This manual is valid for the - TENS Machines & Pain Relief Blog
Contents
1. gt 95 dip in UT for 5 sec Power 3 A m 3 A m Power frequency frequency magnetic fields 50 60Hz should be at levels magnetic characteristic of a field IEC typical location in a 61000 4 8 typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Immunity IEC 60501 Compliance _ Electromagnetic test test level level environment guidance Portable and mobile RF Communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms 3 Vrms RF IEC 150 kHz d 3 5 yp 61000 4 6 to 80 MHz v1 Radiated 3 V m80 3 Vim d 3 51 yp 80MHz RF IEC MHz to bead VP 45 800MHz 61000 4 3 2 5 GHz ep 800MHz ae ET179 to 2 5MHz Where P is the maximum output power rating of the transmitter In watts W according to the Transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic si2. i Treatment Therapeutic Frequency Pulse Wide Waveform time Min part program Hz us default NECK Modulation 60 100 100 150 30 Pulse rate SHOULDER modulation 800 100 260 30 MID BACK Pulse rate 400 4150 100 30 modulation Frequency LOW BACK modulation 50 80 260 30 ELBOW Continuous 100 100 30 WRIST Continuous 100 260 30 Pulse rate HIP modulation 100 150 200 30 Pulse width KNEE modulation 120 100 150 30 ANKLE Continuous 100 100 30 FOOT Modulation 60 100 100 160 30 6 CLEANING AND CARE 6 1 Tips for skin care To avoid skin irritation especially if you have sensitive skin follow these suggestions 1 2 3 4 5 6 7 8 Wash the area of skin where you will be placing the electrodes using mild soap and water before applying electrodes and after taking them off Be sure to rinse soap off thoroughly and dry skin well Excess hair may be clipped with scissors do not shave stimulation area Wipe the area with the skin preparation your clinician has recommended Let this dry Apply electrodes as directed Many skin problems arise from the pulling stress from adhesive patches that are excessively stretched across the skin during application To prevent this apply electrodes from centre outward avoid stretching over the skin To minimize pulling stress tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes When removing electro
3. Channel Intensity 4 8 Safety Lock Feature 4 9 Turn OFF 4 10 Low battery indicator 5 PROGRAMo ee readin tine Ea RHI OS A ES 21 6 CLEANING AND CARE sia coccestencees neata ainne a 22 6 1 Tips for skin care 6 2 Cleaning the device 6 3 Electrodes 6 4 Cleaning the Electrodes cords 6 5 Maintenance T TROUBLESHOOTING ci sisi c steele ir daca 26 8 STORAGE mm 9 BiIsSi ais immi mnmmmmavmrmmmmaiarirrnriri iriiririiririveh 28 10 ELECTROMAGNETIC COMPATIBILITY EMC TABLES 28 11 GLOSSARY OF SYMBOLS SS 12 WARRANTY osoena a ara a ea Eo Soluce dts 1 SAFETY INFORMATION 1 1 General LG SMART TENS stimulator is a portable electrotherapy device featuring Transcutaneous Electrical Nerve Stimulation TENS therapeutic device which is used for pain relief The stimulator sends a gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin The parameters of device are controlled by the buttons Its intensity level is adjustable according to the needs of patients 1 2 Medical background EXPLANATION OF PAIN Pain is a warning system and the body s method of telling us that something is wrong Pain is important without it abnormal conditions may go undetected causing damage or injury to vital parts of our bodies Even though pain is a necessary warning signal of trauma or malfunction in the body nature may have gone too far in its design Aside from its value in diagnosis long
4. LG SMART TENS 5 8 ee ee ea Output socket Adapter Receptacle LCD display Shows the operating state of the device 4 Increasing the output intensity of channel 1 Decreasing the output intensity of channel 1 Select the treatment time from 15 minutes 30 minutes 60 minutes and continuous Increasing the output intensity of channel 2 Decreasing the output intensity of channel 2 9 Therapeutic part program selection and stop treatment 10 Turn on or turn off the device 11 Belt Clip 12 The battery compartment cover 2 2 LCD Displa ANOaARWN re sate aE AA e oA iega eo ANCAQ IRAR 8 Display TENS therapeutic mode Lock function indicator Low battery indicator Display numbers of the treatment time Timer symbol Display numbers of the output intensity for channel 1 Display numbers of the output intensity for channel 2 Display therapeutic program by body part 3 1 Accessories 3 SPECIFICATION No DESCRIPTION QTY 1 TENS stimulator device 1 piece 2 Electrodes Leads 2 pieces 3 40mm x 40mm adhesive electrodes 4 pieces 4 9V Alkaline Battery type 6LR61 1 piece 5 Instruction Manual 1 piece 6 Carrying case 1 piece 3 2 Technical Information Channel Dual isolated between channels Power suppl 9 0 V Alkaline battery type 6LR61 Pply Adapter output 9 0Vdc 800mA optional o ti 5 C to 40 C 41 FH to 104 FH witha Fa
