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EMSI Flex-Tens, Instruction Manual

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EMSI Flex-Tens Instruction Manual Download Page 4

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

 

Stimulation Mode Descriptions

 .............................

14

10.0

  Instructions for Use

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

17 

11.0

  Patient Compliance Timer

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

22

12.0

  Principles of TENS Treatment

 ...............................

24

13.0

  Care and Maintenance

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

25 

14.0

  Troubleshooting

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

26

Summary of Contents for Flex-Tens

Page 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 ...

Page 2: ...110103 Flex TENS 1Rev Illustrstor C版 02 0101 03 2011 07 15 58 3504 Cragmont Dr Suite 100 Tampa FL 33619 P 800 588 8383 813 931 2369 F 800 588 9282 E customerservice wecontrolpain com ...

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

Page 4: ...s 6 5 0 Precautions 7 6 0 Adverse Reactions 9 7 0 Unit Description 10 8 0 Specifications 13 9 0 Stimulation Mode Descriptions 14 10 0 Instructions for Use 17 11 0 Patient Compliance Timer 22 12 0 Principles of TENS Treatment 24 13 0 Care and Maintenance 25 14 0 Troubleshooting 26 ...

Page 5: ...d be particularly familiar with the prescription information and precautions before proceeding 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 re...

Page 6: ...uscles may occur and the contractions may occur and the contractions may be strong enough to close the airway or cause di culty in breathing 4 Stimulation 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 sk...

Page 7: ...only 13 involuntary muscle contractions may put the user at undue risk of injury 14 15 16 17 TENS is a symptomatic treatment and as it suppresses the sensation of pain which would otherwise serve as a protective mechanism 5 0 Precautions 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 Caut...

Page 8: ...timulation or medium or alternate electrode placement 5 Electrode placement and stimulation settings should be based on the guidance 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 E ctiveness is highly dependent upon patient selection by a person qualified in the management of...

Page 9: ...ximity and with relatively high transmitting power Flex TENS meets EMC requirements and is designed in such a way that under normal conditions 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 rul...

Page 10: ... pulses MODE Button Choose the TENS stimulation modes SET Button Set the pulse width pulse rate TIMER Button Sets the timer INCREASE DECREASE Button Increase and decrease pulse width pulse rate and choose the timer LOCK UNLOCK Button Locks or unlocks the unit Symmetric Asymmetric Button Choose symmetric or asymmetric waveform ...

Page 11: ...11 ...

Page 12: ...12 7 0 Unit Description continued Battery Indicator ...

Page 13: ...tric waveform Level 1 Level 20 Each level increases 1 35V Level 1 2 7V Level 2 L evel 20 Ea ch level increases 1 95V Variable 50 300 µs Variable 2 150 Hz Output Peak Pulse Output Level Output Peak Pulse Output Level Channel Power Source Output waveform Symmetric Asymmetric Pulse Width Pulse Frequency All values or 10 ...

Page 14: ... range 10 C 35 C Humidity range 20 90 RH Storage transportation Temperature Range 0 C 70 C Humidity Range 20 90 RH Timer 5 90 minutes auto shutoff or Constant 9 0 Stimulation Mode Descriptions button Be sure that when adjusting these stimulation modes the intensity output controls should be set to the minimum output first 8 0 Specifications continued ...

Page 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 o er a variety of di erent electrical stimulation thus preventing nerve accommodation so that less intensity is required for long and e ective treatment In this mode during the begin...

Page 16: ...l cycle time is 6 seconds Pulse rate from 2 to 150Hz and pulse width from 50 to 300µs are fully adjustable Bi Pulse Bi Pulse pulse rate of Channel 1 is fixed at 4Hz while delivering 100 pulses per second to Channel 2 i e the pulse rate of Channel 2 is fixed at 100Hz Stimulation vertical line Pulse width from 50 to 300 µs is fully adjustable 9 0 Stimulation Mode Descriptions continued ...

Page 17: ...O THE SOCKET A green indicator on a fully discharged battery a green steady light will illuminate Typical charge may last 2 hours of use depending on frequency and intensity of treatment 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 warr...

Page 18: ...ace electrodes on skin Before applying electrodes be sure that the skin surface over which electrodes are placed is thor oughly cleaned and dried Apply electrodes to the exact site indicated by your physician following the instruction included with the electrodes labeling Make sure that the electrodes are placed firmly 10 0 Instructions For Use continued Caution 1 Always use 1 5 x 1 5 16cm electro...

Page 19: ...tach them properly firmly and evenly Clean and dry the skin surface of the body area to be treated Inspect the electrode cords and electrode pads for wear If they are not in good condition they 6 Turn Unit O by the plug not the cord If treatment will be resumed shortly the electrodes may be left on the skin When the electrodes are removed clean the skin thoroughly with mild soap and water If there...

Page 20: ...es 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 possibility of electromagnetic disturbance from other equipment in or outsid...

Page 21: ... Level Start to Operate Choose MODE Choose Symmetric or Asymmetric waveform Press MODE Button SET ADJUST Press Symmetric Asymmetric Button CLOCK ADJUST Amplitude Control 10 0 Instructions For Use continued Operation Procedure Chart BEE P OPTION press and hold SET ...

Page 22: ...nce timer 1 Individual treatment time Press INCREASE button 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 22 ...

Page 23: ...er 999 minutes 2 Cumulative treatment time When initiating patient compliance timer press Mode to shift the record of individual treatment time with the number of sessions to the record of cumulative treatment 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...

Page 24: ...to the surface skin to have electric currents stimulate the peripheral nerve fibers TENS is believed to work by two di erent mechanisms First electrical stimulation of the fast conducting nerve fibers can block override a slow conducting pain signal from being carried to the brain spinal cord If the signal is blocked pain is not perceived Secondly the body has its own mechanism for suppressing pai...

Page 25: ...ng Clean the housing by wiping with clean damp cloth only To avoid corrosion do not immerse in water Do not store in direct sunlight or humid environments i e Bathrooms 3 Electrode Pad Disposal Electrodes should not be used if they will no longer adhere firmly to the treatment area Electrodes are single use and should not be used by more than one patient ...

Page 26: ...irmly sealed See Section 10 Instructions for Use and the electrode manufactures instruction for applying the electrodes 4 Replace cord set with another to check for broken wires Recharge battery pack Recharge battery pack If none of these measures correct the problem please contact a Customer Service Representative 1 Check all control settings Are they set to values prescribed by your medical prof...

Page 27: ...ption from your physician before use of this product WARRANTY warranty is voided if this product has been damaged by misuse abuse neglect or otherwise considered to be normal wear and tear replacement of batteries lead wires electrodes and ...

Page 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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