ACUPAD PRO-TENS Dual Channel TENS with Timer Instructions for Use

PRO-TENS - Model PT150

Instructions for use. Copyright © 2005 5th Edition 05/2005 Product Labelling

CAUTION

PRO-TENS is a Class BF Medical Device. Please ensure that instructions printed in the product labels are followed and that the instructions and precautions provided in this booklet are read and fully understood before attempting use.

GUARANTEE

A 5 year guarantee applies from the date of original purchase against faulty workmanship, materials or components arising from normal intended use, contingent upon proper use of the device, and does not apply to damage caused by misuse, neglect or accident. The warranty excludes electrodes, lead wires, batteries, belt clips and carrying case, subject to normal statutory rights.

During the warranty period the equipment will be repaired or replaced free of charge at the manufacturerʼs option. The manufacturers liability is limited to repair or replacement of the equipment. In the event of fault, the unit should be returned to the manufacturer carriage paid. The manufacturers liability only applies when professional medical diagnosis, instruction and guidance for correct use of this device has been taken by the user and that the accessories, in particular the electrodes, used with this device originate from, or have been approved for use by, the manufacturer.

Notes

ESSENTIAL PRECAUTIONS DO NOT use TENS without first taking medical advice:

1. If your pain has not been medically diagnosed 2. If you have a heart pacemaker or if you have any previous history of cardiovascular (Heart) problems. 3. If you suffer with epilepsy 4. If you are in the first six months of pregnacy 5. If you wish to treat children under 12 years of age

Do NOT apply TENS:

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1. To undiagnosed pain 2. Across the chest, temples or on the front of your neck 3. On damaged skin, varicose veins or recent scars 4. Over any area of skin which is numb to the touch -1-

PRO-TENS Technical Specification

SPECIAL NOTE PRO-TENS TIMER If you are going to be using the PRO-TENS timer it will require to ʻsettle inʼ before it will operate within the specification. The miniaturised components used in the assembly need to be powered for a period of 2-4 hours for this to happen.

To accomplish this simply use the TENS as normal but switch the timer control to 60 minutes for the first 3 or 4 uses - after this it will function normally.

Please note that this is not a precision timer and will switch off between 20-40 minutes at the 30 minute setting and between 40 and 80 minutes at the 60 minute setting.

REMEMBER - the unit will not switch ON if the timer control is left at the 30 or 60 minute settings ALWAYS SET THE TIMER CONTROL TO ʻCʼ BEFORE SWITCHING ON (see page 7 in the Instructions For Use) -2-

0473

Manufactured and tested for compliance to MDD 93/42 EEC and to the following standards: Safety - EN60601-1:1990 incl.A2:1996 EMC - EN60601-1-2:2001

Parameters established using 1Kohm test load. Accuracy to BS5724 part1:1979 - ±30%

Pulse Amplitude Pulse Frequency Pulse Width Burst Mode

Modulation Mode Timer Battery Type: Battery Life (Alkaline) Weight inc. Battery Dimensions Storage Temp. Operating Temp.

60mA max. 2Hz-150Hz adjustable 50µS-250µS adjustable 2 bursts per Sec.(2Hz) 9 pulses per Burst 100Hz pulse stream Pulse width adjustable

5 secs cycle repeated 3 secs on - 2 secs off Pulse width & frequency remain adjustable

30 mins. ± 10 mins. 60 mins. ± 20 mins. or constant treatment time. Alkaline PP3 MN1604 20 hrs average usage 130 Grams 24 x 64 x 93mm -0˚C-+50˚C(32˚F - 122˚F) -0˚C-+50˚C(32˚F - 122˚F)

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MAINTENANCE

The stimulator Clean the outside of the case with surgical spirit. Do not use detergents or plastic solvents and do not allow any liquid to get inside the stimulator case and do not tamper with the inside of the unit as this will invalidate the warranty.

Leadwires Clean with surgical spirit. Check for damage and replace with new lead wires as necessary.

Electrodes Effective pain relief can be marred by poorly cared for electrodes. Keep the gel surface clean using a damp sponge. DO NOT remove electrodes by pulling on the pigtail wires. Follow the care instructions provided in the stimulator kit or supplied in each new pack.

Batteries PRO-TENS is a high output unit and battery life will vary with the type used and intensity required for treatment. Rechargeable batteries are recommended for economy ask your supplier for details. Remove the battery if you are not going to be using PROTENS for any length of time. Refer to the battery manufacturers instructions for safe disposal of batteries. NEVER throw batteries on the fire.

