NeuroTrac TENS Operation Manual March 2006

NeuroTrac™ TENS Operation Manual

Warnings *

This unit must be used with the guidance of a Physiotherapist or Doctor

*

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 a flammable anaesthetic gas mixture and air or with Oxygen or Nitrous Oxide

*

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

*

Never connect the NeuroTrac™ TENS unit directly to a battery charger 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 under strict guidance from a qualified Clinician

Revised Issue Date: 25/03/2006 Document Number: VM-ECS300-OM002-10 2

NeuroTrac™ TENS Operation Manual

Contents Contents

Page

Warnings What is Pain? What is TENS? Contra Indications & Precautions Description of TENS Unit & Functions Quick Start Instructions Programmes Lock Mode Function Using the NeuroTrac™TENS Unit Treatment Modes How Long do I Use TENS For? Electrode Placement Dermatomes & Myotomes Contiguous Placement Acupuncture Points Electrode Types & Tips Suggested Electrode Placement Care & Maintenance Conditions Respond to TENS Commonly Asked Questions Specifications Warranty Dermatome Charts Clinical References

2 4 4 5 6 7 8 9 10 11 11 12 12 12 12 13 14 18 19 20 21 22 23 25

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NeuroTrac™ TENS Operation Manual

What is Pain? When we feel pain it is the body’s process of informing us that something is wrong. To feel pain is important, without this feeling abnormal conditions may go 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 pain has no useful value apart from its importance in diagnosis. Pain begins when a coded signal travels to the brain where it is decoded, and analysed. The pain message travels from the injured area of the body along small diameter nerves leading to the spinal cord. At this point the message is switched to a different kind of nerve that travels up the spinal cord to the brain area. The brain then analyses the pain message, refers it back and the pain is felt.

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

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NeuroTrac™ TENS Operation Manual

Contra Indications & Precautions Before using this equipment you must first seek the advice of your Physiotherapist 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 so advised by their Doctor During pregnancy [unless medically advised] By patients with undiagnosed pain conditions By patients with undiagnosed skin 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 cartoid 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 periods prescribed. 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 coating on the surface of the electrode. If this happens use a different make of electrode or change the electrode. If it continues try reducing the pulse width. If the problem still persists try moving the electrode position each day by just the width of the electrode, making sure the electrode positioning is still over the dermatome Keep unit out of reach of children Only use CE approved skin electrodes If in doubt about the use of the NeuroTrac™ TENS unit, call your Doctor, Therapist, Clinician or you distributor for advice

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NeuroTrac™ TENS Operation Manual

Description of TENS Unit & Functions.

Channel A

Channel B

CH.B

CH.A

LCD Display

Lead Wire and Pin Select Programme

NeuroTrac™ TENS

SET ESC

Front

Rear

* PRG button

Selects the desired set programme from P01 - P11 or customised programme PC1 - PC3.

* SET button

Displays the menu and changes the parameters for Pulse Rate, Pulse Width and Time for custom programmes.

* ESC button

Stores customised programme and returns to the home position.

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NeuroTrac™ TENS Operation Manual

Quick Start Instructions 1. 2. 3. 4. 5. 6.

Insert a 9 volt PP3 Alkaline battery. Alternatively insert a rechargeable Nickel Hydride battery [Which has a much longer life than the Ni-Cad rechargeable batteries] into the battery compartment. Insert lead wire/s to channel A and B if both channels are to be used. Switch on the unit by pressing the ON/OFF button Press the PRG [Programme] button to select one of the programmes as detailed in table 1 and table 2 on page 8. To start press channel A + and B + button if you are using both channels. To stop the programme, press the ON/OFF button which will turn the unit off.

Setting up your own continuous mode parameters for PC 1 or PC 2.. 1. Select PC1 or PC2 by pressing the PRG button on the front panel. Remove the battery lid where you will see two buttons SET and ESC. Press the SET button and the Hz symbol will flash, then press the + or – button on the front panel to adjust the Pulse Rate (frequency) from 2 - 200 Hz 2. Press the SET button again and the µS symbol will flash, then press the + or – button to adjust the Pulse Duration from 50 - 300 µS Setting up your own Modulated mode paramters for PC3. 3. Select PC3 by pressing the PRG button on the front panel. Press the + or - button on the front panel to adjust the high pulse rate (frequency) from 2 - 200 Hz. 4. Press the SET button and F LO will display. Press the + or - button on the front panel to adjust the low pulse rate (frequency) from 2 - 200 Hz. 5. Press the SET button and µS symbol will flash and W LO will display. Press the + or - button on the front panel to adjust the high pulse width from 50 - 300 µS. 6. Press the SET button and W LO will display. Press the + or - button on the front panel to adjust the low pulse width from 50 - 300 µS. 7.

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 – button to hours and Channel B + or – button to change minutes.

8.

After setting up the customised programme parameters, press the ESC button to store the information. Simply repeating the above procedure can reprogramme customised programmes.

