeling Disabeling System Sound 70 Enable or Disable the Auto Lock 70 Displaying the Serial Number cccccccsssssssenssscesscesseesnsscnsuuseusseesenseraeausesensans 71 SPSCIICATIONS 2 names cases nee caen ne sn atese neo 72 CSAS SC CATIONS rensei EEEa n 72 IF Moge SD CIICA TION sen rs ti rene 73 WA LCT a a oi 73 IF Proset POO AR a ne en 74 UF GTO SP FOOT AIA rera E E E aaeeen ec eee scen aioe 10 IF SWCD POS nee in Fo NIVIES WCE SOCCIICALON SR ae au een 76 NIMES Preset PIONEER rm de a rene r F D MOS CIC OR nn LT IF NMES Combination Mode Specification ccccccccseeceseeeseeeeeeeeneeeneeeseeesnees 18 IF NMES Combination Preset Treatment ccccccsecseseccesesese
20. System Works ss 5 About iNe MAO eee a 7 Prescribing Information ccscenecseesecsseneeneeeeeseeseesensensess 9 grelieisiilelg oa eee eet emer 9 SoU E oa AE EEE T E E E T 10 NAO aE E E re aeatianbonraiens 10 SO EE E A E E E E 11 AVE ES ara E E E E OEE E 12 Quick Reference essssnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnna 13 RUNANGA Nera de SCI EE E a 13 Changing a Therapy Session RL 13 Ending a Session Prior to the End of Therapy ccceccceceeseeeeeeseeeneeteeeeenees 14 System Components ccsccsseseessscneeeeeessensensenssensenseneeenseneens 15 Contents of the Standard Package 15 a 16 Device Physical Features ins 17 ED CO a a EE E E 17 Socia Fs OAS A EA T E EE ET TT TEET 17 Be ORO WAGE ER E A 17 OTT QE EL EC PR esac arunad sure E E TE T T Ae Rechargeable Batteries a dede no deb ne me 18 CAO SR ee ee eee eee eee er eet er eee ere ee 18 PONS POON as ne a ho eas 19 be ES SP EE 19 POUSSE ea a a nea 20 FEC 1 O 0 SC EE 21 Reusable Self adhering Electrodes cccccecceseeesneeeeeeeeeeeeeeeneeeaeeeas 22 Disposable Multi day Electrodes 23 Carbon R bber El6CIIODSS tn 23 NN SE RE 24 DOCS NO a aay eee en ean 24 PCD secteur a an ab er A 24 IF 3wave Users Manual 1 926940_IF3Wave_Guts_Fr indd 1 2 27 14 8 57 PM ETN Table of Contents SNY ODA area E AEE 25 VSO EE ER EU 25 installing the IF OWAVE ALG madovosckasitnsovancanisniaarandehasceepbasuctbageiataabarets 26 Chargi
21. and release the eo button twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section NMES Single Channel Treatment On this screen the Ramp Up On Time Ramp Down Off Time and Pulse Width parameters are set up Refer to the Specifications section for mode specifications NMES Single Ch fy O1 sec Ramp Up 01 sec On Time Oi sec Ramp Down o1 sec Off Time W Select Back Value NMES Single Channel Setup Screen To set the Single Channel parameter 1 Highlight the Single Channel treatment on the NMES Manual screen and press the Select button The NMES Single Ch Set screen appears and the first parameter is highlighted 2 Press the Value button to scroll through the preset values until the desired one is found IF 3wave User s Manual 63 926940_IF3Wave_Guts_Fr indd 63 2 27 14 8 57 PM ow Clinician Setup 3 Press the Select button The next parameter is highlighted 4 Repeat steps 2 and 3 to set the values for all parameters When finished the program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction 5 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added Clinician Setup 6 Do one of the following a Press the Yes button to go back to the Sel
22. b Receptacle Stimulator Back View 16 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 16 2 27 14 8 57 PM EN System Components Device Physical Features LCD Screen This is the area that displays the therapy settings as you program and use the stimulator Operating Buttons These are the buttons you use to program your therapy settings such as selecting the treatment program and intensity e On Off used to turn the stimulator on and off e Ch1 Increase used to increase the intensity amplitude of the electrical impulses sent through the channel 1 output jack e Ch1 Decrease used to decrease the intensity amplitude of the electrical impulses sent through the channel 1 output jack e Ch2 Increase used to increase the intensity amplitude of the electrical impulses sent through the channel 2 output jack e Ch2 Decrease used to decrease the intensity amplitude of the electrical impulses sent through the channel 2 output jack Battery Compartment The device holds one rechargeable battery The battery clips into the compartment only one way Output Jacks The output jacks are where you connect the lead wires The output jack labeled Ch1 is the channel 1 Ch2 is the channel 2 Each jack is shaped like an old fashioned keyhole Each lead wire has a corresponding plug that matches the shape of the jack Position the plug so that its shape matches the jack pattern Forcing the plug into the jack incorr
23. backing from the center of the electrode tape patch and attach it to the back of the electrode The raised portion of the electrode should protrude through the tape Moisten the lead wire pin to make insertion easier Insert the metal pin from the lead wire into the hole on the back of the electrode Identify the side of the electrode to be attached to your skin and cover its entire surface with electrode gel if necessary Remove the rest of the tape backing Position the electrode over the prescribed skin area and press the tape and electrode firmly onto the skin Do not moisten the lead wire pin in your mouth Doing so can cause severe injury or death Do not pull on the electrode wire Doing so may damage the wire and electrode IF 3wave User s Manual 23 926940_IF3Wave_Guts_Fr indd 23 2 27 14 8 57 PM ey System Components Carrying Case A carrying case is included to help protect the IF 3wave system and keep it clean Store your device and its components in the case when they are not in use Documentation Read and understand this user s manual carefully before operating the IF Swave device The device is provided in English Spanish USA and French Canada If you have questions or cannot read these languages contact your clinician Belt Clip A belt clip is provided so that the IF 3wave unit can be securely clipped to a belt or other clothing allowing you to go about your activities 24 IF Swave User
24. carrying case 24 documentation 24 IF SWAVE 16 lead wires 19 password card 51 power adaptor 19 skin care 41 84 926940 IF3Wave Guts Fr indd 84 Connections lead wires to device 31 lead wires to electrodes 29 D Delete button 50 Deleting a program 68 Disable auto lock 70 Display serial number 71 Disposable multi day electrodes connecting lead 29 E Editing program list 68 deleting and moving 68 Editing program setup 69 Editing programs 67 Electrode description carbon rubber 23 disposable multi day 21 reusable self adhering 21 Electrodes applying to skin 32 connecting lead wires 30 Enable auto lock 70 Ending therapy session 40 quick reference 14 Entering password 51 Entering setup mode 51 F Function buttons 49 G General specifications 72 Glossary 82 86 IF 3wave User s Manual 2 27 14 8 57 PM IF mode specification 73 IF program setup 51 IF setup continuous treatment 56 preset treatments 55 sweep treatment 58 IF treatment program running 35 IF NMES combination See Combination IF NMES setup IF NMES combination mode specification 79 IF NMES combo program running 38 Input password 51 Installing the battery 26 L Language setup 67 user instructions 7 Lead wires connecting to device 31 connecting to electrodes 29 reverse splitter 20 LED indicator battery 28 M Making selections setup 49 Messages battery indicator 43 low battery 43 open lead 44 program completed 37 39 recov
25. dance IF 3wave User s Manual 25 926940_IF3Wave_Guts_Fr indd 25 2 27 14 8 57 PM oe Operation Installing the IF Swave Battery The IF Swave operates with a removable rechargeable Lithium ion battery Two are supplied with the device Additional batteries can be ordered by contacting Empi at 1 800 328 2536 For information about charging the battery refer to Charging the Battery in this Operation section Install the battery before using the device Recharge the battery whenever the Battery Low message appears in the device s LCD screen For information about the display messages refer to Understanding Special Display Messages in this Operation section e Do not connect the device to any electrical outlet e Do not attempt to remove moisture from the battery with heat Excessive heat can cause the battery to explode catch fire and leak chemicals Failure to observe these warnings can result in severe personal injury or death or cause damage to the device and battery e Do not use other battery types Use only Empi battery Part Number 360102 which is designed for the system e When storing the batteries for long periods of time they should be charged at least every six months e Replace a battery that has been immersed in water or liquid e Never heat the battery or throw it into a fire e Fully drain the electrical charge from the battery before recharging e If the battery is leaking a liquid do not touch the l
