SELECT Combo INSTRUCTION MANUAL
Contents
1. Ali Eil ie outside of the box will be flashing eS 2 Set Cycle Time Optional Cycle time is adjustable from 5 to 30 seconds Only modulation has this parameter setting Press S button cycle to enter this menu and then press the A Jand V button to adjusting the setting 3 Set Timer Press S button cycle to enter this setting The treatment time is adjustable from 1 to 60 minutes or Continuous Press A or V button control to adjust setting You can set the timer to Continuous mode by pressing the A control when it shows 60 minutes The output will be shut off when time is up 4 Set Pulse Width Pulse Width is adjustable from 50 uS to 300 uS Press S button to enter this menu then press A or V button to adjust the setting 5 Set Pulse Rate Pulse rate is adjustable from 1 Hz to 150 Hz 0 5 Hz to 5 Hz for Burst Press S button cycle to enter this menu and then press A or Y button to adjust the setting 4 7 2 EMS Setting Press the S button cycle to enter the setting state The settings can be adjusted according to the following steps 1 Set the Therapeutic Program There are 3 programs in EMS therapeutic ane TT a mode available Synchronous Alternate and s A D Delay The therapeutic program can be a M selected by pressing the A and V button V Hi mmn When you choose to S program program S YER R outside of the box will be flashing aS 2 Set T2. 8 Decreasing the output intensity of channel 2 V Use to set the application program and the parameter of the waveform in the setting state Use to unlock the current treatment program 9 Parameter Selection press the button to enter setting state you can select the different parameters in conjunction with A and V 10 Press toturn ON Press amp button and hold for approximately 3 seconds to turn off the device 11 Belt Clip 12 The battery compartment cover for user access 13 Adapter Receptacle 2 2 LCD display o fai S ILE Tai ES D Tai N y i min Ac VN AI 1 Displays therapeutic mode 2 Displays therapeutic program for TENS and EMS therapeutic mode 3 Displays therapeutic program for IF and MIC therapeutic mode or displays the cycle time for TENS IF and MIC therapeutic mode in setting state Timer symbol EMS waveform of ramp up and ramp down time Display of waveform pulse width Displays channel 1 Display of the output intensity for channel 1 CH1 Display of waveform pulse width or EMS waveform of contraction working time in setting state CONDOS Nuo eZ Nuo Nuo Nuo gt 9 EMS waveform of contraction working time 10 The device is locked indicator 11 Display of waveform pulse rate 12 Display of the output intensity for channel 2 CH2 Display of waveform pulse rate or EMS waveform of relaxation time in setting state
3. 13 Displays channel 2 14 EMS waveform of relaxation time 15 Displays the treatment time or EMS waveform of ramp up and ramp down time 16 Low battery indicator 3 Specification 3 1 Accessories 9V Alkaline Battery type 6LR61 Instruction Manual AC Adaptor optional 1 piece 3 2 Technical information 9 0 V Alkaline DC 1 6LR61 battery Adapter output 9 0Vdc 800mA optional 5 C to 40 C 41 F t0104F with a relative Operating conditions humidity of 10 C to 50 C 14F to 122F with a relative Storage conditions humidity of Dimensions 4 5x2 55x0 9 inches L W H Weight 0 28 Ibs With battery Tolerance There may be a 5 tolerance of all setting and 10 Timer Adjustable from 1 to 60 minutes or continuous Adjusts in 1 minute steps Treatment time countdown is automatic Electrode Detection The amplitude level will be reset to OMA when the Function amplitude level is 12mA or greater and an open circuit at either channel is detected Technical specifications for Transcutaneous Electrical Nerve Stimulator TENS mode Waveform Mono phase square pulse wave Pulse amplitude Adjustable 0 105mA peak at 1000 ohm Load each channel 1mA Step Pulse Width Adjustable from 50 to300us microseconds 10uS step Pulse Rate Adjustable from 1 to 150 Hz 1 Hz step Burst B Burst rate Adjustable 0 5 5Hz Pulse width adjustable 50 300uS Frequency fixed 100 Hz Normal N The pulse rate and pu
4. 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 pressure 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 some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or silicone rubber If rash develops or pain persists discontinue use and consult a doctor 14 15 16 17 18 19 20 21 22 23 Electrode placement and stimulation settings should be based on the guidance of prescribing practitioner Effectiveness is highly dependent upon patient selection by a person gualified in the management of pain afflicted patients 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 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 Inten