5. buildings used for 61000 3 2 domestic purposes Voltage fluctuations flicker Not emissions applicable IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Electromagnetic environment guidance Compliance Immunity IEC 60601 ME evel test test level Floors should be wood concrete or Electrostatic 6 kV ceramic tile If floors 6 kV discharge are covered with ESD IEC contact coritact synthetic material 61000 4 2 F i therelative humidity 8 kV air ia should be at least 30 2kV for Electrical Not applicable Mains power quality fast power supply should be that of a transient lines typical commercial burst IEC 1kV for or hospital 61000 4 4 _ input output environment lines Surge 1kV Not applicable Mains power quality IEC differential should be that of a 61000 4 5 mode typical commercial 2kV common or hospital mode environment Voltage dips lt 5 UT Not applicable Mains power quality short gt 95 dip in should be that of a interruptions UT for 0 5 typical commercial or and voltage cycle hospital environment variations on power supply 40 UT input lines 60 dip in IEC UT for 5 61000 4 11 Cycles 70 UT 30 dip in UT for 25 Cycles lt 5 UT
6. much as three to four times longer In others pain is only modified while stimulation actually occurs You may discuss this with your physician or therapist 1 3 Indication for use LG SMART TENS Stimulator should be used for the Symptomatic relief of chronic intractable pain acute post traumatic pain acute post surgical pain and arthritis pain MPORTANT SAFETY INFORMATION Read instruction manual before operation Be sure to comply with all Contraindications Warnings Cautions and Adverse reactions in the manual Failure to follow instructions can cause harm to user or device 1 4 Contraindications 1 This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed 2 This device should not be used when cancerous lesions are 3 4 5 6 8 9 10 a 1 5 present in the treatment area Stimulation should not be applied over swollen infected inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Electrodes must not be applied to sites that might cause current stimulation to flow through the carotid sinus region anterior neck or transcerebrally through the head Do not use this device if the patient has a demand type cardiac pacemaker or any implanted defibrillator This device should not be used over poorly enervated areas Epilepsy Serious arterial circulator
7. or repairs by unauthorized persons The user must not attempt any repairs to the device or any of its accessories Please contact the retailer for repair Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty Check the unit before each use for signs of wear and or damage Replace wear items as required 7 TROUBLESHOOTING If your device does not seem to be operating correctly refer to the chart below to determine what may be wrong Should none of these measures correct the problem the device should be serviced Stimulation is Problem Possible Cause Solution Displays fail Battery contact 1 Try fresh batteries to light up failure 2 Ensure batteries are inserted correctly Check the following contacts All contacts are in place All contacts are not broken Stimulation Electrodes weak or cannot 1 Dried out or Replace and feel any contaminated re connect stimulation 2 Placement Lead wires Old worn damaged Replace Intensity is too high Decrease intensity uncomfortable Electrodes are too close together Damaged or worn electrodes or lead wires Electrode active area size is too small Reposition the electrodes Replace Replace electrodes with ones that have an active area no less than 16 0cm 4cm 4cm Mayn t operate the device according to the manual Please check the manual before use Intermittent output Lead
8. wires 1 Verify connection is secure Insure firmly 2 Turn down the intensity Rotate lead wires in socket 90 If still intermittent replace lead wire 3 If still intermittent after replacing lead wire a component may have failed Call the repair department Some programs will seem intermittent This is expected Refer to the Program Program option in use Option Controls in the Operation section for a description of the program option Stimulation is ineffective Improper electrode and applicator placement Unknown Use the electrodes Reposition electrode and applicator Contact clinician Re position the electrodes If The skin becomes red and or you feel a stabbing pain on the same site every time The electrodes aren t stuck onto the skin properly at any time you feel pain or discomfort stop use immediately Ensure the electrode is stuck securely on the skin The electrodes are dirty The surface of the electrode was scratched Clean the electrode pads with a damp lint free cloth or replace new electrode pads Clean the electrode belt according the description in user manual Replace new electrode Output current stops during therapy The electrode pads come off the skin Turn off the device and stick the electrode pad firmly to the skin The cable is disconnected Turn off the device and connect the cable The pow