26. e Battery indicator 42 Check leads 44 Key unlock 40 Program Complete 37 86 926940 IF3Wave Guts Fr indd 86 Therapy ending a session 14 Troubleshooting 80 U Up button 49 Using belt clip 24 Using Charger base charging the battery 28 Using the IF 3WAVE 34 V Value button 50 Y Yes button 50 IF 3wave User s Manual 2 27 14 8 57 PM Replacement Parts The following replacement parts can be ordered from Empi at 1 800 328 2536 Part Part Number IF Swave Stimulator 7110S Battery Lithium lon Rechargable 102 North America Only erate Carrying Case 370000 series Charger Base North America Only SHUDA Power Supply 590029 Electrodes Optional Refer to Clinic Services Lead Wires 620000 series Reverse Splitter 620049 User s Manual 926940 IF 3wave User s Manual 87 926940_IF3Wave_Guts_Fr indd 87 2 27 14 8 57 PM Federal Law USA restricts this device to sale by or on the order of a physician or licensed practitioner The following symbols are located on the back of the IF Swave stimulator HH IEC 417 5333 Type BF Applied Part A IEC 348 Attention consult accompanying documents Lead wires comply with the Performance Standard for electrode lead wires 21 CFR part 898 CL j Electronic Testing Lab indicates product meets US and Canadian product safety standards Susceptible to electro static charge CSA Canadian Standards Association This device complies with UL 60601 1 and CS
27. e Serial Number screen appears in the display release the number 2 button 6 Turn the device off IF 3wave User s Manual 45 926940_IF3Wave_Guts_Fr indd 45 2 27 14 8 57 PM AN Operation Using the Belt Clip The IF SwAE is supplied with a belt clip so that you can clip the device to your clothing allowing you to receive your treatment while going about your daily activities The belt clip s locking tab allows you remove the device from the belt clip Attaching the Tab You will need to attach the tab to the device Refer to the illustration below as you follow the steps To attach the tab to the device 1 Lay the IF 3wave face down on a soft cloth 2 Position the tab in the round depression so that the two scores are vertical to the length of the device 3 Insert the supplied Phillips screw into the hole and tighten but do not over tighten The tab should be snug Attaching the tab to the IF 3wave 46 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 46 2 27 14 8 57 PM EX Operation et You can leave the belt clip on your clothing and attach and detach the IF Swave from the clip To attach the IF Swave to the belt clip 1 Squeeze the belt clip so that it opens and slip it onto your belt or clothing 2 Position the IF 3wave so that it is parallel to the clip 3 Slide the tab down into the slot until it clicks 4 Rotate the device so that it hangs freely on the clip To remove the IF 3wave fro
28. e connected to the large dispersive electrode for the device to work properly The reverse splitter is not used for one channel PDC treatments Reverse Splitter Reverse Splitter Connected to Electrodes 20 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 20 2 27 14 8 57 PM EN System Components o Use the device with only the leads and electrodes provided for use by the manufacturer Use only the electrode placements and stimulation settings prescribed by your practitioner Other market released electrodes may be used as recommended by your practitioner IF Mode It is advisable not to use electrodes smaller than 4 sq in 25 sq cm when the device is used in IF mode at higher amplitude settings to prevent skin burn and irritation It is recommended that at a minimum 2 x 2 square electrodes are used when the device is operated in IF mode PDC Mode It is advisable not to use electrodes smaller than 6 sq in 87 50 sq cm at the treatment area when the device is used in PDC mode at higher amplitude settings to prevent skin burn and irritation In addition it is advisable to use only carbon based electrodes at the treatment area when the device is used in PDC mode It is recommended that at a minimum 2 x 4 carbon based oval electrodes are used at the treatment area and at a minimum a 5 x 8 rectangle dispersive electrode is used at the dispersive area A variety of electrode styles can be used i
29. e on Refer to Running IF NMES and PDC Treatment Program in the Operation section Setting Up PDC Programs The PDC Pulsed Direct Current offers four treatments The treatment may be run using one or two channels When using two channels both channels deliver a net DC output Refer to the Specifications section for mode specifications NOTE If only one treatment area is required select the C1 pdc red active or C1 pdc red active program and connect the lead wire to the Ch1 output jack e Channel 1 PDC e Channel 1 PDC PDC Programs C1 pdc red active C1 2 pdc red active C1 pdc red active C1 2 pdc red active W Select PDC Treatment Selection Screen IF 3wave User s Manual 65 926940_IF3Wave_Guts_Fr indd 65 2 27 14 8 57 PM aw Clinician Setup NOTE If two treatment areas are required select the C1 C2 pdc red active or C1 C2 pdc red active program and connect both lead wires to the device in the Ch1 and Ch2 output jacks Refer to Reverse Splitter in the Components section e Channels 1 and 2 PDC e Channels 1 and 2 PDC To set the PDC or PDC parameters The setup procedures are the same for the Channel 1 and Channels 1 and 2 treatments Q ed Q i c o O 1 Highlight the desired treatment on the PDC Programs screen and press the Select button The program s treatment time parameter screen appears 2 Press the Value button to set the treatment time 3 Press
30. e package for storing electrodes If necessary use adhesive remover to remove any remaining adhesive or gel from your skin 6 Optionally use skin cream or lotion to moisturize your skin after removing the electrodes 7 Optionally remove the battery from the device prior to storing 8 Store the components in the carrying case 14 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 14 2 27 14 8 57 PM System Components Contents of the Standard Package The IF Swave system contains the following components IF 3wave Stimulator _ Rechargeable Batteries Power Adaptor Charger Base J Je NET Lead L Wires 2 EU En Ear Reverse Splitter _ Electrodes Belt Clip Carrying Case Main Components Additional components IF Swave Users Manual and medical documentation You may receive an alternate charger The modem base and the telephone g jack on this style of charger are no longer available IF 3wave User s Manual N 15 926940_IF3Wave_Guts_Fr indd 15 2 27 14 8 57 PM oy System Components Seve The IF Swave is a battery operated electrical stimulator The device has preset programs and treatment programs that can be customized by a clinician C1 Increase Button C1 Decrease Button On Off Button LCD Ch1 Decrease Button Ch2 Decrease Button Stimulator Front View Battery Compartment Ch2 Output Jack Ch1 Output Jack Belt Clip Ta
31. e screen is entered Use the Scroll button to highlight an option and then press the Select button 50 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 50 2 27 14 8 57 PM Clinician Setup Entering the Setup Mode To enter the setup screens with the IF 3wave off press and hold the Start button for more than five seconds When the Setup Inout Password screen appears release the button Entering the Password The Password Card provides a code for the clinician to access the device setup functions dnes UeISIUIID Using the Function buttons enter the password and then press the Select button A Password Acceptance screen appears and then the Setup screen appears Password Input Screen If the password is not accepted after three attempts the patient s Program List screen appears If the clinician is unable to access the Setup Mode with the password contact Empi at 1 800 328 2536 NOTE The setup password is provided on a separate card and packaged with the device The card should be removed from the package before giving the unit and documentation to the patient Keep the password in a safe place such as the patient s medical file IF 3wave User s Manual 51 926940_IF3Wave_Guts_Fr indd 51 2 27 14 8 57 PM ow Clinician Setup System Selection Setup From this screen the clinician can choose from a list of options peeleer sui Type Select Language English Clinician Setup Edit Programs
