Perfect MamaTENS - Electronic muscle stimulator TensCare - Free user manual and instructions

USER MANUAL Perfect MamaTENS TensCare

Dear Customer, Thank you for choosing Perfect mamaTENS. TensCare stands for high- quality, thoroughly tested products for the applications in the areas of gentle electrotherapy, muscle toning, continence management and pain relief during labour. Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain. Best regards, Your TensCare Team3 CONTENTS

SYMBOLS USED TYPE BF APPLIED PART: Equipment providing a degree of protection against electric shock, with isolated applied part. Indicates that this device has conductive contact with the end user. This symbol on the unit means “Refer to instructions for use”. Temperature Limitation: indicates the temperature limits to which the medical device can be safely exposed. Lot Number: indicates the manufacturer’s batch code so that the batch or lot can be identified. Humidity Limitation: indicates the humidity limits to which the medical device can be safely exposed.

Serial Number: indicates the manufacturer’s serial number so that a specific medical device can be identified.

Do not dispose in household waste. Catalogue Number: indicates the manufacturer’s catalogue number so that the device can be identified.

Atmospheric Pressure: indicates the atmospheric limits to which the medical device can be safely exposed. Manufacturer Symbol Date of Manufacture: indicates the date which the medical device was manufactured. This is included within the serial number found on the device (usually on the back of the device), either as “E/Year/Number” (YY/123456) or “E/Month/Year/Number” (MM/YY/123456).

CE Mark Medical Device This medical device is indicated for home use. Importer Symbol This medical device is not water resistant and should be protected from liquids. The first number 2: Protected against access to hazardous parts with a finger, and the jointed test finger of 12 mm ø, 80 mm length, shall have adequate clearance from hazardous parts, and protected against solid foreign objects of

12.5 mm ø and greater.

The second number 2: Protected against vertically falling water drops when enclosure is tilted up to 15˚. Vertically falling drops shall have no harmful effects when the enclosure is tilted at any angle up to 15˚ on either side of the vertical.5

Device Description & Principles of Design The Perfect mamaTENS machine is safe and effective to use from the onset of labour providing mums-to-be with pain relief in the comfort of their own home. The unit also enables the mother to remain mobile and upright, which can aid descent and dilatation. TENS could also be used to relieve back pain in the last 3 weeks of pregnancy and to ease post-operative pain following caesarean, perineal tear or episiotomy. Note: Whilst some expectant mothers will achieve sufficient pain relief using just the Perfect mamaTENS, others may require additional pain relief. Perfect mamaTENS can be used with other pain relief options such as gas and air however, due to the electrical nature it cannot be used for water births.

Perfect mamaTENS is a medical device designed to be used in the home healthcare and hospital environments to provide symptomatic relief and management of acute pain in the perinatal* and postpartum period and is suitable for use by all who can control the device and understand the instructions. Do not use the device for any purpose other than this intended use.

• Perinatal: Pertaining to the period immediately before and after birth. The perinatal period is defined in diverse ways. Depending on the definition, it starts at the 20th to 28th week of gestation and ends 1 to 4 weeks after birth.

• Dual Channel Two channels with four electrode pads and a single intensity control for ease of use during labour.

• Comfortable Stimulation Gentle stimulation with 50 steps of intensity in programme A and B, and 60 steps in programme C maximizes the comfort level.

• 3 Preset Programmes Specifically designed to counter labour pain at every stage. Integrated Boost button provides additional pain relief during contractions.

• Large Backlit Screen Makes the screen easy to read under all conditions as well as clearly shows the programme and intensity being used.

• Large Electrode Pads Rectangular electrode pads with integrated leads ensure maximum nerve coverage and promote good hygiene.

• Open Circuit Detection6 Intensity returns to zero if the electrode pads come loose. Zeros will flash on the screen until connection is re- established.

• Keypad Lock Enables the user to manually lock the controls to prevent any accidental changes in settings.

