Chattanooga Intelect TENS, Instruction Manual

Page 1: ...Intelect TENS ...

Page 2: ...Precautions 2 1 6 Adverse Reactions 3 2 PRODUCT DESCRIPTIONS 2 1 Front and Rear Panel 4 6 3 STIMULATION MODES 7 9 4 INSTRUCTIONS FOR USE 4 1 Check Battery 10 4 2 Connect electrodes to lead wires 11 4 3 Connect lead wires to unit 12 4 4 Place electrodes on skin 13 4 5 Adjust Output 13 4 6 Select the mode 14 Contents ...

Page 3: ...ust Channel Amplitude 15 4 11 Turn Unit Off 17 4 12 Patient Compliance Timer 17 4 13 Portability 20 4 14 Low Battery indicator 20 4 15 Battery 21 4 16 Care of Electrodes 21 4 17 Care of Electrode cords 21 5 HANDLING AND STORAGE 22 6 SPECIFICATION 22 7 ACCESSORIES 23 8 TROUBLESHOOTING 24 9 WARRANTY 25 ...

Page 4: ... in symptomatic relief of chronic intractable pain post traumatic and post surgical pain 1 4 Warnings 1 4 1 The long term effects of chronic electrical stimulation are unknown 1 4 2 Stimulation should not be applied over the carotid sinus nerves particularly in patients with a known sensitivity to the carotid sinus reflex 1 4 3 Stimulation should not be applied over the neck or mouth Severe spasm ...

Page 5: ...des to clean dry and unbroken skin only 1 4 13 This device should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may put the user at undue risk of injury 1 4 14 This device should be kept out of the reach of children 1 4 15 Keep electrodes separate during treatment Electrodes in contact with each other could result in improper stimulat...

Page 6: ...hould be used only with the leads and electrodes recommended for use by the manufacturer 1 5 7 Isolated cases of skin irritation may occur at the site of the electrode placement following long term application 1 5 8 Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain afflicted patients 1 5 9 If the stimulation levels are uncomfortable or become ...

Page 7: ...itude Control Channel 1 Output Receptacle Channel 2 Output Receptacle Channel 2 On Off and Amplitude Control Amplitude Knob Pulse Rate Pulse Width Battery Cover Clip Timer Lid Cover Mode Button Mode Battery Indicator Set Button Increase Button Decrease Button Channel Output Knob Cover Knob Cover Knob Cover ...

Page 8: ...lating pulses These controls located at the top of the unit regulate the amplitude or intensity of the stimulation and are the ON OFF CONTROL The ON indicator signal will stay lit as long as the unit is working and mimics the output of the electrical pulse Caution If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation intensity to a comfortable level and contact...

Page 9: ... SET button round button on the middle of the control panel This button sets the rate width and timer Press the SET button to enter a parameter setting mode including rate width and timer LCD screen This LCD will be utilized to display stimulating mode pulse width pulse rate and to display the timer The channel output is indicated on the left side Channel 1 and right side Channel 2 of the LCD scre...

Page 10: ...rsts that are delivered per second Positive pulse and negative pulse are delivered continuously at fixed 100 Hz Pulse width are adjustable from 50 300µs 3 2 NORMAL Mode The Normal mode produces a continuous train of impulses The stimulation parameters are not automatically interrupted nor varied in any way In this mode the pulse rate from 2 to 150Hz and pulse width from 50 to 300µs are fully adjus...

Page 11: ...nd thus would require increasing the intensity to further block the pain The Modulation mode offers different electrical stimulation thus preventing nerve accommodation so less intensity is required for long and effective treatment In this mode during the beginning of 0 5 sec period the WIDTH is decreased to 50 of its original setting and during the next 0 5 sec period the RATE is decreased to 50 ...

Page 12: ...ted to 67 of setting intensity equal to setting Total cycle time is 6 seconds Pulse rate from 2 150Hz and pulse width from 50 300µs are fully adjustable 3 5 Bi Pulse Mode Delivers 4 pulses per second to Channel 1 i e the pulse rate of Channel 1 is fixed at 4 Hz while delivering 100 pulses per second to Channel 2 i e the pulse rate of Channel 2 is fixed at 100 Hz Stimulation is burst on for 1 0 sec...

Page 13: ...ure that you are installing the battery properly The battery is inserted in the casing on the back of the stimulator unit BE SURE TO MATCH THE POSITIVE AND NEGATIVE ENDS OF THE BATTERY TO THE MARKINGS IN THE BATTERY COMPARTMENT OF UNIT To remove the battery cover press and pull down following the direction of the arrow indicated on the battery cover 4 INSTRUCTIONS FOR USE 10 ...

Page 14: ...nector 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 EN60601 1 and EN60601 2 such as with CE mark or which are legally marketed in the US under 510 K procedure 11 ...

Page 15: ... the lead wires are inserted correctly The unit has two output receptacles which are controlled by Channel 1 and Channel 2 Amplitude Control knobs 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 12 Self adhesive Elec...