32. ect Stim Type screen b Press the No button to go to the Setup screen twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section NOTE To return to the Setup screen press and release the button Setting Up Combination IF NMES Programs The combination of IF and NMES programs offers two preset treatments which are not adjustable Refer to the Specifications section for mode specifications e COMBO Low Back e COMBO Neck COMBO PANNES cu COMBO Low Back COMBO Neck W Select Back Combination IF NMES Treatment Selection Screen 64 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 64 2 27 14 8 57 PM Clinician Setup To set the combination IF NMES treatments 1 Highlight the desired treatment on the COMBO IF NMES screen 2 Press the Select button The program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction 3 Press the Save button Saving a program puts it in the Program List A screen appears and asks If another program should be added dnjes ueu 4 Doone of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen NOTE To return to the Setup screen press and release the O button twice within two seconds and press again to turn the devic
33. ectly could cause damage to the device IF 3wave User s Manual 17 926940_IF3Wave_Guts_Fr indd 17 2 27 14 8 57 PM IAA System Components Rechargeable Batteries The IF 3wave is supplied with two rechargeable Lithium ion batteries The device uses only one battery at a time While one battery is in use the other can be recharged in the charger base Charger Base The charger base serves one purpose e Charges the battery The battery charger recharges the device s battery The charger base is supplied with a power adaptor Power Adaptor Battery Channel a Charger Base 18 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 18 2 27 14 8 57 PM EN System Components Power Adaptor The power adaptor supplies power to the charger base to recharge the batteries Lead wires are wires that connect the device to the electrodes They carry the electrical pulses from the device to the electrodes on your skin You must have an electrode on both the red and the black pins for the device to work properly Pins Lead Wires IF 3wave User s Manual 19 926940_IF3Wave_Guts_Fr indd 19 2 27 14 8 57 PM ey System Components Reverse Splitter The reverse splitter is connected to the lead wires when using two channel PDC Pulse Direct Current The black pins from both Ch1 and Ch2 must be connected to the female connectors on the reverse splitter The pin connector on the reverse splitter should b
34. eeeesseeeeens 79 TFOUDICSNOOUNG criitsdceiserinintetsseseisasuesescnnsnceawssnnaanesewsaneawsaaceaens 80 COS SA so 82 RCE LES PR RER ERP EM EE 84 Replacement Parts c ccscsessesensenensesensenenseeenseeensenenseeensenes 87 OR eneececcndeneeeeceneudeceuecneseeesee uee 88 IF Swave User s Manual 3 926940 IF3Wave Guts Fr indd 3 2 27 14 8 57 PM 4 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 4 2 27 14 8 57 PM Introduction Congratulations Your physician has prescribed Empi s IF 3wave system to help you with pain management and rehabilitation therapy Empi is dedicated to helping you regain your active lifestyle from our field sales representatives training you how to use the system to our patient coordinators following up with you We make your Success Our goal How the IF 3wave System Works The IF Swave is a digital dual channel interferential IF current device Modalities also included are neuromuscular electrical stimulation NMES pulse direct current PDC and IF NMES combination stimulation The device sends electrical impulses through the skin These impulses stimulate the nerves or muscle fibers The IF Swave is used by a variety of patients in conjunction with other forms of therapy to treat acute and chronic pain edema muscle spasms and increase muscle strength and retard muscle disuse atrophy The operating components of the system are the IF Swave device lead wires electrodes and char
35. electrode firmly against the skin To remove your electrodes 1 Lift the corner of the electrode and gently remove it from the skin 2 Apply the protective backing to the tacky side of the electrode Place the electrode on the side of the protective backing that is labeled with the word On 3 Store the electrodes in the resealable pouch or a plastic bag Do not pull on the electrode wire Doing so may damage the wire and eletrode To prolong the life of these electrodes apply a drop of tap water to the tacky side when they show signs of drying out or of losing their stickiness This can be done before use or storage 22 IF 3wave User s Manual 926940_IF3Wave_Guts_Fr indd 22 2 27 14 8 57 PM EN System Components k Disposable Multi day Electrodes Empi offers a complete line of disposable multi day electrodes which are available in a variety of sizes and shapes To use these electrodes 1 o Attach the lead wire to the electrode If nesessary moisten the pin on the lead wire to make insertion easier Remove the liner from the tape patch and discard Apply the electrode to the prescribed skin area Replace electrodes that do not adhere properly to the skin or that fail to deliver proper stimulation Carbon Rubber Electrodes Some carbon rubber electrodes require a conductive medium such as a conductive gel while others have self adhering gel already in place To use these electrodes 1 Remove the
36. en appears 2 Highlight Edit Program List and press the Select button The Edit Program List screen appears with a list of current programs 3 Highlight the program you want to delete and press the Delete button 4 When finished press the Back button to return to the Edit Program List screen 5 To return to the Setup screen press the Back button again To move a program up in the list 1 On the Setup screen highlight Edit Program List and press the Select button The Edit Program List screen appears with a list of Current programs 2 Highlight the program you want to move up and press the Up button 3 When finished press the Back button to return to the Edit Program List screen 4 To return to the Setup screen press the Back button again 68 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 68 2 27 14 8 57 PM Clinician Setup Edit Program Setup The clinician can edit existing programs without having to delete the program and setting it up again This feature can also be used to edit an existing program and save it as anew program The parameters of preset treatments cannot be edited Edit Program Setup IF Continuous Default Program 1 dnes UueISIUIID Program 2 Program 3 W Select Edit Program Setup Screen To edit an existing program 1 On the Setup screen highlight Edit Programs and press the Select button The Edit Program Setup screen appears Highlight Edit Pro
37. ery 44 Modalities 53 Modality selection 53 Moving a program 68 Multiple day electrodes 32 IF 3wave User s Manual 926940 IF3Wave Guts Fr indd 85 ANS Index N NMES mode specification 76 NMES program setup 59 NMES setup alternative treatment 59 lag treatment 62 manual set treatments 60 preset treatments 59 simultaneous treatment 61 single channel treatment 63 NMES treatment programs 37 39 No button 50 O Open lead 44 Operation overview 25 Output jacks 17 P Password card 51 entering 51 PDC program setup 65 PDC treatment programs 37 39 Preparation skin for therapy 32 Program editing 67 Program list edit 68 Program list full message 61 Program setup combo IF NMES 64 IF 54 NMES 59 PDC 65 Q Quick reference 13 85 2 27 14 8 57 PM A Index en R Reusable self adhering electrodes applying to skin 32 connecting lead wire 31 Reverse splitter 20 Running IF program 35 IF NMES combo program 38 NMES program 35 PDC program 35 Running therapy session 35 quick reference 13 S Save button 50 screen Auto Lock Function 70 Combo IF NMES 64 Device Serial Number 71 Edit Program List 67 Edit Program Setup 67 Edit Programs 67 IF Continuous 56 IF Preset 55 IF Programs 54 IF Sweep 58 Input Password 51 Last Used Program 36 NMES LAG 62 NMES Manual Set 60 NMES Preset 59 NMES Programs 59 NMES Simultaneous 61 NMES Single Channel 63 PDC Programs 65 Program List 35 Program Nam
38. g Up NMES Programs The NMES Neuromuscular Electrical Stimulation offers two treatments Refer to the Specifications section for mode specifications e Preset e Manual Set NMES Programs Preset Manual set dnes UeIDIUIID W Select NMES Program Selection Screen NMES Preset Treatments This screen lists preset treatments available for the patient Preset treatment parameters are not adjustable The preset choices are e Low Back e Neck Shoulder e Mid Low Back e rigger Point e Quadriceps Strengthening e Quadriceps Re education NMES Preset Low Back Neck Shoulder Mid Low Back Trigger Point W Select NMES Preset Treatment Selection Screen IF 3wave User s Manual 59 926940_IF3Wave_Guts_Fr indd 59 2 27 14 8 57 PM ow Clinician Setup To select a NMES Preset treatment When the clinician enters the screen the first treatment is highlighted 1 Scroll to highlight the desired treatment 2 Press the Select button The program s treatment time and amplitude screen appears The amplitude of each channel is zero which the patient adjusts following the clinician s direction Clinician Setup 3 Ifthe program is suitable press the Save button Saving a program outs It in the Program List A screen appears and asks if another program should be added 4 Doone of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button
