Twin Stim Plus 3rd Edition Manual
Contents
1. Chapter 9 PARAMETER CONTROLS There are 4 therapeutic modes available TENS EMS IF and RUSS Each mode s parameters can be set by pressing SET button to enter setting mode and then adjust the parameters by pressing A or V button 9 1 Steps to set a new TENS program 9 1 1 Select TENS therapeutic mode and program Press MODE button until the LCD display TENS and expected program B N M SD1 SD2 9 1 2 Set pulse width Press SET button to enter setting mode the Width indicator displays on LCD press A or V button to adjust the parameter from 505 to 300 5 9 1 3 Set pulse rate Press SET button again The Rate indicator displays on LCD press A V button to adjust the parameter from 2Hz to 150Hz In Burst B program you can set the burst rate from 0 5Hz to 5 2 9 1 4 Set timer There are two adjustable timers available The left timer controlling the treatment time of CH1 and CH2 The right timer controlling the treatment time of CH3 and CH4 The treatment time is adjustable from 1 to 60 minutes or C Continuous Press SET button to enter this menu then press A or button to adjust the setting Press A button when the timer shows 60 minutes it will be switched to continuous stimulation Two timers can be set in the same way 9 2 Steps to set a new EMS program 9 2 1 Select EMS therapeutic mode and program Press MODE button until the LCD display EMS and expected progra2. be applied over the anterior neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing 9 Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may 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 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
3. 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 A Caution 1 Before applying the self adhesive electrodes it is recommended to wash and degrease the skin and then dry it 2 Do not turns on the device when the self adhesive electrodes are not positioned on the body 3 Never remove the self adhesive electrodes from the skin while the device is still turned on 4 It is recommended that at a minimum 4cm x 4cm self adhering based square electrodes are used at the treatment area 8 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 at
4. on the setting value Normal program N Modulation mode is a combination of pulse rate and pulse width modulation The pulse rate and width are automatically varied in a cycle pattern The pulse width is decreased by 50 from its original setting in 0 55 and then the pulse rate is decreased by 5096 from its original setting in 0 5 seconds Total cycle time is 1 second In this mode pulse rate 2 150Hz and pulse width 50 300us are fully adjustable Modulation program M The 501 Strength Duration mode consists of automatic modulation intensity and pulse width in 4096 range The intensity is always increasing while the pulse width is decreasing and vice versa The intensity is decreased by 4096 while the pulse width is increased by 4096 in 5 seconds In the next 5 seconds the intensity is increased by 40 while the pulse width is decreased by 40 Total cycle time is 10 Strength Duration program SD1 seconds Pulse rate 2 150Hz and pulse width 50 300us are fully adjustable The SD2 Strength Duration mode consists of automatic modulation intensity and pulse width in 7096 range The intensity is always increasing while the pulse width is decreasing and vice versa The intensity is decreased by 7096 while the pulse width is increased by 70 in 5 seconds In the next 5 seconds the intensity is increased by 70 while the pulse width is decreased by 709 Total cycle time is 10 seconds Pulse rate 2 150Hz an
5. 9 PATIENT COMPLIANCE 32 MAINTENANCE AND STORAGE 33 TROUBEESPROQ TINO 34 NORMALIZED SYMBOL Serene aan 36 WARAN M EPI 37 Chapter 1 GENERAL DESCRIPTION The Twin Stim Plus 3 Edition Combo Stimulator is a battery operated pulse generator that sends electrical impulses electrodes to the body and reaches the nerves and underlying muscle group This unit is a combination stimulator of TENS EMS IF Interferential and RUSSIAN which can be used for muscle stimulation and pain relief The device is provided with four controllable output channels each independent of each other An electrode pair can be connected to each output channel The intensity level is controlled by press buttons Chapter 2 INTRODUCTION EXPLANATION OF PAIN Pain is a warning system and the body s method of telling us that something is wrong Pain is important without it abnormal conditions may go undetected causing damage or injury to vital parts of our bodies Even though pain is a necessary warning signal of trauma or malfunction in the body nature may have gone too far in its design Aside from its value in diagnosis long 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
6. 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 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 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 want to discuss this therapy option with your physician or therapist to see if it will benefit your pain management needs EXPLANATION OF EMS Electrical