5. F button control to adjust setting You can set the timer to Continuous mode by pressing the A control when it shows 60 minutes Its output will be shut off when time is up 3 Set Pulse Width Pulse Width is adjustable from 2ms to 200ms Press S button cycle to enter this menu then press A or V button to adjust the setting lt 4 Set Pulse Rate Pulse rate is adjustable from 1 Hz to 150 Hz Press S button cycle to enter this menu and then press A or V button to adjust the setting 5 Set Cycle Time Optional T o Cycle time is adjustable form 5 to 30 seconds Tene oe ie sus Only modulation mode has this parameter gL setting Press S button cycle to enter this menu and then press the A and Y button to adjusting the setting eee 2 4 8 Adjust Channel Intensity Press the intensity control button A and V 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 stimulation levels are uncomfortable or become uncomfortable reduce the stimulation intensity to a comfortable level and contact your medical practitioner if problems persist 2 TENS EMS and IF therapeutic mode If the electrodes are not placed firmly on skin or the device is not connected to the electrodes and the stimulators output intensity surpa
6. 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 electrode firmly against the skin To remove your electrodes 1 2 3 Lift the corner of the electrode and gently remove it from the Skin 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 gt Always use the electrodes with the reguirements of the IEC EN60601 1 ISO10993 1 5 10 and IEC EN60601 1 2 such as with CE mark or are legally marketed in the US under 510 K procedure 6 4 Cleaning the Electrode s cords Clean the electrode cords by wiping them with a damp cloth Coating them lightly with talcum powder will reduce tangles and prolong the life 6 5 M
7. Verify connection is secure amp firmly seated 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 Program option in use some programs will seem intermittent This is expected Refer to the Program Option Controls in the Operation section for a description of the program option Improper electrode and Reposition electrode and applicator applicator placement Contact clinician Unknown 8 Storage 1 Fora prolonged pause in treatment store the device in a dry room and protect it against heat sunshine and moisture and remove the battery 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 Please dispose of the device in accordance with the law AN 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 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The devic
8. button cycle to enter this setting The treatment time is adjustable from 1 to 60 minutes or Continuous d Press A or VY control to adjust setting You can set the timer to Continuous mode by pressing the A button when it shows 60 minutes Its output will be shut off when time is up 3 Set Interference frequency optional Channel 1 has 4000 Hz fixed Fundamental frequency Channel has selectable frequency from 4001 to 4150Hz Interference frequency is adjustable form 1 Hz to 150 Hz Only P4 has this parameter setting Press S button cycle to enter this menu and then press the A and VY button to adjusting the setting 4 Set Cycle Timer Cycle time is adjustable form 5 to 30 seconds Press S button cycle to enter this menu and then press the A and V button to adjusting the setting 4 7 4 Microcurrent Setting Press the S button cycle to enter the setting state The settings can be adjusted according to the following steps 1 Set the Therapeutic Program There are 3 programs in MIC therapeutic program ais 1 Tae em available Constant Pulse Width Modulation and Pulse Rate Modulation Pi HN The therapeutic program can be selected by pressing the A and V button The mode you rath it selected will show up on the top of LCD Display 2 Set Timer Press S button cycle to enter this setting The treatment time is adjustable from 1 to 60 minutes or Continuous Press A or
9. come on and come off gradually and smoothly The ramp time is adjustable from 1 to 6 seconds 7 Set Contract Time The contract Time controls the time of stimulation and can be adjusted Press S button cycle to enter this menu and then press the A and VY button to adjust the setting Both channels Stimulation is cycled on and off by the contraction and relaxation settings The range is adjustable from 1 to 60 seconds Caution Contract time does not include the ramp up and ramp down time ON time Ramp up Contract time Ramp down 8 Set Relaxation OFF time The Off Time controls the time of relaxation and can be adjusted Press S button cycle to enter this menu and then press the A and VY button to adjusting the setting Both channels stimulation is cycled on and off by the contraction and relaxation settings The range is adjustable from O to 60 seconds In Alternate program the OFF Time should be equal or more than the ON Time OFF TIME 2 ON TIME 4 7 3 IF Setting Press the S button to enter the setting state The settings can be adjusted according to the following steps 1 Set the Therapeutic Program There are 4 programs in IF therapeutic mode reus Cug mie cms available The therapeutic program can be Wr selected by pressing the A and V button imi min The mode you selected will show up on the oR EN top of liquid crystal display CE mw BUY 2 Set Timer Press S
