Unicare - Pain therapy device TensCare - Free user manual and instructions

USER MANUAL Unicare TensCare

Simple graphic with a white flag and a stylized exclamation mark on a pink background (no text or symbols)

UK Clean the probe with an alcohol-free anti-bacterial wipe or with warm soapy water.

Simple line drawing of a device with three circular components and a handle, no text or symbols present.

UK Connect the lead wires to the electrode pads or vaginal probe and then insert the white pin into the device.

Abstract graphic with white geometric shapes on pink background, no text or symbols present

UK Place electrode or insert the vaginal probe (apply lubricant or water beforehand).

Abstract graphic with a white rounded rectangle and pink background, no text or symbols present.

UK Press and hold the power button for 3-5 seconds to switch the device on.

Pure diagram of a floppy disk with control buttons and gear symbols, no text or labels present

UK Select the programme by pressing the settings button.

Illustration of a retro-style computer monitor with two circular buttons and a control panel labeled 'CH', set against a pink background (no text or symbols beyond the label)

UK Adjust the intensity with the up and down buttons.

Thank you for choosing Unicare. 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 Team

CONTENTS

1. INTRODUCTION....7
2. INTENDED USE 8
3. UNICARE FEATURES....8
4. PELVIC FLOOR EXERCISES 9

4.1. PELVIC FLOOR MUSCLES....9
4.2. PERFORMING PELVIC FLOOR EXERCISES....10

1. TYPES OF INCONTINENCE....11
2. PERIOD PAIN....12
3. HOW 'EMS' WORKS....13
4. HOW 'TENS' WORKS 14
5. CONTRAINDICATIONS, WARNINGS & CAUTIONS....15
6. INFORMATION ABOUT THE PROGRAMME SETTINGS....20
7. PROGRAMMES....21

11.1. PROGRAMME SETTINGS....21
11.2. PRESET PROGRAMMES....21

1. CONTENT....22
2. UNIT INFORMATION ....23

13.1. CONTROLS & DISPLAY 23
13.2. OPERATING INSTRUCTIONS....24

1. SETTING UP AND USING THE UNICARE....26

14.1. CHARGING THE BATTERY 26
14.2. CONNECTING LEAD WIRE 28
14.3. PREPARING FOR SESSION....28
14.4. TRAINING SESSION 29
14.5. AFTER YOUR TRAINING SESSION....32

1. PAIN PROGRAMME....32
2. CLEANING....33
3. EMC....33
4. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE)......34
5. ACCESSORIES ....34
6. WARRANTY....35
7. TROUBLESHOOTING....36
8. GENERAL SPECIFICATION....39

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	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.
SN	Serial Number: indicates the manufacturer's serial number so that a specific medical device can be identified.
	Do not dispose in household waste.
REF	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 2797	CE Mark
MD	Medical Device
	This medical device is indicated for home use.

IP22

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 ∅, 80 mm length, shall have adequate clearance from hazardous parts, and protected against solid foreign objects of 12.5 mm ∅ 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.

Notes are used to provide clarification or recommendation.

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.

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.

1. INTRODUCTION

Device Description & Principles of Design

Bladder leakage and incontinence are common problems for both women and men, affecting their long-term health. Exercising the pelvic floor muscles is recognised as the way of preventing and treating symptoms of incontinence and pelvic floor weakness.

The Unicare is a powered muscle stimulator used for strengthening the pelvic floor muscles.

It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Unicare can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.

Additionally, the Unicare offers drug-free relief from period pain.

Period Pain (Dysmenorrhoea) is a widespread problem which affects 40-90% of women. Period pain can have a real impact on quality of life,

leading to absences from work and school.

If you are unsure of the cause of the pain, then you should seek medical advice to establish the cause and identify the correct treatment.

The Unicare provides relief from conditions such as:

- Urinary and faecal incontinence: including stress, urge and mixed types as well as post prostatectomy urinary incontinence in men. Additionally, it may help improve sexual intimacy by toning the pelvic floor muscles.

- Anal stimulation may also help men who are otherwise unable to execute Kegel exercises to strengthen their pelvic floor. Pelvic floor muscle training is recommended for recovery from some causes of Erectile Dysfunction. 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.

- Period pain: primary menstrual pain (dysmenorrhoea) and secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease.

2. INTENDED USE

Unicare is a medical device designed to be used in the home healthcare

environment to treat symptoms of urinary and/or faecal incontinence as well as symptoms of primary menstrual pain (dysmenorrhoea); and is suitable for use by all who can control the device and understand the instructions.

The Unicare may also help to relieve the pain of secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease.

Do not use the device for any purpose other than this intended use.

Warning: Not suitable for use in children without medical supervision.

3. UNICARE FEATURES

- Single Channel

Single channel unit to treat symptoms of urinary incontinence via a probe with biofeedback pointer.

• Comfortable Stimulation

Gentle stimulation with fine tune adjustment settings for different levels of intensity, 1 mA per step.

- 5 Preset Programmes

EMS programmes including STRES, URGE, MIXED and TONE aftercare; and one additional TENS programme providing relief from period pain.

- Memory

Features 3 functions: programme retention (automatically starts in the last programme used), duration of use and average strength used.

- Treatment Timer

Unit defaults to 20 minutes' treatment to ensure the pelvic floor muscles are not over-worked. The user can manually reset this (Continuous, 10, 20, 30, 45, 60 or 90 mins).

- Open Circuit Detection

Automatically resets the strength to zero and flashes 'LEADS' if the connection comes loose.

• Automatic Keypad Lock

Automatic keypad lock prevents any accidental changes in settings.

- Large LCD Screen

Clearly shows the operation of the unit and the programme and intensity being used.

4. PELVIC FLOOR EXERCISES

4.1. PELVIC FLOOR MUSCLES

The “FLOOR” of your pelvis is made up of layers of muscles that support the bowel, bladder, urethra and uterus. These muscles are like a hammock, or the bottom and sides of a bowl, in shape. They run from the pubic bone in the front to the end of the spinal column (or tail bone) in the back.

Rectum Uterus (womb) Coccyx (Tail Bone) Pelvic Floor Muscles Bladder Pubic Bone Vagina

The pelvic floor muscles:

• Assist in supporting the abdominal and pelvic organs.
  • Work with the abdominal and back muscles to stabilise and support the spine.
• Provide support for the baby during pregnancy and assist in the birthing process

Pelvic floor muscles are also important for sexual function:

• In women, voluntary contractions (squeezing) of the pelvic floor

contribute to sexual sensation and arousal.

