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1 NeuroTrac TENS Operators Manual Visit our website: www.VerityMedical.co.uk for detailed application protocols DUAL CHANNEL TENS UNIT

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Page 1: NeuroTrac TENS - media.supplychain.nhs.uk · NeuroTrac™ TENS Operation Manual 4 When we feel pain it is the body’s process of informing us that something is wrong. To feel pain

NeuroTrac™ TENS Operation Manual

1

NeuroTrac™

TENS

Operators ManualVisit our website: www.VerityMedical.co.uk for

detailed application protocols

DUAL CHANNEL TENS UNIT

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* This unit must be used with the guidance of a Physiotherapist orDoctor

* Type BF equipment

* Do not insert lead wires into a mains power supply

* Do not immerse unit into water or any other substance

* Do not use the NeuroTrac™ TENS unit in the presence of aflammable anaesthetic gas mixture and air or with Oxygen or NitrousOxide

* If using rechargeable 9 volt PP3 Nickel Metal Hydride or Ni-Cadbatteries be sure to use a CE approved battery charger

* Never connect the NeuroTrac™ TENS unit directly to a batterycharger or any other mains powered equipment

* Patient Electrodes are for single patient use only

* Keep out of reach of children

* Do not use this stimulator on your facial area unless you are understrict guidance from a qualified Clinician

Warnings

Revised Issue Date: 07/08/2002 Document Number ECS300-OM002-7

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Contents Page

Warnings 2What is Pain? 4What is TENS? 4Contra Indications & Precautions 5Description of TENS Unit & Functions 6Quick Start Instructions 7Programmes 8Lock Mode Function 9Using the NeuroTrac™TENS Unit 10Treatment Modes 11How Long do I Use TENS For? 11Electrode Placement 12Dermatomes & Myotomes 12Contiguous Placement 12Acupuncture Points 12Electrode Types & Tips 13Suggested Electrode Placement 14Care & Maintenance 18Conditions Respond to TENS 19Commonly Asked Questions 20Specifications 21Warranty 22Dermatome Charts 23Clinical References 25

Contents

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When we feel pain it is the body’s process of informing us that something iswrong. To feel pain is important, without this feeling abnormal conditions maygo undetected, creating damage or injury to critical parts of the body.

Although pain is essential in warning our body of trauma or malfunction,nature may have gone too far in its design. Continued long-term chronic painhas no useful value apart from its importance in diagnosis. Pain begins when acoded signal travels to the brain where it is decoded, and analysed. The painmessage travels from the injured area of the body along smalldiameter nerves leading to the spinal cord. At this point the message isswitched to a different kind of nerve that travels up the spinal cord to the brainarea. The brain then analyses the pain message, refers it back and the pain isfelt.

What is TENS?Transcutaneous Electrical Nerve Stimulation (TENS) uses a small batteryoperated unit to provide a non-invasive, drug free method of controlling acuteand principally long term intractable pain. It can also be used as anadjunctive treatment in the management of post surgical traumatic painproblems. In TENS mild electrical impulses are transmuted through the skinvia surface electrodes to modify the body’s pain perception. TENS does notcure problematic physiological conditions; it only helps to control the painperception. TENS will not work for every user. However Physiotherapists andDoctors throughout the world prescribe TENS extensively and it isgenerally seen to work for the majority of users. There are millions of smallnerve fibres throughout the body and it only requires a few impulses toproduce chronic pain. In addition to small fibres, which allow the sensation ofpain to be felt, the body is also made up of larger diameter nerve fibres. Theselarger nerve fibres transmit less unpleasant sensations such as touch or warmth,assisting us to form an impression of our environment. Stimulating the largernerve fibres using TENS may have the effect of inhibiting the transmission ofpain along the smaller nerve fibres to the spinal cord [known as the ‘Pain GateTheory’].

What is Pain?

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Before using this equipment you must first seek the advice of yourPhysiotherapist or Doctor.

Read this operating manual before using the TENS unit

TENS should not be used:

* By patients fitted with a demand style cardiac pacemakers unless soadvised by their Doctor

* During pregnancy [unless medically advised]* By patients with undiagnosed pain conditions* With patients who have diminished mental capacity or physical

competence who cannot handle the device properly* On anaesthetised or desensitised skin* When driving a vehicle or operating potentially dangerous

equipment* Do not place electrodes:

* Over carotid sinus nerves* Over larynx or trachea* Inside mouth* Over the area of the heart unless so advised by your Doctor* On your facial area unless under strict guidance from a

qualified Clinician* The patient should use the unit only as prescribed* Do not immerse the unit in water or any other liquid* If you experience skin irritation this may be due to over-stimulation.