10. level This deep tissue penetration stimulates parasympathetic nerve fibers for increased blood flow and edema reduction It utilizes the low electric current to stimulate muscle nerves to achieve the symptomatic relief of chronic intractable pain post traumatic pain and post surgical pain WHAT IS MICROCURRENT Microcurrent stimulation is a type of therapy in which very low current is sent into the cells of the body Microcurrent is a very faint current that is so small it is measured in millionths of an amp Microamps Human cells generate a current that is in the micro amp range which is why you can t feel it the current is so low it doesn t stimulate the sensory nerves Microcurrent is a physiological electric modality that increases ATP energy production in the cells of your body This dramatically increases the tissue s healing rate The immediate response to the correct microcurrent frequency suggests that other mechanisms are involved as well The exact effects or changes in the tissue are unmistakable scars will often suddenly soften trigger points often become less painful within minutes when the correct frequency is applied In many situations the changes seen seem to be long lasting and in many cases permanent 1 3 Indication for use INTENSity Select Combo TENS EMS IF MIC Stimulator may be used for the following conditions For Transcutaneous Electrical Nerve Stimulator Interferential Microcurrent ther
11. the skin during application To prevent this apply electrodes from center 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 electrodes 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 Remove the battery from the device every time when you clean the device 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 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 1 5 x 1 5 self adhering electrodes should be used at the treatment area Inspect your electrodes before every use Replace electrodes as needed Reusable electrodes may cause slight skin irritation lose adhesion properties and deliver less stimulation if overused Connector for Inserting Lead Wire Pin Adhesive Pad Reusable Self adhering Electrodes To use these electrodes Attach the electrode to the lead wire
12. NMIU SELECT COMBO INSTRUCTION MANUAL This manual is valid for the InTENSity Select Combo TENS IF MIC EMS 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 1 2010 N 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 document IEC60601 1 IEC60601 1 2 IEC60601 2 10 IEC60601 1 4 I5S010993 5 15010993 10 15010993 1 Table of Contents SAFETY INFORMATION aaa aaa aaa aaa aaa aaa anna aaa 4 1 General description 2 Medical background 3 Indication for use 4 Contraindications 5 Warnings Cautions Adverse Reactions 2 PRESENTATION kaka kana anna a aaa aaa cece eee e eee e eee eeeees 14 2 1 Front and Rear panel 2 2 LCD display J SPECIFICATION aotatinastusiin iii e ias aaa i ss 17 3 1 Accessories 3 2 Technical information 3 3 The waveforms of the stimulation programs 4 INSTRUCTIONS FOR USE 0 ccc akanai 23 4 1 Battery 4 2 Connect electrodes to lead wires 4 3 Connect lead wires to device 4 4 Electrodes 4 5 Turn ON 4 6 Select
13. advice of your physician to ensure proper guality Follow application procedures outlined in electrode 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 clean and dry Make sure the electrodes are pressed 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 and dry the skin 2 Do not turn 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 turned on 4 It is recommended that at minimum 1 5 x 1 5 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 suggest
14. aintenance 1 Maintenance and all repairs should only be carried out by an authorized agency The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons 2 The user must not attempt any repairs to the device or accessories Please contact the retailer for repair 3 Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty 4 Check the unit before each use for signs of wear and or damage Replace worn 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 Possible Cause Battery contact failure 1 Try fresh batteries 2 Ensure batteries are inserted correctly Check the following All contacts are in place All contacts are not broken Stimulation weak Electrodes Lead Wires Replace and re connect 1 Dried out or contaminated Follow instruction manual 2 Placement of lead wires Follow instruction manual 3 Old worn damaged lead Replace wires or electrodes Intensity is too high Decrease intensity Electrodes are too Reposition the electrodes close together Damaged or worn Replace electrodes or lead wires Electrode active area size Replace electrodes with ones that is too small have an active area no less than Lead wires 1
