Touch TENS

INSTRUCTIONS FOR USE

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Touch TENS

Instructions for Use

Section Page No

1 Introduction 1 2 How TENS works 1 3 Side Effects 2 4 Contents 2 5 Installation of Batteries 3 6 Belt clip 4 7 The Programmes 4 8 Programme Settings 6 9 Controls and Display 7 10 Controls 8 11 Connecting Lead wires 11 12 Positioning of Electrode Pads 12 13 General Pad Advice 14 14 Cleaning 14 15 Troubleshooting 15 16 Caution and Warnings 16 17 Consumables and servicing 18 18 WEEE 19 19 Guarantee 19 20 Technical Specifications 20 21 EMC Precautions 21

1. INTRODUCTION Device Description & Principles of Design

The Touch Tens is a dual Channel TENS unit with pre-set energy output levels for easy use. A choice of eight pre-set programmes is available . The operation of the controls is described in detail in Sections 9 & 10. The Tenscare Touch TENS is a dual channel TENS. It has: two independent strength controls 60 mA output over 500 Ohm load 8 pre-set programmes including Burst, Strength and Frequency Modulation, and Han Programme Timer Compliance Memory 2. HOW “TENS” WORKS

T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. T.E.N.S. stimulates your body’s own natural defences against pain, namely the release of endorphins. T.E.N.S. is totally safe and has been used successfully by thousands of pain sufferers.

TENS sends a gentle stimulation through the skin which works in TWO ways:-

Pain Gate

Stimulating the sensory nerves, which carry touch and temperature signals. These nerves go to the same connections in the spine as the nerves carrying pain. A strong sensory signal will block the pain signal travelling up the spine to the brain, this is known as closing the “Pain Gate” and takes effect quite quickly after the unit is switched on. You can use TENS several times a day, for as long as you like.

Endorphin Release At low frequency settings, and slightly stronger output, TENS drives the motor nerves to produce a small repetitive muscle contraction. This is seen by the brain as exercise, and this promotes release of Endorphins – your body’s own natural pain killer. The relief builds up and normally takes about 40 minutes to reach a maximum level which can last for hours after the machine is switched off.

By using TENS you can expect to achieve a significant reduction in pain if not complete pain relief.

3. SIDE EFFECTS

There are no known side effects to TENS use and long-term TENS use is not harmful. 4. CONTENTS

The pack contains: Touch TENS Pain Relief unit Belt Clip 2 x Leadwire Pack of 4, 50x50mm, self-adhesive electrode pads (item code: E-CM5050) 2 x AA 1.5V(Type LR6) alkaline batteries Instruction Manual Storage Pouch

5. INSTALLATION OF BATTERIES Remove battery tray from side of unit i) Slide down button in centre of battery cover to unlock. ii) Pull tray out in direction of raised arrows.

iii) Insert batteries

Ensure that the batteries are inserted the right way as shown in battery compartment.

iv) Lock battery cover

When the batteries are running low a low battery indicator will show on the screen (battery symbol) and it is important to change the batteries as soon as possible.

Rechargeable batteries The unit will not work with rechargeable batteries. Low voltage cut-out may be above the normal operating voltage of rechargeable batteries

Storage Remove batteries from your TENS machine if the unit is unlikely to be used for a long period. Some types of battery may leak corrosive fluid.

Disposal of batteries Always dispose of batteries safely. Do not throw batteries onto a fire. Risk of explosion

Battery Life Batteries should last about 48 hours at full power. Unused batteries have a nominal shelf life of 3 years, but will usually last longer than this.

Warning Keep batteries out of the reach of small children If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with lots of water. Do not attempt to recharge alkaline batteries 6. BELT CLIP A belt clip is provided to allow you to attach the touch TENS to your clothing. It can be inserted either way up. Slide along the base of the unit until it locks in position. You can also hang the unit from your neck using the hook provided. Use thread or wool that will snap easily if the unit snags on something.

7. THE PROGRAMMES

There is no one programme for a particular condition, and the best choice varies from one person to another, even if they have the same type of pain. Each user needs to select both the programme and the positioning of the pads that is best for them. You may need to try a few positions/programmes before finding the one that suits you.

If you are using TENS for the first time, it is recommended that you start with Programme A, which gives the gentlest stimulation.

The Touch TENS has 8 pre-set pain relief programmes.

Research has shown that some programmes are particularly effective for certain pains. These have been indicated under the “Specific uses” section.