7. Muscle Stimulation 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 The Twin Stim Plus 39 Edition Combo Stimulator has low frequency and this 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 strength increases the muscle flexes as in physical exercise Then when the pulse ceases the muscle relaxes and the cycle starts over again Stimulation Contraction and Relaxation Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions EXPLANATION OF IF Interferential Interferential Stimulation IF is an anti inflammatory based treatment modality Interf
8. Twin Stim Plus 3 Edition Combo Stimulator INSTRUCTION MANUAL This manual is valid for the Twin Stim Plus 3 Edition Combo Stimulator This user manual is published by Roscoe Medical Inc Roscoe Medical Inc does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice Amendments may however be published in new editions of this manual All Rights Reserved Rev V1 0 O 2013 20130719 United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner Declaration of conformity Roscoe Medical Inc declares that the device complies with following normative documents 60601 1 IEC60601 1 2 IEC60601 1 11 IEC60601 2 10 15010993 1 15010993 5 15010993 10 15014971 Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Chapter 13 Chapter 14 TABLE OF CONTENTS GENERAL DESCRIPTION 4 INTRODUC TION DP rne 9 IMPORTANT SAFETY INFORMATION 8 CONSTRUC TION aiii Ha ERE 12 TECHNICAL 15 THERAPY PROGRAM AND WAVEFORMS 17 UNIT AND ACCESSORIES 24 5 25 PARAMETER 5 2
9. cardiac arrhythmia 10 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 11 Do not place electrodes on your head or at any sites that may cause the electrical current to flow trans cerebrally through the head 12 Patients with heart disease epilepsy cancer or any other health condition should not use this device without first consulting a physician 13 Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or silicone rubber If rash develops or pain persists discontinue use and consult a doctor 14 Electrode placement and stimulation settings should be based on the guidance of prescribing practitioner 15 Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain afflicted patients 16 Isolated cases of skin irritation may occur at the site of the electrode placement following long term application If this occurs discontinue use and consult your physician 17 The electrodes are only to be placed on healthy skin Avoid skin irritation by ensuring that good contact is achieved between electrodes and skin 18 If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation I
10. cm L x7 8cm W x2 8cm H Weight 425 grams with battery TENS EMS 2Hz 150Hz IF 4000Hz 4150 Hz Pulse Rate RUSS fixed rate 2500 Hz Burst rate 20HZ 80Hz Pulse width 50us 300us Adjustable 2 90 seconds 1Sec step Off Time Adjustable 0 90 seconds 1Sec step Adjustable 1 8 seconds 1 Sec step The Ramp Time On time will increase and decrease in the setting value 02 from 15 to 60 minutes Treatment time countdown automatically 33 Patient Compliance This unit can store 60 sets of operation records Total recorded time is 999 hours Two adjustable timers from 1 to 60 minutes or Continuous Adjustable in 1 minute each step 13 Treatment time from 1 to 15 minutes and 5 minutes each step 15 Low battery symbol A low battery symbol will show up when the battery is low Temperature 0 C 40 C Relative Humidity 3096 7596 Atmosphere Pressure 700hPa 1060hPa Temperature 10 C 50 C Storage conditions Relative humidity 10 90 Atmospheric pressure 700hPa 1060hPa Operating conditions Chapter 6 THERAPY PROGRAM AND WAVEFORMS TENS PROGRAM No MECHANISM TECHNICAL DESCRIPTION Five TENS program B Burst N Normal Program M Modulation SD1 Strength Duration 1 SD2 Strength Duration 2 Burst rate Adjustable 0 5 5Hz Burst program B Pulse width adjustable 50 300 Frequency fixed 100 Hz The pulse rate and pulse width are adjustable It generates continuous stimulation based
11. crease from 50 to 1096 in next 10 seconds In this program burst frequency is adjustable from 20Hz to 80Hz Modulation program M1 Burst frequency is decreased from the setting value to 20Hz in 10 seconds and then increased from 20Hz to the setting value in next 10 seconds In this program the burst RUSSIAN WAVEFORM frequency is adjustable from 20Hz to 80Hz Chapter 7 ACCESSORIES Twin Stim Plus 3 Edition Combo Stimulator comes complete with standard accessories as below Ne DESCRIPTION 50 X 50 mm Adhesive Electrodes 8PCS AA Battery 4PCS Carrying Case 1PC 8 AC Adapter 1PC Chapter 8 OPERATING INSTRUCTIONS 8 1 Check Replace the batteries Over time in order to ensure the functional safety of device changing the batteries is necessary 1 Slide the battery cover and open 2 Insert four AA batteries into the battery compartment 3 Make sure you are installing the batteries properly Be sure to match the positive and negative ends of the battery to the marking in the battery compartment of the device 4 Replace the battery cover and press to close A Caution Remove the batteries if the device is not in use for long periods of time Do not mix old and new batteries or difference type of batteries Warning If batteries leak and come into contact with the skin or eyes wash immediately with copious amounts
