Transcutaneous Electrical Nerve Stimulator for Pain
Contents
1. Transcutaneous Electrical Nerve Stimulator for Pain Treatment USER GUIDE gt Direct TENS CONTENTS Quick Start Guide General Information 1 Pom TO Note BOR US Gnako N ca eee tects E taarateasaeesotnassdenieecsncteaus Page 6 2 How does the Direct TENS Device FUNCTION ceesessssesessssesesscsescsscscsesecsesesesseseseseesesesessesssesscsesescsesssesscseseseeseseeseseaees Page 9 2 1 TENS Therapy UNOS ecg cae eez coc ecye uy essesaceaeaaeascavecatstasssetnecersaserseancavrarasseeseevaeu teresa OAE EEEE EEE rE E EEN aS N EEES Page 10 2 2 Description of the Programs and the Corresponding Indications sseesseesseesseesseesseesseesssesseessseossessseossesssessseesse Page 11 3 Prepara O eunn r E E E EE E N E EE emi tersterenes Page 14 3 1 N EES E E E E AEE E E E Page 14 3 2 Applying Electrodes Connecting LeadwireS c ssscsssssecsssssssssssssscsssssessssssssseassesecsssssssseassesecassssecsesssecseassesscseseseeseaees Page 14 3 3 Selection Care and Placement of the Electrodes es sssesesessseesseesseesseesseesseceecesecesecesscesscesseesseesseesseeoseeoseesserosereseeeseees Page 15 4 EEEIEE E g N E PAE N TA AEO EN TAA O EN AT A O EO tee Page 19 4 1 Sarung TNO a Py aep Page 19 4 2 Ending TPED y seee an E E E S E E EEO EE Page 20 5 Special Direct TENS FUNCTIONS sa ssessese tussccesaontatesaceeussatncssehaasncathes nesses ateccsucsve ayia toreeess a raS E aa ra a einet ae iaa ae saii Page 21 5 1 THOTA O penen2. If you have had medical or physical treatment for your pain consult your physician before using this device If your pain does not improve worsens or continues for more than five days stop using the device and consult your physician e Do not apply electrodes around the throat area or the anterior neck as this could cause severe muscle Spasms resulting in closure of your airway difficulty in breathing or adverse effects on heart rhythm or blood pressure Do not use the stimulator when in the bath shower or humid environment sauna hydrotherapy pools etc Do not use the stimulator while driving operating machinery or during any activity in which electrical stimulation can put you at risk of injury Stimulation should not be carried out over swollen infected and inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Stimulation should not be carried out over or in proximity to cancerous lesions Never carry out the first 5 minutes of any stimulation session standing Make sure you are seated or lying down In rare instances people of a nervous disposition may experience a vasovagal reaction This is a psychological response triggered by fear of the procedure Never connect the stimulation cables to an external power source due to risk of electric shock Sudden temperature changes can cause condensation to build up inside the stimulator To prevent this allow it to reach am
3. felt clearly Additionally icons may appear on the screen The keys are locked automatic function To prevent inadvertent activation the keys are automatically locked 10 seconds after the current intensity has been set The keys can be unlocked with e or by switching the device off The electric circuit is interrupted see chapter 6 What to do if Batteries need to be replaced When you see this icon replace the batteries as soon as possible Operation Information e You can interrupt therapy at any time with the ON OFF switch e If the stimulator is not used it switches off automatically after approx 5 minutes e When the therapy timer is activated the device switches automatically off at the end of the programmed interval The remaining therapy time is always indicated on the display e The program can only be changed when the intensity in both channels is 0 gt Direct TENS 4 2 Ending Therapy The default setting of the Direct TENS device is continuous operation If you want to end the therapy switch off the device with the ON OFF switch When the therapy timer is activated the device switches automatically off at the end of the programmed interval The remaining time is indicated at the top of the display Check that the Direct TENS stimulator is switched off before you remove the electrodes e If the therapy timer is not activated switch off the Direct TENS stimulator with the ON OFF swit