The following grid summarises the programmes available and how they vary. Pr Output Sensation Specific Uses Frequen

cy Hz

Pulse Width µS

A Constant

Tingling/Pins and needles sensation. Increase strength slowly until a strong but comfortable sensation.

Pain Gate 110 50

B Constant

Pulsing or tapping sensation associated with muscle contractions. Increase the strength to a level that just produces muscle activity.

Not for injured muscles Endorphin Release

4 200

C Burst

Stimulus is delivered in bursts, i.e. a group of pulses rather than a single pulse. You will get muscle activity at a lower strength and thus you may find it more comfortable.

Not for injured muscles Pain Gate/Endorphin

100in 2Hzburst

200

D Constant

Is similar to B, but has a Freq specifically recommended for nausea, travel sickness and morning sickness (see body map for position of electrode pads).

Menstrual pain, nausea, travel sickness and morning sickness. Not for injured muscles Endorphin Release

10 200

E Constant This is similar to A, but has deeper penetration and a stronger feel. It is more likely to produce muscle contractions at a lower strength

Pain Gate 110 200

F Strength Modulated

This is similar to E, but with the strength modulating continuously, this gives a pleasant slow relaxing massage sensation.

Pain Gate 110 200

G FrequencyModulated

This changes the frequency every 3 minutes,

stepping from 2 to 110 Hz. This constant change helps to prevent accommodation occurring. 2, 10, 50, 80, 90, 100,110Hz,

Pain Gate 2-110 in 7steps

200

H HAN Alternating

This changes the frequency from 2 to 100 Hz every 3 seconds. It is claimed to be the most effective form of TENS, but may be less comfortable

Pain Gate/Endorphin

100/2 100 /200

USAGE TENS can be used for as long as is necessary. Continuous treatment is fine, but electrode pads should be repositioned regularly (at least every 12 hours) to allow the skin to be exposed to the air. The Endorphin Release modes work better when the strength is high enough to cause small muscle contractions. Best results are achieved at between 20 and 40 minutes. Longer use may cause muscle ache. 8. INFORMATION ABOUT THE PROGRAMME SETTINGS • Frequency (measured in Hz - pulses per second) PAIN GATE: A high frequency of 110Hz is good at blocking pain signals. ENDORPHINE RELEASE: A low frequency of 4 or 10Hz allows for the release of endorphins, the body’s natural morphine-like substances. • Pulse Width (measure in μS - millionths of a second) The Touch TENS unit has pulse widths of 50 and 200 μS. Higher Pulse Widths are more likely to cause muscle contractions. • Constant and Burst Modes Constant mode is when the sensation is continuous as against Burst mode when the sensation, is as its name implies, is one of on and off. • Modulation Modes Modulation is when either the frequency or pulse width sweep across range of settings. This enables the body to receive many different signals and can be very beneficial and lessen any effect of accommodation. See programmes F and G. • HAN Stimulation Invented by a Professor Han, this alternates between high and low frequencies to give - in theory - the best pain relief.

9. CONTROLS AND DISPLAY

Channel 1 Strength Programme selected Keypad Lock Channel 2 Strength

Low battery Time Selected

Channel 1 Strength Channel 2 Strength

UP UP

ON/OFF Programme selector

Channel 1 Strength Channel 2 Strength

DOWN DOWN Time Selector

10. CONTROLS ON/OFF To turn the unit ON, press the ON/OFF button on the side of the unit and hold for 2 secs until the display shows. To turn the unit OFF, press the ON/OFF button on the side of the unit and hold for 2 seconds until the display stops. The unit will turn OFF automatically : When the Timer reaches zero, If it is left at zero strength for more than 5 minutes. At first use, or after changing batteries, the display shows that the unit is automatically set in Programme A at zero strength. On the top of the XL-Y1 unit there are four coloured buttons: STRENGTH CONTROLS The BLUE BUTTONS, marked , are strength controls.

The left hand buttons change strength in the left hand lead, Ch1, and the right hand buttons change the right hand lead, Ch2.

To increase strength in steps of 1, press and release the top part of the two blue buttons marked . The strength levels are shown on the LCD.

The strength control buttons will not operate until the unit is properly connected to you. Touch TENS detects a disconnection and automatically returns the strength to zero.

The unit has 60 levels of strength. If you hold down the button for 2 seconds, the strength will start scrolling.

You may feel nothing over the first few presses. Continue pressing until the sensation is strong but comfortable. Further increases during use may be necessary if your body becomes used to the sensation.

To lower the strength, press and release the lower part of the blue buttons marked . PROGRAMME CONTROL The YELLOW BUTTON, marked #, is the Programme control. The Touch TENS has eight different, specially developed programmes lettered A-H.