However pelvic floor muscles may become weak. If your pelvic floor muscles become stretched or weakened, your pelvic organs may no longer be fully supported, and you may lose control of your bladder or bowel movements.

For some women, the pelvic floor muscles can also become too tight. This condition is less common, but it can lead to pelvic pain and make it difficult for you to empty your bladder or bowel completely.

Common signs that can indicate a pelvic floor problem include:

• Accidentally leaking urine when you exercise, laugh, cough or sneeze
• Needing to get to the toilet in a hurry or not making it there in time
  • Constantly needing to go to the toilet
  • Finding it difficult to empty the bladder or bowel
  • Accidentally losing control of the bladder or bowel
  • Accidentally passing wind
• Pain in your pelvic area
• Painful sex, or
• A prolapse

In women, this may be felt as a bulge in the vagina or a feeling of heaviness, discomfort, pulling, dragging or dropping. This occurs

when one or more of the pelvic organs (bladder, bowel or uterus) become displaced and sag down into the vagina. It is very common in the United Kingdom and occurs in about 40% of women. Symptoms tend to become exacerbated towards the end of each day and if left untreated, they will generally worsen over time.

In men, this may be felt as a bulge in the rectum or a feeling of needing to use the bowel but not actually needing to go.

Like other muscles in your body, the pelvic floor can be strengthened with regular exercise. Building pelvic floor strength enables the muscles to better support your pelvic organs, improves your bladder and bowel control and can stop accidental urine, faeces or wind leakage.

It can also reduce your risk of prolapse, improve your recovery from childbirth and gynaecological surgery, and increase your sexual pleasure. A continence therapist can help you learn how to exercise your pelvic floor.

Doing just a few pelvic floor exercises every day will help to treat bladder weakness or prolapse symptoms and will help to prevent problems later.

4.2. PERFORMING PELVIC FLOOR EXERCISES

It is recommended to make Pelvic Floor Exercises (sometimes called Kegel Exercises) part of your daily life.

1) Kegel exercises can be done at any time and are very discreet so you can do them almost anywhere; lying in bed, sitting at the computer or waiting for a bus. It is a good idea to try and develop a routine which you can repeat each day.

2) First, it is important to find your pelvic floor muscles and feel them working. So here are a couple of techniques which might help:

Try inserting one or two clean fingers into your vagina and then squeezing the surrounding muscles, lifting up and towards your belly button – a squeezing and lifting sensation.

Another way is to try and stop the flow of urine during urination. If you are successful, then you know you are exercising the correct muscles.

Note: These techniques are just to help you confirm that you are using the correct muscles. It is important to have an empty bladder before starting the exercises.

3) Try to remember the lifting and squeezing sensation and when you are ready try to recreate it just using the muscles you identified earlier; don't tense the muscles in your legs, stomach or buttocks and remember to breathe normally.
4) Aim to hold each squeeze or 'contraction' for three to five seconds, then release and relax. You should feel a 'letting go' of the muscles. Rest for five seconds and then repeat.
5) Try and do about ten squeezes in this way.
6) Repeat the whole process three or four times a day.
7) Over a period of time try to increase the muscle contractions up to about ten seconds, but remember to rest in between each squeeze for longer periods.

Note: It is important to aim for quality contractions, not quantity, so a few good hard squeezes are better than a series of weak ones.

Do not worry if you find holding for 3 seconds difficult at first. Just squeeze for as long as you feel comfortable to do so. The more exercise you do, the stronger the muscles will become and the longer you will be able to squeeze.

8) Using your Unicare pelvic floor stimulator in conjunction with

Kegel exercises will give you a better understanding of how they work and how to get the greatest benefit from them.

Use the pointer as an indication of how well you are performing the Kegel exercises.

• When performed correctly, the pointer will move downwards.
• When performed incorrectly, the pointer will move upwards.

Illustration of a handheld device with a vertical arrow indicating upward motion (no text or symbols)

5. TYPES OF INCONTINENCE

There are three types of incontinence: Stress, Urge, and Mixed.

Stress Incontinence

If you leak urine when you cough, sneeze, laugh, strain or make sudden movements, this is called Stress Incontinence.

It is particularly common in women who have had a natural childbirth and occurs when the bladder neck and the other mechanisms that act to hold urine in the bladder are not working properly. The most common cause is a weak pelvic floor.

Urge Incontinence

Describes an overactive bladder. A person may experience a strong and sudden urge to go to the toilet but are not always able to hold on, or must go so frequently that it becomes inconvenient.

Mixed Incontinence

Is a combination of both Stress and Urge Incontinence.

6. PERIOD PAIN

Painful periods are common in teenagers and young adults.

Most women have some pain during periods. The pain is often mild but, in about 5 in 10 women, the pain is severe enough to affect day-to-day activities. The pain can be so severe that they are unable to go to school or work.

Period pain generally falls into two categories: primary dysmenorrhea and secondary dysmenorrhea.

Primary dysmenorrhoea has no specific cause yet is the most common type of painful periods affecting 9 out of 10 women. It occurs where there is no underlying problem of the womb (uterus) or pelvis. The main symptom is a cramping type of pain in the lower tummy (abdomen); it may in some cases spread to the lower back, or to the top of the legs. Pains are generally worst in the first few years after starting your period, with symptoms tending to improve with age or after childbirth.

Secondary dysmenorrhoea is less common and is more likely to occur in women in their 30s and 40s. It is caused by a specific underlying condition such as endometriosis (when cells that normally line the uterus are found at other sites in the body – usually the ovaries and fallopian tubes). Again, the main symptom is cramping pain in the lower tummy during your periods. In some women with secondary dysmenorrhoea the pain starts several days before the period begins and lasts all the way through the period. (This is uncommon with primary dysmenorrhoea).

With secondary dysmenorrhoea it is likely to have other symptoms - for example:

• Irregular periods.
• Bleeding between periods.
• Pains between periods.
• The bleeding becomes heavier than previously.
  • Vaginal discharge.
• Pain during sex.
• Pain in your back passage (rectum).

Secondary dysmenorrhoea may occur as a result of:

• Endometriosis/adenomyosis.
- Pelvic inflammatory disease.

• Fibroids when it is often associated with heavy menstrual bleeding.
• Adhesions.
  • Developmental abnormalities.

Consult your healthcare professional if you are experiencing any of the above symptoms.