9. E I At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 11 GLOSSARY OF SYMBOLS Batch code Serial number Electrical devices are recyclable material and should not be disposed of with household waste after their useful life Help us to protect the environment and save resources and take this device to the appropriate collection points Please contact the organization which is responsible for waste disposal in your area if you have any questions Is Attention Read the operating instruction for use Type BF Applied Part Type of protection against electric shock Class Il Equipment Is D 12 WARRANTY Please contact your dealer in case of a claim under the warranty If you have to send in the unit enclose a copy of your receipt and state what the defect is The following warranty terms apply 1 The warranty period for device is one year from date of 2 3 purchase In case of a warranty claim the date of purchase has to be proven by means of the sales receipt or invoice Repairs under warranty do not extend the warranty period either for the device or for the replacement parts The following is excluded under the warranty All damage which has arisen due to improper treatment e
10. LG SMART TENS INSTRUCTION MANUAL LG SMART TENS This manual is valid for the LG SMART TENS Stimulator This user manual is published by Current Solutions LLC Current Solutions LLC does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice Amendments may however be published in new editions of this manual All Rights Reserved Rev V1 0 2011 A United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner Conformity to safety standards Current Solutions LLC declares that the device complies with following normative documents IEC60601 1 IEC60601 1 2 EC60601 2 10 IEC60601 1 4 1S010993 5 1S010993 10 ISO10993 1 TABLE OF CONTENTS i SAFETY INFORMATION ves ccdcccssaccatscuan etwanndonemantsraddteacehiebded 4 1 1 General 1 2 Medical background 1 3 Indication for use 1 4 Contraindications 1 5 Warnings Cautions Adverse Reactions 2 PRESENTATION j2ssisitsnsecancwctncenicatecsieedveveratpariberdslionssaeies 10 2 1 Front and Rear panel 2 2 LCD display 3 SPECIFICATION aparesis nae wien t chav tude EEEE EEEE 13 3 1 Accessories 3 2 Technical information 3 3 The waveforms of the stimulation programs 4cINSTRUCTIONIFOR USE siinon neoin EERE ENERE 15 4 1 Battery 4 2 Connect electrodes to lead wires 4 3 Connect lead wires to device 4 4 Electrode 4 5 Turn ON 4 6 Select the Therapeutic Program 4 7Adjust
11. ative stimulation settings and or electrode placements Once an acceptable placement has been achieved mark down the electrodes sites and the settings so the patient can easily continue treatment at home 4 5 Turn on Before using the device for the first time you are strongly advised to take careful note of the contraindications and safety measures detailed at the beginning of this manual Safety information as this powerful equipment is neither a toy nor a gadget In order to turn on the device press the button and then the operation page appears on the screen 4 6 Select the therapeutic part program LG SMART TENS Stimulator with 10 pre set programs the details please refer to Page 21 lt Programs gt The therapeutic part program can be selected by pressing the S button control The therapeutic part program indicator will flash after you selected Apply electrodes to the exact site indicated by your physician or therapist 4 7 Select the treatment time There are 4 choices available for the treatment time 15 min 30min 60min and continuous The treatment time can be selected by press T button 4 8 Adjust channel intensity Press the intensity control button 4 and to control the intensity output Slowly press the intensity button control until you reach the setting recommended by your physician or therapist Repeat for the other channel if both channels are to be used CAUTION 1 If the sti
12. bile RF communications equipment transmitters and the as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated m maximum output 150 kHz to 80 MHz 800 MHz power of 80 MHz to 800 MHz to 2 5 GHz transmitter af oD 3 5 ep A W d 5 yp a 32 vp a Lp V1 E1 E1 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the transmitter manufacturer NOT