• Belt Clip and Neck Cord A belt clip and a neck strap allow you to attach the unit to your clothing or your neck; neck cord has a quick-release system for safety if pulled. Note: The electrode pads need to be applied directly to the skin before the intensity increase buttons will operate. If the Perfect mamaTENS detects the unit is not properly connected to you (for example if the electrode pads or leads come loose) then the unit switches the intensity to zero. This safety feature prevents any unpleasant changes in output.

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. TENS 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 It stimulates 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. When the gate is open, pain messages get through to the brain and we feel pain. When the gate is closed, these pain messages are blocked and we do not feel pain. Evidence suggests that TENS produce pain relief in a similar way to ‘rubbing the pain better’. The pain gate can be closed by activation of mechanoreceptors through ‘rubbing the skin’. Scientifically, the pain gate works by release of chemical in the synapse at spinal level that inhibits transmission of pain signal. Endorphin Release At low frequency settings, and slightly stronger outputs, TENS drives the motor nerves to produce a small repetitive muscle contraction. This is seen by the brain as exercise, and this promotes the release of endorphins - your body’s own natural pain killer. The relief builds up and normally takes about 40 minutes to7 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 relief from pain.

• TENS is effective for pain from a very wide range of causes.

• TENS machines can be used to help reduce pain from problems in muscles, joints and nerves.

• It can be also used for people with musculoskeletal pain such as long- term (chronic) back pain or knee joint arthritis. Perfect mamaTENS is designed to be used for pain relief in the early stages of labour particularly whilst a pregnant woman remains at home.

• TENS may also be used to treat many types of pain, such as period pain and endometriosis (see Ova+), cystitis, sports injuries, fibromyalgia and neuralgia, plantar fasciitis, post- operative pain, TMJ disorder, diabetic neuropathy, osteo-arthritis and sometimes non-painful conditions such as travel sickness.

• You can use low frequency (<10 Hz) programmes on acupuncture points, to achieve similar effects to acupuncture.

• With neurogenic pain (caused by inflamed nerves) such as neuralgia, TENS may start by increasing the pain. We recommend that you only use TENS for these conditions under medical supervision.

• You can safely use TENS as long as it gives you pain relief. The effect may wear off after a few hours (this is called “accommodation”). If this happens, take a break of an hour or so before trying again. If you use settings that cause muscle movement for more than 40 minutes, you may experience aching muscles a few hours later.

