IF COMBO INSTRUCTION MANUAL
Contents
1. 14 tt 15 16 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 precautionary 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 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 wi2. Interference may occur In the vicinity of equipment marked with the following symbol 0 NOTE 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 3 V m80 MHZ 3 jm a 124F 80MHz to 800MHz to 2 5 GHz 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 can help prevent electromagnetic interference b
3. relief of chronic intractable pain acute post traumatic pain or acute post surgical pain IMPORTANT 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 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 device should not be used over poorly enervated areas 7 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
4. The customer or the user should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic environment Immunity test test level level guidance Floors should be wood concrete or ceramic tile If 6 kV contact 6 kV contact floors are covered with 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 Electrostatic discharge ESD IEC 61000 4 2 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 Electromagnetic environment test test level level 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 150 RF IEC kHz to 80 3 Vrms 61000 4 6 MHz Radiated RF IEC 61000 4 3 Where P is the maximum output power rating of the transmitter In watts W according to the Transmitter manufacturer and d Is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range
5. 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 F button to adjusting the setting Tone GE TENS IE 4 8 Adjust Channel Intensity Press the intensity control button A and W 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 Ifthe stimulation levels are uncomfortable or become uncomfortable reduce the stimulation intensity to a comfortable level and contact your medical practitioner if problems persist 2 Ifthe 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 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 VW 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 VW button to control stop the treatment Caution Defa
6. 5 Warnings Cautions and Adverse Reactions WARNINGS 1 This device should be used only under the continued supervision of a licensed physician 2 The long term effects of chronic electrical stimulation are unknown Electrical stimulation devices do not have any curative value 3 TENS is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism 4 Safety has not been established for the use of therapeutic electrical stimulation during pregnancy Do not use during pregnancy unless directed by your physician 5 Electrical stimulation is not effective for pain of central origin 6 Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when electrical stimulation is in use 7 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 neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enougpn 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 cause cardiac arrhythmias 10 Stimulation should not take place while the user is connected to high frequency surgical equipment it may cause burn injuries on the skin under th
7. WI IF COMBO INSTRUCTION MANUAL This manual is valid for the InTENSity IF Combo TENS and IF Stimulator This user manual is published by Current Solutions LLC Current Solutions Y 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 O 2010 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 document IEC60601 1 IEC60601 1 2 IEC60601 2 10 IEC60601 1 4 IS010993 5 15010993 10 15010993 1 Table of Contents 1 SAFETY INFORMATION 0 cece cece cece cece eceeeeeeeeeeaaaaes 4 1 1 General description 1 2 Medical background 1 3 Indication for use 1 4 Contraindications 1 5 Warnings Cautions Adverse Reactions 2 PRESENTATION rear 10 2 1 Front and Rear panel 2 2 LCD display 3 SPECIFICATION 0 ccc cece cece ee eee ee ee ee eeeeeeeeeeeeeeeaaaas 12 3 1 Accessories 3 2 Technical information 3 3 The waveforms of the stimulation programs 4 INSTRUCTION FOR USE Lecce eee eens 16 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 the Therapeutic Mode 4 7 Steps to se
8. act 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 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 e All damage which has arisen due to improper treatment e g nonobservance of the user instruction e All damage which is due to repairs or tampering by the customer or unauthorized third parities Oo 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 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 amp CURRENT SOLUTIONS Manufactured for Current Solutions LLC 3814 Woodbury Drive Austin TX 78704 Ph 800 871 7858 www currentsolutionsnow com
9. 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 IF Setting Press the S button to enter the setting state The settings can be adjusted according to the following steps 1 Setthe Therapeutic Program There are 4 programs in IF therapeutic mode available The therapeutic program can be selected by pressing the A and F button The mode you selected will show up on the top of liquid crystal display Ten nre TEN IE FA n j E ww U nf Py ivy Y Li ts tf oo CREARA A 5 Kn 1 r gt 4 ji fy min m m Kai NT IT ful pen A An AR Se UA ni NEW IA 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 F control to adjust setting You can set the timer to Continuous mode by pressing the A button when it shows 60 minutes lts 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 4150 Hz 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 F button to