12. d pulse width 50 300us are fully adjustable Strength Duration program SD2 TENS WAVEFORMS 1 Burst Burst Frequency 2 Normal 3 Modulation Cycle time 4 Strength Duration EMS PROGRAM MECHANISM TECHNICAL DESCRIPTION Bronram Three EMS Modes 9 S Synchronous A Alternate Constant stimulation based on setting value Constant Only pulse width pulse rate and timer are program C adjustable in this mode Constant is equal to the Normal mode in TENS Stimulation of both channels occurs synchronously The ON time including Ramp Synchronous up and Ramp down time Therefore the program S setting ON time should be no less than two times the Ramp time in this mode ON timezRamp up Ramp down The stimulation of the CH2 will occur after the 1 contraction of CH1 is completed In this mode the setting of ON time should be no less than two times of the Ramp time The OFF time should be equal or more than the ON time ON time 2Ramp up Ramp down OFF time 2ON time Alternate program A EMS WAVEFORMS Constant C Synchronous S CH1 CH2 ON TIME OFF TIME Alternate A IF Interferential PROGRAM MECHANISM Normal program N Modulation program M TECHNICAL DESCRIPTION Three IF Modes N Normal M Modulation and M1 Modulation 1 The pulse rates of the CH1 and are fixed in 4000Hz The interference freque
13. de and stimulation is applicator placement applicator ineffective ar Unknown Contact Clinician Re position the electrodes If at any time you feel pain or discomfort stop use immediately Please check the manual before use Use the electrodes on the same site every time The electrodes aren t E cure the electrode is stuck The skin becomes Stuck onto the skin Securely on the skin red and or you feel Properly a stabbing pain Clean the electrode pads with a The electrodes dirty damp lint free cloth or replace new electrode pads The surface of the Replace new electrode electrode was scratched The electrode pads Turn off the device and stick come off the skin the electrode pad firmly to the skin Output The cable is Turn off the device and connect stops during disconnected the cable therapy The power of the Please replace them with batteries has been new batteries exhausted Chapter 13 NORMALIZED SYMBOLS Applied part of type BF 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 Refer to Instruction Manual Equipment capable of delivering output values in excess of 10mA r m s or 10V
14. erential 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 4 150 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 EXPLANATION OF RUSSIAN Russian stimulation uses medium frequencies to provide electrical stimulation to muscle groups and is used to reduce muscle spasms as well as for muscle strengthening Russian stimulation is a specific form of electro stimulation with a Symmetrical Biphasic Square waveform produced by dividing a 2500Hz carrier frequency into 20 80Hz packets This method was claimed by its author Kots to produce maximal muscle strengthening effects without significant disc
15. hed to continuous stimulation Two timers can be set in the same way Chapter 10 PATIENT COMPLIANCE METER This unit can store 60 sets of operation records Total treatment time up to 999 hours can be stored Check amp Delete Individual Record Press MODE button and turn on the power simultaneously The LCD will show the number of records and operation time Press the A or V button to check each record To delete a record press SET button for 3 seconds Check amp Delete Accumulative Record At the individual records menu press MODE button to switch to accumulative record menu Press the SET button first then press the MODE button simultaneously for 3 seconds and all of the records will be deleted followed by a beeper sound Chapter 11 MAINTENANCE AND STORAGE 1 Non flammable cleaning solution is suitable for cleaning the device Note Do not smoke or work with open lights for example candles etc when working with flammable liquids 2 Stains and spots can be removed with a cleaning agent 3 Do not submerge the device in liquids or expose it to large amounts of water 4 Return the device to the carrying box to ensure that the unit is well protected before transportation 5 If the device is not to be used for a long period of time remove the batteries from the battery compartment acid may leak from used batteries and damage the device Put the device and accessories in carrying box and keep it in coo
16. home 8 5 Turn on Before using the device for the first time you are strongly advised to take careful note of the counter indications and safety measures detailed at the beginning of this manual Safety information as this powerful equipment is neither a toy nor a gadget Press the 1 button to turn on the device 8 6 Select the therapeutic mode and program m m m n There are 4 therapeutic modes available __ _ TENS EMS IF and RUSS The therapeutic mode and program can be Width S Min selected by pressing the MODE button An n n The LCD displays as n 5 gt 5 gt TENS M TENS GSD1 5 gt 502 8 gt EMS 5S EMS A gt gt gt 1 RUSS 5N RUSS M RUSS MI e 8 7 Adjust output intensity There are 4 sets of intensity buttons which correlate to each of the 4 channels Slowly increase or decrease the intensity as directed by your physician by pressing the up or down intensity buttons under the respective channel Press the up arrow A button to increase intensity and press the down arrow V button to decrease intensity A Caution 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 8 8 Turn off the device After treatment turn the device off by pressing 1 button