When the unit is first switched on it automatically enters PROGRAMME A.

Each time you press and release the YELLOW BUTTON, the programme changes and the letter is shown on the LCD.

Each time you change the programme, the strength level reverts back to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each Programme gives a different sensation. TIMER

The GREEN BUTTON, marked with a clock symbol, can be used to set the session duration. When you switch the unit on, it is automatically set at continuous, (displayed as CO) which means that the unit will continue functioning until you switch it off.

You can set session times of 20,40, or 60 minutes by pressing the green button repeatedly.

The LCD shows the session duration next to the clock symbol. The unit automatically counts down the minutes set and switches off when this reaches zero.

A LOW BATTERY display, with a symbol of empty batteries, will show when you need to change the batteries. The unit will shut down about 2 minutes after this. KEYPAD LOCK

If you do not press any keys for 30 seconds, the keypad will lock so that only the keys marked ▼ will work. This is to avoid accidental changes in setting.

To unlock, press either ▼ key.

OPEN CIRCUIT CUTOUT If the Touch TENS is not correctly connected to your body, the strength will automatically reset to zero. This is to prevent sudden changes if a broken connection is re-made. MEMORY

The XL-Y1 has a Memory with three functions:

1) Programme Retention. When you switch the unit On, it will automatically start in the Programme which was being used when it was switched Off.

2) Frequency of Use. Press Programme and Left blue ▲ together and hold down for 3 seconds. The display will show T (for no. of Times) and a number from 1 to 999, indicating the number of times the unit has been used. Press the same buttons again to return to normal controls.

3) Elapsed Time. Press Programme and Right blue ▲ together and hold down for 3 seconds. The display will show U (for Usage) and a number from 1 to 999 hours, indicating the total number of hours the unit has been above zero strength. Press the Programme button again to return to normal controls. Memory Reset. To reset Memory to zero, hold down the Programme and Timer buttons together for 3 seconds. 11. CONNECTING LEAD WIRES

Insert the leadwire plug into the base of the unit.

Attaching the electrode pads to Lead wire Push the pin ends firmly into the pigtail ends of the electrode pads. The leadwires may be damaged by rough handling, and should be treated with care. Lead wire colour coding The ends of the lead wire are coloured white or red. This coding is provided for some professional uses, For most purposes, the orientation makes no difference, and you can ignore this colour coding.

12. POSITIONING OF ELECTRODE PADS The following body maps in this instruction booklet will show you where to place the electrode pads for a range of common complaints, dependent on your symptoms.

For symptoms not illustrated, apply the pads around/near to the source of the pain or seek advice from your doctor or physiotherapist.

The electrode pads must always be used in pairs, so that the signal can flow in a circuit. NOTE: Always check unit is OFF before attaching or removing pads. NOTE: Touch TENS resets strength to zero if the pad or lead is disconnected from your body.

This is to prevent sudden changes in sensation when the pad is re-connected.

For areas that are difficult to reach, why not ask a friend to help you attach the pads? See Section 16 for information on where you should not place pads.

ELECTRODE PAD POSITIONS Where only two pads are shown on the arm, shoulder, and leg, use the other two pads either on the opposite limb

Low Back Pain Neck and Shoulder Tension Sciatica

Ankle Pain Headache Leg Pain

Shoulder Pain Knee Pain Elbow Pain

13. GENERAL PAD ADVICE

The electrode pads supplied are reusable but are for single patient use.

In order to obtain the best conductivity through the pads always ensure that they are in good condition and tacky.

Before use make sure your skin is clean and dry.

Peel the electrode pads from their protective plastic shield by holding and lifting one corner of the pad and pulling. Do not pull on the pigtail wire of the pad.

After use always replace the pads on the plastic liner and replace in the re-sealable plastic bag.

If the pads dry out then it is best to buy a replacement pack of electrodes. In an emergency it may be possible to restore some of the tackiness of the pad by adding a tiny drop of water on each pad and spreading around. If too much water is added the pads will become too soft then it is suggested in order to try re-establish some adhesiveness to place them sticky side up in a refrigerator for a few hours.

In very hot weather the gel on the pads may become soft. In such cases place the pads, still on their plastic liners and in their bag into a fridge until they return to their normal condition.

The pads provided are latex –free.

Replace pads when they lose their stickiness. Poor connection may cause discomfort and skin irritation

Storage life of an unopened pack of electrodes is 2 years. This may be affected by very high temperatures or very low humidity.