5. CONTRAINDICATIONS,

WARNINGS & CAUTIONS In this manual: A Contraindication is used when a device should not be used because the risk of use clearly outweighs any foreseeable benefits and may result in serious injury or death. A Warning is used when failure to follow the instructions may result in serious injury or death. A Caution is used when failure to follow the instructions may result in a minor or moderate injury, or damage to the device or other property. Notes are used to provide clarification or recommendation. CONTRAINDICATIONS: Do NOT use if you have a pacemaker (or if you have a heart rhythm problem) or with any electronic medical devices. Using this unit with electronic medical devices may cause erroneous operation of the device. Stimulation in the direct vicinity of an implanted device may affect some models.8 Do NOT use during the first three months of pregnancy. It is not known whether TENS may affect foetal development. Do NOT use on the abdomen in the later stages of pregnancy. Stop using immediately if you experience unexpected contractions. WARNINGS: Do NOT use when driving, operating machinery, or similar actions needing muscular control. Loose electrode pads, damaged leads, or sudden changes in contact may cause brief involuntary muscle movements. Do NOT use to mask or relieve undiagnosed pain. This may delay diagnosis of a progressive condition. Do NOT use if you have, in the area being treated: active or suspected cancer or undiagnosed pain with a history of cancer. Stimulation directly through a confirmed or suspected malignancy should be avoided as it may stimulate growth and promote spread of cancer cells. Do NOT use electrodes on the front of the neck. Stimulation on the front of the neck can affect your heart rate or cause contraction of the throat. Do NOT use electrodes across the chest. Very strong stimulation across the chest may cause an extra heartbeat and/or rhythm disturbances to your heart, which could be lethal. Do NOT use Perfect mamaTENS while simultaneously connected to high frequency surgical equipment as it may result in burns at the site of stimulator electrodes and possible damage to the stimulator. Do NOT use Perfect mamaTENS in close proximity (e.g. 1 m) to a shortwave or microwave as this may produce instability in the stimulator output. Do NOT use electrodes near the thorax as this may increase the risk of cardiac fibrillation. CAUTIONS: Caution should be used if you have a bleeding disorder as stimulation may increase blood flow to the stimulated region. Caution should be used if you have suspected or diagnosed epilepsy as electrical stimulation may affect seizure threshold. Caution should be observed when using the device at the same time as being connected to monitoring equipment with body worn electrode pads. TENS machines may affect ECG based foetal heart rate monitors, causing them to give a very high reading. Please advise hospital staff that you are using a TENS device. Caution should be used following recent surgical procedures. Stimulation may disrupt the healing process. Caution Not intended for use in an oxygen rich environment. Caution Not intended for use in conjunction with flammable anaesthetics or flammable agents. Caution The patient is an intended operator.9 Caution Do not service and maintain the device while in use. Caution Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons. If necessary, we will provide circuit diagrams, component part lists or other information that will assist authorized service personnel to repair the device. Caution The operator should not touch the patient at the same time when touching the battery output. Caution Keep away from pets and pests Caution Do not permit use by persons unable to understand the instructions such as those with cognitive disabilities, i.e.; Alzheimer’s disease or dementia. Caution Keep away from children under 5 years of age. Long cord - risk of strangulation in infants. Caution should be observed when using the Perfect mamaTENS at high strength settings. Prolonged use at high settings may cause muscle injury or tissue inflammation. The Perfect mamaTENS is capable of delivering outputs in excess of 10 mA (RMS) or 10 V averaged over any period of 1 sec. DO NOT PLACE ELECTRODE PADS:

• 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 broken skin. The electrode pads could encourage infection.

• On the front of the neck. This 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 your sense of balance. The effects of stimulation on the brain are unknown. ELECTRODE PADS CAUTION: Caution: Do not ignore any allergic reaction to the electrode pads: If a skin irritation develops, stop using TENS, as this type of electrodes may not be suitable for you. Alternative electrode pads specially made for sensitive skin are available. Caution: Do not use this device with leads or electrode pads other than those recommended by the manufacturer. Performance may vary from specification. Electrodes with smaller surface area may cause tissue irritation. Caution: Do not use high intensity settings if electrodes are smaller than 50x50mm. Note: Electrode pads supplied have no measurable latex content.

TO KEEP YOUR DEVICE IN GOOD

WORKING ORDER, OBSERVE THE

FOLLOWING ADDITIONAL CAUTIONS: Caution: Do not immerse your device in water or place it close to excessive heat such as a fireplace or radiant10 heater or sources of high humidity such as a nebulizer or kettle as this may cause it to cease to operate correctly. Caution: Keep the device away from sunlight, as long-term exposure to sunlight may affect the rubber causing it to become less elastic and crack. Caution: Keep the device away from lint and dust, as long-term exposure to lint or dust may affect the sockets or cause the battery connector to develop a bad contact. Caution: Temperature & Relative Humidity of operating: 5°C to +40°C, 15% to 93% R.H. Temperature & Relative Humidity of storage: -25°C to +70°C, up to 93% R.H. Caution: There are no serviceable user parts. Do not attempt to open or modify the TENS unit. This may affect the safe operation of the unit and will invalidate the warranty. Note: There are no known side effect to TENS use and long- term TENS use is not harmful.

6. INFORMATION ABOUT

THE PROGRAMME SETTINGS Each programme has its own combination of Frequency and Pulse Width settings which allow for different sensations through the electrode pads and suppress pain in different ways.