In this case leave the skin to heal and use TENS only for the periodsprescribed. Turning the current up too high can cause skin irritation.In this case allow the skin to heal and use TENS at a lower intensity.Some people experience an allergic reaction to the adhesive coatingon the surface of the electrode. If this happens use a different makeof electrode or change the electrode. If it continues try reducing thepulse width. If the problem still persists try moving the electrodeposition each day by just the width of the electrode, making sure theelectrode positioning is still over the dermatome

* Keep unit out of reach of children* If in doubt about the use of the NeuroTrac™ TENS unit, call your

Doctor, Therapist, Clinician or Verity Medical Ltd. for advice

Contra Indications & Precautions

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Front Rear

* PRG button Selects the desired set programme from P01 - P12 orcustomised programme PC1 - PC2.

* SET button Displays the menu and changes the parameters forPulse Rate, Pulse Width and Time for customprogrammes.

* ESC button Stores customised programme and returns to thehome position.

Description of TENS Unit & Functions.

LCDDisplay

SelectProgramme

SET

Channel A Channel B

NeuroTrac™TENS

CH.B CH.A

LeadWire

and Pin LockButton

ESC

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1. Insert a 9 volt PP3 Alkaline battery. Alternatively insert a rechargeableNickel Hydride battery [Which has a much longer life than the Ni-Cadrechargeable batteries] into the battery compartment.

2. Insert lead wire/s to channel A and B if both channels are to be used.3. Switch on the unit by pressing the ON/OFF button4. Press the PRG [Programme] button to select one of the programmes as

detailed in table 1 and table 2 on page 8.5. To start press channel A + and B + button if you are using both

channels.6. To stop the programme, press the ON/OFF button which will turn the

unit off.

Setting up your own Constant mode parameters.

1. Select PC1 or PC2 by pressing the PRG button on the front panelRemove the battery lid where you will see two buttons SET and ESC.Press the SET button and the Hz symbol will flash IN/OFF, then pressthe + or – button on the front panel to adjust the Pulse Rate from 2-200 Hz

2. Press the SET button again and the µS symbol will flash on/off, thenpress the + or – button to adjust the Pulse Duration from 50 - 300µS

3. Press the SET button again and the Clock symbol will flash ON/OFF,then press the + or – button to adjust the time. Channel A + or – buttonto hours and Channel B + or – button to change minutes.

After setting up the customised programme parameters, press the ESC buttonto store the information. Simply repeating the above procedure canreprogramme customised programmes.

Note: You must press the ESC button before locking the unit.

Quick Start Instructions

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Programmes

grP 1P 2P 3P 4P 5P 6P 7P 8P

edoM noC noC tsruB FM noC noC noC noC

zHqerF 08 08 2 56/001 01 001 05 06

esluPhtdiW

002 571 002 001/002 571 571 001 57

emiT rh4 rh4 rh4 rh4 rh4 rh4 rh4 rh4

grP 9P 01P 11P 21P 1CP 2CP

edoM noC noC FM tsruB motsuC motsuC

qerFzH

2 08 001/56 2

esluPhtdiW

571 571 001/002 571

emiT rh4 rh5.1 snim54 snim53

Table 1

Table 2

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Lock Mode Function

A "concealed" Lock button is included in the NeuroTrac™ TENS unit, whichallows the clinician to accurately monitor the "Home Compliance" of thepatient between appointments. The lock function allows the device to belocked in two ways:- One {L:T} to measure the time in use over one hour, andthe average mA current used, leaving the parameters i.e. Constant, Burst,Modulation and the Rate and Pulse Width to be freely altered by the user oralternatively {L:PT} Locking the device to measure, time, mA current usedand locking the parameters in place, which then cannot be changed or alteredby the patient during use.

Locking the Unit

Remove the battery cover and, using the end of the lead wire, gently press onthe concealed lock button as shown in the diagram on page 6 until you hear adouble bleep. {L:T} Lock time and Current will appear on the LCD screen. Ifyou want to lock the parameters as well press the +/- button until {L:PT}appears. Press the ESC button to lock parameters in place.

L:T L:PT0mA 0mA 0mA 0mA

Ch.A Ch.B Ch.A Ch.B

To Unlock the Unit

To unlock the unit and display the lock information, remove the battery cover,using the end of the 2mm dia pin press the concealed switch once and you willhere a single bleep, this indicates the unit is now unlocked. The information fortime in use and the average m A current used can be read on the front of theLCD display as seen on the diagram below. When you have noted theinformation press the ESC button to bring the unit back to the Home position.

