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table of contents

1.0

 

Intended Use

 ..........................................................

5

2.0

 

 ........................................................

5 

3.0

 

Contraindications

 ..................................................

5

4.0

 

Warnings

 ................................................................

6

5.0

 

Precautions

 .............................................................

7

6.0

 

Adverse Reactions

...................................................

9

7.0

 

Unit Description

 ....................................................

10

8.0

 

Specifications

 ..........................................................

13

9.0

 

TENS Treatment Functions Descriptions

 ..............

14

10.0

  Instructions For Use

 ...............................................

17 

11.0

  Patient Compliance Timer

 .....................................

23

12.0

  Principles of TENS Treatment

 ...............................

24

13.0

  Care and Maintenance

 ...........................................

26 

14.0

  Troubleshooting

 .....................................................

26

 

                                                                      

  

   

Содержание Flex-IT

Страница 1: ...Instruction Manual Please read the Instruction Manual prior to use CAUTION Federal law requires a prescription from your physician before use of this product ...

Страница 2: ...3504 Cragmont Dr Suite 100 Tampa FL 33619 P 800 588 8383 813 931 2369 F 800 588 9282 E customerservice wecontrolpain com ...

Страница 3: ...CAUTION Federal law requires a prescription from your physician before use of this product ...

Страница 4: ...5 0 Precautions 7 6 0 Adverse Reactions 9 7 0 Unit Description 10 8 0 Specifications 13 9 0 TENS Treatment Functions Descriptions 14 10 0 Instructions For Use 17 11 0 Patient Compliance Timer 23 12 0 Principles of TENS Treatment 24 13 0 Care and Maintenance 26 14 0 Troubleshooting 26 ...

Страница 5: ...g You should consult with your clinician if you have specific questions or problems regarding the use of your device CAUTION Federal law restricts this device to sell by or on the order of a physician 3 0 Contraindications 1 Any electrode placement that applies current to the carotid sinus front of neck region 2 Any electrode placement that causes current to flow transcerebrally through the head 3...

Страница 6: ...tion should not be applied transthoracically through front and back of chest in that the introduction of electrical current into the heart may cause cardiac arrhythmias 5 Stimulation should not be applied over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc 6 Stimulation should not be applied over or in proximity to cancerous lesions 7 For ext...

Страница 7: ...autions 1 Caution should be used for patients with suspected or diagnosed heart problems 2 Caution should be used for patients with suspected or diagnosed epilepsy 3 Caution should be used in the presence of the following a When there is a tendency to hemorrhage following acute trauma or fracture b Following recent surgical procedures when muscle contraction may disrupt the healing process c Over ...

Страница 8: ...nce of the prescribing practitioner 6 the manufacturer 7 Isolated cases of skin irritation may occur at the site of the electrode placement following long term application 8 Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients 9 If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation amplitude to a comf...

Страница 9: ...ice if such equipment is operated in close proximity and with relatively high transmitting power there is no risk of malfunction caused by electromagnetic interference However in the case of signals from high frequency transmitters the risk of electromagnetic incompatibility when operated in close proximity to electronic apparatus cannot be totally ruled out In unusual circumstances unintended fun...

Страница 10: ...the TENS stimulation modes Burst Normal Modulated rate and width MRW Alternating modulated intensity and pulse width SD and Bi Pulse SET Button Sets the pulse width pulse rate in TENS Mode Treatment function pulse rate in INTERFERENTIAL mode TIMER Button Sets the timer INCREASE DECREASE Button Increase and decrease pulse width pulse rate and choose the the INTERFERENTIAL mode LOCK UNLOCK Button Lo...

Страница 11: ...11 LCD Display IFC Amplitude Control ...

Страница 12: ...S Mode Area Timer Channel 2 Output Level Pulse Width Battery Indicator Channel 1 Output Level Lock On Indicator Cumulative Treatment Time Function Mark IF Treatment Function Area IF Electrodes Area Pulse Rate ...

Страница 13: ...ween channels 700 mAh 4 8V Ni MH rechargeable battery pack Symmetric waveform 0 27V Loading 500Ω 54mA Loading 500Ω 1 20 levels each level increment 1 35V Variable 50 300 µs Variable 2 150 Hz Burst Normal MRW SD Bi Pulse 0 15V Loading 500Ω 30mA Loading 500Ω First level 1 5V 2 20 level each level increment 0 71V 125 µs for each phase Fixed 4000Hz Variable 1 150 Hz 1 1 abrupt Continuous 8 8 abrupt 10...

Страница 14: ...rature Range 0 C 70 C Humidity Range 20 90 RH Timer 5 90 minutes auto shutoff or Constant Mode BURST NORMAL MRW SD BI PULSE Pulse Rate Fixed 100Hz 2 150Hz 2 150Hz 2 150Hz Channel 1 fixed at 4Hz Channel 2 fixed at 100 Hz Pulse Width 50 300 µs 50 300 µs 50 300 µs 50 300 µs 50 300 µs Cycle Time 0 5 Sec Constant 1 Sec 6 Sec 2 Sec 9 0 TENS Treatment Functions Descriptions 8 0 Specifications continued A...