10. de Detection when the amplitude level is 12mA or greater Function and an open circuit at either channel is detected Technical specifications for Transcutaneous Electrical Nerve Stimulator TENS mode Mono phase square pulse wave Puise amolitude Adjustable 0 105mA peak at 1000 P ohm Load each channel 1mA Step Pulse Width Adjustable from 50 to 300us microseconds 10uS step Adjustable from 1 to 150 Hz 1 Pulse Rate Hz step Burst rate Adjustable 0 5 5Hz 0 1Hz step Sia il Pulse width adjustable 50 300uS Frequency fixed 100 Hz The pulse rate and pulse width are adjustable lt generates continuous PE NE stimulation based on the setting value The pulse width is automatically varied in a cycle time The pulse width is decreased from its original setting to 60 in setting cycle time FAIRE WEL AA and then increased from 60 to its P3 a on 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 The pulse rate is automatically varied in a cycle 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 Pulse Rate Modulation P4 Technical specifications for In
11. e 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 3 Wipe the area with the skin preparation your clinician has recommended Let this dry Apply electrodes as directed 4 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 5 To minimize pulling stress tape extra lengths of lead wires to the skin in a loop to prevent tugging on electrodes 6 When removing electrodes always remove by pulling in the direction of hair growth 7 It may be helpful to rub skin lotion on electrode placement area when not wearing electrodes 8 Never apply electrodes over irritated or broken skin 6 2 Cleaning the device 1 Remove the battery from the device every time when you clean 2 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 3 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 set
12. e 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 CAUTIONS 1 Federal law 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 10 11 12 13
13. ed 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 test Compliance Electromagnetic environment guidance RF The device uses RF energy only for its internal function Therefore its RF emissions emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equipment oor ene emissions Class B CISPR11 Harmonic emissions Noranpleable The device is suitable for use in all IEC 61000 pp establishments other than domestic and those 3 2 directly connected to the public low voltage Voltage power supply network that supplies buildings fluctuations used for domestic purposes flicker emissions IEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below
14. electric signal output after connection of the cable with adhesive electrodes channel 2 3 Therapeutic mode selection M Stop the treatment Exit setting mode to the user interface 4 Increasing the output intensity of channel 1 A To set the application program and the parameter of the waveform in the setting state 5 Decreasing the output intensity of channel 1 W To set the application program and the parameter of the waveform in the setting state To unlock the current treatment program 6 LCD display Shows the operating state of the device 7 Parameter Selection S press the button to enter setting state you can select the difference parameters in conjunction with A and V QM 8 Increasing the output intensity of channel 2 A To set the application program and the parameter of the waveform in the setting state 9 Press button to turn on Press button and hold for approx 3 seconds to turn off the device 10 Decreasing the output intensity of channel 2 VW To set the application program and the parameter of the waveform in the setting state To unlock the current treatment program 11 Belt Clip 12 The battery compartment cover for opening 13 Adapter Receptacle 2 2 LCD display EEE EEE EINE E N o rews va Lie ale C gt O HU en pw O ern 00 IA s i EBBS 348 A O j 1 Display therapeutic mode 2 Display therapeutic program or Di
15. ignal 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 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 stimulation will greatly reduce or eliminate the pain sensation the patient feels Pain relief varies by individual patient mode selected for therapy and the type
16. 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 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 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 1 3 Indication for use InTENSIity IF Combo Stimulator may be used for the Symptomatic
17. peration page appears on the screen 4 6 Select the Therapeutic Mode There are two therapeutic modes available TENS and IF The therapeutic mode can be selected by pressing the M control O Caution Consult your physician for your suitable therapeutic mode 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 Setthe Therapeutic Program There are 4 programs in TENS therapeutic mode available Burst P1 Normal P2 Pulse Width Modulation P3 and Pulse Rate Modulation P4 The therapeutic program TENS IE can be selected by pressing the A and Y py er button HK A 2 Set Cycle Time Optional IE Ar OF Be Cycle time is adjustable form 5 to 30 seconds 9384 WW Only modulation has this parameter setting Press S button cycle to enter this menu and then press the A and 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 Y 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 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 VW button to