39. ger base The IF Swave device is battery operated lightweight and portable It features an LCD user interface screen and easy to use push buttons The lead wires connect the device to electrodes which are placed on the skin The device is then used to send cycles of electrical stimulation through the lead wires and electrodes into the skin When combined the components complete an electrical circuit allowing current to flow through the skin delivering the desired treatment stimulation IF Swave User s Manual 5 926940 IF3Wave Guts Fr indd 5 2 27 14 8 57 PM Introduction NY Electrodes Lead Wires Charger Base A Main Operating Components Consult your healthcare professional clinician if you have specific questions or problems regarding the use of the device They are most familiar with your situation and are the best source of additional guidance This system should be used only under proper medical supervision and only as described by this manual Before using your IF 3wave system please read all of the indications contraindications warnings and precautions in the Prescribing Information section 6 IF Swave User s Manual 926940 IF3Wave Guts Fr indd 6 2 27 14 8 57 PM PR Introduction About This Manual This manual describes the IF 8wave system and provides instructions for using it Please read the entire manual carefully IMPORTANT The IF Swave screens are provided in English Spanish USA
40. gnosis Effectiveness Effectiveness is highly dependent upon patient selection by a clinician qualified in the management of pain or rehabilitation IF Swave User s Manual 11 926940_IF3Wave_Guts_Fr indd 11 2 27 14 8 57 PM lt Prescribing Information 7 Keep out of reach of children Keep this device out of reach of children If the patient is a child make sure he she is properly supervised during the electrical stimulation Leads and electrodes Use the device with only the leads and electrodes provided for use by the manufacturer Use only the electrode placements and stimulation settings prescribed by your practitioner Electrode usage Other market released electrodes may be used as recommended by your practitioner IF Mode It is advisable not to use electrodes smaller than 4 sq in 25 sq cm when the device is used in IF mode at higher amplitude settings to prevent skin burn and irritation It is recommended that at a minimum 2 x 2 square electrodes are used when the device is operated in IF mode PDC Mode It is advisable not to use electrodes smaller than 6 sq in 37 50 sq cm at the treatment area when the device is used in PDC mode at higher amplitude settings to prevent skin burn and Irritation In addition it is advisable to use only carbon based electrodes at the treatment area when the device is used in PDC mode It is recommended that at a minimum 2 x 4 carbon based oval elec
41. gram Setup and press the Select button The Edit Program Setup screen appears with a list of current programs Highlight the program to be edited and press the Select button A screen with the parameters for the selected program appears Edit the settings as needed For assistance see the appropriate procedures in this section After completing the last screen a screen prompts whether to save the program or edit another one Do one of the following a Highlight Save Changes and press the Select button This saves the program with the same name b Highlight Save as New and press the Select button This saves the program with a new name c Highlight Back to Edit Program and press the Select button This returns to the Edit Program List screen When completed a message screen appears confirming that the program was saved IF 3wave User s Manual 69 926940_IF3Wave_Guts_Fr indd 69 2 27 14 8 57 PM NN Clinician Setup Enabling Disabling System Sound 1 Onthe Setup screen highlight System Sound and press the select button Available options appears and ON is highlighted 2 Press the Arrow button to select the desired option 3 When completed press the Select button Clinician Setup Enable or Disable the Auto Lock The auto lock feature prevents accidental changes to the amplitude output during treatment It locks the amplitude 30 seconds after the patient has set it The patient can unlock the setting temporarily
42. he pain path of your arm or leg 2 Wash the area with mild soap and water do not use alcohol Rinse and dry thoroughly 3 Trim excess body hair from the area with scissors do not shave 4 Optionally apply skin prep to the area to form a protective barrier on your skin 1 Make sure the device is off 2 Depending on the type of electrodes being used do one of the following to prepare the first electrode for application e Reusable self adhering electrodes remove the protective backing from the electrode and save the protective backing for reuse DO NOT pull on the electrode s wire to remove the protective backing rather bend the backing and peel the electrode from the backing NOTE If reusable electrodes begin to dry out or lose their stickiness apply a drop of tap water to the adhesive side This can be done before use or storage e Disposable multi day electrodes using the tabbed edge remove the protective backing from the electrode Discard the backing 32 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 32 2 27 14 8 57 PM EX Operation Se e Carbon rubber electrodes a Remove and discard the center backing from the tape patch and attach the tape patch to the top of the electrode The raised portion of the electrode should protrude through the tape b If necessary cover the entire bottom surface of the electrode with electrode gel c Remove and discard the rest of the ta
43. he clinician sets the Ramp Up On Time Ramp Down and Off Time parameters for Channel 1 The same parameters plus Lag Time for Channel 2 are set Finally the Lag parameters are set Refer to the Specifications section for mode specifications NMES LAG Ch2 NMES LAG Ch2 O sec Lag Time O sec Ramp Time 0 sec On Time O sec Ramp Down O sec Off Time Next O sec On Time QO sec Ramp Down CW _ Select Back Value Top Portion Bottom Portion NMES LAG Setup Screen To set the LAG parameters 1 Highlight the LAG treatment on the NMES Manual screen and press the Select button The NMES LAG Set Ch1 screen appears 2 Press the Value button to scroll through the preset values until the desired one is found 62 IF Swave User s Manual Clinician Setup 3 Press the Select button The next parameter is highlighted 4 Repeat steps 2 and 3 to set the values for all parameters When finished the program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction 5 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added dnes UeISIUIID 6 Doone of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen NOTE To return to the Setup screen press
44. ian Setup Stimulation Program Selection Screen If a Program list is full message appears on the Select Stimulation Type screen the clinician will need to delete an existing program from the Program List in order to add another program The maximum number of saved programs is 10 Press the Back button to return to the previous screen To delete a program refer to Edit Programs in this Clinician Setup section Q ed 0 V o O Select Stim Type Program list is full Max number of programs Saved are 10 Program List Full Message Screen Setting Up IF Programs The IF interferential program offers three types of treatments e Preset e Continuous e Sweep IF Programs Preset Continuous Sweep W Select IF Program Type Selection Screen 54 IF 3wave User s Manual 926940_IF3Wave_Guts_Fr indd 54 2 27 14 8 57 PM ENS Clinician Setup IF Preset Treatments O The IF Preset screen lists preset treatments available for the patient Preset treatment parameters are not adjustable The preset treatment programs include O e Low Back Pain gt e Neck Pain ep e Knee Pain 7 e Shoulder Pan O e Wrist Pain e Ankle Pain e C Pain CIF preset Low Back Pain Neck Pain Knee Pain Shoulder Pain W Select Back IF Preset Treatment Selection Screen To select an IF Preset treatment program 1 Using the Scroll button highlight the desired treatment 2 P