4. see also Figure 3 15 Recommended electrode placement Parallel Figure 3 12 Electrode application on the shoulder blade Indications e g General pain in the shoulder accompanied by headache Figure 3 14 Electrode application on the cervical spine Indications e g pain caused by intervertebral disk or vertebral arch joint problems cervical spine syndrome cervical syndrome tension headache migraine Recommended electrode placement Diagonal gt Direct TENS Figure 3 16 Electrode application on the knee joint Indications e g arthrosis of the knee joint gonarthrosis generalized pain in the knee TEP Recommended electrode placement Attach electrodes above superficial skin nerves or acupuncture points around the knee joint The electrode configuration may be parallel medial lateral or crosswise above or below the knee Figure 3 18 Electrode application on the back Indications Radicular radiating pain Recommended electrode placement Channel 1 proximal and distal to the pain area channel 2 above the nerve Figure 3 20 Electrode application for phantom limb pain version 1 Figure 3 17 Electrode application on the back Indications e g lumbar spine syndrome lumboischialgia pseudoradicular back pain Recommended electrode placement paraspinal proximal and distal to the pain area Channels 1 and 2 diagonal Figure 3 19 Electrode application on the back Indications Radicular rad
5. time more than approx 3 months e Liquids or foreign matter soil metal etc must not enter the stimulator If liquids have entered the stimulator or if it was accidentally immersed in liquid stop using it and return it to DJO for inspection gt Direct TENS 2 HOW DOES THE DIRECT TENS DEVICE FUNCTION Via electrodes attached to the skin Direct TENS sends electrical pulses to the nerves This will block the pain impulses Four electrodes two for each channel can be connected to the device Pain relief is most efficient during stimulation but the effect can last after the treatment Additionally the TENS treatment increases the blood circulation You can use Direct TENS at any time for pain relief and muscle relaxation Each therapy session should last 30 minutes minimum and can be continued for several hours This is where you connect the electrode lead wires This key are used to increase the current and thus the intensity of stimulation Increase the intensity very These keys are used to select one of the 13 programs carefully This key are used to decrease the intensit y This button is used to switch and to unlock the the stimulator on and off If locked keys during j ie no stimulation is started for operation approximately 5 minutes the stimulator automatically switches off to save batteries These are the quick select keys for choosing an indication related program gt
6. Direct TENS 2 1 TENS therapy principle Two pain theories play an important role in the application and parameter settings of the Direct TENS device e The Gate Control Theory by WALL and MELZACK 1965 The Endorphine Theory by ERIKSON and SJ LUND 1979 According to the Gate Control Theory weak TENS impulses block the pain impulses travelling to the brain sensor stimulation ERIKSON and SJOLUND found that strong TENS impulses increase the release of internal substances e g endorphins that also alleviate pain motor stimulation Theory Gate Control Theory Endorphin Theory Intensity Low light tingling High just bearable Impulse Width Short e g 100 us Long e g 250 us Frequency 100 Hz 2 10Hz For easier operation intensity and pulse width are combined in Direct TENS low intensity short pulse width high intensity long pulse width gt Direct TENS 2 2 DESCRIPTION OF THE PROGRAMS AND THE CORRESPONDING INDICATIONS Program Stimulation Frequency Hz General Advantages Indications Kaada TENS similar to acupuncture 1 impulse every 2 seconds 0 5 Ideal for sensitive people Supports acupuncture treatment Double pulse at 20 Hz Cervical spine Muscle relaxation pulse separation 3 ms syndrome by double pulses O Tense muscles High frequency 1000 Hz Acute strong back Strong analgesia pain lumbar spine p4 Brief very intensive TENS treat
7. EEE N E E E E E E Page 21 5 2 Factory Defaults Settings es cascasiecvsessisceiecstsenantecssanctnveenstogucerecsnsnanteessascssasionsavdscasadversseseaetsnyeqconton le yatalerresttinaeneta aa eaenayenien Page 21 6 WE MOOG aer e E ORE E EE E E AE Page 22 7 Care Storage Battery Replacement Disposal cccssscsssssessssssecscsssesecsssssssscsssesscsssssscsesssecscassesscsesssecseaesesscassesecseaees Page 23 8 Ordering Information Specifications e ssessesesseessseesseesseesseesseesseesseesseeoseesseeeseeeseceseceseceseeesseesseesseesseessresseesseesseesseeoseesseeos Page 24 8 1 Information related to electromagnetic compatibility EMC ssseesssesssseesseessseessseesssesssseosseeosseeosseessseonsseosserosseees Page 24 gt Direct TENS QUICK START GUIDE 1 Insert batteries 2 Attach belt clip and close battery compartment 4 Apply the electrodes The electrode placement depends on the indication see also chapter 2 2 page 11 5 Connect the electrode leadwire to the device gt Direct TENS QUICK START GUIDE 6 Switch the therapy unit on 7 Select a program only possible when intensity 0 The program depends on the indication to treat see also chapter 2 2 page 11 OR 8 9 After approx 10 seconds the keys are automatically locked a to prevent the treatment parameters from being changed inadvertently To unlock the keys press either C key channel 1 or 2 10 To term