18. 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 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 suggested here If the initial results are not positive speak to your physician about alternative 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 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 and relase the button The o
19. sh 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 O a 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 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 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 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 O Caution 1 Before applying the
20. splay the cycle time in setting state 3 Timer symbol 4 Display the channel 1 5 Display of waveform pulse width 6 Display numbers of the output intensity for channel 1 CH1 Display numbers of waveform pulse width in setting state 7 Display of waveform pulse rate Display numbers of the output intensity for channel 2 CH2 Display numbers of waveform pulse rate in setting state 9 The device is locked indicator 10 Low battery indicator 11 Display numbers of the treatment time 12 Display the channel 2 3 Specification 3 1 Accessories DESCRIPTION Electrical stimulator device Electrodes Leads 5 Instruction Manual i A piece 6 Carmingcease i A piece 7 AC Adaptor optional 1 piece 3 2 Technical information 9 0 V Alkaline DC 1 6LR61 battery Adapter output 9 0Vdc 800mA Operating conte 5 C to 40 C 41 F to 104F with a Operating conditions relative humidity of 30 75 atmospheric pressure from 700 to 1060 Hpa Storage oo 10 C to 50 C 14 F to 122F with a Storage conditions relative humidity of 10 90 atmospheric pressure from 700 to 1060 Hpa 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 tolerance of output of intensity Adjustable from 1 to 60 minutes or Ti continuous Adjustable in 1minutes each imer step Treatment time countdown automatically The amplitude level will be reset to OMA Electro
21. t 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 PROGRAM cccccceeceeeeeeeeeee eee ee eee eeeee cece seen eeeeeeeeeeeggaes 23 6 CLEANING AND CARE ocio 24 6 1 Tips for skin care 6 2 Cleaning the device 6 3 Electrodes 6 4 Cleaning the Electrode cords 6 5 Maintenance fs TROUBLESHOOTIN Giacomino 27 8 STORAGE een an a nen ee ewadaesiumasamapaoemmatiabedt 28 de DISPO SA a an ea en ae Er an 28 10 ELECTROMAGNETIC COMPATIBILITY EMC TABLES 29 11 GLOSSARY OF SYMBLOS 222s0ussssennenenneneen nennen 32 PA EE OA 32 1 Safety information 1 1 General InTENSIity IF Combo stimulator is a portable electrotherapy device featuring two therapeutic modes Transcutaneous Electrical Nerve Stimulation TENS and Interferential IF which are used for pain relief The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin The parameters of 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 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 s
22. t belong in the 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 lots of 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 4 2 Connect electrodes to lead wires Insert the lead wire connector into electrodes connector standard 0 08 inch female connection Make sure no bare metal of the pins is exposed Caution Always use the electrodes with the requirements of the IEC EN60601 1 15010993 1 5 10 and IEC EN60601 1 2 such as 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 Holding the insulated portion of the connector pu
23. t 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 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 2 Ifthe 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 Ag JOA o Y 0 a D chi U cha O AVG INTENSITY O o O 1 Output socket electric signal output after connection of the cable with adhesive electrodes channel 1 2 Output socket
24. terferential IF mode Waveform Bi phase square pulse Pulse amplitude Adjustable 0 70mA peak to peak at 1000 ohm Load each channel 1mA Step Channel 1 Fundamental frequency 4000 Hz fixed Pulse Rate Channel 2 Selectable frequency 4001 to 4150 Hz Interference frequency 1 to 150 Hz Phase Width The pulse rate of the CH 1 is fixed in 4000Hz CH2 pulse rate is increased from 4001Hz to 4010Hz in a cycle time and then decreased from 4010Hz to 4001 Hz in nest setting cycle time In this program CH2 interference frequency is varied from 1Hz to 10Hz cycle time 5 to 30 sec is fully adjustable CH 2 pulse rate 4000Hz Interference frequency The pulse rate of the CH1 is fixed in 4000Hz CH2 pulse rate is increased from 4001Hz to 4150Hz in a cycle time and then decreased from 4150Hz to 4001Hz in nest setting cycle time In this program CH2 interference frequency is varied from 1Hz to 150Hz cycle time 5 to 30 sec is fully adjustable CH 2 pulse rate 4000Hz Interference frequency The pulse rate of the CH1 is fixed in 4000Hz CH2 pulse rate is increased from 4080Hz to 4150Hz in a cycle time and then decreased from 4150Hz to 4080Hz in nest setting cycle time In this program CH2 interference frequency is varied from 80Hz to 150Hz cycle time 5 to 30 sec is fully adjustable CH 2 pulse rate 4000Hz Interference frequency 1 OO NO The pulse rate of the CH1 is fixed in 4000Hz CH2 pulse rate is au