17. l dry place 6 The packed TENS EMS device should be stored and transported under the temperature range of 10 C 50 relative humidity 1096 9096 atmosphere pressure 700 hPa 1060 hPa Chapter 12 TROUBLESHOOTING Make sure that the Try new batteries batteries are full and were inserted with the Reinsert batteries ensure Displays fail to correct polarity batteries are inserted correctly light up Remove the batteries and reinsert them after approx 3 seconds Electrodes Dried out or Replace contaminated p or cannot feel read Wi any stimulation ead w res Old worn damaged Replace Verify connection is secure Insure firmly Turn down the intensity Rotate lead wires in socket 90 Intermittent If still intermittent replace lead Lead wires i output wires If still intermittent after replacing lead wires a component may have failed Call the repair department Some programs will seem intermittent This is expected Option Controls in the Operation section for a description of the program option Intensity is too high Decrease intensity Stimulation is electrodes or lead wires There is an error in the electronics Intermittent Program option in output use Electrode active area Replace electrodes with size is too small large more area Stimulation is uncomfortable May not be operating the device according to the manual Improper electrode and Reposition electro
18. m C S A 9 2 2 Set ramp time A or S program Press SET button to enter setting mode The Ramp indicator displays on LCD when you select Alternate A or Synchronous S program press A or V button to adjust the parameter from 1s to 8s 9 2 3 Set ON time A or S program Press SET button again The On indicator displays on LCD press A or V button to adjust the parameter from 2s to 90s 9 2 4 Set OFF time A or S program Press SET button again The indicator displays on LCD press A or V button to adjust the parameter from 2s to 90s 9 2 5 Set pulse width Press SET button again the Width indicator displays on LCD press A V button to adjust the parameter from 50us to 300us 9 2 6 Set pulse rate Press SET button again The Rate indicator displays on LCD press A or V button to adjust the parameter from 2Hz to 150Hz 9 2 7 Set timer There are two adjustable timers available The left timer controlling the treatment time of CH1 and CH2 The right timer controlling the treatment time of CH3 and CH4 The treatment time is adjustable from 1 to 60 minutes or C Continuous Press SET button to enter this menu then press A or button to adjust the setting Press A button when the timer shows 60 minutes it will be switched to continuous stimulation Two timers can be set in the same way 9 3 Steps to set a new IF program 9 3 1 Select IF therapeutic m
19. ncies of CH2 and 4 adjustable from 1Hz to 150Hz The pulse rates of CH2 and CH4 are based on the setting value and fixed frequency 4000 2 means that pulse rate 4000Hz Interference frequency The pulse rates of the CH1 and CH3 is fixed in 4000Hz The pulse rates of CH2 and CH4 are based on the interference frequencies and fixed frequency 4000Hz means that pulse rate 4000Hz Interference frequency The interference frequencies are adjustable from 1Hz to 80Hz The pulse rates of CH2 and CH4 are modulated between setting value and 4001Hz in 10 seconds Modulation program M1 The pulse rates of the CH1 and CH3 is fixed in 4000Hz The pulse rates of CH2 and CH4 are based on the interference frequencies and fixed frequency 4000Hz means that pulse rate 4000Hz Interference frequency interference frequencies are adjustable from 80Hz to 150Hz The pulse rates of CH2 and CH4 are modulated between setting value and 4080Hz in 10 seconds IF Interferential WAVEFORM RUSS Russian PROGRAM MECHANISM Program Normal program N Modulation program M TECHNICAL DESCRIPTION Three RUSS Modes N Normal M Modulation and M1 Modulation 1 Constant stimulation based on setting value Burst frequency is adjustable from 20Hz to 80 Hz duty cycle keep at 50 Duty cycle is automatically varied in a cycle time The duty cycle is increase from 10 to 5096 in 10 seconds and then de
20. nder 510K guidelines Chapter 4 CONSTRUCTION PANEL tht ht us 1 Turn on the power 2 Select mode 3 Select setting LW 4 Increase or decrease setting value Lead connector Channel 1 Channel 2 Channel 3 and Channel 4 Liquid crystal display Panel cover Mode control Power on off control AC Adapter Set control Increment control for Pulse Rate Pulse Width and time indicators interference frequency 10 Decrement control for Pulse Rate Pulse Width and time indicators interference frequency 11 Intensity decrease control 12 Intensity increase control 13 Belt clip 14 15 Uc MEI Battery case Battery cover 1 2 3 4 5 6 7 8 Width Rate M Hr Min K D gt us Output intensity from channel 1 to channel 4 TENS EMS IF Interferential and RUSS Russian mode Therapy program Time symbol Pulse rate and pulse width indicator Lock symbol Low battery symbol Time indicator Chapter 5 TECHNICAL SPECIFICATIONS The technical specification details of Twin Stim Plus 34 Edition Combo stimulator are as follows MECHANISM TECHNICAL DESCRIPTION Four isolated between channels Type of protection against electric Class Equipment u shock Output intensity 0 40Vpp at 500 ohm load Bi Phasic Square Pulse EoWareoltes DC 6V 4xAA 1 5V battery or AC Adapter output DC 9V 800mA Size 13 8