Hours 4520 mA 20 mA

Ch.A Ch.B

Lock Mode Function

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RATE [Hz or pulses per second]

The RATE to be selected depends primarily on the electrode placement on thepatient’s body. If one uses contiguous and dermatome (the electrodes alongsideor over the area of pain) electrode placement, a higher rate of 80 Hz –100Hz isdesirable. The patient should experience steady continuous stimulation. It hasbeen found that an optimal setting of 80 or 90 Hz with a pulse width of 200µShas good effect for most patients and is a good first choice for pain-gating.Patients using Trigger, motor or acupuncture points tend to respond to low ratestimulation 2 Hz-10 Hz and pulse width of 200µS. The desired effect is for thepatient to feel individual pulses.

PULSE WIDTH [Duration]

The wider pulse widths will deliver stronger stimulation for any givenintensity [mA] setting. By using a combination of intensity and pulseduration, it is felt that various pulse widths are capable of stimulatingdifferent groups of nerve fibres. The wider pulse duration is needed to recruitmotor fibres, where as the narrow pulse duration is used more on the sensoryfibres.The selection of which pulse duration to use is dependent upon the intendedtreatment protocol.

Stimulating the larger nerve fibres is thought to reduce the speed and theamount at which information is transmitted along the smaller nerve fibres. Alsounder certain circumstances the brain is thought to produce its ownanalgesic pain-killing substances, known as endorphins or endogenous opiods.

Using the Neurotrac™ TENS Unit

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There are three treatment modes available on the NeuroTrac™ TENS unit:

1. Conventional TENS or normal. This mode enables the user to select anyrate between 2 Hz – 200 Hz, and a pulse width between 50µS-300µS. This isthe most frequently used of the three modes. The most common selection is 80Hz with a 200µS pulse width.

2. Burst Mode. This mode is comparable to the low rate TENS techniqueexcept that each low rate pulse is substituted for by a short BURST of 9 pulses[200µS] at 150 Hz. It is a combination of conventional and low rate TENS.The burst mode is often referred to as acupuncture - like TENS.

3. Modulation TENS this mode was designed to help prevent nerveaccommodation that some patient’s experience. It is achieved bycontinuously cycling the pulse width and rate.

Intensity [mA]Patients respond differently to the level of intensity, this is due to differences inindividual patient’s skin resistance, enervation and the type and condition ofelectrode being used.

A good formula for setting the intensity is to increase the current so that thepatient feels slight muscle contraction, but not strong enough to move a joint,and then slightly reduce the intensity so that it feels comfortable. When usinglow rate TENS settings, individual twitches will occur. The higher rate TENSsettings will increase muscle tension. It is not advised to increase the intensityto experience strong muscle contraction.

How Long Do I Use TENS For?This depends on the individual patient’s condition, accuracy of electrodeplacement, stimulation and the characteristics selected, but typically the onsetof pain relief starts after 20-30 minutes. Generally TENS is used for longerperiods of normally 1 hour 30 minutes per session. With some patients it canbe much longer.

Treatment Modes

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The placement of electrodes is one of the most important parameters inachieving effective pain relief using TENS. This is best left to yourPhysiotherapist or Doctor to advise as to which location is most appropriate. Itmay transpire that various positions need to be experimented with before theuser finds the most effective positioning. The positioning may be via thecontiguous, dermatome, myotome, motor, trigger or acupuncture points.

Dermatomes & MyotomesThese are areas of the body enervated by a single nerve root via the spinalcord. Each nerve root serves a known area of the skin. The dermatomes arenamed after the nerve root which serves it. For details of dermatome sites referto diagrams on pages 23 & 24.

Contiguous PlacementThis form of electrode placement is the most common method used. Itinvolves placing the red lead [proximal] alongside the spine where thedermatome [on which your pain lies] enters and exists. The black lead [distal]is normally placed over or near to the pain site. Your Physiotherapist orDoctor may direct the current to cross through the pain area or using the‘bracket’ system allow the current to flow on either side of the pain sitethrough the nerve branches that supply the pain location.

Acupuncture PointsThe placement of the red and black electrodes on the skin forms the electricalcircuit for TENS. It is the skin itself that creates the highest electricalresistance to stimulation. The Physiotherapist or Doctor may consider usingacupuncture loci, which offer much lower resistance properties, as a moreeffective site for placing the electrodes.Accurately locating an acupuncture point can be difficult, please seek advicefrom you doctor or physiotherapist.