Page 16: ...nd make good contact between the skin and the electrodes Place the electrodes over the skin attach them properly firmly and evenly ADJUSTING THE CONTROLS 4 5 Adjust Output Turn Amplitude Control knob for Channel 1 or 2 clockwise then you will hear a beep sound Before you increase the Amplitude you must select the mode rate and width Caution If the stimulation levels are uncomfortable or become unc...

Page 17: ...ec 3 Stimulation Modes Caution Consult physicians for your suitable stimulation mode 4 7 Adjust the Pulse Rate The pulses rate are adjustable 2 150Hz 2Hz 20 Hz in 1 Hz increment and 20 150 Hz in 5 Hz increment Press the SET button to enter the Pulse Rate set function then press INCREASE or DECREASE buttons to adjust Pulse Rate to the setting recommended by your medical professional ...

Page 18: ...es is a cycle During the 5 minute final count down the clock symbol will flash once every second 4 10 Adjust Channel Amplitude Turn Channel 1 or 2 clockwise The output indication will be showed on the left side Channel 1 and right side Channel 2 of the LCD screen as long as the unit is in operation Slowly turn the Channel Amplitude control until you reach the setting recommended by your medical pr...

Page 19: ...ulse Width 2 Timer by SET INCREASE DECREASE button Adjust 1 Pulse Rate 2 Pulse Width 3 Timer by SET INCREASE DECREASE button Adjust 1 Pulse Rate 2 Pulse Width 3 Timer by SET INCREASE DECREASE button Adjust 1 Pulse Rate 2 Pulse Width 3 Timer by SET INCREASE DECREASE button Adjust 1 Pulse Width 2 Timer by SET INCREASE DECREASE button Operation Procedure Chart ...

Page 20: ...ribing medical practitioner Caution When the therapy time is completed if the user doesn t turn off the amplitude knob the unit will continue beeping every 10 seconds until the amplitude knob is turned off completely 4 12 Patient Compliance Timer The patient compliance timer can memorize 60 sets of operation records the total record time is 999 hours After the unit is turned off you can start to u...

Page 21: ...ecord is deleted the unit will make a beeping sound NOTE 1 If the treatment time is under one minute it will not be recorded For example If your treatment time is 10 minutes and 30 seconds the patient compliance timer will record 10 minutes not 11 minutes 2 The patient compliance timer can only record up to 999 minutes for each treatment Therefore if you keep using the stimulator for over 999 minu...

Page 22: ... of cumulative treatment time there will be an M mark flashing on the upper right corner of middle right screen Press and hold Mode Set button simultaneously for 3 seconds to delete all the records including individual treatment time record and cumulative treatment time record The patient compliance timer will keep the records even when the battery has no charge To delect all the records press and...

Page 23: ... may be clipped to a belt shirt pocket bra or other clothing 4 14 Low Battery indicator When the low power indicator flashes the battery should be replaced with a new one as soon as possible However the stimulator will continue to operate for several more hours 20 ...

Page 24: ...er electrodes with soap and water frequently The electrodes must be dried completely before using If you are using self adhesive electrodes disregard this procedure Always use the electrodes with the requirements of the EN60601 1 and EN60601 2 such as with CE mark or which are legally marketed in the US under 510 K procedure 4 17 Care of Electrode cords Clean the electrode cords by wiping them wit...

Page 25: ...C square shape battery Size D x W x H 0 9 x 2 3 x 4 0 24 mm x 59 mm x 101 mm Weight including battery 4 4 oz 124 g Safety standard EN EN60601 1 EN EN60601 1 2 IEC 60601 2 10 Operation Ambient Temperature Range 50 95º F 10 35ºC Operation Ambient Humidity Range 20 90 RH Storage Transportation Temperature Range 32 158ºF 0 70ºC Storage Transportation Humidity Range 20 90 RH All values have 10 toleranc...

Page 26: ...z 2 150Hz Channel 1 fixed at 4Hz Channel 2 fixed at 100Hz Pulse Width 50 300µs 50 300µs 50 300µs 50 300µs 50 300µs Cycle Time 0 5 Sec Constant 1 Sec 6 Sec 2 Sec Loading 500Ω All values have 10 tolerance 7 ACCESSORIES Self Adhesive Electrodes 4 PCS 9 V Battery 1 PC Lead Wires 2 PCS Instruction Manual 1 PC 23 ...

Page 27: ...ical professional 2 Are electrodes in proper position 3 Check lead wires Be sure all connectors are firmly sealed 4 Replace cord set with another to check for broken wires 1 Replace battery with a new one 1 Replace battery with a new one If your unit does not seem to be operating correctly refer to the chart below to determine what may be wrong If none of these measures correct the problem the uni...

Page 28: ...rvice from Chattanooga Group or the selling dealer under this warranty a written claim must be made within the warranty period to Chattanooga Group or the selling dealer Chattanooga Group shall not be held liable in any event for incidental or consequential damages Some states do not allow exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not a...

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Page 30: ...2003 Encore Medical 77393A ...