13. des always remove by pulling in the direction of hair growth It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes Never apply electrodes over irritated or broken skin 6 2 Cleaning the device 1 2 3 Remove the battery from the device every time when you clean Clean the device after use with a soft slight moistened cloth In case of more extreme soiling you can also moisten the cloth with mild soapy water Do not use any chemical cleaners or abrasive agents for cleaning 6 3 Electrodes 1 Use the device only with the leads and electrodes provided by the manufacturer Use only the electrode placements and stimulation settings prescribed by your physician or therapist It is recommended that at minimum 40mm 40mm self adhering based square electrodes are used at the treatment area 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 Adhesive Pad Connector for inserting Lead wire Pin Reusable Self adhering electrodes To use these electrodes 1 2 3 Attach the electrode to the lead wire 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 Place the tacky surface to the prescribed skin area by pressing the
14. electrode firmly against the skin To remove your electrodes 1 Lift the corner of the electrode and gently remove it from the skin 4 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 It may be helpful to improve repeated application by spreading a few drops of cold water over the adhesive and turn the surface up to air dry Over Saturation with water will reduce the adhesive properties Between uses store the electrodes in the resealable bag in a cool dry place CAUTION Do not pull on the electrode wire Doing so may damage the wire and electrode Do not apply to broken skin The electrodes should be discarded when they are no longer adhering The electrodes are intended for single patient use only If irritation occurs discontinue use and consult your clinician Read the instructions for use of self adhesive electrodes before application Always use the electrodes with CE mark or are legally marketed in the US under 510 K procedure 6 4 Cleaning the Electrodes cords Clean the electrode cords by wiping them with damp cloth Coating them lightly with talcum powder will reduce tangles and prolong the life 6 5 Maintenance 1 Maintenance and all repairs should only be carried out by an authorized agency The manufacturer will not be held D responsible for the results of maintenance
15. er of the batteries has been Please replace them with new batteries exhausted amp 8 STORAGE 1 Fora prolonged pause in treatment store the device in a dry room and protect it against heat sunshine and moisture 2 Store the device in a cool well ventilated place 3 Never place any heavy objects on the device 9 DISPOSAL Used fully discharged batteries must be disposed of in a specially labeled collection container at toxic waste collection points or through an electrical retailer You are under legal obligation to dispose of batteries correctly Please dispose of the device in accordance with the legal obligation 10 ELECTROMAGNETIC COMPATIBILITY EMC TABLES Guidance and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagnetic environment specified below The customer or the user assures that it is used in such an environment Emissions A Electromagnetic environment t st Compliance guidance The device uses RF energy only for its internal function Therefore RF its RF emissions are very low and emissions Group 1 are not likely to cause any CISPR 11 interference in nearby electronic equipment RF emissions CISPR11 The device is suitable for use in all establishments other than domestic and those directly Harmonic connected to the public low emissions Not voltage power supply network IEC applicable that supplies
16. g nonobservance of the user instruction All damage which is due to repairs or tampering by the customer or unauthorized third parities Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre Accessories which are subject to normal wear and tear Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim CURRENT SOLUTIONS Manufactured for Current Solutions LLC 3814 Woodbury Drive Austin TX 78704 Ph 800 871 7858 www currentsolutionsnow com
17. il Ing relative humidity of 30 75 atmospheric onaikons pressure from 700 to 1060 Hpa 10 C to 50 C 14 FH to 122 FH with a Siaor relative humidity of 10 90 atmospheric pressure from 700 to 1060 Hpa Dimensions 4 5x2 55x0 9 inches L W H Weight 0 28 Ibs With battery Tol There may be a 5 tolerance of all setting OSEE and 10 tolerance of output of intensity Electrode The amplitude level will be reset to OmA Detection when the amplitude level is 12mA or Function greater and an open circuit at either channel is detected Timer 15 30 60 minutes and continuous Technical specifications Waveform Mono phase square pulse wave Pulse Adjustable 0 105mA peak at 1000 ohm amplitude Load each channel 1mA Step Pulse Width From 100 to 260us microseconds Pulse Rate From 50 to 150 Hz 3 3 The waveforms of the stimulation programs Pulse Width Modulation Cycle time Pulse Rate Modulation Cycle time Modulation Pulse width and Pulse rate WU WL Cycle time D 4 INSTRUCTION FOR USE 4 1 Battery 4 1 1 Check Replace the battery Over time in order to ensure the functional safety of device changing the battery is necessary 1 Slide the battery compartment cover and open 2 Insert the 9V battery into the battery compartment 3 Make sure you are installing the battery properly Be sure to match the positive and negative ends