Electrode Placement

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Types Available:

* Self-Adhesive Hypoallergenic electrodes have a typical life span(if looked after) of 4/6 weeks. We recommend cleaning the skin beforeuse. After use place the electrodes back onto the plastic film thenenclose them back into the ziptag plastic pouch and store in a coolenvironment.

Types available:VS.4040 40 x 40 mm (square),VS.5050 50 x 50 mm (square) (recommended for general use),

VS.9050 90 x 50 mm (rectangular)VS.10050 100 x 50 mm (rectangular) (recommended for large muscles),VS.13050 130 x 50 mm (rectangular),

VS.30 30 mm Diameter (round),VS.50 50 mm Diameter (round),VS.62 62 mm Diameter (round),VS.75 75mm Diameter (round).

A Few Good Tips [Self- Adhesive Electrodes]

* If you find the electrodes will not stick due to oily skin, cleanse theskin with soap and water, then rinse and dry the area around theelectrode site. If this does not work, try cleansing the skin with a swabimpregnated with alcohol.

* Clip away hairy skin using a scissors; don’t use a razor to remove thehairs!

The electrodes conductive material is water- based. If it becomes saturated(e.g. from perspiration), it will lose its adhesive qualities. After use leave theelectrodes face up overnight to dry out. At some point the electrodes willbecome dry. Moisten the adhesive surface with a few drops of water, and applyonto the plastic film overnight. This procedure will give you a few more daysof electrode life.

Electrode Types & Tips

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Suggested Electrode Placement

Finger Arthritis Knee Arthritis

Neuralgia of Trigeninus

Cervical (2 Positions)

1 2

+ = Red- = Black

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Mandibular Syndrome

Herpes Zoster Phantom Limb

Cephalalgia Overorbital

If you are using electrodes on your face, we recommend

you contact your physiotherapist or clinician for guidance

+ = Red- = Black

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Back Pain Menstrual Pain

Lumbar Pain (2 Positions)

Tooth Ache

1 2

+ = Red- = Black

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Feet Pain Ankle Pain

Sciatic Pain (2 Positions)

Epicondylitis Shoulder Pain

1

2

+ = Red- = Black

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Control Unit:

* Wipe the surface once a week with a damp cloth or antiseptic wipe* Do not use cleaning sprays or alcohol based cleaning solutions

Battery:

* Check periodically for any discharge from the battery* Remove battery completely from unit if not in use for any

extended period of time (typically one week)* Low battery indicator of 6.9 volts shown on LCD display When

flashing change battery for a new one* Preferably use a PP3 alkaline battery

Lead Wires

* The lead wires should be handled carefully and never stretched, as thiscan cause the stimulation to function below normal standards or not atall

* Examine lead wires before each treatment for loose connections ordamage

* Avoid stretching and twisting the lead wires* Store the lead wires carefully after each use

Self-Adhesive Electrodes

* Check the short connectors have not become separated from theelectrodes

* Replace electrodes onto plastic film after use. If they drop onto thefloor debris will adhere to conductive gel rendering the electrodesineffective

Caution: Static electricity may damage this product

Note: Only Verity Medical Ltd or appointed distributors/importers areapproved to undertake servicing.

Care & Maintenance

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Conditions that respond to TENS

* Arthritis* Post Operative Pain* Lumbago* Sports injury* Phantom Limb Pain

following Amputation* Skeletal Pains* Neuralgia* Whiplash* Rheumatoid and* Osteo Arthritis

* Period Pain* Cancer Pain* Back Pain* General Pain* Sciatica* Muscular Shoulder

Aches* Travel Sickness* Tension* Nausea

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Q - Does TENS work for all pain conditions and on all patients?A - There is significant variation between patients with similar pain

conditions. However, it is known that TENS does work in up to 70%of cases.

Q - How can I have a better chance of success?A - Seeking professional advice from your Physiotherapist or Doctor on

how to best apply TENS is the best answer we can give to thisquestion.

Q - Are there circumstances in which TENS should not be used? A - Yes. For undiagnosed pain; When using a cardiac pace maker;

During pregnancy and other Instances as fully detailed in this manualon page 5.

Q - Can there be any permanent side effects?A - There are no known permanent side effects caused by using a TENS

stimulator.