Note: You must press the ESC button before locking the unit. 7

NeuroTrac™ TENS Operation Manual

Programmes Table 1

Table 2

Programme

P9

P10

P11

PC1

PC2

PC3

M ode

Bst

A=Con B=Bst

MF

Con

Con

MF / MP

Pulese Rate Hz

See Below

See Below

2& 100

2 to 200

2 to 200

Low: 2 to 200 High: 2 to 200

Pulse Width µS

200

200

200

50 to 50 to 300 300

Low: 50 to 300 High: 50 to 300

Time

2 hr

2 hr

2 hr

Cust

Cust

Cust

Notes: Programme 7: Pulse width modulating from 200 µS to 100 µS to 200 µS, Pulse rate modulating from 100 Hz to 65 Hz to 100 Hz over 3 seconds. Programme 9: Burst of 9 pulses of 200 µS at 150 Hz repeated 2 times per second. Programme 10: Channel A Constant 80 Hz and 200 µS. Channel B Burst of 9 pulses of 200 µS at 150 Hz repeated 2 times per second. Programme 11: 2 Hz for 3 seconds, 100 Hz for 3 seconds, repeating. Programme PC3: Pulse width modulating from high value to low value to high value, Pulse rate modulating from high value to low value to high value over 3 seconds. 8

NeuroTrac™ TENS Operation Manual

Lock Mode Function Lock Mode Function A "concealed" Lock button is included in the NeuroTrac™ TENS unit, which allows the clinician to accurately monitor the "Home Compliance" of the patient between appointments. The lock function allows the device to be locked in two ways:- One {L:T} to measure the time in use over one hour, and the 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 or alternatively {L:PT} Locking the device to measure, time, mA current used and locking the parameters in place, which then cannot be changed or altered by the patient during use. Locking the Unit Remove the battery cover and, using the end of the lead wire, gently press on the concealed lock button as shown in the diagram on page 6 until you hear a double bleep. {L:T} Lock time and Current will appear on the LCD screen. If you want to lock the parameters as well press the +/- button until {L:PT} appears. Press the ESC button to lock parameters in place. 0mA

L:T 0mA

0mA

L:PT 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 will here a single bleep, this indicates the unit is now unlocked. The information for time in use and the average m A current used can be read on the front of the LCD display as seen on the diagram below. When you have noted the information press the ESC button to bring the unit back to the Home position. Hours

45 20 mA 20 mA Ch.A

Ch.B

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NeuroTrac™ TENS Operation Manual

Using the Neurotrac™ TENS Unit RATE [Hz or pulses per second] The RATE to be selected depends primarily on the electrode placement on the patient’s body. If one uses contiguous and dermatome (the electrodes alongside or over the area of pain) electrode placement, a higher rate of 80 Hz –100Hz is desirable. The patient should experience steady continuous stimulation. It has been found that an optimal setting of 80 or 90 Hz with a pulse width of 200mS has 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 rate stimulation 2 Hz-10 Hz and pulse width of 200mS. The desired effect is for the patient to feel individual pulses. PULSE WIDTH [Duration] The wider pulse widths will deliver stronger stimulation for any given intensity [mA] setting. By using a combination of intensity and pulse duration, it is felt that various pulse widths are capable of stimulating different groups of nerve fibres. The wider pulse duration is needed to recruit motor fibres, where as the narrow pulse duration is used more on the sensory fibres. The selection of which pulse duration to use is dependent upon the intended treatment protocol. Stimulating the larger nerve fibres is thought to reduce the speed and the amount at which information is transmitted along the smaller nerve fibres. Also under certain circumstances the brain is thought to produce its own analgesic pain-killing substances, known as endorphins or endogenous opiates. Intensity [mA] Patients respond differently to the level of intensity, this is due to differences in individual patient’s skin resistance, enervation and the type and condition of electrode being used. A good formula for setting the intensity is to increase the current so that the patient feels slight muscle contraction, but not strong enough to move a joint, and then slightly reduce the intensity so that it feels comfortable. When using low rate TENS settings, individual twitches will occur. The higher rate TENS settings will increase muscle tension. It is not advised to increase the intensity to experience strong muscle contraction.

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NeuroTrac™ TENS Operation Manual

Treatment Modes There are three treatment modes available on the NeuroTrac™ TENS unit: 1. Conventional TENS or normal. This mode enables the user to select any rate between 2 Hz – 200 Hz, and a pulse width between 50mS-300mS. This is the most frequently used of the three modes. The most common selection is 80 Hz with a 200mS pulse width. 2. Burst Mode. This mode is comparable to the low rate TENS technique except that each low rate pulse is substituted for by a short BURST of 9 pulses [200mS] 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 nerve accommodation that some patient’s experience. It is achieved by continuously cycling the pulse width and rate. How Long Do I Use TENS For? This depends on the individual patient’s condition, accuracy of electrode placement, stimulation and the characteristics selected, but typically the onset of pain relief starts after 20-30 minutes. Generally TENS is used for longer periods of normally 1 hour 30 minutes per session. With some patients it can be much longer.

