Elise 2 - Pain therapy device TensCare - Free user manual and instructions

USER MANUAL Elise 2 TensCare

Simple line drawing of a flag and a stylized object with a dark oval shape inside, no text or symbols present.

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

Regulate the output intensity with + and -

Medical illustration showing a human leg with a small dot and a digital device connected to a screen displaying P, T, and + symbols.

Connect the unit with the vaginal probe and insert the probe

Select the programme by pressing the button P

Thank you for choosing Elise 2. 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 and observe the information they contain.

Best regards,

Your TensCare Team

Contents

1. INTRODUCTION 6
2. INTENDED USE....6
3. ELISE 2 FEATURES ....6
4. PELVIC FLOOR EXERCISES 7

4.1. PELVIC FLOOR MUSCLES....7
4.2. PERFORMING PELVIC FLOOR EXERCISES 8

1. TYPES OF INCONTINENCE....9
2. HOW 'EMS' WORKS 9
3. CONTRAINDICATIONS, WARNINGS & CAUTIONS....10
4. INFORMATION ABOUT THE PROGRAMME SETTINGS 14
5. PROGRAMMES 14

9.1 PROGRAMME SETTINGS 14
9.2. PRESET PROGRAMMES 14

1. CONTENT 15
2. UNIT INFORMATION.... 16

11.1. CONTROLS & DISPLAY 16
11.2. OPERATING INSTRUCTIONS.... 17

1. SETTING UP AND USING THE ELISE 2....19

12.1. CHARGING THE BATTERY 19
12.2. CONNECTING LEAD WIRE 20
12.3. PREPARING FOR SESSION 20
12.4. TRAINING SESSION....21
12.5. AFTER YOUR TRAINING SESSION....23

1. ANAL PROBE 23

13.1. CONDITIONS THAT MAY BE TREATED....23
13.2. HOW TO INSERT THE ANAL PROBE 24

1. CLEANING 24

2. EMC 25

3. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE) 25

4. ACCESSORIES 25

5. WARRANTY....26
6. TROUBLESHOOTING 27
7. GENERAL SPECIFICATION....29

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 medica 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.
[2DBA]	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

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 Elise 2 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 Elise 2 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. The Elise 2 is very easy to use, with four clearly labelled pre-set training programmes and a simple push button control.

The Elise 2 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.

2. INTENDED USE

Elise 2 is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence 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.

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

3. ELISE 2 FEATURES

- Single Channel

Single channel unit provides relief from symptoms of all types of incontinence via a tampon-shaped probe.

• Comfortable Stimulation

Gentle, comfortable stimulation with small steps of intensity, 0.5mA per step.

• 4 Pre-set Programmes

Clinically tested programmes for all types of incontinence including STRESS, URGE, MIXED and a TONE aftercare programme.

- Treatment Timer

Unit defaults to 20 minutes treatment to ensure the pelvic floor muscle is not over-worked. The user can manually reset this to 10, 20, 30, 45, 60 or 90 minutes.

For the Urge programme the unit defaults to a C (Continuous) treatment session. This timer is ONLY available for the Urge programme.

- Open Circuit Detection

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

• Large Backlit Screen

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

- Memory

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

○ 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 on.

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 Elise 2 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.

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. 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. Elise 2 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). The oxygen supply to the muscle is improved.

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.

7. 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 in the first 6 weeks following a pelvic surgery or vaginal childbirth. 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.

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 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 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 Elise 2 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.

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 lead wires - risk of strangulation in infants.

Caution should be observed when using the Elise 2 at high strength settings. Prolonged use at high settings may cause muscle injury or tissue inflammation.

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.

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: Interconnect this device with other equipment may damage this device or unintended output may be delivered to end user.

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. When symptoms have gone, try resuming at a lower intensity setting.

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–+60°C, 15%-75% R.H. Temperature & Relative Humidity of transportation: -10°C–+60°C, 15%-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.

PROBE CAUTIONS:

Caution: The Elise 2 vaginal probe is intended for single patient use only. Do not share your Elise 2 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 Elise 2's muscle stimulation.

Caution: Do not use this device with vaginal probe or anal probe other than those recommended by the manufacturer in section 17. Electrodes with smaller surface area may cause tissue irritation.

DO NOT PLACE OPTIONAL 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.

ELECTRODE PADS CAUTION:

Caution: Do not ignore any allergic reaction to the electrode pads: If a skin irritation develops, stop use immediately, as this type of electrodes may not be suitable for you. Alternative electrode pads specially made for sensitive skin are available (see E-696-SS).

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.

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

Note: You may safely use the stimulator during menstruation, although it may be a little less able.