• Frequency (measured in Hz - pulses per second) PAIN GATE: A high frequency of 110 Hz is good at blocking pain signals.

• Pulse Width (measured in μs - millionths of a second) The Perfect mamaTENS unit has pulse widths of 150 to 250 μs. Generally speaking, the higher the pulse width, the more "aggressive" the stimulation feels, and eventually, if the pulse width is set high enough, it will usually elicit a muscle contraction, which is typically not the desired result with a TENS unit. However, if the pulse width is too low, the patient may not perceive the stimulation. Pulse Rate is important because different frequency settings target different nerve groups and the setting will determine if the "Gate Theory" or "Endorphin Theory" of TENS will be used.

• Constant and Burst Modes Constant mode is when the sensation is continuous versus Burst mode when the sensation, as its name implies, is one of on and off. Constant mode is often used for acute pain via Pain Gate Effect whereas Burst mode is useful in chronic pain relief. Burst gives a combination of Pain Gate and Endorphin Release, but the squeezing feeling may not be as comfortable. The stimulation intensity will need to be relatively high. In Constant mode, the sensation is continuous and is more of a tingling pins and needles type.

• Active Power Ramp Mode When pressing the BOOST button in programme C, the power or level of intensity during the final contractions ramps up to give additional short-term pain relief through a third mechanism called “Brief intense”.11

7.1. PROGRAMME A You can start using Perfect mamaTENS as soon your contractions start to become regular. When you switch the machine on, it automatically selects programme A. The LCD screen will display A1. This programme is designed to provide a pulsing sensation that triggers the release of endorphins, relaxing you and relieving you from pain. This programme has 50 small steps of intensity, so you have fine control of the strength of stimulation. There are two modes, A1 and A2. Mode A1 is for use between contractions and mode A2 is for use during contractions. You can switch between the two modes at any time by pressing the BOOST button. The Perfect mamaTENS will start at zero intensity. Increase the intensity until you feel a pulsing on-off-on-off sensation. When the next contraction starts press the BOOST button once and the mode will change to mode A2, at the same intensity level as it was when in mode A1. Mode A2 feels like a constant strong tingling. At the end of the contraction, press the BOOST button to return to mode A1. Repeat this each time a contraction starts. As the contractions become stronger simply increase the intensity. 7.2. PROGRAMME B You should stay in programme A as long as possible, but when your contractions intensify and become more frequent you can progress to programme B. Do this by pressing the programme button P. The LCD screen will display B1. To avoid discomfort with the change in programme, the set intensity will drop by half. This programme has 50 small steps of intensity, so you have fine control of the strength of stimulation. Press and release the ▲ button until you reach a comfortable intensity setting. Programme B provides you with a stimulation pattern which is set to block the heightened pain which you may suffer. You will feel that the stimulation in the higher set of pads CH1 (left channel) which have been placed just below your bra line is stronger than the lower set of pads CH2 (right channel) at the bottom of your back - this is intentional and part of the therapy. As the contractions become more intense and closer together, increase the intensity. Program

Pulse Width μs Mode A1 80 150 Burst A2 Boost 80 150 Constant B1 150 150 Burst B2 Boost 150 150 Constant C 80 250 Ramp12 Note: If the lower electrode pads feel stronger then the upper ones then the leads have probably been incorrectly inserted into the Perfect mamaTENS. To correct this, change over the leads as per

section 6, and reset the intensity.