15. an help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile 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 maximum output power of transmitter 150 kHz to 80 80 MHz to 800 800 MHz y 2 5 GHz 7 MHz d 1 2 P MHz d 1 2 P d 2 3 P on oz 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 11 Glossary of Symbols Batch code 01000001 Serial number 50000001 Attention Read the operating instruction for use 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 e a organization which is responsible for w
16. apeutic modes TENS IF MIC 1 Symptomatic relief of chronic pain 2 Post traumatic pain 3 Post surgical pain For Electrical Muscle Stimulation Neuromuscular Stimulation therapeutic mode EMS 1 Relaxation of muscle spasms Increase of blood flow circulation 3 Prevention of disuse atrophy 4 Muscle re education 5 Maintaining or increasing range of motion 6 Immediate post surgical stimulation of lower leg muscles to prevent venous thrombosis IMPORTANT SAFETY INFORMATION Read the 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 present in the treatment area 3 Stimulation should not be applied over swollen infected inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc 4 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 5 Do not use this device if the patient has a demand type cardiac pacemaker or any implanted defibrillator 6 This d
17. aste disposal in your area if you have any questions Degree of Electrical Protection BF 12 Warranty Please contact your dealer in case of a claim under the warranty If you have to send the unit back to your provider 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 purchase In case of a warranty claim the date of purchase has to be proven by means of the sales receipt or invoice 2 Repairs under warranty do not extend the warranty period either for the device or for the replacement parts 3 The following is excluded under the warranty All damage which has arisen due to improper treatment e g nonobservance of the user instruction All damage which is due to repairs or tampering by the customer or unauthorized third parities e Damage which has arisen during transport from the manufacturer to the consumer or during transport to the retailer e Accessories which are subject to normal wear and tear 4 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
18. d timer are adjustable in this program Constant is equal to the Normal mode of a TENS therapeutic mode Pulse Width The pulse width is automatically varied in a cycle Modulation P2 time The pulse width is decreased from its original setting to 60 in setting cycle time and then increased from 60 to its original setting in nest setting cycle time In this program pulse rate 1 to 150Hz pulse width 2 to 200ms and cycle time 5 to 30 sec are fully adjustable Pulse Rate The pulse rate is automatically varied in a cycle time Modulation P3 The pulse rate is decreased from its original setting to 60 in setting cycle time and then increased from 60 to its original setting in nest setting cycle time In this program pulse rate 1 to 150Hz pulse width 2 to 200ms and cycle time 5 to 30 sec are fully adjustable 3 3 The waveforms of the stimulation programs Burst B Burst Freguency 7 pulses per burst Normal N Pulse Width Modulation cycle time Pulse Rate Modulation cycle time Synchronous S rim ON TIME OFF TIME CH2 J J Alternate A CH2 Delay time Interferential Microcurrent Constant Jo LL LJ OL 4 Instructions for use 4 1 Battery 4 1 1 Check Replace the battery Over time in order to ensure the functional safety of device the battery must be periodically changed 1 Slide the battery compartment cover and open 2 Insert the 9V ba
19. e is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 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 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are 8 kV air covered with synthetic material the relative humidity should be at least 30 Guidance and manufacturer s declaration Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below part of the device including cables than the R Radiated 3 V m80 800MHz to 2 5MHz RF IEC MHz to d 1 2 61000 4 3 2 5 GHz VP Field strengths from fixed RF transmitters as eguipment marked with the following symbol recommended separation distance calculated d 2 3 P determined by an electromagnetic site survey ie The customer or the from the eguation applicable to the freguency Where P is the maximum output power rating should be less than the compliance level in NOTE At 80 MHz ends 800 MHz the higher frequency range applies Immunity IEC 60501 Compliance Electromagnetic environment guidance test test level Level Portable and mobile RF communications of the transmitter Recommended separation distance of the transmitte