7. HOW 'EMS' WORKS

E.M.S. stands for Electrical Muscle Stimulation and has successfully been used in medical rehabilitation and training in competitive sports. EMS produces intensive and effective muscular contraction.

In rehabilitation, EMS is a well-established method for treatment of a broad field of musculoskeletal diagnoses as well as pelvic floor weakness. Electrical stimulation of an intact peripheral nervous system may create motor responses in patients with impaired or lost ability for voluntary muscle activity.

EMS is a complement to other physical therapy and should always be combined with active training such as Kegel exercises (see section 4.2.).

Advantages of EMS

Use of EMS may lead to faster progress in the patient's treatment programme. The method is simple and appropriate for treatment in the clinical setting as well as for self-treatment at home.

How EMS Works

Electrical Muscle Stimulators can play a vital role in educating women and men about their pelvic floor and the sensation they should feel when doing pelvic floor exercises. Electrical Pelvic Floor Exercisers (PFE) offer a non-invasive method of producing contraction of muscles via a gentle stimulation to the pelvic floor through a discreet probe or electrode pads when they are placed close to the nerve that controls the pelvic floor muscles. This current then passes into the nerve fibres controlling that part of the muscle stimulating it to contract. So, electrical stimulation (EMS) artificially activates a muscle for you enabling you to develop your own muscle control. These contractions exercise the muscles and, as with any kind of exercise if performed regularly, build strength and tone.

In urge incontinence, pelvic floor exercisers work in a slightly different way. The electrical stimulation is designed to soothe your bladder muscles rather than exercise your pelvic floor. Unicare uses a gentler, low frequency setting which promotes release of endorphins and reduces involuntary contractions of the bladder (detrusor) muscle.

Different frequencies have different effects; low frequencies (1-10 Hz)

coupled with long impulse times, for example, have a purifying and relaxing effect through individual contractions, whereby the circulation in the treated muscle is simultaneously improved and removal of metabolic end products is supported (lymphatic drainage).

In contrast, by means of a rapid succession of contractions (fibrillation), medium frequencies (20-50 Hz) can put a high level of strain on the muscle, thus promoting the muscular structure.

Each preset programme has a specific frequency and pulse width that will offer the best results for the type of incontinence treated.

8. 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. 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

Illustration of a human back with colored anatomical markers (no text or symbols)

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

Human back with two purple rectangular markers on the spine (no text or symbols)

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 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 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. They are also often used for pain relief in the early stages of labour (see perfect mamaTENS and perfect mama+), 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, cystitis, sports injuries, fibromyalgia and neuralgia, plantar fasciitis, post-operative pain, TMJ disorder, diabetic neuropathy, osteoarthritis 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 shingles and 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.

9. CONTRAINDICATIONS, WARNINGS & CAUTIONS

CONTRAINDICATIONS:

Do NOT use if you are or may be pregnant. It is not known whether TENS may affect foetal development.

Do NOT use with optional electrode pads 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.

Do NOT use following a pelvic surgery or vaginal childbirth until you are fully healed. Stimulation may disrupt the healing process.

Do NOT use if you have symptoms of active urinary tract infection, vaginal infections, or localized lesions. Introducing the probe may irritate sensitive tissue.

Do NOT use if you have poor sensation in the pelvic region. You may not be able to control the intensity of stimulation safely.

Do NOT use Unicare on any area of the body not specified in these instructions for use. Use on the chest or neck may affect heart or implanted devices and may affect epileptic seizure threshold. May also affect body worn monitoring devices.

WARNINGS:

Do NOT use if you are unable to properly insert the vaginal or anal probe. If you have a severe prolapse, or if any discomfort occurs when inserting the probe, consult your healthcare professional before use.

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 near the thorax as this may increase the risk of cardiac fibrillation.

Do NOT use optional 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 optional 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 simultaneously with high frequency hospital diagnostic /therapeutic equipment. Doing so may result in burns at the site of the electrodes and possible damage to device.

Do NOT apply Unicare near the thorax because the introduction of electrical current may increase the risk of cardiac fibrillation.

Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus), or from electrodes placed on the upper back or crossing over the heart.

Do NOT use Unicare in close proximity (e.g. 1 m) to a shortwave or microwave as this may produce instability in the stimulator output

Do NOT connect Unicare with devices not described in this instruction manual.

Do NOT use any charger other than the one supplied. Use of other chargers could be hazardous.

Do NOT use the device whilst charging.

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. It may interfere with the signals being monitored.

Caution Do not permit use by persons unable to understand the instructions or persons with cognitive disabilities, i.e.; Alzheimer's disease or dementia.

Caution: Insertion of the vaginal or anal electrode makes it unsuitable for use in children without clinical supervision

Caution: Keep away from children under 5 years of age. Long cord - risk of strangulation in infants.

Caution should be observed when using the Unicare at high strength settings. Prolonged use at high settings may cause muscle injury or tissue inflammation.

Caution: There are no user serviceable parts. No modification of this equipment is allowed.

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.

Caution: Do not service and maintain the device while in use with a patient.

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 Keep away from children under 5 years of age, pets and

pests. Long cord - risk of strangulation in infants.

Caution: Do not put the lead wire on or wrapped around the neck

Caution: should be observed when using the Unicare at high strength settings. Unicare has a Yellow LED light on output socket which means the output will exceed 10 mA (R.M.S) or 10 V (R.M.S) averaged over any period of 1 sec. Prolonged use at high settings may cause muscle injury or tissue inflammation.

Note: No serious or long-term adverse effects have been reported. Mild adverse

reactions are very rarely reported, but these have included muscular pain and cramps, vaginal tenderness, irritation and bleeding, mild or short-term urge or faecal incontinence, and tingling sensation in legs. If you experience any of these, stop use immediately. When symptoms have gone, try resuming at a lower intensity setting.

PROBE CAUTIONS:

Caution: The Unicare vaginal probe is intended for single patient use only. Do not share your Unicare probe with anyone else. Improper treatment or cross-infection may occur.

Caution: It is important that the vaginal probe is cleaned after each use. Ineffective cleaning may lead to irritation or infection.

Caution: Never insert or remove vaginal probe unless the control unit is powered OFF as insertion or removal when stimulation is active may cause discomfort or tissue irritation.

Caution: If tissue irritation occurs, discontinue treatment immediately. Ask your healthcare professional for advice before continuing further treatment to prevent injury.