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CONTENTS Introduction For Your Safety The Stimulator Controls Dual Output sockets Mode change slider switch Pulse Frequency Control Pulse Width Control Timer slider switch On/Off and Amplitude Control Knob Indicator Lamps Removing the Control Cover Operating Procedure Systematic Treatment Problems & Faults In Use Maintenance The Stimulator Electrodes Batteries Technical Specification -3-

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4 6 8 9 9 9 9 9 10 10 10 11 12 13 14 14 14 14 15

INTRODUCTION

What is TENS? Transcutaneous Electrical Nerve Stimulation is a safe, noninvasive and drug-free method of pain control which relieves pain by sending small, electrical impulses through conductive electrodes placed over the painful area. The pulses stimulate the underlying nerves which carry sensations such as warmth, pressure and touch. This produces natural nerve impulses which are able to block out, or reduce, pain.

TENS is believed to work in two ways: First, electrical nerve stimulation blocks pain signals. When pain signals arrive at the brain pain is perceived - if they are blocked en-route, it is not.

Secondly, the body is able to make its own natural pain killers called endorphins. These act as very powerful analgesics and suppress pain. TENS can help to activate these chemicals.

By following these easy instructions, PRO-TENS will help reduce most types of pain. It is advisable to seek clinical guidance for best results.

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PROBLEMS & FAULTS IN USE

Whenever a fault is suspected Check that the battery is fitted properly. Clean the battery contacts with a dry cloth. Replace (or recharge) the battery.

Weak or erratic pulse Clean the gel using a damp sponge. Replace damaged or worn out electrodes and lead wires.

No pulse at all Check that the battery is making contact and is inserted the correct way round. Replace the electrodes and/or the lead wires. If there is still no pulse contact your supplier.

Irritation under electrodes Replace soiled, worn out or damaged electrodes. Apply a little water to the gel surface and the skin before application to ensure good contact. Skin problems If any soreness or rash occurs under the electrodes, reposition them for a few days until the skin has recovered.

Use a good quality Aloe-vera and Vitamin E cream over the affected area.

When you are ready to re-start treatment, use brand NEW electrodes and soften the gel with de-ionised water to reduce the possibility of further irritation. (Also see the note on page 5)

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SYSTEMATIC TREATMENT

Place 1 pair of electrodes at either side of the painful area or use 2 pairs to surround the pain area. Keeping the electrodes in the same position, apply each of the following methods for 1 hour. Follow each application with a 1 hour rest period to gauge the previous results before starting the next application. 1 Apply CONTINUOUS mode (set the pulse width to 180µSec). Adjust the frequency to a level which you find pleasant and then adjust the intensity to maintain a strong ʻtingleʼ sensation between the electrodes. Apply 1 hour - rest one hour.

2 Switch to BURST mode (set the pulse width to 250µSec). Adjust the intensity to produce a definite but comfortable ʻtwitchʼ in the muscles close to the electrodes. Apply 1 hour - rest one hour.

3 Switch to MODULATION mode (set the pulse width to 250µSec). Adjust the frequency to a level which you find pleasant and then adjust the intensity to maintain a strong but comfortable massage effect in the muscles under and around the electrodes. Apply 1 hour - rest one hour. Continue to use the mode which produced the best results. Use it for at least 1 hour whenever your pain returns. TENS - The Usersʼ Guide to Pain Relief will help you to understand exactly what you are doing and will systematically take you through all the different electrode positions and options appropriate to your specific problem.

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PRO-TENS has three modes, each producing a different effect.

Continuous (Normal) Mode closes the “pain gate” and slows down pain signals.

Burst Mode is used to help the body produce its own natural pain killers.

Modulation (Massage) Mode is used to gently massage tight muscles to help reduce musculoskeletal and referred pain.

In addition, PRO-TENS has variable pulse widths so that you can make adjustments to find the best possible combination for your particular problem.

Please be patient - successful pain relief depends on correct electrode placement and choice of stimulation mode for your specific pain pattern. Wherever possible, take advice from an experienced TENS clinician.

The response to TENS varies from person to person. Some conditions may require longer and more frequent treatment.

Remember that TENS is not a cure so your pain may not always be eliminated completely.

By persevering, you will soon find that you are taking fewer pain killers, that the periods between pain attacks have become longer, and that the intensity of pain is much reduced.

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FOR YOUR SAFETY

1. PRO-TENS is designed to relieve pain caused by a medical condition. It must not be used for any other purpose.

2. Pain is a warning of injury or disease. Do not use PRO-TENS on undiagnosed pain - it may mask important diagnostic symptoms and prevent a serious condition from being recognised.