8. Voltage Up to a resistance of 1000 Centre Europ en de Fret ohms 64990 Mouguerre Prance Output Intensity 0 60 adjustable in 0 5 Phone 33 0 5 59 52 86 90 steps Fax 33 0 5 59 52 86 91 Maximum Output 40 mA 1000 ohms 250 E mail sce cial DJOglobal com Us Internet www DJOglobal eu Waveform Asymmetrical biphasic ed Square impulse 8 1 Information related to electromagnetic o5 100047 compatibility EMC Frequency Range 0 5 1000 Hz Impluse Duration Determined by intensity The Direct TENS is designed to be used in typical setting 0 250 Us domestic or clinical environments and approved Power Supply 2 x 1 5 V AA disposable according to the EMC safety standard of EN 60601 1 2 batteries or This device emits very low levels in the radio frequency 2 x 1 2 V AA rechargeable RF interval and is therefore not likely to cause any batteries interference with nearby electronic equipment radios Current consumption 50 mA computers telephones etc for 1 channel 200 us impulse duration 100 Hz The Direct TENS is designed to withstand foreseeable om 40V disturbances originating from electrostatic discharges mains supply magnetic fields or radio frequency transmitters such as mobile telephones Ambient conditions Temperature 10 C to 40 C operation Relative humidity 30 75 no condensation Atmospheric pressure 700 to 1060 hPa For more detailed information regarding electromagnetic emission and i
9. a prolonged period of time more than approx 3 months Battery Replacement Use only Alkaline batteries 15 A LR6 size AA 1 5 Volt or NiMH rechargeable batteries size AA 1 2 Volt rechargeable batteries and charger not provided e Switch off the Direct TENS device e Turn the belt clip 90 to the right see also section 3 1 e Push the battery cover down then up see also section 3 1 e Insert the batteries Observe the correct polarity see also section 3 1 e Reinstall the battery cover and close the compartment e Dispose of the old batteries observing the local regulations Disposal at the End of Its Service Life The symbol AME indicates that the waste of electrical and electronic equipment must not be disposed as unsorted domestic waste and must be collected separately Please contact DJO for information about the possible recycling of the product or comply with your local regulation gt Direct TENS 8 ORDERING INFORMATION SPECIFICATIONS Ordering Information Electrodes used up Questions about the product We at DJO would be happy to help To avoid wrong deliveries please indicate the part numbers when ordering products PartNumber Product 42190 Electrodes Square 5x5 cm Durastick Wire pkg of 4 electrodes 42191 Electrodes Rectangular 5x9 cm Durastick Wire pkg of 4 electrodes 193068 100 Lead wire 100cm 40 inches To reorder please contact Specifications DJO France Constant
10. agnosed Biocompatibility Those parts of the Direct TENS that come into contact with the user when the device is used as intended are designed to fulfil the biocompatibility requirements of the applicable standards gt Direct TENS Warnings Magnetic and electrical fields are capable of interfering with the proper performance of the device Do not use the Direct TENS device in the vicinity of equipment that emits high levels of electromagnetic radiation such as X ray equipment MRI devices radio systems and mobile telephones These devices may affect the Direct TENS output power Keep the device away from such equipment and verify its performance before use section Treatment Not for use in presence of shortwave therapy device Disconnect the Direct TENS stimulation electrodes before using electrosurgical equipment or defibrillators Otherwise skin burns may be caused below the electrodes and the Direct TENS device may be destroyed Avoid the simultaneous use of Direct TENS and electronic patient monitoring systems Direct TENS may interfere with the proper functioning of these systems compromising the monitoring quality Do not use more than one stimulator at a time Avoid stimulation in the vicinity of your heart unless approved by your physician Keep the stimulator out of reach of children If you are in the care of a physician consult your physician before using this device
