NeuroTrac TENS Dual Unit Channel TENS Operators Manual Aug 2015

NeuroTrac® TENS Operation Manual

Symbols on the unit and case Caution! (electrical output).

Follow operating instructions! Failure to do so could place the patient or operator at risk. afgafadf TENS should not be used by those fitted with a demand style pacemaker, unless directed to do so by a healthcare provider.

REF

Patient’s shock protection type: BF (Body Floated) Equipment. This equipment is not earthed but contains a battery within an insulated unit. Indicates the manufacturer’s catalogue number so that the medical device can be identified. Manufacturer's LOT/Batch number. Present it together with SN number when you report a technical fault or claim a warranty return. Manufacturer's serial number of the unit. Present it together with LOT number when you report a technical fault or claim a warranty return. Name and address of Manufacturer. Date of manufacture. Conformity indication with the essential health and safety requirements set out in European Directives. 0088 - Notified Body identification (LRQA Ltd.) This product should be kept dry.

IP20 on the unit

This is an indication for protection against ingress of water and particulate matter. The mark IP20 on your unit means: your unit is protected against solid foreign objects of 12.5mm dia and greater. Not protected against water.

IP02 on the case

IP02 on the carrying case means: Protected from the ingress of water droplets from a shower of rain. Do not dispose in normal dustbin (see page 19 for the disposal instructions).

2

NeuroTrac® TENS Operation Manual

Warnings * * * * * * *

* * * * * * *

This unit must be used with the guidance of a Physiotherapist or Doctor. Type BF equipment, Continuous Operation. Do not insert lead wires into a mains power supply. Do not immerse unit into water or any other substance. The unit is not protected from the ingress of water droplets from a shower of rain if used outside the carrying case. 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 batteries, be sure to use a CE approved battery charger. Never connect the NeuroTrac® TENS directly to a battery charger or to any other mains powered equipment. We advise not to use Ni-Cad rechargeable batteries. Skin electrode pads are for single patient use only. Keep out of reach of children. Do not use this TENS machine on your face unless you are under strict guidance from a qualified Clinician. Application of electrodes near the thorax may increase the risk of cardiac fibrillation. Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy equipment may produce instability in the stimulator output. Simultaneous connection of a patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator. No modification of this equipment is allowed!

3

NeuroTrac® TENS Operation Manual

Contents Contents:

Page:

Unit symbols explained Warnings Intended Purpose 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, Accessories and Disposal Indications for use Specifications Information regarding Electromagnetic compatibility and interference (EMC) Troubleshooting Commonly Asked Questions Warranty Dermatome Charts Clinical References

2 3 5 5 5 6 7 8 9 10 11 12 12 13 13 13 13 14 15 19 20 21

4

22 26 27 28 29 31

NeuroTrac® TENS Operation Manual

Intended Purpose 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 adjunctive treatment in the management of post surgical traumatic pain problems. Mild electrical impulses are transmitted through the skin via surface electrodes to modify the body's pain perception.

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 transmitted 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. Please seek advice from your Doctor. 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’].

5

NeuroTrac® TENS Operation Manual

Contra Indications & Precautions Before using this equipment you must first seek the advice of your Physiotherapist or Doctor. Please read this manual before using the TENS machine. 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 the mouth. > Over the area of the heart unless so advised by your Doctor. > On your face unless under strict guidance from a qualified Clinician. > Do not apply stimulation across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus) or via electrodes placed on the chest and upper back or crossing over the heart. 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. 6

NeuroTrac® TENS Operation Manual

Description of TENS Unit & Functions

Channel A

Concealed button locks the selected programme and records the patient’s home compliance. Use a metal pin of the lead wire to press the concealed button located in the battery compartment.

Channel B

+ to start programme ESC to stop programme or escape from settings

Select Programme

Press SET for 3 seconds to go to Custom programme settings

Lead Wire and Pin

Lock Button

Back

Front

* PRG button * SET button

* ESC button

Selects the desired set programme from P01 - P11 or customised programme PC1 - PC3. This button works only for programmes PC1-PC3. Press and hold SET button for 3 seconds to set parameters of your custom treatment: Pulse Rate, Pulse Width, Time, etc. Stores customised programme and returns to the home position.