Caution: Do not use a silicone-based lubricant on the metal plates of the probe as it may decrease the effectiveness of Unicare's muscle stimulation.

Caution: The stainless steel in the probe's metal plates contain some Nickel. This could cause a reaction if you have a Nickel allergy. Alternative gold probe specially made without Nickel is available (see X-VPG).

Caution: Do not use this device with vaginal probe or anal probe other than those recommended by the manufacturer in section 18. Electrodes with smaller surface area may cause tissue irritation.

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.

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 (see E-696SS).

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.

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 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.

- The operator should pay special attention when using the device at frequencies above a level of 24 (24 mA application).

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 radiant 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 storage: -10°C–+45°C (≤ 3 months), 45%–75% R.H. Temperature & Relative Humidity of transportation: -10°C–+60°C, 45%–75% R.H.

Caution: There are no user serviceable parts. Do not attempt to open or modify the unit. This may affect the safe operation of the unit and will invalidate the warranty

10. INFORMATION ABOUT THE PROGRAMME SETTINGS

Each programme has its own combination of Frequency and Pulse Width settings which allow for different sensations through the probe or optional electrode pads and help treating the different types of incontinence.

- Frequency (measured in Hz - pulses per second)

Low frequencies (1-10 Hz) have a purifying and relaxing effect through individual contractions.

Medium frequencies (20-50 Hz) can put a high level of strain on the muscle, thus promoting the muscular structure

Pain Gate (programme PAIN only): A high frequency of 110 Hz is good at blocking pain signals.

- Pulse Width (measured in s - millionths of a second)

The Unicare unit has pulse widths of 100 to 300 s. Generally speaking, the higher the pulse width, the more "aggressive" the stimulation feels, if the pulse width is set high enough, it will usually elicit a muscle contraction, which is required for an effective toning of the pelvic floor muscles.

11. PROGRAMMES

11.1. PROGRAMME SETTINGS

Prog	STRES	URGE	MIXED	TONE	PAIN
Freq. (Hz)	50	10	10/50	35	110
Pulse width (μs)	300	200	200/300	250	100
Ramp Up & Down (s)	1	Constant	Con/1	2	Constant
Plateau (s)	5		Con/5	3
Rest (s)	10		Con/10	6
Default duration (min)	20	Continuous	20	20	Continuous

11.2. PRESET PROGRAMMES

The Unicare has five preset programmes. One for each type of incontinence (STRESS, URGE and MIXED), one for toning the pelvic floor muscles (TONE), and one for period pain (PAIN).

STRESS INCONTINENCE:

Shown on the screen as: STRES

The STRES incontinence programme strengthens the muscles of the pelvic floor using gentle stimulation. Once these muscles are stronger, they are better able to resist urinary leakage caused by external pressure being applied to the

bladder such as with a cough, sneeze or physical exertion.

The stimulation causes the muscles to contract and work. This builds their strength. Like other fitness training, successful treatment requires stimulation once a day for one to three months. Improvement starts becoming apparent after about four weeks.

The sensation is like a strong drawing in of the muscles of the vagina, pulling up the pelvic floor. Your natural reaction will be to pull your muscles in and up, and this exercises and strengthens them.

URGE INCONTINENCE:

Shown on the screen as: URGE

The URGE programme works in a different way to the STRES programme. The gentle continuous stimulation soothes the bladder (detrusor) muscle, reducing its involuntary contractions. This prevents the unwanted and unexpected emptying of the bladder.

Successful treatment requires stimulation once a day and improvements can sometimes be seen in as little as two weeks.

The sensation is a softer, vibrating, stimulation. Nevertheless, when the programme finishes, and your pelvic floor relaxes, it will become apparent how much your pelvic floor has been exercised.

MIXED INCONTINENCE:

Shown on the screen as: MIXED

This programme is perfect if you are suffering from both Stress and Urge incontinence. It is a combination of the STRES and URGE programmes.

The first 10 minutes uses the URGE programme to reduce sensitivity, then in the second 10 minutes, the STRES programme exercises the pelvic floor muscles. You may need to increase the strength to feel the muscle contraction when the STRES programme starts.

TONE:

Shown on the screen as: TONE

Once the pelvic floor muscles have been strengthened with Unicare, continue to exercise them.

Regular use of this programme, about twice a week, will ensure that your muscles remain fit and toned.

The TONE programme may also be used as an alternative treatment for stress incontinence.

The sensation when using the TONE programme is a mixture of a strong drawing in of the muscles and then releasing.

A strong and fit pelvic floor may increase sexual health and enjoyment.

PAIN:

Shown on the screen as: PAIN

The PAIN programme can be used to alleviate period pain. It has a constant output that produces a tingling sensation, activating the Pain Gate. It is the programme that is likely to result in the greatest pain relief.

12. CONTENT

The pack contains:

• 1 x Unicare continence stimulator unit
  • 1 x Go Gel 50 ml (K-GO50)
• 1 x Lead wire (L-CPT)
• 1 x Liberty Loop vaginal probe with detachable pointer (X-VPL)
• 2 x 50x90 mm electrode pads (E-CM5090)
  • 1 x Charging adapter (UK/EU)
• 1 x Detachable belt clip
• 1 x Storage pouch
  • 1 x Instructions manual

Assorted medical and health products including a Go Cell, medical device, and medical kit (no visible text or symbols)

13. UNIT INFORMATION

13.1. CONTROLS & DISPLAY

Programme selected Keypad Lock Low Battery 20 min STRES mA 0 ON/OFF Programme duration (min) Strength selected (mA) PROGRAMME CONTROL TREATMENT TIMER CH unicare Strength UP Strength DOWN

13.2. 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 ▼ button to remove keypad lock and press the OFF button and hold for 3 to 5 seconds until the display stops.

At first use, or after changing batteries, the display shows that the unit is automatically set in programme STRES at zero strength.

When switched on the unit will automatically start in the programme which was being used when it was last switched off.

The unit will turn off automatically:

• When the Timer reaches zero,
• If it is left at zero strength for more than 5 minutes.

Note: Always check unit is OFF before applying or removing probe or pads.

The backlight will turn off 10 seconds after the last button press.

STRENGTH CONTROLS

The buttons marked ▲ and ▼ are the strength controls.

To increase strength, press and hold down the button

▲ until required strength is achieved.

To decrease the strength, press and release the button ▼.

To increase strength in steps of 1 mA, press and release the button ▲.

The unit will remain in the WORK part of the cycle for 5 seconds while intensity is being adjusted.