Again, there are two modes, B1 and B2. The second mode B2 is triggered by pressing the BOOST button when you experience a strong contraction. This mode provides a constant tingling sensation. When the contraction passes, press the BOOST button once more and your Perfect mamaTENS unit will change back to mode B1. 7.3. PROGRAMME C If you find programs A and B do not meet your needs for pain relief there is a third program C, which provides a higher level of pain relief. Press the programme button P again and this will take you to programme C which will be displayed on the screen as C. To avoid discomfort with the change in programme, the set intensity will drop by half. This programme has 60 steps of intensity. Press and release the ▲ button until you reach a comfortable intensity setting. This is a very natural way for you to control your pain as you rapidly increase and decrease the intensity to match the strength of your contractions. Again, there are two modes, C and C UP (Active Power Ramp mode). However, this time mode C is constant. Pressing the BOOST button starts the Active Power Ramp mode which ramps the power or level of intensity during the final contractions to give the additional “Brief intense” pain relief. In between contractions use the ▲ and ▼ buttons until you reach a comfortable level. When you experience a contraction just press the BOOST button down and HOLD IT. The intensity will increase until you release the BOOST button because the intensity may become too much to bear. When you release, the intensity will drop rapidly and return to the background setting you pre-selected. As it falls, you can press and hold the BOOST button again to keep the intensity at a fixed level to the end of your contraction. When instructed to start ‘pushing’ you can use the programme button P to switch Perfect mamaTENS back to programme A. Just remember the three programmes A, B and C which you can choose at any time as your labour progresses, and when you need a boost, just press the BOOST button. TENS can be used for as long as it is necessary. Continuous treatment is fine, but, except during labour, the electrode pads should be repositioned regularly (about every 12 hours) to allow the skin to be exposed to the air.13

The electrode pads must always be used in pairs (two electrode pads on each channel), so that the signal can flow in a circuit. The electrode pads need to be placed over the junctions of the nerves joining the womb and birth canal to the spinal cord. Correct positioning of the pads will give maximum pain relief so please study the images in section 11 and then follow these instructions. Always check that the unit is OFF before attaching or removing electrode pads. Perfect mamaTENS 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. ELECTRODE PADS ADVICE:

• The electrode pads supplied are reusable but for single patient use. The adhesive is a peelable hydrogel (water based).

• In order to obtain the best conductivity through the electrode 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 electrode pads on the plastic liner and replace them in the re-sealable plastic bag. If using before or after labour:

• If the electrode pads dry out, then it is best to buy a replacement pack. 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 electrode pad will become too soft. If that happens then it is suggested in order to try and 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 electrode pads may become soft. In such cases place them, still on their plastic liners and in their pouch into a fridge until they return to their normal condition.

• The electrode pads provided are latex-free.

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

• Storage life of an unopened pack of electrode pads is 2 years. This may be affected by very high temperatures or very low humidity.14

• 1 x Perfect mamaTENS unit, pain relief during labour

• 4 x 50x100 mm electrode pads with integrated leads (E-CM50100-PM)

Programme selected BOOST button Strength selected Strength UP Programme selector Strength DOWN Keypad lock OFF button ON button Low Battery Output active indicators16 10.2. OPERATING INSTRUCTIONS ON/OFF To turn the unit ON, press the ON button and hold for 3 to 5 seconds until the display shows. To turn the unit OFF, press the OFF button and hold for 3 to 5 seconds until the display stops. The unit will turn OFF automatically if it is left at zero strength for more than 5 minutes. When switching the unit on, the display shows that the unit is automatically set in programme A at zero strength. Note: Always check unit is OFF before applying or removing electrode pads. The backlight will turn off 10 seconds after the last button press. On the front of the unit there are six buttons: STRENGTH CONTROLS The buttons marked ▲ and ▼ are the strength controls. To increase strength in steps of 1, press and release the ▲ button. The strength level is shown on the LCD.

The strength control buttons will not operate until the unit is properly connected to you. Perfect mamaTENS detects a disconnection and automatically returns the strength to zero. The unit has 50 levels of strength in programme A & B, and 60 levels in programme C. If you hold down the button for 3 to 5 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 decrease the strength, press and release the lower part of the button marked ▼. The yellow LED on the output socket indicates that there is an active output. The display will remain on for 5 seconds after the plug is removed. PROGRAMME CONTROL The button marked P is the programme control. The Perfect mamaTENS has 3 different preset programmes lettered A, B and

Each time you press and release the P button, the programme changes and the letter is shown on the LCD. Each time the programme changes the intensity of stimulation is automatically reduced by 50%.