45. in in 5 min increments 10 to 60MIN in 5 min increments 10 to 60 min in 5 min increments 10 to 600 min in 5 min increments IF 3wave User s Manual 75 926940 IF3Wave Guts_Fr indd 75 2 27 14 8 57 PM TIA Specifications NMES Mode Specification Parameters Device Specifications Waveform Biphasic square wave zero DC A 70 us N 10 us NMES Waveform Output Frequency 10 to 80 Hz selectable in 5 Hz increments Pulse Width 70 to 300 us selectable in 10 us increments Maximum Charge 30 u Coulombs Per Pulse Output Current O to 100 mA constant current into 1000 Q load selectable in 1 mA increments Output Voltage O to 100 V into 1000 Q load O to peak Ramp Up Time O to 10 seconds in 1 second increments OnTime 1 to 30 seconds in 1 second increments Ramp Down Time O to 10 seconds in 0 5 second increments Off Time 1 to 60 seconds in 1 second increments LAG Time O to 15 seconds in 1 second increments Treatment Time 10 to 60 minutes in 5 minute increments 76 IF Swave Users Manual 926940_IF3Wave_Guts_Fr indd 76 2 27 14 8 57 PM Specifications NMES Preset Program Preset Treatment Ramp Up On Low Back Spasm 20 min 80 Hz 300 Us 2 Sec 8 sec 2 Sec 2 Sec Reduction Neck Upper Back 59 min 50 Hz 150 us 3 sec 6 sec 3 sec 2 Sec Spasm Reduction Mid Low Back 15 min 35 Hz 300 us 2 Sec 10 sec 2 Sec 10 sec Strengthening Trigger Point 30 min 50 Hz 300 ps 3 sec 10 sec 3 sec 10 sec Therapy uaan epe
46. iquid with bare skin e Dispose of the battery according to current federal state and local regulations Failure to observe these precautions can result in injury damage to the device and battery or the environment Return used batteries to Empl 205 Hwy 22 East Clear Lake SD 57226 26 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 26 2 27 14 8 57 PM EN Operation k To install the battery into the device 1 Place the device face down in the palm of your hand 2 Slide the battery into the battery channel until it clicks The Empi label on the battery should be facing down Insert Battery Installation Caution VAN Never force the battery into the battery channel or charger base Forcing it can damage the device and battery IF 3wave User s Manual 27 926940_IF3Wave_Guts_Fr indd 27 2 27 14 8 57 PM TP Operation Charging the Battery The battery must be removed from the IF Swave and placed in the charger base to charge it Fully charge the battery approximately 4 5 hours before using it again It is a good practice to drain the batteries completely before recharging them LED Battery Indicator Power Jack Battery Charger Base Never force the battery into the battery channel Forcing it can damage the charger base and battery Battery LED Indicator Bright green Battery is charging No green light off Battery recharge is complete Red Battery is defective Charger shuts
47. l on the electrode wires gently peel the electrodes from your skin Place the electrodes in their original re sealable plastic bag e Disposable multi day electrodes Leave these electrodes on for the number of days instructed by your clinician When required remove each electrode by lifting one edge and then peeling the electrode from your skin Discard the electrodes e Carbon rubber electrodes Remove each electrode by lifting one edge of the tape patch and then peeling the patch from your skin Clean and store the electrodes according to the manufacturer s instructions 5 If necessary use adhesive remover to remove any remaining adhesive from your skin Wash the skin area with mild soap and water do not use alcohol Optionally use skin cream or lotion to moisturize your skin For more information about adhesive remover and skin cream refer to Skin Care Samples in the System Components section of this manual 6 Optionally remove the battery from the device See Installing the Battery in this Operation section 7 Store the components in the carrying case To end a therapy session prior to the end of a program 1 Press and release the amp button twice After pressing the button once a screen appears asking you to confirm that you want to shut the power off Press the button again The device shuts off 2 Follow steps 2 through 7 to end a therapy session above IF 3wave User s Manual 41 Operation
48. lectrodes not oroperly applied Weak battery Weak battery Solution Replace electrodes Reapply electrodes secure firmly Replace electrodes Reapply electrodes secure firmly Replace lead wires and or electrodes Replace recharge batteries Restart stimulator Increase intensity Decrease intensity Decrease intensity Reposition electrodes Reapply electrodes secure firmly Reposition electrodes Replace or resecure lead wires Reapply electrodes secure firmly Replace recharge batteries Replace recharge battery IF 3wave User s Manual 2 27 14 8 57 PM PSS Troubleshooting eS Problem Possible Cause Solution Unable to turn device Improper shut down Press oF button off during treatment procedure twice rapidly LED battery indicator Battery not in Slide battery into does not illuminate charger base charger base during charging firmly Charger base not Plug power adaptor into plugged in 110 Vac outlet If problems continue call Empi s Technical Service department at 1 800 328 2536 IF 3wave User s Manual 81 926940_IF3Wave_Guts_Fr indd 81 2 27 14 8 57 PM This Glossary contains definitions of terms and abbreviations that apply to the IF SWAVE system and are used within this manual Term Alternate treatment Amplitude Chronic pain Clinician Continuous stimulation Electrode Frequency IF LAG treatment LCD Modality NMES Off time Patient PDC Progra
49. m the belt clip 1 Rotate the device so that it is parallel to the clip 2 Press the release button at the top of the belt clio downward 3 While pressing the button slide the device upward 4 Release the button IF 3wave User s Manual 47 926940_IF3Wave_Guts_Fr indd 47 2 27 14 8 57 PM 48 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 48 2 27 14 8 57 PM Clinician Setup This setup section is intended for the health care professional clinician and access is protected with a password In some cases patients are granted access to the setup so that they can adjust their treatment The setup displays are used to set up the desired treatment programs select the desired display language and edit existing treatment programs Function Buttons and Making Selections Function Buttons dnes UeBISIUIID Four function buttons numbered 1 through 4 are used for the setup Open the protective cover to access them Icons on the LCD directly above the buttons indicate the function of each button Buttons without a function designation on the LCD are not used for that screen Function Buttons 1 through 4 Function Buttons With Protective Cover Removed The button s function may change with various screens These functions are Scroll Downward pointing arrow or Double Arrows Scrolls through the listed choices When the last item in the list is reached it returns to the top of the list The button must be p
50. m type Ramp down 82 926940 IF3Wave Guts Fr indd 82 Definition The output of channels 1 and 2 operate at different times The level of output Continuous long term pain Licensed health care professional such as physician nurse or physical therapist An output mode used by the patient to adjust the stimulation to a maximum comfort level A medium used to apply electric current The number of pulses per second used to describe pulsed electrical currents Interferential modality type of electrotherapy that uses two separate electrical frequencies to stimulate large impulse nerve fibers Helps relieve pain and increase fluid movement The output for channel 2 starts after the output of channel 1 Liquid Crystal Display The user interface where all messages and information appears The user uses this to interact with the stimulator The stimulation type IF NMES Combination of IF and NMES and PDC Neuromuscular Electrical Stimulation modality The use of electrical stimulation to contract a muscle The treatment output cycle for each channel occurs simultaneously The time period of the treatment where there is no stimulation The person who is undergoing medical investigation or treatment Pulsed Direct Current modality The type of program available within a modality such as sweep continuous manual set and preset Time period of the treatment that decreases from the level that the pa