The strength levels are shown on the LCD display.

The strength control buttons will not operate until the unit is properly connected to you (probe inserted correctly). Unicare detects a disconnection and automatically returns the strength to zero.

The unit has 99 levels of strength. 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.

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 illustrated is the programme control. The

Unicare has five preset

programmes. At first use, the unit automatically goes to programme STRES. Next time it is switched on, it will default to the programme used last.

Each time you press and release the PROGRAMME CONTROL button, the programme changes and 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.

TREATMENT TIMER

The button illustrated can be used to set the session duration. When you switch

the unit on, it is automatically set at 20 min or Continuous, (displayed as C) depending on the programme chosen.

To set a different time, set the strength to zero and press TIMER. The min display will flash.

You can set session times of C (Continuous) or 10, 20, 30, 45, 60 or 90 minutes with the buttons ▲ and ▼.

Press TIMER again to save your selection.

The LCD shows the session duration next to the clock symbol. The unit automatically counts down the minutes set and switches off when it reaches 0.

LOW BATTERY

An empty battery symbol will show when you need to

recharge 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. This is to avoid accidental changes in setting.

To unlock, press and hold the strength down control (button ▼).

LEADS ALARM

The Unicare monitors the connection and the contact between you and the probe, or the pads. This is to prevent sudden changes if a broken connection is re-made. If either of these goes outside of a standard range while the strength is above 20, the unit will flash LEADS and return the strength to 0.

Check the lead and if necessary, lubricate the probe with a water-based lubricant such as TensCare Go Gel (see K-GO). Please see section 21 for more troubleshooting tips.

MEMORY

The Unicare 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) Usage. Press T and ▼ together and hold down for 3 to 5 seconds. The display will show the number of times the unit has been used and the duration of use in hours.

Press the same buttons again to return to normal controls.

3) Memory Reset. To reset memory to zero, hold down the T and OFF buttons together for 3 to 5 seconds.

Number of uses 5 10 Time used in hours unicore

14. SETTING UP AND USING THE UNICARE

14.1. CHARGING THE BATTERY

The Unicare is powered by a built-in rechargeable Li-ion battery. A charging adapter is included in the kit. The battery should need charging about once a month. The battery should last at least 15 hours at 50mA, 300 s, 50Hz. To fully charge the battery it will take about 2 hours.

When the battery is running low, the battery icons will show on the screen. Although the display fades as the batteries run down, the strength of the output does not change until the warning is shown.

Warning: Use only the charging cable supplied. Use of other cables could be hazardous and will negate the warranty.

To charge the battery:

Connect the charger to the unit and plug it onto the mains socket.

The word BATT and three flashing lines will show on the screen display – that means the battery is being charged.

When the battery is charged, the word FULL will display.

i Note: The device should be charged at least once every 3 months to ensure the battery life is maintained.

i Note: The device cannot be used while being charged.

i Note: Charging voltage: DC 5V, charging current: 60mA.

i Note: Use adapters of the following specifications. Output: DC 5 V; 1A

✿ Rated input voltage shall not exceed 250 V
✧ Classification of protection against electric shock: Class II
✨ IP classification: at least IP21
✿ The adapter need to comply with IEC 60601-1 or IEC 60950-1

Battery Warnings

This product is equipped with a Lithium-ion battery. Failure to follow these instructions could cause the lithium-ion battery to leak acid, become hot, explode or ignite and cause injury and/or damage:

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 (a vehicle in extremely hot conditions), 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 directly solder the pack or battery, tamper with the circuit or reverse the positive and negative terminals

Do NOT transport and store the battery together with sharp metal objects that could pierce the battery. i.e. necklaces, hairpins, nail etc.

Do NOT strike at pack with any sharp edge or throw the pack.

Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Do NOT replace your own batteries. Changing lithium batteries or fuel cells incorrectly can lead to unacceptable risks.

Do NOT replace the battery without adequately trained personnel, otherwise it will cause danger (such as overtemperature, fire or explosion).

Do not position the equipment during charging such that it is difficult to use the charging adapter. The provided charging adapter is used to isolate the equipment circuits from the mains power supply.

Only use the battery charger provided for recharging batteries.

Do not connect the pack to an electrical outlet.

Keep batteries out of the reach of children to prevent them from swallowing them by mistake. If swallowed by child, contact your healthcare professional immediately.

Battery Caution

Caution: Do NOT use in a location where there is a large amount of static electricity, otherwise, the safety devices in the battery pack may be compromised.

Caution: If the battery pack creates an odour, generates heat, becomes discoloured or deformed, or in any way appear abnormal during use, recharging or storage, immediately remove it from the device or battery charge and stop using it.

Caution: If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with lots of water and immediately seek medical attention

If necessary, to obtain a replacement battery please send the device to Tenscare. (See back cover for contact details)

Disposal: Always dispose of batteries and device responsibly according to local government guidelines. Do not throw batteries onto a fire. Risk of explosion.

14.2. CONNECTING LEAD WIRE

Insert the lead wire plug into the base of the unit.

Pink square button with two dots and a label, pointing right with an arrow (no readable text or symbols)

Connect the lead from the base of the unit to the lead in the probe.

Line drawing of two hands holding a pen, no text or symbols present

Push the pin ends firmly into the pigtail ends of the probe lead.

The lead wires may be damaged by rough handling and should be treated with care.

Lead wire colour coding.

The ends of the lead wire are coloured black 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.

14.3. PREPARING FOR SESSION

1) Before using Unicare you will need to urinate.
2) Lubricate the metal electrode surfaces and probe tip with a water-based lubricant, such as TensCare Go Gel or water.

Caution: Do not use a silicone-based lubricant on the stimulation contacts as it may decrease the effectiveness of the Unicare's muscle stimulation.

3) Choose a comfortable position, such as lying down on your bed on your side with your knees raised.

Warning: Ensure the Unicare is switched OFF before inserting the probe.

4) After the wire is securely connected, insert the probe into your vagina, in the same way as you would a tampon, until only the plastic rim at the base of the probe is visible.

Anatomical illustration of a human ear with a needle inserted, showing no text or labels

5) The metal parts conduct the electrical pulse and should be in contact with the main part of the muscle at all times. The tissues close to the entrance are more sensitive, so you should avoid stimulating them.

Ensure that the probe is aligned so that the contact plates are to the sides and the longer sides of the positioning end rim are vertical.