▼17 KEYPAD LOCK The button marked is the LOCK button, it can be used to lock the keypad. This is to avoid accidental changes in setting. To lock the controls, press and hold the LOCK button down for 3 seconds. will appear on the LCD screen and none of the controls will be working except for the ▼ button. Press and hold to unlock. BOOST BUTTON On the side of the unit there is a BOOST button. Its action depends upon the programme selected and is detailed within the

LOW BATTERY An empty battery symbol will show when you need to change the batteries. The unit will shut down about 2 minutes after this.

If the Perfect mamaTENS 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.

1) Remove belt clip by sliding down.

2) Remove battery cover by pulling on

Ensure that the batteries are inserted the right way as shown in battery compartment and that the ribbon is behind them.

4) Replace battery cover and belt clip.

When the batteries are running low, a low battery indicator will show on the screen and it is important to change the batteries as soon as possible. Rechargeable batteries Do not use rechargeable batteries. They have a lower voltage and may activate the low battery cut-out. BOOST18 Caution: Remove batteries from your Perfect mamaTENS if the unit is unlikely to be used for a long period. Some types of batteries may leak corrosive fluid. Battery Life Batteries should last at least 30 hours (Programme A, both channels 40mA). Unused batteries have a nominal shelf life of 3 years, but will usually last longer than this. Battery Warnings Do NOT pierce, open, disassemble, or use in a humid and/or corrosive environment. Do NOT expose to temperatures over 60°C(140F). Do NOT put, store or leave near sources of heat, in direct strong sunlight, in a high temperature location, in a pressurized container or in a microwave oven. Do NOT immerse in water or sea water, or get wet. Do NOT short-circuit. Do NOT connect the device unless the battery cover is in place. If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with lots of water and immediately seek medical attention.

Warning: Keep batteries out of the

reach of children to prevent them from swallowing them by mistake. If swallowed by child, contact doctor immediately. Caution NEVER attempt to recharge an alkaline battery. Risk of explosion. Caution Do not mix old, new or different types of batteries as this may lead to battery leakage or low battery indication. Disposal: Always dispose of batteries and device responsibly according to local government guidelines. Do not throw batteries onto a fire. Risk of explosion. 11.2. CONNECTING LEAD WIRES Connect the lead wires to each channel as shown on the image.

Insert the lead wire for the pads to be used under the bra line into Channel 1 at the base of the machine. The lead wire for the pads which will be used on your lower back should then be inserted into Channel 2. CH1 Channel 1 CH2 Channel 219 The lead wires may be damaged by rough handling, and should be treated with care. 11.3. PREPARING FOR SESSION

1) After the lead wires are securely

connected you will need to ask your birthing partner to place the electrode pads into the correct position on your back. To ensure good adhesion of pads, the area of skin they are going to be applied to needs to be clean, dry, and free from grease or powder.

2) For contraction, episiotomy pain or

perineal tear, place the top pair of pads (connected to CH1) either side of the spinal column 2 inches (50 mm) apart from each other and about 3 inches (75 mm) below the bottom of the shoulder blades (close to vertebrae T10, T11, T12 and L1). This is just below the bra line.

3) Place the lower pair of pads

(connected to CH2) either side of the spine about 4 inches (100 mm) apart and about 1 inch (25 mm) above the dimples at the base of the spine, just above the buttocks (close to vertebrae S2, S3 and S4).

Warning: Ensure the Perfect

mamaTENS is switched OFF before applying the electrode pads on the skin.

4) You can safely lean on the electrode

pads. The sensation might change.