20. ed here If the initial results are not positive speak to your physician about alternative stimulation settings and or electrode placements Once an acceptable location has been achieved mark down the electrode sites and the device settings so the patient can easily continue treatment 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 f this manual Safety information as this 2 powerful eguipment is neither a toy nor p a gadget In order to turn on the device PRESS and RELEASE the button The operation page appears on the screen 4 6 Select the Therapeutic Mode There are 4 therapeutic modes available TENS EMS IF and MIC The therapeutic mode can be selected by pressing the M control Caution Consult your physician for your suitable therapeutic mode a gt 4 7 Steps to Set a New Program 4 7 1 TENS Setting Press the S button cycle to enter the setting state The settings can be adjusted according to the following steps 1 Set the Therapeutic Program There are 4 programs in TENS therapeutic mode available Burst B Normal N Pulse EEG ww mwe ewe Width Modulation M and Pulse Rate a EPR Modulation M1 The therapeutic program can S Am be selected by pressing the A and Y button M S When you choose to B program program B
21. evice should not be used over poorly enervated areas This device should not be used on patients with epilepsy 8 This device should not be used on patients with serious arterial circulatory problems in the lower limbs 9 This device should not be used on patients with abdominal or inguinal hernia 10 Do not use this device if you have heart disease without consulting your physician 1 5 Warnings Cautions and Adverse Reactions WARNINGS 1 2 10 11 12 13 This device should be used only under the continued supervision of a licensed physician or practitioner 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 such as headache 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 Stimulation should not be applied over the neck or mouth severe
22. hod 0 5 5Hz 50 300us 1 60min continuous 1 150Hz 50 300us 1 60min continuous TENS a Pulse width 1 150Hz 50 300us 1 60min continuous Frequency 1 150Hz 50 300us 1 60min continuous modulation Synchronous 1 150Hz 50 300us 1 60min continuous mode S 1 150Hz 50 300us 1 60min continuous Mode D Delaymode 1 150Hz 50 300us 1 60min continuous P1 Frequency 4kHz 125us 1 60min continuous modulation 4001 4010Hz P2 Frequency 4kHz 125us 1 60min continuous modulation 4001 4150Hz P3 Frequency 4kHz 125us modulation 4080 4150Hz 1 60min continuous P4 Frequency 4kHz 125us 1 60min continuous modulation 4001 4150Hz 1 150Hz 2 200ms 1 60min continuous P2 Pulse width 1 150Hz 2 200ms 1 60min continuous modulation P3 Frequency 1 150Hz 2 200ms 1 60min continuous modulation 6 Cleaning and Care 6 1 Tips for skin care To avoid skin irritation especially if you have sensitive skin follow these suggestions 1 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 2 Excess hair may be clipped with scissors do not shave Stimulation area gt 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
23. imer Press S button cycle to enter this setting The treatment time is adjustable from 1 to 60 minutes or Continuous Press A or V control to adjust setting You can set the timer to Continuous mode by pressing the A button when it shows 60 minutes The output will be shut off when time is up 3 Set Pulse Width The pulse width determines the length of time Each electrical Signal is applied through the skin which controls the strength and sensation of the stimulation Press S button cycle to enter this setting The pulse width is adjustable from 50 to 300 uS Press A or VY button to adjust the setting 4 Set Pulse Rate The pulse rate determines how many electrical impulses are applied through the skin each second Press S button cycle to enter this menu Adjust the setting by pressing the A or V buttons The pulse rate is adjustable from 1 Hz to 150 Hz 5 Set Delay Time Optional Delay time is adjustable form 1 to 10 seconds ns ir moe ews Only the Delay therapeutic program has this s A B parameter setting Press S button cycle to im sec enter this menu and then press the A and V p button to adjusting the setting Apt E 6 Set Ramp Time The ramp time controls the time of output current that increase from 4 28 0 to the setting level and from the setting value to 0 When the ramp time is set each contraction may be ramped up and down in order that the signals