Contact plate Positioning end rim

6) The Liberty Loop probe has a pointer attachment which enables you to visually monitor the successfulness of your pelvic floor contractions (the probe can be used without the pointer).

The pointer demonstrates the strength and duration of each contraction, whether caused by stimulation or performed manually. For example, weak contractions are defined by little or no movement in the pointer.

Assemble the pointer and attach to the probe as follows:

- When performed correctly, the pointer will move downwards.

- When performed incorrectly, the pointer will move upwards.

Simple line drawing of a handheld device with a vertical arrow indicating upward motion (no text or symbols)

14.4. TRAINING SESSION

1) Press and hold the ON button on the control unit for 3 to 5 seconds to switch the control unit on.

2) You can select from the five preset programmes. Details in section 10 will help you identify the best programme to suit you. To change between the programmes, press the programme selector, which is labelled P, in the centre of the control unit keypad.

3) With the required programme selected, you can adjust the intensity of the muscle stimulation until you reach a comfortable level. Once you have reached a comfortable level, 5 seconds after you stop pressing the button, the intermittent work/rest phase will start. The machine will take itself to 0 mA for a rest period and then take itself back up to the level of intensity you chose, to work the muscle. This cycle will continue for the 20 minutes of the programme.

Note: The strength required varies widely between users - some will use the Unicare at full power - 99 mA. The Unicare strength will go up at 1 mA increments.

Initially the sensation through the probe may be limited but will improve during treatment. Take care not to use too much strength and thereby over stimulate the muscles until normal sensation is restored. The sensation may not be

even as it may vary depending on the sensitivity of the nerves.

The LCD display shows the strength of intensity used. The aim is to increase this over a few days. But remember there is no hurry, so only increase the strength of the stimulation as and when you are comfortable and ready to progress.

Note: If the sensation becomes uncomfortable, reduce the intensity using the button ▼.

When switched on, in STRES and TONE programmes the unit will go through an exercise programme for 4-5 seconds, followed by a rest period of 8-10 seconds. The Unicare causes a sensation which feels like a strong drawing in of the vagina and pulling up of the pelvic floor. The natural reaction will be to pull in and up with the muscles.

At lower strength settings, you may not feel any sensation at all, this depends very much on the individual and any pre-existing physical conditions, so slowly increase the intensity by repeatedly pressing the ▲ button until you begin to feel the muscles around your vagina contract.

For best results in these programmes try to contract the pelvic floor muscles along with the Unicare, and to sustain the contraction into the rest interval. If possible, link the

contraction to your breathing to get into a gentle rhythm.

Increase the strength as high as it is comfortable, and then take it back down one step.

The strength display on the control unit will reduce to 0 and flash during the rest period.

The URGE programme works differently. There is no need to have a contraction. The strength should be comfortable, but always remain noticeable. You may need to increase it over the course of the treatment.

The length of each session is automatically set to 20 minutes. The length of each session for muscle strengthening will also depend on your ability to contract and your resistance to fatigue. Be careful not to overuse early on, as the resulting aches may not be felt until the next day.

Note: If you experience cramping, switch the unit off until the symptoms go away

then continue the session with the intensity set at a lower level.

Optional skin surface electrode placement for URGE (this may not be as effective as the stimulation with the vaginal probe)

An alternative method to a vaginal probe is to stimulate areas of the skin that are close to the nerves that go to the bladder and urethra. These come from the parts of the spinal cord segment called S2-S3. See electrode placement picture below.

The strength should be comfortable, but always remain noticeable. You may need to increase it over the course of the treatment.

Simple line drawing of a human torso with a rectangular object on the chest (no text or symbols)

Optional skin surface electrode placement for STRESS (this may not be as effective as the stimulation with the vaginal probe)

The electrodes are placed on the skin between the anus and the genitals. See electrode placement picture below.

The stimulation should be strong enough to make your anus contract slightly.

Simple line drawing of a human torso with a small dark oval object on the chest (no text or symbols)

14.5. AFTER YOUR TRAINING SESSION

When the timer reaches zero, your session is complete, and the unit turns off.

1) Check that the control unit is off. If it is not, hold down the OFF button to switch off then remove the probe from your vagina by holding the positioning end rim and gently pulling outwards. If you are using the pointer, detach this first before removing the probe.

2) Wash and thoroughly dry the probe and return it to the storage pouch.

3) The Unicare will not only improve your pelvic floor muscles but also help you to recognise the correct sensation you need to feel when doing your Kegel exercises (explained in section 4.2.).

Note: When removing the probe, DO NOT PULL ON THE LEAD WIRE.

15. PAIN PROGRAMME

In order to obtain the best relief, the pads need to be placed over the dermatomes T10, T11 and T12, which are the nerve roots that supply the sensory fibres to the uterus. These dermatomes wrap around the body, but do not quite meet up at the front. They run from around waist height at the back down to the groin area at the front.

As each person's body is different, the Unicare is supplied with pads which are large enough to be effective even if not located exactly over all three dermatomes. When the pads are placed correctly the Unicare will work very well.

Therefore, if after thirty minutes considerable relief has not been achieved, either move the pads slightly or try one of the other pad positioning areas.

There are THREE positions where the pads can be placed for maximum benefit. It is recommended that the positions are tried in the following order until maximum relief is obtained:

• On the lower back
• On the front, in a vertical format
• On the front, in a diagonal format

Please refer to the diagrams below:

On the lower back:

Place the pads vertically either side of the spine, approximately 10cms (4 inches) apart, with the bottom of the electrodes no higher than the top of your buttocks. The "pigtails" should hang down from the pads.

Illustration of a human abdomen with two white oval markers on the lower abdomen (no text or symbols)

On the front, in a vertical format:

In the vicinity of your groin, place the pads vertically, about 10cms (4 inches) apart. The "pigtails" should be uppermost.

Illustration of a human abdomen with two hanging objects (no text or symbols)

On the front, in a diagonal format:

In the vicinity of your groin, place the pads in a V-shape, narrowing to about 10cms (4 inches) apart at the lower end of the pads. The "pigtails" should be uppermost.

Illustration of a human pelvis with two medical devices on the abdomen (no text or symbols)

The strength should be comfortable, but always remain noticeable. You may need to increase it over the course of the treatment. There is no need to have a contraction.

Caution: The self-adhesive pads supplied are intended for multi-use by one person only. Do not lend used pads to others, nor use someone else's used pads yourself.