14. CLEANING

Clean the case and lead wires at least once a week by wiping with a damp cloth and a solution of mild soap and water. Wipe dry. Do not immerse your TENS machine in water. Do not use any other cleaning solution than soap and water.

15. TROUBLESHOOTING If your TENS machine is not working properly please check the following:

Problem Possible causes Solution

No display Flat batteries Replace batteries

Batteries inserted incorrectly

Check

Damaged battery tray contacts

Contact supplier

Low battery display

Low batteries Replace batteries

No sensation

Incorrect connection Have you applied both electrode pads (per lead wire) to ensure a complete circuit?

Not strong enough Increase strength. Most users will feel something at a setting below 20

Output will not increase above zero

Open circuit cut-out operating. Lead not connected to body or faulty/damaged

Ensure machine is attached to your body correctly. Try using the second lead. Purchase replacement if necessary.

(Lead wires can break at the bend where they leave the machine, giving no, or intermittent, output)

Sudden change in sensation

If you disconnect and re-connect a few minutes later, the signal will feel quite a lot stronger.

Always return strength to zero after disconnecting the lead or pads.

If the above review has failed to resolve your problem, or to report unexpected operation or events, call TensCare or your local dealer (address on back cover) for advice.

16. CAUTIONS & WARNINGS

If you are in any doubt about any of these warnings please consult your medical adviser. Do not use TENS :

If you have a heart pacemaker or have a heart rhythm problem

TENS in the direct vicinity of a pacemaker may affect some models. If TENS is applied on the front of the neck this can affect your heart rate. Very strong TENS across the chest may cause an extra heartbeat.

If you have epilepsy TENS may affect seizure threshold.

During the first three months of pregnancy

It is not known whether TENS may affect foetal development

On the abdomen in the later stages of pregnancy. Stop use immediately if you experience unexpected contractions.

When driving, operating machinery, or similar actions needing fine control Loose pads, damaged leads, or sudden changes in contact may cause brief involuntary muscle movements

To mask or relieve undiagnosed pain

may delay diagnosis of progressive condition.

Caution:

Observe caution when using the Touch TENS at the same time as being connected to monitoring equipment with body worn electrode pads it may interfere with the signals being monitored.

Strong electromagnetic fields (electrosurgery/microwave cookers/mobile phones) may affect the correct operation of this unit—See section 21. If it appears to behave unusually, move it away from these devices.

Use caution following recent surgical procedures stimulation may disrupt the healing process.

Do not place electrode pads : On broken skin The pads could encourage infection On skin which does not have normal sensation.

If the skin is numb, too great a strength may be used, which could result in skin inflammation.

On the front of the neck Could cause the airway to close, giving breathing problems. May cause sudden drop in blood pressure (vasovagal response) Over the eyes- May affect eyesight or cause headaches

Across the front of the head Effect on patients who have had strokes or seizures is not known.

May affect sense of balance The effects of stimulation of the brain are unknown,

Near malignant tumours In vitro experiments have shown that electricity can promote cell growth

Do not:

Ignore any allergic reaction to the electrode pads:

If a skin irritation develops stop using TENS, and try a different type of electrode. Alternative pads specially made for sensitive skin are available, see section 16

Also do not : Immerse your TENS unit in water or place it close to excessive heat. It may cease to operate correctly

Attempt to open up the TENS unit.

This will invalidate the guarantee.

Mix old, new or different types of batteries.

Use this device leads, electrodes, and accessories other than those recommended by the manufacturer. Performance may vary from specification

17. ACESSORIES AND SPARES Expected Service Life The machine will often last for more than 5 years, but is guaranteed for 2 years. Accessories (leads, pads,

and batteries) are not covered by the guarantee. Lead life depends greatly on use. Always handle the leads with care Pads should last 12-20 applications, depending on skin condition and humidity. AA Alkaline Batteries should last about 48 hours continuous use.

Replacement electrode pads, new batteries and lead wires are available from your supplier or distributor (see back cover for contact details), by mail order from TensCare, by telephone using a credit or debit card, or through our website.