18. lasting persistent pain serves no useful purpose Pain does not begin until coded message travels to the brain where it is decoded analyzed and then reacted to The pain message travels from the injured area along the small nerves leading to the spinal cord Here the message is switched to different nerves that travel up the spinal cord to the brain The pain message is then interpreted referred back and the pain is felt EXPLANATION OF TENS Transcutaneous Electrical Nerve Stimulation TENS is a non invasive drug free method of controlling pain TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception TENS does not cure any physiological problem it only helps control the pain TENS does not work for everyone however in most patients it is effective in reducing or eliminating the pain allowing for a return to normal activity HOW TENS WORKS There is nothing magic about Transcutaneous Electrical Nerve Stimulations TENS TENS is intended to be used to relieve pain The TENS unit sends comfortable impulses through the skin that stimulate the nerve or nerves in the treatment area In many cases this stimulation will greatly reduce or eliminate the pain sensation the patient feels Pain relief varies by individual patients mode selected for therapy and the type of pain In many patients the reduction or elimination of pain lasts longer than the actual period of stimulation sometimes as
19. mulation levels are uncomfortable or become uncomfortable reduce the stimulation intensity to a comfortable level and contact your medical practitioner if problems persist 2 If the electrodes no placed firmly on skin or the device has not connected on the electrodes the stimulator s output intensity surpasses 12mA the intensity will enulls automatically 3 You can press S button to stop the treatment if you want and the device enter into waiting mode If the button is locked you should press only one of the Y button first 4 9 Safety Lock Feature The Safety Lock Feature automatically activates after there is no operation in the panel for 30 seconds by locking out the ability to press the buttons This is a safety feature to prevent accidental changes to your settings and to prevent accidental increases to the intensity levels You can press either one of the Y button to unlock the device 4 10 Turn OFF If you want to turn off the device Press button is OK CAUTION If there is no operation in the panel for 2 minutes in the waiting state the device will be turns off automatically 4 11 Low battery indicator A battery symbol is shown on the display when the battery is almost empty As long as the stimulator is working normally you can continue the treatment When stimulation feels weaker than usual or the stimulator turns off it is time to replace the new battery 5 PROGRAMS
20. ode packing to maintain optimal stimulation and to prevent skin irritation 4 4 2 Place electrodes on skin Apply electrodes to the exact site indicated by your physician or therapist before applying electrodes be sure the skin surface over which electrodes are placed is thoroughly cleaned and dried Make sure the electrodes are placed firmly to the skin and make good contact between the skin and the electrodes Place the electrodes over the skin attach them properly firmly and evenly CAUTION 1 Before applying the self adhesive electrodes it is recommended to wash and degrease the skin and then dry it 2 Do not turns on the device when the self adhesive electrodes are not positioned on the body 3 Never remove the self adhesive electrodes from the skin while the device is still turns on 4 It is recommended that at minimum 40mm x 40mm self adhering based square electrodes are used at the treatment area 4 4 3 Electrode placement The placement of electrodes can be one of the most important parameters in achieving success with therapy Of utmost importance is the willingness of the physician to try the various styles of electrode placement to find which method best fits the needs of the individual patient Every patient responds to electrical stimulation differently and their needs may vary from the conventional settings suggested here If the initial results are not positive speak to your physician about altern