51. moisten the lead wire pin to make insertion easier Connect only one lead wire to each electrode Do not moisten lead wire pin in your mouth Doing so can cause severe injury or death 30 IF 3wave User s Manual 926940 IF3Wave Guts Fr indd 30 2 27 14 8 57 PM PS Operation Connecting the Lead Wires to the Device To connect the lead wire s to the device 1 Locate the plug s at the end of the lead wire s If necessary refer to the illustration in the System Components section 2 Locate the output jacks at the bottom of the device They are labeled Ch1 for channel 1 and Ch2 for channel 2 Output Jacks Lead Wire Connection to the Device 3 Insert one lead wire plug into each output jack If using only one lead wire use the Ch1 output jack NOTE The lead wire plugs and jacks are key shaped Match the shapes when inserting the plugs IF 3wave User s Manual 31 926940_IF3Wave_Guts_Fr indd 31 2 27 14 8 57 PM TN Operation Preparing the Skin for a Therapy Session Proper preparation of the skin covered by the electrodes allows more stimulation to reach targeted tissues prolongs electrode life and reduces the risk of skin irritation To prepare your skin at the electrode placement sites 1 Determine the placement sites for the electrodes Follow your clinician s instructions NOTE Your clinician generally has you place the electrodes above and below or surrounding the area of pain or along t
52. ncluding the following types e Reusable self adhering e Disposable multi day e Carbon rubber Refer to the following subsections and the information on the electrode packages for use and care information for each electrode type Following these instructions will maximize their effectiveness and longevity Inspect your electrodes before every use Replace electrodes as needed Reusable electrodes may cause slight skin irritation lose adhesion and deliver less stimulation if overused If you need additional electrodes contact Empi at 1 800 328 2536 IF 3wave User s Manual 21 926940_IF3Wave_Guts_Fr indd 21 2 27 14 8 57 PM ow System Components KT Connector for Inserting Lead Wire Pin CC lt gt pe Adhesive Pad T D S m LA Reusable Self adhering Electrodes NOTE The large single electrode Dispersive Electrode is used for one channel and two channel PDC treatments Before using please refer to the Setting Up PDC Programs in the Clinician section Reusable Self adhering Electrodes Empi offers a complete line of reusable self adhering electrodes which are available in a variety of sizes and shapes To use these electrodes 1 Attach the electrode to the lead wire 2 Remove the protective backing from the electrode surface Do not throw away the protective backing because it is reused after the treatment session has been completed 3 Place the tacky surface to the prescribed skin area by pressing the
53. ng the Battery in 28 ery EE DIN 62 Fe PR Re es 28 Storing the Battery einen 29 Connecting the Lead Wires to the Electrodes cccccseeeseeeeseeeeeeeeeeeeneeeeeeeas 29 Connecting the Lead Wires to the Device ccc ccecccccecceceeeeeeeeeeseeeeeneeesaeeesneess 31 Preparing the Skin for a Therapy Session LR o2 Applying the Electrodes to the SKIN cccecccesccseeeeeeeeeeeaeeeaeeeaeseeaeenaeeeaeeetees 32 Using the Device for a Therapy Session 34 Running IF NMES and PDC Treatment Programs 35 Running IF NMES Combination Treatment Program 38 Adjusting Amplitude During Treatment ccccccccesseeeseeeseeeeeeeeeeeeeeeeeaeeens 40 HONOR SO es a as et 40 Caring for the IF BWAVE System Rs 42 Understanding Special Display Messages 42 Battery Indicator and Battery LOW ccccccccseecsceeeseeeeeeeeeeeeeeeeeeeeneeeaeeaeeeees 42 OS te A a 44 Finding the Software Version and Serial Number 45 CO ABS E EEE 46 Attaching AR a an 46 PUTA PUIG Wee OR aan a dr de en 47 Clinician SCD aa de en nna 49 Function Buttons and Making Selections ccccecesseseccseeseeeseeeeeeeeeerseeeees 49 FUNCION BUTON hace aac epee ose sec ee asec a 49 KAKNO OCO UONE aena EEEE 50 Ent ring the Setup ModE ss ss riirii ENAS EAEE 91 Bntonng the FaSSWOrG ia eee aa ar 51 D SCI SElCCNOM SUD been aan a E 52 SUNAN MOGAE Grene a en 53 selecting the Stimulation Modality 53 Stimulation Program Selection Screen 54 UCT IPP ROC LS IR
54. ons are displayed in that language The IF Swave can be set up in one language and then changed for a patient who reads one of the other languages Select Language English Spanish 3 O Y eg D FF Le French W Select Select Language Screen To choose a different language 1 Scroll to the desired language 2 Press the Select button Editing Programs From this screen you can choose from two options e Edit Program List Allows you to delete programs from the Program List screen e Edit Program Setup Allows you to edit existing programs in the Program List screen Edit Programs Edit Program List Edit Program Setup W Select Edit Programs Screen IF Swave User s Manual 67 926940_IF3Wave_Guts_Fr indd 67 2 27 14 8 57 PM TN Clinician Setup Edit Program List The Program List holds up to 10 programs These can be a combination of preset and custom programs All programs except the IF Continuous Treatment program can be deleted from the list The IF Continuous program is always at the top of the list The order in which the programs are listed can be changed Edit Program List IF Continuous Default Program 1 Clinician Setup Program 2 Program 3 W IDelete Back Up Edit Program List Selection Screen To delete a program from the list 1 Onthe Setup screen highlight Edit Programs and press the Select button The Edit Programs scre
55. pe backing 3 Place the adhesive gel surface of the electrode on the skin placement site prescribed by your clinician 4 Press the entire surface of the electrode into place making sure it is secure 5 Repeat steps 2 through 4 for all electrodes e Inspect the electrodes before each use e Position the electrodes with a minimum of 1 inch between them do not let them touch each other Do not reposition the electrodes while the device is turned on e Do not place electrodes on cut broken or irritated skin If skin irritation develops immediately discontinue device use remove the electrodes and contact your clinician e For long term stimulation change electrode sites whenever possible Contact your clinician for new placement sites e Replace self adhesive electrodes that do not adhere well or fail to deliver proper stimulation e Do not overuse reusable electrodes Doing so may cause skin irritation loss of adhesion and weak stimulation e Do not refrigerate electrodes Keep them from heat sources Refer to the electrode packaging for information about electrode use and care e For descriptions of the electrode types refer to Electrodes in the System Components section e For more information about electrode placement visit www empi com As the electrode size gets smaller below the standard 2 sq in or 4 sq in 25 sq cm the tendency for skin Irritation increases IF 3wave User s Manual 33 926940_I
56. r s Manual ENS Clinician Setup To set the Continuous parameters When the clinician enters the screen the first parameter is highlighted 1 With the parameter highlighted press the Value button to scroll through the preset values until the desired one is found 2 Press the Select button The next parameter is highlighted 3 Repeat steps 1 and 2 to set each parameter When finished the program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction dn S UeIDIUIID IF Continuous 1 Time Remain 39 min Chi AMPL__________ OO Ch2 AMP 0 The Program s Treatment and Amplitude Run Screen 4 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added 5 Doone of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen NOTE To return to the Setup screen press and release the button twice within 2 seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section IF 3wave User s Manual 57 ow Clinician Setup IF Sweep Treatment The Sweep treatment modulates the beat frequency over a range It ramps up from minimum to maximum and ramps down from maximum to minimum for the set amount of time This screen lis
57. r equipment not specified as safe for the lead wires Heart Disease Use caution prior to using this device on patients suspected of having heart disease Epilepsy Use caution for patients with suspected or diagnosed epilepsy when using this device Hemorrhages Use caution when there is a tendency to hemorrhage such as following acute trauma or fracture Postsurgical use Use caution following recent surgical procedures when muscle contraction may disrupt the healing process Uterus Do not use electrical stimulation over a menstruating or pregnant uterus Sensory loss Do not use electrical stimulation where sensory nerve damage is present by a loss of normal skin sensation Unequal electrode size Using different size electrodes together can cause skin Irritation or increased stimulation intensity under the smaller electrode Some programs may require the use of different sized electrodes for treatment Skin irritation If patient experiences skin irritation due to electrical stimulation or the electrical conductive medium used remove the electrodes discontinue stimulation and consult the clinician Irritation may be reduced by an alternative conductive medium or an alternative electrode placement Isolated cases of skin irritation may occur at the site of electrode placement following longterm application Prescription Use electrical stimulation only in the prescribed manner and for the prescribed dia