Note: EU Regulations require that any incident involving this

medical device that led or might have led to the death of a patient, serious deterioration of state of health of a patient, or a serious public health threat, should be reported immediately to the manufacturer, and to the Competent Authority in the Member State in which the user resides.

8. 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.

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

The Elise 2 unit has pulse widths of 200 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.

9. PROGRAMMES

9.1 PROGRAMME SETTINGS

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

9.2. PRESET PROGRAMMES

The Elise 2 has four pre-set programmes. One for each type of incontinence (stress, urge and mixed), and one for toning the pelvic floor muscles (TONE).

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.

The Mixed programme can ONLY be set to a 20-minute time session.

TONE:

Shown on the screen as: TONE

Once the pelvic floor muscles have been strengthened with Elise 2, 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.

10. CONTENT

The pack contains:

• 1 x Elise 2 continence stimulator unit
- 1 x Lead wire (L-ELGR)
• 1 x Short probe lead (L-VPCE)
• 1 x Liberty probe (X-VP)
• 1 x Li-ion battery BL-4B (B-BL4B)
- 1 x Battery Cover (X-EL2C)
- 1 x Charger (UK/EU)
(X-EL2CH1000MA)
- 1 x Storage pouch
- 1 x Manual instruction

Product display of medical and dental health products including a teal box, battery pack, and digital devices (no visible text or labels)

11.1. CONTROLS & DISPLAY

ON/OFF button Programme duration (min) Programme selected Strength selected (mA) Programme selector Strength down P T Elise2 Time selector

11.2. OPERATING INSTRUCTIONS

ON/OFF

To turn the unit on, press the ON/OFF button and hold for 3 to 5 seconds until the display shows.

To turn the unit off, press the ON/OFF button and hold for 3 to 5 seconds until the display stops.

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

During start up to stop the increase in strength at any time, press any key once.

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.

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 0.5 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.

The strength control buttons will not operate until the unit is properly connected to you (probe inserted correctly). Elise 2 detects a disconnection and automatically returns the strength to zero.

The unit has levels of strength from 0 to 99.0 mA in steps of 00.5 mA. 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.

PROGRAMME CONTROL

The button marked P is the programme control. The Elise 2

has four pre-set 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 P 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 marked T can be used to set the session duration.

When you switch the unit on, it is automatically set at 20 minutes.

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

You can set session times of 10, 20, 30, 45, 60 or 90 minutes with the T button. The C (Continuous) session timer is ONLY available for the Urge programme.

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

If you hold down this key for 3 to 5 seconds, you can pause the timer, allowing you to interrupt the treatment session, and resume it later. Return to main screen by pressing any other key.

LOW BATTERY

When the battery is running low, the word BATT 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.

LEADS ALARM

The Elise 2 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 20.0 mA, the unit will flash LEADS, bleep three times, and return the strength to 00.0 mA.

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 19 for more troubleshooting tips.

MEMORY

The Elise 2 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. To activate hold down the T and + buttons together for 3 to 5 seconds. The display will show the total duration of use in 10 minute intervals (where 1=10 minutes, 2=20 minutes etc.) and the average strength used.

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.

Time used in 10 minute intervals MEM 30.5 Average strength Elise 2

12. SETTING UP AND USING THE ELISE 2

12.1. CHARGING THE BATTERY

The Elise 2 is powered by a type BL4B rechargeable Li-ion battery. A power adaptor with an interchangeable plug is also included in the kit. The battery should need charging about once a month. The battery should last at least 15 hours at 50 mA, 300 s, 50 Hz. Unused batteries have a nominal shelf life of 1 year, but will usually last linger than this. To fully charge the battery it will take about 2 hours.

When the battery is running low, the word BATT 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.

Note: The device comes with the battery already inside.

Avoid removing the battery

cover on the back unless absolutely necessary. A replacement battery cover is required if the original cover is removed.

Warning: Use only the charger supplied. Use of other chargers could be hazardous and will negate the warranty.

To charge the battery:

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

The word "BATT" will appear on the charging display – that means the battery is being charged.

When the battery is charged, the word will change from "BATT" to "FULL".

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

Note: The device cannot be used while being charged.

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

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, in a pressurized container or in a microwave oven.

Do NOT immerse in water or sea water, or get wet.

Do NOT short-circuit.

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.

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

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.

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

12.2. CONNECTING LEAD WIRE

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

Close-up of a green medical device with a glucose meter and arrow indicator (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 small object, possibly a tool or component (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.

12.3. PREPARING FOR SESSION

1) Before using Elise 2, you will need to visit the toilet.
2) Clean the probe with an alcohol-free anti-bacterial wipe or with warm soapy water.
3) 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 Elise 2's muscle stimulation.

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

Warning: Ensure the Elise 2 is switched OFF before inserting the probe.