21. of the battery to the marking in the battery compartment of the device 4 Press and pull down following the direction of the arrow indicated on the photo 5 Replace the battery compartment cover and press to close 6 If replace the battery you should slide the battery compartment cover and open Pull up the battery following the direction of the arrow indicated on the photo And insert the 9V battery according to the above step 2 to 5 4 1 2 Disposal of battery Spent batteries do not belong in the household waste Dispose of the battery according to the current federal state and local regulations As a consumer you are obligated by law to return spent battery CAUTION 1 Battery may be fatal if swallowed Therefore keep the battery and the product out of the range of children if a battery was swallowed consult a physician immediately DB 2 3 4 5 If a battery has leaked avoid contact with skin eyes and mucus membranes Rinse the affected spots with lots of clear water immediately and contact a physician right away Battery may not be charged dismantled thrown into fire or short circuited Protect battery from excess heat Take the battery out of the product if they are spent or in case you no longer use the article This prevents damage caused by leaking battery Always replace the same type battery 4 2 Connect electrodes to lead wires Insert the lead wire connector into electrodes c
22. onnector standard 0 08 inch female connection Make sure no bare metal of the pins is exposed Connection Cables Transparent Film CAUTION Always use the electrodes with CE mark or which are legally marketed in the US under 510 K procedure 4 3 Connect lead wires to device 1 Before proceeding to this step be sure the device is completely turns OFF 2 The wires provided with the system insert into the jack sockets located on top of the device 3 Holding the insulated portion of the connector push the plug end of the wire into one of the jacks see drawing one or two sets of wires may be used 4 This device has two output receptacles controlled by Channel 1 and Channel 2 at the top of the unit You may choose to use one channel with one pair of lead wires or both channels with two pairs of lead wires Using both channels gives the user the advantage of stimulating two different areas at the same time CAUTION Do not insert the plug of the patient lead wire into any AC power supply socket 4 4 Electrode 4 4 1 Electrode options The electrodes are disposable and should be routinely replaced when they start to lose their adhesive nature If you are unsure of your electrode adhesive properties order new replacement electrodes Replacement electrodes should be re ordered through or on the advice of your physician to ensure proper quality Follow application procedures outlined in electr
23. re 11 Do not place electrodes on your head or at any sites that may cause the electrical current to flow transcerebrally through the head Patients with heart disease epilepsy cancer or any other health condition should not use this device without first consulting a physician 13 Some patients may experience skin irritation or 10 a 12 YS hypersensitivity due to the electrical stimulation or silicone rubber If rash develops or pain persists discontinue use and consult a doctor 14 Electrode placement and stimulation settings should be based on the guidance of prescribing practitioner 15 Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain afflicted patients 16 Isolated cases of skin irritation may occur at the site of the electrode placement following long term application If this occurs discontinue use and consult your physician 17 The electrodes are only to be placed on healthy skin Avoid skin irritation by ensuring that good contact is achieved between electrodes and skin If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist 19 This device should not be used while driving operating machinery close to water or during any activity in which involuntary muscle contractions may put the user at undue risk of injury 20 Never
24. te survey a should be less than the compliance level in each frequency range b ta NOTE I At 80 MHz ends 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than Vi V m Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mo