7

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 is safer and 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. Press and hold the SET button for 3 seconds 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 parameters for PC3. 1. Select PC3 by pressing the PRG button on the front panel. Press and hold the SET button for 3 seconds until FHI is displaid. Press the + or button on the front panel to adjust the high pulse rate (frequency) from 2 - 200 Hz. 2. Press the SET button and FLO will display. Press the + or - button on the front panel to adjust the low pulse rate (frequency) from 2 - 200 Hz. 3. Press the SET button and µS symbol will flash and WLO will display. Press the + or - button on the front panel to adjust the high pulse width from 50 - 300 µS. 4. Press the SET button and WLO will display. Press the + or - button on the front panel to adjust the low pulse width from 50 - 300 µS. 5. 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. 6. After setting up the customised programme parameters, press the ESC button to store the information. Simply repeating the above procedurecan reprogramme customised programmes. Note: You must press the ESC button before locking the unit. 8

NeuroTrac® TENS Operation Manual

Programmes Table 1 Programme Mode Pulse rate [Hz]

P1

P2

P3

CON

CON

CON CON

CON CON MP/MF

90

90

80

100

10

2

100/65

10/90

Pulse duration [µS] Time

200

175

200

200

200

200

200/100

200

4hr

4hr

4hr

4hr

4hr

4hr

2hr

2hr

P9

P11

PC1

PC2

MF

CON

CON MF/MP

Pulse rate [Hz] see below Pulse duration [µS] 200

P10 A=con B=BST see below

2& 100

2 to 100

2 to 100

175

200

50 to 50 to Low:50 to300 300 300 High:50 to300

Time

2hr

35min

cust

P4

P5

P6

P7

P8 MF

Table 2 Programme Mode

BST

2hr

Notes: Programme 7:

cust

PC3

Low:2 to100 High:2 to100

cust

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.

9

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

10

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 –100 Hz 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 200µS 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 200µS. 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.

11

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 50µS-300µS. This is the most frequently used of the three modes. The most common selection is 80 Hz with a 200µS 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 [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 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.

12

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 26 & 27. 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.

13

NeuroTrac® TENS Operation Manual

Electrodes Types and Tips *

Self-Adhesive reusable long-term electrodes (if looked after) have a typical life span of 4/6 weeks. We recommend cleaning the skin with an alcohol-based wipe before placing the electrodes. The wipe should not contain fat as any grease will degrade the electrode stickiness. After use, place the electrodes back onto the plastic film and in the zip-tag plastic pouch. Store in a cool environment which is not too dry. Skin Electrode Types Available: SHAPE

CODE VS.4040

DESCRIPTION 40 x 40 mm, square [** max 53mA]

VS.5050 VS.9040

"50 x50 mm, square (recommended for general use)" 90x40mm, rectangular

VS.9050

90 x 50 mm, rectangular

VS.10050 100 x 50 mm, rectangular VS.30 VS.50

30mm diameter, round [** max 46mA] 50 mm diameter, round

** IMPORTANT : Don’t use VS 4040 at more than 53mA and VS3030 at more than 46 mA.

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 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 increase the electrode life by few more days. 14

NeuroTrac® TENS Operation Manual

Suggested Electrode Placement + = Red - = Black

Pain caused by Finger Arthritis

Pain caused by Knee Arthritis

Neuralgia of Trigeninus

1

Cervical (2 Positions)

15

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

16

NeuroTrac® TENS Operation Manual

+ = Red - = Black

Menstrual Pain Back Pain

1

Lumbar Pain (2 Positions)

Tooth Ache

17

2

NeuroTrac® TENS Operation Manual

+ = Red - = Black

Sciatic Pain (2 Positions)

1

2

Epicondylitis

Shoulder Pain

Feet Pain

Ankle Pain

18

NeuroTrac® TENS Operation Manual

Care, Maintenance, Accessories and Disposal WARNING! Only medically approved accessories should be used! CONTROL UNIT * Wipe the surface after each use with a damp cloth or antiseptic wipe or baby wipe. * Do not use cleaning sprays or alcohol based cleaning solutions * Control unit disposal: please return to Verity Medical LTD or to the appointed distributor. ACCESSORIES Battery: * To change the battery, open the battery door on the rear of the control unit by pressing down on the raised rib pattern just below the belt clip. Lift the battery out of the compartment. This is very easy and can be done by the user. * 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 * Battery disposal: please return to the supplier from whom you’ve purchased it. 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 * Lead wires Disposal: please return to the supplier from whom you’ve purchased them. 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 19

NeuroTrac® TENS Operation Manual

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 /imporers are approved to undertake servicing.

Indications for use * * * *

back pain phantom limb pain postoperative pain pain associated with knee arthritis

20