24. lation levels are uncomfortable reduce the Stimulation Intensity to a comfortable level and contact your physician if any problems persist 2 Presentation 2 1 Front and Rear Panel ui LT m ao Ses 1 2 m 4 a 7 ip TENSITY 3 SELECT COMBO 1 Output socket electric signal output after connection of the cable with adhesive electrodes on channel 1 2 Output socket electric signal output after connection of the cable with adhesive electrodes on channel 2 3 Increasing the output intensity of channel 1 A Use to set the application program and the parameter of the waveform in the setting state 4 Decreasing the output intensity of channel 1 Y Use to set the application program and the parameter of the waveform in the setting state and to unlock the current treatment program 5 Therapeutic mode selection Stop the treatment Exit setting mode to return to the user interface 6 LCD display Shows the operating state of the device 7 Increasing the output intensity of channel 2 A Use to set the application program and the parameter of the waveform in the setting state
25. lse width are adjustable It generates continuous stimulation based on the setting value Pulse Width The pulse width is automatically varied in a Modulation M cycle time The pulse width is decreased from its original setting to 60 in setting cycle time and then increased from 60 to its original setting in nest setting cycle time In this program pulse rate 1 to 150Hz pulse width 50 to 300us and cycle time 5 to 30 sec are fully adjustable Pulse Rate The pulse rate is automatically varied in a cycle Modulation M1 time The pulse rate is decreased from its Original setting to 60 in setting cycle time and then increased from 60 to its original setting in nest setting cycle time In this program pulse rate 1 to 150HZ pulse width 50 to 300us and cycle time 5 to 30 sec are fully adjustable Technical specifications for Electrical Muscle Stimulation EMS mode Mono phase square pulse wave Pulse amplitude Adjustable 0 105mA peak at 1000 ohm Load each channel 1mA Step Pulse Width Adjustable from 50 to 300uS microseconds 10uS step Pulse Rate Adjustable from 1 to 150 Hz 1 Hz step Contraction time Adjustable 1 60 seconds 1 Sec step Relaxation OFF Adjustable 0 60 seconds 1 Sec step Ramp time Adjustable 1 6 seconds 1 Sec step The On time will increase and decrease in the setting value synchronous S Stimulation of both channels occurs synchronously The ON time inc
26. luding Contraction Ramp Up and Ramp Down time ON TIME Contraction Ramp up Ramp down Alternate A The Stimulation of the CH2 will occur after the 1st working of CH1 is completed In this program The ON time including Contraction Ramp Up and Ramp Down time The OFF Time should be equal or more than the ON Time ON TIME Contraction Ramp up Ramp down OFF TIME2ON TIME Delay D The Stimulation of the CH2 will occur after the 1st operation of CH1 is started Delay Time In this program The ON time including Contraction Ramp Up and Ramp Down time The OFF Time should be equal or more than the ON Time Delay Time ON TIME Contraction Ramp up Ramp down Technical specifications for Interferential IF mode Bi phase square pulse Pulse amplitude Adjustable 0 70mA peak to peak at 1000 ohm Load Pulse Rate Channel 1 Fundamental frequency 4000 Hz fixed Channel 2 Selectable frequency 4001 to 4150 Hz Interference frequency 1 to 150 Hz Phase Width 125uS Technical specifications for Microcurrent MIC mode Waveform Mono phase square pulse wave Pulse amplitude Adjustable 0 0 7mA peak at 1000 ohm Load each channel 0 01mA Step Pulse Width P W Adjustable from 2 to 200ms 1ms step Pulse Rate P R Adjustable from 1 to 150 Hz 1 Hz step 1 Constant P1 Constant stimulation based on setting value Only pulse width pulse rate an
27. mportant 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 lasting persistent pain serves no useful purpose Pain does not begin until the 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 Stimulation 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 s
28. ngth increases the muscle flexes as in physical exercise Then when the pulse ceases the muscle relaxes and the cycle is repeated The goal of electrical muscle stimulation is to achieve contractions or vibrations in the muscles Normal muscular activity is controlled by the central and peripheral nervous systems which transmit electrical signals to the muscles EMS works similarly but uses an external source the stimulator with electrodes attached to the skin for transmitting electrical impulses into the body The impulses stimulate the nerves to send signals to a specifically targeted muscle which reacts by contracting just as it does with normal muscular activity WHAT IS IF Interferential Stimulation IF is an anti inflammatory based treatment modality Interferential stimulation is characterized by two alternating current sine waves or square waves of differing frequencies that work together to produce an interferential current that is also known as a beat pulse or alternating modulation frequency One of the two currents is usually held at 4 000 Hz and the other can be held constant or varied over a range of 4 001 to 4 100 Hz Because of the frequency the interferential wave meets low impedance when crossing the skin to enter deep into soft tissues The interferential currents reportedly can stimulate sensory motor and pain fibers These large impulse fibers interfere with the transmission of pain messages at the spinal cord