The following replacement parts may be ordered from Tenscare at www.tenscare.co.uk or +44(0) 1372 723434 E-CM5050 Pack of 4 50 x 50 electrode pads: E-696-SS-3 Pack of 4 50 x 50 hypoallergenic electrode pads L-BPT Lead wire for units with S/N lower than 120020001 L-CPT Lead wire for units with S/N higher than 120020001 B-AA Batteries 1.5V AA batteries X- BC-TT Replacement belt clip X- BH-TT Replacement Battery Holder

18. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE) One of the provisions of the European Directive 2002/96/CE is that anything electrical or electronic should not be treated as domestic waste and simply thrown away. To remind you of this Directive all affected products are now being marked with a crossed-out wheelie bin symbol, as depicted below. To comply with the Directive you can return your old electro-therapy unit to us for disposal. Simply print a postage-paid PACKETPOST RETURNS label from our website www.tenscare.co.uk, attach this to an envelope or padded bag with the unit enclosed, and post it back to us. Upon receipt we willyour old device for components recovery and recyclinghelp to conserve the world's resources and minimise adverse effects on the environment. 19. GUARANTEE

Your TensCare device is guaranteed for two years from the date of purchase. If a fault develops return the unit to TensCare at the address below, together with a copy of your invoice and details of the problem. The guarantee does not cover accessories (the batteries, electrode pads or lead wires).

Please note that the Guarantee is invalidated if incorrect batteries have been fitted, or the unit has been immersed in water, maltreated or tampered with.

20. TECHNICAL SPECIFICATION

Waveform Asymmetrical Bi-Phasic

Amplitude (over 500 ohm load)

60mA zero to peak +ve in 15 steps. +/- 10%

Output plug Fully shielded: touch proof

Channels Dual Channel

Batteries 2 x AA Alkaline (Two AA batteries)

Weight 80 gms without batteries

Dimensions 115 x 53 x 27 mm

Safety Classification Internal power source. Type BFDesigned for continuous use. No special moisture protection.

Operating: Environmental Specifications: Storage:

Temperature range:5 to 40C Humidity: 15 to 93% RH non-condensingTemperature range: -25-+70C RH 93% non condensing

TYPE BF EQUIPMENT

Equipment providing a degree of protection against electric shock, with isolated applied part.

This symbol on the unit means “ Refer to Instructions for use”

The unit is not water resistant, and should be protected from liquids.

NB The electrical specifications are nominal and subject to variation from the listed values due to normal production tolerances of at least 5%

21. EMC PRECAUTIONS Use special precautions regarding EMC according to the information provided below. Other portable and mobile RF communications equipment can affect performance. Do not use when adjacent to or stacked with other electrical equipment. Use of leads or probes other than those listed in section 18 may affect EMC performance. 

Guidance and manufacturer’s declaration - electromagnetic emissions

The Touch TENS is intended for use in the electromagnetic environment specified below. The customer or the user of the Touch TENS should assure that it is used in such an environment.

Emissions test Compliance

Electromagnatic environment - guidance

RF emissions CISPR 11

Group 1 The model itouch uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B The model itouch is suitable for used in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Harmonic emissions IEC61000-3-2

Not applicable

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable

The Touch TENS is intended for use in the electromagnetic environment specified below. The customer or the user of the Touch TENS should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance Level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz

3 Vrms 3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the model itouch, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3V d = 1.2 P 80M Hz to 800MHz d = 2.3 P 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the symbol on the left of this box

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model itouch is used exceeds the applicable RF compliance level above, the model itouch should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the model itouch. b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

The Touch TENS is intended for use in the electromagnetic environment specified below. The customer or the user of the Touch TENS should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level

Electromagnetic environment guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile

. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for Input/output lines

Not applicable Not applicable

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

Not applicable Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT(60 % dip in UT ) for 5 cycles 70 % UT (30 % dip in UT )for 25 cycles <5 % UT (>95 % dip in UT ) For 5s

Not applicable Not applicable

Power frequency (50/60 Hz) magnetic field. IEC 61000-4-8

3 A/m

Not applicable Not applicable

NOTE UT is the a.c. mains voltage prior to application of the test level

Recommended separation distances between portable and mobile RF communications equipment and the Touch TENS

The model itouch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model itouch can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model itouch as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter M

150kHz to 80MHz d=1.2 P

80 MHz to 800 MHz d=1.2 P

800MHz to 2.5GHz d=2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 .38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

EC Declaration of Conformity TensCare Ltd hereby declare that an examination of the production quality assurance system has been carried out following the requirements of the UK national legislation according to Annex V of the Directive 93/42/EEC on medical devices. We certify that the production quality system conforms with the relevant provisions of the aforementioned legislation, and the result entitles the organization to use the CE 0473 marking on this product.

Manufactured by:

TensCare Ltd, 9 Blenheim Road, Epsom, Surrey KT19 9BE, UK

Tel: +44(0) 1372 723434 www.tenscare.co.uk

Pub No.: I-XLY1T-UK Version 1.1 06/13