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NeuroTrac™ TENS Operation Manual

Electrode Placement The placement of electrodes is one of the most important parameters in achieving effective pain relief using TENS. This is best left to your Physiotherapist or Doctor to advise as to which location is most appropriate. It may transpire that various positions need to be experimented with before the user finds the most effective positioning. The positioning may be via the contiguous, dermatome, myotome, motor, trigger or acupuncture points. Dermatomes & Myotomes These are areas of the body enervated by a single nerve root via the spinal cord. Each nerve root serves a known area of the skin. The dermatomes are named after the nerve root which serves it. For details of dermatome sites refer to diagrams on pages 23 & 24. Contiguous Placement This form of electrode placement is the most common method used. It involves placing the red lead [proximal] alongside the spine where the dermatome [on which your pain lies] enters and exists. The black lead [distal] is normally placed over or near to the pain site. Your Physiotherapist or Doctor 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 site through the nerve branches that supply the pain location. Acupuncture Points The placement of the red and black electrodes on the skin forms the electrical circuit for TENS. It is the skin itself that creates the highest electrical resistance to stimulation. The Physiotherapist or Doctor may consider using acupuncture loci, which offer much lower resistance properties, as a more effective site for placing the electrodes. Accurately locating an acupuncture point can be difficult, please seek advice from your Doctor or Physiotherapist.

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NeuroTrac™ TENS Operation Manual

Electrode Types & Tips Types Available: *

Self-Adhesive Hypoallergenic electrodes have a typical life span (if looked after) of 4/6 weeks. We recommend cleaning the skin before use. After use place the electrodes back onto the plastic film then enclose them back into the ziptag plastic pouch and store in a cool environment. 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.20450 204 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 the skin with soap and water, then rinse and dry the area around the electrode site. If this does not work, try cleansing the skin with a swab impregnated with alcohol.

*

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

*

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

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NeuroTrac™ TENS Operation Manual

Suggested Electrode Placement + = Red - = Black

Finger Arthritis

Knee Arthritis

Neuralgia of Trigeninus

1

Cervical (2 Positions)

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2

NeuroTrac™ TENS Operation Manual If you are using electrodes on your face, we recommend you contact your physiotherapist or clinician for guidance

+ = Red - = Black

Cephalalgia Overorbital

Mandibular Syndrome

Phantom Limb

Herpes Zoster 15

NeuroTrac™ TENS Operation Manual

+ = Red - = Black

Back Pain

Menstrual Pain

1

Lumbar Pain (2 Positions)

Tooth Ache

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2

NeuroTrac™ TENS Operation Manual

+ = Red - = Black

Sciatic Pain (2 Positions)

1

2

Epicondylitis

Shoulder Pain

Feet Pain

Ankle Pain

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NeuroTrac™ TENS Operation Manual

Care & Maintenance 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 this can cause the stimulation to function below normal standards or not at all Examine lead wires before each treatment for loose connections or damage 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 the electrodes * Replace electrodes onto plastic film after use. If they drop onto the floor debris will adhere to conductive gel rendering the electrodes ineffective Electrode life can be considerably reduced by: * The type and condition of the skin * Deep seated moisturisers or make-up For the Best Results: * *

Before each use cleanse the skin After each use stick the pads on the shiny insert card and store in a cool and dry place, such as the fridge. (not freezer). Caution: Static electricity may damage this product

NOTE:

Only Verity Medical Ltd or appointed distributors /importers are approved to undertake servicing. 18

NeuroTrac™ TENS Operation Manual

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

* * * * * * * * *

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Period Pain Cancer Pain Back Pain General Pain Sciatica Muscular Shoulder Aches Travel Sickness Tension Nausea

NeuroTrac™ TENS Operation Manual

Commonly Asked Questions QA-

Does TENS work for all pain conditions and on all patients? There is significant variation between patients with similar pain conditions. However, it is known that TENS does work in up to 70% of cases.

QA-

How can I have a better chance of success? Seeking professional advice from your Physiotherapist or Doctor on how to best apply TENS is the best answer we can give to this question.

QA-

Are there circumstances in which TENS should not be used? Yes. For undiagnosed pain; When using a cardiac pace maker; During pregnancy and other instances as fully detailed in this manual on page 5.

QA-

Can there be any permanent side effects? There are no known permanent side effects caused by using a TENS stimulator.

QA-

How long will I have to use the TENS stimulator? Some long term chronic pain sufferers may have to use a stimulator for extended periods of time, even years. Other conditions may only need a short period of treatment lasting weeks.

QA-

If I have any medical or product queries how can I get help? Any clinical advice on the TENS stimulator should be provided by your Physiotherapist or Doctor.

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