Страница 15: ...and width settings Modulated Rate Width MRW massage like sensation It s believed that nerves can become accustomed to or ac commodated to the same electrical stimulus after a period of time and thus would produced to offer a variety of different electrical stimulation thus preventing nerve accommodation so that less intensity is required for long and effective treatment In this mode during the beg...

Страница 16: ...ime is 6 seconds Pulse rate from 2 to 150Hz and pulse width from 50 to 300µs are fully adjustable Bi Pulse Bi Pulse rate of Channel 1 is fixed at 4Hz while delivering 100 pulses per second to Chan nel 2 i e the pulse rate of Channel 2 is fixed at 100Hz Stimulation is burst on Pulse width from 50 to 300 µs is fully adjustable 9 0 TENS Treatment Functions Descriptions continued ...

Страница 17: ...rence frequency changes over time 8 8 abrupt 75Hz to 155Hz in the above example is held for 8 seconds 10 10 ramped of rapidly For example when the frequency control was set at 100 the device will sweep gradually from 75Hz to 155Hz over a 10 second period then from 155Hz to 75Hz during the next 10 seconds 10 0 Interferential Treatment Functions Descriptions NOTE In order to receive a true interfere...

Страница 18: ...eatment NOTE charger plug is plugged into an outlet Once charged or not in a charging mode disconnect the plug from the device Use of unapproved charger not issued by EMSI may cause damage to device and will void any warranty CONNECTING THE STIMULATOR 2 Connect electrodes to lead wires Insert the lead wire connector into electrodes connector standard 0 08 inch female connection MAKE SURE THAT NO B...

Страница 19: ...ons on the front 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 4 Place electrodes on skin Before applying electrodes be sure that the skin surface over which electrodes are placed is thoroughly cleaned and dried Apply electrodes to the exact site indicated by your physician following Caution Always use leadwires that came wi...

Страница 20: ...our medical professional NOTE treatment is in session Lock the settings for the duration of the treatment by pressing and holding the key button for locks if no treatment button is pressed for 1 minute Once locked other than the power button no buttons are active To disable the Lock during treatment session for adjustment or stoppage press and hold the key Caution When the timer runs out the unit ...

Страница 21: ...ncreasing intensity until you can feel the tingling sensation high pulse rates or pulsing sensation low pulse rates of the stimulation Your prescribing clinician will tell you how far they wish you to turn up the intensity If at any time the electrical stimulation begins to feel uncomfortable reduce the stimulation amplitude to a comfortable level and contact your physician if the problem persist ...

Страница 22: ...OUTPUT LEVEL START TO OPERATE BEEP OPTION p ess and hold SET button to activate deactivate AMPLITUDE CONTROL SET ADJUSTMENT CHOOSE B N MRW SD B Pulse as ecommended by you cl n c an SET PARAMETER Pulse Rate Pulse W dth as SET T MER as ecommended by you cl n c an TENS IF MODE SET ADJUST CHOOSE VARY PERIOD 1 1 C 8 8 10 10 as SET FREQUENCY as ecommended by you cl n c an SET TIMER as ecommended by you ...

Страница 23: ...utton triangle button or DECREASE button inverted triangle button to scroll through the records of treatment times Press and hold Set button for 3 seconds to delete the displayed record After the displayed record is deleted the unit will acknowledge with an audible response Bi NOTE a If the treatment time is under one minute it will not be recorded For example if your treatment time 23 ...

Страница 24: ...reatment time When showing the record of cumulative treatment time there will be an M mark flashing on the screen Press and hold Mode Set button simultaneously for 3 seconds to delete all the records includ ing individual treatment time record and cumulative treatment time record users press and hold Set or Mode Set the records will be deleted 12 0 Principles of TENS Treatment TENS Transcutaneous ...

Страница 25: ...al is blocked pain is not perceived Secondly the body has its own mechanism for suppressing pain It does this by releasing non addictive natural chemicals called of TENS treatment is not 100 for all pain syndromes Experimentation with setting and electrode placement may be required for best results 13 0 Care and Maintenance 1 Low Battery Indicator When the low battery indicator flashes the batteri...

Страница 26: ...d by your medical professional 2 Are electrodes in proper position and adhering to the skin 3 Check lead wires Be sure all connectors are firmly sealed 4 Replace cord set with another to check for broken wires None of LCD indicators illuminate 1 Ensure battery pack is inserted in battery compartment 2 Ensure battery pack is matched with correct polarity as shown on battery and compartment 3 Ensure...

Страница 27: ...arranted against defect or workmanship for this period This warranty is voided if this product has been damaged by misuse abuse neglect or otherwise used in a manner not suited or prescribed for this product This warranty is voided with use of unapproved electrodes lead wires chargers or batteries This warranty does not cover what is considered to be normal wear and tear replacement of batteries l...

Страница 28: ...a prescription from your physician before use of this product 3504 Cragmont Dr Suite 100 Tampa FL 33619 P 800 588 8383 813 931 2369 F 800 588 9282 E customerservice wecontrolpain com Copyright 2016 by EMSI All Rights Reserved REV G ...

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