25. use cardiac arrhythmias Stimulation should not take place while the user is connected to high frequency surgical equipment it may cause burn injuries on the skin under the electrodes as well as problems with the stimulator 11 Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment since this may affect the output power of the stimulator 12 Never use in environments with high humidity such as in the bathroom or when having a bath or shower 13 Caution should be used in applying electrical stimulation to patients suspected of having heart disease Further clinical data is needed to show there are no adverse results 14 Never use near the heart Stimulation electrodes should never be placed anywhere on the front of the thorax marked by ribs and breastbone but above all not on the two large pectoral muscles Here it can increase the risk of ventricular fibrillation and lead to cardiac arrest 15 Electrodes should not be placed over the eyes in the mouth near the genitals or internally 16 Never use on the areas of the skin which lack normal sensation 17 Apply the electrodes to clean dry and unbroken skin only 18 Keep electrodes separate during treatment electrodes in contact with other could result in improper stimulation or skin burns 19 Keep the stimulator out of reach of children 20 Consult your doctor if you are in any doubt whatsoever 10 a CAUTIONS 1 Federal la
26. use the device in rooms where aerosols sprays are used or pure oxygen is being administered 21 Do not use it near any highly flammable substances gases or explosives 22 Do not use this device at the same time as other equipment which sends electrical pulses to your body 23 Do not confuse the electrode cables and contacts with your headphones or other devices and do not connect the electrodes to other devices 24 Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel 25 Inspect Applicator cables and associated connectors before each use 26 Turn the device off before applying or removing electrodes 27 Electrical stimulators should be used only with the leads and electrodes recommended for use by the manufacturer 28 This device has no AP APG protection Do not use it in the 18 lt presence of explosive atmosphere and flammable mixture ADVERSE REACTIONS 1 Skin irritation from the electrode gel and electrode burns are potential adverse reactions If skin irritation occurs discontinue use and consult your physician 2 If the stimulation levels are uncomfortable reduce the stimulation Intensity to a comfortable level and contact your physician if problems persist 2 PRESENTATION 2 1 Front and Rear Panel AL OH O pe ee aige 1 Op te Gere cg 3
27. w USA restricts this device to sale by or on the order of a physician 2 For single patient use only 3 Keep yourself informed of the contraindications 4 This stimulator not intended for unattended personal use by patients who have noncompliant emotionally disturbed dementia or low IQ 5 Read understand and practice the warnings cautions and operating instructions Know the limitations and hazards associated with using any device Observe the precautionary and operational decals placed on the unit Always follow the operating instructions prescribed by your healthcare practitioner 6 The instruction of use was listed any improper use may be dangerous 7 Donotuse this device for undiagnosed pain syndromes until consulting a physician 8 Patients with an implanted electronic device such as a cardiac pacemaker implanted defibrillator or any other metallic or electronic device should not use this device without first consulting a doctor 9 Stimulation delivered by this device may be sufficient to cause electrocution Electrical current of this magnitude must not flow through the thorax or across the chest because it may cause a cardiac arrhythmia Do not place electrodes on the front of the throat as spasm of the Laryngeal and Pharyngeal muscle may occur Stimulation over the carotid sinus neck region may close the airways make breathing difficult and may have adverse effects on the heart rhythm or blood pressu
28. y problems in the lower limbs Abdominal or inguinal hernia Do not use this device if you have heart disease without consulting your physician Warnings Cautions and Adverse Reactions WARNINGS 1 2 3 4 5 6 7 This device should be used only under the continued supervision of a licensed physician The long term effects of chronic electrical stimulation are unknown Electrical stimulation devices do not have any curative value TENS is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism Safety has not been established for the use of therapeutic electrical stimulation during pregnancy Do not use during pregnancy unless directed by your physician Electrical stimulation is not effective for pain of central origin Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when electrical stimulation is in use Stimulation should not be applied over the carotid sinus nerves particularly in patients with a known sensitivity to the carotid sinus reflex 8 Stimulation should not be applied over the anterior neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing 9 Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may ca
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