16. CLEANING

It is important that the probe is cleaned before using for the first time and after each use. Clean with either an alcohol-free antibacterial wipe such as TensCare Wipes (see X-WIPES) or by washing with warm soapy water. Rinse in clean water and dry thoroughly and return the unit to the storage pouch. Do not immerse the probe in a liquid.

Clean the case of the unit and lead wire at least once a week using the same method.

• Do not immerse your Unicare unit in water.
• Do not use any other cleaning solution.

17. EMC

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 used no closer than 30 cm (12 inches) to any part of the device.

(Note. As indicated in 5.2.1.1(f) of IEC 60601-1-2:2014 for ME EQUIPMENT).

Note: For hospital use, full EMC advice tables are available on request.

18. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE)

One of the provisions of the European Directive 2012/19/EU 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.

19. ACCESSORIES

Expected Service Life

- The machine, including battery, will often last for more than 5

years, but is warranted for 2 years. Accessories (lead wire, probe, and batteries) are not covered by the warranty.

• Lead life depends greatly on use. Always handle the leads with care. We recommend replacing the lead wires regularly (about every 6 months).
• Replace the probe every 6 months to ensure hygiene.
• Electrode pads should last 12-20 applications, depending on skin condition and humidity.
• The battery should last at least 15 hours at 50mA, 300μs, 50Hz.

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 the TensCare website.

The following replacement parts may be ordered from TensCare at www.tenscare.co.uk or [phone].

X-VPL Liberty Loop Vaginal Probe (32 mm dia.)

E-CM5090 Pack of 2 electrode pads (50x90 mm)

E-696SS Square hypoallergenic electrode pads Pack of 4

X-VP Liberty Vaginal Probe (28 mm dia.)

X-VPM Liberty Plus Vaginal Probe (32 mm dia.)

X-VPG Gold Vaginal Probe (26 mm dia.)

L-CPT Replacement lead wire, 1.25 m length

K-GO Go Gel Personal Water-based Lubricant

X- BC-UR Replacement belt clip

X-WIPES Pack of 30 wipes

X-UNICH Charging adapter (UK/EU)

Caution: You should only use the probe/electrodes supplied with the unit or the

replacements above as performance may vary with other probes/electrodes.

Warning: Do NOT use silicone based or hybrid (mixed water and silicone)

lubricants.

20. WARRANTY

This warranty refers to the unit only. It does not cover the probe, electrode pads, charging adapter or the lead wires.

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 instruction 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 1987.

Our goods come with guarantees that cannot be excluded under the UK consumer Law. You are entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality.

If necessary, we will provide circuit diagrams, component part lists or other information that will assist authorized service personnel to repair the device.

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.

Returning your unit for service

Should repair be needed within the warranty period, enclose the tear off section of the warranty card (see page 40) 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 probe or electrode pads. Send only the unit and the lead wire.

Please return the unit and warranty card (see page 41):

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].

21. TROUBLESHOOTING

If your Unicare is not working properly, please check the following:

Problem	Possible causes	Solution
No display	Flat batteries.	Recharge batteries.
	Damaged battery	Contact supplier. There is no maintenance or calibration other than replacement of gel pads and battery charging. Do not modify the device as this may reduce safety or effectiveness.
Low battery display	Low batteries.	Recharge batteries.
Controls won't work	Keypad is locked.	If LOCK is shown on display, press and hold the▼button.If no LOCK is showing, remove and replace the batteries.
No sensation and LEADS alarm showing	TheUnicarehas a safety feature which will not allow the intensity to pass 20 mA if the machine detects a connection error. If a connection error is detected the intensity will return to 0 mA and the screen will flashLEADS. This safety feature will prevent the machine from giving an uncomfortable stimulation should the contact break between the machine and your skin. This will also prevent anyone from increasing the intensity to a high level without firm contact between the machine and the skin.A connection error can occur if:
	1. A break has developed within one of the two lead wires.	If this happens, you can try to test the unit by holding the probe in your hand:i) Dampen your hand with water and a little table salt. Squeeze the probe firmly and make sure your skin is covering the metal parts of the probe and carefully increase strength until you can feel something. Most people will start to feel the stimulation in their hand at around 25 mAii) If theLEADSalarm shows and the unit will not allow you to pass 20 mA. The leaf wires need to be replaced.
	If you have tried the test above and DO have sensation when the probe is in your hand, then it may be that:2. The skin is dry, meaning poor conductivity between the metal plates on the probe and your skin.	If this happens, you can try the below solutions:i) Using a water-based lubricant such as TensCare Go Gel (seeK-GO), which will improve conduction.ii) Crossing your legs and squeezing to increase pressure on the probe, which should improve the connection. If this enables you to use the unit, you should find that in a few weeks of stimulation the contact improves. If it does not, this unit may not be suitable for you. You may need to contact your healthcareprofessional to discuss other suitable options.iii) Optional probes and probe sizes are available. See accessories.
No sensation and no LEADS alarm showing	Intensity level is not high enough and/or reduced sensitivity in the area being treated.	i) Please make sure you are increasing the intensity high enough. Most people will start to feel the stimulation in their hand at around 25 mA and with the probe inserted you will need to increase the intensity higher to around 40 mA – 60 mA.Max power is 99 mA. Everyone is different so just keep increasing the intensity until you can feel it. The intensity increases in very small steps of 1 mA.ii) You may have reduced sensitivity due to previously damaged or desensitised pudendal nerves (this can happen in childbirth or some surgical procedures). Please consult your healthcare professional.
No sensation on one side of the probe (or electrode)	Position is not optimal – needs adjusting.	The current flows from one side of the probe to the other, so it is not possible to have one side “not working”. However, the strength of the sensation depends on how close to the nerve the current flows, and also in which direction it flows relative to the nerve. You can try slightly adjusting the position on the probe or exchanging the connection of the wires in the probe.
Sudden change in sensation	If you disconnect and reconnect a few minutes later, the signal will feel quite a lot stronger.	Always return strength to zero after disconnecting the lead or the probe.

The patient is an intended operator. There are no user-serviceable parts inside the unit, and no calibration is required.

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.

