Elle TENS Instructions for Use May 2006

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Elle TENS Quick Reference Guide

4. Position the electrode pads on the body as indicated on page 7.

If you are in labour, please use the quick reference guide set out below. It is however recommended that you read the section entitled “Setting Up Your Elle TENS” found on page 5 to obtain the best performance from your unit.

5. Make sure that the ‘boost’ button at the side of the unit is NOT pressed in. This ensures that the unit will start in the BURST 1 mode (see page 3).

Before using the Elle TENS, please read the contraindications and warnings on page 2. 1. Insert 2 x AA batteries in the compartment at the back of the unit (see figs 1 and 2, page 6). 2. Insert the leadwire plugs into the top of the unit (see fig 3, page 6). 3. Insert the pins at the other end of the leadwires into the sockets attached to the electrode pads. Do not remove the electrodes from their backing at this stage (see fig 4, page 6)

6. Press the on.

(on/off) to turn the unit

7. Now push the (CH1 +) key until you feel a pulsating sensation. 8. Repeat the same with the key.

(CH2+)

9. At the onset of a contraction press the ‘boost’ button for the additional surge of power needed to combat the pain. 10.Release the ‘boost’ button once the contraction has passed and continue in the BURST 1 mode as before.

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Contents Elle TENS Quick Reference Guide How will the Elle TENS Help Your Pain?...1 Introduction to the Elle TENS ...1 Frequently Asked Questions ...1 When Should TENS Not be Used? ...2 Controls for the Elle TENS ...3 Display Symbols and Their Meanings...4 Setting Up Your Elle TENS ...5 Useful Diagrams ...6 Suggested Electrode Placement Chart ...7 Using you Elle TENS ...8 Useful Information ...10 Troubleshoooting Questions...10 Technical Specifications ...11 Explanation of Symbols on Unit Equipment providing a particular degree of protection against electric shock particularly regarding allowable leakage currents having an F type (floating) applied part. Warning - refer to page 2 of these instructions.

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How will the Elle TENS Help Your Pain?

Frequently Asked Questions

TENS (Transcutaneous Electrical Nerve Stimulation) works by passing mild electrical impulses through the skin, via electrode pads, into the nerve fibres which lie below. The TENS impulses help your body produce its own pain killing chemicals, such as ‘endorphins’.

Q) When shall I start using my Elle TENS? A) Use as early as you can after the onset of labour to allow time for your body’s pain-killing chemicals to rise.

The level of pain relief obtained varies from person to person. Some find that the Elle TENS provides all the pain relief required during the whole of labour, whereas others find that other analgesics are also needed during the later stages of labour.

Q) Can I try the Elle TENS before going into labour? A) Yes, place 2 pads on your forearm to feel the different pulse sensations following the instructions on page 5. Q) Can I combine the Elle TENS with other medication? A) Yes, you can still use analgesics such as gas and air (entinox) or pethidine.

Introduction to the Elle TENS

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The Elle TENS is the state-of-the-art, efficient method of drug-free pain relief with no known side effects. In order to obtain maximum benefit, it is advised that you seek guidance from your medical adviser as well as reading this instruction guide.

Q) Can the Elle TENS be used in hospital? A) Yes. However, a midwife may ask you to switch it off temporarily. Q) Can I use the Elle TENS if I am considering a water birth? A) Yes, but not in the water itself.

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When Should TENS Not Be Used? Contraindications 1. Do NOT use TENS before 37 weeks of pregnancy unless under medical supervision. 2. Electrodes should only be positioned as recommended (see page 7) unless otherwise stated by your midwife or medical adviser. 3. Do NOT place electrodes on the abdomen (before birth), the front or side of the neck, or areas on the head, which could cause current to flow transcerebrally. 4. Do NOT use TENS if you have a demand-type cardiac pacemaker. 5. If you suffer from epilepsy, or any undiagnosed pain, consult your medical adviser. Warnings 1. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS stimulation is in use.

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2. Skin irritation can occur following long term application. General Precautions 1. Do not use this unit without first reading these instructions. 2. Do not immerse the Elle TENS unit in water or any liquid. 3. Do not place it close to any source of excessive heat. 4. Do not operate this unit in the presence of flammable gas. 5. Do not drop this unit onto a hard surface. 6. Do not attempt to open the Elle TENS unit. 7. Only use the specified batteries and electrodes. 8. If damaged as in precautions 2-5 above, do not use. Return to supplier. 9. Remove the batteries when the Elle TENS unit is not in use. 10. Do not use TENS whilst driving or operating potentially dangerous machinery. 2

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Controls for the Elle TENS

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Leadwire Jack Plug Socket Connectors