11. bient temperature before use Never use the electrodes contra laterally i e do not use two poles connected to the same channel on opposite segments of the body Stimulate with precaution while treating angina pectoris and the thoracic region on patients with cardiac arrhythmia gt Direct TENS Caution User s hazard and comfort e Inspect the stimulator and its accessories for integrity before use If you detect signs of damage do not use the stimulator e Use only original accessories electrodes cables e Do not use the stimulator during sleep e Do not open the battery compartment while the stimulator is operating e Use caution if you have a tendency to bleed internally such as following an injury or fracture e Consult your physician prior to using the device after a recent surgical procedure because stimulation may disrupt the healing process e Always switch off the stimulator before disconnecting any stimulation cables during a session e TENS is a symptomatic treatment and as such suppresses the sensation of pain that would otherwise serve as a protective mechanism TENS devices have no curative value e Use caution if stimulation is carried out over areas of skin that lack normal sensation e Attach the electrodes in such a way that their entire surface is in contact with the skin Equipment damage e Remove the batteries from the Direct TENS device if it is not used for a prolonged period of
12. ch e Remove the electrodes very carefully Do not pull on the leadwires but on the electrode e Reattach the electrode to its protective paper Be sure to attach the electrode to the side marked on not to the side marked no e Disconnect the electrodes from the leadwire e Clean the skin with a mild soap solution e Electrodes no longer fit for use can be disposed of with the normal domestic waste gt Direct TENS 5 SPECIAL DIRECT TENS FUNCTIONS 5 1 Therapy Timer The Direct TENS stimulator comes with a therapy timer function When the timer is activated the remaining therapy time appears on the display When this interval has elapsed the device switches off automatically You can set therapy times of e 1 to 59 minutes in 1 minute increments 1 to 24 hours in 30 minutes increments e Continuous operation displayed as CONT this is the default setting the timer is not activated Follow these steps to activate the timer e Press the quick select program key low back hip and hold it depressed e Then press the ON OFF key to switch the device on e The display indicates Time and the currently set therapy time default setting CONT e Press the intensity control keys for channel 2 to set the therapy time With you select a longer time with KJ a shorter time Go back to 00 00 to get the Continuous mode CONT To save the timer settings turn off th
13. e electrodes will be reattached to the protective paper after use and stored in the bag see also 3 3 2 Care of the Electrodes e Carefully apply the electrodes on the skin see also 3 3 3 Electrode Placement e Connect the electrode leadwire s to the Direct TENS device Figure 3 6 Figure 3 1 Turning the belt clip Figure 3 2 Opening the battery compartment Figure 3 3 Inserting the batteries Figure 3 4 Removing attaching the belt clip Figure 3 5 Connecting the electrode leadwire to the electrodes Figure 3 6 Connecting the electrode leadwire to the device gt Direct TENS 3 3 Selection Care and Placement of the Electrodes 3 3 1 Electrode Selection Use large electrodes e g 50 x 90 mm to be purchased separately for large body areas e g back leg and for general conditions of pain Use small electrodes e g 50 x 50 mm for small body areas e g face hand and for deep local pain 3 3 2 Care of the Electrodes When properly handled and maintained the supplied electrodes can be used 20 times or more Important for a long service life e Clean the skin application sites with mild soap water before attaching the electrodes After cleaning thoroughly rinse with water and dry the skin carefully e Dry electrodes with poor adhesion can be reconditioned as follows apply a small quantity of water to the adhesive surface with your finger tip e If you face bad c
14. e stimulator When you turn the stimulator on again the timer setting you saved is displayed 5 2 Factory Defaults Settings e Hold the program selection key depressed e Then press the ON OFF key to switch the device on e The display shows DATA 000 000 flashing e Next press the two intensity decrease keys r simultaneously for channels 1 and 2 to reset the device to the factory defaults All stored data will be deleted The timer function is deactivated The program lock is deactivated The frequency for all programs is reset to the respective default value Program 9 is selected The initial screen is displayed gt Direct TENS 6 WHAT TO DO IF the stimulation feels unpleasant or different from previous sessions e Check whether The device settings were changed The electrodes are correctly placed and applied on the skin Electrodes with poor adhesion must be replaced The skin is irritated the stimulation is weak or not felt e Check whether The electrodes are properly applied to the skin Electrodes with poor adhesion must be replaced The battery replacement symbol is displayed and the batteries need to be replaced see the Battery Replacement section in chapter 7 The electric circuit interrupted icon is displayed This icon appears when the resistance between electrode and skin is too high Reasons may be a poor electrode attachment or an interrup