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/36683/attachments/1/translations/en/renditions/pdf

22. GENERAL SPECIFICATION

Waveform		Asymmetrical rectangular
Amplitude (> 500 Ohm load)		99.0 mA +/- 10%
Max intensity (across a load resistance of 500Ω)		50V zero to peak across 500ΩConstant voltage over 470-1500 OhmConstant current over 160-470 Ohm
Output plug		Fully shielded
Channels		Single channel
Battery		Built-in lithium-ion batteryModel: YJ 523450-1000MaHManufacturer: YJ Power Group LimitedRatings: 1000mAh, 3.7Wh, 3.7V
Weight		103g
Dimensions		120 x 60 x 20 mm
Safety Classification		Internal power source.
Software version		R1
Applied Part		Vaginal and anal electrodes. Optional skin surface electrode pads.
Environmental Specifications:
Operating:		Temperature range: 5 to 40°C(max temperature under applied part at 40°C is 41.5°C)Humidity: 15 to 90% RH non-condensingAtmospheric pressure: 700hPa to 1060hPa
Storage (≤ 3 month):		Temperature range: -10-+60°C (≤ 1 month)-10-+45°C (≤ 3 month)-10-+28°C (≤ 1 year)
		Humidity: 45 to 75% RH non-condensingAtmospheric pressure: 700hPa to 1060hPa
TYPE BFAPPLIED 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”
IP22		This medical device is not water resistant and should be protected from liquids.
		Complies with EU WEEE regulations

Contact duration: At least 10 minutes.

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 use.

PLEASE RETAIN THIS WARRANTY CARD.

RETURN THIS PORTION ONLY WHEN YOU RETURN YOUR PRODUCT FOR REPAIR UNDER WARRANTY.

NAME:

ADDRESS:

POSTCODE:

DAYTIME TELEPHONE: ____

E-MAIL:

MODEL:

DATE OF PURCHASE: ____

ATTACH PROOF OF PURCHASE

DO NOT SEND IN PROBE OR ELECTRODE PADS

RETAILERS NAME: ____

RETAILERS ADDRESS:

RETAILERS POSTCODE: ____

BRIEF DESCRIPTION OF PROBLEM YOU ARE EXPERIENCING: ____

WARRANTY IS VOID UNLESS THE ABOVE INFORMATION IS COMPLETED AND CORRECT.

Estimado cliente

Illustration of a human back with colored anatomical markers (no text or symbols)

Human back with two purple rectangular overlays on the spine (no text or symbols)

Assorted medical and health products including a Go Gel, blood glucose meter, and medical device (no visible text or symbols)

Line drawing of two hands holding a pen, no text or symbols present

Anatomical illustration of a human ear with surgical instrument placement (no text or labels)

Illustration of a handheld electronic device with a vertical measurement arrow (no text or symbols)

Simple line drawing of a human figure with no text or symbols

Simple line drawing of a human torso with a small dark oval object on the chest (no text or symbols)

Illustration of a human abdomen with two white oval markers on the lower abdomen (no text or symbols)

Illustration of a human abdomen with two hanging objects (no text or symbols)

Illustration of a human pelvis with two medical devices on the abdomen (no text or symbols)

Longmead Business Park,

Epsom, Surrey

KT19 9BE, UK

https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/en/renditions/pdf

22. ESPECIFICACIONES GENERALES

Illustration of a handheld device with a vertical arrow indicating measurement or direction (no text or symbols)

5. TYPES D'INCONTINENCE

Illustration of a human back with colored anatomical markers indicating different regions (no text or symbols present)

Human back with four circular markers on the shoulder area, no text or symbols present

Assorted medical and dental products including a glucose meter, a pink tablet, and a white package (no visible text or symbols)

13. INFORMATION SUR L'APPAREIL

13.1. COMMANDES & AFFICHAGE

Simple pink button with four circular buttons and a white outline, pointing right (no text or symbols)

Line drawing of two hands holding a small object, possibly a tool or component (no text or symbols)

Anatomical illustration of a human abdomen with a catheter and needle inserted (no text or labels)

Illustration of a handheld device with a curved handle and vertical arrow indicating upward motion (no text or symbols)

14.4. SESSION D'EXERCICES

Simple line drawing of a human figure with no text or symbols

Simple line drawing of a human torso with a small dark oval object on the chest (no text or symbols)

Illustration of a human abdomen with two white oval markers on the lower abdomen (no text or symbols)

Illustration of a human abdomen with two hanging objects (no text or symbols)

Illustration of a human pelvis with two medical devices on the lower abdomen (no text or symbols)

INFORMATIONS SUR LA GARANTIE PRODUIT

Longmead Business Park,

Epsom, Surrey

https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/en/renditions/pdf

22. CARACTERISTIQUES TECHNIQUES

Illustration of a handheld electronic device with a curved arm and vertical arrow indicating measurement (no text or symbols)

5. FORMEN

INKONTINENZ

DER

Illustration of a human back with colored rectangular overlays indicating different anatomical regions (no text or symbols)

weiterleiten.

Human back with purple circular markers on the spine (no text or symbols)

Assorted medical and health products including a glucose meter, earplifier, and medical kit (no visible text or symbols)

13. GERÄTEINFORMATION

Simple pink square button with a white outline and two circular dots, connected by a cable to the right (no text or symbols)

Line drawing of two hands holding a small object, possibly a tool or component (no text or symbols present)

Illustration of a handheld electronic device with a curved handle and vertical arrow indicating measurement (no text or symbols)

14.4. BEHANDLUNG

Simple line drawing of a human torso with a small dark object on the chest (no text or symbols)

Simple line drawing of a human torso with a rectangular object on the chest (no text or symbols)

Illustration of a human abdomen with two white rectangular markers on the lower abdomen (no text or symbols)

Illustration of a human abdomen with two hanging objects (no text or symbols)

Illustration of a human pelvis with two medical devices on the abdomen (no text or symbols)

Longmead Business Park,

Epsom, Surrey

KT19 9BE, UK

21. FEHLERBEHEBUNG

https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/en/renditions/pdf.

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

CE

2797

EC Declaration of Conformity

Tenscare Ltd herewith declare that the product meets the provisions of REGULATION (EU) 2017/745 which apply to it. The medical device has been assigned to class IIa according to Annex IV of the REGULATION (EU) 2017/745. The product concerned has been designed and manufactured under a quality management system according to Annex IX, of REGULATION (EU) 2017/745. This EU declaration of conformity is issued under the sole responsibility of the manufacturer. No “Common Specification” is applicable.

TensCare Ltd. 9 Blenheim Rd.

Epsom, Surrey, KT19 9BE, UK

[phone]

EC REP

Advena Ltd. Tower Business

Centre. 2nd Flr. Tower Street,

Swatar, BKR 4013, Malta

TensCare Europe BV