Top

The Elle TENS is very simple to use. However, it is advisable to read these instructions to obtain the most out of the unit. Please ensure that all of the precautions have been read thoroughly. See page 2. Opti-max Key - adjusts depth of the pulses - upwards or downwards. Particularly useful in the final stages of labour or when you may need extra power

User Display Boost Button used for extra surge during contractions On/Off Button

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Left Channel Intensity Keys

Right Channel Intensity Keys

Mode Key

Hoop for attaching neck cord used for portability during labour

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Display Symbols and Their Meanings

Power Bar: This shows the output from 0 to 15 for both left and right channels. Each segment represents approximately 7% of the total output. : Pressing the ‘Boost’ button at the top right of the unit activates the Boost mode. This function is used during contractions. The small arrow to the left of the word Boost will remain on, indicating the unit is in a continuous mode. There are two Boost modes available indicated by a 1 or 2 in a small circle next to the word

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BOOST. You can switch between them by pressing the Mode key. : This function is used at the onset of labour and in-between contractions. The small arrow to the left of the word Burst will flash in time with the bursting rhythm you feel from the Elle TENS. There are two Burst modes available indicated by a 1 or 2 in a small circle next to the word BURST. You can switch between them by pressing the Mode Key. Low Battery Indicator: This sign will start flashing when the batteries are running low. If this is the case, change both batteries. Please refer to page 5 for instructions. Opti-max: Indicates the Opti-max output. Each segment represents 20% of total Opti-max power. Please refer to page 8 for more details. 4

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Setting Up Your Elle TENS Check the following contents: • 1 x Elle TENS unit • 1 x Pack of 4 self adhesive electrodes (40mm x 100mm) • 3 x Leadwires (2 for use and 1 spare) • 4 x AA batteries (2 for use and 2 spare) • 1 x Carrying pouch • 1 x Easy-release neck cord • 1 x Instruction manual • 1 x Women’s Guide to Drug Free Pain Relief (if you have purchased this unit)

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negative (-) terminals are correctly positioned as marked in the battery compartment. Replace the cover. c) Take two of the purple leadwires and insert each of the black jack plugs (at one end of each leadwire) into the sockets at the top of the Elle TENS unit (see fig 3, page 6). d) Now insert the pins (at the other end of the leadwires) into the sockets attached to the sticky electrodes. Do not remove the electrodes from the backing at this stage (see fig 4, page 6).

The Assembly Stage a) Press and rotate the belt clip at the back of the Elle TENS in either direction to reveal the battery compartment (see fig 1, page 6). b) Release the battery compartment cover and insert 2 x AA batteries (see fig 2, page 6), ensuring the positive (+) and 5

NB. Each leadwire has a red and black pin. It makes NO difference whatsoever which electrode they are attached to! e) If you wish, attach the easy-release neck cord which enables you to hang the Elle TENS from your neck whilst in labour (see fig 5, page 6).

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Useful Diagrams

Figure 1

Inserting the battery

Connecting the Electrode Pads

Press and rotate the belt clip to reveal the battery compartment.

Insert a red and black pin (at the end of each lead wire) into each pair of electrodes.

Figure 4

Using the Neck Cord for mobility during labour.

Release the battery compartment and insert the batteries. Figure 2

Figure 5

Connecting the leads

Thread the loop of the neck cord through the space at the base of the unit. Slip the other end of the neck cord through the loop and pull into position.

Insert both black jack plugs into the sockets. Figure 3 6

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Suggested Electrode Placement Chart The sticky electrode pads need to be placed in the correct position for maximum pain relief. It is preferable to obtain assistance from either your birthing partner or medical adviser when positioning the pads. Please read the following instructions carefully: 1. Carefully peel the pads from the plastic backing using your forefinger and thumb. Do not pull on the lead wires. 2. Position the top two pads (connected to the left socket CH1) approximately 4cm either side of the spine and 4-5cm above the imaginary navel line as seen in the diagram. 3. Position the bottom two pads (connected to the right socket CH2) approximately 4cm either side of the spine and 4-5cm below the imaginary navel line as seen in the diagram. 7

Bra line In line with navel Panty line

Reference: Cluett E. (1994) SRN RM ADM PGCEA. Analgesia in Labour: A review of the TENS method. Professional Care of Mother and Child. Mar;4 (2): 50-2.

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Using your Elle TENS a) You are now ready to start using your Elle TENS. Switch the unit on by pressing the on/off button. Ensure that the ‘boost’ button located at the top right of the unit is NOT pressed in. The Elle TENS will always start up in BURST 1 mode. b) Begin by pressing the CH1+ key. Each time you press this key, a small ‘half-moon’ shape will appear on the screen increasing in number and size as the intensity is increased. You will begin to feel a pulsating sensation which will burst in time with the small arrow flashing on the screen. c) Repeat the previous step with the . CH2+ key. You will now feel a sensation in both sets of pads.