15. iating pain alternative Recommended electrode placement Channel 1 proximal and distal to the pain area channel 2 above the nerve Figure 3 21 Electrode application for phantom limb pain version 2 gt Direct TENS 4 TREATMENT 4 1 Starting Therapy e Switch the stimulator on Once switched on the display will briefly show the software version A functional test where all display indicators appear for a short time is performed The initial screen appears next Figure 4 2 When the initial screen is displayed the device has successfully passed the functional test If the letter E is displayed instead of the initial screen the stimulator is defective and must be replaced Do not use this stimulator any more On the initial screen you will see The remaining stimulation duration The intensity of the stimulation indication of the selected intensity level adjustable in steps of 0 5 from 0 to 60 The selected program Figure 4 1 Switching the stimulator on m odd Duratiowofthe simali LILI AA Sec et e Select the program either via the quick select keys or via pure pure the program selection keys i i i pelea Died Increase the stimulation intensity for a channel Ol d P g Stimulation Intensty 1 or 2 by pressing the corresponding key Figure 4 2 Initial screen Increase the intensity with great care and in small increments Select a level which causes a pleasant sensation that is
16. inate the treatment simply turn off the device with the ON OFF key When the therapy timer is activated the stimulator switches automatically off at the end of the programmed interval Note The Belt Clip can be attached or removed as required You can find the procedure to attach remove the belt clip on page 14 chapter 3 1 gt Direct TENS GENERAL INFORMATION e The product Direct TENS bears the CE marking CE 0473 Notified Body AMTAC Certification Services Limited showing that it complies with the Council Directive 93 42 EEC as amended concerning medical devices and fulfils the essential requirements of Annex of this directive It has an internal power source and is classified as Ila equipment MDD e The device has a type BF applied part e The device fulfils the requirements of the standard EN 60601 1 Medical electrical equipment Part 1 General requirements for safety as well as the immunity requirements of the standard EN 60601 1 2 Electromagnetic compatibility medical electrical equipment e This manual is an integral part of the device and should be kept near the device at all times Close observance of the information given in this manual is a prerequisite for using the device as intended and for correct operation to ensure user s safety Please note that information pertinent to several chapters is given only once Therefore carefully read the manual once in its entirety e Using the device for pu
17. ment Bi modal Channel 1 Tension headache Simultaneous treatment 100Hz with high and low Channel 2 4Hz Neck back pain frequency Radiating pain In 2 channel mode channel 1 stimulation is superimposed on the low frequency stimulation in channel 2 Burst with alternating work and Work 100Hz Tense muscles Easily tolerable stimulation rest phases of 3 and 2 seconds Rest OHz for chronic pain conditions respectively Amputation stump phantom limp Sensory as well as motor pain stimulation Herpes zoster Reflex sympathetic dystrophy RSD Work 100Hz See program 5 Similar to program 5 but channels 1 and 2 alternating Similar to program 5 but channels 1 and 2 alternating and longer work rest times 6 seconds respectively Rest OHz 100 Lumbar back pain Similar to massage Intensity decreases 40 in 0 5 second intervals Joint pain Effects both on the sensory and on the motor level Avoids habituation gt Direct TENS Program Stimulation Frequency Hz General Advantages Indications Chronic pain Avoids habituation resisting therapy Random modulation 8 Random modulation of intensity and frequency down to 50 of set intensity and frequency modulation between 8 different frequencies 2 150 Hz Sensory as well as motor stimulation 2 150 Standard TENS Fast pain relief in acute pain conditions Continuo
18. mmunity please contact DJO Ambient conditions Temperature 10 C to 40 C storage transport Relative humidity 30 75 no condensation Atmospheric pressure 500 to 1060 hPa Dimensions HxWxD 110 x 70 x 30 mm Weight 165 g including batteries gt Direct TENS You have more questions Get in touch with us DJO LLC 1430 Decision Street 92018 Vista CA USA Phone 1 800 336 6569 Fax 1 800 936 6569 a www DJOglobal eu Y Empi a DJO brand