5) With the electrodes pads in place

you can choose to use the belt clip or the neck cord, whichever you are most comfortable with, so you are able to remain as mobile as possible. A belt clip is provided to allow you to attach the unit to your clothing. It can be inserted either way up. Slide the clip along the base of the unit until it locks in position. You can also hang the unit from your neck with the neck cord using the holes on each shoulder of the unit. The neck cord is designed to open for safety if pulled. Feed a loop of the neck cord through the hole in the shoulder of the unit and pull through. Feed cord through the loop and pull tight towards the unit.20

Warning: Do not use other

cords than the one provided. Alternative pad placements for caesarean The electrodes can be placed in a crossed pattern with close proximity to suture site over the incision, two being above and two below the incision. 11.4. TREATMENT SESSION

1) Press and hold the ON button on the

control unit for 3 to 5 seconds to switch the control unit on. The LCD display will appear as A1 00 indicating that the unit has set itself into Labour Pain Phase A and Mode 1 at Zero intensity (00 mA).

2) You can now adjust the intensity of

the stimulation with the buttons ▲ and ▼ until you reach a comfortable level. The LCD display shows the strength of intensity.

3) Just remember the three

programmes A, B and C which you can choose at any time as your labour progresses, and when you need a boost, just press the BOOST button (see section 7). Note: If the sensation becomes uncomfortable, reduce the intensity. 11.5. AFTER YOUR TREATMENT SESSION After use, press and hold the OFF button on the control unit for 3 to 5 seconds to switch the control unit off

1) Once the unit off, remove the

electrode pads from your skin by holding the pad itself and gently pulling.

2) Replace the electrode pads to their

protective plastic shield and return them to the re-sealable plastic bag. Note: When removing the electrode pads, DO NOT PULL ON LEAD WIRES. Before the birth, you can use your Perfect mamaTENS to help with back pain, and after with post birth pain. Perfect mamaTENS programme A1 stimulation can be used with the breast electrode pads* (see E-CMR60130) to help initiate lactation. However, it is not intended to treat any medical issues and your first step in deciding appropriate therapy should be to consult your professional medical advisor.21 If you plan to put your Perfect mamaTENS into storage for your next baby then do the following:

• Clean as instructed in section 12

• Store or throw away the electrode pads with integrated leads

• Remember to buy new electrode pads and batteries before you need to use your Perfect mamaTENS again.

STORAGE Clean the case and lead wires after each use 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. Storage life

• Storage life of an unopened pack of self-adhesive electrode pads is 2 years. This may be affected by very high temperatures or very low humidity.

• The unit has no fixed shelf life.

Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment. (Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m). Note: For hospital use, full EMC advice tables are available on request.

14. 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 will process your old device for components recovery and recycling to help conserve the world’s resources and minimise adverse effects on the environment.22

Expected Service Life

• The machine will often last for more than 5 years, but is warrantied for 2 years. Accessories (electrode pads, neck cord, belt clip and batteries) are not covered by the warranty.

• Electrode pads should last 12 to 20 applications, depending on skin condition and humidity.

• Batteries should last at least 15 hours at 50 mA, 300 μs, 50 Hz. Replacement electrode pads, new batteries and separate 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 the TensCare website. The following replacement parts may be ordered from TensCare at www.tenscare.co.uk or +44(0) 1372

E-CM50100-PM Pack of 4 50x100 mm electrode pads with integrated leads E-CMR60130 Breast electrode pads Pack of 4 (2 pairs) L-CPT Separate lead wire B-AA 1.5V AA batteries X- BC-PT Replacement belt clip X-NC-MR Replacement neck cord X- BL-PTT Replacement battery cover