58. r two lead wires four electrodes Follow your clinician s instructions 2 Locate the pins at the ends of the lead wire s If necessary refer to the illustration in the System Components section 3 Locate the pin insertion points on two or four electrodes as necessary and do one of the following e On a reusable self adhering electrode the insertion point is at the loose end of the wire attached to the electrode as shown in the next illustration e On a disposable multiple day electrode the insertion point is a small hole on the top of the electrode There are two holes use only one of them e Onacarbon rubber electrode the insertion point is a small hole on the top of the electrode There are two holes use only one of them IF 3wave User s Manual 29 926940_IF3Wave_Guts_Fr indd 29 2 27 14 8 57 PM EN Operation LT NOTE Refer to Reverse Splitter in the System Components section for complete instructions on connecting the lead wires to the electrodes with the reverse splitter when using PDC programs C1 2 pdc red active and C1 2 dc red active Electrode Connection to Lead Wire NOTE Refer to the electrode package for complete instructions 4 With the electrodes still attached to the protective backing reusable and disposable electrodes only insert one lead wire pin into each electrode s insertion point Insert the pins entirely so that no metal shows NOTE If using disposable or carbon rubber electrodes
59. ress the Select button The program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction Low Back Pain Time Remain 39 min Chi AMPL______ O CO Ch2 AMPL ___________ 0 The Program s Treatment Time and Amplitude Screen IF 3wave User s Manual 55 926940_IF3Wave_Guts_Fr indd 55 2 27 14 8 57 PM ow Clinician Setup 3 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added Low Back Pain Low Back Pain is saved Q shad Q dp a O Add another program O Program is Saved Message Screen 4 Doone of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen ZTN NOTE To return to the Setup screen press and release the E button twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section The IF Continuous treatment delivers interference frequency with a fixed beat which the clinician sets This screen lists the Hz frequency and the treatment time Each of these can be edited Refer to the Specifications section for mode specifications IF Continuous 1 50 Hz Frequency 40 min Treatment Next W Select Back Value IF Continuous Setup Screen 56 IF Swave Use
60. ressed and released to advance to the next item listed e Select Selects the highlighted option puts it into the program memory and then goes to the next item or display e Back Returns to the previous screen e Up Used when editing programs It moves the highlighted program upward in the program list IF 3wave User s Manual 49 926940_IF3Wave_Guts_Fr indd 49 2 27 14 8 57 PM ow Clinician Setup e Value Scrolls through a list of predefined values for the highlighted item It starts at the top of the list continues through the list and returns to the top of the list When the list has less than 15 choices the clinician must press and release the button For longer lists the button can be pressed and held to advance through the list e Save Saves the treatment program and places it on the Program List screen e Yes Used after saving a treatment program If selected it returns to the Select Stim Type screen Q hed Q i c o O e No Used after setting up a treatment program If selected it returns to the Program List screen e Delete Deletes a program when editing the Edit Program List screen Highlighted IF Sweep Option 1 150 Hz Range Select 6 6 sec Cycle 40 min Treatment Scroll Next TT Value TW Select Back Value Sample LCD Icons Making Selections Many screens offer options to choose from The first option on a screen is highlighted when th
61. s a protective mechanism Central origin pain Electrical stimulation is not effective for central origin pain such as headache Pregnancy The safety of using electrical stimulation during pregnancy or birth has not been established Neck stimulation Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrodes are placed across the neck or mouth This may be strong enough to close off the airway or cause breathing difficulty Transthoracic stimulation Do not apply electrical stimulation transthoracically through the chest area in that the introduction of electrical current into the heart may cause cardiac arrhythmias Skin and vascular problems Do not use this device over infected areas skin eruptions or areas of decreased sensation Cancer patients Do not use this device over known cancerous sites Heart disease Precaution should be taken prior to using electrical stimulation on patients suspected of having heart disease 10 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 10 2 27 14 8 57 PM END Prescribing Information eS High frequency surgical devices Simultaneous connections of a patient to a high frequency surgical device may result in burns at the site of the electrodes and possible damage to the device Damage from liquids Do not immerse the device in water or other liquids Lead connection Do not connect the lead wires to an AC power source or othe
62. ssage Program Completed and the device will shut down in 15 seconds Program Name nn Program Completed Auto Shut Down Program Complete Screen IF 3wave User s Manual 37 926940_IF3Wave_Guts_Fr indd 37 2 27 14 8 57 PM TP Operation Running IF NMES Combination Treatment Program The IF NMES program combines two treatment modes The treatment begins with the IF program and then changes to a NMES program When the NMES program ends the IF program repeats Each program runs 20 minutes and the total treatment time is 60 minutes To start an IF NMES therapy session 1 Press and release the button to turn the device on Two title screens briefly appear in the display and then the Program List screen appears The last program used is highlighted Program List IF Continuous Saved Programi Saved Program2 Last Used Program Chi Scroll Select Ch2 Program Selection Screen 2 With the Program List screen displayed immediately use either the Ch1 Aor V buttons to highlight the desired therapy program 3 Press the Ch2 A or V buttons to select the program The Selected Program screen appears The treatment time shows how much time is left in the treatment session and the amplitude is set at zero for both channels Program Name cu Time Remain 39 min Chi AMP go Os S0 Ch2 AMP 42 fi lt Hold to unlock A Selected Program Run Screen 38 IF Swave User s Manual 926940_
63. start up IF 3wave User s Manual 43 926940_IF3Wave_Guts_Fr indd 43 2 27 14 8 57 PM ESN Operation IT Program Name amm Time Remain 39 min Check Ch1 lead wire or electrodes Check Leads Message If a lead wire becomes disconnected or an electrode becomes separated from the skin a message tells you to check the leads and electrodes as shown above Ensure that the leads are properly connected When they are properly connected a message appears indicting recovery and the therapy session continues where it left off Program Name amm Time Remain 39 min Recovery complete Returning to program Recovery Screen 44 IF 3wave User s Manual 926940_IF3Wave_Guts_Fr indd 44 2 27 14 8 57 PM EX Operation Finding the Software Version and Serial Number When you turn on the IF 3wave two title screens appear The first screen displays the Empi logo and the second screen displays the device s logo and the version number of the software In addition you can display the serial number of the device This is useful when you need to report the number for Technical Service Number 2 Button IF Swave with Function Button Cover Removed To display the device s serial number 1 Make sure the device is off 2 Lift the cover on the front of the device to access the function buttons 3 Press and hold the number 2 button 4 While holding the number 2 button press and release the button 5 When th