19. n this manual Other uses of the stimulator are not permitted Indications e Direct TENS can be used to alleviate different types of acute and chronic pain such as e Joint pain e g knee hip arthrosis e Chronic pain originating in the spine e Degenerative diseases of the musculoskeletal system e Tension headache e Radiating pain e g back pain cervicobrachial syndrome e Amputation stump phantom limb pain Pain from rheumatic diseases Contraindications Do not use Direct TENS in the following situations e If you have an implanted demand pacemaker intracardiac defibrillator or other active implants e Undiagnosed pain until the cause has been ascertained e Epilepsy e During pregnancy unless approved by your referring gynaecologist Treatment should never be applied near the area of an implant such as cochlear pacemakers skeletal or electrical Do not apply stimulation in the vicinity of metal Remove jewellery body piercings buckles or any other removable metallic product or device in the area of stimulation Do not attempt to place electrodes on any part of the body not directly visible without assistance Do not stimulate at the front or side of the neck to avoid a drop in blood pressure Furthermore it is not permitted to attach electrodes to the head This device should not be used for symptomatic local pain relief unless diagnosis is established or unless a pain syndrome has been di
20. ontact with the skin or repeated open lead detection change the electrodes e Remove electrodes by pulling on their edges Do not pull on the leadwire After use reattach the electrodes to their protective paper Store the electrodes in their bags e Store the electrodes in a refrigerator if possible Do not store them in warm rooms e We recommend shaving skin sites where electrodes will be applied if very hairy Shaving irritates the skin Therefore wait 24 hours after shaving before you attach the electrodes Then you may start therapy e Do not leave the electrodes attached to your skin for a prolonged period of time Remove the electrodes after each use Apply the electrodes on different sites to avoid skin irritations For the same reason clean the skin thoroughly after treatment If you observe skin irritations consult your physician and suspend therapy until clarification gt Direct TENS 3 3 3 Electrode Placement If your physician showed you the best application points we recommend that you use them Otherwise figures 3 7 to 3 11 show possible electrode configurations Figures 3 12 to 3 21 show electrode configurations for different indications However check that the configuration is appropriate and adapt if necessary Depending on the site and cause of the pain electrodes may be placed on acupuncture points or in specific dermatomic areas In other situations we recommend applying the electrodes a
21. program 13 Changing the frequency 1 Turn on the device and select one of the programs 9 to 13 2 Simultaneously press the program selection keys and release them 3 Using the intensity keys choose the set frequency 4 Press the two program selection keys again or switch the device off to save the settings gt Direct TENS 3 PREPARATION 3 1 Inserting Batteries e Adjust the belt clip until it points to the right at a 90 angle Figure 3 1 e Push the battery cover down and lift Figure 3 2 e Insert the batteries as shown in the illustration Observe the correct polarity see label in battery compartment Figure 3 3 e Reinstall the battery cover and close the compartment Notes e Use only new AA type batteries e You may or may not use the belt clip as preferred Open the battery compartment If you wish to remove the clip pull it out towards the left If you wish to attach the clip push it into the holder from the left When you close the battery compartment the belt clip is automatically secured onto the device Figure 3 4 e Dispose of the worn out batteries in accordance with local and national regulations 3 2 Applying Electrodes Connecting Leadwires e First connect the electrode leadwires to the electrodes Figure 3 5 The colour of the electrode connectors is irrelevant e Peel the electrodes off their protective paper Keep the protective paper and the bag because th
22. round the center of the pain at a distance of 3 to 5 cm where you feel the pain Caution Failed stimulation skin irritation malfunction e Use only the original electrodes supplied with the system and replacement electrodes provided by DJO e Attach the electrodes on intact skin only avoid skin areas with reduced sensitivity e Ensure that good contact is achieved between electrode and skin Although the stimulator switches off when the electrode skin contact resistance is too high poor electrode techniques may cause skin irritations under the electrodes Notes e Concerning the choice of indication specific programs please refer to the Notes in section 2 2 e Before applying the electrodes observe the care instructions in section 3 3 2 e If appropriate you can also use only two electrodes one channel Figure 3 7 Bilateral placement Figure 3 8 Diagonal placement e g cervical dysfunction e g shoulder or knee oo B wae Figure 3 9 Parallel placement e g on scarred tissue Figure 3 10 Bracket position gt Direct TENS Figure 3 11 Electrode application in pain conditions involving the shoulder and shoulder blade Figure 3 13 Electrode application on the shoulder joint Indications e g General pain in the shoulder bursitis Figure 3 15 Electrode application on the cervical spine Picture to be replaced Indications e g for conditions of pain in the muscles or soft parts