29. r In watts W according to the Transmitter manufacturer and d Is the each frequency range Interference may occur In the vicinity of NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects equipment should be used no closer to any Conducted Vrms 3 Vrms FIEC 150 kHz to d 1 2 P 61000 4 6 80 MHz recommended separation distance in meters m and people 1 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 2 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 c
30. rodes separate during treatment electrodes in contact with other could result in improper stimulation or skin burns Keep the stimulator out of reach of children Consult your doctor if you are in any doubt whatsoever CAUTIONS 1 2 3 4 5 10 11 12 13 Federal law USA restricts this device to sale by or on the order of a physician For single patient use only Keep yourself informed of the contraindications This stimulator not intended for unattended personal use by patients who have noncompliant emotionally disturbed dementia or low IQ Read understand and practice the warnings cautions and operating instructions Know the limitations and hazards associated with using any device Observe the cautionary and operational decals placed on the unit Always follow the operating instructions prescribed by your healthcare practitioner The instruction of use was listed any improper use may be dangerous Do not use this device for undiagnosed pain syndromes until consulting a physician 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 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
31. sert the lead wire connector into electrode connector standard 0 08 inch a E female connection Make sure there are no bare metal of the pins exposed o Caution Always use the electrodes with the requirements of the IEC EN60601 1 I8010993 1 5 10 and IEC EN60601 1 2 such as with CE mark or which are legally marketed in the US under 510 K listing 4 3 Connect lead wires to device 1 Before proceeding to this step be sure the device is completely turned OFF 2 Insert the wires provided with the system 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 Or 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 electrodes adhesive properties order replacement electrodes Replacement electrodes should be re ordered through or on the
32. sity to a comfortable level and contact your physician if problems persist 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 Never use the device in rooms where aerosols Sprays are used or pure oxygen Is being administered Do not use it near any highly flammable substances gases or explosives Do not use this device at the same time as other equipment which sends electrical pulses to your body Do not confuse the electrode cables and contacts with your headphones or other devices and do not connect the electrodes to other devices Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons onthe control panel Inspect Applicator cables and associated connectors before each use Turn the device off before applying or removing electrodes Electrical stimulators should be used only with the leads and electrodes recommended for use by the manufacturer This device has no AP APG protection Do not use it in the 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 Note Always use electrodes that are legally marketed and sold in the United States under 510K guidelines If the stimu
33. 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 Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause 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 Do not use the stimulator in the vicinity of shortwave or microwave therapy equipment since this may affect the output power of the stimulator Never use in environments with high humidity such as in the bathroom or when having a bath or shower Caution should be used in applying electrical stimulation to 14 patients suspected of having heart disease Further clinical data is needed to show there are no adverse results Never use near the heart Stimulation electrodes should never be placed anywhere on the front of the thorax marked by ribs and breastbone take extreme caution not to place near or on the two large pectoral muscles Here it can increase the risk of ventricular fibrillation and lead to cardiac arrest Electrodes should not be placed over the eyes in the mouth near the genitals or internally Never use on the areas of the skin which lack normal sensation Apply the electrodes to clean dry and unbroken skin only Keep elect