64. stment in the IF NMES and PDC treatment programs The clinician may enable or disable this feature for each program e f a message screen appears refer to Understanding Special Display Messages in this section Running IF NMES and PDC Treatment Programs Follow these procedures for all programs EXCEPT the IF NMES combination treatment program The IF NMES combination procedures are provided in a later section of the manual NOTE While performing the following steps if you do nothing for two minutes the device will shut off automatically If this happens start over with step 1 To run most therapy programs 1 Press and release the button to turn the device on Two title screens briefly appear on the display for 5 seconds and then the Program List screen appears The last program used is highlighted and will automatically begin after 10 seconds if no other program is selected Program List IF Continuous Saved Programi Saved Program2 Last Used Program Chi Scroll Select Ch2 Program Selection Screen IF 3wave User s Manual 35 926940 IF3Wave Guts Fr indd 35 2 27 14 8 57 PM ESN Operation LT 2 With the Program List screen displayed immediately use either the Ch1 A or V buttons to select a different therapy program 3 Press the Ch2 Aor V buttons to select the program The Selected Program screen appears The treatment time shows how much time is left in the treatment session and the amplitude
65. t 10 min Treatment Next W ISelect Back value gt W Select Back Value Top Portion Bottom Portion NMES Simultaneous Setup Screens To set the Simultaneous and Alternative parameters 1 Highlight the appropriate treatment on the NMES Manual screen and press the Select button The program s Set Ch1 screen appears and the first parameter is highlighted 2 Press the Value button to scroll through the preset values until the desired one is found 3 Press the Select button The next parameter is highlighted IF 3wave User s Manual 61 926940_IF3Wave_Guts_Fr indd 61 2 27 14 8 57 PM ow Clinician Setup 4 Repeat steps 2 and 3 to set the values for all parameters When finished the programs treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction 5 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added 6 Doone of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen Q hed Q Cp c o O NOTE To return to the Setup screen press and release the E button twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section NMES LAG Treatment On the first screen t
66. tient set during continuous stimulation down to no stimulation IF Swave User s Manual 2 27 14 8 57 PM EN Glossary k Term Definition Ramp up Time period of the treatment that increases from no stimulation to the level that the patient set during continuous stimulation Simultaneous The output for channels 1 and 2 start at the same time treatment Single Channel Output is at only channel 1 treatment Treatment time The total time the patient is receiving treatment from the device Treatment type The type of treatment within a program type such as for low back pain neck pain and quadriceps reduction IF 3wave User s Manual 83 926940_IF3Wave_Guts_Fr indd 83 2 27 14 8 57 PM A Adjusting amplitude 40 IF PDC and NMES programs 35 Applying electrodes 32 Attaching belt clip 47 Attaching belt clip tab 46 Auto lock 37 enable and disable 70 Back button 49 Batteries 15 Battery charging 28 installing 26 LED indicator 28 storing 29 Battery compartment 17 Battery indicator 42 Belt clio 14 24 46 Belt clip attaching 46 Belt clip tab 46 Button identification 34 C Carbon rubber electrodes applying to skin 33 connecting lead wire 30 Care IF 3WAVE system 42 Carrying case 24 Changing a therapy session quick reference 13 Charger base 18 Charging the battery 27 Cleaning 42 Clinician setup 49 Combination IF NMES setup 64 Components 15 25 batteries 18 battery compartment 17 belt clip 24
67. to adjust the amplitude By default the auto lock feature is enabled for the IF and PDC programs and disabled for the NMES program Auto Lock Function ON IF Mode OFF NMES Mode ON PDC Mode Chi Scroll Select Ch2 Auto Lock Function Screen To enable or disable the auto lock 1 With the IF Swave turned off press and hold the Ch1 A button while turning the device on The Auto Lock Function screen appears 2 Use the Ch1 or buttons to highlight the parameter 3 Use the Ch2 A or buttons to toggle between On and Off Note Change will be applied at next power up 4 When finished turn the device off 70 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 70 2 27 14 8 57 PM Clinician Setup Displaying the Serial Number Each IF 3wave has its own serial number which should be recorded Device Serial Number EL 123 456789 O 3 Y gt eg D FF Le Device Serial Number Screen To display the serial number 1 With the IF Swave turned off press and hold the Function 2 button while turning the device on The Device Serial Number screen appears 2 When finished turn the device off IF 3wave User s Manual 71 926940_IF3Wave_Guts_Fr indd 71 2 27 14 8 57 PM Specifications General Specifications Parameters Dimensions Weight Power Source Electrical Protection Rating Lead Wire Rating Ambient Operating Conditions Shipping and Storage Condition
68. to go to the Setup screen NOTE To return to the Setup screen press and release the button twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section NMES Manual Treatments The clinician sets up and stores one manual muscle stimulation treatment These programs can be set up using a single channel output or two channel outputs From this screen the following treatments can be edited e Simultaneous e Alternative e LAG e Single Channel NMES Manual ki Simultaneous SIM Alternate ALT LAG Single Channel CH W Select Back NMES Manual Program Selection Screen 60 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 60 2 27 14 8 57 PM Clinician Setup NMES Simultaneous or Alternative Treatments The clinician sets the Ramp Up On Time and Ramp Down parameters for each channel Then the Pulse Width Pulse Rate Off Time and Treatment time are set Refer to the Specifications section for mode specifications NOTE The screens and set up procedure for the Simultaneous and Alternative programs are the same dn S ueldIUllD NMES SIM Ch1 01 sec Ramp Up 01 sec On Time 01 sec Ramp Down Next W Select Back Value NMES Simultaneous Set Channel 1 Screen CAMES SIN mm NES 10 sec Off time 10 Hz Pulse Rate 10 Hz Pulse Rate 7O us Pulse Width 70 us Pulse Width 10 min Treatmen
69. trodes are used at the treatment area and at a minimum a 5 x 8 rectangle dispersive electrode is used at the dispersive area Microwave or radio frequency sources Operation in close proximity such as 3 feet 1 meter to shortwave or microwave therapy equipment may produce instability in the device output and may shut the device off Electronic equipment Electronic monitoring equipment such as ECG and ECG alarms may not operate properly when electrical stimulation is in use Machinery operation Patient should never operate potentially dangerous machinery such as power saws automobiles etc during electrical stimulation Flammable Do not use the device in an environment where flammable or explosive fumes may exist External use This device is for external use only Skin irritation inflammation and electrode burns beneath the electrodes are potential adverse reactions 12 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 12 2 27 14 8 57 PM Quick Reference When you are very familiar with the operation of the IF 3wave system use the following steps as a quick reference to operate the device For more information refer to the Operation section in this manual Running a Therapy Session 1 Wash and dry the skin areas where you will be applying the electrodes Use skin prep if necessary 2 Connect the lead wire s to the electrodes and the device 3 Apply the electrodes to your skin 4
70. ts the frequency range in Hz the modulating cycles in seconds time and the treatment time in minutes The clinician can edit each of these Refer to the Specifications section for mode specifications Clinician Setup sweep 1 150 Hz Range 6 6 sec Cycle 40 min Treatment Next W ISelect Back Value IF Sweep Setup Screen To set the Sweep parameters When the clinician enters the screen the first parameter is highlighted 1 With the parameter highlighted press the Value button to scroll through the preset values until the desired one is found 2 Press the Select button The next parameter is highlighted Repeat steps 1 and 2 to set each parameter When finished the program s treatment time and amplitude screen appears The amplitude is set at zero which the patient adjusts following the clinician s direction 4 Press the Save button Saving a program puts it in the Program List A screen appears and asks if another program should be added 5 Do one of the following a Press the Yes button to go back to the Select Stim Type screen b Press the No button to go to the Setup screen NOTE To return to the Setup screen press and release the button twice within two seconds and press again to turn the device on Refer to Running IF NMES and PDC Treatment Program in the Operation section 58 IF Swave User s Manual 926940_IF3Wave_Guts_Fr indd 58 2 27 14 8 57 PM Clinician Setup Settin

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