This warranty refers to the unit only. It does not cover electrode pads or battery. PRODUCT WARRANTY INFORMATION This product is warranted to be free from manufacturing defects for 2 years from date of purchase. This warranty is void if the product is modified or altered, is subject to misuse or abuse; damaged in transit; lack of responsible care; is dropped; if incorrect battery has been fitted; if the unit has been immersed in water; if damage occurs by reason of failure to follow the written instructions for use booklet enclosed; or if product repairs are carried out without authority from TensCare Ltd. We will repair, or at our option replace free of charge, any parts necessary to correct material or workmanship, or replace the entire unit and return to you during the period of the warranty. Otherwise, we will quote for any repair which will be carried out on acceptance of our quotation. The benefits conferred by this warranty are in addition to all other rights and remedies in respect of the product, which the consumer has under the Consumer Protection Act

Our goods come with warrantees that cannot be excluded under the UK consumer Law. You are entitled to have23 the goods repaired or replaced if the goods fail to be of acceptable quality. Before you send your unit for service Before sending in your unit for service, please take a few minutes to do the following: Read your manual and make sure you follow all the instructions for use. Returning your unit for service Should repair be needed within the warranty period, enclose the tear off section of the warranty card (see page

26) and your proof of purchase receipt.

Please ensure all relevant details are completed before sending your unit in for service. Please ensure your contact details are still current and include a brief description of the problem you are experiencing together with your purchase receipt. For hygiene reasons, please do not include used electrode pads. Send only the unit. Please return the unit and warranty card (see page 26) at your cost to: TensCare Ltd PainAway House, 9 Blenheim Road, Longmead Business Park, Epsom, Surrey KT19 9BE, UK Should you require any further information please do not hesitate to contact us by calling our number: [phone].

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. Remove plastic wrap. Check + / - .24 Damaged springs in battery compartment. Contact supplier. Low battery display Low batteries. Replace batteries. No sensation Incorrect connection. Check that you have applied the 4 electrode pads to ensure a complete circuit. Intensity is not strong enough. Increase strength. Most users will feel something at a setting below 10. Output will not increase above zero Open circuit cut-out operating. Ensure machine is attached to your body correctly. Lead not connected to body or faulty/damaged. Try using the second lead wire. 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 leads or electrode pads. If the above review has failed to resolve your problem, or to report unexpected operation or events, or to provide feedback call TensCare or your local supplier or distributor (address on back cover) for advice. Contact TensCare customer service on [phone]. Our staff are trained to assist you with most issues you may have experienced, without the need to send your product in for service. European Medical Device Regulation requires that any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority in your country. This can be found at: https://ec.europa.eu/docsroom/documents/3683/attachments/1/translations/en/renditi ons/pdf

75.0 mA zero to peak, 50 steps in A & B, 60 steps in C

+/- 10% Output plug Fully shielded: touch proof25 Channels Dual channel Batteries 2 x AA alkaline (two AA batteries) Weight 75 g without batteries Dimensions 120 x 60 x 20 mm Safety Classification Internal power source. Designed for continuous use. No special moisture protection. Environmental specifications: Operating:

Storage: Temperature range: 5 to 40⁰C Humidity: 15 to 93% RH non-condensing Atmospheric pressure: 700hPa to 1060hPa Temperature range: -25 to +70⁰C Humidity: Up to 93% RH non-condensing TYPE BF APPLIED PART Equipment providing a degree of protection against electric shock, with isolated applied part.

This symbol on the unit means “Refer to Instructions for use”. IP22 The unit is not water resistant, and should be protected from liquids.

Complies with EU WEEE regulations Note: The electrical specifications are nominal and subject to variation from the listed values due to normal production tolerances of at least 5%. Note: At least 30min required for the device to warm / cool from the minimum / maximum storage temperature between uses until it is ready for intended use26

TensCare aim to give you the best possible product and service. We listen to your suggestions and are constantly trying to improve our products. We also want to learn about the way our products are used, and the benefits they give. If you have anything you would like to share with us, please get in touch. www.tenscare.co.uk Follow us: TensCare Ltd @TensCareLtd TensCare Limited @tenscareltd

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 2797 marking on this product.107

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