34. sses 12mA the intensity will automatically reset to OmA 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 VY buttons to unlock the device 4 10 Stop the treatment When you have activated the treatment timer you can press the M button or the VY button to control stop the treatment Caution Default state if the button is locked you can press only one of the VY buttons to unlock and then press the M button or the VY button to control stop the treatment 4 11 Turn OFF PRESS button and HOLD for approximately 3 seconds to turn OFF the device Caution 1 If there is no operation in the panel for 2 minutes in the waiting state the device turns off automatically 2 In shutdown state keep pressing the channel 2 V first and then press button at the same to restore factory parameter settings 4 12 Low battery indicator When the low power indicator flashes the device will be turns off automatically the battery should be replaced with a new one as soon as possible However the unit may continue to operate for an extended period of time depending on the setting and intensity level 5 Program Met
35. the Therapeutic Mode 4 7 Steps to set a new program 4 8 Adjust Channel Intensity 4 9 Safety Lock Feature 4 10 Stop the treatment 4 11 Turn OFF 4 12 Low battery indicator 5 PRO 2 Nirsironissenianotikavian Lisos byianas bis sein sono ai 33 6 CLEANING AND CARE aaa aaaaa aaa aaa aaa ananasas OQ 6 1 Tips for skin care 6 2 Cleaning the device 6 3 Electrodes 6 4 Cleaning the Electrode cables 6 5 Maintenance 1 1 1 1 1 1 7 TROUBLESHOOTING 0 00cccccccseeceeseeeteescensteseeteeetene 37 8 STORAGE LLL aaa aaa aaa 38 9 DISPOSAL LL aaa aaa 38 10 ELECTROMAGNETIC COMPATIBILITY EMC TABLES 39 11 GLOSSARY OF SYMBOLS JLL re 12s VARRANT Y imuninio ei EARTE EE o a o 42 1 Safety information 1 1 General INTENSity Select Combo is a portable electrotherapy device featuring four therapeutic modes Transcutaneous Electrical Nerve Stimulation TENS Electrical Muscle Stimulation EMS Interferential IF and Microcurrent MIC which are used for pain relief and electrical muscle stimulation The stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin The parameters of the device are controlled by the buttons on the front panel The 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 i
36. timulation will greatly reduce or eliminate the pain sensation the patient feels Pain relief varies by individual patient 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 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 EXPLANATION OF EMS Electrical Muscle Stimulation EMS is an internationally accepted and proven way of treating muscular injuries It works by sending electronic pulses to the muscle needing treatment this causes the muscle to exercise passively It is a product derived from the Square waveform originally invented by John Faraday in 1831 Through the square wave pattern it is able to work directly on muscle motor neurons This device has low frequency and in conjunction with the square wave pattern allows direct work on muscle groupings This is being widely used in hospitals and sports clinics for the treatment of muscular injuries and for the re education of paralyzed muscles to prevent atrophy in affected muscles and improving muscle tone and blood circulation HOW EMS WORKS The EMS units send comfortable impulses through the skin that stimulate the nerves in the treatment area When the muscle receives this signal it contracts as if the brain has sent the signal itself As the signal stre
37. ttery into the battery compartment 3 Make sure you are installing the battery properly Be sure to match the positive and negative ends 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 Replacing the battery compartment cover and press to close 6 If replacing 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 steps 2 5 4 1 2 Disposal of battery spent batteries do not belong in household waste Dispose of the battery according to the current federal state and local regulations 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 2 If a battery has leaked avoid contact with skin eyes and mucus membranes Rinse the affected spots with clear water immediately and contact a physician right away 3 Battery may not be charged dismantled thrown into fire or short circuited 4 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 5 Always replace the same type battery 237 4 2 Connect electrodes to lead wires In
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