5) After wires are securely connected, insert the probe into the vagina, in the same way as a tampon, with the two silver plates side to side: one plate on left and the other on the right, until only the flange at the end is visible. The probe will naturally position itself with the widest part of the flange vertically. 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.

Medical illustration showing a human leg with a catheter connected to a digital blood glucose meter displaying P and T readings.

Note: The flange should not be inserted into the vagina and should remain outside of the at all times.

Flange

12.4. 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 four pre-set programmes. Details in section 9 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 00.0 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 Elise 2 at full power - 99.0 mA. The Elise 2's strength will go up at 0.5 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 Elise 2 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 Elise 2, 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 00.0 mA 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 above.

Simple line drawing of a human figure with 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.

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.

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

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

12.5. AFTER YOUR TRAINING SESSION

When the timer reaches 00.0 mA, your session is complete, and the unit turns off.

1) Check that the control unit is off. If it is not, hold down the ON/OFF button to switch off then remove the probe from your vagina by holding the positioning end rim and gently pulling outwards.
2) Wash and thoroughly dry the probe as per section 14 and return it to the storage pouch.
3) The Elise 2 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.

13. ANAL PROBE

13.1. CONDITIONS THAT MAY BE TREATED

An anal probe such as TensCare X-PR13 can be purchased. This probe can be used for urinary and faecal incontinence in both males and females.

This anal probe may be used to treat Urinary and Faecal Incontinence in a similar way to the vaginal probe. Because the stimulation cannot be restricted to one muscle group, and the mucosal tissue has different electrical characteristics, anal stimulation is less comfortable than vaginal.

You should consult your healthcare professional before starting treatment.

Faecal Incontinence

Faecal incontinence can be the result of weakened or poorly functioning anal sphincter muscles or damage to the nerves controlling them. The purpose is to re-educate the anal sphincter and other muscles of the pelvic floor to contract. The treatments aim to progress towards graduated active exercises, in order to improve pelvic floor muscles' strength and endurance and to regain function.

You may benefit from the Elise 2 if you either have no active anal sphincter contraction, or a weak or poorly sustained contraction. Use the STRES or TONE programmes. Intensity should be as strong as possible without being painful. When possible, try to contract the muscles at the same time as the Elise 2.

Post Prostatectomy Urinary Incontinence

Electrical stimulation has been found to help urinary incontinence in men after radical prostatectomy in some trials. Use the same programmes as for vaginal stimulation. Increase intensity in STRES, MIXED, or TONE programmes to the highest tolerable.

13.2. HOW TO INSERT THE ANAL PROBE

1) Before using Elise 2, you will need to visit the toilet.
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 Elise 2'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 Elise 2 is switched OFF before inserting the probe.

4) After wires are securely connected, insert the probe into the anus whilst 'bearing down' (as in the action of passing stool) to a comfortable limit until the base of the flange on the probe touches the anus. 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. It is recommended that the probe is inserted past the sphincter muscles of the anus, unless directed otherwise by a healthcare professional.

5) Anal probes with long electrodes (the metal part) that run up and down the length of the attachment should always be inserted with the metal parts facing hip-to-hip. Anal probes with circular electrodes (the metal part) should be inserted simply to the desired depth.

Note: Sometimes the wearing of tight fitting undergarments or a tight pair of jeans will help to keep the probe in place and maintain correct contact during the programme.

For Faecal incontinence, the aim is to stimulate the external sphincter and/or pubo-rectal muscle, so circular electrodes should be placed so that the external ring is just inside the sphincter.

For Urinary Stress incontinence, the aim is to stimulate the levator muscles and the probe should be inserted deeper.

14. 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 Elise 2 unit in water.
• Do not use any other cleaning solution.

15. 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 30cm (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.

16. 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.

17. ACCESSORIES

Expected Service Life

• The machine 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 to replace the lead wires regularly (about every 6 months).
• Replace the probe every 6 months to ensure hygiene.
• Optional electrode pads should last 12-20 applications, depending on skin condition and humidity.
• The battery should last about 15 hours of continuous use.

Replacement electrode pads 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-VP Liberty Vaginal Probe (28 mm dia.)

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

X-VPL Liberty Loop Vaginal Probe

X-PR13 Anal probe (19.6 mm dia.)

E-CM5050 Pack of 4 electrode pads (50x50 mm)

K-GO Go Gel Personal Water-based Lubricant

X-WIPES Pack of 30 wipes

L-ELGR Replacement lead wire

X-EL2CHM1000MA Charger (UK/EU)

X-EL2C Battery Cover

Note: from serial number: 0619071970 the "Elise" lead wires have been upgraded to comply with the latest IP22 safety regulations. These lead wires have green ends.

Caution: You should only use the probe supplied with the unit or the replacements above as performance may vary with other probes.