21. ntensity 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 at the same time as other equipment which sends electrical pulses to your body 23 Do not confuse the electrode cables and contacts with your headphones or other devices and do not connect the electrodes to other devices 24 Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel 25 Inspect Applicator cables and associated connectors before each use 26 Turn the device off before applying or removing electrodes 27 Electrical stimulators should be used only with the leads and electrodes recommended for use by the manufacturer 28 This device has no AP APG protection Do not use it in the presence of explosive atmosphere and flammable mixture Adverse reactions 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 u
22. ode and program Press MODE button until the LCD display IF and expected program N M M1 9 3 2 Set interference frequency Press SET button to enter setting mode press A or V button to adjust the parameter from 1Hz to 150Hz 9 3 3 Set timer There are two adjustable timers available The left timer controlling the treatment time of CH1 and CH2 The right timer controlling the treatment time of CH3 and CH4 The treatment time is adjustable from 1 to 60 minutes or C Continuous Press SET button to enter this menu then press A or V button to adjust the setting Press A button when the timer shows 60 minutes it will be switched to continuous stimulation Two timers can be set in the same way 9 4 Steps to set a new RUSS program 9 4 1 Select RUSS therapeutic mode and program Press MODE button until the LCD display RUSS and expected program N M M1 9 4 2 Set burst frequency Press SET button to enter setting mode press A or V button to adjust the burst frequency from 20Hz to 80Hz 9 4 3 Set timer There are two adjustable timers available The left timer controlling the treatment time of CH1 and CH2 The right timer controlling the treatment time of CH3 and CH4 The treatment time is adjustable from 1 to 60 minutes or C Continuous Press SET button to enter this menu then press A or V button to adjust the setting Press A button when the timer shows 60 minutes it will be switc
23. of water Batteries must be handled by an adult Keep batteries out of the reach of children Remove exhausted batteries from the unit Dispose of batteries safety according to local regulation rmm TERRE 8 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 A Caution Always use the electrodes with CE mark or which are legally marketed in the US under 510 K procedure Connection Cables 8 3 Connect lead wires to device 1 Before proceeding to this step be sure the device is completely turned OFF 2 Insert the lead wires into the lead connectors on top of the device LEAD CONECTOR Caution Do not insert the plug of the patient lead wire into any AC power supply socket 8 4 Electrode 8 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 8 4 2 Place electrodes on skin Apply electrodes to the exact site indicated by your physician or therapist before applying
24. omfort to the patient INDICATION FOR USE For TENS and IF Interferential gt Symptomatic relief of chronic intractable pain gt Reduction of inflammation Post traumatic acute pain and edema Post surgical acute pain and edema For EMS and Russian Relaxation of Muscle spasms and edema reduction Prevention or retardation of disuse atrophy gt Increasing local blood circulation Muscle re education Maintaining or increasing range of motion gt Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis Chapter 3 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 3 1 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 trans cerebrally through the head 5 not use this device if the
25. patient has 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 Do not use this device if you have heart disease without consulting your physician 3 2 Warnings cautions and adverse reactions A 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
26. r m s averaged over any period of 5s Type of protection against electric shock Class Equipment Chapter 14 WARRANTY Twin Stim Plus 3 Edition Combo Stimulator carries a warranty of one year from the date of delivery The warranty applies to the stimulator only and covers both parts and labor relating thereto The warranty does not apply to damage resulting from failure to follow the operating instructions accidents abuse alteration or disassembly by unauthorized personnel Manufacturer for Roscoe Medical Inc 21973 Commerce Parkway Strongsville Ohio 44149 www roscoemedical com
27. to clean dry and unbroken skin only 18 Keep electrodes separate during treatment electrodes in contact with other could result in improper stimulation or skin burns 19 Keep the stimulator out of reach of children 20 Consult your doctor if you are in any doubt whatsoever 10 A Cautions 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 is 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
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