Q - How long will I have to use the TENS stimulator?A - Some long term chronic pain sufferers may have to use a stimulator

for extended periods of time, even years. Other conditions may onlyneed a short period of treatment lasting weeks.

Q - If I have any medical or product queries how can I get help?A - Any clinical advice on the TENS stimulator should be provided by

your Physiotherapist or Doctor.

Commonly Asked Questions

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TENS

1. Dual channel: individually isolated circuits.2. Amplitude: 0-80 mA; indication only; actual mA will tend to be less

than indicated due to electrode impedance.3. Type: Constant Current.4. Waveform: Asymmetrical, rectangular bi-phasic with zero DC

current.5. Selectable pulse width: 50µS -300µS [2% accuracy].6. Pulse Rate selection: in the continuous mode 2 – 200 Hz

[2% accuracy].7. Mode: Continuous, Burst or Modulated.8. Burst mode: Bursts of 9 pulses [200 µS] at 150 Hz, repeating twice

every second.9. Modulation mode: 6-second cycle of concurrent width

modulation and pulse repetition rate modulation. Width starting at200µS and decreasing exponentially to 100µS in three seconds andthen returning back to 200µS in the next three seconds. Rate startingat 100Hz, decreasing exponentially to 65 Hz and then returning to100Hz.

10. Time duration of the treatment selectable: 1 minute to 12 hours.11. Low Battery Indicator: If the battery goes below 6.9 volts +/- 0.2

volts the battery symbol will flash on/off once every second.12. If the battery voltage is below 6.6 (+/- 0.2) volts the unit will not turn

on.13. Open Electrode Detect: If an open circuit is detected at the

output of channel A or B the output current will be reset at zero.14. Physical dimensions: 108 x 62 x 23 mm.15. Weight: 0.07KG without battery, 0.1KG with battery.16. Environmental conditions for storage & transport:

-10 to +50 degrees Centigrade0-90% Humidity.

Specifications

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Verity Medical Ltd provides a warranty to the original purchaser that thisproduct will be free from defects in the material, components andworkmanship for a period of 2 years from the date of purchase [invoice date].If Verity Medical Ltd are satisfied that the product/s is defective thepurchaser may return this unit/s to Verity Medical Ltd or the appointeddistributor for repair or replacement with a new unit. All returns must first beauthorised by Verity Medical Ltd in advance. The liability of Verity MedicalLtd under this limited product warranty does not extend to any misuse or abusesuch as dropping or immersing the unit in water or other liquidsubstance or tampering with the unit or normal wear and tear. Any evidence oftampering will nullify this warranty.

Customer ServiceAny queries should be addressed to:Verity Medical Ltd :- Uplands Place

Drove RoadChilboltonNr StockbridgeHampshire SO20 6ADEngland

Tele: +44 (0)1264 860354Fax: +44 (0)1264 860825

Email: [email protected]: www.VerityMedical.co.uk

The NeuroTrac is CE Approved

Design Registration Numbers: 2095095, 2095096, 2098278

Warranty

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Anterior View

Dermatome Charts

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Posterior View.

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Conventional TENS:

Bates JAV, Nathan PW [1980] Transcutaneous electrical nervestimulation for chronic pain. Anaesthesia 35: 817-22

Ellis B [1995] Transcutaneous electrical nerve stimulators: outpatientresponse to a temporary home loan programme Br J The Rehabil 2 [8]:419-23

Frampton V, Bowesher D, eds. Pain Management by Physiotherapy.Butterworth Heinemann, London: 115 –39

Hosobuchi Y, Adams J E, Linchitz R [1977] Pain relief by electrical stimula-tion of the central gray matter in humans and its reversal by naloxone. Science197: 183 –186

Lundberg TMD. Et, al [1984] Physiotherapy Vol. 70 No. 3 98-100

Melzack R, Wall P D [1965] Pain mechanisms: a new theory. Science 150:971 –979

Tulgar M, McGlone F, Bowsher D, Miles J B [1991b]Comparitive effective-ness of different stimulation modes in relieving pain: part II. A double blindcontrolled long-term clinical trial Pain 4: 156-62

Walker J [1992] When self-help begins at home Prof Nurse 7 [10]: 662-4

Clinical References

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Revised Issue Date: 07/08/2002 Document Number ECS300-OM002-7

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Uplands PlaceDrove RoadChilboltonNr StockbridgeHampshire SO20 6ADEngland

Tele: +44 (0)1264 860354Fax: +44 (0)1264 860825

Email: [email protected]: www.VerityMedical.co.uk

Not for sale or use in the USA