25. tery contact failure 1 Try fresh batteries fails to 2 Ensure batteries are inserted light up correctly Check the following contacts e All contacts are in place e All contacts are not broken Stimulation Electrodes Replace and re connect is weak 1 Dried out or contaminated 2 Placement Lead wires Replace 1 Old worn damaged Stimulation Intensity is too high Decrease intensity IS Electrodes are too Reposition the electrodes uncomfort close together able Damaged or worn Replace electrodes or lead wires Electrode active area Replace electrodes with ones that have size is too small an active area no less than 16 0cm2 4cm 4cm Intermittent Lead wires 1 Verify connection is secure Insure output 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 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 Stimulation Improper electrode and Reposition electrode and applicator is applicator placement Contact clinician ineffective Unknown en 8 Storage 1 For a 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 ventilat
26. th 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 Electrode placement and stimulation settings should be based on the guidance of prescribing practitioner Effectiveness is highly dependent upon patient selection by a person qualified 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 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 18 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 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 a
27. tings prescribed by your physician or therapist 2 It is recommended that at minimum 1 5 X1 5 self adhering square electrodes are used at the treatment area 3 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 Connector for Insertina Lead Wire Pin bN sp Adhesive Pad Reusable Self adhering Electrodes To use these electrodes 1 Attach the electrode to the lead wire 2 Remove the protective backing from the electrode surface Do not throw away the protective backing because it is reused after the treatment session has been completed 3 Place the tacky surface to the prescribed skin area by pressing the electrode firmly against the skin To remove your electrodes 1 Lift the corner of the electrode and gently remove it from the skin 2 Apply the protective backing to the tacky side of the electrode Place the electrode on the side of the protective backing that is labeled with the word on 3 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 4 Between uses store the electrodes in the resealable bag in a cool dry place Caution 1 Do not pull on the electrode wire Doing so may damage the wire and electrode 2 Do not apply
28. to broken skin 3 The electrodes should be discarded when they are no longer adhering 4 The electrodes are intended for single patient use only 5 If irritation occurs discontinue use and consult your clinician 6 Read the instructions for use of self adhesive electrodes before application 7 Always use the electrodes with the requirements of the IEC EN60601 1 1I5010993 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 Maintenance 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 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 Possible Cause Display Bat
29. tomatically varied in a cycle time Interference frequency is increased from its original setting to 60 in setting cycle time and then decreased from 60 to its original setting in nest setting cycle time In this program CH2 interference frequency 2 to 150Hz and cycle time 5 to 30 sec are fully adjustable CH 2 pulse rate 4000Hz Interference frequency 3 3 The waveforms of the stimulation programs Burst Burst Frequency 7 pulses per burst Normal Pulse Width Modulation i cycle tlme O Pulse Rate Modulation cycle time Interferential A 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 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 steps 2 5 O 4 1 2 Disposal of battery Spent batteries do no
30. ult state if the button is locked you can press only one of the V buttons to unlock and then press the M button or the V button to control stop the treatment 4 11 Turn OFF Press button and hold for approx 3 seconds to turn OFF the device Caution 1 Ifthere is no operation in the panel for 2 minutes in the waiting state the device will be turns off automatically 2 In shutdown state keep pressing the channel 2 F first and then press button at the same to restore factory parameter settings 4 12 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 9 Program Modulation Pulse 0 5 SHz 90 300us 1 60min continous 1 150Hz 50 300us 1 60min continous TENS wich 1 150Hz 50 300us 1 60min continous modulation deans 1 150Hz 50 300us 1 60min continous modulation Frequency AkHz 4001 4010Hz 125us 1 60min continous Frequency 4kHz 4001 4150Hz 125us 1 60min continous Frequency 4kHz modulation 4080 4150Hz Pa Frequency 4kHz pa Frequency 4001 4150Hz 125us 1 60min continous 125us 1 60min continous 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 th
31. y 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 transmitterm 150 kHz to 80 MHZ to 800 MHz to 2 5 Rated maximum output power of transmitter 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 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 organization which is responsible for waste disposal in your area if you have any questions Type BF Applied Part 12 Warranty Please cont
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