3. If you use a heart pacemaker or have any history of heart problems, you must only use TENS under medical supervision.

4. Do not use PRO-TENS during the first 6 months of pregnancy (or if you are attempting to become pregnant) without first taking medical advice.

OPERATING PROCEDURE

1. Remove the cover and insert a 9V battery. CAUTION Amplitude Controls must be set to OFF before removing or fitting the battery.

2. Set the

Timer Selector Switch to ʻCʼ. Mode Selector Switch to ʻNʼ. Frequency Control to 100Hz. Pulse Width Control to 200µSecs.

3. Replace the battery compartment cover

4. Insert lead wire pins into the electrodes so that no bare metal is exposed

5. Place electrodes on clean, unbroken skin as instructed by your clinician. (See also page 10)

6. Plug the electrode lead wire jack plugs into the Stimulator output socket(s). CAUTION - do not attempt to fit the lead wire jack plug into any other electrical socket.

5. Do not use PRO-TENS over the cartid sinus, laryngeal or pharyngeal muscles. 6. Do not place electrodes in the mouth, over the eye-lids, varicose veins, open wounds or recent scar tissue without first taking medical advice.

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7. Switch ON and slowly increase the amplitude until a gentle tingling sensation is felt between each pair of electrodes. Periodically adjust the amplitude during treatment to maintain this sensation.

8. Set the Timer Switch to 30 or 60 minutes if timed treatment is required.

9. At the end of treatment, switch OFF both channels before removing the electrodes. Remember to switch the timer back to ʻCʼ.

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On/Off and amplitude control knobs Used to switch each channel ON/OFF and to adjust the pulse strength. Indicator lamps The yellow Indicator glows when the unit is switched on. The green channel indicators glow or flash depending on the mode selected.

Removing the control cover Hold the unit in both hands with the controls facing you. Place both thumbs on the centre of the lid - press downwards and away from you. The lid will open to the first stop exposing the controls.

9. For the safety of yourself and others do not use TENS whilst operating or driving motorised machinery or a vehicle.

10. Do not use excessive pulse strengths.

There are no known side effects from using TENS other than a very small risk of skin irritation. Long term application of TENS may cause soreness or rash but this is minimised by using hypoallergenic electrodes. (also see page 10).

If skin rash occurs, reposition the electrodes away from the affected skin or change to Blue gel electrodes (see below). If the problem persists, discontinue use and consult a medical practitioner.

Before fitting a new battery make sure that the unit is switched OFF.

Fig 3

To replace cover, slide the lid back to the first stop and push it firmly to move it over the stop.

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8. Keep out of reach of children and do not allow relatives or friends to use TENS without medical diagnosis. What is suitable for you may not be suitable for them.

Side Effects

Press and push again to slide the cover over the stop to expose the battery.

Insert a new battery making sure that the (+) stud lines up with the smaller recess in the compartment. If the larger (-) stud does not sit correctly in its recess, lightly squeeze the battery terminal to make it fit.

7. Do not handle the electrodes when the stimulator is switched on.

Sensitive Skin and body hair

Blue gel electrodes are available for very sensitive skin and areas where body hair causes adhesion problems. Your clinician or supplier will give you details.

If in doubt, speak to your doctor. -7-

THE STIMULATOR CONTROLS

Dual Output sockets The lead wires are plugged into these two sockets to supply either 1 or 2 pairs of electrodes. Mode change slider switch N - Normal (continuous) Mode - Pulse frequency and pulse width remain adjustable B - Burst (or beat) Mode - Pulse frequency is fixed but pulse width remains adjustable M - Modulation (massage) Mode - Pulse frequency and pulse width remain adjustable.

Pulse frequency control Sets the pulse frequency from 2 to 150 pulses per second (2Hz - 150Hz). The normal conventional TENS setting is between 80 and 120Hz.

Pulse width control Adjusts the duration of each individual pulse from 50 to 250 (µS). The normal conventional TENS setting is between 180 and 220µS.

Timer slider switch Can be set to give approximately 30 or 60 minutes or continuous treatment time. The output is automatically switched off after the preset time but the yellow light remains ON.

Fig. 2 - The PRO-TENS Controls -8-

To reset the timer - switch OFF - move the switch to ʻCʼ Switch ON - adjust the output to required level then move the switch to desired time. PRO-TENS will not be switched ON unless the timer is switched to ʻCʼ.

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