23. rposes other than those described in this manual is not permitted e The safety information given in this manual is classified as follows Warning Caution N N Indicates a hazard If not avoided the hazard can Indicates a potential hazard If not avoided the result in death or serious injury hazard may result in minor injury and or product property damage e No part of this manual may be reproduced without written permission from DJO e Key to symbols used on the equipment Caution consult accompanying documents pN Patient part type BF Body floating Device complies with the Council Directive 93 42 EEC about medical devices tested and approved by AMTAC Certification Services Limited Do not dispose with unsorted domestic waste Manufacturer MDSS GmbH DJO LLC Schiffgraben 41 1430 Decision Street 30175 Hannover 920181 Vista CA EC Germany USA Phone 49 51 1 6262 8630 Phone 1 800 336 6569 Fax 49 511 6262 8633 Fax 1 800 936 6569 gt Direct TENS 1 POINTS TO NOTE BEFORE USE Intended Use Direct TENS is a transcutaneous electrical nerve stimulator Transcutaneous electrical nerve stimulation TENS uses electrical pulses that are delivered through the skin to the cutaneous outer and afferent deeper nerves to alleviate pain Contrary to medication and cream used on the skin there are no known side effects resulting from TENS therapy Use Direct TENS only as described i
24. ted electric circuit When the electric circuit is interrupted the intensity drops to 0 In this case check whether the electrode leadwire is correctly connected to the device and whether the electrodes are properly connected If the problem persists the electrode leadwire is probably broken and must be replaced the letter E is displayed instead of the initial screen In this case the device is defective and must not be used Return the device to DJO for replacement the device cannot be switched on e Check whether The batteries are inserted The batteries are correctly inserted The batteries are charged gt Direct TENS 7 CARE STORAGE BATTERY REPLACEMENT DISPOSAL Care Maintenance e Switch off the device before cleaning Then clean it with a moist cloth Liquids must not enter the device If necessary apply a drop of dishwashing liquid to remove stubborn stains e Do not use abrasive substances or other domestic cleaning agents e To clean the leadwire disconnect it from the device and wipe it down with a moist cloth Never immerse the leadwire in liquids e Direct TENS does not require regular maintenance Storage e Always store the Direct TENS stimulator in its original pouch e Keep the device and the pouch out of reach of children e Store the device in a cool and dry place Do not expose the device to direct sunlight e Remove the batteries from the device if it is not used for
25. us Fast acceptance of therapy Different programmable frequencies e g 100 Hz Standard 2 Hz Similar to acupuncture Burst with alternating work and Long term Classic burst rest phases of 2 seconds each treatment Pleasant form of stimulation Reduces muscle fatigue Prolongs battery life Mixed frequency Phase 1 Strong pain Pleasant stimulation also at 2 150 Hz higher intensities Phase 2 50 Permanent stimulation of of work freq the deep afferent nerve fibers with modulated muscle activation Multi modulation 2 150 Chronic pain Avoids habituation Simultaneous sensory and motor stimulation Fixed modulation pattern for intensity and frequency 2 150 Chronic pain Avoids habituation Simultaneous sensory and motor stimulation Intensity and frequency modulation according to fixed pattern but diametrically opposed i e when the intensity increases the frequency decreases and vice versa Simple modulated pulse SMP intensity modulation diametrically opposite to frequency modulation according to a fixed 12 second cycle gt Direct TENS Frequency Selection for Programs 9 to 13 2 60 Hz 60 150 Hz Preferred in the treatment of chronic pain Preferred in the treatment of acute pain With the standard TENS programs 9 to 13 the frequency can be adapted manually Possible settings 2 10 20 40 60 100 125 150 Hz Factory defaults for programs 9 to 12 is 100 Hz and 125 Hz for
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