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d) BURST 1 (use between contractions): This is the first mode that you will use. It feels like a bursting, tingling sensation i.e. the pulses are off and on periodically. This mode will help to promote those allimportant natural pain-killing chemicals known as ‘endorphins’ and ‘encephalins’. e) BOOST 1 (use during contractions): When experiencing a contraction, simply press the ‘boost’ button located at the top right of the unit. The Elle TENS will then switch automatically into the BOOST 1 mode for that extra surge of power required to combat the pain during contractions. This will feel like a continuous sensation. f ) Once the contraction has passed, simply release the ‘boost’ button. The Elle TENS will return to the orignial BURST 1 mode. Continue this cycle during your early stages of labour.

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The Mode Button

The Opti-max Key

There are two modes available on the Elle TENS, each with a Burst and Boost function.

This provides extra versatility to your Elle TENS. Increasing or decreasing the Optimax key will allow you to either heighten or lessen the level of pulse power transmitted to the electrode pads.

Mode 1 (Burst 1 and Boost 1), which has been described above, is primarily used for the earlier stages of labour. Mode 2 (Burst 2 and Boost 2) can be used when your labour advances and your contractions become more frequent.

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Pressing the OM key either + or - will increase or decrease Opti-max sensation, this is extremely useful for the final stages of labour when you need an extra surge of power.

Press the Mode button to switch between modes. You will see from the User Display, that the number in the small circle next to the BURST or BOOST will change from 1 to 2 and vice-versa.

There are 5 Opti-max levels indicated by 5 dots, enlarging in size as the Opti-max power is increased. The unit will always start up at Opti-max 3, which is exactly half way between the highest and lowest setting.

NB. Both modes are interchangeable and can be used according to your preference, not necessarily for the stage of labour you are in.

NB. The Opti-max key can be used according to your preference and not necessarily for the stage of labour you are in.

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Useful information

Troubleshooting Questions

Continue stimulation for as long as necessary, unless you experience discomfort.

Q) Why does the stimulation not appear to be as strong after you have used the Elle TENS for a while? A) Increase the intensity, you may have become used to a lower setting.

If you stimulate for a number of hours ensure the pads do not become dry. If this occurs, switch off the unit, disconnect the electrodes, and apply a small drop of water to them. Always ensure that the unit is switched off before you remove the leads. Do not pull the wires. Always remove the jack plugs from their sockets by holding the plugs between the forefinger and thumb. N.B. The Elle TENS can also be used as a standard TENS unit for relief of numerous conditions, including after pains and post operative pains. It is worth bearing this in mind if you have a caesarian section. Please seek medical advice first.

Q) Why does the stimulation feel strong but ineffective? A) You may need to reposition the electrode pads. Q) Why does the stimulation not feel sufficiently strong even on a high setting? A) The batteries may need replacing. Q) What do I do if there is no stimulation, intermittent stimulation, or weak stimulation felt even with a new battery? A) Check electrode contact. Check leads. Check batteries. Phone Babycare TENS on 0845 230 9737. 10

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Elle TENS - Technical Specifications Equipment type Display Modes

Dual Channel Digital TENS Digital LCD - 5 seven segment digits around 42 segments 2 burst modes and 2 boost modes Pulse Frequency (Hz)

Pulse Width (애s)

Description

Burst 1

16

150*

Burst 2

32

150*

Boost 1 Boost 2

80 100

150* 150*

1 burst per second, 8 pulses per burst 2 bursts per second, 8 pulses per burst Continuous Continuous

* Default pulse width after mode changed (pulse width is NOT changed when switched between BURST and BOOST mode) 5 selectable pulse widths in all modes: 50, 100, 150, 200, 250

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Elle TENS - Technical Specifications Continued Automatic Power Off Output Voltage Output Intensity Output Waveform Output Jacks Battery Unit Size Unit Weight Low Battery Indicator

The Elle TENS will switch off after 5 minutes if not used 0 - 55v zero to peak adjustable in 15 steps at 500⏲ load 0 - 110mA adjustable in 15 steps at 500⏲ load Intensity level will drop back to zero after programme changes Symmetrical bi-phasic rectangular CE Touch-proof jacks 2 x 1.5v AA Battery (Type LR6) 115mm x 55mm x 30mm 75 grams 2.2v±0.2v

Classification This unit is fully compliant with EEC Directive 93/42/EEC, classified as internally powered equipment type BF. It is intended for continuous operation.

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ISO 9001: 2000

Page 1

ISO 13485:2003

EC DIRECTIVE 93/42/EEC Annex V

Babycare TENS 108 George Lane, South Woodford, London E18 1AD Tel (+44) (0)20 8532 9595 Fax (+44) (0)20 8532 9551 www.babycaretens.com e-mail [email protected]

Babycare TENS is part of the Body Clock group of companies

0120 May 2006 (2)