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

18. WARRANTY

This warranty refers to the unit only. It does not cover, electrode pads, battery, 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 31) 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 31):

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].

19. TROUBLESHOOTING

If your Elise 2 is not working properly, please check the following:

Problem	Possible causes	Solution
No display	Flat battery	Charge battery. See section 12.1.
	Damaged battery	Contact supplier.
Low battery display	Low battery.	Charge battery.
No sensation and LEADS alarm showing	The Elise 2 has a safety feature which will not allow the intensity to pass 20.0 mA if the machine detects a connection error. If a connection error is detected the intensity will return to 00.0 mA and the screen will flash LEADS. This safety feature will prevent the machine from giving any 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 tab salt. Squeeze the probe firmly and make sure your skin is covering the metal parts of the probe and carefully increase strength until yo can feel something. Most people will start tofeel the stimulation in their hand at around 25.0 mA.ii) If the LEADS alarm shows and the unit will not allow you to pass 20.0 mA. The lead 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 (see K-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 healthcare professional to discuss other suitable options.iii) The probe supplied with the unit has a 28 mm diameter. An optional 32 mm probe, part no. X-VPM, is available.
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 25.0 mA and with the probe inserted you will need to increase the intensity higher to around 40.0 mA – 60.0 mA. Max power is 99.0 mA. Everyone is different so just keep increasing the intensity until you can feel it. The intensity increases in very small steps of 00.5 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 re-connect 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, or to provide feedback, 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

20. GENERAL SPECIFICATION

Waveform	Asymmetrical rectangular
Amplitude (over 500 Ohm load)	99.0 mA +/- 10%
Max intensity	50V zero to peak across 500 Ω. Setting 0-99.0 mA in steps of 00.5 mA Constant voltage over 470-2000 Ohm Constant current over 160-470 Ohm OC cutout below 160 Ohm.
Max pulse energy	Total output limited to 25 μC per pulse
Output plug	Fully shielded: touch proof mini USB
Channels	Single channel
Battery	Rechargeable Li-ion battery Model: BL-4B Manufacturer: YJ Power Group Limited Ratings: 600 mAh, 2.22Wh, 3.7V
Battery life	At least 15 hours at 50 mA, 300 μs, 50Hz
Weight	90g
Dimensions	100 x 65 x 18 mm
Safety Classification	Internal power source. Designed for continuous use.

Environmental Specifications:

Operating:	Temperature range: 5 to 40°C
	Humidity: 15 to 90% RH non-condensing
	Atmospheric pressure: 700hPa to 1060hPa
Storage:	Temperature range: -10 to 60°C
	Humidity: 15% to 75% RH non-condensing
	Atmospheric pressure: 700hPa to 1060hPa
	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
Applied Part	Vaginal and anal electrodes. Optional skin surface electrode pads. See section 17.

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, LEADS OR ELECTRODE PADS

RETAILER'S NAME: ____

RETAILER'S ADDRESS: ____

RETAILER'S POSTCODE:

BRIEF DESCRIPTION OF PROBLEM YOU ARE EXPERIENCING:

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

Estimado cliente

Product display of Clue 2 medical devices including blood glucose meter, catheter, and storage case (no visible text or labels)

Close-up of a green medical device with a white body and a small plug, showing no visible text or symbols.

Medical illustration showing a human leg with a small dot and connected to a digital blood glucose meter displaying P and T.

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

Simple line drawing of a human torso with a small dark oval object on the chest (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

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

Product display of Ulce 2 medical products including a teal box, blood glucose meter, and digital meters (no visible text or labels)

11.1. COMMANDES & AFFICHAGE

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

Illustration of a human leg with a medical device connected to a digital display (no text or symbols present)

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

Simple line drawing of a human torso with a small dark object on the chest (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

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

Product display of a medical or dental kit with digital devices and a teal medical device (no visible text or symbols)

11. GERÄTEINFORMATION

Close-up of a green medical device with a white body and a small connector, showing no visible text or symbols.

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

Medical catheter device with metallic bulb and tubing, no visible text or symbols

Illustration of a human leg with a small dark object connected to a digital blood glucose meter (no text or symbols present)

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

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

INFORMATIONEN ZUR PRODUKTGARANTIE

Longmead Business Park,

Epsom, Surrey

KT19 9BE, UK

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

20. ALLGEMEINE SPEZIFIKATIONEN

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.

Distributed by:

TensCare Ltd

9 Blenheim Road, Epsom,

Surrey, KT19 9BE, UK

Tel: [phone]

www.tenscare.co.uk

EC

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Tower Business Centre,

2 ^nd Flr, Tower Street,

Swatar, BKR 4013,

Malta

TensCare Europe BV